HbA1c-testing: Evaluation of two point-of-care analysers

Abstract

Background HbA1c is a critical parameter for the medical management of patients with diabetes mellitus. Interventions that reduce HbA1c levels lead to a diminution of microvascular complications. For two decades, point of care testing (POCT) methods have been regularly used to measure HbA1c. The results significantly impact on the management of patients with diabetes mellitus and the accuracy of the results is critical. It is important to know the performance of common methods of HbA1c measurements in daily life. We, therefore, aimed at evaluating the accuracy of two different analysers especially developed for POCT and compared them to a reference method.
Methods We prospectively tested two widely used POCT methods to measure HbA1c, namely Afinion™ AS100 Analyzer (Axis-Shield, Oslo Norway) and DCA Vantage™ Analyzer (Siemens Healthcare Diagnostics, Tarrytown NY, US) in venous samples of 100 patients. As a reference method, we used the high-performance liquid chromatography method G8 HPLC used in the Biochemistry Laboratory of the Inselspital Bern. The National Glycohaemoglobin Standardization Program (NGSP) has certificated all methods used in this study. The comparability and degree of agreement was assessed using Bland–Altman plot.
Results The HbA1c levels ranged from 33 to 116 mmol/mol (5.2–12.8%), 31–122 mmol/mol (5.0–13.3%) and 30–119 mmol/mol (4.9–13%) for Afinion™, DCA Vantage™ and G8 HPLC Analyzer, respectively. The 95% limits of agreement were between −0.84 and +0.30 for the Afinion™ and −0.71 and +0.29 for DCA Vantage™. The results of both POCT were significantly lower with a bias of −0.27% and −0.21% (p < 0.0001) for Afinion™ and DCA Vantage™ Analyzer, respectively.
Conclusions