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

  • Carsten Stephan , Thomas Köpke , Axel Semjonow , Michael Lein , Serdar Deger , Mark Schrader , Kurt Miller and Klaus Jung
Published/Copyright: September 25, 2009
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Clinical Chemistry and Laboratory Medicine
From the journal Clinical Chemistry and Laboratory Medicine Volume 47 Issue 11

Abstract

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
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,
Received: 2009-6-21
Accepted: 2009-7-9
Published Online: 2009-09-25
Published in Print: 2009-11-01

©2009 by Walter de Gruyter Berlin New York

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https://doi.org/10.1515/CCLM.2009.285
Keywords for this article
method comparison; prostate cancer; prostate-specific antigen; WHO PSA standards

Articles in the same Issue

  1. Editorial
  2. The journal impact factor: navigating between Scylla and Charybdis
  3. Opinion Papers
  4. Journal Impact Factor: it will go away soon
  5. The Journal Impact Factor: don't expect its demise any time soon
  6. Reviews
  7. Discordant total and free prostate-specific antigen (PSA) assays: does calibration with WHO reference materials diminish the problem?
  8. Molecular diagnostics in acute leukemias
  9. Opinion Paper
  10. Considerations for the development of a reference method for sequencing of haploid DNA – an opinion paper on behalf of the IFCC Committee on Molecular Diagnostics. International Federation of Clinical Chemistry and Laboratory Medicine
  11. General Clinical Chemistry and Laboratory Medicine
  12. Meta-analyses of diagnostic studies
  13. Development and implementation of an automatic system for verification, validation and delivery of laboratory test results
  14. Comparison of visual vs. automated detection of lipemic, icteric and hemolyzed specimens: can we rely on a human eye?
  15. Prevalence of thyroid autoimmunity and subclinical hypothyroidism in persons with chronic kidney disease not requiring chronic dialysis
  16. Serum albumin fragmentation in end-stage renal disease patients – a pilot study
  17. Enhanced bone metabolism in vegetarians – the role of vitamin B12 deficiency
  18. Impaired anti-inflammatory function of apolipoprotein A-II concentrations predicts metabolic syndrome and diabetes at 4 years follow-up in elderly Turks
  19. Detection of myelin autoantibodies: evaluation of an assay system for diagnosis of multiple sclerosis in differentiation from other central nervous system diseases
  20. The rate of manual peripheral blood smear reviews in outpatients
  21. Markers of infection in inpatients and outpatients with acute Q-fever
  22. Validation and Outcome Studies
  23. Potential utility of the new Sysmex XE 5000 red blood cell extended parameters in the study of disorders of iron metabolism
  24. A new turbidimetric method for assaying serum C-reactive protein based on phosphocholine interaction
  25. Potential of the Sebia Capillarys® neonat fast automated system for neonatal screening of sickle cell disease
  26. Biochemical role of intravaginal sildenafil citrate as a novel antiabortive agent in unexplained recurrent spontaneous miscarriage: first clinical study of four case reports from Egypt
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  28. Hypoxia related growth factors and p53 in preoperative sera from patients with colorectal cancer – evaluation of the prognostic significance of these agents
  29. Letters to the Editor
  30. Quick and easy colorimetric test for calibration control of liquid handling workstations
  31. GSTP1*B allele increases the risk for asthma in children
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