Accuracy of three hemoglobin A1c point-of-care systems for glucose monitoring in patients with diabetes mellitus

Abstract

Abstract Objectives Use of hemoglobin A1c point-of-care devices in physician offices provides immediate results and reduces inconveniences for the patients. We compared the analytical performances of 3 point-of-care HbA 1c analyzers to high pressure liquid chromatography (HPLC). Material and methods We preselected a pool of 40 EDTA-preserved whole blood samples from our laboratory with HbA1c results obtained by HPLC (mean 6.6% [49 mmol/mol] and range: 4.6–9.9% [27–87 mmol/mol]). Aliquots of theses samples were tested by Afinion AS100, DCA Vantage and In2it point-of-care systems. According the Clinical Laboratory Standards Institute EP-09 protocol we determined linearity (linear regression and correlation coefficient between point-of-care and reference methods), bias (Bland–Altman analysis) and coefficient of variation (%). We used the acceptability criteria endorsed by the National Glycohemoglobin Standardization Program. Results The calculated correlation coefficients ( r ) were 0.98, 0.98 and 0.83 for Afinion AS100, DCA Vantage and In2it systems, respectively. The 95% confidence interval of the error between point-of-care systems and the reference method was −0.41% and +0.34% ( p = 0.22) for Afinion AS100, −0.62% and +0.05% ( p = 0.57) for DCA Vantage, and −1.15% and +1.26% ( p Conclusion Only the Afinion AS100 point-of-care system met all NGSP performance criteria.