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Feasibility to develop reference measurement systems for Thyrotropin (TSH) and for free Thyroxine (FT4), and validation of reference measurement systems (procedure and material) for Thyroxine (T4) and Triiodothyronine (T3) in human

Feasibility to develop reference measurement systems for Thyrotropin (TSH) and for free Thyroxine (FT4), and validation of reference measurement systems (procedure and material) for Thyroxine (T4) and Triiodothyronine (T3) in human

Objective

This proposal addresses in-vitro diagnostic procedures in Thyroid Disease (TD) in the light of the traceability demand of the EC IVD Directive and its supporting EN ISO Standards. The prevalence of TD worldwide is high, particularly in elderly women. Clinicians heavily rely on three parameters for diagnosis and monitoring of therapeutic measures in TD:
1. Thyrotropin (TSH),
2. Thyroxine, Total or Free (TT4/FT4) and
3. Triiodothyronine (TT3).

There is a high need for standardisation of these measurements. The proposal deals with:
a. identifying a sub-group of serum TSH glycoforms, believed to be indicative of hypothyroidism,
b. to study the optimal conditions of the step to separate Free from Bound T4, and
c. validation of reference measurement procedures for TT4 and TT3 in serum, including the establishment of primary reference materials for T4 and T3.

This project proposal has been developed in close collaboration with IFCC/IRMM.

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Coordinator

DIAGNOSTICS CONSULTANCY

Address

Netherlands

Administrative Contact

Rudolf M. LEQUIN (Dr)

Participants (10)

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BUNDESREPUBLIK DEUTSCHLAND

Germany

CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE

France

CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE

France

COMMISSION OF THE EUROPEAN COMMUNITIES

Belgium

DEUTSCHE GESELLSCHAFT FUER KLINISCHE CHEMIE

Germany

GENT UNIVERSITY

Belgium

INTERNATIONAL FEDERATION OF CLINICAL CHEMISTRY AND LABORATORY MEDICINE

Netherlands

LGC LIMITED

United Kingdom

UNIVERSITY MEDICAL CENTRE UTRECHT

Netherlands

UNIVERSITY OF SCIENCE AND TECHNOLOGY OF LILLE

France

Project information

Grant agreement ID: G6RD-CT-2001-00587

  • Start date

    1 November 2001

  • End date

    31 December 2005

Funded under:

FP5-GROWTH

  • Overall budget:

    € 1 046 623

  • EU contribution

    € 659 249

Coordinated by:

DIAGNOSTICS CONSULTANCY

Netherlands