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).
G01N 27/27 - Association of two or more measuring systems or cells, each measuring a different parameter, where the measurement results may be either used independently, the systems or cells being physically associated, or combined to produce a value for a further parameter
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G01N 21/31 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
G01N 21/78 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
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.
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 40/20 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
G16H 40/60 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
G16Z 99/00 - Subject matter not provided for in other main groups of this subclass
3.
Combined Immunoassay and Magnetic Immunoassay Methods for Extended Range of Sensitivity
The present invention relates to 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 method includes forming, in a biological sample, a first complex of signal antibodies and analyte, and a second complex of the first complex and capture antibodies immobilized on magnetic beads, and contacting a first immunosensor with the biological sample to form a third complex localized on or near a surface of the first immunosensor. The first immunosensor includes an immobilized layer of capture antibodies configured to bind to the analyte, and the third complex includes the first complex bound to the immobilized layer of capture antibodies. The method further includes contacting a magnetic field localized around a second immunosensor with the biological sample such that the second complex is localized on or near a surface of the second immunosensor.
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
G01N 27/74 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating magnetic variables of fluids
G01N 33/539 - ImmunoassayBiospecific binding assayMaterials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody involving precipitating reagent
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids
4.
IMPROVED ASSAYS, CARTRIDGES, AND KITS FOR DETECTION OF BIOMARKERS, INCLUDING BRAIN INJURY BIOMARKERS
Disclosed herein are improved assays, cartridges, kits, and methods of use thereof for detecting biomarkers, e.g., one or more biomarkers of brain injury, including, without limitation, biomarkers of acquired brain injury (ABI), such as, traumatic brain injury (TBI). The improved assays described herein may aid in the diagnosis and evaluation of a subject (e.g., a human subject) that has sustained or may have sustained an injury to the head (e.g., TBI) by detecting levels of a biomarker, such as UCH-L1, GFAP, or a combination thereof, in samples taken from a subject (e.g., a human subject).
Disclosed herein are improved assays, cartridges, kits, and methods of use thereof for detecting biomarkers, e.g., one or more biomarkers of brain injury, including, without limitation, biomarkers of acquired brain injury (ABI), such as, traumatic brain injury (TBI). The improved assays described herein may aid in the diagnosis and evaluation of a subject (e.g., a human subject) that has sustained or may have sustained an injury to the head (e.g., TBI) by detecting levels of a biomarker, such as UCH-L1, GFAP, or a combination thereof, in samples taken from a subject (e.g., a human subject).
Disclosed herein is an apparatus for processing fluid samples such as blood or blood products. Also disclosed are devices comprising the apparatus as well as methods for separating plasma from blood or blood products using said apparatus.
Disclosed herein is an apparatus for processing fluid samples such as blood or blood products. Also disclosed are devices comprising the apparatus as well as methods for separating plasma from blood or blood products using said apparatus.
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
B32B 7/00 - Layered products characterised by the relation between layers Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties Layered products characterised by the interconnection of layers
Disclosed herein are systems and methods for determining ubiquitin carboxy-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP), or a combination thereof in a blood sample obtained from a subject. Also disclosed herein are systems and methods for determining CK-MB, β-hCG, thyroid stimulating hormone (TSH), homocysteine, free thyroxine (free T4) or any combinations thereof in a blood sample.
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
B32B 7/00 - Layered products characterised by the relation between layers Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties Layered products characterised by the interconnection of layers
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids
G01N 33/74 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving hormones
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.
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 40/20 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
G16H 40/60 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
G16Z 99/00 - Subject matter not provided for in other main groups of this subclass
Disclosed herein are methods and systems of determining whether a subject's levels of GFAP, UCH-L1, or GFAP and UCH-L1 are elevated in a sample collected from the subject. The methods comprise determining whether the levels of GFAP, UCH-L1, or GFAP and UCH-L1 are elevated in the sample, and communicating the determination on or from an instrument. The methods may be used to aid in the diagnosis and evaluation of a subject (e.g., a human subject) that has sustained or may have sustained an injury to the head, such as to determine whether the subject is suffering from a mild, moderate, severe, or moderate to severe traumatic brain injury (TBI).
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.
G01N 27/74 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating magnetic variables of fluids
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
12.
DEVICES, SYSTEMS, AND METHODS FOR PERFORMING OPTICAL ASSAYS
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).
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.
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.
