SPADA Working Groups ~ April Meeting Book

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AOAC SMPR 2015.XXX; Version 3, March 6, 2015 1 2 Method Name: Detection of Coxiella burnetii

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AOAC Stakeholder Panel on Agent Detection Assays

Approved Body:

1. Intended Use :

Laboratory or field use by trained operators.

Specific detection of Coxiella burnetii in collection buffers from aerosol collection devices. Field-deployable assays are preferred.

2. Applicability :

10 11 3. Analytical Technique : Polymerase Chain Reaction (PCR)

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4. Definitions :

Acceptable Minimum Detection Level (AMDL)

The predetermined minimum level of an analyte, as specified by an expert committee which must be detected by the candidate method at a specified probability of detection (POD). For this SMPR, SPADA has established the AMDL at: 2,000 copies/ml of Coxiella burnetii target DNA in the candidate method sample collection buffer. Copies/ml refers to number of Coxiella burnetii genomes or equivalent plasmid copies containing target gene or gene

fragment.

Coxiella burnetii

Naturally obligate intracellular bacterial pathogen of the Legionellales family.

Exclusivity

Study involving pure non-target strains, which are potentially cross-reactive, that shall not

be detected or enumerated by the tested method.

Inclusivity

Study involving pure target strains that shall be detected or enumerated by the alternative

method.

Maximum Time-To- Result

Maximum time to complete an analysis starting from the test portion preparation to assay

result.

Probability of Detection (POD)

The proportion of positive analytical outcomes for a qualitative method for a given matrix at a specified analyte level or concentration with a ≥ 0.95 confidence interval.

1 Draft SMPR Coxiella burnetii V3