Abstract: Hemoglobin, its variants, and glycated forms of each are determined individually in a multiplex assay that permits correction of the measured level of HbA1c to account for glycated variants and other factors related to the inclusion of the variants in the sample. New antibodies that are particularly well adapted to the multiplex assay are also provided.

Abstract: The invention relates to a method for detecting a plurality of antigenic molecules carried by erythrocytes and/or a plurality of anti-erythrocyte antibodies, said antigenic molecules carried by the erythrocytes consisting of antigenic molecules carried not only by the erythrocytes, but also by at least one other cell population, other than the blood group antigen molecules, said method comprising bringing a sample into contact with distinguishable beads, on which are attached a) antibodies specific for said antigens, or b) erythrocytes or erythrocyte membrane fragment.

Abstract: The invention relates to a method for detecting a plurality of antigenic molecules carried by erythrocytes and/or a plurality of anti-erythrocyte antibodies of an individual, comprising bringing a sample into contact with distinguishable beads, on which are attached a) antibodies specific for said antigens, or b) erythrocytes, erythrocyte membrane fragments or blood group antigens.

Abstract: A method and system for performing a serological agglutination assay in a liquid sample. The system provides a simple method for creating an in-situ sample/reagent admixture within a sample analysis chamber without the use of any precision fluid-handling components.

Abstract: The invention provides a device and method for the rapid identification of patients suspected of having thalassemia. The invention provides a test strip for the aqueous detection of thalassemia related proteins in whole blood. The test strip includes antibodies specific to the gamma 4, (?4) protein and provides easy visual discrimination between a positive result and a negative result. The invention can be used in remote or clinical settings.

Abstract: Endothelial cells are detected in a blood sample by enriching the endothelial cells from the blood sample followed by performing on the enriched endothelial cells an immunoassay capable of detecting antigens expressed by the endothelial cells. The immunoassay is capable of detecting antigen expressed from 300 endothelial cells per milliliter of blood. The method can be used for assaying mature circulating endothelial cells or circulating endothelial progenitor cells.

Abstract: A method for measuring glycated hemoglobin includes hemolyzing a blood sample with a hemolysate; reacting the hemolyzed blood sample with bead conjugates in which beads are conjugated with glycated hemoglobin binding materials; measuring the amount of total hemoglobin in the reacted blood sample; isolating normal hemoglobin from the glycated hemoglobin conjugated with the bead conjugates; measuring the amount of glycated hemoglobin isolated from the normal hemoglobin; and determining the percentage of the glycated hemoglobin in the blood sample on the basis of the measured amounts of total hemoglobin and glycated hemoglobin. The isolation of normal hemoglobin is performed by absorbing the normal hemoglobin using an absorption pad that is a porous pad having pores, each of which has a size greater than the size of the normal hemoglobin and smaller than the size of the bead.

Abstract: The methods of the disclosure provide fluorescence-based assays for calcineurin activity, especially in isolated T cells. The methods include the stimulation of the T cells with agents that specifically target the TCR with or without influencing co-stimulatory pathways. One TCR agonist is monoclonal antibodies specific for CD3, which more precisely distinguish the inducible activity of calcineurin than does an alternative method targeting the T cell receptor (CD3) combined with CD28 costimulation. This method more accurately distinguishes between the measured level of calcineurin activity of T cells from immunosuppressed transplant recipients and normal individuals, and thus has improved diagnostic accuracy with respect to the response of an individual to immunosuppressant therapy following an organ transplant.

Abstract: The present invention provides a method for reducing undesirable light emission from a sample using at least one photon producing agent and at least one photon reducing agent (e.g. dye-based photon reducing agents). The present invention further provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one collisional quencher. The present invention also provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one quencher, such as an electronic quencher. The present invention also provides a system and method of screening test chemicals in fluorescent assays using photon reducing agents. The present invention also provides compositions, pharmaceutical compositions, and kits for practicing these methods.

