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Reference Materials - Resources

Quality Control and Reference Material Producers websites

Name	Description
NIBSC	NIBSC strategic aims: To respond to and advise on public health problems involving biologicals; To provide a national scientific capacity in the field of biological medicine, and to maintain the flexibility, expertise and facilities needed to address new developments in science and medicine; To operate, and be recognised, as a leading international authority on methods of assay such as those to quantify biological activity and to characterise and assess the safety of biologicals; To maintain a central role in the development of the scientific basis for control and standardisation of biologicals within Europe; To assist in the development of international consensus on scientific aspects of the regulation of biological medicines and, in this respect, work closely with the World Health Organisation; To achieve and maintain Quality Accreditation in key areas of control and standardisation.
Coriell	The Coriell Institute for Medical Research is an independent, non-profit research organization dedicated to understanding human genetic diseases and providing the highest quality genetic resources.In addition to conducting its own research in cancer (including breast cancer and leukaemia), human genetic variation, mechanisms of cellular differentiation, and other genetic disorders, the Coriell Institute for Medical Research also serves the entire scientific community by maintaining the world's largest collection of human cells for research. The identification of genes associated with Huntington Disease, cystic fibrosis, Alzheimer Disease, Down Syndrome and a severe form of manic depression, among many others, relied on cells from these collections.
IRMM	The Institute for Reference Materials and Measurements (IRMM) is one of the seven institutes of the Joint Research Centre (JRC), a Directorate-General of the European Commission (EC). The mission of the IRMM is to promote a common and reliable European measurement system in support of EU policies. The prime objective of the IRMM is to build confidence in the comparability of measurements by the production and dissemination of internationally accepted quality assurance tools, including validated methods, reference materials, reference measurements, interlaboratory comparisons and training.
LGC	LGC Promochem is Europe's most comprehensive source of reference materials. The UK's leading independent provider of analytical and diagnostic services, LGC offers chemical, biochemical and forensic analysis, DNA testing and genetic screening, research, method validation, consultancy and analytical outsourcing. LGC also distributes reference standards and ATCC biomaterials throughout Europe.
BAM	BAM is the German Federal Institute for Materials Research and Testing. Its competences are to improve safety and reliability in chemical and materials technologies through research and development, testing, analysis, approvals, advice and information. >Areas of expertise include analytical chemistry, chemical safety engineering, containment systems for dangerous goods, Materials and Environment, Materials engineering, Materials Protection and Surface Technologies, safety of structures, non-destructive testing, Accreditation; Quality in Testing.
NIST	NIST's mission is to develop and promote measurement, standards, and technology to enhance productivity, facilitate trade, and improve the quality of life. ;
ECACC	The European Collection of Cell Cultures (ECACC) was established in 1984 as a cell culture collection to service the research community and provide an International Depository Authority recognised patent depository for Europe.
WHO	The World Health Organization is the United Nations specialized agency for health. WHO provides International Biological Reference Preparations which serve as reference sources of defined biological activity expressed in an internationally agreed unit.
ATCC	LGC Promochem's partnership with ATCC facilitates the distribution of ATCC cultures and bioproducts to life science researchers throughout Europe. Their specific aim is to ensure the very highest levels of customer service and LGC
Maine Molecular Quality Controls Inc	Maine Molecular Quality Controls Inc. designs, manufactures, and sells unique quality controls for molecular diagnostic testing. MMQCI is dedicated to providing quality products in support of the highest standard of laboratory medicine.
ParagonDx	ParagonDx has developed human genomic reference control products as a source of quality control materials for laboratories. ParagonDx controls are isolated from immortalized cell lines, each of which is derived from a properly consented individual. All controls are manufactured and quality control tested in a cGMP facility. In addition, six of the ParagonDx CYP2D6 controls have received FDA-clearance, and are the only controls of this kind to have gone through this rigorous validation process.
SeraCare	SeraCare offers a comprehensive line of independent positive and negative controls to enhance quality control and quality assurance in your testing lab. ACCURUN controls are available for genetic tests, NAT and serology and are used to help validate test methods, monitor test performance, train staff, troubleshoot problems and meet regulatory requirements. Our facilities are cGMP compliant and ISO:9001 and 13485 certified. SeraCare also provides a broad range of bioservices to meet your research and testing needs in virology, serology, immunology, and molecular biology.

