CLSI C45
Measurement of Free Thyroid Hormones
CLSI C45 provides comprehensive guidance on the measurement of free (nonprotein-bound) thyroid hormones (FTH), addressing key factors such as test design, specimen selection, and confounding variables. This guideline emphasizes the analytical and clinical validation of FTH measurement procedures, ensuring accuracy, metrological traceability, and robustness against influencing factors. It also includes recommendations for implementing a reference measurement system to enhance the development and validation of in vitro diagnostic medical devices.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical 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.
This document is available in electronic format only.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
A CLSI-IFCC joint project.
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.
This document is available in electronic format only.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
A CLSI-IFCC joint project.