The comparability study and the bias evaluation on the result of serum enzymes with self-developed and matching biochemical detecting systems

Objective To study the coincidence of serum enzyme results of self-developed and matching biochemical detecting systems through the method comparison and bias evaluation.Methods According to National Committee for Clinical Laboratory Standards(NCCLS) document EP9-A2,OLYMPUS AU400 biochemical analyzer,original reagent and its calibrator were performed as the detecting system,and OLYMPUS AU400 biochemical analyzer,homemade reagent and Roche cfas calibrator were the self-developed detecting system.6 serum enzyme items including alanine aminotransferase(ALT),aspartate aminotransferase(AST),gamma-glutamyltransferase(GGT),alkaline phosphatase(ALP),lactate dehydrogenase(LDH) and creatine kinase(CK) were determined,and the results were used to analyze the prospective bias between these two systems.When the bias was not acceptable,a fresh mixed serum was assayed in OLYMPUS AU400 reagent testing system,and the result was adopted as temporary calibrator to calibrate self-developed detecting system.Results The system bias of AST was not acceptable,and the other 5 items could be accepted.After the value of temporary calibrator was determined and used,the bias between the two systems was significantly decreased and acceptable.Conclusions The traceability and comparability of self-developed detecting system can be achieved by calibration and verification.The value of calibrator can be determined using fresh mixed serum for the coincidence of different biochemical detecting systems.