The present invention relates to systems and methods that utilize a combination of immunoassay and magnetic immunoassay techniques to detect an analyte within an extended range of specified concentrations. In particular, a device includes a housing, a heterogeneous surface capture immunosensor within the housing and configured to generate a first signal indicative of the concentration of the analyte in an upper concentration range, and a homogeneous magnetic bead capture immunosensor within the housing and configured to generate a second signal indicative of the concentration of the analyte in a lower concentration range.

Screening assays and methods of performing such assays are provided. In certain examples, the assays and methods may be designed to determine whether or not two or more species can associate with each other. In some examples, the assays and methods may be used to determine if a known antigen binds to an unknown monoclonal antibody.

A fluidic device includes a fluidic layer, a capture material, and an electronics layer, the fluidic layer includes a main channel and a pair of sample channels fluidly coupled to the main channel. The pair of sample channels is configured to receive and introduce a sample material into the device. The sample material includes an analyte. The capture material is positioned in a portion of the main channel that is spaced from the pair of sample channels. The capture material has a three-dimensional matrix of receptors therein configured to bond with the analyte. The capture material has a length that is associated with a dynamic range of the fluidic device and a cross-sectional area that is associated with a sensitivity of the fluidic device. The electronics layer includes electrodes configured to measure an electrical resistance through a portion of the capture material.

Some embodiments described herein relate to systems and methods operable to combine immunoassay and Total Protein techniques in a single sample run. Some embodiments described herein allow for multiple sequential immunoassays to be performed in the same microfluidic device. Some embodiments described herein relate to stripping reagents operable to remove primary antibodies associated with immunoassays. Such stripping reagents can allow for additional immunoassays and/or Total Protein assays to be performed on the same sample.

Some embodiments described herein relate to systems and methods operable to combine immunoassay and Total Protein techniques in a single sample run. Some embodiments described herein allow for multiple sequential immunoassays to be performed in the same microfluidic device. Some embodiments described herein relate to stripping reagents operable to remove primary antibodies associated with immunoassays. Such stripping reagents can allow for additional immunoassays and/or Total Protein assays to be performed on the same sample.

A flow cell is provided that includes surface-attached structures in a chamber. The structures are movable in response to a magnetic or electric field. A target extraction or isolation system includes the flow cell and a driver configured for applying a magnetic or electric field to the interior of the flow cell to actuate movement of the structures. The flow cell may be utilized to extract or isolate a target from a sample flowing through the flow cell. Further, a microfluidic system is provided that includes surface-attached structures and a microarray, wherein actuated motion of the surface-attached structures is used to enhance flow, circulation, and/or mixing action for analyte capture on the microarray.

In a method of detecting a test substance, a test substance is detected using a sample analysis cartridge supplied with a sample. The sample analysis cartridge includes: a passage part having a gas-phase space; and liquid containers communicating with the passage part through openings. The liquid containers include: a first liquid container containing a first liquid containing magnetic particles; and a second liquid container containing a second liquid containing a labeled substance. The magnetic particles are sequentially transported to the liquid containers through the gas-phase space in the passage part. Thus, the magnetic particles carry a complex of the test substance and the labeled substance. The test substance is detected based on the labeled substance in the complex.

The present invention relates to diagnostic devices as well as methods of using these devices for detecting proteins of interest associated with diseases or disorders in mammals. In particular, the proteins of interest may be misfolded proteins associated with certain misfolded-protein disorders in mammals including those mammals suspected of or at risk of having such disorders.

There is provided a microfluidic device comprising: a plurality of wells, each well comprising one opening to function as an inlet and an outlet for the well, wherein each opening is in fluid communication with a common fluidic channel, and wherein each opening is connected to the common fluidic channel via an isolation channel, and wherein the plurality of wells is arranged on the device in a radially symmetrical pattern. There is also provided a system and method comprising the device.

A point-of birth system and instrument, biochemical cartridge, and methods for newborn screening is disclosed. Namely, a point-of-birth system is provided the includes a point-of-birth instrument for receiving and processing a biochemical cartridge for performing newborn screening. Further, a portable smart device, such as a smartphone or tablet, is in communication with point-of birth instrument, wherein the smart device may include a newborn screening (NBS) mobile app. In one example, the point-of-birth system and point-of-birth instrument support newborn biological screening only. However, in another example, the point-of-birth system and point-of birth instrument support both newborn biological screening and newborn physiological screening.