NG-Test CARBA 5
Specimen: Culture | Format: cassette | Packaging: 20 tests | Storage: 4-30°C | Shelf-life: 24 months | Cat. Ref: NGB-CAR-S23-002
The detection limits were determined using purified recombinant enzymes:
NG-Test CARBA 5 was evaluated at the NRC (AMR French National Reference Centre) of CHU Kremlin Bicêtre Paris-France during a prospecyive study.
116 strains were blind-tested and the results were compared to the PCR sequencing test. One IMI-producing isolate was excluded from the result analysis because this type is not in the device intended use.
Sensitivity : 100% CI 95% = 93,5% - 100%
Specificity : 100% CI 95% = 90,4% - 100%
A retrospective evaluation performed at the NRC on 180 isolates characterised by PCR permitted to identify variants detected by NG-Test CARBA 5:
Type NDM : NDM-1 -4 -5 -6 -7 -9
Type KPC : KPC-2 -3
Type IMP : IMP-1 -8 -11
Type VIM : VIM-1 -2 -4 -19
OXA-48-like : OXA-48 -162 -181 -204 -232 -244 -517 -519 -535
Non-Carbapenemases (cross-reactivity) : OXA-163 and OXA-405 (OXA-48-like extended spectrum oxacillinases with very weak Carbapenemase activity).