The GenePOC™ Carba assay, performed on the revogene™ instrument, is a qualitative in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa, when grown on blood agar or MacConkey agar. The test utilizes automated real-time Polymerase Chain Reaction (PCR).The GenePOC Carba assay should be used in conjunction with other laboratory tests including phenotypic antimicrobial susceptibility testing. A negative GenePOC Carba assay result does not preclude the presence of other resistance mechanisms.The GenePOC Carba assay is intended as an aid for infection control in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The identification of a blaIMP, blaNDM or blaVIM metallo-B-lactamase gene (i.e., the genes that encode the IMP, NDM and VIM metallo-B-lactamases, respectively) may be used as an aid to clinicians in determining appropriate therapeutic strategies for patients with known or suspected carbapenem non-susceptible infections.
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple genes conferring resistance to multiple antimicrobial drugs in multiple types of bacteria present in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Genes detected may include, but are not limited to, carbapenemase genes (KPC, NDM, VIM, and OXA), extended spectrum beta-lactamase (ESBL)-encoding genes (e.g., TEM, SHV, IMP, NDM-1 and CTX-M) and/or vancomycin resistance genes (vanA and vanB).
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