AOAC SPADA February 2015 Meeting Book

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