Disclosed herein are methods, complexes, kits, systems and algorithms for detecting or determining an amount, quantity, concentration and/or level of at least one type of anti-β-coronavirus antibody, such as, for example, an anti-SARS-CoV antibody or anti-SARS-CoV-2 antibody (including an IgA, IgG and/or an IgM antibody), in one or more samples obtained from a subject.
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).
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G01N 21/31 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
G01N 27/27 - Association of two or more measuring systems or cells, each measuring a different parameter, where the measurement results may be either used independently, the systems or cells being physically associated, or combined to produce a value for a further parameter
G01N 21/77 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
G01N 33/48 - Biological material, e.g. blood, urineHaemocytometers
17.
Devices, systems, and methods for performing optical and electrochemical assays
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).
G01N 27/27 - Association of two or more measuring systems or cells, each measuring a different parameter, where the measurement results may be either used independently, the systems or cells being physically associated, or combined to produce a value for a further parameter
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G01N 21/31 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
G01N 21/78 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
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. In particular, the systems and methods ensure that only instruments that pass a quality assurance protocol are used for point-of-care testing.
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
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.
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 40/60 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
G16H 40/20 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
G16Z 99/00 - Subject matter not provided for in other main groups of this subclass
20.
PORTABLE CLINICAL ANALYSIS SYSTEM FOR IMMUNOMETRIC MEASUREMENT
The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof.
The invention relates to a thermal control system for controlling the temperature of a fluid. In particular, the invention relates to a control system having at least two heating elements, at least one of which is used for directly or indirectly heating a fluid, and at least one of which is used for heating a thermal probe used to determine the temperature of the fluid. The heating systems are controlled by at least one feedback controller.
The present invention relates to 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 method includes forming, in a biological sample, a first complex of signal antibodies and analyte, and a second complex of the first complex and capture antibodies immobilized on magnetic beads, and contacting a first immunosensor with the biological sample to form a third complex localized on or near a surface of the first immunosensor. The first immunosensor includes an immobilized layer of capture antibodies configured to bind to the analyte, and the third complex includes the first complex bound to the immobilized layer of capture antibodies. The method further includes contacting a magnetic field localized around a second immunosensor with the biological sample such that the second complex is localized on or near a surface of the second immunosensor.
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
G01N 27/74 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating magnetic variables of fluids
G01N 33/539 - ImmunoassayBiospecific binding assayMaterials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody involving precipitating reagent
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids
23.
Combined immunoassay and magnetic immunoassay systems and devices for extended range of sensitivity
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.
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
G01N 33/549 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals the carrier being organic with antigen or antibody entrapped within the carrier
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
C08L 79/08 - PolyimidesPolyester-imidesPolyamide-imidesPolyamide acids or similar polyimide precursors
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.
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16Z 99/00 - Subject matter not provided for in other main groups of this subclass
25.
DUAL RANGE CARDIAC TROPONIN IMMUNOASSAY DEVICES AND METHODS USING IMMUNOSENSOR AND MAGNETIC IMMUNOSENSOR
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 first immunosensor including an immobilized layer of capture antibodies configured to bind to a first complex of signal antibodies and cardiac troponin such that a second complex of the first complex and the immobilized layer of capture antibodies is localized on or near the first immunosensor. The device further includes a second immunosensor having a magnetic field disposed locally around the second immunosensor. The magnetic field is configured to attract magnetic beads such that a third complex of the first complex and capture antibodies immobilized on the magnetic beads is localized on or near the second immunosensor sensor.
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids
G01N 27/74 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating magnetic variables of fluids
G01N 33/539 - ImmunoassayBiospecific binding assayMaterials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody involving precipitating reagent
26.
Cartridge device with bypass channel for mitigating drift of fluid samples
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.
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
A61B 10/00 - Instruments for taking body samples for diagnostic purposesOther methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determinationThroat striking implements
27.
CARTRIDGE DEVICE WITH BYPASS CHANNEL FOR MITIGATING DRIFT OF FLUID SAMPLES
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.
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.
The invention relates to a cartridge housing for forming a cartridge capable of measuring an analyte or property of a liquid sample. The housing including a top portion having a first substantially rigid zone and a substantially flexible zone, a bottom portion separate from the top portion including a second substantially rigid zone, and at least one sensor recess containing a sensor. The top portion and the bottom portion are bonded to form the cartridge having a conduit over at least a portion of the sensor. The invention also relates to methods for forming such cartridges and to various features of such cartridges.
