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.

Abstract: A lateral flow, membrane-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes phosphorescence to detect the signals generated by excited phosphorescent labels. The labels may have a long emission lifetime so that background interference from many sources, such as scattered light and autofluorescence, is practically eliminated during detection. In addition, the phosphorescent labels may be encapsulated within particles to shield the labels from quenchers, such as oxygen or water, which might disrupt the phosphorescent signal.

Abstract: A test strip to assist in determining the concentration of an analyte in a fluid sample comprises a base, at least one tab and a break line. The base includes a capillary channel and a test element. The capillary channel is in fluid communication with the test element. The test element is adapted to receive the fluid sample. The at least one tab is removably attached to the base. The capillary channel extends from the base into a portion of the tab. The break line intersects the capillary channel in which an inlet to the capillary channel is exposed along the break line when the tab is separated from the base.

Abstract: A multilayered optical sensing patch, for the measurement of conditions, such as pH, oxygen level, etc, within containers, is provided. The multilayered optical sensing patch of the present invention is comprised of a heat sealable polymer substrate layer, and a polymeric sensing membrane later attached thereto. The polymer sensing membrane layer is formed of a porous polymer support membrane, and an optical sensing composition (comprising a reactive indicator) covalently bonded thereto. The heat sealable polymer substrate layer is capable of being securely bonded to the inner layer of bioreactor bags, as well as the porous polymer support substrate layer. Further, the porous polymer support membrane layer provides a firm supporting structure for the polymeric sensing layer, thereby protecting the optical sensing composition disposed therein from degradation/damage.

Abstract: A device for testing a specimen comprising a first panel, a metering aperture structure having a plurality of metering apertures formed therein for receiving the specimen therethrough, a second panel opposite the first panel, a sheet disposed between the first and second panels, the sheet including a test area aligned with the plurality of metering apertures, a spacer element disposed between the first panel and the sheet, wherein the metering aperture structure is spaced away from the test area thereby improving readability of the testing. A method of manufacturing a specimen testing device is also disclosed.

Abstract: Provided are a sensing device and a biosensor that are capable of achieving stable performance in sensing saccharides or hydroxyl group-containing polymers, and that can be stored for a long time. The biosensor 8 of the present invention uses, as a component for sensing glucose, a sensing device 16 in which a completely synthetic phenylboronic acid compound 21 is bound without using enzymes that have been conventionally used. Consequently, the biosensor 8 can eliminate the problem of protein denaturation to achieve stable performance in sensing glucose, and it is possible to achieve the biosensor 8 can be stored for a long time.

Abstract: A system for detecting an adulterant in a sample of milk. One or more drops of milk are added to a first location of a system and the presence or absence of the adulterant is detected in a second location of the system using a material treated with a detection reagent.

Abstract: An immunochemical filter device which has filter material attached to a support member (such as a cap) which is, in turn, attachable to a sample collection vessel. The filter material includes a labeled binding reagent that is released from the filter material into solution by migration of a liquid sample solution through the filter material. The mixture of the sample solution and the labeled specific binding reagent is transferred to an analyzer device for performance of a method for determining the presence or absence of an analyte in a sample solution.

Abstract: The invention is directed to an apparatus useful in conducting detection of compounds on blotting membranes. The device is comprised of several layers including a porous support layer below the blotting membrane(s), a flow distributor above the blotting membrane(s) and optionally a well on the flow distributor to contain the liquid to the desired area and to allow for lower starting volumes of such liquid. Preferably, the flow distributor is a non-binding or low binding hydrophilic porous membrane such as a 0.22 micron membrane and the support layer is a grid or sintered porous material. The distributor and support are held together to form an envelope around the membrane(s). The use of a hinge, clips and other such devices is preferred in doing so.

Abstract: The invention is directed to an apparatus useful in conducting detection of compounds on blotting membranes. The device is comprised of several layers including a porous support layer below the blotting membrane(s), a flow distributor above the blotting membrane(s) and optionally a well on the flow distributor to contain the liquid to the desired area and to allow for lower starting volumes of such liquid. Preferably, the flow distributor is a non-binding or low binding hydrophilic porous membrane such as a 0.22 micron membrane and the support layer is a grid or sintered porous material. The distributor and support are held together to form an envelope around the membrane(s). The use of a hinge, clips and other such devices is preferred in doing so.

