Nelles M J, Taylor L, Filer S, Wellerson R, Haberzettl C, Sito A, Geltosky J E
Ortho Diagnostic Systems Inc., Raritan, New Jersey 08869.
J Virol Methods. 1988 Jul;20(3):219-26. doi: 10.1016/0166-0934(88)90125-5.
A direct (antiglobulin) solid-phase enzyme immunoassay for the detection of antibody to hepatitis B core antigen (anti-HBc) is described. The assay utilizes recombinant hepatitis B core antigen as the solid-phase 'capture' reagent and a mixture of monoclonal antibodies specific for human IgG and IgM conjugated to horseradish peroxidase as the 'detector' reagent. The direct assay demonstrated excellent sensitivity and specificity when compared with a commercially available competitive enzyme immunoassay. The direct assay format lends itself to a confirmatory assay for anti-HBc by addition of monoclonal anti-HBc to the reaction mixture. Feasibility of the confirmatory assay for anti-HBc was demonstrated using specimens reactive for anti-HBc as documented by both the direct and competitive assays.
本文描述了一种用于检测乙型肝炎核心抗原抗体（抗-HBc）的直接（抗球蛋白）固相酶免疫测定法。该测定法利用重组乙型肝炎核心抗原作为固相“捕获”试剂，并使用与人IgG和IgM特异性结合的单克隆抗体混合物与辣根过氧化物酶结合作为“检测”试剂。与市售的竞争性酶免疫测定法相比，直接测定法显示出优异的灵敏度和特异性。通过向反应混合物中添加单克隆抗-HBc，直接测定法形式适用于抗-HBc的确认测定。使用直接测定法和竞争性测定法记录的对抗-HBc呈反应性的标本证明了抗-HBc确认测定法的可行性。
