SPADA Docs

( g ) Assay performance .—An overall assessment of the assay including sensitivity,

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specificity, and LOD of an assay in a particular sample matrix.

( h ) Assay stewardship (assay performance monitoring) .— In silico validation of assay

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performance with the availability of new genomic sequences over time.

( i ) Assay validation .—A comprehensive analysis of the test system (i.e. the sample to answer 947 process including steps such as extraction, testing, and analysis) to define the assay performance 948 characteristics in the intended matrix. The test system is only validated for use in that specific 949 matrix. 950 ( j ) Background panel .—A panel of organisms found in the typical matrix of the sample (e.g., 951 human genome or human microbiome for human samples, soil microbes for environmental 952 samples, etc.). 953 ( k ) Bias .—The difference between the expectation of the test result or measurement result 954 and the true value [from ISO 3534-2 (49)]. 955 ( l ) Certified Reference Material (CRM) .—Reference material accompanied by 956 documentation issued by an authoritative body and providing one or more specified property 957 values with associated uncertainties and traceability, using valid procedures [from VIM 2012 958 (48)]. 959 ( m ) Data packages .—Refers to DOD-specific CB56 or FDA-specific Emergency Use 960 Authorization (EUA) or 510(k) body of data that contains all the required information and data. 961 ( n ) Exclusivity .—The non-target agents, which are potentially cross-reactive, but are not 962 expected to be detected by the method. 963 ( o ) Exclusivity panel .—A panel of near neighbors that are expected to be negative for the 964 assay. Exceptions (i.e., false positives) are expected and need to be tested. 965

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