Abstract: Paper microfluidic devices for the detection of bodily fluids are provided. Such devices can be used, for example, for detection of bodily fluids from or at crime scenes, including blood, saliva, semen, urine, feces, vaginal fluids, and perspiration. Detection can be performed using colorimetric reagents that react when placed in contact with the fluid of interest. A single device can be used to test for multiple bodily fluids at the same time.

Abstract: A dry chemical test strip with multiple layers of membranes based on concentration gradient, comprising a substrate, an indicator layer, a reagent layer and a diffusion layer, further comprises a concentration gradient layer. Wherein a first reagent is uniformly applied on the reagent layer, a second reagent is applied on the concentration gradient layer. The concentration gradient increment ?? of the second reagent is 0 in the width direction of the test strip, and is a constant or a function of the variable of length in the length direction of the test strip, a chromogenic reagent is uniformly applied on the indicator layer. The dry chemical test strip with multiple layers of membranes based on concentration gradient can allow all the testing and analysis procedures to be directly carried out on the test strip, test results to be directly obtained on the spot without the help of instruments.

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: The present invention provides a novel assay for detecting human antibodies specific for a platelet factor 4 (PF4)/heparin complex in a fluid sample. The assay utilizes an immobilized PF4/polyanion complex and an anti-human antibody conjugated to a non-particulate fluorescent dye to capture and detect human PF4/heparin antibodies. Various devices, methods and systems based on the disclosed PF4/heparin assay are also provided.

Abstract: The present invention refers to a portable device for the collection of biological samples. The device comprises a receptacle (8) with a cover (2), which comprises a pierceable area (3) and may include a collection instrument (1), comprising a rod (4), and a collection arrangement at the end, which may include a solid matrix, for instance a sponge or a tampon (5). The receptacle (8) has a rounded or conical shaped bottom (10), at the center of which there is a conical or rounded-shaped projection (11), with one or more holes (12). The bottom of the receptacle (8) is in contact with a collector recipient through a system of close-aperture, which may comprise screw or a fitting system with protrusions (13). In this way, the device referred in the present invention allows for the collection, storage, transportation and separation of biological material without significant manipulation and without risk of cross-contamination.

Abstract: The invention describes a color-developing composition that contains at least four major components: (1) a leuco dye or a combination of leuco dyes, (2) an electron-withdrawing color-developer agent or a combination of color-developers that can form colored complexes with the leuco dyes, (3) a separator or combination of separators that when present in sufficient amounts, can prevent the formation of the colored complexes between the color-developer and leuco dyes, all contained within (4) an encapsulation matrix that includes at least one film-forming and one aqueous-insoluble polymer. All of the foregoing components are dissolved together in a volatile organic solvent medium to form a homogeneous solution that can be applied as an ink on substrates, which can be incorporated as part of absorbent articles or personal care products.

Abstract: A three-in-one apparatus for analyzing liquids, such as some body fluids, uses labeled molecular affinity binding, such as immunochromatography. The multi-functional diagnostic test device can detect an analyte, such as an antibody or antigen, which may indicate a particular condition. The multi-functional diagnostic test device provides multi-functional formats to apply in multiple different sampling methods, including the “dip”, “cassette” and “collection” formats. The diagnostic test device can accommodate a plurality of test strips, such as 18 test strips for analyzing up to 90 analytes.

Abstract: Provided is a fluidic device including: a support member; a porous layer; and an adhesive layer bonding the support member and the porous layer with each other. A partition wall made of a thermoplastic material is formed in the porous layer. The support member has a heatproof temperature that is higher than a melting start temperature of the thermoplastic material.

Abstract: A method is provided for enhancing the binding of reagents to ligands. In the method a ligand is immobilized on a porous support and incubated with a reagent solution. The binding of the reagent to the ligand is increased by a cycling process of passing the reagent solution through the support multiple times. A device that facilitates the cycling process is disclosed. Provided is a method to detect multiple ligands using the cycling process.

Abstract: Devices and methods for immobilizing micrometer sized liquid domains onto a chemically functionalized substrate surface are disclosed. A multifunctional polymer is adsorbed at the surface interface of the liquid microdomains, and the liquid microdomains are immobilized by covalent bonding or non-covalent forces such as electrostatic attraction between the adsorbed multifunctional polymer and the functionalized substrate surface.

