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
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.