Possibility of improving the acceptance rate of early detection testing for prostate cancer with a one-step test for prostate-specific antigen in whole blood

In order to increase the acceptance rate of early detection testing for pro state cancer, a qualitative prostate-specific antigen (PSA) one-step test h as been developed. Determining the PSA level with this test system takes 10 min. The blood samples of 190 men were tested in this qualitative assay, w hich uses 50 mu l of EDTA whole blood and in which the results are ascertai ned visually. Parallel samples were tested in serum-based, quantitative ass ays (Abbott Imx, EIA). The findings of the two kinds of assays were compare d and evaluated regarding their correspondence (<4.0 and greater than or eq ual to 4.0 ng/ml). For the 74 blood samples in which the quantitative assay showed PSA levels <4.0 ng/ml, the PSA one-step test showed 83.8% correct n egative results (corresponds to diagnostic specificity). For the 116 sample s in which the classic assay showed PSA levels greater than or equal to 4.0 ng/ml, the one-step test showed 90.5% correct positive results (sensitivit y). The noted deviations appear especially around the cut-off value of 4.0 ng/ml, i.e. within the PSA concentration range of 3.0 < 4.0 and 4.0 < 5.0 n g/ml. The qualitative PSA one-step test presented here demonstrates good re producibility. It can be conducted by the patient and is easy to use. The t est offers a simple, feasible method for early detection programs for prost ate cancer. Copyright (C) 1999 S. Karger AG, Basel.