Abstract: The present invention describes the method for determining the risk of future major adverse cardiovascular events, which comprises detection proteolytic fragments of IGFBP-4 or IGFBP-5 (insulin-like growth factor binding protein 4 or insulin-like growth factor binding protein 5) in patients' blood. The present invention provides antibodies and immunoas-says, suitable for specific measurement of proteolytic fragments of IGFBPs. In current invention the IGFBP fragments are suggested to be utilized as blood biomarkers for the risk prediction of major adverse cardiovascular events (MACE).

Abstract: Novel immuno-interactive fragments of the ?C portion of a mammalian inhibin ? subunit, together with their variants and derivatives, produce antigen-binding molecules that are interactive with the ?C portion, and which are chemically well defined and which can be produced in commercially significant quantities. The antigen-binding molecules of the invention can be used for the detection of a mammalian inhibin and for the treatment and/or prevention of conditions associated with aberrant levels of a mammalian inhibin.

Abstract: A system combining a clonogenic differentiation assay with an instrument-based ATP bioluminescence proliferation assay to produce a standardized colony-forming stem and progenitor cell potency assay is provided.

Abstract: The invention provides assay methods for the detection and quantitation of gastrin hormones, including total and free gastrin hormone in a sample. ELISA-type heterogeneous phase assays suitable for use with biological fluid samples such as blood, plasma or other bodily fluids of a mammal, particularly a human subject are provided. The method provides a precise assay for the amounts of free and total G17 and G34 in biological fluid samples, as well as the amounts of free and total Gly-extended G17, and Gly-extended G34. Also provided are methods of determining suitable treatment for patient suffering from a gastrin hormone-mediated disease or condition employing gastrin hormone immunoassays.

Abstract: The invention relates to methods for determining the progression of cartilage degeneration diseases, such as osteoarthritis and rheumatoid arthritis, by quantitating collagen synthesis and degradation markers in patient samples. One can determine whether a cartilage degeneration condition is progressing, regressing, or remaining stable by quantitating collagen synthesis and degradation markers in patient samples and comparing the value obtained to a reference value. When a joint affected by cartilage degeneration in question expresses collagen synthesis and degradation markers, a change in this value is indicative of a change in the progression of the cartilage degeneration condition. The methods and apparatus of the invention allow accurate determination of the therapeutic effects certain cartilage degeneration drug treatments, including osteoarthritis and rheumatoid arthritis drug treatments, so are also useful for pharmaceutical efficacy studies in mammals.

Abstract: A method of assaying nucleotide receptor P2X7 pore activity in white blood cells contained within a mixed cell sample is provided comprising labeling white blood cells with a white blood cell-specific label; depolarizing the labeled white blood cells with an isotonic depolarizing solution; contacting the labeled white blood cells with dye and a P2X7 agonist in an amount sufficient to activate P2X7 pore activity; contacting the labeled white blood cells with a divalent cation in an amount sufficient to deactivate P2X7 pore activity; and analyzing dye uptake whereby P2X7 pore activity is quantified by the amount of dye taken up in labeled white blood cells treated with the P2X7 agonist relative to labeled white blood cells in the absence of said P2X7 agonist, said P2X7 pore activity being corrected for sample age and by subtraction of P2X7 pore activity contributed by nonviable white blood cells.

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: Bodily fluid is analyzed for the presence of drugs of a selected panel of drugs in a simultaneous assay in which sample of the fluid is incubated with additional amounts of all drugs of the panel, antibodies specific to each of the drugs of the panel, and microparticles, the microparticles being divided into subsets, one subset for each drug in the panel and each subset distinguishable from the others. The incubation is performed in a liquid medium in which competitive binding occurs, the drugs in the sample competing with those added to the assay medium for binding to the antibodies. In one procedure, the added drugs are pre-coupled to the microparticles while the antibodies are not, and the incubation is followed by further incubating the microparticles with labeled ligands that have affinity for the antibodies.

Abstract: The enumeration of cells in fluids by flow cytometry is widely used across many disciplines such as assessment of leukocyte subsets in different bodily fluids or of bacterial contamination in environmental samples, food products and bodily fluids. For many applications the cost, size and complexity of the instruments prevents wider use, for example, CD4 analysis in HIV monitoring in resource-poor countries. The novel device, methods and algorithms disclosed herein largely overcome these limitations. Briefly, all cells in a biological sample are fluorescently labeled, but only the target cells are also magnetically labeled. The labeled sample, in a chamber or cuvet, is placed between two wedge-shaped magnets to selectively move the magnetically labeled cells to the observation surface of the cuvet. An LED illuminates the cells and a CCD camera captures the images of the fluorescent light emitted by the target cells.

