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目的 探讨影响结核感染T细胞斑点试验(T-SPOT.TB)检测结果的因素.方法 收集2014年5月至2015年4月同济大学附属上海市肺科医院共1537例住院患者的临床资料.以《临床诊疗指南:结核病分册》的标准将患者分为临床诊断结核病组(1159例)和临床诊断非结核病组(378例);再经病原学诊断及随访排除不能做出最终诊断的39例患者后,将患者分为结核病组(1103例;包括经分枝杆菌培养及菌种鉴定确诊的229例和最终临床诊断的874例)和非结核病组(395例;包括既往有结核病史或肺部存在陈旧性病灶者94例,无病史者301例1103例结核病组患者中,肺结核557例,结核性胸膜炎107例,淋巴结结核16例,骨关节结核51例,脑结核7例,多组织器官结核363例,其他肺外结核2例;395例非结核病组患者中,经分枝杆菌培养及菌种鉴定确诊的非结核分枝杆菌(NTM)感染患者93例.回顾性分析临床诊断结核病组和结核病组患者T-SPOT. TB检测结果的敏感度、特异度,结核病组与非结核病组患者T-SPOT. TB检测反应强度,不同结核病类型T-SPOT. TB检测阳性率,以及NTM感染患者与结核病患者的年龄差异.结果 (1)临床诊断结核病组T-SPOT. TB检测的敏感度为81.97％ (950/1159)、特异度为53.44％(202/378);结核病组T-SPOT.TB检测的敏感度为83.77％(924/1103)、特异度为54.43％(215/395);结核病组中抗酸染色阳性患者T-SPOT. TB检测阳性率为90.73％(235/259);培养阳性患者T-SPOT. TB检测阳性率为92.58％(212/229).(2)非结核病组有结核病史或肺部显示陈旧性结核病灶的患者与无病史者T-SPOT. TB检测的阳性率分别为69.15％(65/94)和38.21％(115/301),两组间差异有统计学意义(χ2=27.65,P=0.000).(3)结核病组与非结核病组T-SPOT. TB检测结果以斑点计数表示反应强度,结核病组对A、B抗原刺激出现阳性反应(斑点数≥1)的患者中,明显阳性及超强阳性(斑点数≥11)的比率分别为 69.81％(652/934)和69.67％(627/900),明显高于非结核病组[分别为46.83％(96/205)和46.63％(83/178)];经曼-惠特尼秩和检验,差异有统计学意义(Z值分别为-14.20、-14.63,P值均<0.01).(4)1103例结核病组患者中,T-SPOT.TB检测阳性率以淋巴结结核(87.50％,14/16)为最高,随后依次为多组织器官结核(87.33％, 317/363)、肺结核(86.54％, 482/557)、结核性胸膜炎(74.77％, 80/107),脑结核(57.14％, 4/7)和骨关节结核(50.98％,26/51)相对较低.(5)T-SPOT. TB检测阳性的NTM感染患者的平均年龄[(53.61± 18.43)岁]较 T-SPOT.TB检测阳性的确诊结核病患者[(44.98±18.88)岁]高,差异有统计学意义(t=- 2.63,P=0.009).结论 T-SPOT. TB检测结果受结核病诊断依据、痰菌量、既往结核病史或肺部陈旧性结核病灶、NTM感染、结核病灶存在的部位等多种因素的影响;T-SPOT. TB检测用于指导结核病诊断时,需综合考虑各项因素.“,”Objective To explore factors influencing T-SPOT. TB results in order to improve the accuracy of tuberculosis diagnosis. Methods Clinical data from 1537 inpatients was collected between May 2014 and April 2015 in Shanghai Pulmonary Hospital. Patients were grouped into a clinical TB group (1159 cases) and a clinical non-TB group (378 cases),according to the preliminary clinical diagnosis. Patients were then regrouped into a TB group and non-TB group according to the pathogenic diagnosis. The TB group (1103 cases) included 229 cases confirmed by acid-fast bacillus (AFB) staining and mycobacterium bacillus culture, and 874 cases confirmed by final clinical diagnosis, and the non-TB group (395 cases) included 94 cases with a previous history of tuberculosis or old tuberculosis lesions demonstrated by radiology, and 301 patients with no past history of tuberculosis. Thirty-nine cases, whose final diagnosis was uncertain, were excluded from the study. The 1103 cases in the TB group consisted of 557 cases of pulmonary tuberculosis,107 cases of tuberculous pleurisy, 16 cases of lymphoid tuberculosis,51 cases of osteoarticular tuberculosis,7 cases of cerebral tuberculosis, 363 cases of multiple organ tuberculosis and 2 cases of other extrapulmonary tuberculosis. There were 93 cases of nontuberculous mycobacterial (NTM) infection among the 395 cases in the non-TB group. We retrospectively analyzed the sensitivity and specificity of T-SPOT. TB in the different groups and discuss factors influencing the results. Results (1) The diagnostic sensitivity of T-SPOT. TB in the clinical TB group and the TB group were 81.97％ (950/1159) and 83.77％ (924/1103), respectively, and the diagnostic specificity of T-SPOT. TB in these two groups were 53.44％ (202/378) and 54.43％ (215/395), respectively. The positive diagnostic ratio of T-SPOT. TB was 90.73％ (235/259) for TB cases with positive AFB results and 92.58％ (212/229) for those with positive culture results. (2) There was a significant difference in the positive rate of T-SPOT. TB between non-TB cases with a previous history of tuberculosis or with old tuberculosis lesions demonstrated by radiology (69.15％,65/94), and non-TB cases with no previous history of TB (38.21％,115/301; χ2=27.65,P = 0.000). (3) The TB specific antigen A and B spot counts in the TB-group (69.81％ (652/934) and 69.67％ (627/900) for spot counts and spot counts ≥11) were significantly higher than in the non-TB group (46.83％ (96/205) and 46.63％ (83/178) for spot counts ≥1 and spot counts ≥11; Z=-14.20,-14, 63,respectively; P<0.01). (4) The positive ratios of T-SPOT. TB for tuberculosis varied according to the type of organ lesion. The positive diagnostic ratio was highest for lymph node tuberculosis (87.50％, 14/16),followed by multiple organ tuberculosis (87.33％, 317/363), pulmonary tuberculosis (86.54％, 482/557), tuberculous pleurisy (74.77％, 80/107). The positive diagnostic ratio was low for cerebral tuberculosis (57.14％,4/7) and osteoarticular tuberculosis (50.98％,26/51). (5) The average age of NTM cases with positive T-SPOT. TB results (53.61±18.43) was higher than that of TB cases with positive T-SPOT. TB results (44.98±18.88) (t=-2.63, P=0.009). Conclusion Diagnostic methods, sputum bacteria counts, previous history of tuberculosis or old tuberculosis lesions, non-tubercular mycobacterium infection secondary to tuberculosis, and the type of tuberculosis can influence T-SPOT. TB results and should not be ignored in T-SPOT, TB-based TB diagnosis.