罗氏Modular E170与Cobas e601电化学发光免疫分析系统检测血清甲胎蛋白的比对分析

Comparative analysis on the results of serum α-fetoprotein with Roche electrochemiluminescence immunoassay system Modular E170 and Cobas e601

目的探讨同一临床实验室内罗氏Modular E170与Cobas e601两台电化学发光仪检测结果的可比性,确保两套分析系统检测血清甲胎蛋白结果的准确性和一致性。方法根据美国临床和实验室标准协会(CLSI)指南文件EP9-A2文件要求,以罗氏Modular E170电化学发光免疫分析仪为对比仪器,罗氏Cobas e601电化学发光免疫分析仪为实验仪器,采用用患者血清样本检测甲胎蛋白(AFP)含量,通过实验数据的比对分析,对两套分析系统之间的预期偏倚进行评估。结果在AFP测定的线性范围内,两系统相关性好,在AFP医学决定水平处的预期偏倚均可接受。结论两套系统检测AFP结果具有较好的一致性。临床实验室内同一检测项目同时在两套或两套以上系统检测时应进行比对和偏倚评估,确保检测结果具有可比性。

Objective To investigate the comparability of the results of serum AFP detected by Roche electrochemiluminescence immunoassay system Modular E170 and Cobas e601 ,and to insure the accuracy and the concord ance of detecting the serum AFP in two systems. Methods The value of AFP of patient＇s serum detected by Cobas e601（ experimental method ）was compared with Roche E170 （control method ） according to the document of the CLSI EP9-A2. The comparability and bias of the two systems were evaluated. Results The relativity of the two systems in the AFP detecting linearity range was good,and the bias of the AFP concentration on the medicine decide level （MDL） was acceptable. Conclusion Two systems have good concordance in detecting the serum AFP. It is neces sary to analyze comparison and bias of the results by two or more than two systems in clinical laboratory,which can insure the comparability.