At least 15 million Americans and 5% of children under 5 years old suffer from food allergies. Many countriesnow have mandatory food labeling requirements for common allergens that are intentionally added to foodproducts. Unfortunately, there are at least 170 known food allergens, and undeclared food allergens canaccidentally contaminate a product through shared processing equipment, during transport, in storage, orbecause of fraud and terrorism, and result in adverse reactions or fatalities. The industry currently tests forundeclared food allergens with single-target ELISAs, high-resolution mass spectrometry, or related methods.Food processors and testing laboratories therefore continuously request and need a sensitive, specific, andeasy-to-use multi-allergen test to minimize consumer health risk, and the potential for food recalls. The objectiveof this project is to fill this important public health technology gap by incorporating BioFront's proprietarymonoclonal allergen antibodies within Akonni's FDA-cleared Dx2000 lateral flow microarray (LFA) platform, andvalidating system performance within the context of MicroBac's ISO 17025-compliant food safety testing service.In Phase 1, we will verify the functionality and specificity of BioFront monoclonal antibodies in Akonni's lateralflow array; establish a test method that achieves a 1 ppm limit of detection for each of the target allergens; anddemonstrate feasibility of the test with processed food extracts. These results will lay the foundation for a Phase2 project, where we will expand the test for all remaining high-priority allergens; transfer manufacturing andpackaging to Akonni's ISO13485-compliant production lines; use the platform to develop an AOAC-approvedanalysis method at MicroBac; validate the system for MicroBac's top 10 foods/tests; and finish all other activitiesrequired to commercialize the system and testing/analysis service(s). Completing these milestones will establisha new class of multiplexed, component-resolved allergen detection products and food testing services that areexpected to improve consumer/public safety, and provide producers an affordable mechanism to comply withzero-tolerance food safety policies.
Public Health Relevance Statement: PROJECT NARRATIVE
Food allergens can accidentally contaminate a product through shared processing equipment, during transport,
in storage, or because of intentional fraud and terrorism, resulting in adverse reactions or fatalities. This project
will provide the industry with a much-needed platform and test to simultaneously detect multiple, undeclared food
allergens from a single food sample. The results of this project will be new class of multiplexed, component-
resolved allergen detection products and food testing services that will improve consumer/public safety, and the
integrity of the US food supply.
Project Terms:
