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Endocrinology and Metabolism |
1 Roche Diagnostics GmbH, Penzberg, Germany.
2 SKZL Queen Beatrix Hospital, Winterswijk, The Netherlands.
3 Department of Clinical Chemistry, Malmo University Hospital, Lund University, Malmo, Sweden.
4 Department of Clinical Chemistry, Isala Klinieken, NA 8000 GM Zwolle, The Netherlands.
5 Centers for Disease Control and Prevention, Atlanta, GA.
6 Department of Laboratory Medicine. Austin & Repatriation Medical Centre, Melbourne, Australia.
7 Institute of Biopathological Medicine, Ono, Japan.
8 Department of Clinical Biochemistry, Norfolk and Norwich University Hospital, Norwich, Norfolk, United Kingdom.
9 University of Missouri School of Medicine, Columbia, MO.
10 Department of Science and Biomedical Technology, University of Milan, Milan, Italy.
11 Institute of Biomedical Technology, Consiglio Nazionale Delle Ricerche, Milan, Italy.
12 Istituto di Ricovero e Cura a Carattere Scientifico, Hospital San Raffaele, Milan, Italy.
13 German Diabetes Research Institute, Duesseldorf, Germany.
14 Department of Laboratory Medicine, School of Medicine, Keio University, Tokyo, Japan.
15 Laboratory of Analytical Chemistry, Faculty of Pharmaceutical Sciences, University of Gent, Ghent, Belgium.
16 Standard Reference Center, Kawasaki, Japan.
aAuthor for correspondence. Fax 31-38-4242676; e-mail k.miedema{at}isala.nl.
Background: The national programs for the harmonization of hemoglobin (Hb)A1c measurements in the US [National Glycohemoglobin Standardization Program (NGSP)], Japan [Japanese Diabetes Society (JDS)/Japanese Society of Clinical Chemistry (JSCC)], and Sweden are based on different designated comparison methods (DCMs). The future basis for international standardization will be the reference system developed by the IFCC Working Group on HbA1c Standardization. The aim of the present study was to determine the relationships between the IFCC Reference Method (RM) and the DCMs.
Methods: Four method-comparison studies were performed in 2001–2003. In each study five to eight pooled blood samples were measured by 11 reference laboratories of the IFCC Network of Reference Laboratories, 9 Secondary Reference Laboratories of the NGSP, 3 reference laboratories of the JDS/JSCC program, and a Swedish reference laboratory. Regression equations were determined for the relationship between the IFCC RM and each of the DCMs.
Results: Significant differences were observed between the HbA1c results of the IFCC RM and those of the DCMs. Significant differences were also demonstrated between the three DCMs. However, in all cases the relationship of the DCMs with the RM were linear. There were no statistically significant differences between the regression equations calculated for each of the four studies; therefore, the results could be combined. The relationship is described by the following regression equations: NGSP-HbA1c = 0.915(IFCC-HbA1c) + 2.15% (r2 = 0.998); JDS/JSCC-HbA1c = 0.927(IFCC-HbA1c) + 1.73% (r2 = 0.997); Swedish-HbA1c = 0.989(IFCC-HbA1c) + 0.88% (r2 = 0.996).
Conclusion: There is a firm and reproducible link between the IFCC RM and DCM HbA1c values.
The following articles in journals at HighWire Press have cited this article:
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 C. G. Gustavsson and C.-D. Agardh Markers of inflammation in patients with coronary artery disease are also associated with glycosylated haemoglobin A1c within the normal range Eur. Heart J., December 1, 2004; 25(23): 2120 - 2124. [Abstract] [Full Text] [PDF]
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