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 glassware; Droppers
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 propert; 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 glassware; Droppers
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 propert; Layered products characterised by the interconnection of layers
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
G01N 33/74 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones
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).
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.
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.
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 glassware; Droppers
G01N 27/07 - Construction of measuring vessels; Electrodes 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.
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 glassware; Droppers
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 glassware; Droppers
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 glassware; Droppers
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
13.
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.
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.
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 - Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological 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
19.
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)
20.
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)
21.
CARTRIDGE DEVICE WITH SEGMENTED FLUIDICS FOR ASSAYING COAGULATION IN FLUID SAMPLES
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 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.
An apparatus and method for imaging a sample of substantially undiluted whole blood is provided. The method includes the steps of: providing a substantially undiluted whole blood sample admixed with at least one non-Wright stain colorant, which colorant is operable to differentially identify constituents containing cytoplasmic material; providing an analysis device having an analyzer with at least one processor, at least one sample illuminator, and at least one image sensor; creating an image of the sample using the analysis device; and using the analysis device to transform the image to a transformed image having a coloration recognizable as a Wright stained sample.
A method and apparatus for determining hemoglobin concentration is provided. A method aspect includes the steps of: a) depositing an unlysed, substantially undiluted blood sample into an analysis chamber adapted to quiescently hold the sample for analysis; b) imaging the sample in a region of the analysis chamber where the height of the chamber is no more than about twenty microns (20µ) or no less than about two microns (2µ), to produce image signals representative of the optical density of the imaged region; c) determining a sample representative optical density value using the image signals representative of the optical density of the imaged region; and d) determining the hemoglobin concentration of the sample using the sample representative optical density value.
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 two heating elements, one of which is used for directly or indirectly heating a fluid, and the second one is used for heating a thermal probe used to determine the temperature of the fluid. The heating systems are controlled by a feedback controller.
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.
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)
G06Q 10/06 - Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
32.
GLUTAMATE OXIDASE MUTAGENESIS FOR DIAGNOSTIC TESTING
The described invention provides a method of generating a catalytically active oxidase enzyme preparation. The described invention also provides a means of generating reagents for a protease detection sensor which can use colorimetric, fluorescent, or electrochemical detection. Further, the invention describes a system for a protease detecting sensor.
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
C12N 15/00 - Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
The present invention relates to analytical testing devices and methods for fabricating electrochemical creatinine biosensors, and in particular using point of care electrochemical biosensors for testing for creatinine in samples. For example, the present invention may be directed to a biosensor having an electrode, a first printed layer formed on the electrode and having a first matrix that includes creatinine amidohydrolase (CNH), creatine amidinohydrolase (CRH), and sarcosine oxidase (SOX), and second printed layer formed over the first printed layer and having a second matrix that includes CRH, SOX, and catalase.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
34.
BIOLOGIC FLUID SAMPLE ANALYSIS CARTRIDGE WITH NON-REFLECTIVE BEADS
A biological fluid sample analysis chamber and a method for analyzing a biological fluid sample is provided. The chamber includes a first chamber panel, a second chamber panel, and a plurality of beads disposed between the first chamber panel and the second chamber panel, which beads are configured to not reflect light incident to the beads in an amount that appreciably interferes with a photometric analysis of the biologic fluid.
The present invention relates to systems, devices and methods for the rapid in situ determination of the existence of a hook effect and expansion of the dynamic range of a point of care immunoassay. For example, a device for identifying a hook effect and expanding the dynamic range of an immunoassay is provided that may include a primary sensor having first immobilized antibodies that may be configured to generate a first signal based on a presence or absence of a target analyte in a sample. The device may further include an attenuated sensor having second immobilized antibodies at a reduced concentration relative to a concentration of the first immobilized antibodies on the primary sensor and that may be configured to generate a second signal based on the presence or absence of the target analyte in the sample. The device may further include a processor configured to determine a presence of a hook effect in the immunoassay based on relative values of the first and second signals and optionally determine the target analyte concentration of 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.
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, motion 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. More particularly, it allows to correct test results which are sensitive to fluidic artefacts such as blood cell sedimentation.
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.
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 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 device for volumetric metering a liquid biologic sample is provided. The device includes an initial chamber, a second chamber, a third chamber, a first valve, a second valve and a third valve. The chambers are each configured so that liquid sample disposed in the respective chamber is subject to capillary forces. Each chamber has a volume, and the volume of the initial chamber is greater than the volume of either the second or the third chambers. The valves each have a burst pressure. The burst pressure of the first valve is greater than the third burst pressure. The first valve is in fluid communication with the second chamber. The second valve is disposed between, and is in fluid communication with, the initial chamber and the third chamber. The third valve is in fluid communication with the third chamber.
