CLSI EP06

Evaluation of Linearity of Quantitative Measurement Procedures, 2nd Edition

This guideline provides information for characterizing the linearity interval of a measurement procedure, validating a linearity interval claim (to be performed by the manufacturer), and verifying an established linearity interval claim (to be performed by the end user).

This edition of the document was corrected in September 2021. Read the full correction notice here, and learn more about our corrections process here.

This document is available in electronic format only.

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Chairholder: Robert J. McEnroe, PhD

Date of Publication: November 24, 2020

Order Code PDF: CLSI EP06Ed2E
ISBN Number: 978-1-68440-097-3

Order Code Print: print not available

Edition: Second

Pages: 152

CLSI EP06 Additional Details

A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process.

CLSI EP06 Abstract

Clinical and Laboratory Standards Institute guideline EP06—Evaluation of Linearity of Quantitative Measurement Procedures is intended to provide both manufacturers and users of quantitative measurement procedures with an economical and user-friendly method of validating and verifying the linearity interval. This guideline also can be used to determine the extent to which a quantitative measurement procedure meets medical requirements or the manufacturer's linearity interval claims.