SULM – Schweizerische Union für Labormedizin | Union Suisse de Médecine de Laboratoire | Swiss Union of Laboratory Medicine

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J.M. Nuoffer1 , F. Egger1 , U. Marti1

1Institute of Clinical Chemistry, University of Bern, Inselspital Bern, CH-3010 Bern

Introduction
Glycated hemoglobin in particularly HbA1c has been well established as long-term glycemic control in diabetics. The non-enzymatic glycosylation of hemoglobin is a two-step reaction, in which glucose binds reversibly to the terminal aminogroup of the beta-chain to give the so-called "labile Hb". In a second step this product undergoes a slow and irreversible Amadori rearrangement, giving rise to the HbA1c molecule. The amount of HbA1c is a good measure of the mean glucose concentration in blood over the last 2-3 months. There are various methods and systems for HbA1c determination.
Aim
The aim of this work was the comparison of different methods for HbA1c determination: the Ceofix-HbA1c capillary electrophoresis kit from Analis (CE), the HPLC systems Tosoh G7 (G7) and BioRad D10 (D10) and the immunological system DCA 2000 (DCA) from Bayer. The following criterias were evaluated: precision performances, method comparison according to Passing-Bablok, handling.
Results:
Passing-Bablok linear regressions for the compared methods were 1.046x+1.978 (CE vs. G7, n=224), 1.058x+2.15 (CE vs. D10, n=234), 1.081x+2.063 (CE vs. DCA, n=204), 0.988x-0.140 (D10 vs. G7, n=224), 1.0x-0.100 (D10 vs. DCA, n=204), and 0.986x-0.042 (DCA vs. G7, n=197). The precision performances for all methods were evaluated with a normal and a high value sample. VC values were below 3% for all methods. Day-to-day precisions showed a VC of less then 3% for all methods.
The capillary electrophoresis method shows results according to the new IFCC reference whereas the other three methods are calibrated to the DCCT standards.
Conclusions
The handling and the hand-on time for the tested methods showed large differences. All methods gave HbA1c values with a good precision performance, and revealed comparable HbA1c values, if we take into consideration the corrected IFCC values measured by the CE method.

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