Partnering with microbiologists to diagnose and prevent diseaseTM

About Us

Hardy Employees Banner

Our Mission

"We are committed to producing and distributing the finest products for the detection of microorganisms, as we partner with our laboratory customers to diagnose and prevent disease."

At Hardy Diagnostics, you’re not just a number. You’re not a figure on a graph in a quarterly report. At Hardy Diagnostics, you’re a partner. From laboratories that utilize our tests to diagnose illness, to our employee owners who ensure that every lot meets your rigorous expectations, Hardy Diagnostics is about a group of people coming together to better the world, one test at a time.

Hardy Diagnostics is a 100% employee-owned company that has been helping people live healthier lives for the last 39 years. Our microbiology products are used all over the world to diagnose and prevent disease.
The dedication and skill of the people who work here have resulted in remarkable success. Inc. Magazine has recognized us as one of the “Fastest Growing Private Companies in America” for six years. In addition, we are a “Fit Friendly” business as certified by the American Heart Association and a “Green Business” as certified by the County of Santa Barbara. In 39 years, Hardy Diagnostics has never had a year of declining sales or an unprofitable year.

Meet the Team

Hardy's History

  • Hardy Diagnostics is featured on Man. Marvels

    At Hardy Diagnostics, you will find a complete selection of laboratory and microbiology supplies for the clinical, industrial, and molecular biology labs.

    Hardy Diagnostics is a 100% employee-owned company that has been helping people live healthier lives since 1980. Our microbiology products are used all over the world to diagnose and prevent disease. The dedication and skill of the people who work here have resulted in remarkable success. Inc. Magazine has recognized us as one of the “Fastest Growing Private Companies in America” for six years. In addition, we are a “Fit Friendly” business as certified by the American Heart Association and a “Green Business” as certified by the County of Santa Barbara.

    www.hardydiagnostics.com

  • Sushi and Sashimi – Are They Safe to Consume?

    How can you be sure the bacteria and parasites are dead?

    In the United States, 62% of the population has tried sushi at least once. (1) However, recent studies from Norway and Brazil indicate that consumers should be checking that their sushi and sashimi were recently prepared and stored properly. To define our terms, many non-Japanese use the terms sashimi and sushi interchangeably, but the two dishes are distinct and separate. Sushi refers to any dish made with vinegared rice. While raw fish is one traditional sushi ingredient, many sushi dishes contain seafood that has been cooked, and others have no seafood at all. Sashimi by contrast, consists of raw fish or meat and is always served on its own.

    Sushi and sashimi are a complex meal to prepare and distribute due to the nature of multiple lightly prepared vegetables and raw meats, which may harbor various pathogens. Furthermore, they often have strict storage temperature requirements and a short shelf life, which further adds to the complexity. Additionally, they are typically prepared by hand, which could lead to unintentional pathogen contamination risk due to improper hand hygiene by the chef. The use of raw or uncooked meats is especially risky, because their use may lead to an increased risk of foodborne illness due to common food pathogens such as Salmonella, Listeria,AeromonasVibrio parahaemolyticus and parasites especially the fish tapeworm, Diphyllobothrium latum. (2, 5)

    Even though freezing will kill parasites, it won’t kill bacteria. Those who prepare fish should be aware that cooking at a temperature of only 55°C for 5 minutes will kill the larvae; if consuming raw fish, freezing to − 20°C for 7 days, or flash freezing to − 35°C for 15 hours, as long as the flesh is less than 15cm thick, effectively kills the larvae also. Sushi and sashimi chefs should use only fish frozen in this way. While these freezing protocols are the standards required by public health regulations, they are not easy for public health inspectors to verify.(6) The x-ray shown above is from a Chinese man who regularly consumed raw improperly prepared fish and complained of itching and abdominal pain. His body was infected with hundreds of fish tapeworms. (5)

    In a study conducted in Norway by Hoel et al., various types of pre-made ready-to-eat (RTE) sushi were analyzed and a multitude of bacteria were discovered.(2) After microbial analysis, approximately half of the 58 sushi samples analyzed were considered unsatisfactory for consumers with >6 log CFU/g. The distributors prepared the meals for distribution and products were sold within 2-3 days. This study determined that poor temperature control during distribution from the preparation sites to the stores led to increased microorganism concentrations.

    In Brazil, a study was conducted by Gomes et al. to determine the microbiological quality of sushi and sashimi in the Federal District.(3) In this study, 27 samples of sashimi and sushi were collected and analyzed for various microorganisms. Overall, 40.7% of the sashimi samples and 25.9% of the sushi samples were deemed unfit for consumption based on food safety guidelines in Brazil. The study concluded that the ingredients must be of very high quality in order to produce RTE foods with a low concentration of microorganisms. Since sushi and sashimi are prepared manually with raw ingredients and no heat processing, hygienic preparation is extremely important.

    At the grocery store, sell by dates and prepared by dates can be observed on sushi and sashimi boxes. If sushi or sashimi is consumed immediately after preparation, then it is more likely to be safe. If it is not consumed immediately, it should be stored at refrigerated temperatures.(4) These studies support that with good preparation practices by the producers, more temperature controlled transportation implemented by distributors, and due diligence by consumers to ensure the sushi is freshly prepared, people are more likely to avoid contracting foodborne illness.

    by Anna Klavins
    Performance Studies Supervisor
    Works Cited: 123456

  • What’s all the hyphae about?: Sustainable fungi-based plastic alternatives

    Plastic is invaluable to the scientific community from Petri plates to syringes and almost everything in between. Scientific research alone accounts for approximately 1.8% of global plastic production.(1) With the COVID-19 pandemic the need of the scientific community is increasing due to the increased need for plastic used for PPE, plastic tubes, pipets, etc.(2) While plastic use is vital for many applications, about 91% of all plastic isn’t recycled.(3) It is cheaper and faster to make more plastic than to use recycled materials. With the added hazards associated with plastics used in various scientific and medical applications, recycling plastic in the sciences is more challenging, expensive, and therefore more limited.(4)

    While alternatives to plastic cups and cutlery are increasingly available, replacing single-use items in a laboratory or healthcare setting is more challenging. One plastic alternative comes from the lab in the form of filamentous fungi.

    Fungi, more specifically their hyphae, can provide an alternative to reduce overall plastic consumption while also reducing energy usage and carbon dioxide production associated with plastic production.(5)
    A fungi-based plastic alternative “foam” is created by first inoculating a matrix of agricultural wastes with fungal spores. These spores germinate and are allowed to grow at the optimal conditions for the specific organism. The mycelial network develops within a shaped form that “molds” the fungi into a specific shape. The form also prevents the development of a fruiting body which allows for the formation of more mycelia.

    Figure 2: Ecovative in New York is producing packaging materials made from fungal mycelia in order to replace Styrofoam.

    In the future, living fungi could even become our wearable technology and reduce e-waste in addition to plastics.

    Figure 3: Pycnoporus cinnabarinus is a fungus often used for fungal molding.
    It has the added advantage of offering color without adding dyes.

    The process is somewhat similar to using injection and similar molds with inorganic materials. This fungal growth takes about a week to complete.(6, 7) After the mycelia have taken shape, the fungi mixture is heated and dried to stop the growth by killing the fungi.(8) The resulting foam is fairly inexpensive and hardy like plastics but biodegradable in soil within 45 days.

    Thermal insulation and water resistance make this material ideal for packaging. The foam-like properties can help absorb impact and different forms can be customized to fit a variety of products, cutting down on the need for plastic-based options.

    Figure 1: A handbag made from fungal leather from Bolt Threads

    The applications don’t end there as mycelia building materials, insulation, “un-leather,”
    meat alternatives, soundproofing, and more are already on the market(10). Even Adidas has incorporated mushroom-based materials into a line of shoes.(8, 9)

    Figure 4: The Nat-2 shoe is made in Germany of fungi derived leather.

    For instance, it takes 2,500 liters of water, fertilizer, and pesticides to create one cotton T shirt. A fungal alternative takes only 12 liters of water.

    Figure 5: Mycotex is made 100% from fungal mycelia and is produced in the Netherlands.

    While fungi foam can’t currently take the place of many of the plastics used in the sciences, the technology is still fairly new and new applications could replace more single use plastics.
    For now, reducing our plastic consumption and replacing it with renewable and sustainable fungi can make a big difference to our environment.

    By Lauren Hamilton
    Technical Services Microbiologist II
    HARDY DIAGNOSTICS

    Works Cited:

    1. https://www.sciencedaily.com/releases/2015/12/151223221353.htm
    2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7726519/
    3. https://www.epa.gov/facts-and-figures-about-materials-waste-and-recycling/plastics-material-specific-data
    4. https://reader.elsevier.com/reader/sd/pii/S2542504821000348?token=D215208256797DD49B27110A579F5DD0D6545272A15C94FE0BB67CADA92CA3D3DD69F861FC4EC75543B18AF53CE18942&originRegion=us-east-1&originCreation=20211029223809
    5. https://www.researchgate.net/publication/336146038_Mushroom_Packages_An_Ecovative_Approach_in_Packaging_Industry
    6. https://blogs.scientificamerican.com/observations/the-mycelium-revolution-is-upon-us/
    7. https://matmatch.com/resources/blog/mycelium-using-mushrooms-to-make-packaging-materials/#:~:text=There%20are%20also%20many%20applicable,textiles%2C%20clothing%2C%20and%20shoes.
    8. https://undecidedmf.com/episodes/is-fungus-the-plastic-of-the-future
    9. https://www.adidas.com/us/blog/663481-stan-smith-mylotm-made-using-mushrooms
    10. https://insights.globalspec.com/article/14950/fungi-based-leather-could-be-the-most-sustainable-leather-option
    Figure 6: Even furniture can be constructed with fungal materials, by bioMASON.
  • The Tick-Borne Powassan Virus

    More deadly than Lyme Disease…

    In 1958, a five-year-old boy from Powassan, Ontario, Canada presented to a children’s hospital complaining of dizziness; his parents also described tremors of his left arm. Electroencephalogram readings showed a widespread disturbance in the patient’s brain. The patient’s condition began to rapidly decline, and within six days he died.

    Portions of the patient’s brain were prepared into suspensions and inoculated into mice. A new virus was isolated from the brains of the inoculated mice and was designated as the Powassan Virus, after the patient’s hometown.(1)

    Today, we know Powassan virus is a rare Flavivirus that utilizes multiple species of ticks as vectors. In the United States, Powassan virus is endemic to the northeastern states and the Great Lakes region.(2) The true geographic distribution of Powassan virus is not well known due to underdiagnoses of human cases. However, cases have been reported as far west as California.

    According to the CDC, approximately one in ten cases of severe Powassan virus infection are fatal. Infection with Powassan virus has been shown to occur in as little as 15 minutes after a tick bite.(3) The virus can cause severe symptoms including confusion, loss of coordination, and seizures.(4) Although some infections are asymptomatic, the disease often progresses rapidly into encephalitis or meningitis that is far worse than Lyme Disease.

    From 1999 to 2016, only 98 cases of Powassan virus were reported—however, some experts believe the virus may be encountered with higher frequency due to ecological changes.(3) In the past, Powassan virus typically infected a species of tick that was not widely reported to bite humans. Recently, the virus infects the deer tick, which more commonly bites humans. The deer tick has a wide geographic distribution, increasing the chance of infection for much of the population.

    “The Powassan virus is rarely diagnosed as a cause of encephalitis, however when it is, Powassan encephalitis is severe, and neurologic sequelae are common. Powassan encephalitis has symptoms that are compatible with acute disseminated encephalomyelitis, oftentimes making it difficult to diagnose. Powassan virus encephalitis is a challenge to diagnose because there are only a few laboratories that offer testing, the most effective being serologic testing.(6)

    Prevention of Powassan virus is crucial because no treatment exists, and availability of testing is scarce.(3) The CDC recommends using common insecticides such as DEET and checking for tick bites after exploring potentially infested areas.(5) Next time you take a trip outdoors, remember to factor in protection from tick bites; these vectors for disease can be much more than just a nuisance.

    By Manuel Escalera
    Performance Studies Technician
    HARDY DIAGNOSTICS

    References: 1, 23456

  • The COVID-19 Vaccines

    What are the differences and will they work?

    COVID-19 has dominated our lives for the better part of a year and yet we are left with more questions than we are answers. One of these questions most frequently brought up is how long will the antibodies be effective after a vaccination is given?
    IgG is a specific type of antibody that the human body keeps on call in case it encounters a future infection by the same pathogen. IgG antibodies stay in the bloodstream long-term, potentially lifelong, to prevent reinfection by
    repeat pathogens. However, not every IgG antibody will remain effective forever, and immunity can eventually wan or be lost entirely.(1)
    There are currently three vaccine manufacturing candidates in the running to be the first approved COVID-19 vaccine, with Moderna, University of Oxford (AstraZenecaOxford), and Pfizer-BioNTech all developing one of these viable options.(4)

    THE MODERNA VACCINE

    Moderna’s COVID-19 vaccine uses messenger RNA, or mRNA, which is showing efficacy of over 95% in early clinical trials. The mRNA codes for the spike protein of the virus and uses our cells own protein synthesis apparatus to create multiple copies that our bodies can recognize and form antibodies against (see diagram below). The Pfizer vaccine also uses
    mRNA. Moderna is expected to have over 20 million doses available to ship by the end of the 2020 calendar year.(5) Moderna’s claims regarding side effects indicate a lack of serious risk, including fatigue, muscle and joint pain, and headache.(8)

    THE ASTRAZENECA VACCINE

    Data on the AstraZeneca-Oxford vaccine shows only 62% effectiveness with its two dose regimen, though claims of lower costs hope to offset the lower protection rates.(6) Recent data for this vaccine seem to be lowering its validity in the American market due to risky side effects, including a report of transverse myelitits, an inflammatory disorder of the spinal cord.(9) Oddly enough, an error in the clinical trials led to a serendipitous finding. When only a half dose of the initial injection was mistakenly given, the efficacy shot up to 90%.(12)

    THE PFIZER VACCINE

    In a recent New York Times article, PfizerBioNTech also claimed its vaccine is 95% effective and shows no serious side effects, only low percentages of fatigue and headache. Pfizer hopes to receive EUA (Emergency Use Authorization) within a matter of days, placing itself as a frontrunner in terms of distribution scheduling.(7) However, Pfizer currently has stringent limitations regarding temperature controls for its vaccine distribution. Its shelf life is only five days in a regular -20 deg C freezer.(8) Long term storage must be carried out in a -70 deg C ultra-low freezer.

    Most of what we know in regard to COVID-19 and its relationship with IgG has been determined from other, previous Coronavirus infections. The main conclusions drawn from previous Coronaviridae viral family studies remain cautiously optimistic. However, immediately following infection or
    vaccination, antibody concentrations have been found to decrease over time resulting in a greater risk for re-infection, especially in mild cases of infection. This suggests that multiple rounds of vaccine therapy may be necessary to keep Coronavirus IgG antibodies boosted to the level they can prevent a serious infection.(2)(3)

    As for how long the vaccines will offer protection; that is not yet known and will take time to make that determination. Another possible reason for vaccine failure would be if the virus mutates in such a way to decrease the efficacy of the vaccine.

    The human immune system is a vast and complex set of machinery, and COVID-19 is proving to be quite an opponent. As vaccines begin to become more widely available, it looks hopeful that we will have the tools to win this drawn-out war against an invisible enemy, especially with this competitive race to the vaccination finish line.

    Authored by Lo Johnson

    References:

    (1) 2018 review performed by Mary M. Mary, PhD, DABCC, FACC, Global
    Medical and Scientific Affairs, Beckman Coulter, 16-NOV-2020.

    (2) Sariol, A, Perlman, S. (2020). Lessons for COVID-19 Immunity from Other
    Coronavirus Infections. Elsevier Public Health Emergency Collection, 53(2), 248-263.

    (3) Fact Sheet for Healthcare Providers qSARS-CoV-2 IgG/IgM Rapid Test – Cellex Inc.. 16-NOV-2020

    (4) Craven, J. (Nov 2020). COVID-19 vaccine tracker. Regulatory Affairs
    Professionals Society. Retrieved from https://www.raps.org/news-andarticles/news-articles/2020/3/covid-19- vaccine-tracker

    (5) Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy
    Endpoint in the First Interim Analysis of the Phase 3 COVE Study [moderna]
    (2020). Retreived from https://investors.modernatx.com/node/10316/pdf. 23-NOV-2020.

    (6) Gallagher, J. Covid-19: Oxford University vaccine is highly effective.
    BBC News. (Nov 2020). Retrieved from https://www.bbc.com/news/health55040635.

    (7) Thomas, K. (Nov 2020). New Pfizer Results: Coronavirus Vaccine is Safe
    and 95% Effective. The New York Times.

    (8) Wadman, M. (Nov 2020). Public needs to prep for vaccine side effects.
    Science Mag, 370(6520), 1022.

    (9) Allen, A, Szabo, L. (Sep 2020). NIH ‘very concerned’ about serious side
    effect in coronavirus vaccine trial. Fierce Pharma. Retrieved from
    https://www.fiercepharma.com/vaccines/nih-very-concerned-about-seriousside-effect-coronavirus-vaccine-trial

    (10) About the Oxford COVID-19 vaccine. (JUL 2020) University of Oxford. 23-JUL-2020

    (11)Cao, S. Covid-19 Vaccine Prices Revealed from Pfizer, Moderna, and
    AztraZeneca. Observer. (Nov 2020).

    (12) https://www.healthline.com/healthnews/what-to-know-about-theastrazeneca-vaccine-controversy

  • A Caffeinated Conundrum

    Coffee drinkers beware…

    Does coffee lead to increased risk of dementia and stroke?

    Moderation is best!

    Coffee, with over 22 billion pounds consumed annually, is without a doubt one of the most popular drinks worldwide. (1) Many of us wake up each morning and seek energy from this bitter bean as it provides a high source of caffeine. Coffee is low in calories, high in potassium, and very high in antioxidants. Is this a super drink? Perhaps a miracle elixir? Research indicates that there are key advantages and disadvantages for those who consume this brewed beverage.

    Coffee’s appeal comes from the popular psychoactive stimulant caffeine, which works by antagonizing the A1 and A2A receptors in the brain.(2) This causes stimulation of the central nervous system and ultimately leads to a boost of energy.

    In a study led by Ricardo Magalhaes et al, researchers examined human brain networks using functional magnetic resonance imaging (fMRI) on volunteers who consumed or did not consume coffee. After examining the neural networks of the volunteers, the researchers’ data showed decreased functional connectivity of the cerebellar, subcortical and motor cortex regions of the brain. A decreased functional connectivity demonstrated a higher overall efficiency due to a reduced inter-regional dependence. (2)

    Not all data supports the health benefits of habitual coffee drinking. A study conducted by the University of South Australia demonstrated a connection between overconsumption (more than six cups per day) of coffee and increased probability of developing dementia. Researchers gathered 398,646 participants between the ages of 37-73 and grouped them by their coffee consumption frequency. Pre-existing medical conditions were screened via a background check and MRI of the brain. An MRI was repeated 4-6 years after the initial assessment in order to evaluate brain volume changes. After covariate adjustment, the data showed that people who consumed greater than six cups of coffee per day demonstrated a reduction in brain volume, a 53% increased probability of developing dementia, and a 0-37% increased association of stroke compared to participants that consumed 1-2 cups per day. (3)

    Based on these studies, the evidence suggests coffee can have both positive and negative effects. Light to moderate consumption (1-5 cups) provides acceptable stimulation to the body. Low-dose caffeine usage displays a lower functional connectivity in segregated brain regions and an overall increase in efficiency.(2) New data, however, suggests a correlation between heavy consumption (more than 6 cups per day) and shrinkage of the brain with increased probability of dementia and strokes. (3) The main takeaway here is that moderation is key for anything and further data may provide definitive causal analysis on this popular morning beverage.

    By Miles Amby

    Research Microbiologist, Hardy Diagnostics

    References: 123

  • The Nipah Virus…

    Another Emerging Virus With a Very High Mortality Rate

    Originates from bats

    The Nipah virus (NiV) is a zoonotic virus of the genus Henipavirus, family Paramyxoviridae, and has been identified as a biosafety level-4 pathogen with a 40-75% fatality rate. The virus was first discovered in 1999 following a Malaysian outbreak among pig farmers which resulted in nearly 300 human cases and more than 100 deaths.(1) Given the virus’ genetic relation to Hendra virus, a rare bat-borne zoonotic disease, the fruit bat (genus Pteropus) was quickly identified as the host reservoir of NiV. This puts many South and Southeast Asian countries at risk for potential outbreaks.

    Humans are mainly exposed to NiV from infected fruit bats that pass the virus to farm animals. In countries like Bangladesh and India, consumption of fruit that has been contaminated with fruit bat urine or saliva has also been a main source of infection. Direct human to human transmission is also possible, usually with healthcare workers and family members of the infected. The symptoms of NiV infection in humans ranges from asymptomatic to acute respiratory infection or fatal encephalitis. Signs of NiV can include labored breathing, fever, cough, and headache. Severe cases can usually lead to seizures, which can progress to a coma within 24 to 48 hours.(2) The nonspecific initial symptoms of NiV make it difficult for accurate diagnosis and control measures. During the acute phase of the disease, real time polymerase chain reaction (RT-PCR) and antibody detection via enzyme-linked immunosorbent assay (ELISA) can be used to diagnose NiV.(3)

    There are currently no approved vaccines or specific drugs designed to cure or prevent the Nipah virus infection. The main treatment for those with severe NiV cases is supportive care. Human-to-human transmission in this context is a concern, especially for exposed healthcare workers. The only way to prevent infection and transmission is to employ effective education strategies about reducing the risk of exposure to NiV. As of July 2022, the National Institute of Allergy and Infectious Diseases (NIAID) launched an early-stage clinical trial for a NiV mRNA vaccine.(4) This is the first clinical trial using the NIAID’s Pandemic Preparedness Plan approach, which prioritizes research on prototype pathogens and viruses with pandemic potential.

    The World Health Organization (WHO) is supporting at risk countries by offering guidance for preventing and managing outbreaks.(2) If feasible, all bats must be kept away from fresh fruit products and sap collection sites. When this is not feasible, stopping consumption of specific fruits or fruit sap altogether, or washing and peeling all fruits potentially contaminated with fruit bat urine or saliva is recommended. To reduce animal-to-human transmission, protective attire should be worn when handling sick animals and animal premises should be quarantined as soon as signs of infection are detected. WHO recommends avoiding close physical contact with NiV infected patients and washing hands often. The high fatality rate of the Nipah virus has garnered attention from WHO as a priority disease and there will likely be additional research needed to generate better treatments and prevention methods.

    References: 1, 2, 34

    by Anna Klavins and Taylor Slouka

    R&D Department

    Hardy Diagnostics

  • A New and Better Way? Novavax COVID-19 Vaccine

    Effective vaccinations for COVID-19 have been readily available in the United States for well over a year and a new vaccine has just been added to the arsenal. Novavax (NVX-CoV2373), created by a company of the same name, was granted emergency use authorization in early July and has now been endorsed by the CDC.(2) Novavax is approved for adults who are 18 years and older and currently is limited to those who have not yet received a COVID-19 vaccine. Novavax is a two-dose primary series with each shot typically administered three weeks apart.(1)

    Novavax operates through a different mechanism compared to the current vaccines, Moderna, Pfizer, and Johnson & Johnson. The Moderna and Pfizer vaccines utilize mRNA technology to transport genetic instructions for making copies of the SARS-CoV-2 spike protein inside of the body. Johnson & Johnson also provides the same genetic instruction, but instead of mRNA, the J&J vaccine utilizes a disabled adenovirus for transport. Once the body detects copies of the spike protein, an immune response will be triggered.(3)

    Alternatively, Novavax is a protein-based vaccine that uses traditional technology that is similar to the influenza and shingles vaccines.(4) With Novavax, copies of the SARS-CoV-2 spike protein are grown in a lab from moth cells that are infected with a viral transmitter, packaged within nanoparticles, and injected intramuscularly. These packaged spike proteins resemble the SARS-CoV-2 virus. To assist the body in provoking an immune response, Novavax contains an adjuvant made from soapbark tree extract.(5) Potential side effects of Novavax include chills, headache, fever, and tiredness.(1) Instances of pericarditis and myocarditis are rare.(4)

    Protein-based vaccinations have been a well-understood technology for many years and medical experts are hopeful that Novavax may ease some vaccine hesitancy in some people.(3) Studies done in both Mexico and United States show an efficacy of 90% after two doses for mild, moderate, or severe COVID-19.(2) While Novavax may not surpass the efficacy of the mRNA vaccines currently available, Novavax has the added benefit of being easier to ship and store. The downside to Novavax is that producing and purifying protein for the vaccine means manufacturing costs are much higher.(4)

    Officials from the CDC stressed that a booster will need to be cleared for use around five months after Novavax recipients receive their second dose. The United States currently has 3.2 million doses on order and the first vaccines are expected to be available at US pharmacies during the end of July or the beginning of August.(3)

    References: 1, 234, 5

    by Alexandra Lopez

    Business Development

    Hardy Diagnostics

  • The Rising Resistance of Group B Strep and Group A Strep

    Group A Streptococcus (GAS) is the most common bacterial cause of pharyngitis, often referred to as strep throat. GAS can also cause severe invasive infections. People who are elderly, have skin breakdown (when the skin is deprived of blood flow, the skin can become damaged or develop ulcers), or have chronic medical conditions, such as diabetes, are at increased risk. Each year in the United States, GAS causes approximately one to 2.6 million cases of strep throat, 12,500 to 20,000 invasive infections, and 1,250 to 1,900 deaths.

    Strep throat is treated using antibiotics, typically penicillin and amoxicillin. (1) Currently, GAS is not resistant to penicillin or amoxicillin. However, doctors often use erythromycin and azithromycin to treat strep throat, particularly for people who are allergic to penicillin. Clindamycin, in combination with penicillin, is the recommended treatment for severe, life threatening GAS infections such as flesh-eating disease and streptococcal toxic shock syndrome. However, GAS infections have developed increased resistance to erythromycin and other macrolides, as well as to clindamycin. In fact, the percent of invasive GAS infections that are resistant to erythromycin has nearly tripled in eight years. In the six years between the CDC’s first Antibiotic Resistance (AR) Threats Report in 2013 to the latest AR Threats Report in 2019, GAS infections increased by 4100 while deaths increased by 290. (2) Due to this rise in resistance, in 2019, the CDC raised the treatment level of GAS to “CONCERNING.”

    Not only did the CDC add GAS to its list of 2019 AR Threats Report, but it has also added Group B Streptococcus (GBS) to the list, designating the bacteria also as “CONCERNING.” Overall, about 31,000 severe GBS infections occurred in 2016, causing 1,700 deaths. GBS causes severe illnesses—including bloodstream infections, pneumonia, meningitis, and skin infections—in people of all ages. In adults, GBS causes infections among pregnant women, older adults, and people with certain medical conditions, such as diabetes. About one in every four pregnant women carry GBS bacteria in their body. Mothers can pass GBS to their infants during labor, threatening newborns with sepsis during the first week of life. When indicated, practitioners give mothers antibiotics, often penicillin or ampicillin, during labor to protect their newborns from GBS disease. Clindamycin is recommended when a mother has a severe penicillin allergy. Clindamycin can also be used to treat adult GBS infections if the patient has a severe penicillin allergy. However, clindamycin-resistant GBS account for more than 40% of infections and resistance to erythromycin is even more common—more than 50%. This seriously limits options for GBS disease prevention and treatment. (2) 

    More than 2.8 million antibiotic-resistant infections occur in the United States each year, and more than 35,000 people die as a result. Antibiotic resistance disproportionately affects the most vulnerable—the young, elderly, and sick—who often receive medical care. While the development of new treatments is one of these key actions, the CDC, One World, and other infection prevention networks worldwide, urge new treatment options as well as the use of vaccines to prevent infections from occurring. 

    While these agencies work towards new options, Hardy Diagnostics continues to innovate and create quality products aimed toward the detection of the microorganisms causing such infections. 

    HardyCHROM Group A Strep Agar

    Hardy Diagnostics recently released its HardyCHROM™ Group A Strep agar (Cat. No. G337, 15x100mm plate, pack/10), a chromogenic medium recommended for the selective cultivation and differentiation of Group A Streptococcus from clinical specimens. Identification can be made based on colony color. The medium will display red-brown or red-orange colonies when Streptococcus pyogenes is present; non-Group A Streptococcus isolates will appear as blue, clear, or white colonies (shown in photo below). Detection is enhanced by the white background.

    Carrot Broth, One Step

    Hardy Diagnostic’s breakthrough patented Carrot Broth™ One Step (Cat. No. z40, 13x100mm tubes, pack/20), with its unique chromogenic reaction, turns orange when positive for beta-hemolytic GBS. Positive results do not require additional work ups. Hardy Diagnostics GBS Detect™ plate can be used in combination with Carrot Broth to identify all strains of GBC, hemolytic and non-hemolytic. Any negatives in Carrot Broth can be sub-cultured to GBS Detect and non-hemolytic GBC will be able to be identified on the plate. 

    By Megan Roesner

    Clinical Marketing Coordinator

    Works Cited: 12345

  • Human Metapneumovirus

    Another respiratory virus of concern. Common, yet underdiagnosed…

    Every year we anticipate the rounds of respiratory syncytial virus (RSV), influenza, and now Covid-19; but there is a lesser-known culprit of seasonal respiratory infections.

    Human metapneumovirus (HMPV) is a negative-sense single-stranded virus from the family Pneumoviridae and the second most common cause of lower respiratory infection in young children, after RSV.(1) HMPV is a newly discovered virus, first detected in 2001 by scientists in the Netherlands.(2) Genetic analysis shows that HMPV is most similar to type C of avian metapneumovirus. Based on Bayesian estimates, human metapneumovirus may have emerged 119-133 years ago, diverting from avian metapneumovirus around 1800.(1)

    Human metapneumovirus follows a seasonal pattern similar to RSV and influenza, occurring during late winter through spring. Serologic studies indicate that worldwide, all children are exposed to HMPV by the age of five.(1) The risk of severe disease is highest in immunocompromised individuals, premature infants, and adults older than 65. The virus does its damage by infecting airway epithelial cells. Symptoms of HMPV include cough, nasal congestion, fever, and shortness of breath. These symptoms can progress to pneumonia or bronchitis in severe cases. HMPV infections can be confirmed with PCR assays or detection of viral antigens in respiratory secretions using immunofluorescence or enzyme immunoassay.(3)

    There is currently no treatment for human metapneumovirus other than supportive care for symptoms, but the illness usually clears up on its own in healthy individuals. Over-the-counter medications such as ibuprofen, acetaminophen, and decongestants may be used for any fever or discomfort. Inhaled corticosteroids may be prescribed to patients with severe cases of HMPV.(2) Moderna is currently in Phase 1 of clinical trials for an HMPV vaccine. Early results show that the vaccine is well tolerated at all dose levels after two months, and that the vaccine provokes an immune response that boosts production of neutralizing antibodies.(4)

    The spread of HMPV is facilitated by close personal contact, coughing, sneezing, or touching of the mouth, eyes, or nose after contact with a contaminated surface. The CDC recommends washing hands often, avoiding touching the face, and avoiding contact with sick individuals. Those experiencing symptoms should cover their mouth and nose when sneezing or coughing, avoid sharing cups and utensils with others, wash their hands frequently, and stay home.(3) Lastly, during winter and spring, healthcare professionals should consider the likelihood of an HMPV infection and test accordingly.

    By Alexandra Lopez

    Business development associate

    References: 1234

  • 2022

    Hardy Diagnostics receives 3 awards in June:
    1. “Best Employee Owned Company” of the Pacific Coast
    2. “Business of the Month” in Santa Maria
    3. “Best Places to Work” in the Central Coast

  • What’s Behind the Baby Formula Shortage?

    Many parents in the United States are reeling from the effects of an outbreak of Cronobacter sakazakii in powdered infant formula. Between September 2021 and January 2022, four cases of Cronobacter infections in infants were reported to the FDA. In each case, the infants were fed powdered formula from Abbott Nutrition.(1)

    Cronobacter sakazakii (formerly genus: Enterobacter) is an opportunistic Gram-negative, rod-shaped pathogen that can tolerate a wide range of temperatures and persist in dry environments, known as xerotolerance.(4) Symptoms of infection include irritability, poor feeding, temperature changes, abnormal body movements, grunting breaths, and jaundice. Severe infections can lead to sepsis and meningitis.(3) The chance of developing meningitis is highest in infants that are two months old or younger.(2) The bacterium is ubiquitous, being isolated from a range of environments and foods; the majority of Cronobacter cases occur in the adult population. However it is the association with intrinsically or extrinsically contaminated powdered formula which has attracted the main attention. 

    After two infant deaths, Abbott voluntarily recalled multiple lots of powered formula produced in their Sturgis, Michigan plant. Similac Sensitive, Similac Pro-total Comfort, Similac Advance, and Similac PM 60/40 were all implicated.(2) Using whole genome sequencing, an initial comparison of patient and environmental samples from the Michigan plant revealed that the identified strains of Cronobacter were not closely related. Additional sample analysis is still ongoing.(2)

    Abbott is the largest manufacturer of infant formula in the United States. In addition to disruptions in the supply chain and limited formula suppliers, the temporary closure of Abbott’s Michigan plant, which is also their largest, has exacerbated the formula shortage. Many parents have been met with empty shelves or tight limits on purchases.(5) On May 18th, President Biden invoked the Defense Production Act to increase the domestic production of infant formula. Biden also authorized the Defense Department to import thousands of pounds of formula from overseas.(6)

    The FDA recently reached an agreement with Abbott to reopen the Michigan plant in the first week of June. Abbott estimates an eight to ten week lead time for new formula to be produced.(6) Infant formula should not be diluted and caretakers should never attempt to make their own formula. Do not purchase imported formula online due to the risk of counterfeit products.(3) ) If your regular formula is unavailable, contact your baby’s healthcare provider for assistance or visit healthychildren.org for more information.(7) The CDC encourages individuals to report any diagnosed Cronobacter infections to local or state health departments.(2)

    Early identification of Cronobacter sakazakii is important to avoid additional infant infections from powdered formula. Hardy Diagnostic offers HardyCHROM™ sakazakii for the selective isolation and differentiation of Cronobacter sakazakii. This chromogenic medium provides easy identification of colonies of Cronobacter sakazakii, which appear smooth and blue-green as seen in the photo below.

    References: 1, 2, 3, 4, 5, 6

  • 2022

    The R&D microbiologists at Hardy Diagnostics present four research posters at the National ASM Convention in Washington DC in June after a long hiatus due to the pandemic. They were: the new Candida auris chromogenic plate, improved Carba 5 detection of ESBLs evaluation, the Hardy MALDI comparison to Biotyper, and the new TRIO.BAS™ air sampler for viral enumeration.

  • Can this bacterium prevent weight gain and lower inflammation?

    Miracle in the Mucin… Discovered in 2004, Akkermansia muciniphila is a relative newcomer to microbiology. Akkermansia was named for the microbial ecologist Antoon Akkermans, and muciniphila meaning preferring mucin. This organism in the phylum Verrucomicrobia was the result of a study that used purified mucin as a growth medium, looking for organisms that could use this as their food source. A. muciniphila was the result, a Gram-negative bacterium that uses mucin as its sole carbon and nitrogen source. A photo of normal healthy gut tissue with mucin producing goblet cells is shown above. Since its discovery, the behavior of this organism in vivo has been studied extensively in both mouse models and human subjects, and a correlation between the presence of A. muciniphila and overall health is becoming increasingly clear.

    Because chronic diseases like obesity and type II diabetes are linked with a low abundance of A. muciniphila, its role in gut barrier could be important. For example, increased gut permeability is a characteristic of obesity, and this increase is associated with a reduced mucus thickness. However, A. muciniphila can restore the mucus layer and improve gut barrier function. It has been found that people that are lean with normal glucose tolerance have higher levels of Akkermansia than diabetics and obese individuals. (7)

    A. muciniphila is integrally linked with the intestinal mucus layer, which serves as both its primary food source and habitat. This layer varies in thickness amongst subjects, but is continually replenished by goblet cells in the epithelia of the intestine. Commensal microorganisms make their home in the outer, less-dense periphery of this layer (3). Studies in Apolipoprotein E knockout mice, a model used to study cardiovascular disease and fat metabolism, show that A. muciniphila supplementation led to overall increases in the mucin layer. This thickening prevents “leaky gut” and reduces overall inflammation.(2) Additional studies also show reduced levels of Akkermansia in Alzheimer, cancer, and rheumatoid arthritis patients.(8)

    For diabetic patients, the role of the gut microbiome is increasingly of interest. Recent studies have shown that treatment with the common diabetic drug, metformin, led to an increase in mucin-producing goblet cells in the intestinal epithelia, which also led to an increased population of A. muciniphila in mice undergoing treatment (5). This is a tantalizing hint that the moderating effects of A. muciniphila may have an impact on diabetic patients, and more study is warranted to further examine the connection between diabetes treatment and the bacterium. In addition, It has also been found that those suffering from irritable bowel disease have lower levels of gut Akkermansia (8).

    A.muciniphila has been featured in multiple supplementation strategies designed to increase the overall abundance of the organism, and evaluate whether supplementation regimens can produce positive outcomes for overall health. Early studies established that regular dosing regimens of up to 1010 bacteria per day were safe and well-tolerated. As part of the normal adult gut microbiota, A. muciniphila makes up around 1 to 3% of all microorganisms. Supplementation regimens have established that a dearth of population can be restored to this level, but that concentrations higher than this aren’t achieved. This may indicate that A. muciniphila reaches its carrying capacity in healthy adults, and that supplementation can’t bring additional benefit. (1, 4)

    So how do we encourage the growth of this important bacterium? One of the best ways to increase your levels naturally is by eating plenty of high fiber plant foods that contain prebiotics and polyphenols to feed and grow those good bugs. (8)

    As the understanding of the complexity of the human gut microbiota increases, it is becoming increasingly apparent that the balance of this ecosystem has diverse health ramifications. The evidence from the mouse and limited human studies confirm that Akkermansia muciniphila is linked to dramatic impacts in health and physiology. This fascinating microorganism deserves further study to fully understand its place as part of a healthy microbiome. 

    By Weston Mangin

    Senior R&D Engineer 

    References: 1,23456,78

  • Lyme Disease: Why it’s so difficult to treat?

    Lyme disease is one of the most common types of tick-borne diseases (TBDs), yet many questions remain surrounding long-term treatment of this disease. Borrelia burgdorferi, the spirochete causing the disease, is transmitted to humans through the bite of an infected Ixodes tick. (1) The first symptoms will often include a bullseye rash forming around the tick bite, as seen in the photo to the left. Approximately 35,000 cases are reported to the CDC annually, however, the CDC believes this number is severely underreported and estimates the actual number of cases to be closer to 476,000. (2)

    Early detection can be difficult because of the low concentrations of bacteria present in a patient’s blood sample, frequently yielding false negatives.(3) Additionally, TBD testing is pathogen-specific, meaning a specific test must be ordered by a clinician who suspects a TBD. This makes the diagnosis heavily reliant on the clinical picture. (3) The gold standard for testing has been a two-tiered system including an ELISA test followed by a Western blot test, as recommended by the CDC. (3) However, this testing method is very time consuming and is more accurate the longer the patient has had the disease.(3)

    Lyme disease initially causes symptoms that mimic common illnesses such as the flu, making it difficult to diagnose, especially in regions where TBDs are uncommon. (3) Initial symptoms are treated with a cocktail of oral antibiotics including doxycycline, amoxicillin, or cefuroxime. (4) Patients left untreated may experience persistent symptoms such as facial palsy, joint and muscle pain, and cognitive impairment. (5) The puzzling question researchers face is what causes these persistent symptoms in many Lyme disease patients?

