Abstract: Provided is an assay device and kit for detecting the presence or amount of an analyte of interest.

Abstract: The present invention related to a pregnancy test device that can selectively detect hyperglycosylated human chorionic gonadotropin (hCG-H) in a liquid sample. The sample can be deposited on a proximal portion of the device for transport to a distal 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 capture site, in fluid communication with the release medium and formed of a second, different material. At least one of the release medium and the capture medium includes a binding member that exhibits a moderate to high affinity for hCG-H and is selectively or preferentially reactive with hCG-H.

Abstract: The present invention relates to a tissue paper with pH-indicator function, specifically a toilet paper that can be used to diagnose abnormal pH changes of the human urine as accompanying for instance acetonemic vomiting or diabetes.

Abstract: The present invention relates to a color-changing material and to a multiple-component material that includes a color-changing composition. The color-changing materials and color-changing compositions are capable of changing color in order to indicate a change in condition, such as a change in pH. The color-changing materials and color-changing compositions include a hydrogel-forming composition, a charged colorant and a pH adjuster. The hydrogel-forming composition includes at least one charged species.

Abstract: The invention comprises a device for detecting an analyte in a liquid sample deposited on a first portion of the device for transport to a second portion of the device that is in fluid contact with the first portion. In specific embodiments, the device comprises a labeled conjugate comprising a binding member reactive with a first epitope of the analyte and a label comprising a gold colloid, preferably having a mean particle size of 50 nm to 100 nm. In further embodiments, the device comprises a capture component comprising polymerized streptavidin. The diagnostic device is particularly useful in the preparation of pregnancy test kits.

Abstract: The present invention relates to using a marker in a functional fluid, which survives the use of the functional fluid in an application, with a reagent solution to identify the functional fluid rapidly either before, during or after the functional fluid's use and which is a suitable method for identifying a functional fluid in the field, and which may employ the use of test wipe, or medium, that contains the reagent solution.

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: Herein are disclosed methods and devices for optically monitoring multiple parameters of an oil sample. In one embodiment, the methods and devices can be used for determining the quality of cooking or flying oil in terms of the free fatty acid content and total polar compound content of the oil. The methods use an optical absorbtive/reflective property in evaluating the free fatty acid content, and use optical fluorescence in evaluating the total polar compound content, with both measurements using a single sampling substrate and a single measuring device.

Abstract: The invention relates to an analytical test element for analysis of a liquid sample. The analytical test element may contain a channel which is suitable for capillary transport of the liquid sample and which is provided with an inlet opening for the liquid sample and with an air outlet opening. At least one test field may be arranged in the channel, spaced apart from the inlet opening. The test element comprises a sample application site which is closed with a seal and which is designed in such a way that, when the seal is opened, the sample application site and the inlet opening of the channel are simultaneously open to the outside environment of the test element. The test element can then receive the liquid sample inside the channel via the sample application site and inlet opening, for analysis in the test field. The invention also relates to a test element magazine and to a system for analysis of liquid samples with at least one test element.

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: The disclosed invention relates to monoclonal antibodies (MAbs) which recognize human fatty acid synthase (hFAS) and are distinct from previously known anti-hFAS antibodies. Compositions, devices and kits comprising the MAbs are provided along with methods of using the MAbs in a variety of applications.

Abstract: Test cells have a first sorbent strip with a sample receiving location and defining a first migration path, a distinct second sorbent strip which receives buffer solution and at least partially defines a second migration path distinct from and elongated relative to the first migration path, conjugate supported by the second strip, a test site located at a junction of the first and second strips and having an immobilized ligand-binding mechanism, and a divider which directs a first amount of the buffer to the first strip to move the sample to the test site and a second amount to the second strip to move the conjugate to the test site. The first and second migration paths have first and second lengths chosen so that ligand in the sample reaches the test site and binds to the immobilized ligand-binding mechanism prior to the conjugate reaching the test site.

