SPADA Meeting Book

( r ) Inclusivity panel .— A panel of strains of the intended PCR assay target organism to 912 include members that represent the organism’s entire genetic diversity. Ideally, the assay is 913 expected to be positive (i.e. sensitive) for all the panel strains. Exceptions (i.e., false negatives) 914 are expected and need to be tested. 915 ( s ) Intended use .—Use for which a product, process, or service is intended according to the 916 specifications, instructions, and information provided by the manufacturer (from ISO 14971). 917 ( t ) Limit of detection (LOD) .—The lowest concentration or mass of analyte in a test sample 918 that can be distinguished from a true blank sample at a specified probability level. 919 ( u ) Limit of quantitation (LOQ) .—The lowest level of analyte in a test sample that can be 920 reasonably quantified at a specified level of precision. 921 ( v ) Matrix .—Totality of components of a material system except the analyte (from ISO 922 17511). 923 ( w ) Matrix testing – Testing the final assay in specific matrices relevant to the end user; e.g., 924 clinically relevant matrices such as blood, sputum, etc. or environmentally relevant matrices such 925 as soil. 926 ( x ) Matrix panel .—alternate term for background panel (see above for definition). 927 ( y ) Metrology .—The science of measurement and its application (from ISO/IEC Guide 928 99:2007). 929 ( z ) Near neighbors .—Organisms and/or substances selected to be either closely related or 930 potentially cross-reactive with the organism and/or substance under test. These are targets that 931 are likely to give a false positive for a given assay. 932

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