血清尿素、肌酐在两生化分析系统间检测的偏倚评估

The Evaluation of the Outcome Bias of UREA and CREA between Two Different Biochemical Analysis Systems

目的 通过对同一临床实验室两生化分析系统进行方法对比分析和预期偏倚评估,探讨UREA、CREA在两生化分析系统之间是否具有可比性或检测结果的偏倚是否在允许的范围内,以确保检测结果的准确稳定。方法 按照美国临床实验室标准化委员会(NCCLS)EP9-A文件的要求,以美国强生Vitros-750生化分析仪为比较方法,日立7600生化分析仪为实验方法,用患者样品对UREA、CREA进行了检测,对两分析系统之间的预期偏倚进行评估。结果 在所测定UREA、CREA中,预期偏倚在方法线性范围内均可以被接受。结论 UREA、CREA可在两生化系统上任意检测。当实验室内同一项目存在两套以上分析系统检测时,需对其进行对比分析和偏倚评估,对这些项目在分析系统间的偏倚有了准确的评价管理依据,才能保证检测结果的准确稳定。

Objective To ensure the accuracy of the testing results ,the methodology and the anticipated bias of the two biochemical analytical systems in the same clinical laboratory were analyzed comparatively and evaluated to study whether UREA and CREA in the two biochemical and analytical systems was comparative or whether their testing results bias were within the limitation. Methods According to the profile NCCLS-EP9-A,two different biochemical analysis systems,Johnson & Johnson Vitros-750(comparison method)and Hitachi 7600(laboratory method),were used respectively to test the UREA and CREA of samples and evaluate the outcome bias between these two systems. Results Among these testing results of UREA and CREA,the anticipated bias was acceptable within methodological linear limitation. Conclusion UREA and CREA could be tested in either of the two biochemical and analytical systems. But for the tests,which have more than two sets of analytical systems,the analytical comparison and bias evaluation should be made. Only after accurate evaluation knowledge about the bias of these items in the different analytical systems was obtained,the accuracy and stability of testing results could be ensured.