SPADA

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Diagnostics: Nucleic acid testing
Real time PCR Assays
• Platform supported at Laboratory Response
Network (LRN)
• High throughput
• Sensitive/specific
– Sensitive to 1-50 genome copies
– Historically lesion samples contained 104-107
infectious virions
– Assays validated against authentic Variola virus
genomic material
• Limitations:
– time to get samples to reference labs
Diagnostics developed
• CDC developed/evaluated (real time) PCR assays targeting Orthopoxvirus
genus and various species (Variola, Monkeypox, Vaccinia, etc. )
– Provide reagents/facilities for others to evaluate assays
• ~Thirteen peer-reviewed publications evaluate PCR assays against authentic
Variola virus genomic material
• Subset used in LRN (Variola, Monkeypox, Cowpox and Vaccinia virus
detection)
– 2002 onward: vaccine AE identification
– 2003: response to monkeypox outbreak
• Regulatory agency approval
– De novo 510K submitted on Orthopoxvirus non-variola assay
• Approved September 2012
– Discussion initiated with FDA (2002) on Variola virus assay
• Submission on newly validated assays to occur in 2016
• Initiating, technology transfer to other countries
– Monkeypox
– Smallpox laboratory diagnostics network (WHO sponsored)