EVALUATION OF A NEW METHOD FOR MEASUREMEN T OF GLYCATED HEMOGLOBIN WITH MONOCLONAL-ANTIBODIES

HPLC (High Performance Liquid Chromatography) is commonly regarded as the reference method for HbA1c measurements. However, HPLC requires a relatively large technical staff, expensive laboratory equipment and i s rather time consuming. The mobile DCA 2000 instrument determines HbA 1c in only 9 minutes, using only one microlitre of capillary blood. It uses an immunoassay based on the inhibition of latex agglutination an d a monoclonal antibody specific for the glycated N-terminal end of th e beta-chain of haemoglobin. In order to determine the reliability of this new method for clinical practice we compared HbA1c measurements o n DCA 2000 with HPLC values. A correlation analysis in 283 diabetic pa tients 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% HbA1c), in 58 samples (20.8%) it was higher (mean deviation: 0.39 %). In 10 samples the values were identical. The maximum deviations we re plus 1.6% and minus 1.3% HbA1c. DCA 2000 is easy to handle and give s rapid and reliable information on long-term metabolic control. Hence , it could be very useful for clinical practice and outpatient departm ents.