Mean Absolute Relative Difference of Blood Glucose Monitoring Systems and Relationship to ISO 15197

Background: The analytical quality of a blood glucose monitoring system (BGMS) is often assessed according to the requirements described in the international standard ISO 15197. However, the mean absolute relative difference (MARD) is sometimes used as well. This analysis aims at providing empirical data from BGMS evaluation studies conducted according to ISO 15197 and at providing an estimation of how MARD and percentage of measurement results within ISO accuracy limits are related. Methods: Results of 77 system accuracy evaluations conducted according to ISO 15197 were used to calculate MARD between BGMS and a laboratory comparison method’s results (glucose oxidase or hexokinase method). Additionally, bias and 95%-limits of agreement (LoA) using the Bland and Altman method were calculated. Results: MARD results ranged from 2.3% to 20.5%. The lowest MARD of a test strip lot that showed