自建检测系统与目标检测系统检测结果一致性的方法探讨

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

目的通过对不同检测系统间常规生化测定结果进行方法学比对和偏倚评估,探讨实现在BeckmanLX20全自动生化分析仪上原装试剂与国产试剂测定结果一致性的方法。方法在Beckman LX20原装试剂检测系统上对新鲜混合血清定值后校准自建检测系统,经校准验证有效后,在自建检测系统上对日常校准品进行定值,用新的校准值校准自建检测系统,经校准验证后,与原装试剂检测系统进行检测结果的比对分析,以评估自建检测系统与目标检测系统检测结果的偏倚是否在可接受范围内。结果在标准品重新定值前,10个常规生化检测项目在自建检测系统与目标检测系统之间依项目的不同而存在不同程度的偏差;重新定值后,自建检测系统与目标检测系统的偏倚明显减小,两者具有较好的一致性。结论校准和校准验证是实现自建检测系统量值溯源性和可比性的有效途径,通过校准品重新定值,国产试剂与原装试剂可达到临床意义的一致性结果。

Objective To study the coincidence of tbe 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.