| Home |
|
SPADA Approves Method Performance Requirements, Modified Panels for B. anthracis HHAs The AOAC Stakeholder Panel on Agent Detection Assays (SPADA) reached consensus on April 14-15, 2009 on method performance requirements and modifications of the exclusivity and environmental panels for hand-held assays (HHAs) for the detection of Bacillus anthracis. The modifications are based on SPADA recommendations from a previous stakeholder meeting in January 2009. In January 2009, SPADA approved criteria for panel selection and inclusivity and exclusivity panels for B. anthracis HHAs. At that time, however, SPADA determined that the method performance requirements needed further review by the B. anthracis Working Group on Hand-Held Assays (BAWG-HHA). Per SPADA recommendations, the BAWG-HHA modified method performance requirements to address issues, including justification of the acceptable minimum detection level (AMDL), requirement for determining limit of detection (LOD), clarification and justification of the starting point for validation (spores on nonporous surfaces versus spores in aqueous suspension), consideration of the addition of sampling materials to the environmental panel, inclusion of end-users (for example, first responders and public health) as part of the working group, clarification of the acceptance criteria of the exclusivity panel, and inclusion of criteria for false positives in addition to inhibition to the environmental interference panel. On April 15, 2009, modified method performance requirements for B. anthracis HHAs, as presented by Marian McKee, ATCC, chair of the BAWG-HHA, were reviewed and subsequently approved by SPADA. Also in April 2009, the BAWG-HHA recommended (1) addition of strains to the exclusivity panel to better assess false positives due to cross-reactivity and to better represent both phylogenetic and antigenetic diversity, and (2) removal of strains from the environmental panel. SPADA approved by consensus the modified exclusivity and environmental panels for B. anthracis HHAs. AOAC has issued calls for experts, and B. anthracis HHA methods for suspicious powders. Methods submitted will be reviewed in late spring by an expert review panel, comprising nationally recognized scientists, which will recommend at least one candidate method for further validation. It is expected that method developer validation studies will take place this summer. The next SPADA meeting is scheduled for August 3-4, 2009, in Rockville, Maryland, USA. more information, or if you would like to be part of the work of SPADA, contact 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 April 2009 SPADA meeting is scheduled for the May/June 2009 issue of Inside Laboratory Management.
|
