To establish the stabile calibrator of a self-developed biochemical testing system

Objective:To establish the stabile calibrator of a self-developed biochemical testing system.Methods: From the standard testing system that was composed of Hitachi 7600 automatic biochemical analyzer,Roche reagent,Roche cfas and Roche quality control,the quality of cfas was transmitted into the fresh mixed patient′s serum.By which the indicative value of the cfas was transferred into the actual value of the calibrator on the ARCHITECT C8000/Shanghai Kehua system,which was then regarded as a new calibrator to evaluate self-developed testing system.Following National Committee for Clinical Laboratory Standards(NCCLS) document EP-9A2,before and after calibration a comparative study progressed by two testing system was used respectively to 7 serum enzyme items including ALT,AST,ALP,GGT,CK,LDH and AMY to obtain the correlation and the linear equation.Then the correlation and the linear equation were used to evaluate the system bias.Results: Before calibration the correlation coefficient ≥0.975 of all items between two testing systems,The bias of Self-developed system of ALT and GGT(SE%)1/4 CLIA′88;After calibration the bias of self-developed system of all items(SE%)≤1/4 CLIA′88,all items could be accepted.Conclusion: By using fresh mixed serum which transferred from the quantitatively-defined cfas for calibrate a self-developed biochemical testing system,which can establish the stabile calibration of a Self-developed Biochemical Testing System.