SPADA Book - April 11, 2017

Possible Standard Guidance on Prokaryotic Strain Characterization and/or Lineage Documentation Microbial materials used for R&D, T&E, and training on biothreat detection technologies should be appropriately and consistently characterized. “NIH expects that key biological and/or chemical resources will be regularly authenticated to ensure their identity and validity for use in the proposed studies.” --NIH, Enhancing Reproducibility through Rigor and Transparency Strains “must be characterized and documented to truly be the species and strains they are purported to be.” --AOAC. SMPR® 2016.006. Standard Method Performance Requirements for DNA- Based Methods of Detecting Bacillus anthracis in Field-Deployable, Department of Defense Aerosol Collection Devices, 2016.

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Conclusions • Modified yeast strains have potential to be used as training materials in lieu of biothreats in a variety of applications • Opportunity for involvement in participating (and helping design) future interlaboratory studies and field tests • Mixed microbial RMs and characterization methods can help increase confidence in sequencing and other technologies • Opportunity to provide input on strains to include for biosurveillance applications • Documentary standards continue to be needed • In addition to SPADA, there are opportunities to be involved in standards development activities

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