不同类型标本中GeneXpert MTB/RIF检测结核分枝杆菌及其利福平耐药性的分析

目的 分析比较不同类型标本中GeneXpert MTB/RIF检测结核分枝杆菌及其利福平耐药性的效能,评价GeneXpert MTB/RIF在肺及肺外结核诊断中的应用价值。方法 以2019年1月1日—2020年12月31日西安市胸科医院7 687例BACTEC MGIT 960培养（简称“960液体培养”）阳性的标本为研究对象。以960液体培养为金标准,评价GeneXpert MTB/RIF在不同类型标本中检测结核分枝杆菌效能;以微孔板法药敏试验为金标准,评价GeneXpert MTB/RIF在不同类型标本中检测利福平耐药性的效能。结果 GeneXpert MTB/RIF在痰标本、肺泡灌洗液、浆膜腔积液、脓液及组织中检测出结核分枝杆菌的阳性率分别为：75.1%（653/869）、82.1%(1 093/1 332)、57.3%(110/192)、80.0%(60/75)、77.3%（34/44）,差异具有统计学意义（χ²=64.100,P<0.001）;以微孔板法药敏试验为金标准,GeneXpert MTB/RIF检测结核分枝杆菌利福平耐药性的灵敏度、特异度、阳性预测值、阴性预测值、Kappa值分别为：95.3%、95.2%、74.9%、99.3%、0.81;以微孔板法药敏试验为金标准,在痰标本、肺泡灌洗液、浆膜腔积液、脓液及组织标本中GeneXpert MTB/RIF检测利福平耐药性的灵敏度、特异度、Kappa值分别为：94.6%、95.1%、0.83;95.1%、95.2%、0.78;100%、97.3%、0.89;100%、92.3%、0.73;100%、90.9%、0.86。结论 GeneXpert MTB/RIF在痰标本、肺泡灌洗液、浆膜腔积液、脓液及组织标本中检测结核分枝杆菌均有较高的灵敏度,可作为检测结核分枝杆菌的有效方法;GeneXpert MTB/RIF在痰标本、肺泡灌洗液、浆膜腔积液（包含胸水、腹水、脑脊液）、脓液及组织标本中检测结核分枝杆菌利福平耐药性准确度较高。

Diagnostic valve for GeneXpert MTB/RIF to detect Mycobacterium tuberculosis and rifampicin resistance in different types of specimens

Objective To analyze the efficacy of Genexpert MTB / RIF in the detection of Mycobacterium tuberculosis and rifampicin resistance in different types of specimens,and we evaluate the valve of Genexpert MTB / RIF to detect Mycobacterium tuberculosis. Methods Totally 7 687 specimens of BACTEC MGIT 960 culture (MGIT 960 ) positive in Xi'an Chest Hospital from January 1, 2019 to December 31, 2020 were selected as the research objects, MGIT 960 and Micro DST test were used as standard to analyze the efficacy of GeneXpert MTB/RIF to detect Mycobacterium tuberculosis (MTB) and its drug resistance in different sputums. Results With MGIT 960 as standard, the sensitivity of GeneXpert MTB / RIF of detect MTB in sputum samples, bronchoalveolar lavage samples(BALF), serous cavity effusion, pus and tissue samples were 75.1%（653/869）, 82.1%(1 093/1 332), 57.3%(110/192), 80.0%(60/75), 77.3%（34/44）, and had significant difference between these specimens (χ²=64.100,P<0.001) . With Micro DST as standard, the sensitivity, specificity, positive predictive value, negative predictive value and Kappa value of GeneXpert MTB / RIF in detecting rifampicin resistance of Mycobacterium tuberculosis were 95.3%, 95.2%, 74.9%, 99.3% and 0.81 respectively; With Micro DST as standard, the sensitivity, specificity and Kappa value of GeneXpert MTB / RIF in detecting rifampicin resistance in sputum samples, BALF, serous cavity effusion, pus and tissue samples were 94.6%, 95.1%, 0.83;95.1%, 95.2%, 0.78;100%, 97.3%, 0.89;100%, 92.3%, 0.73;100%, 90.9%, 0.86. Conclusion GeneXpert MTB / RIF has high sensitivity in the detection of Mycobacterium tuberculosis in sputum samples, BALF, serous cavity effusion, pus and tissue samples, and can be used as an effective method for the detection of tuberculosis . The accuracy of GeneXpert MTB / RIF in detecting rifampicin resistance of Mycobacterium tuberculosis was higher in sputum samples, BALF, serous cavity effusion(including pleural fluid, ascites and cerebrospinal fluid) , pus and tissue samples .