This present disclosure provides devices, systems, and methods for performing point-of-care analysis of a target analyte in a biological fluid via a binding assay. The present disclosure includes a cartridge for collecting the target analyte contained in a fluid sample and performing an assay. The cartridge includes an assay stack having a first separation layer, a second separation layer, and a detection membrane. The cartridge also includes a plurality of first complexes comprising a capture molecule and a magnetic bead and a plurality of second complexes comprising a detection molecule and a detection label. Further, the detection membrane includes a substrate that interacts with the detection label to elicit a quantifiable response in the presence of the target analyte. The quantifiable response corresponds to an amount of detection antibody present in the detection membrane, and the amount of detection antibody present corresponds to an amount of the target analyte present.

A fluidic device holder configured to orient a fluidic device. The device holder includes a support structure configured to receive a fluidic device. The support structure includes a base surface that faces in a direction along the Z-axis and is configured to have the fluidic device positioned thereon. The device holder also includes a plurality of reference surfaces facing in respective directions along an XY-plane. The device holder also includes an alignment assembly having an actuator and a movable locator arm that is operatively coupled to the actuator. The locator arm has an engagement end. The actuator moves the locator arm between retracted and biased positions to move the engagement end away from and toward the reference surfaces. The locator arm is configured to hold the fluidic device against the reference surfaces when the locator arm is in the biased position.

Methods for detecting target analytes utilizing an array of wells are advantageous for detection of low concentrations of target analytes. Use of an array of wells requires sealing of the wells. The methods provided herein utilize digital microfluidics to seal wells of an array with a fluid that is immiscible with the aqueous liquid present in the wells to prevent evaporation and contamination of the aqueous fluid during analysis of signals from the wells. The disclosed method include generating a biphasic droplet composed of the immiscible fluid and an aqueous fluid. The immiscible fluid present in the biphasic droplet is moved over the array of wells to seal the wells by electrically actuating the aqueous fluid present in the biphasic droplet which in turn pulls the immiscible fluid.

The present invention provides a work hood that allows for free rotation in a work box to provide a wide work area and easy decontamination of a sealing portion present at the boundary between the work hood and the work box. A rotation support for rotatably supporting the entire half suit is provided. The rotation support includes a base portion, a rotating portion, a bearing portion, a sealing member, and a communication hole. The base portion is airtightly and annularly provided around an opening, and the rotating portion is provided around the base portion through the bearing portion, with a hem portion of the half suit being fixed to the rotating portion. The sealing member is annularly provided in an annular space formed by the base portion and the rotating portion so as to separate the work box and the external environment. The communication hole is provided so as to lead to the external environmental side from the annular small space side formed by the sealing member together with the base portion, the rotating portion, and the bearing portion, and is connected to a supply means for supplying a decontamination gas and the like to the inside of the small space and to a suction means for sucking clean air and the like from the inside of the small space.

The invention relates to a device for sealed transfer between two enclosed volumes, comprising a first flange and a second flange (10) which define a passage opening into the enclosed volumes and can be secured to each other by a first bayonet connection, a first door and a second door (11) which close off the passage openings and can be secured to each other by a second bayonet connection, the first door (11) being hingedly mounted on the first flange (10) by means of a hinge (4) comprising a hinge pin, characterized in that the device comprises an external manual control lever (9) which is secured to a rotary pin penetrating the first flange (10) and which is coupled to the hinge pin in such a way that the actuation of the control lever (9) drives the hinge pin, thus opening or closing the first door (11).

A body fluid analyte detection device, includes: a transmitter, provided with at least one first clamping part; a bottom shell, provided with a second clamping part corresponding to the first clamping part, the transmitter being assembled on the bottom shell by mutual snap fitting of the first clamping part and the second clamping part, the bottom shell including a fixing part and a force application part, and the fixing part being fixed and applying a force to the force application part in a direction to disable the bottom shell, so that the first clamping part and the second clamping part are separated from each other, and then the bottom shell and the transmitter are separated; a battery, used for supplying power to the transmitter; a sensor, used for detecting body fluid analyte parameter information and electrically connected to the transmitter to transmit a parameter signal.

A body fluid analyte detection apparatus is provided. Applying a force to a force applying portion of a bottom case in one direction can make the bottom case fail, and then separate the bottom case and a transmitter from each other. Before the bottom case is mounted to a human body, the bottom case is fixed together with a mounting unit by means of a snap-fit portion. Operation steps of a user when separating the bottom case from the transmitter are reduced, and the failure rate of the bottom case before being mounted to the human body is also reduced, thereby improving the user experience, and enhancing the reliability of the body fluid analyte detection apparatus.

A microchannel chip with which channel deformation does not occur even when high-temperature and high-pressure sterilization treatment is performed and with which strong joining performance of substrates is maintained; and a method for manufacturing the same are provided. A microchannel chip comprising: a channel substrate having a microchannel formed on at least one surface thereof; a lid substrate; and a joining layer joining the channel substrate and the lid substrate, wherein the channel substrate, the lid substrate, and the joining layer are each formed of a cycloolefin polymer, a glass-transition temperature Tg.sub.s1 of a cycloolefin polymer forming the channel substrate, a glass-transition temperature Tg.sub.s2 of a cycloolefin polymer forming the lid substrate, and a glass-transition temperature Tg.sub.2 of a cycloolefin polymer forming the joining layer have relationships: Tg.sub.s1>Tg.sub.2; and Tg.sub.s2>Tg.sub.2, and the joining layer has a thickness within a specific range.

Embodiments of a platelet testing system include an analyzer console device and a blood testing cartridge configured to releasably install into the console device. The cartridge device is configured with one or more measuring chambers and one or more mixing chambers that are fluidically connected within the cartridge device that enable the mixing of saline and a blood sample to a desired dilution. Additionally, the cartridge device is further configured with a cartridge slider that provides a reagent bead to the saline and blood mixture at a desired time. As such, one or more platelet activation assays can be conducted by measuring, through cartridge electrodes of the cartridge device, the detectable changes in platelet activity within the blood and saline mixture.

Systems, methods, and apparatuses are provided for self-contained nucleic acid preparation, amplification, and analysis.