An apparatus and a method for identifying at least one type of white blood cell (WBC) within a whole blood sample is provided. The method includes: adding at least one colorant to the sample; providing at least one fluorescent excitation light and at least one transmission light; receiving both light fluorescing from and transmitted through the sample and producing signals representative thereof; creating at least one image of the sample using the signals; identifying WBCs within the sample image; quantitatively analyzing at least some of the identified WBCs within the image, including determining one or more quantitative values; and identifying at least one type of WBC from the identified WBCs using the quantitative values.
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.
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).
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G01N 21/31 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
G01N 27/27 - Association of two or more measuring systems or cells, each measuring a different parameter, where the measurement results may be either used independently, the systems or cells being physically associated, or combined to produce a value for a further parameter
G01N 21/77 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
G01N 33/48 - Biological material, e.g. blood, urineHaemocytometers
G01N 27/07 - Construction of measuring vesselsElectrodes therefor
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).
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G01N 21/31 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
G01N 33/487 - Physical analysis of biological material of liquid biological material
G01N 21/78 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
Devices, systems, and methods for performing optical and electrochemical assays are disclosed, more particularly, devices and systems having universal channel circuitry (245, 1000) 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 (1063, 1065, 1070), and thus any sensor contact pad in a testing device (1062), can be connected to one or more channels (1005) capable of taking on one or more measurement modes or configurations, e.g. an amperometric measurement mode or a current drive mode.
G01N 21/31 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G01N 27/07 - Construction of measuring vesselsElectrodes therefor
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.
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 assay beads. 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 wells having a predetermined average well height and disposed between the first planar member and the second planar member; and an imager chip forming at least a portion of the planar member.
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 method is provided for imaging assay beads. The method includes moving a blood sample into a sample testing conduit having a first wall formed from at least a portion of an imager chip, a second wall formed from a transparent material layer, and a plurality of wells. The method further including driving a light emitter to project light through the wells, recording an output signal of at least one of absorbance and fluorescence, and converting the output signal to a value indicative of a reaction of a biological sample within each of the plurality of wells.
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).
G01N 27/27 - Association of two or more measuring systems or cells, each measuring a different parameter, where the measurement results may be either used independently, the systems or cells being physically associated, or combined to produce a value for a further parameter
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G01N 21/31 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
G01N 21/78 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
39.
DEVICES, SYSTEMS, AND METHODS FOR PERFORMING OPTICAL ASSAYS
Devices, systems, and methods for performing optical and electrochemical assays are disclosed, more particularly, devices and systems having universal channel circuitry (245, 1000) 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 (1063, 1065, 1070), and thus any sensor contact pad in a testing device (1062), can be connected to one or more channels (1005) capable of taking on one or more measurement modes or configurations, e.g. an amperometric measurement mode or a current drive mode.
G01N 21/31 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
Devices, systems, and methods for performing optical and electrochemical assays and, more particularly, to devices and systems having universal channel circuitry (245, 1000) 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 (1063, 1065, 1070), and thus any sensor contact pad in a testing device (1062), can be connected to one or more channels (1005) capable of taking on one or more measurement modes or configurations, e.g. an amperometric measurement mode or a current drive mode.
G01N 21/31 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
Devices, systems, and methods for performing bioimaging at the microscopic scale are disclosed, more particularly, devices and systems including a disposable testing device (105) configured to perform bioimaging at the microscopic scale, and methods of performing the bioimaging using the disposable testing device (105). A method is provided for performing a differential blood cell count. The method includes moving a blood sample into a sample testing conduit (525) having a first wall formed from at least a portion of an imager chip (505), a second wall formed from a transparent material layer (540), and a plurality of spacer elements (815). The method further including driving a light emitter (555) to project light through the chamber (550), recording an output signal of at least one of absorbance and fluorescence, and converting the output signal to a number count or percentage for each type of cell in the blood sample.
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G01N 21/77 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
G01N 21/17 - Systems in which incident light is modified in accordance with the properties of the material investigated
42.
Method for imaging biologic fluid samples using a predetermined distribution
A method for analyzing a biologic fluid sample includes the steps of: a) providing a spatially mapped chamber; b) providing a predetermined repeatable non-uniform spatial distribution of one or more constituents within the sample, which distribution indicates the presence or absence of a statistically significant number of constituents within the sample in each chamber sub-region; c) selecting one or more image techniques for each sub-region based on the presence or absence of the statistically significant number of one or more constituents in that sub-region as indicated by the distribution; d) creating image data representative of the biologic fluid sample in each sub-region, using the one or more image techniques selected for that sub-region; and e) analyzing the sample.