Abstract: The present invention related to a test strip and a method for humidity detection. The test strip comprises two humidity detecting materials for detecting humidity change and one of the humidity detecting materials is exposed to outer environment. Detect the two humidity changes to obtain a ratio that is used for comparing with a value and then it can prevent from exceeding a predetermined humidity value, and whereby the test strip and the method could achieve the goal of simple humidity detection.

Abstract: The present describes a system and method for determining the concentration of tetrahydrocannabinol (THC) including a tray comprising a first analyte including an infusion of a solvent and cannabis, a light emitting element configured to illuminate the first analyte, a light receiving element configured to receive a first light transmitted through the first analyte, and a control circuit configured to calculate a concentration of tetrahydrocannabinol in the first analyte based at least in part on the first light.

Abstract: A pH measuring method includes: illuminating a medium solution, which includes: a first material; and a second material, with a plurality of light beams, which includes: a first light beam, a wavelength of which corresponds to a first absorption peak; a second light beam, a wavelength of which corresponds to a second absorption peak or a second convergence point; a third light beam, a wavelength of which corresponds to a third absorption peak or a third convergence point; and a fourth light beam, a wavelength of the fourth light beam at which an absorbance of at least one of the first and second materials is converged irrespective of a pH; receiving transmitted or reflected light beams of the first to fourth light beams; measuring absorbances at the wavelengths of the received light beams respectively; and calculating a pH of the medium solution based on the absorbances.

Abstract: Provided is a liquid reagent containing microchip having a fluid circuit formed of a space inside thereof. Liquid present in the fluid circuit is transferred to a desired position in the fluid circuit by applying centrifugal force. The fluid circuit includes a reagent retaining portion for accommodating a liquid reagent. The microchip includes an air introduction path formed of a groove provided on an outer surface of the microchip and coupled to the reagent retaining portion for introducing air into the reagent retaining portion, and a sealing portion provided so as to be detachable from the microchip for sealing the air introduction path. A method of using the microchip and a packaged liquid reagent containing microchip using the microchip are also provided.

Abstract: An apparatus is provided for performing an chemical, biochemical, or biological assay on a sample comprising: a microfluidic assay cartridge (1) that contains at least one sample inlet well (2) configured to receive a sample; and a microfluidic sub-unit (3) associated with the microfluidic assay cartridge (1) and comprising microfluidic channels (8), micro-valves (4, 4a, 9) and at least one separate and fluidicly-isolated isolation channel (5), and at least one hollow element (14); the at least one hollow element (14) being functionalized with a capture moiety or molecules (15) so as to form at least one reaction vessel (19); the microfluidic channels (8) and micro-valves (4, 4a, 9) configured to respond to signaling containing information about performing the assay and to controllably receive the sample and at least one reagent in the at least one reaction vessel (19), and to provide from the at least one reaction vessel (19) light containing information about the assay performed on the sample inside the at

Abstract: The present disclosure relates to devices and methods for detecting the presence of a target analyte in a fluid sample using an assay.

Abstract: A specimen sample collection system includes a handle having opposing first and second ends, and a sufficiency indicator coupled to the handle, wherein the handle second end and sufficiency indicator form a cavity adapted to receive a sample collection pad; a sample collection pad having opposing ends, the sample collection pad partially contained within and extending from the handle second end and in contact with the sufficiency indicator, the sample collection pad having a cylindrical cross section; and, a pad compression tube having a first open end to go over the sample collection pad and second end of the handle, an opposing second end, an interior surface extending therebetween, and at least outlet port proximal to the pad compression tube second end and in fluid communication with the pad compression tube interior. The system may include wherein the sufficiency indicator is a light pipe or other indicating element, providing visual, aural or haptic indication of sufficient sample volume.

Abstract: A microfluidic flow cell subassembly, which may be assembled into a flow cell having fluidic connections outside of the main substrate, is described for encapsulating a sample to allow for subsequent controlled delivery of reagents to the sample, such as multiplexed in situ biomarker staining and analysis. The fluidic connectors are thin film fluidic connectors capable of connecting to a fluid delivery system. The subassembly may be sealed against a solid support to form a flow cell. Methods of use are also disclosed.

