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General Analytical Needs
•
Infectious dose for humans 10‐100
organisms
•
Diagnostic testing for Q fever is
serologic tittering of IgG and IgM,
using phase I and phase II antigens
•
To date, no PCR based diagnostic
approved for human samples to
diagnose acute Q fever, in part,
because of transient appearance in
serum and whole blood
Regulatory Guidance (continued)
•
Coxiella burnetii is a B list Select Agent requiring
BSL3 containment
•
Nine Mile, RSA439, clone 4, is not a Select Agent,
can be manipulated at BSL2 and does
not
revert
because of a well characterized, large deletion ((~20
Kbp) which encodes critical O‐antigen biosynthetic
genes.
•
Human vaccination is not available in US and Q‐vax,
is not licensed in US