应用NCCLS Ep9-A2对两种血糖仪的血糖检测结果进行比较

目的:通过对强生SureStep稳步系统血糖仪和拜安康TM血糖监测仪进行比对,评价两种血糖仪检测血糖结果的一致性。方法:按照美国临床实验室标准化委员会(NCCLS)EP9-A2文件的要求,以强生SureStep血糖分析仪为比较仪器,拜安康TM血糖分析仪为待评仪器,两台血糖仪分别测定44例患者静脉全血的血糖值,并对两仪器进行方法比对和偏倚估计。结果:强生和拜安康的血糖结果具有较好的相关性,其回归式方程为 ,相关系数。两种血糖仪器测定结果的预期偏倚在Xc为2.8mmo1/L、7.0mmo1/L和11.2mmol/L时分别是0.178、-0.435和-1.408,预期偏倚95%的可信区间包含了规定的可接受偏倚。结论:强生和拜安康两种血糖仪测定静脉血样本时,测定结果的预期偏倚可以接受。检测血糖可以在强生和拜安康两种血糖仪上任意检测。

Compared the Results of Two Kinds of Glucometer by NCCLS EP9-A2

Objective:To evaluate the correspondence of two kinds of glucometer through comparing the patients results tested by SureStep and Bayer Counter gluscometer.Methods:According to the standards of NCCLS EP9-A2 files,evaluate the value of whole blood sugar respectively of 44 specimens which collected from patients when taking SureStep glucometer as a comparison analyzer and Bayer Counter glucometer as a evaluation analyzer.Results:There is good correspondence between the two analyzers,the regression equation is,and the related coefficient is.The expected bias of the results at the points of Xc is equal to 2.8mmo1/L、7.0mmo1/L and 11.2mmol/L is 0.178、-0.435 and-1.408,the 95% reference ranges of expected bais include permitted acceptable bais.Conclusion:The expected bias is acceptable when use the two glucometers to evalute the specimen of whole blood.It is discretionarily to choose glucometer between SureStep and Bayer Counter when you want to evaluate blood sugar by the methods of POCT.