Comparaison des interferences analytiques sur le dosage de I'HbA1c par deux analyseurs de chromatographie liquide haute pression Comparison of analytical interferences on HbA1c measurement by two high pressure liquid chromatography analyzers

摘要

Le dosage de I'HbAlc par technique de chromatographie liquide haute pression (CLHP) reste soumis a differentes interferences analytiques. Nous avons evalue le comportement des analyseurs G8 (To soh Bioscience) et Variant 11 (BioRad) vis-a-vis des interferences les plus couramment rencontrees (HbAlc labile, hemoglobine carbamylee, bilirubine, triglycerides, hemoglobines anormales). Cette etude comparative montre que l'influence de ces interferences est variable selon l'analyseur et depend de parametres tels que la resolution de la separation chromatographique ou le mode d' integration des pies. Cependant, cette influence reste moderee si des regles de validation technique strictes propres a chaque automate sont etablies au prealable. Cette evaluation souligne egalement l'importance de linterpretation detaillee des chromatogrammes lors de la validation biologique, et la necessite de mettre en place des procedures specifiques pour la conduite a tenir en presence d'interferences, afin de garantir la fiabilite des resultats de dosage d'HbA1c. HbAlc assay by high-pressure liquid chromatography (HPLC) remains submitted to various analytical interferences. We have evaluated the behaviour of the analyzers G8 (Tosoh Bioscience) and Variant 11 (BioRad) towards the most common interferences (i.e. labile fraction of HbA1c. carbamylatcd hemoglobin, bilirubin. triglyccrides, hernoglobin variants). This comparative study showed that the influence of these interferences varied according to the analyzer and depended on various settings such as the chro?matographic resolution and the peak integration mode. However. this influence remains limited when strict and analyzcr-speciric rules of technical validation have been previously determined. The outcome of the study underlines the importance of a detailed interpretation of chromatograms during the biological validation process. and recommends specific procedures in case of interferences. in order to ensure the reliability of HbAlc results.