September 2015 SPADA Meeting

Independent Laboratory Validation • The independent validation verifies the method performance observed in  the method developer’s laboratory using viable Bacillus anthracis cultures.   The independent laboratory assessed  method performance including  • 1) probability of detection (POD) at the acceptable minimum detection level (AMDL)  or lower

• 2) inclusivity • 3) exclusivity • 4) environmental interference  

• Certified reference materials were used for POD repeatability dynamic range and specificity ,  ,  testing. Other reference materials are used for inclusivity, exclusivity and environmental  factors testing. • Robustness testing (instruments and people) • Shelf life testing of Developer Kits

Multicenter Validation Testing

• Identify test centers A li • ssure comp ance w t 

i h CDC l i  regu at ons an e era aw • Identify individuals not associated with developer or independent  laboratory to do the testing.  • Determine the acceptable skill of testers • Determine when testing will be done • Assure administrators, safety officers and support staff are qualified, aware and  support the project • Have a well vetted test plan in place with easy data recording instructions d F d l l

• Assure samples can be sent to receiving laboratories • level Randomize and blind code the subsamples • Conduct testing over a short period of time if possible • Record results (pos or neg) for each primer pair and each sample