Evaluation of a new, rapid, qualitative, one-step PSA Test for prostate cancer screening: the PSA RapidScreen test.

ABSTRACT

To increase the acceptance rate and reduce the cost of the screening programme for prostate cancer, a new qualitative and one-step test for prostate-specific antigen (PSA), called PSA RapidScreen, has been evaluated. PSA RapidScreen test is a chromatographic lateral flow immunoassay, which generates a positive or negative result for PSA values >or=or <4 ng/ml, respectively. Capillary blood samples from 188 men were evaluated. Two independent observers interpreted the test at 10, 15, 20 and 25 min. A total of 10 women were tested as controls. Parallel serum samples were simultaneously collected and tested with an ordinary quantitative assay (Elecsys 2010, Roche). Sensitivity, specificity, accuracy, negative and positive predictive values of the test were 97.6, 90.4, 94, 98 and 89%, respectively. PSA RapidScreen tests on female capillary samples were negative. Reproducibility of the test was 99.5%, while interobserver variation was 5%. Specificity of the test was altered by variations in the reading time. Quantitative assessment of the intensity of the band correlated with the PSA value (r=0.87; t=23.97; P<0.001). PSA RapidScreen is a rapid, simple and reproducible one-step test. The low cost and the speed of the test make it a powerful and convenient tool for prostate cancer screening programmes.