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7
SMPR for Detection of
Yersinia pestis
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Part 2: Environmental Panel Organisms -
This list is comprised of identified organisms from the
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environment.
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Inclusion of all environmental panel organisms is not a requirement if a method developer
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provides appropriate justification that the intended use of the assay permits the exclusion of
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specific panel organisms. Justification for exclusion of any environmental panel organism(s)
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must be documented and submitted.
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Organisms and cell lines may be tested as isolated DNA, or as pools of isolated DNA. Isolated
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DNA may be combined into pools of up to 10 panel organisms, with each panel organism
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represented at 10 times the AMDL, where possible. The combined DNA pools are tested in the
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presence (at 2 times the AMDL) and absence of the
target gene or gene fragment.
If an
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unexpected result occurs, each of the individual environmental organisms from a failed pool
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must be individually re-tested at 10 times the AMDL with and without the
target gene or gene
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fragment
at 2x the AMDL in the candidate method DNA elution buffer.
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DNA in this list that already appear in the inclusivity or exclusivity panel do not need to be
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tested again as part of the environmental factors panel.
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•
Potential bacterial biothreat agents
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Bacillus anthracis
Ames
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Yersinia pestis
Colorado-92
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Francisella tularensis
subsp.
tularensis
Schu-S4
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Burkholderia pseudomallei
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Burkholderia mallei
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Brucella melitensis
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•
Cultivatable bacteria identified as being present in air soil or water
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Acinetobacter lwoffii
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Agrobacterium tumefaciens
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Bacillus amyloliquefaciens
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Bacillus cohnii
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Bacillus psychrosaccharolyticus
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Bacillus benzoevorans
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Bacillus megaterium
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Bacillus horikoshii
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Bacillus macroides
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Bacteroides fragilis
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Burkholderia cepacia
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Burkholderia gladoli
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Burkholderia stabilis
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Burkholderia plantarii
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Chryseobacterium indologenes
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Clostridium sardiniense
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Clostridium perfringens
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Deinococcus radiodurans
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Delftia acidovorans
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Escherichia coli
K12
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