Abstract: The disclosure relates to methods, medical profiles, kits and apparatus for use in determining the risk that a pregnant individual has for developing pre-eclampsia based on amounts of certain biochemical markers in a biological sample from the individual and biophysical markers. The disclosure also relates to methods, medical profiles, kits and apparatus for use in determining the risk that a pregnant individual is carrying a fetus having a chromosomal abnormality based on amounts of certain biochemical markers in a biological sample from the individual and biophysical markers.

Abstract: Devices, systems, and methods for the collection of biological samples. In at least one exemplary embodiment, a device comprises a collection medium having top and bottom surfaces and a predetermined size and shape, the top surface comprising a position marker and at least one binding site operable to bind a biological sample, a protective facing substantially impermeable to the biological sample, the protective facing coupled to the top surface of the collection medium and having a size and shape substantially similar to the predetermined size and shape of the collection medium. The protective facing being sized and shaped to define a first void positioned to allow for the transfer of the biological sample through the protective facing and onto the at least one binding site of the collection medium, and a second void positioned to expose the position marker for alignment of the collection medium.

Abstract: The present invention is related to a diagnostic test kit for detecting luteinizing hormone (LH) in a biological sample at a concentration relative to a threshold concentration of LH. The device can include a release medium formed of a first material and including a labeled conjugate with a detectable label and a first binding member reactive with a first epitope of LH and a capture medium formed of a second, different material, in fluid communication with the release medium. The capture medium includes a result site having immobilized thereon a capture component capable of directly or indirectly binding LH that is bound to the labeled conjugate. The device is calibrated such that color development at the result site occurs only when the LH concentration of the liquid sample is greater than the threshold concentration.

Abstract: A device and a process are proposed for separating constituents of a sample fluid, wherein the sample fluid is supplied by capillary force to a receiving region (7) for metering, stopping or delaying the sample fluid and the sample fluid is pre-treated with a soluble chemical (13) in the receiving region (7) before the sample fluid is supplied to a separating device (5) for separating off constituents of the sample fluid.

Abstract: A sensor device includes a flow path and a metal layer disposed in the flow path. The flow path is configured to allow a sample containing analytes to flow and to allow a carrier to be disposed therein. The carrier has acceptors that are fixed on a surface thereof and specifically bound with the analytes for producing aggregates. The flow path includes an aggregate trapping section at which the analytes locally concentrate to the section. This sensor device has high detection sensitivity with a simple structure.

Abstract: The present invention refers to articles for collecting samples from a surface, articles for microbiological analyses of said samples, and methods of use of said articles. The articles include sample collectors, sample housings with optional barrier layers, and sample-ready reagent strips comprising hydrophilic agents to grow and detect microorganisms. The disclosure includes methods to collect, detect, and quantify microorganisms in a surface sample.

Abstract: A wetness indicator material may be used on a substrate to form a wetness sensor. The sensor may show either the presence or absence of an aqueous-based fluid or water-containing medium, such as vaginal fluid or urine in a personal hygiene article. The wetness sensor may be incorporated into the article. The wetness indicator material includes a standard colorant that does not change color when wetted. The standard colorant increases the range of hues exhibited by the wetness indicator material.

Abstract: A single injection gradient with a biosensor, both structural and methodological, achieves the binding of analyte to immobilized ligand over a wide concentration range without the necessity of regeneration of the sensing area. A gradient of concentrations adjacent to or within a flow cell facilitates kinetic analysis of interactions without requiring multiple discrete volumes or injections to achieve a range of concentrations. A continuous gradient fluid is preferably formed directly adjacent to the flow cell inlet or a region of sample/buffer dispersion at an injection point into a flow channel of a flow cell. The analyte gradient may be flowed through the flow cell from a low analyte concentration. Multiple component gradients are also provided.

Abstract: The present invention relates to a quantitative assay device and a method for the determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains two bands having deposited on there high and low concentrations of different calibrator agents and a test band capable of reacting with conjugated analyte complexes giving rise to a measurable signal.

Abstract: The present invention provides high throughput assays for identifying compounds that modulate a contractile function, as well as devices suitable for these assays.

