MULTICENTER EVALUATION OF THE DCA-2000 SYSTEM FOR MEASURING GLYCATED HEMOGLOBIN

The recommended method for assessing long-term blood glucose control i n diabetic patients is the measurement of glycated haemoglobin (Hb), T he Ames DCA 2000 system for assaying glycated Hb uses an immunoassay w ith a monoclonal antibody specific for an aminoacid sequence within th e HblAc molecule. This study compared the performance of the DCA 2000 system for HblAc measurement with that of high-performance liquid chro matography (HPLC). A total of 1.016 insulin-dependent and non-insulin- dependent diabetic patients from 5 outpatient clinics took part. The c orrelation coefficients between DCA 2000 and HPLC data ranged between 0.94 and 0.98, depending on site. The mean variations and 95 % confide nce intervals for the differences between the results for each sample were: site A 0.172 (-1.186 to 1.53), site B-0.275 (-1.317 to 0.767), s ite C - 0.146 (-0.868 to 0.576), site D - 0.088 (- 0.864 to 0.688), an d site E - 0.251 (- 1.099 to 0.597). The sensitivity of the DCA 2000 a ssay ranged between 80 and 94 %, and the specificity between 88 and 10 0 %, depending on site, For pooled results, the correlation coefficien t assayed by the two methods was 0.95. The mean variation was - 0.116 and the 95 % confidence interval - 1.23 to 0.998. The sensitivity of D CA 2000 was 91 %, and the specificity 94 %. DCA tended to underestimat e HbAlc slightly as compared to HPLC. This study confirms the reliabil ity of DCA 2000 for measuring glycated Hb. The system is easy to use a nd provides valuable information for the care of diabetic patients.