Measurement of glycated hemoglobin (GHb) is already gaining acceptance for management of persons with diabetes mellitus. GHb levels are not only useful for diagnosis but also for the establishment of care goals and for measurements for the routine management of diabetes which will require test methodologies to be more reliable and cost effective. To this end we propose to develop a semiautomated instrument for measurement of GHb which will reduce human and mechanical error. The heart of the instrument is an affinity support which possesses sufficient ligand side chains and has excellent flow properties. The development of this affinity support was accomplished in phase I. During phase II the instrumental design and sample protocol will be established. As the instrumental outlay and sample protocol are developed, additional refinement of the affinity support will most certainly be required. The composition of other reagents including the eluant(s) and the hemoglobin controls will be evaluated and their stability during use and storage determined.
