Kabir Muhammad Humaun, Meunier Daniele, Hopkins Katie L, Giske Christian G, Woodford Neil
Division of Clinical Microbiology, Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.
Antimicrobial Resistance and Healthcare Associated Infections (AMRHAI) Reference Unit, Public Health England, 61 Colindale Avenue, London NW9 5EQ, UK.
J Antimicrob Chemother. 2016 May;71(5):1213-6. doi: 10.1093/jac/dkv468. Epub 2016 Jan 13.
We evaluated the RAPIDEC(®) CARBA NP assay (bioMérieux SA, Marcy-l'Étoile, France), a colorimetric test for rapid detection of carbapenemases, at two sites: Karolinska University Laboratory and PHE's national reference laboratory.
A total of 138 bacterial isolates previously characterized as positive for class A, B and/or D carbapenemase genes and 138 supposed non-carbapenemase producers were tested with RAPIDEC(®) CARBA NP according to the manufacturer's protocol. Two carbapenemase-producing isolates carried both NDM and OXA-48-like genes. Molecular detection of the expected carbapenemase gene(s) was used as the gold standard, and was performed by conventional and real-time PCR in-house assays.
The RAPIDEC(®) CARBA NP assay detected 135 of 138 carbapenemase producers; one OXA-48-producing Klebsiella pneumoniae and two Acinetobacter baumannii producing OXA-23 or OXA-24 were not detected. Among 'negative' controls, 135 of 138 isolates were negative by RAPIDEC(®) CARBA NP. The exceptions were one Klebsiella oxytoca, which was later found to produce GES-5 carbapenemase, one Pseudomonas aeruginosa with OprD loss and increased efflux, and one Enterobacter cloacae with impermeability. When numbers were adjusted for the GES-5 producer, the overall sensitivity of the RAPIDEC(®) CARBA NP test was 97.8% and its specificity was 98.5%.
The assay took less than 2.5 h to carry out, was user-friendly and had a high overall performance, making it an attractive option for clinical laboratories.
我们在两个地点——卡罗林斯卡大学实验室和英国公共卫生部国家参考实验室,评估了用于快速检测碳青霉烯酶的比色法检测试剂盒RAPIDEC(®) CARBA NP(法国生物梅里埃公司,马尔西伊图瓦勒)。
根据制造商的方案,使用RAPIDEC(®) CARBA NP对总共138株先前被鉴定为A类、B类和/或D类碳青霉烯酶基因阳性的细菌分离株以及138株假定的非碳青霉烯酶产生菌进行检测。两株产碳青霉烯酶的分离株同时携带NDM和OXA - 48样基因。预期碳青霉烯酶基因的分子检测用作金标准,通过内部常规和实时PCR检测进行。
RAPIDEC(®) CARBA NP检测试剂盒检测出138株产碳青霉烯酶菌株中的135株;未检测出一株产OXA - 48的肺炎克雷伯菌以及两株产OXA - 23或OXA - 24的鲍曼不动杆菌。在“阴性”对照中,138株分离株中有135株经RAPIDEC(®) CARBA NP检测为阴性。例外情况包括一株产GES - 5碳青霉烯酶的产酸克雷伯菌、一株外膜孔蛋白D缺失且外排增加的铜绿假单胞菌以及一株具有通透性障碍的阴沟肠杆菌。对产GES - 5的菌株进行数据调整后,RAPIDEC(®) CARBA NP检测的总体灵敏度为97.8%,特异性为98.5%。
该检测方法耗时不到2.5小时,操作简便且总体性能良好,使其成为临床实验室颇具吸引力的选择。