    B. burgdorferi has evolved many adaptations that have allowed it to persist within its host’s tissues, whether it be animal, tick, or human host. These adaptations have also allowed it to survive harsh antibiotic treatments as well. In vitro studies have demonstrated that when treated with antibiotics, a small number of B. burgdorferi survive but are non-cultivable.(4) The spirochete alters its gene expression, allowing it to transform into a variety of shapes and remain dormant during an attack by antibiotics. (4) While researchers have yet to demonstrate this in vivo, these studies may suggest why many patients’ symptoms resurge and persist after initial diagnosis and seemingly successful treatment. (4)

    Research progression has been slow, mostly attributed to the lack of public awareness and concerns surrounding Lyme disease and other TBDs. The number of cases also falsely appears to be relatively small, which translates to less funding and investments for new technologies and detection methods.(3) It is also a difficult bacterium to study, since it requires a complex growth medium and takes two to four weeks of incubation.(8) A critical advancement would be a readily available detection method that tests for multiple TBDs simultaneously. (3) The Far Clinic has produced an excellent video that explains how B. burgdorferi can evade detection by the immune system and develop resistance to antibiotics.(9)

    Understanding long-term treatment is essential due to the growing concern of the geographical expansion of ticks as well as the increased prevalence of TBDs such as Powassan virus.(6) According to the CDC, the Powassan virus is very rare, but the reported number of cases has increased in recent years from only six cases reported in 2015 to 39 cases reported in 2019. (7) Time-consuming test methods that yield false negatives at early stages of disease beg for more specific and sensitive technologies. As warmer temperatures have allowed ticks to survive in areas they previously could not, public education is key to preventing misdiagnosis and treating TBDs in their early stages.

    References: 1, 2, 3, 4, 5, 6, 7, 8, 9

    By Allie Malmberg

    Technical Support Microbiologist HARDY DIAGNOSTICS

  • Is Bird Flu Only For The Birds?

    In December 2021, Canada reported the first case of the 2021-2022 highly pathogenic avian influenza (HPAI) H5N1 in North America. Subsequently, HPAI H5N1 viruses have been confirmed in wild birds, backyard flocks, and commercial poultry facilities in both Canada and the United States. (1) According to the United States Department of Agriculture (USDA), as of April 26, 2022, there have been almost 37 million chickens and turkeys killed by this disease from 239 flocks in 29 states across the United States. (2) Additionally, the CDC announced, there have been 899 wild birds detected with the bird flu in 34 states, including cases of bald eagles being affected. (3) These statistics continue to rise daily.


    Avian influenza virus (AIV), also known as bird flu, refers to the disease caused by infection with avian influenza Type A viruses. Wild aquatic birds are considered reservoirs, or natural hosts, for AIV. (4) These viruses have been found in more than 100 different species of wild birds globally and most infected wild birds are asymptomatic. (4) Unfortunately, AIV can infect the respiratory and digestive tracts of domestic poultry and other domestic birds. Due to this, outbreaks of AVI in domestic poultry can occur worldwide. (5)


    The disease is spread through saliva, nasal secretions, and feces of infected animals, which other animals or humans then come into contact with. (5) Infected birds can experience a lack of energy and appetite, diarrhea, a decrease in egg production, paralysis, swelling of the head and eyelids, neurological impairment, and death. (6) Due to the transmissibility of the virus, there is little choice but to cull the entirety of an infected flock.


    Some AIVs have infected other mammals but have rarely infected humans; however, high mortality rates occur when humans are infected. (4, 5) Human infection with AVI is a result from direct exposure to infected poultry or their environment. (3) The first human disease caused by H5N1 was reported in Hong Kong in 1997. This outbreak caused 18 cases in humans, of which, six resulted in death. Meanwhile, 1.5 million chickens died, either from infection or from being culled in order to control the outbreak. (7) Since 2003, the World Health Organization (WHO) has recorded a total of 863 cases of human infection with H5N1 virus globally, of which 455 were fatal, resulting in a case fatality rate of 53%. (8) A prison inmate in Colorado became the first case of a human being infected by this virus in April of this year. (9).

    Though the threat to humans is low, AIV poses a global economic, agricultural, and public health concern. Add this to the list of problems causing prices to rise in the grocery stores, such as inflation and the war in the Ukraine. Nevertheless, outbreaks of AIV must be mitigated before the virus can possibly adapt to transmit more efficiently to humans, making this a continuing potential threat. (7) Additionally, AIV can threaten whole populations of wild migratory birds and cause the death of millions of chickens. (5)

    AIV outbreaks also cause serious economic implications in the poultry industry, as well as in the upstream and downstream sectors. Therefore, decreasing the exposure of poultry to this virus through improvements in biosecurity, reduction of flock sizes, and avoidance of poultry production in areas habituated with water fowl may be advantageous in reducing AIV outbreaks.


    By Makena Brand

    Technical Support Microbiologist

    Hardy Diagnostics

    References: 123,45,67, 89

  • 2022

    In May of this year, Ashleigh Rickey was promoted to the position of Quality Assurance Director after three years of employment with the company. Ashleigh is a Clinical Laboratory Scientist and has a Master’s degree in Public Health. She has also been certified by the Regulatory Affairs Professional Society for Medical Devices. Ashleigh manages a team of 19 technicians in QA engineering, supplier quality, regulatory affairs, and document control.

  • E. coli Used in the Fight Against Cancer

    Genetic engineering can help preserve endangered species

    Since 1978, Escherichia coli has been used in the development of synthetic “human” insulin (1). More recently, E. coli has become an essential part in the development of cancer drugs (2). Researchers at The Novo Nordisk Foundation Center for Biosustainability in Denmark have developed a method for the large-scale production of P450 enzymes using E. coli as a cell factory. P450s are usually extracted from plants and used to synthesize a variety of drugs through an environmentally harmful process. Plant P450 enzymes are essential in the biosynthesis of active ingredients of cancer drugs, such as Taxo (2). A model of this protein can be seen in the illustration above.

    P450 enzymes generate a variety of different compounds, which plants use to protect themselves from the sun, dehydration, herbivores, insects, and microbes. Researchers at Novo Nordisk Foundation Center for Biosustainability modified and transferred the P450 genes from plants to different E. coli strains to determine whether the microbes could produce functional enzymes. They developed a toolbox of DNA sequences capable of expressing approximately 50 P450 enzymes from different plants. Although the function of many compounds synthesized by P450s are not fully studied, their availability through this new method provides a huge potential in the development of new drugs (2).

    Tragically, these enzymes are extracted from plants, such as Taxus baccata, which are an endangered species (2). Using engineered E. coli as the cell factory provides a yield 10-fold higher than plants and is less harmful to the environment (4). A focus on this new method using engineered E. coli provides a better alternative for the advancement of cancer drug development, while protecting endangered species and the environment.


    By Elide Herrera

    Technical Services Microbiologist I


    References: 1234

  • Is Roundup Giving you a Pain in the Gut?

    Glyphosate linked to microbial dysbiosis and intestinal disease

    Glyphosate-based herbicides may be to blame for the rise in cases of celiac disease and gluten intolerance. Though the proponents of glyphosate have always maintained that it has no effect on human and animal cells, an ever-increasing amount of research suggests that the herbicide inhibits the healthy microbial flora, including microbes needed to properly digest gluten. These claims are compelling because there appears to be a correlation in the last few decades between the increased use of glyphosate and the increase in gluten-related disease. (1)  

    Though glyphosate was first synthesized in 1950, the herbicide didn’t see widespread commercial use until the 1990’s when the agrochemical company Monsanto brought “Round Up Ready” seeds to the industrial agriculture market. These seeds were genetically modified to be resistant to glyphosate, which allowed farmers to easily increase crop yield through weed control and pre-harvest desiccation. Due to its remarkable effectiveness, glyphosate became the most widely used herbicide in the world.(2) In Europe, in 2017, the EU granted a five year provisional approval for glyphosate that expires in December of this year. (7) Unfortunately more than half of the corn, soy, wheat, and oat crops in the US are sprayed with glyphosate. The WHO has deemed this chemical as a “probable carcinogen.” (9) 

    While glyphosate is not directly toxic to human and animal cells, it can disrupt the metabolism of some microbes which can, in turn, be a possible cause of gastrointestinal disease. Critical probiotic flora like LactobacilliEnterococci and Bifidobacteria are susceptible to this disruption, and harmful pathogens like Salmonella and Clostridia are highly resistant. Studies on bees, fish, rats, pigs, cattle, and poultry have all shown that exposure to glyphosate can cause microbiome dysbiosis as healthy gut flora is inhibited. (3,4) 

    The effects of this dysbiosis manifested similar conditions to the symptoms of celiac disease (CD) in humans. Diarrhea is a symptom in only one third of adults; more likely is arthritis, fatigue, anemia, bone loss, anxiety, depression and others.(8) Cases of CD have skyrocketed in recent history alongside the increased usage of glyphosate (see the chart below). While some attribute this alarming rise in CD cases to improved diagnostic screening, others find the correlation between the herbicide and the disease too compelling to ignore. Studies of CD have shown that the condition emerges from the same kind of dysbiosis observed in the animal studies, and that the condition can be improved if probiotics are allowed to flourish. Conversely, it has been proven that glyphosate suppresses healthy gut flora. Therefore, whether or not CD is directly caused by glyphosate, it is clear than the herbicide can cause serious harm to human digestion. (1) 

    Avoiding exposure to glyphosate is easier said than done. Switching to an organic diet can help, because the use of glyphosate is prohibited in organic agriculture. Detoxifying binders such as activated charcoal, humic acid, and the plant extract berberine have shown promise in removing residual glyphosate from human tissue. Probiotic supplements including Bifidobacteria and Lactobacilli may suppress the growth of harmful pathogens and improve overall digestive health, especially when supplemented with a variety healthy prebiotic fibers. (5,6) 

    Though much of the agricultural industry still defends glyphosate as harmless to humans, these studies that highlight the importance of maintaining a healthy gut microbiome should not be ignored.


    References: 123456789 

    By Mark PruettPerformance Studies Technician

  • New Drugs in the Fight Against COVID-19

    As the COVID-19 pandemic moves into its third year, new treatment options to combat the coronavirus disease are being authorized by the U.S. Food and Drug Administration. In December, 2021, the FDA issued emergency use authorization (EUA) for two oral antiviral treatments for COVID-19, Molnupiravir and Paxlovid.(1,2)
    This comes at a crucial time in the pandemic as new variants emerge and COVID-19 cases are rapidly increasing since the first U.S. Omicron case was reported on December 1, 2021.(3) Effective antivirals may decrease the impact of the current public health emergency by reducing the risk of severe illness, hospitalization, and allowing accessibility to treatment for high-risk patients.  Merck’s Molnupiravir is a nucleoside analogue that inhibits SARS-CoV-2 replication by viral mutagenesis for the treatment of mild-to-moderate coronavirus disease in adults with positive results of direct SARS-CoV-2 viral testing, who are at high risk for progressing to severe COVID-19, and for whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate.(4) The study showed that Molnupiravir significantly reduced the risk of hospitalization or death from 14.1% (53/377) in the placebo group to 7.3% (28/385) in the Molnupiravir group (absolute risk reduction 6.8%; 95% CI: 2.4, 11.3; p=0.0012), for a relative risk reduction of 48%. (4)

    Pfizer’s Paxlovid, includes nirmatrelvir, a SARS-CoV-2 main protease inhibitor, and ritonavir, an HIV-1 protease inhibitor and CYP3A inhibitor. (6) Nirmatrelvir blocks the activity of the SARS-CoV-2-3CL protease, an enzyme that the coronavirus needs to replicate. Administration along with a low dose of ritonavir helps slow the metabolism of nirmatrelvir, thus remaining active in the body for a longer period of time at higher concentrations to help fight the virus. In clinical trials, Paxlovid was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19.(7) Until recently, COVID-19 treatments (monoclonal antibodies and remdesivir) have been only available in hospitals because they are intravenous medications, and although the authorization of oral antivirals may seem as light at the end of the tunnel, the availability of these novel therapies is concerning.(8) While the supply is expected to increase, allocation varies by jurisdiction/ facility and is not comparable to the supply of vaccines. To place in perspective, the United States ordered 13 million courses of oral antiviral therapies, short of the 200 million vaccine doses ordered when they first launched in 2021.(9)

    Nevertheless, vaccination remains the best protection against serious illness, hospitalization, and death from COVID-19, since neither Paxlovid nor Molnupiravir are authorized for pre-exposure or post-exposure prevention of COVID-19. These FDA Emergency Use Authorizations represent an important milestone in the fight against COVID-19. 

    By Yesenia MoralesTechnical Support,

    Hardy Diagnostics
    Ref: 123456789

  • Do you have bacteria living in your brain?

    Is there a cranial microbiome? Can it be harmful?

    Over the decades, scientists have dedicated their entire careers to studying microorganisms on and in our bodies. Although the brain has largely been considered a sterile environment, research has shown evidence of microorganisms living harmlessly in the brain.

    In what could be considered a serendipitous event, researchers at the University of Alabama in Birmingham (UAB) made unusual observations in slices of brain tissue from cadavers.(1) At the lab of neuroanatomist Rosalinda Roberts, they look for differences in brain tissue between healthy people and people with schizophrenia in the hours after death. One of the scientists in Dr. Roberts’ lab noticed unidentified rod-shaped objects while examining brain tissue slices with an electron microscope. Although she had seen these odd objects before, she dismissed them at the time. Eventually, the researchers utilized the help of a bacteriologist and discovered that these unexpected objects were bacteria. Dr. Roberts’ team checked every brain they had – 34 in total – and found bacteria in every single one, half of them healthy, half from people with schizophrenia.

    This image has an empty alt attribute; its file name is blog-1.jpg

    Further examination revealed that the bacteria were rod shaped and contained a capsule, nucleoid, ribosomes, and vacuoles. The density of the bacteria varied according to the brain region, with abundant bacteria in the substantia nigra, hippocampus, and prefrontal cortex but sparse numbers in the striatum. The bacteria were also found in star-shaped brain cells known as astrocytes that were near the blood-brain barrier.(2) When the genetic material from the bacteria was sequenced, they found that most of the microbes were from three phyla common to the gut: Firmicutes, Proteobacteria, and Bacteroidetes.

    Roberts considered whether bacteria from the gut could have leaked from the blood vessels into the brain in the hours between a person’s death and the brain’s removal. To further investigate this, she looked at healthy mouse brains preserved immediately after the mice were killed. She found bacteria in similar locations found in the human brain samples. She then looked at brains of germ-free mice raised in sterile environments and these mouse brains were void of any microbial life. Also important to note is that the researchers found no signs of inflammation or bacterial disease in any of the brains they examined. More work still needs to be done to completely rule out the possibility of contamination, whether from the air or from surgical instruments, but Dr. Roberts plans to run a few more experiments to further substantiate the findings.

    If there truly is a “brain microbiome,” a big question that remains is how the organisms get there. Dr. Roberts hypothesizes that they may have crossed from blood vessels, traveling up nerves from the gut, or even come in through the nose.(1) There is currently no evidence to show whether these bacteria are helpful or harmful as the researchers have not determined if there are any major differences in the bacteria between the schizophrenic and healthy brains. Further investigation is needed to determine whether this possible microbiome can have brain-related health outcomes.

    Bacterial presence in the brain is a field that has yet to be explored but the fascinating findings from Dr. Roberts’ lab may lead to discoveries that the gut-brain link may be a lot more direct than originally thought.

     

    Ref: 1, 2  
    By Alani Vasquez
    Research and Development Manager
    HARDY DIAGNOSTICS

  • 2022

    Hardy signs a distributorship agreement with Applied BioCode of Santa Fe Springs, California. The BioCode MDx-3000 offers a new and exciting technology that involves microscopic bar-coded beads to simultaneously detect multiple pathogenic organisms (bacteria, viruses, fungi, and parasites) as developed by Dr. Winston Ho. This advanced PCR multiplex system is FDA cleared for two panels that can detect 17 pathogens each: respiratory and gastrointestinal. It can produce fast results for up to 188 patient samples per 8-hour shift. Hardy is looking forward to expanding its microbiology offering into the world of molecular diagnostics.

  • Drug resistance on the rise… A Sinister Salmonella Strain

    Salmonella Infantis

    Globally, Salmonella causes illness in 93.8 million people and causes approximately 155,000 deaths each year.(1) Within the United States alone, Salmonella is responsible for 1.35 million infections, 26,000 of which are severe enough to warrant hospitalization and over 400 deaths.(2)
    Infection occurs after ingesting more than 50,000 bacterial cells from contaminated food or water with symptoms appearing from 6 to 72 hours after consumption.(3) In addition, the actual morbidity rate worldwide is likely higher than reported, especially in developing countries.
    Typically, the gastroenteritis will resolve itself in 5–7 days without need for treatment other than IV fluids. Antibiotics are usually contraindicated unless there is evidence of invasive disease (i.e. bacteremia) or typhoid fever, as antibiotics are unlikely to lessen the duration of illness or decrease the severity of symptoms and have the potential to increase bacterial antibiotic resistance.(3)
    Typhoid fever is immediately treated with antibiotics, due to the systemic nature of the infection. Broad spectrum Fluoroquinolones (i.e. ciprofloxacin) have become the primary treatment, however resistance to this class of antimicrobials is increasing, as evidenced in studies conducted in endemic regions. Third generation cephalosporins are now often the second-line treatment for typhoid fever. Multiple Drug Resistant (MDR) strains are becoming increasingly more common, highlighting the need for better prophylactic therapeutics.(3)

    Ninety-nine percent of all cases of salmonellosis are caused by S. enterica, and now a serovar of that species is causing great concern. Salmonella enterica serovar Infantis has been in the news lately for escalating anxiety levels of clinicians and the general population alike. Salmonella Infantis contains a multifaceted danger profile. Worldwide geographical distribution paired with multiple drug resistance genes are a combination befitting an infamous bacteria.(4,5,6) These characteristics of Salmonella Infantis make it challenging to investigate in the case of an outbreak.
    For example, in 2019, a single outbreak of Salmonella Infantis from chicken resulted in 129 illnesses across 32 different states.(7) When the Centers for Disease Control and Prevention (CDC) launched the official investigation, 76 different chicken processing establishments showed the presence of Salmonella Infantis, which caused ambiguity as to the source of the outbreak. Further genetic analysis from 97 patients and 139 environmental samples showed that Salmonella Infantis contains resistance genes to many of the most commonly used broad-spectrum antibiotics.(7) Even with antibiotics and proper food handling, there is no guarantee of Salmonella-free chicken. The CDC estimates that one out of every twenty-five packs of chicken from the store is contaminated with Salmonella.(8)
    The United States has one of the safest food supply chains globally. Still, the United States Department of Agriculture (USDA) regulatory authority begins at the slaughterhouse and does not have the labor force or authority to check all farming operations. The extensive presence of this pathogen paired with antibiotic resistance results in an alarming combination with a single solution. If you plan to eat chicken, you must store it properly -18ºC (0ºF) and thoroughly cook it to an internal temperature of 74ºC (165ºF).(8)One monitoring method for food products is to enrich samples in Buffered peptone water (Cat. no.U142) and plate to HardyCHROM Salmonella (Cat no. G309). Hardy Diagnostics also offers SS NoPRO (Cat. no. G327) agar to screen clinical samples to assist clinicians in getting the most accurate and expedited results. This plated media is especially useful in that Proteus, which can mimic Salmonella in appearance, will be inhibited, thus eliminating many false positives. Hardy Diagnostics is here to help by providing the best microbiological solutions for the food and clinical laboratories.


    Works Cited: 12345678


    By Isaac Adelman

    Technical Services Microbiologist

    Hardy Diagnostics 

  • 2022

    In January, Hardy launched its new HardyCHROM™ Campy Plate (Catalog no. G339). This new medium can detect species of Campylobacter by the red color development of the colonies, thus making it extremely easy for the microbiologist to identify this troublesome organism that so often causes food poisoning.

  • 2022

    At the beginning of 2022 a new employee breakroom was completed at our Ohio facility. Employees can relax in a Bistro-like atmosphere in a newly decorated space for their enjoyment.

  • SARS-CoV-2, Omicron is now dominant, but…Are More Variants Coming?

    How dangerous are the BA.2 and BA.3 sub-variants compared to the Omicron BA.1 that we already know?

    South Africa has one of the most robust public health systems in the world, carefully monitoring their SARS-CoV-2 case load, which has been dominated these last few months by the Delta variant. In recent months, however, South Africa’s case load has increased sharply due to the variant: B.1.1.529, sub-lineage BA.1.(1) First detected in a specimen collected on November 9th 2021, the new variant was reported to the World Health Organization (WHO) on the 24th and deemed a “variant of concern.”(3)
    This variant has nearly twice as many mutations as the Delta variant, many of which are associated with transmissibility and immune evasion.(2)The increased transmissibility of Omicron, the ability of the virus to spread between people, when compared to the already-highly-transmissible Delta variant, is of great international concern. 
    Now a new sub-variant of Omicron B.1.1.529 is making the news: Called BA.2. The BA.2 strain is a prevalent form of Omicron in Denmark, making up about half of the cases there. It has been found in 40 countries and is prevalent in India, Sweden, and Singapore. It is now the most prevalent variant in South Africa. In the US, it is estimated that BA.2 makes up about 5% of all Covid cases. It is believed that that the BA.2 sub-variant is no more lethal that the original BA.1 variant, although research is ongoing. Hospitalization rates so far have been reported to be the same as the original Omicron BA.1 sub-variant. However, this new omicron coronavirus sub-variant appears to be slightly more contagious. Data out of Denmark suggests that BA.2 is about 1.5 times more contagious than the original BA.1 strain of omicron.(6) BA.2 has been nicknamed the “Stealth Variant” because it is more difficult for the PCR test to identify the variant, although it can identify the virus itself without difficulty. (5)


    BA.3 is another sub-lineage of Omicron that shows mutations in the in spike protein. However, they are not unique mutations, and show a combination of mutations found in the BA.1 and BA.2 spike proteins.(8)
    Meanwhile, sewage wastewater continues to be monitored for the virus overall. The wastewater district in South Boston reports on January 29th that an average of 1,328 copies of viral RNA per milliliter of water were found, which is about an 88% plummet from the Omicron peak in early January.(6)
    Preventive steps remain our first and best methods of reducing the spread of SARS-CoV-2; physical distancing and avoiding crowded spaces, masking, and maintenance of an up-to-date vaccination status. Please consult your local public health professionals for further advice and recommendations to protect yourself, your family, and your community. Also, it is encouraging that early treatment protocols have been found to be of value in preventing hospitalizations.(7)

    By David Cochran and Jay Hardy
    Ref: 12, 345678

  • 2022

    We made about 1.5 million Viral Transports (#R99) in one month, thanks to Hardy co-workers that put in extra time at night and on weekends, and Partners from other departments that helped out in packaging.

  • Can our gut microbiome help to overcome Covid-19?
    Bacteria forming part of the intestinal microbial flora

    Probiotics found to assist in restoring normal immune function…

    COVID-19 disrupts normal bowel flora

    SARS-CoV-2 infection induces an aggressive inflammatory response which is strongly implicated in the cause of multi-organ dysfunction in some patients.(3) As a result, disease severity is likely caused not only by viral infection, but also an extreme host immune reaction. Patients with severe disease have been observed to have high levels of inflammatory markers and cytokines that reflect a strong immune response.(1)


    The GI tract is the largest immunological organ and the gut microbiota is known to modulate host immune responses.(3) Gut microbial metabolic processes have been observed to strongly impact the production of cytokines. Cytokines are small proteins that act as signaling molecules that coordinate the host’s response against infection and inflammation.(4) In response to infection, excessive levels of cytokines are released leading to hyper inflammation that is observed in some patients infected with SARS-CoV-2.(4)


    There is increasing evidence that the GI tract, and therefore the gut microbiome, is involved in the COVID-19 immune response observed in patients. SARS-CoV-2 has the ability to infect and replicate in the human small intestine enterocytes and viral RNA has been consistently detected in stool samples, suggesting involvement of the GI tract.(2)


    In a study conducted in Hong Kong by Yeoh et al., records from 100 patients with laboratory-confirmed SARS-CoV-2 infections and 78 adults without infection were obtained. These patients’ blood and serial stool specimens were further analyzed. Shotgun sequencing of total DNA extracted from the stool samples characterized the gut microbiome composition and the concentration of inflammatory cytokines were determined from blood plasma.(2) The study found that the composition of the gut microbiome was significantly different in the patients with COVID-19 compared to the patients without COVID-19.(1)


    Several commensal gut bacteria with known immunomodulatory potential, including Faecalibacterium prausnitziiEubacterium rectale and several bifidobacterial species were underrepresented in COVID-19 patients and remained low in samples collected up to one month after disease resolution.(2) The microbial imbalance found in the COVID-19 patients correlated with elevated concentrations of inflammatory cytokines and plasma concentrations of several cytokines, chemokines and inflammation markers.(2) These findings suggest that the gut microbiota could play a role in modulating host immune response and potentially influence disease severity and outcomes.(1)


    “Our results suggest that dysbiosis weakens our immune defense, thereby predisposing to more severe SARS-CoV-2 infection and contributing to ‘long COVID,’” claimed Dr. Siew Ng of the Chinese University of Hong Kong. “Probiotics, if using the right combination of missing bacteria to boost immunity, may be potentially useful as an adjuvant therapy.” She went on to say, “The abnormal gut microbiota (dysbiosis) in COVID patients persists after clearance of the virus. These alterations could play a role in ‘long COVID.’ Clinical management not only should aim at clearing the virus but also restoring the abnormal gut microbiota,”


    As a result, Dr. Ng and her colleagues developed a probiotic capsule that they used to treat patients recovering from Covid infections that helped to achieve complete symptom resolution, showed significantly reduced proinflammatory markers in their blood, had increased favorable bacteria in their stool, and developed neutralizing antibody.


    These results suggest that dysbiosis, an unhealthy and unbalanced microbiome due to a loss of diversity and a decrease in beneficial microbes, weakens our immune system defenses and therefore prompts a more severe infection from SARS-CoV-2.(1) Therefore, increasing beneficial gut species could serve as a novel avenue to mitigate severe disease from SARS-CoV-2.

    By Makena BrandTechnical Services Microbiologist I Works Cited: 1234

  • 2022

    After being involved in manufacturing at Hardy Diagnostics for six years, Ethan Brannon is named to head up the entire Manufacturing Department, which includes the both of the facilities in California and Ohio. Ethan became the Director of Manufacturing in January of 2022 and has successfully led numerous projects as a part of the company’s Continuous Improvement program.

  • INULIN – Do the many benefits outweigh the discomfort?

    Do food labels tell the full story of what consumers are eating? In the U.S., many citizens may be unaware of how much inulin they may be consuming on a daily basis.

    As a result, individuals who consume inulin may suffer from digestive discomfort without knowing the true cause.(1) On many food labels, there is helpful and descriptive information that allows the consumer to be aware of what they are going to eat. However, one piece of information may be missing: how much inulin is in the product.

    Inulin is a starchy, soluble fiber found in approximately 36,000 species of plants with the highest content from chicory root and Jerusalem artichoke. Inulin is also fructan. Like other fructans, it is a prebiotic, meaning that it feeds the good bacteria in the gut. Fructans are chains of fructose molecules. The molecules link together in a way that the small intestine cannot break down. Instead, they travel to the lower gut, where they feed beneficial gut bacteria. The gut bacteria convert inulin and other prebiotics into short-chain fatty acids, which nourish colon cells and provide various other health benefits.
    Inulin tends to be added to many types of foods, including protein bars, dairy, baked goods, and certain drinks.(9) Moreover, inulin can alter the texture of foods and may make certain foods healthier to consume.(2) Consequently, by adding inulin (usually from chicory root as pictured above), the prebiotic content of foods can be boosted and may replace less healthy ingredients like fats or sugars.

    As a whole, inulin has several major health benefits, but there are also a few negative outcomes that may occur. Among the known positive side effects are improved digestive health, constipation relief, weight loss promotion, promotion of mineral absorption, and diabetes prevention. Other possible, but less documented benefits are the prevention of colon cancer, heart disease, and irritable bowel disease (IBD) (2,3,8) Additionally, inulin has been found to stimulate beneficial digestive bacteria and help support a balanced gut microbiota.(1) As a result, consuming inulin is expected to boost the overall health of an individual. After inulin supplementation in humans, the most consistent change was an increase in Bifidobacterium. Other results included an increase in relative abundance of AnaerostipesFaecalibacterium, and Lactobacillus, and a decrease in the relative abundance of Bacteroides.(7)

    Because of its high fiber content, which cannot be digested by stomach acid or pancreatic enzymes, one of the negative aspects of consuming inulin is that individuals who consume inulin may experience bloating, gas, diarrhea, and digestive discomfort. Doctors suggest gradually increasing the amount of inulin consumed over a long period of time to reduce these negative symptoms.(1,8)

    Throughout the world, inulin is slowly being accepted as a beneficial dietary fiber. Some countries have included the substance on food labels, while others are slow to do the same.(4) If inulin is not labeled in the dietary fiber section of foods, it may be listed in the ingredients as chicory root or extract.

    As inulin is slowly added to nutrition labels, more consumers may be able to correlate increased consumption with gastrointestinal discomfort and adjust their intake accordingly. Being armed with this information will allow consumers to better control any negative experiences and reap the potential health benefits of choosing a diet higher in inulin.

    References: 12345678, 9
    By Anna Klavins and Emily Edds
    R&D Microbiologists, Hardy Diagnostics

  • Self-Destructing Mosquitoes: A new way to combat malaria and other mosquito vector diseases.

    Will Releasing Genetically Modified Mosquitos Finally Conquer Malaria?

    For the first time, scientists have shown that a new kind of genetic engineering, known as a “gene drive,” can crash populations of malaria-spreading mosquitoes.

    Infected erythrocyte with the characteristic malaria ring form.

    The objective of the study was to alter three species of mosquito most responsible for disease transmission – Anopheles gambiae, A. coluzzii and A. arabiensis. The photo above shows an infected erythrocyte with the characteristic malaria ring form.

    Despite years of effort, malaria remains a major health problem. This mosquito-borne parasitic disease infects more than 200 million people every year and kills more than 400,000, many of whom are children. 1 Worldwide, it is the fourth biggest infectious disease killer behind tuberculosis, HIV/AIDS, and hepatitis C.

    Dr. Ruth Müeller, PhD, and her colleagues utilized CRISPR to make precise edits to the Anopheles species. CRISPR, shorthanded for CRISPR-Cas9, acts as “molecular scissors” that cut DNA at a specific location when guided by a RNA template. Once snipped, the cell activates a DNA repair mechanism and scientists can use this mechanism to introduce, delete, or mutate a gene of interest. 7

    In this study, the modification consisted of a mutation in a gene known as “doublesex” which female mosquitoes need for normal development. While genetically female, the transformed insects have distorted mouths, resembling their male counterparts; which prevent them from biting and spreading malaria. In addition, the females’ reproductive organs are deformed preventing them from laying eggs. 2 Essentially, the mutated gene converts female mosquitos into males, thus drastically reducing the population of the mosquitos capable of carrying and transmitting the malaria parasite.

    “[This] gene drive is like a ‘selfish gene’…. All the mosquito offspring – have this modification,” Müeller says. “The idea and hope is that they would spread their mutation and eventually sterilize all the females. That would crash – or drastically reduce – local populations of the main species of mosquitoes that spreads malaria”.6

    To safely test the mosquitoes under more natural conditions, researchers built a special high-security lab in Italy (far away from Africa) designed to keep the mutated mosquitoes from escaping. The researchers then released dozens of the gene-drive mosquitoes into special large cages containing hundreds of wild-type mosquitoes. The gene-driven mosquitoes decimated the natural mosquito populations in less than a year. 5, 2

    Some researchers are welcoming the advance while others are highly skeptical and say the technology is too dangerous. Dr. Ethan Bier, PhD, noted, “One should never predicate the use of a gene drive…Just like with insecticides, you can expect that the insect will become resistant one way or another. The drive itself [could] create a mutation preventing the drive from going further.”4

    Dr. Alekos Simoni, PhD, cautiously noted, “Looking at the roles of Anopheles mosquitoes is crucial in terms of the food web, pollination and the general ecosystem. I think there can be a problem for species that are distributed around the world like the mosquito because it is difficult to constrain in the area”.4

    So what does the future hold for gene drives? Whether gene drives will end up being utilized as a tool to control wild populations or remain a tool to be used in the lab, remains to be seen. It is a complex issue, with valid arguments being made for and against the use of the technology.

    by Francisco Pinon
    R&D Microbiologist
    HARDY DIAGNOSTICS

    References: 12,3456,7

  • Aromatherapy Spray Found to be Deadly

    Melioidosis (also called Whitmore’s Disease) is an infectious and potentially fatal bacterial disease affecting approximately 165,000 individuals worldwide.(1) Symptoms of this disease range from mild fever, chest pain, and cough to more severe symptoms such as ulcers, chronic respiratory illness, and even central nervous system infection.(2, 3) Thankfully, person-to-person spread is extremely rare.(4) Yet, Burkholderia pseudomallei has been an ongoing bioterrorism concern because of its high transmissibility through air, water, and soil.(5)

    Melioidosis is often difficult to diagnose, in the United States, because it is not a part of routine diagnostic screening and is commonly confused with tuberculosis. Melioidosis is primarily found in tropical climates such as Southeast Asia where Burkholderia pseudomallei, the microorganism causing this infectious disease, is endemic and commonly found in water and soil.(2) For this reason, most Americans have never had to worry about Melioidosis, however, recently four cases of Melioidosis were reported in Georgia, Kansas, Minnesota, and Texas over a four month time frame. How did the tropical microorganism Burkholderia pseudomallei find its way to the central U.S.?

    This was a puzzling question for CDC public health investigators. Approximately, 12 cases of Melioidosis are reported annually in the U.S., almost all exclusively to individuals who recently traveled outside of the country to areas where Burkholderia pseudomallei is endemic.(4) However, this was not the case for the most recent outbreak, as all infected individuals had not travelled internationally. Even more puzzling, the four cases emerged in four separate states among both adults and children who became sick months apart from each other.(6)

    In order to help narrow down the culprit, investigators performed whole genome sequencing of the Burkholderia pseudomallei strains found in the infected patients.(7) Sequencing showed that all four strains were highly related, indicating a common source of infection among the individuals. Interestingly, the strains were also found to be highly similar to strains found in Southeast Asia.(7) Since travel was out of the equation, investigators suspected that an imported household product may be the common source of infection.

    To investigate, CDC officials surveyed the families for common household products and compiled a list of products ranging from cleaning supplies to garden soil.(8) Additionally, blood samples were collected and some family members were found to have antibodies to Burkolderia pseudomallei, although they did not develop serious symptoms.(8) This may be worrisome as Burhkolderia pseduomallei has shown to have a long latency period, with one such reported case of 29 years.(2) 

    After months of testing household products, the CDC announced in October 2021 that Burkholderia pseudomallei was identified in a scented room spray from the Georgia patient’s home.(4) The CDC was able to confirm by the genetic fingerprint of the bacteria that the three other cases were also linked to this room spray or at least one of its ingredients.(8) The aromatherapy room spray, “Better Homes & Gardens Lavender & Chamomile Essential Oil Infused Aromatherapy Room Spray with Gemstones,” was sold in over 55 Walmart stores between February and October 2021.(4) Walmart has issued a recall of this product and five other scents in this product line. The CDC is working closely with the manufacturer in India to determine if additional products are at risk.(8) Of the four patients originally infected, two have died and the four-year-old patient from Texas has suffered severe brain damage.(8)

    Consumers who still own this product are urged to dispose of it properly by not simply throwing it in the trash or down the sink as this may have detrimental effects on U.S. water and soil.(8, 9) Healthcare providers are being asked to consider Melioidosis for patients who have not travelled outside the U.S. and for those with symptoms similar to tuberculosis and who are not responding to antibiotics.(9)

    Culture of B. pseudomallei from any clinical specimen is considered diagnostic for melioidosis. Ideal specimens for culture include blood, urine, throat swab, and, when relevant, respiratory specimens, abscesses, or wound swabs. Serological testing is available at CDC for diagnostic testing but is less sensitive and requires paired sera.

    The CDC cautions microbiologists that the MALDI-TOF and Vitek-2 have been noted for misidentifying this dangerous pathogen. Details on how to successfully identify this difficult organism are provided in various articles.(11, 12) Once properly diagnosed, the disease can be successfully treated using ceftazidime, trimethoprim-sulfamethoxazole, meropenem, or amoxicillin/clavulanic acid.(13)

    As this case demonstrates, Melioidosis is a severe bacterial disease that can be difficult to diagnose and identify when discovered in non-endemic regions. Further research into how this organism is spread, how this disease can be treated, as well as increased screening for Burkholderia pseudomallei is needed to ensure another outbreak does not occur again.

    References: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13

    By Allie Malmberg
    Technical Support Microbiologist
    Hardy Diagnostics

  • Beware of Canine Campy!

    In the United States, Campylobacter is the most common bacterial cause of diarrhea, affecting 1.5 million U.S. residents every year.(1) Approximately 30% of Campylobacter strains have decreased susceptibility to fluoroquinolones (e.g., ciprofloxacin) or macrolides (e.g., azithromycin), the antibiotics commonly used to treat infections, which poses a serious threat to public health.(2)
    In August 2017, the Florida Department of Health reported six patients diagnosed with Campylobacter jejuni infections, who had exposure to puppies sold by a nationwide pet retailer, primarily based in Ohio. Using PulseNet, the Centers for Disease Control and Prevention (CDC) compared the DNA fingerprints of Campylobacter from the Florida puppies to an infected patient in Ohio, who was a recent customer of the implicated pet retailer. Whole-genome sequencing (WGS) data revealed that the isolates produced by the samples were substantially linked.(3)

    In response, the CDC, the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (USDA-APHIS), and several state agencies, investigated a multistate outbreak of multidrug-resistant Campylobacter infections linked to pet store puppies. For this multistate investigation, fecal specimens from puppies were collected at associated pet stores in Kentucky, Ohio, Pennsylvania, and Wisconsin for culture and Whole-genome sequencing, to determine isolate relatedness. Also, the genomes were sequenced for resistance determinants in order to predict antibiotic resistance. Additionally, patients were interviewed regarding demographic characteristics (age, sex, race, ethnicity, and state of residence), health outcomes, and dog exposure during seven days before illness onset (contact with dog or puppy, type of exposure, pet store, or breeder affiliation).(3)

    113 people with laboratory-confirmed infections or symptoms consistent with Campylobacter infection were linked to this outbreak. Illnesses were reported from 18 states. 99% of people reported contact with a puppy in the week before the illness started. 29 of the infected persons worked at the pet store chain in question. Outbreak isolates were resistant by antibiotic susceptibility testing to all antibiotics commonly used to treat Campylobacter infections, including macrolides and quinolones. Store records revealed that among 149 investigated puppies, 142 (95%) received one or more courses of antibiotics, raising concern that antibiotic use might have led to the development of resistance in the Campylobacter isolates.

