Abstract: In some aspects, the present invention provides methods for predicting whether a subject will develop autoantibodies to an anti-TNF? drug during the course of anti-TNF? drug therapy. In other aspects, the present invention provides methods for predicting the level of an anti-TNF? drug in a subject during the course of anti-TNF? drug therapy. Systems for predicting anti-TNF? drug levels and the likelihood of autoantibody formation during the course of anti-TNF? drug therapy are also provided herein. The present invention further provides methods for predicting a clinical outcome (e.g., endoscopic response) of a subject on anti-TNF? drug therapy.

Abstract: The invention provides compositions comprising Eno1 for delivery to a muscle. Further, the invention provides a method for normalizing blood glucose in a subject with elevated blood glucose, comprising administering to the subject enolase 1 (Eno1), thereby normalizing blood glucose in the subject. The invention also provides methods of treating one or more conditions including impaired glucose tolerance, insulin resistance, pre-diabetes, and diabetes, especially type 2 diabetes in a subject, comprising administering to the subject enolase 1 (Eno1), thereby treating the condition in the subject. In certain methods of the invention, the Eno1 is delivered to muscle.

Abstract: The invention refers to a method for diagnosing an individual who is to be subjected to or is being subjected to an anti-tumor necrosis factor alpha (TNF? or TNF) treatment to assess the responsiveness to an anti-TNF treatment which comprises the detection of immunoglobulin(s) against one or more biomarker proteins in a bodily fluid or an excrement of said patient, and sorting the individual into one of two categories based on detection of said immunoglobulin(s), wherein individuals are classified as NON-responder or responder. The invention refers to diagnostic kits comprising said one or more biomarker proteins and the use of these kits for assessing the responsiveness to an anti-TNF treatment of an individual who is to be subjected to or is being subjected to an anti-TNF? treatment.

Abstract: The invention relates to a method for diagnosis of multiple sclerosis (MS) wherein, presence or absence of an anti-AT1 receptor antibody is determined in a sample from a patient to be diagnosed and wherein, the presence of an anti-AT1-receptor antibody is indicative of the disease.

Abstract: The invention generally provides three-component molecular biosensors. The molecular biosensors are useful in several methods including in the identification and quantification of target molecules.

Abstract: Provided herein are compositions comprising native and denatured human leukocyte antigens (HLA) and methods of making said compositions. Also provided herein are methods and kits for the detection of antibodies to native HLAs.

Abstract: The present invention includes assays and kits for detecting the assembly of an RNA binding protein-RNA complex and for detecting the activity of an RNA binding protein.

Abstract: The invention relates to in vitro method for quantitating the antibodies specific for High mobility group box I (HMGB1) contained in a sample, in particular a serum sample or a cerebrospinal fluid sample obtained from a patient, and the use of this method in the prognostic and/or diagnosis of neurological disorders. These methods are in particular applicable to the monitoring of the human immunodeficiency virus (HIV) infection of a subject who is known to be infected with HIV and in the prognostic and/or diagnostic of the state of progression of Acquired immune deficiency syndrome (AIDS) or the state of progression toward AIDS, in particular the state of progression or the state of progression toward neurological disorders associated with AIDS. Finally, the invention is also about method to determine the immune deficiency or level of immune activation of a patient, in particular a HIV-infected patient.

Abstract: An immunoassay reagent is provided which comprises an analyte binding agent in a diluent, and a glycosaminoglycan in an amount sufficient to reduce non-specific binding in an assay of a sample for the analyte. Provided is such an immunoassay reagent in which the analyte is troponin I, the analyte binding agent is a biotinylated anti-troponin I antibody, and the glycosaminoglycan is chondroitin sulfate. A sample composition is also provided which comprises a sample to be assayed for the presence of an analyte, an analyte binding agent, and a glycosaminoglycan other than heparin. Further provided is a method of detecting an analyte in a sample, in which non-specific binding is reduced in the method using a glycosaminoglycan.

