CURRENTLY, EXCEPT FOR PEANUT ALLERGY, THERE IS NO APPROVED TREATMENT FOR FOOD ALLERGY, WHICH CAN ONLY BE CONTROLLED BY STRICT DIETARY AVOIDANCE AND TREATMENT OF SYMPTOMS. IN ORDER TO IDENTIFY AN UNKNOWN FOOD ALLERGY, THE RECOMMENDED METHOD IS IN VIVO CLINICAL DIAGNOSTIC TESTS, INCLUDING SKIN PRICK TEST AND ORAL FOOD CHALLENGES, WHICH ARE INCONVENIENT, TIME-CONSUMING, AND EXPENSIVE. IT IS ESTIMATED THAT 1.2% OF THE AMERICAN POPULATION HAVE ALLERGIC-REACTIONS TO CRUSTACEAN SHELLFISH. IT IS NOTED THAT BETWEEN 2013 AND 2018, ABOUT 33% OF THE FOOD RECALLS IN THE U.S. WERE DUE TO THE PRESENCE OF MISBRANDING AND/OR UNDECLARED FOOD ALLERGENIC RESIDUES. IT INCREASED BY ABOUT 10% COMPARED WITH THAT IN 2012, WHICH IS THE NO. 1 CAUSE OF FOOD RECALLS IN THE U.S. IN ORDER TO REDUCE ALLERGEN RECALLS, THE FDA FOOD SAFETY MODERNIZATION ACT (FSMA) REQUIRED THE U.S. FOOD MANUFACTURERS TO FULLY DOCUMENT HAZARD ANALYSIS, PREVENTIVE CONTROLS, PROCEDURES FOR MONITORING THE IMPLEMENTATION OF PREVENTIVE CONTROLS, CORRECTIVE ACTION PROCEDURES IN ORDER TO SUCCESSFULLY PREVENT ALLERGEN CROSS-CONTACT. IN ADDITION, THE NEWLY ENACTED INTENTIONAL ADULTERATION RULE REQUIRES MITIGATION (RISK-REDUCING) STRATEGIES FOR PROCESSES IN CERTAIN REGISTERED FOOD FACILITIES. THE GOAL IS TO PROTECT AGAINST INTENTIONAL CONTAMINATION OF THE FOOD SUPPLY THAT MAY CAUSE WIDE-SCALE PUBLIC HEALTH HARM.THEREFORE, IN ORDER TO 1) REDUCE THE RISK OF INTENTIONAL OR UNINTENTIONAL CONTAMINATION OF FOODS, 2) REDUCE THE RISK OF FOOD ALLERGY, 3) BETTER COMPLY WITH FOOD REGULATIONS, AND 4) DECREASE ECONOMIC LOSS TO THE FOOD INDUSTRY CAUSED BY RECALL, IT IS NECESSARY TO DEVELOP RELIABLE, EFFECTIVE AND ROBUST IN VITRO DETECTION METHODS TO PREVENT THE OCCURRENCE OF UNDECLARED ALLERGENIC RESIDUES IN FOODS. THE LONG-TERM GOAL OF THIS PROJECT IS TO PROVIDE A CONVENIENT, RELIABLE, AND EFFECTIVE ANALYTICAL TOOL FOR THE ENFORCEMENT OF THE FSMA IN ORDER TO PREVENT INTENTIONAL OR UNINTENTIONAL CROSS-CONTAMINATION OF CRUSTACEAN SHELLFISH ALLERGENS IN FOODS. TO ACCOMPLISH OUR GOAL, USING THE HIGHLY SPECIFIC APTAMERS AND MONOCLONAL ANTIBODIES (MABS) AS THE CAPTURING AND DETECTION TOOLS WILL BE EXPLOITED FOR ASSAY DEVELOPMENT. IN THIS PROPOSED RESEARCH, AN EFFECTIVE SAMPLE EXTRACTION METHOD WILL BE ESTABLISHED. THE RELIABLE IMMUNOASSAYS WILL BE DEVELOPED AND VALIDATED USING DIFFERENT PAIRED APTAMERS AND MABS TO DETECT DIFFERENT SHELLFISH ALLERGENIC RESIDUES IN FOODS. THROUGH THIS PROPOSED PROJECT, WE EXPECT THAT THE OVERALL PERFORMANCE FROM SAMPLE PREPARATION TO THE ANALYSIS OF THE OPTIMIZED ASSAY WILL BE BETTER THAN CURRENTLY PUBLISHED IMMUNOASSAYS. MORE IMPORTANTLY, WE EXPECT THAT THESE IMMUNOASSAYS MAY OPEN UP NEW DIAGNOSTIC METHODS FOR THE FOOD INDUSTRY AND THE FOOD REGULATORY AUTHORITIES.