Carbapenemase Rapid Test – EZER™ 5-Target Detection

What is in the Carbapenemase Rapid Test?

Each EZER™ Carbapenemase Rapid Test kit includes:

• 20 individual test devices (2-strip format)

• 20 extraction tubes pre-filled with buffer

• 1 package insert with detailed instructions

The two-strip configuration allows for clear differentiation:

• Strip 1: Detects NDM (N), KPC (K), OXA-48-like (O), with a control line (C)

• Strip 2: Detects IMP (I) and VIM (V), with a separate control line (C)

The red lines that appear correspond to the presence of one or more carbapenemase-positive enzymes. A control line ensures the validity of each test.

Role of Carbapenemases in Antimicrobial Resistance

Carbapenemases are β-lactamase enzymes that hydrolyze carbapenem antibiotics—often considered the last resort for treating Gram-negative infections. The most prevalent types include:

• KPC (Class A)

• NDM, VIM, IMP (Class B metallo-β-lactamases)

• OXA-48-like (Class D)

These enzymes contribute to resistance in:

• Enterobacterales, such as Klebsiella pneumoniae, E. coli

• Non-fermenters, like Pseudomonas aeruginosa

Infections caused by carbapenemase-producing organisms (CPOs) are associated with high morbidity, mortality, and healthcare costs. Rapid detection is essential for implementing isolation measures, optimizing therapy, and preventing nosocomial outbreaks.

About the EZER™ Carbapenemase Rapid Test

Developed by Genesis Biotech, the EZER™ test uses gold-conjugated monoclonal antibodies specific to each carbapenemase type. Validated against Xpert® Carba-R (Cepheid) and phenotypic AST methods, its performance is unmatched:

• Sensitivity: 100%

• Specificity: 100%

• Accuracy: 100% (n=265)

Detection Limits:

• NDM: 0.1 ng/mL

• KPC: 0.5 ng/mL

• OXA-48-like: 0.125 ng/mL

• IMP: 0.125 ng/mL

• VIM: 0.05 ng/mL

No Cross-Reactivity:

The test shows no cross-reactivity with 40+ non-target resistance mechanisms, including ESBLs, AmpC, and MBL variants not among the 5 detected. This makes it ideal for carbapenemase-positive identification with high confidence.

Principle and Workflow

This is a visual immunochromatographic assay using a double-strip cassette:

Sample Preparation:

1. Pick 3 colonies from 18–24h blood/MacConkey agar using a 1µL loop

2. Suspend in the provided extraction buffer

3. Vortex to homogenize

Testing:

1. Apply 3 drops (80 µL) of extract to each sample well

2. Wait 15 minutes

3. Read red lines at designated positions (N, K, O, I, V, C)

Result Interpretation:

• Positive: Line at C + at one or more of the enzyme lines

• Negative: Line at C only, no enzyme line

• Invalid: No control line visible – retest required

This Carbapenemase-targeted test is easy to read and does not require additional instrumentation.

Clinical Application

The EZER™ Carbapenemase Rapid Test is ideal for:

• Clinical microbiology labs performing MDR surveillance

• Infection control units in hospitals

• Reference and public health labs monitoring CRE spread

• ICU and emergency settings needing rapid isolation decisions

By offering rapid, cost-effective, and accurate carbapenemase-positive screening, it plays a crucial role in antimicrobial resistance containment strategies.

It supports:

• Early outbreak containment

• Antimicrobial therapy optimization

• Laboratory-based stewardship protocols