AOAC SPADA Meeting

Why SPADA for this?

• SPADA is an ideal forum to develop a standard because of its history in developing standards and developing a consensus thorough brining in SMEs from across the domains (Sponsor, government, industry, academia- national and international). • SMPR: • 6 Validation Guidance • AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Biological Threat Agent Methods and/or Procedures (Official Methods of Analysis of AOAC INTERNATIONAL, 2016, 20th Ed., Appendix I). • Inclusivity and exclusivity panel organisms used for evaluation must be characterized and documented to truly be the species and strains they are purported to be.

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What is the objective for the WG • Evolve a standard for bacterial strain characterization • Set minimal information needed for such a strain verification and validation • Write the document and publish • What are the broad categories of information to be captured? Process and not the specific method/instrument • What is the outline of the document- this is not the usual run of the mill SMPR. • What is the forum/journal to publish? • Developed many SMPRs for agent specific assays and user scenarios that help the assay developers and stakeholders who use the assays

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