title: Retrospective evaluation of the accuracy of Roche AccuChek Inform and Nova StatStrip glucose meters when used on critically ill patients.
abstract: BACKGROUND
  More stringent accuracy guidelines for hospital-use glucose meters have recently been published, but it remains unclear whether glucose meters can meet these accuracy guidelines when measurement is performed on critically ill patients with fresh whole blood samples.
  
  
  METHODS
  We performed a retrospective evaluation of a conventional (Roche Diagnostics [Indianapolis, IN] AccuChek® Inform) and a newer-generation (Nova Biomedical [Waltham, MA] StatStrip®) glucose system by comparing paired (drawn within 5 min of each other) whole blood glucose meter and laboratory serum glucose values obtained from intensive care unit (ICU) patients. We also performed a prospective evaluation of the accuracy of the Nova StatStrip.
  
  
  RESULTS
  The median (interquartile range) bias between Roche AccuChek Inform and serum laboratory glucose measurements was 11 (6-18) mg/dL, compared with a median bias between the Nova StatStrip and serum glucose measurements of 1 (-5 to 5) mg/dL. StatStrip met International Organization for Standardization 15197 and Clinical and Laboratory Standards Institute (CLSI) POCT12-A3 accuracy guidelines using both retrospective and prospective datasets.
  
  
  CONCLUSIONS
  The newer-generation (StatStrip) glucose meter met more stringent CLSI POCT12-A3 accuracy criteria because of reduced bias compared with the previous-generation device. Reduced glucose meter bias led to fewer insulin dosing discrepancies when the insulin dose determined from serum glucose was compared with that determined from the glucose meter value using the institutional glycemic control protocol.
authors.affiliation: Department of Laboratory Medicine and Pathology, Mayo Clinic , Rochester, Minnesota.
authors.forename: Brad S
authors.initials: BS
authors.lastname: Karon
authors.forename: Chanse T
authors.initials: CT
authors.lastname: Blanshan
authors.forename: Gayle R
authors.initials: GR
authors.lastname: Deobald
authors.forename: Amy M
authors.initials: AM
authors.lastname: Wockenfus
mesh_terms: D001774:Blood Chemical Analysis / Q000295:instrumentation* / Q000592:standards; D001786:Blood Glucose / Q000032:analysis*; D003422:Critical Care / Q000592:standards; D006801:Humans; D006943:Hyperglycemia / Q000097:blood / Q000175:diagnosis*; D007003:Hypoglycemia / Q000097:blood / Q000175:diagnosis*; D007362:Intensive Care Units; D007390:International Agencies; D008422:Materials Testing; D008508:Medication Errors / Q000517:prevention & control; D008910:Minnesota; D019095:Point-of-Care Systems / Q000592:standards; D017410:Practice Guidelines as Topic; D011446:Prospective Studies; D011934:Reagent Strips; D015203:Reproducibility of Results; D012189:Retrospective Studies
chemical_list: D001786:Blood Glucose; D011934:Reagent Strips