Evaluation and Clinical Application of a Two-Site Immunoradiometric Assay for Alpha-1-Foetoprotein Using Readily Available Reagents

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Abstract
The development and evaluation in routine clinical practice of a simple, rapid, high-throughput, immunoradiometric assay (IRMA) for alpha-foetoprotein (AFP) in serum and amniotic fluid is described. The assay uses readily available reagents; a radioiodinated mouse monoclonal antibody produced by the authors and the immunoglobulin G (IgG) fraction of a polyclonal sheep anti-human-AFP serum covalently linked to Sepharose CL-4B. Both antibodies are distributed by the Scottish Antibody Production Unit (Law Hospital, Carluke). The results of an extensive comparative trial between the IRMA and a radioimmunoassay (RIA) are presented. A high-dose ‘hook’ effect is not a problem in this system. Quantitative recovery was obtained, independent of the assay diluent. The IRMA has high sensitivity and a wide working range. Improved assay precision allowed a clinically significant change in the intervention limits.