Technical performance evaluation of BM/Hitachi 747-200 serum fructosamine assay

Abstract

The technical performance of serum fructosamine assay as a short-term index of diabetic control was evaluated by using the BM/Hitachi 747-200 Automatic Analyzer (Boehringer Mannheim Corp). Intra- and interassay precisions (CV) were <2%. Linearity was confirmed up to 1000 μmol/L. Lipemia, produced artificially or from hypertriglyceridemia in vivo, did not interfere with measurement of serum fructosamine concentration. However, hemoglobin (Hb) interfered with measurement substantially at concentrations >15.5 μmol/L, and bilirubin interfered substantially at concentrations >68.4 μmol/L. A normal reference range of up to 282 μmol/L (mean ± 2SD = 242 ± 40) was derived from results obtained from 228 nondiabetic subjects. In 222 diabetic subjects, serum fructosamine concentration correlated well with fasting glucose concentration (r = 0.74) and with Hb A(1c) concentration (r = 0.80). This automated fructosamine assay has the advantages of technical simplicity, low cost, and reduced analytical time compared with the Hb A(1c) method.