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Development of standard method performance requirements for biological threat agent detection methods.

Standards and third-party testing are necessary to demonstrate the performance and limitations of biological threat agent (biothreat) detection technologies to allow appropriate response actions by end-users and responders. In order to address this need, the Department of Homeland Security, Science and Technology Directorate has funded AOAC INTERNATIONAL to develop standards and perform conformity assessment. AOAC formed the Stakeholder Panel on Agent Detection Assays to develop consensus performance criteria (standard method performance requirements; SMPRs) for methods that detect biothreats. This paper documents the development of the first five biothreat SMPRs, including the voluntary consensus process, the components of an SMPR, the use of SMPRs in developing validation protocols, and a description of the development efforts and considerations for each of the current SMPRs.