Abstract: A blood glucose meter includes a front attachment part to which a test piece is attached, a measurement part for measuring a component of blood collected via a blood guide passage in the test piece, and a monitor for displaying the measurement results obtained by the measurement part. When the device is placed on a horizontal plane by referring to the display face of the monitor as the upper side and the opposite side as the lower side and placing the display face of the monitor upward, the central axis of the test piece extends obliquely downward toward the front side. The blood glucose meter comprises a main part provided with the monitor and a linking part between the main part and the front attachment part. The top face of the linking part is placed roughly parallel to the central axis line and is provided with an ejector lever.

Abstract: An object of the invention is to provide various flow cells and a method for manufacturing the same, in which formation of a groove on a substrate and formation of components such as an electrode, auxiliary parts such as a pump are not necessary. The inventive flow cells are capable of realize complicated chemical analysis or synthesis or the like. A channel of a porous member provided on a sample-incompatible substrate is formed; the porous member is composed of an air non-contact region having a network structure and an air contact region covering the air non-contact region and having a lower pore density than the air non-contact region; in which a capillary force to be generated within the porous member is a drive force for pumping a liquid.

Abstract: Disclosed is a pinhole inspection apparatus, system and method for a membrane electrode assembly of a fuel cell, which can easily detect the position of a pinhole using water and a pH test paper from discoloration caused when the water is in contact with the pH test paper through the pinhole, thus solving the existing problems and allowing the membrane electrode assembly to be reused after the inspection. In particular, a lower fixture is configured to support the membrane electrode assembly and water is uniformly distributed on an upper surface of the membrane electrode assembly. A pH test paper is inserted between the membrane electrode assembly and the lower fixture and discolored upon coming in contact with water that passes through a pinhole in the membrane electrode assembly, thus detecting the presence and position of the pinhole.

Abstract: In one aspect, a diagnostic test system includes a receptacle, optical detectors, and a logic circuit. Each of the optical detectors has a corresponding view in the receptacle and produces an electrical signal at a respective detector output in response to light from the corresponding view. The logic circuit includes logic inputs that are respectively coupled to the detector outputs and that produce an output logic signal corresponding to a logical combination of signals received at the logic inputs. In another aspect, respective detection signals are produced in response to light received from respective ones of multiple views of the test strip, and at least one output logic signal corresponding to a respective logical combination of the detection signals is generated.

Abstract: Three-dimensional microfluidic devices including by a plurality of patterned porous, hydrophilic layers and a fluid-impermeable layer disposed between every two adjacent patterned porous, hydrophilic layers are described. Each patterned porous, hydrophilic layer has a fluid-impermeable barrier which substantially permeates the thickness of the porous, hydrophilic layer and defines boundaries of one or more hydrophilic regions within the patterned porous, hydrophilic layer. The fluid-impermeable layer has openings which are aligned with at least part of the hydrophilic region within at least one adjacent patterned porous, hydrophilic layer. Microfluidic assay device, microfluidic mixer, microfluidic flow control device are also described.

Abstract: The present invention relates to an assay device capable of testing for multiple analytes such as drugs using individual test strips for each analyte.

Abstract: A lateral flow assay device for determining the relative ionic strength of urine is described. The device includes a buffering zone having a polyelectrolyte disposed therein, and an indicator zone having a pH indicator non-diffusively immobilized therein, the indicator zone being separate from the buffering zone and positioned adjacent to and in fluid communication with the buffering zone. A detection zone is part of the buffering zone, and has a buffering component comprising a weak polymeric acid and weak polymeric base with a pKa ?10?3, and a class of charged polymeric surfactants that are responsive to relative ion concentrations in a sample solution, and a charged pH indicator with a charge opposite to that of the charged polymeric surfactant. The charged polymeric surfactant is soluble in amounts of greater than or equal to about 1% by weight (?1 wt. % solute) in water and aqueous solutions of low ionic concentration of ?0.1 wt. % salts, but insoluble (<1 wt.

