Determination of reference values for a novel ketoamine-specific fructosamine assay for assessment of diabetic glycemic control

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 (HbA1c) 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. Reference range values for this new, enzymatic glycated-serum-protein assay (GlyPro; Genzyme Corporation, Cambridge, MA) are reported. 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 mumol/L. 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 A1c (HbA1c) assays.