Validation of free prostate specific antigen immuno radiometric assay kit for in vitro monitoring of benign prostatic hyperplasia

Prostate Specific Antigen (PSA) is produced by epithelial cells lining the acini and ducts of the prostate gland. Elevated levels of PSA in the blood caused by resulting prostate inflammation or tissue damage resulting prostate cancer or benign prostate enlargement (benign prostatic hyperplasia, BPH). Among methods to determine free PSA is immunoradiometric assay (IRMA) which based on immunological reactions between antigens and specific antibodies, and using monoclonal antibodies labeled with I¹²⁵ as a tracer. The Center for Radioisotopes and Radiopharmaceuticals Technology BATAN has successfully developed free PSA IRMA kit for the determination of free PSA. PTRR BATAN performed validation of the kit, comprises the determination of detection limit of sensitivity, precision and the assay parameters (non-Specific Binding, NSB and Maximum Binding, MB). This study aims to determine the limit of detection, precision of intra-assay and inter-assay and assay parameters which resulted a detection limit of 0.39 ng/ml, intra-assay precision showed coefficients of variation (% CV) of 7.18 % while for inter-assay precision was 14.95 % and the assay parameters of free PSA IRMA kits showed 0.9 % NSB and 19.57 %B/T. These indicate that this free PSA IRMA kit conformed to the requirements. (author)