In an effort to integrate its various activities in the biothreat detection arena, AOAC has expanded the Stakeholders Panel on Agent Detection Assays (SPADA), originally established to focus on PCR-based assays for B. anthracis, Y. pestis, and F. tularensis, to include members of the Working Group on Standards for Hand-Held Assays (WGSH). WGSH was created to evaluate hand-held assays for detecting B. anthracis and ricin. As such, SPADA recently approved criteria for panel selection and inclusivity and exclusivity panels for the detection of Bacillus anthracis and ricin hand-held assays (HHAs).

Recommendations on test panel criteria for B. anthracis HHAs were approved by SPADA. The criteria are designed to be as consistent as possible with the applicable SPADA recommendations, PCR protocols, and draft Bacterial Threat Agent Method Validation Guideline.

Inclusivity and exclusivity panels for B. anthracis HHAs were also approved by SPADA. The strains included in the inclusivity panel for B. anthracis HHA reflects the panel approved for the B. anthracis PCR assay. For the exclusivity near-neighbors panel, the species/strains approved are those most likely to occur in the United States and Europe.

SPADA determined that the method performance requirements for B. anthracis HHAs, which were not approved, required further review by the B. anthracis Working Group on Hand-Held Assays.

For ricin HHAs, SPADA approved the inclusivity and exclusivity (with provisions) panels. Recommendations for selection criteria of the inclusivity panel are based on the most likely forms in which ricin might be encountered. Items selected for the exclusivity panel are either structural or functional homologs of ricin, thus posing potential cross-reactivities.

Future meetings will be convened to finalize method performance requirements for B. anthracis and ricin HHAs. The next meeting is scheduled for April 14-15, 2009, in Rockville, Maryland, USA.

For more information, or if you would like to be part of the work of SPADA, contact Deborah McKenzie, senior director, methods development and approval processes, at dmckenzie@aoac.org or Scott Coates, chief scientific officer, microbiology, and senior managing director, AOAC Research Institute, at scoates@aoac.org”.

Full coverage of the most recent SPADA meeting is scheduled for the March/April 2009 issue of Inside Laboratory Management.

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