Scope of Proposed Standard: The standard specification will include a tiered approach to testing biodetection instruments and assays with different levels of performance (e.g., probability of detection, confidence level) and different levels of rigor (e.g., varying numbers of sample types). Testing modules 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) tested to established statistical criteria (guidance on DNA and/or organism inclusivity panels will be given). 3)Exclusivity Testing (e.g., non-target sample DNA or organism) to established statistical criteria (guidance on DNA and/or organism exclusivity panels will be given) 4)Environmental Sample Testing (e.g., common hoax powders or environmental material such as dust or building material) to established statistical criteria (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.
KeywordsBiothreat, 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.Back to Top
Draft Under Development