自建生化检测系统的量值溯源性和可比性研究

Study on the traceability and comparability of a self-developed biochemical testing system

目的探讨实现自建生化检测系统量值溯源性和可比性的方法。方法以新鲜患者血清为临时校准品,在目标检测系统上定值后校准自建检测系统,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,进行方法比对,评估自建检测系统与目标系统检测结果的偏倚是否在可接受范围内。结果自建检测系统Ⅰ与目标系统不具可比性的6个项目包括总胆红素(TBil)、直接胆红素(DBil)、γ-谷氨酰基转移酶(GGT)、三酰甘油(TG)、总钙(TCa2+)、无机磷(IP),自建检测系统Ⅱ与目标系统不具可比性的5个项目包括白蛋白(Alb)、TBil、DBil、TG、IP,经校准和校准验证后,与目标系统的偏倚均<1/2CLIA′88允许总误差(TEa),临床可以接受。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。

Objective To establish a method to achieve the traceability and comparability of a self-developed biochemical testing system. Methods The fresh serum of patients was adopted as temporary calibrator and assayed in objective testing system before it was applied to calibrate self-developed testing system. After successful calibration verification, daily calibrators were determined in self-developed system and attained a new calibration value. Then this value of calibrator was used to calibrate self-developed testing systems again. After effective verification, we evaluated the bias between self-developed system and objective system by comparative test, and decided that the bias was acceptable or not. Results The bias of six items with no comparability between self-developed systems Ⅰ and objective system, and the bias of five items with no comparability between self-developed system Ⅱ and objective system, after calibration and verification, all the bias were lower than half of CLIA＇88 allowable total error. Conclusions The traceability and comparability of self-developed biochemical testing system can be achieved by calibration and verification.