This standard is intended to be used to assess commercially available products for the specific application of screening suspicious substances in the field by first responders. This standard is specific to nucleic acid-based technologies and only addresses bacterial pathogens, not viruses or protein toxins (which we hope to develop in the near future). The purpose of this standard specification is to guide testing protocols, identify representative panels of nucleic acid and/or organism samples for testing (or alternates when they are not available from suppliers), and establish the number of samples required and number of acceptable failed tests to achieve defined levels of probability of detection at given confidence levels. Some panels have not quite been finalized comments are included in those tables in the Annex. The standard incorporates two different performance levels and has three options for different extensiveness of inclusivity and exclusivity panel strain testing. The intent of this approach is to initiate the generation of at least some amount of statistically-based testing results while not being cost prohibitive.
Relevance to Homeland Security: It is of critical importance to develop and use national standards for third-party evaluation of biothreat detection tools. Standards and third-party testing enable the mission of stakeholders through independent evaluation of technology to guide end-user procurements and provide the commercial sector with guidance for developing biodetection tools.
KeywordsBiothreat, Biodetection Equipment, Performance Specification, Biological Detection Technologies,inclusivity and exclusivity testing, nucleic acid, PCR
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Ballot Item Approved as E3131-2017 and Pending Publication