SPADA Meeting Book

detailed on the manufacturer’s website (2), identified 5 single nucleotide polymorphisms in 213 noncoding regions of the bacterial genomes and generated identical genus and species calls on 214 the Biolog and Vitek 2 GN assays. Based on these results, we conclude that the test and index 215 cultures are sufficiently related for the test culture to be used as a surrogate for the index culture 216 in the sponsored study. 217 The manufacturer’s Certificate of Analysis (1) reports that the test and index lots exhibit 219 identical responses to a proprietary fluorescent tagged monoclonal antibody that similarly targets 220 the O-antigen used in the current study’s lateral flow assay. 221 222 (1) Certificate of Analysis for F. tularensis Lot 2425-3243, 9 SEP 2018, Manufacturer A, 223 Boston, MA. 224 (2) Supporting Data, Manufacturer A, http://ManA.com/24253243/SNP.html References Application-Oriented Testing 218

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