Abstract: A portable test module for excitation of electrochemiluminescent probes configured to detect target nucleic acid sequences, the test module having an outer casing configured for hand-held portability, the outer casing having a receptacle for receiving a fluid containing the target nucleic acid sequences, electrochemiluminescent (ECL) probes having an ECL luminophore for emitting photons when in an excited state and a functional moiety for quenching photon emission from the ECL luminophore by resonant energy transfer, and, electrodes for receiving an electrical pulse to excite the ECL luminophores, wherein during use, the ECL probes that have detected one of the target nucleic acid sequences reconfigure such that the functional moiety does not quench the photon emission from the ECL luminophore when excited by the electrodes.

Abstract: An object of the present invention is to provide a cartridge for automatic measurement used in an automatic measuring device, capable of automatically performing measurement including heat treatment of a sample, and a measuring device using the cartridge. The present invention relates to a cartridge for use in measuring a component to be measured contained in a sample, comprising: at least a heat-treatment well for performing heat treatment of the sample; and a reaction well for reacting the component to be measured in the sample with a material specifically reacting therewith.

Abstract: A test module for detecting target nucleic acid sequences in a fluid, the test module having an outer casing having a receptacle for receiving the fluid containing the target nucleic acid sequences, electrochemiluminescent (ECL) probes having an ECL luminophore for emitting photons when in an excited state and a functional moiety for quenching photon emission from the ECL luminophore by resonant energy transfer, electrodes for receiving an electrical pulse to excite the ECL luminophores, and, a detection photosensor for exposure to the photons emitted by the ECL luminophores.

Abstract: The present invention provides a plate for mass spectrometry comprising a support and a PVDF-containing coating (that is, a PVDF-deposited thin layer) thereon, and a method of preparing a plate for mass spectrometry, which comprises coating the support surface with PVDF. The present invention also provides a method of analyte identification comprising subjecting an analyte-containing sample to gel electrophoresis to separate the analyte, blotting the separated analyte from the gel to the above-described plate for mass spectrometry, and subjecting the plate to mass spectrometry, whereby the transferred analyte is analyzed.

Abstract: The invention provides methods of detecting a change in cell growth patterns.

Abstract: Systems and methods are disclosed to automatically detect the presence of a substance on a test swipe by capturing a background image of the test swipe; applying one or more test chemicals to a test swipe; adjusting the temperature of the test swipe to a predetermined temperature range; controlling a variable speed fan to avoid fogging the camera's lens; capturing an in-situ image of the test swipe after the application of chemical at the predetermined temperature range; subtracting the background image from the in-situ image; generating a difference value from the two images; and searching a known database to identify the substance.

Abstract: A test module for concentrating pathogens in a biological sample, the test module having an outer casing with a receptacle for receiving the sample, a dialysis device in fluid communication with the receptacle and configured to separate the pathogens from other constituents in the sample, and, a lab-on-a-chip (LOC) device being in fluid communication with the dialysis device and configured to analyze the pathogens.

Abstract: A method for assaying a sample for each of multiple analysis is described. The method includes contacting an array of spaced-apart test zones with a liquid sample (e.g., whole blood). The test zones are disposed within a channel of a microfluidic device. The channel is defined by at least one flexible wall and a second wall which may or may not be flexible. Each test zone includes a probe compound specific for a respective target analyte. The microfluidic device is compressed to reduce the thickness of the channel, which is the distance between the inner surfaces of the walls within the channel. The presence of each analyte is determined by optically detecting an interaction at each of multiple zones for which the distance between the inner surfaces at the corresponding location is reduced. The interaction at each test zone is indicative of the presence in the sample of a target analyte.

