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Ostlund delivered a presentation

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to launch the SPADA Venezuelan Equine Encephalitis (VEE)

project. She reviewed the history of the virus, its geographic prevalence and the closely related

Western Equine Encephalitis (WEE) and Eastern Equine Encephalitis (EEE). VEE has been

experimented with as a biological weapon as an incapacitating agent. It is a select agent and there

are a limited number of laboratories that are permitted to work with it. Not many methods have

been published for PCR detection of VEE, WEE or EEE. The goal of the working group is to develop

SMPRs for detection of VEE by PCR methods, with the possibility of developing a single SMPR for a

combination of VEE, WEE and EEE.

After further discussion the group agreed to the following fitness for purpose statement to help

guide the working group in their proceedings:

“Identification of VEEV, and possible EEEV and WEEV. RNA by assays in liquid samples. The

limit of detection must be less than 100 genome copies per reaction. The preferential

method would be a field-deployable assay.”

VII. Q-Fever

Samuels delivered a presentation

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describing the background, impact, regulatory guidance and

current detection technologies for

Coxiella burnetti

, the causative agent of Q-Fever. The organism is

found in goats and other domestic mammals. Hundreds of cases of Q-Fever were documented

during the Iraq war, and it is prevalent on Dutch goat farms. The typical route for transmission is

aerosolization of contaminated soils. There is a currently a vaccine approved for use in Australia for

people at the highest risk, such as goat farmers. There are two common targets in existing PCR

assays, IS1111 and Com01. 95% of work currently being conducted is with the Nine Mile RSA439

clone.

After a lengthy discussion on potential requirements and geographic challenges, the group agreed

to the following fitness for purpose statement:

Detection of C. burnetii by PCR in liquid samples. Field deployable PCR assay would be

desirable.

VIII.

Staphyloccocus enterotoxin B

(SEB)

Tallent delivered a presentation

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on the history, background, and current technologies for

thedetection of SEB. There are 23 homologous distinct staphylococcus enterotoxins identified and

all of them are superantigenic. They are considered biological threat agents because they can be

collected and disseminated quickly, and potentially cause widespread illness. The general analytical

need would be to detect low levels of SEA, SEB and SEC. Tallent led the group in a discussion on the

proposed fitness for purpose for the SEB Working Group and the following statement was agreed

upon:

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Attachment 5 – Ostlund VEE Presentation

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Attachment 6 – Samuel Q-Fever Presentation

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Attachment 7 – Tallent SEB Presentation