☆ 4.5 Article

A standardized framework for the validation and verification of clinical molecular genetic tests

EUROPEAN JOURNAL OF HUMAN GENETICS (2010)

期刊

EUROPEAN JOURNAL OF HUMAN GENETICS

卷 18, 期 12, 页码 1276-1288

出版社

NATURE PUBLISHING GROUP

DOI: 10.1038/ejhg.2010.101

关键词

validation; verification; molecular genetics; statistics; diagnostic

类别

Biochemistry & Molecular Biology Genetics & Heredity

资金

Eurogentest
UK Department of Health

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Protocol

Reagent

摘要

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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