重组结核分枝杆菌11 kDa蛋白皮肤试验与结核菌素皮肤试验的比较研究  

Comparison of Recombinant Mycobacterium Tuberculosis 11 kDa Protein Skin Test and TB-PPD

作　　者：赵淑娟 李春 关永春 张悦琴 郭金红 郑素华[2] 

机构地区：[1]北京市大兴区结核病预防控制中心,北京102600 [2]首都医科大学附属北京胸科医院流研室,北京101149

出　　处：《医学综述》2017年第20期4146-4149,共4页Medical Recapitulate

基　　金：国家科技重大专项课题(2012ZX10004701)

摘　　要：目的比较重组结核分枝杆菌11 kDa蛋白(重组11 kDa蛋白)皮肤试验与结核菌素皮肤试验(PPD)两种检测方法,探讨更适合结核分枝杆菌潜伏感染者的筛查方法。方法选取2015年9月北京市大兴区某大学新生共461名,进行重组11 kDa蛋白和PPD的同体双臂皮肤试验,分别于不同前臂皮内注射0.1 mL重组11 kDa蛋白(10μg/L)和0.1 mL结核菌素纯蛋白衍生物(TB-PPD)(50 U/mL),观察注射后72 h后皮肤反应。于皮肤试验前采集461名志愿者的静脉血,进行体外γ干扰素释放试验(T-SPOT.TB)检测,采用T-SPOT.TB试剂盒进行。比较重组11 kDa蛋白皮肤试验、结核菌素PPD皮肤试验的差异性。结果以注射72 h后的硬结反应进行统计,2种检测结果显示男女阳性率比较,差异无统计学意义。重组11 kDa蛋白皮肤试验中阳性反应者为17名,阳性率为3.68%;PPD皮肤试验中强阳性反应者为8名,强阳性率为1.74%。以T-SPOT检测结果为标准,重组11 kDa蛋白皮肤试验灵敏度、特异度、准确度分别为39.53%,100.00%,94.36%;PPD皮肤试验灵敏度、特异度、准确度分别为16.28%,99.76%,91.97%。结论重组11 kDa蛋白皮肤试验灵敏度高,与体外T-SPOT.TB检测结果一致且简便易行,有望成为结核分枝杆菌潜伏感染的新的筛查方法。Objective To compare recombinant Mycobacterium tuberculosis（MTB） 11 kDa protein（recombinant 11 kDa protein） skin test and tuberculin skin test（PPD）,and to explore the screening method more suitable for latent MTB infection.Methods A total of 461 freshmen from a university in Daxing District of Beijing in September 2015 were selected to carry out the skin test of recombinant 11 kDa protein and PPD on two arms of the same body respectively.Each volunteer was injected i.d.with 0.1 mL recombinant 11 kDa protein（10 μg/L） and 0.1 mL TB-PPD（50 U/mL） in two arms respectively,and the skin reaction was observed 72 hours after the injection.The venous blood samples of the 461 volunteers were collected before skin test for interferon γ release assay（IGRA） by T-SPOT.TB kit.The differences of two kinds of the detection methods were compared.Results There was no significant difference in the positive rate of male and female between the two test results based on the duration reaction 72 h after injection.Positive results were observed in 17 volunteers of skin test with recombinant 11 kDa protein,indicating a positive rate of 3.68%.In skin test with TB-PPD,strong positive results were observed in 8 volunteers,indicating a strong positive rate of 1.74%.Using the T-SPOT test results as the standard,the sensitivity of the recombinant 11 kDa protein skin test was 39.53%,the specificity was 100.00% and the accuracy was 94.36%; the sensitivity of PPD skin test was 16.28%,the specificity was 99.76% and the accuracy was91.97%.Conclusion Recombinant 11 kDa protein skin test has high sensitivity and is consistent with the results of T-SPOT.TB,which is also simple and feasible,therefore is expected to be a new screening method for latent MTB infection.

关 键 词：重组结核分枝杆菌11 kDa蛋白 结核菌素纯蛋白衍生物 体外γ干扰素释放试验 皮肤试验 筛查 

分 类 号：R378.911[医药卫生—病原生物学]