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Reference systems for in vitro diagnostics and health

Objective

Specific Objectives:
1. Enhance collaboration within the Joint Committee on Traceability in Laboratory Medicine (JCTLM) under the auspices of BIPM and IFCC. Co-chair with NIST the Working Group on Certified Reference Materials (CRMs) and host a joint meeting in March 2003;
2. Intensify the collaboration with the International Federation for Clinical Chemistry (IFCC), NIST and National Metrology Institutes (NMIs) to produce CRMs as required by the EC In Vitro Diagnostics Directive. - Production of the Â" AST Â" candidate RM by October 2003. - Production of the progesterone candidate RM by March 2003. - Project agreement with IFCC and collaborators on the certification campaign of total protein, prothrombin and glycated haemoglobin by April 2003. - Project agreement with IFCC and collaborators on the certification campaign of myoglobin by December 2003. - Produce the candidate RMs thyroxine and thyronine by March 2003. - Evaluate the results of purity measurements of thyroid hormones by June 2003. - Produce CRMs for substances causing adverse health reactions such as food allergens, candidate RM for gliadin from European wheat by March 2003. - Produce four Reference Materials for genetic testing by December 2003. - Certify BCR-491 pharmaceutical glass containers by April 2003. - Publish an ESTO study report on “Genetic Testing Services - Quality Assurance and Harmonisation in the EU” with JRC-IPTS by April 2003. Anticipated milestones and schedule Many of the activities (sales, stock keeping, stability control etc) are continuous actions. In co-operation with JCTLM: Composition of a list of RM and the respective metrological order/level - 31/12/2003.

In co-operation with IPTS (project leader) JRC-IPTS ESTO report concerning "genetic testing services-quality assurance and harmonisation in the EU" - 31/12/2003. Project agreement with IFCC for certification campaign for IRMM/IFCC-457, Aspartate Aminotransferase (AST) - 31/03/2003. Production of the candidate Reference Material (RM) for IRMM/IFCC-457, Aspartate Aminotransferase (AST) as lyophilised material - 31/03/2003. Project agreement with IFCC for certification campaign for IRMM/IFCC-458, Myoglobin - 31/12/2003. Project agreement with IFCC for certification campaign for IRMM/IFCC-466 and 467, Glycated Haemoglobin (HbA1c) and Haemoglobin (HbA0) - 31/03/2003. Production of candidate RM for BCR-348R, progesterone in serum, high level - 28/02/2003. Project agreement with IFCC for certification campaign for IRMM460, total protein - 30/04/2003. Production of the candidate Reference Material for IRMM-478, 3,3',5-L- Thyronine - 31/10/2003. Production of the candidate Reference Material for IRMM-478, L-Thyroxine - 31/10/2003. Project agreement with the International working group on Prolamin analysis and toxicity (PWG) on the study design for certification campaign for IRMM- 480, Gliadin from European flour - 30/06/2003. Production of the candidate Reference Material for IRMM-480, Gliadin from European flour - 31/10/2003. Project agreement with IFCC for certification campaign for IRMM-490, prothrombin G20210A - 31/03/2003. Production of the candidate Reference Material for IRMM-490, prothrombin G20210A as lyophilised material - 30/06/2003.
Planned Deliverables:

Definition of priority lists of clinical analytes - Installation of projects concerning specific analytes, for which Reference Measurement Procedures and Certified Reference Materials are needed - Set up of international consortia including reference and routine laboratories to run such development projects for the selected CRMs Participation in the Shared cost action IVD-Thyroid G6RD-CT2001-00587 for development of CRMs and reference measurement procedures for thyroid hormones Participation in the Shared cost action CRMGEN G6RD-CT2001-00581 for development of CRMs and reference measurement procedures in the field of human genetics Participation in JRC-IPTS ESTO project entitled genetic testing services- quality assurance and harmonisation in the EU Continuation of certification campaign for IRMM/IFCC-457, AST.

Continuation of certification campaign for IRMM/IFCC-458, Myoglobin. Continuation of certification campaign for IRMM/IFCC-466, HbA1c. Continuation of certification campaign for IRMM/IFCC-467, HbA0. Continuation of certification campaign for BCR-348R, Progesterone in serum. Continuation of certification campaign for IRMM-460, total protein. Continuation of certification campaign for IRMM-478, triiodo-L-Thyronine (T3). Continuation of certification campaign for IRMM-479, L-Thyroxine (T4). Continuation of certification campaign studies for IRMM-480, Gliadin. Continuation of certification campaign studies for IRMM-490, prothrombin G20210A. Start of certification campaign studies for at least two more genetic markers (priorities to be defined).
Summary of the Action:

Medical diagnosis of diseases is seriously hampered by the lack of comparability of laboratory data. This lead to the enactment of important Community legislation (98/79/EC Directive on in-vitro diagnostics and medical devices (IVD - MD)). For its implementation reference systems, consisting of reference materials and methods of higher metrological order, must be developed in collaboration with professionals in laboratory medicine, international organisations, like the International Federation of Clinical Chemistry (IFCC) and other relevant international medical associations as well as in-vitro diagnostics and medical devices industry. International co-operation is necessary to develop global reference systems, due to the international dimension of the IVD market. Recently the Joint Committee for Traceability in Laboratory Medicine (JCTLM) was established.

JCTLM operates under the auspices of the IFCC, BIPM and WHO and comprises all relevant institutions. Co-operation with EMQM (European Molecular Testing Quality Management) has been launched. Future co-operation may include pathology and thrombosis-haemostasis associations. IRMM will function as a link between the relevant organisations and serve as a platform for standardisation. Priorities for the development of reference systems considering the medical priorities, the expected improvement of measurement quality and the economical and health benefit will be defined in direct collaboration with the above mentioned societies, associations and committees. IRMM activities will specifically concentrate on the development and production of Certified Reference Materials for the diagnosis of important diseases or risk factors such as pathogens, cardiovascular disorders, diabetes, hormones and humoral factors, enzyme activities, in general markers for organ function and detection of tumors, allergens, cell and cell surface markers and genetic testing. Especially with its involvement in genetic testing standardisation IRMM has entered a new area with potentially large scientific merits. Rationale Supporting European health policy and implementation of IVD and Medical device Directives, consolidation of "European reference materials" concept, provision of clinical CRMs for calibration, method validation in order to improve EU diagnostic systems towards better comparability of results, better quality of diagnostics and higher cost-effectiveness of laboratory medicine.

Coordinator

Institute for Reference Materials and Measurements
Address
Retieseweg
B-2440 Geel
Belgium