    No deaths were reported, although 26 patients were hospitalized. Whole genome sequencing (WGS) showed that isolates from people infected with Campylobacter were closely related genetically. This close genetic relationship means that people in this outbreak were more likely to share a common source of infection. It was concluded that the puppies became infected at the breeders, rather than at the pet stores.

    Traceback investigations did not implicate any particular retailer, distributor, transporter, or breeder. Nevertheless, Campylobacter can be part of the normal gut microbiota of many dogs and has zoonotic potential to create illness in humans, while most dogs will be asymptomatic. The two usual culprits are C. jejuni and C. upsaliensis. (5) It’s estimated that 78 million dogs are owned in the United States. Approximately 44% of all households in the United States have a dog.(6) To help prevent the spread of Campylobacter infections, the CDC advises to maintain good hygiene and handling practices after touching a puppy or dog, after handling their food, and after cleaning up after them.(7)

    References: 1234567
    By Yesenia Morales
    Technical Support Microbiologist
    Hardy Diagnostics

  • Can you control Rheumatoid Arthritis by diet and gut microbes?

    The discovery of a cause, as well as treatment, for Rheumatoid Arthritis (RA) may involve our commensal gut bacteria.

    Millions of adults suffering from RA experience chronic pain, chronic inflammation, and often severe functional disability of the joints. Onset in older populations is a well-known risk factor, and RA is three times as likely in women.(1)

    Many anecdotes of restrictive diets alleviating the severity of arthritic symptoms inspired scientific inquiry. A 13-month long study evaluating clinical variables such as pain, swelling, and grip strength after switching to a plant-based diet was performed on RA patients. The controlled, single-blind trial demonstrated some patients placed on a plant-based diet had positive effects on clinical variables.(2)

    A particularly interesting factor is the genetic component of RA. The disease occurs predominantly in individuals expressing HLA-DR1 or HLA-DR4, proteins related to immune function. The human leukocyte antigen (HLA) system or complex is a composite of genes on chromosome 6 in humans which encode cell-surface proteins responsible for the regulation of the immune system. These proteins found on the surface of the HLA system are also known as the human version of the major histocompatibility complex (MHC) found in many animals. These HLA proteins are found on the surface of dendritic cells, mononuclear phagocytes, some endothelial cells, thymic epithelial cells, and B cells, and are instrumental in initiating an immune response. Researchers discovered a common amino acid sequence found in both HLA-DR1/4, thus named the “shared epitope.”

    Investigations into the ‘shared epitope’ demonstrated potential cross-reactivity with Proteus hemolysin. Serological studies showed rabbits injected with Human HLA-DR4 lymphocytes produced sera with specificity against Proteus mirabilis and Proteus vulgaris.(3) Another sequence from type XI collagen found in joints was shown to resemble the urease enzyme produced by Proteus. In the diagram above you can see the similarity in protein structure between joint collagen and Proteus urease, which presumably confuses the immune system.

    The evidence paints RA as a case of molecular mimicry; Proteus inducing an autoimmune response in at-risk individuals.

    Bacterial molecular mimicry is not uncommon. It is infamous for its role in rheumatic fever, where anti-Streptococcal antibodies target antigens in the heart.(4) It is likely that the immune response to Proteus, particularly in HLA-DR1/4-positive individuals, is behaving in a similar way. This answer can also explain the female susceptibility to RA, as women are more likely to acquire Proteus mirabilis-related UTIs than men.

    One question remains: How could diet alleviate arthritic symptoms?

    In the plant-based diet study, antibody activity measured in the RA patients showed a significant drop in anti-Proteus mirabilis IgG for those who switched to the plant-based diet. The decline was more noticeable in patients who responded to the diet, and it was present just a few months after the plant-based diet began. From this we can infer that the plant-based diet quickly lowers the population of Proteus in the gut of RA patients, therefore reducing the autoimmune attack.

    Take some time to evaluate your diet; the wrong one could take a toll on your health!

    By Manuel Escalera
    Performance Studies Technician
    HARDY DIAGNOSTICS

    References: 1, 2, 3, 4 

  • 2021

    Sales of ImmuView begin to soar. This new kit that Hardy distributes from Denmark will detect Legionella pneumophila and Streptococcus pneumonia antigens in the urine of patients that are suffering from pneumonia.

  • You Are What You Eat: The Importance of Environmental Monitoring in Food Processing

    Why We Inspect Food Before Consumption, From Contamination to Cause

    We have all heard the phrase, “The way to a person’s heart is through their stomach.” While taking that concept with a grain of salt, most people would not want their appetite spoiled with the thought of consuming rotten or tainted food. In the United States, food safety has only been considered for a little more than 100 years due to President Theodore “Teddy” Roosevelt signing in two bills that established federal regulation of food processing.1

    According to FDA Reader, environmental monitoring can be described as the “process used in facilities that produce ready-to-eat (RTE) foods that assesses how effectively the plant is being cleaned.”2 This process incorporates several types of testing, including swab samples from various surfaces within the facility. These tests confirm if a processor has implemented adequate disinfection and sanitation protocols, so the food they distribute is safe for the population to consume.

    With such a new system in place and an ever-changing set of guidelines to follow on a federal level, environmental monitoring  results and processes must be examined closely to make sure you can have your cake and eat it too, so to speak.

    A Basic Overview of Why Environmental Monitoring is Necessary in a Food Processing Facility

    Microorganisms are always present in food handling environments. These microorganisms are characterized as belonging to two distinct groups: transient and resident. Transient microorganisms are usually introduced into the food environment through raw materials, water and employees. Typically, the routine application of good sanitation practices are able to kill these organisms. However, if contamination levels are high or cleaning procedures are inadequate, transient microorganisms may be able to establish themselves, multiply and become resident.

    Organisms such as coliforms, Salmonella spp., and Listeria spp. have a well-established history of becoming residents in food handling environments. Food processors should employ environmental sampling programs to monitor for general levels of hygiene (the efficacy of general cleaning and disinfection for the removal of transient microorganisms and biofilms). Furthermore, indicator testing may be achieved through a variety of methods including visual inspection, ATP monitoring, or the detection of surface protein residues. In addition, pathogen specific environmental sampling should be conducted to monitor for the presence of specific pathogens that may be present as transient or resident microorganisms.

    The detection of specific pathogens serves two important roles. First, it highlights the presence of important food pathogens, which may have been introduced into a food-handling environment but may not have been eliminated by routine sanitation practices. Secondly, it assists in determining the sources of pathogens that may be resident.

    Sampling should not only be conducted on food contact surfaces, but the evaluation of non-food contact surfaces such as conveyor belts, rollers, walls, drains and air is equally as important as there are many ways in which microorganisms can migrate from non-food contact surfaces to food.

    Having High Standards for Your Food

    The average consumer most likely assumes that as long as a food or beverage they purchase is on the shelf with an expiration date, they are safe from bacteria and disease. Nevertheless, the type of testing that people should rely on is a more complex matter.

    The pyramid showcased above reflects several acronyms that tie back to the food processing system. Starting at the bottom, the pyramid references ‘PRP,’ ‘cGMPs,’ and ‘SSOP,’ all of which are associated with terms of practice. A ‘PRP’ is defined as a prerequisite program, a cGMP stands for current good manufacturing practices, and SSOP is short for a sanitation standard operating procedure.2 These quality management tools are the foundation of the food industry and ensure the products are safe for consumption.

    As the pyramid climbs, the similar-looking acronyms of ‘HACCP’ and ‘HARPC’ come to light. While they are both vital processes in food testing, they also are considered regulatory actions. When the Food Safety Modernization Act (FSMA) became law in the United States in 2011, it required all food facilities that are subject to the legislation administer a ‘Hazard Analysis and Critical Control Point.’ HARPC is close to what a HACCP does; its main difference is that it is geared to find potential threats and risks in food to then prevent future contamination.3

    At the top of the pyramid lies three manufacturing schemes for food processing. ‘BRC’ stands for the British Retail Consortium, which follows a group of worldwide standards for safety, like process requirements and hygienic control. The ‘FSSC 22000’ is owned by the Foundation for Food Safety Certification. It brings the requirements of the ISO 22000 Food Safety Management Standard and the Publicly Available Specification 220 together. The scheme is typically used by food manufacturers that provide their goods to major retailers. Lastly, the ‘SQF’ standards for Safe Quality Food 2000 Standard, which applies to both manufacturing and distribution. This system reassures consumers that food is meeting both domestic and international requirements before heading out to stores.4

    When Did Safety Procedures Become Relevant in Food Processing

    The history of environmental monitoring and testing in food processing within the United States actually started with standardizing drugs. According to the FDA’s timeline of U.S. Food and Drug Law, the first step to food safety was in 1820 when 11 physicians met and created the U.S. Pharmacopeia. This became the first collection of what many refer to as standard drugs within the nation.5

    Fast forward nearly 90 years later to the passage of the Food and Drugs Act of 1906, which was signed by President Theodore Roosevelt. The legislation banned the transporting of food and drugs that were considered “misbranded or adulterated.”6 The Meat Inspection Act was also passed on that same day.

    The Food and Drug Administration (FDA) was technically founded in 1927, but got its official name that citizens know it as today in 1930 due in part to an agricultural appropriations act.

    As the decades go by, the FDA implements dozens of new acts in order to keep up with the food safety practices of the time. In 1997, the Food and Drug Administration Modernization Act puts some of the strictest requirements into effect since the late 1930s. These measures included review of devices, regulation of advertising improper uses of standard drugs, and monitoring what companies would promote about their foods.

    Regulations for food processing facilities are constantly changing in order to keep the consumer safe, and it is up to the plants to follow the guidelines as they adapt to modern times.

    How Does the FDA Tie Into All of This?

    Many people rely on the FDA as the stamp of approval to consume certain products. While the organization is responsible for many types of products, it is not necessarily an across-the-board mandate.

    According to the FDA’s website, it is in charge of “regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.”7 However, the FDA does list and specify how these regulations are applied. For example, the FDA doesn’t exactly approve tobacco products, but rather holds them to a certain standard set by public health risks. It also does not approve food labels, but the organization makes sure the claims written on those labels are not false.

    With this in mind, the FDA is cleared to collect environmental samples from food processing facilities for several reasons. If the organization utilizes environmental monitoring ‘for cause,’ this means it is looking into a plant that may be posing a significant health risk due to the contamination of the product they make. It could also be due to reports of insanitary procedures or lack of an environmental monitoring method. If, at some point, a pathogen is found in the sample, the FDA can follow up by filing a report to the Reportable Food Registry.8 Officials will then encourage either a voluntary recall or a mandatory recall, and possibly alert the public to the issue at hand.

    The FDA wants the public to be kept safe from the items they consume, so its utilization and campaigning for environmental monitoring is key to its regulatory actions for all food processing plants.

    Hardy’s Solutions for Environmental Monitoring

    At Hardy, we are here to help with your environmental monitoring needs. From a full line of environmental testing swabs to the most advanced air sampling systems available, Hardy is a compliance partner with the experience and expertise you need.

    Hardy Diagnostics is a proud distributor of TRIO.BAS™ Microbial Air Samplers by Orum International. These devices are designed as the next generation of impact air samplers for viable airborne particle sampling in a cleanroom setting or general production environment. The lines features several different models: MINI, MONO, DUO, AIRBIO DUO, TRIO, MULTIFLEX 1 + 2, RABS ISOLATOR, and TRIO GAS. Hardy also allows customers to request a demonstration of the Trio Bas™ Microbial Air Samplers to make sure it fits their facility’s and lab’s needs.

    The EnSURE™ Touch by Hygiena is another reliable option Hardy offers in environmental monitoring testing for the food and beverage industry. It functions just like a smartphone, complete with a shatter-proof touchscreen, to ease the instructions of use for labs. The convenient device verifies the sanitation of surfaces, liquids, and product testing in a matter of just ten seconds for ATP testing, Escherichia coli, coliform, and total microbial load indicator tests. Its testing capabilities meet FSMA, GFSI, and ISO standards while storing all records through the SureTrend Cloud™ software program. The EnSURE™ Touch by Hygiena can also be requested for demonstration ahead of ordering to get a clear picture at how the device will work for environmental monitoring testing.

    Hardy Diagnostics manufactures contact plates for surface sampling that include a variety of agar media for selective and differential isolation of flat surfaces. The EnviroTrans™ line is a great way to sample and subsequently transport surface samples to a laboratory for further testing and includes various media types.

    When it comes to the food industry, Hardy is here to help prevent and diagnose disease to protect consumers from farm to table. Inspecting what consumers may eat is vital to maintaining a vibrant business while nourishing the stomachs and the hearts of many. If it is like they say and you are what you eat, why wouldn’t you want the best, healthiest, and safest options available?

    By Kelly Brickey, Digital Marketing Specialist I
    Jessa Youngblood, Food and Beverage Marketing Coordinator
    HARDY DIAGNOSTICS

    References

    1. https://www.foodsafetynews.com/2014/08/looking-back-100-years-of-food-safety-history-in-the-u-s/#:~:text=Federal%20food%20safety%20regulation%20really,and%20the%20Meat%20Inspection%20Act.
    2. https://www.sciencedirect.com/science/article/pii/B9780128007235000103
    3. https://safefoodalliance.com/haccp/what-is-the-difference-between-the-haccp-and-harpc/
    4. https://www.sgs.com/~/media/global/documents/white%20papers/sgs-global-food-safety-initiative-whitepaper-en-11.ashx
    5. https://www.fda.gov/about-fda/fda-history/milestones-us-food-and-drug-law
    6. https://www.visitthecapitol.gov/exhibitions/congress-and-progressive-era/pure-food-and-drug-act#:~:text=The%20Pure%20Food%20and%20Drug%20Act%20of%201906%20prohibited%20the,and%20Drug%20Administration%20(FDA).&text=preventing%20the%20manufacture%2C%E2%80%A6-,The%20Pure%20Food%20and%20Drug%20Act,items%20shipped%20through%20interstate%20commerce.
    7. https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved
    8. https://www.fda.gov/food/sampling-protect-food-supply/environmental-sampling

  • 2021

    In September, a new high speed automated plate pouring line was installed at Hardy’s Springboro, Ohio facility. It can pour ten petri plates at a time, making it the largest and fastest in America. It also fully automates the bagging, sealing, and labeling process so that the plates are never handled by human hands.

  • 2021

    In September, Hardy released its newest addition to its extensive line of Chromogenic media plates. HardyCHROM Candida+auris detects all the clinically significant yeasts (C. albicans, tropicalis, krusei, and glabrata) and now includes Candida auris. C. auris is a potentially deadly fungus that is highly resistant to most of the anti-fungal drugs. To aid in its identification, the colonies will fluoresce under a UV light as shown above.

  • What happens to your skin microbiome after a day at the beach?

    Ocean bacteria and viruses take up residence, but for a limited amount of time.

    As an individual initiates their first stride into the piercing cold ocean, our lungs are not the only part of our body greeted by the shock of the drastic change in environment. A brutal battle, invisible to the naked eye, has detrimentally affected those complex organisms who call our skin microbiome “home.”

    In a 2019 study, scientists examined the survival of organisms introduced by the ocean onto the human skin. What researchers found may surprise those who enjoy swimming in the sea.

    After spending an afternoon on the shore and partaking in water-related activities, organisms previously living on the skin are washed away and replaced with new ones. (2) As a result, this new environment causes changes to the composition and diversity of the microbiome. Potential pathogens along with hazardous organisms are introduced onto the body which could result in vulnerability to infections. (5)Subjects of these studies were selected according to the strict criteria below:

    1.    Subjects could not be undergoing any antibiotic treatments.
    2.    Application of sunblock was prohibited.
    3.    Individuals must classify themselves as a non-frequent ocean swimmer.
    4.    Subjects were not able to shower the morning of the experiment along with a full twenty-four hours after the zero hour sample was taken. 

    Individuals were swabbed four times throughout a 24-hour period to assess how long the newly introduced microbes could survive. (5) After the sixth hour, the microbiomes of the individuals had lost most of the invasive organisms from the ocean and regenerated the original organisms seen before swimming. By the twenty-four hour mark, the skin microbiome returned to nearly normal. (3)

    Marisa Chattman Nielsen, MS, a Ph. D. graduate from the University of California, Irvine, noted, “Ocean water is a unique exposure, because not only does it wash off normal skin bacteria, it also deposits foreign bacteria onto the skin. This is very different than a shower or even a pool, because those water sources usually have a low concentration of bacteria.” (2)

    Organisms such as Salmonella spp., Campylobacter spp., Vibrio spp., intestinal parasites, viruses and over fifty more species of bacteria found in storm-water and untreated raw sewage runoff can severely impact an individual’s health. This is especially of concern with a growing homeless population that does not properly dispose of solid waste.(2)

    Stephen Morse, PhD, a professor of epidemiology at Columbia University says, “Don’t swim where you see ‘red tides’ or fish die-offs. The authorities will almost always close these places to recreational use anyway. Immunocompromised people and weak swimmers should be especially careful. If you think you caught a disease or injured yourself while swimming, see a doctor.” (2)

    One of the most concerning issues is the rapid change occurring as we speak. Rising temperatures due to climate change could lead to a substantial increase in infections from swimming as a result of more suitable conditions for specific hazardous organisms. (4,6)

    To eliminate posing a threat to your health, scientists suggest practicing good hygiene after enjoying a day at the beach. Luckily, with a quick shower, foreign organisms and potential pathogens can be washed from the skin. (1,5,6) Chattman Nielsen reminds us, “This research isn’t meant to scare anyone. We already know that people can get infections from their environment, and the ocean is no different. Much of the bacteria found in the ocean does not cause human disease. Enjoy your time at the beach, and don’t forget to take a quick shower when you’re done.” (2)

    Sources: 123456

    By Emily Edds
    Microbiology Intern
    HARDY DIAGNOSTICS

  • Hans Christian Gram: The inventor of the Gram stain

    Hans Christian Gram, credited as the inventor of the Gram staining technique, was a pioneering biologist who devised the system of classification which led to as many as 30,000 formally named species of bacteria being investigated. Gram, working with German pathologist and microbiologist Karl Friedländer, devised the technique in Berlin in the early 1880s.

    Today marks the 168th birth anniversary of Hans Christian Gram. The Gram stain allows one to distinguish between Gram-positive and Gram-negative bacteria based on the bases of differential staining with a crystal violet-iodine complex and a safranin counterstain.

    In honor of his birth anniversary, Hardy Diagnostics demonstrates how to make the perfect Gram stain.  

    By Megan Roesner
    Clinical Marketing Coordinator
    Hardy Diagnostics

  • The Novavax protein antigen vaccine

    Is a New and Better Vaccine Coming Soon?

    A new player in the field of COVID vaccines could be arriving soon. The trials so far are encouraging for both safety and efficacy. It even has some advantages over the Pfizer, Moderna, and J&J vaccines that have become so familiar to us.

    Novavax, headquartered in Maryland, has enrolled over 30,000 volunteer individuals in the US and Mexico in their Phase 3 clinical trials of their new COVID-19 vaccine. This vaccine is both innovative and “old school” in that it uses viral protein (antigen) rather than mRNA.

    Here are the characteristics of this upcoming vaccine:

    • Clinical trials so far, show 90% effectivity against Covid-19 overall, and 100% protection from moderate to severe disease.
    • In people at high risk of developing complications from COVID-19 (people 65 years or older and people under age 65 with certain comorbidities or with likely regular exposure to COVID-19), the vaccine showed 91% efficacy in preventing symptomatic COVID-19 disease.
    • It is a protein based vaccine engineered from the first strain of SARS-CoV-2 virus. It uses recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. This antigen can neither replicate nor cause COVID-19 infection.
    • The vaccine is created using a genetically modified baculovirus which infects a culture of Sf9 moth cells, which create the spike protein and display it on their cell membranes. The spike proteins are then harvested and assembled onto a synthetic lipid nanoparticle about 50 nanometers across, each displaying up to 14 spike proteins. This complicated manufacturing process takes weeks rather than days as with the mRNA vaccines.
    • The adjuvant used is Novavax’s patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies.
    • It demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall.
    • It is stored and stable at refrigerator temperature (2 to 8 deg. C), so it can use existing supply chain modalities.
    • It requires two injections, 21 days apart, and possibly followed by a booster six months later.
    • Analysis of sera from primary vaccination series showed cross-reactive functional antibodies to Alpha, Beta and Delta variants, all of which increased 6- to 10-fold with the secondary booster injection.
    • Early human trials showed strong antibody responses, was well tolerated with no serious adverse events and few side effects. Injection-site tenderness and pain, fatigue, headache, and muscle pain were the most reported side events.
    • Novavax was originally backed by $388 million from the Coalition for Epidemic Preparedness and Innovation (CEPI), a non-profit founded by Bill Gates in 2015.

    Novavax has previous experience with recombinant and nanotechnology for the development of novel vaccines. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will soon be advanced for regulatory submission.

    This new COVID-19 vaccine may find its greatest use as a booster (known as a heterologous booster) to the previously released vaccines, which have shown rare but concerning adverse effects, such as blood clots and myocarditis (heart inflammation). Due to the low rate of side effects and adverse events shown so far, the Novavax may be the preferred booster vaccine of choice as our immunity eventually wanes with the Pfizer, Moderna, and J&J vaccines.

    References: 1, 2, 3, 4, 5, 6, 7

    by Jay Hardy, CLS, SM(NRCM)
    CEO
    HARDY DIAGNOSTICS

  • 2021

    In August, Hardy released yet another Chromogenic media plate that will easily detect Group A Strep (Streptococcus pyogenes) which is the cause of Strep throat infections. Clinical microbiologists appreciate the fact that the Group A Strep colonies develop a distinct red-orange color within 24 hours of incubation. Also, the colors are intensified by the pure white background.

  • 2021

    In 2021, Hardy Diagnostics had one of the biggest and best Food Drives in company history. Overall, between Ohio and California, we were able to donate over $20,000 worth of food and cash. These donations help lift up our local communities by donation to the Dayton Food Bank, The Santa Barbara County Food Bank, and The Salvation Army.

  • How the Gram stain identifies bacteria

    In 1884, Danish microbiologist Hans Christian Gram discovered that crystal violet irreversibly stained certain bacteria but can be washed from others. The Gram stain technique identifies bacteria as gram-positive (the stain is retained) or gram-negative (the stain is washed away.)

    Gram found that his stain worked for visualizing a series of bacteria associated with disease such as the “cocci of suppurative arthritis following scarlet fever.” He found, however, that Typhoid bacilli were easily decolorized after the treatment with crystal violet and iodine, when ethanol was added. We now know that those organisms that stained blue/violet with Gram’s stain are gram-positive bacteria and include Streptococcus pneumoniae (found in the lungs of those with pneumonia) and Streptococcus pyogenes (from patients with scarlet fever) while those that were decolorized are gram-negative bacteria such as the Salmonella Typhi that is associated with Typhoid fever.   

    Today, the Gram stain is still considered the “gold standard.” In this short video below, Hardy Diagnostics demonstrates how to perform the perfect Gram stain. 

    By Megan Roesner
    Clinical Marketing Coordinator
    Hardy Diagnostics

  • Mycobacterium avium paratuberculosis: A little known, but dangerous bug!

    Want to lower your risk of contracting a MAP-related malady? Here’s how.

    Emerging research is implicating Mycobacterium avium paratuberculosis (MAP) as the etiological cause of various diseases including inflammatory bowel disease, Crohn’s disease, Type 1 diabetes, rheumatoid arthritis, Hashimoto’s thyroiditis, multiple sclerosis and autism.(8) This species of bacteria is a relative of M. tuberculosis and belongs to the Mycobacterium avium complex (MAC) which consists of four subspecies:  aviumhominissuissilvaticum, and paratuberculosis.

    Due to the diseases that have become associated with this bacteria, it has us asking ourselves: What measures can be taken to prevent a MAP infection?”

    Cattle have long been identified as a main vector for MAP. The infection arises when calves younger than one year of age are exposed to MAP-contaminated manure or milk. In that first year of life, it is critical that the calves are quarantined in a clean, controlled area where they can be protected from exposure to infected adult cattle. Unfortunately, since MAP is not categorized as a zoonotic pathogen, regulations do not exist to enforce preventative measures like these at the farm level. Consequently, farmers generally turn a blind eye to the problem. Livestock MAP infections increased by 69% from 1996 to 2007, and dairy and meat products taken from grocery stores shelves were found to have MAP contamination that survived industrial pasteurization(1,2,3).

    If boiling your milk and cooking your beef beyond a crisp well done are not agreeable precautions, you may turn your attention to your home water supply. MAP is not destroyed by the chlorine levels introduced by water treatment plants, so it can make its home in your water filtration system, your shower heads, and even your water heater. Preventive measures that you can take at home include changing your water filters regularly, sanitizing your shower heads in bleach, throwing your humidifier in the trash, and draining your water heater every two weeks. Flee outdoors to escape your plumbing, and you may inhale MAP from the soil in your garden (4). For this reason, the author recommends filling your watering can with concrete.

    Perhaps a more practical preventive measure than staying away from water and soil can be found in probiotics. A 2008 study analyzed the impact of giving mice a 45 day supplement of Lactobacillus acidophilus before inoculating them with MAP. This research showed that the probiotic significantly increased the immune response to MAP in the mice (5).

    Vaccination may also prove a powerful weapon in the war on MAP. In populations with high exposure to Mycobacterium tuberculosis, the BGC vaccine is administered to infants. Studies have suggested that this vaccine, developed from Mycobacterium bovis, may also protect children from diseases triggered by other mycobacteria including MAP. One study found that children who received a BCG vaccine within one month from birth were less susceptible to MAP infection and less likely to develop Type 1 Diabetes (6,7). 

    MAP is a formidable microbe that will not be easily defeated, so batten down the hatches and never apologize for demanding well-done steaks.

    By Mark Andrew Pruett
    Performance Studies Technician
    Hardy Diagnostics

    Works Cited:
    12345678

  • Unmasking the Facts in a Post-Pandemic World

    Is there a correlation between the end of mask mandates and the rise in cases of the common cold and influenza?

    The start of the summer is aligning with another new beginning, one in which many around the world make a return to the “New Normal” and relearn what life was like before COVID-19. While some take baby steps in adjusting to a post-pandemic landscape, most are ready to step into their typical routines that they once knew.

    A major change has erupted across the United States in the past couple months in terms of leaving COVID-19 in the past: unmasking. The U.S. Centers for Disease Control and Prevention stated on May 13, 2021, that those who are fully vaccinated—meaning they have received the single dose of the Johnson & Johnson vaccine or both doses of the Pfizer/Moderna vaccines, and have had these vaccines in their systems for two weeks—may go maskless in the majority of public settings. As states and local governments across the country have come to terms with this new advisory, more people have felt comfortable following the guidelines and discarding their face coverings from over the past year. However, with that shift, common ailments are making a comeback in a peculiar fashion.

    The difference between seasonal influenza and COVID-19

    According to the CDC, “influenza (flu) and COVID-19 are both contagious respiratory illnesses, but they are caused by different viruses.”1Despite the similarities of each illness, there are distinct qualities about the two diseases. Both viruses lead to several critical symptoms including coughing, fever, fatigue, shortness of breath and muscle aches. The two types of viral infections vary in the timing of when these symptoms typically occur. With the flu, patients will begin to experience symptoms around one to four days post-exposure; whereas with COVID-19, patients experience symptoms anywhere from two to 14 days post-exposure. Another major difference between the two diseases is in their recovery states. While most people who come down with the flu will recover within a few days with medications and rest, COVID-19 recovery can last anywhere from weeks to months. The CDC also states that even though both viruses spread in the environment in a similar fashion, COVID-19 is more contagious than influenza.

    Understanding how a virus, like influenza or SARS-CoV-2, spreads is important in determining its rate of infection. Scientific experts rely on the basic reproduction number, R0 or R-naught, to determine the average amount of people that can be infected by an individual who carries the virus.2The R0 is calculated using the average of three factors: the infectious period of the disease, the way of transmission and the amount of people who have been in contact with an infected subject.

    According to an article published by the University of Michigan School of Public Health, the R0 range of seasonal influenza sits at 0.9 to 2.1.3The data also shows SARS-CoV-2, the virus that causes COVID-19, has an R0 range of 1.5 to 3.5, which demonstrates how much more it can reproduce as opposed to the flu. While scientists are working on determining the R0 for the Delta variant of COVID-19, a table produced by Imperial College London estimates the range being anywhere in between 5-84, with the CDC saying the strain is as contagious as chickenpox.

    How the seasonal flu declined during the time of COVID-19

    Throughout the pandemic in 2020, COVID-19 took center stage and the typical flu season received little to no attention. This is not necessarily a coincidence though; the incidence of seasonal influenza was not as common as in years past. According to data from the CDC’s website, there was only one influenza-related pediatric death reported in the 2020-2021 flu season. Meanwhile, the previous flu season in 2019-2020 resulted in 199 deaths.5On that same wavelength, Scientific American reported there were approximately 600 deaths from influenza in the U.S. during the 2020-2021 season.6This number is small compared to the 22,000 deaths in the 2019-2020 season and the 34,000-recorded deaths in the 2018-2019 season.

    The novel Coronavirus took precedent in the headlines during the regular flu season in 2020-2021 due to its substantial amount of deaths in the U.S. and worldwide. According to data published by the Center for Systems Science and Engineering at Johns Hopkins University, there have been more than 3.8 million deaths related to COVID-19 globally, with more than 600,000 of those in the U.S. alone (as of June 23, 2021).5

    What does the most recent flu season mean for the upcoming season

    Public Health officials have noted the decrease in seasonal influenza cases throughout the span of the COVID-19 pandemic, and several are raising concern about the negative effects of the non-existent flu season last year. The CDC reported that the hospitalization rate for seasonal flu during the 2020-2021 season was 0.7 per every 100,000 people in the U.S.7 This marked the lowest number of cases on record.

    Advisory Board spoke with Rachel Baker, who studies public health and infectious disease at Princeton University for its High Meadows Environmental Institute, to see what her research has found in correlation to the low flu numbers. She and her team attributed the increase in social distancing to prevent the spread of COVID to the 20% decrease in respiratory syncytial virus (RSV) in the U.S.8

    In an article published by CNN, Lynette Brammer, the head of the CDC’s Domestic Influenza Surveillance Team, predicted an uptick in flu cases as the general population returns to its routine lifestyle.9

    “I certainly think as the mitigation measures as we have in place for COVID come down and kids go back to school in person and we all start traveling again, particularly internationally, we know all sorts of respiratory viruses are going to have much more opportunities to spread,” Brammer explained.

    University of Michigan School of Public Health epidemiologist Aubree Gordon studies the influenza virus. She told CNN that another reason this flu season may be heightened is due to a decrease in exposure throughout the past 15 months.

    “The longer you go without exposure, the more likely you are to be symptomatic and more likely to be sicker. We do know the longer you go without being exposed to influenza, the more symptomatic you are. Sicker individuals lead to more severe cases. We absolutely know that,” Gordon said.

    Due to a lack of information about the 2020-2021 flu strain, Advisory Board reports that it may be more difficult for scientists to create the vaccine for the upcoming flu season as they typically base the treatment off the previous outbreak. Nevertheless, experts cannot conclude what will lie ahead in the upcoming flu season.

    Should people start wearing masks if they have seasonal influenza?

    As unmasking across the country continues to happen, some may wonder whether they will have to bring their face coverings back out by the time the 2021-2022 flu season comes around. Establishing masking guidelines for a non-pandemic-related illness is under consideration by scientists and researchers.

    The CDC released its “Interim Guidance for the Use of Masks to Control Seasonal Influenza Virus Transmission,” which covers the common procedures recommended if someone has the flu.8 In a healthcare setting, symptomatic patients should wear a mask until they are isolated in a room by themselves. Healthcare officials should also wear a mask if they are within six feet of an infected individual for treatment.

    While the guideline is clear about the precautions to take for symptomatic patients, the direction for those outside of healthcare settings or asymptomatic patients leans into a few different measures to take. The CDC recommends putting pharmaceutical and social practices in place to decrease the development of the virus. Personal preventive measures include the proper washing of hands, covering one’s mouth when they are coughing and/or sneezing and practicing social distancing from those who are not sick.

    Ultimately, the CDC advises that getting the flu vaccine is the main way to stop the spread of seasonal influenza. While the organization recognizes that those who get their flu shot can still become infected, the chances of experiencing high-risk complications from the virus are low. There are also antiviral medications available for those who are greatly affected by the flu and are hospitalized.

    Moving Forward to Protect Others

    In order to keep our customers and our community safe from disease, Hardy Diagnostics sells numerous products that can prevent a dramatic spread of viral illnesses in order to protect others in the future. Hardy Diagnostics is an authorized distributor for the Quidel QuickVue lateral flow tests10, with the purpose of diagnosing Influenza A and B. The rapid lateral flow test is CLIA waived and delivers results in just 10 minutes.

    When COVID-19 started to spread rapidly across the U.S., Hardy Diagnostics also became a distributor of a rapid test kit that was essential in detecting antibodies related to the SARS-CoV-2 virus.11 The Premier Biotech COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow immunochromatographic assay can detect SARS-CoV-2 antibodies in venous whole blood, serum or plasma. The results are available in only 10 minutes and this test is CLIA waived. This test is also convenient because it does not require any equipment to perform.

    As for basic protection from such viral infections, Hardy Diagnostics manufactures and distributes laboratory supplies to help keep everyone safe. These products include sanitizers and cleansers such as AloeSafe™ Antiseptic Hand Sanitizer and personal protective equipment like Exam Gloves and NIOSH-approved N95 masks with a V-fold design. These products, aligned with health guidelines, will allow healthcare workers, caregivers, and the general population to defend themselves against diseases such as COVID-19 and the seasonal flu.

    To further support our healthcare heroes and laboratorians, Hardy is continuing to manufacture a room-temperature stable formulation of Viral Transport Media. This is an essential medium to transfer specimens to the laboratory for viral testing methods. Our VTM, R99, is a non-propagating culture media that complies with the CDC formulation and has the room temperature storage capability of 270 days.

    At Hardy Diagnostics, we are dedicated to “A Culture of Service,” and our mission is to “partner with our laboratory customers to diagnose and prevent disease.” We are very serious about manufacturing and distributing products that can reduce the spread of viral diseases, such as COVID-19 and influenza.

    By Kelly Brickey
    Digital Marketing Specialist I
    Hardy Diagnostics

    References

    1. https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm
    2. https://globalhealth.harvard.edu/understanding-predictions-what-is-r-naught/
    3. https://sph.umich.edu/pursuit/2020posts/how-scientists-quantify-outbreaks.html
    4. https://newsroom.unsw.edu.au/news/health/what-we-know-about-sars-cov-2-delta-variant
    5. https://www.cdc.gov/flu/weekly/index.htm#S3
    6. https://www.scientificamerican.com/article/flu-has-disappeared-worldwide-during-the-covid-pandemic1/
    7. https://www.arcgis.com/apps/dashboards/bda7594740fd40299423467b48e9ecf6
    8. https://www.advisory.com/en/daily-briefing/2021/03/30/flu-season
    9. https://www.cnn.com/2021/06/08/health/influenza-season-doozy/index.html
    10. https://hardydiagnostics.com/rapid-tests-quidel/
    11. https://hardydiagnostics.com/coronavirus-covid-19-update/

  • Is there a simple and inexpensive treatment for Ebola?

    Antidepressants may be our best bet in treating Ebola

    The 2013 to 2016 Ebola outbreak in West Africa made global headlines and inflamed discussion as the largest single outbreak of this deadly virus. The lack of a vaccine approved for use in humans and the rapid rate of mutation in the Ebolavirus genus create a particular vulnerability to large-scale outbreaks. While vaccination development focuses on traditional antiviral approaches, screens of FDA-approved drugs have shown that a multitude of agents will inhibit the progression of Ebola to varying degrees. A University of Oxford research group has demonstrated in three publications that protection from Ebolavirus can be achieved with existing pharmaceuticals.

    Viruses consist of genetic material encapsulated in a protein coat. Elements of this protein coat are responsible for mediating entry of the virus into a host cell. The various ebolaviruses specifically use a glycoprotein trimer for essentially all functions of entry to a host cell, from attachment to membrane fusion. The critical importance of the glycoprotein and its subcomponents to ebolavirus infection make it of interest for controlling future epidemics: if the glycoprotein can be disrupted, Ebola loses its key to entering human cells.

    The Oxford team started their research by crystallizing GP1, one of the components of the Ebola glycoprotein. By introducing pharmaceutical compounds and measuring the change in melting temperature of the protein, the binding strength of the compounds to the GP1 protein can be evaluated. Zhao et al conducted their first study in 2016, using the well-known painkiller ibuprofen and a selective estrogen receptor modulator used for breast cancer treatment called toremifene. They found that toremifene was particularly effective, reducing the melting temperature of the GP1 protein by 14°C at physiological pH and a concentration of 100 μM. The derived binding constant for toremifene based on this data becomes 16±4 μM, while ibuprofen was only hitting at 6±2 mM. The team was able to demonstrate that both agents were binding in a particular pocket on the GP1 protein.

    In their 2017 study, Zhao et al chose a selection of eight compounds reported to have activity against Ebola, and repeated their thermal-shift assay with the new set of compounds. Four of the selected agents showed no affinity for the crystallized GP1, but the other four produced a significant effect. Their structures, and currently approved uses, are fairly diverse: bepridil is a calcium-channel blocker, sertraline and paroxetine are both selective serotonin reuptake inhibitors (SSRIs); and benztropine is a muscarinic antagonist prescribed to reduce extrapyramidal side effects. X-ray data showed that the same sub-pocket bound by ibuprofen and toremifene was the target for this set of drugs as well, with binding constants in the range of 0.29 – 1.3 mM. Recently, the same group has demonstrated that the antidepressants imipramine and clomipramine as well as the antipsychotic thioridazine are also capable of binding Ebola’s GP1 via the same sub-pocket.

    The affinity of small molecules for the GP1 sub-pocket isn’t just a curiosity. In work funded by the Defense Threat Reduction Agency (DTRA), a team has tested some of these screening hits in mouse models to evaluate actual effectiveness. Over two studies, Lisa M. Johansen et al evaluated toremifene and the related drug clomipramine, as well as bepridil and sertraline. In mouse models, they found that dosing mice with toremifene led to a 50% survival rate against Ebolavirus, and clomipramine was particularly impressive, with a 90% survival rate. The antidepressant sertraline resulted in a 70% survival rate, but bepridil was the most impressive of all, with 100% of the mice surviving Ebola infection.

    The work these two teams have done is an excellent lead on creating a true Ebolavirus treatment. While the high survival rates of the murine models in the DTRA studies is impressive, the drugs tested all had median inhibitory concentrations in the micromolar range, while typically drugs for use in humans only get to high nanomolar concentrations in vivo. The real utility of this research can come in conjunction with the structural analysis of the drug’s binding characteristics carried out by the Oxford team.

