Clinical and Laboratory Standards Institute document C28-A-3c - Defining, Estalishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Editions is written for users of diagnosic 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 valuse for a new analyte or a analytical method of previously measured analyte. Also discussed is the transfer of established reference values from one laboratory to another.
CLSI C28-A3c-2008 history
1970CLSI C28-A3c-2008 Defining, Establishing, and Verifying Reference Intervals in the Clinical laboratory