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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 antigenicity of HCV epitopes in 12 fusion proteins expressed by gene fusion of four antigenic determinants of cholera toxin B subunit and HCV was systematically investigated and the anti-HCV detection of the fusion protein was explored Way. The results showed that most of the fusion protein in the HCV epitopes can be associated with the corresponding HCV antibodies. The anti-HCV ELISA reagent developed by the fusion protein 95082 was used to detect the serum of 122 blood donors. The results were in good agreement with the results of the anti-HCV ELISA reagent from Abbott Laboratories. The specificity, sensitivity, Precision and stability have reached the national Ministry of Health anti-HCV ELISA reagent interim test standards.