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Field biodetection products widely used, but performance largely
unknown
Standards written only for one application:
field screening of visible
suspicious powders
Allow flexibility in the rigor of testing (cost/time)
Two LCB/confidence level options
3 levels of testing rigor
Once the standard is approved, market forces may decide the
balance between testing rigor/costs and user acceptance of certain
validated performance levels
Revisions and refinements to the standard can be made in the
future – but we need something as a starting point
Background and Guiding Principles
for this Standard
Test Modules (TM) for Nucleic Acid
Testing
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TM1: Inclusivity
Samples expected to give a positive result
TM2: Exclusivity
Near-neighbor samples expected to give a negative result
Tested at 10X inclusivity test concentration
TM3: Commonly Encountered Suspicious Powders
Assessment of whether powders generate a false positive result
TM4: Biothreat-spiked powders
Assessment of whether the presence of powder causes a false negative result
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