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现行 CLSI EP28-A3cS(R2018)
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Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third Edition, EP28A3E 在临床实验室中定义、建立和验证参考间隔;批准的指南 第三版 EP28A3E
发布日期: 2010-10-01
临床和实验室标准协会文件EP28-A3c——定义、建立和验证临床实验室中的参考间隔;批准的指南——第三版是为诊断实验室测试的用户编写的。它提供了一个协议,用于确定满足可靠性和实用性最低要求的参考间隔。该指南侧重于与定量临床实验室测试相关的健康相关参考值。包括各种研究要求,以确定新分析物的参考值或先前测量分析物的新分析方法。还讨论了将确定的参考值从一个实验室转移到另一个实验室的过程。
Clinical and Laboratory Standards Institute document EP28-A3c--Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline--Third Edition is written for users of diagnostic laboratory tests. It offers a protocol for determining reference intervals that meet the minimum requirements for reliability and usefulness. The guideline focuses on health-associated reference values as they relate to quantitative clinical laboratory tests. Included are various requirements for studies to determine reference values for a new analyte or a new analytical method of a previously measured analyte. Also discussed is the transfer of established reference values from one laboratory to another.
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