Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third Edition, EP28A3E

Published by	Publication Date	Number of Pages
CLSI	10/01/2010	76

Category: CLSI

Description

CLSI EP28-A3cS (R2018) – Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline, Third Edition, 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.