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

  

Authors:	Vucetic, Z.; Dnistrian, A.; Nilsson, O.; Lilja, H. G.; Plebani, M.
Article Title:	Suitability of quality control materials for prostate-specific antigen (PSA) measurement: Inter-method variability of common tumor marker control materials
Abstract:	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:	controlled study; prostate specific antigen; protein blood level; quality control; tumor markers, biological; tumor marker; prostate-specific antigen; prostatic neoplasms; control group; immunoassay; diagnostic kit; prostate-specific antigen (psa); commutability; free-psa; internal quality control; quality control materials; inter-assay variation
Journal Title:	Clinical Chemistry and Laboratory Medicine
Volume:	51
Issue:	4
ISSN:	1434-6621
Publisher:	Walter de Gruyter & Co
Date Published:	2013-04-01
Start Page:	873
End Page:	880
Language:	English
DOI:	10.1515/cclm-2012-0660
PROVIDER:	scopus
PUBMED:	23314549
DOI/URL:	http://www.scopus.com/inward/record.url?eid=2-s2.0-84882240502&partnerID=40&md5=eb037b3017194a1a2854e26dd27d7045
Notes:	--- - Cited By (since 1996):1 - "Export Date: 4 September 2013" - "CODEN: CCLMF" - "Source: Scopus"

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