SPADA

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 10 4 -10 7 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

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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)