    While an Ebola vaccine would be the preferred approach for preventing outbreaks, these two research teams have provided an unusually detailed look at what it would take to develop a structural inhibitor of Ebola glycoprotein by simply repurposing existing drugs that have a proven track record for decades.

    Granted that murine studies do not always correlate with humans, but the creation of a small-molecule inhibitor, tailor-made to fit into the GP1 sub-pocket, may be a major step towards controlling the next Ebola outbreak when it occurs.

    By Weston Mangin
    Biomedical Engineer
    HARDY DIAGNOSTICS

    Sources: 1, 2, 3, 4, 5, 6

  • Helicobacter pylori: Friend or Foe?

    Can H. pylori colonization offer some protection against disease?

    Helicobacter pylori is an organism typically known as the culprit of painful stomach ulcers and severe abdominal pain, although there is now growing evidence which suggesting that there may be advantages to colonization by this acid-loving organism.

    In several studies conducted during the 1990s and 2000s, correlations emerged between H. pylori colonization and reduced risk of several diseases or symptoms such as bacterial diarrhea, asthma, and allergies in children, as well as gastroesophageal reflux disease (GERD), and celiac disease.(1, 2, 3)

    Many people are asymptomatically colonized with H. pylori and do not suffer adverse effects. In these instances, H. pylori may play a beneficial role and does not necessarily require eradication through treatment.

    The menacing complications caused by H. pylori infection described on the Johns Hopkins Medicine website are stomach bleeding, perforation of the stomach wall, ulcers blocking food from leaving the stomach, and stomach cancer.(4) Despite these complications, research suggests that there is no health benefit to eliminating H. pylori when a child is asymptomatically colonized with the organism.(5) In a study by Monajemzadeh, et. al., H. pylori prevented bacterial diarrhea in children.(6) In 2008, Chen and Blaser showed reduced asthma and allergies in patients colonized by H. pylori.(7) Based on these and other publications, non-invasive H. pylori colonization appears to be a beneficial organism of the gut microbiome.

    The symptoms and diseases caused by invasive H. pylori can be severe and are important to detect and diagnose in patients presenting illness. However, this organism appears to be important to the human microbiome by providing an immunity boost to other diseases and allergies.

    More research is needed in this area to determine whether the presence of this organism could prevent or eliminate some types of disease states. Presently, the eradication of H. pylori does not seem necessary for asymptomatically colonized individuals, and may even prove to reduce the beneficial effects.

    by Anna Klavins
    R&D Microbiologist, Hardy Diagnostics

    Works cited:
    1.     https://www.naspghan.org/files/documents/pdfs/annual-meeting/2014/czinn.pdf
    2.     https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4291894/
    3.     https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3858109/
    4.     https://www.hopkinsmedicine.org/health/conditions-and-diseases/helicobacter-pylori
    5.     https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3928165/
    6.     https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3950475/
    7.     https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3902975/

  • Bone Grafts: A life-giving procedure becomes life-threatening…

    Some patients have become infected with TB from contaminated graft material. How are they screened for infectious disease?

    In June of this year, it was discovered over 100 patients may have been exposed to tuberculosis originating from cadaver-derived material used in their bone graft procedures.

    Second only to blood, human bone is the next most transplanted tissue and is uniquely suited to heal itself. With an aging population, demand for bone grafts used for procedures such as bone and joint disorders, as well as dental bone grafts, is expected to see a market boom in the coming years.

    Currently, there are approximately 500,000 bone grafts performed in the U.S. each year. Though autologous bone—bone taken directly from the patient’s own bone—is the gold standard, this type of graft is not always possible, especially because of the limitations in terms of the graft amount that can be harvested. Therefore, allogenic bone—dead bone harvested from a human cadaver—can be used as a scaffold over which the patient’s own bone can re-grow and fill in the defect or void.

    Allogenic bone is available in a variety of preparations: morselized and cancellous, corticocancellous, cortical graft, osteochondral, whole bone segment, and demineralized bone matrix.(1) It is advantageous in that it doesn’t require a
    procedure to harvest the patient’s own bone, so it can be used in time-sensitive procedures, such as those caused by trauma, or when performing an autograft (using autologous bone) may not be feasible.

    However, one of the critical risks to using allogenic bone is the potential for transmission of an infectious agent, such as a virus or bacterium, that may be present in the sample despite thorough donor testing. A review of literature cases shows HIV, HBV, HCV, and bacterial infections, including Clostridiodes difficile, have been reported.(1)

    Moreover, many infectious agents, like spores, cannot be completely removed through a sterilizing process due to the density of cortical bone, though viruses can be eliminated via the popular freeze or freeze-drying process. Consequently, there is a higher level of risk to the recipient when using allogenic bone grafts.

    The risk of infectious disease transmission highlights the need for appropriate sterilization techniques or testing methods in the tissue banking practice.(2) For example, recent news reports document several patients became sickened by tainted allograft (allogenic bone) material known as FiberCel.(3,4) FiberCel is a fiber-based, malleable, putty-like bone repair product made from human cadaver tissue engineered to maintain natural tissue
    characteristics.(4) It can be used in orthopedic or reconstructive procedures alone, or in combination with autologous bone or other forms of allogenic bone.

    The affected allogenic FiberCel bone had been infected with tuberculosis and used in various orthopedic and spinal graft procedures. Sickened patients were tested and their wounds found to be contaminated by the same bacterium. The lot of contaminated allogenic bone consisted of 154 units, which had been sent to 37 facilities in 20 states, all derived from a single donor. The CDC states between March 3rd and April 2nd, 136 units were implanted into 113 patients.(7)

    Aziyo, the company at the center of the investigation, is performing a voluntary recall and is currently being sued.(5)

    The unfortunate consequence of infection by tuberculosis is significant. Mycobacterium tuberculosis often affects the lungs, but the bacterium can attack any part of the human body; if not treated properly, the infection can become
    fatal.(6) In addition, because tuberculosis is a communicable disease and a threat to public health, infections must be
    reported to local or state health authorities. Infected patients must endure a lengthy treatment period with antibiotics, and there may be concerns for infection by a multi-drug resistant strain of the bacterium, which could further complicate patient treatment and recovery.

    Without antibiotic treatment, TB often becomes latent: not causing symptoms in people until their health declines for other reasons. But in less healthy or immunocompromised people, TB can cause serious, life-threatening illness. Outside of the U.S., TB remains one of the more common deadly diseases in the world, killing upwards of a million people annually. The United States reported nearly 9,000 cases of tuberculosis in 2019. Up to 13 million people in the United States are estimated to be living with latent TB infection, according to the CDC.

    Oversight of tissue processing in the U.S. is by federal and state regulatory authorities under the Uniform Anatomical Gift Act (UAGA). Tissue banks are governed by the National Organ and Tissue Transplant Act (NOTA). The recent event outlined above may result in testing or frequency of inspection changes, especially due to the potential growth in bone
    graft market needs in the coming years, and has already resulted in a bulletin on the American Association of Tissue Banks (AATB) website: Potential Mycobacterium tuberculosis Transmission Through Tissue Transplantation.

    Tissue banks must follow guidance documents to assess tissue donor material, follow comprehensive, stringent microbiological testing processes, and have environmental controls and monitoring procedures in place, in addition to other regulatory procedures and practices to become or remain accredited. For more information on standards for tissue banking or tissue banking guidance documents, or to find an accredited tissue bank, see the AATB website: https://www.aatb.org/.

    By Kerry Pierce
    Design and Development Microbiologist
    Hardy Diagnostics

    References:

    1. Sohn HS, Oh JK. Review of bone graft and bone substitutes with an emphasis on fracture surgeries. Biomater Res. 2019;23:9. Published 2019 Mar 14. doi:10.1186/s40824-019-0157-y
    2. Fahmida Binte Atique, Md. Masudur Rahman Khalil, “The Bacterial Contamination of Allogeneic Bone and Emergence of Multidrug-Resistant Bacteria in Tissue Bank”, BioMed Research International, vol. 2014, Article ID 430581, 5 pages, 2014. doi.org/10.1155/2014/430581
    3. https://menafn.com/1102225912/AziyoBiologics-Comments-on-June-2ndVoluntary-Recall-of
    4. https://www.beckersspine.com/spine/ite
      m/52021-patient-sickened-by-taintedspine-allograft-sues-aziyo-medtronic.htm
    5. https://www.fda.gov/vaccines-bloodbiologics/recalls-biologics/urgent-voluntary-notification-fibercel-fiberviable-bone-matrix-fibercel-lot-numbernmds210011
    6. https://www.cdc.gov/tb/topic/basics/default.htm
    7. https://www.washingtonpost.com/health/2021/06/18/tb-bone-product/

  • Bald’s Eye Salve: A Thousand-Year-Old Effective Antibiotic

    Medieval doctors didn’t always prescribe what was best for an ailing patient (leeches were a popular therapy). However, a medical manuscript from the 10th Century called Bald’s Leechbook recently found in the British Library details a concoction of wine, oxbile, and two species of Allium (garlic, onion, or leek) used to treat styes, now known as an infection caused by Staphylococcus aureus.

    The Old English leather-bound volume – Bald’s Leechbook – is widely thought of as one of the earliest known medical textbooks and contains Anglo-Saxon medical advice and recipes for medicines, salves and treatments.

    Based on knowledge of antimicrobial molecules in the mixture, a group of historians and microbiologists teamed up to interpret the text to determine the actual efficacy of this ancient brew.

    While wine, oxbile, onion, and garlic are believed to contain antimicrobial compounds by themselves, when combined they are far more effective than each individual ingredient.

    Unexpectedly, individual preparations of wine, oxbile, and onion had limited antimicrobial activity against planktonic (free-floating single bacterial) cells in Mueller Hinton Broth and synthetic wound fluid. The addition of garlic, which contains the thiosulfinate allicin, enhanced the activity of the remaining three ingredients.

    In a S. aureus biofilm model, Bald’s eye salve outperformed pure allicin as well. Allicin, at 500µg/mL resulted in only a two to three log reduction of bacteria, while eye salve with an allicin concentration of 275-486 µg/mL resulted in a 6-7 log reduction or eradication. However, omitting one of the other ingredients somehow led to a loss of potency.

    The thousand-year-old Bald’s eye salve was then tested against clinically significant organisms in a number of studies. It exhibited bactericidal activity against planktonic cultures of several ESKAPE pathogens (Enterococcus faecium, S. aureus, Klebsiella pneumonia, Acinetobacter baumannii, Pseudomonas aeruginosa, and Enterobacter spp.) in a broth microdilution. A synthetic wound model showed a 2-6 log reduction of S. aureus, Staphylococcus epidermidis, Streptococcus pyogenes, and A. baumanii biofilms.

    Application of Bald’s eye salve in mice infected with methicillin-resistant S. aureus (MRSA) resulted in notable reduction compared to vancomycin. Eye salve preparations tested by disk diffusion also exhibited statistically significant activity against a multi-drug resistant Neisseria gonorrhoeae strain.

    While medieval medicine was largely a craft, this “ancientbiotic” demonstrates the synergistic activity of natural compounds that individually or in pure form, render little effect. It also shows how drastic the efficacy of a mixture of compounds can be against planktonic cells versus biofilms.

    Scientists are often so fixated on isolating one compound in a natural product that they overlook possible reactions with synergistic medicinals.

    Bald’s eye salve is not the first antimicrobial mixture rediscovered from ancient texts (the antimalarial Artemisinin was described in Chinese manuscripts). However, there may be more solutions to antimicrobial resistance yet to be discovered in the history books.

    By Sarah Hepler
    R&D Microbiologist
    Hardy Diagnostics

    References:
    1. https://www.cnn.com/2020/07/28/health/medieval-remedy-antibiotic-resistance-alternativesscn-trnd/index.html
    2. https://www.cnn.com/2015/03/31/health/anglo-saxon-potion-mrsa/index.html
    3. https://www.nature.com/articles/s41598-020-69273-8
    4. https://www.biorxiv.org/content/10.1101/2020.04.23.041749v1

  • Will More COVID Variants Emerge?

    Although of great concern, vaccination will help

    When will the pandemic end? How many more COVID-19 waves will the U.S. go through? Will we go back to “normal” in the fall? All these questions depend largely on one factor: the epidemiology of the variants.

    As the virus spreads around the world, variant strains have emerged. Some variants are more infectious and spread rapidly; they show an increase in transmissibility. Other variants are more successful at evading the immune system; they show an increase in infectiousness. Variants with these characteristics have caused massive waves of COVID-19 from Brazil, South Africa, the United Kingdom – and now India. There are currently five variants of concern (1). 


    These variants have several interesting modifications to the spike protein when compared to other closely related variants. The spike protein projects from the spherical viral particle ready to cling on to unsuspecting cells that have the ACE2 receptor.(2)

    Research led by Dr. Bing Chen, PhD, at Boston Children’s Hospital, analyzed how the structure of the spike protein changes when the amino acid aspartic acid is mutated to a glycine.

    When Dr. Chen and colleagues imaged the mutant spike protein, the authors noted that this particular mutation “prevented premature disassociation…effectively increasing the number of spikes and enhancing the infectivity for membrane fusion.” As Dr. Chen further explained, “Say the original virus has 100 spikes…Because of the shape instability; you may have just 50% of them functional. In the G614 variants, you may have 90% that are functional, so even though they do not bind as well, the chances are greater that you will have infection.”(5)

    The spike protein is also the basis of current COVID-19 vaccines, which were designed to generate an immune response against it. Furthermore, if the spike protein continues to mutate, this can affect diagnostic detection, therapeutic treatment, and/or the body’s immune response which could lead to an increase in unique COVID-19 variant outbreak clusters. (3)


    The potential for global viral mutation increases with the frequency of circulation in human and animal populations. Therefore, reducing transmission using established disease control measures to stop the spread of new variants remains key–good hygiene (especially hand hygiene), mask wearing, physical distancing, and good ventilation. Vaccination on a global scale in a timely manner is also necessary to prevent the emergence of new variants. Current studies show that vaccine efficacy against severe, critical, or fatal disease is very high at 97.4% against most known variants.(4) As more people are vaccinated, the circulation of COVID-19 is expected to decrease; therefore, leading to fewer opportunities for mutations to arise and less chance for the evolution of new variants.

    References: 123456

    By: Francisco Pinon, R&D Microbiologist
    HARDY DIAGNOSTICS

  • Are we getting closer to herd immunity?

    How far do we have to go to reach herd immunity?

    First of all we must know that herd immunity is defined as a form of indirect protection from infectious disease that can occur with some diseases when a sufficient percentage of a population has become immune to an infection, either through vaccination or previous infections, thereby reducing the likelihood of infection for individuals who lack immunity.(1)

    Although many different percentages have been declared to reach herd immunity, the WHO states the target percentage for COVID-19 is not currently known. This explanation is from the WHO website (2):

    “The percentage of people who need to be immune in order to achieve herd immunity varies with each disease. For example, herd immunity against measles requires about 95% of a population to be vaccinated. The remaining 5% will be protected by the fact that measles will not spread among those who are vaccinated. For polio, the threshold is about 80%. The proportion of the population that must be vaccinated against COVID-19 to begin inducing herd immunity is not known. This is an important area of research and will likely vary according to the community, the vaccine, the populations prioritized for vaccination, and other factors.” 

    However, in an effort to determine the herd immunity percentage, a recently CDC published study examined infection rates in ten communities in Qatar and concluded that an infection rate of 65 – 70% would be needed to reach herd immunity. Alternatively, herd immunity might be reached at a vaccination coverage of about 75% if vaccine efficacy is 95%, similar to that of the recently licensed SARS-CoV-2 vaccines, the researchers claimed.(3)

    By Jay Hardy, CLS, SM(NRCM)
    President, Hardy Diagnostics

    References: 1234

  • 2021

    Hardy becomes the exclusive distributor for the AutoBio Autof ms 1000 spectrometer for the rapid identification of microorganisms. This MALDI-TOF instrument is capable of identifying 96 samples in less than 20 minutes hands-on time. Its database is the largest in the industry and contains 5,000 species with over 15,000 strains of bacteria, yeast, and filamentous fungi. The set up and operation is simple and the cost per test is extremely low. Hardy’s first sale of this advanced instrument was to the Animal Health Diagnostic Center at the Cornell University in New York.

  • Why Public Health Depends Upon Antimicrobial Stewardship

    Public health is facing a looming crisis. However, unlike many more obvious public health emergencies, the majority of us may not recognize or realize the culprit: antimicrobial resistance. As hundreds of thousands of patients come face-to-face with health issues related to antibiotic-resistant infections, the scientific community must address the significance of antimicrobial stewardship and its core principles.

    What is antimicrobial stewardship?

    According to the Centers for Disease Control and Prevention (CDC), antimicrobial stewardship is the endeavor to measure and improve how antibiotics are prescribed and used in a healthcare setting.1 This type of conservancy creates an innovative approach to identifying the critical and complex need for antibiotic therapies, while measuring the outcome to prevent misuse or overuse of antibiotics.

    While antibiotics are prescribed to fight bacterial infections, the CDC reports approximately 30% of all antibiotics prescribed to acute care patients in the United States are not necessary in the progression of treatment.2 Overuse of antibiotics has led to an increase in antimicrobial resistance, which has been identified as a serious ongoing threat to public health.

    Who was Sir Alexander Fleming, and how did he contribute to antimicrobial stewardship?

    In 1928, Scottish scientist Sir Alexander Fleming made his monumental discovery of penicillin while experimenting with staphylococcal bacteria.3 Quite by accident, he found one of his uncovered agar plates had become contaminated with mold spores, and bacteria surrounding the mold growth were inhibited. He later identified the mold as a member of the Penicillium genus and began to perform further experiments to determine the inhibitory agent. The agent, now termed penicillin, was later found to fight against bacteria that cause diseases such as pneumonia, meningitis and scarlet fever.3

    Fleming’s findings did not catch on quickly, as it took more than a decade from the time of his publications for the scientific community to embrace penicillin. It was scientists Howard Florey and Ernst Chain who wanted to use penicillin as a treatment for soldiers during World War II.3 After mass production and successful use of penicillin throughout the war, Fleming was ultimately awarded the Nobel Prize for Physiology/Medicine in 1945.3

    What we now refer to as antimicrobial resistance was first addressed by Fleming during a 1945 interview with the New York Times.  While noting the importance of an antibiotic, such as penicillin, he also warned about the abuse of such a critical discovery, “In such cases, the thoughtless person playing with penicillin is morally responsible for the death of the man who finally succumbs to infection with the penicillin-resistant organism. I hope this evil can be averted.”4 As if on cue from Fleming’s ominous prediction, just ten years into its widespread use, penicillin resistance began to emerge.

    Rising resistance

    During the past few decades, many strains of bacteria have evolved resistant to antibiotics. Infectious bacteria are much harder to control than their predecessors were ten or twenty years ago.

    The uptick in multi-drug resistant organisms (or MDROs) has resulted in the magnification of hospital-acquired infections (HAI) and a decrease in antibiotic efficacy against certain microorganisms. These consequences bring complexities to medical decisions regarding patient treatment and patient management. MDRO diagnosis in a hospital or long-term care setting requires additional controls, patient isolation, often-prolonged patient hospitalization, and the use of last-line-of-defense treatments, which bring even further risk. While the pace of antibiotic discovery was stunted in the early 2000s, there has been an uptick of new broad spectrum antibiotics approved by the FDA within the last ten years geared toward MDROs such as Ceftolozane/Tazobactam, Ceftazidime/Avibactam, Meropenem/Vaborbactam, Delafloxacin, Plazomycin, Omadacycline, Eravacycline, Lefamulin, Imipenem/Relebactam, and Cefiderocol. In order to confront the matter of the escalation of antimicrobial resistance, hospitals and medical staff must establish procedures in correlation to an antimicrobial stewardship mindset.

    How hospitals and clinicians can help

    Saving patients from contracting resistant organisms must start with initiating the development of an antimicrobial stewardship group within the facility. There are several elements needed of an effective infection prevention team: leadership, accountability, drug expertise, action, tracking, reporting and education.7 These key points encompass the mission of antimicrobial stewardship.

    Leadership comes first in the medical institution by simply incorporating an antimicrobial stewardship standard of duty in professional job descriptions, exhaustive stewardship training, and contractual obligations required by those positions. With that principle at the foundation, accountability follows by forming policies to support antibiotic use, requiring interventions with certain prescriptions, and reassessment by a subject matter expert (i.e. pharmacists, clinicians, etc.).

    The action comes when policies are implemented into the daily course of action, and are enforced when an “antibiotic time-out” must occur to reassess the most fitting treatment for the patient. As the strategy for preserving antibiotic stewardship is solidified, it can be tracked through documentation, noting dosage, duration and indication before reporting information. All of these steps ultimately help achieve a successful antimicrobial stewardship program, which is the core consensus of the process.

    Hardy Diagnostics’ role in the fight against antimicrobial resistance

    Patient health is our priority. We know antimicrobial resistance is on the rise. We also know that our company can and has made a difference by focusing on detection, identification and diagnosis to assist laboratorians and physicians keep patients safe and healthy. Because we know that public health is facing this threat on an evolutionary scale, Hardy Diagnostics continues to strive to set a standard of antimicrobial stewardship through leadership, accountability, expertise, research, education and action. Reducing the flow of resistant genes among pathogenic bacteria and developing new treatments for future generations is key to this fight.

    In 1996, Hardy Diagnostics became the first manufacturer to introduce chromogenic prepared culture media to the United States. Since then, Hardy continues to expand its line of chromogenic media to aid in the detection of resistant strains by creating media such as: HardyCHROM™ ESBL (extended spectrum β-lactamases); HardyCHROM™ CRE (carbapenem resistant Enterobacterales); and HardyCHROM™ MRSA  (methicillin-resistant Staphylococcus aureus).

    Additionally, Hardy has been offering an array of products focused on promoting antimicrobial stewardship, from environmental monitoring to patient management, including culture media and rapid identification tests targeted at detection and effective treatment.

    HardyCHROM™ MRSA

    Studies show 33% of the population carry S. aureus as part of their microbiome. Furthermore, the CDC estimates two out of every 100 people routinely carry MRSA, most commonly in their anterior nares.8 Though most do not develop a serious infection, the potential to transmit MRSA to other patients in a healthcare setting is significant. Over the past five decades, the CDC has engaged in surveillance of HAI using a combination of voluntary reporting and a national system of sentinel hospitals. HardyCHROM™ MRSA can be used in that capacity, and is recommended for the qualitative detection of nasal colonization by MRSA to aid in the prevention and control of this organism.

    HardyCHROM™ ESBL

    Regarding the Gram negative organisms, ESBLs are enzymes produced by certain Enterobacterales that can break down and destroy commonly used antibiotics, such as broad spectrum penicillins or cephalosporins, making these drugs ineffective in treating infections. These mechanisms of resistance have been around for some time, first emerging in the medical literature as a β-lactamase (narrow spectrum) identified in Escherichia coli even prior to the medical use of penicillin.10 However, the number of known β-lactamases has quickly grown and, being plasmid and transposon mediated, they’ve spread rapidly worldwide. These mechanisms of resistance have broadened to new enzymes capable of hydrolyzing newer β-lactam antibiotics, leaving very few remaining effective antibiotic treatment options available for patient care. HardyCHROM™ ESBL can aid in the detection of these microorganisms. The medium is intended for the qualitative and presumptive detection of Enterobacterales potentially non-susceptible to broad spectrum cephalosporins, and ESBL-producing E. coli, Klebsiella pneumonia, and K. oxytoca from stool.

    NG-Test® CARBA 5

    Carbapenem antibiotics are one of the few remaining antibiotics effective in treating ESBL infections or MDRO.9 However, carbapenemases, or enzymes produced by bacteria that cause resistance to this class of antibiotics, are also on the rise. NG-Test® CARBA 5 is a rapid, multiplex, phenotypic lateral flow confirmatory test for the qualitative detection of five common carbapenemases produced by Enterobacterales and Pseudomonas aeruginosa: KPC, OXA-48-like, VIM, IMP, and NDM, that can be used with colonies that screen positive via HardyCHROM™ CRE. CARBA 5 is a game-changer in effective patient management, allowing clinicians a clear and rapid understanding of which drugs will benefit patient treatment from those that will not. This allows for better outcomes and more cost-effective care, better control over potential HAI, and aids in the principals of antimicrobial stewardship.

    Additional lateral flow format detection devices (NG-Test® MCR-1 and NG-Test® CTX-M MULTI), both labeled for Research Use Only.

    Hardy is expanding the diversity of antimicrobial resistance tests to include NG-Test® MCR-1, to detect the colistin resistance gene mcr-1, and NG-Test® CTX-M MULTI, to detect CTX-M variants when an ESBL is suspected, though both products are labeled for Research Use Only as of now. NG-Test® MCR-1 is a rapid immunoassay designed to detect the colistin resistance gene mcr-1 from bacterial colonies. The MCR (mobilized colistin resistance) gene family— mcr-1, mcr-2, and mcr-3—are an emerging AMR threat. These genes confer plasmid-mediated resistance to colistin (polymyxin E), known as one of the last-line antibiotics for treating patients infected with multi-drug resistant Enterobacterales.  NG-Test® CTX-M MULTI is to detect CTX-M variants in bacterial colonies when an ESBL is suspected. Currently, more than 170 CTX-M variants have been identified and are presently the most widespread resistance enzymes of clinical significance. All plasmid-mediated types of resistance are easily transferable within hospitals and in the community. Identifying CTX-M ESBLs early is crucial for preventing spread of resistance genes. Although ESBLs are less common in the U.S. compared to other regions in the world, NG-Test® CTX-M MULTI is useful in cases where hospitals have a higher CTX-M prevalence within the institution or in the immediate community, as it would provide a more rapid and cost-effective tool compared to molecular detection methods.

    Here at Hardy Diagnostics, we take our mission statement to heart: “We are committed to producing and distributing the finest products for the detection of microorganisms, as we partner with our laboratory customers to diagnose and prevent disease.” Hardy Diagnostics pledges to continue to do its part to provide innovative solutions to promote antimicrobial stewardship.

    By:
    Kelly Brickey, Digital Marketing Specialist
    Daniel Ballew, Marketing Manager
    Megan Roesner, Clinical Marketing Coordinator
    Kerry Pierce, M.S., RM(NRCM), Design and Development Specialist
    Andre Hsiung, M.S., M(ASCP), Chief Scientific Officer

    References

    1. “Core Elements of Antibiotic Stewardship | Antibiotic Use | CDC.” Centers for Disease Control and Prevention, 2019, https://www.cdc.gov/antibiotic-use/core-elements/index.html.
    2. “Core Elements of Hospital Antibiotic Stewardship Programs | Antibiotic Use | CDC.” Centers for Disease Control and Prevention, 2019, https://www.cdc.gov/antibiotic-use/core-elements/hospital.html#.
    3. Tan, MD, JD, Siang Yong, and Yvonne Tatsumura, MA, MD. “Alexander Fleming (1881–1955): Discoverer of Penicillin.” PubMed Central (PMC), Singapore Med J, July 2015, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4520913/.
    4. Rosenblatt-Farrell, Noah. “The Landscape of Antibiotic Resistance.” PubMed Central (PMC), Environment Health Perspectives, June 2009, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2702430/.
    5. Doron, MD, Shira, and Lisa Davidson, MD. “Antimicrobial Stewardship.” PubMed Central (PMC), Mayo Clinic Proceedings, Nov. 2011, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3203003/#R1.
    6. “CRE Bacteria: What You Should Know – Mayo Clinic.” Mayo Clinic, Mayo Clinic, 24 Feb. 2021, https://www.mayoclinic.org/diseases-conditions/infectious-diseases/in-depth/cre-bacteria/art-20166387#:~:text=Carbapenem-resistant%20Enterobacteriaceae%20(CRE),cases%20to%20all%20available%20antibiotics.
    7. Frieden, Thomas R., and Beth P. Bell. “Core Elements of Hospital Antibiotic Stewardship Programs.” American Hospital Association’s Physician Leadership Forum, 2014, https://www.ahaphysicianforum.org/resources/appropriate-use/antimicrobial/.
    8. Healthcare Settings – Preventing the spread of MRSA. Accessed April 21, 2021. https://www.cdc.gov/mrsa/healthcare/index.html  
    9. ESBL-producing Enterobacterales in Healthcare Settings. Accessed April 21, 2021. https://www.cdc.gov/hai/organisms/ESBL.html
    10. Bradford, P.A. Extended-Spectrum β-Lactamases in the 21st Century: Characterization, Epidemiology, and Detection of this Important Resistance Threat.
    11. . 2001 Oct; 14(4): 933-951. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC89009/pdf/cm0401000933.pdf



  • Nanotechnology and the COVID-19 Vaccine

    Nanotechnology refers to the manipulation of molecules for large-scale manufacturing purposes. It is a broad field of science, which combines chemistry, physics, energy storage, microfabrication, and molecular engineering.

    Recently, it has been popularized by its role in nanomedicine for the COVID-19 vaccine. (1) Currently, with the introduction of mRNA vaccines by Pfizer and Moderna, the importance of nanotechnology and the use of liposomes has become even more apparent. Advances in nanotechnology allow for the transport of molecular information, increased protein expression, protection from nucleases, and the improvement of the overall safety of mRNA-based vaccines. (2) Note that the new Johnson & Johnson vaccine uses a modified adenovirus carrier to transport DNA rather than a liposome to transport mRNA.

    The primary improvement for mRNA vaccines has to do with the lipid nanoparticle. Lipid nanoparticles (liposomes) are comprised of a phospholipid bilayer, which can be loaded with target drug or mRNA that codes for a target protein, such as those developed for the SARS-CoV-2 vaccine. Although a newer improvement for vaccines, this delivery method has existed for many years and originally gained popularity in 2018 by Onpattro. This was the first drug approved by the FDA to deliver siRNA to treat polyneuropathy. (3) Onpattro offers protection for RNA to avoid host RNAses and, consequently, improves the safe transport of the mRNA to target cells where it is readily absorbed. (2)

    The liposomes deliver their mRNA payload into the cell, but the mRNA does not enter the nucleus, nor does it replicate.

    Molecular transport is not the only hurdle for mRNA vaccine development. Due to their fragile nature, RNA strands must also go through a strand optimization process. RNA sequences are optimized by adjusting the 5’ and 3’ flanking UTR regions. (2) Alteration of the 5’ cap can be done by several methods and provides more efficient protein synthesis whereas changes to the 3’ poly (A) tail provide greater stability and enhanced translation. (2) In addition, scientists also look at the rarity of codons in the sequence as well and the G:C content for further strand optimization. (2)

    With the FDA emergency use authorization (EUA) of the SARS-CoV-2 mRNA vaccines, safety is the main concern for patients. So far, these vaccines have shown to be both safe and effective via large scale clinical trials, after their data was reviewed by the US FDA. (4) The main reason these vaccines are considered safer than other types of vaccines is due to the nature of mRNA’s function within cells. Once mRNA enters the host, it remains in the cytosol until the strand is translated by the ribosomes into a protein product. Soon thereafter, the mRNA transcript is degraded by host enzymes, which reduces the chance of repeated protein production. Furthermore, when the liposome encapsulated mRNA enters the cell in this artificial manner, it lacks the necessary machinery needed to enter the cell nucleus. Thus, new mRNA molecules from the original vaccine source cannot be reproduced. (5)


    The diagram above shows how liposomes can be used to transport both mRNA or DNA into the cell. The liposomal carriers penetrate the cell membrane and release their nucleic acid cargo where it is then used for protein production

    In conclusion, the use of nanotechnology and liposomal mRNA based vaccines are a promising advancement for future vaccine development. Their current use during the COVID-19 pandemic is showing promising results, and they have the potential for swift modification over other types of vaccines should the need arise with SARS-CoV-2 variants. Their use on a global scale is still new, yet more research and developments in the coming years are being conducted with this technology.

    by Miles Amby
    R&D Microbiologist
    HARDY DIAGNOSTICS

    Work Cited: 1234, 5

  • The ACE2 Receptors

    Could this explain why some are more susceptible to COVID-19?

    The SARS-CoV-2 virus gains entry to the epithelial cells lining the respiratory tract by way of the ACE2 (angiotensin-converting enzyme 2) receptor. This is the protein to which the viral spike proteins attach in order to gain entry into the cell.

    If we knew more about this important receptor, it could be the key to unlock future therapies and preventive measures. 

    This ACE2 receptor is a transmembrane protein, in that it is embedded in the cell membrane. This protein is found on epithelial and endothelial cells of the upper and lower respiratory tract, heart and vasculature, kidneys, and portions of the gastrointestinal tract. It is an ectoenzyme, meaning its actions occur outside of cells. The ubiquitous nature of this receptor explains, in part, why so many different organs can be affected by SARS-CoV-2. ACE2 is a vital element in a biochemical pathway that is critical to regulating processes such as blood pressure, wound healing and inflammation, called the renin-angiotensin-aldosterone system (RAAS) pathway.

    Why are children so rarely affected by the disease?

    ACE2 is present in all people but the quantity can vary among individuals and in different tissues and cells. Some evidence suggests that ACE2 may be higher in patients with hypertension, diabetes and coronary heart disease. This may explain why these patient groups are more prone to serious COVID-19 disease.The ACE2 receptor concentration in the cell membranes may also explain why children are less susceptible to serious COVID-19 disease. It is known that children have less ACE2 receptors in their tissues. Also, their ACE2 receptors have less maturity and functionality while having less expression and affinity to invading viruses.

    Researchers have also found that ACE2 lung airway expression is upregulated and intensified in smokers and those with COPD (chronic obstructive pulmonary disease.) When the amount of ACE2 is reduced because the virus is occupying the receptor sites, individuals may be more susceptible to severe illness from COVID-19 thus increasing susceptibility to inflammation, cell death and organ failure, especially in the heart and the lung. Currently, clinical trials are being conducted to determine if ACE inhibitors could be effective in treating COVID-19. Undoubtedly, the extensive research being conducted on this topic will eventually bring exciting news and relief to many.

    Ref: 1234, 56

    By Jay Hardy, CLS, SM (NRCM)
    CEO, HARDY DIAGNOSTICS

  • Can COVID vaccine technology be used against cancer?

    Information on messenger RNA (mRNA) vaccines is frequently in the news due to the ongoing COVID-19 pandemic, since mRNA technology is used in the Moderna and Pfizer vaccines against SARS-CoV-2. Long before the start of the pandemic, however, researchers have been trying to use this technology to treat cancer.

    Colorectal cancer is the third leading cause of cancer-related deaths in the United States. (1) It is also the third most common cancer worldwide. (2) The standard treatment for many colorectal cancer patients is surgery, but this can leave some cancer cells undetected in the body. Cancer cells left behind can shed DNA into the bloodstream, known as circulating tumor DNA, or ctDNA. ctDNA detection after surgery treatment is associated with higher rates of cancer recurrence. (3) A clinical trial led by Van Morris, M.D. and Scott Kopetz, M.D., Ph.D. follows high risk patients with stage II or stage III colorectal cancer who test positive for ctDNA after surgery. (4)

    During his procedure, tissue from the tumor removed during surgery is sent to a specialized lab and tested to find genetic mutations in the patient’s own DNA that lead to cancer growth. A targeted mRNA vaccine is then created based on a prioritized list of the mutations found. In this way, each patient receives a personalized mRNA vaccine based on their individual mutated DNA test results. Once administered, the mRNA encodes the instructions for the patient’s cells to produce protein fragments based off the identified mutations. Cells present these fragments as foreign to the body’s immune cells. The immune system can then search for other cells with mutated proteins and destroy any circulating tumor cells, thus eradicating the cancer for good. This clinical trial is currently in Phase II and is estimated to be completed in July 2027. (4)

    These clinical trials are just one of many research studies involving the use of mRNA to treat cancer. In another study, researchers tested a way to stabilize mRNA and allow for slow release using hydrogels. One of the challenges in using mRNA technology to treat disease is that mRNA deteriorates quickly in the body due to exposure to degrading enzymes. With this newly developed method, mice with melanoma were given a treatment and experienced both reductions in tumor size, as well as obstruction of metastasis in lung tissue after treatment with the mRNA vaccine. (5) With these promising results, the future of this type of treatment would allow therapies to last over the course of 30 days.

    Additionally, in a separate study, a clinical trial in humans found success in treating melanoma patients with personalized mRNA vaccines. (6) To date, mRNA vaccines have been applied to treat aggressive, less accessible and metastatic solid tumors, including non-small cell lung cancers, colorectal carcinoma, melanoma, and others. (7)

    There is an unending need for safe and effective cancer treatment, and mRNA technology allows for personalized treatment specifically designed for each patient. There is great headway in this field and the future looks hopeful for those that can benefit from this type of targeted therapy.

    By Alani Vasquez
    R&D Manager

    References:

    1. https://www.cdc.gov/cancer/colorectal/statistics/index.htm
    2. https://www.wcrf.org/dietandcancer/cancer-trends/colorectal-cancer-statistics
    3. https://www.healio.com/news/hematology-oncology/20210122/circulating-tumor-dna-predicts-relapse-risk-among-patients-with-colorectal-cancer#:~:text=Researchers%20found%20that%20a%20positive,CI%2C%204.9%2D27).
    4. https://www.mdanderson.org/cancerwise/can-mrna-vaccines-like-those-used-for-covid-19-be-used-in-cancer-care.h00-159457689.html
    5. https://clinicaltrials.gov/ct2/show/study/NCT04486378
    6. https://pubs.acs.org/doi/full/10.1021/acs.nanolett.0c05039
    7. https://www.nature.com/articles/nature23003
    8. https://molecular-cancer.biomedcentral.com/articles/10.1186/s12943-021-01335-5

  • Flu Season…Where are you?

    As COVID-19 presses forward, it is easy to look back at the past year and see nothing but the ruin left behind by the pandemic.

    However, as 2021 advances, there appears to be a light at the end of the tunnel. Unlike previous years, the 2020-2021 flu season has diminished immensely. Healthcare workers are reporting extraordinarily low levels of Influenza-Like-Illness (ILI) and it may be due to several precautions taken during the pandemic.(1)

    In the early part of 2020, many restrictions were instated in the United States and around the world to prevent spread of viral particles. Travel became more restrictive; lockdowns occurred in certain countries; many businesses were forced to close or move to remote operation; masks became mandatory; and social distancing was enforced. For many, these restrictions were not met with open arms and they came at a great sacrifice. Now that flu season should be in full swing, we are seeing some positive side effects to the pandemic we had not fully anticipated: a drastic decrease in ILI.

    It is estimated that a typical flu season in the U.S. results in anywhere from 9-45 million illnesses, from 140,000-180,000 hospitalizations, and from 12,000-61,000 deaths. For this year’s season, the CDC is currently reporting that of 886,237 collected samples, only 1,553 have tested positive (0.2%) for flu. (2) A typical flu year, as seen in 2019-2020, typically contains a 27.7% positive ILI sample rate. (3) To further emphasize the quell in flu cases, the CDC reports that national percentage of visits to health centers for ILI is at 1.08%, which is much lower than last year’s 6.7%. (4)

    Another factor to consider when looking at the depression in ILI rates for the 2020-2021 flu season is vaccination rates. In 2020, the CDC reported a record 175 million flu vaccination doses were distributed, and projected that for 2021 the U.S. could provide up to about 195 million doses. (5)  As of January 15th, 2021, there have been 193 million doses distributed with several months before flu season officially ends. (6)

    Why is there more than a 100-fold decrease in flu infections this season?

