Clinical Chemistry
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Clinical Chemistry 43: 1203-1208, 1997;
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(Clinical Chemistry. 1997;43:1203-1208.)
© 1997 American Association for Clinical Chemistry, Inc.

Articles

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

David L. Woodruma, Chester M. French, Timothy M. Hill, Steven J. Roman, Harold L. Slatore, Jennifer L. Shaffer, Lisa G. York, Kathy L. Eure, Kathleen G. Loveland, Gail H. Gasior, Paula C. Southwick and L. Blair Shamel

Department of Research and Development, Hybritech Inc., San Diego, CA 92196.
a Author for correspondence. Fax 619-536-8058; e-mail dlwoodrum{at}beckman.com

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 µg/L. The within-run and between-day CVs were <=5% for samples with >0.3 µg/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.


Key Words: indexing terms: tumor markers • prostate cancer




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