Abstract: A platform for biological assays includes a base substrate providing structural support to the platform, at least one surface of the base substrate coated with position markers, a first deformable layer positioned on top of the base substrate, and a second deformable layer positioned on top of the first deformable layer, the second deformable layer embedded with deformation markers.

Abstract: Disclosed herein are an apparatus and method for measuring biomedical data and a measurement strip. The apparatus includes a plurality of detection units arranged within a strip reception area on a plane and spaced apart from each other, a measurement type determination unit for determining whether reactive portions are present in areas of the measurement strip corresponding to the plurality of detection units based on detection results obtained by the detection units and determining a type of measurement based on results of the determination, a biomedical data measurement unit for activating part or all of the detection units according to the type of measurement determined by the measurement type determination unit, and measuring the biomedical data using the activated detection units, and an output unit for outputting the measured biomedical data to an outside.

Abstract: A sensor comprises a sensor housing, having a channel; a porous substrate, in the channel; an analysis chemistry reagent, on the porous substrate; and a nozzle, in fluid connection with the channel. The porous substrate fills a cross section of the channel, and the cross-sectional area of the channel at the porous substrate is greater than the cross-sectional area at the nozzle.

Abstract: In one embodiment, a system includes a bioreactor coupled to a substrate. The bioreactor includes: a plurality of walls defining a reservoir; a plurality of fluidic channels in at least some of the walls; a fluidic inlet in fluidic communication with the reservoir via, the fluidic channels; a fluidic outlet in fluidic communication with the reservoir via the fluidic channels; and one or more sensors coupled to the reservoir, each sensor being configured to detect one or more of: environmental conditions in the reservoir; and physiological conditions of one or more cells optionally present in the reservoir. In another embodiment, a method includes delivering media to a reservoir of a bioreactor; delivering a, plurality of cells to the reservoir, controlling a reservoir temperature and a reservoir gas composition; using one or more of the sensors to monitor environmental and physiological conditions; and reporting the environmental and/or physiological conditions.

Abstract: The present invention relates to a nucleic acid analysis device for analysis of nucleic acid in a sample through fluorometry, in which a localized surface plasmon by light irradiation, and in which a nucleic acid probe or a nucleic acid synthase for the analysis of the nucleic acid in the sample is disposed in a region of generation of the surface plasmon. The present invention allows the fluorescence intensifying effect of the surface plasmon to be produced efficiently and also enables the immobilization of a DNA probe or the nucleic acid synthase in a region on which the fluorescence intensifying effect is exerted, thus making it possible to carry out a measurement on the base elongation reaction without having to remove the unreacted substrate with the fluorescent molecule.

Abstract: The invention relates to a flow through system for quantifying a target component in a liquid. The flow through system comprises a flow-through device comprising a flow path comprising a marker section, a capture section downstream to said marker section, and at least two quantification sections. The marker section comprises a non-immobilized marker. The capture section comprises a capture zone with an immobilized capture agent, and the at least two quantification sections comprise a pre-capture quantification section placed downstream to the marker section and up stream to the capture section, and a post-capture quantification section placed downstream to the capture section. The system further comprises a quantification unit for each of said quantification sections. The quantification unit(s) being arranged to quantify marker containing components and/or particles passing through said respective quantification sections.

Abstract: A nanosensor and methods to manufacture are disclosed. For example, a detection system for detecting the presence of a target substance can include a nanosensor that includes a sensing layer, and a plurality of sockets embedded within the body of the sensing layer, each socket having a physical profile matching a shape of the target substance such that, when target substances occupy the sockets, at least one measurable physical characteristic of the sensing layer changes.

Abstract: This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.

Abstract: An apparatus sensing two or more reactants or analytes in a sample is provided. The apparatus has an one or more light sources emitting energy with two or more detection targets having an immobilized reagent within the target surface. One or more detectors are provided where the two or more detection targets having immobilized reagent thereon are in communication with the sample and the immobilized reagent interacts with the sample. Energy is incident on the targets from the at least one light source such that the energy is changed by the interaction and the change is in turn detected by the at least one detector and associated with a measurement of the level of the reactant or analyte in the sample. A method of making a sensing apparatus and a method of sensing using the sensing apparatus are also disclosed.

