title: Evaluation of a next generation direct whole blood enzymatic assay for hemoglobin A1c on the ARCHITECT c8000 chemistry system.
abstract: BACKGROUND
  The utility of HbA1c for the diagnosis of type 2 diabetes requires an accurate, precise and robust test measurement system. Currently, immunoassay and HPLC are the most popular methods for HbA1c quantification, noting however the limitations associated with some platforms, such as imprecision or interference from common hemoglobin variants. Abbott Diagnostics has introduced a fully automated direct enzymatic method for the quantification of HbA1c from whole blood on the ARCHITECT chemistry system.
  
  
  METHODS
  Here we completed a method evaluation of the ARCHITECT HbA1c enzymatic assay for imprecision, accuracy, method comparison, interference from hemoglobin variants and specimen stability. This was completed at three independent clinical laboratories in North America and Europe.
  
  
  RESULTS
  The total imprecision ranged from 0.5% to 2.2% CV with low and high level control materials. Around the diagnostic cut-off of 48 mmol/mol, the total imprecision was 0.6% CV. Mean bias using reference samples from IFCC and CAP ranged from -1.1 to 1.0 mmol/mol. The enzymatic assay also showed excellent agreement with HPLC methods, with slopes of 1.01 and correlation coefficients ranging from 0.984 to 0.996 compared to Menarini Adams HA-8160, Bio-Rad Variant II and Variant II Turbo instruments. Finally, no significant effect was observed for erythrocyte sedimentation or interference from common hemoglobin variants in patient samples containing heterozygous HbS, HbC, HbD, HbE, and up to 10% HbF.
  
  
  CONCLUSIONS
  The ARCHITECT enzymatic assay for HbA1c is a robust and fully automated method that meets the performance requirements to support the diagnosis of type 2 diabetes.
authors.forename: Tracy
authors.initials: T
authors.lastname: Teodoro-Morrison
authors.forename: Marcel J W
authors.initials: MJ
authors.lastname: Janssen
authors.forename: Jasper
authors.initials: J
authors.lastname: Mols
authors.forename: Ben H E
authors.initials: BH
authors.lastname: Hendrickx
authors.forename: Mathieu H
authors.initials: MH
authors.lastname: Velmans
authors.forename: Johannes
authors.initials: J
authors.lastname: Lotz
authors.forename: Karl
authors.initials: K
authors.lastname: Lackner
authors.forename: Lieselotte
authors.initials: L
authors.lastname: Lennartz
authors.forename: David
authors.initials: D
authors.lastname: Armbruster
authors.forename: Gregory
authors.initials: G
authors.lastname: Maine
authors.forename: Paul M
authors.initials: PM
authors.lastname: Yip
mesh_terms: D000594:Amino Acid Oxidoreductases / Q000378:metabolism*; D001774:Blood Chemical Analysis / Q000379:methods*; D015925:Cryopreservation; D003924:Diabetes Mellitus, Type 2 / Q000097:blood; D004912:Erythrocytes / Q000166:cytology; D006442:Glycated Hemoglobin / Q000032:analysis* / Q000378:metabolism; D006801:Humans; D016014:Linear Models
chemical_list: D000594:Amino Acid Oxidoreductases; D006442:Glycated Hemoglobin; C520096:fructosyl-peptide oxidase