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中国防痨杂志 ›› 2014, Vol. 36 ›› Issue (6): 472-476.doi: 10.3969/j.issn.1000-6621.2014.06.013

所属专题： GeneXpert MTB/RIF检测技术相关研究

• 论著 • 上一篇    下一篇

利福平耐药实时荧光定量核酸扩增检测技术的诊断效果对比研究

李辉 谭耀驹 李洪敏 马晓光 邢进 郝宝林 赵雁林   

  1. 461005 郑州，河南省疾病预防控制中心结核病参比实验室（李辉、马晓光、邢进、郝宝林）；广州市胸科医院检验科（谭耀驹）；解放军第三〇九医院  全军结核病研究所（李洪敏）；中国疾病预防控制中心结核病预防控制中心  国家结核病参比实验室（赵雁林）
  • 收稿日期:2014-04-17 出版日期:2014-06-10 发布日期:2014-06-28
  • 通信作者: 李辉 E-mail:lihui2005yan@126.com

Evaluation of GeneXpert Mtb/RIF assay for diagnosis of tuberculosis and rifampin-resistant tuberculosis

LI Hui, TAN Yao-ju, LI Hong-min, MA Xiao-guang, XING Jin, HAO Bao-lin, ZHAO Yan-lin   

  1. The Tuberculosis Reference Laboratory, He’nan Provincial Center for Disease Control and Prevention, Zhengzhou 461005, China
  • Received:2014-04-17 Online:2014-06-10 Published:2014-06-28
  • Contact: LI Hui E-mail:lihui2005yan@126.com

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摘要： 目的  评价利福平耐药实时荧光定量核酸扩增检测技术（GeneXpert Mtb/RIF）检测临床标本诊断结核病和耐利福平结核病的效能。 方法  2011年1—5月从解放军第三〇九医院、广州市胸科医院和河南省疾病预防控制中心3家单位，连续收集门诊就诊的1971例疑似结核病患者的痰标本，进行涂片、金标准培养和金标准比例法传统药敏试验和GeneXpert Mtb/RIF 检测。应用SPSS 11.5统计软件对GeneXpert Mtb/RIF与不同检测方法进行敏感度和特异度分析，以P＜0.05为差异有统计学意义。 结果  与涂片及培养比较，GeneXpert Mtb/RIF检测1968例（1971例中有3例污染排除）痰标本诊断结核病的敏感度和特异度分别为93.27%（748/802）、91.93%（797/867）和91.60%（1068/1166）、95.55%（1052/1101）；与临床诊断比较， GeneXpert Mtb/RIF检测1945例（1971例中有26例无法定诊）痰标本诊断结核病的敏感度和特异度分别为78.66%（822/1045）、98.67%（888/900）；与金标准传统药敏试验比较，GeneXpert Mtb/RIF检测797例标本诊断耐利福平结核病的敏感度和特异度分别为97.92%（188/192）、100.00%（595/595）。 结论 GeneXpert Mtb/RIF是一种检测痰标本诊断结核病及耐利福平结核病的快速简便、自动化、敏感度和特异度较高的分子生物学方法，适用于结核病和耐利福平结核病的临床诊断。

关键词: 结核/诊断, 利福平, 抗药性, 细菌, 核酸扩增技术, 对比研究

Abstract: Objective To evaluate the performance of GeneXpert Mtb/RIF assay for the diagnosis of Mycobacterium tuberculosis (Mtb) and rifampin-resistant tuberculosis (TB) in clinical samples. Methods The sputum samples were collected from all TB suspects who visited the outpatient departments of the 309th Hospital of Chinese People’s Liberation Army and Guangzhou Chest Hospital, as well as the TB clinic of He’nan Provincial Center for Disease Control and Prevention (He’nan Provincial CDC) from January to May 2011. Smear microscopy, culture (golden-standard method), drug susceptibility testing (DST, conventional proportion method) and GeneXpert Mtb/RIF assay were respectively performed on each clinical sample. SPSS software version 11.5 was used for statistical analysis to compare the diagnostic sensitivity and specificity of GeneXpert Mtb/RIF assay and other examination methods, P<0.05 was regarded as a significant difference. Results Sputum samples were collected from 1971 TB suspects. The samples from 3 suspected cases were contaminated and were excluded from the analysis. Thus 1968 suspected cases were involved in the analysis. Compared with the results of smear microscopy and culture, the sensitivity and specificity of GeneXpert Mtb/RIF assay for diagnosis of TB was 93.27%(748/802), 91.93%(797/867) and 91.60%(1068/1166), 95.55%(1052/1101) respectively; compared with the results of clinical diagnosis, the sensitivity and specificity of GeneXpert Mtb/RIF assay for diagnosis of TB was 78.66%(822/1045) and 98.67%(888/900) respectively; compared with the results of conventional DST, the sensitivity and specificity of GeneXpert Mtb/RIF assay for diagnosis of rifampin-resistant TB was 97.92%(188/192) and 100.00%(595/595) respectively. Conclusion GeneXpert Mtb/RIF assay is a rapid, simple and hand-free molecular diagnostic tool with high sensitivity and specificity for the diagnosis of TB and rifampin-resistant TB. It can be used for clinical diagnosis of TB and rifampin-resistant TB.

Key words: Tuberculosis/diagnosis, Rifampin, Drug resistance, bacterial, Nucleic acid amplification techniques, Comparative study

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