新鲜血清赋值传递提高自建与配套生化检测系统结果一致性的研究  

Improvement Consistency by Transferring Value Assignment in Fresh Sera between Self-built and Matching Biochemistry Detection System

作　　者：孙宏华[1] 石凌波[1] 康红[1] 胡远明[1] 谢进进[1] 沙瑶[1] 王露霞[2] 史惠群 

机构地区：[1]广州中医药大学祈福医院检验科,511495 [2]广州军区广州总医院检验科,510000 [3]广东省广州市越秀区第二人民医院检验科,510000

出　　处：《国际检验医学杂志》2011年第2期156-158,共3页International Journal of Laboratory Medicine

基　　金：广东省广州市番禺区科技局科研课题(2007-Z-74-1)

摘　　要：目的通过新鲜血清赋值传递提高自建与配套生化检测系统结果的一致性。方法依据美国临床实验室标准化委员会EP9-A2文件要求,分别用配套和自建检测系统测定AST、Urea、Cr、TCH、TG,进行相关回归分析。计算在各医学决定水平处的预期偏差及其95%置信区间,与生物学变异的偏倚限度相比较,判断其偏差是否可接受。不可接受的项目通过新鲜血清赋值传递,使自建与配套检测系统的结果之间具有较好的一致性。结果自建系统检测AST、Urea、Cr、TCH、TG的结果与配套系统之间的偏差不可接受,经新鲜血清赋值传递后偏差小于允许范围。结论应用EP9-A2评估偏差的可接受性,并通过新鲜血清赋值传递、校准、验证,是使自建与配套检测系统结果具有一致性的有效途径。Objective To improve consistency by transferring value assignment in fresh sera between self-built and matching biochemistry detection system. Methods , Regarding to the Protocol EP9-A2 of National Committee for Clinical Laboratory Standards （NCCLS） ,matching biochemistry and self-built detection systems were used respectively to measure value of AST, Urea, Cr, TCH and TG. Correlated regression analysis was performed. An estimated deviation and its 95 % confidence interval were calculated to compare the bias limitation of biological variation so as to judge the acceptance of its deviation. A better consistency could be confirmed between self-built system and matching biochemistry one. Results The deviations of self-built system and matching bio- chemistry cannot be accepted in AST, Urea,Cr,TCH and TG. The deviation was permitted in the conference limitation after trans- ferring value assignment in fresh sera. Conclusion The method was confirmed to be a consistent pathway between self-built and matching biochemistry detection system, by using EP9 A2 to evaluate the acceptance of deviation and fresh sera value assignment in transferring,calibrating and verifying.

关 键 词：血清 赋值 检测系统 

分 类 号：R446.1[医药卫生—诊断学]