ASTM WK46895

    New Specification for Standard Specification for Hand Portable Biodetection Instruments for Homeland Security Applications

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    Developed by Subcommittee: E54.01 | Committee E54 | Contact Staff Manager



    WK46895

    1. Scope

    Scope of Proposed Standard: The standard specification will include: 1) Limit of Detection (LOD) study guidance, only if necessary, to determine the appropriate inclusivity concentration to perform inclusivity testing. Inclusivity concentration is often derived from peer-reviewed published studies, but may need to be determined experimentally with consideration of the intended application of the detection technology. 2)Inclusivity Testing (e.g., target sample DNA or organism) to statistical criteria shown below (guidance on DNA and/or organism inclusivity panels will be given) 3)Exclusivity Testing (e.g., non-target sample DNA or organism) to statistical criteria shown below (guidance on DNA and/or organism exclusivity panels will be given) 4)Environmental Sample Testing (e.g., common hoax powders or environmental material) to statistical criteria shown below (guidance on environmental sample types will be given)

    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


    Keywords

    Biothreat, Biodetection Equipment, Performance Specification,Biological Detection Technologies,inclusivity and exclusivity testing

    The title and scope are in draft form and are under development within this ASTM Committee.

    Citing ASTM Standards
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    Work Item Status

    Date Initiated:
    07-31-2014

    Technical Contact:
    Richard Ozanich

    Status:
    Draft Under Development