结核杆菌特异性细胞免疫反应检测试剂的临床试验  

Clinical test of Mycobacterium tuberculosis specific cell mediated immune response detection kit

作　　者：陈雪林[1] 邢俊蓬 刘佳文[2] 马亮亮[1] 石芸[1] 崔嘉[1] 任海涛[1] 

机构地区：[1]北京老年医院感染疾病科,北京100095 [2]北京老年医院检验科,北京100095

出　　处：《临床肺科杂志》2015年第9期1580-1583,共4页Journal of Clinical Pulmonary Medicine

摘　　要：目的验证武汉海吉力生物科技有限公司新研制的"结核杆菌特异性细胞免疫反应检测试剂盒(酶联免疫法)"(简称海吉力试剂)的诊断性能,探讨γ-干扰素释放试验在结核病诊断中的价值。方法以北京万泰生物药业有限公司生产的"结核杆菌相关γ-干扰素检测试剂盒(体外酶联免疫法)"(简称万泰试剂)为对照,同时用海吉力试剂对武汉市医疗救治中心、北京老年医院、河北胸科医院1084例受试者的外周血进行检测,比较两种检测试剂盒的一致性、诊断性能。结果海吉力试剂与万泰试剂检测结果的总符合率为90.6%,Kappa值为0.812(P=0.000)。海吉力试剂的敏感性为80.7%,万泰试剂的敏感性为78.6%,两者差异无统计学意义(χ2=1.64,P=0.20),海吉力试剂的特异性为74.1%,万泰试剂的特异性为75.0%,两者差异无统计学意义(χ2=0.09,P=0.76)。对肺外结核、菌阴结核患者,两种试剂敏感性稍高,差异均无统计学意义(P>0.05)。结论新研制的海吉力试剂与万泰试剂具有很好的一致性,两者对结核病的诊断效能相当,对肺外结核、菌阴结核患者的诊断价值较高。Objective To test and verify the diagnostic effect of Mycobacterium Tuberculosis Specific Cell Mediated Immune Response Detection Kit （HG-IGRA, Wuhan Hygeianey Bioscience Co. Ltd. ）, and to discuss the clinical value of interferon-γ release assay （IGRA） on tuberculosis （TB）. Methods The serum specimens of 1084 subjects were detected by HG-IGRA and TB-IGRA, respectively. Taking Mycobacterium tuberculosis correlative IFN- γ release assay kit as reference （TB-IGRA, Beijing Wantai Biological Pharmacy Co. Ltd. ） , the sensitivity and specificity of HG-IGRA were evaluated. Results The tested agreement between the two kits was 90.6% with a Kappa value of 0.81 （P 〈 0.01 ）. The sensitivity and specificity of HG-IGRA were 80.7% and 74.1%, and 78.6% and 75.0% for TB-IGRA （ P 〉 0.05 ）. In extra-pulmonary TB or bacterial-negative TB patients, there was no significant difference in sensitivity between the two kits （ P 〉 0.05 ）. Conclusion HG-IGRA and TB-IGRA have good consistency, that is they have the similar diagnostic value on TB, extra-pulmonary TB and bacterial-negative TB patients.

关 键 词：结核 诊断 Γ-干扰素释放试验 

分 类 号：R446.5[医药卫生—诊断学]