Abstract: The invention encompasses microfluidic microarray assemblies (MMA) and subassemblies and methods for their manufacture and use. In one embodiment, first and second channel plates are provided and are sealingly connected to a test chip in consecutive steps. Each plate includes microfluidic channels configured in a predetermined reagent distribution pattern. The test chip comprises a plurality of discrete test positions, each test position being located at the intersection between a first predetermined reagent pattern and a second predetermined reagent pattern, wherein at least one of said patterns is non-linear. The first channel plate allows the distribution of a first reagent on said test chip, wherein said first reagent is immobilized at said test positions. The second channel plate allows the distribution of a second reagent on said test chip, wherein said second reagent comprises a plurality of different test samples.

Abstract: The invention relates to a device for performing binding assays. In particular, the invention relates to a centrifugal device for performing such assays. The invention also relates to a method of performing binding assays involving antigen-antibody binding, nucleic acid hybridization, or receptor-ligand interaction.

Abstract: Fluid analyte sensors include a photoelectrocatalytic element that is configured to be exposed to the fluid, if present, and to respond to photoelectrocatalysis of at least one analyte in the fluid that occurs in response to impingement of optical radiation upon the photoelectrocatalytic element. A semiconductor light emitting source is also provided that is configured to impinge the optical radiation upon the photoelectrocatalytic element. Related solid state devices and sensing methods are also described.

Abstract: We describe assay modules (e.g., assay plates, cartridges, multi-well assay plates, reaction vessels, etc.), processes for their preparation, and method of their use for conducting assays. Reagents may be present in free form or supported on solid phases including the surfaces of compartments (e.g., chambers, channels, flow cells, wells, etc.) in the assay modules or the surface of colloids, beads, or other particulate supports. In particular, dry reagents can be incorporated into the compartments of these assay modules and reconstituted prior to their use in accordance with the assay methods. A desiccant material may be used to maintain and stabilize these reagents in a dry state.

Abstract: A scanning sensor system, methods of use and kits for detecting a biologically active analyte are provided. The scanning sensor system includes a light source, a detector, a substrate comprising a plurality of waveguides and a plurality of optical sensing sites in optical communication with one or more waveguide of the substrate, and at least one adapter configured to couple with the substrate and provide optical communication between the light source, the waveguides of the substrate, and the detector.

Abstract: Carriers or holders for holding microfluidic devices are provided. Some of the carriers that are provided include a hydration control device and/or a source of controlled fluid pressure to facilitate use of the carrier in conducting various types of analyses.

Abstract: The invention provides methods of detecting a change in cell growth patterns.

Abstract: A miniaturized assembly is provided whereby a fluid sample can be divided into a plurality of sample portions in retaining wells and the sample fluid can be displaced from open ends of the wells while simultaneously being sealed in the wells. A method of dividing a fluid sample using the assembly is also provided.

Abstract: In one embodiment the present invention provides a blood analyte meter that is user-friendly and easy to use. In accordance with an embodiment of the present invention an analyte measurement device, for use with a test strip for determining the amount of an analyte in a sample, displays a hierarchy of information or options to a user. The hierarchy of information or options may include, among other information or options, subroutines that are performable by the processor of the device, stored data related to past tests performed by the user, and alarm features of the device. A user scrolls through and selects individual options or pieces of information by rotating and translating a rotatable user interface around and along an axis of rotation.

Abstract: The disclosure provides a simple and effective way of synthesizing robust organic-inorganic hybrid gels and ultra-thin films using vaporization of a gel precursor. The gels are synthesized at relatively low temperature allowing the activity of the immobilized species to be maintained. The disclosure provides robust, synthetic, selective, active and/or passive transport systems in the form of functional biologically active species and mechanisms for forming them. These systems allow selective and passive or active transport of ionic, molecular and biological species through the incorporation of functional biological molecules and biomolecular assemblies in a rigid matrix.

Abstract: Sensing device and method for detecting presence and concentration of generic target analytes of interest. The device and method are based on detecting changes in effective dielectric induced by the target analytes of interest. Applications of the invention include, but are not restricted to, detecting and characterizing the presence of chemical and/or biological target analytes of interest as well as detecting and characterizing target analytes of interest from a separation apparatus. In one embodiment of the invention, the device comprises at least two electrodes in a rigid architecture such as a solid surface, where the electrodes have sizes and inter-electrode spacings that are on the order of sizes of target analytes of interest to improve sensitivity of the device. Changes in effective dielectric and, therefore, capacitance induced by a presence of the target analytes of interest are measured electronically.

