Vol. 1, Issue 7 ‣ October 2024
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Carbapenem-Resistant Enterobacterales and the key to rapid phenotypic detection
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Carbapenem-resistant Enterobacterales (CRE) is a term used to describe a group of bacteria within the Enterobacterales order that have developed resistance to carbapenem antibiotics. Carbapenems are a class of broad-spectrum antibiotics used as a last-resort treatment for serious infections caused by multi-drug-resistant bacteria.
Enterobacterales include a variety of pathogens such as Escherichia coli, Klebsiella pneumoniae, Enterobacter spp., and Serratia spp. When these bacteria become resistant to carbapenems, it makes infections caused by them significantly more difficult to treat.
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Resistance to carbapenems typically occurs due to the production of enzymes called carbapenemases, which break down the antibiotics and render them ineffective. Invasive CRE infections can lead to severe health complications, including bloodstream infections, pneumonia, and wound infections. They are often associated with healthcare settings and can be particularly problematic for patients with weakened immune systems or those undergoing invasive procedures.
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Invasive CRE infections have an estimated mortality rate of up to 50%, making rapid identification and targeted treatment critical.
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Preventing and controlling CRE involves stringent infection control practices, judicious use of antibiotics, and regular monitoring in healthcare settings to prevent the spread of these resistant bacteria.
In 2017, CRE caused about 13,100 infections in hospital patients and about 1,100 deaths in the United States.¹
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CRE infections have an estimated mortality rate of up to 50%, therefore it is imperative to know if and what type of carbapenemase is being produced by a pathogen, quickly and accurately.
Only NG-Test® CARBA 5 can provide these critical answers.
Hardy Diagnostics is the exclusive distributor in the USA of the NG-Test® CARBA 5, the only FDA-cleared, rapid in vitro multiplex immunochromatographic assay for the phenotypic detection of the five most common carbapenemases: KPC, NDM, VIM, OXA-48-like, and IMP.
This device delivers phenotypic test results in 15 minutes using colonies from HardyCHROM™ CRE agar, blood agar, or MacConkey agar. With about one minute of hands-on time and results in 15 minutes per test, CARBA 5 naturally integrates into any laboratory workflow.
Unlike molecular methods, CARBA 5 detects the presence of the big five carbapenemase enzymes, which is crucial for aiding therapeutic decisions. Furthermore, CARBA 5 has been shown to detect several carbapenemase variants that predicate PCR methods may miss.
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NG-Test® CARBA 5 offers a faster, cost-effective alternative to molecular methods by detecting and differentiating multiple carbapenemases in a single assay, recommended by IDSA guidelines. Click to learn more.
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Sources:
1 CDC. Antibiotic Resistance Threats in the United States, 2019. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2019.
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Product Spotlight:
CARBA 5
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- NG-Test® CARBA 5 is the only rapid, multiplex, phenotypic test capable of simultaneously detecting KPC, OXA-48-like, VIM, IMP, and NDM carbapenemases produced by Enterobacterales and P. aeruginosa.
- Cost effective - Per test, NG-Test® CARBA 5 is more economical than molecular methods. Reimbursement for up to five CPT codes.
- Accurate - NG-Test® CARBA 5, unlike molecular methods, detects the carbapenemase enzyme which is crucial to aiding therapeutic decisions.
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Example of interpretation
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Per test, CARBA 5 is more economical than molecular methods and the test can be reimbursed for up to five CPT codes.
Buy Now or Request a Quote to secure your supply and experience the power of rapid, accurate detection.
As a token of our commitment to your success, claim your FREE Sample to witness firsthand the effectiveness of NG-Test® CARBA 5.
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Using CARBA 5 requires colony isolation on a plated media, either MacConkey agar, blood agar, or HardyCHROM™ CRE agar.
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For the detection of E. coli and KES (K. aerogenes, K. oxytoca, K. pneumoniae, E. cloacae complex, S. marcescens) that are not susceptible to carbapenems directly from stool specimens.