Abstract: In one embodiment, the present invention provides the description of an inexpensive and disposable handheld device for detecting Circulating tumor cells (CTC) in blood called a handheld CTC detector (HCTCD). The HCTCD is capable of detecting less than 1 CTC per milliliter. The HCTCD consists of a dense array of high aspect ratio freestanding metallic nanoneedles, functionalized with antibodies that integrated within a microfluidic device and selectively capture and count (using electrical signal detection) the CTCs. By selecting a right functionalization protocol for the nanoneedles array, the HCTCD can be used for selective capturing a variety of rare cells that are mixed in human fluids.

Abstract: A method and device for the rapid quantification of biomolecules (320) present in a nanochannel (210) is claimed. In particular, the present invention relates to a novel concept of liquid actuation and selectively functionalized surfaces in a nanochannel that create a concentration gradient of transitory immobilized biomolecules (340) across the nanochannel. The present concept enables the quantification of biomolecular interactions of interest (320).

Abstract: Removable cartridges are used on automated flow-through systems for the purpose of extracting and purifying genetic material from complex matrices. Different types of cartridges are paired with specific automated protocols to concentrate, extract, and purifying pathogenic or human genetic material. Their flow-through nature allows large quantities sample to be processed. Matrices may be filtered using size exclusion and/or affinity filters to concentrate the pathogen of interest. Lysed material is ultimately passed through a filter to remove the insoluble material before the soluble genetic material is delivered past a silica-like membrane that binds the genetic material, where it is washed, dried, and eluted. Cartridges are inserted into the housing areas of flow-through automated instruments, which are equipped with sensors to ensure proper placement and usage of the cartridges. Properly inserted cartridges create fluid- and air-tight seals with the flow lines of an automated instrument.

Abstract: A method for characterizing particle adhesion in microfluidic bifurcations and junctions comprises at least one idealized bifurcation or junction. Multiple bifurcations and/or junctions can be combined on a single microfluidic chip to create microfluidic networks configured for assays specifically to characterize particle interactions at junctions or to screen particles for desired interactions with microfluidic bifurcations and/or junctions.

Abstract: The invention is directed to methods and devices for reducing interference from heterophile antibodies in an analyte immunoassay. 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 non-human IgM or fragments thereof by dissolving into said sample a dry reagent to yield a non-human IgM concentration of at least about 20 ?g/mL or equivalent fragment concentration; and (b) performing an electrochemical immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG or fragments thereof in addition to the IgM of fragments thereof.

Abstract: Rapid lateral flow immunoassays have an extensive history of use in both the clinical and home settings. These devices are used to test for a variety of analytes, such as drugs of abuse, hormones, proteins, urine or plasma components and the like. The present invention provides an improved procedural control that indicates to the test user that at least a portion of the applied sample has passed through the test result zone of the test strip, and optionally that the test is complete and the test results may be read.

Abstract: The invention includes a base, a working wire, a grounding wire, a first division layer, a second division layer and a cover layer. The base has a reaction area. The working wire is formed with a first measure contact and a first bioreaction contact. The grounding wire is formed with a second measure contact and a second bioreaction contact. The first division layer and second division layer have a first inlet and a second inlet, respectively. The first inlet and the second inlet correspond to the reaction area in position to expose the first and second bioreaction contacts. The guiding trough is formed by the cover layer, the base and the first and second inlets.

Abstract: The invention relates to a continuous water monitoring system, including components thereof, and a method relating thereto for continuously monitoring, in real-time, a water supply in order to detect contaminants therein. The system employs the use of a live culture of bioluminescent bacteria and suitable light detecting means.

Abstract: A microfluidic device including a platform and a cartridge is disclosed. The platform includes a chamber containing a fluid. The reagent cartridge is mounted to the platform. and contains a solid reagent for detecting material contained in the fluid.