Abstract: The present invention is directed to methods for conducting multiplexed assays. The methods are particularly well suited for measuring a plurality of analytes that may be present in very different abundances. The invention also relates to systems, devices, equipment, kits and reagents for use in such methods.

Abstract: The present invention relates to the field of immunology and hyperproliferative diseases. More specifically, the present invention relates to a method of detecting and monitoring therapeutic antibody:antigen complex, soluble antigen and soluble therapeutic antibody, wherein a patient has undergone at least one course of immunotherapy. Yet further, levels of therapeutic antibody:antigen complexes, soluble antigens or soluble therapeutic antibodies may be measured and used to stage or monitor a hyperproliferative disease.

Abstract: An immunodiagnostic test card includes a plurality of transparent chambers wherein each chamber includes a quantity of testing material that combines with a patient sample, when mixed, to produce an agglutination reaction. A plurality of indicia are disposed to aid in the manufacture and determining the usability of the cards prior to test and also in objectively grading the agglutination reactions that are formed or lack of agglutination.

Abstract: The invention provides methods of detecting a change in cell growth patterns, methods of screening many different antibodies in one receptacle, and methods of detecting specific binding of an antibody to a protein or cell, wherein the antibody is in a mixture of many different antibodies.

Abstract: The present disclosure provides immunoassays and kits for detection or quantification of an analyte of interest in a test sample that potentially contains endogenously produced autoantibodies reactive with the analyte.

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: A rack for an automated processing system. The rack includes a number of wells adapted to hold at least a first sample container having a first size, and a second sample container having a second size. The second size, which may be a diameter, a height, or both, is substantially different from the first size. A structure joins the wells. The rack is adapted to fit in an automated processing system that is adapted to remove both the first sample container and the second sample container from the rack.

Abstract: A substrate plate or device adapted for use with biological or chemical assays is disclosed. The device may take the form of a multi-well plate having a three-dimensional, porous layer as part of a support surface within each well for immobilizing probe species. The porous layer is characterized as having a plurality of interconnected voids defined by a matrix of contiguous solid material. A method and its variants are also described.

Abstract: The invention provides an improved method for identifying and interpreting tissue specimens and/or cells derived from tissue specimens. A panel of cell-based reagents provides a number of readouts of cellular states or biomarkers that together define a profile of a diversity of cellular states or biomarkers in a tissue specimen representing the “systems” nature of biology. This cellular profile is interpreted using informatics tools, to identify similarities between specimens, in vivo medical conditions, and suggest options for treating medical conditions.

Abstract: The present invention relates to the field of immunology and hyperproliferative diseases. More specifically, the present invention relates to a method of detecting and monitoring therapeutic antibody:antigen complex, soluble antigen and soluble therapeutic antibody, wherein a patient has undergone at least one course of immunotherapy. Yet further, levels of therapeutic antibody:antigen complexes, soluble antigens or soluble therapeutic antibodies may be measured and used to stage or monitor a hyperproliferative disease.

Abstract: The invention provides an ELISA assay for the determination of serum mast cell ?-tryptase levels using rabbit anti-tryptase as the capture antibody and alkaline phosphatase conjugated G3 as the detecting antibody. Luminescent substrate CPSD was used to enhance the assay sensitivity. Also provided are methods for aiding in the diagnosis of irritable bowel syndrome by detecting the serum level of ?-tryptase, histamine and/or prostaglandin E2.

Abstract: The invention describes specific sialylated structures present on human stem cells and cell populations derived thereof. The invention is especially directed to methods to control the status of stem cells by observing changes in sialylation of the cells; and control of potential contaminations of biological materials; and reagents and methods used in connection with the cells in order to avoid alterations of the cell glycosylation by contaminating materials. The invention is further directed to novel stem cells, the glycosylation of which has been specifically altered.

