title: Evaluation of OneTouch Verio(®), a new blood glucose self-monitoring system for patients with diabetes.
abstract: BACKGROUND
  Self-monitoring of blood glucose (SMBG) is important in diabetes management. Reliable and user-friendly instruments are essential. OneTouch Verio(®) is a new blood glucose concentration-measuring system designed to be used by patients with diabetes and healthcare professionals. The objective of the present study was to evaluate the analytical performance of the OneTouch Verio(®).
  
  
  METHODS
  The OneTouch Verio(®) was evaluated by the Scandinavian evaluation of laboratory equipment for primary healthcare (SKUP) according to a protocol based on ISO 15197 and the American Diabetes Association (ADA) quality goals. Blood samples were collected and measured on the OneTouch Verio(®) by laboratory personnel and patients with diabetes (n = 91, randomized into groups receiving personal training or mail instructions for the OneTouch Verio(®) system). Results were compared to a validated routine method, imprecision and bias were calculated. User-friendliness was evaluated with a questionnaire.
  
  
  RESULTS
  Quality specifications for blood glucose concentration monitoring systems according to ISO 15197 were fulfilled. The mean coefficients of variation (CV%) of repeatability was 3.4% when tested by laboratory personnel and within the goal of imprecision suggested by ADA. Mean CV% of repeatability for patient self-monitoring was 5.0% and 5.1% in the training- and the mail group, respectively. Total error was 6.4-10.0%. The OneTouch Verio(®) showed no hematocrit interference or variation between strip lots.
  
  
  CONCLUSIONS
  The OneTouch Verio(®) displayed sufficient analytical quality and satisfactory user-friendliness. It is suitable for point-of-care testing of blood glucose concentration when handled by patients and healthcare professionals.
authors.affiliation: a Department of Clinical Chemistry, Karolinska University Hospital , Stockholm, Sweden.
authors.forename: Karin
authors.initials: K
authors.lastname: Littmann
authors.affiliation: b Department of Clinical Immunology and Biochemistry, Lillebaelt Hospital , Vejle, Denmark.
authors.forename: Eva R B
authors.initials: ER
authors.lastname: Petersen
authors.affiliation: c Helsinki University Hospital Laboratory, Primary Healthcare Laboratory Services Finland.
authors.forename: Christel
authors.initials: C
authors.lastname: Pussinen
authors.affiliation: a Department of Clinical Chemistry, Karolinska University Hospital , Stockholm, Sweden.
authors.forename: Kristin
authors.initials: K
authors.lastname: Danielson
authors.affiliation: d Department of Clinical Biochemistry, Copenhagen University Hospital , Copenhagen, Denmark.
authors.forename: Snezana
authors.initials: S
authors.lastname: Djurisic
authors.affiliation: e Institute of Pharmacy and Biomedical Sciences, Faculty of Health Sciences , Oslo, and Akershus University College of Applied Sciences , Oslo, Norway.
authors.forename: Heidi
authors.initials: H
authors.lastname: Eilertsen
authors.affiliation: f Department of Diagnostics and Technology, Akershus University Hospital , Loerenskog, Norway.
authors.forename: Lamya
authors.initials: L
authors.lastname: Garabet
authors.affiliation: g Department of Clinical Biochemistry, Aarhus University Hospital , Aarhus, Denmark.
authors.forename: Eva
authors.initials: E
authors.lastname: Greibe
authors.affiliation: h Drammen Hospital, Department of Clinical Chemistry , Norway.
authors.forename: Trine
authors.initials: T
authors.lastname: Lauritzen
authors.affiliation: b Department of Clinical Immunology and Biochemistry, Lillebaelt Hospital , Vejle, Denmark.
authors.forename: Dorte A
authors.initials: DA
authors.lastname: Olsen
authors.affiliation: i Hillerød Hospital, Department of Clinical Biochemistry , Denmark.
authors.forename: Suher
authors.initials: S
authors.lastname: Othman
authors.affiliation: g Department of Clinical Biochemistry, Aarhus University Hospital , Aarhus, Denmark.
authors.forename: Irina
authors.initials: I
authors.lastname: Palimaru
authors.affiliation: j United Medix Laboratories Ltd , Espoo, Finland.
authors.forename: Johanna
authors.initials: J
authors.lastname: Westerlund
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D001786:Blood Glucose / Q000032:analysis*; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation* / Q000592:standards / Q000706:statistics & numerical data; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D001786:Blood Glucose
keywords: Blood glucose self-monitoring; blood glucose; diabetes mellitus; point-of-care system; validation