Abstract: Systems and methods for medical diagnosis or risk assessment for a patient are provided. These systems and methods are designed to be employed at the point of care, such as in emergency rooms and operating rooms, or in any situation in which a rapid and accurate result is desired. The systems and methods process patient data, particularly data from point of care diagnostic tests or assays, including immunoassays, electrocardiograms, X-rays and other such tests, and provide an indication of a medical condition or risk or absence thereof. The systems include an instrument for reading or evaluating the test data and software for converting the data into diagnostic or risk assessment information.

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: Methods and reagents for rapid purification and/or identification of particles in a liquid sample are described. The technique uses centrifugation to concentrate particles against a slanted surface having an agent specifically binding to the particles. This method is applicable for the rapid identification of viruses and other difficult or impossible to culture microorganisms without replication or amplification of the microorganism.

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: This invention relates to an improved method and system for sensing of one or more analytes. A host molecule, which serves as an adapter/carrier, is used to facilitate interaction between the analyte and the sensor element. A detectable signal is produced reflecting the identity and concentration of analyte present.

Abstract: A liquid composition comprising a colloidal suspension of a biomolecule-binding matrix material (preferably nitrocellulose) dispersed in a liquid, with particles of the matrix material being of a defined particle size, and replicate copies of a biomolecule, e.g., protein or nucleic acid probes, which are distributed, preferably uniformly, throughout the colloidal suspension and are bound to the matrix material particles, is disclosed. The liquid composition of the invention can be used directly for sample analysis or preparation of biomolecules, or aliquots of the composition can be spotted onto a support to form a microporous matrix system or microarray for analysis or preparation of biomolecules. Compositions and microarrays according to the invention are useful in any type of analytical or preparative procedure relating to biomolecules. They are particularly useful, e.g.

Abstract: A method for judging an autoimmune disease by detecting the existence of an anti-Reg protein autoantibody in a specimen; and a method for judging insulin-dependent or non-insulin-dependent diabetes mellitus. A method for detecting an anti-Reg protein autoantibody by bringing into a specimen into contact with an antigen component and detecting the formation of an immune complex. A reagent for diagnosing autoimmune disease which contain an antigen component capable of binding specifically to the anti-Reg protein autoantibody; and a reagent for diagnosing insulin-dependent or non-insulin-dependent diabetes mellitus.

Abstract: Methods of using a complex (scuPA/suPAR) which has thrombolytic activity under physiological conditions and in the presence of IgG, or of at least one IgG-derived peptide, which complex comprises a single chain urokinase type plasminogen activator (scuPA) and a soluble urokinase plasminogen activator receptor (suPAR), for the treatment and/or prevention of thromboembolic disorders associated with the formation of fibrin clots are disclosed.

Abstract: A method for analyzing blood enables one to isolate, detect, enumerate and confirm under magnification the presence of target cells which have expressed surface epitopes that indicate intracellular infection by various viruses or other infectious agents, and also cells which have expressed surface epitopes that indicate the presence of non-infectious medical conditions. The analysis involves the examination of cells in the blood sample for the presence or absence of particular surface epitopes while the blood sample is disposed in a centrifuged blood sampling container. The epitopic analysis for the presence or absence of infected cells, or cells which indicate the presence of non-infectious medical conditions relies on the detection of known target expressed epitopes. The target epitopes on the target cell types are epitopes which are also known to be absent on normal circulating cells in the blood.

Abstract: This invention provides a simple and convenient, single stage, single vessel cell extraction and assay method which is suitable for the extraction and measurement of a range of different types of analyte which occur as cellular components. The invention also provides kits of reagents suitable for performing cellular extraction and measurement as a single stage, single vessel process.

Abstract: Arrays of protein-capture agents useful for the simultaneous detection of a plurality of proteins which are the expression products, or fragments thereof, of a cell or population of cells in an organism are provided. A variety of antibody arrays, in particular, are described. Methods of both making and using the arrays of protein-capture agents are also disclosed. The invention arrays are particularly useful for various proteomics applications including assessing patterns of protein expression and modification in cells.

Abstract: A method is disclosed for determining whether a compound binds to a lipoprotein such as LDL or VLDL in a manner which will lower plasma cholesterol. The method provided includes assessing the ability of the compound to form a complex with the lipoprotein, and then determining whether the newly formed complex causes a change in the structure of apoB-100 that results in increased binding affinity to an LDL receptor.

