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Environmental Factors For Validating
Biological Threat Agent Detection Assays
Scott Coates, AOAC CSO
September 1, 2015
AOAC INTERNATIONAL, 2275 Research Blvd., Rockville, Maryland,
20850
Background
•
First version appeared in 2004
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for hand held immunoassays.
•
Second version first appeared in 2007
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for PCR assays.
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to demonstrate robustness in the face of
external contaminants that might inhibit the
PCR chain reaction.
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to demonstrate specificity in the field in which a
practically endless variety of DNA is found.