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: 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: 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: 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 device for application of even pressure on a plunger head includes: a center rod with a pressure plate affixed at a first end and a back plate positioned adjacent to a second end; a positioning spring adjacent to the pressure plate at a surface distal to the center rod; a positioning plate adjacent to an end of the positioning spring distal to the pressure plate; a housing including an aperture at a position adjacent to a distal surface of the positioning plate; a main spring surrounding the center rod between the back plate and the pressure plate; and a mechanism positioned to move the center rod between the pressure plate and the back plate, the mechanism positioned to compress the main spring between the pressure plate and the back plate in response to force applied by a user.

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: The invention provides disposable microfluidic devices that incorporate magnetic media and methods of using such devices to perform diagnostic assays on a sample. One exemplary microfluidic device comprises a first magnetic layer, a second magnetic layer, and a substantially planar member containing at least one hydrophilic region, where the substantially planar member is disposed between the first magnetic layer and the second magnetic layer, and the magnetic layers provide an attractive force useful for reducing the loss of fluid and/or s reagent from the device.

Abstract: The invention provides molecular diagnostic test devices and methods for using such diagnostic test devices to detect analytes of biological significance in a patient. The diagnostic test devices are particularly useful for detecting a polynucleotide analyte in a sample obtained from a patient. Further, the diagnostic test devices are inexpensive, disposable, easy to use, and are useful at the point of care.