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EP06-A: Evaluation of the Linearity of Quantitative ...

April 2003EP06-AEvaluation of the Linearity of Quantitative measurement Procedures: A Statistical Approach; Approved GuidelineThis document provides guidance for characterizing the Linearity of a method during a method Evaluation ; for checking Linearity as part of routine quality assurance; and for determining and stating a manufacturer s claim for linear guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process. SAMPLEC linical and Laboratory Standards InstituteSetting the standard for quality in clinical laboratory testing around the Clinical and Laboratory Standards Institute (CLSI) is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability.

Evaluation of the Linearity of Quantitative Measurement Procedures: A St. atistical Approach; Approved Guideline. 1 Scope This document presents a method to establish, verify and/or demonstrate the linear range of a quantitative measurement procedure. These methods do not identify the causes of significant nonlinearity. The method

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