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DRAFT ENVIRONMENTAL ORGANISMS PANEL, VERSION
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Environmental Factors For Validating Biological Threat Agent Detection Assays
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[Adapted from the Environmental Factors Panel approved by SPADA on June 10, 2010.]
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The Environmental Factors Studies supplement the biological threat agent near‐neighbor exclusivity
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testing panel. There are three parts to Environmental Factors studies: part 1 ‐ environmental matrix
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samples; part 2 ‐ the environmental organisms study; and part 3 ‐ the potential interferants applicable
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to Department of Defense applications.
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Part 1:
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Environmental Matrix Samples ‐ Aerosol Environmental Matrices
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Method developers shall obtain environmental matrix samples that are representative and consistent
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with the collection method that is anticipated to ultimately be used in the field. This includes
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considerations that may be encountered when the collection system
is
deployed operationally such as
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collection medium, duration of collection, diversity of geographical areas that will be sampled,
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climatic/environmental conditions that may be encountered and seasonal changes in the regions of
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deployment.
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Justifications for the selected conditions that were used to generate the environmental matrix and
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limitations of the validation based on those criteria must be documented.
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Method developers shall test the environmental matrix samples for interference using samples
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inoculated with a target biological threat agent sufficient to achieve 95% probability of detection.
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Cross‐reactivity testing will include sufficient samples and replicates to ensure each environmental
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condition is adequately represented
.
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Interference from Soil
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To evaluate robustness to soil interferents, samples of each regional soil types* should be spiked at
2x,
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5x and
10x AMDL with the archetype organism (usually specified in the SMPR for AMDL testing, such as
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strain CO92 for
Yersinia pestis
in SMPR 2016.008) and then the samples evaluated for inhibition.
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Inhibition testing should be done using intact target organisms so that potential interference can be
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determined.
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* Arizona Test Dust is available as a baseline starting point.
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Added in June 2015 for the Department of Defense project.