Xpert Mtb/RIF检测技术在县级肺结核诊断中的应用评价

陈玮 李杨 陈依江 陈再平 商宇 覃常宇 雷世光

[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）检测技术快速诊断肺结核的可靠性和评估Xpert MTB/RIF检测技术快速诊断利福平耐药的效能。方法 在贵州省24个县对研究期间内就诊的肺结核可疑者同时进行痰抗酸染色涂片检测（痰涂片）、结核分枝杆菌分离培养（痰培养）和Xpert MTB/RIF检测，对培养阳性的标本进行结核分枝杆菌药物敏感性试验（比例法），比较Xpert MTB/RIF检测结核菌和R耐药的效能。结果 以痰培养为金标准，Xpert检测灵敏度为95.6%，特异度为95.0%，约登指数为90.6%；痰涂片检测灵敏度为79.8%，特异度为93.9%，约登指数为73.7%。以传统固体培养基利福平耐药检测为金标准，Xpert检测灵敏度为91.3%，特异度为96.7%，约登指数为88.0%。 结论 Xpert MTB/RIF检测技术检测结核菌和R耐药具有较高的灵敏度、特异度和正确指数，检测时间低于常规培养和药敏，适合在县级基层实验室推广使用。

[关键词] 结核；Xpert；检测；评价

[中图分类號] R44 [文献标识码] A [文章编号] 1672-5654（2017）06（b）-0005-04

[Abstract] Objective To evaluate the reliability of Xpert Mtb/RIF test technique in diagnosis of county-level pulmonary tuberculosis and evaluate the efficacy of Xpert MTB/RIF in rapid diagnosis of rifampin resistance. Methods The suspected pulmonary tuberculosis cases in 24 counties in Guizhou Province during the research period were given the sputum acid fast smear test （sputum smear）， mycobacterium tuberculosis isolation and culture （sputum culture） and Xpert MTB/RIF test， the positive specimens were given the drug sensitivity test of mycobacterium tuberculosis （proportion method）， and the efficacy of Xpert MTB/RIF in testing tubercle bacillus and R tolerance was compared. Results The sensitivity， specificity， Youden index of Xpert test were respectively 95.6%， 95.0% and 90.6% by taking the sputum culture as the golden standards， and the sensitivity， specificity， Youden index of sputum smear was 79.8%， 93.9%， 73.7%； the sensitivity， specificity， Youden index of Xpert test were respectively 91.3%， 96.7%， 88.0% by taking the traditional solid media rifampin resistance as the golden standards. Conclusion Xpert MTB/RIF technique in testing the tubercle bacillus and R tolerance has a higher sensitivity， specificity and correct index， and the test time is lower than that of routine culture and drug sensitivity， which is suitable for the promotion and application in the country-level root laboratory.

[Key words] Tuberculosis； Xpert； Test； Evaluation

肺結核病的快速、准确诊断一直是困扰我国结核病防控的核心问题之一。现阶段我国基层实验室检查结核菌和结核菌耐药仍以痰抗酸染色镜检、结核菌罗氏固体培养和比例法药敏试验为主要检测手段，检测准确率低、耗时太长是这些检测方法的主要不足，严重制约了传染性肺结核患者的及时、准确诊断。近年来国内外出现了多种快速诊断设备，Xpert MTB/RIF检测系统就是其中一种。2014年7月，全球基金结核病耐多药（延期）项目先后为贵州省全球基金项目县（市、区）配备了24套Xpert MTB/RIF检测设备，并免费提供诊断试剂盒，在这24个县（市、区）开展结核的快速检测。……