Abstract: The present invention relates to a method for releasing a ligand from a complex of the ligand with an endogenous protein using a releasing agent.

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 total reflection cell has a total reflection prism on at least one surface thereof. A mixed solution containing a gold colloid labelled antibody which is adsorbed on a gold colloid is stored in the total reflection cell, and a sample solution containing an antigen causing antigen-antibody reaction with the antibody is added thereto for forming a gold colloid labelled immune complex. A measuring beam is introduced into the total reflection prism from an incident optical system at an angle ? of incidence causing total reflection and an outgoing beam from the total reflection prism is received by a measuring optical system, thereby measuring absorption by the gold colloid labelled immune complex and carrying out qualification and determination of the antigen.

Abstract: Newly elucidated sequences of hepatitis C virus type 4 and type 5 are described, together with those of a newly discovered type 6. Unique type-specific sequences in the NS4, NS5 and core regions enable HCV detection and genotyping into types 1 to 6. Antigenic peptides and immunoassays are described.

Abstract: A method for the detection of an analyte of interest in a sample, which method comprises the steps of: (1) forming a composition comprising (a) a sample, (b) at least one substance selected from the group consisting of (i) added analyte of interest or an analog of the analyte of interest, (ii) a binding partner of the analyte of interest or its said analog, and (iii) a reactive component capable of binding with (i) or (ii), wherein one of said substances is linked to a label compound having a chemical moiety capable of being induced to luminesce, and (c) a plurality of particles capable of specifically binding with the analyte and/or a substance defined in (b) (i), (b) (ii), or (b) (iii); (2) inducing the label compound to luminesce; and (3) measuring luminescence emitted by the composition to determine the presence of the analyte of interest in the sample.

Abstract: Disclosed is apparatus and method for controlled surface plasmon resonance analysis having a surface plasmon resonance sensor (200) with a derivatized surface plasmon layer (116) in optical communication with the sensor, derivatizing the surface plasmon layer and placing an analyte detection chamber (102) in fluid communication with the derivatized surface plasmon layer. The chamber is adapted (118, 120) for the generation of a molecular interaction bias across the chamber. A conjugate is provided between an analyte and a bias responsive element, wherein the analyte is reactive with the derivatized surface plasmon layer and the bias responsive element changes the response of the analyte to the molecular interaction bias. A conjugated analyte may be introduced into the chamber, generating a molecular interaction.

Abstract: A sample solution treating instrument is provided for facilitating rapid and simplified adjustment of the condition of a sample solution proper for analysis with a biosensor before supplying the solution to the biosensor. The sample solution treating instrument includes, for example, a catalyst or an adsorbent which can remove any interfering substance in order to adjust the sample solution for measurement with a biosensor.

Abstract: A method for measuring low levels of a substance in a sample includes the formation of a rotor from paramagnetic particles in a substantially uniform magnetic field. The rotor is rotated by rotating the substantially uniform magnetic field. A portion of the substance in a sample is bound to the paramagnetic particles, and a signal having a time-varying component is detected. The signal is then processed using a lock-in amplifier with a reference signal having a frequency twice that of the rotation of the magnetic field. This improves the signal-to-noise ratio of the time-varying component of the signal.

Abstract: Anti-Fas (APO-1, CD95) autoantibodies arm found in human s, which antibodies arm biologically functional. Peptide fragments of Fas recognized by such antibodies, and antibodies specific for such peptides, inhibit or promote apoptosis and cellular proliferation. Assay methods making use of Fas peptides or antibodies enable identification of further agents which modulate apoptosis and/or cellular proliferation.

Abstract: The use of impedance measurements to detect the presence of pathogens attached to antibody-coated beads. In a fluidic device antibodies are immobilized on a surface of a patterned interdigitated electrode. Pathogens in a sample fluid streaming past the electrode attach to the immobilized antibodies, which produces a change in impedance between two adjacent electrodes, which impedance change is measured and used to detect the presence of a pathogen. To amplify the signal, beads coated with antibodies are introduced and the beads would stick to the pathogen causing a greater change in impedance between the two adjacent electrodes.