Abstract: The present invention relates to antigen binding molecules (ABMs). In particular embodiments, the present invention relates to recombinant monoclonal antibodies, including chimeric, primatized or humanized antibodies specific for human EGFR. In addition, the present invention relates to nucleic acid molecules encoding such ABMs, and vectors and host cells comprising such nucleic acid molecules. The invention further relates to methods for producing the ABMs of the invention, and to methods of using these ABMs in treatment of disease. In addition, the present invention relates to ABMs with modified glycosylation having improved therapeutic properties, including antibodies with increased Fc receptor binding and increased effector function.

Abstract: Disclosed is a rapid, non-invasive and highly specific and sensitive diagnostic assay for the identification of individuals with autoimmune chronic urticaria, which makes use of CD203c, and in some embodiments, additional proteins, as a marker for the disease. Test kits for diagnosis of an individual suspected of having autoimmune chronic urticaria are also disclosed. Also disclosed are a method of identifying compounds useful for treating autoimmune chronic urticaria and a method of treating autoimmune chronic urticaria.

Abstract: Compositions and methods for modulating human immunodeficiency virus (HIV) infection involving substances that inhibit the ability of high mobility box 1 (HMGB1) protein to interact with natural killer (NK) cells. Therapeutic compositions comprising antibodies and drugs, such as glycyrrhizin, which bind to HMGB1. Methods of detecting or monitoring HIV infection involving detection or quantitation of HMGB1 or antibodies specific for HMGB1 in a biological sample.

Abstract: A high molecular weight form of Ngal is provided which can be used to diagnose chronic kidney disease. High molecular weight Ngal is about 75 kDa to about 350 kDa, and comprises non-Ngal proteins, such as polymeric immunoglobulin receptor, alpha-2-macroglobulin and immunoglobulin heavy chain. Methods are disclosed for assessing high molecular weight Ngal in a diagnostic sample from a subject.

Abstract: A binding partner, especially an antibody fragment that specifically recognizes an antigen-antibody immune complex between anti-THC and THC (tetrahydrocannabinol), is disclosed. The binding partner facilitates a non-competitive homogenous immunoassay for detection of cannabis use. A test kit comprising the binding partner is also described. Preferably the immunoassay is applied for roadside testing of saliva from suspected drivers.

Abstract: This method and device detects past use of drugs of abuse when the drug substance and its metabolites are no longer present in the body, based on the detection of the antibodies formed in response to said drug, and persist even after this drug and its metabolites are cleared from the body. False positive rate is reduced by screening out subjects with heightened inflammatory state. One embodiment of the invention sets forth the method and device comprising: testing a set of samples for levels of an inflammation biomarker; determining a subset of samples with inflammation biomarker level below a first predetermined threshold; testing samples within the subset of samples for a presence of drug-specific antibodies, for a pre-specified set of drugs; determining which samples within the subset have drug-specific antibody level exceeding pre-specified threshold; and providing an output indicating the samples within the subset having the drug-specific antibodies.

Abstract: A binding partner, especially an antibody fragment that specifically recognizes an antigen-antibody immune complex between anti-THC and THC (tetrahydrocannabinol), is disclosed. The binding partner facilitates a non-competitive homogenous immunoassay for detection of cannabis use. A test kit comprising the binding partner is also described. Preferably the immunoassay is applied for roadside testing of saliva from suspected drivers.

Abstract: The gene associated and causative of classical late infantile neuronal ceroid lipofuscinosis (LINCL), CLN2, has been identified and characterized. The translation product of this gene is a novel protease and a deficiency in this activity results in LINCL. Identification of CLN2 will not only aid in the prevention of LINCL through genetic counseling but provides strategies and test systems for therapeutic intervention. In addition, further characterization of this previously unknown lysosomal enzyme may provide useful insights into other more common human neurodegenerative disorders. Finally, the utility of a general approach for determining the molecular bases for lysosomal disorders of unknown etiology has been demonstrated.

