CLSI EP05

Evaluation of Precision of Quantitative Measurement Procedures, 3rd Edition

This document provides guidance for evaluating the precision performance of quantitative measurement procedures. It is intended for manufacturers of quantitative measurement procedures and for laboratories that develop or modify such procedures.

This edition of the document was corrected in October 2018. Read the full correction notice here, and learn more about our corrections process here.

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 September 2019. The document’s next scheduled review is generally five years after the reaffirmation date.

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Chairholder: Robert J. McEnroe, PhD

Date of Publication: October 1, 2014

Order Code PDF: CLSI EP05A3E
ISBN Number: 1-56238-968-8

Order Code Print: print not available

Edition: Third

Pages: 120

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

CLSI EP05 Abstract

Clinical and Laboratory Standards Institute document EP05-A3—Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition provides guidance for evaluating the precision of in vitro diagnostic quantitative measurement experimental designs and includes recommendations for establishing precision performance. Included are guidelines for duration, experimental designs, materials, data analysis, summarization, and interpretation—techniques adaptable for a wide spectrum of measurands and system complexity. These guidelines are intended for manufacturers or developers of clinical laboratory measurement procedures, and for users who wish to determine their own performance characteristics. A balance is created in the document between complexity of design and analysis, and simplicity of operation.