Hemoglobina glicada

Clin Chem Lab Med 2002; 40(1):78–89 © 2002 by Walter de Gruyter · Berlin · New York

Approved IFCC Reference Method for the Measurement
of HbA1c in Human Blood

International Federation of Clinical Chemistry and
Laboratory Medicine (IFCC)1)2)
Scientific Division
Working Group on HbA1c Standardisation3)and
Network of Reference Laboratories for HbA1c4)
Prepared for publication5),6) byJan-Olof Jeppsson1,7), Uwe Kobold2, John Barr3, Andreas
Finke2, Wieland Hoelzel2, Tadao Hoshino4, Kor Miedema5,
Andrea Mosca6, Pierluigi Mauri7, Rita Paroni8, Linda
Thienpont9, Masao Umemoto10 and Cas Weykamp11
1 Department of Clinical Chemistry, Malmö University
Hospital, Lund University, Malmö, Sweden
2
Roche Diagnostics GmbH, Penzberg, Germany
3 Center of Disease Control, Atlanta, USA
4Institute of Biopathological Medicine, Ono, Japan
5 Department of Clinical Chemistry, Isala Klinieken, Zwolle,
The Netherlands
6 Department of Science and Biomedical Technology,
University of Milan, Milan, Italy
7 Institute of Biomedical Technology, Consiglio Nazionale
Delle Ricerche, Milan, Italy
8
IRCCS Hospital San Raffaele, Milan, Italy
9 Laboratory of Analytical Chemistry, Faculty ofPharmaceutical Sciences, University of Gent, Gent, Belgium

The excluxive  for all languages and countries is vested in
the International Federation of Clinical Chemistry and Laboratory Medicine.
2)
IFCC Sections reprinted in J. Clin. Chem. Clin. Biochem. are
listed in the Cumulative Index, which appeared in connection
with the contents of this journal Volume 27, 1989./Since 1998
havebeen printed in (Eur.) J. Clin. Chem. Clin. Biochem./Since
1998 have been printed in Clin. Chem. Lab. Med.
IFCC 1991/1 Vol. 29, 435–457
IFCC 1991/2 Vol. 29, 531–535
IFCC 1991/3 Vol. 29, 577–586
IFCC 1991/4 Vol. 29, 767–772
IFCC 1992/1 Vol. 30, 901–905
IFCC 1994/1 Vol. 32, 639–655
IFCC 1995/1 Vol. 33, 247–253
IFCC 1995/2 Vol. 33, 399–404
IFCC 1995/3 Vol. 33, 623–625
IFCC 1995/4 Vol. 33,627–636
IFCC 1995/5 Vol. 33, 637–660
IFCC 1997/1 Vol. 35, 317–344
IFCC 1997/2 Vol. 35, 345–349
IFCC 1997/3 Vol. 35, 805–831
IFCC 1997/4 Vol. 35, 833–843
IFCC 1998/1 Vol. 36, 57–65
IFCC 1998/2 Vol. 36, 185–203
IFCC 1998/3 Vol. 36, 887–893
IFCC 2000/1 Vol. 38, 363–370
IFCC 2000/2 Vol. 38, 1301–1314
1)

10
11

IFCC 2002/1

Standard Reference Center, Kawasaki, Japan.
SKZL QueenBeatrix Hospital, Winterswijk, The Netherlands

HbA1c is the stable glucose adduct to the N-terminal
group of the -chain of HbA0. The measurement of
HbA1c in human blood is most important for the longterm 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 methodwhich
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 Nterminal hexapeptides of the -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. Bothprinciples 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 studiesIFCC 2001/1 Vol. 39, 175–179
IFCC 2001/3 Vol. 39, 283–289
IFCC 2001/2 Vol. 39, 875–889
3)
Members are: K. Miedema, Zwolle (Netherlands, chairman), DE. Goldstein, Columbia (USA), W. Hoelzel, Penzberg
(Germany), T. Hoshino, Ono (Japan), J.O. Jeppsson, Malmo
(Sweden), RR. Little, Columbia (USA), A. Mosca, Milano
(Italy), G. Myers, Atlanta (USA), C. Weykamp, Winterswijk
(Netherlands), G....