Abstract: Renal injury and inflammation is diagnosed by detecting an elevation in GSK3b level or activity. Inflammation of bodily tissues such as renal tissue is inhibited by administration of GSK3b inhibitory compositions.

Abstract: The present invention relates to a method of isolating fragments of nucleic acid according to the density of CpG dinucleotides and subsequent procedures for producing a library and/or an array or microarray of these fragments, as well as uses thereof.

Abstract: Described herein is an analyte detection device and method related to a portable instrument suitable for point-of-care analyses. In some embodiments, a portable instrument may include a disposable cartridge, an optical detector, a sample collection device and/or sample reservoir, reagent delivery systems, fluid delivery systems, one or more channels, and/or waste reservoirs. Use of a portable instrument may reduce the hazard to an operator by reducing an operator's contact with a sample for analysis. The device is capable of obtaining diagnostic information using cellular- and/or particle-based analyses and may be used in conjunction with membrane- and/or particle-based analysis cartridges. Analytes, including proteins and cells and/or microbes may be detected using the membrane and/or particle based analysis system.

Abstract: Methods, systems, kits and assays for diagnosing, monitoring or screening for mucopolysaccharidosis (MPS) and methods and systems for assaying test compounds for therapeutic activity are described, whereby MPS marker protein levels are assayed as an indication of MPS.

Abstract: Described herein is an analyte detection device and method related to a portable instrument suitable for point-of-care analyses. In some embodiments, a portable instrument may include a disposable cartridge, an optical detector, a sample collection device and/or sample reservoir, reagent delivery systems, fluid delivery systems, one or more channels, and/or waste reservoirs. Use of a portable instrument may reduce the hazard to an operator by reducing an operator's contact with a sample for analysis. The device is capable of obtaining diagnostic information using cellular- and/or particle-based analyses and may be used in conjunction with membrane- and/or particle-based analysis cartridges. Analytes, including proteins and cells and/or microbes may be detected using the membrane and/or particle based analysis system.

Abstract: The invention relates to a method of using high mass matrix assisted laser desorption-ionization (MALDI) mass spectrometry for the qualitative and quantitative analysis of the effect of drug candidates on protein complexes such as protein-protein interactions in purified samples or complex biological matrices, as well as to the use of this method for lead compound optimization, drug characterization, drug manufacturing processes, and drug quality control processes, including automated high throughput applications.

Abstract: A method of preparing a protein-resistant reactive solid support surface is disclosed. The method comprises the steps of providing a solid support having a hydrogel coating with a plurality of binding elements, coupling a protein resistant compound to the hydrogel via a first fraction of the binding elements, and coupling at least one binding agent to the hydrogel via a second fraction of the binding elements, whereby the protein resistant compound and the at least one binding agent are co-immobilized to the hydrogel. Also the use of the reactive surface in analysis, such as immunogenicity assays, is disclosed.

Abstract: Age-related macular degeneration (AMD) is a leading cause of visual impairment and blindness in the elderly whose etiology remains largely unknown. Previous studies identified chromosome 1q32 as harboring a susceptibility locus for AMD, but it was not identified. We identified a strongly associated haplotype in two independent data sets. DNA sequencing of the complement factor II gene (CFII) within this haplotype revealed a coding variant, Y402II, that significantly increases the risk for AMD with odds ratios between 2.45 and 5.57. This identifies Complement factor II as involved in pathogenesis of AMD. This single variant alone is so common that it likely explains 43 percent of AMD in older adults. In addition, we have replicated and refined previous reports implicating a coding change in LOC387715 as the second major AMD susceptibility allele. The effect of rs10490924 appears to be completely independent of the Y402H variant in the CFH gene.

Abstract: A bioassay substrate and method thereof is provide. In the bioassay substrate, a sample solution is dripped onto a spot area to which a plurality of detection substances is fixed and an interaction between the detection substance and a target substance in the sample solution is detected by fluorescent intensity. The substrate includes: a predetermined number of the spot areas placed in a well arranged on the surface of the substrate; and a fine uneven structure continuously formed on a bottom surface configuring the spot areas.

