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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.
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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.
“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
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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