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Sensitivity analysis
:
• AMDL = 50,000 copies/mL target region of
Variola virus
• ≥ 500 bp must receive permission from WHO
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Variola Working Group SMPR:
Tailor Panel to Assay Based on Bioinformatics
• nser on n o ano er
r opoxv rus
s pro e
Establish Probability of Detection at AMDL w/in collection buffer (≥ 95%)
Establish Probability of Detection at AMDL w/in aerosol environmental
matrix (≥ 95%)
• Inclusivity panel –
Variola virus
: ≥ 2 strain target regions
• at least one from each primary clade
(
Li, et. al. PNAS (2007) Oct. 2;104(40):15787-15792.)
• 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
ATCC VR‐1549
Cowpox
Brighton
ATCC VR‐302
Ectromelia
Moscow
ATCC VR‐1374
Monkeypox
V79‐I‐005
BEI NR‐2324
Monkeypox
USA‐2003
BEI NR‐2500
Raccoonpox
Herman
ATCC VR‐838
Skunkpox
ATCC
l
• 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
Vo epox
ATCC
Camelpox
BEI
Taterapox
BEI
Parapoxvirus Orf
Vaccine
Colorado Serum Company