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Draft, Do Not Distribute
1 Draft SMPR Coxiella burnetii V3
AOAC SMPR 2015.XXX; Version 3, March 6, 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
:
Laboratory or field use by 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
:
Polymerase Chain Reaction (PCR)
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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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For this SMPR, SPADA has established the AMDL at: 2,000 copies/ml of
Coxiella burnetii
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target DNA in the candidate method sample collection buffer. Copies/ml refers to number
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of
Coxiella burnetii
genomes or equivalent plasmid copies containing target gene or gene
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fragment.
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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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