CLSI EP15

User Verification of Precision and Estimation of Bias, 3rd Edition

This document describes the estimation of imprecision and of bias for clinical laboratory quantitative measurement procedures using a protocol that can be completed within as few as five days.

This edition of the document was corrected in October 2015, May 2017, and November 2022. Read the full correction notices here, here, and 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: R. Neill Carey, PhD, FACB

Date of Publication: September 11, 2014

Order Code PDF: CLSI EP15A3E
ISBN Number: 1-56238-966-1

Order Code Print: print not available

Edition: Third

Pages: 106

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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 EP15 Abstract

Clinical and Laboratory Standards Institute document EP15-A3—User Verification of Precision and Estimation of Bias; Approved Guideline—Third Edition describes the verification of precision claims and estimation of relative bias for quantitative methods performed within the laboratory. Included are guidelines for duration, experimental designs, materials, data analysis summarization, and interpretation—techniques adaptable for the widest possible range of analytes and device complexity. A balance is created in the document between the complexity of design and formulae, and the simplicity of operation. The protocol is designed to be completed within five working days based on a uniform experimental design yielding estimates of imprecision and bias.