Background

Carbapenemase-producing Gram-negative bacilli, i.e., Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter, are of increased concern for the public health around the world. There is urgent need for rapid and accurate tests in order to provide correct treatment and to prevent bacterial spread in healthcare settings.

Methods

The aim of this study was to evaluate three commercial multiplex carbapenemase tests with CE-IVD marking: Eazyplex SuperBug complete B (AmplexDiagnostics), Novodiag CarbaR+ (Mobidiag), and Amplidiag CarbaR+MCR (Mobidiag). All these tests recognize KPC, NDM, OXA-48/181 group, VIM, OXA-23 group, and OXA-24/40 group, and Novodiag CarbaR+ and Amplidiag CarbaR+MCR additionally recognize IMP, OXA-51 group (with promoter located within ISAbaI), OXA-58 group, and MCR, and Amplidiag CarbaR+MCR further recognizes GES (carbapenemase-type only).

Results

The sensitivities and specificities of these tests with bacterial isolates were 100%. The sensitivity directly from clinical samples was 100%, but the specificity was lower, which is simply explained by the higher sensitivity of the molecular methods compared with culture method.

Conclusions

Overall, these CE-IVD marked tests provide a good alternative in the detection of carbapenemase-producing organisms.

中文翻译：

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三种分子碳青霉烯酶测试的评估：Eazyplex SuperBug complete B、Novodiag CarbaR+和Amplidiag CarbaR+MCR

背景

产碳青霉烯酶的革兰氏阴性杆菌，即肠杆菌属、铜绿假单胞菌和不动杆菌属越来越受到全世界公众健康的关注。迫切需要快速准确的测试，以便提供正确的治疗并防止细菌在医疗机构中传播。

方法

本研究的目的是评估具有 CE-IVD 标记的三种商业多重碳青霉烯酶测试：Eazyplex SuperBug complete B (AmplexDiagnostics)、Novodiag CarbaR+ (Mobidiag) 和 Amplidiag CarbaR+MCR (Mobidiag)。所有这些测试均识别 KPC、NDM、OXA-48/181 组、VIM、OXA-23 和 OXA-24/40 组，并且 Novodiag CarbaR+ 和 Amplidiag CarbaR+MCR 还识别 IMP、OXA-51 组（启动子位于ISAbaI)、OXA-58 组和 MCR，Amplidiag CarbaR+MCR 进一步识别 GES（仅碳青霉烯酶型）。

结果

这些细菌分离物检测的敏感性和特异性为 100%。直接来自临床样本的灵敏度为100%，但特异性较低，这可以简单地解释为分子方法与培养方法相比灵敏度更高。

结论

总的来说，这些 CE-IVD 标记的测试为检测产碳青霉烯酶的生物提供了一个很好的选择。