The Establishment of an Enzyme linked Immunosorbent Assay for Prostate specific Antigen

The two step assay is based on enzyme linked immunosorbent assay (ELISA). Using two anti PSA monoclonal antibodies, one of them is coated on the microtiter plate, the other is labeled with horseradish peroxidase(HRPO). TMB H 2O 2 solution is used as the substrate of HRPO. The sensitivity of the assay is 0.2 μg/L. The intra assay CVs and the inter assay CVs of 3 samples are lower than 5.3% and 6.4% respectively. The analytical recoveries are ranged from 96.6% to 105.5%. The reference cut off value from 100 healthy men is 4.0 μg/L. The correlation coefficient comparing with PSA ELISA (Maxim Biotech, Inc.) is 0.932 ( n =48). This assay is a rapid, sensitive and precise method. It is suitable for clinical and research application.