Abstract: A functional laminate package comprises a bottom layer, a top layer comprising an opening, and an intermediate layer disposed between the bottom layer and the top layer and comprising a void configured to house a package content, the void in communication with the opening in the top layer, and a removable label affixed to the top layer covering the opening.

Abstract: Embodiments of the present invention provide a lateral flow assay method and strip wherein a sample is injected into a sample pad, a preconcentration kit is coupled to the sample pad to preconcentrate analytes, and a conjugate pad or a test pad is connected to the sample pad to transfer the analytes to the conjugate pad or the test pad, whereby a biomarker present at a low concentration can be detected.

Abstract: A field effect transistor comprising a chelator or derivatized chelator, a device for detecting a marker in a sample comprising said sensor, a method for detecting metal ions in a sample comprising said sensor or device and a sensor and method for detecting a marker in a sample.

Abstract: A test strip with selective white blood cell (WBC) lysis for release of WBC contents and the capture and holding of red blood cells (RBC), allowing for fast clearance and result interpretation and more accurate results at early time points due to the lack of red color interference caused by background red heme color of lysing of RBCs. The removal of the red color interference enhances both visual and digital interpretation of test strips, such as test strips of an immunoassay test. The test strip enhances the detection of both intracellular proteins of WBCs and extracellular proteins of RBCs simultaneously such as MxA and CRP, MxA and PCT, MxA and HNL, and MxA and IL-6, MxA and myeloid cells (STREM-1), MxA and angiopoietin 2, MxA and vascular endothelial growth factor (VEGF) or its soluble vascular endothelial growth factor receptor-1 (sVEGFR1), MxA and heparin binding protein (HBP) or other combinations.

Abstract: Provided are integrated analysis devices having features of macroscale and nanoscale dimensions, and devices that have reduced background signals and that reduce quenching of fluorophores disposed within the devices. Related methods of manufacturing these devices and of using these devices are also provided.

Abstract: Diagnostic assay devices for detecting the presence of an analyte in a sample solution may comprise a microreactor configured to form a sample solution containing the analyte, flow the sample solution therethrough in a first direction to form an analyte-capture molecule complex, and transfer the sample solution to an absorbent strip pad configured to flow therethrough, in a second direction crossing the first direction, the sample solution including the analyte-capture molecule complex and indicate a presence of the analyte-capture molecule complex. The diagnostic devices may be used, for example, to identify the presence of SARS-Cov2, RSV, influenza A, influenza B or other pathogens in samples from patients.

Abstract: The present disclosure relates to a sampling device for a liquid sample. The sampling device can comprise a main case and a sample transfer member that can be configured in a sample acquisition configuration and in a sample transfer configuration.

Abstract: A method for detecting biomaterial by means of a dye having a linear upconversion fluorescent property is provided. The method includes the steps of: i) preparing a fluorophore having a linear upconversion fluorescent property; ii) reacting the fluorophore and biomaterial to obtain a reaction complex thereof; iii) exciting the reaction complex by means of a light source having a longer wavelength than the maximum light-emitting wavelength of the fluorophore; and iv) detecting and measuring the light-emitting signal having a shorter wavelength than the wavelength of the excited light emitted from the excited reaction complex. A system and a kit for detecting biomaterial using a dye having a linear upconversion fluorescent property are also provided.

Abstract: The technology relates to detecting water or fouling on the exterior surface of a sensor cover, for instance due to precipitation or debris (fouling). Such objects on the sensor cover surface may degrade operation of the sensor, which can be problematic for vehicles operating in an autonomous driving mode. According to an aspect of the technology, a waveguide layer is provided on the sensor cover. A laser emits light at a selected wavelength along one side of the waveguide layer. The light waveform propagating along the waveguide layer is affected (distorted) by precipitation and/or fouling on the surface of this layer. A detector receives the distorted waveform. The system determines whether water and/or fouling is present based on the received waveform. This allows the system to determine whether to activate a cleaning module or to factor in the information when processing received sensor data.

