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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。
Objective To evaluate the performance of Medisafe blood glucose meters. Methods The blood glucose of 220 cases of venous blood was detected by Medisafe blood glucose meter and compared with the results of venous plasma glucose measured by automatic biochemical analyzer. The precision and linear range of this instrument were also tested. The effects of different hematocrit (HCT) levels Determination of the impact of the results. Results The regression equation of glucose meter (Y) and biochemical analyzer (X) was Y = 0.9731X (r ~ 2 = 0.9851). Error analysis shows that the detection error between the two is between 0% ~ 18%. The intra-assay coefficient of variation (CV) of the blood glucose meter was 2.3% ~ 3.6%. The CVs between different batches of test strips and between different instruments were 2.8% ~ 3.5% and 3.1% ~ 3.9%, respectively. The test results of 5 samples with HCT ranging from 20% to 60% showed that the detection error between blood glucose meter and biochemical analyzer was 0% ~ 18.4%. Conclusion The blood glucose meter has good accuracy, precision, linear range and ability to interfere with the change of HCT level, and is easy to operate. It is suitable for hospital ward detection and self-monitoring in diabetic patients.