SPADA Docs

( p ) Guideline .—A general rule, principle, or piece of advice; a piece of information that 966 suggests how something should be done - there is some inducement to follow these. 967

( q ) Inclusivity .—The strains or isolates or variants of the target agent(s) that the method can

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detect.

( r ) Inclusivity panel .— A panel of strains of the intended PCR assay target organism to 970 include members that represent the organism’s entire genetic diversity. Ideally, the assay is 971 expected to be positive (i.e. sensitive) for all the panel strains. Exceptions (i.e., false negatives) 972 are expected and need to be tested. 973 ( s ) Intended use .—Use for which a product, process, or service is intended according to the 974 specifications, instructions, and information provided by the manufacturer [from ISO 975 14971(49)]. 976 ( t ) Limit of detection (LOD) .—The lowest concentration or mass of analyte in a test sample 977 that can be distinguished from a true blank sample at a specified probability level. 978 ( u ) Limit of quantitation (LOQ) .—The lowest level of analyte in a test sample that can be 979 reasonably quantified at a specified level of precision. 980 ( v ) Matrix .—Totality of components of a material system except the analyte [from ISO 981 17511 (49)]. 982 ( w ) Matrix testing – Testing the final assay in specific matrices relevant to the end user; e.g., 983 clinically relevant matrices such as blood, sputum, etc. or environmentally relevant matrices such 984 as soil. 985 ( x ) Matrix panel .—alternate term for background panel (see above for definition). 986 ( y ) Metrology .—The science of measurement and its application [from ISO/IEC Guide 987 99:2007 (49)]. 988

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