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On March 31, 2011, the AOAC Stakeholder Panel on Agent Detection Assays (SPADA) approved revised strain panels for PCR-based technologies to detect aerosolized Burkholderia (B. mallei and B. pseudomallei). In addition, AOAC, in support of a contract with the U.S. Department of Homeland Security, has expanded its biothreat activities to include a new agent—Variola (smallpox). Burkholderia The Burkholderia Working Group (BurkWG), chaired by Alex Hoffmaster [Centers for Disease Control and Prevention (CDC)] and Paul Keim (Northern Arizona University), recommended revising four strains in the SPADA-approved strain panels due to inaccessibility of those materials. In June 2010, SPADA had approved a 60-strain panel recommended by the working group for evaluating and validating detection assays targeting B. mallei and B. pseudomallei. Since the meeting in June 2010, it was determined that some strains are not readily acquired, so the working group recommended to substitute them with ones known to be available. On March 31, 2011, SPADA reviewed the working group’s recommendations, as presented by Steven Schutzer (University of Medicine and Dentistry of New Jersey, Department of Medicine) on behalf of the cochairs, to revise the strain panel due to availability issues. Consequently, SPADA approved the substitution of the four strains. Variola AOAC/DHS continue to expand their biothreat activities to include new agents and technologies. The latest effort focuses on developing standards to validate PCR-based technologies to detect aerosolized Variola, the virus that causes smallpox. At the March 2011 meeting, Inger Damon (CDC) provided an overview of the virus’ biology, as well as the regulations and unique challenges of using the organism in development and testing of detection assays. For diagnostic purposes, testing of Variola is being performed using newer technology such as real-time PCR. Some clinical diagnostics are available, however, no assays for orthopoxvirus (or smallpox) have achieved regulatory approval. Damon indicated a need for environmental detection. Analytical issues relevant to implementation of smallpox testing include biosafety; biosecurity; reagents; centralized/regionalized testing; QA/QC, proficiency testing; communication between clinician/epidemiologists/laboratory; and development of a disease confirmatory algorithm. A working group, chaired by Damon and Ted Hadfield of MRI Global, is being formed to develop reference strain panels and standard method performance requirements (SMPRs) for review and approval by SPADA.
For more information, contact Deborah McKenzie, senior director, methods development and approval processes, at dmckenzie@aoac.org or Scott Coates, chief scientific officer, at scoates@aoac.org.
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