Analytical performance of the Tandem-R free PSA immunoassay measuring free prostate-specific antigen.

Autor: Woodrum DL; Department of Research and Development, Hybritech Inc., San Diego, CA 92196, USA. dlwoodrum@beckman.com, French CM, Hill TM, Roman SJ, Slatore HL, Shaffer JL, York LG, Eure KL, Loveland KG, Gasior GH, Southwick PC, Shamel LB
Jazyk: angličtina
Zdroj: Clinical chemistry [Clin Chem] 1997 Jul; Vol. 43 (7), pp. 1203-8.
Abstrakt: 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.
Databáze: MEDLINE