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利用新型 GenePOC Carba/Revogene Carba C 检测试剂盒在常规实验室快速简便地检测 中的碳青霉烯酶。

Rapid and Easy Detection of Carbapenemases in in the Routine Laboratory Using the New GenePOC Carba/Revogene Carba C Assay.

机构信息

Institute for Medical Microbiology, Immunology and Hygiene, University Hospital of Cologne, Cologne, Germany.

Department of Medical Microbiology, Ruhr University Bochum, Bochum, Germany.

出版信息

J Clin Microbiol. 2019 Aug 26;57(9). doi: 10.1128/JCM.00597-19. Print 2019 Sep.

Abstract

The novel, real-time PCR-based GenePOC Carba assay on the microfluidic revogene platform (GenePOC, Québec, Canada; now Meridian Bioscience, Cincinnati, OH, USA) was recently designed for the detection of , , , , and The goals of this study were to evaluate the performance of this assay, to assess its suitability for the routine microbiology laboratory, and to compare it to the Xpert Carba-R assay for the detection of carbapenemase-producing (CPE) strains. The Xpert Carba-R assay (Cepheid) and the GenePOC Carba assay were challenged with a collection of 176 clinical isolates. The collection included 133 CPE strains producing a total of 139 carbapenemases, including VIM ( = 48), OXA-48-like ( = 40), NDM ( = 29), KPC ( = 13), and IMP ( = 9). Six isolates produced two different carbapenemases, and 43 carbapenemase-negative isolates were included as negative controls. The overall sensitivity for carbapenemase detection was 96.4% (95% confidence interval [CI], 91.9% to 98.5%) for the Xpert Carba-R assay and 100% (95% CI, 97.3% to 100%) for the GenePOC assay. The four most common carbapenemases (NDM, KPC, OXA-48-like, and VIM) were detected with a sensitivity of 100% (95% CI, 97.1% to 100%) by the two tests, with all double carbapenemase producers being correctly detected by both assays. The sensitivity of the Xpert Carba-R assay for IMP was 44.4% (95% CI, 18.9% to 73.3%), while that of the GenePOC assay was 100% (95% CI, 70.1% to 100%). The specificity of both assays was 100% (95% CI, 91.8% to 100%). The GenePOC Carba assay showed excellent sensitivity and specificity for the five most common carbapenemases, including IMP variants. Its simplicity and short turnaround time make it suitable for use in the routine microbiology laboratory for CPE detection.

摘要

新型、基于实时 PCR 的 GenePOC Carba assay 采用 revogene 微流控平台(GenePOC,魁北克,加拿大;现为 Meridian Bioscience,辛辛那提,俄亥俄州,美国),最近被设计用于检测 、 、 、 和 。本研究的目的是评估该检测方法的性能,评估其在常规微生物实验室中的适用性,并将其与 Xpert Carba-R 检测方法进行比较,以检测产碳青霉烯酶的 (CPE)菌株。Xpert Carba-R 检测方法(Cepheid)和 GenePOC Carba 检测方法对 176 株临床 分离株进行了检测。该分离株集合包括 133 株产共 139 种碳青霉烯酶的 CPE 株,其中 VIM( = 48)、OXA-48 样( = 40)、NDM( = 29)、KPC( = 13)和 IMP( = 9)。6 株分离株产生两种不同的碳青霉烯酶,43 株碳青霉烯酶阴性分离株作为阴性对照。Xpert Carba-R 检测方法的总体碳青霉烯酶检测灵敏度为 96.4%(95%置信区间[CI],91.9%至 98.5%),而 GenePOC 检测方法的灵敏度为 100%(95%CI,97.3%至 100%)。两种检测方法对四种最常见的碳青霉烯酶(NDM、KPC、OXA-48 样和 VIM)的检测灵敏度均为 100%(95%CI,97.1%至 100%),两种检测方法均正确检测到所有两种碳青霉烯酶的生产者。Xpert Carba-R 检测方法对 IMP 的灵敏度为 44.4%(95%CI,18.9%至 73.3%),而 GenePOC 检测方法的灵敏度为 100%(95%CI,70.1%至 100%)。两种检测方法的特异性均为 100%(95%CI,91.8%至 100%)。GenePOC Carba 检测方法对包括 IMP 变体在内的五种最常见的碳青霉烯酶具有出色的灵敏度和特异性。其简单性和短周转时间使其适合在常规微生物实验室中用于 CPE 检测。

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