不同医院多个检测系统血清酶检验结果的比对研究

Comparative Study and Bias Estimation on the Results of Serum Enzyme with Different Biochemical Testing System Inter-hospital

目的探讨不同医院检测系统检测血清酶ALT、AST、ALP、GGT和AMS的可比性,为实现医院间检验结果的互认提供依据。方法参照EP9-A2文件,通过对6个自建检测系统检测患者新鲜血清的ALT、AST、ALP、GGT和AMS并与目标检测系统进行比对,计算自建检测系统和目标检测系统之间的相对偏差,以CLIA8'8规定的室间质量评价可接受范围的1/2为标准,判断是否为临床可接受。结果(1)检测系统3的GGT相关系数r<0.975,检测系统4的ALP相关系数r<0.975,与目标检测系统不具可比性;(2)ALT(检测系统1、4)、ALP(检测系统3、5、6)和AMS(检测系统2、4)在正常与病理水平偏倚率均超过1/2PT可接受范围,上述检测系统的有关项目与目标检测系统不具可比性。结论6个自建检测系统中部分项目与目标检测系统不具可比性,利用新鲜血进行医院间的比对,对于保证医院间检验结果的可比性具有重要作用。

Objective To study the comparability results of serum enzyme ALT,AST,ALP,GGT and AMS on different biochemical detecting systems inter - hospital through bias estimation and method comparison. Methods Following to CLSI document EP9-A2, we applied native blood samples and tested in different self-buih biochemical testing systems and aim system respectively to obtain the correlation coefficient and the linear equation. The comparabiXity of different investigating systems was judged according to the half of CLIA88 standard. Results （ 1 ）The correlation coefficient of GGT （ system 3） and ALP （systerrd） were less than 0. 975, which were not acceptable, the rest were acceptable. （2） The bias rate of ALT （ system 1,4 ）, ALP （ system 3,5,6 ） and AMS （ system 2,4） were higher than that of the half of CLIA88 standard,which were not acceptable,the rest were acceptable. Conclusion There were several items were not acceptable in self-buih system and it is necessary to do method comparison and bias estimation for judge clinical acceptability in order to insure the comparabihty.