两种生化分析系统间结果的可比性研究  

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

作　　者：胡卫红[1] 刘运周[1] 魏小文[1] 李建业[1] 张薇[1] 王华[1] 王超要[1] 姚尚彦[1] 曹鸿挺[1] 

机构地区：[1]解放军第421医院检验输血科,广东广州510318

出　　处：《中国误诊学杂志》2011年第36期8832-8834,共3页Chinese Journal of Misdiagnostics

摘　　要：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CX4PRO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CX4PRO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。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 correlation coefficient and linear regression equation according to the profile NCCLS（EP9-A2 then.The coefficient and the equation were used to estimate the outcome bias between the two detecting systems.Results The within-run and total precision fit in with the data of BECKMAN COULTER and ROCHE Instrument each.All outcome biases of 20 serological items were acceptable by clinic.Conclusion In order to insure the accuracy and comparability of the test results,the trial of method comparison and bias estimation shall be performed if two or more biochemical analysis systems are used in the same clinical laboratory to catch the goal of providing reliable outcomes to clinical diagnosis and treatment.

关 键 词：生物化学/仪器和设备 评价研究 

分 类 号：R446.1[医药卫生—诊断学]