Abstract: The invention concerns human monoclonal antibodies to the islet cell antigen IA-2, a process for their production, the use of human monoclonal antibodies in a method for detecting antibodies to IA-2, a method for detecting antibodies to the islet cell antigen IA-2 and a method for detecting the islet cell antigen IA-2 in a sample.

Abstract: The present invention provides nucleic acids encoding B7-related factors that modulate the activation of immune or inflammatory response cells, such as T-cells. Also provided are expression vectors and fusion constructs comprising nucleic acids encoding B7-related polypeptides, including BSL1, BSL2, and BSL3. The present invention further provides isolated B7-related polypeptides, isolated fusion proteins comprising B7-related polypeptides, and antibodies that are specifically reactive with B7-related polypeptides, or portions thereof. In addition, the present invention provides assays utilizing B7-related nucleic acids, polypeptides, or peptides. The present invention further provides compositions of B7-related nucleic acids, polypeptides, fusion proteins, or antibodies that are useful for the immunomodulation of a human or animal subject.

Abstract: Methods for diagnosing and monitoring Alzheimer's Disease in a subject comprising measuring hK6 in a sample from the subject. hK6 may be measured using a reagent that detects or binds to hK6, preferably antibodies reactive with hK6.

Abstract: Assay systems and specialized antibodies for the detection and quantitation of troponin I and troponin T in body fluids as an indicator of myocardial infarction. Since troponin I and T exist in various conformations in the blood, the ratios of the monomeric troponin I an T and the binary and ternary complexes, as well as which form of troponin present in the blood, may be related to the metabolic state of the heart. Disclosed is a system to determine the presence of a troponin form or a group of troponin forms in a sample of whole blood, serum or plasma. Disclosed is a stabilized composition of troponin; the stabilized composition can comprise a stabilized composition of troponin I, wherein the troponin I is oxidized, the troponin I can be unbound or the troponin I can be in a complex. Disclosed is a method for improving the recovery of troponin I or T from a surface used in immunoassays.

Abstract: The present invention relates to a specific C-peptide assay method which can eliminate all interference due to proinsulin and its intermediates, in particular des-31,32-proinsulin and/or des-64,65-proinsulin. It also relates to antibodies for carrying out this assay.

Abstract: A monoclonal antibody which reacts strongly with uracil and thymine but scarcely with N-carbamyl-?-alanine; a hybridoma producing this monoclonal antibody; a method of immunochemically assaying uracil or thymine characterized by using the above-described monoclonal antibody; and diagnostics for DPD deficiency containing the above monoclonal antibody. Because of high sensitivity and specific reaction with uracil and thymine, the above-described monoclonal antibody enables convenient, quick, and selective assaying of uracil and thymine in a sample. The antibody is useful in screening patients with DPD deficient cancer with contraindication to the administration of pyrimidine fluoride-based antitumor agents.

Abstract: The present invention provides a method for qualitative determination of low molecular weight soluble CD14 proteins separately. The present invention also provides antibodies specific to high molecular weight soluble CD14 proteins. Further, the present invention provides a measurement method for specifically determining the quality or quantity of high molecular weight soluble CD14 proteins using the antibodies with high sensitivity, simplicity and specificity.

Abstract: The present invention provides monoclonal antibodies which are highly specific for Bacillus spores. Also provided are peptides derived from those monoclonal antibodies. Both the antibodies and peptides are highly specific and can discriminate between spores of potentially lethal organisms such as Bacillus anthracis and other harmless but closely related bacilli and provide a very powerful tool in the construction of detection instruments as counter measures.

Abstract: Monoclonal antibodies which bind specifically to the extracellular domain of the SIRP cell surface glycoproteins, and which, in some cases, block the interaction of SIRP with the surface molecule CD47, are described.

Abstract: Methods for isolating pancreatic progenitor 1 genes are provided. The pancreatic progenitor 1 nucleic acid compositions find use in identifying homologous or related proteins and the DNA sequences encoding such proteins; in producing compositions that modulate the expression or function of the protein; and in studying associated physiological pathways. In addition, modulation of the gene activity in vivo is used for prophylactic and therapeutic purposes, such as identification of cell type based on expression, and the like.

Abstract: A method for determining the presence and/or concentration of a water treatment polymer in an aqueous sample, comprising producing a polyclonal or monoclonal antibody to the water treatment polymer;, and using the antibody so produced as a reagent in an immunoassay, conducted on the aqueous sample.

Abstract: The invention provides monoclonal antibodies and other binding agents to human cytochrome P450 2C19 having advantageous properties, including capacity substantially to inhibit enzyme activity of human cytochrome P450 2C19 and lack of specific binding to other human cytochrome P450s. The binding agents of the invention are useful inter alia in methods for screening drugs for metabolism by cytochrome P450 2C19, and in methods of measuring P450 2C19 levels in individuals relative to P450 2C19 levels in a control population.

