The determination of HbA(1c) (glycated haemoglobin) in a human haemolysate reference material : RM 405Funded under: FP3-MAT
This report describes the preparation and lyophilisation of human haemolysate for calibration or control purposes in the measurement of HbA(1c) by HPLC. The stability and homogeneity of the ampouled samples were assessed. The material has a small quantity of an undefined component (HbA(1X)) which can affect the separation of HbA(1c) from HbA(0) by some HPLC procedures. A method for correcting for this component is described and demonstrated. The programme involved the participation of 10 European laboratories. When HbA(1c) was determined by a procedure not affected by component HbA(1X), the mean +/- 1 SD value obtained was (6.29 +/- 0.18) % of the total haemoglobin. The corresponding mean value obtained for five other HPLC methods, after correction for HbA(1X), was (6.66 +/- 0.55) %. The values for these methods without correction are given in the text. Studies using the same material for measurement of glycated haemoglobin by affinity chromatography are also described. With this manual technique the results are particularly sensitive to methodological changes and such methods cannot therefore be used as reference methods to assign any value to the material.
Bibliographic Reference: EUR 15136 EN (1993) 56 pp., FS, ECU 8.50
ISBN: ISBN 92-826-6247-0
Record Number: 199311406 / Last updated on: 1994-11-28
Original language: en
Available languages: en