Abstract: Disclosed are methods and devices for rapid parallel molecular affinity assays performed in a microfluidic environment. The invention exploits hydrodynamic addressing to provide simultaneous performance of multiple assays in parallel using a minimal sample volume flowing through a single channel.

Abstract: Disclosed is a fluid collection device that comprises a housing having a normally obverse fluid receiving side and an opposing side. The fluid receiving side has an aperture for receiving a fluid and permitting deposition of the fluid into a fluid collector. The fluid collector is normally inclined to permit inclined fluid flow away from the aperture. Also disclosed is a kit that includes the fluid collection device, and various methods for use of the fluid collection device.

Abstract: A feminine care absorbent article (e.g., feminine care pad, sanitary napkin, tampon, etc.) is provided that employs a synergistic combination of an antimicrobial composition for inhibiting thegrowth of microorganisms (e.g., bacteria, protozoa, yeast, fungi, etc.) and a pH sensor for signaling to the user when the antimicrobial composition is no longer operating at its full capacity. In this manner, the user can initially wear the article without fear of infection. After a certain period of time, the user can visually inspect the color of the pH sensor to obtain an indication of whether the antimicrobial composition is still active and effective in inhibiting microorganism growth, or whether it is time to replace or remove the article.

Abstract: A microfluidic flow cell subassembly, which may be assembled into a flow cell having fluidic connections outside of the main substrate, is described for encapsulating a sample to allow for subsequent controlled delivery of reagents to the sample, such as multiplexed in situ biomarker staining and analysis. As configured, the subassembly comprises a substrate layer forms a flexible optically transparent lid which is capable of bending in either direction to alter the internal dimensions of the subassembly. Methods of use are also disclosed.

Abstract: The invention provides a modified form of saturation assay, which is based on the measurement of a free or unbound labelled reagent fraction (such that there is an increase in signal in the presence of analyte) and employs trapping zones to concentrate said unbound or free labelled fraction to avoid loss of sensitivity. Preferably, the assay is a membrane assay.

Abstract: A method may involve forming one or more photoresist layers over a sensor located on a structure, such that the sensor is covered by the one or more photoresist layers. The sensor is configured to detect an analyte. The method may involve forming a first polymer layer. Further, the method may involve positioning the structure on the first polymer layer. Still further, the method may involve forming a second polymer layer over the first polymer layer and the structure, such that the structure is fully enclosed by the first polymer layer, the second polymer layer, and the one or more photoresist layers. The method may also involve removing the one or more photoresist layers to form a channel through the second polymer layer, wherein the sensor is configured to receive the analyte via the channel.

Abstract: A method for generating and localizing a signal in a solid phase substrate detection system comprises applying a solution of target material to a substrate; binding the target with a specific affinity molecule having an attached label, the label comprising multiple signal precursor molecules; applying a carrier to the substrate, and treating the label to convert the signal precursor molecules to signal generating molecules. The carrier comprises solvent for the label and thickener for localizing the signal. The carrier may include developer that converts signal precursor molecules to signal generating molecules. Developer is not necessary if the signal precursor molecules are converted to signal generating molecules by e.g. temperature change, pH change, sonication, light irradiation, microwave heating. A test device for detecting target in a fluid sample, and a kit of parts for determining the presence of target in a fluid sample are also disclosed.

Abstract: A lateral flow assay test device providing a structure for the lateral flow assay reactions provides for a continuous flow path of bibulous material provided in separate but contiguous regions of the device in which the bibulous layers are in fluid contact with each other thereby providing flow control of the timing and speed of the assay reaction. Increased flow control results in increasing reliability of use, increasing sophistication of reactions and increases the range of molecules or diagnosis that can be identified. Such flow control can extend processing times and allow users or test givers to manually delay test processing providing enhanced test results.

Abstract: A food safety detection device includes a xylem fiber substrate, which is configured with a sampling portion and a reaction portion. The reaction portion includes at least one chemical reagent. The sampling portion absorbs a test sample. The test sample moves on the xylem fiber substrate to the reaction portion and reacts with the chemical reagent. A manufacturing method for the food safety detection device is also disclosed. The food safety detection device is advantageous for easy operation, safety and rapid analysis.

