Abstract: The present invention relates to systems 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 is provided for detecting an analyte in a biological sample. The device includes a first electrochemical sensor positioned on a substrate. The first electrochemical sensor includes an immobilized layer of antibody configured to bind to the analyte. The device further includes a second electrochemical sensor positioned adjacent to the first electrochemical sensor on the substrate, and a magnetic material that generates a magnetic field aligned with respect to the second electrochemical sensor. The magnetic field captures magnetic beads that have an immobilized layer of antibody configured to bind to the analyte, and concentrates the magnetic beads on or near a surface of the second electrochemical sensor.

Abstract: A biological fluid analysis cartridge is provided. In certain embodiments, the cartridge includes a base plate extending between a sample handling portion and an analysis chamber portion. A handling upper panel is attached to the base plate within the sample handling portion. A collection port is at least partially formed with the handling upper panel. An initial channel and a secondary channel are formed between the handling upper panel and the base plate. The collection port and initial and secondary channels are in fluid communication with one another. A chamber upper panel is attached to the base plate within the analysis chamber portion. At least one analysis chamber is formed between the chamber upper panel and the base plate. The secondary channel and the analysis chamber are in fluid communication with one another.

Abstract: The present invention relates to a method and system for quality compliance, system and operator verification, and process management for point of care biological sample testing systems used in hospitals and other medical delivery environments. Specifically, the present invention may be directed to a computing device configured to generate a plurality of attributes configured to assess a competency level of an operator to operate at least one sample testing instrument, obtain operator derived data pertaining to the operator's ability to operate the at least one sample testing instrument, and determine a competency level of the operator for the at least one sample testing instrument based the plurality of attributes and the operator derived data.

Abstract: The present invention provides apparatus and methods for the rapid determination of analytes in liquid samples by immunoassays incorporating magnetic capture of beads on a sensor capable of being used in the point-of-care diagnostic field.

Abstract: This present invention relates generally to devices, systems, and methods for performing bioimaging at the microscopic scale and, more particularly, to devices and systems including a disposable testing device configured to perform bioimaging at the microscopic scale, and methods of performing the bioimaging using the disposable testing device. In some aspects, a testing device is provided for imaging blood cells in a blood sample. The testing device having a sample entry port for receiving the blood sample; a sample testing conduit fluidically connected to the sample entry port, the sample testing conduit including: (i) a planar member, (ii) a transparent planar member, and (iii) a plurality of spacer elements having an average spacer height and disposed between the planar member and the transparent planar member; and an imager chip forming at least a portion of the planar member.

Abstract: The present invention provides apparatus and methods for the rapid determination of analytes in liquid samples by immunoassays incorporating magnetic capture of beads on a sensor capable of being used in the point-of-care diagnostic field.

Abstract: The present invention relates to analytical testing devices comprising fluidic junctions and methods for assaying coagulation in a fluid sample received within the fluidic junctions. For example, the present invention may be directed to a sample analysis cartridge including an inlet chamber, a first conduit comprising a first junction configured to split a biological sample into at least first and second segments, a second conduit comprising a first reagent, a first sensor region, and a first fluidic lock valve, and a third conduit comprising a second reagent, a second sensor region, and a second fluidic lock valve. The sample analysis cartridge further includes a pump configured to push the first segment over the first sensor region to the first fluidic lock valve, and push the second segment over the second sensor region to the second fluidic lock valve.

Abstract: This present invention relates generally to devices, systems, and methods for performing optical and electrochemical assays and, more particularly, to devices and systems having universal channel circuitry configured to perform optical and electrochemical assays, and methods of performing the optical and electrochemical assays using the universal channel circuitry. The universal channel circuitry is circuitry that has electronic switching capabilities such that any contact pin, and thus any sensor contact pad in a testing device, can be connected to one or more channels capable of taking on one or more measurement modes or configurations (e.g., an amperometric measurement mode or a current drive mode).

Abstract: This present invention relates generally to devices, systems, and methods for performing optical and electrochemical assays and, more particularly, to devices and systems having universal channel circuitry configured to perform optical and electrochemical assays, and methods of performing the optical and electrochemical assays using the universal channel circuitry. The universal channel circuitry is circuitry that has electronic switching capabilities such that any contact pin, and thus any sensor contact pad in a testing device, can be connected to one or more channels capable of taking on one or more measurement modes or configurations (e.g., an amperometric measurement mode or a current drive mode).

