摘要目的 研究结核感染T细胞斑点试验(T-SPOT.TB)在结核病诊断中的临床应用价值.方法 回顾性分析201 1年2-10月郑州大学第一附属医院收治的结核病疑似患者1 084例,其中男607例,女477例;年龄2 ～ 89岁,中位年龄45岁;根据诊断情况将患者分为肺结核组、肺外结核组和非结核病组.将患者抗结核治疗前的T-SPOT.TB结果与最终临床诊断进行比较,评价其特异度、敏感度、阴性预测值、阳性预测值、阴性似然比及阳性似然比.分析接受抗结核治疗患者T-SPOT.TB的复查结果,比较治疗前后T-SPOT.TB结果斑点数的变化.组间比较采用配对t检验.结果 1 084例中有384例(35.4％)确诊为结核病患者,54例为实验室诊断,其中42例T-SPOT.TB结果阳性,敏感度为77.8％ (42/54);330例为临床诊断,其中289例T-SPOT.TB结果阳性,敏感度为87.6％ (289/330).T-SPOT.TB的综合敏感度为86.2％(331/384).700例(64.6％)非结核病患者中,638例T-SPOT.TB检测结果为阴性,特异度为91.1％ (638/700),阳性预测值为84.2％ (331/393),阴性预测值为92.3％(638/691),阳性似然比为9.69,阴性似然比为0.15.60例经抗结核治疗2～4周后复查T-SPOT.TB,治疗后相对分子质量为6 000的早期分泌抗原靶和相对分子质量为10 000的培养滤液蛋白的特异性斑点数(平均数分别为47个和18个)均显著低于治疗前(平均数分别为99个和49个).结论 T-SPOT.TB诊断结核病的敏感度和特异度较高,具有较好的临床应用价值.

abstractsObjective To evaluate the T-SPOT.TB assay for the diagnosis of tuberculosis in a large clinical samples.Methods We analyzed the T-SPOT.TB results of 1 084 tuberculosis (TB) suspects who were admitted to the First Affiliated Hospital of Zhengzhou University from February 2011 to October 2011.The sensitivity,specificity,positive predictive value,negative predictive value,positive likelihood ratio,negative likelihood ratio of T-SPOT.TB were analyzed according to the final diagnosis.Among these patients,60 were retested by T-SPOT.TB after 2-4 week anti-tuberculosis treatment,and spot forming cells (SFCs) were compared before and after treatment.Paired t-test was used for comparison between groups.Results Three hundred and eighty-four patients were eventually diagnosed to have TB.Among 54 patients with laboratory diagnosis of TB,42 were T-SPOT.TB positive,and the sensitivity was 77.8％ (42/54).In 330 cases clinically diagnosed as tuberculosis,289 were T-SPOT.TB positive,and the sensitivity was 87.6％ (289/330).The total sensitivity of T-SPOT.TB was 86.2％ (331/384).In 700 non-TB patients,638 cases were T-SPOT.TB negative,and the specificity was 91.1％ (638/700).The positive predictive value,negative predictive value,positive likelihood ratio and negative likelihood ratio were 84.2％ (331/393),92.3％ (638/691),9.69 and 0.15,respectively.Sixty patients were retested by the T-SPOT.TB after anti-TB treatment (2-4 weeks),and the results showed that both ESAT-6 and CFP-10 specific SFCs (47 and 18,respectively) decreased significantly compared with those before anti-TB treatment (99 and 49,respectively).Conclusion Results in this large scale study indicate that T-SPOT.TB is a promising test for the diagnosis of tuberculosis due to its high sensitivity and specificity.