[Evaluation of a new method for determining glycated hemoglobin with monoclonal antibodies (DCA 2000)]

HPLC (High Performance Liquid Chromatography) is commonly regarded as the reference method for HbAlc measurements. However, HPLC requires a relatively large technical staff, expensive laboratory equipment and is rather time consuming. The mobile DCA 2000 instrument determines HbAlc in only 9 minutes, using only one microliter of capillary blood. It uses an immunoassay based on the inhibition of latex agglutination and a monoclonal antibody specific for the glycated N-terminal end of the beta-chain of haemoglobin. In order to determine the reliability of this new method for clinical practice we compared HbAlc measurements on DCA 2000 with HPLC values. A correlation analysis in 283 diabetic patients showed a highly significant correlation between the two methods (r = 0.96; p < 0.0001). In 215 samples (75.7%) the value measured by means of DCA 2000 was lower than the reference value (mean deviation: 0.6% HbAlc), in 58 samples (20.8%) it was higher (mean deviation: 0.39%). In 10 samples the values were identical. The maximum deviations were plus 1.6% and minus 1.3% HbAlc. DCA 2000 is easy to handle and gives rapid and reliable information on long-term metabolic control. Hence, it could be very useful for clinical practice and outpatient departments.