Comparative study and bias estimation on the results of serum bilirubin with different biochemical testing system among different hospitals

Objective To study the result comparability of serum total bilirubin(Tbil) and direct bilirubin(Dbil) on different biochemical detecting systems,so as to provide basis for mutual identification of test results among different hospitals.Methods According to CLSI EP9-A2 file,we analyzed the comparability of six self-built biochemical testing systems and aimed testing system by testing the fresh serum samples and calculating relative deviation.As a result,the correlation coefficient and the linear equation were obtained.The comparability of different investigating systems and clinical acceptability were judged according to CLIA'88 standard(half of total error).Results 1) There was no comparability of Dbil level between self-built testing system 2 and aimed testing system(r0.975). 2) The bias rates of self-built testing systems in different medical decision levels(system 1 at Tbil level 24.1μmol/L and 42.8μmol/L,Dbil level 6.8μmol/L and 29.8μmol/L;system 3 at Dbil level 6. 8μmol/L and 29.8μmol/L;system 4 and 6 at Tbil level 342μmol/L,Dbil level 29.8μmol/L) were all higher than the half of CLIA'88 standard,and no comparability was found between self-built testing systems and aimed testing system.Conclusion There are no comparability of bilirubin level between partial self-built testing systems and aimed testing system.It is important for performing comparative test about non-quality assessment items to insure the comparability of test results among different hospitals.