Abstract: Co-topo-polymeric indicator compositions and methods for making and using the same are provided. Indicator compositions of the invention include a polymer and undergo a color change, which may be reversible or irreversible, in response to an applied stimulus, e.g., temperature. Aspects of methods of producing the compositions include setting a fluid co-topo-polymeric precursor composition into a solid product and then subjecting the solid product (either immediately or after a delay period) to polymerizing conditions to produce the desired indicator composition. Also provided are indicator devices that include the indicator compositions of the invention. The compositions of the invention find use in a variety of different applications.

Abstract: Devices and methods incorporate lysis agents into a point-of-care testing device. The sample is loaded, and then the sample travels until it encounters a lysis agent. The lysis agent is preferably pre-loaded onto the collection device. In a preferred embodiment, the initially lysis agent is localized between the sample application zone and the conjugate zone. The lysis agent is preferably soluble or miscible in the sample transport liquid, and the lysis agent is solubilized and activated upon contact with the sample transport liquid. The sample transport liquid then contains both lysis agent in solution or suspension and sample components in suspension. Any lysis-susceptible components in a sample, then being exposed in suspension to the lysis agent, are themselves lysed in situ. The running buffer then carries the analyte, including any lysis-freed components, to the detection zone.

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).

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: Embodiments of the invention provide lateral flow and flow-through bioassay devices based on patterned porous media, methods of making same, and methods of using same. Under one aspect, an assay device includes a porous, hydrophilic medium; a fluid impervious barrier comprising polymerized photoresist, the barrier substantially permeating the thickness of the porous, hydrophilic medium and defining a boundary of an assay region within the porous, hydrophilic medium; and an assay reagent in the assay region.

Abstract: Muscle cramps can be reduced or avoided by monitoring the concentration of salt in perspiration to indicate the degree of salt depletion. Based on the degree of salt depletion, a sufficient amount of rehydration beverage is consumed to normalize the salt level.

Abstract: A (H2) sensor composition includes a gas permeable matrix material intermixed and encapsulating at least one chemochromic pigment. The chemochromic pigment produces a detectable change in color of the overall sensor composition in the presence of H2 gas. The matrix material provides high H2 permeability, which permits fast permeation of H2 gas. In one embodiment, the chemochromic pigment comprises PdO/TiO2. The sensor can be embodied as a two layer structure with the gas permeable matrix material intermixed with the chemochromic pigment in one layer and a second layer which provides a support or overcoat layer.

Abstract: A rapid diagnostic device, assay and multifunctional buffer reagent are provided for the detection of a target analyte in a fluid test sample. The 2-step assay utilizes a dual component flow-through device comprising a test unit and a dried indicator reagent delivery unit for receiving the fluid sample and multifunctional buffer, respectively. The test unit comprises a reaction zone containing immobilized capture reagent that can bind to the target analyte, an absorbent zone supporting the reaction zone, and optionally, a blood separation zone in lateral fluid communication with the reaction zone. The delivery unit comprises a label zone permeated with a dried indicator reagent which can be placed in transient fluid communication with the reaction zone of the test unit during the assay procedure. The rapid diagnostic assay system reduces the number of assay reagents, method steps and time required for performance compared to other conventional assays.

Abstract: Embodiments of the present invention include processing steps and subsystems, within automated-biopolymer-synthesis systems and within other automated systems for organic-chemistry-based processing, for removing reagent solutions and solvents from reaction chambers following various synthetic reaction steps and washing steps undertaken during biopolymer synthesis. Embodiments of the present invention employ any of various different types of liquid-absorbing materials to wick, or remove by capillary action, liquids from reaction chambers. Wicking-based methods and subcomponents of the present invention remove significantly greater fractions of solutions from reaction chambers than conventional methods and subsystems and, in addition, are mechanically simpler and produce fewer deleterious side effects than currently used methods and subsystems.

Abstract: The invention relates to a lateral flow assay test strip and a method for making the same. The strip comprises, in the flow direction, a selectively activated membrane for a test reaction and an absorption pad, which are both made of paper and may comprise an integral paper strip. The absorption pad has the paper strip embossed and/or folded to increase the strip's absorption capacity. The folded pad may have an accordion-like configuration, the strip running to-and-from, or it may have the strip rolled and then flattened to a stack of layers.

