HbA1c Standardisation: History, Science and Politics

Overview

Journal Clin Biochem Rev

Specialty Biochemistry

Date 2008 Apr 9

PMID 18392123

Citations 14

Authors

W Garry John

Andrea Mosca

Cas Weykamp

Ian Goodall

Affiliations

Soon will be listed here.

Abstract

Significant analytical improvements have occurred since glycated haemoglobin (GHb), measured as total HbA(1), was first used in routine clinical laboratories around 1977. Following the publication of the Diabetes Control and Complications Trial (DCCT) study in 1993 the issue of international standardisation became an important objective for scientists and clinicians. The lack of international standardisation led several countries to develop national standardisation programs. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on Standardisation of HbA(1c) established a true international reference measurement system for HbA(1c) and the successful preparation of pure HbA(1c) calibration material that should lead to further improvements in inter-method and inter-laboratory variability. Reporting of HbA(1c) has been agreed using the units of mmol/mol (IFCC) and percent (National Glycohemoglobin Standardization Program, NGSP).

Citing Articles

Clinical Risk Assessment and Comparison of Bias between Laboratory Methods for Estimation of HbA1c for Glycated Hemoglobin in Hyperglycemic Patients.

Mukherjee S, Yadav P, Ray S, Jadhav A, Wakode S Curr Diabetes Rev. 2023; 20(7):e261023222764.

PMID: 37921160 DOI: 10.2174/0115733998257140231011102518.

A New Strategy for Evaluating the Quality of Laboratory Results for Big Data Research: Using External Quality Assessment Survey Data (2010-2020).

Cho E, Jeong T, Kim S, Park H, Yun Y, Chun S Ann Lab Med. 2023; 43(5):425-433.

PMID: 37080743 PMC: 10151270. DOI: 10.3343/alm.2023.43.5.425.

Hemoglobin A-Using Epidemiology to Guide Medical Practice: Kelly West Award Lecture 2020.

Selvin E Diabetes Care. 2021; .

PMID: 34548283 PMC: 8929182. DOI: 10.2337/dci21-0035.

Evaluation of the analytical performances of the Cobas c513 analyser for HbA assay.

Jaisson S, Leroy N, Soulard M, Desmons A, Guillard E, Gillery P Biochem Med (Zagreb). 2018; 28(3):030708.

PMID: 30429676 PMC: 6214704. DOI: 10.11613/BM.2018.030708.

Exhaled breath analysis: a review of 'breath-taking' methods for off-line analysis.

Lawal O, Ahmed W, Nijsen T, Goodacre R, Fowler S Metabolomics. 2017; 13(10):110.

PMID: 28867989 PMC: 5563344. DOI: 10.1007/s11306-017-1241-8.

References

Nathan D, Genuth S, Lachin J, Cleary P, Crofford O, Davis M . The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993; 329(14):977-86. DOI: 10.1056/NEJM199309303291401. View

Eckerbom S, Bergqvist Y, JEPPSSON J . Improved method for analysis of glycated haemoglobin by ion exchange chromatography. Ann Clin Biochem. 1994; 31 ( Pt 4):355-60. DOI: 10.1177/000456329403100409. View

Kilpatrick E . HbA1c or glucose for diabetes diagnosis?. Ann Clin Biochem. 2005; 42(Pt 3):165-6. DOI: 10.1258/0004563053857860. View

Boucher B, Burrin J, GOULD B, John P, Lewis G, Owens C . A collaborative study of the measurement of glycosylated haemoglobin by several methods in seven laboratories in the United Kingdom. Diabetologia. 1983; 24(4):265-71. DOI: 10.1007/BF00282711. View

Panteghini M, Forest J . Standardization in laboratory medicine: new challenges. Clin Chim Acta. 2005; 355(1-2):1-12. DOI: 10.1016/j.cccn.2004.12.003. View

LITTLE R, Rohlfing C, Wiedmeyer H, Myers G, Sacks D, Goldstein D . The national glycohemoglobin standardization program: a five-year progress report. Clin Chem. 2001; 47(11):1985-92. View

Hoelzel W, Weykamp C, Jeppsson J, Miedema K, Barr J, Goodall I . 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(1):166-74. DOI: 10.1373/clinchem.2003.024802. View

Panteghini M, John W . Implementation of haemoglobin A1c results traceable to the IFCC reference system: the way forward. Clin Chem Lab Med. 2007; 45(8):942-4. DOI: 10.1515/CCLM.2007.198. View

Trivelli L, Ranney H, Lai H . Hemoglobin components in patients with diabetes mellitus. N Engl J Med. 1971; 284(7):353-7. DOI: 10.1056/NEJM197102182840703. View

10.

Jeppsson J, Kobold U, Barr J, Finke A, Hoelzel W, Hoshino T . Approved IFCC reference method for the measurement of HbA1c in human blood. Clin Chem Lab Med. 2002; 40(1):78-89. DOI: 10.1515/CCLM.2002.016. View

11.

Little R . Glycated hemoglobin standardization--National Glycohemoglobin Standardization Program (NGSP) perspective. Clin Chem Lab Med. 2003; 41(9):1191-8. DOI: 10.1515/CCLM.2003.183. View

12.

Hoelzel W, Miedema K . Development of a reference system for the international standardization of HbA1c/glycohemoglobin determinations. J Int Fed Clin Chem. 1996; 8(2):62-4, 66-7. View

13.

Finke A, Kobold U, Hoelzel W, Weykamp C, Miedema K, JEPPSSON J . Preparation of a candidate primary reference material for the international standardisation of HbA1c determinations. Clin Chem Lab Med. 1998; 36(5):299-308. DOI: 10.1515/CCLM.1998.051. View

14.

Peterson C, Jovanovic L, Raskin P, Goldstein D . A comparative evaluation of glycosylated haemoglobin assays: feasibility of references and standards. Diabetologia. 1984; 26(3):214-7. DOI: 10.1007/BF00252410. View

15.

Nordin G, Dybkaer R . Recommendation for term and measurement unit for "HbA1c". Clin Chem Lab Med. 2007; 45(8):1081-2. DOI: 10.1515/CCLM.2007.245. View

16.

Sacks D . Global harmonization of hemoglobin A1c. Clin Chem. 2005; 51(4):681-3. DOI: 10.1373/clinchem.2004.047431. View

17.

John W, Edwards R, Price C . Laboratory evaluation of the DCA 2000 clinic HbA1c immunoassay analyser. Ann Clin Biochem. 1994; 31 ( Pt 4):367-70. DOI: 10.1177/000456329403100411. View