For the collection and transport of clinical specimens for the recovery of viral agents.
Coronavirus (COVID-19) Update
Hardy Diagnostics remains an essential business and shall remain open throughout the COVID-19 crisis to continue to support labs across the country.
Please note that all Hardy products are manufactured in California and Ohio, USA.
Resources:
Centers for Disease Control
The White House
United States Food and Drug Administration
COVID-19 Tracking
Featured Product:
Due to the COVID-19 crisis, current demand exceeds supply. When placing an order, please state your daily testing volume needs as we're allocating available supply to meet your daily requirements. We will not be accepting guest orders for this product at this time. Thank you for your cooperation and understanding.
Introducing a rapid one-step test for the qualitative detection and differentiation
of IgM and IgG antibodies to SARS-CoV-2 in human plasma or serum.
Anti-SARS-CoV-2 Rapid Test
This rapid lateral flow assay allows CLIA Licensed labs cleared for moderate and complex testing the ability to detect IgM and IgG antibodies against the SARS-CoV-2 virus in human plasma or serum quickly and efficiently.
• Rapid Results – 15 minutes for a readout
• No special equipment or facilities needed
• Clear, easy-to-interpret results
• Built-in controls
• Room temperature storage
| Antibody | Performance Measure | Estimate of Performance | 95% Confidence Interval |
|---|---|---|---|
| IgM | Sensitivity (PPA) | 95.7% (289/302) | (92.8%; 97.5%) |
| IgM | Specificity (NPA) | 99.7% (311/312) | (98.2%; 99.9%) |
| IgG | Sensitivity (PPA) | 99.0% (299/302) | (97.1%; 99.7%) |
| IgG | Specificity (NPA) | 99.4% (310/312) | (97.7%; 99.8%) |
| Combined | Sensitivity (PPA) | 99.0% (299/302) | (97.1%; 99.7%) |
| Combined | Specificity (NPA) | 99% (309/312) | (97.2%; 99.7%) |
| Combined | PPV at prevalence = 5% | 84.4% | (64.6%; 94.6%) |
| Combined | NPV at prevalence = 5% | 99.9% | (99.8%; 100%) |
Information taken from the FDA EUA Authorized Serology Test Performance page.
Emergency Use Authorization Approved 4/24/2020
Flocked Nasopharyngeal Swabs
Flexible, Mini-tip Size Flocked Swab with 80mm Breakpoint in Peel Pouch – Individually Packaged, Sterile, Nasopharyngeal (NP), PK100
Polyester Oropharyngeal Swab
Regular, Polyester Tip Swab, No Breakpoint, in Peel Pouch – Individually Packaged, Sterile, Oropharyngeal (OP), Pack of 100
UV Crosslinker AH, UV light decontamination of N95 masks
Features and Benefits:
Never run out of N95 masks again, by quickly sanitizing them yourself via UV light.
- Sanitizes four N95 masks at one time, in 4 minutes (120 seconds per side)
- Two modes of operation – Energy or Time
- Open Door Safety mechanism
- Energy Efficient electronic ballasts
- Small footprint
- 2 Year Manufacturer’s Warranty
- UL/CSA/CE Approved
- The unit comes equipped with 5 x 254 nm Shortwave Bulbs
The recommended dosage = 1J/cm2
The bulbs deliver 7-11mW/cm2; therefore, a cycle will complete in 90 – 120 seconds per side.
The unit will accommodate at least 4 masks.
Unit is capable of accommodating other wave length bulbs, 254 nm, 306 nm and 368 nm bulbs. No manual calibration required when switching between wavelengths. The Boekel UV Crosslinker AH comes calibrated for 254 nm Shortwave Bulbs as well as 306 nm and 368 nm bulbs.
This unit may be used for:
- Decontamination by UV light, great for extending the use of N95 Masks
- Crosslinking DNA or RNA to nylon, nitrocellulose or nylon-reinforced nitrocellulose membranes
- UV curing
Ultraviolet germicidal irradiation (UVGI)
UVGI is a promising method but the disinfection efficacy is dependent on dose. Not all UV lamps provide the same intensity thus treatment times would have to be adjusted accordingly.
Acceptable filtration performance was recorded for eleven FFR models exposed to various UV doses ranging from roughly 0.5–950 J/cm2 and UVGI was shown to have minimal effect on fit [2, 3, 7, 8, 9, 10]. Heimbuch et al. tested filtration and fit of 15 FFRs and found no adverse effects to FFR performance [11]. Lindsley et al. reported a reduction of the durability of materials of the FFRs for doses ranging from 120–950 J/cm2; however, an approximate inactivation of 99.9% of bacteriophage MS2, a non-enveloped virus, and H1N1 influenza A/PR/8/34 were achieved with much lower doses of approximately 1 J/cm2 [12–14]. Heimbuch et al. tested the performance of 1 J/cm2 of UVGI against Influenza A (H1N1), Avian influenza A virus (H5N1), Influenza A (H7N9) A/Anhui/1/2013, Influenza A (H7N9) A/Shanghai/1/2013, MERS-CoV, and SARS-CoV and reported virus inactivation from 99.9% to greater than 99.999% [11].