Abstract: A plurality of individual single column test elements are provided for use in a clinical testing apparatus. Each test element is defined by a single test column that includes a quantity of a test material, such as gel material or a bead matrix, including a cover strip used to access the contents of the test column. Individual test elements can be stored, retained and dispensed for testing patient samples.

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 of 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. 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: A microplate for use within an interrogation system and a method of using the microplate are disclosed. The microplate contains within the bottom of each well, an optical waveguide grating based sensor. Approximate to each sensor is a mask having an aperture of predetermined size. The aperture regulates the light that enters and exits the sensor upon successive scans and ensures repeatable readings from the sensor. In an extended embodiment, a method of detection is disclosed that utilizes a launch and receive system while employing the aforementioned microplate.

Abstract: An immunodiagnostic test card includes a plurality of transparent chambers wherein each chamber includes a quantity of testing material that combines with a patient sample, when mixed, to produce an agglutination reaction. A plurality of indicia are disposed to aid in the manufacture and determining the usability of the cards prior to test and also in objectively grading the agglutination reactions that are formed or lack of agglutination.

Abstract: Apparatuses and methods of aligning at least one tip of a tip manifold with a plurality of wells of a multiwell plate. The tip manifold includes a plate, at least one tip depending from the plate, a first tip alignment pin depending from the plate, and a second tip alignment pin depending from the plate. The second tip alignment pin opposes the first tip alignment pin. The multiwell plate includes a body defining a plurality of non-porous wells for holding biological material, a first alignment hole, and a second alignment hole. The second alignment hole opposes the first alignment hole.

Abstract: An assay test strip includes a flow path, a sample receiving zone, a label, a detection zone that includes a region of interest, and at least one position marker. The at least one position marker is aligned with respect to the region of interest such that location of the at least one position marker indicates a position of the region of interest. A diagnostic test system includes a reader that obtains light intensity measurement from exposed regions of the test strip, and a data analyzer that performs at least one of (a) identifying ones of the light intensity measurements obtained from the test region based on at least one measurement obtained from the at least one reference feature, and (b) generating a control signal modifying at least one operational parameter of the reader based on at least one measurement obtained from the at least one reference feature.

Abstract: Ellipsometry systems for imaging binding events between analytes in a sample and an array of ligands in an evanescent field generated by a beam of light reflected from the plane of the ligands is adapted to a multiwell plate structure in common use. In one example, a film of prism arrays is affixed to the underside of the plate with each prism array located in registry with a well and ligand arrays being immobilized on the (planar) bottom surface of the wells. The prism array may be formed in a film and juxtaposed with the bottom surface of the plate or a prism array can be made integral with the plate bottom of a multiwell plate.

Abstract: Each well of a multiwell plate adapted to accept a plurality of biological samples for testing for the presence of analytes in the sample is further adapted herein for immobilizing on the side walls of a well a 3D arrangement of ligand arrays. A well is formed with planar side walls and a stack of sample separators is placed within a well in positions so as to not come in contact with ligand spots in the array(s). The spacing between each pair of adjacent separators in a stack forms a sample chamber in a position corresponding to an array of the 3D arrangement of ligand arrays.

Abstract: Disclosed is a testing device and methods for the identification of an analyte of interest in a sample. In a preferred embodiment, the testing device includes a front panel having at least one sample application aperture; a rear panel having at least one solvent application aperture; a sample collection matrix disposed between the rear panel and the front panel, the sample collection matrix being in communication with the sample and solvent application apertures of the front and rear panels; and at least one insertable test strip containing a reagent enabling detection of the analyte of interest.

Abstract: The present invention relates to a process for detecting one or more analytes in one or more samples of biological origin having complex composition. The present invention also relates to a microarray for quantitative determination of one or more analytes in samples of biological origin having complex composition which are immobilized in measurement ranges of microarray, and also to a quantitative detection method based thereon.