Abstract: A container assembly is disclosed including an outer container, a hollow inner member, and a closure. The outer container has a closed bottom, an open top, and a sidewall extending therebetween. The hollow inner member is disposed within the outer container and has an inner surface defining at least one capillary channel. The inner member includes a first end adjacent to the open top of the outer container and has an outer periphery seated against the sidewall of the outer container. The closure has a proximal end and a distal end. The closure proximal end is seated at least partially within the first end of the inner member to seal the outer container and inner member and define a fluid collection chamber. The closure distal end defines a recessed area shaped to direct fluid under capillary action to the at least one capillary channel in the inner member.

Abstract: A method for generating a module configured to determine concentration of an analyte in a sample of a body fluid is disclosed. The method includes providing a first set of measurement data derived from images of one or more test strips indicating a color transformation in response to a body fluid containing an analyte. The images can be recorded by multiple devices with differing cameras, software and/or hardware device configurations for image recording and image data processing. A neural network model can be generated in a machine learning process applying an artificial neural network and a module configured to determine concentration of an analyte in a second sample of a body fluid can be generated. Further, the present disclosure includes a system for generating the module as well as a method and a system for determining concentration of an analyte in a sample of a bodily fluid.

Abstract: Disclosed are methods and devices for interfacing to or interacting with the flow of liquid passing into or through lateral-flow assays and related paper- or membrane-based in-vitro diagnostic testing platforms. This is done for the purpose of improving their performance, sensitivity, accuracy, repeatability, degree of multiplexing, and/or level of quantitation, and/or reducing their inherent limitations while maintaining, in large part, their simplicity, cost effectiveness, and ease of use. New methods are disclosed for pre-sample purification, aliquoting, sequential liquid delivery, flow control and other functions that are largely automatic and require no action on the part of the user.

Abstract: The invention generally relates to mass spectral analysis. In certain embodiments, methods of the invention involve analyzing a lipid containing sample using a mass spectrometry technique, in which the technique utilizes a liquid phase that does not destroy native tissue morphology during analysis. Due to the use of a liquid phase that does not destroy native tissue morphology during analysis, a subsequent staining technique can be performed on the tissue sample and an overlaid image can be produced of a mass spectral image and a staining image.

Abstract: A device for determining presence or absence of infection due to an infectious agent is described. The device comprises a sample receiving zone configured to receive a liquid sample from a subject suspected of having an infection due to an infectious agent, the sample receiving zone positioned to distribute the sample along a first fluid flow path to a first label zone and along a second fluid flow path to a second label zone. Test lines in each fluid flow path capture a mobile detectable species as an indicator of presence or absence of the infectious agent. The device also comprises a reference line positioned in the one of the fluid flow paths. The bidirectional fluid flow paths emanate from a common sample zone and provide an efficient approach to detection and differentiate two species as indicators of the same infectious agent or as indicators of two different infectious agents.

Abstract: A method is provided for determining, the presence and concentration of an analyte by contacting the sample with a solution comprising: magnetic beads, a capture probe capable of binding the analyte, a reporter probe and cellulose, whereby, if the analyte is present, an MB-analyte-reporter-cellulase sandwich is formed; and then contacting the solution comprising the sandwich with an electrode covered with an electrically insulating layer comprising or consisting of cellulose and/or a cellulose derivative, wherein the MB-analyte-reporter-cellulase sandwich leads to degradation of the insulating layer thereby causing a measurable change in electrical properties at the electrode surface, wherein the change in electrical properties is a function of the amount of analyte in the sample. Devices and biosensor applying the method are also provided.

Abstract: Provided is a test system including at least the following: permeabilising means and/or lysis of at least one pathogen and/or at least one cell, means for capturing and/or making parts of the pathogens and/or cells, means for localising, immobilising and/or enriching at least one component of a pathogen and/or a cell, means for image processing preferably including an optical magnifying unit, enabling an optical reading out of at least one means for localising, immobilising and/or enriching can be carried out.

Abstract: Provided are a microfluidic apparatus and a method for separating a target cell using the same. The microfluidic apparatus for separating a first material in a biological sample from the biological sample, according to an embodiment of the disclosure, includes: a body rotatable on a rotation axis; a mixing chamber included in the body, wherein the biological sample and magnetic beads that are combined with a second material in the biological sample are mixed in the mixing chamber; a separation chamber included in the body and connected to the mixing chamber, wherein a mixed sample of the first material and the second material combined with the magnetic beads is separated in the separation chamber; and a magnetic member positioned on one side of the body outside the separation chamber, wherein, in the separation chamber, the first material is separated from the second material combined with the magnetic beads by a centrifugal force and a magnetic force.