Abstract: A binding assay product (1) for detecting the presence of an analyte in a sample comprising a labelling module (5), a label, a capture module (9) and a visualization module (10). The labelling module (5) comprises a first binding component capable of binding the analyte. The label is connectable to the first binding component. The capture module (9) comprises a second binding component capable of binding the analyte. The visualization module (10) is for detecting the first binding component connected to the label and bound to the second binding component via the analyte. The labelling module and the capture module comprise a fluid conducting medium in which the binding components are embedded. The labelling module (5), the capture module (9) and the visualization module (10) together define a flow path along which the sample is capable of flowing.

Abstract: The invention relates to compositions comprising a hydrogel matrix, where the matrix comprises poly(ethylene glycol) dimethyacrylate (PEGDMA), an acrylate, such as methacrylic acid (MAA) and methyl methacrylate (MMA), as well as 2-hydroxy-2 methyl propiophenone (HMPP).

Abstract: A calibration card and method of using the card to calibrate an analytical instrument capable of reading a photoluminescent oxygen probe. The card includes at least (a) a first mass of an oxygen sensitive photoluminescent dye retained within a hermetically sealed space so as to isolate the dye from environmental oxygen, and in fluid communication with an activated metal-air battery whereby any oxygen permeating into the hermetically sealed space is quickly consumed by the battery, and (b) a second mass of an oxygen sensitive photoluminescent dye in fluid communication with the environment whereby the second mass of photoluminescent dye is exposed to an environmental concentration of oxygen.

Abstract: Disclosed is an assay device for the determination of 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 immobilising a labelled binding reagent and the second assay for said analyte comprises a second flow-path having a sole detection zone capable of immobilising 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: A chemical indicating device (10) for detection of chloride ions in a sample is provided. The chemical indicating device (10) includes a carrier matrix (12) and an indicator (14) having silver and vanadate supported on the carrier matrix (12). A method for detecting chloride ions is also provided.

Abstract: The present invention provides a colorimetric gas detector comprising a substrate bearing a material that can react with a gas in an atmosphere being monitored and wherein the reaction causes the material to change the radiation at which the material absorbs or radiates radiation (the color-change material). The material is located in at least one discrete area of the substrate. By providing the color change material in discrete areas, the amount of such material can be reduced and different types of color-change material can be included on a common substrate to detect two or more gases simultaneously.

Abstract: A liquid delivery apparatus is provided for depositing liquid materials onto prescribed areas. The apparatus includes a sensing and delivery pin and a photo sensor. The apparatus is sized to deliver a droplet of liquid material to the surface of a target area without coming into contact with the target surface. The apparatus is also capable of drawing geometric features, such as lines and grids of liquid material. The photo sensor measures the intensity of light during a processing cycle. Measured reflected-light intensity can be compared in real-time to a reference curve which is based on test process cycles representing the light intensity expected when the process proceeds in the preferred fashion to produce a normal spot having an expected droplet size. The light intensity measurements can also be fitted with a mathematical function such as an asymmetric double sigmoidal curve.

Abstract: A blood glucose measuring system comprising: a computer mouse that transmits data to an associated computer; a LED display residing on the computer mouse; a blood glucose strip receiver residing on the computer mouse; a blood glucose measurement mechanism; and software residing on the associated computer which receives blood glucose data, where the software stores the data onto a database within the associated computer. In one exemplary embodiment, the mouse may include two actuation pads and Bluetooth technology to transmit data from the mouse to the associated computer. The LED display provided on the mouse displays the glucose results measured by the measurement means. The software residing on the associated computer tabulates the blood glucose measurements and stores the data in a predetermined format.

Abstract: The present invention is directed to immunoassays for detecting one or more target analytes in a fluid sample wherein the detection reaction occurs on a solid support and involves an amplification system. In particular, the invention is directed to making and using a test device having at least one site for detecting the presence of at least one target analyte, wherein a conjugate comprising dextran-polystreptavidin is immobilized at the test site(s) as a capture reagent for a complex containing the target analyze.

Abstract: A method and kit for determining a concentration of iron in brake fluid when contacting a colorimetric reagent such that a color results. The level of iron can be used to determine the amount of active corrosion within a brake system and determine if special service procedures are required.

