Comparison of two analytical methods for HbA1c determination: HPLC ADAMS™ (ARKRAY A1c HA-8180T) versus CAPILLARYS 3 OCTA® (Sebia) capillary electrophoresis system.

Abstract

HbA1c is a valuable indicator for the diagnosis and therapeutic monitoring of diabetic patients. Our study aims to compare two methods of measuring HbA1c: capillary electrophoresis on the CAPILLARYS 3 OCTA ® (Sebia) with HPLC ADAMS™ (ARKRAY A1c HA-8180T) used routinely in our laboratory, to avoid any discrepancies in patient monitoring in case of changes in the HbA1c measurement method. A total of 103 blood samples from adult patients received at the laboratory have been analyzed in parallel, singly, on both machines. The results show a good correlation between the two systems with a correlation coefficient of 0.991. The Bland and Altman difference diagram shows that the average bias between ADAMS A1c™ and CAPILLARYS 3 OCTA ® is 2.087 mmol/mol (95% CI: 1.7357 to 2.4390 mmol/mol) in IFCC units and 0.19% (95% CI: 0.1602 to 0.2262%) in the National Glycohemoglobin Standardization Program (NGSP) units, and that out of all the patients studied, only four had values outside the limits of the difference diagram. The latter shows a uniform dispersion of values across all the analyzed measurements, with over 95% of the differences between measurements falling within the range [-1.43; 5.61 mmol/mol] or [-0.14; 0.52%]. These results enable us to confirm the reliable transferability between the two techniques without compromising accuracy. Both machines can therefore be used interchangeably or as backup, ensuring homogeneous patient monitoring.