SPADA

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 in 2016

• Initiating, technology transfer to other countries

– Monkeypox

– Smallpox laboratory diagnostics network (WHO sponsored)

Clinical Diagnostic Approaches used at the

WHO 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