Evaluation of the self-established assay system of serum total bilirubin and direct bilirubin concentration measured by vanadate oxidation reagent kits

Objective To evaluate the comparability and clinical acceptability of the results of serum total bilirubin(TBil) and direct bilirubin(DBil) measured by different self-established assay systems with Shanghai Kehua TBil and DBil kits(Vanadate oxidation method) in Roche Modular and Shimadzu CL-7300 clinical chemistry analyzers compared with the traceable Roche Modular TBil and DBil reference assay system. Methods The levels of TBil and DBil in fresh patient sera were analyzed by three selfestablished systems and Roche Modular reference system.The linear regression and correlation were calculated,and the bias were estimated according to National Committee for Clinical Laboratory Standards(NCCLS) document EP9-A files. Results The comparability of serum TBil and DBil measurment results by self-established systems compared with Roche Modular reference system was acceptable,the correlation coefficient(r) was 0.99,mean relative bias was 15%.The comparability between the self-established systems(bias6%,r=1.00) was better than one with Roche Modular reference system. Conclusions The results of serum TBil and DBil measured by our self-established systems could be used in clinical laboratory compared with Roche Modular reference system.However there are some system positive bias,which could be corrected by the regression equation and the comparability could be modificated.The bias mainly comes from the used method and has not significant correlation with the measured instrument and calibrator.Roche cfas could be used to calibrate the Kehua serum TBil and DBil kits.