【作者】 武洁； 沈鑫； 张阳奕； 桂晓虹； 李静； 江渊； 王莉莉； 孙丕； 梅建； 高谦；

【Author】 Department of TB Control,Shanghai Municipal Center for Disease Control and Prevention.Shanghai,200336, Wu Jie,SHEN Xin,Zhang Yangyi,Gui Xiaohong,Li Jing,Jiang Yuan,Wang Lili,Sun Pi,GAO Qian,MEI Jian.

【机构】 上海市疾病预防控制中心结核病防治科； 复旦大学上海医学院医学分子病毒学重点实验室；

【摘要】 目的利用恒温扩增-防污染核酸试纸条快速诊断试剂盒检测痰液中结核分枝杆菌与传统检测法(涂片抗酸染色、L-J培养)及分枝杆菌检测金标准(液体培养)相比较,评价其在结核分枝杆菌快速检测中的应用。方法收集上海市某结核病定点医疗机构肺科门诊就诊结核病患者痰液样本465例分别对其进行涂片抗酸染色、L-J培养、BD960液体培养及交叉引物恒温扩增技术检测痰液中的结核分枝杆菌。结果以BD960液体培养为金标准,三种方法的检测敏感度分别为AFB 70.7%(157/222),L-J培养89.6%(199/222),恒温扩增法83.8%(186/222);检测特异度分别为AFB 97.6%(206/211),L-J培养97.6%(206/211),恒温扩增法95.7%(202/211)。其中,在AFB阴性BD960阳性的患者中L-J培养的检测敏感度为70.8%(46/65),恒温扩增法为78.5%(51/65),经统计学分析P>0.05,无显著性差异。结论该试剂盒不仅对结核分枝杆菌有很好的阳性检出率,特别是对涂阴培阳结核病患者有较高的敏感度及特异度,而且操作简便快速,无需特殊设备仪器,适合于在基层医疗机构开展。更多还原

【Abstract】 Object To evaluate the application of TB Isothermal Amplification-DNA Strip Diagnostic Kit in the TB patients using methods including Isothermal Amplification-DNA Strip Diagnostic Kit,L-J and BD960 with sputum specimens.Methods The 465 sputum specimens were collected from Shanghai TB hospital patients,which tested by TB Isothermal Amplification-DNA Strip Diagnostic kit,AFB,L-J and BD960 simultaneously.Results As BD960 was the"gold standard",the sensitivity in the patients with the methods for AFB,L-J,and Isothermal Amplification-DNA Strip Diagnostic Kit was70.7%(157/222),89.6%(199/222), 83.8%(186/222)separately.The specificity in the patients with the methods for AFB,L-J,and Isothermal Amplification-DNA Strip Diagnostic Kit was 97.6%(206/211),97.6%(206/211),95.7%(202/211) separately. The sensitivity of L-J and TB Isothermal Amplification-DNA Strip Diagnostic kit from smear-negative and BD 960 culture-positive specimens was 70.8%(46/65 ),78.5%(51/65) separately.These results after statistical analysis have no significant difference.Conclusion Our results suggests that TB Isothermal Amplification -DNA Strip Diagnostic Kit has a high sensitivity and specificity to detect Mycobacterium tuberculosis especially for the smear negative and culture positive cases.The detection procedure is simple,rapid and not require for special equipment which enable it to be applied to the Basic Medical Institutions.更多还原