AOAC SPADA Meeting

Discussion points:  in silico applications • Assay design ‐ Predict conserved regions with limited sequence data? ‐ Analyze deep sequence data from a diverse virus to ID “conserved” region? • Inclusivity testing ‐ Identify isolates that are not an  in silico match and require wet lab testing • Exclusivity testing ‐ Identify organisms that meet a defined primer/probe mapping threshold to  warrant wet lab testing

United States Army Medical Research Institute of Infectious Diseases Biodefense solutions to protect our nation 11

Discussion points:  in silico applications

• If you want to minimize/eliminate wet lab testing, how much risk is  acceptable for potential errors? ‐ We have seen assays unexpectedly cross‐react with high concentrations of a  genetically related organism ‐ What will regulatory agencies (ex. FDA) allow?

United States Army Medical Research Institute of Infectious Diseases Biodefense solutions to protect our nation 12

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