Abstract: The invention provides enzymatic methods for direct determination of percentage of glycated hemoglobin in blood samples without the need of a separated measurement of total hemoglobin content in blood samples. The methods utilizes one or two different types of oxidizing agents which selectively oxidize low-molecular weight reducing substances and high-molecular weight (mainly hemoglobin) reducing substances in blood samples, coupled with enzymatic reactions catalyzed by proteases, fructosyl amino acid oxidase. The amount of hydrogen peroxide generated in the reaction is measured for determination of percentage of glycated hemoglobin in blood samples. The invention provides kits for performing the methods of the invention.

Abstract: Whole cell, simultaneous target and drug-target assay using differentially labeled antibodies and flow cytometry. First antibody binds to total target and second antibody binds to the drug binding site of the target, thus drug binding will competitively inhibit the second antibody allowing for a competitive inhibition assay of drug-target binding. The assay allows for whole cell analysis and even analysis of mixed populations of cells, yet provides detailed kinetic assessment of drug activity.

Abstract: Methods for reducing time to result in blood bank diagnostic testing with an agitation device and a low ionic strength solution are disclosed. Specifically provided are methods for reducing incubation time for antigen-antibody reactions in an immunohematologic assay by subjecting the assay reactants to incubation with agitation and optionally additionally a low ionic strength diluent.

Abstract: The present invention provides an approach for the simultaneous determination of the activation states of a plurality of proteins in single cells. This approach permits the rapid detection of heterogeneity in a complex cell population based on activation states, and the identification of cellular subsets that exhibit correlated changes in activation within the cell population. Moreover, this approach allows the correlation of cellular activities or properties. In addition, the use of potentiators of cellular activation allows for characterization of such pathways and cell populations.

Abstract: New applications for the use of distinguishable particulate labels available in a variety of hues and sized in the submicron range are described. These applications include profiling of cellular components, obtaining secretion patterns, identifying a multiplicity of components in chromatographic or electrophoretic techniques and identification of desired immunoglobulin secreting cells.

Abstract: A method to determine specificity of ligand binding includes comparing a solid phase carrier first extract obtained by pre-treating a sample with a ligand-immobilized solid phase carrier and a solid phase carrier second extract obtained by treating the pretreated sample again with a ligand-immobilized solid phase carrier in terms of the proteins contained therein, and identifying a protein whose content is remarkably decreased in the second extract compared to the first extract, in order to solve 1) the problem of the solubility of subject ligand, 2) the problem of the non-specific protein-denaturing effect of the subject ligand added, and the like, in antagonism experiments in target search using an affinity resin.

Abstract: A method of detecting platelet thrombosis or organ failure in a patient suffering from disseminated intravascular coagulation (DIC) or systemic inflammatory response syndrome (SIRS), comprising analyzing a von Willebrand factor-cleaving protease and/or a cleaving factor thereof, is disclosed. A kit for detecting platelet thrombosis or organ failure in a patient suffering from DIC or SIRS, comprising an antibody or a fragment thereof which specifically binds to a von Willebrand factor-cleaving protease, and/or an antibody or a fragment thereof which specifically binds to a cleaving factor of the von Willebrand factor-cleaving protease, is disclosed.

Abstract: Methods and reagents for determining antithrombin III (AT) in body fluids by adding an AT binding partner to the sample and determining the free AT binding partner.

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 negative isolation method for separately isolating preparations of Th1 and Th2 helper lymphocytes from peripheral blood mononuclear cells involving the use of novel combinations of monoclonal antibodies to separately sequester specific Th1 and Th2 lymphocytes and contaminating leukocytes and erythrocytes, adding a magnetic colloid to the cells, and using a magnetic column for fractionation of Th1 and Th2 cells. Imbalances in the relative numbers of Th1 and Th2 lymphocytes can be used in the diagnosis and prognosis of human diseases.

Abstract: Light-generating fusion proteins having a ligand binding site and a light-generating polypeptide moiety and their use as diagnostics, in drug screening and discovery, and as therapeutics, are disclosed. The light-generating fusion protein has a feature where the bioluminescence of the polypeptide moiety changes upon binding of a ligand at the ligand binding site. The ligand may be, for example, an enzyme present in an environment only under certain conditions, e.g., ubiquitin ligase in a hypoxic state, such that the light-generating fusion protein is “turned on” only under such conditions.