# US 2019/0376982 A1 · Detecting Gluten Peptides in Human Fluids > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0376982 A1 - Document ID: US20190376982A1 - Status: Published application - Kind: A1 - Application number: 16/370,287 - Filed: 2019-03-29 - Published: 2019-12-12 - Earliest claimed: 2014-07-09 - Assignees: Universidad de Sevilla; Biomedal, S.L. - Applicants: Universidad de Sevilla; Biomedal, S.L. - Inventors: Maria de Lourdes Moreno Amador; Carolina Sousa Martin; Alfonso Rodriguez Herrera; Angel Cebolla Ramirez - Web page: https://patentgrep.com/patent/US20190376982A1 ## CPC - G01N 33/6878: {in epitope analysis} - G01N 33/5308: {for analytes not provided for elsewhere, e.g. nucleic acids, uric acid, worms, mites} - G01N 33/68: involving proteins, peptides or amino acids {(involving lipoproteins G01N33/92)} - G01N 2800/06: Gastro-intestinal diseases - G01N 2800/065: Bowel diseases, e.g. Crohn, ulcerative colitis, IBS - G01N 2800/24: Immunology or allergic disorders - G01N 2800/52: Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis - 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) ## Abstract The present invention discloses a process for detecting and quantifying gluten peptides resistant to gastrointestinal digestion in human body fluids, preferably urine. The presence or absence of gluten peptides is controlled by immunological assays based on specific gluten peptide antibodies directed thereagainst. ## Claims ### Claim at position 1 1-23. (canceled) ### Claim 24 A process for monitoring compliance of a patient with a gluten free diet comprising: (a) contacting a urine sample from the patient with a monoclonal antibody selected from the group consisting of G12, R5, and A1 which monoclonal antibody specifically binds gluten immune-toxic peptides having epitopes on any sequence selected from the group consisting of SEQ ID NO: 2 and SEQ ID NO: 6, (b) allowing the monoclonal antibody to form monoclonal antibody-gluten peptide complexes with gluten peptides in the urine sample; (c) detecting the monoclonal antibody-gluten peptide complexes formed in step (b); (d) quantitating extracted immune-toxic peptides in the urine sample based on detection of monoclonal antibody-gluten peptide complexes; and (e) repeating steps (a)-(d) and monitoring a level of quantitated immune-toxic peptides determined in step (d), wherein the quantity of the extracted peptides is indicative of a degree of compliance with a gluten free diet. ### Claim 25 (depends on 24) The process for monitoring according to claim 24 wherein step (d) is carried out by a process selected from the group consisting of an indirect ELISA, a competitive ELISA, a sandwich ELISA, immunochromatographic strips, fluorescent immune-microparticles, magnetic immune-particles, Western blot, electronic biosensors and resonance biosensors. ### Claim 26 (depends on 24) The process for monitoring according to claim 24 wherein the antibody of step (a) is a monoclonal antibody conjugated to an enzyme that allows a quantitative assay using a method selected from the group consisting of chromogenic, fluorogenic and luminescent substrates. ### Claim 27 (depends on 24) The process for monitoring according to claim 24, wherein step (d) comprises: quantifying the detected complex using a reference peptide selected from the group consisting of SEQ ID NO: 2 and SEQ ID NO: 6. ### Claim 28 (depends on 24) The process for monitoring according to claim 24, wherein step (d) is carried out using an immunochromatographic strip for rapid detection. ### Claim 29 (depends on 28) The process according to claim 28, further comprising: providing a reference peptide standard comprising at least one of the immunogenic peptide selected from the group consisting of SEQ ID NO: 2 and SEQ ID NO: 6. ### Claim 30 A method of diagnosing refractory celiac disease, comprising: (a) contacting a urine sample from a patient with a monoclonal antibody selected from the group consisting of G12, R5, and A1 which monoclonal antibody specifically binds gluten immune-toxic peptides having epitopes on any sequence selected from the group consisting of SEQ ID NO: 2 and SEQ ID NO: 6, (b) allowing the monoclonal antibody to form monoclonal antibody-gluten peptide complexes with gluten peptides in the urine sample; (c) detecting the monoclonal antibody-gluten peptide complexes formed in step (b); (d) quantitating extracted immune-toxic peptides in the urine sample based on detection of monoclonal antibody-gluten peptide complexes; and (e) using the quantitated immune-toxic peptides determined in step (d) as a factor in diagnosing the patient with refractory celiac disease. ### Claim 31 (depends on 30) The method of diagnosing according to claim 30 wherein step (d) is carried out by a process selected from the group consisting of an indirect ELISA, a competitive ELISA, a sandwich ELISA, immunochromatographic strips, fluorescent immune-microparticles, magnetic immune-particles, Western blot, electronic biosensors and resonance biosensors. ### Claim 32 (depends on 30) The method of diagnosing according to claim 30 wherein the antibody of step (a) is a monoclonal antibody conjugated to an enzyme that allows a quantitative assay using a method selected from the group consisting of chromogenic, fluorogenic and luminescent substrates. ### Claim 33 (depends on 30) The method of diagnosing according to claim 30, wherein step (d) comprises: quantifying the detected complex using a reference peptide selected from the group consisting of SEQ ID NO: 2 and SEQ ID NO: 6. ### Claim 34 (depends on 33) The method of diagnosing the according to claim 33, wherein step (d) is carried out using an immunochromatographic strip for rapid detection. ### Claim 35 (depends on 34) The method of diagnosing to claim 34, further comprising: providing a reference peptide standard comprising at least one of the immunogenic peptide selected from the group consisting of SEQ ID NO: 2 and SEQ ID NO: 6. ### Claim 36 A method of diagnosing sensitivity to gluten proteins, comprising: (a) contacting a urine sample from a patient with a monoclonal antibody selected from the group consisting of G12, R5, and A1 which monoclonal antibody specifically binds gluten immune-toxic peptides having epitopes on any sequence selected from the group consisting of SEQ ID NO: 2 and SEQ ID NO: 6, (b) allowing the monoclonal antibody to form monoclonal antibody-gluten peptide complexes with gluten peptides in the urine sample; (c) detecting the monoclonal antibody-gluten peptide complexes formed in step (b); (d) quantitating extracted immune-toxic peptides in the urine sample based on detection of monoclonal antibody-gluten peptide complexes; and (e) using the quantitated immune-toxic peptides determined in step (d) as a factor in diagnosing the patient with sensitivity to gluten protein. ### Claim 37 (depends on 36) The method of diagnosing according to claim 36 wherein step (d) is carried out by a process selected from the group consisting of an indirect ELISA, a competitive ELISA, a sandwich ELISA, immunochromatographic strips, fluorescent immune-microparticles, magnetic immune-particles, Western blot, electronic biosensors and resonance biosensors. ### Claim 38 (depends on 36) The method of diagnosing according to claim 36 wherein the antibody of step (a) is a monoclonal antibody conjugated to an enzyme that allows a quantitative assay using a method selected from the group consisting of chromogenic, fluorogenic and luminescent substrates. ### Claim 39 (depends on 36) The method of diagnosing according to claim 36, wherein step (d) comprises: quantifying the detected complex using a reference peptide selected from the group consisting of SEQ ID NO: 2 and SEQ ID NO: 6. ### Claim 40 (depends on 36) The method of diagnosing the according to claim 36, wherein step (d) is carried out using an immunochromatographic strip for rapid detection. ### Claim 41 (depends on 40) The method of diagnosing to claim 40, further comprising: providing a reference peptide standard comprising at least one of the immunogenic peptides selected from the group consisting of SEQ ID NO: 2 and SEQ ID NO: 6.