Abstract: The invention comprises a device for detecting an analyte in a liquid sample deposited on a first portion of the device for transport to a second portion of the device that is in fluid contact with the first portion. In specific embodiments, the device comprises a labeled conjugate comprising a binding member reactive with a first epitope of the analyte and a label comprising a gold colloid, preferably having a mean particle size of 50 nm to 100 nm. In further embodiments, the device comprises a capture component comprising polymerized streptavidin. The diagnostic device is particularly useful in the preparation of pregnancy test kits.

Abstract: An assay device for testing of liquid samples for drugs of abuse has a transparent container for retaining a liquid sample. A backing member is within the container and is curved so that its front surface corresponds to the curvature of the container wall. Immunoassay test strips are on the front face of the backing and are visible through the container wall. Each test strip is enclosed in a transparent pocket which has a bottom opening through which the bottom portion of the test strip protrudes to contact the liquid sample within the container. The liquid then flows upwardly through the test strip to react with reagents within the test strip.

Abstract: An assay device allowing for the testing for multiple analytes in a liquid sample simultaneously by employing a multiplicity of analyte testing strips which protrude from a housing containing slots for each assay test strip and wherein the flow of sample of the test strip is controlled by a cover over the sample contact pad which is inserted into the sample.

Abstract: A test device and method for determining the presence or absence of an analyte in a fluid sample, the test device including a support bearing a mark thereon, and a matrix defining an axial flow path. In operation, an observation area in the test device becomes transparent, thereby allowing the user to view a mark that is present on a support that is disposed beneath the observation area. Typically, the mark on the underlying support is configured as a minus (?) sign. In the absence of analyte in the sample, the test device presents a negative result as a minus (?) signal. In the presence of analyte in the sample, however, the mark operates in concert with a perpendicular test line on the observation area to present a positive result as a plus (+) signal that is visible to the user.

Abstract: A continuous indicator strip having a multiplicity of separate individual sequential test sections along the surface thereof, wherein a plurality of test sections are impregnated with the same indicator enabling the utilization of the strip for sequential repetitive testing of samples, the strip being provided with at least 20 such test sections.

Abstract: The present invention relates to a dry stick test device for the determination of an analyte in a sample by means of a chemical assay. The device comprises: (i) optionally a solid support, (ii) at least one reagent pad comprising a reagent capable of reacting with the analyte, a derivative of said analyte or an indicator compound for said analyte to provide a detectable signal when in moistened state, and (iii) a development pad which is located in contact with the at least one reagent pad, optionally between the solid support and the at least one reagent pad, said development pad comprises at least one controlling compound capable of providing a condition required for the reagent to react with the analyte to provide a detectable signal, wherein the at least one reagent pad and the development pad are arranged to avoid precipitation of sample component(s) on the top-face of the device.

Abstract: A dehydration sensor having a stable, printable, buffered-ink composition that enables one to miniaturize the detection zone and permits both buffer and indicator dye to be applied in the same area of a detection zone, without need for a conventional, large buffer pad region. The ink composition includes a weak polymeric base as its primary buffering agent.

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: It is intended to provide a target substance detection element wherein a target substance capturing body for capturing target substances is immobilized with good orientation in a desired region on the surface of the target substance detection element, a method for producing the target substance detection element, and a detection method using the target substance detection element.

Abstract: Devices and methods for the detection of antigens are disclosed. Devices and methods for detecting food-borne pathogens are disclosed.

Abstract: With respect to a lead detection method that uses rhodizonic acid, it is made possible to clearly identify pink or red coloration caused by a reaction between lead and rhodizonic acid even in cases where Sn is present in a specimen. To this end, an acidic aqueous solution or a buffer solution thereof (e.g., tartaric acid) in which hydrogen peroxide coexists is used as a reagent. Hydrogen peroxide oxidizes Sn2+ into Sn4+. Since Sn4+ does not react with rhodizonic acid, the presence of Sn does not interfere with the visual identification of any pink or red coloration caused by the reaction between lead and rhodizonic acid.

