两种γ-干扰素释放试验方法在结核病诊断中的应用价值比较  

Comparison of the value of two tuberculosis-IFN-γ release assay kits in the diagnosis of tuberculosis

作　　者：卫卫[1] 肖和平[1] 李红[1] 胡海琍[1] 顾瑾[1] 刘一典[1] 桂徐蔚[1] 沈芸[1] 郝晓晖[1] 沈彦恒[1] 楼海[1] 王鹏[1] 孙勤[1] 沙巍[1] 

机构地区：[1]同济大学附属上海市肺科医院结核病诊疗中心上海市结核肺重点实验室,200433

出　　处：《中国防痨杂志》2015年第7期768-773,共6页Chinese Journal of Antituberculosis

摘　　要：目的对比研究两种γ干扰素释放试验方法IGRA-ELISA技术和结核感染T细胞斑点试验（T-SPOT．TB）在结核病诊断中的应用价值。方法前瞻性研究纳入2014年1月1日至2014年12月31日在上海市肺科医院结核科门诊及住院诊治的疑似结核病患者81例，最终53例确诊为活动性结核病、28例为非活动性结核病。每例患者分别采用IGRA-ELISA技术和T-SPOT．TB两种方法进行平行检测，采用卡方检验比较两种诊断方法的检测结果，两种方法检测结果一致性评价采用Kappa一致性检验。结果81例疑似结核病患者中，IGRA-ELISA检测阳性52例，阴性29例；T-SPOT．TB检测阳性54例，阴性27例，两种方法阳性符合率92．6％（50／54），阴性符合率92．6％（25／27），总符合率为92．6％（75／81）。两种诊断方法检测结果比较，差异无统计学意义（χ^2=55．984，P〉0．05），诊断一致性高（Kappa值=0．836）。IGRA-ELISA技术和T-SPOT．TB检测活动性结核病的阳性检出率分别为81．1％（43／53）和84．9％（45／53），远高于涂片（21．2％，11／52）、核酸检测（16．7％，6／36）和结核抗体检测（36．5％，19／52），两种诊断技术检测非活动性结核病的阴性检出率均为67．9％（19／28）。结论IGRA-ELISA技术和T-SPOT．TB检测性能相似，在结核病诊断方面均具有较高的敏感度，对临床有较好的应用价值。Objective To evaluate the clinical application value of two interferon-gamma release assay, IGRA-ELISA and T-SPOT. TB, in the diagnosis of tuberculosis （TB）. Methods A total of 81 patients with sus- pected TB who were in clinic or hospitalized in Shanghai Pulmonary Hospital from Jav 1st, 2014 to Dee. 31th, 2014 were enrolled in this prospective study. Among them, fifty-three patients were diagnosed as active TB, and 28 were diagnosed as non-TB. Each patient was tested by both IGRA-ELISA and T-SPOT. TB. The performance of the two tests was compared by chi square X2 test. Consistency of the two tests was compared by Kappa test. Results Fifty-two patients were positive and 29 patients were negative using IGRA ELISA, while 54 patients were positive and 27 patients were negative using T-SPOT. TB. The positive, negative and total coincidence rates of the two tests were 92.6% （50/54）, 92.6% （25/27） and 92.6% （75/81）, respectively. The two tests were highly con- sistent （X2 =55. 984, P〉0.05, Kappa=0. 836）. The positive rates of IGRA-ELISA and T-SPOT. TB were 81.1 %（43/53） and 84.9% （45/53）, respectively, which was much higher than those of smear （21.2%,11/52）, nucleic acid （16.7%, 6/36） and tuberculosis antibody （36.5%, 19/52）. The negative rates of the two tests in non-TB patients were both 67.9% （19/28）. Conclusion Both of IGRA ELISA and T-SPOT. TB had high sensitivities in the diagnosis of TB and can be used as valuable tools in the diagnosis of TB infection.

关 键 词：结核/诊断 干扰素γ释放试验 酶联免疫吸附测定 酶联免疫斑点测定 

分 类 号：R52[医药卫生—内科学]