合成肽抗原抗丙型肝炎病毒ELISA诊断方法的研究

A Preliminary Study on Anti HCV-IgG by Enzyme-linked Immunosorbent Assay with Syntketic Oligopolypeptide

用人工合成的丙型肝炎病毒（ＨＣＶ）结构区寡肽Ｃｐ－１９及非结构区寡肽ＮＳ４－２１组装成抗－ＨＣＶＥＬＩＳＡ试剂。经中国药品生物制品检定所抗－ＨＣＶ标准系列血清验证二次。第一次参比血清组结果与预期结果完全相符，第二次参比血清组除１份弱阳性标本漏检外，其余也完全相符，但检测血清的稀释度较标准稀释度低。试剂重复性好，在１８～２０℃放置７天，４℃放置３个月，仍保持原活性。试剂与国内合成肽抗－ＨＣＶＥＬＩＳＡ试剂水平相当，可供临床检测之用。

By using synthetic oligopolypeptide Cp-19 (core region) and Ns-21 (Ns4 region) as the coating antigen, an anti HCV IgG enzyme-linked immunosorbent assay (ELISA) was established. The specifieity and sensitivity of the reagent was confirmed by two sets of coded reference serum samples supplied by the National Institute for the Control of Pharmaceutical and Biological Products. The specificity was the same as the first set panel and only one diversion was found in a weak positive serum when tested with the second set panel. While for sensitivity the Kit was slightly lower than that panel when tested by serum mutual duplicated dilutions. The Kit was stable, and resisted 7 days at room temperature and 3 months in 4℃ refrigerator. It is able to be used for clinical investigation.