评价 Acuitas® 耐药组学检测试剂盒和 Acuitas Lighthouse® 软件在检测产β-内酰胺酶微生物中的性能。
Evaluation of the performance of Acuitas® Resistome Test and the Acuitas Lighthouse® software for the detection of β-lactamase-producing microorganisms.
机构信息
Laboratory of Bacteriology, Hellenic Pasteur Institute, Athens, Greece.
Laboratory of Bacteriology, Hellenic Pasteur Institute, Athens, Greece; Department of Microbiology, Medical School, University of Athens, Athens, Greece.
出版信息
J Glob Antimicrob Resist. 2020 Sep;22:184-189. doi: 10.1016/j.jgar.2020.01.017. Epub 2020 Feb 13.
OBJECTIVES
Given the international spread of multidrug-resistant Gram-negative bacteria the need for prompt and precise characterization of underlying resistance traits has evolved into the cornerstone of infection control strategies. Novel commercial molecular tests enable rapid simultaneous testing for multiple resistance genes. We aimed to evaluate the performance of OpGen's Acuitas® Resistome Test and the Acuitas Lighthouse® software.
METHODS
The test is tailored towards detecting 46 β-lactamase genes (SHV and TEM variants associated with wild-type penicillin resistance, extended-spectrum β-lactamases [ESBLs], acquired AmpCs and carbapenemases) via a microfluidic polymerase chain reaction (PCR) array. In total 118 isolates part of the collection of the Bacteriology Laboratory of the Hellenic Pasteur Institute, specifically 96 enterobacterial isolates and 21 Acinetobacter baumannii, of divergent origins, with previously characterized β-lactamase content, were tested.
RESULTS
In the enterobacterial group all 69 carbapenemase genes of the KPC, VIM, NDM and OXA-48 types were correctly identified (sensitivity, specificity, positive predictive value [PPV] and negative predictive value [NPV] of 100%). Non-ESBL SHV enzymes, ESBLs (CTX-M, GES, VEB types) and acquired AmpC enzymes were also correctly characterized. Of the 35 SHV-ESBLs harboured, correct identification was possible in 32/35 isolates, with overall sensitivity, specificity, PPV and NPV for the Klebsiella pneumoniae group of 89.29%, 100%, 100% and 91.18%, respectively. For the A. baumannii group the test exhibited an overall sensitivity for carbapenemase detection of 96.55% and 100% PPV.
CONCLUSIONS
The OpGen Acuitas Resistome Test is an efficient molecular tool that can identify resistance threats in health care institutions with high diagnostic accuracy and be integrated into targeted surveillance protocols.
目的
鉴于多药耐药革兰氏阴性菌的国际传播，快速准确地确定潜在的耐药特征已成为感染控制策略的基石。新型商业分子检测可实现多种耐药基因的快速同步检测。我们旨在评估 OpGen 的 Acuitas® Resistome Test 和 Acuitas Lighthouse® 软件的性能。
方法
该测试针对通过微流控聚合酶链反应（PCR）阵列检测 46 种β-内酰胺酶基因（与野生型青霉素耐药相关的 SHV 和 TEM 变体、扩展谱β-内酰胺酶 [ESBLs]、获得性 AmpC 和碳青霉烯酶）进行了定制。共有 118 株分离株是希腊巴斯德研究所细菌学实验室收集的一部分，特别是 96 株肠杆菌分离株和 21 株鲍曼不动杆菌，来源不同，具有先前特征化的β-内酰胺酶含量，进行了测试。
结果
在肠杆菌组中，所有 69 种 KPC、VIM、NDM 和 OXA-48 型碳青霉烯酶基因均被正确识别（灵敏度、特异性、阳性预测值 [PPV] 和阴性预测值 [NPV] 为 100%）。非 ESBL SHV 酶、ESBLs（CTX-M、GES、VEB 型）和获得性 AmpC 酶也得到了正确的鉴定。在 35 株 SHV-ESBL 中，32/35 株分离株的鉴定结果正确，Klebsiella pneumoniae 组的总体灵敏度、特异性、PPV 和 NPV 分别为 89.29%、100%、100%和 91.18%。对于鲍曼不动杆菌组，该测试对碳青霉烯酶检测的总体灵敏度为 96.55%，PPV 为 100%。
结论
OpGen 的 Acuitas Resistome Test 是一种高效的分子工具，可在医疗机构中以高诊断准确性识别耐药威胁，并可整合到靶向监测方案中。
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