A method and apparatus for identifying platelets within a whole blood sample. The method includes the steps of: a) adding at least one colorant to the whole blood sample, which colorant is operable to tag platelets; b) disposing the blood sample into a chamber defined by at least one transparent panel; c) imaging at least a portion of the sample quiescently residing within the chamber to create one or more images; and d) identifying one or more platelets within the sample using an analyzer adapted to identify the platelets based on quantitatively determinable features within the image using a analyzer, which quantitatively determinable features include intensity differences.
A method for analyzing a biologic fluid sample is provided. The method includes the steps of: a) disposing the biologic fluid sample within a chamber; b) imaging the biologic fluid sample at a first resolution, and producing first image signals representative of a low resolution image of the sample; c) analyzing the first image signals to identify one or more first characteristics of the sample, and determining a position of each first characteristic within the chamber using a map of the chamber; d) imaging a portion of the biologic fluid sample at a second resolution and producing second image signals, which portion of the sample is determined using the first characteristics and the map, and wherein the second resolution is greater than the first resolution; and e) analyzing the biologic fluid sample using the second image signals.
A biological fluid sample analysis cartridge (10) is provided that includes a collection port (28) and a body (30). The body has one or more internal channels (36, 38) in selective fluid communication with the collection port. The collection port includes a collection bowl (50), and a slide valve assembly (52) operable to be selectively positioned in an open position and a closed position. In the open position, the collection bowl (50) is accessible for sample deposition, and in the closed position the collection bowl (50) is inaccessible for sample deposition.
This invention relates to devices for performing optical and electrochemical assays and, more particularly, to testing devices having an optically readable microspot array and an electrochemical detector. The present invention is particularly useful for performing optical immunoassays and electrochemical assays at the point-of- care.
This invention relates generally to test devices and methods for performing optical and electrochemical assays and, more particularly, to test devices having the ability to perform optical and electrochemical assays on a sample and to methods of performing optical and electrochemical assays using such test devices. The present invention is particularly useful for performing immunoassays and/or electrochemical assays at the point-of-care.
This invention relates generally to devices and methods for performing optical and electrochemical assays and, more particularly, to devices having optical and electrochemical detectors and to methods of performing optical and electrochemical assays using such devices. The present invention is particularly useful for performing immunoassays and/or electrochemical assays at the point-of-care.
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.
A biological fluid sample analysis cartridge, analysis system, and method for analyzing a biologic fluid sample are provided. The cartridge includes a collection port, at least one channel within the cartridge in fluid communication with the collection port, a passage in fluid communication with the at least one channel, and an analysis chamber mounted on a tray. The tray is mounted relative to the cartridge and selectively positionable relative to the passage in a first position where the analysis chamber will engage a bolus of sample extending out from the passage to permit selective transfer of sample from the bolus to the analysis chamber.
Methods and devices for determining sensing device usability, e.g., for self-monitoring and point of care devices. In one embodiment, the invention is to a method of determining device usability, comprising the steps of providing a device comprising a first electrical pad; a second electrical pad; and a humidity-responsive polymer layer contacting at least a portion of the first and second electrical pads; applying a potential across the first and second electrical pads; measuring an electrical property associated with the humidity-responsive polymer layer; and determining whether the measured electrical property associated with the humidity-responsive polymer layer has exceeded a humidity threshold level associated with the device usability.
G01N 27/22 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating capacitance
Methods and devices for correcting sensing device signals, e.g., for point of care immunoassay devices. In one embodiment, the invention is to a method of correcting a signal in a sensing device, comprising the steps of: providing a sensing device comprising a sensor, a first electrical pad, a second electrical pad, and a continuous polymer layer contacting at least a portion of the first and second electrical pads; applying a potential across the first and second electrical pads; measuring an electrical property associated with the continuous polymer layer; determining a correction factor associated with the measured electrical property; and applying the correction factor to a signal generated by the sensor to produce a corrected signal.
Methods and devices for determining device usability, e.g., for point of care assay devices. In one embodiment, the invention is to a method of determining device usability in a sensing device, including the steps of: providing a device comprising a first electrical pad; a second electrical pad; and a first polymer layer contacting at least a portion of the first and the second electrical pads and a second polymer layer contacting the first polymer layer and not the first and second electrical pads; applying a potential across the first and the second electrical pads; measuring an electrical property associated with the first and the second polymer layers; and determining whether the measured electrical property associated with the first and the second polymer layers has exceeded a threshold level associated with the device usability.
