血糖仪与生化分析仪测试血糖结果的比对评价  

Comparison evaluation of blood glucose testing results between blood glucometer and biochemical analyzer

作　　者：侯超 唐晓琴 曾道萍 阳瑀涵 赵世永 HOU Chao;TANG Xiaoqin;ZENG Daoping;YANG Yuhan;ZHAO Shiyong(School of Biological and Chemical Engineering,Panzhihua University,Panzhihua,Sichuan 617000,China)

机构地区：[1]攀枝花学院生物与化学工程学院,四川攀枝花617000

出　　处：《国际检验医学杂志》2021年第S02期79-82,共4页International Journal of Laboratory Medicine

摘　　要：目的依据ISO 15197:2013标准中对系统准确度的要求对鱼跃310型血糖仪和罗氏Cobas 8000生化分析仪测试的200例临床患者静脉全血的血糖值进行评价。方法按照ISO15197:2013标准对系统准确度的要求,对测试结果进行统计分析。结果有58例血糖浓度<5.55 mmol/L,其中56例(96.6%)偏差±0.83 mmol/L范围内;有142例血糖浓度≥5.55 mmol/L,其中139例(97.9%)偏差±15%范围内。有199例(99.5%)分布在误差格栅的A区(临床准确),有1例(0.5%)落在A区和B区交界处,没有样本落在C区、D区和E区。血糖仪和生化分析仪测试值经过配对t检验,差异无统计学意义(P>0.05)。线性回归方程Y=0.9989X-0.0123,相关系数r=0.9953,表明两者呈高度正相关。结论与罗氏Cobas 8000生化分析仪相比较,鱼跃310型血糖仪测试的200例临床患者静脉全血的血糖值的系统准确度符合ISO 15197:2013标准的要求。鱼跃310型血糖仪能很好地满足临床需求。Objective To compare the blood glucose values of venous blood detected by the Yuwell 310 glucometer and the Roche Cobas 8000 biochemical analyzer in the 200 clinical impatients for evaluating the accuracy of the 310 glucometer according to the requierments for syetem accuracy in ISO 15197:2013.Methods The results were analysed statistically according to the requirements for system accuracy in ISO 15197:2013.Results There were 58 cases at glucose concentrations<5.55 mmol/L,and 56 cases(96.6%)had the discrepance within±0.83 mmol/1.There were 142 cases at glucose concentrations≥5.55 mmol/1,and 139 cases(96.6%)had the discrepance within±15%.199 cases(99.5%)were distributed in the zone A,and only 1case(0.5%)was distributed on the border between the zone A and B in the Concensus Error Grid(CEG).No result was distributed in the zone C,D and E.The glucose values detected by blood glucometer and biochemical analyzer had no significant difference revealed by paired t-test,the difference was not statistically significant(P>0.05).Highly positive correlation was revealed by the regression linear curve equation Y=0.9989X-0.0123 and the correlation coefficient r=0.9953.Conclusion Compared with the values detected by the Roche Cobas 8000 biochemical analyzer,the venous blood glucose values detected by the Yuwell 310 glucometer in the 200 clinical impatients reach the requierments for syetem accuracy in ISO 15197:2013,and the 310 glucometer can meet clinical needs fully.

关 键 词：血糖仪 生化分析仪 系统准确度 

分 类 号：R44[医药卫生—诊断学]