Comparative study on the results of serum biochemical parameters with different biochemical detecting systems

Objective To investigate the comparability of the results of 10 serum biochemical parameters including alanine aminotransferase(ALT)and total protein(TP)with different biochemical detecting systems in the same laboratory through bias estimation and method comparison,so as to provide reliable experimental data for laboratory accreditation.Methods According to Clinical and Laboratory Standard Institute(CLSI)document EP9-A2,different biochemical detecting systems [with Vitros950 automatic dry chemical assay method as reference(X),Olympus AU640 and two Dimension Xpand-HM biochemical analyzer assays as laboratory methods(Y1-3)] were applied to measuring the levels of the above biochemical parameters for different concentrations of fresh sera,and then the coefficient correlation and linear regression equation were obtained and used to evaluate the system bias between laboratory method and comparison method.The different detecting systems' bias acceptability was judged at different medical decisive levels with the half of CLIA'88 standard as reference.Results The bias of all detecting results with 3 kinds of laboratory methods was clinically acceptable at different medical decisive levels except for that of ALT level with system Y1.Conclusion When the same item is determined with more than two detecting systems,it is necessary to perform method comparison and bias estimation for judging clinical acceptability in order to ensure the comparability of detecting results.