Vitek 2 Compact AST-N334、AST-N335、AST-P639中国定制药敏卡性能评估

Performance evaluation of Vitek 2 Compact AST-N334,AST-N335,AST-P639 Chinese antimicrobial susceptibility test cards

目的评估Vitek 2 Compact AST-N334、AST-N335和AST-P639中国定制药敏卡的性能。方法随机收集权威机构质控菌株73株和2018年1—6月华山医院住院患者首次临床分离株112株。以权威机构提供的质控菌株为检测对象,采用3种中国定制药敏卡及微量肉汤稀释法(BMM)进行平行试验,以室间质量评价结果为参考标准,评估中国定制药敏卡及BMM的可靠性。以临床分离株为检测对象,以BMM结果为参考标准,评估中国定制药敏卡对临床分离株耐药多样性检测的准确性。结果以质控菌株为检测对象,以权威机构提供的抗菌药物敏感性试验结果为标准,AST-N334、AST-N335、AST-P639的分类一致率(CA)分别为95.5%(126/132)、96.8%(179/185)、99.5%(182/183)。以临床分离株为检测对象,以BMM药物敏感性试验结果为参考标准,AST-N334标准一致率(EA)为88.4%(961/1087)、CA为94.6%(903/955)、非常重大错误(VME)占0.3%(3/955)、重大错误(ME)占1.9%(18/955)、微小错误(MIE)占3.2%(31/955);AST-N335 EA为89.9%(1388/1544)、CA为95.1%(1414/1487)、VME占0.3%(5/1487)、ME占0.8%(12/1487)、MIE占3.8%(56/1487);AST-P639 EA为95.4%(541/567)、CA为98.7%(389/394)、ME占0.5%(2/394)、MIE占0.8%(3/394)。结论Vitek 2 Compact AST-N334、AST-N335、AST-P639中国定制药敏卡准确性高,具有临床应用可信度,但也存在一定的错误率及局限性,实验室检测人员应予以关注。

Objective To evaluate the performance of Vitek 2 Compact AST-N334,AST-N335,AST-P639 Chinese antimicrobial susceptibility test(AST)cards.Methods Totally,73 strains of quality control bacteria were collected from authoritative institutions and 112 strains of clinical bacteria were randomly collected from hospitalized patients in Huashan Hospital from January to June 2018.The reliability of AST cards was evaluated,the accuracy of AST cards and broth microdilution method(BMM)was evaluated by quality control bacteria and AST results provided by authoritative institutions.The accuracy of AST cards in the detection of antibiotic resistance diversity was evaluated,and the accuracy of AST cards was evaluated by the clinical bacteria using BMM results as the reference standard.Results With the results of AST provided by the authoritative institutions as the reference standard,the percentages of AST-N334,AST-N335 and AST-P639 categorical agreement(CA)were 95.5%(126/132),96.8%(179/185)and 99.5%(182/183).With the results of BMM as the reference standard,the percentage of AST-N334 essential agreement(EA)was 88.4%(961/1087),CA was 94.6%(903/955),very major error(VME)accounted for 0.3%(3/955),major error(ME)accounted for 1.9%(18/955),and minor error(MIE)accounted for 3.2%(31/955).AST-N335 EA was 89.9%(1388/1544),CA was 95.1%(1414/1487),VME accounted for 0.3%(5/1487),ME accounted for 0.8%(12/1487),and MIE accounted for 3.8%(56/1487).AST-P639 EA was 95.4%(541/567),CA was 98.7%(389/394),ME accounted for 0.5%(2/394),and MIE accounted for 0.8%(3/394).Conclusions Vitek 2 Compact AST-N334,AST-N335,AST-P639 Chinese AST cards have high accuracy and reliability in clinical application.However,there are some error rates and limitations,which should be paid attention.