title: Analytical performance of the Tandem-R free PSA immunoassay measuring free prostate-specific antigen.
abstract: The analytical performance of the Tandem-R free PSA assay available from Hybritech Inc. was evaluated. Comparison of recoveries of purified free (unbound) prostate-specific antigen (PSA) diluted in female serum in the Tandem-R free PSA assay and the Tandem-R (total) PSA assay demonstrated a link in calibration between the assays and an accurate determination of percent free PSA. The cross-reactivity of the assay to purified PSA-alpha 1-antichymotrypsin was determined to be < 1%. The minimum-detectable concentration was < 0.05 microgram/L. The within-run and between-day CVs were < or = 5% for samples with > 0.3 microgram/L free PSA. Dilution and recovery showed no significant deviations from linearity across the assay range. The assay was insensitive to interference from blood components. The Tandem-R free PSA kit was shown to be an accurate, precise, and reliable assay for the measurement of free PSA.
authors.affiliation: Department of Research and Development, Hybritech Inc., San Diego, CA 92196, USA. dlwoodrum@beckman.com
authors.forename: D L
authors.initials: DL
authors.lastname: Woodrum
authors.forename: C M
authors.initials: CM
authors.lastname: French
authors.forename: T M
authors.initials: TM
authors.lastname: Hill
authors.forename: S J
authors.initials: SJ
authors.lastname: Roman
authors.forename: H L
authors.initials: HL
authors.lastname: Slatore
authors.forename: J L
authors.initials: JL
authors.lastname: Shaffer
authors.forename: L G
authors.initials: LG
authors.lastname: York
authors.forename: K L
authors.initials: KL
authors.lastname: Eure
authors.forename: K G
authors.initials: KG
authors.lastname: Loveland
authors.forename: G H
authors.initials: GH
authors.lastname: Gasior
authors.forename: P C
authors.initials: PC
authors.lastname: Southwick
authors.forename: L B
authors.initials: LB
authors.lastname: Shamel
mesh_terms: D002138:Calibration; D005260:Female; D006801:Humans; D015592:Immunoradiometric Assay / Q000379:methods* / Q000706:statistics & numerical data; D017430:Prostate-Specific Antigen / Q000097:blood*; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000706:statistics & numerical data; D012680:Sensitivity and Specificity; D000514:alpha 1-Antichymotrypsin / Q000097:blood
chemical_list: D011933:Reagent Kits, Diagnostic; D000514:alpha 1-Antichymotrypsin; D017430:Prostate-Specific Antigen