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使用Vitek 2(2009年美国食品药品监督管理局标准)和2014年临床和实验室标准协会(CLSI)断点标准对肠杆菌科细菌进行抗菌药物敏感性测试时Vitek 2的性能表现。

Performance of Vitek 2 for antimicrobial susceptibility testing of Enterobacteriaceae with Vitek 2 (2009 FDA) and 2014 CLSI breakpoints.

作者信息

Bobenchik April M, Deak Eszter, Hindler Janet A, Charlton Carmen L, Humphries Romney M

机构信息

Department of Pathology and Laboratory Medicine, David Geffen School of Medicine at UCLA, Los Angeles, California, USA.

UCLA Health System, Los Angeles, California, USA.

出版信息

J Clin Microbiol. 2015 Mar;53(3):816-23. doi: 10.1128/JCM.02697-14. Epub 2014 Dec 24.

Abstract

Vitek 2 (bioMérieux Inc., Durham, NC) is a widely used commercial antimicrobial susceptibility test system. We compared the MIC results obtained using the Vitek 2 AST-GN69 and AST-XN06 cards to those obtained by CLSI broth microdilution (BMD) for 255 isolates of Enterobacteriaceae, including 25 isolates of carbapenem-resistant Enterobacteriaceae. In total, 25 antimicrobial agents were examined. For 10 agents, the MIC data were evaluated using two sets of breakpoints: (i) the Vitek 2 breakpoints, which utilized the 2009 FDA breakpoints at the time of the study and are equivalent to the 2009 CLSI M100-S19 breakpoints, and (ii) the 2014 CLSI M100-S24 breakpoints. There was an overall 98.7% essential agreement (EA). The categorical agreement was 95.5% (CA) using the Vitek 2 breakpoints and 95.7% using the CLSI breakpoints. There was 1 very major error (VME) (0.05%) observed using the Vitek 2 breakpoints (cefazolin) and 8 VMEs (0.5%) using the CLSI breakpoints (2 each for aztreonam, cefepime, and ceftriaxone, and 1 for cefazolin and ceftazidime). Fifteen major errors (MEs) (0.4%) were noted using the Vitek 2 breakpoints and 8 (0.5%) using the CLSI breakpoints. Overall, the Vitek 2 performance was comparable to that of BMD for testing a limited number of Enterobacteriaceae commonly isolated by clinical laboratories. Ongoing studies are warranted to assess performance in isolates with emerging resistance.

摘要

Vitek 2(法国生物梅里埃公司,北卡罗来纳州达勒姆)是一种广泛使用的商业抗菌药物敏感性测试系统。我们将使用Vitek 2 AST - GN69和AST - XN06卡片获得的最低抑菌浓度(MIC)结果与通过CLSI肉汤微量稀释法(BMD)对255株肠杆菌科细菌(包括25株耐碳青霉烯类肠杆菌科细菌)获得的结果进行了比较。总共检测了25种抗菌药物。对于10种药物,使用两组折点评估MIC数据:(i)Vitek 2折点,在研究时采用2009年美国食品药品监督管理局(FDA)折点,等同于2009年CLSI M100 - S19折点;(ii)2014年CLSI M100 - S24折点。总体基本一致率(EA)为98.7%。使用Vitek 2折点时分类一致率(CA)为95.5%,使用CLSI折点时为95.7%。使用Vitek 2折点(头孢唑林)观察到1个非常重大错误(VME)(0.05%),使用CLSI折点观察到8个VME(0.5%)(氨曲南、头孢吡肟和头孢曲松各2个,头孢唑林和头孢他啶各1个)。使用Vitek 2折点记录到15个重大错误(ME)(0.4%),使用CLSI折点记录到8个(0.5%)。总体而言,对于临床实验室常见分离的有限数量的肠杆菌科细菌进行检测时,Vitek 2的性能与BMD相当。有必要进行持续研究以评估其在新出现耐药菌株中的性能。

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