SPADA Docs

51 989 potentially cross-reactive with the organism and/or substance under test. These are targets that 990 are likely to give a false positive for a given assay. 991 ( aa ) Probability of detection (POD) .—The proportion of positive analytical outcomes for a 992 qualitative method for a given matrix at a given agent level or concentration. POD is 993 concentration dependent. 994 ( bb ) Recommendation.— A suggestion or proposal as to the best course of action, especially 995 one put forward by an authoritative body, that is beneficial to follow. 996 ( cc ) Reference material (RM) .—Material that is sufficiently homogeneous and stable with 997 reference to specified properties, which has been established to be fit for its intended use in 998 measurement or in examination of nominal properties [from VIM 2012 (48)]. For purposes of 999 assay development, reference materials are templates used in development, testing, validation, 1000 test and evaluation of the assay; e.g., live organisms, inactivated organisms, genomic materials 1001 (DNA or RNA), synthetic plasmids, or even synthetic amplicons. 1002 ( dd ) Robustness .—A study that tests the capacity of a method to remain unaffected by small 1003 but deliberate variations in method parameters and which provides an indication of its reliability 1004 during normal usage [from USP 1225 (50)]. 1005 ( ee ) Sample (Material) .—The batch of matrix from which replicate test portions are removed 1006 for analysis. The sample (uncontaminated or contaminated) contains agent at one specified level. 1007 ( ff ) Sensitivity .—The true positive rate, which is the fraction of actual positive samples that 1008 the assay returns a positive result. This is also called the “probability of detection.” Assays with 1009 ൌ ൅ ( z ) Near neighbors .—Organisms and/or substances selected to be either closely related or