Abstract: The present invention relates to the use of the assessment of the binding between—antibodies elicited against a first glycoprotein, and—at least one glycoform of a second glycoprotein, said second glycoprotein being itself a glycoform of the first protein, wherein said glycoform of the second glycoprotein is selected from a group of glycoforms of the second glycoprotein, each glycoform of said group corresponding to a determined glycosylation state defined by a determined sialylation state, and/or a determined branching state, and/or a determined fucosylation state, provided that said glycosylation state is not uniquely defined by a substantially unsialylated state, for the screening of glycoform specific antibodies directed against a given glycoform of the second glycoprotein.

Abstract: The present invention relates to a method for diagnosis of a disease selected from the group of diabetes, vasculitis, collagenosis, an inflammatory rheumatic disease and arteriosclerosis wherein, presence or absence of an anti-AT1-receptor antibody is determined in a sample from a patient to be diagnosed and wherein, the presence of an anti-AT1-receptor antibody is indicative of the disease. The invention further relates to the use of an inhibitor of an anti-AT1-receptor antibody or an inhibitor of an AT1-receptor for the production of a medicament as well as plasmapheresis of blood for the removal of anti-AT1-receptor antibodies.

Abstract: Disclosed herein are antibodies, systems and methods for assessing the risk of hemolysis following a blood transfusion with crossmatch incompatible blood. The disclosure provides a method for determining the relative hemolytic index and therefore the risk of post-transfusion hemolysis for said patient.

Abstract: The present invention provides compositions and methods for treating or preventing antibody mediated graft rejection and blood typing.

Abstract: The present invention relates to the identification and use of proteins with clinical relevance to rheumatoid arthritis (RA). In particular, the invention provides the identity of marker proteins that specifically react with RA-associated autoantibodies. Also provided are methods, arrays and kits for using these proteins in the diagnosis of RA, and in the selection and/or monitoring of treatment regimens.

Abstract: Methods and reagents are disclosed for pretreating a sample suspected of containing a hydrophobic drug for conducting an assay method for detecting the hydrophobic drug. A combination is provided in a medium that includes the sample, a releasing agent for releasing the hydrophobic drug and the metabolites from endogenous binding moieties, and a selective solubility agent that provides for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The selective solubility agent includes a water miscible, non-volatile organic solvent and is present in the medium in a concentration sufficient to provide for substantially equal solubility of the hydrophobic drug and the metabolites in the medium. The medium, which may further include a hemolytic agent, is incubated under conditions for releasing the hydrophobic drug and the metabolites from endogenous binding moieties. The pretreated sample may be subjected to an assay for determining the hydrophobic drug.

Abstract: The present invention relates to methods and devices for detecting biological entities and components associated with hypersensitivity reactions in patients with allergies, cancer or autoimmune disease. Specifically, the assays of the invention are capable of qualitatively and/or quantitatively detecting allergen specific immunocomplexes by assaying for immobilized C3b in a biological sample produced as a result of exposure to food.

Abstract: By detecting an antibody which immunologically reacts with amylase ?2-A in a sample, AIP or FT1DM is examined or the possibility of developing FT1DM is determined. For instance, detection of this antibody is carried out by an immunological method using an antigen which immunologically reacts with this antibody. The antigen is preferably a partial fragment containing the amino acid sequence of amino acid numbers 299 to 511 of human amylase ?2-A (SEQ ID NO: 1).

Abstract: Disclosed is a rapid, non-invasive and highly specific and sensitive diagnostic assay for the identification of individuals with autoimmune chronic urticaria, which makes use of CD203c, and in some embodiments, additional proteins, as a marker for the disease. Test kits for diagnosis of an individual suspected of having autoimmune chronic urticaria are also disclosed. Also disclosed are a method of identifying compounds useful for treating autoimmune chronic urticaria and a method of treating autoimmune chronic urticaria.

