title: Evaluation of the BYG Carba Test, a New Electrochemical Assay for Rapid Laboratory Detection of Carbapenemase-Producing Enterobacteriaceae.
abstract: Accurate detection of carbapenemase-producing Enterobacteriaceae (CPE) constitutes a major laboratory diagnostic challenge. We evaluated an electrochemical technique (the BYG Carba test) which allows detection of CPE in less than 35 min. The BYG Carba test was first validated in triplicate against 57 collection isolates with previously characterized β-lactam resistance mechanisms (OXA-48, n = 12; KPC, n = 8; NDM, n = 8; VIM, n = 8; IMP, n = 3; GIM, n = 1; GES-6, n = 1; no carbapenemase, n = 16) and against a panel of 10 isolates obtained from the United Kingdom National External Quality Assessment Service (NEQAS). The test was then evaluated prospectively against 324 isolates referred to the national reference center for suspicion of CPE. The BYG Carba test results were compared with those obtained with the Carba NP test using multiplex PCR sequencing as the gold standard. Of the 57 collection and the 10 NEQAS isolates, all but one GES-6-producing isolate were correctly identified by the Carba BYG test. Among the 324 consecutive Enterobacteriaceae isolates tested prospectively, 146 were confirmed as noncarbapenemase producers by PCR while 178 harbored a carbapenemase gene (OXA-48, n = 117; KPC, n = 25; NDM, n = 23; and VIM, n = 13). Prospectively, in comparison with PCR results, the BYG Carba test displayed 95% sensitivity and 100% specificity versus 89% and 100%, respectively, for the Carba NP test. The BYG Carba test is a novel, rapid, and efficient assay based on an electro-active polymer biosensing technology discriminating between CPE and non-CPE. The precise electrochemical signal (electrochemical impedance variations) allows the establishment of real-time objective measurement and interpretation criteria which should facilitate the accreditation process of this technology.
authors.affiliation: Laboratory of Clinical Microbiology, Belgian National Reference Center for Monitoring Antimicrobial Resistance in Gram-Negative Bacteria, CHU Dinant Godinne UCL Namur, Yvoir, Belgium pierre.bogaerts@uclouvain.be.
authors.forename: Pierre
authors.initials: P
authors.lastname: Bogaerts
authors.affiliation: Bio and Soft Matter, Institute of Condensed Matter and Nanosciences, Université Catholique de Louvain, Louvain-La-Neuve, Belgium.
authors.forename: Sami
authors.initials: S
authors.lastname: Yunus
authors.affiliation: Laboratory of Clinical Microbiology, Belgian National Reference Center for Monitoring Antimicrobial Resistance in Gram-Negative Bacteria, CHU Dinant Godinne UCL Namur, Yvoir, Belgium.
authors.forename: Marion
authors.initials: M
authors.lastname: Massart
authors.affiliation: Laboratory of Clinical Microbiology, Belgian National Reference Center for Monitoring Antimicrobial Resistance in Gram-Negative Bacteria, CHU Dinant Godinne UCL Namur, Yvoir, Belgium.
authors.forename: Te-Din
authors.initials: TD
authors.lastname: Huang
authors.affiliation: Laboratory of Clinical Microbiology, Belgian National Reference Center for Monitoring Antimicrobial Resistance in Gram-Negative Bacteria, CHU Dinant Godinne UCL Namur, Yvoir, Belgium Institut de Recherche Expérimentale et Clinique, Pôle de Microbiologie, Université Catholique de Louvain, Brussels, Belgium.
authors.forename: Youri
authors.initials: Y
authors.lastname: Glupczynski
mesh_terms: D001426:Bacterial Proteins / Q000096:biosynthesis / Q000235:genetics*; D015373:Bacterial Typing Techniques / Q000295:instrumentation / Q000379:methods; D055664:Electrochemical Techniques / Q000295:instrumentation / Q000379:methods; D004755:Enterobacteriaceae / Q000145:classification* / Q000187:drug effects / Q000235:genetics* / Q000302:isolation & purification; D004756:Enterobacteriaceae Infections / Q000175:diagnosis* / Q000382:microbiology*; D006801:Humans; D008826:Microbial Sensitivity Tests; D011786:Quality Control; D015203:Reproducibility of Results; D001618:beta-Lactamases / Q000096:biosynthesis / Q000235:genetics*
chemical_list: D001426:Bacterial Proteins; D001618:beta-Lactamases; C063912:carbapenemase