    Although healthcare workers may enjoy seeing a decrease in ILI, the implications have some epidemiologists worried. Richard Webby, a virologist at St. Jude’s Hospital in Tennessee, warns that the reduction in influenza outbreaks for the 2020-2021 flu season may reduce circulation of several less common but less severe strains, which could limit viral competition and potentially allow for new, more aggressive swine flu variants to thrive. He states, “One of the things holding those viruses back a lot is natural immunity. If flu is low for a few seasons, that might leave a gap for swine viruses to have more impact.”(7)

    There is no question that 2020 hit the world hard, but with it came some enduring lessons in preventive measures to limit viral outbreaks.  The combination of quarantine, masks, social distancing, and vaccination have shown a notable increase in empty hospital beds for our more common winter nemesis, and resulted in a 100-fold reduction in positive ILI samples. The lack of flu this season does have some worried, but it is a pleasant sign to see a reduction in at least one viral illness after the havoc from the pandemic.

    Oddly enough, in spite of the flu decrease, the rhinovirus, which is responsible for the common cold, has had some sharp increases this season. One reason may be that, unlike the coronaviruses, the rhinovirus lacks an outer lipid coat, which makes the coronavirus vulnerable to soaps and sanitizers.

    Hopefully, we have all learned a valuable lesson from this experience. If many of the safety precautions can continue to be upheld to some degree for future flu seasons, perhaps the trend will continue downward.  

    By Miles Amby
    R&D Microbiologist II

    References

    1. https://clpmag.com/disease-states/infectious-diseases/covid-19/the-pandemic-broke-the-flu/
    2. https://www.cdc.gov/flu/weekly/index.htm#ILIActivityMap
    3. https://www.statista.com/chart/20704/us-flu-seasons-percent-of-samples-tested-positive/
    4. https://gis.cdc.gov/grasp/fluview/fluportaldashboard.html
    5. https://www.cdc.gov/flu/fluvaxview/coverage-1920estimates.htm
    6. https://www.cdc.gov/flu/fluvaxview/dashboard/vaccination-dashboard.html
    7. https://www.nature.com/articles/d41586-020-03519-3

  • SARS-CoV-2 Variants: A New Public Health Crisis?

    Many states are relaxing restrictions amid both vaccination efforts and slowly decreasing case numbers, however, scientists warn that this pandemic is far from over. Researchers are working to gather more information about the SARS CoV-2 and its variants while the virus continues to mutate.

    So, what are variants?

    Complex recombination across genetically similar viruses plays an important role in the evolution of coronaviruses both within human and animal hosts.(1) RNA viruses are more likely to accrue mutations compared with DNA viruses .(2) However, due to a novel exoribonuclease (ExoN), SARS-CoV-2 accumulates mutations at about half the rate of the influenza virus and one-fourth the rate of HIV.(2, 3)

    Due to the redundancy of the genetic code, many mutations are “silent” and will not alter a virus’s ability to spread or cause disease. However, changes in amino acids can alter a protein’s structure and charge. Altered proteins are more likely to impair virulence rather than improve it. However, in rare cases, a small change in the amino acid structure can increase virulence. When detected clinically, these strains with potentially beneficial mutations are dubbed ‘variants.’

    The CDC estimates the B.1.1.7 variant first emerged in the UK during September 2020.(4) As of February 25th, 2021, this variant has been reported in over 200 countries, with the US reporting 2,102 cases across 45 states.(5, 6) B.1.1.7 comprises multiple mutations that make it approximately 50% more transmissible.(7, 8) The N501Y mutation occurs in the receptor binding domain (RBD) of the spike protein (S protein) at position 501.(2, 4) The 69/70 deletion and P681H and also affect the S protein making the variant better able to bind to human ACE2 receptors.(4, 7, 8)

    Variant B.1.351, first identified in Nelson Mandela Bay, South Africa, has multiple mutations in the spike protein, but does not contain the deletion at 69/70.(4) As of February 25th, 2021 it has been reported in over 30 countries with the United States reporting 49 cases across ten states.(5, 6) This variant has the RBD spike protein mutations N501Y and E484K. In addition to increased transmissibility, E484K may affect recognition by antibodies allowing the virus to evade the immune system.(9)

    Though these variants receive most news coverage, they are far from the only variants out there.  In January 2021, a variant known as P.1 was first identified in travelers from Brazil and was subsequently detected in the US a month later.(10, 11) CAL.20C, the variant first detected in Southern California in late 2020, has similar RBD mutations. This variant is responsible for 44% of new infections in Southern California and is circulating around the globe.(12)

    The vaccines developed by Pfizer-BioNTech and Moderna appear to be effective against the UK B.1.1.7 variant. However they showed a slight decrease in effectiveness against the South African B.1.351 was observed.(2) Moderna conducted a study using sera from immunized patients and B.1.351 like pseudoviruses. These showed 2.7 and 6.4-fold reductions in neutralization, respectively.(13) Despite this reduced activity, the B.1.351 was fully neutralized.(2, 13) Both companies are working to develop a booster shot.(2, 14)

    Numbers are the name of the game. More infections mean more replications and higher chances of beneficial (for the virus) mutations occurring. Essentially, each infected person is a chance for SARS-CoV-2 to become more effective at causing disease in humans. Even with a vaccination, individuals may be able to spread the virus.(15)

    As restrictions lift, keeping cases low will be integral to preventing new variants and causing further public health issues.

    References

    1. https://advances.sciencemag.org/content/6/27/eabb9153
    2. https://asm.org/Articles/2021/February/SARS-CoV-2-Variants-vs-Vaccines
    3. https://www.nature.com/articles/d41586-020-02544-6
    4. https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/scientific-brief-emerging-variants.html
    5. https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant-cases.html
    6. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-surveillance/global-variant-map.html
    7. https://www.biorxiv.org/content/10.1101/2020.11.19.389916v1
    8. https://www.biorxiv.org/content/10.1101/2020.12.14.422555v4
    9. https://www.scientificamerican.com/article/the-most-worrying-mutations-in-five-emerging-coronavirus-variants/
    10. https://www.niid.go.jp/niid/en/2019-ncov-e/10108-covid19-33-en.html
    11. https://www.health.state.mn.us/news/pressrel/2021/covid012521.html#:~:text=The%20Minnesota%20Department%20of%20Health,recent%20travel%20history%20to%20Brazil.&text=The%20variant%20was%20found%20through%20the%20MDH’s%20variant%20surveillance%20program.
    12. https://www.cidrap.umn.edu/news-perspective/2021/02/new-covid-variant-5-mutations-identified-california
    13. https://investors.modernatx.com/news-releases/news-release-details/moderna-covid-19-vaccine-retains-neutralizing-activity-against
    14. https://www.statnews.com/2021/02/25/is-more-simply-better-why-pfizer-thinks-a-booster-of-its-covid-vaccine-might-work-against-new-variants/
    15. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/keythingstoknow.html#:~:text=It%20typically%20takes%20a%20few,time%20to%20provide%20protection.

  • 2021

    Hardy continued to do its part to control the Covid-19 Pandemic. Millions of Viral Transport Media tubes were produced, along with the sales of swabs, masks, face shields, sanitizers, and disinfectants. Hardy also became a distributor for the Covid-19 Antibody and Antigen rapid test kits, that produce results in about 15 minutes.

  • Probiotics – Current Benefits of an Old Idea

    Can they assist with COVID-19 immunity?

    The idea of probiotics is for centuries something well known in other cultures. Many old cultures count with them in yogurts, kefirs and even something thought to be new but made recently popular by savvy Hollywood stars, called: Kombucha. A group of researchers looked at Malaysian Kefir, made from fermented grains which contain embedded organisms. Looking at the microbial makeup, the researchers found varied results, depending on the region or grains used. However, they found Lactobacillus spp. was among the most abundant regardless of origin. The effectivity of providing the host with benefit was measured by the organism’s ability to tolerate bile salts, adherence to gut cells, their antioxidant inducing properties and antibiotic susceptibility. (1)

    But let’s back up a little bit. The gut microbiome is something we acquire while in the womb, and in fact, those same beneficial organisms have also been found available in human milk. An interesting study looked at the importance of commensal cell lines in children born naturally vs. by cesarean intervention, finding that necessary immune system education or immune response was lessened.(2) The good news is that they found that breast milk restores this important microbiota of children born by cesarean means.

    The list of benefits is long and reveals that a balanced gut microbial system may be as important as the immune system. Treatment of Liver Cirrhosis patients showed that SCFA (short-chain fatty acids) work to control abnormal levels of lipids which are typical of the disease. SCFAs are secreted by many organism in the gut which effectively mediate gut hormones and promote cleavage of enzymes that impute metabolic restoration of loss or impaired metabolic functions.(3)

    Patients with recurrent Clostridium difficile infections have also been helped by FMT (fecal microbial transplantation) which isn’t what you think, but rather an introduction of probiotics from healthy individuals to the ill patient. When treated overtime, genes known to function in 1°and 2° bile acid biosynthesis were inferred to be upregulated.(4) In addition, they deduced that competition for nutrients, post treatment, may indeed be a factor in suppressing C. difficile infection. Of interest here is that the treatment managed to increase the microbiome similarity almost to that of healthy individuals resulting in reduced occurrences, however, they note that even healthy individuals varied vastly in the bacteria they have in common.

    Well, but in 2020 and going on 2021, you might ask: How about the SARS-CoV-2 virus? The CDC is still the best current source, though in my opinion, virologists are not being consulted much these days. Prevention includes hygiene, washing of hands, disinfecting and soon; vaccination! Vaccines are effective for current strains but are rendered less effective as virus mutate. Bacteria found in the gut, on the other hand, have been found to act to emit the stimuli needed for the activation of Interferons (IFNs), inflammatory cytokines, receptors among other gene expression inductions. (5) For example, Lactobacillus rhamnosus was found to cause an increase in serum IgG of children suffering from rotavirus induced diarrhea. While in Japan, L. lactic JCM5805 found in certain yogurts enhanced the IFN-α-mediated response to the influenza virus.(5)

    But wait, before you run to the store and buy a bottle of Probiotics, or order Malaysian Kefir, a consultation with your physician is in order, as bacterial or even fungal sepsis cases do exists predominantly to those with organ lesions, infants and the immune deficient. Benefits are reaped overtime, and let’s not forget, that a good and healthy diet goes a long way in creating and maintaining your own unique and ideal gut microbiota. Lastly, if you feel savvy, enjoy a kombucha. The actress Lindsay Lohan likes it and even used it as an excuse when jailed for drunk driving. Yes, some do contain alcohol, but Lindsay did not only drink Kombucha that day.

    References:

    1. Talib, N., Mohamad, N., Yeap, S., Hussin, Y., Aziz, M., Masarudin, M., Sharifuddin, S., Hui, Y., Ho, C. and Alitheen, N., 2019. Isolation and Characterization of Lactobacillus spp. from Kefri Samples in Malaysia. Molecules, 24(2606), pp.1-18.

    2. Guo, C., Zhou, Q., Li, M., Zhou, L., Xu, L., Zhang, Y., Li, D., Wang, Y., Dai, W., Li, S. and Zhang, L., 2020. Breastfeeding restored the gut microbiota in caesarean section infants and lowered the infection risk in early life. BMC Pediatrics, 20(1).

    3. Usami, M., Miyoshi, M. and Yamashita, H., 2015. Gut microbiota and host metabolism in liver cirrhosis. World Journal of Gastroenterology, 21(41), pp.11597-11608.

    4. Staley, C., Kaiser, T., Vaughn, B., Graiziger, C., Hamilton, M., Rehman, T., Song, K., Khoruts, A. and Sadowsky, M., 2018. Predicting recurrence of Clostridium difficile infection following encapsulated fecal microbiota transplantation. Microbiome, 6(1).

    5. Kanauchi, O., Andoh, A., AbuBakar, S. and Yamamoto, N., 2018. Probiotics and Paraprobiotics in Viral Infection: Clinical Application and Effects on the Innate and Acquired Immune Systems. Current Pharmaceutical Design, 24(6), pp.710-717.

    References: 1, 2, 3, 4, 5

  • How Does The COVID-19 Virus Affect Our Gut Microbiome?

    The Gut Microbiome Composition and COVID-19 Related Disease Severity

    The gut microbiome refers to a group of commensal or symbiotic bacteria that make up the composition of microorganisms in the human intestines. At any given period in time, most healthy adults may have up to 1,000 different species of bacteria that inhabit the digestive tract.(1) Most of these fall into the Bacteroidetes or Firmicutes phyla, which include a variety of beneficial species that play an important role in human well-being by aiding in digestion, providing beneficial vitamins, supporting immune health, and preventing certain types of cancers. Studies show an imbalance in the gut microbiome can play an important role in certain disorders such as obesity, high cholesterol, high blood sugar leading to Type 2 diabetes, arthritis, and more. (1) Consequently, due to the range of disease severity observed in patients with confirmed SARS-CoV-2 infection, researchers looked for clues in the gut microbiome composition to determine the impact on the severity of COVID-19 symptoms.(2)

    A two-hospital cohort study was designed to examine blood, stool, and other evidence from health records for contributing factors from patients with laboratory confirmed SARS-CoV-2 infection. Testing occurred up to a maximum of 30 days after a patient was cleared of the virus, and used a shotgun sequencing approach for total DNA extracted from stool. (2) For comparison, inflammatory cytokines, chemokines, and peptides were also measured from patient blood samples, and patients were separated into four severity groups based on their disease symptoms. (2)

    What researchers found from the study was an overall change in the composition of the gut microbiome in SARS-CoV-2 infected patients compared to non-infected individuals. Data also suggested the change was unrelated to whether patients required medication, but alterations in the microbiome appeared concordant with disease severity.(2) Many of the previously documented commensal bacteria known to inhabit the gut and modulate the immune response in healthy adults were dramatically underrepresented in infected patients, and continued to remained low even after recuperation and confirmed negative infection. (2)

    Not surprisingly, results from the study found a correlation between the gut microbiota composition, levels of inflammatory cytokines in blood, and the severity of COVID-19 symptoms. These initial results suggest the gut microbiome may modulate the host immune response to COVID-19 infection. More research is needed to determine how this interaction contributes to the inflammatory response, and the mechanisms which may aid in patient recovery.

    References: 1, 2
    Written by Kerry Pierce
    Microbiologist
    HARDY DIAGNOSTICS

  • Can a T Cell Test Predict Immune Status?

    New Study shows that assays for T Cells against COVID-19 can be good predictor of disease susceptibility.

    Ensuring that essential workers are healthy and can receive a vaccine against SARS-CoV-2 during the pandemic is extremely important. However, a major question must be considered: How can we identify which individuals are most at risk for severe COVID-19 infection? The answer to this question could start with a simple blood test for T cell immunity.

    T cells originate in the bone marrow, but are matured in the thymus. However, they are not activated until they find their specific antigen, which in this case is the SARS-CoV-2 virus.


    Increasing the number of immune T cells is crucial to clearing the SARS-CoV-2 virus from the patient’s body. It has been shown that 95% of patients in ICU show an alarming decrease in T cell numbers. As we age, it is known that T cell function decreases. However, it is not known for certain if the decrease of T cells in COVID-19 patients is due to age or the cytokine response that could also impair T cell function. (4) Young people are less prone to severe infection due to their more robust T cell response and a lesser cytokine response in comparison to the elderly.


    In a study by Oxford Immunotec Global and David Wyllie, nearly 3,000 first responders (police, fire, and healthcare workers) were evaluated for the antibody and T cell response to SARS-CoV-2. The T cell response to various SARS-CoV-2 proteins were determined using a research use only (RUO) T-SPOT Discovery SARS-CoV-2 assay (Oxford Immunotec, Oxford, England). The cumulative responsiveness of T cells to the spike (S), nuclear (N) and membrane (M) proteins was measured, and workers were placed into a high or low T cell response group.(1,2)


    None of the participants with a high T cell response developed symptomatic SARS-CoV-2 infection in the follow-up period, whereas amongst those with low T cell responses, there were 20 confirmed infections. From the high T cell response group, about half of the individuals also had detectable antibodies against the N or S proteins. These results suggest that T cell assays may be able to predict the risk of patients becoming sick with COVID-19.(1,2) It also indicates that a T cell assay could be a far better predictor of immune status than an antibody test (either IgG or IgM).


    Unfortunately, the numbers of individuals with a high T cell response to SARS-CoV-2 were shown to decline with increasing age; this may be another factor that could put the elderly at risk for a high severity of illness or fatality.(1,2,3) The results from this study are most important to consider for essential workers. In this case, those who may be at higher risk of infection by COVID-19 should take extra precautions while working in shared workspaces.


    Hopefully, this type of diagnostic test can be used beyond an RUO setting and become implemented into standard clinical care to help essential workers and the general community identify individuals most at risk for COVID-19. In the near future, these high-risk individuals will also benefit from the three recently developed vaccines.(Figure 1)

    Learn more about T Cell Tests for COVID-19.

    Written by Anna Klavins

  • T cells vs Antibodies – The Unsung Warriors Against COVID-19

    A novel test for T cells show great promise in detecting immune status

    Antibodies often steal the spotlight when talking about immunity, but they are not the only protagonist in the immune system.

    T cells are specialized defenders activated in the adaptive immune response. They multiply and differentiate into cytotoxic, helper, or regulatory t-cells. These types of lymphocytes are critical in the identification, management, and clearance of infections.

    New research shows that T-cells are optimal targets for evaluating immunity to SARSCoV-2 infection because of their critical role in the immune response. Up to this point, we have exclusively focused on the use of serological tests for an indication of prior COVID-19 infection. In the current state, the Food and Drug Administration (FDA) issues emergency use authorization (EUA) to over sixty serology products to detect SARS-CoV-2 antibodies. (1) Antibody testing for COVID-19 on the market may shortly be challenged by a new competitor: a novel test for the detection of T-cells.

    Adaptive Biotechnologies, an innovative biotechnology company based in Seattle, in collaboration with Microsoft, has developed a T cell-based clinical test that can detect an immune response to past Covid-19 infections. This test utilizes a unique T-cell signature, developed via identified “shared” T-cell Receptors (TCRs) of multiple infected individuals worldwide. (2) If authorized by the Food and Drug Administration (FDA), TDetect™ would become the first commercial product to detect T cell response to SARSCoV-2. (3)

    Adaptive Biotechnologies Logo. (PRNewsFoto/Adaptive Biotechnologies Corporation)

    In a study by Gittelman et al., researchers analyzed T cell and antibody levels in 2,200 individuals from the municipality of Vo, Italy. Vo initially became famous as the location of Italy’s first COVID-19 related fatality. Of the 2,200 samples, 70 were previously collected from confirmed PCR positive patients. TDetect™ identified 97% of (68 of 70) individuals with previously confirmed PCR results, compared to 77% (54 of 70) from a
    positive serology test result. Additionally, this study observed more significant T-cell detection in symptomatic versus asymptomatic
    patients, whereas antibody levels did not correlate with disease severity. (4, 5)

    T cells’ ability to detect the severity of the disease, unlike antibody’s, can offer insight into the reason for a wide range of clinical presentations, from asymptomatic to severe illness or even death of individuals with different backgrounds. This new test may additionally help researchers measure longterm immunity or potential level of protection after infection or vaccination.

    Middle East Respiratory Syndrome (MERS) and SARS-CoV-1 infections have previously indicated that coronavirus-specific T cells have long-term effectivity and contribute to protection even in individuals with minimal
    antibody production. (6, 7) If this test proves to be specific to COVID-19, a more sensitive method of measuring previous exposure will be available, potentially detecting cases faster and more accurately.

    Written by Yesenia Morales

    Works Cited:

    1. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covid19euas
    2. https://www.t-detect.com/about-t-detect/
    3. https://clpmag.com/disease-states/infectious-diseases/covid-19/preliminary-data-suggests-t-cell-testing-outperforms-antibody-testing-to-id-past-covid-19/?campaign_type=newsletter&_hsmi=101385627&_hsenc=p2ANqtz-8S5_veVvW4BZRj5_CMYI1itcQaGNBzsPdUHLe2F4rnG1i6rgMcEVtX_ikech_V7z8TT_TRuXNQ1m-BOVMiKHC6cxFJX6blKtsJR_t9FzU8WwzfrYc
    4. https://www.medrxiv.org/content/10.1101/2020.11.09.20228023v1
    5. https://www.adaptivebiotech.com/t-cell-testing-outperforms-antibody-testing-in-determining-prior-covid-19-infection/
    6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4178831/
    7. https://immunology.sciencemag.org/content/2/14/eaan5393.abstract

  • 2020

    At the end of the year, a three-year long expansion project was finished at the Ohio manufacturing facility, which doubled the space needed for new clean rooms, warehousing, shipping, and walk-in coolers.

  • Coronaphobia and Coinfections

    The World Health Organization (WHO) declared the Coronavirus Disease 2019 (COVID-19) outbreak, caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), a pandemic on March 11, 2020. 1 Since then—at the time of writing—63,098,003 cases and 1,465,111 deaths have been reported from 191 afflicted countries/regions across the globe. 2 Along with its high transmissibility and mortality (observed case-fatality ratio) rates, COVID-19 has elicited a universal psychosocial impact by bringing about mass hysteria, economic burdens, and financial losses.3 The resultant “coronaphobia,” or mass fear of COVID-19, has produced a variety of psychiatric manifestations that affect day-to-day life, including the management and prognostication of disease, relating to availability heuristics. These cognitive biases have the potential to introduce prejudice that favors one outcome over another, playing a significant role in medical errors.4,5 In one particular study, 74% of diagnostic errors in internal medicine practice were linked to such cognitive factors.6 Reports like these underscore the importance of objectivity in healthcare; in the context of the COVID-19 pandemic, differential diagnosis is unequivocally paramount—especially in instances of co-infection.

    During the 2009 influenza A(H1N1)2009pdm pandemic, reports of bacterial coinfection were plenty, resulting in substantially higher morbidity and mortality rates from misdiagnoses.7,11 The CDC estimated there were 60.8 million cases of H1N1 in the U.S, which, similarly, fostered availability biases8. These cognitive factors precluded proper diagnosis of otherwise treatable bacterial and parasitic infections, because they were mistakenly labelled as influenza.9 From a collection of 16 studies, bacterial coinfection rates for A(H1N1)2009pdm cases were 19% in ICU admissions and 12% in non-ICU admissions. Streptococcus pneumoniae was the culprit in 26% and 33% of ICU and non-ICU cases, respectively. For those cases that didn’t present with bacterial coinfection at the time of A(H1N1)2009pdm diagnosis, nearly one in four patients developed a bacterial infection after the fact—a secondary bacterial infection. Prevention and treatment of these complications should thus be instituted as part of pandemic planning.7

    Much like the 2009 influenza A(H1N1)2009pdm pandemic, clinicians have noted incidences of patients with COVID-19 that are experiencing coinfections. As such, many (early) studies report the empirical use of antibiotics for COVID-19 patients out of an abundance of caution—albeit inappropriate per antimicrobial stewardship.10,12 This dynamic has since shifted, because there is now a paucity of data available that supports the routine use of antibiotics in the management of COVID-19 infection.11 Like other respiratory viruses, COVID-19 has a great degree of overlap with certain bacterial infections in symptomatology.12 While some hallmarks may be more characteristic of viral compared to bacterial infections (i.e. neutrophilic leukocytosis and lymphopenia, respectively), there is still a need for a quick differential diagnosis of potential respiratory pathogens when a patient presents with symptoms. While nucleic acid tests are the gold standard for COVID-19 diagnostics, delays and reports of “false-negatives” are hampering timely diagnosis and treatment.13 As the demand for COVID-19 testing continues to rise, reference laboratories like LabCorp and Quest Diagnostics are reporting turnaround times for results of two to three days, respectively.14 While COVID-19 is certainly running rampant, the institution of secondary rapid tests may aid with differential diagnosis and prevent the oversight of complications that take the form of bacterial coinfection and secondary infection. Bacteria-based diseases like Legionnaires and pneumonia present symptoms that can be similar to those from COVID-19,15 but the treatments are different.  A simultaneous use of COVID-19 tests, as well as other tests, should be considered to ensure correct treatment. A rapid option is Immuview® S. pneumoniae & Legionella (P&L) Urinary Antigen Test as it allows professionals to quickly determine an appropriate course of action. To further objectivity and stewardship in medical practice, Hardy Diagnostics has partnered with SSI Diagnostica to bring ImmuView P&L to its customers to aid in the differential diagnosis of bacterial pneumonia. This rapid assay produces results in 15 minutes and needs no equipment. 

    authored by Andrew Kravariotis, Hardy Diagnostics

    Click here to learn more

    References

    1. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen
    2. https://coronavirus.jhu.edu/map.html
    3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7255207/
    4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4056786/
    5. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7405980/#:~:text=Another%20cognitive%20bias%20demonstrated%20by,the%20United%20States%20%5B5%5D.
    6. https://pubmed.ncbi.nlm.nih.gov/16009864/
    7. https://pubmed.ncbi.nlm.nih.gov/30526505/
    8. https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.html
    9. https://pubmed.ncbi.nlm.nih.gov/20071428/
    10. https://www.idsociety.org/covid-19-real-time-learning-network/disease-manifestations–complications/co-infection/
    11. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7255350/
    12. https://www.ccjm.org/content/87/11/659
    13. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7447615/
    14. https://www.usatoday.com/story/news/health/2020/11/26/covid-19-testing-delays-record-demand-thanksgiving/6417506002/
    15. www.nice.org.uk/guidance/ng173

  • 2020

    In December, HDx completed a renovation project of its manufacturing facility in California, in which a new walk-in cooler, employee locker room, and chemistry lab were completed.

  • The Winnable Battles: HAIs and Antimicrobial Stewardship

    Control of drug-resistant organisms is a national problem. Pathogens are acquiring resistances and developing novel ways of surmounting antimicrobials at unprecedented rates.

    Drug discovery has dropped precipitously, and these organisms are nearly ahead of the curve.1 In some instances, orders of bacteria, such as carbapenem-resistant Enterobacterales are impenetrable to most available drugs, limiting treatment options drastically.

    Disinfection and sterilization in hospitals is now a focus of concern, as these infections are most pervasive in such settings. Transmission of healthcare-acquired pathogens (HAP) is chiefly related to the contamination of surfaces and equipment, including medical devices (i.e. catheters and ventilators).2,7

    Nosocomial, or hospital-associated infections (HAI), are a leading cause of morbidity and mortality in the United States; each year, about 1 in 25 U.S hospital admissions are diagnosed with at least one infection because of complications in healthcare.3,4

    HAIs are characterized as infections that occur while receiving healthcare and were otherwise absent or incubating at the time of admission.5

    These types of infections are scrupulously monitored by the National Healthcare Safety Network (NHSN) of the Center for Disease Control and Prevention (CDC) and are a top priority for the U.S. Department of Health and Human Services (HHS).5,6

    The CDC classifies HAIs as “Winnable Battles”, and commits to this level of surveillance to reduce the incidence of HAIs and improve patient outcome.4,5,8

    HAIs include central line-associated bloodstream infections (CLABSI), catheter-associated urinary tract infections (CAUTI), surgical site infections (SSI), Hospital-acquired Pneumonia (HAP), and Ventilator-associated Pneumonia (VAP).5,7

    While there are many diseases and organisms in healthcare settings, the CDC regards the emergence of Carbapenem-Resistant Enterobacterales (CRE) as an urgent threat, requiring immediate action.9

    CRE are a serious threat to public health. Mortality rates of up to 50% have been associated with hospitalized patients.10

    According to the CDC’s 2019 Antibiotic Resistance (AR) Threat Report, U.S CRE cases are stable. This observation speaks to the success of the currently implemented infection control and other preventive strategies; however, continued action is needed.11,12

    CDC’s AR initiative, dubbed ‘Detect and Protect,’ heavily relies on the institution of surveillance programs. The lack of preemptive screening of patients in healthcare facilities has contributed to the preventable transmission and spread of CRE.13,14.

    Carbapenem resistance among Enterobacterales can result from several different resistance mechanisms; however, resistance through the production of carbapenemases is of utmost concern.

    Carbapenems are generally administered as a last resort for treating drug-resistant Gram-negative infections.15

    Approximately 30% of all CRE carries a mobile genetic element (MGE) that codes for carbapenemase production, which can facilitate the transfer of resistance. 9,12

    While there are many variants of these enzymes, most carbapenemase producers harbor one or more of the ‘big five’ families: KPC, OXA-48-like, NDM, VIM, and IMP. Diagnostic laboratories should therefore implement assays that detect at least four, or preferably, all five of these families.18

    Enzyme detection is critical to effective treatment, since it directs the course of antibiotic therapy, and thus promotes Antimicrobial Stewardship.

    Antimicrobial Stewardship refers to a collection of efforts that promotes the appropriate use of antimicrobials aimed at improving patient outcomes, reducing AMR, and decreasing the spread of multidrug-resistant organisms.16

    More than 2.8 million antibiotic-resistance infections occur in the U.S each year, and more than 35,000 people die as a result.12

    In 1945, Alexander Fleming, the discoverer of penicillin (1928), had a premonition of antibiotic-resistant infections; he warned that doctors were abusing penicillin by prescribing it to those who did not need it.

    He said: “In such cases, the thoughtless person playing with penicillin is morally responsible for the death of the man who finally succumbs to infection with the penicillin-resistant organism. I hope this evil can be averted.”17

    To help its customers fight back against AMR, Hardy Diagnostics offers tools to implement the most robust infection control measures.

    These rapid and convenient methods screen suspect CRE* isolates with HardyCHROM CRE  and then confirm and identify the major carbapenemase enzymes with the phenotypic NG-Test® CARBA 5  kit. This kit produces results in only 15 minutes and requires no equipment.

    * HardyCHROM CRE for the screening of E. coliK. pneumoniaeK. aerogenesK. oxytoca, Enterobacter cloacae complex (ECC), and Serratia marcescens.

    References:

    1. ‘Race against time to develop new antibiotics’  
    2. Options for Evaluating Environmental Cleaning  ‘.(download)
    3. Nosocomial or Hospital-acquired Infections: An Overview  ‘. 
    4. CDC Winnable Battles Final Report  
    5. Hospital Acquired Infections  .
    6. Preventing Healthcare-associated infections  .
    7. Types of healthcare-associated infections  
    8. CDC: What is a Winnable Battle?   
    9. Carbapenem-Resistant Enterobacteriaceae   (Factsheet for download)
    10. Healthcare Facilities: Information about CRE  
    11. ‘Key Takeaways From the U.S. CDC’s 2019 Antibiotic Resistance Threats Report for Frontline Providers’  
    12. Antibiotic Threats in the United States (2019)   
    13. ‘Screening for carbapenem-resistant Enterobacteriaceae: Who, When, and How?’  
    14. Detect and Protect Against Antibiotic Resistance.   (download)
    15. Association between antibiotic consumption and the rate of carbapenem-resistant Gram-negative bacteria from China based on 153 tertiary hospitals data in 2014.   
    16. Antimicrobial stewardship.   
    17. How Can We Turn the Tide Against Inappropriate Antibiotic Prescriptions? 
    18. Introducing NG-Test® CARBA 5  

  • New Technology in the Fight Against Pneumonia

    Saving Patient Lives with Rapid Pneumonia Testing

    Streptococcus pneumoniae and Legionella pneumophila pose a severe threat of morbidity and mortality, with acute symptoms that include shortness of breath and chest pain. High-risk cases are known to result in respiratory failure, sepsis, pneumonia, bacteremia, and meningitis.(1)


    Consequently, “Pneumonia is the world’s leading cause of death among children under five years of age, accounting for 16% of all deaths of children” and “killing approximately 2,400 children a day in 2015″ according to the American Thoracic Society.(2)

    In the case of L. pneumophila, 90% of patients often regress with the development of Legionnaire’s Disease, which is estimated to afflict 10,000 to 18,000 people per year.(3) A follow-up study of 122 patients who had survived the disease found a long-term persistence of fatigue (75%), neurological symptoms (66%) neuromuscular symptoms (63%), and increased risk of lung disease in children. These long-term effects are expected to last for several months or even years.(4)


    S. pneumoniae, on the other hand, causes 150,000 U.S. hospitalizations annually, with a case-fatality rate of 5-7%.(5)


    The issue is further complicated with the rise in antibiotic resistance due to the misuse and overuse of antibiotics, such as issuing improper treatment when prescribing antibiotics for viral-causing cases of pneumonia.(2)


    In essence, a patient’s survival may depend on the difference between rapid and prolonged diagnostic testing, and the difference between efficiency and inadequacy.

    In assisting health care professionals save lives and treat patients, while simultaneously ruling out common and deadly causes of bacterial pneumonia, Hardy Diagnostics is honored to distribute ImmuView®.

    This image has an empty alt attribute; its file name is linkedin-image-1024x536.jpg

    This product is unique, in that it is the only antigen test that is able to identify both infectious bacterial agents simultaneously, utilizing a urine specimen. (6) Test results are available in 15 minutes, offering confident and rapid urinary detection of both Legionnaires’ Disease and S. pneumoniae serogroup 1. ImmuView® requires no equipment or special technologist expertise.


    Urinary antigen tests are recommended by The Infectious Disease Society of America/American Thoracic Society due to same-day results, increased sensitivity/specificity over culture methods, and urine availability over sputum samples.(7) All of these factors improve diagnostic yield by 23-39%; with ImmuView® offering easy-to-read, immunochromatographic assay results.(7,8)

    This image has an empty alt attribute; its file name is easy-fast-reliable-1024x255.png


    Our collective work in offering ImmuView® makes a difference in the vitality of patients around the world. For that reason, we are inspired and grateful to continue to fulfill our mission of distributing products for the prevention and diagnosis of disease.

    Learn more about ImmuView®


    Don’t assume it’s viral pneumonia

    Hardy Diagnostics is proud to announce our upcoming webinar in partnership with SSI Diagnostica discussing co-infections and the benefits of testing for both viral and bacterial infection upon admission of a patient with pneumonia.

  • Can Regeneron’s Antibody Cocktail Speed Recovery of COVID-19?

    Is this why President Trump Recovered so Quickly?

    In 1900, Nobel Laureate Emil von Behring demonstrated antibodies in blood plasma, or serum, could be transferred from one person or animal to another person, conferring immunity against an infectious agent-as illustrated in his work with horses to cure and prevent diphtheria. (1)

    With advances in technology, medicine has transitioned from using convalescent serum to fully human recombinant antibodies. (2) Such technologies are now capable of creating animal models of human disease, using genetically modified, or “humanized”, mice that produce fully-human antibodies—as in the case of the proprietary VelociSuite® technologies by Regeneron Pharmaceuticals (3). Regeneron Pharmaceuticals, a leading biotechnology company, is accelerating and improving traditional drug development processes through such technologies, as evidenced by their latest artificial “antibody cocktail” treatment for COVID-19—REGN-COV2.

    REGN-COV2’s development is a testament to Regeneron’s expeditious drug discovery model, having started research efforts in the beginning of February and moving into production at the start of June. Regeneron’s antibody “cocktail” was developed using parallel efforts: deriving antibodies from both genetically humanized mice as well as B cells sourced from convalescent patients.

    This methodology enabled researchers to collect a swath of fully human antibodies with diverse sequences, binding properties, and antiviral activities (2).

    Recombinant fully human antibodies were then surveyed for high degrees of potency and cross-referenced against similarly performing antibodies from human COVID-19 survivors (4). Researchers then aimed to select a set of antibodies that bound to discrete, non-overlapping portions of the Receptor Binding Domain (RBD) of the SARS-CoV-2 spike protein—a selection process that protects against a virus’ proclivity for mutational escape (4). This tactic was successfully employed during the development of treatments for Ebola, so it had promising applications for the SARS-CoV-2 pandemic (2).

    On September 29th, 2020 Regeneron announced its first data from a descriptive analysis from a concurrent Phase 1/2/3 clinical trial that showed a reduction in viral loads, time to alleviate symptoms (non-hospitalized), and medical visits (6).

    On October 1st, 2020, President Donald J. Trump contracted COVID-19, and that same day received a single 8 gram dose of the REGN-COV2 under the FDA’s Expanded Access, or “Compassionate Use”, authorization. This is a pathway for a  patient to receive an investigational medical product outside of clinical trials when no satisfactory alternatives are available (7). In addition to the Regeneron Antibodies, President Trump also received doses of zinc, vitamin D, famotidine, dexamethazone, Remdesivir, melatonin and a daily aspirin tablet.

    Figure 2: Regeneron, a New York based biotech company, is developing and testing a new antibody therapy for COVID-19.

    President Trump’s expeditious recovery has largely in part been attributed to REGN-COV2, which the President has routinely touted as an “unbelievable” drug and a “cure” (8). Under the Trump administration’s Operation Warp Speed, Regeneron was awarded $450 million in federal funding to accelerate the manufacturing and distribution of REGN-COV2. Following President Trump’s illness, Regeneron submitted an Emergency Use Authorization application to the FDA to accelerate its availability.  If approved, the Trump Administration has agreed to make the therapeutic available to the American people at no cost and be responsible for its distribution (4).

    Clinical data is continuing to be released as part of its ongoing investigational study. Read the latest efficacy study here: https://investor.regeneron.com/news-releases/news-release-details/regenerons-covid-19-outpatient-trial-prospectively-demonstrates

    Regeneron’s method of drug development is so well established, that it reflects in their mission statement: “To use the power of science to bring new medicines to patients … over and over again.”

    HOW ANTIBODIES WORK AGAINST SARS-COV-2

    References:

    1. https://www.nobelprize.org/prizes/medicine/1901/behring
      /facts/
    2. https://science.sciencemag.org/content/369/6506/1010
    3. https://www.regeneron.com/technology
    4. https://www.regeneron.com/covid19
    5. http://science.sciencemag.org/content/369/6506/1014
    6. https://investor.regeneron.com/news-releases/newsrelease-details/regenerons-regn-cov2-antibody-cocktailreduced-viral-levels-and
    7. https://www.fda.gov/news-events/public-healthfocus/expanded-access
    8. https://nypost.com/2020/10/08/regeneron-seeksemergency-approval-for-trump-backed-covid-drug/

  • 2020

    In October, the Hardy Partners celebrated their eighth year of being an Employee Owned company (ESOP). As a company that is 100% owned by its employees, the workers receive free shares in the company every year on November 30th. The theme this year was “Backing Your Future!”

  • Ruthenium Based Antibacterials – Can this be useful in the fight against resistant bacteria?
    Figure 1: ruthenium is a rare metal related to platinum

    A team of researches at the University of Sheffield in South Yorkshire, England, have reported a new compound that displays the ability to kill both gram-positive and gram-negative antibiotic-resistant bacteria (1).

    PhD student Kirsty Smitten, Principal Investigator Jim Thomas, and their team in the Department of Chemistry first published their findings in Chemical Science in October 2019. They described a dinuclear Ruthenium (RuII)-based antimicrobial theranostic that was “particularly active against pathogenic gram-negative bacteria”(2).

    Ruthenium is a chemical element with the symbol Ru and atomic number 44. It is a rare transition metal belonging to the platinum group of the periodic table. Like the other metals of the platinum group, ruthenium is inert to most other chemicals.

