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A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests, 1st Edition

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CLSI EP39

A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests, 1st Edition

This guideline establishes a definition of a surrogate sample, provides recommendations for determining when to use surrogate samples, and describes a process for selecting the most appropriate surrogate sample.

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Details

Chairholder: April Veoukas, BS, JD

Date of Publication: November 11, 2021

Order Code PDF: CLSI EP39Ed1E
ISBN Number: 978-1-68440-131-4

Order Code Print: CLSI EP39Ed1
ISBN Number: 978-1-68440-130-7

Edition: First

Pages: 144

CLSI EP39 Abstract

Clinical and Laboratory Standards Institute guideline EP39—A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests establishes a standard definition of a surrogate sample. It presents a hierarchical approach for determining when to use surrogate samples and selecting an appropriate one. It also describes elements of a surrogate sample plan and includes technical preparation guidance for the characteristic to be measured or detected and for artificial matrix compositions. This guideline provides examples for specific performance study types.

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