# US 2014/0154714 A1 · Detection of Intraamniotic Infection > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0154714 A1 - Document ID: US20140154714A1 - Status: Published application - Kind: A1 - Application number: 14/175,476 - Filed: 2014-02-07 - Published: 2014-06-05 - Earliest claimed: 2009-11-25 - Assignees: Hologic, Inc. - Applicants: Hologic, Inc. - Inventors: Thomas H. Grove - Web page: https://patentgrep.com/patent/US20140154714A1 ## CPC - G01N 33/689: {related to pregnancy or the gonads} - G01N 33/56933: {Mycoplasma} - G01N 33/6869: {Interleukin} - G01N 2333/47: Assays involving proteins of known structure or function as defined in the subgroups - G01N 2333/5412: IL-6 - G01N 2800/36: Gynecology or obstetrics - G01N 2800/368: Pregnancy complicated by disease or abnormalities of pregnancy, e.g. preeclampsia, preterm labour - 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 concerns the identification of biomarkers and groups or combinations of biomarkers that can be used for non-invasive diagnosis of intra-amniotic infection, and diagnostic assays using such biomarkers. ## Claims ### Claim at position 1 1-33. (canceled) ### Claim 34 A method for the diagnosis of intra-amniotic infection in a pregnant female mammalian subject comprising: (a) measuring in a sample of cervical-vaginal fluid obtained from said subject the levels of interleukin-6 (IL-6) and fetal fibronectin (fFN) relative to the corresponding levels of said proteins in normal cervical-vaginal fluid or cervical-vaginal fluid known to be indicative of intra-amniotic infection; and (b) diagnosing said subject with intra-amniotic infection if each of said levels of each of said proteins in said sample is determined to show a statistically significant difference relative to the corresponding levels of each of said proteins in said normal cervical-vaginal fluid, or is determined not to show a statistically significant difference relative to the corresponding levels of each of said proteins in said cervical-vaginal fluid known to be indicative of intra-amniotic infection. ### Claim 35 (depends on 34) The method of claim 34 wherein the subject is a human patient. ### Claim 36 (depends on 34, 52) The method of claim 34 or 52 wherein said protein level is determined by methods comprising the use of an immunoassay, a protein array, an immunochromatographic test, mass spectrometry, or combinations thereof. ### Claim 37 (depends on 36) The method of claim 36 wherein said level is determined using an immunochromtaographic test employing a lateral flow device. ### Claim 38 (depends on 37) The method of claim 37, wherein the lateral flow device is an immunochromatographic strip (ICS) test. ### Claim 39 (depends on 36) The method of claim 36 wherein said immunoassay employs antibodies and reagents for the detection of IL-6 and fFN. ### Claim 40 (depends on 39) The method of claim 39, wherein the antibodies and reagents comprise a capture antibody and a detector antibody. ### Claim 41 (depends on 40) The method of claim 40, wherein the capture antibody and detector antibody are monoclonal antibodies. ### Claim 42 (depends on 40) The method of claim 40, wherein the capture antibody and detector antibody are polyclonal antibodies. ### Claim 43 (depends on 40) The method of claim 40, wherein the capture antibody and detector antibody are either monoclonal or polyclonal antibodies. ### Claim 44 (depends on 41) The method of claim 41, wherein the antibodies comprise monoclonal antibodies having binding specificity for IL-6 and fFN, and wherein the method further comprises use of an anti-antibody immunoglobulin. ### Claim 45 (depends on 44) The method of claim 44, wherein the monoclonal antibodies and the anti-antibody immunoglobulin are provided in an amount of about 0.001 mg to about 100 grams. ### Claim 46 (depends on 44) The method of claim 44, wherein the monoclonal antibodies and the anti-antibody immunoglobulin are provided in an amount of about 0.01 mg to about 1 gram. ### Claim 47 (depends on 44) The method of claim 44, wherein the anti-antibody immunoglobulin is selected from the group consisting of a polyclonal immunoglobulin, protein A and protein G, or functional fragments thereof. ### Claim 48 (depends on 47) The method of claim 47, wherein the anti-antibody immunoglobulin is labeled. ### Claim 49 (depends on 39) The method of claim 39, further comprising use of agents for reducing background interference in a test or agents for increasing signal. ### Claim 50 (depends on 39) The method of claim 39, further comprising use of software and algorithms for combining and interpolating marker values to produce a prediction of clinical outcome of interest. ### Claim 51 (depends on 39) The method of claim 39, further comprising use of an apparatus for conducting a test. ### Claim 52 A method for determining signs and symptoms indicating intra-amniotic infection comprising (a) measuring in a sample of cervical-vaginal fluid obtained from said subject the levels of interleukin-6 (IL-6) and fetal fibronectin (fFN), relative to the levels of IL-6 and fFN in normal cervical-vaginal fluid or cervical-vaginal fluid known to be indicative of intra-amniotic infection; and (b) diagnosing said subject with intra-amniotic infection if each of said levels of IL-6 and fFN in said sample are determined to show a statistically significant difference relative to the corresponding levels of IL-6 and fFN in said normal cervical-vaginal fluid, or are determined not to show a statistically significant difference relative to the corresponding levels of IL-6 and fFN in said cervical-vaginal fluid known to be indicative of intra-amniotic infection. ### Claim 53 (depends on 52) The method of claim 52, wherein the signs and symptoms comprise maternal fever (>37.8° C.), maternal leukocytosis (>15,000/mm3), maternal and/or fetal tachycardia, uterine tenderness, and/or foul-smelling amniotic fluid. ### Claim 54 An immunochromatographic test device comprising one or more chromatography strips for the detection of interleukin-6 (IL-6) and fetal fibronectin (fFN). ### Claim 55 (depends on 54) The immunochromatographic test device of claim 54 wherein said test strip or test strips comprise(s) antibodies to interleukin-6 (IL-6) and fetal fibronectin (fFN). ### Claim 56 (depends on 54, 55) The immunochromatographic test device of claim 54 or claim 55, which is a lateral flow device.