Abstract: The present invention relates to a process for the total synthesis of epicocconone analogs of formula (I): The invention also relates to novel epicocconone analogs.

Abstract: A method of determining the immune response of a mammal to circulating tumour marker proteins is described in which a sample of bodily fluid, for example plasma or serum, is contacted with a panel of two or more distinct tumour marker antigen. The presence of complexes between the tumour marker antigens and any autoantibodies to the antigens present in the sample are detected and provide an indication of an immune response to a circulating tumour marker protein. The method is useful for the diagnosis of cancer, particularly for identifying new or recurrent cancer in an otherwise assymptomatic patient.

Abstract: Embodiments of the present invention relate to devices and methods for detecting cellular products using detection particles having product-specific detection reagents and having a characteristic spectral feature. In particular, devices and methods are provided for measuring secreted cellular products including cytokines. Detection substrates, include microwells having product-specific capture reagents thereon or comprising hydrophobic membranes are described having greater capability to detect products from individual cells in a mixture of heterogeneous cells. With the use of multiple detection particles, multiple cellular products can be detected in a single well. Additionally, using the inherent spectral properties of detection particles, no enzymatic reactions are needed to visualize a secreted product, thereby increasing the sensitivity, reproducibility and ease of use.

Abstract: The present invention provides methods for the isolation, identification, and purification of adrenomedullin (AM)-binding proteins. Also, provided are methods for utilizing the purified AM-binding proteins, or functional portions thereof, to diagnose, treat, and monitor AM-related diseases, for example, diseases or disorders associated with abnormally elevated AM levels. In addition, the present invention provides a newly identified complex between AM and a specific AM-binding protein 1 (AMBP-1); which has been isolated and identified herein as factor H (fH). The invention also provides AM/AMBP complexes, particularly AM/FH complexes, and antibodies specifically reactive with this complexes. Further provided are methods for identifying and purifying complexes of AM and an AM binding protein using anti-AM/fH antibodies, and methods for treating conditions such as cancer or diabetes utilizing compositions comprising these antibodies.

Abstract: The present invention concerns a method for determining an allergic response by determining the extent of degranulation of human IgE sensitized cells upon activation by allergens in food products.

Abstract: The present invention relates to the field of therapeutic antibodies. It especially relates to the study of therapeutic antibodies in an experimental animal. The present invention discloses a method of detecting a therapeutic antibody in a sample obtained from an experimental animal comprising the steps of a) providing the sample to be analyzed, b) incubating said sample with an antibody binding to a therapeutic antibody and not binding to the immunoglobulin of said experimental animal, c) optionally incubating said sample with a reagent appropriate for the selective detection of total, active or antigen-bound therapeutic antibody, and d) correlating the complex formed in (b) or (c) to the concentration of said therapeutic antibody. A monoclonal antibody directed to a certain epitope that is present on all classes of human immunoglobulin of class G, but not on the immunoglobulin of any experimental animal except on the IgG of chimpanzees was used (MAB-M-R10Z8E9).

Abstract: Clinical samples can be analyzed using microparticles to determine the serodiagnosis of a viral infection from two candidate viral infections of the same viral group. Serodiagnosis can be determined via a pooled population of subsets of microparticles, with the particles in the pooled population having a bound viral group-reactive antibody and the particles in each subset having at least one characteristic classification parameter that distinguishes between subsets. Viral antigens of antibodies of interest in the same viral-class as the viral group-reactive antibody can be bound to the viral group-reactive antibody on the microparticles, and subsequently exposed to a clinical sample. Binding and labeling can be used. Automated analysis of data from multiplexed flow analysis can determine the presence or absence of antibodies of interest in the sample, thereby diagnosing for two candidate viral infections in a single assay.

