This study aimed to provide an easy and effective method for extraction and purification of prostate-specific antigen (PSA) from human seminal fluid with high quantity (14 mg) and high purity (98%). The obtained PSA was injected into rabbits for production of anti-PSA polyclonal antibody (titer 1/1000), labeled with radioactive iodine-125 for preparation of radioactive PSA tracer (purity 98 ± 1.8% and specific activity 64 ± 1.9 µCi/µg), and used in preparation of PSA standards. All prepared components can be used in PSA immunoassays specially radioimmunoassay (RIA) kit preparation as a diagnostic tool for prostatic diseases.

The main objective of this study was the preparation and evaluation of the primary reagents for the liquid phase human chorionic gonadotropin-radioimmunoassay (HCG-RIA) kit. Polyclonal antibody is specific and valid; monoclonal antibodies are more specific. In HCG-RIA technique, polyclonal antibodies for βHCG subunits with high binding and displacement % were used. 125I-HCG radioactive tracer was prepared with high yield 71.58 ± 0.92%, purity 99.2 ± 0.05%, and specific activity 170.42 ± 1.65 µCi/µg using chloramine T method, βHCG polyclonal antisera and HCG standards in assay buffer matrix were locally prepared. In-house HCG-RIA was developed with high sensitivity 0.5 mIU/ml, specificity (99%), precision (CV% < 6.4 and < 8.3 for intra-and inter-assay, respectively), and accuracy (recovery range 96.4–104.3%) could be used for quantitative estimation of HCG in human sera for monitoring pregnancy and diagnosis of gestational trophoblastic diseases.

Abbreviations RIA Radioimmunoassay PSA Prostate specific antigen PCa Prostate cancer PEG Polyethelene glycol NRS Normal rabbit serum Background: Prostate specific antigen (PSA), a glycoprotein secreted exclusively from epithelial cell lining the prostate gland. The level of PSA in human serum may play a critical role in diagnosis of prostatic diseases. Objectives: This study was carried out to set up Radioimmunoassay system for PSA estimation in human serum as a diagnostic tool for Prostatic diseases. Methods: locally produced highly purified PSA was used for preparation of radioimmunoassay components; PSA Polyclonal antibody, radioiodinated PSA Tracer and PSA standards. Optimization and Formulation have been achieved, then validity of this technique confirmed by measuring the quality control parameters; Sensitivity, accuracy, crossreactivity, intra and inter assay precision and method comparison. Results: we found that; Optimized and Characterized Radioimmunoassay system is the most Sensitive, specific, precise and accurate tool for estimation of prostate specific antigen level in human serum. Conclusion: Estimation of PSA with locally produced radioimmunoassay system can be used as a diagnostic tool for diagnosis of prostatic diseases.