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Title: Developing a sustainable process to provide quality control materials for genetic testing
Authors: Chen, B
O' Connell, Catherine D
Boone, D Joe
Amos, Jean A
Beck, Jeanne C
Chan, Maria M
Farkas, Daniel H
Lebo, Roger V
Richards, Carolyn Sue
Roa, Benjamin B
Silverman, Lawrence M
Barton, David E
Bejjani, Bassem A
Belloni, Dorothy R
Bernacki, Susan H
Caggana, Michele
Charache, Patricia
Dequeker, Elisabeth
Ferreira-Gonzalez, Andrea
Friedman, Kenneth J
Greene, Carol L
Grody, Wayne W
Highsmith, William Edward
Hinkel, Cecelia S
Kalman, Lisa V
Lubin, Ira M
Lyon, Elaine
Payne, Deborah A
Pratt, Victoria M
Rohlfs, Elizabeth
Rundell, Clark A
Schneider, Erasmus
Willey, Ann M
Williams, Laurina O
Willey, James C
Winn-Deen, Emily S
Wolff, Daynna J #
Issue Date: Oct-2005
Publisher: Williams & Wilkins
Series Title: Genetics in medicine vol:7 issue:8 pages:534-49
Abstract: PURPOSE: To provide a summary of the outcomes of two working conferences organized by the Centers for Disease Control and Prevention (CDC), to develop recommendations for practical, sustainable mechanisms to make quality control (QC) materials available to the genetic testing community. METHODS: Participants were selected to include experts in genetic testing and molecular diagnostics from professional organizations, government agencies, industry, laboratories, academic institutions, cell repositories, and proficiency testing (PT)/external Quality Assessment (EQA) programs. Current efforts to develop QC materials for genetic tests were reviewed; key issues and areas of need were identified; and workgroups were formed to address each area of need and to formulate recommendations and next steps. RESULTS: Recommendations were developed toward establishing a sustainable process to improve the availability of appropriate QC materials for genetic testing, with an emphasis on molecular genetic testing as an initial step. CONCLUSIONS: Improving the availability of appropriate QC materials is of critical importance for assuring the quality of genetic testing, enhancing performance evaluation and PT/EQA programs, and facilitating new test development. To meet the needs of the rapidly expanding capacity of genetic testing in clinical and public health settings, a comprehensive, coordinated program should be developed. A Genetic Testing Quality Control Materials Program has therefore been established by CDC in March 2005 to serve these needs.
URI: 
ISSN: 1098-3600
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Human Mutations and Polymorphisms Section (-)
Biomedical Quality Assurance Research Unit
# (joint) last author

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