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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 MGIT 960液体培养(简称“MGIT 960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MGIT960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,MGIT960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MGIT 960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 960-1iquid-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.