1 Department of Clinical Medicine - Clinical Biochemistry, Department of Clinical Medicine, Health, Aarhus University2 Karolinska University Hospital3 Lillebaelt Hospital4 Helsinki University Hospital Laboratories5 Copenhagen University Hospital6 Akershus University College of Applied Sciences7 Akershus University Hospital8 Drammen Hospital9 Hillerød Hospital10 Aarhus University Hospital11 United Medix Laboratories Ltd12 Department of Clinical Medicine - Clinical Biochemistry, Department of Clinical Medicine, Health, Aarhus University
Introduction. 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®. Method. 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. Conclusion. 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.
Scandinavian Journal of Clinical and Laboratory Investigation, 2013