便携式血糖仪与生化分析仪血糖检测结果的相关性研究

摘要

目的 通过对三台不同型号便携式血糖仪与生化分析仪血糖检测结果进行比对和偏差分析,了解血糖仪与生化仪血糖检测结果的相关性.方法 参照《医疗机构便携式血糖检测仪管理和临床操作规范(试行)》中静脉血样比对试验方案,收集50例不同血糖浓度患者静脉全血样本,血糖仪测定全血葡萄糖,剩余样本立刻离心分离血浆,30 min内用生化仪测定血浆葡萄糖,计算血糖仪与生化分析仪测定结果的相关系数和偏差.结果 三台血糖仪批内CV在1.28％～4.87％之间；日间不精密度低浓度质控品s ＜0.13 mmol/L,中、高浓度质控品CV 在0.81％～2.14％之间,符合《规范》中精密度的要求.三台血糖仪与生化仪测定结果的相关系数r均＞0.98.回归方程斜率b＞1.0±0.05的理想范围.血糖浓度2.3～4.2 mmol/L的样本,稳步、卓越和活力血糖仪只有60％,30％和80％检测结果误差在±0.83 mmol/L的范围内；血糖浓度4.6～22.6 mmol/L样本,有95％～97.5％检测结果误差在允许范围内.结论 三台血糖仪精密度符合《规范》要求,与生化分析仪血糖测定结果有较好相关性.血糖仪的低浓度样本(血糖＜4.2 mmol/L)误差不符合《规范》要求,必要时抽取静脉血生化仪复查；中、高浓度样本误差符合《规范》要求.%Objective To investigate the glucose testing results correlation between portable blood glucose meter and biochemical analyzer by comparing the testing results of three different modes of portable blood glucose meters and biochemical analyzer. Methods With reference to the protocol of venous sample comparison from < the management and clinical practices of portable blood glucose monitoring device in medical institution (Trail) ), 50 cases of heparin anti-coagulation venous whole blood were collected. Whole blood glucose was measured by glucose meter firstly,and then the remaining samples were cen-trifuged immediately to get plasma. The plasma glucose was tested by biochemical analyzer within 30 minutes. The correlation coefficients and deviations were calculated from the results between three glucose meters and biochemical analyzer and also the relevant analysis was conducted. Results The within-run CV of three glucose meters was between 1. 28% and 4. 87%. The intra-day imprecision of low concentration QC material was s <0.13 mmol/L. The CV of middle and high concentration QC material was between 1. 28% and 4. 87%,which meet the precision requirement of the specification. The results coefficients of these two different testing equipments ( r) were higher than 0. 98. The slope of linear regression equation b>l. 0±0. 05 and for samples which the glucose concentration was between 2. 3 and 4. 2 mmol/L, the percentages of testing results within the acceptable error(±0. 83 mmol/L) were 60%,30% and 80% for Sure Step,Performa and Active blood glucose meter, respectively. While for samples which the glucose concentration was between 4. 6 and 22. 6 mmol/L, the percentage of testing results within the acceptable error was between 95% and 97. 5%. Conclusion Results of three portable glucose meters were all correlated very well with those of biochemical analyser and meet the requirement of the specification. But results of glucose meters were lower than biochemical analyser,generally. The results deviation of glucose meters and biochemical analyser could meet the requirement of the specification only when the glucose concentration was higher than 4. 2 mmol/L, which means biochemical analyzer should be used to re-test the low concentration glucose sample.