title: Comparison of Arkray/ELITech ADAMS HA-8180V with Bio-Rad Variant, II Turbo2.0 and Tosoh Bioscience HLC-723G8 for HbA1c determination.
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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Biochemistry, Montpellier University Hospital, Montpellier, France; UMR 204 NUTRIPASS, Université Montpellier I/II, Montpellier, France.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Badiou
authors.forename: Julie
authors.initials: J
authors.lastname: Guillot
authors.forename: Nils
authors.initials: N
authors.lastname: Kuster
authors.forename: Anne-Sophie
authors.initials: AS
authors.lastname: Bargnoux
authors.forename: Patricia
authors.initials: P
authors.lastname: Aguilar-Martinez
authors.forename: Elodie
authors.initials: E
authors.lastname: Boissier
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Cristol
authors.forename: Anne-Marie
authors.initials: AM
authors.lastname: Dupuy
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods / Q000592:standards; D006442:Glycated Hemoglobin / Q000032:analysis*; D006403:Hematologic Tests / Q000379:methods* / Q000592:standards; D006801:Humans; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human
keywords: HPLC; HbA1c; analytical performance; diabetes; interchangeability