# US 9,903,866 B2 · Portable devices for detection of antibodies against therapeutic drugs > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,903,866 B2 - Document ID: US9903866B2 - Status: Granted - Kind: B2 - Application number: 15/376,775 - Filed: 2016-12-13 - Published: 2017-10-05 - Granted: 2018-02-27 - Earliest claimed: 2016-04-05 - Assignees: ConquerAb Inc. - Applicants: Maria D. F. S. Barbosa - Inventors: Maria D. F. S. Barbosa - Web page: https://patentgrep.com/patent/US9903866B2 ## CPC - G01N 33/564: for pre-existing immune complex or autoimmune disease {, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9} - G01N 21/75: Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated (systems in which material is burnt in a flame or plasma G01N21/72, G01N21/73) - G01N 33/54388: {based on lateral flow} - G01N 33/6854: {Immunoglobulins} - G06F 7/06: Arrangements for sorting, selecting, merging, or comparing data on individual record carriers - A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes} - A61B 5/7275: {Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor} - G01N 2021/752: {Devices comprising reaction zones} - G01N 2021/757: {using immobilised reagents} - G01N 2800/24: Immunology or allergic disorders - G01N 2800/50: Determining the risk of developing a disease - 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) - G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N) - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Portable devices for anti-drug antibodies (ADAs) testing are provided. These devices can be used in various applications, including but not restricted to the following: uniform testing of patients for ADAs; selection of therapeutic drug for patient treatment; evaluation of the need to change therapeutic drug or to apply tolerance regimens; selection of patients for clinical trials; comparison of therapeutic drugs marketed for a given disease and also gene therapy; scientific guidance for discovering therapeutic drugs; therapeutic drug development; postmarketing surveillance of therapeutic drugs. ## Claims ### Claim 1 A portable device comprising: a sample-receiving port adjacent to a sample-collecting pad; a conjugate pad comprising labeled antibodies capable of binding to a constant region of an anti-drug antibody; and a membrane comprising a capture agent comprising a chimeric protein comprising a therapeutic drug and a constant region of a different antibody; wherein the therapeutic drug is a variable region of a therapeutic antibody that is capable of binding to anti-drug antibodies that are specific to the therapeutic drug; wherein the constant region is from a different species than the species producing the anti-drug antibodies to be detected; wherein a sample contacted with the sample-collecting pad would laterally flow through the conjugate pad and subsequently to the membrane; and wherein the anti-drug antibodies are human anti-drug antibodies. ### Claim 2 (depends on 1) The portable device of claim 1, further comprising a filter positioned upstream from the sample-collecting pad. ### Claim 3 (depends on 1) The portable device of claim 1, further comprising a liquid reservoir positioned upstream from the sample-collecting pad. ### Claim 4 (depends on 1) The portable device of claim 1, further comprising a filter and a liquid reservoir positioned upstream from the sample-collecting pad. ### Claim 5 (depends on 1) The portable device of claim 1, wherein the constant region is a constant region from a non-human immunoglobulin. ### Claim 6 (depends on 1) The portable device of claim 1, wherein the membrane comprises two or more groups of capture agents, each group positioned at a different location on the membrane. ### Claim 7 (depends on 1) The portable device of claim 1, wherein the anti-drug antibodies are one or more of the antibody isotypes selected from the group consisting of IgG, IgM, and IgE. ### Claim 8 (depends on 1) The portable device of claim 1, wherein the labeled antibodies are capable of binding to anti-infliximab and anti-adalimumab antibodies. ### Claim 9 (depends on 1) The portable device of claim 1, wherein the capture agents comprise the variable regions of adalimumab or infliximab. ### Claim 10 (depends on 6) The portable device of claim 6, wherein the capture agents comprise either the variable region of adalimumab or the variable region of infliximab, wherein the capture agents comprising the variable region of adalimumab are positioned at a different location on the membrane than the capture agents comprising the variable region of infliximab. ### Claim 11 A portable device for testing human anti-drug antibodies in tissues and body fluids, comprising: a sample-receiving port adjacent to a sample-collecting pad; a conjugate pad comprising labeled entities capable of binding to a constant region of a human anti-drug antibody; and a membrane comprising a capture agent comprising a chimeric protein comprising a therapeutic drug and a constant region of an antibody; wherein the therapeutic drug is capable of binding to human anti-drug antibodies that are specific to the therapeutic drug; wherein the constant region is from a different species than the species producing the anti-drug antibody to be detected; and wherein a sample contacted with the sample-collecting pad would laterally flow through the conjugate pad and subsequently to the membrane. ### Claim 12 (depends on 11) The portable device of claim 11, wherein the labeled entities are labeled antibodies. ### Claim 13 (depends on 11) The portable device of claim 11, wherein the therapeutic drug is an antibody. ### Claim 14 (depends on 11) The portable device of claim 11, wherein the therapeutic drug is a variable section of an antibody. ### Claim 15 (depends on 11) The portable device of claim 11, wherein the therapeutic drug is a natural product. ### Claim 16 (depends on 11) The portable device of claim 11, wherein the therapeutic drug is a small molecule drug. ### Claim 17 (depends on 11) The portable device of claim 11, wherein the therapeutic drug is a peptide. ### Claim 18 (depends on 11) The portable device of claim 11, wherein the therapeutic drug is a therapeutic protein. ### Claim 19 (depends on 11) The portable device of claim 11, wherein the therapeutic drug is a small-molecule-biotherapeutic conjugate.