FDA-Cleared Test Detects Carbapenem Resistance Genes

By LabMedica International staff writers
Posted on 21 Mar 2016

A qualitative in vitro diagnostic test for fast, accurate, and reproducible identification of five distinct families of carbapenem resistance genes that together represent the most common carbapenemases has been approved for marketing.

The test is for the detection and differentiation of carbapenemase genes in pure bacterial isolates, previously shown to be non-susceptible to carbapenem antibiotics, which may be cultured from a wide range of clinical specimens, including blood cultures, urine, respiratory samples, abscesses and swab surveillance specimens.

Image: Xpert Carba-R, an on-demand molecular test for rapid and accurate detection of carbapenemase-producing Gram-negative bacteria. The test runs on the GeneXpertSystem (Photo courtesy of Cepheid).

The test, known as Xpert Carba-R (Cepheid; Sunnyvale, CA; USA) has received clearance from the US Food and Drug Administration (FDA; Silver Springs, MD, USA) for marketing. The five distinct families of carbapenem resistance genes identified include Klebsiella pneumoniae carbapenemase (KPC), New Delhi metallo-beta-lactamase (NDM), Vimentin (VIM), OXA-48 Carbapenemase (OXA-48) and, the metallo-beta-lactamase “active on imipenem” gene (IMP-1). Xpert Carba-R will begin shipping in the USA later this month, and is the 20th US-IVD test available to run on Cepheid's GeneXpertSystem, the world's leading molecular diagnostic platform with more than 10,000 systems installed globally. Xpert Carba-R is the latest diagnostic solution from Cepheid to help infection control professionals fight antimicrobial resistance, building on their portfolio.

Paul Schreckenberger, PhD, Director of Microbiology at Loyola University Medical Center (Maywood, IL, USA), said, “The availability of a rapid and accurate molecular test for the most prevalent mechanisms of carbapenem resistance represents an important addition to the limited tools the laboratory has available to fight the emergence of multidrug resistant organisms, like carbapenemase producing organisms (CPOs). Knowing which carbapenemase gene is present in a resistant isolate helps the hospital identify and manage outbreaks and can also be valuable for monitoring the spread of multi-resistant bacteria among hospital populations considered most at risk. Xpert Carba-R delivers a result in under an hour, allowing timely detection and differentiation of the most prevalent carbapenemase genes associated with CPO outbreaks to support infection control efforts.”

Related Links:
Cepheid
US Food and Drug Administration
Loyola University Medical Center