GeneXpert MTB/RIF检测出入境人员结核病及利福平耐药结核病的研究

A study on Gene Xpert MTB/RIF assay for screening tuberculosis and Rifampin resistance tuberculosis among entry–exit persons

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 capability of Gene Xpert MTB/RIF assay for screening tuberculosis and Rifampin resistance tuberculosis among entry-exit persons. Methods The sputum samples of suscepted tuberculosis patients were collected in Henan International Travel Health Care Center and Henan Center for Disease Control and Prevention. The samples were detected by using smear microscopy, germiculture, conventional drug susceptibility testing and Gene Xpert MTB/RIF assay, respectively. Results Comparing with smear microscopy and media culture,the sensitivity and specificity of Gene Xpert MTB/RIF assay for detection of tuberculosis was 92.50%（ 74/80）,91.95%（80/87） and 95.39%（207/217）、 97.62%（205/210）, respectively in 297 smear samples. Comparing with clinical criterion, the sensitivity and specificity of Gene Xpert MTB/RIF assay was 80.37%（86/107）,98.95%（188/190）.Comparing with conventional drug susceptibility testing, the sensitivity and specificity of Gene Xpert MTB/RIF assay for diagnosis of Rifampin resistance tuberculosis was 94.74%（ 18/19）, 100%（ 68/68） in 87 sample. Conclusion Gene Xpert MTB/RIF was a fast, simple, sensitive and specific method for molecular biology detection, and it could be used for the screening of tuberculosis.