AOAC SPADA Meeting

3/11/2020

CASE STUDY: MODERNIZATION OF TESTS FOR BIOLOGICAL THREAT AGENTS • Project funded by DBPAO (Project managed by JHU-APL) o Previous PCR assays only available in singleplex. o Signature erosion has occurred with time. o Multiplexing would save money on large number of environmental tests. o Previously multiplex reactions were difficult to design and involved extensive experimental optimization. • DNA Software, Inc. used database driven approach described in the SPADA manuscript • Design of Bacterial 35-plex and Virus 18-plex • Wet-Lab testing done by MRI Global • Preliminary Results for bacterial panel: (used synthetic targets for first round of testing) o 35/35 assays worked in singleplex reactions with LOD below 50 molecules o 35/35 of the assays showed no amplification in the NTC o 30/35 of the targets detected in multiplex format (without any optimization, LOD <100)

AOAC_SPADA_ISA_presentation

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3/12/2020

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GLOSSARY

• Standards • “something set up and established by authority as a rule for the measure of quantity, weight, extent, value, or quality”- there is no ambiguity here. If we are adopting a standard, we follow the rules set forth here • Guidelines • a general rule, principle, or piece of advice. • a piece of information that suggests how something should be done - there is some inducement to follow these • Recommendations • a suggestion or proposal as to the best course of action, especially one put forward by an authoritative body and its beneficial to follow these • Considerations • Something to think about; no obligation to follow • Best Practices • Following these practices will potentially yield a better assay

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