ANALYTICAL EVALUATION OF THE NEW PROSTATUS(TM) PSA FREE TOTAL ASSAY FOR PROSTATE-SPECIFIC ANTIGEN AS PART OF A SCREENING STUDY FOR PROSTATE-CANCER/

In this communication a limited analytical study is described on the n ew Prostatus(TM) PSA Free/Total assay. The study is considered as a si de study of the European Randomized Study of Screening for Prostate Ca ncer. The between-day imprecision with 8 control samples for free pros tate-specific antigen ranged from 10.3% al 0.17 mu g/l to 3.7% at a co ncentration of 35.5 mu g/l, while for total prostate-specific antigen we found 7.3% at 0.69 mu g/l and 4.3% at 70.7 mu g/l. For total prosta te-specific antigen we found excellent agreement between the new assay and well-established assays like Abbott IMx and Hybritech Tandem-E, b oth for prostate cancer and benign prostate hyperplasia specimens. The age-specific reference ranges proved to be well-comparable with the l iterature data both for free and total prostate-specific antigen.