Performance Verification of Electrochemiluminescence Immunoassay System in the Detection of T_3 and T_4

Objective To verify the analytical performance of Roche Cobas E601 automatic electrochemiluminescence immunoassay(ECLIA) system in the detection of triiodothyronine(T_3) and thyronine(T_4) and to explore a simple verification strategy of the matching detection system.Methods By analysis of internal quality control data and test according to Clinical and Laboratory Standards Institute(CLSI) related guideline,the precision,trueness,reportable range and reference interval of Roche Cobas E601 ECLIA system in the detection of T_3 and T_4were verified.The results were compared with manufacturer's claims or acceptable quality standards.Results The within-run precision coefficients of variation(CV) of T_3 and T_4 was 1.29% -6.15% , 1/4Tea(CLIA' 88).The within-laboratory precision CV was 4.02% - 5.65% , 1/3Tea(CLIA'88).The system error(SE% ) of external quality assessment control samples was-1.38% --4.18% , 1/2Tea(CLIA' 88).The reportable range was comparable with the declaration of the manufacturer.The verification results of reference interval of T_3 and T_4were in line with manufacturer reference interval.Conclusion The main analytical performance of T_3 and T_4 measurement by Roche Cobas E601 automatic ECLIA system is consistent with acceptable quality standards,and the used verification projects are simple,feasible and practical.