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

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 concordance 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 necessary to analyze comparison and bias of the results by two or more than two systems in clinical laboratory,which can insure the comparability.