Evaluation of diagnostic reliability of DCA 2000 for rapid and simple monitoring of HbA1c

The monitoring of diabetic patients by evaluating glycated protein levels i s now widely accepted and performed. The microchromatographic version of th e high performance liquid chromatography method is the technique most frequ ently used in clinical practice. The DCA 2000 instrument (Bayer Diagnostics , Milan, Italy), based on an immunochemical technique, has been proposed fo r the rapid and simple evaluation of HbA1c, using even capillary blood. We evaluated 171 subjects including 22 healthy volunteers, 78 type 2 diabetic patients with different degrees of metabolic control, 11 women affected by gestational diabetes mellitus (GDM), 6 patients with hyperlipemia, 38 patie nts with chronic renal failure, 13 diabetic patients with chronic renal fai lure, and 3 patients with hemoglobinopathies. The DCA 2000 model was compar ed with the Diamat HPLC system. Data from within-run imprecision studies sh owed excellent precision, for both DCA 2000 and the HPLC system. The correl ation between the two different systems, as shown by other statistical eval uations, was good (y = 0.911x + 0.462, r = 0.923). Results from the control group and diabetic patients were used to compare the two methods. Values o btained using the DCA 2000 were significantly lower (p < 0.0001) than those obtained with the HPLC system, in both healthy subjects and diabetic patie nts. To detect possible interferences, selected samples were analyzed from patients with hyperlipemia, diabetes and chronic renal failure, and hemoglo binopathies. While in the case of hyperlipemia, an acceptable correlation c oefficient between the two systems was confirmed (y = 1.047x - 1.236, r = 0 .876), in the case of chronic renal failure the correlation turned out to b e very low (y = 0.254x + 3.456, r = 0.203). Our results indicate that the D CA 2000 gives accurate and reliable results in the clinical field of intere st.