Abstract: Immunoassays and antibodies useful in conducting them for human and canine brain natriuretic peptide are described.

Abstract: The present invention provides an immunoassay for specifically measuring with high sensitivity PIVKA-II in serum or plasma through antigen-antibody reaction by adding an animal serum containing thrombin and/or an antibody reacting with human fibrin-like related substances to the reagents. The immunoassay of the invention comprises the steps of adding thrombin and/or an antibody reacting with human fibrin-like related substances to the reagents, and measuring PIVKA-II in serum or plasma.

Abstract: The present invention concerns a method of treating LBP-mediated LPS-induced myeloid cell activation comprising administering a therapeutically effective amount of an anti-LBP monoclonal antibody molecule. A therapeutic composition comprising anti-LBP antibody molecules in a pharmaceutically acceptable excipient is also contemplated.

Abstract: The invention provides immunological reagents (antibodies) capable of binding to plasmacytoid dendritic cells (pDC), to cell lines which express such antibodies and to a process for identifying and purifying plasmacytoid dendriticcells from tissues containing pDC using such antibodies.

Abstract: The vascular endothelial growth factor (VEGF) activity in a patient's bloodstream or other biological sample can serve as a diagnostic and prognostic index for cancer, diabetes, heart conditions, and other pathologies. Antibody-sandwich ELISA method and kits for VEGF as an antigen were developed to detect VEGF levels in biological samples from animal models and human patients and are used as a diagnostic/prognostic index.

Abstract: There are provided monoclonal antibodies to the LDL receptor which are useful for the identification and purification of LDL and in treatment of e.g. hepatitis C infection.

Abstract: A method and kit for monitoring autoantibodies to thyroid stimulating hormone (TSH) receptor in a sample of body fluid, which employs the steps of: (i) incubating TSH receptor with a sample of body fluid; (ii) reacting the incubated sample of body fluid with at least one binding agent which is capable of binding to the TSH receptor in competitive reaction with TSH receptor autoantibodies (TRAb), or in a case where TSH receptor is complexed to labelled antibody, reacting the sample of body fluid with at least one binding agent which can bind to TRAb in such a way as not substantially to interfere with binding of the TRAb to the TSH receptor; and (iii) detecting bound TRAb in the reacted incubated sample of body fluid.

Abstract: The present invention relates to new CRP immunoassay compositions. The compositions include a low affinity anti-human CRP monoclonal antibody, and an antiidiotypic antibody raised against it. The invention further provides a method for obtaining antiidiotypic monoclonal antibody populations directed to an antibody that is specific for a high concentration, high molecular weight target antigen.

Abstract: The present invention provides a process and regent for analyzing annexin-V, wherein the measurement of a concentration of annexin-V can be easily carried out without need for addition of chemicals for inhibiting the bonding of various proteins with calcium ion and for adjusting a specimen solution to the specimen at a measuring stage, and a process and medicine for diagnosing an internal organ disorder based on the analyzing process and regent. A urine is brought into contact with an anti-annexin-V monoclonal antibody to perform an antigen-antibody reaction of annexin-V in the urine with the anti-annexin-V monoclonal antibody, thereby forming an annexin-V antigen/anti-annexin-V monoclonal antibody complex, and the amount of the formed annexin-V antigen/anti-annexin-V monoclonal antibody complex is quantitatively measured.

Abstract: The invention provides a method for generating and identifying antibodies directed against a B7 antigen having SEQ ID NO. 8 or a fragment of SEQ ID NO. 8, which antibodies inhibit B cells from binding CD28, comprising immunizing an animal with the B7 antigen so as to produce the antibodies; and screening the antibodies for antibodies that bind B7 and inhibit CD28 binding to B cells.

Abstract: Monoclonal antibodies that are specific for a physiological disorder of interest are used to conduct an immunometric assay for antigens correlated with that specific disorder. The invention provides a method which comprises a process having one probe and one target detection. Multiple probes are applied tissue samples without destroying the integrity of the tissue sample. The inventive method utilizes a specific reagent system that is a Probe-Tagging system. This system utilizes a cleavable linker and a specific tagging molecule that upon dissociation may be analyzed using micro-array-based detection systems or other detection methods known within the art.

Abstract: The present invention is drawn to a monoclonal antibody reacting specfically with (1) apoA-I occurring in HDL containing no apoA-II and having a molecular weight of 150,000 or less; and (2) apoA-I not binding to a lipid; a hybridoma producing this antibody; a method of immunologically assaying apoA-I characterized by reacting the antibody with a specimen; and an assay reagent for apoA-I which contains the antibody. The invention realizes measurement of a specific apoA-I, which provides a novel index of lipid metabolism disorder, etc.

