September 2015 SPADA Meeting

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  – for hand held immunoassays. • Second version first appeared in 2007 – for PCR assays.

– to demonstrate robustness in the face of  external contaminants that might inhibit the  PCR chain reaction. – to demonstrate specificity in the field in which a  practically endless variety of DNA is found.