Objective To evaluate the applicability of the Clinical and Laboratory Standards Institute(CLSI)guideline EP09-A3 in 2 chemiluminescence immunoassay systems determining serum total triiodothyronine(TT3).Methods Totally,111 serum samples were determined for TT3 and analyzed by System 1 and System 2.Analytical performance and method comparison were performed according to EP09-A3.Outliers were computed by extreme studentized deviate(ESD),and 5 classified regression techniques were performed to evaluate the 2 methods and interpret biases.Results No outliers were determined in this study by visual judgement or ESD.The biases with 95％confidence interval(CI)of medical decision points(0.75 and 1.91 ng·mL-1)were within the allowable total error(TEa)(±12.5％)by applying general linear regression,weighted least square regression,Deming regression and Passing-Bablock regression,and the outcomes were interpreted as type A or B which were acceptable.While the outcome of weighted Deming regression was interpreted as type C which may be judged as unacceptable.Conclusions The results of 2 systems determining TT3 are comparable,and the analysis methods and interpretation of EP09-A3 are more scientific and reasonable.
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