Hombach Michael, von Gunten Barbara, Castelberg Claudio, Bloemberg Guido V
Institut für Medizinische Mikrobiologie, Universität Zürich, Zurich, Switzerland
Viollier AG, Basel, Switzerland.
J Clin Microbiol. 2015 Dec;53(12):3828-33. doi: 10.1128/JCM.02327-15. Epub 2015 Sep 30.
This study evaluated the performance of the Rapidec Carba NP test, which was introduced recently into the market for the detection of carbapenemase production in a broad spectrum of β-lactamase-producing Enterobacteriaceae clinical isolates. In total, 252 clinical Enterobacteriaceae isolates that had been genetically characterized with respect to carbapenemase, extended-spectrum β-lactamase (ESBL), and AmpC genes were analyzed; 51/252 isolates (20.2%) were genetically confirmed to be carbapenemase producers, whereas 201/252 isolates (79.8%) were genetically negative for the presence of carbapenemase genes. The Rapidec Carba NP test was applied according to the manufacturer's instructions, and results were read after 30 and 120 min of incubation. The overall sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the Rapidec Carba NP test were 90.2%, 100%, 100%, and 97.6%, respectively, when the manufacturer's instructions were followed. Four of 5 false-negative results occurred with OXA-48-like enzymes. After an incubation time of 30 min, the sensitivity was 49%. The sensitivity increased to 100% when the recommended bacterial inoculum was doubled and the test was read strictly after 120 min of incubation. The Rapidec Carba NP test is a useful tool for the reliable confirmation of carbapenemase-producing Enterobacteriaceae isolates. The test should be read strictly after 120 min of incubation and the inoculum should be larger than recommended by the manufacturer.
本研究评估了Rapidec Carba NP检测的性能,该检测最近已投放市场,用于检测广泛的产β-内酰胺酶肠杆菌科临床分离株中的碳青霉烯酶产生情况。总共分析了252株已对碳青霉烯酶、超广谱β-内酰胺酶(ESBL)和AmpC基因进行基因特征分析的临床肠杆菌科分离株;252株分离株中有51株(20.2%)经基因确认是碳青霉烯酶产生菌,而252株分离株中有201株(79.8%)经基因检测碳青霉烯酶基因呈阴性。Rapidec Carba NP检测按照制造商的说明进行,孵育30分钟和120分钟后读取结果。按照制造商的说明进行操作时,Rapidec Carba NP检测的总体灵敏度、特异性、阳性预测值(PPV)和阴性预测值(NPV)分别为90.2%、100%、100%和97.6%。5例假阴性结果中有4例是由OXA - 48样酶导致的。孵育时间为30分钟时,灵敏度为49%。当推荐的细菌接种量加倍且严格在孵育120分钟后读取检测结果时,灵敏度提高到100%。Rapidec Carba NP检测是可靠确认产碳青霉烯酶肠杆菌科分离株的有用工具。检测应在孵育120分钟后严格读取,接种量应大于制造商推荐的量。