Performance and clinical significance of the new fructosamine assay in diabetic patients.

Abstract

The performance of the assay and the clinical usefulness of a new short-term index (Fructosamine Plus: FP) of metabolic control in diabetes was evaluated. The FP concentration was determined with the Hitachi 704, Cobas Mira, and Cobas Fara analyzers. The "within run" and "between run" CVs were less than 2.67% and less than 4.26%, respectively. The reference interval (determined from data on 125 blood donors) was 191 to 288 mumol/l (mean 240 mumol/l). In poorly controlled diabetic patients FP was significantly higher than in the well controlled ones. Moreover FP was significantly correlated with HbA1c and blood glucose levels. Our preliminary data seem to demonstrate that relating FP to total protein does not improve the clinical value of the new index.