Abstract: A container with a rotatable lid for reading and handling diagnostic reagents in tape form comprising a body portion, a lid portion, a continuous tape, a reagent-sensing device, and a storage device. The body portion includes an inner and outer surface. The lid portion is attached to the body portion and is adapted to rotate from a closed position to an open position. The continuous tape includes a diagnostic reagent. The reagent-sensing device is attached to either the body portion or the lid portion and adapted to read the diagnostic reagent. The storage device is attached to the body portion that is adapted to hold and dispense an unused portion of the continuous tape. During the rotation of the lid portion, the continuous tape is advanced from the first storage device and is extended over the reagent-sensing device.

Abstract: The present invention provides a composition for detecting an object substance (X). This detection composition contains a gel (Y). The gel (Y) contains a colorable aqueous solution (A) that can be colored upon contact with the object substance (X), and a crosslinked polymer (B). This composition is preferably used to evaluate packaging materials.

Abstract: A sheet of sensors and a method of manufacturing such sheet of sensors. The sheet is configured with (A) a tessellated zipper pattern of identically shaped elements defining (i) a right longitudinal column consisting of a base portion of a right set of elements, (ii) a left longitudinal column consisting of a base portion of a left set of elements, and (iii) an intermediate longitudinal column consisting of alternating tab portions of the right and left elements, and (B) a continuous longitudinal strip of functional material positioned only within the intermediate column.

Abstract: Electrochemical devices, methods, and systems for detecting and quantifying analytes are disclosed. A chemical detection reagent is locally generated in a test solution by electrochemical reaction of a precursor compound caused to migrate into the test solution from a precursor solution separated from the test solution by a cell separator. This approach provides precise metering of the reagent, via the charge passed, and avoids the need to store a reagent solution that may be chemically unstable. In one embodiment, the starch concentration in a colloidal solution can be measured via spectroscopic detection of a blue complex formed by the interaction of starch with iodine produced, on demand, by electrochemical oxidation of iodide ion. The approach may also be used to characterize certain types of analytes. The invention is amenable to automation and is particularly useful for on-line monitoring of production processes, including the inclusion of feed back loop mechanisms for process control.

Abstract: According to one embodiment of the present invention, an optical-based test sensor for use in the determination of an analyte in a liquid sample is disclosed. The test sensor includes a base, a polymer carrier, and a test membrane. The base has a capillary channel formed in a surface of the base that is adapted to move a liquid sample from an inlet to a reaction area formed in the base. The polymer carrier has a lower surface adhered to the surface of the base and is disposed over at least a portion of the capillary channel. The test membrane, which contains a reagent, is adhered to the lower surface of the polymer carrier and extends from the polymer carrier into the reaction area.

Abstract: Disclosed is an assay result reading apparatus, for reading the result of an assay, comprising: a) first and second control thresholds; b) a data processing means for processing an analyte measurement signal indicative of the presence and/or amount of an analyte; and for processing a control signal indicative of whether the assay has been carried out satisfactorily; to: up until a time t1 after commencement of the assay measurement, to compare the control signal with the first control threshold and determine that the assay has been carried out satisfactorily if the control signal exceeds or is equal to the first control threshold, and if the control signal is less than the first control threshold to continue the assay measurement; and at a time t>t1 to compare the control signal with a second control threshold and provide an assay result if the control signal exceeds or is equal to the second control threshold.

Abstract: The invention concerns a reagent system for the so-called on-board control of analytical elements, in particular test strips, containing an organic N-oxide or a nitroso compound. The invention also concerns analytical elements containing a reagent system for a detection reaction and a reagent system for an on-board control. Furthermore, the invention concerns a method for checking analytical elements in which a reagent system for an on-board control is examined optically or electrochemically with the aid of a measuring instrument for changes which could indicate a stress of the analytical element.

