SPADA Book - April 11, 2017

Background and Guiding Principles for this Standard

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

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Test Modules (TM) for Nucleic Acid Testing

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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