SPADA Draft Documents

the Biolog and Vitek 2 GN assays. Based on these results, we conclude that the test and index 209 cultures are sufficiently identical for one to be used as a surrogate for the other in the sponsored 210 study. 211

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Application-Oriented Testing

The manufacturer’s Certificate of Analysis (1) reports that the test and index lots stain 213 similarly with a proprietary fluorescent tagged monoclonal antibody which targets the O-antigen 214 in a similar way to the monoclonal antibody contained in the lateral flow assay that is the subject 215 of the current study. 216 217 (1) Certificate of Analysis for F. tularensis Lot 2425-3243, 9 SEP 2018, Manufacturer A, 218 Boston, MA. 219 (2) Supporting Data, Manufacturer A, http://ManA.com/24253243/SNP.html References

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