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Nucleic acid reference materials (NARMs): definitions and issues

  • Deborah A. Payne , Cyril D.S. Mamotte , David Gancberg , Mario Pazzagli , Ron H.N. van Schaik , Heinz Schimmel , Francois Rousseau and on behalf of the IFCC Committee for Molecular Diagnostics (C-MD)
Published/Copyright: October 25, 2010
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Clinical Chemistry and Laboratory Medicine
From the journal Clinical Chemistry and Laboratory Medicine Volume 48 Issue 11

Abstract

Molecular diagnostics is one of the most rapidly growing areas of laboratory medicine. This rapid growth of clinical molecular tests has outpaced the availability and development of reference methods and reference materials. Such methods and materials are important for the development, validation, and interpretation of diagnostic methods and tests. Yet, there is a lack of harmonization between the numerous international organizations currently either certifying or defining reference materials. The objective of this position paper is to review and clarify the definition, attributes and applications for the use of reference materials in the context of molecular diagnostics.

Clin Chem Lab Med 2010;48:1531–5.

Keywords: calibrator; control; DNA; genes; quality; quality assurance; reference materials; validation
Corresponding author: Deborah A. Payne, PhD, 6116 East Warren Avenue, Denver, CO 80227, USA Phone: +1-303-515-2217, Fax: +1-303-512-2288,
Published Online: 2010-10-25
Published in Print: 2010-11-01

©2010 by Walter de Gruyter Berlin New York

Articles in the same Issue

  1. Editorial
  2. IFCC Scientific Division
  3. IFCC Documents
  4. Nucleic acid reference materials (NARMs): definitions and issues
  5. An appraisal of statistical procedures used in derivation of reference intervals
  6. An outline for a vocabulary of nominal properties and examinations – basic and general concepts and associated terms
  7. Review
  8. Standardizing plasma protein measurements worldwide: a challenging enterprise
  9. Status Reports
  10. Standardization activities in the field of thyroid function tests: a status report
  11. Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: II. Performance of a laboratory network running the HPLC candidate reference measurement procedure and evaluation of a candidate reference material
  12. Research Articles
  13. Common reference intervals for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT) in serum: results from an IFCC multicenter study
  14. Development of a candidate secondary reference procedure (immunoassay based measurement procedure of higher metrological order) for cardiac troponin I: I. Antibody characterization and preliminary validation
  15. Towards the development of a certified reference material for hemoglobin A2
  16. Short Communication
  17. First certified reference material for cystatin C in human serum ERM-DA471/IFCC
  18. General Clinical Chemistry and Laboratory Medicine
  19. Increased γ-glutamyltransferase and decreased total bilirubin are associated with metabolic syndrome in Korean postmenopausal women
  20. Effect of homeostasis model assessment computational method on the definition and associations of insulin resistance
  21. Association between thyroid hormones, lipids and oxidative stress biomarkers in overt hypothyroidism
  22. Biochemical markers of particle induced osteolysis in C57BL/6 mice
  23. An on-line solid phase extraction procedure for the routine quantification of urinary methylmalonic acid by liquid chromatography-tandem mass spectrometry
  24. Cancer Diagnostics
  25. Increased integrity of circulating cell-free DNA in plasma of patients with acute leukemia
  26. The relationship between three heat shock protein 70 gene polymorphisms and susceptibility to lung cancer
  27. Real-time polymerase chain reaction quantification of free DNA in serum of patients with polyps and colorectal cancers
  28. Letters to the Editor
  29. Thyroid hormones are stable even during prolonged frozen storage
  30. Thyroid hormones after long-term cold storage: stable or unstable, that is the question
  31. Biomarkers for early detection of mesothelioma in asbestos-exposed subjects
  32. Mean platelet volume and platelet distribution width are useful in the differential diagnosis of aplastic anemia and idiopathic thrombocytopenic purpura
  33. Kinetics of highly sensitive troponin I and T after eccentric exercise
  34. Interferences in red blood cell counting in urinalysis using evacuated tubes
  35. Congress Abstracts
  36. 3rd Annual Congress of the Austrian Society for Laboratory Medicine and Clinical Chemistry Salzburg, Austria, 27-30 October 2010
https://doi.org/10.1515/CCLM.2010.313
Keywords for this article
calibrator; control; DNA; genes; quality; quality assurance; reference materials; validation

Articles in the same Issue

  1. Editorial
  2. IFCC Scientific Division
  3. IFCC Documents
  4. Nucleic acid reference materials (NARMs): definitions and issues
  5. An appraisal of statistical procedures used in derivation of reference intervals
  6. An outline for a vocabulary of nominal properties and examinations – basic and general concepts and associated terms
  7. Review
  8. Standardizing plasma protein measurements worldwide: a challenging enterprise
  9. Status Reports
  10. Standardization activities in the field of thyroid function tests: a status report
  11. Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: II. Performance of a laboratory network running the HPLC candidate reference measurement procedure and evaluation of a candidate reference material
  12. Research Articles
  13. Common reference intervals for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and γ-glutamyl transferase (GGT) in serum: results from an IFCC multicenter study
  14. Development of a candidate secondary reference procedure (immunoassay based measurement procedure of higher metrological order) for cardiac troponin I: I. Antibody characterization and preliminary validation
  15. Towards the development of a certified reference material for hemoglobin A2
  16. Short Communication
  17. First certified reference material for cystatin C in human serum ERM-DA471/IFCC
  18. General Clinical Chemistry and Laboratory Medicine
  19. Increased γ-glutamyltransferase and decreased total bilirubin are associated with metabolic syndrome in Korean postmenopausal women
  20. Effect of homeostasis model assessment computational method on the definition and associations of insulin resistance
  21. Association between thyroid hormones, lipids and oxidative stress biomarkers in overt hypothyroidism
  22. Biochemical markers of particle induced osteolysis in C57BL/6 mice
  23. An on-line solid phase extraction procedure for the routine quantification of urinary methylmalonic acid by liquid chromatography-tandem mass spectrometry
  24. Cancer Diagnostics
  25. Increased integrity of circulating cell-free DNA in plasma of patients with acute leukemia
  26. The relationship between three heat shock protein 70 gene polymorphisms and susceptibility to lung cancer
  27. Real-time polymerase chain reaction quantification of free DNA in serum of patients with polyps and colorectal cancers
  28. Letters to the Editor
  29. Thyroid hormones are stable even during prolonged frozen storage
  30. Thyroid hormones after long-term cold storage: stable or unstable, that is the question
  31. Biomarkers for early detection of mesothelioma in asbestos-exposed subjects
  32. Mean platelet volume and platelet distribution width are useful in the differential diagnosis of aplastic anemia and idiopathic thrombocytopenic purpura
  33. Kinetics of highly sensitive troponin I and T after eccentric exercise
  34. Interferences in red blood cell counting in urinalysis using evacuated tubes
  35. Congress Abstracts
  36. 3rd Annual Congress of the Austrian Society for Laboratory Medicine and Clinical Chemistry Salzburg, Austria, 27-30 October 2010
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