SPADA Meeting Book

( i ) Assay validation .—A comprehensive analysis of the test system (i.e. the sample to answer 889 process including steps such as extraction, testing, and analysis) to define the assay performance 890 characteristics in the intended matrix. The test system is only validated for use in that specific 891 matrix. 892 ( j ) Background panel .—A panel of organisms found in the typical matrix of the sample (e.g., 893 human genome or human microbiome for human samples, soil microbes for environmental 894 samples, etc.). 895 ( k ) Bias .—The difference between the expectation of the test result or measurement result 896 and the true value (from ISO 3534-2). 897 ( l ) Certified Reference Material (CRM) .—Reference material accompanied by 898 documentation issued by an authoritative body and providing one or more specified property 899 values with associated uncertainties and traceability, using valid procedures [from VIM 2012 900 (46)]. 901 ( m ) Data packages .—Refers to DOD-specific CB56 or FDA-specific Emergency Use 902 Authorization (EUA) or 510(k) body of data that contains all the required information and data. 903 ( n ) Exclusivity .—The non-target agents, which are potentially cross-reactive, but are not 904 expected to be detected by the method. 905 ( o ) Exclusivity panel .—A panel of near neighbors that are expected to be negative for the 906 assay. Exceptions (i.e., false positives) are expected and need to be tested. 907 ( p ) Guideline .—A general rule, principle, or piece of advice; a piece of information that 908 suggests how something should be done - there is some inducement to follow these. 909 ( q ) Inclusivity .—The strains or isolates or variants of the target agent(s) that the method can 910 detect. 911

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