This invention relates generally to devices and methods for performing optical and electrochemical assays and, more particularly, to test devices, e.g., cartridges, methods and systems, wherein the test devices have an entry port configured to receive a test sample into a holding chamber; a first conduit having at least one lateral flow test strip; and a displacement device, such as a pneumatic pump, configured to move a portion of said test sample from said holding chamber into said first conduit. The present invention is particularly useful for performing immunoassays and/or electrochemical assays at the point-of-care.
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.
The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof.
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.
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
G01N 27/74 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating magnetic variables of fluids
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
47.
Ellagic acid formulations for use in coagulation assays
The present invention relates to ellagic acid formulations for performing coagulation assays that are highly stable for long term storage and reduce assay time. Particularly, aspects of the present invention are directed to a composition and method of preparing ellagic acid in a highly soluble format for use in a coagulation assay. For example, the ellagic acid may be solubilized in one or more of sodium hydroxide, methanol, a polyether compound, particularly polyethylene glycol, polyethylene oxide, or polyoxyethylene, and a cyclodextrin guest-host complex.
The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof.
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.
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.
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing
G01N 27/74 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating magnetic variables of fluids
51.
Ameliorated crosstalk immunoassay test device for determining a concentration of an analyte
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 includes a first electrochemical sensor positioned within a conduit adjacent to a second electrochemical sensor and spaced apart from one another at a predetermined distance. The first electrochemical sensor includes an immobilized layer of antibodies. The second electrochemical sensor includes a magnetic field disposed locally around the second electrochemical sensor, and the magnetic field is configured to attract magnetic beads onto a surface of the second electrochemical sensor. The device further includes a scavenging electrode positioned between the first electrochemical sensor and the second electrochemical sensor. The scavenging electrode is configured to prevent crosstalk between the first electrochemical immunosensor and the second electrical immunosensor.
G01N 27/27 - Association of two or more measuring systems or cells, each measuring a different parameter, where the measurement results may be either used independently, the systems or cells being physically associated, or combined to produce a value for a further parameter
The present invention relates to analytical testing devices including micro-environment sensors and methods for assaying coagulation in a fluid sample applied to the micro-environment sensors, and in particular, performing one or more types of coagulation assays using one or more micro-environment sensors in a single point of care combined test cartridge. For example, the present invention may be directed to test sensor including at least one transducer coated with a polymer layer. The polymer layer comprises a thrombin-cleavable peptide with a detectable moiety.
The present invention relates to 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 method includes forming, in a biological sample, a first complex of signal antibodies and analyte, and a second complex of the first complex and capture antibodies immobilized on magnetic beads, and contacting a first immunosensor with the biological sample to form a third complex localized on or near a surface of the first immunosensor. The first immunosensor includes an immobilized layer of capture antibodies configured to bind to the analyte, and the third complex includes the first complex bound to the immobilized layer of capture antibodies. The method further includes contacting a magnetic field localized around a second immunosensor with the biological sample such that the second complex is localized on or near a surface of the second immunosensor.
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 method includes determining a first concentration of an analyte at a first immunosensor from a reaction of a signal agent with a first complex of signal antibodies, the analyte, and capture antibodies immobilized on a surface of the first immunosensor, determining a second concentration of the analyte at a second immunosensor from a reaction of the signal agent with a second complex of the signal antibodies, the analyte, and capture antibodies immobilized on magnetic beads that are localized on or near a surface of the second immunosensor via a magnetic field, determining a weighted average of the first concentration and the second concentration, and comparing the weighted average to a predetermined crossover concentration point or zone.
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.
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 includes a first electrochemical sensor positioned within a conduit adjacent to a second electrochemical sensor and spaced apart from one another at a predetermined distance. The first electrochemical sensor includes an immobilized layer of antibodies. The second electrochemical sensor includes a magnetic field disposed locally around the second electrochemical sensor, and the magnetic field is configured to attract magnetic beads onto a surface of the second electrochemical sensor. The device further includes a scavenging electrode positioned between the first electrochemical sensor and the second electrochemical sensor. The scavenging electrode is configured to prevent crosstalk between the first electrochemical immunosensor and the second electrochemical immunosensor.
