T-SPOT.TB实验在结核感染临床诊断中的应用价值

Clinical value of T-SPOT. TB assay in the diagnosis of patients with tuberculosis

目的通过对疑似结核感染者进行T-SPOT.TB检测,并与TST实验进行比较分析,评估T-SPOT.TB实验应用于结核分枝杆菌感染的临床诊断价值。方法纳入260例疑似结核病患者作为研究对象,进行T-SPOT.TB检测和TST实验,同时设立健康对照组122例,计算T-SPOT.TB实验的敏感度、特异度、阳性预测值、阴性预测值并与TST实验进行比较分析。结果结核组T-SPOT.TB的阳性率高于非结核组和健康对照组,差异均有统计学意义(P<0.05);T-SPOT.TB对于结核确诊患者诊断敏感度为91.4%;非结核组诊断特异度为70.7%;健康对照组诊断特异度为89.3%。对于疑似结核病患者,T-SPOT.TB实验的阳性预测值、阴性预测值分别为88.5%和76.8%;结核组T-SPOT.TB实验阳性斑点数目高于非结核组和对照组,差异均有统计学意义(P<0.01);T-SPOT.TB阳性斑点数目与TST实验阳性硬结直径的大小之间呈正向相关(r2=0.345,P<0.05)。结论 T-SPOT.TB实验具有较高的敏感度和特异度,是临床诊断和排除活动性结核感染的有效工具,具有较高的临床推广和应用价值。

Objective To detect the suspicious patients with tuberculosis with T - SPOT. TB assay and compare the result with TST assay, so as to evaluate the clinical value of T - SPOT. TB assay in the diagnosis of tuberculosis （TB）. Methods 260 sus- picious patients with TB and 122 healthy volunteers were prospectively recruited in this study for T - SPOT. TB assay and TST assay. The sensitivity, specificity, positive predictive value, negative predictive value in T - SPOT. TB assay for the diagnosis of active TB were detected, and then were compared with that in TST assay. Results The positive rate of the T - SPOT. TB in TB patients was significantly higher than that in non - TB patients and the healthy controls, and the differences were statistically sig- nificant （P 〈0.05）. The sensitivity of the T - SPOT. TB assay for the diagnosis of active TB was 91.4%. The specificity was 70.7% in non - TB patients and 89.3% in healthy controls. The positive and negative predictive values of the assay were 88.5% and 76.8% respectively in suspected TB cases. The number of spot - forming cells in TB patients was significantly higher than that of the non - TB patients and the controls group, and there was statistical significance on the difference between them （P 〈0.01 ）. Regression analysis demonstrated a good positive correlation between the number of spot- forming cells in the T- SPOT. TB assay and the size of the induration in the TST assay（r2 =0.345, P 〈0.05）. Conclusion The T- SPOT. TB assay has high sensitivity and specificity in the T - SPOT. TB assay, which is a useful clinical tool for the diagnosis and ex- clusion of active TB, and has higher clinical value on promotion and application.