AOAC SPADA Meeting

3/11/2020

GLOSSARY (CONT.)

• Matrix testing • Testing the final assay in specific matrices relevant to the end user; e.g., clinically relevant matrices such blood, sputum etc. and environmentally relevant matrices such as soil. • Matrix testing • Mock clinical trials • Data packages • Refers to DoD specific CB56 or FDA specific EUA or 510K that contain all the required information and data • Assay performance monitoring (assay stewardship) • In silico validation of assay performance with the availability of new genomic sequences over time • Test and Evaluation • FDA Vetting

• EUA • 510k • FDA licensure • Matrix panel

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CONTACT Shanmuga Sozhamannan, Ph. D. Shanmuga.Sozhamannan.ctr@mail.mil 301 619 8430 John SantaLucia, Ph. D. john@dnasoftware.com 734 282 1063

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