# US 10,309,962 B2 · Diagnostic reagents > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,309,962 B2 - Document ID: US10309962B2 - Status: Granted - Kind: B2 - Application number: 15/343,522 - Filed: 2016-11-04 - Published: 2017-04-06 - Granted: 2019-06-04 - Earliest claimed: 2010-07-19 - Assignees: The Secretary of the State for Environment, Food & Rural Affairs acting through the Animal and Veterinary Laboratories Agency - Applicants: The Secretary of State for Environment, Food and Rural Affairs - Inventors: Gareth Jones; Hans Vordermeier - Web page: https://patentgrep.com/patent/US10309962B2 ## CPC - G01N 33/5695: {Mycobacteria} - A61K 49/0006: {Skin tests, e.g. intradermal testing, test strips, delayed hypersensitivity} - C07K 7/08: having 12 to 20 amino acids (gastrins C07K14/595; somatostatins C07K14/655; melanotropins C07K14/68) - C07K 14/35: from Mycobacteriaceae (F) - G01N 2333/35: from Mycobacteriaceae (F) - G01N 2333/7156: for interferons [IFN] - 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) - 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 There is provided a diagnostic reagent useful to determine whether an animal has a tuberculosis infection or has been exposed to a tuberculosis agent, for example a Mycobacterium. The reagent is useful to distinguish between such an animal and an animal which has been vaccinated against a tuberculosis infection. ## Claims ### Claim 1 A diagnostic reagent comprising a polypeptide consisting of amino acid sequence QANLGEAAGTYVAADAAAAS (SEQ ID NO:8), wherein the diagnostic reagent is a sterile injectable preparation, and the diagnostic reagent optionally further comprises a polypeptide consisting of amino acid sequence MTENLTVQPERLGVLASHHDNAAVDASSGVEAAAGLGESVAITHGPYCSQFNDTLNVYLTAHNALGSSLHTAGVDLAKSLRIAAKIYSEADEAWRKAIDGLFT (SEQ ID NO:46). ### Claim 2 (depends on 1) A method of detecting a tuberculosis infection in an animal, or exposure of an animal to a tuberculosis agent, comprising the steps of (i) contacting a population of cells from the animal with at least one diagnostic reagent as defined in claim 1; and (ii) determining whether the cells of said population recognise the diagnostic reagent; optionally wherein the population of cells includes T-cells. ### Claim 3 (depends on 2) The method of claim 2, comprising a cell-mediated immunity (CMI) assay, optionally wherein the CMI assay detects interferon gamma (IFN-γ). ### Claim 4 (depends on 1) A method of detecting a tuberculosis infection in an animal, or exposure of an animal to a tuberculosis agent, comprising conducting a skin test on the animal using at least one diagnostic reagent as defined in claim 1. ### Claim 5 (depends on 1) A diagnostic kit comprising at least one diagnostic reagent as defined in claim 1. ### Claim 6 (depends on 5) The kit of claim 5 in which the diagnostic reagent is able to detect a tuberculosis infection in an animal, or exposure of an animal to a tuberculosis agent. ### Claim 7 (depends on 1) The diagnostic reagent of claim 1, wherein the sterile injectable preparation is an aqueous or an oleaginous suspension, or a suspension in a non-toxic parenterally-acceptable diluent or solvent. ### Claim 8 (depends on 1) The diagnostic reagent of claim 1, which is suitable for use to differentiate between an animal having a tuberculosis infection and an animal vaccinated against tuberculosis infection. ### Claim 9 A diagnostic reagent comprising a polypeptide consisting of amino acid sequence QANLGEAAGTYVAADAAAAS (SEQ ID NO:8), the diagnostic reagent optionally further comprising a polypeptide consisting of amino acid sequence MTENLTVQPERLGVLASHHDNAAVDASSGVEAAAGLGESVAITHGPYCSQFNDTLNVYLTAHNALGSSLHTAGVDLAKSLRIAAKIYSEADEAWRKAIDGLFT (SEQ ID NO:46), wherein the diagnostic reagent is a sterile injectable preparation, and wherein the diagnostic reagent is capable of eliciting a positive result when used in an assay to determine whether an animal has a tuberculosis infection or has been exposed to a tuberculosis agent, is capable of eliciting a negative result when the animal has been vaccinated against infection by a tuberculosis agent, and is capable of eliciting a negative result when the animal is unvaccinated and uninfected or unexposed to a tuberculosis agent. ### Claim 10 (depends on 9) The diagnostic reagent of claim 9, wherein the sterile injectable preparation is an aqueous or an oleaginous suspension, or a suspension in a non-toxic parenterally-acceptable diluent or solvent.