高敏感度酶联免疫吸附测定法检测分泌蛋白MPB64对于活动性肺结核诊断的价值  

Diagnostic value of high-sensitivity ELISA in active tuberculosis through detecting the secretion protein MPB64

作　　者：赵冰[1] 侯萍 黄静[3] 贺文从 欧喜超[1] 刘东鑫[4] 赵雁林[1] ZHAO Bing;HOU Ping;HUANG Jing;HE Wen-cong;OU Xi-chao;LIU Dong-xin;ZHAO Yan-lin(National Tuberculosis Reference Laboratory, Chinese Center for Disease Control and Prevention, Beijing 102206, China)

机构地区：[1]中国疾病预防控制中心国家结核病参比实验室,北京102206 [2]哈尔滨市结核病防治所检验科 [3]新疆生产建设兵团第八师152团医院 [4]中国疾病预防控制中心传染病预防控制所结核室

出　　处：《中国防痨杂志》2017年第12期1303-1308,共6页Chinese Journal of Antituberculosis

摘　　要：目的评价以结核分枝杆菌（MTB）分泌蛋白MPB64为检测抗原的高敏感度酶联免疫吸附测定法（high sensitivityenzyme-linked immunosorbent assay，HI-ELISA）用于检测痰液中MTB的价值。方法选取97份储存的疑似肺结核患者的痰标本，分别进行BACTEC MGIT960液体培养（简称“MGIT960培养”）、MTB／利福平耐药实时荧光定量核酸扩增检测系统（Gene Xpert MTB／RIF，简称“Xpert检测”）和HI-ELISA检测，通过与MGIT 960培养比较来评价HI-ELISA的诊断效能。结果本研究97份痰标本中，MGIT 960培养、HI-ELISA检测MTB的阳性率分别为36．08％（35／97）、32．99％（32／97）；与MGIT 960培养比较，HI-ELISA的检测敏感度、特异度、总体符合率分别为88．57％（31／35）、98．39％（61／62）、94．85％（92／97）。在Xpert检测阳性的66份痰标本中，MGIT 960培养、HI-ELISA检测MTB的阳性率分别为51．51％（34／66）、48．48％（32／66）；与MGIT 960培养相比，HI-ELISA的检测敏感度、特异度、总体符合率分别为91．18％（31／34）、96．88％（31／32）、93．93％（62／66）。Xpert检测MTB为阴性的31份痰标本中，仅有1份标本的MGIT960培养阳性而HI-ELISA未能检测到MTB，其他30份标本检测结果全部相符，符合率为96．77％（30／31）。结论HI-ELISA可以特异性检测MTB活菌，对活动性肺结核的诊断及治疗评价有很高的应用价值。Objective The aim of this study was to evaluate the value of high-sensitivity-ELISA test （HI-ELISA） in detecting Mycobacterium tuberculosis （MTB） in sputum, which is based on detecting the secretory protein MPB64. Methods Ninety-seven stored sputum specimens from suspected tuberculosis patients were subjected to cultivation in BACTEC MGIT 960 tubes, Xpert MTB/RIF test and HI-ELISA test, respectively, the results of HI-ELISA test and 960-liquid-culture test were compared to evaluate the diagnostic efficacy of HI-ELISA method. Results Among the 97 sputum specimens collected in this study, the positive rates of detecting MTB of 960-liquid-culture method and HI-ELISA method were 36.08% （35/97） and 32. 99% （32/97） respectively. When compared with liquid-culture, the sensitivity of HI-ELISA was 88.57% （31/35）, the specificity of HI-ELISA was 98.39% （61/62） and the overall coincidence rate was 94. 85% （92/97）. Of the 66 positives putum specimens using Xpert MTB/RIF, the positive rate of 960-liquid-culture method and HI-ELISA method in detecting MTB were 51.51% （34/66） and 48.48% （32/66）, respectively; furthermore, compared with 960-liquid-culture,the sensitivity of HI-ELISA was 91.18% （31/34）, the specificity was 96.88% （31/32） and the coincidence rate was 93.93% （62/66）. Among the 31 negative sample stested by Xpert MTB/RIF, MTB was detected in only one sample by 960- liquid-culture method but HI-ELISA method failed to detect it, however, in the other 30 sputum samples, the results of HI-ELISA method were entirely consistent with the results of 960-liquid-culture method and the coincidence rate was 96.77% （30/31）. Conclusion HI-ELISA assay was able to detecting viable MTB with high sensitivity and specificity, it was of high evaluate in diagnosis and treatment of active tuberculosis.

关 键 词：分枝杆菌 结核 分泌蛋白 MPB64 酶联免疫吸附测定 敏感性与特异性 诊断 

分 类 号：R446.61[医药卫生—诊断学]