Abstract: A sensor substrate includes a base and fibrous projections on an upper surface of the base. The fibrous projections have fixed ends fixed to the upper surface of the base and free ends opposite to the fixed ends, respectively. The fibrous projections provide a fixed end-side region including the fixed ends and a free end-side region including the free ends. The total surface area at which the fibrous projections in the fixed end-side region is larger than that in the free end-side region.

Abstract: A lateral flow, membrane-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes phosphorescence to detect the signals generated by excited phosphorescent labels. The labels may have a long emission lifetime so that background interference from many sources, such as scattered light and autofluorescence, is practically eliminated during detection. In addition, the phosphorescent labels may be encapsulated within particles to shield the labels from quenchers, such as oxygen or water, which might disrupt the phosphorescent signal.

Abstract: Analytical cartridges, systems and methods of processing a sample for analysis using capillary flows. Vertical gradient sample filtration provides filtrate to an incubation chamber for a time controlled by a flow modulator at the outlet of the incubation chamber. The flow modulator can include a serpentine capillary flow path without side walls. Incubated filtrate can flow from the incubation chamber to a detection channel after a predetermined time. The detection chamber can include one or more analytical regions in a porous substrate for detection of two or more analytes on the same cartridge from the same sample.

Abstract: A carrier tape (20) wound on and extending between first and second spools (40) rotatably mounted to a read head (12) is submerged with a detector (44) mounted on a guide mechanism (42) into a fluid thermal media in the form of water or air contained in tanks (76-79). While submerged, the carrier tape (20) can be wound from one spool (40) to another. Further, the read head (12) can be plunged multiple times in opposite directions in the fluid thermal media. The detector (44) allows readings while the carrier tape (20) and the contents carried thereby are submerged in the fluid thermal media and can be a multi-channel, time-resolving photometer measuring fluorescence with at least one channel per row of wells (30) arranged in an array.

Abstract: The present disclosure generally relates to a color indicator that signals when the concentration of an antimicrobial solution changes. In some embodiments, the color indicator is specific for changes in the concentration of an antimicrobial quaternary ammonium compound in an antimicrobial solution. The color indicator can be incorporated into a variety of articles including towels, labels, containers, buckets, trays, sinks, spray bottles, liners for containers, buckets, sinks, or spray bottles, indictor wands or strips, and test kits.

Abstract: A lateral flow device for analyzing a whole blood sample is provided. More specifically, the lateral flow device contains a porous membrane that defines a barrier zone for separating red blood cells from blood plasma (includes plasma in which clotting factors haven been removed), which may then flow to a subsequent detection zone for analysis. The barrier zone is formed from a blood cell barrier composition that includes an unsaturated aliphatic fatty acid or an ester thereof. Without intending to be limited by theory, the present inventors believe such unsaturated aliphatic fatty acid molecules undergo autoxidation in the presence of air and hemoglobin to release peroxides (e.g., hydrogen peroxide) via oxidative saturation of double bonds. In turn, the released peroxides are believed to induce the formation of echinocytes or crenated blood cells.

Abstract: A method is provided for detecting alkylating agents, the method comprising bringing together a first solvent, one or more surfactants, a base, a reagent comprising a nucleophilic nitrogen atom, and a suspected alkylating agent. A device suitable for putting said method into effect is also provided.

Abstract: The present invention relates generally to the field of analysis, for example biological analysis.

Abstract: Disclosed is a lateral flow capillary device and uses thereof comprising a unipath bibulous capillary flow matrix and at least two reservoirs each in fluid communication with the capillary flow matrix wherein a reservoir contacts the capillary flow matrix through a passage having a rim pressing the matrix. The pressure that the rim applies on the matrix prevents leakage of liquids out of the capillary flow matrix at the reservoir/ matrix interface, allowing accurate sequential draining of liquid from the reservoirs.

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: A portable rapid diagnostic test reader system includes a mobile phone having a camera and one or more processors contained within the mobile phone and a modular housing configured to mount to the mobile phone. The modular housing including a receptacle configured to receive a sample tray holding a rapid diagnostic test. At least one illumination source is disposed in the modular housing and located on one side of the rapid diagnostic test. An optical demagnifier is disposed in the modular housing interposed between the rapid diagnostic test and the mobile phone camera.

