Rapid desktop method for the measurement of glycated haemoglobin HbA1c.

Abstract

A new desktop monoclonal antibody-based test system (Bayer Diagnostics DCA 2000) for quantitation of glycated haemoglobin HbA1c is described and evaluated. This method involves a monoclonal antibody to HbA1c which defines its specificity. It requires 9 minutes to complete, and shows good intra- and inter-run precisions (1.3%-3.7%), at 5 HbA1c levels tested--4.1%, 5.7%, 6.1%, 9.2% and 12.4%. Results from 81 blood samples obtained from diabetic patients (3.9%-13.2% HbA1c) showed excellent correlation with a laboratory-based ion-exchange HPLC technique (y = 1.03 [Lab] + 0.103%; Pearson coefficient, r = 0.99). The test can be performed either with a capillary fingerprick or venous blood sample. Only 1 microliter of blood volume is required. Comparison of HbA1c levels of 43 paired capillary and venous samples showed excellent correlation (y = 1.00 [venous] + 0.042%; r = 0.99). The HbA1c values obtained from a cohort of 37 healthy adults, mean (+/- SD) age 33 +/- 9.01 years, gave a value of 5.5 +/- 0.42%. The calculated 95% confidence limits are 4.7%-6.3%. This quick method provides 'stat' HbA1c results, which were hitherto not possible with the laboratory-based methods.