title: Analytical evaluation of the new Prostatus PSA Free/Total assay for prostate-specific antigen as part of a screening study for prostate cancer.
abstract: In this communication a limited analytical study is described on the new Prostatus PSA Free/Total assay. The study is considered as a side study of the European Randomized Study of Screening for Prostate Cancer. The between-day imprecision with 8 control samples for free prostate-specific antigen ranged from 10.3% at 0.17 microg/l to 3.7% at a concentration of 35.5 microg/l, while for total prostate-specific antigen we found 7.3% at 0.69 microg/l and 4.3% at 70.7 microg/l. For total prostate-specific antigen we found excellent agreement between the new assay and well-established assays like Abbott IMx and Hybritech Tandem-E, both for prostate cancer and benign prostate hyperplasia specimens. The age-specific reference ranges proved to be well-comparable with the literature data both for free and total prostate-specific antigen.
authors.affiliation: Department of Clinical Chemistry, University Hospital Rotterdam, The Netherlands.
authors.forename: B G
authors.initials: BG
authors.lastname: Blijenberg
authors.forename: C H
authors.initials: CH
authors.lastname: Bangma
authors.forename: R
authors.initials: R
authors.lastname: Kranse
authors.forename: I
authors.initials: I
authors.lastname: Eman
authors.forename: F H
authors.initials: FH
authors.lastname: Schröder
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D005069:Evaluation Studies as Topic; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood* / Q000517:prevention & control*; D011933:Reagent Kits, Diagnostic; D012016:Reference Values; D012680:Sensitivity and Specificity
chemical_list: D011933:Reagent Kits, Diagnostic; D017430:Prostate-Specific Antigen