SPADA Working Groups ~ April Meeting Book

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. Incorporate the validation guidance and introduction paragraph into the VEE SMPR. Provide a definition of SEA-C for the definitions section of the SEB SMPR. Contact Goodwin and Wolcott for strain characterization sub-group. Search AOAC archive for rationale of 2000 genome equivalents per mL., and 20,000 genome equivalent / dry filter. Research appropriate AMDL for SEA-C.

Ostlund

Coates / Dent

Tallent

Johns

McIver / Dent Coates / Dent

Organize follow up working group calls.

Coates / Dent