Preliminary functional evaluation on chemiluminescence immunoassay system by CLSI EP10-A2

Objective To evaluate the performance of UniCel DXI800 automated chemiluminescence immunoassay system.Methods The indexes of E2,FSH,PRL,TT3 were detected according to the CLSI Document EP10-A2 preliminary evaluation of quantitative clinical laboratory methods:approved guideline.Results The high,medium,low total imprecision of E2 were 7.79%,5.21%,4.48%,the bias of them were-2.45%,-1.90%,-0.40%.The high,medium,low total imprecision of FSH were 3.58%,4.81%,4.71%,the bias of them were 6.84%,4.73%,0.93%.The high,medium,low total imprecision of PRL were 2.63%,3.10%,2.24%,the bias of them were-0.03%,-0.65%,-0.50%.The high,medium,low total imprecision of TT3 were 2.71%,1.60%,2.05%,the bias of them were-0.01%,0.01%,-0.05%.The indexes of slope,intercept, precision,carryover rate,linearity and total repeatability accorded with the prescriptive range.Conclusion The performance of DXI800 automated chemiluminescence immunoassay system is reliable and suitable for clinical laboratory to use.