Comparison of Methods and Verification of Some Performance Characteristics of Accu-Chek® Instant Glucose Meter

Abstract

Introduction: Frequent and accurate blood glucose measurements and control can delay the onset of diabetic complications. This is facilitated by the use of point-of-care glucose meters (POCGM). There is a need to verify some claims made by manufacturers of POCGM with regard to accuracy, precision and linearity. We compared blood glucose results obtained from Accu-Check Instant blood glucose meters with laboratory results as reference in order to verify some of these claims. Method: This prospective analytical study involved the verification of some characteristics of Accu-Chek Instant POCGM using different concentrations of glucose calibrators prepared in-house. Blood was obtained from volunteers who had no need for an overnight fast. It was tested using Accu-Chek Instant POCGM and routine laboratory glucose oxidase method as reference and compared using the Bland-Altman plot. Statistical significance was set at p<0.05 Results: There were188 blood samples tested using the two methods. The difference between the means of glucose values from the two methods was 10.3 mg/dL (12.8%) with Accu-Chek POCGM returning higher results than the routine laboratory method. The difference was not statistically significant using the Bland-Altman plot (p=0.60). The analytical range of the POCGM was determined to be between 20mg/dl to 300 mg/dL. Results indicating ‘Hi’ on the POCGM were below 600 mg/dL contrary to what was claimed by the manufacturer. Conclusions and Implications: There was some level of agreement between the two methods studied. Results obtained at high glycaemic states may be more precise but are lower than central laboratory values.