Methods and devices for determining sensing device usability, e.g., for point of care immunoassay devices. In one embodiment, the invention is to a method of determining device usability, comprising the steps of providing a device comprising a first electrical pad; a second electrical pad; and a continuous polymer layer contacting at least a portion of the first and second electrical pads; applying a potential across the first and second electrical pads; measuring an electrical property associated with the continuous polymer layer; and determining whether the measured electrical property associated with the continuous polymer layer has exceeded a threshold level associated with the device usability.
The invention relates to low wash Thyroid Stimulating Hormone (TSH) immunoassays using an ELISA sandwich assay having limited or no wash step between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG).
The invention relates to antibody characteristics used to design a whole blood Point of Care Thyroid Stimulating Hormone (TSH) immunoassay using an ELISA sandwich assay lacking one or more wash steps between the antigen capture, detection antibody addition and substrate introduction steps. This invention exhibits low cross reactivity with biologically similar interfering cross reacting species, such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG).
The invention relates to Thyroid Stimulating Hormone (TSH) immunoassays using an ELISA sandwich assay that employs scavenging or sacrificial beads for reducing interference caused by cross-reacting endocrine glycoprotein hormone analogues such as Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH) and Chorionic Gonadotropin (CG).
S system and method for initiating and maintaining a secure wireless communication between a wireless analyzer (102) and a target network (108) (e.g. a hospital network connected to a LIS and/or HIS). The present disclosure provides novel processes and systems for securely networking a wireless analyze (102) with a Wi-Fi network (108) without the need for an operator or user to engage in manual initiation steps on, or through, the wireless analyzer (102).
A system and method for initiating and maintaining a secure wireless communication between a wireless analyzer (102) and a target network (108) (e.g., a hospital network connected to a LIS and/or HIS). The present disclosure provides novel processes and systems for securely networking a wireless analyzer (102) with a Wi-Fi network (108) without the need for an operator or user to engage in manual initiation steps on, or through, the wireless analyzer (102).
A method and apparatus for analyzing white blood cells (WBCs) within a whole blood sample quiescently residing within a chamber is provided. The chamber is defined by at least one transparent panel, and the whole blood sample includes at least one colorant operable to differentially identify at least one WBC type from another WBC type within the sample. The method includes the steps of: a) creating at least one image of the sample quiescently residing within the chamber; b) identifying portions of the sample image, with each portion representing a single WBC; c) compressing the sample image portions using a first compression algorithm; and d) one of compressing a remainder of the sample image not included in the portions using a second compression algorithm, or discarding the remainder.
The invention is directed to multi-fluidic cartridges for sample analysis and to methods of using said cartridges. In one embodiment, the cartridge comprises: (a) a first conduit beginning at a sample entry port for receiving a fluid sample and in fluid communication with one or more sensors; (b) a plurality of rupturable fluidic pouches, each containing a different fluid and in fluid communication with a respective delivery conduit configured for delivering a respective fluid to said first conduit; and (c) at least one pneumatic pump configured to move said fluid sample to said one or more sensors and for transporting at least one of said different fluids to said first conduit.
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.
A reader for mechanical actuation of fluids within a test cartridge. The instrument interface including multiple independently-controlled plungers aligned to respective fluidic pouches on a test cartridge that is inserted into a testing apparatus embodying the instrument interface. The plungers include tips for applying mechanical force to the respective fluidic pouches.
An apparatus and method for analyzing a biological fluid sample is provided. The method includes the steps of: a) providing an analysis cartridge having a channel and an analysis chamber, wherein the channel is in fluid communication with the analysis chamber and includes at least one hydrophobic interior wall surface; b) admixing one or more anti-adsorption agents with fluid sample disposed within the channel, wherein the anti-adsorption agents are operable to inhibit adsorption of fluid sample onto the interior wall surface of the channel; c) moving the fluid sample into the analysis chamber; and d) analyzing the sample within the analysis chamber.
In one embodiment, the invention is to a sample metering device, comprising a sample holding chamber oriented between a sample entry port and a sample isolation unit and having a diluent introduction port disposed therebetween for introduction of a diluent into the sample holding chamber. The volume within the sample holding chamber between the diluent introduction port and the sample isolation unit defines a metered volume of a sample for analysis. In another embodiment, the invention is to an apparatus and method for rapid determination of analytes in liquid samples by various assays including immunoassays incorporating a sample dilution feature, preferably suitable for low range sample dilution, and preferably capable of being used in the point-of-care diagnostic field.
