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中国防痨杂志 ›› 2017, Vol. 39 ›› Issue (12): 1303-1308.doi: 10.3969/j.issn.1000-6621.2017.12.010

• 论著 • 上一篇    下一篇

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

赵冰, 侯萍, 黄静, 贺文从, 欧喜超, 刘东鑫, 赵雁林   

  1. 102206 北京,中国疾病预防控制中心国家结核病参比实验室(赵冰、欧喜超、赵雁林);
    哈尔滨市结核病防治所检验科(侯萍);新疆生产建设兵团第八师152团医院(黄静);
    中国疾病预防控制中心传染病预防控制所结核室(贺文从、刘东鑫)
  • 收稿日期:2017-08-02 修回日期:2018-01-10 出版日期:2017-12-10 发布日期:2018-01-11
  • 通信作者: 赵雁林,Email:zhaoyanlin@chinatb.org
  • 基金资助:

    国家科技重大专项(2014ZX10003002)

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

ZHAO Bing*, HOU Ping, HUANG Jing, HE Wen-cong, OU Xi-chao, LIU Dong-xin, ZHAO Yan-lin   

  1. *National Tuberculosis Reference Laboratory, Chinese Center for Disease Control and Prevention, Beijing 102206, China
  • Received:2017-08-02 Revised:2018-01-10 Online:2017-12-10 Published:2018-01-11
  • Contact: ZHAO Yan-lin, Email: zhaoyanlin@chinatb.org

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 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。

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

Abstract: 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.

Key words: Mycobacterium tuberculosis, Secretory protein, MPB64, Enzyme-linked immunosorbentassay, Sensitivity and specificity, Diagnosis