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: An immunoassay reagent is obtained whereby a microscale substance such as an antigen or antibody can be assayed at a high sensitivity, and whereby a need to separate a reacted substance, e.g., an immunoreacted substance, from an unreacted substance can be eliminated or such a separation can be simplified. An immunoassay reagent, for use in the quantitative determination of a target antigen or antibody present in a sample, containing an insoluble carrier which carries an enzyme and an antibody or antigen corresponding to the antigen or antibody, an enzyme inhibitor for inhibiting the activity of the enzyme and a substrate with which the enzyme reacts.

Abstract: The invention provides isolated nucleic acid and amino acid sequences of TL-&ggr;, antibodies to TL-&ggr;, methods of screening for TL-&ggr; modulators using biologically active TL-&ggr;, and kits for screening for TL-&ggr; modulators.

Abstract: A method for determining the level of tyrosine kinase activity in a biological sample is disclosed. The method employs an anti-phosphotyrosine antibody as both the capture agent and the detecting agent. The detecting antibody is labeled with a fluorescent label, for instance, Cy5, Cy5.5 or Cy7 or a lanthanide ion, such as europium, as the signal generating entity. The method is particularly well suited to high throughput screening, for example, for compounds which modulate tyrosine kinase activity.

Abstract: A cell culture preparation and methods are provided which are suitable for production in cells of a first protein in a class of proteins where the medium is deficient in a second protein in a related class, where the second protein is normally present in the serum and capable of interfering with the purification of the first compound.

Abstract: The invention is directed to methods of producing a protein by administering a nucleic acid encoding the protein to an animal. Following the administration of the nucleic acid to the animal, the protein is produced in vivo and is isolated by removing a biological sample from the animal. These methods allow for the rapid and efficient production and isolation of a protein encoded by any nucleic acid sequence of interest and can be used to generate antibodies that bind to the protein sequence.

Abstract: A method for purifying proteins by Protein A chromatography is described which comprises the steps of: (a) adsorbing the protein to Protein A immobilized on a solid phase comprising silica or glass; (b) removing contaminants bound to the solid phase by washing the solid phase with a hydrophobic electrolyte solvent; and (c) recovering the protein from the solid phase.

Abstract: This invention provides a method of isolating CD8+ cells which employs an antibody which specifically binds to CD8 molecules present on the surface of CD8+ cells but does not activate the CD8+ cells once bound. This invention also provides related hybridoma cell lines, monoclonal antibodies, antigenic polypeptides, isolated CD8+ cells, and kits.

Abstract: A monoclonal antibody (Mab) capable of binding Placental Protein 13 (pp-13) is disclosed. Also disclosed are hybridoma clone producing the Mab, an immunoassay using the Mab for measuring the level of PP-13 in a biological fluid, and a kit for measuring the level of PP-13 in a biological fluid.

Abstract: Diagnostic systems, methods, polypeptides and antibodies for detecting the presence of C-terminal hGPIIb fragment of the platelet receptor GPIIb-IIIa in a body fluid sample are disclosed.

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: A monoclonal antibody by which medullasin that is a kind of serine proteases existing in granulocytes, production process thereof and an immunoassay of human medullasin using the antibody are disclosed. The monoclonal antibody specifically recognizes human medullasin. The process for producing the anti-human medullasin antibody comprises culturing hybridomas prepared by cell fusion between antibody-producing cells recovered from an animal immunized with human medullasin and myeloma cells, and recovering anti-human medullasin monoclonal antibody which specifically recognizes human medullasin from the culture in which the hybridomas are cultured. The immunoassay utilizes the anti-human medullasin antibody.

Abstract: The invention relates to a method of generating human monoclonal antibodies suitable as therapeutic candidates from a pool of human peripheral blood lymphocytes extracted from a number of individuals who have all been exposed to the same disease antigen. Peripheral blood lymphocytes extracted from said individuals are immortalized, and a high throughput functional screening assay of the immortalized lymphocytes against target cells associated with or affected by the disease is peformed, in which the target cells are coated onto microbeads and placed in wells formed in one of the ends of a bundle of optical fibers, and wherein changes to the target cells resulting from the assay can be optically detected at the opposite end of the bundle. The immortalized lymphocytes producing human antibodies having specific, desired effects on the target cells, as determined by the assay are selected, grown, and the antibodies are further characterized, in order to select therapeutic candidate antibodies.

