[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.
Kopp
H P
HP
I. Medizinische Abteilung, Krankenanstalt Rudolfstiftung, Wien.
Festa
A
A
Hopmeier
P
P
Schernthaner
G
G
D000911:Antibodies, Monoclonal; D002851:Chromatography, High Pressure Liquid / Q000295:instrumentation; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D011237:Predictive Value of Tests; D015203:Reproducibility of Results
D000911:Antibodies, Monoclonal; D006442:Glycated Hemoglobin
Evaluation einer neuen Methode zur Bestimmung von glykiertem Hämoglobin mittels monoklonaler Antikörper (DCA 2000).