TEST FOR VEROTOXIC E COLI TO PREVENT FOODBORNE INFECTION

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The incidence of food-borne infections with verocytotoxic E. coli (VTEC) has increased significantly over the past decade and threatens the health of millions of persons. The rapid, accurate, and sensitive detection of VTEC in food and animals is paramount to the control of the disease. Montana ImmunoTech has demonstrated the feasibility of using immunomagnetic separation technology that, in a single test, captures and identifies verotoxic VTEC from meat. The test is rapid (3-6 hours) and has a detection level of 100 to 1000 VTEC per gram. The aims of the Phase II SBIR project is to perfect the assay by (a) developing and testing reagents that enhance the detection VTEC-specific antigenic factors and (b) developing a detection assay for automation of the assay. Specifically, formulations of antibodies against O somatic antigens and VTEC-specific cell surface and verotoxin adhesins will be employed to enhance capture of VTEC organisms and verotoxins from pre- harvest and post-harvest meat, waste water and fecal specimens. Protocols for the use of a prototype assay kit in detecting VTEC in both pre- and post-harvest specimens from cattle will be evaluated under field conditions in cattle herds and slaughterhouses. MIT is working with two diagnostic firms interested in commercialization. PROPOSED COMMERCIAL APPLICATION The technology/product to be perfected in the Phase II SBIR has the potential for worldwide applications in the food industry, medical and veterinary community, as well as regulatory agencies concerned with water quality. The market for the VTEC diagnostic assay is estimated at 300 million dollars annually and the uses of the assay will effectively diminish the incidence of diarrheal diseases caused by VTEC. Two major diagnostic firms are exploring licensing as a diagnostic assay.