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Draft, Do Not Distribute

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

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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

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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

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10 times the AMDL, where possible. The combined DNA pools are tested in the presence (at 2 times

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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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Other biothreat agents

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Bacillus anthracis

Ames

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Yersinia pestis

Colorado-92

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Francisella tularensis

subsp.

tularensis

Schu-S4

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Burkholderia pseudomallei

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Burkholderia mallei

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Coxiella burnetii

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Brucella melitensis

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Ricinus communis

– use ricin plant leaves as source of DNA

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Clostridium botulinum

Type A

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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

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Bacillus amyloliquefaciens

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Bacillus cohnii

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Bacillus psychrosaccharolyticus

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Bacillus benzoevorans

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Bacillus megaterium

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Bacillus horikoshii

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Bacillus macroides

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Bacteroides fragilis

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Burkholderia cepacia

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Burkholderia gladoli

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Burkholderia stabilis

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Burkholderia plantarii

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Chryseobacterium indologenes

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Clostridium sardiniense

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Clostridium perfringens

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8 Approved

Variola

SMPR v7.5