title: System accuracy evaluation of systems for point-of-care testing of blood glucose: a comparison of a patient-use system with six professional-use systems.
abstract: BACKGROUND
  Point-of-care testing (POCT) of blood glucose (BG) is performed by medical personnel in clinical settings as well as by patients themselves for self-monitoring of blood glucose (SMBG) at home. We investigated if a system mainly intended for SMBG by people with diabetes, but also suitable for BG measurements by medical personnel, can achieve measurement accuracy on capillary blood samples comparable with professional-use POCT systems.
  
  
  METHODS
  System accuracy was evaluated under standardised conditions, following the ISO standard 15197:2003. For each system (one SMBG system with three test strip lots and six professional-use systems), measurement results from capillary blood samples of 100 subjects were compared with a standardised laboratory glucose oxidase method (YSI 2300 glucose analyser).
  
  
  RESULTS
  The seven evaluated systems showed 99.5% or 100% of the measurement results within the required system accuracy limits of ISO 15197:2003 (±0.83 mmol/L at BG concentrations <4.2 mmol/L and ±20% at BG concentrations ≥4.2 mmol/L). Applying the more stringent requirements of the revision ISO 15197:2013, the systems showed between 99% and 100% of the measurement results within the accuracy limits (±0.83 mmol/L at BG concentrations <5.55 mmol/L and ±15% at BG concentrations ≥5.55 mmol/L) and between 82% and 98% when even more restrictive limits were applied (±0.56 mmol/L and ±10%, respectively).
  
  
  CONCLUSIONS
  Data from this study, which focused on system accuracy, suggest that SMBG systems can achieve system accuracy that is comparable with professional-use systems when measurements are performed on capillary blood samples by trained personnel in a standardised and controlled setting.
authors.forename: Guido
authors.initials: G
authors.lastname: Freckmann
authors.forename: Christina
authors.initials: C
authors.lastname: Schmid
authors.forename: Stefan
authors.initials: S
authors.lastname: Pleus
authors.forename: Annette
authors.initials: A
authors.lastname: Baumstark
authors.forename: Manuela
authors.initials: M
authors.lastname: Link
authors.forename: Erhard
authors.initials: E
authors.lastname: Stolberg
authors.forename: Cornelia
authors.initials: C
authors.lastname: Haug
authors.forename: Jochen
authors.initials: J
authors.lastname: Sieber
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000032:analysis*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000175:diagnosis*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000175:diagnosis*; D006801:Humans; D019095:Point-of-Care Systems / Q000592:standards; D014584:User-Computer Interface; D055815:Young Adult
chemical_list: D001786:Blood Glucose