Abstract: The present invention provides methods, diagnostic assays, and diagnostic kits based on said methods, to determine levels of immunosuppressive complexes containing immunosuppressive drugs tacrolimus, sirolimus and cyclosporine A separately and in combination, formed in the blood of a drug-treated patient or in a patient candidate to immunosuppressive drug therapy. These methods, assays and kits are especially useful when using automated systems.

Abstract: A method for identifying or monitoring SLE in an individual is provided. The method includes quantitating complement component C4d on the surfaces of platelets and comparing the amounts of C4d to reference levels of C4d on platelets of individuals without SLE and/or on platelets of the individual obtained at a different time. Kits for use in the above-described methods are provided along with computer readable media tangibly embodying executable instructions to perform the methods.

Abstract: The invention is related to methods of diagnosing inflammatory diseases or conditions by determining levels of components of the complement pathway on the surface of white blood cells.

Abstract: The present invention provides a method for the measurement capable of measuring an endocrine substance such as feline insulin in an analyte of an animal such as feline or the like with high accuracy, rapidity and brevity. The method for the measurement of the endocrine substance in the analyte according to the present invention comprises pre-treating the analyte derived from the animal such as feline or the like by removing an autoantibody bound to the endocrine substance present in the analyte therefrom and measuring the endocrine substance in the pre-treated analyte. Further, the present invention can measure a value of the autoantibody bound to the endocrine substance in the analyte. In addition, the present invention allows a diagnosis and treatment of diseases associated with the endocrine substance by measuring the autoantibody value of the endocrine substance in the analyte.

Abstract: The invention relates to demonstrate the presence of non covalently linked complement proteins with CIC. Invention demonstrate the presence of C5 and MAC on CIC. The invention provides methods to measure M complement proteins C1q, C3, C4, C5 bound to CIC as markers of disease activity and pathogenicity for complement and CIC mediated diseases. The invention also relates to modifications and blocking of formation of MAC on the CIC by developing a useful reagent that can be monoclonal antibody, active molecule, mimotope or peptide molecule. The invention describes usefulness to reduce the non-covalent complement components, formation of MAC and association of C5 to CIC for therapeutic application in pathological disease with involvement of CIC and complement.

Abstract: Methods are provided for diagnosing and/or characterizing chronic immune disease activity in a subject. In the subject methods, a sample is obtained from a subject suspected of having or known to have a chronic immune disease. The sample is then assayed for the presence of low molecular actin fragments. The assay results are used to diagnose the presence of chronic immune disease activity and/or characterize chronic immune disease activity in the subject, e.g. to confirm an initial chronic immune disease diagnosis, to determine the stage of the disease, to monitor disease progression, to predict disease attacks, and the like. Also provided by the subject invention are kits for practicing the methods.

Abstract: A mutated TSHR preparation which includes at least one point mutation characterised in that at least amino acid Arg at a position corresponding to amino acid 255 of a full length human TSHR has been mutated to a different amino acid residue in said mutated TSHR preparation, whereby said mutated TSHR preparation differentially interacts with patient serum stimulating TSHR autoantibodies, patient serum blocking TSHR autoantibodies and TSH, in that (i) the stimulatory effect of patient serum stimulating TSHR autoantibodies interacting with the mutated TSHR preparation is substantially reduced or essentially abolished, when compared to the stimulatory effect of the patient serum stimulating TSHR autoantibodies interacting with a reference TSHR preparation which has an amino acid sequence corresponding to that of said mutated TSHR preparation with the exception that said mutation of Arg at a position corresponding to amino acid 255 of a full length human TSHR is not present in said reference TSHR preparation, (ii)

Abstract: Methods and kits for simultaneously measuring both members of a binding pair are described.

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 antigens. 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: Methods for diagnosing and monitoring systemic lupus erythematosus (SLE) or scleroderma by determining, in a blood sample from the individual being diagnosed or monitored, complement component C4d deposited on surfaces of red blood cells in the sample, and optionally also determining complement receptor CR1 deposited on the red blood cell surfaces. For diagnosis this is compared with the quantity of C4d (and optionally CR1) present on red blood cells of normal individuals. For monitoring it is compared with a value in a sample or samples previously obtained from the individual patient. The comparison may be made with individual values for C4d and CR1 and/or with a ratio of the two found in normal individuals.

