SPADA

Clinical diagnostic approaches used at theWHO CC at CDC • Nucleic acid testing

• Viral isolation

• Serologic assays

• Protein based/virus detection – In development – Commercial assay available

• Only one Orthopoxvirus diagnostic assay has achieved regulatory approval – LRN Orthopoxvirus non-variola real-time PCR assay • FDA de novo 510(k) approved September 2012 • Dependent upon LRN algorithm

Clinical laboratory algorithm development and successes

• Focuses clinical attention to most serious look-a-likes • Focuses lab attention to most serious contenders • Helps define/remind what conditions are most frequently confused with possible smallpox • Frames logic for approaching diagnostics

• Minimizes false positives

• Use of the algorithm in 2002*

Sewardet. al. CID 2004