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| J. AOAC Int. to Publish Technical Guidelines for Validation of Hand-Held Assays In support of a contract with the Department of Homeland Security (DHS), AOAC embarked on a project in 2006 to develop technical guidelines for validation of lateral-flow immunoassays, widely referred to as hand-held assays (HHAs). The guidelines include method performance requirements for HHAs used for detection of Bacillus anthracis spores, and internal, independent, and collaborative testing plans based on the method performance requirements. Publication of the guidelines in the Journal of AOAC INTERNATIONAL is expected in the very near future. The effort stems from earlier work, sponsored by DHS, completed in 2005 to validate HHAs for detection of Bacillus anthracis spores in suspicious powders. As part of the project, AOAC formed in 2003 a Task Force for Bacillus anthracis to provide both technical expertise and knowledge of first responder needs for HHAs. In doing so, the Task Force oversaw the development of testing plans with acceptance criteria for these assays. Five HHAs were evaluated, first as Performance-Tested MethodsSM in an independent laboratory, and then in a 12-laboratory collaborative study for Official MethodsSM evaluation. One HHA, the BioResponse RAMP Anthrax Test Cartridge, was granted Performance-Tested MethodSM and Official MethodSM (2004.08) status for laboratory use (RAMP® Anthrax Test Cartridge, Stephenson, J. AOAC Int., Vol. 88, No. 1, 2005, pp 202-203). The acceptance criteria were published in the Journal of AOAC INTERNATIONAL (Vol. 88, No. 1, 2005, pp 13A-14A). The initial project was followed up by a second project in the fall of 2005 to develop and validate a standardized sample collection procedure, and to evaluate the RAMP Anthrax Test Cartridge in a simulated field setting using the standardized sample collection procedure. This project was completed in 2006 and resulted in the adoption of the standardized sample collection procedure by both ASTM INTERNATIONAL [ASTM E2458-06 (2006) Standard Practice for Bulk Sample Collection and Swab Sample Collection of Visible Powders Suspected of Being Biological Agents from Nonporous Surfaces, ASTM, West Conshohocken, PA] and AOAC INTERNATIONAL (Locascio et al., Standard Practice for Bulk Sample Collection and Swab Sample Collection of Visible Powders Suspected of Being Biological Agents from Nonporous Surfaces: Collaborative Study, J. AOAC Int., Vol. 90, No. 1, 2007, pp 299-333). The RAMP Anthrax Test Cartridge was granted Official MethodSM status (2004.08 Revised) for field use in 2006 (Harper & Robinson, J. AOAC Int., Vol. 89, No. 6, 2006, pp 1622-1628). The project was sponsored by the Science and Technology Directorate of the DHS. A third follow-up project was initiated in 2006 to review the acceptance criteria and test plans for HHAs for Bacillus anthracis previously developed, and in parallel to develop acceptance criteria and test plans for use of HHAs for detection of ricin in suspicious powders. AOAC formed a Working Group for Standards for Hand-Held Assays made up of volunteers from state and federal agencies as well as first responder organizations. The working group also oversaw the development and implementation of a survey to determine user expectations of HHA performance. Based on the results of the survey, the group developed method performance requirements, and then developed internal, independent, and collaborative testing plans based on those requirements. Subsequently, the method performance requirements for HHAs used in detection of Bacillus anthracis spores and internal, independent, and collaborative testing plans based on the method performance requirements have been incorporated into a technical guideline to be published in J. AOAC Int. A similar technical guideline has been prepared for HHAs used in detection of ricin. Although most of the work of the project was completed by the fall of 2007, publication of method performance requirements and internal, independent, and collaborative testing plans has been delayed in order to synchronize the technical guidelines with the efforts of the DHS/AOAC Stakeholders Panel on Agent Detection Assays (SPADA) that is nearing completion. --Bert M. Coursey --Scott Coates
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