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Approved IFCC reference method for the measurement of HbA1c in human blood.

Jeppsson, Jan-Olof LU ; Kobold, Uwe; Barr, John; Finke, Andreas; Hoelzel, Wieland; Hoshino, Tadao; Miedema, Kor; Mosca, Andrea; Mauri, Pierluigi and Paroni, Rita, et al. (2002) In Clinical Chemistry and Laboratory Medicine 40(1). p.78-89
Abstract
HbA1C is the stable glucose adduct to the N-terminal group of the beta-chain of HbA0. The measurement of HbA1c in human blood is most important for the long-term control of the glycaemic state in diabetic patients. Because there was no internationally agreed reference method the IFCC Working Group on HbA1c Standardization developed a reference method which is here described. In a first step haemoglobin is cleaved into peptides by the enzyme endoproteinase Glu-C, and in a second step the glycated and non-glycated N-terminal hexapeptides of the beta-chain obtained are separated and quantified by HPLC and electrospray ionisation mass spectrometry or in a two-dimensional approach using HPLC and capillary electrophoresis with UV-detection. Both... (More)
HbA1C is the stable glucose adduct to the N-terminal group of the beta-chain of HbA0. The measurement of HbA1c in human blood is most important for the long-term control of the glycaemic state in diabetic patients. Because there was no internationally agreed reference method the IFCC Working Group on HbA1c Standardization developed a reference method which is here described. In a first step haemoglobin is cleaved into peptides by the enzyme endoproteinase Glu-C, and in a second step the glycated and non-glycated N-terminal hexapeptides of the beta-chain obtained are separated and quantified by HPLC and electrospray ionisation mass spectrometry or in a two-dimensional approach using HPLC and capillary electrophoresis with UV-detection. Both principles give identical results. HbA1c is measured as ratio between the glycated and non-glycated hexapeptides. Calibrators consisting of mixtures of highly purified HbA1c and HbA0 are used. The analytical performance of the reference method has been evaluated by an international network of reference laboratories comprising laboratories from Europe, Japan and the USA. The intercomparison studies of the network showed excellent results with intra-laboratory CVs of 0.5 to 2% and inter-laboratory CVs of 1.4 to 2.3%. Possible interferences have been carefully investigated. Due to the higher specificity of the reference method the results are lower than those generated with most of the present commercial methods which currently are calibrated with unspecific designated comparison methods. The new reference method has been approved by the member societies of the International Federation of Clinical Chemistry and Laboratory Medicine and will be the basis for the future uniform standardization of HbA1c routine assays worldwide. (Less)
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Clinical Chemistry and Laboratory Medicine
volume
40
issue
1
pages
78 - 89
publisher
De Gruyter
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  • wos:000174691000015
  • pmid:11916276
  • scopus:18244404332
ISSN
1434-6621
language
English
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yes
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e15c0a37-3e59-4006-9377-6b80151a3bdd (old id 107200)
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http://www.degruyter.de/journals/cclm/pdf/401_78.pdf
date added to LUP
2007-07-25 14:00:42
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2017-11-19 03:34:21
@article{e15c0a37-3e59-4006-9377-6b80151a3bdd,
  abstract     = {HbA1C is the stable glucose adduct to the N-terminal group of the beta-chain of HbA0. The measurement of HbA1c in human blood is most important for the long-term control of the glycaemic state in diabetic patients. Because there was no internationally agreed reference method the IFCC Working Group on HbA1c Standardization developed a reference method which is here described. In a first step haemoglobin is cleaved into peptides by the enzyme endoproteinase Glu-C, and in a second step the glycated and non-glycated N-terminal hexapeptides of the beta-chain obtained are separated and quantified by HPLC and electrospray ionisation mass spectrometry or in a two-dimensional approach using HPLC and capillary electrophoresis with UV-detection. Both principles give identical results. HbA1c is measured as ratio between the glycated and non-glycated hexapeptides. Calibrators consisting of mixtures of highly purified HbA1c and HbA0 are used. The analytical performance of the reference method has been evaluated by an international network of reference laboratories comprising laboratories from Europe, Japan and the USA. The intercomparison studies of the network showed excellent results with intra-laboratory CVs of 0.5 to 2% and inter-laboratory CVs of 1.4 to 2.3%. Possible interferences have been carefully investigated. Due to the higher specificity of the reference method the results are lower than those generated with most of the present commercial methods which currently are calibrated with unspecific designated comparison methods. The new reference method has been approved by the member societies of the International Federation of Clinical Chemistry and Laboratory Medicine and will be the basis for the future uniform standardization of HbA1c routine assays worldwide.},
  author       = {Jeppsson, Jan-Olof and Kobold, Uwe and Barr, John and Finke, Andreas and Hoelzel, Wieland and Hoshino, Tadao and Miedema, Kor and Mosca, Andrea and Mauri, Pierluigi and Paroni, Rita and Thienpont, Linda and Umemoto, Masao and Weykamp, Cas},
  issn         = {1434-6621},
  language     = {eng},
  number       = {1},
  pages        = {78--89},
  publisher    = {De Gruyter},
  series       = {Clinical Chemistry and Laboratory Medicine},
  title        = {Approved IFCC reference method for the measurement of HbA1c in human blood.},
  volume       = {40},
  year         = {2002},
}