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To fulfill our commitment to make it easy for our laboratory partners to screen for dangerous antimicrobial-resistant pathogens, Hardy Diagnostics has developed additional novel chromogenic media, such as HardyCHROM™ MRSA, HardyCHROM™ ESBL, and HardyCHROM™ Candida + auris
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For the detection of methicillin-resistant Staphylococcus aureus directly from anterior nares swabs. After 24 hours of incubation, MRSA produce pink to magenta colonies. Compatible with automated microbiology systems.
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For the detection of Enterobacterales that are potentially non-susceptible to ceftazidime and cefpodoxime and ESBL-producing E. coli, K. pneumoniae, and K. oxytoca directly from stool specimens.
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HardyCHROM™
Candida + auris
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For the detection and differentiation of C. auris, C. albicans, C. tropicalis, C. krusei, and C. glabrata. All species develop a unique colony color and morphology, and C. auris fluoresces under UV light for rapid differentiation.
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Quick Facts: Lateral Flow Assays (LFAs)
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The Evolution of
Lateral Flow Assays
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LFAs have transformed diagnostics with their portability and speed, but recent advances have enhanced their precision and range. From simple pregnancy tests to detecting multiple carbapenemase enzymes in resistant bacteria, LFAs are evolving into complex tools.
With advancements in nanoparticle labeling and detection chemistry, modern LFAs can detect specific enzymes like those targeted by the CARBA 5, providing phenotypic results that guide critical treatment decisions in minutes.
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Sensitivity and Specificity: A Closer Look
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Historically, LFAs were considered less sensitive than molecular tests. However, assays like NG-Test® CARBA 5 now rival PCR methods in both sensitivity and specificity, with CARBA 5 demonstrating 98.4% sensitivity and 99.6% specificity.
These figures show how LFAs can compete with, and sometimes outperform, molecular methods, especially when paired with well-optimized reagents and detection markers. Understanding this shift is critical for microbiologists who rely on accurate phenotypic results to guide antimicrobial therapy.
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Beyond Single-Target Detection
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Modern LFAs, such as the CARBA 5, can detect multiple targets in a single assay. This multiplexing capability allows for rapid identification of various carbapenemases, such as KPC, NDM, and OXA-48-like enzymes, which may otherwise require multiple PCR runs or molecular assays.
LFAs also offer real-time results that confirm active enzyme production, providing crucial insight for clinicians to select the appropriate antimicrobial therapy without waiting for gene expression confirmation.
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Why LFAs Matter in
Today’s Labs
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With the growing global threat of AMR, LFAs play an increasingly vital role in surveillance and monitoring. They offer a cost-effective, rapid, and scalable solution for detecting resistant organisms, making them ideal for use in resource-limited settings or for large-scale AMR surveillance efforts.
Tests like CARBA 5 that provide phenotypic results—indicating not just gene presence but actual enzyme presence—are instrumental in timely decision-making and containment of resistant infections in healthcare settings.
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Video/Catalog Spotlight:
NG-Test® CARBA 5
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See our collection of CARBA 5 Videos and Catalogs
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NG-Test® CARBA 5 Training Guide •
Carbapenem-resistant Enterobacterales
Carbapenem-resistant Enterobacterales, or CRE, are a group of gram-negative bacteria that are resistant to “last line” antibiotics and are very challenging to treat. These microorganisms may confer their resistance via the production of a carbapenemase, an enzyme that inactivates carbapenem antibiotics. NG-Test® CARBA 5 detects the carbapenemase enzyme which is crucial to aiding therapeutic decisions.
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Megan is an award-winning journalist, marketer, and current Clinical Microbiology Laboratory Marketing Product Manager at Hardy Diagnostics, brings over 20 years of experience in brand management, healthcare marketing, and communications to her role.
If you have any suggestions for content, a comment, or a question, please contact Megan here.
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"A Culture of Service"
Hardy Diagnostics, 1430 West McCoy Lane, Santa Maria, CA, 93455, USA, +1.800.266.2222
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