Display options
Cite
Penttilä I, Penttilä K, Holm P, et al. Methods, units and quality requirements for the analysis of haemoglobin A1c in diabetes mellitus. World J Methodol. 2016;6(2):133-42doi: 10.5662/wjm.v6.i2.133.
Penttilä, I., Penttilä, K., Holm, P., Laitinen, H., Ranta, P., Törrönen, J., & Rauramaa, R. (2016). Methods, units and quality requirements for the analysis of haemoglobin A1c in diabetes mellitus. World journal of methodology, 6(2), 133-42. https://doi.org/10.5662/wjm.v6.i2.133
Penttilä, Ilkka, et al. "Methods, units and quality requirements for the analysis of haemoglobin A1c in diabetes mellitus." World journal of methodology vol. 6,2 (2016): 133-42. doi: https://doi.org/10.5662/wjm.v6.i2.133
Penttilä I, Penttilä K, Holm P, Laitinen H, Ranta P, Törrönen J, Rauramaa R. Methods, units and quality requirements for the analysis of haemoglobin A1c in diabetes mellitus. World J Methodol. 2016 Jun 26;6(2):133-42. doi: 10.5662/wjm.v6.i2.133. eCollection 2016 Jun 26. PMID: 27376018; PMCID: PMC4921944.
Copy Download .nbib Format: NLM
Share it on

World J Methodol. 2016 Jun 26;6(2):133-42. doi: 10.5662/wjm.v6.i2.133. eCollection 2016 Jun 26.

Methods, units and quality requirements for the analysis of haemoglobin A1c in diabetes mellitus.

World journal of methodology

Ilkka Penttilä, Karri Penttilä, Päivi Holm, Harri Laitinen, Päivi Ranta, Jukka Törrönen, Rainer Rauramaa

Affiliations

  1. Ilkka Penttilä, Jukka Törrönen, Rainer Rauramaa, Kuopio Research Institute of Exercise Medicine, University of Eastern Finland, 70100 Kuopio, Finland.

PMID: 27376018 PMCID: PMC4921944 DOI: 10.5662/wjm.v6.i2.133

Abstract

The formation of glycohemoglobin, especially the hemoglobin A1c (HbA1c) fraction, occurs when glucose becomes coupled with the amino acid valine in the β-chain of Hb; this reaction is dependent on the plasma concentration of glucose. Since the early 1970s it has been known that diabetics display higher values OF HbA1C because they have elevated blood glucose concentrations. Thus HbA1c has acquired a very important role in the treatment and diagnosis of diabetes mellitus. After the introduction of the first quantitative measurement OF HbA1C, numerous methods for glycohemoglobin have been introduced with different assay principles: From a simple mini-column technique to the very accurate automated high-pressure chromatography and lastly to many automated immunochemical or enzymatic assays. In early days, the results of the quality control reports for HbA1c varied extensively between laboratories, therefore in United States and Canada working groups (WG) of the Diabetes Controls and Complications Trial (DCCT) were set up to standardize the HbA1c assays against the DCCT/National Glycohemoglobin Standardization Program reference method based on liquid chromatography. In the 1990s, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) appointed a new WG to plan a reference preparation and method for the HBA1c measurement. When the reference procedures were established, in 2004 IFCC recommended that all manufacturers for equipment used in HbA1c assays should calibrate their methods to their proposals. This led to an improvement in the coefficient of variation (CV%) associated with the assay. In this review, we describe the glycation of Hb, methods, standardization of the HbA1c assays, analytical problems, problems with the units in which HbA1c values are expressed, reference values, quality control aspects, target requirements for HbA1c, and the relationship of the plasma glucose values to HbA1c concentrations. We also note that the acceptance of the mmol/mol system for HbA1c as recommended by IFCC, i.e., the new unit and reference ranges, are becoming only slowly accepted outside of Europe where it seems that expressing HbA1c values either only in per cent units or with parallel reporting of percent and mmol/mol will continue. We believe that these issues should be resolved in the future and that it would avoid confusion if mmol/mol unit for HbA1c were to gain worldwide acceptance.

