不同检测系统测定血清肌酐、谷丙转氨酶的比对分析和偏倚评估

Comparison and bias estimation of the results of CREA and ALT between different automated chemistry analyzers

[目的]探讨血清肌酐(CREA)、谷丙转氨酶(ALT)在两台全自动生化分析仪之间测定结果的可比性,为不同全自动生化分析仪测定结果差异的可接受性提供依据。[方法]按照美国临床实验室标准化委员会(NCCLS)EP9-A文件要求,以日立7600-110全自动生化分析仪为参比方法(X),日立7170s全自动生化分析仪为实验方法(Y),用不同浓度的患者血清分别对CREA、ALT进行检测,计算相关系数(r)及直线回归方程,按照美国实验室修正法规(CLIA’88)规定的室间质量评价标准允许误差范围的1/2为判断依据,判断不同生化分析仪之间测定结果的可比性。[结果]同一样本在两台全自动生化分析仪器上测定结果比较,差异无显著性意义(P>0.05),CREA、ALT在两台仪器之间测定结果的误差临床均可以接受。[结论]在两台全自动生化分析仪上CREA、ALT的测定结果具有可比性。当实验室同一项目由不同仪器检测时,应对其进行比对研究,以保证检测结果的准确与稳定。

[Objective] To study results of CREA and ALT tested in the two different automated chemistry analyzers,in order to prove the deviation of the results between them and to determine their clinical acceptability.[Methods] According to the profile NCCLS EP9-A,two different automated chemistry analyzers,HITACHI 7600-110（X）,HITACHI 7170s（Y）were used to examine different concentrations of fresh serum CREA and ALT and to obtain the correlation coefficient and linear equation.The comparability of the different systems was evaluated according to the 1/2 of CLIA＇88 standard.[Results] The difference was not significant between the two different automated chemistry analyzers（P〉0.05）.The bias could be accepted by clinic.[Conclusions] The results of CREA and ALT are comparative in two kinds of detection systems according to clinic requirement.If the same test is determined by different system,it is necessary to do method comparison and bias estimation.