Format

Send to

Choose Destination
Eur J Hum Genet. 2010 Dec;18(12):1276-88. doi: 10.1038/ejhg.2010.101. Epub 2010 Jul 28.

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

Author information

1
National Genetics Reference Laboratory (Wessex), Salisbury District Hospital, Salisbury, UK. chris.mattocks@salisbury.nhs.uk

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.

PMID:
20664632
PMCID:
PMC3002854
DOI:
10.1038/ejhg.2010.101
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Nature Publishing Group Icon for PubMed Central
Loading ...
Support Center