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 tow anti-PSA monoclonal antibodies, one of them is coated on the microtiter plate, the other is labelled with horseradish peroxidase (HRPO). TMB-H2O2 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