Abstract: A device for rapid detection of a tuberculosis lipoarabinomannan (TB-LAM) is provided. The device includes a pre-concentrator unit for concentrating the TB-LAM comprising: an ion-exchange medium comprising one or more ligands configured to capture the TB-LAM from the source biological sample, wherein the captured-TB-LAM is eluted from the ion-exchange medium as an eluate comprising a concentrated form of TB-LAM; a cassette; a lateral flow assay unit disposed in the cassette; and an integration unit attached to the pre-concentrator unit and the cassette. The integration unit is configured to operatively couple and de-couple the pre-concentrator unit and the cassette. The pre-concentrator unit and the lateral flow assay unit disposed in the cassette are in a fluidic communication in a coupled form. The device for rapid detection of TB-LAM further comprises a dilutor unit.

Abstract: An embodiment of a system includes a compartment-generating device, a compartment detector, and electronic computing circuitry. The device is configured to generate compartments of a digital assay, at least one of the compartments having a respective volume that is different from a respective volume of each of at least another one of the compartments. The detector is configured to determine a number of the compartments each having a respective number of a target that is greater than a threshold number of the target. And the electronic circuitry is configured to determine a bulk concentration of the target in a source of the sample in response to the determined number of compartments. Because such a system can be configured to estimate a bulk concentration of a target in a source from a polydisperse digital assay, the system can be portable, and lower-cost and faster, than conventional systems.

Abstract: Described herein are systems and methods for multiplexed analysis of two or more targets in a test sample including a first set of particles including a first set of target-specific reagents and a first optically detectable identifier capable of emitting a first wavelength indicative of a first target, and at least one second set of particles including a second set of target-specific reagents and a second optically detectable identifier capable of emitting a second wavelength indicative of a second target; and at least one optically detectable reporter probe capable of constitutively emitting a third wavelength in response to reaction of the first set of target-specific reagents with the first target in the test sample and/or reaction of the second set of target-specific reagents with the second target in the test sample, wherein the first wavelength, the second wavelength, and the third wavelength are optically discernable from one another.

Abstract: An embodiment of a system includes a compartment-generating device, a compartment detector, and electronic computing circuitry. The device is configured to generate compartments of a digital assay, at least one of the compartments having a respective volume that is different from a respective volume of each of at least another one of the compartments. The detector is configured to determine a number of the compartments each having a respective number of a target that is greater than a threshold number of the target. And the electronic circuitry is configured to determine a bulk concentration of the target in a source of the sample in response to the determined number of compartments. Because such a system can be configured to estimate a bulk concentration of a target in a source from a polydisperse digital assay, the system can be portable, and lower-cost and faster, than conventional systems.

Abstract: Described herein are systems and methods for multiplexed analysis of two or more targets in a test sample including a first set of particles including a first set of target-specific reagents and a first optically detectable identifier capable of emitting a first wavelength indicative of a first target, and at least one second set of particles including a second set of target-specific reagents and a second optically detectable identifier capable of emitting a second wavelength indicative of a second target; and at least one optically detectable reporter probe capable of constitutively emitting a third wavelength in response to reaction of the first set of target-specific reagents with the first target in the test sample and/or reaction of the second set of target-specific reagents with the second target in the test sample, wherein the first wavelength, the second wavelength, and the third wavelength are optically discernable from one another.

Abstract: An embodiment of a system includes a compartment-generating device, a compartment detector, and electronic computing circuitry. The device is configured to generate compartments of a digital assay, at least one of the compartments having a respective volume that is different from a respective volume of each of at least another one of the compartments. The detector is configured to determine a number of the compartments each having a respective number of a target that is greater than a threshold number of the target. And the electronic circuitry is configured to determine a bulk concentration of the target in a source of the sample in response to the determined number of compartments. Because such a system can be configured to estimate a bulk concentration of a target in a source from a polydisperse digital assay, the system can be portable, and lower-cost and faster, than conventional systems.

