Journal
EUROPEAN JOURNAL OF HUMAN GENETICS
Volume 18, Issue 12, Pages 1276-1288Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/ejhg.2010.101
Keywords
validation; verification; molecular genetics; statistics; diagnostic
Funding
- Eurogentest
- UK Department of Health
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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 (2010) 18, 1276-1288; doi: 10.1038/ejhg.2010.101; published online 28 July 2010
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