1. ¹Department of Urology, Policlinico Tor Vergata, University of Rome 'Tor Vergata', Rome, Italy
2. ²Italian Tumour League, Provincial Section of Cosenza, Italy

Correspondence: R Miano, Via Giulio Curioni, 131, 00157 – Rome, Italy. E-mail: mianor@virgilio.it

Received 27 February 2005; Accepted 24 March 2005; Published online 17 May 2005.

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 <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.