Abstract: The present invention relates to methods, compositions and kits for affinity isolation, affinity purification and affinity assay based on microbubbles coated with an affinity molecule. Particularly, the invention provides protein microbubbles coated with an affinity molecule. In addition, the invention provides glass microbubbles coated with an affinity molecule. Methods of using the microbubbles of the invention for isolating analytes and cells are specifically provided.

Abstract: A method of detection comprising a conjugate of a randomly and asymmetrically branched dendritic polymer.

Abstract: The present invention relates generally to microfluidic structures, and more specifically, to microfluidic structures and methods including meandering and wide channels. Microfluidic systems can provide an advantageous environment for performing various reactions and analysis due to a reduction in sample and reagent quantities that are required, a reduction in the size of the operating system, and a decrease in reaction time compared to conventional systems. Unfortunately, the small size of microfluidic channels can sometimes result in difficulty in detecting a species without magnifying optics (such as a microscope or a photomultiplier). A series of tightly packed microchannels, i.e., a meandering region, or a wide channel having a dimension on the order of millimeters, can serve as a solution to this problem by creating a wide measurement area.

Abstract: Methods and apparatuses for determining whether a fluid has been introduced into an assay measurement apparatus involving delivering a fluid to a surface of a resonant device. The methods also involve monitoring an electrical signal output by the resonant device, wherein properties of the electrical signal vary based on physical properties of the fluid in contact with the surface of the resonant device and determining if the electrical signal output by the resonant device satisfies a predetermined condition indicative of the presence of the fluid.

Abstract: Methods and devices for reducing interference from leukocytes in an analyte immunoassay are provided. In one embodiment, a method is provided comprising the steps of amending a biological sample with magnetic sacrificial beads opsonized to leukocytes, binding leukocytes in the sample to the magnetic sacrificial beads, and magnetically retaining the beads out of contact from an immunosensor.

Abstract: Luminescence assays and compositions for assay of biomolecular interaction and activity and detection of modulators of biomolecular interaction and activity are provided. Technology described herein has utility in a variety of assay formats and types, for example, simultaneous monitoring multiple parameters which affect interaction and activity of biological molecules. Compositions and methods are provided herein which include a first solid-phase support associated with a first specific binding agent and a photosensitizer; a second solid-phase support associated with a second specific binding agent and a first emission system; and a third solid-phase support associated with a third specific binding agent and a second emission system.

Abstract: This invention refers to continuous flow devices for detecting and/or removal of contaminants from a liquid stream. The device comprises a cartridge with an inlet and outlet for the liquid stream, a radiation incident and emerging wall portion and optically transparent support material packed in the cartridge such that a liquid stream can pass between voids or spaces formed within the optically transparent material, as well as a radiation source and detector. The support material comprises molecules for capturing at least one contaminant on the surface of the support material and each of the capture molecules comprises at least one reporter group which emits a signal upon binding of the contaminant. Another form of the invention refers to a rotatable support within the liquid stream.

Abstract: A surface grafted conjugated polyelectrolyte (CPE) is formed by coupling a CPE by a coupling moiety to the surface of a substrate. The substrate can be of any shape and size, and for many uses of the surface grafted CPE, it is advantageous that the substrate is a nanoparticle or microparticle. Surface grafted CPEs are presented that use silica particles as the substrate, where a modified silane coupling agent connects the surface to the CPE by a series of covalent bonds. Two methods of preparing the surface grafted CPEs are presented. One method involves the inclusion of the surface being modified by the coupling agent and condensed with monomers that form the CPE in a grafted state to the substrate. A second method involves the formation of a CPE with terminal groups that are complimentary to functionality that has been placed on the surface of the substrate by reaction with a coupling agent. The surface grafted CPEs are also described for use as biosensors and biocides.

Abstract: The present invention is related to compositions useful for the measurement of free or unbound analyte concentrations in a fluid. The present invention includes the use of capture ligands and stabilizing agents to improve the accuracy of analyte concentration assays. Methods and tools for using the present invention are also disclosed.

Abstract: Disclosed herein are compositions and methods for combining the output obtained from redundant sensor elements in a sensor array.

