Abstract: A rapid immunoassay method and apparatus for detecting foot and mouth disease virus are disclosed. The method and test device permit pen-side testing of animals and provide test results within a relatively short time period. In a preferred embodiment, the method and apparatus provide a means for differentiating between FMDV-infected and FMDV-vaccinated animals.

Abstract: A biosensor detector device is disclosed suitable for use in measuring membrane fluidity or membrane permeability. The biosensor detector device is formed of a solid substrate having a lipid bilayer compatible surface, a multi-lamellar lipid membrane structure derived from a biological cell and localized on the lipid bilayer compatible surface, an aqueous layer interposed between each lipid bilayer of the multi-lamellar lipid membrane structure. The biological membrane is derived from human red blood cells and localized on the lipid bilayer compatible surface. An electrode forming all or part of the lipid bilayer compatible surface may be used to detect disruptions in the multi-lamellar lipid membrane structure and hemolytic activity in a test sample.

Abstract: A method for image analysis of medical test results, comprising receiving, at a server, information from a mobile device regarding test results from a test performed using a testing device, wherein the testing device includes an alignment target disposed on the testing device and a plurality of immunoassay test strips, receiving at the server an image of the testing device from the mobile device, determining by the server RGB values for a plurality of pixels of the image, normalizing by the server the RGB values into a single value, comparing by the server the single value to a control value stored on the server, and providing by the server a risk indicator, wherein the risk indicator indicates a likelihood of a presence of a medical condition.

Abstract: Various aspects of the system and methods described herein rely upon the operation of lateral flow assays specially configured to evaluate a bodily fluid for at least the presence or absence of pregnanediol glucuronide at a threshold selected from the range inclusive of 1 ?g/mL-10 ?g/mL. The results from the lateral flow assays are optionally interpreted in association with an application operating upon a mobile device or a system for the collection, interpretation and storage of results. The interpretations are useful in accordance with facilitating diagnoses and treatments associated with medical conditions related to the generated interpretations of the lateral flow assays.

Abstract: Among other things, the present disclosure is related to devices and methods of performing biological and chemical assays, such as but not limited to immunoassays and nucleic assay acid, particularly a homogeneous assay that does not use a wash step and that is fast (e.g., 60 seconds from dropping a sample to displaying results). The present disclosure is related to both competitive and non-competitive homogeneous assays.

Abstract: A multiplexed lateral flow assay device includes an impermeable internal reservoir having an opening to receive a sample deposition. A fluid distributor pad is arranged in fluid communication with a lower surface of the internal reservoir and divides a portion of the sample deposition substantially equally among a plurality of flow paths. Lateral flow assays having a plurality of flow lines are aligned with flow paths of the distributor pad. An impermeable paper top cover has a first window arranged over the opening of the internal reservoir, and at least a second window arranged over the test results of the lateral flow assays. A housing element houses the reservoir, the distributor pad and lateral flow assays. The housing element includes an impermeable bottom cover and a spacer element arranged between the top and bottom covers and, provides a gap between the lateral flow assays and the impermeable paper top cover.

Abstract: A sensing device includes a sample loading chamber configured to receive a sample, a detection antibody drying or lyophilization chamber configured to receive a first portion of the sample, one or more substrate drying or lyophilization chambers configured to receive a second portion of the sample, and one or more reaction chambers connected to the detection antibody drying or lyophilization chamber and the one or more substrate drying or lyophilization chambers. The detection antibody drying or lyophilization chamber and one or more substrate drying or lyophilization chambers are placed in parallel between the sample loading chamber and the one or more reaction chambers.

Abstract: Natural and/or synthetic antibodies for specific proteins are adhered to nanoparticles. The nanoparticles are adhered to a substrate and the substrate is exposed to a sample that may contain the specific proteins. The substrates are then tested with surface enhanced Raman scattering techniques and/or localized surface plasmon resonance techniques to quantify the amount of the specific protein in the sample.

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: Natural and/or synthetic antibodies for specific proteins are adhered to nanoparticles. The nanoparticles are adhered to a substrate and the substrate is exposed to a sample that may contain the specific proteins. The substrates are then tested with surface enhanced Raman scattering techniques and/or localized surface plasmon resonance techniques to quantify the amount of the specific protein in the sample.

Abstract: An elongated incubation trough has an indentation open toward a top end as well as a bottom. The indentation has a first receiving area to receive an elongated test strip as well as a second receiving area to receive an end section of a fluid line. The second receiving area is in fluidic communication with the first receiving area. A maximum width of the second receiving area at bottom height is greater than a maximum width of the first receiving area at bottom height.

Abstract: According to the present disclosure, a method for detecting an analyte using surface enhanced Raman spectroscopy (SERS) is provided. The method comprises (a) contacting one or more analyte-binding molecules with the analyte under conditions that allow binding of the analyte to the one or more analyte-binding molecules to form a first mixture, wherein the analyte is preferably haptogloblin and the analyte-binding molecule may comprise haemoglobin or is a haptogloblin antibody, (b) contacting a liquid reagent comprising a peroxidase substrate and a peroxide source with the first mixture to form a second mixture, while maintaining pH of the second mixture at 10 or less, (c) quenching the second mixture to form a third mixture, (d) optionally contacting the third mixture with a SERS-active substrate, and (e) detecting a surface enhanced Raman signal from the third mixture and/or a surface of the SERS-active substrate.

Abstract: Described herein are microfluidic devices and methods that can greatly improve cell quality, streamline workflows, and lower costs. Applications include research and clinical diagnostics in cancer, infectious disease, and inflammatory disease, among other disease areas.

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 present disclosure relates to water dispersible or soluble diagnostic assay methods, devices, kits, and methods of manufacture.

Abstract: A microfluidic detection system for micrometer-sized entities, such as biological cells, includes a detector component incorporating a plate with a plurality of opening, the plate separating two chambers, one in communication with a fluid source containing target cells bound to magnetic beads. The openings are sized to always permit passage of the magnetic beads therethrough into a lower one of the chambers and are further sized to always prevent passage of the target cells from the upper one of the chambers. The detector component further includes a magnet positioned to pull unbound magnetic beads through the openings and to capture target cells bound to magnetic beads on the surface of the plate. The microfluidic detection system includes a pump flowing the fluid through the detector component at high flow rates of milliliters per minute for high throughput detection of target cells.

Abstract: Methods and systems are provided for isolating fetal cells from a maternal blood supply in order to perform non-invasive prenatal testing. In one example, a system for non-invasive prenatal testing includes a substrate coated with a cell-capturing surface, the cell-capturing surface including an array of pillar-like structures, each pillar-like structure including a plurality of intersecting arms.

Abstract: Methods and systems are provided for isolating fetal cells from a maternal blood supply in order to perform non-invasive prenatal testing. In one example, a system for non-invasive prenatal testing includes a substrate coated with a cell-capturing surface, the cell-capturing surface including an array of pillar-like structures, each pillar-like structure including a plurality of intersecting arms.

Abstract: This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications. In particular, the medical device reduces interference with an optical signal which is indicative of the presence of an analyte in a bodily sample.

Abstract: The present invention relates to surface plasmon-coupled bioluminescence, wherein bioluminescent emission from a bioluminescent chemical reaction couples to surface plasmons in metalized particles thereby enhancing the signal. Importantly, these plasmonic emissions emitted from metallic particles generated without an external excitation source but instead from induced electronically excited states caused by the bioluminescent chemical reaction.