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Open Access Performance Standards for Biological Threat Agent Assays for Department of Defense Applications

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There has been a proliferation in the development of biological threat agent detection technologies for use in the field by first responders and private-sector end-users as well as in Department of Defense (DoD) applications in which active combat may be occurring and in other parts of the world. In contrast to the proliferation of detection methodology, there has been a lack of standards defining the required performance of these technologies. Standards are necessary to demonstrate the performance and limitations of the tools, providing confidence in the data to allow appropriate response actions by end-users and responders. In the past, the Department of Homeland Security (DHS), Science and Technology Directorate, funded AOAC to develop standards and perform conformity assessment under three efforts. The first effort began in 2003 to evaluate the performance of lateral flow immunoassay devices used by first responders to screen suspicious powders for Bacillus anthracis spores. These devices are colloquially known as “handheld assays” and are frequently referred to as “HHAs.” AOAC formed the Task Force on Bacillus anthracis (TFBA), which created a specific set of consensus performance criteria and test protocols (i.e., standards). Five HHA manufacturers submitted their technologies to AOAC so that third-party laboratories could evaluate the tools against the criteria.
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Keywords: Standard Method Performance Requirements

Affiliations: 1: Joint Research and Development, Inc. 2: AOAC INTERNATIONAL 3: CDC 4: HADECO, LLC 5: Lawrence Livermore National Laboratory 6: Pathogen and Microbiome Institute 7: DHS 8: CDC 9: USDA 10: Idaho National Laboratory 11: Texas A&M University 12: FDA-CFSAN 13: FDA-ORS/DM 14: Pathogen and Microbiome Institute

Appeared or available online: August 22, 2018

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