Comparison Of HbA1C Measurements Using Ion Exchange-High Performance Liquid Chromatography (IE-HPLC) Method On Biorad D10 Instrument With Tosoh HLC-723GX

Introduction: HbA1c has been established as a fundamental parameter in establishing a diagnosis of diabetes mellitus (DM). The Ion Exchange High-Performance Liquid Chromatography (IE-HPLC) method has been standardized by both the NGSP and DCCT. Numerous vendors offer NGSP-certified HbA1c IE-HPLC analyzers, necessitating meticulous evaluation by users to select instruments that are accurate, reliable, effective, and efficient in accordance with the specific requirements of their respective laboratories. This research was conducted to ascertain the comparative outcomes of HbA1c level assessments between the BioRad D-10 and Tosoh HLC-723GX instruments. Methods: Using an observational cross-sectional approach, patients from inpatient and outpatient settings were consecutively sampled. IE-HPLC measured HbA1c from 5 cc EDTA blood samples on both instruments. The researcher calculated the coefficient of variance (CV) for the Tosoh instrument before comparing it with the D-10 instrument. Correlation tests, the coefficient of concordance, and Passing-Bablok regression were performed to compare the performance of these two instruments Result: The results of the correlation test show that the Tosoh instrument has a strong correlation with the BioRad instrument in determining the HbA1c level, with r=0.979 (p=0.000). The coefficient of concordance analysis indicates strong agreement between the two instruments. Passing-Bablok regression results confirm that there is no significant difference in the HbA1c levels tested with both instruments. Conclusion: The study revealed no significant disparity in performance between the BioRad D-10 and Tosoh HLC-723GX instruments concerning the determination of HbA1C levels.