Abstract: The present invention relates to, in part, methods of improved healthcare in female subjects that, for example, relay on menstrual fluid sampling for long term biomarker monitoring.

Abstract: Methods and devices for microfluidic detection of a biological maker in a biospecimen collected from a subject are disclosed. The microfluidic devices include nanoparticle-based nanosensors comprising supramolecular recognition sequences, protease consensus sequences, post-translationally modifiable sequences, or sterically hindered benzylether bonds for specific interaction with a biological marker. Also disclosed are particular nanosensors for detecting cytokines, and other proteins based upon supramolecular recognition without chemical modification or enzymatic cleavage.

Abstract: A method of quantitating free (unbound) human C5 complement protein (C5) from a sample comprising: binding biotinylated anti-C5 capture antibody to strepavidin-coated particles; capturing the free (unbound) C5 in the sample; detecting the captured free C5; and quantitating the captured free C5 using laser-induced fluorescence detection; wherein the method is performed in a Gyros Bioaffy 200 CD in a Gyrolab xPlore or a Gyrolab XP instrument.

Abstract: The automatic analyzer includes: a sample dispensing unit that dispenses a sample into a reaction vessel; a reagent dispensing unit that dispenses a reagent into the reaction vessel; a control unit that controls the sample dispensing unit and the reagent dispensing unit; and a measurement unit that measures a mixed solution of the sample and the reagent mixed in the reaction vessel. The reagent includes three types of reagents of: a first reagent that specifically binds to an antigen in the sample; a second reagent that specifically binds to a site different from that to which the first reagent binds with respect to the antigen and has a label to be detected by the measurement unit; and a third reagent that specifically binds to a site different from the binding site of the first reagent and the antigen and contains insoluble carriers.

Abstract: A device for storing reagent containers on several planes for an automatic analysis appliance comprises a pipetting device comprising a pipetting needle for pipetting of reagents, a first device comprising a plurality of first receiving positions for reagent containers, wherein the first receiving positions are arranged on a first plane, and a second device comprising a plurality of second receiving positions for reagent containers, wherein the second receiving positions are arranged on a second plane.

Abstract: The present invention provides point-of-care blood typing devices. The devices require only a small sample of blood and are able to provide results within minutes. The devices are capable of identifying A, B, AB, and O type blood. The devices are also capable of identifying blood that is positive (+) or negative (?) for the D antigen.

Abstract: An apparatus for treating biological samples disposed on substrates, including: an input buffer for receiving one or more substrate holders each being adapted to support a plurality of the substrates; a treatment zone including a plurality of treatment stations each being adapted to receive one of the substrates; a reagent dispenser configured by a controller to dispense reagents to the substrates at the treatment stations; a substrate transport device configured by the controller to transport individual substrates between the substrate holders in the input buffer and the treatment stations.

Abstract: Provided herein are high throughput methods for measuring the protease activity of the complement C3 convertase by detecting the consumption of C3 or the production of C3a in vivo and in vitro.

Abstract: The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.

Abstract: Seroprotection analysis systems, kits, and techniques are described for testing oral fluid for the presence of protective levels of antibodies of interest. In one aspect, the presence of protective levels of target antibodies indicates a test subject has achieved a target seroprotection level, such as but not limited to a target seroprotection level following vaccination. A collection kit can include a swab that enables collection of oral fluid containing antibodies from both dentulous and edentulous individuals, a container that can be pre-filled with an extraction solution, and a nozzle that can be coupled to the container to form a fluid-tight device. A user can use the nozzle to seal the swab in the container and to compress the swab within the container.

Abstract: The present disclosure relates to a sensitive, multidimensional chromatography method for extraction, detection, and quantification of non-conjugated cytotoxic agents and associated linker molecules used in cysteine based antibody-drug-conjugate production.

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: Described herein are biosensor microarrays comprising detector polypeptide monolayers substantially free of contaminants. Also provided are methods for generation of such biosensor microarrays by capture of polypeptides by arrays comprising capture moieties and associated sensors.

Abstract: A method of quantitating free (unbound) human C5a complement protein (C5a) from a sample comprising: binding biotinylated anti-C5a capture antibody to strepavidin-coated particles; capturing the free (unbound) C5 in the sample; detecting the captured free C5a; and quantitating the captured free C5 using laser-induced fluorescence detection; wherein the method is performed in a Gyros Bioaffy 200 CD in a Gyrolab xPlore or a Gyrolab XP instrument; wherein human C5 is first removed from the sample.

Abstract: Provided is a membrane carrier for a liquid sample test kit (3) that detects a substance to be detected in a liquid sample, the liquid sample test kit including at least one flow path (2) capable of transporting the liquid sample, in which a microstructure that causes a capillary action for transporting the liquid sample is provided on a bottom surface of the flow path (2), and a level difference at which a height level of the bottom surface changes, is provided in the flow path (2). The membrane carrier preferably has a detection zone for detecting a substance to be detected in the liquid sample.

Abstract: A microfluidic chip with an array of pillars for directing flow of beads is used to measure reaction kinetics. A stream may be continuously drawn from the reaction volume into the microfluidic chip. The bead is attached to a primary antibody. The reaction volume has an antigen and a second antibody with a label. The primary antibody binds to the antigen, and the secondary antibody binds to the antigen, creating a sandwich of bead, antigen, and label. The binding reactions occur over time in the reaction volume. The beads may be imaged after traversing a laminar wash buffer, and the signal intensity is measured. Each bead provides a kinetic monitoring of the immunoassay over the reaction time at which the bead is removed from the reaction media. Methods and systems are described in this disclosure.

Abstract: This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow 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.

Abstract: An apparatus includes a housing that defines a fluid reservoir and includes a port that is in fluid communication with the fluid reservoir. An inlet adapter is removably coupleable to the housing. A user can engage an actuator to move a plunger from a first position in which the fluid reservoir has a first volume, to a second position in which the fluid reservoir has a second volume greater than the first volume, which draws bodily fluid into the fluid reservoir via the inlet adapter. The actuator modulates a plunger rate of motion below a threshold as the plunger is moved. When a predetermined volume of bodily fluid is transferred into the fluid reservoir, a volume indicator transitions from a first state to a second state and the inlet adapter can then be removed to transfer the predetermined volume into a sample bottle external to the housing via the port.

Abstract: A method to detect local antibodies such as antigen-specific IgE via a brush biopsy specimen of a mucosal surface of a subject is disclosed. The method is easily performed in an office setting on both adult and pediatric patients. Also disclosed is a brush device specially designed for harvesting materials from a mucosal surface such as the medial surface of the inferior turbinate.

Abstract: Provided is a membrane carrier for a liquid sample test kit (3) that detects a substance to be detected in a liquid sample, the liquid sample test kit including at least one flow path (2) capable of transporting the liquid sample, in which a microstructure that causes a capillary action for transporting the liquid sample is provided on a bottom surface of the flow path (2), and a level difference at which a height level of the bottom surface changes, is provided in the flow path (2). The membrane carrier preferably has a detection zone for detecting a substance to be detected in the liquid sample.