Alpha-fetoprotein monoclonal assay: preliminary clinical findings in a high risk population.
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%.
Pizzocolo
G
G
3rd Laboratory of Clinical Chemistry, Spedali Civili, Brescia, Italy.
Salmi
A
A
Lanza
E
E
Rangoni
G
G
Gussago
A
A
Dovis
M
M
Callegaro
L
L
Albertini
A
A
D000818:Animals; D000911:Antibodies, Monoclonal; D006528:Carcinoma, Hepatocellular / Q000150:complications / Q000175:diagnosis*; D003937:Diagnosis, Differential; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications; D008113:Liver Neoplasms / Q000150:complications / Q000175:diagnosis*; D051379:Mice; D008807:Mice, Inbred BALB C; D011237:Predictive Value of Tests; D011863:Radioimmunoassay / Q000379:methods*; D000509:alpha-Fetoproteins / Q000032:analysis*
D000911:Antibodies, Monoclonal; D000509:alpha-Fetoproteins