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中国防痨杂志 ›› 2012, Vol. 34 ›› Issue (6): 377-379.

• 论著 • 上一篇    下一篇

实时荧光核酸恒温放大检测(SAT)法对肺结核诊断价值的研究

沙巍 何娅 蒋瑞华 方勇 景玲杰 韩敏 肖和平   

  1. 200433  同济大学附属上海市肺科医院结核科 上海市结核病重点实验室
  • 收稿日期:2012-11-24 出版日期:2012-06-10 发布日期:2012-06-13
  • 通信作者: 肖和平 E-mail:xiaoheping_sars@163.com

Diagnostic value of simultaneous amplification and testing in patients with pulmonary tuberculosis

SHA Wei, HE Ya, JIANG Rui-hua, FANG Yong, JING Ling-jie, HAN Min, XIAO He-ping   

  1. Department of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji Universisty, Shanghai 200433,China
  • Received:2012-11-24 Online:2012-06-10 Published:2012-06-13
  • Contact: XIAO He-ping E-mail:xiaoheping_sars@163.com

摘要: 目的  检测实时荧光核酸恒温放大检测(SAT)法对结核病诊断的作用。 方法  收集172例疑似肺结核患者的痰液标本2份/例,1份进行涂涂片金-胺染色,另一份进行罗氏培养基培养与菌种鉴定及SAT法检测结核分枝杆菌,如SAT法和培养结果不符合则使用痰荧光定量PCR法(FQ-PCR)进行复核。 结果  172例入组患者中有156例根据临床及实验室结果确诊为肺结核病。如果以Mtb培养鉴定结果和荧光PCR结果作为判定金标准,SAT检测的敏感度和特异度分别为97.8%(89/91)和97.5%(79/81)。如以临床诊断为标准,SAT诊断结核的敏感度为58.3%(91/156),特异度为100.0%(16/16)。对于痰菌阳性肺结核患者,SAT 阳性率为84.9%(79/93);对于痰菌阴性患者,SAT的阳性率为19.0%(12/63)。 结论  SAT法可以作为临床对结核病的辅助诊断方法。

关键词: 结核, 肺/诊断, 核酸扩增技术, 分子诊断技术

Abstract: Objective  To evaluate the value of simultaneous amplification and testing(SAT)in diagnosis of patients with pulmonary tuberculosis.  Methods Sputum smear, culture with species identification, and TB-SAT were studied in 172 patients with suspected pulmonary tuberculosis. The samples, which had inconsistent results between culture and SAT, should be rechecked with fluorescent quantitative PCR(FQ-PCR).  Results 156 patients were clinically diagnosed with pulmonary tuberculosis. If taking the culture plus FQ-PCR as the gold standard, the sensitivity and specificity of TB-SAT were 97.8%(89/91)and 97.5%(79/81),respectively. However, the sensitivity and specificity of TB-SAT were 58.3% (91/156)and 100.0%(16/16)with the clinical diagnosis as standard. The positive rates of TB-SAT were 84.9%(79/93) for sputum positive patients and 19.0%(12/63) for sputum negative patients.  Conclusion  TB-SAT is an effective method for diagnosis of patients with pulmonary tuberculosis.

Key words: Tuberculosis, pulmonary/diagnosis, Nucleic acid amplification techniques, Molecular diagnostic techniques