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Obtaining reference intervals traceable to reference measurement systems: is it possible, who is responsible, what is the strategy?

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Published/Copyright: December 20, 2011
Clinical Chemistry and Laboratory Medicine
From the journal Clinical Chemistry and Laboratory Medicine Volume 50 Issue 5

Abstract

An issue associated with standardization efforts is the need to develop useful reference intervals (RI). Lack of proper RI may hamper the implementation of standardization in Laboratory Medicine as standardization can modify analyte results and, without adequate RI, this can impair the result interpretation. Once defined, RI obtained with analytical procedures that produce results traceable to the corresponding reference system can be transferred among laboratories, providing that they use commercial assays that produce results traceable to the same reference system and populations have the same characteristics. Multicenter studies are needed for a robust definition of traceable RI, using experimental protocols that include well defined prerequisites. Particularly, employed methods must produce results that are traceable to the reference system for that specific analyte. Thus, the trueness of laboratories producing reference values should be verified and, if necessary, experimental results corrected in accordance with correlation results with the selected reference. If requirements in the adoption of traceable RI are fulfilled, the possibility of providing RI that are applicable to any laboratory, able to produce results traceable to the reference system, is realistic. The definition of traceable RI should hopefully cause the disappearance of different RI employed for the same analyte, providing more effective information to clinicians.

Keywords: reference values; standardization; traceability
Corresponding author: Prof. Mauro Panteghini, Laboratorio Analisi Chimico Cliniche, Ospedale Luigi Sacco, Via GB Grassi 74, 20157 Milan, Italy Phone: +39 02 3904 2806, Fax: +39 02 503 19835
Received: 2011-11-3
Accepted: 2011-11-22
Published Online: 2011-12-20
Published in Print: 2012-05-01

©2012 by Walter de Gruyter Berlin Boston

Articles in the same Issue

  1. Masthead
  2. Masthead
  3. Editorials
  4. Reference values and the journal: why the past is now present
  5. Other-than-annual variations in morning determinations of uric acid
  6. Reviews
  7. Blood biochemical markers of bone turnover: pre-analytical and technical aspects of sample collection and handling
  8. A comprehensive review of upper reference limits reported for (high-)sensitivity cardiac troponin assays: the challenges that lie ahead
  9. Mini Review
  10. Reference change values
  11. Opinion Papers
  12. Obtaining reference intervals traceable to reference measurement systems: is it possible, who is responsible, what is the strategy?
  13. Analytical performance, reference values and decision limits. A need to differentiate between reference intervals and decision limits and to define analytical quality specifications
  14. A pragmatic proposal for permissible limits in external quality assessment schemes with a compromise between biological variation and the state of the art
  15. Original Articles
  16. Age dependence of within-subject biological variation of nine common clinical chemistry analytes
  17. Population-based pediatric reference intervals for general clinical chemistry analytes on the Abbott Architect ci8200 instrument
  18. Uric acid biorhythm, a feature of long-term variation in a clinical laboratory database
  19. Age-related changes in serum amino acids concentrations in healthy individuals
  20. Characterisation of a highly sensitive troponin I assay and its application to a cardio-healthy population
  21. Are the currently used reference intervals for creatine kinase (CK) reflecting the general population? The Tromsø Study
  22. Age-specific thyroid hormone and thyrotropin reference intervals for a pediatric and adolescent population
  23. Serum thyroglobulin reference values according to NACB criteria in healthy subjects with normal thyroid ultrasound
  24. Thyroid volume influences serum calcitonin levels in a thyroid-healthy population: results of a 3-assay, 519 subjects study
  25. Impact of the reference values on the clinically-relevant cut-offs. The example of cortisol testing in children
  26. Trimester-specific reference intervals for haemoglobin A1c (HbA1c) in pregnancy
  27. The concentration of adiponectin in breast milk is related to maternal hormonal and inflammatory status during 6 months of lactation
  28. Age- and sex-specific reference limits for creatinine, cystatin C and the estimated glomerular filtration rate
  29. Determination of the biological variation of S100β and lactate dehydrogenase in disease-free patients with malignant melanoma
  30. Reference intervals and biological variation for kallikrein 6: influence of age and renal failure
  31. Faecal haemoglobin concentrations by gender and age: implications for population-based screening for colorectal cancer
  32. Reference intervals of extended erythrocyte and reticulocyte parameters
  33. Haematological and iron metabolism parameters in professional cyclists during the Giro d’Italia 3-weeks stage race
  34. Reference change values for lens culinaris agglutinin-reactive α-fetoprotein and des-γ-carboxy prothrombin in patients with chronic hepatitis C
  35. Letters to the Editor
  36. Disadvantages of using biological variation data for reference change values
  37. Reference change values may need some improvement but are invaluable tools in laboratory medicine
  38. Insulin-like growth factor 1 reference intervals for a chemiluminescent enzyme immunometric assay (Immulite 2000®) in an adult Mediterranean population
  39. Reference values for new red blood cell and platelet parameters on the Abbott Diagnostics Cell-Dyn Sapphire
  40. Congress Abstracts
  41. Swiss MedLab 2012 Congress of the Swiss Union of Laboratory Medicine (SULM)
https://doi.org/10.1515/cclm.2011.828
Keywords for this article
reference values; standardization; traceability

