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Sci Rep. 2017 Aug 30;7(1):9937. doi: 10.1038/s41598-017-09820-y.

Multicentre evaluation of the BYG Carba v2.0 test, a simplified electrochemical assay for the rapid laboratory detection of carbapenemase-producing Enterobacteriaceae.

Author information

1
Laboratory of clinical microbiology, National reference center for monitoring antimicrobial resistance in Gram-negative bacteria, CHU UCL Namur, Yvoir, Belgium. pierre.bogaerts@uclouvain.be.
2
Bacteriology-Hygiene unit, Assistance Publique/Hôpitaux de Paris, Bicêtre Hospital, Le Kremlin-Bicêtre, France.
3
EA7361 "Structure, dynamic, function and expression of broad spectrum β-lactamases", Université Paris Sud, Université Paris Saclay, LabEx Lermit, Faculty of Medicine, Le Kremlin-Bicêtre, France.
4
Associated French National Reference Center for Antibiotic Resistance: Carbapenemase-producing Enterobacteriaceae, Le Kremlin-Bicêtre, France.
5
Antimicrobial Resistance and Healthcare Associated Infections (AMRHAI) Reference Unit, National Infection Service, Public Health England, London, NW9 5EQ, UK.
6
Department of Microbiology, Associated national reference center, Hôpital Erasme, Université Libre de Bruxelles, Route de Lennik 808, 1070, Brussels, Belgium.
7
Bio and Soft Matter, Institute of Condensed Matter and Nanosciences, Université catholique de Louvain, Louvain-La-Neuve, Belgium.
8
Laboratory of clinical microbiology, National reference center for monitoring antimicrobial resistance in Gram-negative bacteria, CHU UCL Namur, Yvoir, Belgium.

Abstract

Rapid detection of carbapenemase-producing Enterobacteriaceae (CPE) represents a major challenge for microbiology laboratories. We evaluated the BYG Carba v2.0 using a simplified protocol, which detects CPE in less than 30 minutes. This new procedure reduces the hands-on-time from 5 to one minute and only requires a limited amount of material (one to three colonies) thereby preventing the need for subculturing bacterial isolates to reach a larger amount of pure biomass. This multicentre study involved four European reference laboratories. For the 1181 isolates tested across four centres, BYG Carba v2.0 yielded overall sensitivity and specificity of 96.3% (CI95: 94.5-97.5) and 99.7% (CI95: 98.6-100) respectively. Considering only the 670 consecutive isolates tested prospectively, the BYG Carba v2.0 displayed overall positive and negative predictive values of 99.7% (CI95: 95.4-98.9) and 97.5% (CI95: 94.9-98.8). Regarding time to positivity, 85% of CPE detected were positive within ten minutes. The BYG Carba v2.0 is a new highly simplified, rapid and accurate electrochemical assay discriminating between CPE and non-CPE in less than 30 min. The real-time quantified signal allows objective and traceable interpretation of the results.

PMID:
28855689
PMCID:
PMC5577128
DOI:
10.1038/s41598-017-09820-y
[Indexed for MEDLINE]
Free PMC Article

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