Abstract: Freeze indicators can include an indicator dispersion, a liquid medium, indicator particles dispersed in the liquid medium and a particulate inorganic nucleating agent to inhibit supercooling of the liquid medium. The inorganic nucleating agent can have an ionic surface coating which can help provide a sharp end point. Optionally, freeze indicators can include indicator particles comprising an organic material and a softener to soften the indicator particles and provide the freeze indication with an enhanced visual appearance. Another option is to provide a temperature-sensitive stabilizer to inhibit coagulation of the indicator dispersion at temperatures above the liquid medium frozen state melting point while permitting coagulation of the indicator dispersion at the liquid medium frozen state melting point.

Abstract: A method is provided for producing an analytical element comprising at least one test field for analyzing a liquid sample, wherein provision is made for a carrier on which a polymer fabric is arranged. At least one portion of the polymer fabric is irradiated with UV laser light and thereby hydrophobized.

Abstract: Articles for testing a coagulation process in whole blood.

Abstract: A dehydration sensor having a stable, printable, buffered-ink composition that enables one to miniaturize the detection zone and permits both buffer and indicator dye to be applied in the same area of a detection zone, without need for a conventional, large buffer pad region.

Abstract: Methods and devices for rapid lateral flow immunoassays to detect specific antibodies within a liquid sample while also validating the adequacy of the liquid sample for the presence of immunoglobulin and the integrity and immunoreactivity of the test reagents that detect the antibodies of interest, without requiring instrumentation. The methods and devices provide for delivery of a diluted liquid sample to a single location that simultaneously directs the liquid flow along two or more separate flow paths, one that serves as a positive control to confirm that all critical reagents of the test are immunoreactive, and that the sample being tested is adequate, and the other to detect specific antibodies if present.

Abstract: The invention provides devices, test kits and methods for removing target agents from a sample. The device contains one or more porous matrices having pore sizes larger than 10 ?m, and a plurality of particles impregnated therein. The target agents attach the device and are removed from the sample.

Abstract: The present disclosure provides a device for simultaneously detecting hemoglobin and glycohemoglobin in blood. The device includes a lateral flow assay strip, a laser-induced epifluorescence detection device, and an LED detection device. The present disclosure further provides a method for simultaneously quantifying hemoglobin and glycohemoglobin in blood by an immunological method using the same.

Abstract: A calibration tool for use in combination with a photoluminescent oxygen-sensitive working probe and an analytical instrument capable of reading the working probe. The calibration tool is effective for achieving two-point calibration of the analytical instrument, and includes at least first and second solid state compositions having different sensitivities to oxygen. The first composition is an oxygen-sensitive photoluminescent dye that is the same as that in the working probe, embedded within an oxygen-permeable carrier matrix that is the same as that in the working probe. The second composition is an oxygen-sensitive photoluminescent dye that is the same as that in the first composition, embedded within a carrier matrix that is different from that in the first composition. The oxygen sensitivity of the second composition is less than the oxygen sensitivity of the first composition.

Abstract: A biochip substrate capable of realizing the high detection accuracy by restricting a nonspecific adsorption or bonding of a substance to be detected, when used for a detection or analysis of protein, nucleic acids and the like. The biochip substrate is for fixing a biologically active substance on a surface of a solid substrate, and characterized in that it has a layer comprising a polymer compound obtained by copolymerizing an ethylenically unsaturated polymerizable monomer having an alkylene glycol residue, an ethylenically unsaturated polymerizable monomer having a functional group for fixing a biologically active substance and an ethylenically unsaturated polymerizable monomer having a cross-linkable functional group, on the surface of the substrate.

Abstract: A vessel (102) containing a detector solution (101) is prepared. The detector solution (101) is an aqueous solution prepared by dissolving a detector component containing a dye which changes its color when reacting with ozone gas, a humectant, and an ultraviolet absorber having a hydrophilic group. A prepared sheet-like carrier (103) is dipped in the detector solution (101) for, e.g., 30 sec, thereby forming an impregnated sheet (104) by impregnating the sheet-like carrier (103) with the detector solution (101). The impregnated sheet (104) is then dried by evaporating the solvent (medium) such as water contained in the impregnated sheet (104), thereby forming a sheet-like ozone detecting device (105).