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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

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.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

DIAGNOSTICS CONSULTANCY
Address

5604 CD Eindhoven
Netherlands

Participants (10)

BUNDESREPUBLIK DEUTSCHLAND
Germany
Address
Bundesallee 100
38116 Braunschweig
CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE
France
Address
Université Des Sciences Et Technologies De Lille,
59655 Villeneuve D'ascq
CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE
France
Address
Chemin Joseph Aiguier 31
13402 Marseille
COMMISSION OF THE EUROPEAN COMMUNITIES
Belgium
Address
Retieseweg
2440 Geel
DEUTSCHE GESELLSCHAFT FUER KLINISCHE CHEMIE
Germany
Address
Im Muehlenbach 52A
53125 Bonn
GENT UNIVERSITY
Belgium
Address
Proeftuinstraat 86
9000 Gent
INTERNATIONAL FEDERATION OF CLINICAL CHEMISTRY AND LABORATORY MEDICINE
Netherlands
Address
Lundlaan 6
3508 AB Utrecht
LGC LIMITED
United Kingdom
Address
Queens Road
TW11 0LY Teddington
UNIVERSITY MEDICAL CENTRE UTRECHT
Netherlands
Address
Heidelberglaan 100, Asl Endocrinology Ke.03.139.2
3584CX Utrecht
UNIVERSITY OF SCIENCE AND TECHNOLOGY OF LILLE
France
Address
Bètiment C9
59655 Villeneuve D'ascq