September 2015 SPADA Meeting

Test Design

• Three Distinct Phases • Developer Testing

• Independent Laboratory Testing • Multicenter Testing

Developer Study • This study will evaluate PCR‐based methods for detection of Bacillus  anthracis  spores intended for use with aerosol collection samples.   The PCR‐based methods are systems using either filter or liquid air  collection technology and are intended for laboratory use only.   Candidate method instructions must include procedures for recovery  of spores from the claimed matrix, DNA extraction and PCR.  Filter  recovery DNA extraction of spores may be done with surrogate  organisms as the developer will likely not have access to Bacillus  anthracis.   PCR testing will likely be done with DNA from Bacillus  anthracis obtained by the developer from a select agent laboratory