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Draft, Do Not Distribute
6 Draft SMPR Coxiella burnetii v7
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Part 2: Environmental Panel Organisms -
This list is comprised of identified organisms from the
130
environment.
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Inclusion of all environmental panel organisms is not a requirement if a method developer provides
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appropriate justification that the intended use of the assay permits the exclusion of specific panel
134
organisms. Justification for exclusion of any environmental panel organism(s) must be documented
135
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
139
10 times the AMDL, where possible. The combined DNA pools are tested in the presence (at 2 times
140
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
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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
147
Yersinia pestis
Colorado-92
148
Francisella tularensis
subsp.
tularensis
Schu-S4
149
Burkholderia pseudomallei
150
Burkholderia mallei
151
Brucella melitensis
152
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•
Cultivatable bacteria identified as being present in air and soil
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Acinetobacter lwoffii
155
Agrobacterium tumefaciens
156
Bacillus amyloliquefaciens
157
Bacillus cohnii
158
Bacillus psychrosaccharolyticus
159
Bacillus benzoevorans
160
Bacillus megaterium
161
Bacillus horikoshii
162
Bacillus macroides
163
Bacteroides fragilis
164
Burkholderia cepacia
165
Burkholderia gladoli
166
Burkholderia stabilis
167
Burkholderia plantarii
168
Chryseobacterium indologenes
169
Clostridium sardiniense
170
Clostridium perfringens
171
Deinococcus radiodurans
172
Delftia acidovorans
173
Escherichia coli
K12
174
Fusobacterium nucleatum
175
Lactobacillus plantarum
176