SPADA Draft Documents

( i ) Assay validation .—A comprehensive analysis of the test system (i.e. the sample to answer 868 process including extraction, testing, and analysis) to define the assay performance 869 characteristics in the intended matrix. The test system is only validated for that specific use. 870 ( j ) Background panel .—A panel of organisms found in the matrix of the assay (e.g., human 871 genome, human microbiome, soil microbes, etc.). 872 ( k ) Bias .—The difference between the expectation of the test result or measurement result 873 and the true value (from ISO 3534-2). 874 ( l ) Certified Reference Material (CRM) .—Reference material accompanied by 875 documentation issued by an authoritative body and providing one or more specified property 876 values with associated uncertainties and traceability, using valid procedures (from VIM 2007). 877 ( m ) Data packages .—Refers to DoD-specific CB56 or FDA-specific EUA or 510K body of 878 data that contains all the required information and data 879 ( n ) Exclusivity .—The non-target agents, which are potentially cross-reactive, that are not 880 detected by the method. 881 ( o ) Exclusivity panel .—A panel of near neighbors that are expected to be negative for the 882 assay [exceptions i.e., false positives are expected] and need to be captured 883 ( p ) Guidelines .—A general rule, principle, or piece of advice; a piece of information that 884 suggests how something should be done - there is some inducement to follow these. 885 ( q ) Inclusivity .—The strains or isolates or variants of the target agent(s) that the method can 886 detect. 887 ( r ) Inclusivity panel .—A panel of strains of the intended PCR assay target organism. Ideally, 888 the assay is expected to be positive (i.e. sensitive) for all the panel strains [exceptions i.e., false 889

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