title: Automated Cobas Core PSA assays: sensitive, precise, and specific measurement of PSA-total and PSA-total/PSA-free ratio.
abstract: We describe the analytical performance of the newly developed Roche Cobas Core PSA Total EIA and the Cobas Core PSA Free EIA. The assays are designed for the random access immunochemistry analyzer Cobas Core. Both assays are highly precise (CV's < 4%) and highly sensitive (PSA Total: analytical sensitivity < 0.02 ng/ml; PSA Free: < 0.01 ng/ml). The PSA Total EIA measures PSA-ACT and PSA free equimolarly. The assays are standardized against the reference material of the Stanford group and correlate very well with the designated golden standard Hybritech Tandem-R assays. The high-dose-hook is beyond 20,000 ng/ml and 4500 ng/ml for the PSA Total and PSA Free assay, respectively. In summary, the data indicate clearly the reliability of the measuring system and the achievement of the demands of PSA diagnostics.
authors.affiliation: Roche Diagnostics, Division of F. Hoffmann-La Roche LTD., Basel, Switzerland. dieter.groche@roche.com
authors.forename: D
authors.initials: D
authors.lastname: Groche
authors.forename: R
authors.initials: R
authors.lastname: Trebo
authors.forename: I
authors.initials: I
authors.lastname: Peters
authors.forename: P
authors.initials: P
authors.lastname: Pfleiderer
mesh_terms: D001322:Autoanalysis / Q000295:instrumentation / Q000379:methods; D001331:Automation; D002138:Calibration; D006801:Humans; D007150:Immunohistochemistry / Q000295:instrumentation / Q000379:methods; D008297:Male; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood / Q000175:diagnosis*; D011485:Protein Binding; D012015:Reference Standards; D012044:Regression Analysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D017430:Prostate-Specific Antigen