Abstract: A container for culturing a test sample includes a molded monolithic single layer polymeric container body having an upwardly extending, visually transmissive wall with an inner surface and a wall thickness that is between about 0.2 mm and 10 mm. The container also has a thin gas barrier coating comprising silica on the inner surface of the sealed container body and an internal top coating on the gas barrier coating. The gas barrier and top coating are visually transmissive (after curing). The container includes a cap sealably attached to the container body. The sealed container has an oxygen transmission rate (OTR) after autoclaving and aging that is between about 0.0001 to about 0.04 (cc/package/day/atm).

Abstract: Provided herein is a composition for detection of a microbial product in a sample comprising a polydiacetylene (PDA) and a packaging polymer, wherein the sample contacts the PDA and a change of PDA color indicates detection. Also provided herein are methods of making a packaging material comprising a PDA and methods of using the composition for detection of a microbial product in a sample.

Abstract: A biosensing system that measures the concentration of halogenated alkenes is disclosed.

Abstract: The present invention relates to methods and products associated with in vivo enzyme profiling. In particular, the invention relates to methods of in vivo processing of exogenous molecules followed by detection of signature molecules as representative of the presence of active enzymes associated with diseases or conditions. The invention also relates to products, kits, and databases for use in the methods of the invention.

Abstract: The present invention relates to an immunoaffinity device for capturing one or more analytes present at high or low concentrations in simple or complex matrices. The device is designed as an integrated modular unit and connected to capillary electrophoresis or liquid chromatography for the isolation, enrichment, separation and identification of polymeric macromolecules, primarily protein biomarkers. The integrated modular unit includes an analyte-concentrator-microreaction device connected to a modified cartridge-cassette.

Abstract: The present invention is related to a diagnostic test kit that assesses ovarian reserve by measuring Follicle Stimulating Hormone (FSH) in a liquid sample. The sample can be deposited on a first portion of the device for transport to a second portion of the device. The device can include a release medium formed of a first material and including a detectable label thereon and a capture medium, including a test site, in fluid communication with the release medium and formed of a second, different material.

Abstract: A method of component assembly on a substrate, and an assembly of a bound component on a substrate. The method comprises the steps of forming a free-standing component having an optical characteristic; providing a pattern of a first binding species on the substrate or the free standing component; and forming a bound component on the substrate through a binding interaction via the first binding species; wherein the bound component exhibits substantially the same optical characteristic compared to the free-standing component.

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: A fluid sensor comprises a formed plastic body and a reagent. The body has a top face with an integral first surface. The body also has a bottom face opposed to the first surface and a sidewall that extends from the periphery of the top face. The first surface is adapted to accept a fluid sample. The reagent is disposed on the integral first surface and causes a color change detectable on the bottom face when the reagent reacts with an analyte in the fluid sample.

Abstract: A reader for mechanical actuation of fluids within a test cartridge. The instrument interface including multiple independently-controlled plungers aligned to respective fluidic pouches on a test cartridge that is inserted into a testing apparatus embodying the instrument interface. The plungers include tips for applying mechanical force to the respective fluidic pouches.

Abstract: Embodiments of the invention relate to portable detection apparatus, comprising one or more detector regions adapted to visually indicate the presence or amount of an analyte in a beverage. The detection apparatus is shaped substantially the same as a consumer product.

Abstract: A reagent composition for a biosensor sensor strip is disclosed that provides for rapid rehydration after drying. The composition includes porous particles and is preferably formed as a colloidal suspension. The dried reagent composition including porous particles may provide analytically useful output from the sensor strip in a shorter time period than observed from dried reagent compositions using solid particles. The output signal from the porous particle compositions may be correlated to the analyte concentration of a sample within about two seconds. In this manner, an accurate concentration determination of an analyte concentration in a sample may be obtained in less time than from sensor strips including conventional compositions. The reagent composition including the porous particles also may allow for the redox reaction between the reagents and the analyte to reach a maximum kinetic performance in a shorter time period than observed from conventional sensor strips.

