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Draft, Do Not Distribute
1 Draft SMPR Coxiella burnetii v7
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AOAC SMPR 2015.XXX; Version 7; June 19, 2015.
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Method Name:
Detection of
Coxiella burnetii
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Approved Body:
AOAC Stakeholder Panel on Agent Detection Assays
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1.
Intended Use
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Laboratory or field use by Department of Defense trained operators.
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2.
Applicability
:
Specific detection of
Coxiella burnetii
in collection buffers from aerosol
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collection devices. Field-deployable assays are preferred.
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3.
Analytical Technique
:
Molecular detection of nucleic acid.
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4.
Definitions
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Acceptable Minimum Detection Level (AMDL)
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The predetermined minimum level of an analyte, as specified by an expert committee which
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must be detected by the candidate method at a specified probability of detection (POD).
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Coxiella burnetii
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Naturally obligate intracellular bacterial pathogen of the
Legionellales
family.
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Exclusivity
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Study involving pure non-target strains, which are potentially cross-reactive, that shall not
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be detected or enumerated by the tested method.
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Inclusivity
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Study involving pure target strains that shall be detected or enumerated by the alternative
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method.
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Maximum Time-To- Result
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Maximum time to complete an analysis starting from the test portion preparation to assay
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result.
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Probability of Detection (POD)
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The proportion of positive analytical outcomes for a qualitative method for a given matrix at
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a specified analyte level or concentration with a ≥ 0.95 confidence interval.
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System false-negative rate
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Proportion of test results that are negative contained within a population of known
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positives
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System false-positive rate
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Proportion of test results that are positive contained within a population of known
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negatives.
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