Solnica Bogdan, Kusnierz-Cabala Beata, Slowinska-Solnica Krystyna, Witek Przemyslaw, Cempa Agnieszka, Malecki Maciej T
Department of Diagnostics, Jagiellonian University Medical College, Krakow, Poland.
J Diabetes Sci Technol. 2011 Nov 1;5(6):1612-7. doi: 10.1177/193229681100500640.
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.
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.
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.
The evaluated Optium Omega glucose meter fits the analytical requirements for its use in blood glucose monitoring in diabetes patients.
糖尿病治疗的目标是基于自我血糖监测（SMBG）维持血糖接近正常水平。在本研究中，对用于SMBG的基于库仑法的Optium Omega™血糖仪的分析性能进行了评估。
精密度和批次间变异性的评估基于乙二胺四乙酸静脉血样本中的葡萄糖测量。比较了使用Omega血糖仪和Biosen C_line分析仪在289份新鲜毛细血管血样本中测得的葡萄糖浓度。
较低和较高葡萄糖浓度的批内不精密度变异系数分别为5.09%和2.1%。较低和较高葡萄糖浓度下发现的相对批次依赖性差异分别为6.8%和2.6%。不同浓度范围计算出的血糖仪误差为2.22%至4.48%。血糖仪误差符合国际标准化组织和美国糖尿病协会推荐的准确性标准。Passing-Bablok一致性检验和误差网格分析显示，96%的结果在A区，表明结果具有良好的一致性，包括葡萄糖浓度低于100mg/dl的情况。
评估的Optium Omega血糖仪符合其用于糖尿病患者血糖监测的分析要求。
