利福平耐药实时荧光定量核酸扩增技术检测痰标本中结核分枝杆菌及其耐药性的研究  

Study on Mycobacteria tuberculosis and rifampin resistance detection of Xpert Mtb/RIF test

作　　者：张治国[1] 欧喜超[2] 孙倩[1] 杜春英[1] 高铁杰[1] 赵雁林[2] 

机构地区：[1]北京市昌平区结核病防治所检验科,102200 [2]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

出　　处：《中国防痨杂志》2013年第1期13-16,共4页Chinese Journal of Antituberculosis

基　　金："十一五"国家科技重大专项(2008ZX10003-009);首都医学发展基金(2009_1055)

摘　　要：目的评估利福平耐药实时荧光定量核酸扩增检测技术(Xpert Mtb/RIF)对结核病及利福平耐药性的检测效能。方法选取588例初诊患者痰标本,分别进行涂片镜检、固体培养、传统比例法药敏试验和XpertMtb/RIF检测,分析Xpert Mtb/RIF方法检测痰标本中Mtb及其耐药性的敏感度和特异度。结果以固体培养试验结果作为金标准,Xpert Mtb/RIF方法检测痰标本Mtb的敏感度和特异度为95.0%(345/363)和89.6%(147/164),以传统比例法药敏试验结果为金标准,Xpert Mtb/RIF方法检测利福平耐药的敏感度和特异度分别为89.1%(41/46)和96.3%(289/300)。结论Xpert Mtb/RIF检测敏感度和特异度较高,在Mtb及其利福平耐药快速检测方面具有比较好的应用前景。Objective To evaluate the performance of Xpert Mtb/RIF test on detecting tuberculosis and ri fampin resistance for patients. Methods Recruited 588 initial diagnosis patients, selected sputum samples to do smear, solid culture, traditional proportion method drug susceptibility test and Xpert Mtb/RIF test. Analyze the sensitivity and specificity of Xpert Mtb/RIF method in detecting tuberculosis and refampin resistance. Results According to the solid culture result, the sensitivity and specificity of Xpert Mtb/RIF test in detecting tuberculosis are 95.0% （345/363） and 89.6% （147/164）. According to the conventional drug susceptibility test result, the sensitivity and specificity in detecting rifampin resistance are 89.1 % （41/46） and 96.3 % （289/300） respectively. Conclusion The Xpert Mtb/RIF test has very high sensitivity and specificity. It has very good application prospects in rapidly detection tuberculosis and rifampin resistance.

关 键 词：分枝杆菌 结核 利福平 抗药性 细菌 核酸扩增技术 敏感性与特异性 

分 类 号：R440[医药卫生—诊断学]