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

Authors
  • Woodrum, D L
  • French, C M
  • Hill, T M
  • Roman, S J
  • Slatore, H L
  • Shaffer, J L
  • York, L G
  • Eure, K L
  • Loveland, K G
  • Gasior, G H
  • Southwick, P C
  • Shamel, L B
Type
Published Article
Journal
Clinical chemistry
Publication Date
Jul 01, 1997
Volume
43
Issue
7
Pages
1203–1208
Identifiers
PMID: 9216457
Source
Medline
License
Unknown

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.

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