Abstract: A process for the detection of antibodies in a test sample by preparing a suspension of erythrocytes with a test serum or plasma by mixing a test serum or plasma with erythrocytes; incubating the suspension of erythrocytes at a temperature of from 37° C. to 45° C. to bind any antibodies in the test serum or plasma to the surface of said erythrocytes; combining the suspension of erythrocytes with an amount of a solution of a macromolecule which is effective to agglutinate the erythrocytes; packing the resultant red cell agglutinates by centrifuging the suspension of erythrocytes; and, determining the presence of anti-erythrocyte antibodies by observing if antibody-dependent erythrocyte agglutination has occurred.

Abstract: The present invention provides compositions and methods for treating or preventing antibody mediated graft rejection and blood typing.

Abstract: The disclosure provides methods of detecting autoantibodies present in the serum of subjects suffering from rheumatoid arthritis. The methods use capture probes and detection probes that can bind to the antifilaggrin autoantibodies or other epitope related autoantibodies. The presence, absence, and/or amount of the autoantibody complex may be detected, wherein the presence of the complex may indicate a positive diagnosis of rheumatoid arthritis.

Abstract: Lateral flow assay devices and methods for detecting an analyte in a sample which comprises a plurality of nonspecific binding pair members are adapted for two step determinations.

Abstract: The present invention relates to compositions and methods for the detection of anti-ECPKA autoantibodies in a biological sample, and to the use of such compositions and methods in the diagnosis of cancer in humans and non-human mammals.

Abstract: The present invention provides improved and rapid detection methods for an antigen such as a chemical compound, a peptide, a nucleic acid, or a protein released from cells or virus particles in situ. The detection time for an antigen can be dramatically reduced relative to conventional technologies. The technology can particularly be used, for example, to modify and reduce the detection time significantly in traditional ELISA, and also Western blot or Dot blot assays. The improved ELISA method is rapid, economical, reproducible, simple and automatable. Also provided are compositions and kits for using the improved ELISA methods for the rapid detection of antigens.

Abstract: This invention relates to the field of determining, assaying or quantifying activity of components of the complement system. More particularly, the invention relates to methods for detecting the presence or level of activity in a sample of mannan-binding-lectin associated serine proteases (MASPs) or complexes of such proteases with lectins and to detection of the particular lectins themselves. Provided is a method for determining the activity of a MASP in a sample, comprising incubating the sample with a pro-urokinase comprising at its activation site the consensus sequence Arg/Leu/Gly-Yyy-Arg/Lys-Ile/Leu/Val-Zzz-Gly-Gly cleavable by a MASP, wherein Yyy can be any amino acid and Zzz is preferably an aliphatic amino acid, and determining proteolytic activation of said pro-urokinase.

Abstract: The present invention concerns methods for diagnosing myocardial infarction, for performing risk stratification of myocardial infarction, for making a prognosis of a disease course in a myocardial infarction patient, for identifying a patient with elevated risk of myocardial infarction, or combinations thereof, wherein a determination of at least three markers is performed on a patient sample. Furthermore, kits for performing the methods are provided.

Abstract: The present invention provides methods for identifying and/or enriching fetal cells from maternal blood, using as fetal cell markers the antibodies that the mother produces against paternally inherited fetal antigens. The fetal cell-maternal antibody complexes are identified and isolated using labelled agents that bind to the maternal antibodies. The present invention also provides fetal cells, isolated by use of said maternal antibodies, as a source of fetal DNA for prenatal genetic diagnosis of the fetus.

Abstract: Disclosed is a rapid, non-invasive and highly specific and sensitive diagnostic assay for the identification of individuals with autoimmune chronic urticaria, which makes use of CD203c, and in some embodiments, additional proteins, as a marker for the disease. Test kits for diagnosis of an individual suspected of having autoimmune chronic urticaria are also disclosed. Also disclosed are a method of identifying compounds useful for treating autoimmune chronic urticaria and a method of treating autoimmune chronic urticaria.

