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应用CLSI制定的EP9-A2文件,在丙氨酸氨基转移酶项目检测上,对易捷XC-100干式分析仪全血测试和日立7180全自动生化分析仪血浆测试两种方法的检测结果进行方法学比对和偏差评估。经过对44份临床样本的两种方法学结果的统计分析,获得两种方法的线性回归方程为y=0.900x+2.271,线性相关系数R2=0.960≥0.95,残差的标准差Sy,X为5.29 U/L。在20U/L、40U/L、60U/L三个浓度水平上,两种方法间的结果均在厂家声明的允许误差范围内,属可接受水平。
Application CLSI EP9-A2 file in the alanine aminotransferase test, the Xeon XC-100 dry analyzer whole blood test and Hitachi 7180 automatic biochemical analyzer plasma test two test results Methodological alignment and bias assessment. After the statistical analysis of the two methodological results of 44 clinical samples, the linear regression equation of the two methods was obtained as y = 0.900x + 2.271, the linear correlation coefficient R2 = 0.960≥0.95, the standard deviation of the residual Sy, X 5.29 U / L. At the three concentration levels of 20U / L, 40U / L and 60U / L, the results between the two methods are within acceptable tolerances stated by the manufacturer and are acceptable levels.