Institute for Medical Microbiology, Immunology and Hygiene, University Hospital of Cologne , Cologne, Germany.
University of Cologne , Cologne, Germany.
Expert Rev Mol Diagn. 2020 Aug;20(8):757-769. doi: 10.1080/14737159.2020.1785287. Epub 2020 Jul 7.
The novel GenePOC/Revogene Carba C assay (GenePOC, Québec, Canada; now Meridian Bioscience, Cincinnati, OH, USA) is a CE-IVD marked, FDA-approved qualitative diagnostic test for the detection of genes associated with carbapenem-non-susceptibility. Colonies of Enterobacterales can be directly tested without prior DNA isolation. The test consists of a fluorescent-based real-time PCR assay that runs on the centripetal microfluidic revogene platform, providing results within 70 minutes. The assay was evaluated in two studies comprising a total of 294 molecularly characterized clinical Enterobacterales isolates. The overall sensitivity for the detection of carbapenemase gene sequences with the GenePOC assay was 100% (95% CI, 98.4% to 100). Besides the common KPC, VIM, NDM and OXA-48-like carbapenemase genes, also the very variable IMP variants were all detected. The specificity of the assay was 100% (95% CI, 98.8% to 100%). In this article the performance of the GenePOC/Revogene Carba C assay is evaluated and other currently available methods for the detection of carbapenemases are reviewed.
新型 GenePOC/Revogene Carba C 检测法（GenePOC，加拿大魁北克；现为美国辛辛那提的 Meridian Bioscience）是一种经 CE-IVD 认证、FDA 批准的定性诊断检测方法，用于检测与碳青霉烯类药物不敏感相关的基因。肠杆菌科的菌落可直接进行检测，无需事先进行 DNA 分离。该检测法由荧光实时 PCR 检测法组成，在离心式微流控 revogene 平台上运行，可在 70 分钟内提供结果。该检测法在两项总计 294 例分子特征明确的临床肠杆菌科分离株的研究中进行了评估。GenePOC 检测法检测碳青霉烯酶基因序列的总体灵敏度为 100%（95%置信区间，98.4%至 100%）。除了常见的 KPC、VIM、NDM 和 OXA-48 样碳青霉烯酶基因外，该检测法还可检测到非常多变的 IMP 变体。该检测法的特异性为 100%（95%置信区间，98.8%至 100%）。本文评估了 GenePOC/Revogene Carba C 检测法的性能，并回顾了目前可用于检测碳青霉烯酶的其他方法。