Articles in the same Issue

  1. Masthead
  2. Masthead
  3. Editorials
  4. Reference values and the journal: why the past is now present
  5. Other-than-annual variations in morning determinations of uric acid
  6. Reviews
  7. Blood biochemical markers of bone turnover: pre-analytical and technical aspects of sample collection and handling
  8. A comprehensive review of upper reference limits reported for (high-)sensitivity cardiac troponin assays: the challenges that lie ahead
  9. Mini Review
  10. Reference change values
  11. Opinion Papers
  12. Obtaining reference intervals traceable to reference measurement systems: is it possible, who is responsible, what is the strategy?
  13. Analytical performance, reference values and decision limits. A need to differentiate between reference intervals and decision limits and to define analytical quality specifications
  14. A pragmatic proposal for permissible limits in external quality assessment schemes with a compromise between biological variation and the state of the art
  15. Original Articles
  16. Age dependence of within-subject biological variation of nine common clinical chemistry analytes
  17. Population-based pediatric reference intervals for general clinical chemistry analytes on the Abbott Architect ci8200 instrument
  18. Uric acid biorhythm, a feature of long-term variation in a clinical laboratory database
  19. Age-related changes in serum amino acids concentrations in healthy individuals
  20. Characterisation of a highly sensitive troponin I assay and its application to a cardio-healthy population
  21. Are the currently used reference intervals for creatine kinase (CK) reflecting the general population? The Tromsø Study
  22. Age-specific thyroid hormone and thyrotropin reference intervals for a pediatric and adolescent population
  23. Serum thyroglobulin reference values according to NACB criteria in healthy subjects with normal thyroid ultrasound
  24. Thyroid volume influences serum calcitonin levels in a thyroid-healthy population: results of a 3-assay, 519 subjects study
  25. Impact of the reference values on the clinically-relevant cut-offs. The example of cortisol testing in children
  26. Trimester-specific reference intervals for haemoglobin A1c (HbA1c) in pregnancy
  27. The concentration of adiponectin in breast milk is related to maternal hormonal and inflammatory status during 6 months of lactation
  28. Age- and sex-specific reference limits for creatinine, cystatin C and the estimated glomerular filtration rate
  29. Determination of the biological variation of S100β and lactate dehydrogenase in disease-free patients with malignant melanoma
  30. Reference intervals and biological variation for kallikrein 6: influence of age and renal failure
  31. Faecal haemoglobin concentrations by gender and age: implications for population-based screening for colorectal cancer
  32. Reference intervals of extended erythrocyte and reticulocyte parameters
  33. Haematological and iron metabolism parameters in professional cyclists during the Giro d’Italia 3-weeks stage race
  34. Reference change values for lens culinaris agglutinin-reactive α-fetoprotein and des-γ-carboxy prothrombin in patients with chronic hepatitis C
  35. Letters to the Editor
  36. Disadvantages of using biological variation data for reference change values
  37. Reference change values may need some improvement but are invaluable tools in laboratory medicine
  38. Insulin-like growth factor 1 reference intervals for a chemiluminescent enzyme immunometric assay (Immulite 2000®) in an adult Mediterranean population
  39. Reference values for new red blood cell and platelet parameters on the Abbott Diagnostics Cell-Dyn Sapphire
  40. Congress Abstracts
  41. Swiss MedLab 2012 Congress of the Swiss Union of Laboratory Medicine (SULM)
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