基于CLSI EP9-A3的血清葡萄糖方法学比对及偏倚评估  

The Methodological Comparison and Bias Evaluation of Serum Glucose According to CLSI EP9-A3

作　　者：马莉 孙江漫 李敏 孟祥兆 邵燕[1] 于洪远[1] MA Li;SUN Jiangman;LI Min;MENG Xiangzhao;SHAO Yan;YU Hongyuan(Beijing Aerospace General Hospital Clinical Laboratory,Beijing 100076,China)

机构地区：[1]北京航天总医院检验科,北京100076

出　　处：《标记免疫分析与临床》2023年第1期170-172,180,共4页Labeled Immunoassays and Clinical Medicine

摘　　要：目的对不同血糖全自动生化分析仪测量结果进行方法学比对,以确保检测结果的准确性和可比性。方法使用雅培(A)、西门子(B)2台血糖检测系统同时测量冰冻人血清葡萄糖标准物质和44份单人份血清样本,参考CLSI EP9-A3文件,将两个系统的测量结果进行比对。结果A系统测量冰冻人血清葡萄糖标准物质的偏倚在0.09%~5.22%范围内,B系统偏倚范围为4.98%~6.96%,均在可接受范围内;两者线性相关性较好(R^(2)=0.994);无离群值且百分比差值成正态分布。两系统间的平均百分比差值为0.29%,Bland-Altman图95%以上数据落在均值±2SD范围内。A、B两系统的Passing-bablok回归方程为Y=0.953 X+0.443,其在各医学决定水平处的预期偏倚范围-0.13%~5.27%,小于可接受范围。结论A、B两系统有较好的一致性,检测结果具有可比性,均可为临床提供准确可靠的结果。Objective To ensure the accuracy and comparability of the test results,methodological comparison was conducted between the measurement results of different types of blood glucose automatic biochemical analyzers.Methods Two blood glucose detection systems,Abbott(A)and Siemens(B),were used to simultaneously measure the frozen human serum glucose reference material and 44 individual serum samples.The measurement results of the two systems were compared by referring to the CLSI EP9-A3 document.Results The bias of system A in measuring the frozen human serum glucose reference material ranged from 0.09%to 5.22%,and the bias of system B ranged from 4.98%to 6.96%,both of which were within the clinically acceptable range.The linear correlation between the two systems was good(R^(2)=0.994).There were no outliers and the percentage difference was normally distributed.The average percentage difference between the two systems was 0.29%,and more than 95%of the data in the Bland-Altman plot fell within the mean±2SD range.Passing-Bablok regression equation of system A and B was Y=0.953 X+0.443,and the expected bias range at each medical decision level was-0.13%-5.27%,which was within the clinically acceptable range.Conclusion System A and B have a good consistency,and the detection results are comparable,which can provide accurate and reliable results for the clinical use.

关 键 词：血糖 EP9-A3 方法学比对 

分 类 号：R-331[医药卫生]