不同检测系统LDH测定结果的可比性研究

目的探讨同一临床实验室不同检测系统间乳酸脱氢酶(LDH)测定结果是否只有可比性,为血清酶测定的标准化提供实验数据。方法参考NCCLS的EP9-A文件,以日立7170生化分析仪、罗氏原装试剂、c.f.a.s校准品和质控品组成的检测系统(已通过ISO/IEC17025实验室认可)为比较方法,检测系统1-4为实验方法,用患者新鲜血清对LDH进行检测,计算试验方法(Y)和比较方法(X)之间的相对偏差(SE%),以CLIA’88规定的室间质量评价允许误差范围的1/2为标准,判断不同检测系统的可比性。结果LDH测定结果各系统的误差临床均可以接受。结论各检测系统测定LDH结果具有可比性。当同一实验室同一检验项目存在2个以上的检测系统时,应进行方法比对和偏差评估,以保证检验结果的可比性。

To explore the comparability of lactate dehydrogenase(LDH) results of different biochemical detecting systems

Objective To exolore the cosparability of lactsic dehydrogenase(LDH) results of different biocbemicol deteeting systems.Methods According to EP9-A file of NCCLS,different biochemical detecting systems,detecting system 1-4(laboratory method)and detecting system 5(target system,comparison method,which includes Hitachi 7170 biochemical analvzer,reagent of Roche,c f.a.s calibrator and controller of Roche,and has accredited by ISO/IEC 17025)were used to detect serum LDH to obtain the correlation coefficient and the lineal equation,respectively.Then the coefficient and equation were used to evaluate the system bias between laboratory method and comparison method.The comparability of different lnvestlgatlve systems was judged according to the half of CLIA'88 standard.Results The system bias of LDH could be accepted between several investigative systems and target system.Conclusion The comparability of LDH results in 5 kinds of detecting system accorded to evaluation of clinical acceptability.If there are more than two systems for the same test,it is necessary to do method comparison and bias estimation in order to insure the comparability.