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Samuel led a discussion on Q-Fever. The group discussed the number of strains that should be used
to evaluate candidate methods. Samuel indicated he already has information on which strains are
most appropriate. Validation guidance was modified to state that strains must be confirmed and
documented.
This led to a discussion on how, and by whom, strains and species should be confirmed and
documented. Davenport noted that this has been an issue with SPADA for years and that the
assumption has been that you are testing with qualified materials. Coates proposed a sub-group to
discuss this further because this issue runs across all of the working groups. Blyn, Hadfield, Kiss,
Lednicky, Naraghi-Arani, and Weaver all volunteered to participate on this group. Davenport
suggested contacting Goodwin and Wolcott (USAMRIID) as well.
The working group reviewed an SMPR developed in 2007-2010 for detection of
Bacillus anthracis
by
PCR. The group tentatively agreed to use the AMDL specified in the SMPR: 20,000 genome
equivalents on dry filter and/or 2,000 per mL genome equivalents in collection buffer. Blyn,
Hadfield, and Davenport discussed the rationale for the AMDL. Coates volunteered to search
through the archives to determine the rationale for these AMDLs.
The working group agreed to an applicability statement as the specific detection of
Coxiella burnetii
in dry filters and/or collection buffer from aerosol collection devices.
The preferential method
would be a field-deployable assay. The group agreed to continue to work on this at the next
teleconference meeting, which is still to be determined.
FEBRUARY 3-4, 2015 SPADA MEETING: ACTION ITEMS
Action
Owner
Provide definition for
Venezuelan Equine
Encephalitis/Encephalomyelitis Virus
for use in SMPR at the next
working group meeting.
Ostlund
Incorporate the validation guidance and introduction paragraph into
the VEE SMPR.
Coates / Dent
Provide a definition of SEA-C for the definitions section of the SEB
SMPR.
Tallent
Research appropriate AMDL for SEA-C.
Johns
Contact Goodwin and Wolcott for strain characterization sub-group.
McIver / Dent
Search AOAC archive for rationale of 2000 genome equivalents per mL.,
and 20,000 genome equivalent / dry filter.
Coates / Dent
Organize follow up working group calls.
Coates / Dent