Introduction of IFCC reference method for calibration of HbA1c: implications for clinical care
- 21 June 2004
- journal article
- Published by Wiley in Diabetic Medicine
- Vol. 21 (7), 673-676
- https://doi.org/10.1111/j.1464-5491.2004.01311.x
Abstract
HbA(1c) is recommended for monitoring glycaemic control and quantifying the risk of complications in patients with diabetes. National guidelines for treatment of patients with diabetes in UK specify that HbA(1c) measurements should be Diabetes Control and Complications Trial (DCCT)-aligned i.e. comparable to the DCCT and UK Prospective Diabetes Study (UKPDS). The IFCC reference method for HbA(1c) will be introduced in Europe in December 2003 for calibration of all laboratory and POCT (point of care testing) methods for HbA(1c) following the recent EC "In Vitro Diagnostic" (IVD) directive. This reference method involves measurement of HbA(1c) and HbA(0) by electron-spray ionisation-mass spectrometry or capillary electrophoresis with the reference range approximately 2% HbA(1c) lower than the corresponding range from the DCCT. However, this EC IVD directive will not change reporting of DCCT-aligned HbA(1c) in the UK. Professionals involved in the care of patients with diabetes in the UK met with Dr Sue Roberts in London in July 2003. It was decided that in the UK DCCT-aligned HbA(1c) will continue to be reported from December 2003 for patient care and that laboratories currently reporting non-aligned DCCT HbA(1c) should change to reporting DCCT-aligned results as soon as possible. It was considered important for diabetes care in the UK that the reporting of HbA(1c) should not fragment. The UK HbA(1c) Standardization Committee was set up to hold "a watching brief " on HbA(1c) especially with relation to reporting of HbA(1c) in other countries.Keywords
This publication has 10 references indexed in Scilit:
- 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 StudyClinical Chemistry, 2004
- Psychological Impact of Changing the Scale of Reported HbA1c Results Affects Metabolic ControlDiabetes Care, 2002
- Approved IFCC Reference Method for the Measurement of HbA1c in Human Bloodcclm, 2002
- The UKPDS risk engine: a model for the risk of coronary heart disease in Type II diabetes (UKPDS 56)Clinical Science, 2001
- Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational studyBMJ, 2000
- Standardization of HbA1c measurements: a consensus statementAnnals of Clinical Biochemistry: International Journal of Laboratory Medicine, 2000
- Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33)The Lancet, 1998
- Candidate reference methods for hemoglobin A1c based on peptide mappingClinical Chemistry, 1997
- The Effect of Intensive Treatment of Diabetes on the Development and Progression of Long-Term Complications in Insulin-Dependent Diabetes MellitusNew England Journal of Medicine, 1993
- A comparative evaluation of glycosylated haemoglobin assays: feasibility of references and standardsDiabetologia, 1984