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Progress and impact of enzyme measurement standardization

  • Ilenia Infusino EMAIL logo , Erika Frusciante , Federica Braga und Mauro Panteghini
Veröffentlicht/Copyright: 8. Oktober 2016
Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 55 Heft 3

Abstract

International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has established reference measurement procedures (RMPs) for the most popular enzymes. Manufacturers should assign values to commercial calibrators traceable to these RMPs to achieve equivalent results in clinical samples, independent of reagent kits, instruments, and laboratory where the measurement is carried out. The situation is, however, far from acceptable. Some manufacturers continue to market assays giving results that are not traceable to internationally accepted RMPs. Meanwhile, end-users often do not abandon assays with demonstrated insufficient quality. Of the enzyme measurements, creatine kinase (CK) is satisfactorily standardized and a substantial improvement in performance of marketed γ-glutamyltranspeptidase (GGT) assays has been demonstrated. Conversely, aminotransferase measurements often exceed the desirable analytical performance because of the lack of pyridoxal-5-phosphate addition in the commercial reagents. Measurements of lactate dehydrogenase (LDH), alkaline phosphatase (ALP), and α-amylase (AMY) still show major disagreement, suggesting the need for improvement in implementing traceability to higher-order references. This is mainly the result of using assays with different analytical selectivities for these enzymes. The definition by laboratory professionals of the clinically acceptable measurement uncertainty for each enzyme together with the adoption by EQAS of commutable materials and use of an evaluation approach based on trueness represent the way forward for reaching standardization in clinical enzymology.

Keywords: enzymes; reference procedures; reference values; traceability; uncertainty

Acknowledgments

The authors acknowledge the long cooperation and the fruitful discussion with Prof. Ferruccio Ceriotti, Chair of the IFCC Committee on Reference Systems in Enzymology.

  1. Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2016-7-25
Accepted: 2016-8-29
Published Online: 2016-10-8
Published in Print: 2017-3-1

©2017 Walter de Gruyter GmbH, Berlin/Boston

Artikel in diesem Heft

  1. Frontmatter
  2. Editorials
  3. Targeting errors in microbiology: the case of the Gram stain
  4. Time for a holistic approach and standardization education in laboratory medicine
  5. Reviews
  6. Serum uric acid levels and risk of prehypertension: a meta-analysis
  7. Lactic acidosis: an update
  8. Mini Review
  9. Progress and impact of enzyme measurement standardization
  10. Opinion Paper
  11. Critical comments to a recent EFLM recommendation for the review of reference intervals
  12. IFCC Paper
  13. Quality Indicators in Laboratory Medicine: the status of the progress of IFCC Working Group “Laboratory Errors and Patient Safety” project
  14. Genetics and Molecular Diagnostics
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  29. Infectious Diseases
  30. Improving Gram stain proficiency in hospital and satellite laboratories that do not have microbiology
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  34. EFLM Recommendation
  35. Corrigendum to: Recommendation for the review of biological reference intervals in medical laboratories
  36. Letters to the Editor
  37. Evaluation of the trueness of serum alkaline phosphatase measurement in a group of Italian laboratories
  38. Innovative software for recording preanalytical errors in accord with the IFCC quality indicators
  39. Mixing studies for abnormal coagulation screen – the current trend
  40. Identification of 5-fluorocytosine as a new interfering compound in serum capillary zone electrophoresis
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https://doi.org/10.1515/cclm-2016-0661
Schlagwörter für diesen Artikel
enzymes; reference procedures; reference values; traceability; uncertainty

Artikel in diesem Heft

  1. Frontmatter
  2. Editorials
  3. Targeting errors in microbiology: the case of the Gram stain
  4. Time for a holistic approach and standardization education in laboratory medicine
  5. Reviews
  6. Serum uric acid levels and risk of prehypertension: a meta-analysis
  7. Lactic acidosis: an update
  8. Mini Review
  9. Progress and impact of enzyme measurement standardization
  10. Opinion Paper
  11. Critical comments to a recent EFLM recommendation for the review of reference intervals
  12. IFCC Paper
  13. Quality Indicators in Laboratory Medicine: the status of the progress of IFCC Working Group “Laboratory Errors and Patient Safety” project
  14. Genetics and Molecular Diagnostics
  15. Evaluation and comparison of three assays for molecular detection of spinal muscular atrophy
  16. General Clinical Chemistry and Laboratory Medicine
  17. Risk analysis of the preanalytical process based on quality indicators data
  18. Analytical and clinical validation of the new Abbot Architect 25(OH)D assay: fit for purpose?
  19. Looking beyond linear regression and Bland-Altman plots: a comparison of the clinical performance of 25-hydroxyvitamin D tests
  20. Next-generation osmotic gradient ektacytometry for the diagnosis of hereditary spherocytosis: interlaboratory method validation and experience
  21. Diagnosis of sphingolipidoses: a new simultaneous measurement of lysosphingolipids by LC-MS/MS
  22. Monitoring nicotine intake from e-cigarettes: measurement of parent drug and metabolites in oral fluid and plasma
  23. Development of a rapid and quantitative lateral flow assay for the simultaneous measurement of serum κ and λ immunoglobulin free light chains (FLC): inception of a new near-patient FLC screening tool
  24. A real-world evidence-based approach to laboratory reorganization using e-Valuate benchmarking data
  25. Cancer Diagnostics
  26. Utility of proGRP as a tumor marker in the medullary thyroid carcinoma
  27. Cardiovascular Diseases
  28. Can non-cholesterol sterols and lipoprotein subclasses distribution predict different patterns of cholesterol metabolism and statin therapy response?
  29. Infectious Diseases
  30. Improving Gram stain proficiency in hospital and satellite laboratories that do not have microbiology
  31. Diabetes
  32. Volumetric absorptive microsampling at home as an alternative tool for the monitoring of HbA1c in diabetes patients
  33. Corrigendum
  34. EFLM Recommendation
  35. Corrigendum to: Recommendation for the review of biological reference intervals in medical laboratories
  36. Letters to the Editor
  37. Evaluation of the trueness of serum alkaline phosphatase measurement in a group of Italian laboratories
  38. Innovative software for recording preanalytical errors in accord with the IFCC quality indicators
  39. Mixing studies for abnormal coagulation screen – the current trend
  40. Identification of 5-fluorocytosine as a new interfering compound in serum capillary zone electrophoresis
  41. How to define reference intervals to rule in healthy individuals for clinical trials?
  42. Evaluation of the performance of INDEXOR® in the archive unit of a clinical laboratory: a step to Lean laboratory
  43. Evaluation of an automated chemiluminescent immunoassay for salivary cortisol measurement. Utility in the diagnosis of Cushing’s syndrome
  44. Analysis of hemolysis, icterus and lipemia in arterial blood gas specimens
  45. Comparison of three routine insulin immunoassays: implications for assessment of insulin sensitivity and response
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