Cepheid Xpert® Carba-R

The Cepheid Xpert Carba-R Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro diagnostic test designed for rapid detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP-1 gene sequences associated with carbapenem-non-susceptibility in gram-negative bacteria obtained from rectal swab specimens from patients at risk for intestinal colonization with carbapenem-non-susceptible bacteria. The test utilizes automated real-time polymerase chain reaction (PCR). The Xpert Carba-R Assay is intended to aid in the detection of carbapenem-non-susceptible bacteria that colonize patients in healthcare settings. The Xpert Carba-R Assay is not intended to guide or monitor treatment for carbapenemnon- susceptible bacterial infections. Concomitant cultures are necessary to recover organisms for epidemiological typing, antimicrobial susceptibility testing, and for further confirmatory identification of carbapenem-non-susceptible bacteria.