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 ethylene-diaminetetraacetic 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 International Organization for Standardization and the American Diabetes Association. The Passing-Bablok agreement test and error grid analysis with 96% of results in zone A indicated good concordance of results, including glucose concentrations below 100 mg/dl. CONCLUSIONS The evaluated Optium Omega glucose meter fits the analytical requirements for its use in blood glucose monitoring in diabetes patients.