In one embodiment, the invention is to a sample metering device, comprising a sample holding chamber oriented between a sample entry port and a sample extraction unit, wherein a portion of said extraction unit defines a metered volume of a sample. A diluent may be transported over and/or through the extraction unit to form a diluted sample for sample analysis. In another embodiment, the invention is to an apparatus and method for rapid determination of analytes in liquid samples by various assays including immunoassays incorporating a sample dilution feature, capable of being used in the point-of-care diagnostic field is provided. The devices and methods of the invention preferably are well-suited for high range sample dilution.
The invention is to devices and methods for rapid determination of analytes in liquid samples. The devices and methods incorporate a sample dilution feature and multiple immunosensors for performing a ratiometric immunoassay on a first analyte and a second analyte, for example, hemoglobin and hemoglobin A1c or albumin and glycosylated albumin. The devices are preferably capable of being used in the point-of-care diagnostic field.
The invention is to devices and method for rapid determination of analytes in liquid samples by various assays including immunoassays incorporating a sample dilution feature for forming a diluted sample for analysis. The devices and methods also include a dilution verification feature for verifying the degree of dilution of the diluted sample. The devices preferably are capable of being used in the point-of-care diagnostic field is provided.
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.
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.
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 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.
An apparatus and method for detecting the presence of anisotropic crystals within a biologic fluid sample is provided. The method includes the steps of: a) disposing the sample within a sample chamber in a sample layer having a height not greater than about fifteen microns (15μ); b) disposing the sample layer within the sample chamber between a polarizing filter and an analyzing filter; c) disposing the polarizing filter, sample chamber, and analyzing filter in a configuration relative to a light source such that polarized light passes through the sample, and subsequently impinges on the analyzing filter; and d) wherein polar orientations of the polarizing filter and the analyzing filter are such that the polarized light will not pass through the analyzing filter, and light passing through an anisotropic crystal disposed within the sample will pass through the analyzing filter and appear as a point of light.
Methods and devices for reducing interference from leukocytes in an analyte immunoassay are provided. In one embodiment, a method is provided comprising the steps of amending a biological sample with magnetic sacrificial beads opsonized to leukocytes, binding leukocytes in the sample to the magnetic sacrificial beads, and magnetically retaining the beads out of contact from an immunosensor.
Methods and devices for reducing interference from leukocytes in an analyte immunoassay are provided. In one embodiment, a method is provided comprising the steps of amending a biological sample such as a whole blood sample with one or more leukocidal reagents that reduce or eliminate the metabolic activity of leukocytes, and performing an immunoassay on the amended sample to determine the concentration of analyte in the sample. Preferably, the sample is amended with one or more enzymes and optionally one or more enzyme substrates and cofactors.
A biologic fluid sample analysis method and system is provided that includes a reagent depository, and analysis chamber, a biologic fluid transfer system, and a programmable analyzer. The reagent depository has a plurality of reagent deposits, and each reagent deposit located at a position within the depository independent of the other reagent deposits. The analysis chamber is adapted to quiescently hold a biologic fluid sample and one or more reagents during analysis. The biologic fluid transfer system has at least one fluid transfer device. The programmable analyzer is adapted to control the biologic fluid transfer system to acquire a volume of sample from a sample reservoir, dispense a volume of the sample into the reagent depository, acquire a volume of sample and reagent from the reagent depository, and to transfer the sample and reagent to the analysis chamber, and to analyze the combined sample and reagent.
G01N 35/02 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
An apparatus for and method of analyzing a biologic fluid sample is provided. The method includes the steps of: a) providing a sample cartridge having at least one channel for fluid sample passage; b) providing an analysis device having imaging hardware, a programmable analyzer, and a sample motion system, which sample motion system includes a bidirectional fluid actuator operable to selectively move a bolus of sample axially within the channel, and to cycle the bolus back and forth within the channel; and c) cycling the bolus of sample disposed within the channel at a predetermined frequency until constituents within the sample are substantially uniformly distributed, using the bidirectional fluid actuator.
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
G01N 35/08 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor using a stream of discrete samples flowing along a tube system, e.g. flow injection analysis
A01N 35/00 - Biocides, pest repellants or attractants, or plant growth regulators containing organic compounds containing a carbon atom having two bonds to hetero atoms with at the most one bond to halogen, e.g. aldehyde radical
80.
