title: System Accuracy Evaluation of Different Blood Glucose Monitoring Systems Following ISO 15197:2013 by Using Two Different Comparison Methods.
abstract: BACKGROUND
  Adherence to established standards (e.g., International Organization for Standardization [ISO] 15197) is important to ensure comparable and sufficient accuracy of systems for self-monitoring of blood glucose (SMBG). Accuracy evaluation was performed for different SMBG systems available in Europe with three reagent lots each.
  
  
  METHODS
  Test procedures followed the recently published revision ISO 15197:2013. Comparison measurements were performed with a glucose oxidase (YSI 2300 STAT Plus™ glucose analyzer; YSI Inc., Yellow Springs, OH) and a hexokinase (cobas Integra(®) 400 Plus analyzer; Roche Instrument Center, Rotkreuz, Switzerland) method. Compliance with ISO 15197:2013 accuracy criteria was determined by calculating the percentage of results within ±15% or within ±0.83 mmol/L of the comparison measurement results for glucose concentrations at and above or below 5.55 mmol/L, respectively, and by calculating the percentage of results within consensus error grid Zones A and B.
  
  
  RESULTS
  Seven systems showed with all three tested lots that 95-100% of the results were within the accuracy limits of ISO 15197:2013 and that 100% of results were within consensus error grid Zones A and B, irrespective of the comparison method used. Regarding results of individual lots, slight differences between the glucose oxidase method and the hexokinase method were found. Accuracy criteria of ISO 15197:2003 (±20% for concentrations ≥4.2 mmol/L and±0.83 mmol/L for concentrations <4.2 mmol/L) were fulfilled by eight systems with all three lots and by one system with two lots.
  
  
  CONCLUSIONS
  In this study, seven systems complied with the accuracy criteria of ISO 15197:2013. The results also indicate that the comparison measurement method/system is important, as it may have a considerable impact on accuracy data obtained for a system.
authors.affiliation: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH , Ulm, Germany .
authors.forename: Guido
authors.initials: G
authors.lastname: Freckmann
authors.affiliation: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH , Ulm, Germany .
authors.forename: Manuela
authors.initials: M
authors.lastname: Link
authors.affiliation: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH , Ulm, Germany .
authors.forename: Christina
authors.initials: C
authors.lastname: Schmid
authors.affiliation: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH , Ulm, Germany .
authors.forename: Stefan
authors.initials: S
authors.lastname: Pleus
authors.affiliation: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH , Ulm, Germany .
authors.forename: Annette
authors.initials: A
authors.lastname: Baumstark
authors.affiliation: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH , Ulm, Germany .
authors.forename: Cornelia
authors.initials: C
authors.lastname: Haug
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000592:standards; D003920:Diabetes Mellitus / Q000097:blood*; D005949:Glucose Oxidase / Q000032:analysis; D006593:Hexokinase / Q000032:analysis; D006801:Humans; D011934:Reagent Strips; D012015:Reference Standards; D015203:Reproducibility of Results
chemical_list: D001786:Blood Glucose; D011934:Reagent Strips; D005949:Glucose Oxidase; D006593:Hexokinase