Abstract: A gel microdrop composition is provided. In certain embodiments, the gel microdrop composition contains a polymer matrix, an effector particle that releases an effector molecule into the polymer matrix, a first reporter particle that emits a first optically detectable signal and a second reporter particle that emits a second optically detectable signal that is distinguishable from the first optically detectable signal, where the effector particle and said first and second reporter particles are encapsulated by the polymer matrix. Methods of screening that employ the gel microdrop composition and methods of making the gel microdrop composition are also disclosed.

Abstract: Viscosity of a test body solution spotted onto a test piece is detected. The test piece has an insoluble support, through which the test body solution is developed, and a test region formed on the insoluble support, the test region reacting with an analyte in the test body solution and undergoing coloration. A washing liquid is fed to the test region and its neighboring regions at the time between a stage, at which the test body solution has been developed through the test region, and a stage, at which a liquid for amplifying the coloration state of the test region is fed to the test piece, such that the quantity of the washing liquid fed to the test region and its neighboring regions is set to be large as the detected viscosity becomes high.

Abstract: Devices, systems, kits, and methods for detecting and/or identifying a plurality of spectrally labeled bodies well-suited for performing multiplexed assays. By spectrally labeling the beads with materials which generate identifiable spectra, a plurality of beads may be identified within the fluid. Reading of the beads is facilitated by restraining the beads in arrays, and/or using a focused laser.

Abstract: A non-specific adsorption inhibitor of formula (1), wherein n is a real number of 4 to 2,000, R1 and R2 individually represent a hydrogen atom or a group comprising 1 to 11 amino group(s) or imino group(s), or both, provided that the total number of amino groups and imino groups contained in R1 and R2 is 2 to 11. Non-specific adsorption inhibitor composition, probe-bonded particles.

Abstract: Methods and devices for reducing interference from leukocytes in an analyte immunoassay are provided. In one embodiment, a method is provided comprising the steps of amending a biological sample with magnetic sacrificial beads opsonized to leukocytes, binding leukocytes in the sample to the magnetic sacrificial beads, and magnetically retaining the beads out of contact from an immunosensor.

Abstract: The invention is directed to methods and devices for reducing interference from leukocytes in competitive analyte immunoassays. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with sacrificial beads opsonized for leukocytes; and (b) performing a competitive immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG-coated sacrificial beads.

Abstract: The invention concerns an internal standard used to quantitative analysis of the risk of humoral (i.e. vascular) transplant rejection. The internal standard consists of a stable composition of the C4d complement bound to a carrier consisting of erythrocytes or microparticles. The invention also concerns a method for analyzing in vitro the risk of humoral organ transplant rejection, which consists in determining the amount of component of C4d component fixed on the erythrocytes contained in a blood sample from a patient.

Abstract: The invention is directed to methods and devices for reducing interference from leukocytes in an analyte immunoassay, and in particular in non-competitive immunoassays. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with sacrificial beads; and (b) performing a non-competitive immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG-coated sacrificial beads.

Abstract: A method for processing multi-phasic dispersions is provided. The method comprises providing a multi-phasic dispersion including dispersed and continuous phases, providing one or more non-solvents comprising an aqueous solution containing at least one multivalent cation, exposing the multi-phasic dispersion to the non-solvent to form a suspension containing one or more liquid phases and the solid microparticles, and removing at least a portion of the resulting one or more liquid phases while retaining at least the microparticles, thereby removing at least a portion of the non-volatile material from the microparticles.

Abstract: A method of assaying a sample with the use of the aggregation reaction of immunological microparticles and an assay kit. The assay is conducted by using microparticles wherein the same or an analog of the analyte and a substance that specifically binds to a substance that can specifically bind to the analyte are both bound to an insoluble carrier. Thus, it becomes possible to conveniently carry out the assay even in the case where the analyte has only a small number of specific binding sites, without especially adding a competitive substance carrying hapten bonded thereto to the reaction system so as to induce simultaneous competition of the target substance and the competitive substance.

Abstract: The present invention provides methods, compositions, and systems for mass spectrometric analysis of magnetic nanoparticles displaying ligands on their surface. For example, the present invention provides methods of screening a sample for the presence of at least one analyte using ligand conjugated magnetic nanoparticles, magnetic separation, and mass spectrometric analysis. The present invention also relates to MALDI matrix compositions comprising ligand conjugated magnetic nanoparticles.

