September 2015 SPADA Meeting

Draft, Do Not Distribute

AOAC SMPR 2015.XXX; Version 5, June 19, 2015

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Method Name:

Identification of Venezuelan Equine Encephalitis Virus (VEEV)

AOAC Stakeholder Panel on Agent Detection Assays

Approved Body:

1. Intended Use :

Laboratory or field use by Department of Defense trained operators.

2. Applicability : Identification of VEEV in liquid samples from aerosol collectors. The preferential method would be a field-deployable assay. 10 11 12 3. Analytical Technique : Molecular methods of detecting target-specific viral component(s).

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4. Definitions :

Acceptable Minimum Identification Level (AMIL)

The predetermined minimum level of an analyte, as specified by an expert committee which must be detected and identified by the candidate method with a specified probability of

identification (POI).

Exclusivity

Study involving pure non-target strains and species, which are potentially cross-reactive,

that shall not be detected or identified by the test method.

Inclusivity

Study involving pure target strains or species that shall be detected and identified by the

alternative method.

Maximum Time-To-Assay Result

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

result.

Probability of Identification (POI)

The proportion of positive analytical outcomes for an identification method for a given

matrix at a given analyte level or concentration.

Venezuelan Equine Encephalitis(VEE) Virus (VEEV) VEEV encompasses several viruses all of which are within the Alphavirus genus of the Togaviridae family. For the purpose of this SMPR VEEV includes the human pathogenic virus variants VEEV-1AB, VEEV-1C, VEEV-1D, and

VEE-1D.

42 43 5. System suitability tests and/or analytical quality control: 44

The controls listed in Table I shall be made available in assays as appropriate. Manufacturer must provide written justification if controls are not available with the assay.

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1 Draft EEVs SMPR V4