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.
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
G01N 33/549 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals the carrier being organic with antigen or antibody entrapped within the carrier
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
C08L 79/08 - PolyimidesPolyester-imidesPolyamide-imidesPolyamide acids or similar polyimide precursors
The present invention relates to 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 method includes forming, in a biological sample, a first complex of signal antibodies and analyte, and a second complex of the first complex and capture antibodies immobilized on magnetic beads, and contacting a first immunosensor with the biological sample to form a third complex localized on or near a surface of the first immunosensor. The first immunosensor includes an immobilized layer of capture antibodies configured to bind to the analyte, and the third complex includes the first complex bound to the immobilized layer of capture antibodies. The method further includes contacting a magnetic field localized around a second immunosensor with the biological sample such that the second complex is localized on or near a surface of the second immunosensor.
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
G01N 33/539 - ImmunoassayBiospecific binding assayMaterials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody involving precipitating reagent
G01N 27/74 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating magnetic variables of fluids
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids
59.
Crossover analytical systems and methods using an immunosensor and magnetic immunosensor
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 method includes determining a first concentration of an analyte at a first immunosensor from a reaction of a signal agent with a first complex of signal antibodies, the analyte, and capture antibodies immobilized on a surface of the first immunosensor, determining a second concentration of the analyte at a second immunosensor from a reaction of the signal agent with a second complex of the signal antibodies, the analyte, and capture antibodies immobilized on magnetic beads that are localized on or near a surface of the second immunosensor via a magnetic field, determining a weighted average of the first concentration and the second concentration, and comparing the weighted average to a predetermined crossover concentration point or zone.
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions
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.
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 first immunosensor including an immobilized layer of capture antibodies configured to bind to a first complex of signal antibodies and cardiac troponin such that a second complex of the first complex and the immobilized layer of capture antibodies is localized on or near the first immunosensor. The device further includes a second immunosensor having a magnetic field disposed locally around the second immunosensor. The magnetic field is configured to attract magnetic beads such that a third complex of the first complex and capture antibodies immobilized on the magnetic beads is localized on or near the second immunosensor sensor.
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids
G01N 27/74 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating magnetic variables of fluids
62.
Method for imaging biologic fluid samples using a predetermined distribution
A method for analyzing a biologic fluid sample includes the steps of: a) providing a spatially mapped chamber; b) providing a predetermined repeatable non-uniform spatial distribution of one or more constituents within the sample, which distribution indicates the presence or absence of a statistically significant number of constituents within the sample in each chamber sub-region; c) selecting one or more image techniques for each sub-region based on the presence or absence of the statistically significant number of one or more constituents in that sub-region as indicated by the distribution; d) creating image data representative of the biologic fluid sample in each sub-region, using the one or more image techniques selected for that sub-region; and e) analyzing the sample.
The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof.
The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof.
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
Goods & Services
(1) Cartridges prefilled with medical diagnostic reagents for use in in vitro diagnostic testing; cartridges prefilled with medical diagnostic reagents; medical diagnostic instruments and accessories, namely, apparatus for medical laboratory and clinical use for use in assays for measuring troponin levels; medical diagnostic instruments for medical laboratory and clinical use for use with medical diagnostic reagents and chemical diagnostic reagents
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
(1) Medical diagnostic reagents; cartridges prefilled with medical diagnostic reagents; assays for measuring troponin levels; in vitro diagnostic tests for the quantitative measurement of cardiac troponin I in whole blood or plasma; medical diagnostic tests for diagnosing myocardial infarction
Medical apparatus in the form of cartridges for containing medical diagnostic reagents for use in in vitro diagnostic testing; medical apparatus in the form of cartridges for containing medical diagnostic reagents; instruments and accessories for use in assays for measuring troponin levels; instruments used with medical diagnostic reagents and chemicals in the healthcare field.
01 - Chemical and biological materials for industrial, scientific and agricultural use
Goods & Services
(1) Control preparations for medical diagnostic instruments used for in vitro diagnostic testing; diagnostic reagents for medical-scientific research use; assays for measuring troponin levels for medical-scientific research use
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Medical diagnostic reagents; cartridges prefilled with medical diagnostic reagents; assays for measuring troponin levels; in vitro diagnostic tests for the quantitative measurement of cardiac troponin I in whole blood or plasma; medical diagnostic tests for diagnosing myocardial infarction.
