Evaluation of the Analytical Performance of the Coulometry-Based Optium Omega Blood Glucose Meter

Background:The goal of diabetes treatment is maintaining near normoglycemia based on self-monitoring of blood glucose (SMBG). In this study, an evaluation of the analytical performance of the coulometry-based Optium Omega™ glucose meter designed for SMBG has been carried out.Methods:The assessment of precision and between-lot variability was based on glucose measurements in ethylenediaminetetraacetic acid venous blood samples. Glucose concentrations measured in 289 fresh capillary blood samples using the Omega glucose meter and the Biosen C_line analyzer were compared.Results:Within-run imprecision coefficient of variation for the lower and higher glucose concentrations amounted to 5.09 and 2.1%, respectively. The relative lot-dependent differences found for the lower and higher glucose concentrations were equal to 6.8 and 2.6%, respectively. The glucose meter error calculated for various concentration ranges amounted from 2.22 to 4.48%. The glucose meter error met the accuracy criteria recommended by the...