Abstract: Embodiments include assay devices within a single use, disposable cassette for biochemical assays with at least one fluid well and at least one capillary valve. The capillary valve in combination with motion of porous sheets within the assay leads to addition of liquid reagents at different times to the assay although a user adds the liquid reagents to the cassette simultaneously.

Abstract: An embodiment of a system includes a compartment-generating device, a compartment detector, and electronic computing circuitry. The device is configured to generate compartments of a digital assay, at least one of the compartments having a respective volume that is different from a respective volume of each of at least another one of the compartments. The detector is configured to determine a number of the compartments each having a respective number of a target that is greater than a threshold number of the target. And the electronic circuitry is configured to determine a bulk concentration of the target in a source of the sample in response to the determined number of compartments. Because such a system can be configured to estimate a bulk concentration of a target in a source from a polydisperse digital assay, the system can be portable, and lower-cost and faster, than conventional systems.

Abstract: Embodiments include assay devices within a single use, disposable cassette for biochemical assays with at least one fluid well and at least one capillary valve. The capillary valve in combination with motion of porous sheets within the assay leads to addition of liquid reagents at different times to the assay although a user adds the liquid reagents to the cassette simultaneously.

Abstract: A device for rapid detection of a tuberculosis lipoarabinomannan (TB-LAM) is provided. The device includes a pre-concentrator unit for concentrating the TB-LAM comprising: an ion-exchange medium comprising one or more ligands configured to capture the TB-LAM from the source biological sample, wherein the captured-TB-LAM is eluted from the ion-exchange medium as an eluate comprising a concentrated form of TB-LAM; a cassette; a lateral flow assay unit disposed in the cassette; and an integration unit attached to the pre-concentrator unit and the cassette. The integration unit is configured to operatively couple and de-couple the pre-concentrator unit and the cassette. The pre-concentrator unit and the lateral flow assay unit disposed in the cassette are in a fluidic communication in a coupled form. The device for rapid detection of TB-LAM further comprises a dilutor unit.

Abstract: A device for rapid detection of a tuberculosis lipoarabinomannan (TB-LAM) is provided. The device includes a pre-concentrator unit for concentrating the TB-LAM comprising: an ion-exchange medium comprising one or more ligands configured to capture the TB-LAM from the source biological sample, wherein the captured-TB-LAM is eluted from the ion-exchange medium as an eluate comprising a concentrated form of TB-LAM; a cassette; a lateral flow assay unit disposed in the cassette; and an integration unit attached to the pre-concentrator unit and the cassette. The integration unit is configured to operatively couple and de-couple the pre-concentrator unit and the cassette. The pre-concentrator unit and the lateral flow assay unit disposed in the cassette are in a fluidic communication in a coupled form. The device for rapid detection of TB-LAM further comprises a dilutor unit.

Abstract: An embodiment of a system includes a compartment-generating device, a compartment detector, and electronic computing circuitry. The device is configured to generate compartments of a digital assay, at least one of the compartments having a respective volume that is different from a respective volume of each of at least another one of the compartments. The detector is configured to determine a number of the compartments each having a respective number of a target that is greater than a threshold number of the target. And the electronic circuitry is configured to determine a bulk concentration of the target in a source of the sample in response to the determined number of compartments. Because such a system can be configured to estimate a bulk concentration of a target in a source from a polydisperse digital assay, the system can be portable, and lower-cost and faster, than conventional systems.

Abstract: Described herein are systems and methods for multiplexed analysis of two or more targets in a test sample including a first set of particles including a first set of target-specific reagents and a first optically detectable identifier capable of emitting a first wavelength indicative of a first target, and at least one second set of particles including a second set of target-specific reagents and a second optically detectable identifier capable of emitting a second wavelength indicative of a second target; and at least one optically detectable reporter probe capable of constitutively emitting a third wavelength in response to reaction of the first set of target-specific reagents with the first target in the test sample and/or reaction of the second set of target-specific reagents with the second target in the test sample, wherein the first wavelength, the second wavelength, and the third wavelength are optically discernable from one another.

