应用替代评价方法评价两检测系统测定血清总胆汁酸结果的一致性

摘要

目的 对Dimension RxL Max全自动生化分析仪与Dimension X Pand全自动生化分析仪两检测系统测定血清总胆汁酸(TBA)结果进行一致性评价.方法 按照美国临床实验室标准化委员会GP29-A文件的要求,对室间质评中不能提供能力验证的检测项目TBA分别在上述两检测系统上进行双份重复测定,样本n=20,分析浓度尽可能分布于检测项目的 整个检测范围内,计算各自检测结果的均值、均值的差值及允许差异值(D).结果 Dimension X Pand检测系统上TBA检测结果均落在Dimension RxL Max检测系统允许差异值(D)范围内.结论 Dimension RxL Max与Dimension X Pand两检测系统测定血清TBA的结果基本一致,临床检测过程中可任选一种检测系统进行TBA测定.%Objective To evaluate the consistency of serum total bile acid (TBA) results from two analytical systems : Dimension RxL Max and Dimension X Pand. Methods According to the NCCLS GP29-A document,the detection item of TBA that could not provide proficiency testing on external quality assessment , was detected repeatedly by using above two analytical systems respectjvely. 20 case8 of serum samples its concentrations of TBA in the measurable range were selected ,and the mean,the differences between the means and the allowed difference values (D) were calculated. Results All the bias of detection results could be accepted between two analytical systems. Conclusion Concordant serum TBA results could be obtained using above two analyiical systems.