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 gene...

Descripción completa

Detalles Bibliográficos
Autores principales: Mattocks, Christopher J, Morris, Michael A, Matthijs, Gert, Swinnen, Elfriede, Corveleyn, Anniek, Dequeker, Els, Müller, Clemens R, Pratt, Victoria, Wallace, Andrew
Formato: Texto
Lenguaje:English
Publicado: Nature Publishing Group 2010
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3002854/
https://www.ncbi.nlm.nih.gov/pubmed/20664632
http://dx.doi.org/10.1038/ejhg.2010.101
_version_ 1782193796405002240
author Mattocks, Christopher J
Morris, Michael A
Matthijs, Gert
Swinnen, Elfriede
Corveleyn, Anniek
Dequeker, Els
Müller, Clemens R
Pratt, Victoria
Wallace, Andrew
author_facet Mattocks, Christopher J
Morris, Michael A
Matthijs, Gert
Swinnen, Elfriede
Corveleyn, Anniek
Dequeker, Els
Müller, Clemens R
Pratt, Victoria
Wallace, Andrew
author_sort Mattocks, Christopher J
collection PubMed
description 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.
format Text
id pubmed-3002854
institution National Center for Biotechnology Information
language English
publishDate 2010
publisher Nature Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-30028542010-12-16 A standardized framework for the validation and verification of clinical molecular genetic tests Mattocks, Christopher J Morris, Michael A Matthijs, Gert Swinnen, Elfriede Corveleyn, Anniek Dequeker, Els Müller, Clemens R Pratt, Victoria Wallace, Andrew Eur J Hum Genet Article 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. Nature Publishing Group 2010-12 2010-07-28 /pmc/articles/PMC3002854/ /pubmed/20664632 http://dx.doi.org/10.1038/ejhg.2010.101 Text en Copyright © 2010 Macmillan Publishers Limited http://creativecommons.org/licenses/by-nc-nd/3.0/ This work is licensed under the Creative Commons Attribution-NonCommercial-No Derivative Works 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-nd/3.0/
spellingShingle Article
Mattocks, Christopher J
Morris, Michael A
Matthijs, Gert
Swinnen, Elfriede
Corveleyn, Anniek
Dequeker, Els
Müller, Clemens R
Pratt, Victoria
Wallace, Andrew
A standardized framework for the validation and verification of clinical molecular genetic tests
title A standardized framework for the validation and verification of clinical molecular genetic tests
title_full A standardized framework for the validation and verification of clinical molecular genetic tests
title_fullStr A standardized framework for the validation and verification of clinical molecular genetic tests
title_full_unstemmed A standardized framework for the validation and verification of clinical molecular genetic tests
title_short A standardized framework for the validation and verification of clinical molecular genetic tests
title_sort standardized framework for the validation and verification of clinical molecular genetic tests
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3002854/
https://www.ncbi.nlm.nih.gov/pubmed/20664632
http://dx.doi.org/10.1038/ejhg.2010.101
work_keys_str_mv AT mattockschristopherj astandardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT morrismichaela astandardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT matthijsgert astandardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT swinnenelfriede astandardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT corveleynanniek astandardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT dequekerels astandardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT mullerclemensr astandardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT prattvictoria astandardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT wallaceandrew astandardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT mattockschristopherj standardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT morrismichaela standardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT matthijsgert standardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT swinnenelfriede standardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT corveleynanniek standardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT dequekerels standardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT mullerclemensr standardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT prattvictoria standardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests
AT wallaceandrew standardizedframeworkforthevalidationandverificationofclinicalmoleculargenetictests

Ejemplares similares