AOAC SPADA Meeting

The impetus for this work (Interagency specific)

• Bio Alliance • Interagency collaboration for a network of repositories for various bacterial and viral reference materials • Networking different repositories • Common standards a must for reliability and confidence in materials • The materials are used for various applications: assay development, Vaccines and therapeutics development

2018_10_17_SPADA_Brief

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• Blindly trusting the information provided by the donor of a strain • Discrepancies in genotypes; end up storing in the wrong containment spaces (PAK1 BACI 224 in BSL3 and YERS 003 in BSL2); CDC is not happy about this. • Lab specific growth conditions may affect the strain’s properties and genetic make up (surface antigen expression in Yp is heavily influenced by growth temperature); major issues: wrong classification of BSATs • The sources for strains having the same designations are many. But they may not have the same genotypic/phenotypic characteristics due to different pedigrees, laboratory propagation and growth conditions (Sterne, BG examples) • Set the standards so that those that are authorized to use BSATs can follow and make sure the strain meets the standards and adds confidence to the identity and authenticity of strains. DBPAOs assurance role !! • Once you characterize the strain the stock is aliquoted, frozen and further distributed from the repository or any other source. You can always trace it back to the stock. Further growth is according to the same protocol. [QR coding vials and electronic tracking] The impetus for this work (Global Issues)

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