UVGI is harmful. Proper precautions are required to avoid UVGI exposure to skin or the eyes.
References:
https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/decontamination-reuse-respirators.html
SARS-CoV-2 Synthetic RNA (N Gene Targets), Helix Elite™ Synthetic Standard
Microbiologics’ SARS-CoV-2 Helix Elite control features a large RNA molecule that matches the sequence of the virus N gene (which codes for the nucleocapsid phosphoprotein found in the shell of the virus) and works with CDC-specified test components to generate positive PCR signals. The synthetic RNA control material is non-infectious and classified as BSL-1, remaining stable at room temperature to allow convenient shipping and storage. The Helix Elite SARS-CoV-2 IVD control is manufactured under ISO 13485 standards, and is designed for extended use and flexibility to match the hectic pace of high-volume testing. Microbiologics aims to continue developing resources for the global response to COVID-19, including IVD RNA controls with other gene sequences from the SARS-CoV-2 virus.
“With all the unknowns of this new coronavirus strain, third party IVD controls with the right genomic targets are more critical than ever,” said Marylou Gibson, Microbiologics’ Chief Virologist. “This new SARS-CoV-2 control comes with the proven quality of the Helix Elite product line to assure your test results. Cat. no. HE0060S
Synthetic RNA molecular standard intended for use as a positive control in molecular applications.
Kit includes:
- 1 vial of dried synthetic RNA (up to 100 reactions)
- 1 vial of molecular standard water for rehydration
- Certificate of Analysis.
Strain Characteristics:
The SARS-CoV-2 synthetic RNA material is a 1044-nucleotide portion of the SARS-CoV-2 N (nucleocapsid) gene. It contains three markers N1, N2 and N3 that are commonly used in diagnostic assays.
IVD
Related Products:
Disposable Face Masks for General Use
Face Shield, Full Face
Face shields are personal protective equipment (PPE) that are used for protection of the facial areas (eyes, nose, mouth) from sprays, aerosols, and splashes. Well suited for protection against COVID-19 and other pathogens. Ideal for healthcare and laboratory workers. Made from PETG. Provides clarity of view. Visors are anti fogging. Once size fits most. Includes a comfortable latex-free forehead cushion. Comes with a protective film on the shield that must be removed before use.
Adenna Precision® Nitrile Gloves
Precision® Violet Blue Nitrile Powder Free Exam Gloves are unique in a sense that they are ultra soft and super stretchy from a low modulus formulation to reduce hand fatigue for maximum comfort. They are 100% synthetic and latex free with a textured surface to provide strong grip in both dry and wet applications. Precision® Nitrile Gloves are thinner for maximum dexterity but very strong to provide superior barrier protection.
AloeSafe™ Antiseptic Hand Sanitizer
AloeSafe™ hand sanitizer leaves hands soft and silky, never sticky.
- Formulated with Aloe and Vitamin E to keep hands from drying.
- Lavender scented
- 62% ethanol
- No Glycerin
- No Parabens
- Kill 99.9% of bacteria
CDC recommends hand sanitizers to have a alcohol content of at least 60% to combat COVID-19 Corona Virus.
Volu-Sol Hand Sanitizer
Sanitizing Solution “Formula 1”, formulated to meet the WHO formulation guidelines, Hand Sanitizer (68% Ethanol) is dispensed, ensuring total saturation of the most critical parts of the hands, the nails and cuticles. The liquid formula will never clog a dispenser. 500mls (16.9 oz.) Made in the USA!
Directions: Apply to clean dry hands. Apply sufficient amount to wet all surfaces of the hands and fingers. Rub hands until dry. Supervise children in the use of this product.
- 68% Ethanol + Hydrogen Peroxide (WHO Formulation)
- Glycerol added to keep your hands from drying.
- CDC recommends hand sanitizers to have an alcohol content of at least 60% to combat COVID-19 Corona Virus.
CaviWipes™
Disinfectant Wipes
Presaturated with CaviCide®, CaviWipes™ are the only cloths proven to kill both TB (in 5 minutes) and HBV (in 3 minutes) with quick, easy-to-use, timesaving convenience. CaviWipes™ are durable, nonwoven, nonabrasive towels that won’t bunch up during use. They offer better surface contact than other wipes, requiring less force to apply solution to a surface. Better fluid capacity keeps the cloths fully saturated with CaviCide® rather than its pooling at the bottom of the canister. CaviWipes™ does the job of three products – cleaner, disinfectant and decontaminant – saving money by reducing repetitive inventory and time. They’re recommended for use on nonporous surfaces and fixtures and are perfect for operating rooms, surgical centers, neonatal units, medical and dental operatories and other critical-care areas.
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