* An updated minimum standard of accuracy is published by ISO15197:2013.
95% of the measured glucose values need to fall within either 0.83mmol/L of the average measured values of the reference measurement procedure at glucose concentrations <5.6mmol/L or within ±15% at glucose concentrations ≥5.6mmol/L. 99% of individual glucose measure values need to fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes.1,2
Results from an analysis of CONTOUR®NEXT demonstrated that >95% of the results were at 0.72mmol/L or ±12.9 % at YSI reference glucose values of <100 or ≥5.6mmol/L.3
1. Caswell M et al. Diabetes Technol Ther 2014;17. (Epublished ahead of print)
2. International Organization for Standardization. In vitro diagnostic test systems-Requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus. Geneva, Switzerland: International Organization for Standardization; 2013.
3. Data on file. Ascensia Diabetes Care 2016