Determination of Reference Values for a Novel Ketoamine-Specific Fructosamine Assay for Assessment of Diabetic Glycemic Control

Abstract

Background: Intensive monitoring to improve glycemic control is essential for effective management of diabetes and reduction of long-term morbidity and pathology. Measurement of glycated serum proteins(fructosamine) allows more frequent assessment (monthly) of glycemic control than the 2- to 3-month window of the traditional glycated hemoglobin (HbA_1c) assay. In response to concerns about assays designed to measure glycated serum proteins based on the nitroblue tetrazolium (NBT) methodology, a novel assay to measure glycated serum proteins has been developed based on the specific oxidation of the ketoamine bonds within the glycated proteins. Methods: Reference range values for this new, enzymatic glycated-serum-protein assay (GlyPro^TM; Genzyme Corporation, Cambridge, MA) are reported. Results: The GlyPro reference range is lower and shows close correlation with ranges reported for the NBT assay. The 95% overall reference range was 122 to 236 mu mol/L. Conclusions: GlyPro is a reliable, accurate assay and correlates well with the NBT assay for the measurement of glycated serum proteins. The assay may be useful in the short-term assessment of diabetes control, a necessary complement to long-term control as assessed by hemoglobin A_1c (HbA_1c) assays.