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.
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 40/60 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Medical diagnostic reagents; assays for measuring troponin levels; in vitro diagnostic tests for the quantitative measurement of cardiac troponin I in whole blood or plasma; medical diagnostic tests for diagnosing and treating myocardial infarction/heart attack; medical diagnostic tests to aid in risk stratification of patients with acute coronary syndromes with respect to relative risk of mortality.
Cartridges featuring medical diagnostic reagents for use in in vitro diagnostic testing; cartridges featuring medical diagnostic reagents; instruments and accessories for use in assays for measuring troponin levels; instruments used with medical diagnostic reagents and chemicals in the healthcare field.
A method and apparatus for identifying one or more target constituents (e.g., white blood cells) within a biological sample is provided. The method includes the steps of: a) adding at least one colorant to the sample; b) disposing the sample into a chamber defined by at least one transparent panel; c) creating at least one image of the sample quiescently residing within the chamber; d) identifying target constituents within the sample image; e) quantitatively analyzing at least some of the identified target constituents within the image relative to one or more predetermined quantitatively determinable features; and f) identifying at least one type of target constituent within the identified target constituents using the quantitatively determinable features.
The invention relates to a cartridge housing for forming a cartridge capable of measuring an analyte or property of a liquid sample. The housing including a top portion having a first substantially rigid zone and a substantially flexible zone, a bottom portion separate from the top portion including a second substantially rigid zone, and at least one sensor recess containing a sensor. The top portion and the bottom portion are bonded to form the cartridge having a conduit over at least a portion of the sensor. The invention also relates to methods for forming such cartridges and to various features of such cartridges.
A method for analyzing a biologic fluid sample includes the steps of: a) providing a spatially mapped chamber; b) providing a predetermined repeatable non-uniform spatial distribution of one or more constituents within the sample, which distribution indicates the presence or absence of a statistically significant number of constituents within the sample in each chamber sub-region; c) selecting one or more image techniques for each sub-region based on the presence or absence of the statistically significant number of one or more constituents in that sub-region as indicated by the distribution; d) creating image data representative of the biologic fluid sample in each sub-region, using the one or more image techniques selected for that sub-region; and e) analyzing the sample.
The present invention covers the integration and utility of accelerometer features into a clinical analysis system. For example, measurement of dynamic acceleration and orientation of a blood-testing instrument with respect to Earth's gravitational field may be used to determine reliability of a test procedure and optionally to provide corrective elements thereof.
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. In particular, the systems and methods ensure that only instruments that pass a quality assurance protocol are used for point-of-care testing.
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
G16H 40/40 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
80.
Systems for assuring quality compliance of point-of-care single-use testing devices
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.
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
81.
SYSTEMS AND METHODS FOR ASSURING QUALITY COMPLIANCE OF POINT-OF-CARE SINGLE-USE TESTING DEVICES
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.
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
82.
SYSTEMS AND METHODS FOR ASSURING QUALITY COMPLIANCE OF POINT-OF-CARE INSTRUMENTS USED WITH SINGLE-USE TESTING DEVICES
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. In particular, the systems and methods ensure that only instruments that pass a quality assurance protocol are used for point-of-care testing
G06F 19/00 - Digital computing or data processing equipment or methods, specially adapted for specific applications (specially adapted for specific functions G06F 17/00;data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q;healthcare informatics G16H)
83.
Optical assay device with pneumatic sample actuation
This invention relates generally to devices and methods for performing optical and electrochemical assays and, more particularly, to test devices, e.g., cartridges, methods and systems, wherein the test devices have an entry port configured to receive a test sample into a holding chamber; a first conduit having at least one lateral flow test strip; and a displacement device, such as a pneumatic pump, configured to move a portion of said test sample from said holding chamber into said first conduit. The present invention is particularly useful for performing immunoassays and/or electrochemical assays at the point-of-care.
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.
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.
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G01N 27/74 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating magnetic variables of fluids
88.
Microfabricated device with micro-environment sensors for assaying coagulation in fluid samples
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.
The present invention relates to analytical testing devices comprising segmented fluidics and methods for assaying coagulation in a fluid sample received within the segmented fluidics. For example, the present invention may be directed to 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 first flow restrictor region, a second reagent, and a second sensor region. The sample analysis cartridge further includes a pump configured to independently mix the first segment in the second conduit and the second segment in the third conduit, and independently position the first segment over the first sensor region and position the second segment over the second sensor region.
