# US 10,768,185 B2 · Tenofovir detection assay > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,768,185 B2 - Document ID: US10768185B2 - Status: Granted - Kind: B2 - Application number: 16/040,994 - Filed: 2018-07-20 - Published: 2019-01-24 - Granted: 2020-09-08 - Earliest claimed: 2017-07-20 - Assignees: Trustees of Boston University - Applicants: Trustees of Boston University - Inventors: Catherine M. Klapperich; George Woodman Pratt, IV; Andy Fan - Web page: https://patentgrep.com/patent/US10768185B2 ## CPC - G01N 33/94: involving narcotics {or drugs or pharmaceuticals, neurotransmitters or associated receptors} - C07K 16/44: against material not provided for elsewhere {, e.g. haptens, metals, DNA, RNA, amino acids} - G01N 33/54388: {based on lateral flow} - 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) - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) ## Abstract Disclosed herein are antibodies capable of specifically binding to tenofovir (TFV), a key small molecule drug for both the treatment and prevention of HIV, and a competitive lateral flow assay that uses these antibodies to monitor urine samples for the presence of the drug. The assay can be deployed as a point-of-care device for adherence monitoring. ## Claims ### Claim 1 A polyclonal antibody composition comprising a heterogeneous population of mammalian antibodies that specifically bind tenofovir (TFV) and a conjugate of TFV-SH and sulfosuccinimidyl 4-(N-maleimidomethyl)cyclohexane-1-carboxylate (sulfo-SMCC) modified bovine serum albumin (BSA), wherein the heterogeneous population of mammalian antibodies is generated against wherein R is keyhole limpet hemocyanin (KLH). ### Claim 2 (depends on 1) The composition of claim 1, wherein the heterogeneous population of mammalian antibodies is produced by immunization of a rabbit. ### Claim 3 (depends on 1) The composition of claim 1, wherein said composition is configured for detection of TFV in a test sample. ### Claim 4 (depends on 1) The composition of claim 1, wherein said composition is configured for detection of TFV in a test sample via a competition assay, a sandwich assay, a displacement assay or an electrochemical detection. ### Claim 5 (depends on 1) The composition of claim 1, wherein at least a portion of the heterogeneous population of mammalian antibodies is conjugated to a solid substrate. ### Claim 6 (depends on 5) The composition of claim 5, wherein the solid substrate is a nanoparticle. ### Claim 7 (depends on 6) The composition of claim 6, wherein the nanoparticle is a gold or silver nanoparticle. ### Claim 8 (depends on 1) The composition of claim 1, wherein at least a portion of the heterogeneous population of mammalian antibodies is immobilized on a first surface of a detection device comprising a sample pad and wherein the sample pad is in operable fluid communication with the first surface. ### Claim 9 (depends on 1) The composition of claim 1, wherein at least a portion of the heterogeneous population of mammalian antibodies is conjugated with a detectable label. ### Claim 10 (depends on 1) A device for detecting presence of TFV in a sample, comprising: a sample pad; and the polyclonal antibody composition of claim 1 immobilized on a first surface; and wherein the sample pad is in operable fluid communication with the first surface. ### Claim 11 (depends on 10) The device of claim 10, wherein the first surface is a porous surface. ### Claim 12 (depends on 10) The device of claim 10, wherein the first surface comprises nitrocellulosic material, polyvinylidene fluoride (PVDF), polyethylene material, nylon, cellulose acetate, polyester material, polyethersulfone (PES), or polysulfone. ### Claim 13 (depends on 10) The device of claim 10, wherein the device is positioned in an enclosed housing. ### Claim 14 (depends on 10) A method of detecting TFV in a test sample, comprising: contacting the test sample with the sample pad of the device of claim 10, and detecting binding of TFV bound with the polyclonal antibody composition immobilized on the first surface. ### Claim 15 (depends on 1) An assay for detecting the presence of tenofovir in a biological sample, comprising: (i) contacting a biological sample with the polyclonal antibody composition of claim 1, wherein the biological sample is from a subject undergoing treatment with TFV or a compound that metabolizes to TFV; and (ii) detecting the polyclonal antibodies bound with tenofovir. ### Claim 16 (depends on 15) The assay of claim 15, wherein the said detection comprising a competition assay, a sandwich assay, a displacement assay or an electrochemical detection. ### Claim 17 (depends on 15) The assay of claim 15, wherein said detection comprises enzyme-linked immunosorbent assay (ELISA). ### Claim 18 (depends on 15) The assay of claim 15, wherein the assay is a dipstick assay.