新型结核分枝杆菌特异性细胞免疫反应检测技术对结核病辅助诊断的价值评估  

Diagnostic Performance of a Novel Mycobacterium tuberculosis Specific T-Cell Based Assay for Tuberculosis

作　　者：潘丽萍[1] 高孟秋[1] 贾红彦[1] 黄麦玲[1] 魏荣荣[1] 孙琦[1] 邢爱英[1] 杜博平 张宗德[1] Pan Liping;Gao Mengqiu;Jia Hongyan;Huang Mailing;Wei Rongrong;Sun Qi;Xing Aiying;Du Boping;Zhang Zongde(Department of Tuberculosis,Beijing Chest Hospital,Capital Medical University,Beijing 101149,China)

机构地区：[1]首都医科大学附属北京胸科医院耐药结核病研究北京市重点实验室北京市结核病胸部肿瘤研究所,110149

出　　处：《结核病与胸部肿瘤》2021年第4期245-250,共6页Tuberculosis and Thoracic Tumor

基　　金：国家自然科学基金(81902024);国家科技重大专项(2015ZX10004801-003,2017ZX10201301-004);北京市自然科学基金(7192038);北京市医管局青苗人才项目(QML20151501);北京市医管局登峰人才项目(DFL20181601);通州区运河人才计划(YH201807,YH201921,YH202001)。

摘　　要：目的评价以干扰素诱导蛋白-10(IP-10)为靶标的新型结核分枝杆菌特异性细胞免疫反应检测技术,即结核感染T细胞检测(PCR荧光探针法,简称IP-10.TB)在结核病辅助诊断中的性能,及该检测技术与结核感染T细胞斑点检测(T-SPOT.TB)技术的一致性。方法2018年3月至2019年11月,在首都医科大学附属北京胸科医院前瞻性纳入疑似结核病患者,并募集结核分枝杆菌低感染风险人群。所有入组者同时行外周血IP-10.TB检测和T-SPOT.TB检测,受试者操作特征曲线计算两种检测技术的诊断价值,两种检测技术的一致性分析采用kappa检验,IP-10相对表达量和释放γ干扰素的斑点形成细胞数量的相关性分析采用Pearson检验。结果纳入结核病患者235例、非结核病患者110例、结核分枝杆菌低感染风险人群153例进行最终分析。IP-10.TB检测(3/498,0.60%)和T-SPOT.TB检测(6/498,1.21%)获得的不确定结果比例差异无统计学意义(P=0.32)。在489例有效检测标本中,IP-10.TB检测的敏感度和特异度分别为91.3%(95%CI 86.8%〜94.6%)和81.1%(95%CI 75.8%〜85.7%),其中结核分枝杆菌低感染风险人群中的诊断特异度为98.0%(95%CI 94.4%〜99.6%);T-SPOT.TB检测的敏感度和特异度分别为93.0%(95%C788.9%〜96.0%)和83.8%(95%CI 78.7%〜88.1%),其中结核分枝杆菌低感染风险人群中的诊断特异度为100%(95%CI97.6%〜100.0%)。两种检测技术的诊断敏感度和特异度差异均无统计学意义(P>0.05)。两种检测技术的阳性符合率为91.0%(95%CI 87.5%〜94.5%),阴性符合率为88.9%(95%CI 84.9%〜92.9%),总符合率为90.0%(95%CI 87.3%〜92.6%),一致性检验kappa值为0.80(95%CI 0.75〜0.85,P<0.001)。结论IP-10.TB检测具有与T-SPOT.TB检测一致的诊断性能,可用于结核病辅助诊断。Objective To evaluate the diagnosic performance of a novel Mycobacterium tuberculosis(MTB)specific T-cell based assay for tuberculosis,which targets the mRNA detection of interferon gamma-induced protein 10(IP-10).Methods Suspected tuberculosis patients were prospectively and consecutively recruited in Beijing Chest Hospital between March 2018 and November 2019.and individuals with lower risk of MTB infection were also recruited.IP-10.TB and T-SPOT.TB assays were simulataneously performed on peripheral blood samples,The diagnostic performance of IP-10.TB and T-SPOT.TB were analyzed using the receiver operating characteristic curve.Accordance of IP-10.TB and T-SPOT.TB was analyzed by Cohen's kappa test,while the correlation between the expression level of IP-10 mRNA in IP-10.TB test and the number of SFCs in T-SPOT.TB test were analyzed by Pearson correlation test.Results A total of 235 patients with tuberculosis,110 patients with other diseases and 153 individuals with lower risk of MTB infection were included in the final analysis.No significant difference was detected in the rate of indeterminate results between IP-10.TB assay(3/498,0.60%)and T-SPOT.TB assay(6/498,1.21%).The total sensitivity and specificity of IP-10.TB assay were 91.3%(95%CI 86.8%-94.6%)and 81.1%(95%CI 75.8%-85.7%).The specificity of IP-10.TB in individuals with lower risk of MTB infection was 98.0%(95%CI 94.4%-99.6%).The total sensitivity and specificity of T-SPOT.TB assay were 93.0%(95%CI88.9%-96.0%)and 83.8%(95%CI 78.7%-88.1%).The specificity of T-SPOT.TB in individuals with lower risk of MTB infection was 100%(95%CI97.6%-100.0%).No significant differences were detected in sensitivity and specificity between IP-10.TB and T-SPOT.TB assays(P>0.05).The positive coincidence rate of these 2 methods was 91.0%(95%C787.5%-94.5%),and the negative coincidence rate was 88.9%(95%CI 84.9%-92.9%)and the total coincidence rate was 90.0%(95%CI 87.3%-92.6%).The Cohen's kappa value was 0.80(95%CI 0.75-0.85,P<0.001)between IP-10.TB and T-SPOT.TB assays.Conclu

关 键 词：结核 分枝杆菌 结核 干扰素诱导蛋白-10 Γ-干扰素释放试验 

分 类 号：R52[医药卫生—内科学]