Document Detail


For the proposition: for the diagnosis of viral infections, commercial assays provide more reliable results than do in-house assays.
MedLine Citation:
PMID:  18306442     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
It cannot be disputed that in-house ('home brew') assays have a part to play in the diagnosis of emerging or evolving infections such as avian influenza H5N1. In such circumstances, diagnostic companies can provide Research Use Only (RUO) or analyte specific reagents (ASR) to facilitate development. In contrast, the provision of commercial assays is governed by regulatory approval and subject to regular audit by the relevant regulatory bodies to ensure continued quality process throughout the continuum of product management. From initial design, through to post-launch support, the process has to meet the requirements of the USA Food and Drug Administration (FDA) Quality System Regulation (FDA, 1996) as well as that of the international quality standards, for example ISO 9001 (Int. Standard ISO 9001, 2000). Because of the quality policies that are implemented in the commercial environment, I will argue that, where available, commercial assays should replace in-house methods in order to ensure long term reliability of results.
Authors:
Alistair James Gammie
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Reviews in medical virology     Volume:  18     ISSN:  1052-9276     ISO Abbreviation:  Rev. Med. Virol.     Publication Date:    2008 Mar-Apr
Date Detail:
Created Date:  2008-03-05     Completed Date:  2008-06-18     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9112448     Medline TA:  Rev Med Virol     Country:  England    
Other Details:
Languages:  eng     Pagination:  73-6     Citation Subset:  IM    
Affiliation:
Siemens Medical Solutions Diagnostics, Bayer House, Newbury RG14 1JA, UK. alistair.gammie@siemens.com
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MeSH Terms
Descriptor/Qualifier:
Genetic Techniques* / standards
Humans
Laboratory Techniques and Procedures* / standards
Reagent Kits, Diagnostic* / standards
Reference Standards
Reproducibility of Results
United States
United States Food and Drug Administration
Virology / methods
Virus Diseases / diagnosis*
Chemical
Reg. No./Substance:
0/Reagent Kits, Diagnostic

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