Abstract: A pharmaceutical composition for preventing or treating chronic inflammatory airway diseases comprising alpha-enolase protein as an active ingredient is provided. The present invention also provides a diagnostic composition and a diagnostic kit for diagnosing chronic inflammatory airway diseases comprising alpha-enolase protein. The present invention further provides a composition for screening a therapeutic agent for chronic inflammatory airway diseases, comprising one or more of alpha-enolase protein or autoantibodies to alpha-enolase obtained from patients with chronic inflammatory airway diseases, and a method for screening a therapeutic agent for chronic inflammatory airway diseases using this composition. The present invention still further provides methods for diagnosing, preventing or treating chronic inflammatory airway diseases using alpha-enolase protein.

Abstract: Provided herein are antibodies having the same epitope specificity as an antibody produced by the hybridoma cell line deposited with the American Type Culture Collection as hybridoma 4-2A6, 1-5A3, or 1-3B4. Further provided herein are methods of identifying and selecting cells that express FcRH1 or FcRH4. Methods of diagnosing and treating a subject with a malignancy of a hematopoietic cell lineage or an autoimmune disease and methods of modulating a humoral immune response in a subject are also provided herein. Further provided herein are polypeptides comprising one or more complementary determining regions of the disclosed antibodies and nucleic acids that encode the disclosed polypeptides.

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 a method of determining the presence or amount of newly synthesized antibody in a sample in response to an immunogen by detecting the released antibodies or parts thereof in a sample containing lymphocytes which have been disrupted whereby to release the synthesized antibodies or parts thereof associated with said lymphocytes whereby to determine the presence or amount of newly synthesized antibody in said sample, methods of diagnosis using said method and kits for performing the method. The method may also be modified to allow detection of non-specific infection indicators.

Abstract: The invention is directed to a method of detecting gluten-induced diseases such as e.g. celiac disease and dermatitis herpetiformis. Said diseases are indicated by the presence of autoantibodies against tissue transglutaminase tTG in the blood The test is carried out on a whole blood sample using tTG liberated from the red blood cells of the blood sample as an autoantigen. The liberated autoantigens react with the autoantibodies in the sample and form antigen-antibody complexes, which are detected. The presence of such complexes indicates the disease. The invention is also directed to the use of the autoantigen in a test and to a test-kit.

Abstract: Methods for diagnosis, early diagnosis, differential diagnosis, assessment of the severity and therapy-accompanying monitoring and prognosis of chronically inflammatory intestinal diseases (Crohn's disease, Colitis ulcerosa), in which the presence and/or the amount of one or more antibodies which bind to ribosomal proteins, in particular P0 and L5, are determined in the serum, plasma, tissue samples and/or stool of a patient who is suffering from a chronically inflammatory intestinal disease or in whom such a disease is suspected. The blocking or removal of such antibodies and/or the influencing of antigen-presenting cells or specifically reactive T-cells which react to ribosomal proteins, such as P0 and L5, by suitable agents can be therapeutically utilized.

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: Disclosed are methods relating to cell membrane fragments associated with microbeads, so that the characteristics of the cells the fragments originated from can be determined. The fragments can be oriented with what was the outer surface of the cell membrane facing outwardly, so that the antigens associated with the membrane can be contacted with ligands (including antibodies) to antigens in the membranes which would be accessible to antibodies in vivo. The system is useful, inter alia, for detection of panel reactive antibodies in donor serum, as well as detection of other cell membrane antigens; or quantitation of particular cell membrane antigens.

Abstract: The present invention provides a process of screening patients for atopic dermatitis. The process includes the step of determining, in sera of the patient, the presence of antibodies against nuclear antigens such as transcription co-activator p75, wherein the presence of such antibodies indicates atopic dermatitis. The screening process can be used to detect atopic dermatitis in patients suffering from other conditions such as asthma or interstitial cystitis.

Abstract: A biochemical analysis unit includes a substrate made of a material capable of attenuating radiation energy and/or light energy and formed with a plurality of holes, and a plurality of absorptive regions formed by forming an absorptive region in every hole. According to the thus constituted biochemical analysis unit, even in the case where the absorptive regions are formed at a high density, when a stimulable phosphor layer formed on a stimulable phosphor sheet is exposed to a radioactive labeling substance contained in the plurality of absorptive regions, electron beams (? rays) released from the radioactive labeling substance contained in the individual absorptive regions are reliably prevented from being scattered in the substrate and advancing to regions of the stimulable phosphor layer that should be exposed to electron beams released from absorptive regions formed in neighboring holes.

