临床化学检测的标准化现状  

Current situation of standardization of clinical chemistry measurement

作　　者：欧元祝 陈宝荣 居漪 OU Yuanzhu;CHEN Baorong;JU Yi(Shanghai Center for Clinical Laboratory,Shanghai 200126,China;Beijing KingMed Medical Laboratory Co.,Ldt.,Beijing 100015,China)

机构地区：[1]上海市临床检验中心,上海200126 [2]北京金域医学检验实验室有限公司,北京100015

出　　处：《检验医学》2021年第3期240-244,共5页Laboratory Medicine

基　　金：上海市卫生健康委员会面上项目(201740013)。

摘　　要：实验室的质量管理和检验结果标准化是临床化学检测项目实现结果互认的2个重要基础。开展标准化工作,建立检验项目的标准化体系可为检验质量提供准确性依据,是确保检验结果准确、具有可比性的最有效措施。实现检验结果准确、可比的重要方法之一是建立和保证检验结果的溯源性。国际组织一般通过建立参考测量程序、参考物质和一致性方案等来解决不同项目的量值溯源性问题。正确度验证计划和能力验证的开展为临床化学检验项目的结果互认提供了依据。文章对临床化学检测标准化的现状进行综述,以期为临床实验室质量管理提供参考。Laboratory quality management and measurement result standardization are important foundations for the mutual accredit of clinical chemistry measurement result.Carrying out standardization work and establishing the standardization system of test items are the most effective means to realize the accuracy and comparability of test results and provide an accurate basis for regional and national laboratory quality.One of the important means to realize the comparability of test results is to establish and ensure the traceability of the results.At present,the metrological traceability of different items is achieved by establishing reference measurement procedures,reference materials and harmonization protocol in international organizations.The development of trueness verification plans and proficiency tests provides the foundations for the mutual accredit of clinical chemical test results.In this review,the current situation of clinical chemistry testing standardization is reviewed,so as to provide a reference for clinical laboratory quality management.

关 键 词：临床化学 标准化 量值溯源 参考系统 一致性 正确度验证 结果互认 

分 类 号：R446[医药卫生—诊断学]