Keywords: Diabetes; Glucose; Glycohemoglobin; Hemoglobin A1c; International Federation of Clinical Chemistry and Laboratory Medicine; Quality assurance; Recommendation; Reference values; Target limits

References

  1. Clin Chem Lab Med. 2011 Jul;49(7):1221-3 - PubMed
  2. Clin Chem. 2011 Jun;57(6):e1-e47 - PubMed
  3. Lakartidningen. 2010 Dec 22;107(51-52):3282-5 - PubMed
  4. Pediatr Diabetes. 2014 May;15(3):e1-2 - PubMed
  5. Clin Chem Lab Med. 2011 Apr;49(4):647-51 - PubMed
  6. PLoS One. 2015 Mar 18;10 (3):e0119882 - PubMed
  7. Clin Chem Lab Med. 2010 May;48(5):623-6 - PubMed
  8. Diabetes Care. 1999 Sep;22(9):1462-70 - PubMed
  9. Science. 1955 Aug 12;122(3163):288 - PubMed
  10. Clin Chem Lab Med. 2014 Jul;52(7):1069-77 - PubMed
  11. Ups J Med Sci. 1993;98(3):335-8 - PubMed
  12. Nutr Metab Cardiovasc Dis. 2011 Jul;21(7):467-75 - PubMed
  13. Clin Chim Acta. 2014 Mar 20;430:1-8 - PubMed
  14. J Biol Chem. 1980 Apr 10;255(7):3120-7 - PubMed
  15. Clin Chem. 2011 Aug;57(8):1204-6 - PubMed
  16. Clin Chem Lab Med. 2007;45(8):1077-80 - PubMed
  17. J Int Fed Clin Chem. 1996 Jun;8(2):62-4, 66-7 - PubMed
  18. Clin Chem. 2001 Nov;47(11):1985-92 - PubMed
  19. Clin Chem. 1994 Jan;40(1):138-44 - PubMed
  20. Ann Lab Med. 2013 Nov;33(6):393-400 - PubMed
  21. Clin Chem Lab Med. 2007;45(8):1081-2 - PubMed
  22. Clin Chem. 2011 Feb;57(2):205-14 - PubMed
  23. Diabetologia. 2009 Jan;52(1):17-30 - PubMed
  24. Am J Clin Pathol. 2008 Jul;130(1):136-40 - PubMed
  25. N Engl J Med. 1971 Feb 18;284(7):353-7 - PubMed
  26. Diabetes Care. 2010 Jan;33 Suppl 1:S62-9 - PubMed
  27. Clin Chem. 2011 Apr;57(4):568-76 - PubMed
  28. Clin Chim Acta. 2011 Jul 15;412(15-16):1412-6 - PubMed
  29. J Diabetes Sci Technol. 2009 May 01;3(3):446-51 - PubMed
  30. Diabetes Care. 2011 Jan;34 Suppl 1:S11-61 - PubMed
  31. Ups J Med Sci. 1990;95(3):185-90 - PubMed
  32. Clin Chem. 1992 Dec;38(12):2472-8 - PubMed
  33. J Diabetes Sci Technol. 2009 May 01;3(3):439-45 - PubMed
  34. Clin Chem Lab Med. 2015 Feb;53(2):319-27 - PubMed
  35. Diabetes Care. 2002 Feb;25(2):275-8 - PubMed
  36. J Diabetes Sci Technol. 2009 May 01;3(3):418-23 - PubMed
  37. Clin Chem. 2015 May;61(5):752-9 - PubMed
  38. J Diabetes Investig. 2010 Oct 19;1(5):202-7 - PubMed
  39. Clin Chem. 1994 Feb;40(2):342-3 - PubMed
  40. Ups J Med Sci. 1993;98(3):395-9 - PubMed
  41. Clin Chim Acta. 1968 Oct;22(2):296-8 - PubMed
  42. Clin Chem. 2004 Jan;50(1):166-74 - PubMed
  43. Diabet Med. 2011 Jan;28(1):31-5 - PubMed
  44. Ups J Med Sci. 1990;95(3):291-7 - PubMed
  45. Clin Chem Lab Med. 2013 Oct;51(10):2045-52 - PubMed
  46. J Chromatogr. 1984 Aug 3;297:327-32 - PubMed
  47. Diabetologia. 2015 Jul;58(7):1409-21 - PubMed
  48. Scand J Clin Lab Invest. 2005;65(6):453-62 - PubMed
  49. Clin Chem Lab Med. 1998 May;36(5):299-308 - PubMed
  50. Ups J Med Sci. 1993;98(3):275-82 - PubMed
  51. Arch Intern Med. 2008 Aug 11;168(15):1699-704 - PubMed
  52. Clin Chem. 2010 Jan;56(1):44-52 - PubMed
  53. Clin Chem. 2014 Dec;60(12):1570-2 - PubMed
  54. Clin Chem Lab Med. 2002 Jan;40(1):78-89 - PubMed
  55. Clin Chem. 1988 Sep;34(9):1726-32 - PubMed
  56. Clin Chem. 1995 Jan;41(1):82-6 - PubMed
  57. Diabetes Technol Ther. 2011 Apr;13(4):429-33 - PubMed
  58. Intern Med. 2015;54(7):717-23 - PubMed
  59. Biochemistry. 1966 Aug;5(8):2489-503 - PubMed
  60. Clin Chem Lab Med. 2015 Aug;53(9):e215-7 - PubMed

Publication Types