Abstract: A method for diagnosing the likelihood and severity of cardiovascular disease in a patient is disclosed. The method determines the levels of antibodies against autoantigens, including myosin, oxidized LDL, ?-2-glycoprotein, heat shock protein-60, platelet glycoprotein, and immune complexes. It then compares the results to normal levels to determine the likelihood and severity of cardiovascular disease.

Abstract: The invention relates to a method for the detection of an analyte in a competitive immunoassay in the presence of an analyte derivative and first and second receptor molecules, and to a kit for carrying out this detection method.

Abstract: Peptides having the following amino acid sequence as well as peptides or proteins which contain this amino acid sequence: R1-X01-X02-X03-X04-X05-X06-X07-X08-X09-X10-X11-X12-X13-R2. These peptides have a high affinity for immunoglobulins. Applications of the peptides according to the invention are also described.

Abstract: The invention relates to a method for detecting and supervising neurodegenerative diseases, which consists in detecting the presence of antibodies of the A-isotype and/or M-isotype which are directed against the antigens which are associated with these diseases. The invention also relates to a kit for the implementation of this method.

Abstract: A method for diagnosing a condition of a patient involves the steps of (a) adding one or more reagents to a test sample from a patient, the test samples comprising at least part of a blood sample from the patient, in order to cause formation of a complex comprising at least one acute phase protein and at least one human lipoprotein, while causing substantially no fiber polymerization; (b) measuring the formation of the complex over time so as to derive a time-dependent measurement profile, and (c) determining a slope and/or total change in the time-dependent measurement profile, so as to diagnose a condition of the patient. A greater formation of the complex is correlated to increased probability of death of the patient.

Abstract: The invention relates to protein-protein interactions and methods for identifying interacting proteins and the amino acid sequence at the site of interaction. Using overlapping hexapeptides that encode for the entire amino acid sequences of the linker domains of human P-glycoprotein gene 1 and 3 (HP-gp1 and HP-gp3), a direct and specific binding between HP-gp1 and 3 linker domains and intracellular proteins was demonstrated. The method of the present invention was further validated with Annexin. The present invention thus demonstrates a novel concept whereby the interactions between two proteins are mediated by strings of few amino acids with high and repulsive binding energies, enabling the identification of high affinity binding sites between any interacting proteins.

Abstract: Methods aiding in the diagnosis of certain painful, predominantly sensory, polyneuropathies are disclosed, in which the amount of antibodies to trisulfated disaccharide is assessed in a test sample. Also disclosed are kits that can be used in the methods of the invention.

Abstract: A microscale binding assay, analyte binding array, and kits are disclosed, which exploit the mass action law to harvest analyte from a liquid sample. This is achieved by fabrication of sorbent zones having up to ten times the binding capacity per unit area generally obtained on polystyrene microtiter plates. The resulting arrays substantially deplete the liquid solution of analyte during incubation. Accordingly, the assays respond to total mass of analyte in the sample, not analyte concentration. This approach, coupled with direct fluorescence detection in the NIR, yields maximal signal intensity and low background for optimal sensitivity.

Abstract: A pharmaceutical composition suitable for administration to human beings in the prevention or treatment of immunologic disorders includes: an immune complex of an antigen and a purified antibody specific thereto, the antigen being selected from a group consisting of antigens that cause pathogenic immunologic reactions in autoimmune disease and graft rejections, and the antigen and antibody being present in a ratio whereby the antibody blocks essentially all binding sites of the antigen; and a pharmacologically acceptable carrier or diluent. The invention also provides a method of administering the composition for treatment of autoimmune disease and treatment or prevention of graft rejections.

Abstract: The present invention relates to a method for monitoring the effect of in vivo administration of Cathepsin S inhibitors by measuring accumulation of an intermediate degradation product of invariant chain (Ii), in particular the p10 Ii fragment, in blood of dosed subjects.

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 invention provides compositions and methods for treatment of amyloidogenic diseases. Such methods entail administering an agent that induces a beneficial immune response against an amyloid deposit in the patient. The methods are particularly useful for prophylactic and therapeutic treatment of Alzheimer's disease. In such methods, a suitable agent is A? peptide or an antibody thereto.

