Performance Standards for Biological Threat Agent Assays for Department of Defense Applications.

There has been a proliferation in the developmentof biological threat agent detection technologies foruse in the field by first responders and private-sectorend-users as well as in Department of Defense(DoD) applications in which active combat maybe occurring and in other parts of the world. Incontrast to the proliferation of detection methodology,there has been a lack of standards defining therequired performance of these technologies. Standardsare necessary to demonstrate the performanceand limitations of the tools, providing confidencein the data to allow appropriate response actions byend-users and responders. In the past, the Departmentof Homeland Security (DHS), Science andTechnology Directorate, funded AOAC to developstandards and perform conformity assessmentunder three efforts. The first effort began in 2003to evaluate the performance of lateral flow immunoassaydevices used by first responders to screensuspicious powders for Bacillus anthracis spores.These devices are colloquially known as "handheldassays" and are frequently referred to as"HHAs." AOAC formed the Task Force on Bacillusanthracis (TFBA), which created a specific set ofconsensus performance criteria and test protocols(i.e., standards). Five HHA manufacturers submittedtheir technologies to AOAC so that third-partylaboratories could evaluate the tools against thecriteria.