基于结核分枝杆菌多表位抗原的诊断试剂研制及临床评价  

Clinical value of a diagnostic reagent for TB antibodies based on multi-epitope fusion antigens of Mycobacterium tuberculosis

作　　者：陈堃[1] 冯晓燕[1] 杨锡琴[1] 宋晓国[1] 王国华[1] 朱翠侠[1] 邓敏 许辛 张贺秋[1] 

机构地区：[1]军事医学科学院基础医学研究所,北京100850 [2]上海荣盛生物制药有限公司,上海200231

出　　处：《中国卫生检验杂志》2012年第10期2379-2380,共2页Chinese Journal of Health Laboratory Technology

基　　金：国家自然科学基金资助项目(30772067);国家"863"高技术研究发展计划资助项目(2011AA02A120)

摘　　要：目的:基于结核分枝杆菌多表位抗原研制的新型结核免疫诊断试剂进行临床评价,评价其灵敏度和特异性,探讨其应用价值。方法:采用建立的间接ELISA方法,分别检测结核病和肺部其他疾病及健康人群血清样品。结果:508份肺结核患者样品中,检出阳性433份,灵敏度85.23%(433/508),健康人523份中,检出阳性49份,特异性90.63%(49/523)。结论:研制的新型的结核抗体免疫诊断试剂灵敏度高,特异性强,可用于结核感染的大规模筛查试验。Objective ： To develop a reagent for detection of TB antibodies based on multi - epitope fusion anti- gens of Mycobacterium tuberculosis and explore the clinical value in diagnosis of tuberculosis. Methods ： Sera samples from patients with pulmonary tuberculosis, other pulmonary diseases and healthy individuals were detected by indi- rect ELISA method respectively. Results： 433 positive cases were found in 508 samples from patients with pulmona- ry tuberculosis, the sensitivity was 85.23% （433/508）, while 49 positive cases were found in 523 samples from healthy controls, the specificity was 90.63% （49/523）. Conclusion： The new developed diagnostic reagent for TB antibodies has high sensitivity and specificity, suitable for the large - scale screening test of tuberculosis infection.

关 键 词：结核分支杆菌 表位抗原 酶联免疫法 

分 类 号：R378.911[医药卫生—病原生物学]