丙型肝炎病毒抗体双抗原夹心法酶联免疫试剂的初步临床评价

目的对研制的丙型肝炎病毒抗体（双抗原夹心）酶联免疫检测试剂进行临床评价。方法以克隆表达的HCV多表位嵌合蛋白作为包被抗原，经多表位嵌合蛋白修饰后用于标记抗原，研制HCV双抗原夹心酶联免疫检测试剂；检测血液筛查阴性标本440份，乙肝表面抗原阳性标本90份，HIV抗体阳性标本10份，梅毒螺旋体抗体阳性标本90份及丙型肝炎病毒抗体阳性标本259份。结果对259份HCV抗体阳性标本进行检测时，有3份标本未检出，应用Chiron RIBA确认试剂检测后，结果为阳性。其余标本的检测结果均为阴性。结论采用HCV双抗原夹心酶联免疫检测试剂共检测889份标本，其中只有3份标本结果不一致，总符合率99．7％，敏感性和特异性较好。

Clinical Evaluation of the HCV-Ab Detection by Direct Sandwich ELISA Method

Objective Clinical evaluation of the HCV-Ab of direct sandwich ELISA method was carried out. Methotis Multi-epitope chimeric recombinant antigens of HCV were used to labeled and coated antigen separately. 440 serum samples of anti-HCV Ab negative, 90 serum samples of HBsAg positive , 10 serum samples of anti-HIV positive, 90 serum samples of anti-Tp positive and 259 serum samples of anti-HCV positive were collected and future evaluated by direct sandwich of anti-HCV ELISA Kit. Results The 440 anti-HCV-hegative serum samples,90 HBsAg-positive serum samples,10 anti-HIV-positive serum samples ,90 anti-Tp-positive serum samples were negative by direct sandwich of anti-HCV ELISA detection. The 256 of 259 anti-HCV-positive serum samples were detected positive by means of direct sandwich of anti HCV ELISA and 3 anti HCV-positive serum samples were missed. The above-mentioned 3 serum samples were detected positive by HCV RIBA, while tested negative by indirect EL1SA of anti-HCV. Conclusion There were only 3 nonconfirmity samples in the 889 serum samples with the total coincidence ratio of 99.7%.