Abstract: An oxygen sensor includes a metalloporphyrin for detecting oxygen levels. The oxygen sensors may also include a light source and a detector. The sensors are configured to measure changes in spectra in response to the redox reaction. They can detect a variety of samples for presence and changes in oxygen concentration in both solution and gaseous form.

Abstract: The invention relates to processes and devices for detecting an analyte in a sample by fluorescence measurement of a fluorophore, wherein the detection medium which contains a fluorophore or a precursor of the fluorophore is admixed with an absorber whose absorbance spectrum superimposes the fluorescence excitation range of the fluorophore. The system consisting of the fluorophore and the absorber, which is produced in the detection medium, has an altered effective fluorescence excitation range with an altered fluorescence excitation maximum. Illumination with fluorescence excitation light can take place within the range of this altered excitation maximum. The measured signal obtained from determining fluorescence emission exhibits only low dependence on the wavelength of the excitation light.

Abstract: Oral, topical and injectable contraceptives, which are based on sperm protein 22 kDa (SP22) polypeptides and antibodies and infertility diagnostics and kits are provided.

Abstract: A device and method for detecting the presence of hemoglobin in a biological sample, more particularly, the presence of blood in a fecal sample as an indicator of upper or lower gastrointestinal tract bleeding.

Abstract: Methods, apparatuses, compositions and kits are disclosed for detecting the presence or absence of an inhibitor in a fluid. In one embodiment, methods, apparatuses, compositions and kits are disclosed for determining if the level of a corrosion inhibitor in a coolant fluid is sufficient to provide protection against corrosion.

Abstract: An indicator device adapted give a detectable signal when the antioxidant capacity of a sample of a mammalian wound fluid exceeds a predetermined minimum level which is characteristic of an infected wound. Also provided system for use in the diagnosis and treatment of wounds comprising the inventive diagnostic device and a wound dressing comprising at least one antimicrobial agent for selective application to infected wounds. Also provided are methods of diagnosis and treatment by means of the inventive device and system.

Abstract: A detection system in a portable assay reader device is enabled or activated after a user applies a manual force to a portion of the reader device, to an object supporting the assay test strip, or to the assay test strip itself. The movement moves a switch from an open state to a closed state. The closed state enables a detection system to monitor one or more test regions in the assay test strip for a reaction. The detection system can include one or more imagers, one or more electrical detectors, one or more magnetic detectors, or one or more optical detectors that monitor the one or more test regions for applicable visible, electrical, magnetic, or optical reactions, respectively. The one or more imagers or detectors transmit data to a processing device to determine the results of a test.

Abstract: The present invention relates to novel lateral flow devices using two dimensional features, preferably, uniform two dimensional test and control features, and the methods for detecting an analyte using the lateral flow devices, and processes for making the lateral flow devices.

Abstract: A microfluidic fluid separator for separating target components of a fluid by filtration is described. Methods for separating target components of a fluid by filtration and methods for processing blood on a large scale with the microfluidic fluid separator are provided.

Abstract: Devices and methods for the detection of target molecules are disclosed. Devices and methods for detecting food-borne target molecules are also disclosed.

Abstract: A disposable immunodiagnostic test system tests for marker proteins in a sample and includes intimately contacting passage, protein, and absorbent layers. The passage layer is non-porous and has an aperture therethrough. The protein layer is porous, has combinable proteins immobilized thereon, and enables passage of the sample therethrough. The protein layer has an active surface aligned with the passage layer aperture. The sample is introduced onto the protein layer through the passage layer aperture. In positive results, the marker proteins are bound to the combinable proteins and immobilized relative to the protein layer. In negative results, the sample passes through the protein layer, and is absorbed by the absorbent layer. A housing may also be provided, as may a wash structure. The system may be constructed of combustible materials that produce non-toxic by-products upon incineration, preferably enabling ecologically responsible disposal after diagnostic use of the system.

Abstract: The sensitivity of visually read lateral flow immunoassay tests is enhanced by adding a small quantity of fluorescing dye or fluorescing latex bead conjugates to the initial conjugate material. When the visible spectrum test line is visibly present, the test result is observed and recorded. However, in the case where the result is indeterminate, a light of an appropriate spectrum, such as a UV, visible, or infrared spectrum, is cast on the test line to excite and fluoresce the fluorescing latex beads which are bound in the test line in true positive tests to enhance the visible color at the test line.