SPADA Meeting Book

867

8.0 Glossary

868

( a ) Accuracy.— Closeness of agreement between a quantity value obtained by measurement 869 and the true value of the measurand [from VIM 2012 (46)]. This is essentially the rate of the 870 assay giving the correct result. Assays with high accuracy have low occurrence of both false 871 positives and false negatives. The equation for accuracy is given by: 872 where TP = true positives, TN = true negatives, FP = false positives, and FN = false negatives. 873 ( b ) PCR assay design .—An in silico process to select the assay components such as primers 874 and probe. 875 ( c ) Assay development .—Refers to the entire process from target identification/ selection, 876 assay design, validation, optimization, matrix testing, preparation of the packages for DOD 877 acceptance, FDA EUA, 510k, etc 878 ( d ) Assay improvement .—Any improvement ( in silico or wet lab testing or both) of existing 879 assays in response to a variety of outcomes from initial testing or field testing. E.g., signature 880 erosion, failure of assays in certain conditions or specific matrices, or in multiplex formats 881 ( e ) Assay optimization .— In silico (IS) optimization of parameters. 882 ( f ) Assay optimization (Wet lab) .—Refers to wet lab testing of the designs from the in silico 883 process under different conditions of PCR (concentrations of components, temperature, etc). 884 ( g ) Assay performance .—An overall assessment of the assay including sensitivity, 885 specificity, and LOD of an assay in a particular sample matrix. 886 ( h ) Assay stewardship (assay performance monitoring) .— In silico validation of assay 887 performance with the availability of new genomic sequences over time. 888 ൌ ൅ ൅ ൅ ൅

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