It is essential to detect carriers of carbapenemase-producing Enterobacterales in order to implement infection control measures. The objectives of this study was to evaluate the NG-Test® CARBA 5 (CARBA 5) assay for detection of five carbapenemases and to assess the cross reactivity of other OXA-type carbapenemases with the OXA-48-like specific antibodies. A total of 197 Enterobacterales isolates were tested. To evaluate the cross reactivity, 73 carbapenem-resistant A. baumannii, harboring OXA-type variants, were tested. Polymerase chain reaction (PCR) served as gold standard for carbapenemase identification. Excellent agreement was found between PCR and CARBA 5, for all but one isolate. The single false positive result (a blaSME positive S. marcescens isolate) was incorrectly positive for blaOXA-48 by CARBA 5. No cross reactivity was observed. The sensitivity and specificity were 100.0% and 98.0%, respectively. The CARBA 5 assay is highly sensitive and specific and is recommended as a tool for the detection of the main carbapenemases of interest in clinical microbiology laboratories.

中文翻译：

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多重侧流免疫层析测定是检测碳青霉烯酶的有效方法，且无 OXA-48 样交叉反应风险

为了实施感染控制措施，检测产碳青霉烯酶肠杆菌的携带者至关重要。本研究的目的是评估 NG-Test® CARBA 5 (CARBA 5) 检测法检测五种碳青霉烯酶的效果，并评估其他 OXA 型碳青霉烯酶与 OXA-48 样特异性抗体的交叉反应性。总共检测了 197 株肠杆菌菌株。为了评估交叉反应性，对 73 个含有 OXA 型变体的碳青霉烯类耐药鲍曼不动杆菌进行了测试。聚合酶链反应（PCR）是碳青霉烯酶鉴定的金标准。对于除一种分离株之外的所有分离株，PCR 和 CARBA 5 之间都具有极好的一致性。CARBA 5 检测到的单一假阳性结果（blaSME 阳性粘质链球菌分离株）对 blaOXA-48 呈错误阳性。未观察到交叉反应。敏感性和特异性分别为 100.0% 和 98.0%。CARBA 5 检测具有高度敏感性和特异性，推荐作为临床微生物实验室检测主要碳青霉烯酶的工具。