Abstract: Devices, systems, and methods are provided for magnetic focus enhanced lateral flow assays. The devices and systems are ultrasensitive and provide for the visual detection of the presence or absence of one or more target analytes—which may include pathogens, proteins, or even molecules smaller than the foregoing—even when such analytes are only present in very limited amounts. The devices and systems include an immunostrip with a magnet positioned adjacent thereto, and magnetic probes specific to a target analyte that bind to the target analyte with specificity if present within a fluid sample to be tested. Methods are also provided for detecting one or more target analytes using magnetic focus, such methods including a step of controlling movement of a target analyte complex on an immunostrip incorporating a magnetic field, where such control slows a flow of the target analyte complex through a capture area on the immunostrip.

Abstract: A simple, sensitive method and device for detecting the LEAD presence in the water. The test involves a sample of water from a subject; followed by determining the presence of LEAD in the water sample by using a LEAD sensitive solution used in the device.

Abstract: Methods are provided for detection of a target cell type within a cell population, and compositions are provided comprising cells and an indicator that indicates the number of cells of the target cell type in the cell population. Examples are provided in which these methods are used to detect human embryonic stem cells within a differentiated cell population with exquisite sensitivity. Differentiated cells produced from embryonic stem cells can be characterized by these methods before transplantation into a recipient, thereby providing further assurance of safety.

Abstract: A resin-metal composite to be used as a marker in an immunoassay, said resin-metal composite comprising a resin particle and metal particles and having the following constitution (A) or constitution (B): (A) the average particle size of the resin-metal composite exceeding 300 nm; or (B) the average particle size of the metal particles being in the range of more than 20 nm and less than 70 nm. It is preferred that a part of the metal particles are two- or three-dimensionally distributed in the surface layer part of the resin particle, a part of the three-dimensionally distributed metal particles are partly exposed to the outside of the resin particle, and a part of the remainder particles are enclosed in the resin particle.

Abstract: According to a first aspect of the invention, there is provided a device for estimation of an ovulation date, comprising a camera, configured to obtain colour data of successive FSH test strips and a processor, configured to evaluate the colour data obtained by the camera. The processor is configured to determine a concentration value of each successive FSH test strip based on the data of the camera and to output a signal, if the processor determines that a first FSH downward trend of the FSH test strip values is occurring in the successive FSH test strips.

Abstract: The microfluidic chip according to an embodiment of the present invention may include a plate, a bridge channel formed in intaglio on one side of the plate, an inlet formed through the plate to communicate with one end of the bridge channel, an outlet formed through the plate to communicate with the other end of the bridge channel, and at least one well extending in an outward direction of the plate from the bridge channel to provide a space, wherein the bridge channel may be in the form of a curved line, a bent line, an arc, a circle, a spiral, or a polygon.

Abstract: The invention provides methods of preparation of lipoproteins from a biological sample, including HDL, LDL, Lp(a), IDL, and VLDL, for diagnostic purposes utilizing differential charged particle mobility analysis methods. Further provided are methods for analyzing the size distribution of lipoproteins by differential charged particle mobility, which lipoproteins are prepared by methods of the invention. Further provided are methods for assessing lipid-related health risk, cardiovascular condition, risk of cardiovascular disease, and responsiveness to a therapeutic intervention, which methods utilize lipoprotein size distributions determined by methods of the invention.

Abstract: A solid support for detecting the presence of antibodies in a biological sample, where the solid support includes microbial antigens immobilized on the solid support, wherein the microbial antigens include at least one antigen prepared from the group consisting of pleomorphic round bodies of Borrelia genus, for example Borrelia burgdorferi, Borrelia afzelii and Borrelia garinii. Also, a method of detecting a tick-borne microbe in a biological sample, wherein the solid support is contacted with a biological sample.

