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

被引:18
作者
Bogaerts, Pierre [1 ]
Oueslati, Saoussen [2 ,3 ,4 ]
Meunier, Daniele [5 ]
Nonhoff, Claire [6 ]
Yunus, Sami [7 ]
Massart, Marion [1 ]
Denis, Olivier [6 ]
Woodford, Neil [5 ]
Hopkins, Katie L. [5 ]
Naas, Thierry [2 ,3 ,4 ]
Dortet, Laurent [2 ,3 ,4 ]
Huang, Te-Din [1 ]
Glupczynski, Youri [1 ]
机构
[1] CHU UCL Namur, Lab Clin Microbiol, Natl Reference Ctr Monitoring Antimicrobial Resis, Yvoir, Belgium
[2] Bicetre Hosp, AP HP, Bacteriol Hyg unit, Le Kremlin Bicetre, France
[3] Univ Paris Sud, Univ Paris Saclay, Fac Med, LabEx Lermit,Struct Dynam Funct & Express Broad S, Le Kremlin Bicetre, France
[4] Associated French Natl Reference Ctr Antibiot Res, Le Kremlin Bicetre, France
[5] Publ Hlth England, Natl Infect Serv, Antimicrobial Resistance & Healthcare Associated, London NW9 5EQ, England
[6] Univ Libre Bruxelles, Hop Erasme, Associated Natl Reference Ctr, Dept Microbiol, Route Lennik 808, B-1070 Brussels, Belgium
[7] Catholic Univ Louvain, Inst Condensed Matter & Nanosci, Bio & Soft Matter, Louvain La Neuve, Belgium
关键词
NP TEST; PSEUDOMONAS-AERUGINOSA; BETA-LACTAMASE; PCR; SPREAD; KPC;
D O I
10.1038/s41598-017-09820-y
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
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: 98.6100) 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.
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页数:8
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