Investigation of coincidence of assay results from Beckman automatic biochemical analyzer using self-developed system and proper system

Objective To study the coincidence of the results from Beckman LX20 automatic biochemical analyzer using Beckman reagent and Domestic reagent by method comparison and bias estimation of different biochemical testing system.Methods The fresh mixed serum was adopted as temporary calibrator and assayed in Beckman LX20 reagents testing system before it applied to calibrate self-developed testing system.After successful calibration verification,daily calibrators were determined by self-developed system and attained a new calibration value.Then this value of calibrator was used to calibrate self-developed testing system again.After effective verification,the bias between proper system and self-developed system was analysed,and decided that the bias was acceptable or not.Results The 10 items of routine biochemistry results had different bias between self-built testing system and Beckman LX20 reagents testing system before the value of calibrator was determined again.After the value of calibrator was determind again,the bias of 10 items in self-developed testing system,bias was significantly decreased and the results were coincided with the Beckman reagents system.Conclusions The traceability and comparability of self-developed biochemical testing system can be achieved by calibration and verification.The value of calibrator was determined again for the traceability of Beckman reagent system to Domestic reagent.