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Introduction of IFCC reference method for calibration of HbA: implications for clinical care
S Manley1, W G John, S Marshall
1Clinical Biochemistry, University Hospital Birmingham NHS Trust, Birmingham, UK. susan.manley@uhb.nhs.uk
Insights
Glycated hemoglobin (HbA1c) monitoring is crucial for diabetes management. In the UK, reporting of DCCT-aligned HbA1c will continue despite the new IFCC reference method to ensure consistent patient care.
Area of Science:
- Clinical Chemistry
- Diabetology
- Laboratory Medicine
Background:
- Glycated hemoglobin (HbA1c) is essential for monitoring glycemic control and diabetes complication risks.
- UK guidelines mandate Diabetes Control and Complications Trial (DCCT)-aligned HbA1c measurements for comparability.
- The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reference method will be introduced in Europe.
Purpose of the Study:
- To inform healthcare professionals about the upcoming IFCC reference method for HbA1c.
- To clarify the continued use of DCCT-aligned HbA1c reporting in the UK.
- To ensure standardized HbA1c reporting for optimal diabetes patient care in the UK.
Main Methods:
- Discussion and decision-making among UK diabetes care professionals.
- Establishment of the UK HbA1c Standardization Committee.
- Monitoring of international HbA1c reporting practices.
Main Results:
- The IFCC reference method will introduce a lower reference range compared to DCCT.
- Despite the IFCC method, the UK will continue reporting DCCT-aligned HbA1c from December 2003.
- Laboratories are urged to transition to DCCT-aligned reporting promptly.
Conclusions:
- Continued reporting of DCCT-aligned HbA1c is vital for UK diabetes care continuity.
- Preventing fragmentation in HbA1c reporting is a key objective.
- The UK HbA1c Standardization Committee will oversee reporting practices.
Abstract:
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.
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