SPADA Docs

2.2 Additional considerations with the availability of inclusivity/exclusivity panel reference 140 materials 141 A 2015 DoD moratorium on Biological Select Agents and Toxins (BSAT) work has 142 constrained the transfer of select agents between labs for testing during assay development (1). 143 In addition, obtaining reference materials from disease outbreaks and foreign locations has 144 become increasingly difficult due to geopolitical sensitivities and the length of time involved in 145 establishing Inter Agency Agreements. For example, in the 2012 Ebola outbreak, there was a 146 delay of over 6 months in obtaining reference materials from Africa for evaluating assay 147 performance (Figure 3). Thus, it took 6 months to realize that there was a gap in detection in that 148 the then-available Bundibugyo assay failed against the outbreak strain. Due to this delay in 149 obtaining reference material or whole genome sequence information an effective redesigned 150 assay could not be developed in a timely manner. In the 2014 outbreak, the availability of whole 151 genome sequences within a short time (≈ 1 month) after the identification of the index case (7) 152 allowed in silico evaluation of the existing assay’s efficacy in detecting the new strain. 153

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