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Considerations in addition to those of
clinical diagnostics….
How to verify authentic agent?
Sufficient vs. necessary
Culture?
Nucleic acid tests
•
How much of the genome?
How to verify infectious risk?
Absent a clinically ill human, what is sufficient, what is necessary?
How and where to evaluate validate
WHO considerations what is sufficient, necessary to have a public
safety/health actionable assay result;
What should that action be?
Mission of the SPADA Variola
Working Group (2014)
•
The VariolaWorking Group of the Stakeholder Panel on
Agent Detection Assays (SPADA) was tasked to develop
voluntary consensus standards required for evaluation of
tools that detect Variola from aerosol collection samples. …
The standards will :
•
Support test and evaluation of Variola-detection tools for the
BioWatch program
•
Provide guidance to industry and other capability developers for
development of future detection tools that BioWatch may solicit
It is expected that any detection result from a tool validated
against the SPADA Variola standards will be confirmed by
the Poxvirus Laboratory at the Centers for Disease Control
and Prevention.