环介导等温扩增技术用于结核病诊断的价值评估  

Evaluation of loop-mediated isothermal amplification for the diagnosis of tuberculosis

作　　者：林晶晶 夏露 刘旭晖 魏剑浩 席秀红 黄威 李涛 卢水华 LIN Jing-jing;XIA Lu;LIU Xu-hui;WEI Jian-hao;XI Xiu-hong;HUANG Wei;LI Tao;LU Shui-hua(Department of Tuberculosis,Shanghai Public Health Clinal Center,Fudan University,Shanghai 201508,China)

机构地区：[1]复旦大学附属公共卫生临床中心结核科,上海201508

出　　处：《复旦学报（医学版）》2021年第1期104-110,共7页Fudan University Journal of Medical Sciences

基　　金：国家科技重大专项(2018ZX10731-301);国家自然科学基金(81770011)。

摘　　要：目的评估环介导等温扩增技术(loop-mediated isothermal amplification,LAMP)在诊断结核病中的应用价值。方法以疑似活动性结核患者为研究对象。前瞻性收集患者临床标本,分装后进行荧光涂片显微镜镜检、BACTEC MGIT 960液体培养、MTB GeneXpert(Xpert)和LAMP检测,分析比较这4种检测方法的灵敏度和特异度,同时进行一致性检验。结果研究共入组315例患者,分为痰标本组和非痰标本组,两组分别有175例和80例纳入分析。对于痰标本的检测,以液体培养为诊断标准时,LAMP的灵敏度为78.9%,特异度为82.7%;在有抗结核活性药物暴露史亚组中,LAMP的灵敏度为92.3%,Xpert的灵敏度为88.5%;以临床诊断为诊断标准时,LAMP的灵敏度优于涂片(58.9%vs.46.0%,P<0.05),特异度为98.0%;亚组分析提示在有抗结核活性药物暴露史的患者标本中,LAMP的灵敏度高于其他检测方法。对于非痰标本的检测,同样显示出优于涂片的灵敏度。结论LAMP在结核病的诊断中具有较好的灵敏度和特异度,与Xpert检测结果一致性较高,与培养一致性中等,优于结核菌涂片法。在有抗结核活性药物暴露史的患者中,LAMP有可靠的检出率。Objective To evaluate the clinical application value of loop-mediated isothermal amplification(LAMP)in the diagnosis of tuberculosis(TB).Methods Aprospective cohort study was conducted.Patients with suspected active TB were screened and enrolled.Samples were divided into four groups,and then examined by fluorescence smear microscopy,BACTEC MGIT 960 liquid culture,MTB Gene Xpert(Xpert)and LAMP respectively.The sensitivity and specificity of the four methods were analyzed and compared,and the consistency test also was carried.Results Totally 315 patients were enrolled,with 175 cases in sputum group and 80 cases in non-sputum groups respectively.Against the gold standard,the sensitivity and specificity of LAMP in sputum samples was 78.9%and 82.7%;the sensitivity of LAMP and Xpert in patients with anti-TB antibiotics was 92.3%and 88.5%,respectively.Against Composite Reference Standards(CRS),the sensitivity of LAMP was higher than smear(58.9%vs.46.0%,P<0.05),and the specificity of LAMP was 98.0%.Subgroup analysis showed that the sensitivity of LAMP was higher than other tests in patients exposed to anti-TB antibiotics.Also,LAMP had a superior sensitivity than smear microscopy in non-sputum group.Conclusion LAMP has better sensitivity and specificity in the diagnosis of pulmonary TB than smear,and shows substantial agreement with Xpert and moderated agreement with MGIT culture.For those exposed to anti-TB antibiotics,LAMP showed superiority.

关 键 词：环介导等温扩增技术(LAMP) 结核病(TB) 诊断 核酸扩增 

分 类 号：R521[医药卫生—内科学]