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

Diabetes Technol Ther. 1999 Winter;1(4):447-55. doi: 10.1089/152091599316982.

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 (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.

Methods: Reference range values for this new, enzymatic glycated-serum-protein assay (GlyPro; 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 mumol/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 A1c (HbA1c) assays.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Biomarkers / blood
  • Blood Glucose / metabolism*
  • Diabetes Mellitus / blood*
  • Female
  • Fructosamine / blood*
  • Glycated Hemoglobin / analysis
  • Humans
  • Male
  • Middle Aged
  • Monitoring, Physiologic / methods
  • Reference Standards
  • Reference Values
  • Regression Analysis
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • Biomarkers
  • Blood Glucose
  • Glycated Hemoglobin A
  • Fructosamine