A two-site solid phase immunoradiometric assay was developed for measurement of human alpha-fetoprotein, utilizing two high-affinity monoclonal antibodies directed against distinct and separate epitopes on the proteic structure. The analytical sensitivity of the assay is 0.5 ng/ml. The clinical sensitivity was evaluated by comparison of patients with cirrhosis and patients with hepatocellular carcinoma with cirrhosis. This assay gave good diagnostic discrimination. In a preliminary clinical trial, the specificity of the assay was 92.3%, the clinical sensitivity 88.2%. and predictive values were 78.9% in the clinically positive stage and 96.0% in the negative stage. The diagnostic efficacy of the assay was 91.3%.
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