Évaluation de la concordance des valeurs d'hémoglobine glyquée entre les automates de biochimie D-10® (Biorad) et Minicap Flex piercing® (Sebia)

Abstract

Glycated hemoglobin (HbAlc) is a key marker in the management of diabetic patients, particularly for the monitoring of glycemic control. Today, various automated glycated hemoglobin assay systems are available on the market. Thus, in order to meet one of the requirements of the ISO 15189 standard, a study was carried out in order to evaluate the agreement between the results obtained by two biochemical machines, in particular the D-10® (Biorad) system based on an ion exchange HPLC method and the Minicap Flex Piercing® (Sebia) that uses the principle of capillary electrophoresis. In total, thirty samples covering the measurement interval defined by the suppliers were tested and for each sample the assays were performed in parallel on the two automata. We found a good correlation between the two systems with a coefficient R = 0.995 (p <0.0001). The difference diagram according to Bland and Altman shows a distribution of differences for both normal HbAlc values and high values (> 86 mmol/mol or 10%). Ninety-five percent of the differences are between - 0.93 and + 11.33 mmol/mol (or - 0.08% and + 1.01%). This large range of differences does not allow to affirm a transferability between the two systems and require the follow-up of patients with the same technique.