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Known Mixtures of DNA or Cells are Needed
• Technologies are advancing from targeted detection of one or a few
agents to untargeted detection of multiple unknowns
• “Ground truth” samples are needed for these technologies to realize
their potential to revolutionize biological detection
27
“Microbial standard reference
materials…will be a valuable
tool for use in this evaluation.”
“FDA intends to regulate
Infectious Disease NGS Dx
devices as systems, including all
of the components necessary to
generate a result.”
Mixtures of Microbial DNA or Whole Cells
•
Goal:
Develop (or enable development of) control and reference materials
based on DNA or cell mixtures to increase confidence in biological detection
technologies
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Organisms
in matrix
Data
DNA
Results
Sequence
Informatics
Extract
Environment
Sample
DNA Mixture
Cell Mixture