Abstract: There is provided a microparticle sorting method including a procedure of collecting a microparticle in a fluid that flows through a main channel in a branch channel that is in communication with the main channel by generating a negative pressure in the branch channel. In the procedure, a flow of a fluid is formed that flows toward a side of the main channel from a side of the branch channel at a communication opening between the main channel and the branch channel.

Abstract: The present invention relates to the field of micro fluidics. Specifically, the present invention relates to a novel flow cell for the selective enrichment of target particles or cells from a fluid. The flow cell exhibits a novel design which greatly improves the target particle or cell yield. The invention also provides a micro fluidic device, comprising the flow cell according to the invention. In another aspect, the invention relates to the use of a flow cell or a micro fluidic device of the invention for the isolation of target particles or cells from a fluid sample. Finally, the invention relates to a method for the selective enrichment of target particles or cells from a fluid using the flow cell of the invention.

Abstract: The present invention provides a diagnostic kit for detecting the presence or quantity of one or more test analytes within a test sample taken from a body surface of a mammal, the diagnostic kit comprising: a separate insert for a lateral flow device (200, 411) comprising a membrane (201) fixed to a rigid support (202) and, the separate insert being configured to obtain the test sample; a lateral-flow assay device configured (300, 400) to accept the separate insert (200, 411); a securing member (210) configured to releasably attach (211) the separate insert to a body surface of a mammal (213); wherein the securing member (210) comprise an expandable layer (212) configured to apply pressure to the separate insert (200, 411) thereby pressing the separate insert (200, 411) against the body surface of the mammal (213).

Abstract: A cell capture, disruption, and extraction method includes a introducing a plurality of abrasives in a disruption chamber, which can include diamond powder, variably and multi dimensionally disbursed therein, and a pestle positioned in the disruption chamber. The method includes agitating the abrasives by moving the disruption chamber and/or pestle, agitation of the abrasives tearing cell structure in the solution to access its contents. A binding column or size exclusion column can be positioned downstream of the disruption chamber. Cell solution can first be introduced in the disruption chamber, the abrasives capturing the cells and allowing therethrough and purging the waste content, then breaking the cell content. The lysate can then bind to an extraction matrix downstream of the disruption chamber or it can be mixed in with the abrasives.

Abstract: A system, apparatus, and method for registering and interpreting the results of lateral flow assay determination by using electric, magnetic, and RF sensors incorporated within the test strip, attached to the inside of the enclosure for same and/or contained in a test fixture; instead of relying on optical inspection techniques. This method features high reliability, low cost, and ability for quantitative and dynamic measurements.

Abstract: The chemical sensing device comprises a substrate of semiconductor material, integrated circuit components and a photodetector formed in the substrate, a dielectric on the substrate, a wiring in the dielectric, and a source of electromagnetic radiation, a waveguide and a fluorescent sensor layer arranged in or above the dielectric. A portion of the waveguide is arranged to allow the electromagnetic radiation emitted by the source of electromagnetic radiation to be coupled into the waveguide. A further portion of the waveguide is arranged between the photodetector and the fluorescent sensor layer.

Abstract: A lateral flow testing device includes a main body adapted to support an element for collecting a sample. The element is supported at a distal end of the testing device and is in fluid communication with one or more testing components having an analyte detection zone for detecting one or more analytes present in said sample. The testing components produce visual information related to said sample, thereby informing the user of the outcome of a test. The device incorporates a handle reconfigurable with respect to said main body such that in a first handle configuration, the handle hinders sight of the visual information to improve privacy of the test, and in a second handle configuration, the handle facilitates the collection of said sample by increasing a distance between a proximal end of the testing device and the element.

Abstract: The present invention provides a detection device, and the device comprises a testing element, wherein the testing element comprises a detection area used for detecting a presence of an analyte in a liquid sample; and a transparent area through which the test result on the detection area is read, and the transparent area includes a hydrophilic area and a hydrophobic area. Thus, the detection device reduces formation of droplets on the transparent area is reduced, that is, it avoids formation of a mist layer on the transparent area; or avoids accumulation of small droplets on the transparent area, thus to make the result on the test area be clearly read.