Abstract: The present invention relates to the field of immunology and hyperproliferative diseases. More specifically, the present invention relates to a method of detecting and monitoring therapeutic antibody:antigen complex, soluble antigen and soluble therapeutic antibody, wherein a patient has undergone at least one course of immunotherapy. Yet further, levels of therapeutic antibody:antigen complexes, soluble antigens or soluble therapeutic antibodies may be measured and used to stage or monitor a hyperproliferative disease.

Abstract: The invention relates to methods for diagnosing and treating macular degeneration-related disorders. The invention also related to methods for identifying genes that cause macular degeneration-related disorders.

Abstract: The present invention provides methods for the isolation, identification, and purification of adrenomedullin (AM)-binding proteins. Also, provided are methods for utilizing the purified AM-binding proteins, or functional portions thereof, to diagnose, treat, and monitor AM-related diseases, for example, diseases or disorders associated with abnormally elevated AM levels. In addition, the present invention provides a newly identified complex between AM and a specific AM-binding protein 1 (AMBP-1); which has been isolated and identified herein as factor H (fH). The invention also provides AM/AMBP complexes, particularly AM/FH complexes, and antibodies specifically reactive with this complexes. Further provided are methods for identifying and purifying complexes of AM and an AM binding protein using anti-AM/fH antibodies, and methods for treating conditions such as cancer or diabetes utilizing compositions comprising these antibodies.

Abstract: Peptide ligands having affinity for IgG or for serum albumin are disclosed. Also disclosed are hybrid molecules comprising a peptide ligand domain and an active domain. The active domain may comprise any molecule having utility as a therapeutic or diagnostic agent The hybrid molecules of the invention may be prepared using any of a number techniques including production in and purification from recombinant organisms transformed or transfected with an isolated nucleic acid encoding the hybrid molecule, or by chemical synthesis of the hybrid. The hybrid molecules have utility as agents to alter the elimination half-times of active domain molecules. Elimination half-time is altered by generating a hybrid molecule of the present invention wherein the peptide ligand has binding affinity for a plasma protein.

Abstract: This disclosure teaches a method and composition for detecting the presence of class specific antibodies reactive with analytes such as bacteria, allergens, autoimmune antigens, viral proteins, haptens, and carbohydrates by lateral flow techniques. In one embodiment of the disclosure, a test sample is added to the test strip, which then migrates to the site of the immobilized allergens, thereby forming a first antibody IgE-allergen complex. A chase release buffer is added upstream to or from the site of the labeled anti-IgE antibodies, which is itself upstream from the sample site. The anti-IgE antibodies migrate downstream to the site of immobilized first complex, thereby forming a second complex indicating the presence of class specific IgE antibodies in the test specimen. In another embodiment of the disclosure, a liquid form of the labeled anti-IgE antibodies can be added to the test strip after the first complex has been formed.

Abstract: Peptide ligands having affinity for IgG or for serum albumin are disclosed. Also disclosed are hybrid molecules comprising a peptide ligand domain and an active domain. The active domain may comprise any molecule having utility as a therapeutic or diagnostic agent. The hybrid molecules of the invention may be prepared using any of a number techniques including production in and purification from recombinant organisms transformed or transfected with an isolated nucleic acid encoding the hybrid molecule, or by chemical synthesis of the hybrid. The hybrid molecules have utility as agents to alter the elimination half-times of active domain molecules. Elimination half-time is altered by generating a hybrid molecule of the present invention wherein the peptide ligand has binding affinity for a plasma protein.

Abstract: Embodiments of the present invention relate to devices and methods for detecting cellular products using detection particles having product-specific detection reagents and having a characteristic spectral feature. In particular, devices and methods are provided for measuring secreted cellular products including cytokines. Detection substrates, include microwells having product-specific capture reagents thereon or comprising hydrophobic membranes are described having greater capability to detect products from individual cells in a mixture of heterogeneous cells. With the use of multiple detection particles, multiple cellular products can be detected in a single well. Additionally, using the inherent spectral properties of detection particles, no enzymatic reactions are needed to visualize a secreted product, thereby increasing the sensitivity, reproducibility and ease of use.