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结核感染T细胞斑点试验中结核特异性抗原和植物血凝素比值对活动性结核的诊断价值

The ratio of tuberculosis-specific antigen to phytohemagglutinin in T-SPOT assay in the diagnosis of active tuberculosis

摘要目的 探讨结核感染T细胞斑点试验(T-SPOT)中结核特异性抗原(TBAg)和植物血凝素(PHA)比值(TBAg/PHA)对活动性结核的诊断价值.方法 纳入2014年1月至2017年1月华中科技大学同济医学院附属同济医院MTB培养阳性患者378例,其中肺结核268例,肺外结核110例;男204例,女174例,年龄16~ 85岁,平均(48.6±18.2)岁.纳入本院同期体检健康者824名,其中男436名,女388名,年龄16 ~ 80岁,平均(41.6±16.4)岁.所有受试者均进行T-SPOT检测并计算TBAg/PHA比值.本研究另在2017年1-12月纳入广州市胸科医院MTB培养阳性且T-SPOT阳性患者223例作为验证组.本研究为回顾性病例对照研究,采用GraphPad Prism 5.01统计软件进行数据分析,连续变量比较使用Mann-Whitney U检验.结果 378例活动性结核患者中T-SPOT阳性344例,824名健康体检者中T-SPOT阳性204名.以健康体检者为对照组,T-SPOT试验阳性诊断活动性结核的敏感度和特异度分别为91.0%(344/378)和75.2%(620/824).直接利用T-SPOT斑点数结果鉴别活动性结核与MTB潜伏感染的效果不佳,受试者工作特征(ROC)曲线下面积为0.7~0.8.使用TBAg/PHA比值区分活动性结核与MTB潜伏感染的效果明显优于T-SPOT斑点数方法,ROC曲线下面积为0.881(95%CI为0.853 ~ 0.909).当TBAg/PHA>0.234时,该比值用于区分活动性结核与MTB潜伏感染的敏感度及特异度分别为69.5%(239/344)和94.1%(192/204).TBAg/PHA比值在验证组中用于区分活动性结核与MTB潜伏感染也具有较好效果,ROC曲线下面积为0.901(95%CI为0.872~ 0.931).本研究入组的344例活动性结核患者中96例为肺外结核患者,当TBAg/PHA>0.234时,TBAg/PHA比值诊断肺外结核的敏感度及特异度分别达到79.2% (76/96)和94.1%(192/204),ROC曲线下面积为0.932(95%CI为0.897~ 0.967).结论 TBAg/PHA比值在区分活动性结核与MTB潜伏感染的效果优于T-SPOT斑点数的结果,该比值在诊断肺外结核时也具有一定的参考意义.

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abstractsObjective The aim of this study was to determine the performance of the ratio of tuberculosis-specific antigen (TBAg) to phytohemagglutinin (PHA) (TBAg/PHA ratio) in T-SPOT assay in the diagnosis of active tuberculosis (ATB).Methods Between January 2014 and January 2017,378 Mycobacterium tuberculosis (MTB) culture positive patients (268 cases of pulmonary tuberculosis,110 extra-pulmonary tuberculosis) and 824 healthy individuals were recruited from Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology.T-SPOT assay was performed and TBAg/PHA ratio was calculated in all the participants.To validate the study,another group of 223 MTB culture positive TB patients with positive T-SPOT results were recruited fron Guangzhou Chest Hospital between January 2017 and December 2017.This was a retrospective case-control study and differences between groups were analyzed using the Mann-Whitney U-test.Results Of the 378 culture positive ATB patients,344 patients had positive T-SPOT results.Of the 824 healthy individuals,204 individuals had positive T-SPOT results.Using healthy individuals as the control group,the sensitivity and specificity of T-SPOT assay in the diagnosis of ATB were 91.0% (344/378) and 75.2% (620/824).Directly using T-SPOT results had a limited accuracy in distinguishing ATB from latent tuberculosis infection (LTBI).The area under the receiver operating characteristic (ROC) curve was between 0.7 and 0.8.However,a further calculation of the TBAg/PHA ratio showed a better performance than TBAg in distinguishing these two conditions,and the area under the ROC curve was 0.881 (95% CI:0.853-0.909).If using the threshold value of 0.234,the sensitivity and specificity of the TBAg/PHA ratio in distinguishing ATB from LTBI were 69.5% (239/344)and 94.12% (192/204).The validation data showed that the performance of the TBAg/PHA ratio in distinguishing ATB from LTBI was also satisfactory,and the area under the ROC curve was 0.901 (95% CI:0.872-0.931).Furthermore,the TBAg/PHA ratio had an important role in the diagnosis of extra-pulmonary tuberculosis.If using the threshold value of 0.234,the sensitivity and specificity of the TBAg/PHA ratio in the diagnosis of extra-pulmonary tuberculosis were 79.2% (76/96) and 94.1% (192/204).The area under the ROC curve was 0.932 (95% CI:0.897-0.967).Conclusions The TBAg/PHA ratio in T-SPOT assay was better than directly using T-SPOT results in distinguishing ATB from LTBI.This ratio also showed a potential use in the diagnosis of extra-pulmonary tuberculosis.

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作者 王婷 [1] 谭耀驹 [2] 吴士及 [1] 黄敏 [1] 殷波涛 [1] 黄劲 [1] 魏娜 [1] 魏巍 [1] 汪峰 [1] 学术成果认领
栏目名称 论著
DOI 10.3760/cma.j.issn.1001-0939.2019.04.003
发布时间 2019-06-12
基金项目
国家自然科学基金(81401639)National Natural Science Foundation of China
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中华结核和呼吸杂志

中华结核和呼吸杂志

2019年42卷4期

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