Abstract: A testing device for identifying an antigen or antibody within a biofluid sample including: a substrate having a hydrophilic surface thereon; the surface including a collection zone, and at least one detection zone extending therefrom; wherein the biofluid sample can be mixed with a specific antigen or antibody, and deposited on the collection zone and transferred by capillary action to the detection zone; the antigen or antibody in the biofluid sample reacting with an appropriate said antibody or antigen thereby resulting in a visual indication within the detection zone.

Abstract: The present invention generally relates to systems and techniques for manipulating fluids and/or making droplets. In certain aspects, the present invention generally relates to droplet production. The droplets may be formed from fluids from different sources. In one set of embodiments, the present invention is directed to a microfluidic device comprising a plurality of droplet-making units, and/or other fluidic units, which may be substantially identical in some cases. Substantially each of the fluidic units may be in fluidic communication with a different source of a first fluid and a common source of a second fluid, in certain embodiments. In one aspect, substantially the same pressure may be applied to substantially all of the different sources of fluid, which may be used to cause fluid to move from the different sources into the microfluidic device. In some cases, the fluids may interact within the fluidic units, e.g., by reacting, or for the production of droplets within the microfluidic device.

Abstract: The present invention discloses a droplet digital PCR chip. The droplet digital PCR chip includes at least one chip unit, each chip unit includes a chip body formed by bonding a top piece and a bottom piece, the chip body is internally provided with an inlet chamber, a droplet storage chamber, and an injection hole. The injection hole connects with the inlet chamber, a plurality of droplet generating channels are disposed between the inlet chamber and the droplet storage chamber, a height of the droplet generating channel is smaller than a height of the droplet storage chamber, an injection fluid is injected into the inlet chamber through the injection hole, and the injection fluid is emulsified and enters the droplet storage chamber at a junction of the droplet generating channels and the droplet storage chamber.

Abstract: A system and method for isolating and analyzing single cells, comprising: a substrate having a broad surface; a set of wells defined at the broad surface of the substrate, and a set of channels, defined by the wall, that fluidly couple each well to at least one adjacent well in the set of wells; and fluid delivery module defining an inlet and comprising a plate, removably coupled to the substrate, the plate defining a recessed region fluidly connected to the inlet and facing the broad surface of the substrate, the fluid delivery module comprising a cell capture mode.

Abstract: A substance testing method, a substance testing system, and a sensor module for a portable substance testing system is disclosed. The sensor module includes: a light source, configured to illuminate a lateral flow test strip of the portable substance testing system; a filter, comprising a plurality of apertures, configured to filter out light from the lateral flow test strip; and a sensor, for sensing the filtered light, and providing one or more signals indicative of an output of the test strip.

Abstract: Provided is a reagent composition for measuring glycated hemoglobin to diagnose the presence or absence of diabetes and a method of measuring glycated hemoglobin using the same, and more particularly is a reagent composition for measuring glycated hemoglobin, the composition including a dye-encapsulated silica nanoparticle-boronic acid, and to a method of measuring glycated hemoglobin using the same. In the reagent composition for measuring the glycated hemoglobin, since a dye is encapsulated in silica nanoparticles, the inherent absorption wavelength of the dye is not affected by pH and the composition has excellent stability even when stored for one month or more.

Abstract: Contamination detection systems, kits, and techniques are described for testing surfaces for the presence of hazardous contaminants, while minimizing user exposure to these contaminants. Even trace amounts of contaminants can be detected. A collection kit provides a swab that is simple to use, easy to hold and grip, allows the user to swab large areas of a surface, and keeps the user's hands away from the surface being tested. The kit also provides open and closed fluid transfer mechanism to transfer the collected fluid to a detection device while minimizing user exposure to hazardous contaminants in the collected fluid. Contamination detection kits can rapidly collect and detect hazardous drugs, including trace amounts of antineoplastic agents, in healthcare settings at the site of contamination.

Abstract: The invention relates to a discoid sample holder (1), on which a device (2) for carrying out at least one processing step is formed. According to the invention, a slot (3), into which a sampling instrument (4) can be introduced, and means (5) for releasing a sample from the sampling instrument (4) arranged in the receptacle (3), are formed in the sample holder.

