SPADA Draft Documents

( bb ) Recommendation.— A suggestion or proposal as to the best course of action, especially

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one put forward by an authoritative body, that is beneficial to follow.

( cc ) Reference material (RM) .—Material that is sufficiently homogeneous and stable with 914 reference to specified properties, which has been established to be fit for its intended use in 915 measurement or in examination of nominal properties (from VIM 2007). For purposes of assay 916 development, reference materials are templates used in development, testing, validation, test and 917 evaluation of the assay; e.g., live organisms, inactivated organisms, genomic materials (DNA or 918 RNA), synthetic plasmids, or even synthetic amplicons. 919 ( dd ) Robustness .—A study that tests the capacity of a method to remain unaffected by small 920 but deliberate variations in method parameters and which provides an indication of its reliability 921 during normal usage (from USP 31). 922 ( ee ) Sample (Material) .—The batch of matrix from which replicate test portions are removed 923 for analysis. The sample (uncontaminated or contaminated) contains agent at one specified level. 924 ( ff ) Sensitivity .—The true positive rate, which is the fraction of actual positive samples that 925 the assay returns a positive result. This is also called the “probability of detection”. Assays with 926 high sensitivity have a low occurrence of false negatives. Sensitivity should not be confused with 927 the limit of detection. The equation for sensitivity is given by: 928 930 primer and/or probe) that experimentally detects (e.g., by PCR or probe-based method) most or 931 all of the desired target sequences (i.e. inclusivity panel) and does not detect most or all non- 932 target sequences (exclusivity panel, near neighbors, and environmental panel). This definition 933 deviates from the traditional definition of a signature as a single oligonucleotide sequence that is 934 = + where TP = true positives and FN = false negatives. 929 ( gg ) Signature .—One or more oligonucleotide sequences (i.e. forward primer and/or reverse

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