Abstract: Methods of detecting antibodies to one or more glycosphingolipid(s) of interest in a sample are disclosed which comprise using a solid-phase reactant having carbonyl groups attached theron, and the glycosphingolipid(s) of interest linked to the solid-phase reactant by an amide bond between an amino group of the glycosphingolipid of interest and a carbonyl group attached to the solid-phase reactant. The methods of detecting antibodies to glycosphingolipid(s) of interest can be used in methods of diagnosing autoimmune diseases in an individual.

Abstract: Immunoassay methods and apparatus are provided which utilize flow cytometry, coated latex microspheres, and fluorochrome labeled antibodies, to simultaneously detect the presence and amount of one or more analytes in a sample. Beads of several different sizes, colors or shapes, each bead are coated with a different analyte, for the simultaneous detection of one or more analytes and of cell components. The invention is also directed to platelet Ig positive control reagents and assays which provide for the setting of the fluorescence positive region for each patient. The platelet control is sized to fit between the platelets and red cells and thus making it ideal as a true biological control.

Abstract: Immunoassay methods and apparatus are provided which utilize flow cytometry, coated latex microspheres, and fluorochrome labeled antibodies, to simultaneously detect the presence and amount of one or more analytes in a sample. By combining FALS and fluorescence, it is practical to use beads of several different sizes, colors or shapes, each bead coated with a different analyte, for the simultaneous detection of one or more analytes and of cell components such as platelets in a sample.

Abstract: The present invention relates to equine Fc epsilon receptor alpha chain nucleic acid molecules, proteins encoded by such nucleic acid molecules, antibodies raised against such proteins, and inhibitors of such proteins. The present invention also includes methods to detect IgE using such proteins and antibodies. Also included in the present invention are therapeutic compositions comprising such proteins, nucleic acid molecules, antibodies and/or inhibitory compounds as well as the use of such therapeutic compositions to mediate Fc epsilon receptor-mediated biological responses.

Abstract: A method for conveniently detecting binding between the von Willebrand factor and glycoprotein Ib and a means to be used therein. The von Willebrand factor fixed in a reactor immobilized in a reaction vessel in the presence of bottrocetin is bound to a chimeric protein constructed by fusing the carboxyl terminal of a partial protein containing the von Willebrand factor-binding site of glycoprotein Ib with the amino terminal of the Fc region of an immunoglobulin molecule. Then the Fc region of the above immunoglobulin molecule is detected to thereby detect the binding between the von Willebrand factor and the glycoprotein Ib or inhibition of this binding.

Abstract: A process for preparing a patient-specific immunoadsorber, which comprises (i) extracting a body fluid from a patient having an immunopathological condition, the fluid containing immune complexes that are relevant to that immunopathological condition, (ii) contacting the extracted fluid with an adsorbent for the immune complexes to form adsorbed immune complexes, (iii) eluting the adsorbed complexes to form an eluate, (iv) fractionating the eluate into a plurality of immune complex component fractions, and (v) immobilizing the immune complex components on one or more biologically compatible carriers activated to bond to its surface one or more desired immune complex components.

Abstract: The invention relates, among other things, a preparation comprising Alzheimer's disease antigen (A68), as well as methods of obtaining this purified antigen, and methods of using this purified antigen, for instance, for diagnosing Alzheimer's disease and for detecting human autoantibodies to the Alzheimer disease antigen. The antigen preparation according to the invention is purified in that it is substantially free of immunoglobulin G. The invention further relates to methods of making Alzheimer disease antigens that can be used instead of or along with the A68 antigen preparation (e.g., for diagnosing AD), such as recombinant human tau, tau isolated from various species including human, and phosphorylated recombinant human tau or isolated tau, as well as A68 anti-idiotypic antibodies.

Abstract: The present invention provides methods and compositions useful in the diagnosis and management of autoimmune diseases. In particular, the present invention provides improved methods and compositions for the diagnosis and management of Graves' disease. The methods of the present invention avoid the need for radioactivity and are much simpler, economical, and rapid than methods traditionally used for the diagnosis of Graves' disease.

Abstract: Disclosed is a class of compounds referred to herein as effector compounds. Effector compounds are useful in connection with the modulation of an immune response. Modulation refers to the ability of the effector compounds of the present invention to either enhance (antigen supercharging) or inhibit (immunosuppressant activities) antigen presentation, depending upon the nature of the particular effector compound and the therapeutic context. Effector compounds include peptides, modified peptides and peptidomimetics. Also disclosed are methods for modulating presentation of an MHC class II restricted antigenic peptide to a T cell. Also disclosed are effector compounds demonstrated to act specifically on a human MHC class II allele. Also disclosed is a second class of compounds, referred to herein as immunomodulatory organic compounds.