    Using super-resolution of STED (Stimulated Emission Depletion) nanoscopy and the inherent luminescent properties of these RuII complexes, Smitten’s investigation confirmed that, white these compounds did show a high affinity to binding and damaging gram-negative bacterial DNA, the compounds tended to bind to the bacterial membranes first.

    This slowed internalization and resulted in a lower amount of damage to the target DNA. New therapeutic opportunities were identified, especially when coupled with additional treatments that could increase the gram-negative bacterial target’s internalization of these new theranostics.

    Theranostics (a portmanteau of therapeutics and diagnostics) is process of diagnostic therapy for individual patients – to test them for possible reaction to taking a new medication and to tailor a treatment for them based on the test results.

    Additional publications,however, showed that Smitten and her team continued with their work. In July 2020, the team again published in Chemical Science, reporting the development of a series of mononuclear RuII complexes that, unlike their dinuclear analogues, did not damage bacterial cell membranes and were rapidly taken up by both gram-negative and grampositive bacteria (3).

    Continuing their use of STED nanoscopy and TEM microscopy, Smitten and her team were able to show that the internal target of these RuII complexes remained the bacterial DNA. Minimum Inhibitory (MIC) and bactericidal concentrations were comparable to that experienced by Ampicillin-sensitive bacterial strains, and this activity was retained even in resistant strains such as MRSA.

    It is important to note that these RuII complexes showed exceptionally low toxicity toward the team’s eukaryotic animal model, Galleria mellonella, even at concentrations that were orders of magnitude greater than the aforementioned MIC values.

    The idea of mononuclear-RuII complexes used for therapeutic antibacterial use are quite promising. The class of DNAbinding antibacterials is quite small, with only Metronidazole and Nitrofurantoin available on the market at this time. An additional advantage of these theranostics would be in their ease of scale. Since they are relatively simple chemical complexes, they would not necessitate the intensive multistep synthesis required of therapeutics based on natural derivatives. Lastly, the expected eukaryotic toxicity of RuII compounds is quite low while still exhibiting broadspectrum antibacterial activity.

    REFERENCES

    1. Scientists develop new compound which kills both types of antibiotic resistant superbugs, University of Sheffield, 4 Sep 2020
      https://phys.org/news/2020-09-scientists-compound-antibiotic-resistant-superbugs.html
    2. Ruthenium based antimicrobial theranostics – using nanoscopy to identify therapeutic targets and resistance mechanisms in Staphylococcus aureus, Smitten, Thomas, et al, 29 Oct 2019
      https://pubs.rsc.org/en/content/articlehtml/2020/sc/c9sc04710g
    3. Mononuclear ruthenium(II) theranostic complexes that function as broad-spectrum antimicrobials in therapeutically resistant pathogens through interaction with DNA, Smitten, Thomas, et al, 30 Jul 2020
      https://pubs.rsc.org/en/content/articlehtml/2020/sc/d0sc03410j

  • Can Bacteria be Used to Attack Tumors?

    Bacteria are commonly considered a culprit leading to cancer. However, recent research suggests that some bacteria, being a potential enemy can also be a friend, and thus be utilized to create novel cancer therapeutics and treatments.(1, Figure 1)

    A great deal of research ahs centered on using bacteria to reduce the size of tumors. Tumors harbor hypoxic regions within them with can be inoculated with anaerobic bacteria (or bacteria engineered to be anaerobic). These bacteria infect the tumor region by cannot survive else in the body.(1,2) Studies have already shown that strains of Clostridia, Bifidobacteria, and Salmonella can effectively invade tumor cells and reduce the size of the tumor, with no harm to the patient.(1)

    Other studies have shown the impactful role of bacteria have in fighting cancer through drug development. Recently, researches have developed methods to increase P450 protein production in bacteria to improve manufacturing processes for cancer drugs. P450s are plant proteins that synthesize other metabolites which can be used to create terpenoids, a class of compoud used in cancer drugs.(3)

    Previously, researches have struggled to produce P450s in recombinant cells. However, Vaxquez-Albacete et. al found that P450s could be efficiently produced in microbes by applying signal peptides to the bacterial host’s recombinant genome and engineering the N terminus of the peptide sequence.(2) After analysis with GFP tagging techniques, increased expression of P450s was observed in an Escherichia coli system. (3)

    what does this mean for cancer drugs? A lot, actually. Many cancer drugs are still produced using plant-based techniques. For example, the chemotherapy trug Taxol is a P450 and is still produced using the needles of a European Yew tree.(4) Harvesting form the trees is a high labor, low yield process leading to a drug that costs over $4,000 per month.(5,6) In 2010, Ajikumar et. al found that Taxol’s precursors can actually be produced in E. coli along its terpenoid pathway.(4) This method, combined with the method of the Vazquez-Albacete group developed, can result in huge increases in P450 proteins.(3,4)

    Although this was a great improvement, there were still process inefficiencies because the final Taxol product required so many (and some undiscovered) reactions.(4) However, the Vaxquez-Albacete group’s discovery could be the framework from future cell factories for cancer medication.(3) A more efficient manufacturing process would allow drugs to be more affordable for patients.

    Bacteria are not solely a cause for concern for cancer research. They can be exploited to both help kill tumors at their source within patience and to produce drugs. As more is understood about their efficacy and safety, oncologists, researchers and patients alike will reap the benefits of more effective and cheaper bacteria-based treatments.

    An external file that holds a picture, illustration, etc.
Object name is 13027_2018_180_Fig1_HTML.jpg
    Figure 1, from ref. source 1.

    Works Cited
    1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5856380/
    2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3365283/
    3. https://pubmed.ncbi.nlm.nih.gov/27748524/
    4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3034138/
    5. https://www.mskcc.org/sites/default/files/node/25097/documents/120915-drug-costs-table.pdf
    6. https://pubmed.ncbi.nlm.nih.gov/21487833/

  • The humble beginnings of Hardy Diagnostics

    “Many people have asked me how I got started in business.

    First of all, you will need to know that our company, currently consisting of 430 co-workers, manufactures culture media that microbiologists use in the laboratory. Culture media is what we call the “bug food” that bacteria and fungi feast upon in order for microbiologists to determine the identity of the pathogen and to help determine how to kill them in order to restore the health of the patient.

    The year was 1980, and I had just finished a one year internship at a hospital in Santa Barbara to train as a Medical Technologist. These are people that are licensed to conduct laboratory tests in a clinical setting. The requirements are a bachelor’s degree and a rigorous year of practical training in the hospital lab. After finishing and passing the California State Board exams, my dream had been realized and I had finally become full-fledged Medical Technologist.

    However, there were no jobs available at the time! Having come from the LA area, spending a year in the Central Coast of California was like paradise to me, so I very much wanted to stay in Santa Barbara. Being disappointed and dejected about not being able to find work in my new profession, I was talking to my friend who had also completed the internship. We did not know which way to turn, but somehow came up with the idea of making culture media. My father was an entrepreneurial pharmacist who operated many drug stores during his career, so starting a new business seemed to be a somewhat natural path for me to follow.

    So my friend and I started our fledgling business on a shoestring budget. We rented two small rooms in what had once been a motel in Santa Barbara. After borrowing $10,000 from each of our Dads, and rescuing some antiquated equipment from a trash heap, our little business was ready to be launched. We started with one customer, which was the hospital where we had trained. Over the years, we began to service more and more hospitals in Central California, and eventually grew to a company that now supplies over 10,000 laboratory customers worldwide with over 13,000 products that are used in the laboratory.

    I often stop and wonder how different my life would have been if I had gotten my wish and had been offered a job back in 1980. I am constantly reminded of one of my favorite sayings when faced with adversity, which is the Marines’ motto: “Adapt, Improvise, Overcome.” We did just that, and I’m now enjoying the ride with no regrets!” – Jay Hardy

    Jay Hardy, CLS, SM(NRCM), Founder and part-owner.
    Jay Hardy, CLS, SM(NRCM),
    Co-Founder and President.

    Hardy Diagnostics may have had humble beginnings but since has grown to become one of the top producers of culture media in the country! Not only that, but Hardy Diagnostics has the unique distinction of being a 100% employee owned company. The Hardy Diagnostics ESOP was created in 2012, and in October 2015, Mr. Hardy sold the remainder of his majority share in Hardy Diagnostics back to his employees. Hardy Diagnostics now operates as a 100% Employee Owned ESOP.

    Read more about ESOP’s, employee ownership, and the Father of ESOP’s- Louis Kelso.

  • Blocking COVID with Antibodies

    As the number of global coronavirus cases continues to increase beyond 20 million, there is an urgent need for treatment for those infected with SARS CoV2. Internationally, biotech companies are working feverishly towards developing a vaccine to reduce infection rates. However, it is still unclear when a final product will be released and to what degree of immunity will be achieved. Until a permanent solution can be developed, it appears that monoclonal antibodies (mAbs) which are frequently used in cancer treatment may provide temporary immunity to SARSCoV-2. (1)

    These mAbs are a form of immunotherapy which can bind to and neutralize antagonistic antigens. For COVID-19, treatment involves intravenous infusion of the recommended concentration of neutralizing antibodies that adhere to the S domain on the spike protein. Attachment of the antibody to a viral particle inhibits binding of the spike protein to the ACE2 receptor on the cell membrane.

    By blocking the binding of the bspikes to the cell, the antibody prevents the virus from entering and replicating within the cell. (2)

    Current data published by Regeneron Pharmaceuticals indicates that antibody therapy may prove vital to immunocompromised individuals suffering from COVID-19. In their study, they looked at the effects of their neutralizing antibody cocktail (REGN-COV2) on SARS-CoV2 infected rhesus macaques and golden hamsters.

    To assess the efficacy of the treatment, nasopharyngeal and oral swabs were collected every other day for seven days and measured for viral load (gRNA, sgRNA). The data suggests that infusion of 50 mg/kg of neutralizing antibody greatly reduced the viral RNA load by the second day of therapy compared to the placebo group. Further pathological analyses of lung tissue in the control groups showed obvious signs of interstitial pneumonia in the placebo group, with minor to no signs of pneumonia in groups that received 0.3 mg/kg, or 50 mg/kg of REGN-COV2. (3)

    In conclusion, the use of neutralizing antibody-based immunotherapy has shown promising results in preliminary animal testing. The data suggests that viral replication can be blocked very quickly, which may support a prompt recovery from SARS-CoV-2 infection. (3)

    Although neutralizing antibody treatment is not permanent, researchers believe immunity could last up to six months. If this type of therapy is approved for treatment of patients, this could potentially provide sufficient time for a more permanent solution to be developed. (1)

    References:

    1. https://www.medscape.com/viewarticle/935018?nlid=136721_5402&src=wnl_dne_200805_mscpedit&uac=166752BK&impID=2491809&faf=1
    2. https://apjai-journal.org/wp-content/uploads/2020/03/2.pdf
    3. https://www.biorxiv.org/content/10.1101/2020.08.02.233320v1.full

  • 2020

    In September, several new executive leadership positions were created. Andre Hsiung became the company’s Chief Scientific Officer in charge of R&D, Technical Services and Performance Studies. Christopher Catani (pictured) was promoted to Chief Operations Officer. Sue Pruett added Quality Control to her Quality Assurance duties.

  • How is Legionnaire’s Disease related to Covid?

    The COVID-19 pandemic is unlike any public health emergency we have seen in many decades. Nations have shut down borders, businesses, and life as people knew it. Aside from the obvious economic side effects of shutting down businesses, offices, schools, and other buildings, another potentially deadly disease may be on the rise as a consequence of the COVID-19 lockdowns and a sudden reopening of previously closed areas.

    There have been reports of rising cases of Legionnaires’ disease and the CDC has even recently closed several buildings in Atlanta that it leases due to the detection of Legionella bacteria in their water systems. (1) The bacteria likely proliferated during the prolonged shutdown. Buildings closed for months end up becoming breeding grounds for Legionella spp. which commonly live in warm environments and feed on pipework sludge and sediment.

    Legionella bacteria are common in water but usually are only a problem when the water is aerosolized and people breathe it in. Showers, taps, cooling towers, air-conditioning systems, spa pools, hot tubs, and water fountains are common sources. Hardy Diagnostics Buffered Charcoal Yeast Extract (BCYE) Agar formulations are recommended for use in the cultivation and primary isolation of Legionella spp. in water and other samples suspected of harboring the bacteria.

    A notable recent outbreak occurred at the Sheraton Hotel in Atlanta in July of 2019. Legionella was traced back to the hotel’s cooling tower but the bacteria was also found in a decorative fountain in the atrium. (2)

    Although the disease does not spread from person to person, large community outbreaks are common and likely to happen when abandoned buildings begin to reopen without proper remediation steps taken. In addition, plans to reopen states during the summer aggravates the problem since Legionella pneumophila is more likely to grow in warm temperatures.

    Legionnaire’s disease shares similar symptoms with COVID19 including fever, dry cough, shortness of breath, and muscle pain. The disease later progresses to pneumonia. If patients with these symptoms test negative for SARS-CoV-2, it is important to consider L. pneumophila as a causative agent and determine the source of contamination in order to prevent larger community outbreaks.

    Offered by Hardy Diagnostics, ImmuView® P&L is the only urinary Antigen Test capable of identifying both S. pneumoniae and Legionella pneumophila at the same time – with just one test.

    People most at risk for contracting Legionnaire’s disease include the elderly, smokers, people with suppressed immune systems, and those with diabetes. (3)

    Since Legionella prefer water between 80°F and 120°F, one way to combat Legionella growth would be to ensure water present in any building’s water systems are outside of that range. Additionally, the bacteria are killed by chlorination and other disinfectants. (1) Another way to prevent the growth of Legionella is to flush water that has been sitting in the plumbing system since Legionella proliferate in stagnant water.

    As we see states begin to reopen across the country, we need to urge that public and private officials require comprehensive assessment of water systems in offices, schools, factories, and other buildings and that adequate cleaning procedures are performed.

    The coronavirus pandemic has already taken a great toll on our communities and reducing the risk of Legionnaires’ disease outbreaks is important now, more than ever.

    Works cited:

    1. https://www.cnn.com/2020/08/07/health/coronaviruslegionnaires-watercdc/index.html
    2. https://www.cnn.com/2019/08/16/us/atlanta-legionnairescooling-tower/index.html
    3. https://www.msn.com/enus/health/medical/anotherdeadly-disease-potentially-cameout-during-covid-19-lockdowns/ar-BB15h6Hh

  • 2020

    In the Fall, two new properties were purchased on McCoy Lane in Santa Maria, CA. A 12,000sf building as added to the seven existing buildings on McCoy to house more office and manufacturing space.  Also, a two acre parcel was purchased to accommodate a future building project.

  • Vitamin D – A neglected option of treatment and prevention of COVID-19 infections

    Below are quotes from numerous studies showing that Vitamin D can be useful in the battle against COVID-19 infections.

    “Several groups of researchers from different countries have found that the sickest patients often have the lowest levels of vitamin D, and that countries with higher death rates had larger numbers of people with vitamin D deficiency than countries with lower death rates.” REFERENCE.

    “Participants positive for COVID-19 were 50% more likely to have low vs normal 25(OH)D levels in a multivariate analysis that controlled for other confounders, for example.”REFERENCE.

    “The main finding of our study was the significant association of low plasma vitamin D level with the likelihood of COVID-19 infection among patients who were tested for COVID-19,even after adjustment for age, gender, socio-economic status and chronic, mental and physical disorders.” REFERENCE.

    “In the United States, for example, the COVID-19 mortality rate among blacks and Hispanic Americans is higher than among the general population, and it is well established that these groups have lower levels of vitamin D, compared with other groups.” REFERENCE.

    “To reduce the risk of infection, it is recommended that people at risk of influenza and/orCOVID-19 consider taking 10,000 IU/d of vitamin D3 for a few weeks to rapidly raise25(OH)D concentrations, followed by 5000 IU/d.” REFERENCE.

    “The researchers noted that patients from countries with high COVID-19 mortality rates,such as Italy, Spain and the UK, had lower levels of vitamin D compared to patients in countries that were not as severely affected.” REFERENCE.

    “Another recent Indonesian retrospective cohort study of 780 Covid-19 patients indicated that the majority of death cases had below-normal vitamin D levels and that vitamin D status was strongly associated with Covid-19 mortality.” REFERENCE.

    “In the meta-analysis, vitamin D supplementation has been shown as safe and effective against acute respiratory tract infections. Thus, people who are at higher risk of vitamin D deficiency during this global pandemic should consider taking vitamin D supplements to maintain the circulating 25(OH)D in the optimal levels (75-125nmol/L).” REFERENCE.

    “Vitamin D deficiency that is not sufficiently treated is associated with COVID-19 risk.”REFERENCE.

    “We concluded that the daily supplementation of 2000-5000 IU/day of vitamin D3 in older adults with PD (Parkinson’s Disease) has the potential to slow the progression of PD while also potentially offering additional protection against COVID-19.” REFERENCE.

    “Vitamin D proved to interact both with the innate immune system, by activating Toll-like receptors (TLRs) or increasing the levels of cathelicidins and β-defensins, and adaptive immune system, by reducing immunoglobulin secretion by plasma cells and pro-inflammatory cytokine production, thus modulating T cell function.” REFERENCE.

    As you can see from the references above, there is solid evidence that Vitamin D supplementation is warranted in order to decrease the severity of COVID-19 infections. So the question is: Why is the media largely ignoring this research that could potentially save many lives?

  • Controlling Weight with Probiotics- Akkermansia muciniphilaand the Microbiome

    Without a doubt one of the greatest health problems plaguing Americans to date is obesity.  The CDC reports that currently 42.4% of adults in the US are obese with a body mass index (BMI) between 30-40. Among these individuals, 9.2% were reported as having severe obesity with a BMI greater than 40. (1) In addition to proper nutrition and physical activity, scientists are looking into the role the microbiome plays in fat storage.  In particular, Akkermansia muciniphila has gained traction in these studies due to its ability to degrade mucin and modulate gut inflammation. (2)

    Evidence of the benefits of A. muciniphila were observed in 2015 by Caesar et al. This group looked at fat intake and microbial composition by splitting mice into two control groups: those who consumed fats (lipids) in the form of lard and those who consumed fats in the form of fish oil.  After eleven weeks, the control groups were pyro sequenced for gut microbial composition and compared.  Final analysis showed the control group fed a fish oil diet had a much higher concentration of A. muciniphila as well as other beneficial probiotic bacteria.  To further rule out additional factors, the cecum from each control group was transplanted into a fresh group of mice and fed lard for three weeks.  The control group containing the cecum from the fish oil mice had less weight gain compared to those in the lard control group.  Moreover, 16S rRNA gene sequencing of the cecum from the fish oil fed mice was found to be high in A. muciniphila. (3)

    In 2017, further analysis by Ottman et al. found there might be more to the mystery of A. muciniphila.  In their study, they observed the immunomodulatory effects of A. muciniphila compared to that of other well-known probiotic organisms, Lactobacillus plantarum WCFS1 and Faecalibacterium prausnitzii A2-165.  In order to compare the organisms, they analyzed a comparison of TNF-alpha (pro-inflammatory)/IL-10 (anti-inflammatory) cytokine induction ratio. Mice containing A. muciniphila had a much lower cytokine ratio, indicating a much greater anti-inflammatory response which is ideal for probiotic use. (4)

    To reduce the growing cases in obesity, current studies in mice suggest that a reduction in overall body fat composition is achievable by probiotic supplementation of A. muciniphila.  If future studies continue to support this claim, people may have another option to consider in regards to body recomposition.

    Miles Amby

    R&D Microbiologist

    https://www.cdc.gov/nchs/products/databriefs/db360.htm (1)

    https://supplementpolice.com/akkermansia-muciniphila/ (2)

    https://www.cell.com/cell-metabolism/fulltext/S1550-4131(15)00389-7?_returnURL=http%3A%2F%2Flinkinghub.elsevier.com%2Fretrieve%2Fpii%2FS1550413115003897%3Fshowall%3Dtrue (3)

    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5332112/#pone.0173004.ref017 (4)

  • CBD: How Pet Parents are Leading the Pack -The current landscape for pets and medical cannabis products

    CBD: How Pet Parents are Leading the Pack -The current landscape for pets and medical cannabis products In America, around 70% of households own a pet. This means that roughly 90.5 million families have welcomed a four legged (or maybe feathered) friend into their homes. (Rainwalk Pet Insurance, 2022) Not only do most people own a pet or two, the way we treat our pets is changing. According to a 2011 Harris poll, 90% of pet owners think of their dogs and cats as members of the family. Therefore it should be no surprise that pet food and care is a rapidly growing market. (Taylor, 2019) As people focus more on the comfort of their animals, products that claim to increase the quality of life for man’s best friend are flying off the shelves.

    CBD oil and other cannabis derived products for human ailments like chronic pain, seizures and other common disorders, have become very popular across the US. The public is turning to these remedies to help their pets as well. Most people live in an area with access to some form of legal, medicinal cannabis oils and extracts. This accessibility is contributing to the growth of these alternative treatments. The demand is pushing the development of an entire veterinary industry in which Fido or Fifi have a full line of cannabis derived products available to them. Some products have been developed by veterinarians and designed to help with the treatment of specific ailments. It is common to find sublingual CBD oils or pills, infused treats, and topical creams. The most common ailments addressed by veterinary CBD products are:

    • Arthritis and other types of inflammation-related pain
    • Behavior problems (including separation anxiety and noise phobias)
    • Cancer
    • Digestive tract disorders and inflammatory bowel disease
    • Bacterial and fungal infections
    • lntervertebral disc disease (IVDD)
    • Kidney and liver diseases
    • Glaucoma
    • Epilepsy, seizures and other disorders of the nervous system
    • Skin disorders
    • Chronic pain management

    Most of the products being made for pets are using CBD oil derived from hemp or marijuana plants through different extraction methods. Hemp is currently defined by the FDA as any cannabis plant with less than 0.3% THC, plants with higher amounts of THC are considered “marijuana.” Both marijuana and hemp are members of the cannabis sativa family and both are commonly used for CBD extraction. THC is often thought of as the “psychoactive” compound, while most varieties of CBD are considered “non-psychoactive.” Hemp is a federally legal cannabis plant, but the products made from hemp-derived CBD are largely not approved for use as medicine. The FDA is clear about its stance on CBD in consumer goods. In a recent consumer update, issued on November 25, 2019, “It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.” (FDA. 2019) From the perspective of the FDA, any CBD containing product claiming to have medicinal benefits or CBD added to food is the same as adding any other prescription drug to the product- and that requires a doctor’s prescription. Adding to the confusion is the myriad of state laws that allow for CBD to be infused in food and drinks, making it difficult for consumers to understand the legality of the products where they live.

    While some are skeptical about the efficacy of CBD for the treatment of disease, others are defending the medicinal benefits they see animals experiencing. CBD has an interesting relationship with the endocannabinoid system, a complex cell-signaling system found in mammals, birds, fish and even reptiles. Scientists only discovered this system in the 1990’s and early indicators suggest the system helps maintain the body’s homeostasis. (Pacher. 2006) Dr. Tim Shu founded VETCBD in 2015, a cannabis company focused on providing cannabis-derived medicinal oils to dogs and cats. According to Shu, “Relief is provided as the cannabinoids in marijuana interact with the endocannabinoid system. It’s a series of receptors that run throughout the body,” he says. “Many people are unaware that pets can safely and effectively benefit from cannabis using proper formulation and dosing. And it’s not just dogs and cats that can benefit, we’ve had ferrets, rabbits, pigs, rodents, and horses find therapeutic relief through cannabinoid therapy.” Shu believes that unlike some traditional pain medicine for dogs, medical cannabis has no life-threatening side effects with proper dosage. “It does~’t damage the kidney, liver, or GI tract. The dogs aren’t high or sedated.” (Semigran, 2019)

    While Dr. Gary Richter of Montclair Veterinary in Oakland, CA, also promotes the use of broad spectrum cannabis derived medicines containing both CBD and THC for veterinary applications, he cautions owners to understand what is in the cannabis medications. “The most significant [risk] is THC toxicity, meaning, essentially, they are high,” Richter says. “Depending on how significantly a pet has been overdosed, the effects of that can be quite long-lasting, even days. Even if the THC toxicity is not excessive, they can sometimes have problems due to these other ingredients.” If an overdose or counteraction is suspected, take the pet to the veterinarian immediately. (Semigran. 2019) Even with that concern in mind, Dr. Richter remains very enthusiastic about the potential for properly administered cannabis medicine. “I had somebody come in with their cat that had chronic inflammatory bowel issues. This kitty was on all kinds of medications. The woman pretty much told me that unless I could do something to help this cat, she was going to have to put him to sleep because he was so miserable and there was nothing more to do. We put him on some supplements and made some dietary alterations but without a doubt the thing that turned a corner for this cat was the cannabis. Literally within two days of putting this cat on cannabis he had his first normal bowel movement that he’d had in almost a year. We were able to drastically improve this kitty’s life to the point where he was stable. The owner was ecstatic.” (HelloMD. 2019)

    All of this is encouraging for those looking for an alternative method to treat the medical needs of their pets. Early indicators from clinical studies (Gamble. 2018) and owner testimonials suggest that CBD oils may have effect on a number of conditions. In addition, there are few, if any, known significant drug interactions between cannabis and traditional medications. There are some cautions, though, that need to be properly addressed.

    We need more research to truly understand the proper dosing for pets and their associated ailments.
    Correct dosage is imperative. “As is the case with any medication, success has everything to do with dosing,” Dr. Richter says. “If you dose pets properly, then they are going to get the positive effect that you’re looking for while not having any psychoactive side effects.” As for now, the best option is to work with a veterinarian experienced in treating animals with CBD products.

    Many CBD products do not contain the amount of active ingredients listed on the label.
    Independent testing has found there can be wide variances when products are taken to lab for analysis. In a recent study by NBC news, 35 products were taken to labs for a cross check. 20 had less than half of the amount of CBD advertised on the label. Some had no CBD at all. (Krauth. 2019) This is extremely concerning and is evidence that consumers should research the products and brands they choose to buy from. This includes reading and understanding the lab certificates of analysis that should be provided upon purchase.

    Most products are not tested to the same standards as traditional medicine.
    Most have come to expect a certain standard of safety when it comes to the quality of products, especially those advertised as medicine. However, CBD is still largely unregulated by agencies such as the FDA. The FDA states, “To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. FDA has, however, approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.” (FDA, 2019) That means that the CBD oil for sale to the public for therapeutic use may or may not have been properly screened for contamination.

    Not all people have access to the most appropriate CBD product.
    Hemp derived CBD is legal in all states thanks to the Farm Bill of 2018. However, “marijuana” derived CBD is not. If a pet has a condition that responds better to product made from marijuana plants with more than 0.3% THC, the owner’s location may prevent them from being able to legally provide that to their pet.

    There are studies underway at veterinary schools such as Cornell University that are studying the effects of CBD for pets with certain degenerative diseases. (Gamble. 2018) The hope is that one day soon vets can safely determine proper application and dosage of medical cannabis and CBD for pets. Many veterinary experts feel confident that CBD oil and other medical cannabis products for pets have the potential to be highly effective medicines, when dosed and used appropriately. “The entire veterinary medical community needs to take a hard look at this and realize that medical cannabis is here to stay in this country,” Richter said. “We need to get involved in this discussion with pet owners to prevent animals from being harmed [by] pet owners using it without appropriate medical guidance.” (HelloMD. 2019)

    Jessa Youngblood is the cannabis industry specialist at Hardy Diagnostics. She is a member of the AOAC CASP committee for Microbial Contaminants Working Group as well as the NC/A Scientific Advisory Committee. Jessa has a passion for safe access to cannabis medicine and regularly leads webinars and trainings to support the development of cannabis microbiology testing programs across the US and Canada.

  • Go with Your Gut—Your Gut Microbiome That Is!

    Listeria hysteria! Outbreaks have been popping up in a variety of foods over the years—however, not all infections are created equal. The severity of L. monocytogenes infection, also known as Listeriosis, is dependent on both the host’s immune system and the virulence of the strain.(1) Immunocompromised populations may experience encephalitis, meningitis, bacteremia, miscarriage, gastroenteritis, or even death. Immune-competent individuals may experience mild to no symptoms.(2) 0.5–5% of humans even carry low levels L. monocytogenes in the gastrointestinal tract with no symptoms.(3)

    Listeria is acquired through ingestion of contaminated foods. The most common culprit is ready to eat (RTE) foods such as deli meats, cheeses, and ice cream. The gut microbiome serves as a form of defense by activating the host’s immune system, production of bacteriocins, and depletion of nutrients.(4) Pregnancy, chemotherapy, and other conditions causing immunodeficiency can affect both the immune system and composition of gut microflora.

    Simone Becattini and Eric G. Pamer’s research group simulated this affect by disrupting the microbiome of healthy and immunocompromised laboratory mice through antibiotic treatments. These treatments made them more susceptible to L. monocytogenes infection and subsequent colonization and dissemination.  A different group of mice treated with cyclophosphamide, doxorubicin, and chemotherapy drugs were more susceptible to L. monocytogenes infection. Once treated with additional antibiotics, the mice were even more likely to be infected. If the mice survived after colonization, L. monocytogenes remained in their intestinal tract for up to 3 weeks allowing the possibility for relapse.(4)

    The researchers found four different species of Clostridia bacteria in the gut microbiome that, when present, were able to limit L. monocytogenes infection. Transfers of these bacteria into germ-free mice limited Listeria colonization and dissemination because the Clostridia outcompeted the Listeria. Transfers of intestinal bacteria, also known as Fecal Microbiota Transplants (FMTs), are used to treat various conditions including Irritable Bowel Syndrome (IBS) and Clostridium difficile infections.(5)

    This study revealed a new potential avenue of Listeria protection and treatment. FMTs could help reduce the instances of Listeriosis and the subsequent deaths associated with these infections. For example, pregnant women in their third trimester show reduced numbers of Clostridia species and are at high risk of infection.(6) FMT treatments could be a safe and helpful way to reduce instances of Listeriosis and save lives for those that are at most risk.

    Ref: 1, 2, 3, 4, 5, 6

    written by Lauren Hamilton
    Technical Services Microbiologist
    Hardy Diagnostics

  • Hardy Diagnostics in the News

    Hardy Diagnostics is proud to partner with labs around the country as they work tirelessly to detect and prevent the further spread of COVID-19. We were recently featured by a local news team to show our community what we’re doing in the fight against this pandemic. Watch our recent highlight and let us know how we can continue to help!

  • Helicobacter May Not Always be Hard to Stomach

    Can it control gluten sensitivity and asthma?

    Helicobacter pylori infection is no laughing matter. Sufferers can look forward to such unpleasant symptoms as chronic gastritis, gastric ulcers, and possibly gastric adenocarcinoma. Only discovered in 1982, H. pylori‘s pervasive presence, particularly in developing countries, is now accepted as the underlying cause of many gastric disorders.Despite the undeniably negative effects of H. pylori colonization, deeper analyses of patient populations are revealing surprising correlations between incidence of the bacterium and immune system effects. For some patients without acute effects, elimination of H. pylori may actually be detrimental.

    Epidemiologic investigation of H. pylori‘s connection to other conditions usually begins with noting the extreme disparity in rates of H. pylori colonization between the developed and developing world, and then examining a correlated condition for actual connection to the bacterium.

    In 2011, Arnold et al designed a study to determine whether the strong negative correlation between allergic asthma and H. pylori colonization indicated an underlying connection between the two. Using mice, the researchers deliberately infected infant and adult mice with H. pylori,and kept a control group for both ages. The researchers induced allergic asthma in both groups and measured their immune response. Mice with H. pylori infection displayed a significantly reduced asthmatic response by several metrics, including bronchoalveolar inflammation,eosinophilia, IL-5 secretion, and IL-13 secretion. [1]

    The connection between digestive infection and a digestive disorder makes for a more intuitive link. Coeliac disease is an autoimmune condition that most visibly involves a reaction to gluten, a protein found in some cereal grains. Although the precise cause of coeliac diseases is still unclear, multiple reviews have found statistically significant negative correlations between H. pylori colonization and coeliac disease, in various patient populations. [2,3]

    The proposed mechanism of action is the same as in the protective effect against allergic asthma; H.pylori infection results in additional recruitment of T-regulatory lymphocytes. These additional recruited cells then down regulate the immune response to gluten,compensating for the out-of-proportion response typical of coeliac disease. [4]

    If evidence for a benefit from H. pylori colonization continues to appear, physicians could face an interesting choice. In a 2012 paper, Melo et al reported that the gastric mucosa of children infected with H.pylori show significantly higher expression of immunologic cells and factors than uninfected children. [5] The bacterium can usually be eliminated simply enough with an antibiotic regimen, but for some patient populations the benefits could outweigh the risks if acute symptoms haven’t yet occurred.

    The potential benefits of an upregulated immune system to stave off chronic allergic conditions deserve further consideration and research.

    Ref: 1, 2, 3, 4, 5

    By Weston Mangin
    Biomedical Engineer
    HARDY DIAGNOSTICS

  • Can Vitamin D be Useful Against COVID-19?

    A study published on May 6th, has produced optimism that vitamin D may help to prevent serious infections of the COVID-19 virus. Researchers from the UK have compiled data on the incidence of COVID-19 infections and correlated it to the blood levels of vitamin D in people from 20 European nations. The results show that as vitamin D serum levels increase, the incidence of infection decreases.(1) 

    They found the same decrease when they looked at the mortality rate.

    They also found that in countries that were hit particularly hard by the virus, the population had, on the average, lower levels of vitamin D. For instance, in Italy the average is 28 nmol/L, whereas in the Nordic countries, which fared much better, the average is 45 nmol/L.(3)

    It is also worth noting that in the institutionalized elderly, which are at high risk of COVID-19 infection, vitamin D levels are severely reduced, with 75% of them showing levels of <25 nmol/L. 

    In 2017, Martineau et al  published a meta-analysis showing that vitamin D supplementation can be effective in preventing respiratory infections in general. They concluded, “Vitamin D supplementation was safe and it protected against acute respiratory tract infection overall.“(2)
    Vitamin D has been known to trigger a heightened immune response by releasing substances, such as antimicrobial peptides. In addition, vitamin D also modulates the macrophages’ response, preventing them from releasing too many inflammatory cytokines and chemokines, which can lead to acute respiratory distress. 

    Hopefully, more studies will verify this simple, yet promising way to control the severity of CCOVID-19 infections. 

    Ref: 1, 2, 3

  • Debugging the Mosquito Crisis

    One of the deadliest species known to man is Aedes aegypti, also known as the Yellow Fever mosquito. This species of mosquito is capable of carrying and spreading diseases such as chikungunya, zika, yellow fever, and dengue fever to more than half of the world’s population. These diseases are the cause for millions of deaths every year and have increased substantially in the last 30 years.(1)

    To prevent further spread of these diseases, attempts have been made to control the mosquitoes’ habitats, however, the breeding grounds are often difficult to locate and eradicate.(2) Pesticides are also effective in controlling the mosquito population, but the incorrect use of these chemicals is a concern to public health and the environment.(2)

    Alternatively, development of vaccines for these deadly viruses are either still in process, or are heavily regulated by the Food & Drug Administration. In May of 2019, the FDA approved the first vaccine to treat dengue fever. The vaccine, Dengvaxia, is intended for children that are 9-16 years old that have already contracted the disease previously.(5) As the second infection with dengue is often much more severe than the first, the FDA’s approval of this vaccine will help protect people previously infected with dengue virus from subsequent development of dengue disease. However, the vaccine increases the risk of severe infection in children who have never been exposed to dengue.(5)

    Aside from the invention of drugs and therapies to treat existing disease, another large organization has taken on efforts to reduce A.aegypti populations in order to prevent disease. Alphabet Inc., a parent company of Google, formed the biological research organization called, Verily. In 2016, Verily attempted to prevent mosquito-borne disease on a global scale with their Debug project.(3)This project uses the Sterile Insect Technique (SIT) to control local populations of A. aegypti in rural and remote locations. This was accomplished by the mass propagation of the male A. aegypti which has been infected with a type of bacteria called, Wolbachia.

    This is an idea that’s been around since the 1950s. It’s called the Sterile Insect Technique (SIT), and it has worked on other kinds of bugs, like fruit flies, screwworms, and codling moths. The idea is simple: raise sterile males and release them into wild insect populations. When a wild female mates with a sterile male, her eggs won’t hatch. The population gets smaller with each generation.

    Wolbachia spp. are gram-negative bacteria that infect arthropods and cause reproductive sterility.(6) The Debug project focuses on infecting the male A. aegypti with Wolbachia in a controlled setting and then releasing them into the environment. The male A. aegypti was chosen because these species lack the ability to bite and spread disease.The infected male mosquitoes subsequently mate with the female population, and produce infertile eggs.(2) Over time, the mosquito population is expected to decrease, as will the spread ofthese infectious diseases.

    Recent studies have shown that at a test site in Fresno,California, a reduction was observed in female A. aegypti,after releasing over 20 million infected males annually, by up to 68% in 2017, 95% in 2018, and 84% in 2019.(4)

    Although Verily’s first field study has come to a close, the experience and technological gains have been transferred to programs in other locations where this mosquito species is endemic.(4) With larger scale implementation of this project, mosquito-borne infectious disease may eventually be a concern of the past.

    Ref: 1, 2, 3, 4, 5, 6

    written by Gabriel Garza, Technical Support Specialist at Hardy Diagnostics

  • 2020

    In May, Hardy Dx continued its endeavor to keep hospitals well supplied with PPE by releasing a new UV light chamber that is used to sanitize N95 face masks. It is capable of sanitizing four masks at a time within four minutes. This UV treatment will allow hospitals to recycle their N95 masks that are currently in short supply for the nursing staff.

  • Enlisting AI for Drug Discovery

    Bacteria are becoming more resistant to drugs while pharmaceutical companies are slowing their antibiotic research. Due to low profits and high time consumption, there are fewer drugs discovered and manufactured by drug companies.(1) Methicillin-resistant Staphylococcus aureus (MRSA), carbapenem-resistant Enterobacterales (CRE), and multidrug-resistant Pseudomonas aeruginosa infections are a major concern with limited treatment options. Treatment is difficult when fewer effective drugs remain and companies are unwilling to invest in developing antibiotics that will quickly become inactive against pathogens.
    Recognizing the lull in upcoming antibiotics to treat resistant bacteria, a team at MIT taught a machine to search for antibiotic candidates. This artificial intelligence (AI) computer generated millions of future possible antibiotics based on their molecular structures and distinction from current antibiotics. The basis for this algorithm is recognizing novel structures, instead of synthesizing different beta-lactams. As a result, bacteria will have no existing resistance mechanisms. 
    The machine discovered an especially promising antibiotic called Halicin, which was initially used to treat diabetes. Halicin was named after the dastardly computer depicted in the movie,  2001: A Space Odyssey

    Halicin has successfully killed CRE isolates from patients and treated Clostridium difficile and Acinetobacter baumannii infections in rats. (2)
    Halicin showed remarkable activity against drug-resistant strains of Clostridium difficileAcinetobacter baumannii, Methicillin Resistant S. aureus, and Mycobacterium tuberculosis, with an unusual mechanism of action involving the sequestration of iron inside the bacterial cells, that thereby interferes with their ability to regulate the pH balance across the cell membrane properly. Since this is a different mode of action from most antibiotics, Halicin retained activity against bacterial strains resistant to many commonly used drugs.
    Preliminary studies suggest that Halicin kills bacteria by disrupting their ability to maintain an electrochemical gradient across their cell membranes. This gradient is necessary, among other functions, to produce ATP (molecules that cells use to store energy); if the gradient breaks down, the cells die. This type of killing mechanism could be difficult for bacteria to develop resistance.
    Patients with a positive reading on HardyCHROM MRSA, HardyCHROM CRE, or NG-Test CARBA 5 may soon be treated with Halicin. The artificial intelligence technology has great potential to treat more patients by cutting down the time and money it takes to identify active compounds. Halicin and other AI-derived drugs can save lives that would be in jeopardy if sole dependence on pharmaceutical companies continues. This encourages further development and investment in efficient antibiotic progress against ever-evolving bacteria.  

