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...

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Published inEuropean journal of human genetics : EJHG Vol. 18; no. 12; pp. 1276 - 1288
Main Authors MATTOCKS, Christopher J, MORRIS, Michael A, MATTHIJS, Gert, SWINNEN, Elfriede, CORVELEYN, Anniek, DEQUEKER, Els, MÜLLER, Clemens R, PRATT, Victoria, WALLACE, Andrew
Format Journal Article
LanguageEnglish
Published Basingstoke Nature Publishing Group 01.12.2010
Subjects
Accreditation
Accuracy
Bioinformatics
Biological and medical sciences
Confidence Intervals
Epidemiology
Fundamental and applied biological sciences. Psychology
Gene Dosage
General aspects. Genetic counseling
Genetic screening
Genetic Testing - methods
Genetic Testing - standards
Genetics
Genetics of eukaryotes. Biological and molecular evolution
Handbooks
Health Plan Implementation
Hospitals
Humans
Laboratories
Medical genetics
Medical sciences
Molecular and cellular biology
Molecular Biology - methods
Molecular Biology - standards
Polymerase Chain Reaction
Reference Standards
Reproducibility of Results
Sample Size
Sensitivity and Specificity
Social impact
Statistics
Testing laboratories
Validation Studies as Topic
Working groups
Netherlands
United Kingdom > UK
Belgium
United States > US
Switzerland
Clinical test
Test validation
molecular genetics
Genetics
Diagnosis
diagnostic
Statistics
validation
verification
genetic testing
quality assurance
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Summary: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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See the appendix for a list of members of the 'EuroGentest (Unit 1) working group'.
Chief editors.
ISSN:1018-4813
1476-5438
DOI:10.1038/ejhg.2010.101