# US 2014/0154712 A1 · Assay of cell mediated immune responsiveness > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0154712 A1 - Document ID: US20140154712A1 - Status: Published application - Kind: A1 - Application number: 14/114,335 - Filed: 2012-04-20 - Published: 2014-06-05 - Earliest claimed: 2011-04-29 - Assignees: Cellestis Limited - Inventors: Jeff Boyle; Emily Manktelow - Web page: https://patentgrep.com/patent/US20140154712A1 ## CPC - G01N 33/56972: {White blood cells} - G01N 33/5047: {Cells of the immune system} - G01N 2800/24: Immunology or allergic disorders - 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 This disclosure relates generally to the field of immunological-based diagnostic assays including an assay to measure cell-mediated immunoresponsiveness. The present disclosure teaches determination of the state, progression and/or severity of disease conditions based on a subject's cell-mediated immunoresponsiveness. The assay contemplated herein is capable of integration into standard pathology architecture to provide a diagnostic reporting system and to facilitate point of care clinical management. ## Claims ### Claim 1 A method for measuring cell-mediated immune response activity in a subject, said method comprising contacting lymphocytes from the subject with an antigen and a limiting amount of a Toll-like receptor (TLR) agonist and measuring the presence or elevation in the level of an immune effector molecule from immune cells wherein the presence or level of the immune effector molecule is indicative of the level of cell-mediated responsiveness of the subject. ### Claim 2 (depends on 1) The method of claim 1 wherein the TLR agonist is selected from the R848 (imidazoquinoline), Lipomannan and poly (I:C). ### Claim 3 (depends on 2) The method of claim 2 wherein the TLR agonist is R848. ### Claim 4 (depends on 1) The method of claim 1 wherein the subject is a human. ### Claim 5 (depends on 1) The method of claim 1 wherein the sample is undiluted whole blood. ### Claim 6 (depends on 1) The method of claim 1 wherein the whole blood is collected in a tube comprising heparin. ### Claim 7 (depends on 1) The method of claim 1 wherein the immune effector molecule is Interferon-γ (IFN-γ). ### Claim 8 (depends on 1) The method of claim 1 wherein the immune effector molecule is detected with antibodies specific for same. ### Claim 9 (depends on 1) The method of claim 1 wherein the subject has an infection by a pathogenic agent selected from the list consisting of Mycobacterium species, Staphylococcus species, Streptococcus species, Borrelia species, Escherichia coli, Salmonella species, Clostridium species, Shigella species, Proteus species, Bacillus species, Herpes virus, Hepatitis B or C virus and Human immune deficiency virus (HIV). ### Claim 10 (depends on 9) The method of claim 9 wherein the subject has an infection by Mycobacterium tuberculosis. ### Claim 11 (depends on 1) The method of claim 1 wherein the subject has a disease condition selected from the list consisting of alopecia areata, ankylosing spondylitis, antiphospholipid syndrome, autoimmune Addison's disease multiple sclerosis, autoimmune disease of the adrenal gland, autoimmune hemolytic anemia, autoimmune hepatitis, autoimmune oophoritis and orchitis, Behcet's disease, bullous pemphigoid, cardiomyopathy, celiac sprue-dermatitis, chronic fatigue syndrome (CFIDS), chronic inflammatory demyelinating, chronic inflammatory polyneuropathy, Churg-Strauss syndrome, cicatricial pemphigoid, crest syndrome, cold agglutinin disease, Crohn's disease, dermatitis herpetiformis, discoid lupus, essential mixed cryoglobulinemia, fibromyalgia, glomerulonephritis, Grave's disease. Guillain-Barre, Hashimoto's thyroiditis, idiopathic pulmonary fibrosis, idiopathic thrombocytopenia purpura (ITP), IgA nephropathy, insulin dependent diabetes (Type 1), lichen planus, lupus, Meniere's disease, mixed connective tissue disease, multiple sclerosis, myasthenia gravis, myocarditis, pemphigus vulgaris, pernicious anemia, polyarteritis nodosa, polychondritis, polyglancular syndromes, polymyalgia rheumatica, polymyositis and dermatomyositis, primary agammaglobulinemia, primary biliary cirrhosis, psoriasis, Raynaud's phenomenon, Reiter's syndrome, rheumatic fever, rheumatoid arthritis, sarcoidosis, scleroderma, Sjogren's syndrome, stiff-man syndrome, systemic lupus erythematosus, Takayasu arteritis, temporal arteritis/giant cell arteritis, ulcerative colitis, uveitis, vasculitis, vitiligo and inflammatory bowel disease. ### Claim 12 (depends on 11) The method of claim 11 wherein the disease is Celiac's disease. ### Claim 13 (depends on 1) The method of claim 1 wherein the subject has a cancer selected from ABL1 protooncogene, AIDS related cancers, acoustic neuroma, acute lymphocytic leukaemia, acute myeloid leukaemia, adenocystic carcinoma, adrenocortical cancer, agnogenic myeloid metaplasia, alopecia, alveolar soft-part sarcoma, anal cancer, angiosarcoma, aplastic anaemia, astrocytoma, ataxia-telangiectasia, basal cell carcinoma (skin), bladder cancer, bone cancers, bowel cancer, brain stem glioma, brain and CNS tumors, breast cancer, CNS tumors, carcinoid tumors, cervical cancer, childhood brain tumors, childhood cancer, childhood leukaemia, childhood soft tissue sarcoma, chondrosarcoma, choriocarcinoma, chronic lymphocytic leukaemia, chronic myeloid leukaemia, colorectal cancers, cutaneous T-Cell lymphoma, dermatofibrosarcoma-protuberans, desmoplastic-small-round-cell-tumor, ductal carcinoma, endocrine cancers, endometrial cancer, ependymoma, esophageal cancer, Ewing's sarcoma, extra-hepatic bile duct cancer, eye cancer, eye: melanoma, retinoblastoma, fallopian tube cancer, fanconi anemia, fibrosarcoma, gall bladder cancer, gastric cancer, gastrointestinal cancers, gastrointestinal-carcinoid-tumor, genitourinary cancers, germ cell tumors, gestational-trophoblastic-disease, glioma, gynaecological cancers, hematological malignancies, hairy cell leukaemia, head and neck cancer, hepatocellular cancer, hereditary breast cancer, histiocytosis. Hodgkin's disease, human papillomavirus, hydatidiform mole, hypercalcemia, hypopharynx cancer, intraocular melanoma, islet cell cancer, Kaposi's sarcoma, kidney cancer, Langerhan's-cell-histiocytosis, laryngeal cancer, leiomyosarcoma, leukemia, Li-Fraumeni syndrome, lip cancer, liposarcoma, liver cancer, lung cancer, lymphedema, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, male breast cancer, malignant-rhabdoid-tumor-of-kidney, medulloblastoma, melanoma, merkel cell cancer, mesothelioma, metastatic cancer, mouth cancer, multiple endocrine neoplasia, mycosis fungoides, myelodysplastic syndromes, myeloma, myeloproliferative disorders, nasal cancer, nasopharyngeal cancer, nephroblastoma, neuroblastoma, neurofibromatosis, nijmegen breakage syndrome, non-melanoma skin cancer, non-small-cell-lung-cancer-(NSCLC), ocular cancers, oesophageal cancer, oral cavity cancer, oropharynx cancer, osteosarcoma, ostomy ovarian cancer, pancreas cancer, paranasal cancer, parathyroid cancer, parotid gland cancer, penile cancer, peripheral-neuroectodermal-tumors, pituitary cancer, polycythemia vera, prostate cancer, rare-cancers-and-associated-disorders, renal cell carcinoma, retinoblastoma, rhabdomyosarcoma, Rothmund-Thomson syndrome, salivary gland cancer, sarcoma, schwannoma, Sezary syndrome, skin cancer, small cell lung cancer (SCLC), small intestine cancer, soft tissue sarcoma, spinal cord tumors, squamous-cell-carcinoma-(skin), stomach cancer, synovial sarcoma, testicular cancer, thymus cancer, thyroid cancer, transitional-cell-cancer-(bladder), transitional-cell-cancer-(renal-pelvis-/-ureter), trophoblastic cancer, urethral cancer, urinary system cancer, uroplakins, uterine sarcoma, uterus cancer, vaginal cancer, vulva cancer. Waldenstrom's-macroglobulinemia and Wilms' tumor. ### Claim 14 (depends on 1) The method of claim 1 wherein the subject was exposed to a toxicant. ### Claim 15 Use of a limiting amount of a TLR agonist in the manufacture of a diagnostic assay of cell-mediated immune responsiveness by the method of incubating limiting amounts of the agonist with lymphocytes and detecting the presence or elevation in effector molecules. ### Claim 16 A method of allowing a user to determine the status of cell-mediated immunoresponsiveness of a subject, the method including: (a) receiving data in the form of levels or concentrations of an immune effector molecule which relative to a control provide a correlation to the state of cell-mediated immunoresponsiveness from the user via a communications network, the immune effector molecule measured after exposure of lymphocytes to an antigen and a limiting amount of TLR agonist; (b) processing the subject data via univariate or multivariate analysis to provide an immunoresponsiveness value; (c) determining the status of the subject in accordance with the results of the immunoresponsiveness value in comparison with predetermined values; and (d) transferring an indication of the status of the subject to the user via the communications network.