Document Detail

Development of a framework for international certification by the OIE of diagnostic tests validated as fit for purpose.
MedLine Citation:
PMID:  18084924     Owner:  NLM     Status:  MEDLINE    
Historically, the OIE has focussed on test methods applicable to trade and the international movement of animals and animal products. With its expanding role as the World Organisation for Animal Health, the OIE has recognised the need to evaluate test methods relative to specific diagnostic applications other than trade. In collaboration with its international partners, the OIE solicited input from experts through consultants meetings on the development of guidelines for validation and certification of diagnostic assays for infectious animal diseases. Recommendations from the first meeting were formally adopted and have subsequently been acted upon by the OIE. A validation template has been developed that specifically requires a test to be fit or suited for its intended purpose (e.g. as a screening or a confirmatory test). This is a key criterion for validation. The template incorporates four distinct stages of validation, each of which has bearing on the evaluation of fitness for purpose. The OIE has just recently created a registry for diagnostic tests that fulfil these validation requirements. Assay developers are invited to submit validation dossiers to the OIE for evaluation by a panel of experts. Recognising that validation is an incremental process, tests methods achieving at least the first stages of validation may be provisionally accepted. To provide additional confidence in assay performance, the OIE, through its network of Reference Laboratories, has embarked on the development of evaluation panels. These panels would contain specially selected test samples that would assist in verifying fitness for purpose.
P Wright; S Edwards; A Diallo; R Jacobson
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Developments in biologicals     Volume:  128     ISSN:  1424-6074     ISO Abbreviation:  Dev Biol (Basel)     Publication Date:  2007  
Date Detail:
Created Date:  2007-12-18     Completed Date:  2008-01-24     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100940058     Medline TA:  Dev Biol (Basel)     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  27-35     Citation Subset:  IM    
Canadian Food Inspection Agency, NCFAD, Winnipeg, Manitoba, Canada.
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MeSH Terms
Animal Diseases / diagnosis*
Diagnostic Tests, Routine / standards,  veterinary*
International Agencies*
Validation Studies as Topic

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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