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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 Vucetic , Ann Dnistrian , Olle Nilsson , Hans G. Lilja and Mario Plebani EMAIL logo
Published/Copyright: January 8, 2013
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 51 Issue 4

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: commutability; free-PSA; internal quality control; inter-assay variation; prostate-specific antigen (PSA); quality control materials
Corresponding author: Dr. Mario Plebani, Department of Laboratory Medicine, University-Hospital of Padova, Via Giustiniani, 2, 35128 Padova, Italy, Fax: +39 049 663240

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Received: 2012-10-01
Accepted: 2012-12-05
Published Online: 2013-01-08
Published in Print: 2013-04-01

©2013 by Walter de Gruyter Berlin Boston

Articles in the same Issue

  1. Letters to the Editor
  2. Missing agreement between the two IMMULITE® PSA assays
  3. “Cerebrovascular stressing”: dipyridamole-induced S100B elevation predicts ischemic cerebrovascular events
  4. Discrepancy in lamellar body counts (LBCs) between the Sysmex XE-2100 and Sysmex XT-2000i instruments
  5. Interphase fluorescent in situ hybridization detection of the 7q11.23 chromosomal inversion in a clinical laboratory: automated versus manual scoring
  6. Adrenocorticotropic hormone stability in preanalytical phase depends on temperature and proteolytic enzyme inhibitor
  7. The impact on costs and efficiency of reducing the number of collected tubes
  8. Improved software on the Sysmex XE-5000 BF mode for counting leukocytes in cerebrospinal fluid
  9. First trimester placental growth factor and soluble fms-like tyrosine kinase 1 are significantly related to PAPP-A levels
  10. Preliminary evaluation of complete blood cell count on Mindray BC-6800
  11. Rational use of laboratory tests: albuminuria
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  14. Editorials
  15. Fifty years of CCLM – invitation to join us for a reception in Milan
  16. Personalized (laboratory) medicine: a bridge to the future
  17. PSA, PCA3 and the phi losophy of prostate cancer management
  18. Reviews
  19. Gender medicine: a task for the third millennium
  20. Evaluation of [−2] proPSA and Prostate Health Index (phi) for the detection of prostate cancer: a systematic review and meta-analysis
  21. Harmonization in laboratory medicine: the complete picture
  22. Opinion Papers
  23. Glycemic control in the clinical management of diabetic patients
  24. Time for a conceptual shift in assessment of internal quality control for whole blood or cell-based testing systems? An evaluation using platelet function and the PFA-100 as a case example
  25. Guidelines and Recommendations
  26. A position paper of the EFLM Committee on Education and Training and Working Group on Distance Education Programmes/E-Learning: developing an e-learning platform for the education of stakeholders in laboratory medicine
  27. General Clinical Chemistry and Laboratory Medicine
  28. A novel weighted cumulative delta-check method for highly sensitive detection of specimen mix-up in the clinical laboratory
  29. Identification and quantification of hemoglobins in whole blood: the analytical and organizational aspects of Capillarys 2 Flex Piercing compared with agarose electrophoresis and HPLC methods
  30. Determination of the fatty acid profile of neutral lipids, free fatty acids and phospholipids in human plasma
  31. Urinary iodine concentrations of pregnant women in Ukraine
  32. Delay in the measurement of eosin-5′-maleimide (EMA) binding does not affect the test result for the diagnosis of hereditary spherocytosis
  33. Faecal calprotectin: comparative study of the Quantum Blue rapid test and an established ELISA method
  34. Target analyte quantification by isotope dilution LC-MS/MS directly referring to internal standard concentrations – validation for serum cortisol measurement
  35. Reference Values and Biological Variations
  36. Reference values and upper reference limits for 26 trace elements in the urine of adults living in Belgium
  37. Biological variation and reference change values of common clinical chemistry and haematologic laboratory analytes in the elderly population
  38. Indirect determination of pediatric blood count reference intervals
  39. Cancer Diagnostics
  40. Suitability of quality control materials for prostate-specific antigen (PSA) measurement: inter-method variability of common tumor marker control materials
  41. Prostate cancer antigen 3 (PCA3) RNA detection in blood and tissue samples for prostate cancer diagnosis
  42. Serum levels of cancer biomarkers in diabetic and non-diabetic proteinuric patients: a preliminary study
  43. Infectious Diseases
  44. Polymorphic mononuclear neutrophils CD64 index for diagnosis of sepsis in postoperative surgical patients and critically ill patients
  45. Plasma long pentraxin 3 (PTX3) concentration is a novel marker of disease activity in patients with community-acquired pneumonia
https://doi.org/10.1515/cclm-2012-0660
Keywords for this article
commutability; free-PSA; internal quality control; inter-assay variation; prostate-specific antigen (PSA); quality control materials

