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Approved IFCC reference method for the measurement of HbA1c in human blood.
Clin Chem Lab Med. 2002 Jan; 40(1):78-89.CC

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.

Authors+Show Affiliations

Department of Clinical Chemistry, Malmö University Hospital, Lund University, Sweden. jan-olof.jeppsson@klkemi.mas.lu.seNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Guideline
Journal Article
Practice Guideline
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11916276

Citation

Jeppsson, Jan-Olof, et al. "Approved IFCC Reference Method for the Measurement of HbA1c in Human Blood." Clinical Chemistry and Laboratory Medicine, vol. 40, no. 1, 2002, pp. 78-89.
Jeppsson JO, Kobold U, Barr J, et al. Approved IFCC reference method for the measurement of HbA1c in human blood. Clin Chem Lab Med. 2002;40(1):78-89.
Jeppsson, J. O., Kobold, U., Barr, J., Finke, A., Hoelzel, W., Hoshino, T., Miedema, K., Mosca, A., Mauri, P., Paroni, R., Thienpont, L., Umemoto, M., & Weykamp, C. (2002). Approved IFCC reference method for the measurement of HbA1c in human blood. Clinical Chemistry and Laboratory Medicine, 40(1), 78-89.
Jeppsson JO, et al. Approved IFCC Reference Method for the Measurement of HbA1c in Human Blood. Clin Chem Lab Med. 2002;40(1):78-89. PubMed PMID: 11916276.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Approved IFCC reference method for the measurement of HbA1c in human blood. AU - Jeppsson,Jan-Olof, AU - Kobold,Uwe, AU - Barr,John, AU - Finke,Andreas, AU - Hoelzel,Wieland, AU - Hoshino,Tadao, AU - Miedema,Kor, AU - Mosca,Andrea, AU - Mauri,Pierluigi, AU - Paroni,Rita, AU - Thienpont,Linda, AU - Umemoto,Masao, AU - Weykamp,Cas, AU - ,, PY - 2002/3/28/pubmed PY - 2002/9/28/medline PY - 2002/3/28/entrez SP - 78 EP - 89 JF - Clinical chemistry and laboratory medicine JO - Clin Chem Lab Med VL - 40 IS - 1 N2 - 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. SN - 1434-6621 UR - https://www.unboundmedicine.com/medline/citation/11916276/Approved_IFCC_reference_method_for_the_measurement_of_HbA1c_in_human_blood_ L2 - https://www.degruyter.com/document/doi/10.1515/CCLM.2002.016 DB - PRIME DP - Unbound Medicine ER -