The DHS Directorate of Science and Technology, Chemical and Biological Defense Division (CBD) has awarded a sole source contract to Tetracore Inc., of Rockville, Md. for the continuing development, testing and evaluation of its proprietary Lateral Flow Assays (LFAs) for biothreat detection in environmental samples.
The overall objective of the effort is to take an existing hand held assay technology, the Bio-threat Alert Assay (BTA), which are individual LFAs for nine separate threat targets and create two multiplexed assays using C-Flat and nanogold technology which are proprietary to Tetracore.
Since the conclusion of the initial award, a total of four modifications have been issued and the scope of the contract has been increased to allow Tetracore to continue the development, test and evaluation of LFAs based upon the requirements of DHS S&T stakeholders.
Thus far, Tetracore has completed its initial internal test and evaluation of three single-plexed bacterial biothreat agent detection lateral flow assays for Bacillus anthracis, Yersinia pestis, and Francisella tularensis. Other toxin and bacterial biothreat agent detection assays for Burkholderia, Botulinum, and SEB remain in progress.
The remaining tasks to accomplish are the production of singleplex lateral LFAs against the additional three toxins and two bacterial targets and the completion of independent test and evaluation of the three remaining bacterial LFAs.
Initial characterization and testing of antibodies to both Burkholderia strains, Botulinum A&B, and SEB, the first steps for preparation of LFAs, were performed during Tasks 1 through 3 of the original award. However, technical issues arose with respect to the specificity and sensitivity of the initial set of antibodies tested for Burkholderia and Botulinum A&B.
Since attempts to create these assays with the reagents on hand proved challenging, a new set of antibodies against unfixed antigens have been developed under the original contract, and they are now undergoing initial characterization studies. It is believed that these antibodies will be successful in meeting DHS performance metrics and that the final development tasks are low risk.
The current contracting action does not alter the original scope of the work; however, an increase in funding was necessary to complete the tasks within scope of the original award due to technical difficulties from the first set of reagents.
Tetracore has possession of the necessary biological select and non-select live agent validation panels and materials required to perform in-house test and evaluation under BSL-3 level conditions in their laboratory for all of the LFAs under development in this effort. These are privately owned strains on site at Tetracore which represent a subset of the full PHAA panels of select agents, their near-neighbors and assorted environmental strains that are necessary to complete the validation.
DHS’s objective is to complete the development and then deploy the rapid biothreat agent detection assays in a portable, LFA format to fulfill the needs of multiple agencies and departments to detect nine high priority threat agents, five bacterial select agents and four biothreat toxins.