Performance Evaluation of the GlucoDr Plus Glucometer

Abstract

Background: Because strict glucose control is important for reducing the complications of diabetes, the self-monitoring of blood glucose is one of the fundamental treatment modalities. Many glucometers have been developed. In the present study, we evaluated a new glucometer: GlucoDr (TM) Plus (Allmedicus, Anyang, Gyeonggi-do, Republic of Korea). Methods: The evaluation was performed based on Clinical and Laboratory Standards Institute guidelines. Interferences by ascorbic acid, uric acid, maltose, and acetaminophen were examined, and the performance of the unit was compared to those of six other glucometers. The effects of hematocrit, of oxygen partial pressure (PaO(2)), and of multiple users were also evaluated. Results: Within-run, between-run, between- day, and total imprecision (coefficients of variation) were 0.99-4.98%. Satisfactory linearity was found for glucose concentrations of 32.5-786.5 mg/dL (R(2) = 0.9985). A comparison with the reference laboratory method showed close concordance over the entire range of concentrations evaluated (R(2) = 0.9869). No significant effects were noted due to added interferents, hematocrit, and PaO(2). Conclusions: The GlucoDr Plus showed acceptable performance in terms of precision and linearity. It was minimally affected by various interferents. GlucoDr Plus is suitable for the self-monitoring of blood glucose by patients with diabetes.