    Ref: 1, 2

    Elizabeth Smith
    Technical Support Microbiologist I

  • Will the new coronavirus go away when the weather warms up?

    This is the question that many are asking, but unfortunately, there is no easy answer. 
    First of all, we have to take a look at why the cold and flu viruses seem to dissipate in the summer months. There are four possible reasons why respiratory viruses are more common in the winter and tend to become less of a problem in the summer.

    1. Less Humidity – In the winter the air is colder and drier. This has been proven to favor the viability of the flu virus. However, this may not be a characteristic of the SARS-CoV-2 virus. It has been pointed out that Singapore had larger numbers of infected people, even though it is very close to the equator and more humid than in the North. The droplets from a sneeze or cough do not stay suspended in humid air as long as with dry air, and the warmer temperatures lead to increased virus degradation.

    2. More Indoor Activity – In the colder months, people tend to remain indoors, where they are more likely to pass on viral disease. People are more confined and children are together in classrooms during this time. Young people are often asymptomatic carriers of Covid-19. This being the case, it could be that school closures will be of some assistance in controlling the spread of the virus this summer.


    3. Weaker Immunity – Vitamin D is involved in many immune functions of the body. During the winter in the Northern Hemisphere, the sun is not high enough in the sky and shining long enough to provide adequate UV-B rays for vitamin D production in the skin, which is usually covered up anyway due to colder temperatures. There is evidence that higher levels of vitamin D help to reduce the incidence of respiratory infection. Whether the novel coronavirus will be inhibited by higher vitamin D levels in the blood remains to be seen.

    4. Less Herd Immunity – When a new stain of virus emerges in the winter, the population in general has less immunity at the beginning of the season. As the season progresses, more people develop immunity, which helps to lower the rate at which infections are passed on to others.When the current flu virus is related to previous strains, the season of infection tends to be shorter due to this herd immunity. However, when a novel virus, different from previous ones, appears, the season is prolonged until more people are exposed and become immune.

    Unfortunately, seasonality does not appear to constrain novel viruses in the same way that it does for the older more familiar viruses. Past coronavirus outbreaks, SARS and MERS, haven’t exhibited clear evidence of being seasonal. Contrast that with the H1N1 Swine Flu of 2008, which did adopt a seasonal pattern. 

    A study published in mid-March by researchers from Spain and Finland, found that 95% of infections globally have so far occurred at temperatures between about 28° and 50° F, and in dry climates. This may sound promising, but Malaysia and Singapore were hit hard by the virus and their average temperature is 80° F year round. Clearly, more research and experience with this novel virus is needed.

    Marc Lipsitch, PhD, an epidemiologist at Harvard University, summed it up in this statement, “Based on the analogy of pandemic flu, we expect that SARS-CoV-2, as a virus new to humans, will face less immunity and thus transmit more readily even outside of the winter season. Changing seasons and school vacation may help, but are unlikely to stop transmission.”

    Ref: 1, 2, 3, 4, 5

  • Antibiotic Resistance in Food Items

    In the United States, approximately 2.8 million people are infected with antibiotic resistant bacteria (ARB) every year resulting in billions of dollars in healthcare costs and approximately 35,000 deaths (1,2).

    About 80% of antibiotic use in the United States comes from the agriculture industry, particularly in the husbandry of cattle and poultry. While antibiotics are not widely used by the produce industry, produce is often contaminated with soil which contains naturally resistant bacteria and organisms from animal waste. (3) Birds flying over crops also contribute to the spread of resistant bacteria.

    Ready to eat foods (RTEs) do not always require additional heating or cooking before serving and therefore could have much higher levels of contamination than foods that require additional heat. In a study conducted at California State University Northridge, the amounts of total bacteria and of bacteria resistant to eight different antibiotics (ciprofloxacin,tetracycline, erythromycin, chloramphenicol, gentamicin,ampicillin, cefotaxime, and colistin) were quantified from organic or conventional fresh produce and dairy products.Although dairy products had very low levels of ARB, the highest level of resistant strains was found in the ARB group resistant to cefotaxime, a broad-spectrum antibiotic. (4)

    On average, both organic and conventional produce, had 10,000times more ARB than dairy products. In produce, the highest levels of resistance were against cefotaxime, as well as a last-resort antibiotic, colistin. (4) In another study, researchers found consumers had a 1.5% chance of exposure to a potentially infectious dose of cephalosporin-resistant Escherichia coli(CREC) in a meal containing chicken due to existing bacteria and cross contamination during food preparation. (5)

    Bacteria naturally present in food products increase the number of potential sources of human exposure to ARBs. Does this mean we should avoid fresh uncooked produce? Of course not. While these foods increase our ARB exposure, they do not necessarily cause infection and often provide beneficial native residents in plant microbiomes that offer nutritional value.

    However, once ingested and or disseminated to other surfaces,these bacteria may be able to spread resistance genes through bacterial gene transfer. These genes increase the gene pool from which pathogenic bacteria can acquire and disseminate resistance traits and pose an indirect risk to public health.

    Ref: 1, 2, 3, 4, 5

    By Lauren Hamilton, Technical Support Microbiologist

    HARDY DIAGNOSTICS

  • COVID-19 Sample Collection Kits for Upper Respiratory Tract Specimens

    Due to the recent 2019 Novel Coronavirus (COVID-19) outbreak, we have been getting many inquiries about what type of swabs, media, and kits should be used for COVID-19 sample collection prior to testing. Below we have a short guide on which COPAN products meet the Centers for Disease Control and Prevention (CDC) Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens for Coronavirus investigations.

    Which Type of Swab Should be Used to Collect Samples to Test for Coronavirus (COVID-19)?

    As outlined in the CDC guidelines for the collection and handling of clinical specimens suspected of Coronavirus Disease 2019 (COVID-19), for upper respiratory tract samples, health workers should only use synthetic fiber swabs with plastic shafts, like COPAN FLOQSwabs®. It is important not to use calcium alginate swabs or swabs with wooden shafts when testing for COVID-19. These swabs can contain substances that inactivate some viruses and can inhibit PCR testing [1]. 

    How Should Collection Kits be Used for Coronavirus (COVID-19) Testing?

    In the CDC Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19), the CDC recommends taking a nasopharyngeal AND oropharyngeal swab (NP/OP swab) from PUI for COVID-19 for upper respiratory tract samples. The CDC guidelines also direct healthcare workers to place swabs immediately into sterile tubes containing 2-3 ml of viral transport media, like COPAN UTM® Universal Transport Medium [1]. It is important to note that each swab should be placed individually in separate vials to avoid possible specimen rejection by testing laboratories.

    COVID-19 Sample Collection Kits and Components that Meet the CDC’s Guidelines

    COPAN makes COVID-19 collection and transport kits that are compatible with the CDC-recommended configuration that pairs 3mL of UTM® universal viral transport medium and a nasopharyngeal or oropharyngeal flocked swab.

    Pre-packaged COVID-19 Kits

    Also, Healthcare Providers can quickly assemble in-house sample collection kits and place the items in a Ziploc/Minigrip bag for distribution using the following COPAN item numbers:

    UTM® 330C – 3 mL UTM® Medium in 16x100mm Tube

    FLOQSwabs® 503CS01 – Flexible Minitip (Nasopharyngeal) Flocked Swab with 100mm Breakpoint

    FLOQSwabs® 519CS01** – Regular Flocked (Oropharyngeal) Swab with 100mm Breakpoint

    Individual Orderable Components: 3mL UTM®, one regular FLOQSwab®, One Flexible Minitip FLOQSwab®

    Distributor Links:

    Copan
    Part #
    TypeDescriptionHardy/
    Healthlink
    Part #
    BD Part # DHI/
    Quidel
    Part #
    Fisher
    Healthcare
    Part #
    305CSample
    Collection Kit
    (Nasopharyngeal)
    Nasopharyngeal
    Collection Kit:
    Minitip Flocked Swab
    + 3 mL UTM® Tube
    3C036NHL220531N/AN/A
    306C Sample
    Collection Kit
    (Oropharyngeal)
    Oropharyngeal
    Collection Kit:
    Regular Flocked Swab
    + 3mL UTM® Tube
    3C038NHL220528N/AN/A
    330C Collection Kit
    Component
    3 mL UTM® Medium
    in 16x100mm Tube**
    330CHL220220330C.DHI 23001720
    503CS01 Collection Kit
    Component
    Flexible Minitip
    (Nasopharyngeal)
    Flocked Swab
    N/A 220252 503CS01.DHI 23600952
    519CS01 Collection Kit
    Component
    Regular
    (Oropharyngeal)
    Flocked Swab
    N/A 220250 N/A23600957

    ** It is important to note that each swab should be placed individually in separate vials to avoid possible specimen rejection by testing laboratories.

    Also available from Hardy Diagnostics:



    Viral Transport Medium, 3ml, No Swab Included: For the collection and transport of clinical specimens for the recovery of viral agents including, but not limited to, Herpes Simplex Type I, Herpes Simplex Type II, Cytomegalovirus (CMV), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), Echovirus, Adenovirus, etc. Viral Transport Medium consists of Modified Hank’s Balanced Salt Solution, supplemented with animal protein and sucrose for virus stabilization. A buffer solution is used to maintain pH at 7.3 +/- 0.2. Phenol red is the pH indicator. Selective agents are added to inhibit bacterial and fungal contaminants. The medium acts as a cryoprotectant to ensure virus stabilization through freezing and thawing.

    Cat. no. R99, Manufactured by Hardy Diagnostics, 20 per box, Storage 2-8°C before inoculation/ 2-30°C once inoculated for up to 48 hours or -70°C for long-term storage.

    Current Demand Exceeds Supply. When you place an order, please state your daily testing volume needs. We will make every attempt to allocate available supply to meet your daily requirements.

    References

    1. Centers for Disease Control and Prevention. (2020, February 14). Coronavirus Disease 2019 (COVID-19): Guidelines for Clinical Specimens. Retrieved February 27, 2020, from https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html

    Contact Us Here for More Information!

    Article contributed by COPAN USA. See the original post here

  • 2020

    In March, HDx immediately responded to increased demand for Viral Transport Media and PPE to help meet our nation’s need for supplies to combat the COVID-19 pandemic. Over 20 million Viral Transports were sold in 2020, along with millions of swabs, masks, face shield, and sanitizers.

  • Is that really pharmaceutical grade cannabis?

    Cannabis has many different modes of delivery and applications for use. The most common ways that cannabis is used in our society today are: a smokeable, an edible, an oil or infused product. According to most market researchers, flower products and concentrates are the top sellers, with edibles and cosmetics also representing a solid segment of the market.[1] With new, innovative applications coming to market all the time, there is a whole world of cannabis derived products available to the public. When one thinks about the contamination that can happen during the production of these goods, either directly from the cannabis plant or from the processes surrounding how the products are made, it is easy to identify failures that have the potential to contaminate the products that patients and consumers are buying.

    The laws for testing cannabis goods are at an early stage. There is considerable variation when it comes to the regulations regarding testing of cannabis products for contamination. The industry is still struggling to define what cannabis is and how to test the multitude of finished goods made with it. What does that mean? Simply put, the cannabis patients are buying for medicinal use is most likely not being tested to the pharmaceutical standards that one would expect. Furthermore, the edible, cosmetics and oils for vaping are coming out of a sparsely regulated industry that is still trying to catch up to the type of finished goods testing expected from every other industry. The industry needs to be testing our finished goods in a way that makes sense for the end user of the product. For example, testing raw cannabis flower or oils for common pathogenic mold and other organisms is a great place to start. However, if we are not testing our cosmetics, lotions, tinctures, suppositories, inhalers, and brownies in a way that reflects the processes and environments they are being made in, or the intended user, we are neglecting the overall safety of that product. Testing our cannabis raw materials to make sure it is safe is really only just the beginning.

    Thankfully, there are cannabis clinicians and professionals who understand the importance of this topic. There are significant hurdles however that need to be addressed. Here are some of the major impediments to the collective ability to properly regulate the cannabis market.

    1. Federal Prohibition Laws

    2020 is poised to be the year Americans finally stop saying if and can in full confidence start talking about when cannabis prohibition will end on a federal level. The most recent projections estimate that 90% of the US population will be living in a jurisdiction with some form of legal cannabis by the end of the year. The states are asking for FDA support when it comes to drafting testing requirements. Furthermore, most states simply do not have the resources required to properly enforce the laws that have been written. The cannabis industry needs the support of the federal government to help ensure that the products and medications are safe in all applications.

    • Variance in Regulations From State to State

    The lack of oversight in the industry as a whole has led to a wide variety of legal requirements from state to state. This patchwork of regulations has made an already complicated discussion even more confusing. There are states requiring broad testing while other states have little to no regulatory requirements at all. Ultimately, this only jeopardizes the public. The industry is selling millions of dollars of product to the public that may or not be safe for human and/or animal consumption.

    • The Idea That “Cannabis Doesn’t Make People Sick.”

    There is medical research out there that supports what many already believe, cannabis can be an amazing therapy for a whole host of diseases and disorders. [2] The type of testing being called for in this article does not speak to the efficacy of the plant as medicine, but instead protects users from the contamination that can be introduced to the finished good during the production and processing steps. Microbial contamination is not a function of the plant, but compromised product does contribute to disease and death.[3] Additives, heavy metals and pesticides are part of the process for creating many of the products on the market and those components have the potential to injure and even kill.

    • “We Can’t Afford It!”

    This is a hard one. Many of the people in this industry have fought for years and even decades to move cannabis into a legal landscape. No small number of the people in the cannabis industry are involved because of a personal story of healing or comfort that lead to a passion to make cannabis accessible to all. At the same time, the businesses are fighting to be profitable. Testing is expensive and companies can feel that they have been delivering safe product with no problems for a long time. Some may be asking, “Why do we have to change now?” The reality remains though; immunocompromised and pediatric patients are more vulnerable than the general population. The testing requirements for products labeled as medicine and sold as such must ensure safety. The general public has an expectation of minimum safety thresholds for goods sold at large. The vaping crisis shows how quickly a small lapse in vigilance can have deadly and costly consequences. The industry is very young and competitor industries will be quick to capitalize on any opportunities to malign cannabis. Through thoughtfully written regulations and proper testing practices, the industry can protect the reputation of the plant that so many believe is improving their quality of life.


    [1] https://bdsanalytics.com/top-10-cannabis-market-trends-2019/

    [2] https://www.calgarycmmc.com/reliefofsymptoms.htm

    [3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3103256/


    Jessa Youngblood is the cannabis industry specialist at Hardy Diagnostics. She sits on the AOAOC CASP committee for Microbial Contaminants Working Group as well as the NCIA Scientific Advisory Committee. Jessa has a passion for safe access to cannabis medicine and regularly leads webinars and trainings to support the development of cannabis microbiology testing programs across the US and Canada.  

    As an industry specialist, I have had the opportunity to speak to many different people in the cannabis market as well as interact with the incredible products that they are bringing to consumers and patients. When I see someone with a new application for cannabis, it is exciting to think of how it can impact and change lives. While I am optimistic for this bold, new industry, I am concerned at the lack of testing requirements when it comes to the finish goods. Let us join together to push forward into a more developed, safer market by addressing the hurdles we face. Reach out to others manufacturing products like yours in similar industries to learn how their processes have evolved to ensure safety. Reach out to regulatory and industry specialists to learn what steps you can take now to be prepared for the end of federal prohibition. Implementing these standards is the best way to protect the clients that use your products and your business future.

  • Can filters add or decrease the bacterial count?

    According to the USGS, the Earth’s surface is comprised of about 71% water (1); however, only a modicum of this supply is potable. Fortunately, modern marvels of mankind are making this supply increasingly accessible through the desalination of salt water and filtration of contaminated water, to name a few. Unlike salt water, the consumption of contaminated drinking water is a major cause for outbreaks of diarrhoeal disease and is the second leading cause of death in children under five years of age (2,3). Filtration systems, both industrial and commercial, supposedly serve to reduce environmental pollution of water by removing substances such as heavy metals, toxic organic compounds, and bacteria (2). These filter systems are typically equipped with ion-exchanging resins and/or activated charcoal that actively bind and adsorb, respectively, the contaminants in water (2). However, many of the commercially available filter systems are made of plastic materials, which are known to lead to biofilm formation and bacterial propagation (2).

    Researchers found that certain filtering systems increased the bacterial counts by 10,000 times, compared to the tap water that was being filtered!

    In a study conducted by ED. Daschner, et. Al., researchers set out to investigate the efficacy of commercial filters in their ability to change the microbial quality of water (2). In this study, filters from the reputable brand, Brita, were evaluated in households and under laboratory conditions. In 64% of households in the field study, filtered water had significantly higher bacterial counts-upwards of 6,000 CFU/mL when compared to tap water from the same household. Even under the controlled environment of laboratory conditions, the same phenomenon was observed. Filtered water from four of six filters had bacterial counts that exceeded that of tap water from the same facility. More specifically, samples exhibited higher counts by the fourth day of use at room temperature and on the 15th day of use at 4°C when observed under controlled conditions (2). In some cases, the bacterial count of the filtered water was noted to be up to 10,000 times greater than that of tap water. Further analysis of the bacterial counts identified significant isolates from filtered water, including Aeromonas hydrophila, Pseudomon ascepacia, Pseudomonas fluorescens, Pseudomonas putida, Sphingomonas paucimobilis, Acinetobacter Iwoffii, and coagulase-negative staphylococci. Many commercially available filters, including Brita filters, claim their products may be used for up to 60 days following the first use. Evidently, these filters can lose their effectiveness in a little as four days, and actually creates higher bacterial counts than in the water it is filtering. Obviously, more work needs to be done to ensure the safety of “filtered” water.

    References: 1, 2, 3

    Written by Andrew Kravariotis, R&D Biochemist at Hardy Diagnostics

  • Are Three Heads Better Than Two?

    The new generation of active viable microbial air samplers represent a new approach to maintaining environmental control. The TRIO and the RABS ISOLATOR instruments are made by Orum International and distributed by Hardy Diagnostics.

    Active impact microbial air sampling is one aspect of the regulatory guidelines related to contamination control. The principle of microbial air sampling by impact method on an agar plate is typically achieved by using an instrument designed to aspirate a controlled volume of air at a consistent speed through a single aspirating head. Instruments with two aspirating heads are also available in the market.  Dual aspirating heads offer certain advantages, such as the ability to sample with two separate types of culture media and achieving faster sampling times and better statistical results.

    If two heads are better than one, what about three?  In the case of maintaining environmental control during aseptic processing of sterile medicinal products using active microbial air samplers, there is an argument to be made for the use of an impact air sampler with three sampling aspirating chambers.

    Roberto and Sandro Ligugnana, brothers residing in Milan, Italy, are noted for designing the first portable air samplers in the early 1970’s. The family has been active in industries required to maintain environmental control since 1956. In 2016, the Ligugnanas decided to relaunch their careers in the development and manufacturing of air samplers with their new company, Orum International, offering the most complete line of impact microbial air sampling instruments available: TRIO.BAS (Biological Air Sampler). The TRIO is their flagship product.

    Orum International studied the difference in CFU results by using a microbial air sampler with three aspirating heads instead of one.

    The TRIO.BAS TRIO, RABS ISOLATOR and MULTIFLEX 1+2 instruments all incorporate up to three sampling aspirating heads, with programming options to capture data throughout the sterile product manufacturing cycle.

    Regulatory and good manufacturing practice standards in a clean room setting require contamination monitoring to be performed “at rest” and “in operation” during each shift. Collecting samples at rest and during the work shift is important in order to analyze air samples that accurately reflect the microbial load in the air throughout the day. With an air sampler using a single aspirating chamber/head to collect samples, the operator must return to the unit multiple times to activate sample collection and transfer culture plates. The use of an air sampler with a single aspirating head requires multiple sample preparation manipulations, activities related to culture media transfer, and cleaning procedures.

    The TRIO.BAS TRIO, along with the other multiple-head Orum products, is dedicated to delivering more accurate results for airborne microbial detection. They offer less chance of operator contamination in clean room settings while maintaining the highest level of quality assurance.

     Learn more about this modern approach by viewing the full study analyzing the results HERE.

  • Cause for Concern: Emerging Pan-resistant Candida auris
    Image result for candida auris
    photo courtesy of UCSF Health

    Candida auris was first described in 2009 and was first reported in the United States in 2016.(1)  It is a member of a growing group of yeasts that can cause candidiasis, yeast infections that are normally of little consequence, and treatable through a number of anti-fungal medications.  Nosocomial candidiasis, however can easily infect ports installed in the body for medical reasons, and then progress to candidemia, a potentially deadly blood infection.(2)  Candida auris is remarkable in that it is often drug resistant and difficult to identify without specific technologies that are not readily available in a clinical setting, namely PCR and MALDI-TOF mass spectrometry.(3)

    As of June 2019, a clinical outbreak of Candida auris was reported in New York.  Of more than 800 patients, three were confirmed to have Candida auris infections resistant to all three classes of commonly prescribed anti-fungal medications; fluconazole, amphotericin B, and echinocandins.  All three patients had Candida infections that exhibited fluconazole resistance and two were found to be amphotericin B resistant.  None had received echinocandins prior to their diagnosis of being infected with Candida auris.  Indeed, isolates from all patients showed an initial sensitivity to echinocandin therapy, and were thus treated.  Resistance was not detected until after completion of echinocandin treatment, indicating that the patient isolates became pan-resistant to all three medications during therapy.  Investigators found no indications of successful patient-to-patient transmission of this pan-resistant strain after the study was completed.(1)

    The emergence of pan-resistant Candida auris is concerning in that, with traditional testing methods, it is easily mistaken for other, more common Candida species, even on differential media.(4)  It can cause invasive candidiasis in at-risk populations, contribute to widespread Candida outbreaks, and progress to candidemia just as readily.  However, as a potentially multi-drug-resistant microorganism, each of the above situations takes on an increased urgency.  Even now, four years after the New York outbreak was identified, the fact that pan-resistant Candida auris isolates appear so rare should be of little consolation. 

    The technology required for Candida auris identification must be advanced.  Even with the promising development of a new class of anti-fungal medications and more prudent anti-fungal prescription practices by healthcare professionals, the average healthcare facility must be able to perform rapid, accurate identification.  Until this happens, our healthcare system will continue losing time, money, and lives to Candida auris outbreaks that have caused up to 60% mortality rates in other healthcare facilities around the world.(5)

    Written by Dave Cochran, Technical Service and Instrumentation Specialist

    References:

    (1) Candida auris Isolates Resistant to Three Classes of Antifungal Medications — New York, 2019

    Morbidity and Mortality Weekly Report (MMWR), January 10, 2020 / 69(1);6–9

    https://www.cdc.gov/mmwr/volumes/69/wr/mm6901a2.htm?s_cid=mm6901a2_w

    (2) About Invasive Candidiasis

    https://www.cdc.gov/fungal/diseases/candidiasis/invasive/definition.html

    (3) General Information about Candida auris

    https://www.cdc.gov/fungal/candida-auris/candida-auris-qanda.html

    (4) Candida auris: A drug-resistant yeast that spreads in healthcare facilities

    https://www.cdc.gov/fungal/candida-auris/pdf/C-Auris-Lab-Workers-FactSheet-H.pdf

    (5) Novel antifungal shows early promise against Candida auris

    http://www.cidrap.umn.edu/news-perspective/2019/04/novel-antifungal-shows-early-promise-against-candida-auris

  • CDC Recommends Nasopharyngeal Swabs AND Oropharyngeal Swabs as Suitable for Upper Respiratory Tract Specimens for Investigations of Novel Coronavirus (2019-nCoV)

    COPAN announces a kit that pairs 3mL of UTM® universal viral transport medium and two FLOQSwabs™: one minitip and one regular flocked swab.


    MURRIETA, Calif., Jan. 31, 2020 /PRNewswire/ — On January 30th, 2020, the World Health Organization (WHO) held its second meeting in Geneva of the International Health Regulations Emergency Committee regarding the outbreak of novel coronavirus (2019-nCoV). During the meeting the committee agreed that the outbreak constitutes a Public Health Emergency of International Concern (PHEIC), and that the PHEIC “should be seen in the spirit of support and appreciation for China, its people, and the actions China has taken on the frontlines of this outbreak, with transparency, and, it is to be hoped, with successi.” A coordinated global effort is critical in order to improve worldwide preparedness and successful measures to contain this outbreak in other regions of the world.

    The Centers for Disease Control and Prevention (CDC) have released an Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Patients Under Investigation (PUIs) for 2019 Novel Coronavirus (2019-nCoV) recommending “[c]ollection of three specimen types, lower respiratory, upper respiratory and serum specimens for testing” from patients under investigation (PUI) of the novel coronavirusii.

    For upper respiratory specimens, the CDC is recommending nasopharyngeal washes/aspirates, nasal aspirates or to collect both a nasopharyngeal swab AND an oropharyngeal swab made of synthetic fiber with plastic applicators. Once the specimens are collected, it is recommended that the swabs are placed in 2-3 ml of viral transport mediaiii.

    One of COPAN’s kits pairs 3mL of UTM® universal viral transport medium and two FLOQSwabs™: one minitip synthetic flocked swab ideal for nasopharyngeal samples and one regular synthetic flocked swab ideal of oropharyngeal samples. COPAN manufactures private label UTM® for Becton Dickinson (as UVT), Diagnostic Hybrids-Quidel, and Hardy Diagnostics (as Healthlink UTM®).

    The open structure of COPAN FLOQSwabs™ acts like a soft brush that efficiently dislodges and collects cells and mucus, then releases the sample immediately when immersed in viral transport medium. COPAN flocked swabs are easy to use and less invasive causing minimal discomfort for the patient when compared to nasopharyngeal washes/aspirates or nasal washes.

    i Statement on the second meeting of the International Health Regulations (2005) Emergency Committee regarding the outbreak of novel coronavirus (2019-nCoV). January 31, 2020. https://www.who.int/news-room/detail/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-outbreak-of-novel-coronavirus-(2019-ncov)
    ii Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Patients Under Investigation (PUIs) for 2019 Novel Coronavirus (2019-nCoV)./ January 31, 2020. https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html
    iii Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Patients Under Investigation (PUIs) for 2019 Novel Coronavirus (2019-nCoV)./ January 31, 2020. https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html

    SOURCE COPAN Diagnostics, Inc.

    For more information on Healthlink UTM® Available from Hardy Diagnostics, visit: https://hardydiagnostics.com/healthlink-utm/

  • Coronavirus Outbreak- What We Know Thus Far

    For the medical community 2020 has arrived with a sinister start. In the midst of Flu season, a new and far more ominous virus has emerged, gripping the world’s attention. We are of course talking about the recent outbreak of coronavirus in Wuhan, China with multinational reports emerging. The virus, a “cousin” of the SARS virus that struck in 2003 that caused nearly 8,100 cases, and resulted in 774 deaths in 37 countries.[1] But what is coronavirus and why does its emergence have the virology community so worried?

    According to the Centers for Disease Control and Prevention, coronaviruses are common in a variety of animal species include camels and bats.[2] Coronaviruses (CoVs), enveloped positive-sense RNA viruses, are physically characterized by club like spikes that shoot out from its surface. Coronavirus has an unusually large RNA genome and a unique replication strategy.[3] In rare cases, coronaviruses become zoonotic meaning that they become transmissible from animals to humans through various means. In the case of the 2003 SARS outbreak, the virus was traced back to the horseshoe bats in Yunnan Province in China, who were infecting civets which acted as the intermediary to humans.[4] Other well-known zoonotic diseases range from Lyme disease which is a bacterial infection transferable to humans via tick bites as well as the Ebola virus which over the course of three years resulted in 28,000 cases and over 11,000 deaths in West Africa.[5] Zoonosis is the means by which many infectious diseases are transferred to humans, however this transmission is not what worries the clinical community. Human transmission is a far more serious issue and one with which we must now contend with this new coronavirus.

    Human transmission of a virus is considered a game changer. Viral transmission between humans can be accomplished a number of ways depending on the virulence of the disease. A simple cough or sneeze is common as the viruses is carried in the droplets through the air. Skin to skin contact is another transmission method of viruses. The virus is transmitted through touch then enters its new host through the touching of the mouth, eyes, or nose.[6] What is worrisome about the Wuhan coronavirus is the mixture of human transmission and the unfortunate geographical location of the outbreak.

    Wuhan is the regional capital of the Chinese Hubei province. It is the largest and most populous city in the region with over 11 million people. Wuhan’s population density reaches highs of 20 thousand people living per square kilometer, is home to one of the four key rail hubs in China as well as Wuhan Tianhe International Airport, one of the countries busiest.[7] This means that the virus has not only become transmissible between humans in one of the most populated cities in the worlds most populated country, but could be spread internationally via one of the world’s busiest international airports.

    As of writing, only three Provinces (Inner Mongolia, Qinghai, and Tibet) have not reported any cases of the Wuhan coronavirus[8]. Internationally, South Korea, Japan, Hong Kong, Thailand, Taiwan, Singapore, Vietnam, and the United States have all had confirmed cases of the virus while the Philippines, Australia, and Scotland are monitoring suspected cases.[9] London based researchers  suspect another 4000 cases – in Wuhan alone and that does not take into account travelers spreading the infection elsewhere.[10] With China’s Lunar New Year on January 25th being the most important holiday on the Chinese calendar and a massive travel holiday, concerns of revelers spreading the disease during or after their travels are mounting. The chances for this epidemic to become a pandemic is not an unfounded fear. With that said, how is the world responding?

    China itself has responded strongly in an effort to contain the further spread of the virus. Major cities including Beijing and Wuhan have banned all large gatherings for the coming Lunar New Year Festival. As of writing, China’s government has also imposed travel restrictions on Wuhan and its surrounding municipalities. No going in and no going out – effectively quarantining 25 million people.  The United States is screening all travelers from Wuhan for symptoms at major international airports in Los Angeles, New York, San Francisco, Chicago, and Atlanta. However, the World Health Organization refused to declare the outbreak a global health emergency saying it is too early citing Chinese efforts in containment and the limited number of international cases.[11] With the international community responding to the outbreak, should you worry about it? What are the symptoms and mortality rate? Is it preventable?

    While the Wuhan coronavirus has a mortality rate far lower than that of SARS or MERS thus far, it is still comparable to the 1918 Spanish flue pandemic.[12] Currently, prevention via vaccine is unavailable. Reduction of risk through proper washing of hands, surface disinfection, and awareness is key to avoiding transmission. As we do not yet know how human transmission of this virus is occurring, the CDC has a notice for travelers that is being updated as new information is obtained.[13]

    Symptoms of the Wuhan coronavirus are similar to that of SARS but with milder symptoms and symptoms take longer to develop. It generally causes upper respiratory problems, beginning with a mild cough that persists for about a week before they begin to experience shortness of breath. The immunocompromised, young children, and the elderly are more at risk of the chance the virus causes far more serious respiratory tract illnesses like pneumonia of bronchitis. So far around 15%-20% of cases have developed into these sever symptoms.

    The Wuhan coronavirus is still a developing story. In a globally connected world, where international travel is trivial, the opportunity for a virus similar to that of SARS to wreak havoc on a global stage is higher than ever in human history. The Wuhan outbreak shows how a perfect storm of human transmissible disease, in a highly populated urban area, with international outlets could take a small regional outbreak and spread it across nations. Hopefully, through international coordination, we can limit the spread of this virus and as we gain more information effectively treat those infected.

    Below is a timeline of events as of the time of writing:

    December 31st : The World Health Organization is alerted by Chinese officials of a string of pneumonia like cases in Wuhan.

    January 1st : The Centers for Disease Control identifies a seafood market as a suspected center of the outbreak. Chinese officials close down and quarantine the market.

    January 9th : The World Health organization announces that the outbreak is being caused by a previously unknown strain of coronavirus, a broad viral family ranging from the common cold to deadly variants such as SARS.

    January 11th : Chinese officials report the first fatality – a 61 year old man in Wuhan who developed pneumonia.

    January 13th : The first international case is announced in Thailand by the World Health Organization. The victim is a Chinese woman who developed a mild case of pneumonia upon returning from a trip to Wuhan.

    January 15th : China’s health commission says that is cannot yet confirm human transmission but the possibility “cannot be excluded”.

    January 16th : A second international case is announced. This time in Japan with someone who had stayed in Wuhan in early January.

    January 17th : A second fatality is reported – a 69 year old man in Wuhan. The same day, the Centers for Disease Control announces it will begin screening passengers arriving from Wuhan at Los Angeles, San Francisco, and New York’s JFK International airports.

    January 20th : A third death and 100 new case reported in China. The virus is detected in South Korea for the first time in a Chinese passenger arriving from Wuhan. China’s President Xi Jinping makes his first public comments on the outbreak saying that it must be “resolutely contained”. Zhong Nanshan, a Chinese expert on infection diseases, announces that human to human transmission is confirmed.

    January 21st : The first US case of Wuhan’s coronavirus is reported in Everett, Washington. The man had traveled to Wuhan earlier in January.

    January 22nd : Airports across Europe step up checks on flights from Wuhan. The same day, the World Health Organization’s Chief, Tedros Adhanom Ghebreyesus, says that he is postponing the decision on whether or not to declare a global health emergency.

    January 23rd: Chinese authorities confirm 17 deaths and more than 500 cases have been reported. Travel access to and from Wuhan is suspended by the Chinese government in Wuhan and neighboring municipalities effectively quarantining 25 million people.

    January 24th : The CDC confirms second confirmed case with multiple potential cases being monitored in the United States while Mayor De Blasio of New York is quoted as saying “The disease will reach New York sooner rather than later.”

    January 25th : As China reports nearly 3000 cases, the CDC announces they are monitoring 110 possible cases across 26 states in the United States. There are now 81 confirmed deaths, 78 of which were in Hubei Province, the epicenter of the outbreak.


    [1] Smith, Richard D (2006). “Responding to global infectious disease outbreaks: Lessons from SARS on the role of risk perception, communication and management”. Social Science & Medicine. 63 (12): 3113–23. doi:10.1016/j.socscimed.2006.08.004. PMID 16978751.

    [2] https://www.cdc.gov/coronavirus/index.html, accessed 1/23/20

    [3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4369385/, accessed 1/23/20

    [4] McKie, Robin (10 December 2017). “Scientists trace 2002 Sars virus to colony of cave-dwelling bats in China”. The Guardian. ISSN 0029-7712.

    [5] Ebola virus disease (Report). World Health Organizationaccessed 1/23/20

    [6] https://www.cdc.gov/coronavirus/about/transmission.html, accessed 1/23/20

    [7] 汉地铁机场线开通 乘地铁赶飞机还需留意这两. Archived from the original on March 4, 2018.

    [8] https://www.cnn.com/asia/live-news/coronavirus-outbreak-intl-hnk/index.html

    [9] https://www.vox.com/2020/1/21/21075017/sars-wuhan-pneumonia-coronavirus

    [10] https://www.imperial.ac.uk/media/imperial-college/medicine/sph/ide/gida-fellowships/2019-nCoV-outbreak-report-22-01-2020.pdf

    [11] https://www.cnbc.com/2020/01/22/who-postpones-decision-declaring-china-coronavirus-a-global-health-emergency.html

    [12] https://www.cnn.com/2020/01/20/health/what-is-coronavirus-explained/index.html

    [13] https://wwwnc.cdc.gov/travel/notices/watch/novel-coronavirus-china

    Reported and Updated by Daniel Ballew, Digital Marketing Specialist for Hardy Diagnostics.

  • 2020

    In January, Hardy purchased the rights to DuraRack, a new design for an exceedingly sturdy and durable Petri Plate rack. This patented, epoxy-coated, steel rack will hold up to 84 100mm Petri plates for incubator or refrigerator use. The last rack you will ever have to buy!

  • 2020

    At the beginning of the year, Hardy gained FDA clearance for the CARBA 5 lateral flow test kit for the rapid detection of five of the carbapenemase enzymes involved in Gram negative bacterial resistance to most antibiotics (the “superbugs”).

  • Hitting Pay Dirt- New Soil-Derived Antibiotics

    Antibiotic resistance has been an emerging critical threat that, according to the CDC, results in more than 2.8 million antibiotic-resistant infections in the U.S each year, of which 35,000 are fatal (1).

    To date, most every antibiotic at our disposal has been discovered in the dirt; these compounds exist as natural products that are produced by various soil-derived microorganisms. Since competition in the soil is fierce, inhabitants produce substances that effectively eliminate the neighboring competition (2). These substances are highly sought after for antibiotic candidacy.

    Soil has long been heralded as an exhausted resource for drug discovery,as soil-screening techniques have long been implemented and practiced in industry. However, recent advances in the hunt for new antibiotics have been made: researchers from Rutgers University-New Brunswick have discovered a new antibiotic with promising applications- Pseudouridimycin (PUM). This compound was found in a species of Streptomyces (ID38640) from soil samples in Italy (1).

    PUM is a nucleoside-analog that disrupts the enzymatic activity of bacterial polymerase through competitive inhibition. This particular inhibitor resembles that of uracil and interacts with the Nucleoside Triphosphate (NTP) active site of RNA polymerase (RNAP). PUM is thus incorporated into RNA during transcription, resulting in a loss of activity and bacterial viability (2).

    RNA polymerase is found in all living organisms, including many viruses,and is essential for life. As a result, inhibitors like PUM have no specifications for the host target, be it Gram-negative and Gram-positive bacteria, or human beings. Fortunately for us, PUM has a substituent chain that reaches and ‘touches’ a neighboring allosteric site that is not present in human RNAP, rendering it far less effective against our own enzymes (3).

    PUM is the first target-specific RNA polymerase inhibitor and, like other nucleoside-analog inhibitors, is most notable for its low resistance rate.These drugs typically exhibit a resistance rate that is ten times fewer than the more conventional antibiotics.Drugs with similar profiles are best suited for use in the treatment of multiple drug resistant (MDR) infections. The bacterial response is not likely to have an existing resistance or the ability to acquire one through repeated exposure.

    This discovery highlights the importance of natural products and where to find them. Over the years, microbes have come to perfect their craft of eliminating competition in the interest of survival by natural selection. (3). The soil is the microbial battleground.

    Ref: 1, 2, 3

    Andrew Kravariotis
    R&D Biochemist
    HARDY DIAGNOSTICS

  • 2019

    In November, Hardy Diagnostics was presented with a “Certificate of Recognition” from the Salvation Army. The company continues their commitment to donate 1% of its earnings to charitable causes to make our world a better place.

  • 2019

    In November, Hardy released the PathFinder Listeria test. This novel test will fluoresce green in the presence of pathogenic Listeria spp. It only takes overnight incubation to detect all the pathogenic species of Listeria that may be lurking on environmental surfaces of a food processing plant.

