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Toward metrological traceability in the determination of prostate-specific antigen (PSA): calibrating Beckman Coulter Hybritech Access PSA assays to WHO standards compared with the traditional Hybritech standards
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Carsten Stephan
Published/Copyright:
March 10, 2008
Abstract
Background: The metrological traceability of prostate-specific antigen (PSA) assay calibration to WHO standards is desirable to potentially improve the comparability between PSA assays. A method comparison was performed between the traditionally standardized Beckman Coulter Hybritech Access PSA and free PSA (fPSA) assays and a new alternate calibration of assays aligned to the WHO standards 96/670 and 96/668, respectively.
Methods: Sera from 641 men with and without prostate cancer, various control materials and mixtures of different proportions of the WHO standards were measured with both assay calibrations.
Results: Excellent comparability between the corresponding assay calibrations was observed, with correlation coefficients of at least 0.996. The Passing-Bablok slopes were 0.747 for total PSA (tPSA), 0.776 for fPSA and 1.02 for the percentage ratio of fPSA to tPSA (%fPSA), while the corresponding percentages of the new WHO-aligned assay results related to the traditional assays were 76.2%, 77% and 102.2%. Receiver operating characteristics revealed no differences between the two PSA assay calibrations.
Conclusions: The WHO calibration yields results approximately 25% lower for tPSA and fPSA values when compared with the conventional Hybritech calibration. Using the WHO-aligned PSA assay, a tPSA cut-off of 3 μg/L should be considered in clinical practice, while %fPSA cut-offs could be retained.
Clin Chem Lab Med 2008;46:623–9.
Keywords: method comparison; metrological traceability; prostate cancer; prostate-specific antigen (PSA); WHO PSA standards
Received: 2007-12-10
Accepted: 2008-1-28
Published Online: 2008-03-10
Published in Print: 2008-05-01
©2008 by Walter de Gruyter Berlin New York
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Keywords for this article
method comparison;
metrological traceability;
prostate cancer;
prostate-specific antigen (PSA);
WHO PSA standards
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- The diagnostic role of autoantibodies in the prediction of organ-specific autoimmune diseases
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