摘要
目的基于克隆表达多个结核分枝杆菌分泌抗原，研制新型结核酶联抗体诊断试剂，并与国家批准上市的同类试剂进行比较。方法克隆表达结核分枝杆菌分泌抗原38kD，CFP10，ESAT6，并将其串联实现嵌合抗原表达，研制间接酶联免疫结核抗体诊断试剂，并与市售同类产品同时检测临床结核病患者结核菌阳性或阴性血清样品。结果47例结核病样品中菌阳35例，菌阴12例，研制的试剂菌阳检出率91．4％（32／35）、菌阴66．7％（8／12），而市场同类产品菌阳检出率88．6％（31／35）、菌阴58．3％（7／12）。研制的试剂与市场同类产品对45例献血员检测特异度分别为95．6％，91.1％。结论结核分枝杆菌嵌合分泌抗原研制的结核酶联抗体诊断试剂具有较好的敏感度和特异度，可用于临床结核病的辅助诊断。
Objective To prepare the TB Kit （EIA） based on epitope-dominant secreting antigens of mycobacterium tuber- culosis. Methods The using the cloned three secreting epitope-dominant antigens of mycobacterium tuberculosis（38kD- ESAT-6-CFP10） were expressed and coated on the microplate. In order to prepare the Enzyme-immunoassay Kit. The 47 samples from TB patient＇s sera and 45 from health＇s sera were detected using the Enzyme-immunoassay Kit and market the same kind product. Results The sensitivity of the Enzyme-immunoassay Kit were 91.4% （32/35） and 66.7% （8/12） respectively for positive and negative samples from bacterium culture. The market the same kind product were 88.6% （31/ 35） and 58.3% （7/12） respectively. The specificity were 95.6% and 91.1% for 45 form health＇s sera respectively. Conclu- sion EIA TB Kit based on secreting epitope-dominant antigens of mycobacterium tuberculosis were better sensitivity and specificity. It may be used the clinical auxiliary diagnosis of tuberculosis.
出处
《现代检验医学杂志》
CAS
2009年第4期59-61,共3页
Journal of Modern Laboratory Medicine
基金
基金项目：国家“863”高技术研究发展计划资助项耳（2006AA02090804）
国家自然科学基金资助项目（30772067）.
关键词
结核抗体
酶联诊断试剂
结核分枝杆菌
tuberculosis antibody
Enzyme-imrnunoassay Kit
mycobacterium tuberculosis
