3种检测系统9种常规生化项目测定结果的比对分析

目的通过3种不同检测系统间9种常规生化项目测定结果的比对分析,探讨不同系统间测定结果的可比性。方法参考美国临床实验室标准化委员会（NCCLS）的EP9-A2文件,以Modular P-800检测系统作为比对系统,用患者新鲜血清在Olympus AU5400检测系统（待评系统1）和强生950检测系统（待评系统2）上测定9种常规生化项目：尿素（UREA）、肌酐（CREA）、尿酸（UA）、总钙（Ca）、总蛋白（TP）、白蛋白（ALB）、总胆固醇（TC）、甘油三酯（TG）以及葡萄糖（GLU）,其测定结果与比对系统进行比对,计算待评系统（Y）和比对系统（X）之间的相对偏差及相关线性方程,以美国临床实验室改进修正案（CLIA′88）建议的允许总误差的1/2为标准,通过各项目医学决定水平处的系统误差与之比较来判定结果的可比性。结果待评系统1的白蛋白（ALB）低值与比对系统存在正偏差（9.50%）、肌酐（Cre）与比对系统存在明显正偏差（3.52%～32.46%）,与比对系统不具可比性。待评系统2的白蛋白（ALB）与比对系统存在明显负偏差（-12.56%～-39.75%）,与比对系统不具可比性。两种待评系统的其他项目在医学决定水平处的预期偏差均小于实验室可接受偏差,与比对系统有可比性。结论不同检测系统之间,某些常规生化项目仍存在不同程度的偏差;当用不同的检测系统检测同一项目时,应进行方法比对,对临床可接受性进行评价,以实现检验结果的可比性。

The comparison of the results of 9 routine biochemistry items on 3 different biochemical testing systems

Objective To study the comparability of 3 different biochemical testing systems by comparing the results of 9 routine items on these 3 systems.Methods According to National Committee for Clinical laboratory Standards（NCCLS） document EP9-A2,9 biochemistry items were analyzed respectively on Modular P-800,Olympus AU5400 and JohnsonJohnson 950 Automatic biochemical analyzers.Using Modular P-800 as the comparative system,to evalate the other two systems.Calculate the relative bias and the linear equtions.The comparability between different systems was judged by comparing the predicted biases on the medical decision levels with the half of clinical laboratory improvement amendment 88（CLIA＇88） allowed total error.Results Compared to the comparative system,there was a positve bias of low level Albumin（ALB）（9.50%） and obvious positive bias of Creatine（Cre）（3.52%~32.46%）for evalated system 1,and there was obvious negative bias of Albumin（ALB）（-12.56%~-39.75%）for the evaluated sytem 2.The predicted biases of other items of medical dicision levels were under the acceptable biases.Conclusion There were still biases among the results of some routine items detected on different systems;and it is necessary to compare the different methods,to evaluate the clinical acceptability as to insure the comparability.