Abstract: The use of impedance measurements to detect the presence of pathogens attached to antibody-coated beads. In a fluidic device antibodies are immobilized on a surface of a patterned interdigitated electrode. Pathogens in a sample fluid streaming past the electrode attach to the immobilized antibodies, which produces a change in impedance between two adjacent electrodes, which impedance change is measured and used to detect the presence of a pathogen. To amplify the signal, beads coated with antibodies are introduced and the beads would stick to the pathogen causing a greater change in impedance between the two adjacent electrodes.

Abstract: A method of single parameter and multiparameter characterizing of cells, particularly immunophenotyping of cells, is provided. The method preferably uses antibody coated microspheres which are adapted to bind to specific types of cells. One or more sets of coated microspheres are added simultaneously or sequentially to a suspension of cells and bind the cells they are adapted to bind. Cells may bind to one or more microspheres. The suspension is then filtered to trap bead-cell complexes. The complexes are preferably stained and then examined to characterize the cells, preferably the cells bound to the microspheres. A kit and apparatus for performing the method are also provided.

Abstract: The invention is directed to a method and device for simultaneously testing a sample for the presence, absence, and/or amounts of one or more a plurality of selected analytes. The invention includes, in one aspect, a device for detecting or quantitating a plurality of different analytes in a liquid sample. The device includes a substrate which defines a sample-distribution network having (i) a sample inlet, (ii) one or more detection chambers, and (iii) channel means providing a dead-end fluid connection between each of the chambers and the inlet. Each chamber may include an analyte-specific reagent effective to react with a selected analyte that may be present in the sample, and detection means for detecting the signal. Also disclosed are methods utilizing the device.

Abstract: This invention provides methods of retentate chromatography for resolving analytes in a sample. The methods involve adsorbing the analytes to a substrate under a plurality of different selectivity conditions, and detecting the analytes retained on the substrate by desorption spectrometry. The methods are useful in biology and medicine, including clinical diagnostics and drug discovery.

Abstract: A device for detecting the presence of an antigen including (1) a cell having antibodies which are expressed on the surface of the cell and are specific for the antigen to be detected, where binding of the antigen to the antibodies results in an increase in calcium concentration in the cytosol of the cell, the cell further having a emitter molecule which, in response to the increased calcium concentration in the cytosol, emits a photon; (2) a liquid medium for receiving the antigen and in which the cell is immersed; and (3) an optical detector arranged for receiving the photon emitted from the cell.

Abstract: The present invention provides methods whereby the positions of peptide amide groups that are labeled with a heavy hydrogen in a polypeptide or protein can be localized at high resolution. The methods are useful for determining which peptide amide groups in a polypeptide or protein are accessible to solvent, mapping the binding site and/or binding surface of a binding protein, and/or studying allosteric or other conformational changes in a polypeptide or protein which alter the rates at which certain peptide amide hydrogens exchange with solvent.

Abstract: A diagnostic method and device for use in detecting or quantitating an analyte present in a liquid sample. The method includes reacting an analyte-containing sample with reagents capable of generating a first coil-forming peptide in solution form. This peptide is then contacted with a biosensor whose detection surface has surface-bound molecules of a second, oppositely charged coil-forming peptide, under conditions effective to form a stable &agr;-helical coiled-coil heterodimer on the detection surface. The formation of the coiled-coil heterodimer produces a measurable change in biosensor signal, which is measured to detect the presence of or quantitate the amount of analyte in a sample. Also disclosed is a biosensor device for carrying out the reaction.

Abstract: The present invention describes a method for the binding of pathogenic microorganisms and their toxic proteins with ligands that have been covalently tethered at some distance from the surface of a substrate: distances of at least fifteen Å are required for microorganism binding ligand tethers and at least six Å are required for protein binding ligand tethers. The ligands described herein include heme compounds, siderophores, polysaccharides, and peptides specific for toxic proteins, outer membrane proteins and conjugated lipids. Non-binding components of the solution to be analyzed are separated from the bound fraction and binding is confirmed by detection of the analyte via microscopy, fluorescence, epifluorescence, luminescence, phosphorescence, radioactivity, or optical absorbance. By patterning numerous ligands in an array on a substrate surface it is possible to taxonomically identify the microorganism by analysis of the binding pattern of the sample to the array.

