摘要
目的参照ISO 15197∶2013标准,评价3款主流品牌血糖仪的主要性能,了解其测定末梢血全血葡萄糖(CBG)与生化分析仪检测血浆葡萄糖(VPG)结果的差异。方法用质控液进行3款血糖仪精密度试验,对随机选取30例临床标本,测定其末梢血的CBG与生化分析仪的VPG,使用SPSS 20.0软件进行统计分析。结果 3款POCT血糖仪测得质控液血糖浓度<5.5 mmol/L时批内与总标准差(SD)均<0.24 mmol/L;质控液血糖浓度>5.5 mmol/L时批内及总变异系数(CV)均<3.9%;3款血糖仪测得CBG与自动生化仪同步测得的VPG之间相关性良好,相关系数(r)均>0.980。在医学决定水平中值与高值处的相对偏倚均<5%,低值处的相对偏倚<10%。结论 3款血糖仪尚可作为患者日常血糖监测,但低值准确度有待提高,有必要加强血糖仪低值准确性的持续性监测,并需加强规范化操作,减小系统误差。
Objective Based on ISO15197∶2013 standard,to evaluate the main performance of three main kinds of point of care testing（ POCT） blood glucose meters and to compare the the difference between the determination of peripheral blood glucose（ CBG） by POCT blood glucose meters and the detection of plasma glucose（ VPG） by biochemical analyzer. Methods 3 blood glucose meter fine density tests were carried out with the control fluid. A total of 30 patients were randomly selected. The CBG of peripheral blood and VPG of biochemical analyzer were measured and analyzed by SPSS 20. 0 software. Results The intraassay and total standard deviation（ SD） of three kinds of POCT blood glucose meters were less than 0. 24 mmol/L when blood glucose concentration was less than 5. 5 mmol/L and coefficient of variation（ CV） were less than 3. 9% when blood glucose concentration was more than 5. 5 mmol/L. The correlation coefficients between VPG by laboratory auto-analyzer and CBG by the three kinds of glucose monitors was good with correlation coefficients（ r） were all 〉0. 980. In the median and high value of medical decision levels,the relative bias were less than 5%,while it was less than 10% in the low value. Conclusion Three kinds of POCT blood glucose meters have high accuracy in high values,which can be used for daily blood glucose monitoring. But it is still necessary to strengthen the glucose meter accuracy of low values through continuous monitoring to reduce the system error.
出处
《中国卫生检验杂志》
CAS
2017年第15期2140-2142,共3页
Chinese Journal of Health Laboratory Technology
关键词
即时检测
比对方案
偏倚
Point of care testing
Comparison scheme
Bias
