AOAC SPADA Meeting

What is the traditional process? Finding a target (user defined- biased vir factor, or agnostic- (just look for unique sequences-Uniquemer, BioVelocity) Designing an assay- primer/probe sets (Primer BLAST) Checking Specificity; hits target sequences/doesn’t hit anything else (BLAST) Downstream all wet lab (use of BSL2, BSL3 and BSL4 organisms depending on the agent) Assay parameters LoD- one prototype strain used- in buffer

Linearity- one prototype strain used – in buffer Inclusivity/Exclusivity- panel of strains – in buffer Matrix Testing- one prototype strain spiked Interference- one prototype strain spiked

2018_10_17_SPADA_Brief

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Stakeholder Panel on Agent Detection Assays (SPADA) • List of Inclusivity and Exclusivity Panel organisms decided by SMEs for each organism (total 84 / 97 ) strains

• Ba ( 15 / 20 ) • Yp ( 16 / 17 ) • Ft ( 9 / 9 ) • Burk (pseudomallei/mallei) ( 24/11 / 24 ) • Brucella ( 6 / 30 ) • Toxins (Various toxins)

• Any assay needs to be wet lab tested against this panel- expectation- the assay will hit all inclusivity panel and will not hit exclusivity panel and the assay is good for the current sequence space • The cost and time for developing a new assay for any new variant of an existing assay is not realistic especially for a rapidly evolving pathogen • The idea is to replace most if not all wet lab testing by in silico analyses using a standard developed by this working group

2018_10_17_SPADA_Brief

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