7600-020型和Vitros-350型生化分析仪测定血清电解质结果的比对分析

The comparison of serum electrolyte results by 7600-020 and Vitros-350 biochemical analyzer

目的:比对分析日立7600-020型全自动生化分析仪与美国强生Vitros-350型干式化学分析仪测定血清电解质的结果,并作偏差评估,以保证测定结果的一致性。方法:按照美国临床实验室标准化委员会《EP9-A2文件》的要求,以7600-020系统为比对方法,Vitros-350系统为试验方法,分别在2台仪器上测定血清电解质,并记录数据,检查离散点,计算线性方程和相关系数(r),并对其进行偏倚评估。结果:2台仪器3个项目的检测结果均具有较好的相关性(P<0.05),临床接受性评价均未超过CLIA'88允许误差的一半。结论:日立7600-020型全自动生化仪和强生Vitros-350型干式生化分析仪电解质测定结果基本一致,具有很好的可比性,临床检测过程中可任选一种进行电解质测定。

Objective：To evaluate the results of serum electrolytes by two automatic biochemistry analyzer systems：7600-020 full-automatic biochemical analyzer（Hitachi,Japan） and VITROS 350 dry-type biochemistry analyzer（Johnson,US）,and assess the bias,which to ensure the consistency of test results.Methods：According to the National Committee for clinical laboratory standards EP9-A documents,7600-020 system was as control,Vitros-350 system was as experimental instrument,measure serum electrolytes by the two instruments,record the data,check the discrete point,calculate linear equations and correlation coefficients（r）,and carry on the bias estimation.Results：Correlations between the two instruments were fine enough（P0.05） and the clinical acceptability assessments did not exceed half of the acceptable error by CLIA′88.Conclusions：The electrolyte results which determined by Hitachi 7600-020 automatic biochemical analyzer and Johnson Vitros-350 dry type biochemistry analyzer are basically consistent and have a good comparability,either of the two instruments can be selected to do electrolyte determination.