• Potential challenges to consider:
o Integration of multiple components or technologies (“detection is done”).
o Effectively maximizing sample concentration and minimizing sample contamination (sample to environmental background).
o High-quality databases, bioinformatics tools, and assay validation are needed for all technologies.
• A multidimensional approach is encouraged:
o Technologies using immunoassays and mass spectrometry are fast; nucleic-acid approaches and genome sequencing can provide specificity and identify novel threats.
o Orthogonal testing increases the reliability of a BioWatch Actionable Result (BAR) and confidence in the system.
• Extensive and repeated field testing will be necessary for a detection system.
• It is important to involve the end user (public health) in system development and testing.
• The Department of Homeland Security (DHS) was encouraged to look beyond the familiar technologies and development pathways.
AUTONOMOUS DETECTION SYSTEMS USING
In the first of the four sessions, Raymond Mariella, Jr., a senior scientist at Lawrence Livermore National Laboratory (LLNL), provided an overview of his commissioned paper reviewing the state-of-the-art technologies available for detecting organisms using nucleic acid signatures (see Appendix G). The following topics were then discussed by the panelists: lessons that could be learned from other industries in autonomous detection and how those lessons might apply to BioWatch; the evolution of assays to include and exclude various threats; the current state-of-theart system used by the U.S. Postal Service (USPS) and next-generation autonomous detection system based on multiplex polymerase chain reaction (PCR) assays; and systems concepts and integration issues.
Nucleic-Acid Signatures at Three Levels of Readiness
In his interpretation of the three tiers of readiness, Mariella said that any system that would be deployable at TRL 6-plus by 2016 would have