Comparison of HbA1c measurement methods between automatic boronate affinity point of care testing and high-performance liquid chromatography

Abstract

Background: This study aimed to assess the comparison between two HbA1c analyzers, Alere Afinion AS100, a boronate affinity based point of care testing (POCT), and High-Performance Liquid Chromatography (HPLC) based analyzer Bio-Rad Variant II Turbo HbA1c kit-2.0 as reference method.Methods: This study involved 120 samples of peripheral K3EDTA whole blood sent to Clinical Pathology Laboratory of Cipto Mangunkusumo National Hospital for HbA1c measurement. Based on reference method, 40 samples with HbA1c ≤ 6.4%, 40 samples with HbA1c > 6.4%, and 40 samples with variant hemoglobin or hemoglobinopathy were included. Precision and accuracy of both analyzers were assessed using control materials. The goodness of fit between these methods were assessed by Bland-Altman plot and Passing-Bablok regression test. Results were compared to National Glycohemoglobin Standardization Program (NGSP) recommendations.Results: Reference method had total error (TE) ranging from 3.15% to 4.9%, while Afinion ranged from 2.16% to 3.24%. Both methods correlated well with Passing-Bablok regression showing no proportional or systematic differences. Linearity between tests was proven by Cusum test value of p > 0.05. Bland-Altman plot yielded 91.74% goodness of fit. No significant differences were observed in hemoglobinopathy and variant hemoglobin analysis of HbA1c.Conclusion: Afinion was precise, accurate, and linear to HPLC reference method. Both methods exhibited no systematic or proportional differences. Despite Bland-Altman plot of less than 95% goodness of fit, no clinically significant result was found based on NGSP criteria.