Validation of the HemoCue® HbA1c 501 System for Point-of-care HbA1c Estimation Using Venous and Capillary Blood: A Comparative Study with HPLC in Eastern India

Abstract Introduction: A valid point-of-care testing (POCT) method for estimating HbA1c values is required in field settings. We conducted this study to compare the validity of the HemoCue HbA1c 501 System (a POCT device) in estimating HbA1c among patients attending a tertiary healthcare facility, considering high-performance liquid chromatography (HPLC) for HbA1c estimation as the gold standard. Methods: This prospective observational study was conducted among the patients attending the outpatient department in a tertiary care hospital in eastern India. The HbA1c was estimated by HPLC and HemoCue ® HbA1c 501 System POCT device using both venous and capillary blood. The HbA1c values were categorized using a cutoff of ≥ 7% to calculate sensitivity, specificity, and positive and negative predictive values. Bland–Altman plot, Lin’s concordance correlation coefficient (CCC), intra-class correlation coefficient, and Kappa statistics were used to assess the validity of the POCT. Results: Lin’s CCC was 0.95 (95% CI: 0.93 to 0.96, P value < 0.001) for venous blood and 0.96 (CI: 0.95–0.97) for capillary blood using POCT. The sensitivity was 95.24%, the specificity was 92.70%, the positive predictive value was 85.71%, and the negative predictive value was 97.69% for HemoCue ® HbA1c 501 using venous blood for the detection of hyperglycemia. The sensitivity was 96.72%, the specificity was 97.12%, the positive predictive value was 93.65%, and the negative predictive value was 98.54% for HemoCue ® HbA1c 501 using capillary blood for the detection of hyperglycemia. Conclusion: HemoCue ® HbA1c has good sensitivity, specificity, almost perfect agreement, and substantial concordance with the gold-standard HPLC for HbA1c estimation.