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
W. Berg et al., 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, UROL INTERN, 63(2), 1999, pp. 102-106
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.