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Draft, Do Not Distribute
Part 2: Environmental Panel Organisms -
This list is comprised of identified organisms from the environment.
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Inclusion of all environmental panel organisms is not a requirement if a method developer provides appropriate justification that the intended use of the assay
94
permits the exclusion of specific panel organisms. Justification for exclusion of any environmental panel organism(s) 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 DNA may be combined into pools of up to 10 panel organisms, with
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each panel organism represented at 10 times the AMDL, where possible. The combined DNA pools are tested in the presence (at 2 times the AMDL) and absence
98
of the
target viral gene or gene fragment.
If an unexpected result occurs, each of the individual environmental organisms from a failed pool must be individually
99
re-tested at 10 times the AMDL with and without the
target viral gene or gene fragment
at 4,000 genome equivalents/mL in the candidate method DNA elution
100
buffer.
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•
Other biothreat agents
105
106
Bacillus anthracis
Ames
107
Yersinia pestis
Colorado-92
108
Francisella tularensis
subsp.
tularensis
Schu-S4
109
Burkholderia pseudomallei
110
Burkholderia mallei
111
Coxiella burnetii
112
Brucella melitensis
113
Ricinus communis
– use ricin plant leaves as source of DNA
114
Clostridium botulinum
Type A
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•
Cultivatable bacteria identified as being present in air and soil
117
Acinetobacter lwoffii
118
Agrobacterium tumefaciens
119
Bacillus amyloliquefaciens
120
Bacillus cohnii
121
Bacillus psychrosaccharolyticus
122
Bacillus benzoevorans
123
9 Draft EEVs SMPR V4