Girlich Delphine, Laguide Marine, Dortet Laurent, Naas Thierry
EA7361 "Structure, dynamic, function and expression of broad spectrum β-lactamases," Université Paris-Saclay, LabEx Lermit, Faculty of Medicine, Le Kremlin-Bicêtre, France.
Evolution and Ecology of Resistance to Antibiotics Unit, Institut Pasteur-APHP, Paris, France.
J Clin Microbiol. 2020 Mar 25;58(4). doi: 10.1128/JCM.01927-19.
The Revogene Carba C assay (formerly GenePOC Carba assay) is a multiplex nucleic acid-based diagnostic test intended for the detection of carbapenemase-producing (CPE) from cultured colonies. This assay was evaluated directly on colonies of 118 well-characterized with reduced susceptibility to carbapenems and on 49 multidrug-resistant (MDR) and 40 MDR isolates. The Revogene Carba C assay's performance was high, as it was able to detect the five major carbapenemases (NDM, VIM, IMP, KPC, and OXA-48). In , sensitivity and specificity were 100%. When extrapolating the results to the French CPE epidemiology between 2012 and 2018, this assay would have detected 99.28% of the 9,624 CPE isolates sent to the French NRC, missing 69 CPE isolates (2 GES-5, 10 OXA-23, 2 TMB-1, 1 SME-4, 53 IMI, and 1 FRI). The overall sensitivity and specificity for CP were 93.7 and 100%, respectively, as two rare IMP variants (IMP-31 and -46) were not detected. Extrapolating these results to the French epidemiology of CP in 2017, 93.3% would have been identified, missing only 1 DIM and 10 GES variants. The Revogene Carba C assay accurately identified the targeted carbapenemase genes in , but when extrapolating these results to the French CP epidemiology of 2017, only 12.50% of them could be detected, as OXA-23 is the most prevalent carbapenemase in CP The Revogene Carba C assay showed excellent sensitivity and specificity for the five most common carbapenemases regardless of the bacterial host. It is well adapted to the CPE and CP epidemiology of many countries worldwide, which makes it suitable for use in the routine microbiology laboratory, with a time to result of ca. 85 min for eight isolates simultaneously.
Revogene Carba C检测（原GenePOC Carba检测）是一种基于多重核酸的诊断测试，旨在从培养菌落中检测产碳青霉烯酶的细菌（CPE）。该检测直接在118株对碳青霉烯类药物敏感性降低且特征明确的菌落以及49株多重耐药（MDR）和40株MDR分离株上进行了评估。Revogene Carba C检测的性能很高，因为它能够检测出五种主要的碳青霉烯酶（NDM、VIM、IMP、KPC和OXA - 48）。在……中，敏感性和特异性均为100%。将结果外推至2012年至2018年法国CPE流行病学情况时，该检测本可检测出送往法国国家参考中心的9624株CPE分离株中的99.28%，漏检69株CPE分离株（2株GES - 5、10株OXA - 23、2株TMB - 1、1株SME - 4、53株IMI和1株FRI）。对于CP，总体敏感性和特异性分别为93.7%和100%，因为两种罕见的IMP变体（IMP - 31和 - 46）未被检测到。将这些结果外推至2017年法国CP流行病学情况时，93.3%的病例本可被识别，仅漏检1株DIM和10株GES变体。Revogene Carba C检测在……中准确鉴定出了目标碳青霉烯酶基因，但将这些结果外推至2017年法国CP流行病学情况时，由于OXA - 23是CP中最常见的碳青霉烯酶，所以只能检测出其中的12.50%。Revogene Carba C检测对五种最常见的碳青霉烯酶显示出优异的敏感性和特异性，无论细菌宿主如何。它非常适合全球许多国家的CPE和CP流行病学情况，这使其适用于常规微生物实验室，同时检测8株分离株时的出结果时间约为85分钟。
