目的:探讨GeneXpert MTB/RIF(简称Xpert)法在快速诊断肺结核及检测利福平耐药性中的临床价值。方法:收集2018年1月至2019年3月上海市松江区中心医院感染科门诊1 059例疑似肺结核患者痰标本，均行Xpert、涂片抗酸染色和结核分枝杆菌液体培养检测。结果:1 059例疑似肺结核患者中，诊断临床肺结核398例(其中确诊病例297例)，非肺结核661例[其中非结核分枝杆菌(NTM)肺病6例]。在疑似病例、临床诊断病例和确诊病例中，Xpert法检测的阳性率分别为21.53%(228/1 059)、57.29%(228/398)和71.04%(211/297)，均较涂片法[12.09%(128/1 059)、30.65%(122/398)和39.39%(117/297)]显著升高(n χ2＝33.77、57.30、60.16，n P值均<0.01)，但疑似和临床诊断病例Xpert法阳性率较液体培养法[28.61%(303/1 059)、74.62%(297/398)]明显偏低(n χ2＝14.14、26.64，n P值均<0.01)。Xpert法在痰涂片阳性和痰培养阳性患者中的阳性率分别为91.41%(117/128)和69.64%(211/303)；确诊病例中，Xpert法对痰涂片阳性患者的诊断符合率为98.29%(115/117)，对痰涂片阴性患者的检出率为53.33%(96/180)。以肺结核确诊为金标准，Xpert法和涂片法诊断肺结核的敏感性分别为71.04%(211/297)、39.39%(117/297)，特异性分别为97.77%(745/762)、98.56%(751/762)；与涂片法相比，Xpert法的敏感性显著升高(n χ2＝60.16，n P<0.01)，2种方法的特异性差异无统计学意义。痰涂片阳性、培养阳性而Xpert检测阴性的患者有8例，其中确诊为NTM者6例；以药敏检测利福平耐药作为金标准，Xpert法诊断利福平耐药的敏感性为76.92%(10/13)，特异性为98.59%(280/284)，阳性预测值为71.43%(10/14)，阴性预测值为98.94%(280/283)。n 结论:Xpert在早期诊断肺结核、NTM鉴定和检测利福平耐药等方面具有较好的临床应用价值。“,”Objective:To investigate the clinical value of GeneXpert MTB/RIF (Xpert) in rapid diagnosis of pulmonary tuberculosis and detection of rifampicin-resistance.Methods:Sputum specimens of a total of 1 059 patients with suspected pulmonary tuberculosis by Xpert assay, smear acid-fast staining and bacterial liquid culture in the Department of Infection, Shanghai Songjiang District Central Hospital from January 2018 to March 2019 were collected.Results:Among 1 059 patients with suspected pulmonary tuberculosis, 398 were diagnosed as clinical pulmonary tuberculosis (including 297 confirmed), and 661 were not pulmonary tuberculosis (including six cases of non-tuberculosis mycobacterium lung disease). In the suspected, clinically diagnosed and confirmed cases, the positive rates detected by Xpert were 21.53%(228/1 059), 57.29% (228/398) and 71.04%(211/297), respectively, which were significantly higher than those by sputum smear [12.09%(128/1 059), 30.65%(122/398) and 39.39%(117/297)](n χ2=33.77, 57.30, 60.16, all n P<0.01), but the positive rates of Xpert in the suspected and clinically diagnosed cases were significantly lower than those of bacterial culture [28.61%(303/1 059), 74.62%(297/398)](n χ2=14.14, 26.64, all n P<0.01). The positive rates of Xpert in patients with positive smear or positive culture were 91.41% (117/128) and 69.64%(211/303), respectively.Among the confirmed cases, the diagnostic coincidence rate of Xpert for smear-positive patients was 98.29%(115/117), and the detection rate for smear-negative ones was 53.33%(96/180). Using the confirmed criteria of pulmonary tuberculosis as the “ gold standard” , the sensitivities of Xpert and smear for diagnosis of pulmonary tuberculosis were 71.04% (211/297) and 39.39%(117/297), and the specificities were 97.77%(745/762) and 98.56%(751/762), respectively.Compared with smear, the sensitivity of Xpert was significantly higher (n χ2=60.16, n P<0.01), but there was no statistical significance in the specificity.Eight cases with both smear-and culture-positive were negative by Xpert.Among them, six cases were diagnosed as non-tuberculosis mycobacterium.Using rifampicin-resistance of drug sensitivity test as the “ gold standard” , the sensitivity of Xpert for rifampicin-resistance was 76.92%(10/13), the specificity was 98.59%(280/284), the positive predictive value was 71.43%(10/14), and the negative predictive value was 98.94%(280/283).n Conclusions:Xpert has good clinical application value in early diagnosis of pulmonary tuberculosis, identification of non-tuberculosis mycobacterium and detection of rifampicin-resistance.