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Test Design
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Three Distinct Phases
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Developer Testing
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Independent Laboratory Testing
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Multicenter Testing
Developer Study
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This study will evaluate PCR‐based methods for detection of
Bacillus
anthracis
spores intended for use with aerosol collection samples.
The PCR‐based methods are systems using either filter or liquid air
collection technology and are intended for laboratory use only.
Candidate method instructions must include procedures for recovery
of spores from the claimed matrix, DNA extraction and PCR. Filter
recovery DNA extraction of spores may be done with surrogate
organisms as the developer will likely not have access to
Bacillus
anthracis.
PCR testing will likely be done with DNA from
Bacillus
anthracis
obtained by the developer from a select agent laboratory