Certification of the Amount-of-Substance Fraction of HbA1c versus the Sum of all Hb Isoforms forming the glycated or non-glycated N-terminal Hexapeptide of the -Chain on Haemoglobin isolated from whole Blood, IRMM/IFCC-466

Abstract

This report describes the preparation, homogeneity, stability and certification studies of HbA1c (IRMM/IFCC-466) from human blood. HbA1c is defined as the beta-N-(1-deoxyfructos-1-yl) haemoglobin. the amount-of-substance fraction of HbA1c in IRMM/IFCC-466 is 934 mmol/mol ± 22 mmol/mol (expressed as mmol HbA1c per mol HbA1c plus HbA0). The intended use of this certified reference material is the calibration of the IFCC reference measurement procedure and other analogous methods based on the quantification of the N-terminal hexapeptide including the stable glycation.JRC.D.2-Reference material