Standardization of Two Immunological HbA 1c Routine Assays According to the New IFCC Reference Method
Groche, D.; Hoeno, W.; Hoss, G.; Vogt, B.; Herrmann, Z.; Witzigmann, A.
Clinical Laboratory 49(11-12): 657-661
2003
ISSN/ISBN: 1433-6510 PMID: 14651337 Document Number: 9941
The measurement of HbA 1c is meanwhile well established as the most important parameter in clinical chemistry for monitoring the long term metabolic control of diabetic patients. However, the comparability of HbA 1c values obtained by different methods in different laboratories and different countries is limited since there was no internationally agreed reference method available. Additionally the % HbA 1c values, based on the most common DCCT values are too high due to well known non specificity of the DCCT standardization protocol. Recently a new reference method for the determination of HbA 1c was developed and has been approved by the IFCC as the future basis for the worldwide standardization of HbA 1c routine assays (1). The two routine methods from Roche Diagnostics (both based on the immunoturbidimetric determination of the stable glucose adduct to the N-terminal group of the hemoglobin ß chain, Roche-Hitachi/Tina-quant® ratio. Good linear correlations were obtained when comparing the routine methods against the new IFCC reference, indicating the high specificity of these immunological approaches.
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