Abstract: Arrays of protein-capture agents useful for the simultaneous detection of a plurality of proteins which are the expression products, or fragments thereof, of a cell or population of cells in an organism are provided. A variety of antibody arrays, in particular, are described. Methods of both making and using the arrays of protein-capture agents are also disclosed. The invention arrays are particularly useful for various proteomics applications including assessing patterns of protein expression and modification in cells.

Abstract: Am improved agglutination immunoassay is characterized by reacting a sample fluid which may contain an analyte with a generic antibody conjugated to latex particles and then adding an antibody specific to the analyte to be determined. Agglutination resulting from adding the antibody specific to the analyte is measured and correlated with the amount of analyte in the sample.

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: The invention provides methods of separating and isolating protein from at least three subcellular compartments of a single biological sample in a single container. Methods are also provided for determining the subcellular compartmentalization of proteins of interest in a biological sample. Furthermore, methods are provided for fingerprinting a biological sample, as well as identifying a sample type, a cancerous tissue or a developmental stage of a tissue sample. Kits for separating and isolating subcellularly compartmentalized proteins in a biological sample are also provided.

Abstract: Compositions of matter and methods for enhancing bioassay performance are disclosed. More particularly, the composition of matter comprises a molecularly compact polymer-ligand conjugate capable of self-orienting on a surface to improve the orientation of the ligand/receptor binding domains within the bioassay at the nanoscopic level. In a preferred embodiment, the molecularly compact polymer comprises a dendrimer polymer such as a fifth generation polyamidoamine dendrimer having exterior surface hydroxyl and amine functional groups, and the ligand/receptor comprises an antibody or Fab.

Abstract: A colloidal system for detection of a variety of analytes involves techniques which permit reconstitution of a desiccated substance such as for surface enhanced Raman spectroscopic analysis and multiple sensors at once, each having different spectra through the use of markers or the like. Competitive assay techniques and a variety of substances are explained to permit a practical an versatile system which can also be used for immunological assays and can include antibodies tagged to provide spectroscopic indicia.

Abstract: There is provided an immunoassay by which the amount of human medullasin present inside granulocytes, which are one leukocyte component in blood, can be determined with high accuracy and with good reproducibility. Also provided is an immunoassay of medullasin, wherein when measuring the medullasin in blood using an anti-human medullasin antibody, the determination of the amount of human medullasin in a blood sample using said anti-human medullasin antibody is carried out after treating the blood sample with an aqueous liquid having a specific osmotic pressure different to the osmotic pressure of blood to completely break up the leukocytes. Also provided is a method of diagnosing multiple sclerosis characterized in that the human medullasin content of a blood sample is measured using an immunoassay, and the onset of multiple sclerosis and the extent of the disease is diagnosed according to the size of, or changes in, this measured value.

Abstract: This invention pertains to chemometric methods for the analysis of chemical, biochemical, and biological data, for example, spectral data, for example, nuclear magnetic resonance (NMR) spectra, and their applications, including, e.g., classification, diagnosis, prognosis, etc., especially in the context of atherosclerosis/coronary heart disease.

Abstract: An ultrasonic energy source is used to provide a variable force for measuring the binding forces between molecular entities and for sensing the presence of an analyte in a test sample. The device includes a surface that has a first binding member attached thereto and one or more particles that have a second binding member attached thereto. A reaction vessel is provided for exposing the surface to the particles whereby, if the first binding member has a binding affinity for the second binding member, a complex is formed between individual first binding members and individual second binding members and the particles thereby become immobilized with respect to the surface. The ultrasonic energy source is positioned for applying a variable ultrasonic force onto the surface, and the position of the particles is monitored as the intensity of the ultrasonic force is varied.

Abstract: Methods are disclosed which separate and identify lipoproteins in biological samples. An ultracentrifuge density gradient is used to separate lipoprotein fractions. The fractions are visualized, resulting in a lipoprotein profile. The fractions can be further analyzed by a wide array of laboratory and clinical methods. The lipoprotein profile can be used in clinical diagnoses and other medical applications.

Abstract: The present invention provides a method of measuring the dissolution rate of an analyte in a non-aqueous liquid composition and in particular to in vitro methods for measuring the dissolution rate of a drug in a sustained release dosage form.

