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DRAFT ENVIRONMENTAL ORGANISMS PANEL, VERSION
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2.3
Environmental Organisms
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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
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organisms. Justification for exclusion of any environmental panel organism(s) must be documented and
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submitted.
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If bioinformatic analysis is completed then DNA from Group 1 organisms should be tested. If bioinformatic
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analysis is not completed then DNA from Group 1 and 2 organisms should be tested.
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Organisms may be tested as pools containing ten organisms each represented at 10 times the AMDL. Cell
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lines should be tested individually at a DNA concentration equivalent to 10X AMDL. These tests should
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be negative for the target sequence. The same pools can be spiked with 2X the AMDL for the target
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organism, mixed and tested. These tests should be positive for the target in the high DNA background.
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Organisms and cell lines may be tested as isolated DNA, or as pools of isolated DNA. Isolated DNA may
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be combined into pools of up to 10 panel organisms, with each panel organism represented at 10 times
88
the AMDL, where possible. The combined DNA pools are tested in the presence (at 2 times the AMDL)
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and absence of the target gene or gene fragment.
If an unexpected result occurs, each of the individual
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environmental organisms from a failed pool must be individually re-tested at 10 times the AMDL with and
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without the
target gene or gene fragment
at 2x the AMDL in the candidate method DNA elution buffer.
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DNA from organisms on this list that already appears in the inclusivity or exclusivity panel does not need
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to be tested again as part of the environmental factors panel.
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Group 1
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Aedes aegypti
(ATCC /CCL-125(tm) mosquito cell line)
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Aedes albopictus
(Mosquito C6/36 cell line)
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Dermatophagoides pteronyssinus
(Dust mite -commercial source)
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Xenopsylla cheopis
Flea (Rocky Mountain labs)
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Drosophilia
cell line
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Musca domestica
(housefly) ARS, USDA, Fargo, ND
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Gypsy moth cell lines LED652Y cell line (baculovirus)– Invitrogen
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Cockroach (commercial source)
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Tick (Amblyomma and
Dermacentor
tick species for
F. tularensis
detection assays)
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Mus musculus
(ATCC/HB-123) mouse
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Rattus norvegicus
(ATCC/CRL-1896) rat
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Homo sapiens
(HeLa cell line ATCC/CCL-2) human
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