A standardized framework for the validation and verification of clinical molecular genetic tests
CJ Mattocks, MA Morris, G Matthijs… - European Journal of …, 2010 - nature.com
CJ Mattocks, MA Morris, G Matthijs, E Swinnen, A Corveleyn, E Dequeker, CR Müller, V Pratt…
European Journal of Human Genetics, 2010•nature.comThe 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.
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.
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.
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