CLSI C45

Measurement of Free Thyroid Hormones, 1st Edition

This document addresses analytical and clinical validation of free (nonprotein-bound) thyroid hormone (FTH) measurement procedures.

This document is available in electronic format only.

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Chairholder: Linda Thienpont, PhD

Date of Publication: October 20, 2004

Order Code PDF: CLSI C45AE
ISBN Number: 1-56238-548-8

Order Code Print: print not available

Edition: First

Pages: 62

CLSI C45 Additional Details

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A NCCLS-IFCC joint project.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of September 2016. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI C45 Abstract

Clinical and Laboratory Standards Institute document C45-A—Measurement of Free Thyroid Hormones; Approved Guideline is a guideline for free (nonprotein- bound) thyroid hormone (FTH) testing. The primary audience for this publication is personnel responsible for the development, manufacture, approval, and/or use of FTH measurement procedures. The guideline briefly discusses FTH measurement procedures with respect to design, factors confounding measurements, and specimen choice and collection, and addresses existing problems in definitions and specific nomenclature. However, it mainly emphasizes analytical and clinical validation of FTH measurement procedures. Assessment of analytical validity of an FTH measurement procedure not only implies demonstration of sufficient intrinsic quality or robustness against challenging factors, but also of metrological traceability to the Système International d'Unités (SI). In this respect, the guideline provides recommendations on the implementation of a reference measurement system in the development/validation process of in vitro diagnostic medical devices.