20-25% lower concentrations of total and free prostate-specific antigen (PSA) after calibration of PSA assays to the WHO reference materials - analysis of 1098 patients in four centers

Stephan, Carsten;Philippe, Marianne;Bangma, Chris;Vignati, Giulio;Catalona, William J.;et.al.
(2009) The International Journal of Biological Markers — Vol. 24, n° 2, p. 65-69 (2009)

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  • Stephan, Carsten
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  • Philippe, MarianneUCLouvain
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  • Bangma, Chris
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  • Vignati, Giulio
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  • Catalona, William J.
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Abstract
Aim: To examine the potential clinical implications of the recalibration of total prostate-specific antigen (PSA) and free PSA (fPSA) assays to the World Health Organization (WHO) standard materials. Material and methods: Data from 1098 patients with or without clinically detected prostate cancer (PCa) from four independent cohort studies were compared using commercial assays calibrated to the traditional Hybritech (R) PSA (PSA-Hyb) and fPSA (fPSA-Hyb) standards and to the WHO 96/670 (PSA-WHO) and 96/668 (fPSA-WHO) standards. The Access (R) Immunoassay System (Beckman Coulter, Inc.) was used in all studies. Results: All studies showed 20% to 25% lower PSA and fPSA test results with the WHO-standardized assays. No significant change in %fPSA (fPSA/PSA x 100) was observed. Continuing to use the traditional clinical PSA cutoffs obtained with the Hybritech standard after changing to the PSA-WHO standard could result in up to one-third of prostate cancer cases being missed. Conclusions: Manufacturers should fully inform laboratories about a calibration change and its clinical impact. Laboratory reports for PSA measurements should indicate the assay's manufacturer and which calibration standard was used to avoid misleading information concerning PCa risk (Int J Biol Markers 2009; 24: 65-9)
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Stephan, C., Philippe, M., Bangma, C., Vignati, G., Bartsch, G., Lein, M., Lung, K., Semjonow, A., & Catalona, W. J. (2009). 20-25% lower concentrations of total and free prostate-specific antigen (PSA) after calibration of PSA assays to the WHO reference materials - analysis of 1098 patients in four centers. The International Journal of Biological Markers, 24(2), 65-69. https://hdl.handle.net/2078.5/70019 (Original work published 2009)