Karin Littmann1, Eva R B Petersen2, Christel Pussinen3, Kristin Danielson1, Snezana Djurisic4, Heidi Eilertsen5, Lamya Garabet6, Eva Greibe7, Trine Lauritzen8, Dorte A Olsen2, Suher Othman9, Irina Palimaru7, Johanna Westerlund10. 1. a Department of Clinical Chemistry, Karolinska University Hospital , Stockholm, Sweden. 2. b Department of Clinical Immunology and Biochemistry, Lillebaelt Hospital , Vejle, Denmark. 3. c Helsinki University Hospital Laboratory, Primary Healthcare Laboratory Services Finland. 4. d Department of Clinical Biochemistry, Copenhagen University Hospital , Copenhagen, Denmark. 5. e Institute of Pharmacy and Biomedical Sciences, Faculty of Health Sciences , Oslo, and Akershus University College of Applied Sciences , Oslo, Norway. 6. f Department of Diagnostics and Technology, Akershus University Hospital , Loerenskog, Norway. 7. g Department of Clinical Biochemistry, Aarhus University Hospital , Aarhus, Denmark. 8. h Drammen Hospital, Department of Clinical Chemistry , Norway. 9. i Hillerød Hospital, Department of Clinical Biochemistry , Denmark. 10. j United Medix Laboratories Ltd , Espoo, Finland.
Abstract
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.
RCT Entities:
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.