Analytical chemistry for clinical applications

Información del proyecto

Identificador del acuerdo de subvención: 4215

Fecha de inicio

Fecha de finalización

Financiado con arreglo a

• Specific programme 2002-2006 for research, technological development and demonstration to be carried out by means of direct actions by the Joint Research Centre (JRC).

Coste total

Sin datos

Aportación de la UE

Sin datos

Coordinado por

Institute for Reference Materials and Measurements
Belgium

Objetivo

Specific Objectives:
The basic work concentrating on the development of analytical methods and procedures will be problem oriented and is essential to generate the basis for a strong analytical capability. They will be applied for the characterisation of clinical reference materials in co-operation with the RM Unit of IRMM and to comply with the needs of the European certified reference system. The main objectives for 2003 are therefore:
1. To characterise the purity of HbA1c and HbA0 hemoglobin isoforms and to implement the IFCC reference method for glycated hemoglobin for the certification of matrix based reference materials. Deliverables: set of data for certification; scientific publication;
2. To develop a candidate reference method for myoglobin based on LC- MS. Deliverables: progress in method development; scientific publication;
3. To determine the purity of crystalline thyroxine and triiodoniumthyronin (thyroid hormones). Deliverables: set of data to be used within certification;
4. To develop a method for the characterisation and purity check of enriched or isolated TSH (thyroid stimulating hormone) isoforms using LC-MS;
5. To perform exploratory research in fields of interest in relation to clinical chemistry (eg. proteins characterisation and determination using CE-MS and LC- MS) The recently established Joint Committee for Traceability in Laboratory Medicine brings together the most important players not only in Europe, but globally. It is the reference network for clinical measurements and therefore fully complies with the ERA objectives. Furthermore this action could contribute to the creation of specialised expert networks with laboratories of the Member and Candidate Countries. The COST project already involves two partners from the Czech Republic. Training for young scientists at post- doctoral level is another important aspect. Anticipated milestones and schedule.
Planned Deliverables:
Set of data for certification; scientific publication on the purity of HbA1c and HbA0 hemoglobin isoforms progress in method development of a candidate reference method for myoglobin based on LC-MS; scientific publication set of data to be used within certification of crystalline thyroxine and triiodoniumthyronin (thyroid hormones).
Summary of the Action:
As the IVD Directive (98/79/EC) requires traceability of clinical data to reference materials or measurements of higher metrological order, quality requirements are necessary for the new CRMs to be developed in the Action Reference systems for in vitro diagnostics and health of this ISA. The major emphasis in this action will thus be on the development and validation of advanced characterisation methods for such protein markers and their application to establish reference values for CRM and PT materials. This will include the optimisation of separation techniques based on Liquid Chromatography, 2D Gel Electrophoresis and Capillary Electrophoresis for characterisation of impurities of the proteins, the development of elaborate mass spectrometric methods based on MS-MS, MALDI-TOF for the determination of the molecular weight of the proteins and their purity, and finally the establishment of methods for the assessment of the quantity of a specific protein in clinical matrix like serum or urine.

While the major emphasis of this action will be on protein diagnostic markers, analytical support will also be provided for other classes of substances, such as hormones and other organic and inorganic compounds. Rationale This action will contribute to improve the EU diagnostic system and thereby directly supports the implementation of the "In-vitro diagnostics and medical devices" (98/79/EC) IVD Directive. This action will provide the necessary analytical support for the development and value assignment of Certified Reference Materials and Proficiency Testing Materials used in BIPM and EUROMET pilot studies or Key Comparisons. The research activities will mainly focus on the development of analytical methods for protein markers. This task is extraordinary challenging since proteins presently used for clinical diagnosis are often heterogeneous (thus the strong dependence of clinical laboratory results on the calibrants used and different results obtained in different laboratories) requiring clear understanding of the isoform distributions and activity in order to set up efficient standardisation.

Ámbito científico (EuroSciVoc)

• ciencias naturales › ciencias químicas › química analítica
• ciencias naturales › ciencias químicas › química inorgánica › compuestos inorgánicos
• ciencias naturales › ciencias biológicas › bioquímica › biomoléculas › proteínas
• ciencias naturales › ciencias químicas › electroquímica › electroforesis

Programa(s)

• FP6-JRC - Specific programme 2002-2006 for research, technological development and demonstration to be carried out by means of direct actions by the Joint Research Centre (JRC).

Tema(s)

• 1.4.1 - Technologies for Health Applications

Convocatoria de propuestas

Datos no disponibles

Régimen de financiación

JRC - Joint Research Centre research

Coordinador

Institute for Reference Materials and Measurements

• Aportación de la UE: Sin datos
• Dirección: Retieseweg ; B-2440 Geel ; Bélgica
• Coste total: Sin datos