Abstract: A testing device is provided. The testing device includes a capturing tool and a microfluidic chip having a plurality of chambers connected in a network, a sample receiving port connected to the network, and a guide structure configured to receive the capturing tool, wherein the capturing tool is configured to capture sample in a distal position from the guide structure and further configured to transfer the captured sample to the sample receiving port in a proximal position from the guide structure.

Abstract: Provided is an analytical device including: a self-flowing microfluidic system, having a sample extraction location, at least one sample preparation location, and at least one sample analytical chamber; wherein the sample extraction location, the sample preparation location, and the at least one sample analytical chamber are interconnected by at least one microfluidic channel on a first substrate; and a signal readout system, having at least one sample analysis elements, and a data gathering and processing element.

Abstract: The present invention related to an electronic assay apparatus and a testing method thereof. The electronic assay apparatus for determining a result of an assay performed using a test strip comprises three light sources, only one detector and a microprocessor. The three light sources respectively illuminate light incident upon three different zones of the test strip. The detector detects light from the three zones alternately and the distances between the only one detector and the three light sources respectively are almost the same. Further, multiple openings corresponding to the three light sources respectively have the same size and/or shape. The microprocessor compares a calculating result value to only one threshold for showing a result.

Abstract: A splittable fluid sample collector for dividing a fluid sample into two or more portions, includes at least first and second fluid collector portions detachably connected to one another, each of the fluid collector portions including a handle and an absorbent sample pad affixed to an end of the handle. Further, a fluid sampling apparatus includes the aforementioned splittable fluid sample collector, at least one container and a closure for the container. Still further, a method for splitting a fluid sample including providing the aforementioned splittable fluid sample collector, collecting a fluid sample with the absorbent sample pads of the splittable fluid sample collector and splitting the first and second fluid collector portions of the splittable fluid sample collector from one another.

Abstract: Substrates comprising a functionalizable layer, a polymer layer comprising a plurality of micro-scale or nano-scale patterns, or combinations thereof, and a backing layer and the preparation thereof by using room-temperature UV nano-embossing processes are disclosed. The substrates can be prepared by a roll-to-roll continuous process. The substrates can be used as flow cells, nanofluidic or microfluidic devices for biological molecules analysis.

Abstract: Compositions and methods for detecting the presence and/or amount of one or more analytes, including analytes such as drugs of abuse, are provided. The compositions include two or more analytes associated with a solid phase, e.g., a particle or a multiwell plate. The compositions and methods also allow the simultaneous, tandem, or serial determination of the presence and/or amount of two or more analytes of interest in a sample.

Abstract: A cell capture, disruption, and extraction apparatus includes a disruption chamber configured to receive cell solution and having therein a plurality of abrasives, which can include diamond powder, variably and multi dimensionally disbursed therein, and a pestle positioned in the disruption chamber. The apparatus includes an actuation device configured to agitate the disruption chamber and/or pestle, movement of the abrasives tearing cell structure in the solution to access its contents. A binding column or size exclusion column can be positioned downstream of the disruption chamber. The pestle can rotate with respect to the disruption chamber. The pestle can include a nut-shaped core or axle, and/or include a plurality of extrusions. Cell solution can first be introduced in the disruption chamber, the abrasives capturing the cells and allowing therethrough and purging the waste content, then breaking the cell content through the foregoing agitation process.

Abstract: A specimen delivery cartridge includes a lower housing, and an upper housing. The upper housing is coupled to the lower housing at a hinge. The specimen delivery cartridge further comprises a testing chamber comprising a paper testing substrate. The paper testing substrate may include a wicking conduit and a plurality of test areas. The specimen delivery cartridge may also include a lens assembly proximate the plurality of test areas and operable to transmit light emissions from the plurality of test areas to an image sensor of a computing device. In some embodiments, the specimen delivery cartridge includes a testing substrate having a plurality of test areas made of an array of electrodes. Each electrode is printed on a first side of the testing substrate and coupled to a conductive via formed in the testing substrate and a conductive trace printed on a second, opposing side of the testing substrate.

Abstract: A method of testing for specificity and strength of an allergic reaction is performed by penetrating the skin of an individual with the microneedle array comprising a plurality of epitopes and determining the response of the skin to the allergens. The response can be measured with a thermal imaging device. Analysis, and optionally treatment, can be provided to the individual.