AOAC SPADA Meeting

Validation Guidelines for Biothreat Agent Methods (BTAM) • Single Laboratory Validation (SLV) – Inclusivity/Exclusivity Study (Selectivity)*

– Laboratory Matrix Study* – Intended Use Matrix Study* – Environmental Interference Study* – Robustness

– Product Consistency and Stability – Instrument Variation (if applicable) • Multi ‐ laboratory Validation (MLV, Collaborative Study) – Intended Use Matrix Study *Repeated by one independent laboratory 3

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New SPADA Recommendations and Standards

• Recommendations for Development of Molecular Assays for Microbial Pathogen Detection Using Next Gen In ‐ Silico Analysis • Affects inclusivity/exclusivity for molecular methods • Strain Verification: Verifying and Documenting the Relationship Between Microbial Cultures • Provides clarity for documentation of inclusivity/exclusivity strains • Voluntary Consensus Standard for Collection and Use of Soils for Biothreat Agent Method Validation and Site Assessments • Provides clarity for matrix and environmental interference studies

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