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Multicenter evaluation of the RAPIDEC® CARBA NP assay for the detection of carbapenemase production in clinical isolates of Enterobacterales and Pseudomonas aeruginosa
European Journal of Clinical Microbiology & Infectious Diseases ( IF 3.7 ) Pub Date : 2020-06-23 , DOI: 10.1007/s10096-020-03937-1
Allison R. McMullen , Meghan A. Wallace , Vincent LaBombardi , Janet Hindler , Shelley Campeau , Romney Humphries , Gary W. Procop , Sandra S. Richter , Mark G. Wise , Carey-Ann D. Burnham

Carbapenem-resistant Gram-negative bacilli are a major public health problem. Accurate and rapid detection of carbapenemase-producing organisms can facilitate appropriate infection prevention measures. The objective was to evaluate the performance of the RAPIDEC® CARBA NP assay (RAPIDEC), a screening assay that utilizes a pH indicator to detect carbapenem hydrolysis within 2 h. A multicenter study evaluated 306 clinical bacterial strains of Enterobacterales (n = 257) and Pseudomonas aeruginosa (n = 49). The RAPIDEC was compared to a composite reference standard—the Clinical Laboratory Standards Institute (CLSI) Carba NP assay, PCR for specific carbapenemase genes (blaKPC, blaNDM, blaOXA-48-like, blaVIM and blaIMP), and phenotypic carbapenem susceptibility testing. The assay was evaluated using two culture incubation times for the bacterial isolates: “routine”(cultures incubated 18-24 h) and “short” (cultures incubated 4-5 h). For the routine incubation, the overall percent agreement was 98.7% with a positive percent agreement (PPA) of 99.6% and a negative percent agreement (NPA) of 97.4%; there were five false positives and one false negative. For the short incubation, the overall percent agreement was 98.0% with a PPA of 98.5% and a NPA of 97.3%; there were five false positives and four false negatives. RAPIDEC results for the P. aeruginosa isolates were 100% concordant with the reference standard for both incubation times. The RAPIDEC assay is an accurate and rapid (≤ 2 h) assay for the detection of the most common carbapenemases in clinical isolates. Growth from a short incubation culture may be used to reliably detect carbapenemase production in clinical strains.



中文翻译:

RAPIDEC®CARBA NP测定的多中心评估,用于检测肠杆菌和铜绿假单胞菌临床分离物中的碳青霉烯酶产生

耐碳青霉烯的革兰氏阴性杆菌是主要的公共卫生问题。准确快速地检测出产生碳青霉烯酶的生物可以促进适当的感染预防措施。目的是评估RAPIDEC®CARBA NP测定法(RAPIDEC)的性能,该测定法是利用pH指示剂在2小时内检测碳青霉烯水解的方法。一项多中心研究评估了306株肠杆菌的临床细菌菌株(n  = 257)和铜绿假单胞菌n  = 49)。将RAPI​​DEC与复合参考标准进行了比较-临床实验室标准协会(CLSI)Carba NP测定,特定碳青霉烯酶基因的PCR(bla KPCbla NDMbla OXA-48-likebla VIMbla IMP)和表型碳青霉烯类药敏试验。使用两种细菌分离培养物的孵育时间评估该测定:“常规”(培养物孵育18-24小时)和“短”(培养物孵育4-5小时)。对于常规孵化,总体百分比一致性为98.7%,正百分比一致性(PPA)为99.6%,负百分比一致性(NPA)为97.4%;有5个误报和1个误报。对于短暂的孵化,总体百分比一致性为98.0%,PPA为98.5%,NPA为97.3%;有五个假阳性和四个假阴性。铜绿假单胞菌的RAPIDEC结果两种孵育时间的分离物均与参考标准品100%一致。RAPIDEC测定法是一种准确,快速(≤2小时)的测定法,用于检测临床分离物中最常见的碳青霉烯酶。短温培养的生长可用于可靠地检测临床菌株中碳青霉烯酶的产生。

更新日期:2020-06-23
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