Quality Control and Reference Materials Databases

Name	Description
GeT-RM (CDC)	The goal of the Genetic Testing Reference Materials Coordination Program (GeT-RM) is to coordinate a self-sustaining community process to improve the availability of appropriate and characterized reference materials for quality control, proficiency testing, test development and validation and research. The purpose of this program is to help the genetic testing community obtain appropriate and characterized reference materials; to facilitate and coordinate information exchange between users and providers of QC and reference materials and to coordinate efforts for contribution, development, characterization and distribution of reference materials for genetic testing.
ERM	European Reference Materials are certified materials, which undergo uncompromising peer evaluation and offer highest quality and reliability. The ERM® concept is a joint collaboration of three major European reference materials producers who produce certified reference materials (IRMM, LGC, BAM).
BIPM	The task of the Bureau International des Poids et Mesures (BIPM) is to ensure world-wide uniformity of measurements and their traceability to the International System of Units (SI). The BIPM carries out measurement-related research. It takes part in, and organizes, international comparisons of national measurement standards, and it carries out calibrations for Member States. BIPM offers a database of higher order reference materials and reference measurement procedures.
RM info	RMinfo is a database for reference materials. You can search for reference materials in Japan and certified reference materials in the world, and related information about reference materials.
COMAR	The mission of COMAR is to disseminate information on available certified reference materials. The COMAR database lists thousands of certified reference materials (CRMs) produced world-wide by about 200 producers in 27 countries.

Other sites of interest

Name	Description
EuroGentest	EuroGentest Unit 1 aims to measurably improve the quality of the management and provision of genetic services for the benefit of the patient; lab accreditation considered the norm. In particular, the objectives are to help and encourage labs to implement a quality system provision of sustainable and harmonized EQA for all genetic labs through National and European EQA to facilitate access to and production of (certified) reference materials to produce validated SOPs for diagnostic procedures
CRMGEN	CRMGEN was a European feasibility study aiming at development of Certified Reference Materials for molecular genetic ( DNA) testing. It ended in 2005.
NGRL(M)	The National Genetics Reference Laboratories were established as an initiative by the Department of Health to support UK Genetic Laboratory Services in 2002. The NGRLs advise the Government and engage with the Genetics Community. This new role was assigned to groups associated with the Manchester and Wessex Regional Genetics Service Laboratories. The NGRL project was funded for five years to: anticipate the development of new genetic technologies, carry out Technology Assessments, develop new and better ways of testing, realise the potential of gene discoveries and take a lead in developing quality assurance systems. The NGRL's RM project is utilising the systems developed through the EC funded CRMGEN initiative (G6RD-CT-2001-00581), and will add value and scope to this effort. This joint project aims to develop prototype RMs for a range of genetic tests and by doing so, develop the know-how and the methodology to produce RMs for any given molecular genetic test.
NGRL(W)	NGRL Wessex are generating sets of plasmid constructs that harbour defined sequence changes and which can be used as controls for a wide range of mutation assays. A set of pilot constructs for analysis of hMLH1 and BRCA2 are also available for performance evaluation.
VIRM	The central mission of this 'Virtual Institute' is to be a knowledge network and a facility to encourage the interaction between all stakeholders in the field of Reference Materials (Certified Reference Materials, Quality Control Materi als) for analysis. VIRM is a non -profit organisation, registered in Luxembourg.
EMQN	EMQN is a not-for-profit organisation promoting quality in molecular genetic testing through the provision of external quality assessment (proficiency testing schemes) and the organisation of best practice meetings and publication of guidelines.
VIM	International Vocabulary of Basic and General Terms in Metrology (VIM), ISO VIM

Last changed: 2009-01-29

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