Abstract: In some embodiments, a medical-sample filtration device includes: a container including at least one wall forming an internal surface, a first aperture adjacent to a first end of the wall, and a second aperture adjacent to a second end of the wall; a movable insert positioned within the container and including an external surface of a size and shape to reversibly mate with the internal surface of the container; a positioning unit affixed to the internal surface close to the second aperture; a filter unit affixed to the second aperture; a sample conduit affixed to the filter unit; a valve unit attached to the sample conduit; and a connector operable to close the valve when the movable insert is in a predefined position relative to the container.

Abstract: Embodiments disclosed herein are directed to flow assays including at least one electrically-actuated valve configured to control fluid flow. Methods of operating such flow assays are also disclosed.

Abstract: Methods and systems for capture concentration of analytes using lectins and other capture ligands are described. For example, stationary phase media functionalized with lectins are used for capture concentration and cleaning of TB lipoarabinomannan (TB LAM) prior to assay on a lateral flow assay (LFA) device, and filtration devices suitable for particulate or bulk capture media are described. Size-exclusion filtration is used to separate particles with captured analyte during washing and concentration steps. Captured analyte can be eluted from stationary phase media prior to application to a LFA or eluted directly onto a customized LFA device that includes a size-selective filter. In various aspects, a size-selective filter on a LFA is used to transfer particulate capture media on a LFA device.

Abstract: A device for rapid detection of a tuberculosis lipoarabinomannan (TB-LAM) is provided. The device includes a pre-concentrator unit for concentrating the TB-LAM comprising: an ion-exchange medium comprising one or more ligands configured to capture the TB-LAM from the source biological sample, wherein the captured-TB-LAM is eluted from the ion-exchange medium as an eluate comprising a concentrated form of TB-LAM; a cassette; a lateral flow assay unit disposed in the cassette; and an integration unit attached to the pre-concentrator unit and the cassette. The integration unit is configured to operatively couple and de-couple the pre-concentrator unit and the cassette. The pre-concentrator unit and the lateral flow assay unit disposed in the cassette are in a fluidic communication in a coupled form. The device for rapid detection of TB-LAM further comprises a dilutor unit.

Abstract: A fluidic assay device and related methods of use and manufacture are disclosed. A fluidic assay device includes a diversion structure pad having a fixed bed volume and capable of producing a capillary flow rate to preferentially draw a first volume of sample fluid delivered by a fluid delivery device to a loading region away from an assay flow path. A second volume of sample fluid delivered from the delivery device flows from the loading region into an assay flow path. For example, the assay flow path may include a lateral flow membrane and components for capture and detection of an analyte of interest. The fluidic assay device can be used with, sandwich immunoassays and other assays suited for use in lateral flow format, for example.

Abstract: In some embodiments, an immunoassay device for detection of recent malaria infection includes: a sample pad positioned adjacent to a first end of a conjugate pad, wherein either the sample pad or the first end of the conjugate pad include a detection complex able to bind anti-ETRAMP5 antibodies; wherein a second end of the conjugate pad includes one or more areas impregnated with a construct protein including ETRAMP5 protein fragments. In some embodiments, the detection complex for anti-ETRAMP5 antibodies includes a capture particle complexed with anti-IgG antibodies. In some embodiments, the detection complex for anti-ETRAMP5 antibodies includes a detection particle complexed with a complex molecule including ETRAMP5 protein fragments.

Abstract: In some embodiments, a medical-sample filtration device includes: a container including at least one wall forming an internal surface, a first aperture adjacent to a first end of the wall, and a second aperture adjacent to a second end of the wall; a movable insert positioned within the container and including an external surface of a size and shape to reversibly mate with the internal surface of the container; a positioning unit affixed to the internal surface close to the second aperture; a filter unit affixed to the second aperture; a sample conduit affixed to the filter unit; a valve unit attached to the sample conduit; and a connector operable to close the valve when the movable insert is in a predefined position relative to the container.