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Reference materials are an essential component of any quality assurance system. Very few reference materials are available for genetic testing. The objective of this work package is to encourage the development of well-validated reference materials and to help make them available to end users: genetic testing laboratories, diagnostic kit manufacturers and external quality assessment scheme organizers. The work package will also explore regulatory issues around reference material development and distribution. To realize these aims, a series of major international symposia on reference materials for genetic testing will be organized during the course of the EuroGentest project, as well as smaller meetings of expert groups to focus on specific areas. Priorities will be set for which reference materials to develop, and specific projects to meet the high-priority needs will be supported.
Quick Guide
New definitions on reference materials - March 2006
The 'RM family': Identification of all of its members - March 2006
IVD Directive
Commission opinion on external samples for in-house assays
IVD Guidance: Research Use Only products
IVD Guidance: Borderline Issues
Contact information and members of the 'Reference Materials' work package
Copyright EuroGentest Network of Excellence Project 2005 - EU Contract no.:FP6-512148 -
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