Evaluation of a rapid qualitative prostate specific antigen assay, the One Step PSA(TM) test.

Recently, highly sensitive prostate specific antigen (PSA) kits have been developed and reported to be useful for the early identification of a chemical relapse. However, if the measurement time was short and the cost low, such an assay kit should be sufficient for cancer screening when dealing with a large number of samples. The One Step PSA test uses an immunochromatographic method to qualitatively, not quantitatively, judge a positive or negative result. We confirmed the sensitivity of the kit using purified PSA. Serum specimens from 147 men with or without prostate diseases were tested using the kit. PSA concentration of each serum specimen was independently measured by a quantitative ACS-PSA2 EIA kit (Chiron, cut-off: 2.1 ng/ml). The sensitivity of this kit was determined to be 4 ng/ml. All 33 samples with a value of greater than 4 ng/ml were clearly positive. Of the 94 samples with values less than 4 ng/ml, nine were judged as positive. The remaining 85 cases were judged as completely negative. These results indicate that the sensitivity of the One Step PSA test is 100% and the specificity is 90.4%. Tests using this kit can be easily performed at outpatient clinics or elsewhere. This kit is useful for initial cancer screening, because results can be obtained within 15 min and at a cost lower than that of ordinary PSA kits.