Medisafe快速血糖仪性能的评价

目的评价Medisafe血糖仪的性能。方法应用Medisafe血糖仪检测220例静脉全血葡萄糖浓度，与全自动生化分析仪测定的静脉血浆葡萄糖结果进行比较；并检测该仪器的精密度和线性范围，分析不同红细胞压积（HCT）水平对测定结果的影响。结果血糖仪测定值（Y）与生化分析仪测定值（X）的回归方程为Y=0．9731X（r^2=0．9851）。误差分析显示二者之间的检测误差在0％～18％之间。该血糖仪测定结果的批内变异系数（CV）为2．3％～3．6％；不同批号试纸间和不同仪器间的批间CV分别为2．8％～3．5％和3．1％～3．9％。HCT在20％～60％范围内的5个样本的检测结果显示，血糖仪与生化分析仪之间的检测误差为0％～18．4％。结论该血糖仪具有良好的准确度、精密度、线性范围及抗HCT水平变化干扰的能力，且操作简便，适合医院病房检测和糖尿病患者家中自我监测使用。

Evaluation of the Medisafe glucometer's performance

Objective To evaluate the performance of strip-Medisafe glucometer（Glucometer）. Methods Vein blood samples of 220 patients were tested by both Medisafe glucometer and automatic biochemistry analyzer, and the correlation between the testing results of two methods was analyzed. Precision and linearity of the glucometer were evaluated, and effects of hematocrit （HCT） variation on the glucometer＇s performance were investigated. Results The whole blood readings of the glucometer （Y） were well correlated with the plasma glucose levels of the biochemistry analyzer （X）, with the linear equation of Y=0. 9731X （r^2= 0. 9851）. Error analysis showed that the difference between two methods was within 0% -18%. The precision test indicated that the within-lot coefficient of variation （CV） of the strip-glucometer was 2.3% - 3.6%, and the lot-to-lot and meter-to-meter CVs were 2.8 - 3. 5% and 3. 1%-3.9% respectively. When the HCT level of blood samples ranged from 20%to 60%, the reading difference between the glucometer and the analyzer were less than 18. 4%. Conclusions Medisafe glucometer holds nice accuracy and precision, wide range of linearity, and good ability of anti-jamming. It is suitable for the glucose testing both in hospital sickroom and at home by the diabetic patients.