Introduction of IFCC reference method for calibration of HbA: implications for clinical care1c: implications for clinical care

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Abstract

HbA1c 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 HbA1c 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 HbA1c will be introduced in Europe in December 2003 for calibration of all laboratory and POCT (point of care testing) methods for HbA1c following the recent EC ‘In Vitro Diagnostic’ (IVD) directive. This reference method involves measurement of HbA1c and HbA0 by electron-spray ionisation-mass spectrometry or capillary electrophoresis with the reference range approximately 2% HbA1c lower than the corresponding range from the DCCT. However, this EC IVD directive will not change reporting of DCCT-aligned HbA1c 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 HbA1c will continue to be reported from December 2003 for patient care and that laboratories currently reporting non-aligned DCCT HbA1c 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 HbA1c should not fragment. The UK HbA1c Standardization Committee was set up to hold ‘a watching brief’ on HbA1c especially with relation to reporting of HbA1c in other countries.

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