# US 12,000,826 B2 · Methods for testing for food allergies and allergens in foods > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,000,826 B2 - Document ID: US12000826B2 - Status: Granted - Kind: B2 - Application number: 17/055,163 - Filed: 2019-05-10 - Published: 2021-07-01 - Granted: 2024-06-04 - Earliest claimed: 2018-05-25 - Applicants: Anant Ramji - Inventors: Anant Ramji - Web page: https://patentgrep.com/patent/US12000826B2 ## CPC - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - G01N 33/5091: {for testing the pathological state of an organism} - A61K 39/35: Allergens - A61P 37/08: Antiallergic agents (antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14) - G01N 21/6428: {Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" (in vivo A61B5/00; immunoassay G01N33/53)} - G01N 33/02: Food - G01N 2021/6432: {Quenching} - G01N 2800/24: Immunology or allergic disorders - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract The present invention provides for methods and compositions for detecting the presence of a food allergy or food intolerance in a subject. In one aspect, the present invention provides for methods and compositions for detecting the presence of a food allergy or food intolerance in a subject without risk of adverse reactions in the test subject. Furthermore, if a subject has multiple allergies, a single test can determine if there is any allergic component in a food composition or mixture, as opposed to doing multiple individual test for each allergen. In an additional aspect, the present invention provides for methods that do not require identification of any particular allergen of interest. In one or more embodiments, a single test can determine if there is any allergic component in a food composition or mixture without needed to identify the particular allergen itself. ## Claims ### Claim 1 A method for determining a presence of food allergy or food intolerance to a food in a human subject, comprising: (a) obtaining an isolated cheek cell sample comprising histamine-releasing cells from a human subject of interest wherein the cheek cells are obtained by a cheek swab of the subject; (b) obtaining a sample of food of interest comprising one or more dietary antigens; (c) contacting the cheek cell sample with the sample of food of interest and a histamine selective chemosensor capable of detecting a histamine response from human histamine-releasing cells; (d) determining a level of histamine response from the cheek cell sample obtained from the subject in response to dietary antigens of the sample of food; and (e) comparing the dietary antigen histamine response level determined in step (d) with normal levels of histamine in cheek cell samples, wherein determining the level of histamine response is accomplished using a quenched chemosensor-cation complex that forms a fluorescent compound after contact with histamine, and wherein higher than normal levels of histamine to dietary food antigens indicate a food allergy or food intolerance by subject of interest. ### Claim 2 (depends on 1) The method according to claim 1, further comprising determining normal baseline levels of histamine in the cheek cell sample. ### Claim 3 (depends on 1) The method according to claim 1, wherein the cheek cell sample obtained from the subject comprise cells capable of releasing histamine upon activation by exposure to or contact with an allergen of interest. ### Claim 4 (depends on 1) The method according to claim 1, wherein the cheek cell sample obtained from the subject comprise basophils or mast cells. ### Claim 5 (depends on 1) The method according to claim 1, wherein the method includes measuring a release of histamine and other mast cell or basophil products which are released upon allergen activation of mast cells and basophils. ### Claim 6 (depends on 1) The method according to claim 1, wherein the dietary antigens are derived from a food category selected from the group consisting of milk and products thereof; eggs and products thereof; meat and products thereof; fish, mollusks, and crustaceans and products thereof; oils, fats, and products thereof; grains and products thereof; pulses, seeds, kernels, peanuts, nuts, tree nuts, and products thereof; vegetables and products thereof; fruits and products thereof; sugar, sugar products, chocolate products, and confectionary; and spices and herbs. ### Claim 7 (depends on 2) The method according to claim 2, wherein the normal levels of histamine are determined by a baseline measurement of histamine from buccal cells in response to dietary antigens for individuals without symptoms relating to food allergy or food intolerance. ### Claim 8 (depends on 7) The method according to claim 7, wherein a 15% or greater increase in histamine response detected with the food antigen over the baseline level response indicates a food allergy or food intolerance to the antigen in the human subject of interest. ### Claim 9 (depends on 1) The method according to claim 1, wherein the chemosensor of the quenched chemosensor-cation complex is selected from the group consisting of hydrophilic coumarins and benzimidazole derivatives, and the cation of the quenched chemosensor-cation complex is selected from the group consisting of Co2+, Cr3+, Cu2+, Fe2+, Fe3+, Mn2+, Ni2+, Hg2+ and Pb2+. ### Claim 10 (depends on 9) The method according to claim 9, wherein the quenched chemosensor-cation complex is selected from the group consisting of calcein blue-cobalt ion (Co2+) complex, calcein-nickel ion (Ni2+) complex. ### Claim 11 (depends on 9) The method according to claim 9, wherein the quenched chemosensor-ion complex is a calcein-nickel ion (Ni2+) complex.