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目的评价结核病和利福平耐药结核病的分子诊断试剂盒(Gene Xpert MTB/RIF)筛查出入境人员中结核病和耐利福平结核病的效果。方法 2011年1月—2014年12月,在河南国际旅行卫生保健中心和河南省疾病预防控制中心采集出入境人员传染病监测体检中发现的297例疑似结核病患者的痰标本,进行涂片镜检、细菌培养、比例法传统药敏试验和Gene Xpert MTB/RIF检测。结果与涂片镜检和分离培养比较,Gene Xpert检测297份痰标本诊断结核病的敏感度和特异度分别为92.50%(74/80)、91.95%(80/87)和95.39%(207/217)、97.62%(205/210);与临床诊断比较,Gene Xpert MTB/RIF检测297份痰标本诊断结核病的敏感度和特异度为80.37%(86/107)、98.95%(188/190);与传统药敏试验比较,Gene Xpert MTB/RIF检测87份标本诊断耐利福平结核病的敏感度和特异度为94.74%(18/19)、100.00%(68/68)。结论 Gene Xpert MTB/RIF是一种快速简便、自动化、灵敏度和特异度较高的分子生物学方法 ,可用于出入境口岸人员结核病和耐利福平结核病的筛查。
Objective To evaluate the effectiveness of the Gene Xpert MTB / RIF kit for screening tuberculosis and rifampicin-resistant tuberculosis among immigrants. Methods From January 2011 to December 2014, sputum samples from 297 suspected TB patients found in the surveillance and examination of infectious diseases of entry and exit personnel were collected from Henan International Travel Health Care Center and Henan Provincial Center for Disease Control and Prevention for smear microscopy , Bacterial culture, traditional susceptibility testing by ratio method, and Gene Xpert MTB / RIF assay. Results The sensitivity and specificity of Gene Xpert for the detection of tuberculosis in sputum specimens were 92.50% (74/80), 91.95% (80/87) and 95.39% (207/217) respectively, compared with smear microscopy and isolation culture ) And 97.62% (205/210) respectively. Compared with the clinical diagnosis, the sensitivity and specificity of Gene Xpert MTB / RIF in detecting 297 sputum specimens were 80.37% (86/107) and 98.95% (188/190), respectively; The sensitivity and specificity of Gene Xpert MTB / RIF in detecting 87 samples of tuberculosis were 94.74% (18/19) and 100.00% (68/68), respectively. Conclusion Gene Xpert MTB / RIF is a rapid, simple, automated, sensitive and specific molecular biological method for screening of tuberculosis and rifampicin-resistant tuberculosis in entry and exit ports.