Abstract: The invention relates to devices comprising a sensor layer capable of binding magnesium ions and a scavenging layer that preferentially binds to calcium ions in the presence of both magnesium ions and calcium ions. The sensor layers can comprise known or novel luminionophores. The invention further relates to methods of selectively detecting magnesium ion concentration in the presence of calcium ions.

Abstract: Disclosed is an assay device for the determination of the presence and/or extent if an analyte in a liquid sample over an extended concentration range comprising a first assay and a second assay, wherein the first assay for an analyte comprises a first flow-path having a sole detection zone capable of immobilizing a labelled binding reagent and the second assay for said analyte comprises a second flow-path having a sole detection zone capable of immobilizing a labelled binding reagent, wherein the presence of labelled binding reagent at the detection zones provides an indication of the presence and/or extent of analyte in said liquid sample.

Abstract: In a chromatography quantitative measuring apparatus, a beam applied from a light source to a chromatography test strip is formed into an elliptical shape by an optical means such as a cylindrical lens, a variation in absorbance that accompanies elution of a marker regent is detected while the elliptical beam is applied between a marker reagent hold part and a detection part, and a measurement is automatically started in a prescribed period of time since the detection of variation. According to the chromatography quantitative measuring apparatus so configured, non-uniform coloration is reduced by shaping the beam elliptically with the optical means, whereby the accuracy of quantitative analysis is enhanced, and the apparatus can be operated easily.

Abstract: The present invention relates generally to an assay for detecting and differentiating multiple analytes, if present, in a single fluid sample, including devices and methods therefore.

Abstract: A method for identifying a subject being at risk for or having a chronic inflammatory disease, fibrillinopathy, atherosclerosis, or coronary artery disease is provided. The method may include determining the concentration of GrA and/or GrB in a blood or serum sample from said subject; and comparing the concentrations to the corresponding concentration in a control sample, wherein an elevated concentration of GrA and/or GrB may be indicative of a chronic inflammatory disease, fibrillinopathy, atherosclerosis, or coronary artery disease. The method may further include identifying concentrations of fibrinogen, elastin and/or fibrillin.

Abstract: The invention is directed towards methods and compositions for identifying the amount of hydrofluoric acid in a buffered oxide etching composition. In buffered oxide etching compositions it is very difficult to measure the amount of hydrofluoric acid because it has varying equilibriums and it is toxic so it hard to handle and sample. When used to manufacture microchips however, incorrect amounts of hydrofluoric acid will ruin those chips. The invention utilizes a unique method of spectrographically measuring the hydrofluoric acid when in contact with added chromogenic agents to obtain exact measurements that are accurate, immediate, and safe.

Abstract: Disclosed are: a biosensor kit in which a bionsensor utilizing a field effect transistor is not deteriorated during storage or transport; and a system for detecting a substance of interest, which is equipped with the biosensor chip. The biosensor kit comprises a biosensor chip which can measure a substance of interest quantitatively and a package which can hermetically seal the biosensor chip and is composed of a packaging material comprising a metal film. The biosensor chip can measure the substance quantitatively based on the value of a current generated in a field effect transistor when the substance is reacted with a molecule that can recognize the substance and is immobilized on a reaction field connected to the field effect transistor. The biosensor chip comprises the field effect transistor and a mounting substrate on which the field effect transistor is mounted.

Abstract: Disclosed are: a biosensor kit in which a biosensor utilizing a field effect transistor is not deteriorated during storage or transport; and a system for detecting a substance of interest, which is equipped with the biosensor chip. The biosensor kit comprises a biosensor chip which can measure a substance of interest quantitatively and a package which can hermetically seal the biosensor chip and is composed of a packaging material comprising a metal film. The biosensor chip can measure the substance quantitatively based on the value of a current generated in a field effect transistor when the substance is reacted with a molecule that can recognize the substance and is immobilized on a reaction field connected to the field effect transistor. The biosensor chip comprises the field effect transistor and a mounting substrate on which the field effect transistor is mounted.

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: A method and device for detecting analytes in a test sample. Embodiments include methods for quantitatively detecting analytes within a range of concentrations. In an embodiment the method includes a lateral flow test strip with multiple test areas for capturing a labeled receptor to provide a detectable signal.