SPADA
Variola Working Group SMPR: tailor panel to assay based on bioinformatics
Sensitivity analysis :
• AMDL = 50,000 copies/mL target region of Variola virus • ≥ 500 bp must receive permission from WHO • insertion into another Orthopoxvirus is prohibited
Establish Probability of Detection at AMDL w/in collection buffer ( ≥ 95%) Establish Probability of Detection at AMDL w/in environmental matrix ( ≥ 95%)
• Inclusivity panel – Variola virus : ≥ 2 strain target regions • at least one from each primary clade • encompass differences in target region • Based on bioinformatic analysis
Ensure all inclusivity strains are detected at 2X AMDL in collection buffer Ensure all inclusivity strains are detected at 2X AMDL in environmental matrix Ensure target is detected at 2X AMDL w/in pool of environmental panel organisms (pools of up to 10 organisms at 10X AMDL for each)
Specificity analysis: • Exclusivity panel – near neighbor ( Orthopoxvirus ): • All poxvirus strains listed in the table (one from each major clade) • See AOAC Website for the most updated list Variola Working Group SMPR: tailor panel to assay based on bioinformatics
Species
Strain
Commercial availability
Vaccinia
Elsree
ATCCVR-1549
Cowpox
Brighton
ATCCVR-302
Ectromelia
Moscow
ATCCVR-1374
Monkeypox
V79-I-005
BEI NR-2324
Monkeypox
USA-2003
BEI NR-2500
Raccoonpox
Herman
ATCCVR-838
Skunkpox
ATCC
Volepox
ATCC
Camelpox
BEI
Taterapox
BEI
ParapoxvirusOrf
Vaccine
Colorado Serum Company
• Any additional strains with greater similarity to the assay’s target region(s) than the strains listed above in the table • Based on bioinformatic analysis Ensure all exclusivity strains are NOT detected at 10X AMDL in collection buffer
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