血糖监测仪性能评价及相关影响因素探讨

目的探讨血糖监测仪的性能及影响其测定的有关因素。方法使用强生稳步倍加型血糖监测仪及血糖仪配套试纸所测毛细血管全血糖（CBG）结果，与同时收集并在美国强生Vitros250全自动干式生化分析仪上用葡萄糖氧化酶法所测的静脉血浆糖（VPG）结果比较，并且对血糖仪的总重复性、同一血标本不同体积、贫血标本、不同抗凝剂标本等进行了摸索，探讨对血糖仪测定的影响。结果（1）CBG与VPG结果差异无统计学意义（P〉0．05）；（2）血糖仪的精度较好，总重复性变异系数（CV）为1．6％；（3）标本体积在10～50μL，测定值之间差异无统计学意义；（4）氟化钠对血糖仪测定有负干扰，结果偏低；（5）使用者的熟练程度对结果无明显影响，熟练者与非熟练者测定值之间差异无统计学意义（P〉0．05）。结论血糖仪测定CBG简便、快速、适用于糖尿病患者床旁监测或家庭使用，并可用于糖尿病的筛选普查、急诊诊断。

Evaluation on performance of the blood glucose monitor and its related influencing factors

Objective To discuss the performance of the blood glucose monitor and its related influencing factors. Methods OneTouchTMSureStepTM blood glucose monitor and its matched test papers was applied to measuring capillary whole .blood glucose （CBG）,and the result was compared with vein plasma glucose （VPG） measured with Vitros-250 Dry Chemistry Fully Automatic Biochemistry Analyzer automatic by means of glucose oxidase method. Additionally,total reproducibility, the effects of different blood volume, samples of anaemia patients,and different decoagulants were investigated. Results There was no significant difference between the level of CBG and VPG （P〉0.05）. The precision of blood glucose monitor was fine,which CV of total reproducibility was 1.6 %; when the volume of the blood sample was between 10 to 50 μL,there was no significant difference in measured value; sodium fluoride negatively interfered with the blood glucose monitor detection; usersr skill exerted no effect on the results （P〉 0.05）. Conclusion CBG measurement with blood glucose monitor is simple and rapid,and it is suitable for point-ofcare monitoring and family use; and it can be used as a mean of screening or emergency diagnosis of diabetes mellitus.