SPADA Draft Documents

of these cultures should be linked to its predecessor via a documented production method. The 114 performer should specifically identify the manufacturer, lot number, production date, and 115 production method of each culture in the passage history. With respect to the production method, 116 the performer will describe the materials and methods used to derive the referenced culture from 117 its predecessor in the lineage declaration. If the current culture is the first in the chain, the 118 production method should clearly describe the clinical, environmental, or laboratory origin of the 119 culture and the method used to propagate the traceable culture from that origin. 120 122 results that show the test and index cultures are related by two or more orthogonal assays. 123 Orthogonal testing relies on multiple analytic techniques to adequately compare one culture to 124 another. Cultures can be compared with respect to morphology, genotypic, and phenotypic 125 properties, metabolic, immunological, and molecular features and microbial functions. However, 126 the quality of microbial verification and confidence associated with it ultimately depends on the 127 number, type, and diversity of applied assays. Culture producers should strive for more 128 comprehensive approaches to orthogonal testing. Minimally, orthogonal testing should include a 129 mix of genotypic and phenotypic assays. Table 1 provides examples of various tests and the 130 largely orthogonal categories to which they apply. 4.2 Orthogonal Test Results 121 It is also important that the culture verification statement summarize any orthogonal test

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