Abstract: Immunoassay displacement methods for detecting (preferably identifying) the presence or amount of a target analyte (e.g. drug) in a sample comprising the steps of: (a) exposing the sample to a complex comprising an immobilized antibody capable of specifically binding the analyte, said antibody being specifically bound to a displacement agent, wherein said agent comprises: (I) an analyte analog capable of specifically binding the antibody, (ii) a surface enhanced resonance raman scattering (SERRS) or a surface enhanced raman scattering (SERS) active label, (iii) a SERRS or SERS surface-seeking group (e.g. benztriazole), whereby any analyte present in the sample causes the displacement of agent from the antibody; (b) exposing any displaced agent to a SERRS or SERS surface; and, (c) detecting any displaced agent associated with said surface using SERRS or SERS. In preferred forms of the invention several target analytes are detected from a single source or sample simultaneously.

Abstract: The present invention provides monocyclic, bicyclic and oligomeric amine compounds with at least two sites of diversity. These compounds are formed from monocyclic scaffolds which can be cyclized to form bicyclic amine scaffolds. These can then be reacted with building blocks to form the amine compounds of the invention. This invention further provides libraries or monocyclic, bicyclic and oligomeric amine compounds. Also provided are methods for preparing monocyclic, bicyclic and oligomeric amine compounds and libraries thereof. The present invention also provides pharmaceutical compositions of the monocyclic, bicyclic and oligomeric amine compounds.

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: A method for counting leukocytes which comprises liberating elastase from granulocytes contained in a specimen, adding an anti-granulocyte elastase antibody to the thus liberated elastase, measuring the antibody bonded to the elastase to thereby determine the concentration of the elastase, and then calculating therefrom the number of leukocytes contained in the specimen with the use of the ratio of the leukocyte count to the elastase concentration. This method makes it possible to conveniently and less expensively count leukocytes at a high accuracy comparable to the one established by using a conventional automatic blood cell counter, as the figure shows.

Abstract: The present invention relates to novel methods and devices for differentiating in a patient parathyroid diseases, such as hyperparathyroidism and related bone diseases, from normal or non-disease states. One detects whole or non-fragmented (1 to 84) parathyroid hormone in a biological sample and also a large non-whole parathyroid hormone peptide fragment that can function as a parathyroid hormone antagonist. By either comparing values or using independently the value of either the large non-whole parathyroid hormone peptide fragment, the whole parathyroid hormone, or the combination of these values one is able to differentiate parathyroid and bone related disease states, as well as differentiate such states from normal states.

Abstract: Staphylococcus aureus virulence genes are identified, thereby allowing the identification of novel anti-bacterial agents that target these virulence genes and their products, and provision of novel S. aureus mutants useful in vaccines.

Abstract: Methods for determining the strongly hydrophobic pulmonary surfactant protein SP-C, SP-C specific antibody and a reagent kit for carrying out the methods are described.

Abstract: A method for determining and diagnosing inflammatory enteric disease using an immunochromatographic test device having a multiplicity of test zones. The method tests for the presence of at least one enteric pathogen and at least one of certain inflammatory enteric disease markers. The enteric pathogens tested for can be any number of enteric pathogens such as the pathogens E. coli O157, Campylobacter, Salmonella, Listeria, Shigella, and Yersinia. The inflammatory enteric disease markers tested for are fecal lactoferrin, a bacteria marker, a virus marker, and a protozoa marker. Positive results for any one of the pathogens indicates that pathogen as the cause of the inflammatory enteric disease. Positive results for fecal lactoferrin indicate an inflammatory condition of the intestines. Positive results for the bacteria, virus, protozoa markers indicate respectively a bacterial, viral, or protozoan cause of infection as the cause of the disease.

Abstract: A synthetic urine formulation, a kit including the synthetic urine formulation and a method of preparing synthetic urine are described. The urine formulation includes urine components in dried form, concentrated form or normal concentration and a compound that, when added to water, increases the temperature of the water (a “heat activator”). When the urine components are present in dried form, the synthetic urine can be provided in one or two parts. When present in concentrated form or in normal concentration, the heat activator must be provided separately. Lithium chloride is a preferred heat activator. The components can be provided in kit form, including a measuring cup with a fill line, the powdered, concentrated or normal concentration synthetic urine components, and the heat activator. Optionally, but preferably, the kit also includes a temperature measuring device to ensure that the appropriate temperature is reached.