两种不同检测系统测定血清总蛋白的可比性分析

Comparative analysis on detection results of serum total protein between two different detection systems

目的探讨COBAS C501模块化全自动生化分析仪与Biosystems A15全自动蛋白分析仪检测结果是否具有可比性。方法依据国家临床实验室标准委员会(NCCLS)EP9-A2文件要求,分别用两种检测系统测定血清总蛋白(TP),计算实验检测系统(Y)和目标检测系统(X)之间的系统误差,以美国临床医学检验部门修正法(CLIA′88)建议的医学决定水平处的系统误差来判断不同检测系统之间的可比性。结果在所测定TP中,预期偏差在方法线性范围内均可以被接受。结论 TP可在两检测系统上任意检测。当同一项目在不同仪器上检测时,结果应进行比对和偏倚评估,以保证检测结果的可比性。

Objective To explore the comparability of detection results by COBAS C501 and Biosystems A15 detection systems. Methods According to National Committee for Clinical Laboratory Standards （NCCLS） document EPgA2,we tested total protein（TP） with two detection systems. Then the system bias between different test sys tems was evaluated by obtained equation. The comparability of different investigated system was judged according to the total error allowed by clinical laboratory improvement amendment 88（CLIA＇88）. Results Among these results of TP,the anticipated bias was acceptable within methodological linear limitation. Conclusion TP could be tested by either of the two analytical systems. But for the tests, there are more than two sets of analytical systems in the labora- tory, the analytical comparison and bias evaluation should be made. Only after accurate evaluation evidence about the bias of their items in the different analytical systems is obtained, the accuracy and stability of testing results could be ensured.