The novel GenePOC/Revogene Carba C assay (GenePOC, Québec, Canada; now Meridian Bioscience, Cincinnati, OH, USA) is a CE-IVD marked, FDA-approved qualitative in vitro 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（GenePOC，魁北克，加拿大；现在 Meridian Bioscience，辛辛那提，俄亥俄州，美国）是 CE-IVD 标记、FDA 批准的体外定性用于检测与碳青霉烯不敏感相关基因的诊断测试。无需事先分离 DNA，即可直接检测肠杆菌属菌落。该测试包括基于荧光的实时 PCR 分析，该分析在向心微流体 revogene 平台上运行，可在 70 分钟内提供结果。该测定在两项研究中进行了评估，包括总共 294 种分子特征的临床肠杆菌分离株。使用 GenePOC 测定法检测碳青霉烯酶基因序列的总体灵敏度为 100%（95% CI，98.4% 至 100）。除了常见的 KPC、VIM、NDM 和 OXA-48 样碳青霉烯酶基因外，还检测到非常可变的 IMP 变体。该测定的特异性为 100%（95% CI，98.8% 至 100%）。