HIV抗体纳米免疫磁珠快速检测试剂的研制  

Development of a rapid test kit for antibody to HIV by nano immunomagnetic lateral flow method

作　　者：杨发青 Tony Lee 王朝南 孙树叶 李姗姗 田辉 

机构地区：[1]天津中新科炬生物制药有限公司,300457

出　　处：《中华实验和临床病毒学杂志》2010年第3期235-237,共3页Chinese Journal of Experimental and Clinical Virology

基　　金：天津市科技支撑计划重点项目（08ZCKFSH00400）

摘　　要：目的 研制一种用纳米免疫磁珠层析技术用以检测HIV抗体的快速诊断试剂.方法 运用碳二亚（EDC）将重组的HIV抗原gp41、gp36偶联到200 nm的超顺磁纳米颗粒上,在硝酸纤维素（NC）膜上包被gp41、gp36抗原,制备成免疫层析检测卡,然后对检测卡进行性能分析评估.结果 对HIV抗体国家参考品血清盘（胶体金类）检测,符合要求;对20份HIV抗体阳性和600份抗体阴性临床血清检测,灵敏度为100%,特异性为98.5%.检测卡室温保存12个月性能稳定.结论 研制出一种纳米免疫磁珠HIV抗体检测试剂,具有检测简便、快速、稳定性好和适于现场检测等特点.Objective To develop a rapid test kit for antibody to HIV by nano immunomagnetic lateral flow method.Methods A rapid test kit was developed by conjugation of the HIV antigen gp41 and gp36 to 200nm super paramagnetic particles by carbodiimide （EDC） and coating of the HIV antigen sp41 and gp36 to nitrocellulose membrane.Then the kit was evaluated with serials of experiments.Results The kit was qualified with examination of national reference panel of anti-HIV antibody for colloidal gold diagnostic kit.The sensitivity was 100% by tested with 20 HIV antibody positive sera,the specificity was 98.5% by tested with 600 HIV antibody negative sera,respectively.The stabilitv of the kit was over 12 month by storage at room temperature.Conclusion A diagnostic kit for antibody to HIV was developed with the advantages of convenience,rapid test,good stability and point of care.

关 键 词：HIV抗体 纳米免疫磁珠 免疫层析 快速检测 

分 类 号：R512.91[医药卫生—内科学]