人结核分枝杆菌相关干扰素-γ释放酶联免疫法对结核病诊断价值的探讨  

Diagnostic Value of MTB IFN-γ Release ELISA Assay for Tuberculosis

作　　者：吴纯[1] 李妮[1] 佟爱华[1] 宫留芳[1] 冯倩茹[1] 邓先平[1] 骆娟[1] 孙彬[1] 

机构地区：[1]解放军第309医院检验科,北京100091

出　　处：《标记免疫分析与临床》2016年第3期244-247,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：目的评价人结核分枝杆菌相关干扰素-γ体外释放酶联免疫免疫法(quantitative diagnostic kit for mycobacterium tuberculosis IFN-γrelease assay,TB-IGRA)在结核病的诊断价值。方法选择确诊肺内结核164例、肺外结核90例、肺部感染90例、结核性胸膜炎60例及体检正常人群107例为对照,分别采用TB-IGRA、结明三项等方法对结核分枝杆菌感染进行辅助诊断,并对全部病例进行血沉、CRP、血常规等项目的检测,对结果进行统计学分析评价,并通过ROC曲线评价特异性IFN-γ释放试验的辅助诊断价值。结果结核患者外周血细胞经结核分枝杆菌抗原刺激后释放入血浆中的IFN-γ的含量明显高于肺部感染组和健康对照组,且肺内结核组略高于肺外结核组,差异均有统计学意义(P<0.05)。全部患者释放入血浆中IFN-γ的含量的高低与WBC、PLT计数无相关性,且与ESR和CRP水平呈负相关,但无统计学意义。用血清结核抗体检测试验诊断结核病的灵敏度为78.03%,特异性为37.06%,而TB-IGRA则为76.43%和84.77%。ROC曲线显示,以youden指数最大处的31.84pg/m L为诊断临界点,TB-IGRA诊断结核病的灵敏度为68.8%,特异性为93.4%。结论 TB-IGRA检测肺内、肺外结核病,特异性高,操作简便、快速,准确有效,值得临床推广应用。Objective To evaluate the diagnostic value of quantitative diagnostic kit for mycobacterium tuberculosis IFN-γ release assay（ TB-IGRA） in tuberculosis. Methods The serum specimens of 164 patients with pulmonary tuberculosis,90 cases with extra pulmonary tuberculosis,90 cases with pulmonary infection,90 cases with tuberculosis pleurisy and 107 health peoples were detected by TB-IGRA and Myco Dot,The ESR,CRP and routine blood examination were detected at the same time. Results The levels of IFN-γ detected in tuberculosis groups were obviously higher than that in pulmonary infection group and health control group,and the levels in pulmonary tuberculosis group were also higher than that in extra pulmonary tuberculosis group（ P〈0. 05）. There was no correlation between the levels of IFN-γ with WBC and PLT. The levels of IFN-γ were negatively correlated with the levels of ESR and CRP. The sensitivity of tuberculosis antibody test and TB-IGRA were 78. 03% and 76. 43%,the specificity were 37. 06% and 84. 77% respectively. ROC curve showed that the sensitivity and specificity at the threshold of 31. 84 pg / m L,the optimal cut-off of IFN-γ to diagnosis tuberculosis,were 68. 8% and 93. 4%. Conclusion TB-IGRA is a convenient,rapid,sensitive,accurate and effective method for the detection of intrapulmonary and extra pulmonary tuberculosis. It is worthy of being developed and adopted in clinical practice.

关 键 词：结核病 干扰素释放酶联免疫法 ROC曲线 灵敏度 特异性 

分 类 号：R52[医药卫生—内科学]