Abstract: A homogeneous immunoassay method and system for quantitative determination of total immunoglobulin E and specific antibody levels to a plurality of allergens, in which a relatively small sampling of blood is required. The method utilizes relatively small microparticles in aqueous suspension. The immunoassay procedure is an immunometric sandwich procedure preferably utilizing biotin-streptavidin signal amplification techniques and R-phycoerytherin fluorescent labels.

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

Abstract: Methods and kits for performing a two-phase optical assay for one or more than one analyte without intrinsic optical contrast in a sample are disclosed. The method requires use of a functionalized microparticle immobilized with two or more than functional components and an additional set of one or more than one functional component. The assay can be performed in one single container and does not need a wash step.

Abstract: The present invention relates in one aspect to a method for determining the cell culture history of a cell unit labelled with more than one type of tag comprising the steps of: (a) measuring one or more parameters of each tag that is used to label the cell unit; (b) identifying each tag in the cell unit; and (c) correlating the identity of each tag to the identity of the cell unit and/or the specific cell culture conditions to which the cell unit has been exposed.

Abstract: In one aspect, this disclosure provides a substrate for determining the concentration of an analyte within a sample. The substrate includes a conductive region and a recognition layer, the conductive region including at least one particle and having a first surface operatively coupled with the recognition layer, the recognition layer comprising at least one recognition molecule. The distance between the first surface of the conductive region and the recognition molecule is selected such that when the analyte is bound to the recognition layer the combination of the at least one particle and the analyte exhibits at least one of the following effects when radiation is directed through the conductive region and the recognition layer: (i) a particle plasmon effect, (ii) a particle bulk interband absorption, (iii) analyte molecular absorption, and (iv) absorption by the analyte-particle combination.

Abstract: A method and kit for assaying a cell sample for the presence of at least a threshold number of cells of a given type are disclosed. The kit includes an assay device having a sample chamber for receiving the cell sample and an elongate collection chamber containing a selected-density and/or viscosity medium and having along its length, a plurality of cell-collection regions, and particles which are capable of specific attachment to cells of the selected cell type, and which are effective, when attached to the cells, to increase the density or magnetic susceptibility of the cells. In operation, particle-bound cells and particles in the cell sample are drawn through the elongate collection chamber under the influence of a gravitational or selected centrifugal or magnetic-field force until the particle-bound cells and particles completely fill successive cell-collection regions in the collection chamber.

Abstract: Novel conjugates and immunogens derived from lenalidomide and antibodies generated by these immunogens are useful in immunoassays for the quantification and monitoring of thalidomide and lenalidomide in biological fluids.

Abstract: Methods and apparatuses for performing assays involving binding material elements with a plurality of bonds over a substantial area of a surface of a resonant device establishing a normalized exposure. The methods and apparatuses also involve controlling an external influence applied to the material elements over a first period of time and measuring a signal during a second period of time that is indicative of the change in the amount of material elements bound to the surface relative to the normalized exposure. In some cases, the measured signals are integrated with respect to time to determine the time averaged amount of material elements bound to the surface.

Abstract: The invention provides among other things methods and kits based on assaying for cardiac troponin autoantibodies, either in conjunction with an assay for cardiac troponin and/or as an independent indicator of cardiac pathology, such as myocarditis, cardiomyopathy, and/or ischemic heart disease. Assay methods of the invention can be employed among other things to identify cardiac pathology, or risk thereof, in subjects who have an autoimmune disease or who are related to an individual with an autoimmune disease. In particular embodiments, the invention also provides a method of determining whether a subject having, or at risk for, a cardiac pathology is a candidate for immunosuppressive therapy or immunoabsorption therapy. The invention also provides kits and kit components that are useful for performing the methods of the invention.

