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The EZER™ CTX-M β-lactamases Rapid Test is an immunochromatographic assay designed for qualitative detection of CTX-M β-lactamases in bacterial colonies. It identifies five CTX-M groups (1, 2, 8, 9, and 25) that represent the majority of extended-spectrum β-lactamases (ESBLs) currently found in clinical Enterobacterales.
CTX-M enzymes have emerged globally as the dominant resistance mechanism against third-generation cephalosporins, especially in E. coli and Klebsiella pneumoniae. Rapid and accurate identification of CTX-M-positive strains helps guide appropriate antimicrobial therapy and containment strategies in healthcare environments.
The EZER™ test uses monoclonal antibodies against CTX-M enzymes and delivers results in just 15 minutes, with 100% sensitivity, specificity, and accuracy confirmed through comparison with reference methods. The test requires no instrumentation, making it ideal for use in clinical microbiology laboratories, infection control units, and field epidemiology settings.
Each kit includes 20 individually sealed cassettes and extraction tubes prefilled with buffer—ready to use straight from the box.
The EZER™ CTX-M Rapid Test kit contains:
20 lateral flow cassettes
20 extraction tubes with buffer
1 instruction leaflet
The test cassette includes two lines:
T line (Test) – Indicates CTX-M enzyme presence
C line (Control) – Confirms test validity
Only 3 drops of prepared extract are needed per test. The result appears within 15 minutes. A red or purple line at the T position (even faint) indicates a CTX-M-positive result.
CTX-M enzymes are part of the extended-spectrum β-lactamases (ESBLs), which hydrolyze third-generation cephalosporins such as cefotaxime and ceftriaxone. These enzymes have become globally dominant due to horizontal gene transfer and clonal expansion.
CTX-M enzymes are particularly prevalent in:
E. coli (especially ST131)
Klebsiella pneumoniae
Other Enterobacterales
Among over 170 known CTX-M variants, CTX-M-15 and CTX-M-14 are the most clinically relevant. Rapid detection allows for timely infection control and prevention of nosocomial transmission, while avoiding unnecessary carbapenem use.
Manufactured by Genesis Biotech, the EZER™ test uses a colloidal gold-based lateral flow system with high-affinity monoclonal antibodies specific to CTX-M β-lactamases.
Sensitivity: 100%
Specificity: 100%
Accuracy: 100%
Detection limit: 250 pg/mL (recombinant enzymes)
No false positives were observed with over 50 resistance mechanisms, including:
KPC, NDM, OXA variants
SHV, TEM, AmpC
MCR, aac, aad, sul, qnr, tet, van, mecA genes
Validated with 178 bacterial isolates and benchmarked against NG-Test® CTX-M Multi, it demonstrated complete concordance.
The test operates on a simple lateral flow format:
Pick 3 bacterial colonies (from blood or MacConkey agar)
Suspend in extraction buffer
Vortex to homogenize
Add 3 drops (80 μL) of the extract to the cassette
Wait exactly 15 minutes
Interpret the result:
Positive: Red/purple bands at T and C
Negative: Band at C only
Invalid: No C band – repeat test
The assay is designed for professional in vitro use with Enterobacterales only.
The EZER™ CTX-M β-lactamases Rapid Test is intended for:
Clinical microbiology labs performing ESBL screening
Hospital infection control departments
Public health surveillance and epidemiology labs
Outbreak investigations involving multidrug-resistant organisms (MDROs)
Its portability and speed make it especially useful in resource-limited settings where molecular diagnostics may not be available. By identifying CTX-M-positive isolates early, clinicians can avoid broad-spectrum misuse and enforce appropriate isolation measures.
The test supports stewardship by distinguishing CTX-M-targeted resistance from other β-lactam mechanisms, reducing reliance on carbapenems and preserving last-resort therapies.
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