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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