  • 2019
    CARBA 5 Timeline

    In October, Hardy gained clearance from the FDA to market the new Carba 5 lateral flow device that detects the five main bacterial enzymes of Carbapenem resistance. Test results are obtained in only 15 minutes and the cost is far less than PCR.

  • 2019
    Wizard CompactDry Reader

    In July, Hardy announced the long-awaited release of The Wizard, an automated colony counting device that is used for the analysis of the Compact Dry plates. These plates are designed to enumerate the contaminating bacteria, yeast, and mold from food specimens.

  • Top 10 Germs in Cannabis That Can Make You Sick

    Many people are concerned about what kinds of microorganisms might be lurking in their cannabis products. Growers and cultivators are trying their best to understand how these contaminants, or “bugs,” may be getting into their products. Testing labs are working hard to properly screen and identify the worst offenders, even when they are not required to by the local jurisdiction. At the end of the day, everyone is chasing the same goal: safe cannabis for the consumer.

    10. Mucor spp.

    This ubiquitous mold is found almost everywhere and rarely presents a problem for most of us. The strains of Mucorales that have the potential to make you sick are most often of the genera RhizopusMucor, and Rhizomuco. A cancer patient diagnosed with this fungal infection died earlier this year and the infection was associated with medicinal marijuana use. [1] While a mucormycosis or zygomycosis infection is rather rare, the consequences can be very dangerous – especially since those most susceptible to the toxic mold are immunocompromised patients.

    Mucor spp. currently lacks screening requirements in most states.

    9. Penicillium spp.

    We can thank certain species of this mold genus for saving millions of lives through the advent of the antibiotic penicillin that this organism produces. However, there are other members of this mold genus that are known as mycotoxin producers and pathogenic. The most important mycotoxins from Penicillium are ochratoxin A (OTA) and patulin. Many jurisdictions require screening for the mycotoxins, but the parent organism still remains largely unchecked. The effects of these toxins on human health have not been thoroughly studied; however, it has been linked to kidney disease. Conversely, its effect on animals is well known and has been proven to be a potent renal carcinogen.[2] Let us not forget, humans are not the only patients and consumers here; the sale of cannabidiol, commonly known as CBD, to the pet market, has grown over 400% since 2017. [3]

    Peniciliium spp. currently lacks screening requirements in most states.

    8. Klebsiella spp.

    This is another organism that has been isolated from cannabis. [4] This bacterium is present in soil and sometimes used in agriculture to increase crop yields. Klebsiella bacteria also live in the digestive tract which means it can spread from human to human. Patients infected with the bacteria have the potential to pass the disease on to others in the environment. This bacterium is a major concern in medical settings and can be life-threatening for many long term care patients who may have weakened immune systems or are on long course antibiotic treatments. Infection can lead to pneumonia, bloodstream infections, wound or surgical site infections, and meningitis.

    Klebsiella currently lacks screening requirements in most states.

    7. Clostridium botulinum

    This killer bug is of greatest concern when talking about edibles such as cannabutter (cannabis-infused coconut oil), peanut butter, or other dense edible material that allows for the formation of anaerobic, or low oxygen, pockets. This bacterium goes a step further when the conditions for survival are poor- it releases spores. The spores of C. botulinum have hard coatings which allow them to remain dormant and survive for years. This bacterium is found in soil and should be a major concern for those producing certain cannabis-infused edibles.

    Clostridium botulinum currently lacks screening requirements in most states.

    6. Pseudomonas aeruginosa

    This is a pathogen that thrives in moist soil, plants, and water. A cannabis cultivation facility provides the ideal conditions for proliferation. The problems from this bacterium are wide-ranging and could gravely impact our most vulnerable patients. We have a case of necrotizing pneumonia associated with the regular use of cannabis in a water pipe. [5] The medical issues resulting from a P. aeruginosa are wide-ranging and include soft tissue infections, bone and joint infections, gastrointestinal infections, respiratory infections and more. As with most of the other offenders, hospital settings and immune-compromised patients are at the highest risk, especially AIDS and cancer patients. Since we know these patients are looking to cannabis products as part of their treatment plan, it is important that the medicine is proven safe. This bug is screened for in a small handful of localities but it makes sense to broaden the scope of testing for this organism.

    Pseudomonas aeruginosa currently lacks screening requirements in most states.

    5. Staphylococcus aureus

    There is some encouraging early evidence that CBD may help in the battle against drug-resistant bacteria.[6] That said, S. aureus is transmitted from humans onto finished goods. Methicillin-resistant S. aureus (MRSA) as a foodborne illness has been documented to be on the rise. [7] Infections from the bacteria can cause severe food poisoning and gastrointestinal illness. This is of special concern for prepared or ready-to-eat foods. When finished goods are packaged and stored for sale, the GMP environments in which these activities are taking must be strict and vigilant. While we may have had an ingredient pass initial testing, do we properly understand the critical points in our processes that could possibly introduce contamination to a product?

    Staphylococcus aureus currently lacks screening requirements in most states.

    4. Salmonella spp.

    Since we have had outbreaks associated with Salmonella in cannabis,[8] this pathogen is very regularly looked for in almost every regulated market that requires cannabis testing. Salmonella is an organism that can be spread to the plant through the agricultural process or through improper handling of other ingredients when preparing edibles. A run-in with Salmonella can result in food poisoning symptoms and severe dehydration. Some serotypes of Salmonella enterica are the cause of the life-threatening illness Typhoid fever. We should be looking for this particular organism in dried cannabis flower and cannabis edibles.

    Salmonella spp. is commonly tested in most states.

    3. Escherichia Coli

    E. coli is an organism that is found in the gut of many animals and easily contaminates soil and water. Natural fertilizers applied to the plant can also be an open door for this bug. Those who become ill from E. coli may experience anything from gastroenteritis to respiratory infections. Certain strains of E. coli produce a toxin that causes severe diarrhea and can, in some cases, cause kidney damage. The presence of E. coli on cannabis products has been confirmed by several independent testing labs. We should be concerned about finding E. coli in both raw flower products as well as edibles.

    E. coli is commonly tested in most states.

    2. Listeria spp.

    Listeriosis is an infection caused by the bacteria Listeria monocytogenesListeria may infect many different systems in the body, such as the brain, spinal cord membranes, or the bloodstream. It can also lead to spontaneous abortion in pregnant women. Listeria bacteria can be found in water and soil, both of which are necessary when cultivating cannabis.  Listeria is a very common pathogen of concern in food testing and is very carefully screened for in many food processing plants. We need to be sure that we are looking for this pathogen in medicines that are made available to cancer, transplant, and HIV patients, who are at a higher risk for contracting the disease.

    Listeria currently lacks screening requirements in most states.

    1. Aspergillus spp.

    Aspergillus molds are the most common pathogens of concern in cannabis products today.  Aspergillus is a potentially pathogenic mold that can cause a lung condition known as Aspergillosis. Aspergillosis is responsible for at least one documented death of an immunocompromised cancer patient who was using cannabis products for the treatment of symptoms.[9]

    Aspergillus has four main species of concern: Aspergillus niger, Aspergillus flavus, Aspergillus terreus, and Aspergillus fumigatus. Many regulated states require testing for Aspergillus but only a few require speciation of the “Big Four.”

    These molds are especially troublesome for pediatric and immunocompromised patients. They produce mycotoxins that will persist even if the mold has been killed in the finishing process. Little is known about the virulence of the mycotoxins or how to remediate them.

    Aspergillus spp. is commonly tested in most states.

    I consider these the top 10 organisms most likely to contribute to the overall decline of health in patients using cannabis products in their treatment program. I have had the great privilege to work with cannabis labs across every major market including Canada. The labs and growers I have worked with have been open about what they are finding and where. Our industry needs to be sure we are screening the right products for the right organisms in the right way and at the right time. As advocates for cannabis as medicine, it is important that we be vigilant when it comes to organisms that could compromise the health of our patients and consumers.


    Jessa Youngblood is the cannabis industry specialist at Hardy Diagnostics. She sits on the AOAOC CASP committee for Microbial Contaminants Working Group as well as the NCIA Scientific Advisory Committee. Jessa has a passion for safe access to cannabis medicine and regularly leads webinars and training to support the development of cannabis microbiology testing programs across the US and Canada.  



    [1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6330507/

    [2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4247821/

    [3]https://www.cnbc.com/2019/05/03/pets-are-hot-new-customer-for-cbd-market-as-owners-use-it-for-anxiety.html 

    [4] https://health.ucdavis.edu/publish/news/newsroom/11791

    [5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5756717/

    [6] https://www.ncbi.nlm.nih.gov/pubmed/18681481

    [7] https://www.ncbi.nlm.nih.gov/pubmed/22850394

    [8] https://www.ncbi.nlm.nih.gov/pubmed/7070444

    [9] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3103256/

  • The Life of Louis Kelso: Father of the ESOP

    “There is no future for those who cannot or will not think.”

    (Louis O. Kelso, In Lectures and Conversation)

    Louis Kelso is often credited as the man who invented the ESOP. Hardy Diagnostics owes Louis Kelso a lifetime of gratitude for his ideas as they have helped shaped our company today. The following is a short biography of the man who gave companies back to their employees for decades and continues to do so today.

    Louis Ortho Kelso was born on December 4th, 1913. His early childhood saw the culmination of the Second Industrial Revolution, the greatest economic growth in history across western society. The modernization of manufacturing and production technology enabled massive advancements in technological systems, such as infrastructure and mass transit. These advancements were pivotal in the First World War, enabling it to become one of the largest and bloodiest conflicts in history.

    In the post-Great War 1920s, the United States gained the leading edge in world finances. The “Roaring 20’s” was the zenith of economic prosperity. Rapid industrial growth, rise in consumer demand, and significant changes in lifestyle and culture saw American businesses cultivate large wealth. The American people now lived in stark contrast to War-era frugality. This opulence was not to last long, however. As the Americans woke up on October 29th, 1929, stocks had plummeted and a decade of prosperity had quite literally ended overnight. “Black Tuesday” as it would be known, was the start of a decade of economic stagnation known as the Great Depression. Millions lost their jobs and the worldwide GDP plummeted by 15%. In comparison, the Great Recession of 2008 only saw worldwide GDP drop of 1%.

    It was in 1931, that a young Kelso began to grow interested in economics. His determination to investigate the true cause of the Great Depression was fueled by his dissatisfaction with available explanations at the time. In 1937, he graduated from the University of Colorado at Boulder with a Bachelor of Science in business administration and finance. The following year, Kelso earned his Doctorate in Jurisprudence at Boulder and joined the Denver law firm Pershing, Bosworth, Dick, and Dawson. Kelso worked for the firm from 1938 until 1942. He might have stayed with the firm longer if it had not been for one fateful December morning.

    On December 7th, a surprise preemptive military attack was launched by the Imperial Japanese Naval Air Service on Pearl Harbor Naval Base in Honolulu, Hawaii. This offensive left 2,403 Americans killed, 1,143 wounded, and the American Navy in the Pacific crippled. The United States had hoped economic pressure through embargos of fuel and steel would deter Japanese Imperial expansion throughout the Pacific while allowing them to retain their neutrality in the War. However, the attack on Pearl Harbor had forced the hand of the “sleeping giant”. The United States declared war on Japan, who had done the same on the day of the attack. Germany and Italy would stand in solidarity with their Japanese allies, declaring war on the United States on December 11th with the United States following suit mere hours later. The United States had officially entered the Second World War alongside its British, Russian, and Chinese allies.

    Soon after, Louis Kelso was commissioned by the United States Navy and given an intelligence assignment in San Francisco. He would later be assigned to the Canal Zone in Panama. It was during this time, during his free afternoons, that he would begin to write his influential work, The Fallacy of Full Employment.

    Years passed and as the Second World War ended, Kelso was honorably discharged by the Navy in 1946. With his manuscript finished, Kelso was excited to share his ideas with the world, however, with the passing of the Full Employment Act of 1946, Kelso decided that his manuscript, with its controversial conclusion, was not ready for the public.

    After a brief stint teaching Constitutional Law at his alma mater in, Kelso moved to San Francisco once more, but this time to become a full law partner. It was during this time with the firm Kelso, Cotton, Seligman, and Ray that Kelso would begin the work on what would become his legacy. Even so, it simply was not enough.

    In 1956, Kelso was contacted by Gene Bishop, who had been Kelso’s Commanding Officer in the Navy and was now Vice President at Peninsula Newspapers Incorporated. The original owners of PNI wished to retire but did not want to sell their paper to William Randolph Hearst, the media mogul who had developed the nation’s largest media chain, Hearst Communications. The employees echoed this sentiment. The employees wanted to own the paper they loved. Bishop was spearheading the effort on the employees’ behalf. The employees tried to pool their resources, dipping into savings accounts, attempting to take second mortgages on their homes, garnering investments from friends and relatives, all in an attempt to accrue the necessary capital to purchase the company.

    The bank found that the employees could only scrape enough money to cover the interest, but not the principle to buy the paper. The employees refused to allow the paper to become the property of Hearst or others like him, so instead Bishop turned to Kelso for advice. The next day, Kelso came to Bishop with a solution that sounded too good to be true. The employees would pay for their ownership of the company out of the company’s future earnings. These profit-sharing trusts were credited with share ownership as the trusts paid off the loans. This meant the retiring owners were bought out in full, and by 1974 the newspaper had gone on to report shareholder equity of more than $6 million. Kelso had invented the ESOP or Employee Stock Ownership Plan.

    Throughout the 1960s and 1970s, Kelso helped establish more of these buyouts, at the time known as “Kelso Plans.” As he rubbed shoulders with some of the world’s most powerful and wealthy men, he secretly loathed the classism of post-war capitalism. “The trouble with today’s techniques of finance is that they’re designed to make the rich richer. None are designed to make the poor richer. That’s why the poor are poor. Because they’re not rich.” To Kelso, capitalism was plagued through the maldistribution of income. The rich got richer as they enjoyed the benefits of capital ownership, while the non-rich barely survived, living off of the fruits of their labor. As automation increased, more workers would lose the only bargaining chip they had at the table: their necessary labor. Kelso, however, did not approve of social redistribution of wealth as seen in socialist models, stating “Socialism has been discredited. Plutocracy is in the process of being discredited. Democratic capitalism has yet to be tried.” In his mind, the only solution to capitalism’s primary fault was to broaden the scope of capital ownership. 

    With newfound momentum, he continued to work on his manuscript while also promoting his “Kelso Plans,” all in an attempt to spark a “capitalist revolution” within the business world. He continued to lobby to Congressmen, economists, and politicians. Barry Goldwater, Richard Nixon, and Gerald Ford were all approached by Kelso and all politely listened to Kelso’s impassioned rhetoric but ultimately none were moved to any action.

    Finally, Kelso was introduced to Russell Long. Long was chairman of the Senate Finance Committee and son of Huey Long. Nicknamed the “Kingfish” Huey Long served as the 40th governor of Louisiana and famously touted the phrase “every man a king” as he promoted his Share Our Wealth plan to stimulate the economy. While Russell Long might not have been the opponent to the rich as his father had been, he was a brilliant politician with populist leanings.

    During the hours of their introductory dinner, Kelso found he had finally won an ally. As their meal concluded, Long simply asked, “Now what can I do for you?” Kelso knew he needed someone to bring his ideas before the Legislature. More than that, he needed his ideas to become law so his capitalist revolution could finally begin.

    Due to Long’s influence, ESOP legislation became a frequent talking point in Washington with small pieces being written into legislative initiatives over the years. The breakthrough for ESOP’s came in 1974 with the passing of the Employee Retirement and Income Security Act (ERISA). This landmark legislation governed company-sponsored retirement accounts. ERISA not only made Kelso Plans more viable, but also made them easier to implement. ERISA was just the start. Long would go on to write many more ESOP relegated legislation pieces that either altered ERISA or tax code to benefit ESOP ideals.

    Many years later, Long would include one of the hallmark reasons for many ESOPs creations. A provision for the deferral of taxes on the sale of private stock to an ESOP was thrown in at the last second before passing the Legislative branch. To this day, this remains one of the key incentives for company owners to switch to an ESOP model.

    For his part, Louis Kelso would continue to be an advocate for Employee Ownership. He would spend the rest of his years giving speeches, authoring books, and writing articles around the idea that capital ownership should not be held and kept only for the lucky few. Louis Kelso would continue his work up until his death in February of 1991. He was 77 years old when he passed.

    “People are hungering for property — for a secure, permanent and independent link with spaceship earth that ownership represents and which only ownership can protect or defend. It is humiliating to possess nothing, to own nothing, and hence to produce nothing and to count for nothing.”

    (Louis O. Kelso and Patricia Hetter, Washington Post, June 18, 1972)

    At Hardy Diagnostics, we are celebrating our fourth year as a 100% Employee-Owned company.

    While Hardy Diagnostics may have arisen from humble beginnings with only two employees, for 40 years Hardy Diagnostics has grown and flourished to over 400 partners! Jay Hardy, President and Found of Hardy Diagnostics, being of entrepreneurial spirit, wanted to instill the blessing and responsibility of business ownership in his employees.

    The Hardy Diagnostics ESOP was created in 2012, and in October 2015, Mr. Hardy sold the remainder of his majority share in Hardy Diagnostics back to his employees. Hardy Diagnostics now operates as a 100% Employee Owned ESOP.

    We do not answer to private investors or venture capitalists. We operate as a company of owners who only answer to our customers and their needs. We are proud in knowing our daily work is helping healthcare professionals and technicians diagnose and prevent disease. We love what we do, and just like Peninsula Newspapers Inc… we would never sell our company. You cannot put a price on purpose.

    Written by Daniel Ballew, Digital Marketing Specialist for Hardy Diagnostics

  • Isn’t It Time We Build a Better Bed Rail?

    Long before Sir Alexander Fleming’s accidental discovery of Penicillin in 1928, our ancestors were already putting the antimicrobial effects of metal to use. 

    Metals such as copper and silver were used as vessels by ancient civilizations to keep their water clean and safe to drink (1). Researchers have also discovered a reference in an ancient Egyptian medical text known as the Edwin Smith Papyrus (circa 1600 BCE), in which copper may have been used to treat and prevent chest infection (2). This biocidal effect of certain heavy metals is known as the Oligodynamic effect.

    Oligodynamic can be defined as “active or effective in very small quantities.” The concept is very simple: the metal ions are killing bacteria (3). Research has determined the cause to be electric charges between the bacterial cell membrane and the metal ions. Using the example of copper, ions dissolved from the surface of the metal bond to the membrane of the bacterial cell wall to create an organocopper compound. These organocopper compounds continue to pull apart the membrane of the bacteria and alter its shape (3). Exposure to copper can damage bacterial respiration and DNA, which will ultimately inactivate and destroy the cell (4).

    _______________________________________

    Copper was used thousands of years ago to kill bacteria…Why are we not doing the same?

    ______________________________________

    Copper is already being tested in the medical field as well as in hospitals to prevent the spread of nosocomial infections, such as methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant Enterococcus (VRE). Frequently touched surfaces or busy areas can become a safe-haven for bacteria. In one study, copper-prototype objects were substituted in the patient room of an ICU to test the antimicrobial effects compared to items composed of other materials (stainless steel, plastics, etc). Although only 7% of touch surfaces were replaced by copper-prototypes, results showed more than a 50% reduction in infection cases (1).

    At this point in time, scientists continue to struggle to develop new antibiotics faster than resistance is evolving. Maybe it’s time that items such as bed rails, door knobs, and faucet handles be composed of copper- containing brass. The ancients knew this thousands of years ago. Why have we not learned from their experience? 

    Additional research into bacteria and the Oligodynamic effect is warranted, since it may be a very useful tool in the fight against the increasing resistance of pathogenic bacteria. 

    Ref: 1, 2, 3, 4

    Gabriel Garza

    Technical Support Representative

    HARDY DIAGNOSTICS

  • We need Cannabis, not CannaBIZ

    We know that cannabis can make people sick. We know that the pathogens present in this medicine, like many others, have killed patients[i]. We know that our most vulnerable and desperate cannabis patients are immunocompromised, terminal, and/or pediatric. WE, US, YOU AND I, must address patient safety in an informed and rational way. We do not want a failure in how we handle cannabis to give way to public distrust in its potential to heal. We have fought too hard to lose our footing at this point.

    I spend a lot of time thinking about how we, as an industry, can responsibly move forward with the screening and testing of cannabis materials for pathogenic, or disease inducing, microbiological organisms. I work for Hardy Diagnostics, a microbiology company that has been a present and important part of this testing for over a decade in the US. We first established relationships with cannabis labs on the West Coast and Colorado in the early days of medical marijuana legislation. Since then, many things have changed across the corporate cannabis landscape, but the effective and reliable science of identifying potentially harmful and deadly contaminants has remained our core strength.

    As we entered the cannabis testing space, we took what we knew about finding dangerous pathogens from established FDA, USP and ISO certified methods and applied these practices to the testing of medicinal, recreational, edibles, and oils. When we look at how the FDA defines the identification of Salmonella, E coli, Yeast/Mold, enterobacteriaceae and other pathogenic organisms in food, cosmetics and nutraceuticals, we see over and over again the dominance of validated and well established methods using culture media technology. I find myself regularly referring to the FDA Bacteriological Analytical Manual (BAM) for the isolation and id of the following organisms:

    Salmonella, FDA BAM Ch. 5

     E coli, FDA BAM Ch 4a

    Yeast, Molds FDA BAM ch 18

    Of course, the FDA is not alone in the use of culture media as the gold standard for microbiological testing. Methods for these and many other organisms of concern are outlined in USP and ISO, as well as the AOAC, and many other globally recognized leaders.

    As a caution I will make this point, culture media does not propose to be the only approach or an independently adequate method for all microbiology testing. To date, there does not exist one single method that answers the major questions we must ask; 1) Is this a living organism, and if so, can I count the colonies? And 2) Which species of organism is this? To most honestly and accurately answer these questions, we must implement complementary technologies. In my experience, and to quote a great movie, “anyone who says otherwise is selling something.”

    I have great optimism that the innovative minds and cutting edge science surrounding the cannabis community will create advances in the field of diagnostics that will benefit many other industries. I have a hope that we will be able to work together to create this world. In the meantime however, it is important that we properly implement the proven tools that we have to keep our public safe from disease.

    Jessa Youngblood
    Cannabis Industry Specialist, Hardy Diagnostics
    1-800-266-2222 ext 5605
    [email protected]

    Hardy Diagnostics is an ISO certified and FDA licensed manufacturing center specializing in the production of culture media. We service food, pharmaceutical, clinical, industrial and cannabis microbiology labs around the world. We work with companies that touch the everyday lives of most Americans.


    [i] (Chest, Hamadeh, 988 Aug;94(2):432-3)

  • Regulatory Standards for the Cosmetics and Personal Care Industry

    Self-policing has long been the standard for the industry, although several entities have a say in what constitutes Best Practice in the manufacturing and production of cosmetics and personal care products. 

    The FDA’s  (Federal Food, Drug, and Cosmetics) oversight is mainly focused on regulating adulterated and misbranded products. Products classified as improving the appearance and causing a change (improvement, cure, or prevention/protection), are considered both a cosmetic and a drug by the FDA and must adhere to more robust requirements.

    FDA’s Bacteriological Analytical Manual (the BAM) states preferred laboratory procedures for the detection in food and cosmetic products of pathogens (bacterial, viral, parasitic, plus yeast and mold) and of microbial toxins.

     ISO 22716 is the international standard for the good manufacturing practices (GMP) for cosmetics, with guidelines accepted by many global regulatory entities, including the FDA.  The ISO standard focuses on the production, control, storage, and shipment of cosmetics products.

    With roots going back to 1894, the Personal Care Products Council (PCPC) is , according to their website, “…the leading national trade association representing cosmetic and personal care products companies and serving as the voice on scientific, legal, regulatory, legislative and international issues….”  The council advocates for modernizing government policies, product safety and sound science, ensuring global access, and maintaining consumer confidence.

  • Hardy Diagnostics aboard the ISS!

    In total silence, a nearly 463 ton marvel is traveling at 17,000 miles per hour, but it garners little attention from those on Earth. In a modern age where space travel has become so mundane that private space flight companies are better known for their founder’s tweets than the incredible feats of scientific achievement they are conquering, little attention is given to the fast-moving speck that darts across the night sky every ninety minutes. For over twenty years, the International Space Station (ISS) has orbited the Earth, allowing astronauts to conduct experiments in biology,  human biology, physics, astronomy, meteorology, and other sciences differently than the planet’s surface.

    The International Space Station is a joint operation of five space agencies: NASA (USA), Roscosmos (Russia), JAXA (Japan), ESA (EU), and CSA (Canada). Launched in 1998, the ISS has been continuously manned for 18 years and 294 days as it has grown via additional modules. The newest module was added in 2016. During that time, 236 people have had the opportunity to visit the most remote workplace possible. However, while we are as fascinated with unfathomable expanse we not so eloquently refer to as space, here at the HardyBlog we are interested in something much, much smaller. Turns out, so were those aboard the ISS.

    Over the course of 14 months and three separate flights, a catalogue of the bacteria found on internal surfaces of the International Space Station was catalogued to better understand the fungal and microbial communities aboard the ISS. Not only was this study done for the pragmatic reasons, such as developing safety measures and protocols for extended space travel, but also to better understand the effects microgravity on the development and proliferation of bacteria and fungi.

    Dr. Kasthuri Venkatewaran, the corresponding author of the study, said, “Specific microbes in indoor spaces on Earth have been shown to impact human health. This is even more important for astronauts during spaceflight as they have altered immunity and do not have access to the sophisticated medical interventions available on Earth.” As you hurdle through space nearly 249 miles above the nearest possible hospital, it is understandable that even the slightest of infections would be far more inconvenient.

    Researchers found that the vast majority of microbes found on the ISS were human-associated in nature. Found most prominently were Staphylococcus bacteria at 26% of total isolates, followed by Pantoea (23% of isolates), and Bacillus (11% of isolates.) While most of these bacteria can be found in gyms, offices, and hospitals, suggesting that the ISS is similar to other human occupied structures, there is still cause for concern.

    “Whether these opportunistic bacteria could cause disease in astronauts aboard the ISS is unknown,” says the primary author, Dr. Checinska Sielaff.  “This would depend on a number of factors, including the health status of each individual and how these organisms function while in a space environment.” Staphyloccocus aureus (10% of isolates identified) is a common Gram-positive bacteria that can commonly cause skin infections that are easily treated. However, the rise of antibiotic-resistant strains of S. aureus such as MRSA (Methicillin-resistant S. aureus) and VRSA(Vancomycin-resistant S. aureus) have researchers far more concerned due to the remote nature of the ISS and her crew.

    The study, which used both Hardy Diagnostics R2A agar and Potato Dextrose Agar, found that while fungal communities were stable over time, microbial communities changed over time. While the first and third flights produced similar results, the second flight had a far more diverse microbial diversity. The authors suggest that the differences could be attributed to the different astronauts on board during these times. As space travel becomes increasingly more common, even commercial in nature, this has interesting implications regarding astronaught hygiene and cleaning protocols of spacecraft.

    The study which acted as the first comprehensive cataloguing of bacteria and fungi found on surfaces of closed space systems could just be the first in a series of studies that intend to further improve safety measures including those in place by NASA for deep space human habitation, such as a manned mission to Mars. Hardy Diagnostics is proud that our products are helping to diagnose and prevent disease , whether it be on this planet or the next.

    References:
    Reference Guide to the International Space Station (PDF) (Assembly Complete ed.). NASA. November 2010. ISBN 978-0-16-086517-6. NP-2010-09-682-HQ.

    Characterization of the total and viable bacterial and fungal communities associated with the International Space Station surfaces,Aleksandra Checinska Sielaff†, Camilla Urbaniak, et. al, Microbiome, April 2019. https://microbiomejournal.biomedcentral.com/articles/10.1186/s40168-019-0666-x

  • Inspiring the Next Generation of Scientists- Amelia’s Story

    Hardy Diagnostics is proud not only to support global organizations and charities whose values mirror our own, but every once in a while we get the unique chance to make a direct impact on someone’s life through giving.

    Recently, we were given that very opportunity when a young girl needed help with her science project. Her name shall remain confidential as she is a minor and will be referred to as Amelia throughout the remainder of this article.

    As her mother informed us, she has some anxiety when speaking to strangers, which is totally understandable especially for a young person, but nevertheless Amelia mustered up the courage to give our customer service department a call to make a request for a donation. This brave girl said she needed two packs of Blood Agar plates (TSA with 5% Sheep Blood- A10) for her science project idea. A. informed us of her plans to swab the environment around her school and streak for growth. We were so pleased to hear a young mind excited about the unseen world of microorganisms, how could we say “no?”

    After sending Amelia her supplies, we all hoped to hear how her project went and we were lucky enough to get an update!

    Both Amelia and her mother contacted us to share the results. Over the course of two months, A. methodically worked to plan, prepare, and execute a full environmental screening of her school! But as science fairs go, there has to be a clear winner…

    Well we are pleased to say that Amelia took the Grand Prize for her work and is now exhibiting her project for the district! Beyond winning first place, stricter cleaning protocols have been put in place at the school due to Amelia’s findings.

    What made this story so special to us wasn’t just that Amelia won her science fair, but what she said at the very end of her letter: “I think I might want to be a scientist when I grow up now!” Children like Amelia are our greatest responsibility. To help them grow, learn, and to inspire them to do good in the world, this is what we as a company strive for. In a time where the number of doctors, microbiologists, and other medical technologists are declining, inspiring children to pursue STEM fields is a necessity!

    Thank you Amelia for being brave and for calling Hardy Diagnostics. Thank you for letting us help you with your project, and we wish you all the best as you grow as a scientist!

  • Fresh water brought to those in need.

    Hardy Diagnostics is proud to annual donate at least 1% of our earnings every year to charity. Our mission statement of “diagnosing and preventing disease” guides our company’s every move and is often extended to the charities which we choose to support. We would like to take a moment to highlight one such organization, Lifewater.

    In 2017, Hardy Diagnostics was introduced to this brilliant organization whose values and mission statement resonated with our company as they sought to bring sustainable, appropriate safe water technologies and practices to the world’s most marginalized communities. According to the CDC, an estimated 780 million people do not have access to an improved water source and 2.5 billion people do not have access to improved sanitation (35% of the world’s population). This lack of fresh drinking water and sanitation causes water borne illness to run rampant among communities which is often compounded by a lack of adequate medical care. This recipe for disaster is responsible for over 800 thousand death per year in children five years or younger, mostly in developing countries (around 2,000 children a day globally).

    It is demonstrable then that global action must be taken to better supply populations with clean sources of water as well as infrastructure for proper sanitation practices to further prevent the spread of water borne disease and neglected tropical diseases, many of which are hygiene related.

    Hardy Diagnostics is proud to support Lifewater in its mission to end the global water and sanitation crisis, step by step, village by village.

    We would like also share this message from Lifewater showing the very real impact of their work:

    Megene is a local Ethiopian woman and mother of five young children. Before her village became healthy, they were exposed to painful, debilitating bouts of sickness. Megene’s family spent 2,400 birr ($87 USD) each year on medical treatment for her five children. For a family making less than $2 a day, the cost is nearly unbearable.

    But, last year, our generous partners changed her story, and Megene no longer drinks contaminated water.

    “Now, I am free from feeling of shame, disgust, and fear,” she said.

    Megene is not some abstract mother from Ethiopia. Her and her family are very real and because of partners like you they will have access to clean water, improved health, and the hope of the gospel. These practices create a healthier, more hopeful future that allows people to thrive and spend time doing the things that matter most.

    You too can support Lifewater by visiting their website.

  • The Changing Face of Safety Practices in the Cosmetics and Personal Care Industry

    The English translation for the French phrase “Il faut souffrir pour etre belle” is: “You must suffer to be beautiful.” Throughout history, the definition of beauty has changed from one era and society to another. A decade of shaved and precisely drawn in eyebrows gave way to a natural, full and almost unruly look. Glued on mouse fur brows were once substituted for natural shaved-off brows; a cosmetic statement that seems extreme. However, this practice seems tame compared with the suffering and lengths some have gone to in the past to achieve the look du jour.

                   Growing up in the 80’s, summer goals included achieving the darkest tan possible. No one talked about sunscreen back then and advertisements for a popular tanning oil touted “the St. Tropez tan.” I can still hear the jingle and remember the image of the bronzed woman I aspired to look like before school started back up in the Fall. I wish I could take back all the sun damage inflicted in those days, but admittedly, I still love the smell of that stuff and the beachy memories the scent invokes.

                   At one time, a sun-kissed look meant one was most likely a laborer or commoner, so the opposite skin tone was desired: pure, white, aristocratic skin was the look of the day. Women (and some men) of the 18th century would liberally apply lead based powder to lighten the skin and cover scars caused by smallpox, “royally” coating the skin of the face, chest, and shoulders. This fad caused serious health problems, including baldness, eye inflammation, rotting skin, high blood pressure, stomach pain, miscarriages, paralysis, and death. After several aristocrats’ deaths were attributed to white lead, its use diminished.

                  The heavy metals mercury and radium both found their way into cosmetics. Cinnabar, a beautiful red volcanic ore composed, in part, of mercury, was an ingredient ground up to bring a rosy hue to the cheeks. The toxic rouge resulted in muscular and nervous system damage.

                  A “glowing complexion” was made possible by skin care creams, and other products, containing radium bromide. Results from the applications of radioactive skincare were marketed as miraculous until incidences of disintegrating jaw bones, cancer, and death were recorded.

                  Perhaps one of the strangest beauty trends was the routine of using belladonna eye drops by Italian fashionistas around the turn of the 20th century. The extract from the poisonous “beautiful lady” nightshade plant dilated one’s pupils, making the eyes look bigger and supposedly simulating a natural state of arousal. Along with the seductive look came increased heart rates, headaches, and blurred vision. Constant use of the drops eventually caused blindness, a huge price to pay for a wide-eyed look.

    The difference between a natural pupil compared to one affected by Belladonna eye drops.

                  In 1938, the FDA began to monitor the cosmetic complaints regarding serious health issues. Monitoring was all the FDA could do, however, since they were not empowered to demand recalls or have any control over ingredients.

                  Reports of crippling injuries unfortunately became more prevalent as the use of cosmetics began to boom from the 1940’s into the 1960’s.

                  The hidden dangers of bacteria, primarily Pseudomonas and Staphylococcus, came to light as bacterial keratitis infections began to crop up as a result of contaminated products.   Bacterial keratitis is an infection of the cornea. The condition usually develops quickly. Eye infections began to lead to permanent blindness on an increasing scale.

                  In the 1970’s, The Cosmetic Toiletry and Fragrance Association (CTFA) established strict microbiology and quality assurance guidelines. Antimicrobials were added to makeup to increase product integrity, safety, and shelf-life.

                  Public campaigns were launched, urging consumers to rotate cosmetics, discarding makeup after three months of use, and immediately if signs of redness, rash, or infection occurred.

                  In 2007, the CTFA became the Personal Care Product Council, a “science-based safety-first organization.”

               Thankfully, the odd attempts at attractiveness of the past are no longer practiced.

                  Today, the FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C) and the Fair Packaging and Labeling Act (FPLA), yet compared to other highly regulated industries, such as pharmaceutical, the cosmetics and personal care industry is largely still self-policed.

                  According to the FDA, “The law does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market, but there are laws and regulations that apply to cosmetics on the market in interstate commerce… Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety of their products.”

                  Hardy Diagnostics has products to support testing guidelines for USP <61> Microbial Quality, USP <62> Selectivity of media, and USP <1111> Microbial examination of non-sterile products.  

  • 2019

    On May 1, Hardy purchased the microbiology division of HealthLink in Jacksonville, Florida. Hardy is pleased to welcome the HealthLink customers and to assist them in purchasing culture media, antibiotic disks, QC microorganisms, specimen collection and transport swabs. One of the main products involved in this transaction is the Selective Strep Agar Plate.

  • 2019

    On April 29, the FDA cleared Hardy’s new chromogenic agar plate, HardyCHROM CRE. This medium is used to detect Carbapenem Resistant Enterobacteriaceae.  Commonly known as highly drug resistant “Super Bugs,” these organisms are an increasing concern in the medical field today. This culture media will assist in their detection and control. Other similar products would include HardyCHROM MRSA, and HardyCHROM ESBL.

  • 2019

    In May, Hardy renovated the design and packaging of their irradiated contact plates. These triple bagged pates are now capable of room temperature storage and are designed to control excess condensation. The plates feature the “twist lock” design that keeps the lids firmly attached to the base in order to reduce the chance of contamination after they are inoculated.

  • Preservation of Art Masterpieces from Microbial Dangers

    Art masterpieces should be protected from microbial damages by applying preventive action.

    Although human occupancy is known as the main source of airborne bacteria and molds in closed environments like hospitals and schools,  art masterpieces in museums are often not considered in this respect.

    Many fungi and bacteria are capable of producing serious damage in historic materials, decomposing them from the impact of specific enzymes, cellulases, proteases, ligninases, and organic acids.

    Pigmentation and physical damages in materials are other deleterious effects in addition to bio deterioration.

    Fungi are particularly dangerous because they show a substantial tolerance to environmental conditions. In addition, they can withstand lower relative humidity (RH) than bacteria for their development and produce spores that are that are easily dispersed by moving air.

    The closed space of a museum or art gallery should be regularly monitored and evaluated to mitigate air contamination that is affected by the number of visitors, residents, tourists, air conditioning, hygienic conditions and cleaning activities.

    Oil paintings and other art masterpieces can be damaged by bacteria and fungi brought in by humans or contaminated heating, ventilation, or air conditioning (HVAC systems).

    High microbial contamination can also be caused by of excessive air humidity conditions.

    An example of a preventive action is the monitoring of the Sistine Chapel in the Vatican, housed  in a heavily occupied environment (e.g. up to 700 visitors at the same time).

    The microbial content of air should be controlled at regular intervals to recognize changes in the environment when they happen. A viable impact air sampling instrument (such as the TRIO.BAS microbial air sampler) may be used to evaluate the risk assessment and to implement a protocol for the specific closed environment, thus alleviating the threat of damage to irreplaceable works of art, in order to preserve them for many future generations to enjoy.

    Contributed by Roberto Ligugnana of Orum International and Kirsten Spallino, the Pharmaceutical Market Coordinator for Hardy Diagnostics

  • 2019

    Hardy Diagnostics was awarded VWR Life Science Supplier of the Year award for 2018 (also the winner for 2016) for the second time since we began our partnership with VWR in 2013.  This is based on percent increase from previous year and voted on by the VWR sales reps.  Hardy Diagnostics also won the platinum supplier of the year award for the highest percentage increase in the VWR bioMarke program for 2018.

  • 2019

    In keeping with Hardy’s Green philosophy, Hardy completed its solar panel project for two of its buildings in Santa Maria, CA during the month of February. This large array consists of almost 700 panels and is the largest solar project in Santa Maria. It will provide the majority of the power needs for both of the buildings.

  • 2019

    In January, Hardy Diagnostics once again was awarded the Life Science “Supplier of the Year” award by VWR. This honor was due to Hardy’s record for prompt delivery, breadth of product line, and excellence in customer service.

  • Urogenital Mycoplasmas

    Seei