Accuracy and precision of four main glucometers used in a Sub-Saharan African Country: a cross-sectional study

Abstract

Introduction: capillary glucose measurement using point-of-care glucometers is an essential part of diabetes care. We determined the technical accuracy, clinical accuracy and precision of commonly available glucometers against standard spectrophotometry in Cameroon.

Methods: a sample of four glucometers was selected. In the 108 diabetic and non-diabetic participants, blood glucose values obtained by glucometers were compared to the reference laboratory method to determine their technical and clinical accuracies. Precision was determined by repeated measurements using standard solutions of different concentrations.

Results: accu-Chek® Active, CodeFree™, Mylife™ Pura™ and OneTouch® Ultra® 2 values had correlation coefficients of 0.96, 0.87, 0.97 and 0.94 respectively with reference values, and biases of 18.7%, 29.1%, 16.1% and 13.8% respectively. All glucometers had ≥ 95% of values located within the confidence limits except OneTouch® Ultra®2. Accu-Chek® Active, CodeFree™, Mylife™ Pura™ and OneTouch® Ultra® 2 had 99%, 93.1%, 100% and 98.0% of values in Parke's zones A and B. The coefficients of variation of the glucometers were all below 5% at all standard concentrations, except for Accu-Chek^® Active for glucose concentrations at100 and 200mg/dL.

Conclusion: no glucometer met all the international recommendations for technical accuracy. Accu-Chek™ Active and Mylife™, Pura™ met the International Organization for Standardization 2013 recommendations for clinical accuracy based on Parke's consensus error grid analysis. All glucometers assessed except Accu-Chek® Active showed a satisfactory level of precision at all concentrations of standard solutions used.