摘要
目的评价采用A.TB试剂[酶联免疫吸附试验（enzyme-linked immunosorbent assay,ELISA）]进行结核杆菌特异性γ-干扰素释放试验（interferon-gamma release assays,IGRAs）对结核病的临床诊断性能及应用价值。方法 108例研究对象中,临床明确诊断结核病60例（结核组）,非结核病对照者48例（非结核对照组）。同时采用A.TB试剂（ELISA法）和T-SPOT.TB试剂[酶联免疫斑点试验（enzyme-linked immunosorbent spot,ELISPOT）]进行IGRAs。结果 A.TB试剂（ELISA法）检测的灵敏度为86.67%,特异度为85.42%,受试者工作特征曲线（receiver-operating characteristic curve,ROC曲线）下面积为0.822,95%可信区间（confidence interval,CI）为0.733~0.912。T-SPOT.TB试剂（ELSPOT法）检测灵敏度为91.67%,特异度为87.50%,ROC曲线下面积为0.884,95%CI为0.806~0.962。ROC曲线下面积差异无统计学意义（χ^20.081,P=0.776）。2种检测方法一致率为87.04%（94/108）,Kappa值为0.738。结论 A.TB试剂和T-SPOT.TB试剂检测的整体诊断性能相似,且A.TB试剂检测在操作和检测结果判读方面明显优于T-SPOT.TB试剂。
Objective To evaluate the diagnostic performance and application value of enzyme-linked immunosorbent assay（ELISA）-based interferon-gamma release assays（IGRAs） with A.TB kit for patients with tuberculosis. Methods Of 108 patients enrolled in the study, 60 were definitely diagnosed with tuberculosis（tuberculosis group）, and 48 were controls（non-tuberculosis group）.ELISA-based IGRAs with A.TB kit and enzyme-linked immunosorbent spot（ELISPOT）-based IGRAs with T-SPOT.TB kit were carried out simultaneously. Results The sensitivity and specificity of ELISA-based IGRAs with A.TB kit were 86.67% and 85.42%,and the area under a receiver-operating characteristic（ROC） curve was 0.822 [95% confidence interval（CI）, 0.733-0.912]. The sensitivity and specificity of ELISPOT-based IGRAs with T-SPOT.TB kit were 91.67% and 87.50%, and the area under ROC curve was 0.884（95% CI, 0.806-0.962）. The difference in the area under ROC curve was not significant between the two assays（χ^20.081, P=0.776）. The consistency of the two assays was 87.04%（94/108） with the Kappa value of 0.738. Conclusions ELISA-based IGRAs with A.TB kit and ELISPOT-based IGRAs with T-SPOT.TB kit have a similar overall diagnostic performance, but ELISA-based IGRAs with A.TB kit is superior to ELISPOT-based IGRAs with T-SPOT.TB kit in the operation and interpretation of the test results.
出处
《传染病信息》
2014年第5期302-305,共4页
Infectious Disease Information
基金
国家"十二五"科技重大专项(2013ZX09J13106-06A)
关键词
干扰素γ释放试验
结核分枝杆菌
预测
免疫印迹法
指示剂和试剂
interferon-gamma release tests
Mycobacterium tuberculosis
forecasting
immunoblotting
indicators and reagents
