Overview of performance standards for biological threat agent assays for department of defense applications

SPADA has produced a set of performance standards for the top 10 priority biological threat agents to help method developers design assays and that method users can utilize to evaluate potential assays. These SMPRs describe the minimum performance requirements as determined by the most respected experts in the world. Four of these SMPRs (F. tularensis, B. pseudomallei, Variola Major, and B. suis) allow for the use of in silico analysis in lieu of direct testing under some circumstances in which inclusivity and/or exclusivity species or stains are not available. In another signifi cant fi rst, in silico analysis is offered as an option to reduce the required number of environmental organism DNA or RNA “wet” tests in the Environmental Study. It is expected that in silico analysis will reduce the amount of testing time and cost required and provide researchers with a much greater ability to determine potential cross-reactive DNA from environmental species..