不同型号生化分析仪间检测结果的偏差评估及应用  

THE EVALUATION AND APPLIANCE OF THE OUTCOME BIAS BETWEEN DIFFERENT BIOCHEMISTRY ANALYZERS

作　　者：邹燕[1] 王英[2] 罗晓红[2] 曾宇娟[3] 

机构地区：[1]广州新海医院,广东广州510300 [2]中山大学附属第二医院,广东广州510120 [3]深圳市龙岗区人民医院,广东深圳518111

出　　处：《现代医院》2007年第12期58-60,共3页Modern Hospitals

摘　　要：目的通过对同一临床实验室两台生化分析仪进行方法对比和预期偏差评估,探讨不同型号的生化分析仪之间检测结果是否具有可比性或检测结果的预期偏差是否可以被临床接受。方法统一试剂、校准品和质控品,实行严格的校准和质控系统的监控,按照EP9-A文件的要求,以日立7060生化分析仪为比较方法,魅力1800生化分析仪为试验方法,用病人标本对无机磷等13个生化项目进行检测,计算相关系数和直线回归方程,对两台仪器间检测结果的预期偏差进行评估。结果所检测的13个项目结果的预期偏差均可以被临床接受。结论在统一试剂、校准品和质控品以及实行严格的校准和质控系统的监控下,可以保证不同型号仪器之间检测结果具有可比性或检测结果的预期偏差可以被临床接受。Objective To explore the comparability of the trial outcomes or investigate the clinical acceptability of the outcome bias of two different biochemistry Analyzers under the same Clinical laboratory conditions. Method With uniting reagent, calibrated product, quality control product and seriously calibrating, supervising by using quality control systems, two different kinds of biochemistry Analyzers, Hitachi 7060 （comparison method） and Glamour 1800（laboratory method）were used respectively to detect 13 serological items such as IP according to the EP9- A file. Then the coefficient and the equation were used to evaluate the outcome bias between these two analyzers. Result All the outcome biases of these 13 tests were accepted by clinical assessment. Conclusion The recommended protocol of uniting reagent, calibrated product, quality control product and seriously calibrating, supervising by using quality control systems is certain to obtain comparable results or clinically acceptable outcome bias between two different biochemistry Analyzers.

关 键 词：方法对比 偏差评估 可接受偏差 医学决定水平 

分 类 号：R446[医药卫生—诊断学]