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中国防痨杂志 ›› 2011, Vol. 33 ›› Issue (9): 600-603.

• 论著 • 上一篇    下一篇

干扰素体外释放酶联免疫法在结核病诊断中的价值


刘佳文 康丽军 翁绳凤 朱新颖   

  1. 北京老年医院
  • 收稿日期:2011-06-20 出版日期:2011-09-10 发布日期:2012-01-29
  • 通信作者: 刘佳文 E-mail:no818@163.com
  • 基金资助:

    “十一五”国家重大科技专项(2008ZX-10003-004)

Diagnostic value of quantitative diagnostic kit for Mycobacterium tuberculosis-IFN-γ release assay

LIU Jia-wen, KANG Li-jun, WENG Sheng-feng, ZHU Xin-ying   

  1. Beijing geriatric Hospital
  • Received:2011-06-20 Online:2011-09-10 Published:2012-01-29
  • Contact: LIU Jia-wen E-mail:no818@163.com

摘要: 目的 分析干扰素体外释放酶联免疫法(quantitative diagnostic kit for Mycobacterium tuberculosis IFN-γ release assay,TB-IGRA)在结核病诊断中的应用价值。 方法 用北京万泰生物药业股份有限公司生产的结核分枝杆菌相关γ-干扰素检测试剂盒(体外释放酶联免疫法)(Wantai quantitative diagnostic kit for Mycobacterium tuberculosis IFN-γ release assay, WT-IGRA)(简称WT试剂)和澳大利亚Cellestis有限公司生产的QuantiFERON®-TB(QuantiFERON®-TB GOLD in tube,QFT-GIT)(简称QFT试剂)检测病区与门诊结核患者(249例)及健康者(140例)的全血标本,结果与其结核菌素试验(PPD)、痰结核分枝杆菌培养及痰涂片结果相比较,分析TB-IGRA阳性率、特异度及试剂间的相关性。结果 249例结核病患者,WT试剂和QFT试剂阳性率分别为76.3%(190/249)和67.1%(167/249),特异度都是83.3%(100/120);痰菌阳性和痰菌阴性结核病组,WT试剂阳性率分别为74.1%(43/58)和76.1%(83/109),差异无统计学意义(χ2=0.082,P>0.05);QFT试剂阳性率分别为67.2%(39/58)和65.1%(71/109),差异无统计学意义(χ2=0.075,P>0.05);WT试剂与QFT试剂总符合率为84.3%。 结论 TB-IGRA对结核病有一定的诊断价值。

关键词: 结核/诊断, 干扰素Ⅱ型, 酶联免疫吸附测定

Abstract: Objective To analyze the clinical value of Mycobacterium tuberculosis IFN-γ release assay (TB-IGRA) in diagnosis of tuberculosis. Methods The serum specimens of 249 patients with tuberculosis and 140 healthy people  were detected by Mycobacterium tuberculosis-IFN-γ release assay with Wantai quantitative diagnostic kit (WT-IGRA, Beijing Wantai Biological Pharmacy Corporation Ltd.) and QuantiFERON®-TB GOLD in tube (QFT®-GIT, Cellestis Limited, Australia), respectively. The results of TB-IGRA with WT-IGRA and QFT-GIT were compared with BCG-PPD skin test, Sputum smear and mycobacterial culture. Results Among 249 patients with tuberculosis, the positive rate of TB-IGRA with WT-IGRA and QFT-GIT were 76.3%(190/249)and 67.1%(167/249),respectively,and the specificity with two methods were all  83.3%(100/120). There were no statistical significant differences on positive rates of TB-IGRA and QFT-GIT between smear-positive patients and smear-negative patients which were 74.1%(43/58),76.1%(83/109)with WT-IGRA(χ2=0.082,P>0.05) and  67.2%(39/58),65.1%(71/109)with QFT-GIT(χ2=0.075,P>0.05). The coincidence rate of the two kits is 84.3%. Conclusion TB-IGRA has certain diagnostic value in tuberculosis.

Key words: Tuberculosis/diagnosis, Interferon type Ⅱ, Enzyme-linked immunosorbent assay