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Rapid Tests
Genesis Distributed by Goffin Diagnostics

Carbapenemase Rapid Test – EZER™ 5-Target Detection

The EZER Carbapenemase Rapid Test detects and differentiates five carbapenemases in a pure bacterial colony within 15 minutes: NDM, KPC, OXA-48-like, IMP and VIM. It is a lateral flow immunoassay with colloidal gold, read by eye. Each pouch contains two strips: one for NDM, KPC and OXA-48-like, one for IMP and VIM, each with its own control line. The test is used on carbapenem non-susceptible colonies of Enterobacterales and Pseudomonas aeruginosa.

LFA CE-IVD Genesis 1 Package (20 Tests)
Technique
LFA
Brand
Genesis
Packaging
1 Package (20 Tests)
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Product details

This kit in detail

  • Five carbapenemases differentiated: NDM, KPC, OXA-48-like, IMP and VIM
  • Result in 15 minutes, read by eye, no instrument needed
  • Two strips per test, each with a control line
  • Limit of detection 0.05 to 0.5 ng/ml depending on the enzyme
  • Pure colonies from blood agar or MacConkey agar after 18 to 24 hours
  • 20 tests per kit, REF P261102

The EZER Carbapenemase Rapid Test identifies which carbapenemase a carbapenem non-susceptible isolate produces, directly from the colony and without an instrument. That answer determines the treatment options and the infection control response, and a lateral flow test delivers it in 15 minutes rather than in a day.

Targets and layout

Five enzymes are detected and distinguished: NDM, KPC, OXA-48-like, IMP and VIM. Each pouch holds two strips. Strip 1 has test regions for NDM (N), KPC (K) and OXA-48-like (O) plus a control line; strip 2 has IMP (I) and VIM (V) plus a control line. A positive result appears as a red line in the corresponding region. The control line confirms that the reagents worked and that the procedure was followed.

Performance

On 265 organism isolates the manufacturer reports 100 per cent relative sensitivity, 100 per cent relative specificity and 100 per cent accuracy. The limit of detection is 0.05 ng/ml for VIM, 0.1 ng/ml for NDM, 0.125 ng/ml for OXA-48-like and IMP, and 0.5 ng/ml for KPC. No cross-reactivity was seen with more than fifty other resistance mechanisms tested, including TEM-1 and the SHV and CTX-M variants.

Procedure and limitations

Touch three colonies grown for 18 to 24 hours on blood or MacConkey agar with a 1 µl loop, suspend them in the buffer of the extraction tube, vortex, and add three drops (80 µl) to the sample wells. A positive line can appear after 3 minutes, but the full 15 minutes is required before a negative result may be reported; results after 30 minutes are not valid. The test is qualitative and applies to pure colonies. A negative result does not exclude other carbapenemases, and the manufacturer states that the test should be used alongside other laboratory tests, including phenotypic susceptibility testing. Storage is at 2 to 30 °C and the kit must not be frozen.

Documentation

Datasheets and regulatory documentation

Everything your quality team needs for evaluation and procurement.

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