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
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