ABSTRACT
Objective To inquire into the clinical acceptability of self-developed biochemical test system by comparing the results and bias estimation with the traceable assay system.Methods According to the requests of National Committee for Clinical Laboratory Standards (NCCLS) EP-9A, comparison test and bias estimation for self-developed test system and traceable Roche reference system (HITACHI 7180) were performed by using patient's sera. The self-developed system was set up as axle Y, the traceable Roche assay system as axle X and 1/2 CLIA (%) was used as the acceptable judge standard.Results The relationship of LDL-C between self-developed system and comparison system was inferior, so the results of LDL-C as well as the low values of HDL-C were of low acceptability. The comparabilities of results of ALT, urea, creatinine, TC, ApoA1 and ApoB were acceptable.Conclusion The self-developed test system must compare with traceable assay system, and estimate its clinical acceptability. The regression equation Y=bX+a can be used to correct the bias of test result.