Evaluation of Two Assay Systems for Determination of HbA1c in Patients of a Tertiary Care Hospital

Introduction: In addition to its monitoring, glycated hemoglobin measurement has drawn increasing attention in recent years for its potential application in diabetes diagnosis. There are currently a number of assay techniques available for estimating HbA1c assay. Current study, compared the efficacy of Immunoturbidimetry and Enzymatic Spectrophotometry with High Performance Liquid Chromatography (HPLC) to determine which technique has a satisfactory correlation and concordance with HPLC as the reference method (IFCC) among patients with diabetes. Simultaneously, we attempted to assess if elevated urea or hemoglobin levels could affect the measurement. Methodology: In this prospective cross-sectional study, 418 blood samples were analyzed in two groups using immunoturbidimetric and enzymatic methods and compared the results with a dedicated HPLC method. Group I consisted of 262 diabetic participants with high urea and group II consisted of 156 diabetic participants with high hemoglobin concentrations. Correlation statistical analysis was performed, Bland-Altman plot and Kappa statistical analysis was done for needful comparison between two methods. Results: Kappa statistical analysis show that HbA1c done by enzymatic method has more agreement than immunoturbidimetric method in both groups. Conclusion: Enzymatic method has an acceptable correlation and concordance with high performance liquid chromatography (HPLC) as compared to the immunoturbidimetric method.