Abstract
In this study we reported the development and analytical validation of new assay for quantitative determination of free prostate-specific antigen, fPSA. It is formulated as one step, two-site "sandwich" immunoradiometric assay. Specificity of this assay was achieved by using epitope-1-reactive anti-fPSA antibody as tracer antibody. Assay was calibrated against first international standard 96/668, and its detection limit was determined as 0.08 mg/L. Intra- and inter-assay coefficients of variation were 3.42-7.53% and 7.04-8.33%, respectively. Measured concentrations of serially diluted serum samples were close to the calculated concentrations, indicating good linearity with recovery percentage ranging from 98.7-107.4%. Analytical performance characteristics of fPSA assay speaks in favor of its use as a reliable tool in laboratory diagnostics relating to prostate diseases.
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