Assay of serum fructosamine that minimizes standardization and matrix problems: Use to assess components of biological variation

Abstract

Methodological problems with the assay of fructosamine in serum - standardization, matrix effects, and dependence on buffer pH - have been minimized with a method involving colorimetric assay of each specimen and subsequent reassay after standard addition of 1-deoxy-1-morpholinofructose. Absorbance at optimum wavelength of 540 nm varies linearly with fructosamine concentration to at least 5.5 mmol/L, and between-run precision is about 6% for both patients' specimens and quality control materials. Correction of fructosamine to serum albumin of 40 g/L minimizes the effect of albumin while maintaining transferability of data and reference values. From data on biological variation, the analytical goal for precision (CV) is ≤2.6%. The square root of the ratio of intra- to interindividual variance is low, indicating that fructosamine concentrations have a high index of individuality; thus conventional population-based reference values are of limited use. Although this assay may be useful in monitoring disease, we doubt that it provides a valid screening test for diabetes.