AOAC SPADA Meeting

• There is no standard on the level/granularity of strain characterization needed to ensure the confidence on the identity of a bacterial or viral strain used in assay development. Each repository/laboratory has their own set of procedures- or they don’t or they do “ad hoc” what is needed. • The cost of extensive characterization may vary widely depending on what assays are done and exorbitant cost can be prohibitive; so need minimum standard, to start with. Do we create tiered standards analogous to sequencing? • Is WGS sequencing good enough? • No- Knowing the genetic make up (genotype) without the phenotype is no use. • The jury is still out there on level of genome sequencing – to finish or not to finish the genome? The impetus for this work (General issues)

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Microbiological analyses essential for strain verification and validation- the B. anthracis like bacteria- B. cereus biovar anthracis B. Ce var anthracis Classic anthracis Klee et al 2006. J Bac 188: 5333-5344

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