Title: A standardized framework for the validation and verification of clinical molecular genetic tests
Authors: Mattocks, Christopher J ×
Morris, Michael A
Matthijs, Gert
Swinnen, Elfriede
Corveleyn, Anniek
Dequeker, Elisabeth
Müller, Clemens R
Pratt, Victoria
Wallace, Andrew #
Issue Date: Dec-2010
Publisher: Karger
Series Title: European Journal of Human Genetics vol:18 issue:12 pages:1276-1288
Abstract: The validation and verification of laboratory methods and procedures before their use in clinical testing is essential for providing a safe and useful service to clinicians and patients. This paper outlines the principles of validation and verification in the context of clinical human molecular genetic testing. We describe implementation processes, types of tests and their key validation components, and suggest some relevant statistical approaches that can be used by individual laboratories to ensure that tests are conducted to defined standards.European Journal of Human Genetics advance online publication, 28 July 2010; doi:10.1038/ejhg.2010.101.
ISSN: 1018-4813
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Department of Human Genetics - miscellaneous
Laboratory for Molecular Diagnosis
Biomedical Quality Assurance Research Unit
× corresponding author
# (joint) last author

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