title: A1c Gear: Laboratory quality HbA1c measurement at the point of care.
abstract: BACKGROUND
  HbA1c is an important part of assessing the diabetic control and since the use of point-of-care devices for monitoring HbA1c is increasing, it is important to determine how these devices compare to the central laboratory.
  
  
  METHODS
  One hundred and twenty patient samples were analyzed on the Bio-Rad Variant™II and one POC analyzer (Sakae A1c Gear). Three patient sample pools containing ~5%, ~7%, and ~10% HbA1c levels were run over 20 days. Three reagent lots and three instruments were evaluated for the A1c Gear.
  
  
  RESULTS
  The 120 patient samples showed strong correlation (R(2)>0.989) when compared to the Variant™II with means=8.06% and 7.81%, for Variant IIand A1c Gear, respectively. Changing reagent lots or instruments had no impact for the A1c Gear. The ~5%, ~7%, and ~10% pools within-run and between-run imprecision was between 0.87-1.33% and 1.03-1.32%, and 1.41-2.35% and 1.24-1.89% with total imprecision of 1.67-2.35% and 1.61-2.31% for the A1c Gear and Variant II, respectively. The A1c Gear showed a small negative bias (0.25% HbA1c) across HbA1c measurement ranges of <11.5%. This bias was, however, acceptable and not considered to be clinically significant.
  
  
  CONCLUSIONS
  The A1c Gear meets the criteria of total CV <3% leading us to the conclusion that the A1c Gear can give results as precise as the laboratory at the POC.
authors: University of Texas Medical Branch, Galveston, TX, United States.
authors: Adetoun
authors: A
authors: Ejilemele
authors: University of Texas Medical Branch, Galveston, TX, United States.
authors: Jamie
authors: J
authors: Unabia
authors: University of Texas Medical Branch, Galveston, TX, United States.
authors: Hyunsu
authors: H
authors: Ju
authors: University of Texas Medical Branch, Galveston, TX, United States. Electronic address: jrpeters@utmb.edu.
authors: John R
authors: JR
authors: Petersen
mesh_terms: D057205:Automation, Laboratory / Q000592:standards*; D003920:Diabetes Mellitus / Q000097:blood* / Q000175:diagnosis; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D019095:Point-of-Care Systems / Q000592:standards*; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D006442:Glycated Hemoglobin; D011933:Reagent Kits, Diagnostic; C517652:hemoglobin A1c protein, human
keywords: Diabetes; HbA1c; POCT