两种细菌药敏板药敏检测性能验证临床研究  

Clinical study on the verification of detection performance of two kinds of medicine sensitivity plates for bacteria on medicine sensitivity

作　　者：杨洋 徐英春 李华茵 汪明[3] 褚云卓[4] YANG Yang;XU Ying-chun;LI Hua-yin(Department of Laboratory Medicine,Beijing Key Laboratory for Mechanisms Research and Precision Diagnosis of Invasive Fungal Diseases,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences,Beijing 100730,China.)

机构地区：[1]中国医学科学院北京协和医院检验科侵袭性真菌病机制研究与精准诊断北京市重点实验室,北京100730 [2]复旦大学附属中山医院检验科,上海200032 [3]武汉大学人民医院检验科,湖北武汉430060 [4]中国医科大学附属第一医院检验科,辽宁沈阳400042

出　　处：《中国医学装备》2021年第9期10-15,共6页China Medical Equipment

基　　金：“十三五”国家科技重大专项(2018ZX10712001)“病原细菌与突发急性真菌感染高通量快速检测与应急筛检技术研究”;北京市临床重点专科医学检验科卓越项目(ZK201000)。

摘　　要：目的:验证新型革兰阳性细菌药敏板BD Phoenix™PMIC-92(简称PMIC-92)和革兰阴性细菌药敏板BD Phoenix™NMIC-413(简称NMIC-413)的药敏检测和耐药机制的准确性。方法:选取国内4家三级甲等医院的1535株临床细菌菌株进行PMIC-92和NMIC-413药敏检测性能验证,其中革兰阳性菌933株,革兰阴性菌602株,参照统一的临床药理试验方案,以旧款Phoenix™细菌鉴定+药敏板、微量肉汤稀释法和琼脂稀释法为对照,与新型药敏板药敏检测结果进行对比;分析各种检测方法药敏检测结果和耐药机制的完全一致率(EA)、类别一致率(CA)、非常重大错误(VME)、重大错误(ME)和微小错误(MIE)。结果:在革兰阳性细菌药敏板检测的933株菌株中,肠球菌472株(占50.6%),葡萄球菌461株(占49.4%);所评价24种抗菌药物,葡萄球菌检测结果中20种药物的EA和22种药物的CA>90%;肠球菌检测结果,19种药物的EA和17种药物的CA>90%;5种耐药机制的阳性一致率和阴性一致率均>95%。在革兰阴性细菌药敏板检测的602株菌株中,肠杆菌科细菌323株(占53.7%),非发酵革兰阴性杆菌279株(占46.3%);所评价29种抗菌药物,肠杆菌科菌结果中,28种药物的EA和25种药物的CA>90%;非发酵革兰阴性杆菌结果中所有29种药物的EA和CA均>90%;对超广谱β-内酰胺酶(ESBL)检测的阳性一致率和阴性一致率均>95%。结论:新型PMIC-92和NMIC-413与对照方法旧款Phoenix™细菌鉴定+药敏板、微量肉汤稀释法和琼脂稀释法相比,在细菌药敏检测结果和耐药机制的判读上具有较高的一致率。Objective:To verify the accuracies of new types of medicine sensitivity plates of Gram-positive bacteria(BD PhoenixTM PMIC-92,PMIC-92)and Gram-negative bacteria(BD Phoenix™NMIC-413,NMIC-413)in the detection of medicine sensitivity and resistance mechanism.Methods:1535 strains of clinical bacteria from 4 third-level-1st-class hospitals were selected to perform the verifications for the detection performance of medicine sensitivities of PMIC-92 and NMIC-413.Among of them,933 strains were Gram-positive bacteria and 602 strains were Gram-negative bacteria.The unique clinical trial protocol was referred,and the conventional Phoenix TM bacteria identification+medicine sensitivity plate,micro broth dilution method and agar dilution were used as the control to compare with the detection results of medicine sensitivity of new type of medicine sensitivity plate.The essential agreement(EA)rate,categorical agreement(CA)rate,very major error(VME),major error(ME)and minor error(MIE)between the detection results of medicine sensitivity of each detection method and resistance mechanism were statistically analyzed.Results:In 933 strains that were detected by medicine sensitivity plate of Gram-positive bacteria,472 strains(50.6%)were Enterococcus,and 461 strains(49.4%)were Staphylococcus.In 24 kinds of antibacterial medicines that were evaluated,the detection results of Staphylococcus indicated that the EA of 20 kinds of medicines and the CA of 22 kinds of medicines were larger than 90%,and the detection results of Enterococcus indicated that the EA of 19 kinds of medicines and the CA of 17 kinds of medicine were larger than 90%,and positive concordance rate and negative concordance rate of 5 kinds of resistance mechanisms were larger than 95%.In 602 strains that were detected by medicine sensitivity plate of Gram-negative bacteria,323 strains(53.7%)were Enterobacteriaceae bacteria,and 279 strains(46.3%)were non fermentative Gram negative bacteria.In 29 kinds of antibacterial medicines that were evaluated,the detection results o

关 键 词：药物敏感性试验 耐药机制 革兰阳性细菌药敏板 革兰阴性细菌药敏板 

分 类 号：R446[医药卫生—诊断学]