AOAC SPADA Meeting

3/11/2020

GLOSSARY (CONT.)

• Assay Development • Refers to the entire process from target identification/ selection, assay design, validation, optimization, matrix testing, preparation of the packages for DoD acceptance, FDA EUA, 510k etc. • Target Selection • Entails identifying suitable “unique regions” in the genome of interest for assay design. This may be longer than the actual PCR amplicon. • Assay (region that contains the assay components) design • In silico process (extensively described by John in his talk) • Assay Optimization (IS) • In silico optimization of parameters • Assay Optimization (Wet lab) • Refers to wet lab testing of the designs from In silico process under different conditions of PCR (concentrations of components, temperature etc.)

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GLOSSARY (CONT.)

• Sensitivity- The true positive rate. In simple terms, the sensitivity of the assay is the number of sick people that are correctly identified as sick.

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• Specificity- The true negative rate. In simple terms, the specificity of the assay is number of healthy people (i.e. without disease) that are correctly identified as healthy.

• Limit of detection (LOD) – Minimal quantity of target that can be detected by the assay • Accuracy – Rate of the assay giving the correct result

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