多个医院间不同检测系统心肌酶检验结果的比对研究

The Comparative study and bias estimation on the results of serum cardiac marker enzyme with different biochemical testing system inter-hospital

目的探讨不同医院间血清心肌酶AST,CK、LDH和α-HBDH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,通过检测患者新鲜血清对6个自建检测系统的AST,CK、LDH和α-HBDH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CLIA’88规定的室间质量评价可接受范围(PT)的1/2为标准,判断是否为临床可接受。结果1.检测系统2的LDH相关系数r<0.975,与目标检测系统不具可比性;2、CK(检测系统4,6),α-HBDH(检测系统3、4)在正常与病理水平偏倚率均超过1/2PT可接受范围,CK(检测系统2)与α-HBDH(检测系统6)在病理高值水平偏倚率超过1/2PT可接受范围,上述有关项目在其相应医学决定水平与目标检测系统不具可比性。结论6个自建检测系统中有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 cardiac marker enzyme AST, CK,LDH and α-HBDH on different bio- chemical detecting systems inter-hospital through bias estimation and method comparison. Methods Following to CISI document EP9-A, 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 comparability of different investigating systems were judged according to the half of CLIA＇ 88 standard. Results 1. the correlation coefficient of LDH（ system 2） was less than 0.975 were not acceptable, the rest were acceptable. 2. the bias rate of CK（ system 4,6 ）, α-HBDH （system 3,4 ） in normal and un-normal level and CK（system 2 ）, α- HBDH （system 6） in un-nonnal were higher than the half of CLIA＇88 standard 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 estimatian for judge clinical acceptability in order to insure the comparability