Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline

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