SPADA Draft Documents

negatives) are expected and need to be captured] and ideally includes members of its entire 890 genetic diversity. 891 ( s ) Intended use .—Use for which a product, process, or service is intended according to the 892 specifications, instructions, and information provided by the manufacturer (from ISO 14971). 893 ( t ) Limit of detection (LOD) .—The lowest concentration or mass of analyte in a test sample 894 that can be distinguished from a true blank sample at a specified probability level. 895 ( u ) Limit of quantitation (LOQ) .—The lowest level of analyte in a test sample that can be 896 reasonably quantified at a specified level of precision. 897 ( v ) Matrix .—Totality of components of a material system except the analyte (from ISO 898 17511). 899 ( w ) Matrix testing – Testing the final assay in specific matrices relevant to the end user; e.g., 900 clinically relevant matrices such blood, sputum etc. and environmentally relevant matrices such 901 as soil. 902 ( x ) Matrix panel .—alternate term for background panel (see above for definition). 903 ( y ) Metrology .—The science of measurement and its application (from ISO/IEC Guide 904 99:2007). 905 ( z ) Near neighbors .—Organisms and/or substances selected to be either closely related or 906 potentially cross-reactive with the organism and/or substance under test. These are targets that 907 are likely to give a false positive for a given assay. 908 ( aa ) Probability of detection (POD) .—The proportion of positive analytical outcomes for a 909 qualitative method for a given matrix at a given agent level or concentration. POD is 910 concentration dependent. 911

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