一种最小抑菌浓度检测试剂盒检测结核分枝杆菌临床菌株药物敏感性的效果评价  

Efficacy of a commercial minimum inhibitory concentration assay kit in detecting drug susceptibility in clinical Mycobacterium tuberculosis isolates

作　　者：曹滨 王泉 于晋杰 邓乐乐 钱程宇 方丹昂 万康林[1] 李马超[1] 刘梦文 赵秀芹[1] 赵丽丽[1] 刘海灿[1] 肖开提·米吉提 袁秀琴[2] 李桂莲[1] CAO Bin;WANG Quan;YU Jin-jie;DENG Le-le;QIAN Cheng-yu;FANG Dan-ang;WAN Kang-lin;LI Ma-chao;LIU Meng-wen;ZHAO Xiu-qin;ZHAO Li-li;LIU Hai-can;Xiaokaiti·Mijiti;YUAN Xiu-qin;LI Gui-lian(State Key Laboratory for Infectious Disease Prevention and Control,National Institute for Communicable Disease Control and Prevention,Chinese Center for Disease Control and Prevention,Beijing 102206,China;School of Public Health,University of South China,Hengyang 421001,China;The Eighth Affiliated Hospital of Xinjiang Medical University,Urumqi 830017,China;National Institute for Viral Disease Control and Prevention,Chinese Center for Disease Control and Prevention,Beijing 102206,China;School of Life Sciences,College of Laboratory Medicine,Wenzhou Medical University,Wenzhou 325035,China;School of Public Health,Xinjiang Medical University,Urumqi 830011,China)

机构地区：[1]中国疾病预防控制中心传染病预防控制所,传染病预防控制国家重点实验室,北京102206 [2]南华大学公共卫生学院,衡阳421001 [3]新疆医科大学第八附属医院,乌鲁木齐830017 [4]中国疾病预防控制中心病毒病预防控制所,北京102206 [5]温州医科大学检验医学院与生命科学学院,温州325035 [6]新疆医科大学公共卫生学院,乌鲁木齐830011

出　　处：《中国人兽共患病学报》2023年第9期827-836,共10页Chinese Journal of Zoonoses

基　　金：新疆维吾尔自治区科技重大专项(No.2017A03006)。

摘　　要：目的评价一种最小抑菌浓度检测试剂盒检测结核分枝杆菌(MTB)临床分离菌株对11种一、二线抗结核药物敏感性的效能。方法从2017年1月至2018年12月期间来自新疆不同地区4家结核病院的住院/门诊结核病患者的847株MTB临床分离菌株中,随机选取188株,采用一种最小抑菌浓度检测试剂盒(MYCOTB)检测其对11种一、二线抗结核药物的耐药性,以常规微孔板微量肉汤稀释法为对照方法,结合全基因组测序技术,评估MYCOTB法检测药物耐药性的灵敏度、特异度及两种表型药敏方法的一致性。结果以常规微孔板微量肉汤稀释法为标准,MYCOTB检测RFP、ETH、RFB、SM、INH、PAS、OFX、AMK、MFX、EMB和KM等11种药物耐药性的灵敏度分别为92.0%、88.6%、86.7%、84.6%、84.3%、75.0%、67.7%、57.4%、56.7%、56.5%和40.0%,特异度分别为97.1%、96.7%、96.2%、97.3%、90.0%、95.6%、96.1%、99.5%、91.1%、96.4%和100.0%,符合率分别为95.7%、95.2%、94.7%、94.7%、87.2%、94.7%、91.0%、97.9%、85.6%、91.5%和96.8%,Kappa值分别为0.89、0.84、0.81、0.84、0.75、0.52、0.68、0.66、0.47、0.57和0.87。对于两种表型药敏方法结果不一致的菌株,基因测序结果更支持MYCOTB的检测结果。结论MYCOTB检测MTB对11种一、二线抗结核药物耐药性具有良好的灵敏度和特异度,可用于MTB菌株耐药性的检测。The performance of a minimum inhibitory concentration test kit in detecting the susceptibility of clinical isolates of Mycobacterium tuberculosis(MTB)to first-and second-line anti-tuberculosis(anti-TB)drugs was evaluated.We randomly selected 188 MTB clinical strains from 847 strains isolated from TB inpatients/outpatients at four TB hospitals in different regions of Xinjiang,China,from January 2017 to December 2018.Drug susceptibility tests(DSTs)of MTB against 11 first-and second-line anti-TB drugs were performed with a minimal concentration inhibition assay kit(MYCOTB).A conventional microplate broth microdilution plate method was used as a control,and whole genome sequencing(WGS)was used to verify the findings for strains with different results between the two phenotypic DST assays.The sensitivity,specificity and feasibility of the MYCOTB method for detecting drug resistance,and the consistency in findings between the two DST assays,were assessed.With the conventional microplate broth microdilution method as a reference,the sensitivity of MYCOTB for detecting drug resistance to RFP,ETH,RFB,SM,INH,PAS,OFX,AMK,MFX,EMB and KM was 92.0%,88.6%,86.7%,84.6%,84.3%,75.0%,67.7%,57.4%,56.7%,56.5%and 40.0%,respectively;the specificity was 97.1%,96.7%,96.2%,97.3%,90.0%,95.6%,96.1%,99.5%,91.1%,96.4%and 100.0%,respectively;the consistency rates were 95.7%,95.2%,94.7%,94.7%,87.2%,94.7%,91.0%,97.9%,85.6%,91.5%and 96.8%,respectively;and the Kappa values were 0.89,0.84,0.81,0.84,0.75,0.52,0.68,0.66,0.47,0.57 and 0.87,respectively.For strains with inconsistent results between the two phenotypic DST methods,the WGS results tended to support those of the MYCOTB assay.In conclusion,MYCOTB has good sensitivity and specificity for detecting the resistance of MTB to 11 first-and second-line anti-tuberculosis drugs and can be applied to detect the resistance of MTB strains.

关 键 词：结核分枝杆菌 药物敏感性试验 MYCOTB 微孔板微量肉汤稀释法 

分 类 号：R378.911[医药卫生—病原生物学]