A standardized framework for the validation and verification of clinical molecular genetic tests.
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ABSTRACT:
SUBMITTER: Mattocks CJ
PROVIDER: S-EPMC3002854 | biostudies-other | 2010 Dec
REPOSITORIES: biostudies-other
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A standardized framework for the validation and verification of clinical molecular genetic tests.
Mattocks Christopher J CJ Morris Michael A MA Matthijs Gert G Swinnen Elfriede E Corveleyn Anniek A Dequeker Els E Müller Clemens R CR Pratt Victoria V Wallace Andrew A
European journal of human genetics : EJHG 20100728 12
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 e ...[more]
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