两种生化分析系统间结果的可比性研究

目的 通过对同一实验室两种生化分析系统进行方法对比及偏差评估试验,研究两者检测结果的可比性.方法先根据美国国家临床实验室标准化委员会(NCCLS)(EP5-T2)文件要求,对美国贝克曼库尔特CX4 PRO及德国罗氏COBAS C501生化分析仪进行精密度试验；然后按照NCCLS(EP9-A2)文件要求,以CX4 PRO为对比方法,以COBAS C501为试验方法,用患者血清对天门冬氨酸氨基转移酶(AST)、总胆红素(TB)等20个生化项目进行检测,统计计算两方法间的相关系数和直线回归方程,并评估两分析系统间的偏差.结果 两分析系统的批内及总精密度(CV)与各自厂商提供的参数无统计学差异；20个检测项目的测定结果的预期偏差在临床上均可接受.结论 为确保检测结果准确一致,必须对同一实验室两种或以上生化分析系统进行方法比对及偏差评估试验,从而为临床提供可靠的检测数据.

Comparative Study and Bias Evaluation on the outcome between two different biochemical analysis systems

Objective To research the comparability of the results which detected by two different biochemical analysis systems in the same clinical laboratory,an approach of method comparison and bias estimation was made.Methods According to the profile NCCLS(EP5-T2),the precision of BECKMAN COULTER CX4 PRO and ROCHE COBAS C501 biochemical analysis systems was evaluate.CX4 PRO(comparison method) and COBAS C501(laboratory method),were used respectively to test 20 serological items such as AST and TB to calculate correl...