Abstract: This invention discloses a method and composition for detecting the presence of class specific antibodies reactive with analytes such as bacteria, allergens, autoimmune antigens, viral proteins, and carbohydrates by lateral flow techniques. In one embodiment of the invention, a test sample obtained from bodily fluids reacts with a gold labeled antigen. The resulting complex travels across the membrane, and along the lateral flow strip. Red colored lines formed in specific locations along the test strip indicate the presence of class specific antibodies in the test specimen. In another embodiment of the invention, the lateral flow assay serves as an immunochromatographic screening test for the detection of allergen-specific IgE antibodies in human serum. Test sample reacts with gold labeled anti-IgE antibody. The resulting complex travels across the membrane where immobilized allergens capture the allergen specific IgE complex.

Abstract: The present invention involves techniques for evaluating in vivo cytokine production through the in vivo capture of secreting cytokines by labeled cytokine-binding reagents, followed by in vitro measurement of serum levels of captured cytokine. The methods of the present invention make use of the ability of a neutralizing antibody to a cytokine, when injected into a person or expierimental animal, to bind that cytokine and prevent its catabolism, excretion, or binding to a cytokine receptor. This causes the cytokine, which may normally have a very short in vivo half life, to accumulate in vivo as a cytokine/anti-cytokine antibody complex. If the anti-cytokine antibody is either labeled with a molecule that can be bound by another molecule (e.g.; biotin, which is bound by avidin or streptavidin), or is itself capable of being bound by another molecule (e.g.

Abstract: Methods and compositions comprising immunoassays for the detection of functional antibodies and the analysis of vaccine efficacy are described. In particular, the present invention provides opsonophagocytic assays. The assays are useful for the rapid and simultaneous detection of multiple different functional antibodies. In preferred embodiments, the assays include fluorescent labels of multiple colors and/or intensities.

Abstract: Methods and compounds are provided for detecting target molecules in a sample using specific binding assays. In particular, methods are provided for detecting a nucleic acid target in a sample. In one embodiment, the presently claimed invention provides a method of labeling a hybridized target wherein the target comprises a binding ligand. In another embodiment, the presently claimed invention provides methods of signal amplification.

Abstract: The invention provides compositions and methods for treatment of amyloidogenic diseases. Such methods entail administering an agent that induces a beneficial immune response against an amyloid deposit in the patient. The methods are particularly useful for prophylactic and therapeutic treatment of Alzheimer's disease. In such methods, a suitable agent is A&bgr; peptide or an antibody thereto.

Abstract: The invention provides compositions and methods for treatment of amyloidogenic diseases. Such methods entail administering an agent that induces a beneficial immune response against an amyloid deposit in the patient. The methods are particularly useful for prophylactic and therapeutic treatment of Alzheimer's disease. In such methods, a suitable agent is A&bgr; peptide or an antibody thereto.

Abstract: The invention provides compositions and methods for treatment of amyloidogenic diseases. Such methods entail administering an agent that induces a beneficial immune response against an amyloid deposit in the patient. The methods are particularly useful for prophylactic and therapeutic treatment of Alzheimer's disease. In such methods, a suitable agent is A&bgr; peptide or an antibody thereto.

Abstract: Methods for detecting anti-lipidic particles antibodies and lipidic particles in cellular membranes for the diagnosis of diseases associated to the antiphospholipid syndrome are disclosed. Kits or sets to put these methods of diagnosis into practice are also disclosed. Methods for the therapeutically treatment of diseases associated to the antiphospholipid syndrome are disclosed as well. In addition, methods for the detection of the diverse physiologic states of cells, and those kits useful for this are also disclosed.

Abstract: Diagnostic methods comprise measuring specifically the level of at least one iso-eosinophilic cationic protein (iso-ECP) in a sample from an individual to be diagnosed, and comparing the measured level of the iso-ECP with a predetermined level of the iso-ECP. The iso-ECP is cytotoxic and the cytotoxicity of the iso-ECP is not capable of neutralization by the monoclonal antibodies EG1 and EG2. Anti-iso-ECP antibody which may be used in the diagnostic methods specifically binds to a cytotoxic isoform of ECP having an epitope which is unique for the native form of the cytotoxic iso-ECP.