SPADA Docs

We also provide broad guidelines for creating data and documentation for successful submission 921 for regulatory reviews. We have also provided a glossary of terms and definitions commonly 922 used in molecular assay development to aid assay developers.

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9.0 Glossary

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( a ) Accuracy.— Closeness of agreement between a quantity value obtained by measurement 926 and the true value of the measurand [from VIM 2012 (48)]. This is essentially the rate of the 927 assay giving the correct result. Assays with high accuracy have low occurrence of both false 928 positives and false negatives. The equation for accuracy is given by: 929 where TP = true positives, TN = true negatives, FP = false positives, and FN = false negatives. 930 ( b ) PCR assay design .—An in silico process to select the assay components such as primers 931 and probe. 932 ( c ) Assay development .—Refers to the entire process from target identification/ selection, 933 assay design, validation, optimization, matrix testing, preparation of the packages for DOD 934 acceptance, FDA EUA, FDA 510(k), etc 935 ( d ) Assay improvement .—Any improvement ( in silico or wet lab testing or both) of existing 936 assays in response to a variety of outcomes from initial testing or field testing. For example, 937 signature erosion, failure of assays in certain conditions or specific matrices, or in multiplex 938 formats 939 ( e ) Assay optimization .— In silico (IS) optimization of parameters. 940 ( f ) Assay optimization (Wet lab) .—Refers to wet lab testing of the designs from the in silico 941 process under different conditions of PCR (concentrations of components, temperature, etc). 942 ൌ ൅ ൅ ൅ ൅

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