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Introduction of IFCC reference method for calibration of HbA: implications for clinical care.
Diabet Med. 2004 Jul; 21(7):673-6.DM

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.

Authors+Show Affiliations

Clinical Biochemistry, University Hospital Birmingham NHS Trust, Birmingham, UK. susan.manley@uhb.nhs.ukNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

15209757

Citation

Manley, S, et al. "Introduction of IFCC Reference Method for Calibration of HbA: Implications for Clinical Care." Diabetic Medicine : a Journal of the British Diabetic Association, vol. 21, no. 7, 2004, pp. 673-6.
Manley S, John WG, Marshall S. Introduction of IFCC reference method for calibration of HbA: implications for clinical care. Diabet Med. 2004;21(7):673-6.
Manley, S., John, W. G., & Marshall, S. (2004). Introduction of IFCC reference method for calibration of HbA: implications for clinical care. Diabetic Medicine : a Journal of the British Diabetic Association, 21(7), 673-6.
Manley S, John WG, Marshall S. Introduction of IFCC Reference Method for Calibration of HbA: Implications for Clinical Care. Diabet Med. 2004;21(7):673-6. PubMed PMID: 15209757.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Introduction of IFCC reference method for calibration of HbA: implications for clinical care. AU - Manley,S, AU - John,W G, AU - Marshall,S, PY - 2004/6/24/pubmed PY - 2004/9/29/medline PY - 2004/6/24/entrez SP - 673 EP - 6 JF - Diabetic medicine : a journal of the British Diabetic Association JO - Diabet Med VL - 21 IS - 7 N2 - 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. SN - 0742-3071 UR - https://www.unboundmedicine.com/medline/citation/15209757/Introduction_of_IFCC_reference_method_for_calibration_of_HbA:_implications_for_clinical_care_ L2 - http://ovidsp.ovid.com/ovidweb.cgi?T=JS&PAGE=linkout&SEARCH=15209757.ui DB - PRIME DP - Unbound Medicine ER -