A standardized framework for the validation and verification of clinical molecular genetic tests
A standardized framework for the validation and verification of clinical molecular genetic tests
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.
1276-1288
Mattocks, Christopher J.
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Morris, Michael A.
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Matthijs, Gert
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Swinnen, Elfriede
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Corveleyn, Anniek
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Dequeker, Els
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Müller, Clemens R.
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Pratt, Victoria
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Wallace, Andrew
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December 2010
Mattocks, Christopher J.
2d943111-cfdf-4f0d-9ecc-0737e541fe36
Morris, Michael A.
7c5bd3d2-1764-496e-b556-6b920a036096
Matthijs, Gert
c85e9151-905f-42cf-a978-66ae262202b5
Swinnen, Elfriede
33ef1d7b-5ff1-4f4a-acdf-42434f5f27dc
Corveleyn, Anniek
ea05e30d-1635-41c5-b139-de97a08ca50e
Dequeker, Els
5f1ae465-0876-4824-8e0f-6e826f3645b9
Müller, Clemens R.
d6e8f902-170b-4538-b954-cf63e98cb561
Pratt, Victoria
8008cc40-6efc-4f58-b5a1-45d81f31e2fa
Wallace, Andrew
94c565bc-4c46-47ef-b67b-fea558f4a97f
Mattocks, Christopher J., Morris, Michael A., Matthijs, Gert, Swinnen, Elfriede, Corveleyn, Anniek, Dequeker, Els, Müller, Clemens R., Pratt, Victoria and Wallace, Andrew
(2010)
A standardized framework for the validation and verification of clinical molecular genetic tests.
European Journal of Human Genetics, 18 (12), .
(doi:10.1038/ejhg.2010.101).
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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Published date: December 2010
Organisations:
Human Development & Health
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Local EPrints ID: 338208
URI: http://eprints.soton.ac.uk/id/eprint/338208
ISSN: 1018-4813
PURE UUID: 096ee18a-5237-49bf-ad6a-96b4c10f9bbd
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Date deposited: 10 May 2012 15:20
Last modified: 14 Mar 2024 11:02
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Contributors
Author:
Christopher J. Mattocks
Author:
Michael A. Morris
Author:
Gert Matthijs
Author:
Elfriede Swinnen
Author:
Anniek Corveleyn
Author:
Els Dequeker
Author:
Clemens R. Müller
Author:
Victoria Pratt
Author:
Andrew Wallace
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