FULLY AUTOMATED-ASSAY OF GLYCOHEMOGLOBIN WITH THE ABBOTT IMX(R) ANALYZER - NOVEL APPROACHES FOR SEPARATION AND DETECTION

We describe a novel assay for measuring glycohemoglobin directly from anticoagulated whole blood with the Abbott IMx(R) analyzer. The glycoh emoglobin is labeled with a soluble polyanionic affinity reagent and t he anionic complex is then captured with a cationic solid-phase matrix . Glycohemoglobin is quantified by measuring the quenching by heme of the static fluorescence from an added fluorophore. The assay is standa rdized to report both percent total glycohemoglobin (%GHb) and percent hemoglobin A1c (%HbA1c). Glucose, bilirubin, triglycerides, labile fr action, and hemoglobin variants do not interfere in the assay. Within- and between-run CVs are approximately 4-5%, with total CVs of approxi mately 6.5%. Highly significant linear correlations (r >0.97) were obt ained in comparison studies with two major assay methodologies. The ti me to obtain one result is approximately 10 min (including assay of a control), 56 min for 22 results. We describe the development, standard ization, and validation of this new method.