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G01N 33/00 - Investigating or analysing materials by specific methods not covered by groups
C12Q 1/56 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
G01N 31/00 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroupsApparatus specially adapted for such methods
G01N 33/86 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood coagulating time
90.
Cartridge device with fluidic junctions for coagulation assays in fluid samples
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.
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G01N 33/00 - Investigating or analysing materials by specific methods not covered by groups
C12Q 1/56 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
G01N 31/00 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroupsApparatus specially adapted for such methods
G01N 33/86 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood coagulating time
The present invention relates to analytical testing devices comprising a single channel with 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 a single channel with micro-environment sensors in a point of care test 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. The conduit includes a sensor chip including a first micro-environment sensor and a second microenvironment sensor, and a fluid lock valve. The sample analysis cartridge further includes a pump configured to push the biological sample over the first micro-environment sensor and the second microenvironment sensor to the fluidic lock valve such that the biological sample is positioned over the first micro-environment sensor and the second micro-environment sensor.
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G01N 33/00 - Investigating or analysing materials by specific methods not covered by groups
C12Q 1/56 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving blood clotting factors, e.g. involving thrombin, thromboplastin, fibrinogen
G01N 31/00 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroupsApparatus specially adapted for such methods
G01N 33/86 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood coagulating time
The present invention relates to ellagic acid formulations for performing coagulation assays that are highly stable for long term storage and reduce assay time. Particularly, aspects of the present invention are directed to a composition and method of preparing ellagic acid in a highly soluble format for use in a coagulation assay. For example, the ellagic acid may be solubilized in one or more of sodium hydroxide, methanol, a polyether compound, particularly polyethylene glycol, polyethylene oxide, or polyoxyethylene, and a cyclodextrin guest-host complex.
The present invention relates to analytical testing devices comprising segmented fluidics and methods for assaying coagulation in a fluid sample received within the segmented fluidics. For example, the present invention may be directed to 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 first flow restrictor region, a second reagent, and a second sensor region. The sample analysis cartridge further includes a pump configured to independently mix the first segment in the second conduit and the second segment in the third conduit, and independently position the first segment over the first sensor region and position the second segment over the second sensor region.
The present invention relates to analytical testing devices comprising a resistor for cartridge device identification and methods for assaying coagulation in a fluid sample based on the cartridge device identification, and in particular, to performing coagulation assays using a resistor for cartridge device identification in a point of care test cartridge. For example, the present invention may be directed to a chip including an analyte electrode connected to a first connection pin, a reference electrode connected to a second connection pin, and a resistor connected to the second connection pin and a third connection pin.
The present invention relates to analytical testing devices including micro-environment sensors and methods for assaying coagulation in a fluid sample applied to the micro-environment sensors, and in particular, performing one or more types of coagulation assays using one or more micro-environment sensors in a single point of care combined test cartridge. For example, the present invention may be directed to test sensor including at least one transducer coated with a polymer layer. The polymer layer comprises a thrombin-cleavable peptide with a detectable moiety.
The present invention relates to analytical testing devices including micro-environment sensors and methods for assaying coagulation in a fluid sample applied to the micro-environment sensors, and in particular, performing one or more types of coagulation assays using one or more micro-environment sensors in a single point of care combined test cartridge. For example, the present invention may be directed to test sensor including at least one transducer coated with a polymer layer. The polymer layer comprises a thrombin-cleavable peptide with a detectable moiety.
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.
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.
The present invention relates to analytical testing devices comprising a single channel with 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 a single channel with micro-environment sensors in a point of care test 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. The conduit includes a sensor chip including a first micro-environment sensor and a second microenvironment sensor, and a fluid lock valve. The sample analysis cartridge further includes a pump configured to push the biological sample over the first micro-environment sensor and the second microenvironment sensor to the fluidic lock valve such that the biological sample is positioned over the first micro-environment sensor and the second micro-environment sensor.
The present invention relates to ellagic acid formulations for performing coagulation assays that are highly stable for long term storage and reduce assay time. Particularly, aspects of the present invention are directed to a composition and method of preparing ellagic acid in a highly soluble format for use in a coagulation assay. For example, the ellagic acid may be solubilized in one or more of sodium hydroxide, methanol, a polyether compound, particularly polyethylene glycol, polyethylene oxide, or polyoxyethylene, and a cyclodextrin guest-host complex.