Abstract: A novel protein profiling method of testing for Lysosomal Storage Diseases (“LSD”) using discovered normalized lysosomal fingerprint patterns. The fingerprint patterns reveal the health of lysosomal organelles, specific LSD, and clinical severity Multiplexing bead technology for simultaneous screening of multiple LSD and normalizing measured enzyme activity or protein levels against other lysosomal proteins, enzymes, or enzyme activities. Compounds, reagents, and methods for identifying and quantifying multiple target enzymes and proteins.

Abstract: The present invention provides a method for reducing undesirable light emission from a sample using at least one photon producing agent and at least one photon reducing agent (e.g. dye-based photon reducing agents). The present invention further provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one collisional quencher. The present invention also provides a method for reducing undesirable light emission from a sample (e.g., a biochemical or cellular sample) with at least one photon producing agent and at least one quencher, such as an electronic quencher. The present invention also provides a system and method of screening test chemicals in fluorescent assays using photon reducing agents. The present invention also provides compositions, pharmaceutical compositions, and kits for practicing these methods.

Abstract: Fetal blood multi-lineage progenitor cells that are capable of a wide spectrum of transdifferentiation are described.

Abstract: A method for the multiplexed diagnostic and genetic analysis of enzymes, DNA fragments, antibodies, and other biomolecules comprises the steps of constructing an appropriately labeled beadset, exposing the beadset to a clinical sample, and analyzing the combined sample/beadset by flow cytometry. Flow cytometric measurements are used to classify, in real-time, beads within an exposed beadset and textual explanations, based on the accumulated data obtained during real-time analysis, are generated for the user. A secondary reagent, such as a metal or magnetic particle, is added to the beadset to assist in the analysis. Detection techniques, such as such as light scatter, Rayleigh scatter, Raman scatter, surface plasmon resonance, magnetic induction, or magnetoresistance are used to detect the particle labels.

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 invention relates to a kit comprising MHC Class I and Class II HLA-coated beads containing specific antigenic peptides for binding to antigen-specific T cells and the appropriate negative control peptides. Also provided are methods for making the coated beads and methods for use. The application of these beads go to the stimulation of peripheral blood cell populations and in vitro-stimulated culture for the elicitation of functional activities such as cell activation and signaling, cytokine secretion, proliferation and cytotoxicity activity.

Abstract: Novel conjugates and immunogens derived from lenalidomide and antibodies generated by these immunogens are useful in immunoassays for the quantification and monitoring of thalidomide and lenalidomide in biological fluids.

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 are disclosed. Troponin I and T exist in various conformations and the ratios of monomeric troponin I and 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 are systems to determine the presence of a troponin form or a group of troponin forms in whole blood, serum or plasma samples. Disclosed is a method for improving the recovery of troponin I or T from a surface used in immunoassays. Also disclosed are antibodies which recognize unbound troponin forms, the forms of troponin in binary complexes, the ternary complex of troponin I, T and C, and the conformations of troponin I having intramolecularly oxidized and reduced cysteines.

Abstract: Methods are provided for detecting and optionally quantitating multiple analytes, including nucleic acid and/or polypeptide analytes, in particle-based assays that can be highly multiplexed. Compositions, systems, and kits related to the methods are also featured.

Abstract: Disclosed is a fluorescent semiconductor microparticle assembly comprising at least three kinds of fluorescent semiconductor microparticles with an average particle size of from 1 to 10 nm, having the same chemical composition, a different average particle size and a different emission maximum wavelength in the emission spectra, wherein a standard deviation of emission intensity in each of the at least three kinds of fluorescent semiconductor microparticles is not more than 15%.

Abstract: The invention relates to a method for detecting specific target-cells in a simple and time saving way, using paramagnetic particles, antibodies recognizing the Fc portions of target-cell associating antibodies and target-cell associating antibodies directed to specific antigen determinants in the target-cell membranes. Incubation of the cell suspension with a mild detergent and/or second set of antibodies or antibody fragments, prelabeled or not with fluorescent agents, metallocolloids, radioisotopes, biotincomplexes or certain enzymes allowing visualization, with dramatically increase the specificity of the method. The method can further be used for isolation of the target-cells by magnetic field application and kit for performing the method according to the invention is described.