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Draft, Do Not Distribute
7 Draft EEVs SMPR V4
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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 provides
110
appropriate justification that the intended use of the assay permits the exclusion of specific panel
111
organisms. Justification for exclusion of any environmental panel organism(s) must be documented
112
and submitted.
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Organisms and cell lines may be tested as isolated DNA, or as pools of isolated DNA. Isolated DNA
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may be combined into pools of up to 10 panel organisms, with each panel organism represented at
116
10 times the AMDL, where possible. The combined DNA pools are tested in the presence (at 2 times
117
the AMDL) and absence of the
target viral gene or gene fragment.
If an unexpected result occurs,
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each of the individual environmental organisms from a failed pool must be individually re-tested at
119
10 times the AMDL with and without the
target viral gene or gene fragment
at 4,000 genome
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equivalents/mL in the candidate method DNA elution buffer.
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•
Potential bacterial biothreat agents
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Bacillus anthracis
Ames
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Yersinia pestis
Colorado-92
125
Francisella tularensis
subsp.
tularensis
Schu-S4
126
Burkholderia pseudomallei
127
Burkholderia mallei
128
Brucella melitensis
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•
Cultivatable bacteria identified as being present in air and soil
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Acinetobacter lwoffii
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Agrobacterium tumefaciens
133
Bacillus amyloliquefaciens
134
Bacillus cohnii
135
Bacillus psychrosaccharolyticus
136
Bacillus benzoevorans
137
Bacillus megaterium
138
Bacillus horikoshii
139
Bacillus macroides
140
Bacteroides fragilis
141
Burkholderia cepacia
142
Burkholderia gladoli
143
Burkholderia stabilis
144
Burkholderia plantarii
145
Chryseobacterium indologenes
146
Clostridium sardiniense
147
Clostridium perfringens
148
Deinococcus radiodurans
149
Delftia acidovorans
150
Escherichia coli
K12
151
Fusobacterium nucleatum
152
Lactobacillus plantarum
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