Articles in the same Issue

  1. Letters to the Editor
  2. Missing agreement between the two IMMULITE® PSA assays
  3. “Cerebrovascular stressing”: dipyridamole-induced S100B elevation predicts ischemic cerebrovascular events
  4. Discrepancy in lamellar body counts (LBCs) between the Sysmex XE-2100 and Sysmex XT-2000i instruments
  5. Interphase fluorescent in situ hybridization detection of the 7q11.23 chromosomal inversion in a clinical laboratory: automated versus manual scoring
  6. Adrenocorticotropic hormone stability in preanalytical phase depends on temperature and proteolytic enzyme inhibitor
  7. The impact on costs and efficiency of reducing the number of collected tubes
  8. Improved software on the Sysmex XE-5000 BF mode for counting leukocytes in cerebrospinal fluid
  9. First trimester placental growth factor and soluble fms-like tyrosine kinase 1 are significantly related to PAPP-A levels
  10. Preliminary evaluation of complete blood cell count on Mindray BC-6800
  11. Rational use of laboratory tests: albuminuria
  12. Masthead
  13. Masthead
  14. Editorials
  15. Fifty years of CCLM – invitation to join us for a reception in Milan
  16. Personalized (laboratory) medicine: a bridge to the future
  17. PSA, PCA3 and the phi losophy of prostate cancer management
  18. Reviews
  19. Gender medicine: a task for the third millennium
  20. Evaluation of [−2] proPSA and Prostate Health Index (phi) for the detection of prostate cancer: a systematic review and meta-analysis
  21. Harmonization in laboratory medicine: the complete picture
  22. Opinion Papers
  23. Glycemic control in the clinical management of diabetic patients
  24. Time for a conceptual shift in assessment of internal quality control for whole blood or cell-based testing systems? An evaluation using platelet function and the PFA-100 as a case example
  25. Guidelines and Recommendations
  26. A position paper of the EFLM Committee on Education and Training and Working Group on Distance Education Programmes/E-Learning: developing an e-learning platform for the education of stakeholders in laboratory medicine
  27. General Clinical Chemistry and Laboratory Medicine
  28. A novel weighted cumulative delta-check method for highly sensitive detection of specimen mix-up in the clinical laboratory
  29. Identification and quantification of hemoglobins in whole blood: the analytical and organizational aspects of Capillarys 2 Flex Piercing compared with agarose electrophoresis and HPLC methods
  30. Determination of the fatty acid profile of neutral lipids, free fatty acids and phospholipids in human plasma
  31. Urinary iodine concentrations of pregnant women in Ukraine
  32. Delay in the measurement of eosin-5′-maleimide (EMA) binding does not affect the test result for the diagnosis of hereditary spherocytosis
  33. Faecal calprotectin: comparative study of the Quantum Blue rapid test and an established ELISA method
  34. Target analyte quantification by isotope dilution LC-MS/MS directly referring to internal standard concentrations – validation for serum cortisol measurement
  35. Reference Values and Biological Variations
  36. Reference values and upper reference limits for 26 trace elements in the urine of adults living in Belgium
  37. Biological variation and reference change values of common clinical chemistry and haematologic laboratory analytes in the elderly population
  38. Indirect determination of pediatric blood count reference intervals
  39. Cancer Diagnostics
  40. Suitability of quality control materials for prostate-specific antigen (PSA) measurement: inter-method variability of common tumor marker control materials
  41. Prostate cancer antigen 3 (PCA3) RNA detection in blood and tissue samples for prostate cancer diagnosis
  42. Serum levels of cancer biomarkers in diabetic and non-diabetic proteinuric patients: a preliminary study
  43. Infectious Diseases
  44. Polymorphic mononuclear neutrophils CD64 index for diagnosis of sepsis in postoperative surgical patients and critically ill patients
  45. Plasma long pentraxin 3 (PTX3) concentration is a novel marker of disease activity in patients with community-acquired pneumonia
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