Abstract
OBJECTIVE: This study aimed to evaluate a new ion-exchange HPLC system to measure hemoglobin A1c (HbA1c) in comparison to two other widely used HPLC systems. METHODS: Analytical performance and hemoglobin variants detection was assessed on the new Arkray/ELITech ADAMS HA-8180V, in parallel to Bio-Rad Variant II Turbo2.0 and Tosoh Bioscience HLC-723G8. A method comparison and concordance for the classification of patients according to the American Diabetes Association (ADA) categories was performed using kappa test. RESULTS: ADAMS HA-8180V demonstrated excellent within-run imprecision (0%) and between-run imprecision: ≤1.21% using blood sample and ≤0.94% using quality controls. Method comparison of ADAMS HA-8180V with the two other systems yielded very high coefficient correlation (r > 0.995). A very good agreement (kappa value ≥0.81) was observed between methods for the classification of patients according to the ADA categories. In addition, all systems were able to detect the presence of most classical variants such as HbC, HbS, HbD, and HbE. CONCLUSION: The Arkray/ELITech ADAMS HA-8180V demonstrated high analytical performance similar to previous systems such as Biorad(TM) Variant II Turbo 2.0 and Tosoh Bioscience HLC-723G8. The three systems allow a high-quality HbA1c measurement and appeared interchangeable for diabetes diagnosis or for the therapeutic monitoring of patients without hemoglobin variants.