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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

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Discordant total and free prostate-specific antigen (PSA) assays: does calibration with WHO reference materials diminish the problem?

Carsten Stephan1 / Thomas Köpke2 / Axel Semjonow2 / Michael Lein1, 3 / Serdar Deger1 / Mark Schrader1 / Kurt Miller1 / Klaus Jung1, 3

1Department of Urology, Charité – Universitätsmedizin Berlin, Berlin, Germany

2Department of Urology, Prostate Center, University Clinic Münster, Münster, Germany

3Berlin Institute for Urologic Research, Berlin, Germany

Corresponding author: Prof. Dr. Klaus Jung, Department of Urology, Charité – Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany Phone: +49-30-450 515041, Fax: +49-30-450 515904,

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 47, Issue 11, Pages 1325–1331, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2009.285, September 2009

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Prostate-specific antigen (PSA) assay-dependent variations could result in misinterpretation of individual PSA values. Therefore, the situation for clinical interpretation of PSA or percent free PSA (%fPSA) results is complicated. This review summarizes the differences in various total PSA (tPSA) and free PSA (fPSA) assays, and results obtained using the new World Health Organization (WHO) calibrated Access assays from various studies. Method comparisons between the traditionally calibrated Hybritech PSA and fPSA assays and the new “standardized” WHO calibrated assays yield results that are ∼25% lower for PSA and fPSA. A PSA cut-off of 3 or 3.1 μg/L should be considered for WHO calibrated assays in order to achieve the same sensitivity/specificity profile as with a cut-off of 4 μg/L in traditionally calibrated assays. The %fPSA cut-offs could be retained.

Clin Chem Lab Med 2009;47:1325–31.

Keywords: method comparison; prostate cancer; prostate-specific antigen; WHO PSA standards

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