CTB与HCV抗原决定簇融合蛋白的抗原性及其在抗HCV ELISA试剂盒中的应用

The Recombinant Fusion Protein of CTB and HCV Epitope: Antigenicity and Application to Anti-HCV ELISA Kit

系统研究了通过霍乱毒素B亚基与HCV的4个抗原决定簇进行基因融合所表达的12种融合蛋白中HCV抗原决定簇的反应原性,探索了以融合蛋白为抗原,进行抗-HCV检测的途径。结果表明,多数融合蛋白中HCV抗原决定簇均能与对应的HCV抗体结合。以融合蛋白95082为抗原研制的抗-HCV ELISA试剂检测122名献血员血清,结果与美国雅培公司抗-HCV ELISA试剂检测的结果完全一致,经药品生物制品检定所检定,其特异性、灵敏度、精密性及稳定性均达到国家卫生部抗-HCV ELISA试剂的暂行检定标准。

The reactivity of the 12 recombinant fusion proteins of cholera toxin protein and 4 HCV epitopes to human and- HCV positive sera was evaluated in this work. The results demostrated that most of the chimeras could react with the anti-HCV antibodies in the sera. 122 of blood donors sera were assayed by ELISA using fusion protein 95082 as antigen. The ELISA kit made from recombinant fusion protein showed high accordance with ABBOTT Anti-HCV ELISA kit, and all the index incuding sensitivity, specificity, accuracy and stability are approved by National Institute of Pharmaceutical and Biological Products of China.