SPADA

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.

125

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Inclusion of all environmental panel organisms is not a requirement if a method developer

127

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)

129

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

144

Yersinia pestis

Colorado-92

145

Francisella tularensis

subsp.

tularensis

Schu-S4

146

Burkholderia pseudomallei

147

Burkholderia mallei

148

Brucella melitensis

149

150

•

Cultivatable bacteria identified as being present in air soil or water

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Acinetobacter lwoffii

152

Agrobacterium tumefaciens

153

Bacillus amyloliquefaciens

154

Bacillus cohnii

155

Bacillus psychrosaccharolyticus

156

Bacillus benzoevorans

157

Bacillus megaterium

158

Bacillus horikoshii

159

Bacillus macroides

160

Bacteroides fragilis

161

Burkholderia cepacia

162

Burkholderia gladoli

163

Burkholderia stabilis

164

Burkholderia plantarii

165

Chryseobacterium indologenes

166

Clostridium sardiniense

167

Clostridium perfringens

168

Deinococcus radiodurans

169

Delftia acidovorans

170

Escherichia coli

K12

171