Xpert MTB/RIF检测利福平耐药的准确性与结核病患者痰细菌载量的相关性:一项天津市的回顾性研究  

Dependence of Xpert MTB/RIF accuracy on sputum bacterial load in detection of rifampin resistance:a retrospective study in Tianjin

作　　者：江丽娜[1] 王志锐[1] 高丽 孙蕊[1] 王秀月 王春花[1] Jiang Lina;Wang Zhirui;Gao Li;Sun Rui;Wang Xiuyue;Wang Chunhua(Tianjin Key Laboratory of Pathogenic Microbiology of Infections Disease,Tianjin Center for Tuberculosis Control,Tianjin 300011,China)

机构地区：[1]天津市病原微生物重点实验室,天津市结核病控制中心,天津300011

出　　处：《疾病监测》2023年第8期944-950,共7页Disease Surveillance

基　　金：天津市卫生健康科技项目(No.TJWJ2022MS047)。

摘　　要：目的分析Xpert MTB/RIF不同细菌载量(1+、2+、3+、4+)检测结核分枝杆菌利福平(RIF)耐药的准确性,为有效临床药敏结果判断提供参考。方法回顾性收集2020年1月至2021年12月天津市结核病控制中心参比室接收的1936份结核病疑似患者痰标本的液体BACTEC MGIT960培养阳性检测结果,排除16份非结核分枝杆菌后,1158份XpertMTB/RIF阳性标本的结果纳入分析,对Xpert MTB/RIF检测阳性且液体BACTEC MGIT960培养阳性的1142例结核分枝杆菌(MTB)菌株进行常规培养法体外药物表型药敏试验(DST)。应用SPSS 19.0软件进行统计学分析,结果采用配对χ^(2)检验,P<0.05为差异有统计学意义;两种检验方法的一致性采用Kappa检验。结果1936份液体BACTEC MGIT960培养阳性标本中XpertMTB/RIF检测结核的阳性筛查率为59.81%,XpertMTB/RIF检测结核的细菌载量1+~4+中,RIF耐药的检出率分别为8.88%、14.91%、11.37%、15.15%。以表型DST作为检测利福平耐药的参照标准,当细菌载量从1+到4+,表型DST与Xpert MTB/RIF检测利福平的符合率分别为95.39%(290/304)、95.96%(380/396)、96.79%(332/343)、96.97%(96/99),差异无统计学意义(趋势χ^(2)=1.069,P=0.785),一致性较高;Xpert MTB/RIF检测利福平的灵敏度呈上升趋势,分别为80.95%(17/21)、97.96%(40/41)、93.75%(30/32)、100.00%(12/12),差异无统计学意义(趋势χ^(2)=7.280,P=0.063);特异度分别为96.47%(273/283)、95.77%(340/355)、97.11%(302/311)、96.55%(84/87),差异无统计学意义(χ^(2)=0.860,P=0.835);阳性预测值分别为62.96%(17/27),72.73%(40/55),76.92%(30/39),80.00%(12/15),差异无统计学意义(χ^(2)=2.047,P=0.563);阴性预测值分别为98.56%(273/304)、99.71%(340/341),99.34%(302/304)、100.00%(84/84),且差异有统计学意义(χ^(2)=64.661,P<0.001)。Xpert MTB/RIF细菌载量从1+到4+的kappa值分别为0.68、0.81、0.83、0.87。表型DST与Xpert MTB/RIF检测RIF结果不一致的菌株中,细菌载量为1+,RIF的检测结果与熔解曲线相比,一致�Objective To analyze the accuracy of Xpert MTB/RIF in the detection of rifampicin(RIF)resistance of Mycobacterium tuberculosis with different sputum bacterial loads(1+,2+,3+,4+)and provide reference for the evaluation of clinical drug susceptibility test results.Methods Positive results of liquid BACTEC MGIT960 culture of 1936 sputum samples of suspected tuberculosis(TB)patients were retrospectively collected from the reference laboratory of Tianjin Tuberculosis Control Center from January 2020 to December 2021,and 16 samples were excluded from the analysis.The results of 1158 Xpert MTB/RIF positive samples were included in the analysis,and 1142 M.tuberculosis strains tested positive for Xpert MTB/RIF and positive for liquid BACTEC MGIT960 culture were tested in vitro for drug phenotype sensitivity(DST)by routine culture method.Software SPSS 19.0 was used for statistical analysis,and pairedχ^(2) test was used.P<0.05 was considered statistically significant.Kappa test was used for the consistency of the two test methods.Results In 1936 liquid BACTEC MGIT960 positive culture samples,the positive screening rate of TB detection by Xpert MTB/RIF was 59.81%,and the bacterial load of the test ranged from 1+to 4+.The detection rates of RIF resistance were 8.88%,14.91%,11.37%and 15.15%,respectively.Phenotypic DST was used as a reference standard for the detection of RIF resistance.When the bacterial loads ranged from 1+to 4+,the coincidence rates of DST and Xpert MTB/RIF for RIF resistance detection were 95.39%(290/304),95.96%(380/396),96.79%(332/343)and 96.97%(96/99),respectively,there were no significant differences(trendχ^(2)=1.069,P=0.785);the sensitivity of Xpert MTB/RIF to RIF resistance showed an increasing trend,which were 80.95%(17/21),97.96%(40/41),93.75%(30/32),100.00%(12/12),respectively,with no significant differences(trendχ^(2)=7.280,P=0.063);the specificity was 96.47%(273/283),95.77%(340/355),97.11%(302/311),96.55%(84/87),respectively,and there were no significant differences(χ^(2)=0.860,P=0.835);the po

关 键 词：结核分枝杆菌 体外药敏试验 利福平 细菌载量 

分 类 号：R211[医药卫生—中医学] R521