Abstract: It has been found that casein and salts of casein are useful as replacements for, or in addition to, BSA as materials for coating solid phases, particularly magnetic particles, used for immunoassays and other binding assays for separation of the desired analyte. By using casein, immunoassays having improved stability and few discordant samples have been developed. Casein used at a concentration of 0.05-4.0 grams per gram of paramagnetic particle (optimally approximately 0.78-1.2 grams of casein per gram of magnetic particle) has been found to confer this benefit. In addition, a process for coating solid phases has been invented, said process comprising the mixing of casein with magnetic particles at 30-60° C. for 5-180 hours, said process resulting in casein-coated paramagnetic particles which either (1) already have combined therewith active ingredients needed in the binding assay or (2) are capable of reacting with active ingredients needed in the binding assay.

Abstract: The differential expression of marker proteins in a targeted population provides a means of identifying and isolating cells. A population of cells associated with the regeneration of pancreatic islets is shown to express certain proteins, including the cell surface proteins ErbB2, ErbB3, and ErbB4; and the nuclear protein Msx-2. Populations of isolated pancreatic islet progenitor cells find use in screening assays, to characterize genes involved in islet development and regulation, and in transplantation to provide a recipient with pancreatic islet functions.

Abstract: The invention provides an antibody having an affinity to water treatment polymers. The antibodies of the invention are used in assays to determine the presence or concentration of a water treatment polymer in a fluid or aqueous system.

Abstract: The invention relates to a method and a kit for the diagnosis of endometriosis using blood and endometrial leukocyte markers or a combination thereof. The marker is a surface antigen from endometrial or blood leukocytes.

Abstract: Immunoassays for malondialdehyde-modified low density lipprotein (MDA-modified LDL) and oxidized low density lipprotein (OxLDL), monoclonal antibodies (and the cell lines for them) for use in the assays, and a storage-stable standard (which may be used as a calibrator and/or control) are disclosed. MDA-modified LDL and OxLDL are implicated in atherosclerosis and its etiology.

Abstract: The present invention is directed to a method for purifying polysaccharides capable of inducing the production of high titers of opsonic antibodies that kill strains of enterococcal bacteria. In addition, the invention is directed to the antigens produced by this purification method and to vaccines which utilize such antigens.

Abstract: A method of making antibodies to hirudin by immunizing with an immunogenic composition containing polymerized hirudin monomers in the absence of carrier protein is taught.

Abstract: The invention provides a novel human Mab Fab, cloned by phage display, and its use in diagnostic and therapeutic methods. In particular the invention provides a method for analyzing the OxLDL components of atherosclerotic plaques in vivo and a means to determine their relative pathology. As the method is based on a human Fab rather than a mouse Mab, the progress or regression of the disease may be monitored over time. The antibody may also be used for the analysis of surgical or serum samples ex vivo for the presence of OxLDL. The antibody may also be used to target therapeutic agents to the site of atherosclerotic plaques or may have use as a therapeutic agent itself.

Abstract: The invention concerns the stabilization and amplification of electrochemiluminescence signals in detection methods.

Abstract: The invention relates to monoclonal antibody capable of specific binding to the molecular weight of 20 kDa variant of human growth hormone. This monoclonal antibody has no substantial binding to hGH of molecular weight 22 kDa. The invention also relates to the use of this monoclonal antibody for measurement of hGH 20K, especially in body fluids. The antibodies can be used for detection and quantification of hGH 20K, especially in serum.

Abstract: A novel monoclonal antibody that specifically recognizes phosphatidylinositol-3,4-biphosphate (PI-3,4-P2) but does not cross-react with structurally similar phospholipid antigens is advantageous for PI-3,4-P2-specific immunoassay. The gene in the variable regions of the monoclonal antibody has been identified, which enables producing recombinant antibodies.

Abstract: This invention relates to the production of polyclonal and monoclonal antibodies to specific sites of rapamycin (Sirolimus). The reactivity of these poly and monoclonal antibodies make them particularly useful for immunoassays for therapeutic drug monitoring (TDM). These immunoassays or TDM kits may include polyclonal or monoclonal antibodies to specific sites of rapamycin. These kits may also include various combinations of polyclonal antibodies, polyclonal and monoclonal antibodies or a panel of monoclonal antibodies. Rapamycin conjugate immunogens are prepared for the immunization of a host animal to produce antibodies directed against specific regions of the rapamycin molecule. By determining the specific binding region of particular antibody, immunoassays which are capable of distinguishing between the parent molecule, active metabolites, inactive metabolites and other structurally similar immunosuppressant compounds are developed.

Abstract: Methods are disclosed for sterilizing preparation of monoclonal immunoglobulins to reduce the level of active biological contaminants such as viruses, bacteria, yeasts, molds, mycoplasmas, prions and parasites.