Abstract: A visual indication test kit is provided. The visual indication test kit includes a single collector including a plurality of plugs, wherein the plurality of plugs are configured to serve as extraction points for analytes, and mix a plurality of reagents with a plurality of analytes extracted onto the plurality of plugs, wherein the mixing of the plurality of reagents and the plurality of analytes facilitates performing a plurality of visual indications.

Abstract: A microwell device is provided. The device includes a plate having a upper surface. The upper surface has first and second recesses formed therein. Each recess has an outer periphery. First and second portions of microwells are formed in upper surface of the plate. The first portion of microwells are spaced about the outer periphery of the first recess and the second portion of microwells spaced about the outer periphery of the first recess. A first barrier is about a first portions of the microwells for fluidicly isolating the first portion of the microwells and a second barrier about a second portions of microwells for fluidicly isolating the second portion of the microwells.

Abstract: The present invention relates to an apparatus for quantifying the binding and dissociation kinetics of molecular interactions of small molecular bio materials with high sensitivity almost without the influence of a change in the reflective index resulting from a buffer solution by making polarized incident light incident on the binding layer of a bio material, formed in a thin dielectric film, so that the polarized incident light satisfies a p-wave non-reflecting condition and a quantifying method using the same.

Abstract: A biosensor manufacturing method including a sheet material forming process and a dicing process. In the sheet material forming process a sheet material with plural biosensor forming sections is formed. Each of the biosensor forming sections includes a first base plate, a second base plate stacked on the first base plate and forming a capillary between the second base plate and the leading end portion of the first base plate for sucking in sample liquid, and a hydrophilic layer formed on the second base plate at least in a region facing the capillary. In the dicing process plural biosensors are obtained by dicing the sheet material with a blade from the first base plate side at the leading end of each of the biosensor forming sections, such that the leading end of the capillary opens onto the leading end face of the first base plate and the second base plate.

Abstract: Paper-based microfluidic systems and methods of making the same are described.

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: There is provided an assay device comprising a lid and a base, said base comprising, a sample addition zone, a reaction zone and an absorbing zone, said components being in fluid connection and being part of a fluid passage leading from the sample addition zone to the absorbing zone, wherein: (a) a sample addition well is integrated in the lid, (b) the absorbing zone consists of an area on an non-porous substrate, having substantially perpendicular projections, said projections defining a volume, which together with the volume of the fluid passage defines the sample volume subjected to the assay, and (c) at least one filter is between the sample addition well and the sample addition zone. There is further provided methods for handling samples.

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: The present invention relates to an improved system for efficiently and accurately performing immunoassays, such as ELISAs. The invention provides an immunoassay assembly which includes a flow-through unit and an aspiration pump. The immunoassay flow-through unit includes an outer seal; at least one bed support; an inner seal; and a packed non-porous bed. The unit is releasably attached to an aspiration pump which enables the controlled flow rate of liquid passing through the packed bed of the flow-through unit. The invention also provides a method of using the immunoassay assembly to identify analytical targets of interest.

Abstract: A device, system and method for sampling sample material for an analyte including a receiving swab, wherein at least a portion of the receiving swab is compressible; a sensor for sensing the analyte; and a casing, wherein the casing at least partially encloses the receiving swab and the sensor and allows for a transfer of sample material received by the receiving swab to the sensor along a transfer path inside of the casing. The compressible portion of the receiving swab is located inside the casing, wherein by compressing the compressible portion, the transfer path is closable towards the outside of the device.

Abstract: A diagnostic test device comprising at least one membrane disposed in any of one, two, and three dimensions; at least one test sample fluid input port that receives and transfers at least one test sample fluid and onto the at least one membrane; at least one contiguous fluid flow manifold within the at least one membrane to multiplex or distribute the at least one test sample fluid; at least one contiguous fluid flow channel that operatively connects the at least one membrane to the at least one contiguous fluid flow manifold; at least one analyte assay test zone disposed within the at least one contiguous fluid flow channel; and at least one chemical capturing reagent disposed within the at least one analyte assay test zone, wherein multiple analyte assay test results are simultaneously obtained and in parallel in the diagnostic test device.

