AOAC ISPAM Meeting eBook, March 17 2015

Draft, Do Not Distribute

Part 2: Environmental Panel Organisms - This list is comprised of identified organisms from the 144 environment. 145 146 Inclusion of all environmental panel organisms is not a requirement if a method developer provides 147 appropriate justification that the intended use of the assay permits the exclusion of specific panel 148 organisms. Justification for exclusion of any environmental panel organism(s) must be documented 149 and submitted. 150 151 Organisms and cell lines may be tested as isolated DNA, or as pools of isolated DNA. Isolated DNA 152 may be combined into pools of up to 10 panel organisms, with each panel organism represented at 153 10 times the AMDL, where possible. The combined DNA pools are tested in the presence (at 2 times 154 the AMDL) and absence of the target viral gene or gene fragment. If an unexpected result occurs, 155 each of the individual environmental organisms from a failed pool must be individually re-tested at 156 10 times the AMDL with and without the target viral gene or gene fragment at 4,000 genome 157 equivalents/mL in the candidate method DNA elution buffer.

158 159 160 161 162 163 164 165 166 167 168 169 170 171 172 173 174 175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191

• Other biothreat agents

Bacillus anthracis Ames Yersinia pestis Colorado-92

Francisella tularensis subsp. tularensis Schu-S4

Burkholderia pseudomallei

Burkholderia mallei Coxiella burnetii Brucella melitensis

Ricinus communis – use ricin plant leaves as source of DNA

Clostridium botulinum Type A

• Cultivatable bacteria identified as being present in air and soil

Acinetobacter lwoffii

Agrobacterium tumefaciens Bacillus amyloliquefaciens

Bacillus cohnii

Bacillus psychrosaccharolyticus

Bacillus benzoevorans Bacillus megaterium Bacillus horikoshii Bacillus macroides Bacteroides fragilis Burkholderia cepacia Burkholderia gladoli Burkholderia stabilis Burkholderia plantarii Clostridium sardiniense Clostridium perfringens

Chryseobacterium indologenes

8 Approved Variola SMPR v7.5