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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 / Schlattmann, Peter / Tate, Jillian R. / Tsongalis, Gregory J.

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Suitability of quality control materials for prostate-specific antigen (PSA) measurement: inter-method variability of common tumor marker control materials

Zivjena Vucetic1 / Ann Dnistrian2 / Olle Nilsson3 / Hans G. Lilja2 / 4

1Fujirebio Diagnostics Inc, Malvern, PA, USA

2Department of Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA

3Fujirebio Diagnostics AB, Gothenburg, Sweden

4Department of Laboratory Medicine, University-Hospital of Padova, Via Giustiniani, 2, 35128 Padova, Italy

Corresponding author: Dr. Mario Plebani, Department of Laboratory Medicine, University-Hospital of Padova, Via Giustiniani, 2, 35128 Padova, Italy, Fax: +39 049 663240

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 51, Issue 4, Pages 873–880, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/cclm-2012-0660, January 2013

Publication History

Published Online:

This article offers supplementary material which is provided at the end of the article.


Background: Quality control materials with minimal inter-assay differences and clinically relevant proportions of different molecular forms of the analyte are needed to optimize intra- and inter-laboratory accuracy and precision.

Methods: We assessed if clinically relevant total prostate-specific antigen (tPSA) levels were present in seven commercially available Multi Constituent Tumor Marker Controls (MC-TMC). Further, we determined the concentration of free PSA (fPSA) and calculated the percentage of free PSA (%fPSA) in all materials. Finally, we determined variability of TMC materials across several commonly used PSA platforms.

Results: All MC-TMC materials contained at least one concentration of tPSA in normal and pathologic range. Control materials varied in the amount of fPSA and %fPSA, with most controls consisting of fPSA only and only one MC-TMC containing medically relevant levels of around 35% fPSA. Only a minority of MC-TMC materials showed minimal variability across four PSA methods while the majority of PSA controls showed wide inter-method differences.

Conclusions: Use of many commercially available controls for PSA could lead to biased PSA measurements because they contain medically irrelevant proportions of fPSA and show significant variation among different PSA assay platforms.

Keywords: commutability; free-PSA; internal quality control; inter-assay variation; prostate-specific antigen (PSA); quality control materials

Supplementary Article Materials

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