Development of a European quality assurance programme of analytical methods used in the detection of and monitoring of treatment of inherited disorders of metabolism

Información del proyecto

Identificador del acuerdo de subvención: BMH4983404

Proyecto cerrado

Fecha de inicio 1 Marzo 1998

Fecha de finalización 29 Febrero 2000

Financiado con arreglo a

• Specific research, technological development and demonstration programme in the field of biomedicine and health, 1994-1998

Coste total

Sin datos

Aportación de la UE

Sin datos

Coordinado por

Dr L.Willems-Instituut v.z.w.
Belgium

Objetivo

Brief description:
During the past years, the laboratory diagnosis of Inherited Disorders of Metabolism (IDM) has evolved from virtually a research activity carried out by a few, predominantly University affiliated academic staff, to assume a more general role in the investigation of patients by non-specialist pediatricians and physicians. Consequently it has become important that, where possible, analytical investigations are standardised, analytical quality control schemes are developed and means of assessing interpretative proficiency are established. These prerequisites provide a proper foundation for accreditation or licensing of laboratories involved in these investigations.

Due to differences in analytical methodologies, equipment and in the interpretation of both qualitative and quantitative analytical results, there is poor reproducibility between the results of metabolite analyses in IDM laboratories of different countries. The critical evaluation of laboratory based diagnostic procedures for inborn disorders of metabolism is a prerequisite for the optimisation of detection, diagnosis and treatment of patients suffering from these disorders. There is a need for a clearer understanding of the relative performance of differing diagnostic procedures that could be gained by a comparison of data from different IDM centres within the European Union. A study of the inter-laboratory reproducibility of metabolite analyses in IDM laboratories in the E.U. has been commenced in June, 1994 (Contract N°: BMH1-CT94-1074) by means of a quality assurance program (QAP) set up on a European-wide scale. From the results obtained in the first years of activity (1), it appears that this development was welcomed: 75% of the IDM laboratories listed in the European Directory of Diagnostic Laboratories have registered in one of the four schemes available. The results obtained in 1994-96 confirm the suspected poor reproducibility of analytical data between the participating IDM laboratories and the need for some degree of standardisation before any improvement can be expected in the detection and monitoring of metabolic diseases.
Therefore, in addition to the existing external quality assurance schemes established as a result of the previous initiative within the E.U. countries, we propose:
-the development of a proficiency testing system open to all laboratories in the E.U. with an emphasis on the critical evaluation of the way in which laboratory analyses are performed and interpreted in the detection of patients suspected of having an inborn error of metabolism.
-an educational and research program to identify and stimulate the use of suitable reference material, standard analytical methods and appropriate age related reference range.
-study of the means by which the technical performance of metabolite analyses in IDM laboratories in the E.U. can be improved.

Keywords:
Inherited Disorders of Metabolism (IDM), Proficiency testing, Inter-laboratory reproducibility.

Objectives:
To improve and standardise the quality of accuracy and precision in laboratories performing analyses to optimise diagnosis at lowest costs. To promote co-operation and exchange of information between E.U.laboratories.

Ámbito científico (EuroSciVoc)

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Programa(s)

• FP4-BIOMED 2 - Specific research, technological development and demonstration programme in the field of biomedicine and health, 1994-1998

Tema(s)

• 4.6.1 - Basic and clinical research in rare diseases

Convocatoria de propuestas

Datos no disponibles

Régimen de financiación

CON - Coordination of research actions

Coordinador

Dr L.Willems-Instituut v.z.w.

• Aportación de la UE: Sin datos
• Dirección: 3590 Diepenbeek ; Bélgica
• Coste total: Sin datos