Tordjeman M, Rabillon V, Abouth D, Trepo C, Hoffenbach A, Somme G
Clonatec, Paris, France.
J Virol Methods. 1993 Jun;43(1):21-30. doi: 10.1016/0166-0934(93)90086-7.
An enzyme immunoassay for the detection of total anti-HBc antibodies in undiluted serum samples was developed. This assay utilizes an anti-HBc monoclonal antibody and a recombinant HBc antigen. The results of the clinical validation are now reported. A total of 1,301 sera were tested using both the Recombinant TOTAL HBc Ab EIA and a reference assay. The specificity was evaluated on a panel of 573 normal human sera and human sera from subjects with pathological findings unrelated to a hepatitis B virus infection. The sensitivity was studied on a total of 455 sera from HBV infected patients at different stages of infection. The final results indicate 99.8% sensitivity and 99.8% specificity. In addition, 273 sera with either isolated anti-HBc antibodies or with anti-HCV antibodies were tested. The agreement between the Recombinant and the reference assay for these two populations, 96.6 and 90.1%, respectively, is discussed.
开发了一种用于检测未稀释血清样本中总抗-HBc抗体的酶免疫测定法。该测定法使用抗-HBc单克隆抗体和重组HBc抗原。现将临床验证结果报告如下。使用重组总抗-HBc抗体酶免疫测定法和一种参考测定法对总共1301份血清进行了检测。在一组573份正常人血清和来自与乙型肝炎病毒感染无关的病理结果受试者的人血清中评估了特异性。在总共455份来自不同感染阶段的HBV感染患者的血清中研究了敏感性。最终结果表明敏感性为99.8%，特异性为99.8%。此外，还对273份具有单独抗-HBc抗体或抗-HCV抗体的血清进行了检测。讨论了这两种人群在重组测定法和参考测定法之间的一致性，分别为96.6%和90.1%。
