title: System Accuracy Evaluation of Four Systems for Self-Monitoring of Blood Glucose Following ISO 15197 Using a Glucose Oxidase and a Hexokinase-Based Comparison Method.
abstract: BACKGROUND
  The standard ISO (International Organization for Standardization) 15197 is widely accepted for the accuracy evaluation of systems for self-monitoring of blood glucose (SMBG). Accuracy evaluation was performed for 4 SMBG systems (Accu-Chek Aviva, ContourXT, GlucoCheck XL, GlucoMen LX PLUS) with 3 test strip lots each. To investigate a possible impact of the comparison method on system accuracy data, 2 different established methods were used.
  
  
  METHODS
  The evaluation was performed in a standardized manner following test procedures described in ISO 15197:2003 (section 7.3). System accuracy was assessed by applying ISO 15197:2003 and in addition ISO 15197:2013 criteria (section 6.3.3). For each system, comparison measurements were performed with a glucose oxidase (YSI 2300 STAT Plus glucose analyzer) and a hexokinase (cobas c111) method.
  
  
  RESULTS
  All 4 systems fulfilled the accuracy requirements of ISO 15197:2003 with the tested lots. More stringent accuracy criteria of ISO 15197:2013 were fulfilled by 3 systems (Accu-Chek Aviva, ContourXT, GlucoMen LX PLUS) when compared to the manufacturer's comparison method and by 2 systems (Accu-Chek Aviva, ContourXT) when compared to the alternative comparison method. All systems showed lot-to-lot variability to a certain degree; 2 systems (Accu-Chek Aviva, ContourXT), however, showed only minimal differences in relative bias between the 3 evaluated lots.
  
  
  CONCLUSIONS
  In this study, all 4 systems complied with the evaluated test strip lots with accuracy criteria of ISO 15197:2003. Applying ISO 15197:2013 accuracy limits, differences in the accuracy of the tested systems were observed, also demonstrating that the applied comparison method/system and the lot-to-lot variability can have a decisive influence on accuracy data obtained for a SMBG system.
authors: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Ulm, Germany.
authors: Manuela
authors: M
authors: Link
authors: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Ulm, Germany.
authors: Christina
authors: C
authors: Schmid
authors: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Ulm, Germany stefan.pleus@uni-ulm.de.
authors: Stefan
authors: S
authors: Pleus
authors: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Ulm, Germany.
authors: Annette
authors: A
authors: Baumstark
authors: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Ulm, Germany.
authors: Delia
authors: D
authors: Rittmeyer
authors: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Ulm, Germany.
authors: Cornelia
authors: C
authors: Haug
authors: Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH, Ulm, Germany.
authors: Guido
authors: G
authors: Freckmann
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D005949:Glucose Oxidase; D006593:Hexokinase; D006801:Humans; D008422:Materials Testing; D008875:Middle Aged; D012015:Reference Standards; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D005949:Glucose Oxidase; D006593:Hexokinase
keywords: ISO 15197:2003; ISO 15197:2013; comparison measurement method; glucose oxidase method; hexokinase method; self-monitoring of blood glucose; system accuracy