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: Multiplex binding assay assemblies are disclosed. The assemblies include at least one assay bar that has a top side, a bottom side, and at least one well accessible from the top side of the assay bar, with each well including a side surface, a bottom surface, an open top end. Each well also includes at least one secondary container, with each secondary container including a capillary tube that (i) begins at a location within an interior volume of the well and (ii) ends at a location beneath the bottom side of the assay bar. The assemblies further include a guiding track, which includes a set of two rails, with each rail having its own separate groove. Such grooves are configured to run parallel to each other with a distance between such grooves, with a first groove configured to receive a protruding element (or an end) of a first side of the assay bar, and a second groove configured to receive a protruding element (or an end) of a second side of the assay bar.

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 test strip or biosensor comprising a base substrate on which an electrode system is formed. One or more laminate layers overlie the base substrate to form a sample-receiving chamber in which a reagent is deposited. An opening is provided from the sample-receiving chamber to the exterior of the biosensor. The layers and the base substrate are laser welded to secure the biosensor. One of the layer and base substrate is light transmissive to allow laser welding at the interface therebetween. The biosensor may be formed from a series of continuous webs that are subsequently sliced to form individual biosensors.

Abstract: A sample receiving chip comprising a substrate that receives an aliquot volume of a sample fluid and a sample region of the substrate, sized such that the volume of the sample fluid is sufficient to operatively cover a portion of the sample region. The energy imparted into the sample fluid is transduced by the sample region to produce an output signal that indicates energy properties of the sample fluid. The sample receiving chip also includes a channel formed in the substrate, the channel configured to collect the aliquot volume of a sample fluid and transfer the aliquot volume of sample fluid to the sample region.

Abstract: An analytical device for performing an assay to determine the presence or approximate quantity of at least one analyte in a liquid sample is described. The device is manufactured to include an integrated desiccant within at least a test strip of the device. Addition of an integrated desiccant within the device improves signal to noise ratio, eases the manufacturing process, and saves in cost of production of the device.

Abstract: A sensor strip apparatus includes: a top plate having an entrance opening downward and a joint formed downward; a pad section including a support having a window opening downward, a reaction pad attached to the window of the support and reacting with a specimen, first and second hemolysis inhibition pads attached to the reaction pad to filter hemocytes from the specimen, a specimen pad attached to the first and second hemolysis inhibition pads to diffuse the specimen crosswise, and an adhesive film attached to the support around the first and second hemolysis inhibition pads to increase adhesion strength of the specimen pad; and a bottom plate having a second joint forcibly coupled with to the joint of the top plate, and a window configured to indentify the reaction pad through the window of the support.

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: 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: A fast acting sensor designed to accommodate an aqueous analyte-containing sample having a volume of less than one microliter and that can be used to quantify the amount and concentration of such analyte in the sample through light reflectance or fiber-optic light reflectance. The sensor includes a storage chamber, a capillary passage, and a reaction membrane. The storage chamber acts to collect the sample and to secure such sample while it undergoes detection. The capillary passage acts to direct the sample over the reaction membrane and controls the diffusion of the sample in the storage chamber. The reaction membrane contains all of the chemicals and enzymes needed to cause a color-change reaction when contacted with the sample. The amount of analyte can be determined by light reflectance intensity with an optical measurement instrument.

Abstract: Provided are a microfluidic device and a microfluidic analysis equipment. The microfluidic device includes guides disposed along both edges, a lower plate including a flow path defined between the guides, and a movable upper plate moved along the guides on the lower plate and having a length less than that the flow path. A fluid flow can be simply accurately controlled by adjusting a position of the movable upper plate. As a result, the fluid can sufficiently react in the detection part and the reaction part. Therefore, effective reaction and detection can be realized using only a small amount of fluid, thereby improving sensitivity. In addition, due to the improved sensitivity, a washing process for removing materials that are not consumed in the reaction can be omitted. Also, the movable upper plate can be manually moved using a user's finger.

Abstract: An analytical device for performing an assay to determine the presence or approximate quantity of at least one analyte in a liquid sample is described. The device is manufactured to include an integrated desiccant within at least a test strip of the device. Addition of an integrated desiccant within the device improves signal to noise ratio, eases the manufacturing process, and saves in cost of production of the device.