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Beastall G.H.

University of Glasgow, Mayfield, Birdston

Brouwer N.

IQ BV, Waterland Hospital

Quiroga S.

Progba, CEMIC Saavedra University Hospital

Myers G.L.

Myers Consulting, Smyrna

Traceability in laboratory medicine: a global driver for accurate results for patient care

Authors:

Beastall G.H., Brouwer N., Quiroga S., Myers G.L.

More about the authors

Journal: Laboratory Service. 2020;9(3): 54‑64

Read: 5250 times


To cite this article:

Beastall GH, Brouwer N, Quiroga S, Myers GL. Traceability in laboratory medicine: a global driver for accurate results for patient care. Laboratory Service. 2020;9(3):54‑64. (In Russ.)
https://doi.org/10.17116/labs2020903154

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References:

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  2. Beastall GH. Adding value to laboratory medicine: a professional responsibility. Clin Chem Lab Med. 2013;51:221-228.  https://doi.org/10.1515/cclm-2012-0630
  3. Greenberg N. Update on current concepts and meanings in laboratory medicine-standardization, traceability and harmonization. Clin Chim Acta. 2014;432:49-54.  https://doi.org/10.1016/j.cca.2013.12.045
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  5. Plebani M. Harmonization in laboratory medicine: requests, samples, measurement and reports. Crit Rev Clin Lab Sci. 2016;53:184-196.  https://doi.org/10.3109/10408363.2015.1116851
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  12. ISO Guide 34:2009. General requirements for the competence of reference material producers, 3rd ed. Geneva, Switzerland: ISO, 2009.
  13. ISO 15194:2009. In vitro diagnostic medical devices-measurement of quantities in samples of biological origin-requirements for certified reference materials and the content of supporting documentation, 2nd ed. Geneva, Switzerland: ISO, 2009.
  14. ISO 17511:2003 In vitro diagnostic medical devices-measurement of quantities in biological samples-metrological traceability of values assigned to calibrators and control materials ISO. Geneva, Switzerland, 2003.
  15. Miller WG, Myers GL, Rej R. Why commutability matters. Clin Chem. 2006;52:553-554.  https://doi.org/10.1373/clinchem.2005.063511
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  20. Myers GL, Kimberly MM, Waymack PP, Smith SJ, Cooper GR, Sampson EJ. A reference laboratory network for cholesterol: a model for standardization and improvement of clinical laboratory measurements. Clin Chem. 2000;46:1762-1772. https://doi.org/10.1093/clinchem/46.11.1762
  21. Ford ES, Ajani UA, Croft JB, Critchley JA, Labarthe DR, Kottke TE, et al. Explaining the decrease in US deaths from coronary disease 1980-2000. N Engl J Med. 2007;356:2388-2398. https://doi.org/10.1056/NEJMsa053935
  22. Hoerger TJ, Wittenborn JS, Young W. A cost-benefit analysis of lipid standardization in the United States. Prev Chron Dis. 2011;8:A136.
  23. Hoelzel W, Weycamp C, Jeppsson JO, Miedema K, Barr JR, Goodall I, et al. IFCC Reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United States, Japan and Sweden: a method comparison study. Clin Chem. 2004;50:166-174.  https://doi.org/10.1373/clinchem.2003.024802
  24. IFCC network laboratories for HbA1c. www.ifcchba1c.net. Accessed 17 Jan 2017.
  25. Consensus statement on the worldwide standardisation of the HbA1c measurement. Diabetologia. 2007;50:2042-2043. https://doi.org/10.2337/dc10-0953
  26. Use of glycated haemoglobin (HbA1c) in the diagnosis of diabetes mellitus. WHO publications, Geneva, Switzerland, 2011.
  27. Weykamp C, John G, Gillery P, English E, Ji L, Lenters-Westra E, et al. Investigation of 2 models to set and evaluate quality targets for HbA1c: biological variation and sigma-metrics. Clin Chem. 2015;61:752-759.  https://doi.org/10.1373/clinchem.2014.235333
  28. Skugor M, Manjula Gupta M, Navaneethan SD. Evolution of current state of assays for measuring parathyroid hormone. Biochem Med. 2010;20:221-228.  https://doi.org/10.11613/BM.2010.027
  29. Almond A, Ellis AR, Walker SW. Current parathyroid hormone immunoassays do not adequately meet the needs of patients with chronic kidney disease. Ann Clin Biochem. 2012;49:63-67.  https://doi.org/10.1258/acb.2011.011094
  30. Sturgeon CM, Sprague SM, Metcalfe W. Variation in parathyroid hormone immunoassay results-a critical governance issue in the management of chronic kidney disease. Nephrol Dial Transplant. 2011;26:3440-3445. https://doi.org/10.1093/ndt/gfr614
  31. Daniel Y, Henthorn J. Sickle cell and thalassaemia: handbook for laboratories. NHS Sickle Cell and Thalassaemia Screening Programme 2012, 3rd ed. ISBN 13: 978-0-9565846-8-7. 
  32. Giordano PC. Editorial: measurement of HbA2. Int J Lab Haematol. 2012;34:335.  https://doi.org/10.1111/j.1751-553x.2012.01399.x
  33. Paleari R, Gulbis B, Cotton F, Mosca A. Interlaboratory comparison of current high-performance methods for HbA2. Int J Lab Haematol. 2012;34:362-368.  https://doi.org/10.1111/j.1751-553X.2012.01403.x
  34. Miller WG, Myers GL, Gantzer ML, Kahn SE, Schönbrunner ER, Thienpont LM, et al. Roadmap for Harmonization of Clinical Laboratory Measurement Procedures. Clin Chem. 2011;57:1108-1117. https://doi.org/10.1373/clinchem.2011.164012
  35. International consortium for harmonization of clinical laboratory results (ICHCLR). www.harmonization.net. Accessed 08 Feb 2017.

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