Rapid, Multiplexed Detection of Algal Toxins in Shellfish

MBio Diagnostics is developing a highly sensitive, inexpensive, easy-to-use test system that will allow growers and regulators to more tightly manage shellfish harvests before, during, and after HAB blooms (see Figure 1). The Interstate Shellfish Sanitation Conference (ISSC) is a primary industry/regulatory cooperative body in the United States, tasked with fostering and improving the sanitation of shellfish through interstate cooperation and through uniformity of state shellfish programs. One of ISSC's stated research priorities is the development of field deployable, rapid, inexpensive screening methods for the analysis of "all toxins and for each commercially-harvested bivalve species [25]." The technology proposed in this Phase I USDA SBIR is designed to address this need. This new technology will enhance the technology base necessary for the expansion of the domestic aquaculture industry.MBio Diagnostics is developing a transformative platform technology that will enable users in the field to perform cost-effective, multiplexed, rapid, laboratory-quality HAB toxin testing. Here, we propose to use this platform technology for the multiplexed, rapid measurement of STX, DA, and OA in shellfish meat. Per tests costs for the multiplexed cartridges are expected to be less than the ~$20 associated with currently available dipstick tests, and we target a reader cost of several hundred dollars. The assay sensitivities will be tuned to match the regulatory limits for these toxins. This technology will protect the safety of the nation's food supply while enabling expansion of aquaculture by reducing the time and cost necessary to bring shellfish to market.