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目的评价半巢式结核分枝杆菌/利福平全自动实时荧光定量核酸扩增技术(Xpert MTB/RIF)用于结核病应急诊断的临床价值。方法采集汕头市2015年1-12月疑似结核病突发公共卫生事件现场、口岸、急诊科、重症观察室的915例患者标本,应用涂片荧光染色法、BACTEC MGIT-960液体培养法、结核分枝杆菌DNA荧光定量法(TBDNA)、Xpert MTB/RIF技术分别进行检测,并将Xpert MTB/RIF利福平耐药结果与BACTEC MGIT-960药敏试验相比较。结果 915例患者中437例为活动性结核病患者,478例为非结核患者,Xpert MTB/RIF法的敏感性为51.72%(226/437),特异性为100%(478/478),Xpert MTB/RIF法的阳性检出率与涂片荧光染色法检测结果比较差异有统计学意义(χ~2=55.91,P<0.01),与BACTEC MGIT-960液体培养法、TB-DNA结果比较差异有统计学意义(χ2值分别为3.85和4.40,P<0.05);以BACTEC MGIT-960液体培养药敏试验为金标准,Xpert MTB/RIF检测利福平耐药的敏感度为92.31%(24/26),特异度为99.41%(168/169),二种方法具有良好的一致性(Kappa值为0.93)。结论 Xpert MTB/RIF法灵敏度和特异性高,操作简便、快速且易于开展,能在2h内报告结核分枝杆菌及利福平耐药结果,对结核病的应急诊断具有较高的应用价值。
Objective To evaluate the clinical value of Xpert MTB / RIF for the diagnosis of tuberculosis in response to Mycobacterium tuberculosis / rifampicin-based automated real-time fluorescence quantitative nucleic acid amplification. Methods A total of 915 specimens of suspected TB public health emergency scene, port, emergency department and critical observation room from January to December 2015 in Shantou City were collected and analyzed by smear fluorescence staining, BACTEC MGIT-960 liquid culture method, Mycobacterium tuberculosis DNA assay (TBDNA), Xpert MTB / RIF technology were detected, and the results of Xpert MTB / RIF rifampicin and BACTEC MGIT-960 susceptibility test was compared. Results Among the 915 patients, 437 were active TB patients and 478 were non-tuberculosis patients. The sensitivity of Xpert MTB / RIF assay was 51.72% (226/437) and the specificity was 100% (478/478). Xpert MTB / RIF method was significantly different from that of smear staining (χ ~ 2 = 55.91, P <0.01). Compared with BACTEC MGIT-960 liquid culture method and TB-DNA results (Χ2 = 3.85 and 4.40, respectively, P <0.05). According to the drug sensitivity test of BACTEC MGIT-960 liquid culture as the gold standard, the sensitivity of Xpert MTB / RIF detection of rifampicin resistance was 92.31% 26) with a specificity of 99.41% (168/169). The two methods showed good agreement (Kappa = 0.93). Conclusion The Xpert MTB / RIF method has high sensitivity and specificity, is simple, rapid and easy to carry out. It can report the drug resistance of Mycobacterium tuberculosis and rifampicin within 2 hours and has high value in emergency diagnosis of tuberculosis.