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Draft, Do Not Distribute

1 Draft EEVs SMPR V4

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

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Method Name:

Identification of Venezuelan Equine Encephalitis Virus (VEEV)

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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 Department of Defense trained operators.

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2.

Applicability

:

Identification of VEEV in liquid samples from aerosol collectors.

The

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preferential method would be a field-deployable assay.

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3.

Analytical Technique

:

Molecular methods of detecting target-specific viral component(s).

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4.

Definitions

:

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Acceptable Minimum Identification Level (AMIL)

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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 and identified by the candidate method with a specified probability of

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identification (POI).

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Exclusivity

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

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

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Inclusivity

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

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alternative method.

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Maximum Time-To-Assay 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 Identification (POI)

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

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matrix at a given analyte level or concentration.

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Venezuelan Equine Encephalitis(VEE) Virus

(VEEV)

VEEV encompasses several viruses all

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of which are within the Alphavirus genus of the

Togaviridae

family. For the purpose of this

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SMPR VEEV includes the human pathogenic virus variants VEEV-1AB, VEEV-1C, VEEV-1D, and

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VEE-1D.

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5.

System suitability tests and/or analytical quality control:

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The controls listed in Table I shall be made available in assays as appropriate. Manufacturer

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must provide written justification if controls are not available with the assay.

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