Glycated Serum Protein (GlycoGap®)
Glycated Serum Protein single calibrator, is intended for the quantitative determination of glycated serum proteins in serum.
Diazyme has developed a 2-part, liquid stable enzymatic test for quantitative determination of glycated serum protein (GSP, glycated albumin) in serum samples of patients. The Diazyme enzymatic GSP test kit (GlycoGap®) is used for short-term to medium-term monitoring of glycemic control for average blood glucose levels over the past 2-3 week period. Diazyme’s GlycoGap® test can be run on most automated clinical chemistry analyzers. The enzymatic assay is more specific for glycated serum protein than the old NBT based fructosamine assay which is significantly interfered by endogenous reducing substances. The GlycoGap® test offers excellent analytical performance in precision, accuracy, linearity and stability. The GlycoGap® liquid stable test provides good correlations as compared to its previous lyophilized version of the GSP test. In 2010, The American Diabetes Association (ADA) Clinical Practice Recommendations recommend using HbA1c to diagnose and screen diabetes.
The enzymatic assay for glycated serum protein provides improved specificity and reliability compared to conventional NBT-based methods. The assay is highly precise with a total CV ≤ 1.3%. The assay offers extensive linearity up to 1354 μmol/L. The assay has no significant interference from: ascorbic acid (5 mg /dL); bilirubin (7.5 mg/dL); bilirubin conjugated (5 mg/dL); glucose (2400 mg/dL; hemoglobin (200 mg/dL); triglycerides (2000 mg/dL); and uric acid (35 mg/dL).
Glycated Serum Protein Assay uses proteinase K to digest GSP into low molecular weight glycated protein fragments (GPF), and uses Diazyme’s specific fructosaminase™, a microorganism originated amadoriase to catalyze the oxidative degradation of Amadori product GPF to yield PF or amino acids, glucosone and H2O2. The H2O2 released is measured by a colorimetric Trinder end-point reaction. The absorbance at 546-600 nm is proportional to the concentration of glycated serum proteins
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