Abstract: The present invention relates to systems and methods of determining quality compliance for a set of biological sample testing devices used with one or more test instruments at the point-of-care in a hospital or other location that delivers medical care. In particular, the systems and methods ensure that only biological sample testing devices that pass a quality assurance protocol are used for point-of-care testing.

Abstract: 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.

Abstract: The present invention relates to sample analysis cartridges comprising micro-environment sensors and methods for assaying coagulation in a fluid sample applied to the micro-environment sensors, and in particular, to performing coagulation assays using micro-environment sensors in a point of care sample analysis cartridge. For example, the present invention may be directed to a sample analysis cartridge including an inlet chamber configured to receive a biological sample, and a conduit fluidically connected to the inlet chamber and configured to receive the biological sample from the inlet chamber. The conduit may include a micro-environment prothrombin time (PT) sensor, and a micro-environment activated partial thromboplastin time (aPTT) sensor.

Abstract: The present disclosure relates to analytical testing devices comprising microfluidics and methods for performing an assay on a fluid sample received within the microfluidics, and in particular, to mitigating drift of fluid samples over a sensor by incorporating a bypass channel into the microfluidics. For example, a test cartridge device is provided that includes a fluid sample entry port and holding chamber connected to a bifurcation junction of a sensor channel and a bypass channel. The sensor channel includes an upstream region and a downstream region, and an analyte sensor is in the upstream region. As a cross-sectional area of the bypass channel is greater than the cross-sectional area of the downstream region of the sensor channel, the bypass channel is a preferred path for excess sample flow and pressure, and thus sample drift above the analyte sensor is mitigated.

Abstract: The present invention relates to sample analysis cartridges comprising micro-environment sensors and methods for assaying coagulation in a fluid sample applied to the micro-environment sensors, and in particular, to performing coagulation assays using micro-environment sensors in a point of care sample analysis cartridge. For example, the present invention may be directed to a sample analysis cartridge including an inlet chamber configured to receive a biological sample, and a conduit fluidically connected to the inlet chamber and configured to receive the biological sample from the inlet chamber. The conduit may include a micro-environment prothrombin time (PT) sensor, and a micro-environment activated partial thromboplastin time (aPTT) sensor.

Abstract: 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.

Abstract: This present invention relates generally to devices, systems, and methods for performing optical and electrochemical assays and, more particularly, to devices and systems having universal channel circuitry configured to perform optical and electrochemical assays, and methods of performing the optical and electrochemical assays using the universal channel circuitry. The universal channel circuitry is circuitry that has electronic switching capabilities such that any contact pin, and thus any sensor contact pad in a testing device, can be connected to one or more channels capable of taking on one or more measurement modes or configurations (e.g., an amperometric measurement mode or a current drive mode).

Abstract: This present invention relates generally to devices, systems, and methods for performing optical and electrochemical assays and, more particularly, to devices and systems having universal channel circuitry configured to perform optical and electrochemical assays, and methods of performing the optical and electrochemical assays using the universal channel circuitry. The universal channel circuitry is circuitry that has electronic switching capabilities such that any contact pin, and thus any sensor contact pad in a testing device, can be connected to one or more channels capable of taking on one or more measurement modes or configurations (e.g., an amperometric measurement mode or a current drive mode).

Abstract: The present invention relates to systems and methods of determining quality compliance for one or more biological sample testing instruments used with one or more type of single-use blood testing cartridge, at the point-of-care in a hospital, or other location that deliver medical care.

Abstract: This present invention relates generally to devices, systems, and methods for performing optical and electrochemical assays and, more particularly, to devices and systems having universal channel circuitry configured to perform optical and electrochemical assays, and methods of performing the optical and electrochemical assays using the universal channel circuitry. The universal channel circuitry is circuitry that has electronic switching capabilities such that any contact pin, and thus any sensor contact pad in a testing device, can be connected to one or more channels capable of taking on one or more measurement modes or configurations (e.g., an amperometric measurement mode or a current drive mode).

Abstract: This present invention relates generally to devices, systems, and methods for performing optical and electrochemical assays and, more particularly, to devices and systems having universal channel circuitry configured to perform optical and electrochemical assays, and methods of performing the optical and electrochemical assays using the universal channel circuitry. The universal channel circuitry is circuitry that has electronic switching capabilities such that any contact pin, and thus any sensor contact pad in a testing device, can be connected to one or more channels capable of taking on one or more measurement modes or configurations (e.g., an amperometric measurement mode or a current drive mode).