# US 7,410,768 B2 · Test methods and devices > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 7,410,768 B2 - Document ID: US7410768B2 - Status: Granted - Kind: B2 - Application number: 09/824,587 - Filed: 2001-04-03 - Published: 2002-04-18 - Granted: 2008-08-12 - Earliest claimed: 2000-04-03 - Assignees: Inverness Medical Switzerland GmbH - Inventors: Lorraine D. Butlin; John Coley; Stephen J. Eida; Mohamed M. Gani - Web page: https://patentgrep.com/patent/US7410768B2 ## CPC - C07K 16/26: against hormones {; against hormone releasing or inhibiting factors} - G01N 33/54306: {Solid-phase reaction mechanisms} - G01N 33/76: Human chorionic gonadotropin {including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors} - G01N 2474/20: Immunohistochemistry assay - Y10S 436/806: Electrical property or magnetic property - Y10S 436/814: Pregnancy - Y10S 436/815: Test for named compound or class of compounds - Y10S 436/817: Steroids or hormones - Y10S 436/818: Human chorionic gonadotropin - 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) - 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) - Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS ## Abstract A method and test device for differentiating between states of an analyte that can exist in different forms, such as follicle stimulating hormone (FSH). The method or test device uses a pair of specific binding agents, especially monoclonal antibodies, in two assays for the same analyte. The assays, applied to contemporaneous samples, differ from one another in format, one being a two step assay and the other being one step. A novel pair of anti-FSH monoclonal antibodies that can be used together in two such assays to differentiate pre-menopausal and post-menopausal FSH samples is disclosed. ## Claims ### Claim 1 A method, comprising: (a) providing a sample obtained from a human female, the sample comprising an analyte compound which is a member of the gonadotrophin family; (b) providing a first and a second binding agent, wherein the first binding agent is specific to a first form of the analyte compound characteristic of a menopausal state and the second binding agent is specific to a second form of the analyte compound characteristic of a pre-menopausal or fertile state; (c) reacting a first portion of the sample with the first binding agent to form a first binding agent/analyte compound complex and subsequently reacting the first binding agent/analyte compound complex with the second binding agent to form a first binding agent/analyte compound/second binding agent complex; (d) reacting a second portion of the sample substantially simultaneously with the first binding agent and the second binding agent to form a first binding agent/analyte compound/second binding agent complex; (e) determining the amount of first binding agent/analyte compound/second binding agent/complex formed in step (c) and step (d) and displaying the amounts as a ratio; and (f) comparing the ratio obtained in step (e) to the ratio obtained from a pre-menopausal control, wherein a difference in the two ratios indicates that the human female is in a post-menopausal state. ### Claim 2 (depends on 1) The method of claim 1, wherein the analyte compound is follicle stimulating hormone. ### Claim 3 (depends on 1) The method according to claim 1, wherein the first and second specific binding agents are antibodies. ### Claim 4 (depends on 3) The method according to claim 3, wherein each binding agent is a monoclonal antibody. ### Claim 5 (depends on 1) The method of claim 1, wherein in the first reacting step, the sample is incubated with a solid phase on which is immobilized the first binding agent, and thereafter, following removal of unbound analyte compound, the solid phase is incubated with the second binding agent. ### Claim 6 (depends on 5) The method of claim 5, wherein in the second reacting step, the sample is substantially simultaneously incubated with a solid phase to which the first binding reagent is immobilized and with the second binding agent in solution or suspension. ### Claim 7 (depends on 1) The method of claim 1, wherein in the second reacting step, the sample is substantially simultaneously incubated with a solid phase to which the first binding reagent is immobilized and with the second binding agent in solution or suspension. ### Claim 8 (depends on 1) The method of claim 1, wherein the first or second binding agent is labeled with a label selected from the group consisting of enzymes, fluorescent labels, radiolabels and direct particulate labels. ### Claim 9 (depends on 1) The method of claim 1, wherein one of the first or second binding agents comprises an anti-FSH antibody expressed by hybridoma cell line ECACC 00032004. ### Claim 10 (depends on 1) The method of claim 1, wherein one of the first or second binding agents comprises an anti-FSH antibody expressed by hybridoma cell line ECACC 00032005. ### Claim 11 (depends on 1) The method of claim 1, wherein one of the first or second binding agents comprises an anti-FSH antibody expressed by hybridoma cell line ECACC 00032004 and the other comprises an anti-FSH antibody expressed by hybridoma cell line ECACC 00032005.