Evaluation of the self-established assay system of serum prealbumin

Objective To assay the comparability and clinical acceptability of the results of serum prealbumin(PA) measured by different self-established assay systems with Shanghai Kehua PA kits in Roche Modular and Shimadzu CL-7300 clinical chemistry analyzers compared with traceable Roche Modular PA reference assay system. Methods PA concentrations of 40 fresh patient serum samples were analyzed in duplicate with two self-established systems and Roche Modular reference system.The linear regression and correlation were calculated,the bias were estimated according to National Committee for Clinical Laboratory Standards(NCCLS) document EP9-A files. Results The comparability of serum PA results measured by self-established systems compared with Roche Modular reference system were accepted,the correlation coefficients(r)0.99,mean relative bias8%;And the comparability between the two self-established systems(r=0.999) was better than one with Roche Modular reference system. Conclusions The results of serum PA measured by our self-established systems could be acceptable by clinic compared with Roche Modular PA reference system, but it shows some system bias,which could be corrected by the regression equation and the comparability could be modificated,but good comparability can not verify the traceability.