High-Resolution HbA1cSeparation and Hemoglobinopathy Detection With Capillary Electrophoresis

Abstract

The CAPILLARYS HbA(1c) kit used on the CAPILLARYS 2 Flex Piercing system is designed for separating and quantifying the HbA(1c) fraction of hemoglobin while detecting hemoglobin variants and HbA(2). The aim of this study was to assess the performance of this new capillary electrophoresis kit for routine HbA(1c) quantification for patients with diabetes. The reliability of the system for HbA(2) measurement was also assessed. Precision, correlation, and linearity studies were performed. The effect of hemoglobin concentration and the presence of coexistent interfering substances were evaluated. The results were found to be accurate and linear in the clinically significant analytic range with excellent precision (mean interassay coefficient of variation of 0.7%). HbA(1c) measurement is independent of the presence of common hemoglobin interferences for HbA(1c) quantification and the total concentration of hemoglobin. Moreover, the technique provides a rapid and reliable separation of HbA(2). The measurement is reproducible and the results in β-thalassemia carriers were statistically different from those in noncarriers. Thus, this technique might be used for β-thalassemia detection. Given the short time of the analysis and the high throughput, this is a suitable system for the control of diabetes and the detection of hemoglobinopathies in laboratories with high workflow.