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Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, 3rd Edition

This document contains guidelines for determining reference values and reference intervals for quantitative clinical laboratory tests. 

This document is available in electronic format only.

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of April 2016. The document’s next scheduled review is generally five years after the reaffirmation date.

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Chairholder: Gary L. Horowitz, MD

Date of Publication: October 19, 2010

Order Code PDF: CLSI EP28A3CE
ISBN Number: 1-56238-682-4

Order Code Print: print not available

Edition: Third

Pages: 72

CLSI EP28 Additional Details

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A CLSI-IFCC joint project.

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guideline for use in satisfying a regulatory requirement.

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This document was formerly published as C28-A3c.

CLSI EP28 Abstract

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.