METHOD AND APPARATUS FOR OPTICALLY DETERMINING AT LEAST ONE HEMOGLOBIN RELATED PARAMETER OF A WHOLE BLOOD SAMPLE
A method and apparatus for determining at least one hemoglobin related parameter of a whole blood sample is provided. The method includes the steps of: a) depositing the sample into an analysis chamber adapted to quiescently hold the sample for analysis, the chamber defined by an interior surface of a first panel, and an interior surface of a second panel, and the chamber has a height extending between the interior surfaces of the panels, wherein the chamber is configured to increase the oxygenation state of the sample to a substantially oxygenated state within a predetermined amount of time after entry into the chamber; b) imaging the at least one red blood cell contacting the interior surfaces, and producing image signals; c) determining an optical density of at least a portion of the imaged red blood cell contacting both interior surfaces; and d) determining the at least one hemoglobin related parameter of the red blood cell contacting the interior surfaces, using the determined optical density and a molar extinction coefficient for oxygenated hemoglobin.
An apparatus and method for imaging a biologic fluid sample quiescently residing within a chamber is provided. The chamber (20) includes a first panel (38) and a second panel (40), between which the biologic fluid sample quiescently resides. At least one of the first and second panels is flexible. The chamber has one or more fields that are each defined by a cross - sectional area. The apparatus comprises a field illuminator, a chamber flattener (27), a positioner, and an image dissector. The field illuminator has an objective lens. The chamber flattener has a platen (54) with a window (60) and a cover plate. The chamber flattener is operable to cause the chamber to assume a substantially uniform Z-axis position for substantially all of the fields within the chamber. The positioner is adapted to position the objective lens and the chamber relative to one another. The image dissector is adapted to image the sample residing within the chamber.
A method and apparatus for imaging a biologic fluid sample quiescently residing within a chamber is provided. The method includes the steps of: a) positioning the chamber at a Z-axis position relative to an objective lens having a lens axis, wherein the Z-axis is parallel to the lens axis; b) moving one or both of the chamber and the objective lens relative to one another at a velocity along the Z-axis; and c) creating one or more images of the biologic fluid sample as one or both of the chamber and the objective lens are moving at a velocity relative to one another within a focus search range along the Z-axis.
A method and apparatus for determining a cell volume of a red blood cell is provided. The method includes the steps of: a) depositing a sample into an analysis chamber, the chamber defined by an first panel interior surface, a second panel interior surface, and a known or determinable height, which height is such that at least one red blood cell subject to a sphering agent assumes a partially compressed spherical shape in contact with the interior surfaces; b) imaging the at least one partially compressed spherical red blood cell contacting the interior surfaces, and producing image signals; c) determining a radius of the partially compressed spherical red blood cell from the image signals; and d) determining a volume of the imaged red blood cell using the determined radius.
The invention relates to a cartridge housing for forming a cartridge capable of measuring an analyte or property of a liquid sample. The housing comprising a first substantially rigid zone, a second substantially flexible zone, a hinge region, and at least one sensor recess containing a sensor. The housing is foldable about said hinge region to form a cartridge having a conduit over at least a portion of said sensor. The invention also relates to methods for forming such cartridges and to various features of such cartridges.
A biological fluid sample analysis cartridge is provided. The cartridge includes a housing, a fluid module, and an analysis chamber. The fluid module includes a sample acquisition port and an initial channel, and is connected to the housing. The initial channel is sized to draw fluid sample by capillary force, and is in fluid communication with the acquisition port. The initial channel is fixedly positioned relative to the acquisition port such that at least a portion of a fluid sample disposed within the acquisition port will draw into the initial channel. The analysis chamber is connected to the housing, and is in fluid communication with the initial channel.
The invention is directed to methods and devices for reducing interference from leukocytes in an analyte immunoassay, and in particular in non-competitive immunoassays. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with sacrificial beads; and (b) performing a non-competitive immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG-coated sacrificial beads.
The invention is directed to methods and devices for reducing interference from leukocytes in an competitive analyte immunoassays. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with sacrificial beads opsonized for leukocytes; and (b) performing a competitive immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG-coated sacrificial beads.
A method for performing a target analyte assay of a thin film anticoagulated blood sample, wherein the target analyte is the presence or absence of specific phagocytosis and/or binding of particles coated with a particular antigen or antigens by white blood cells present in the anticoagulated blood sample, wherein the particles are coated with the particular antigen or antigens, which antigens are similar or identical to antigens expressed by a defined pathogenic infectious agent of interest.
C12Q 1/04 - Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
G01N 33/543 - Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
G01N 33/569 - Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
A biologic fluid sample transfer device (10) and method is provided. The device includes an outer casing (12) and a lance (14). The outer casing has a tip (18) with an exterior surface and a bore (26) extending lengthwise through the tip and out to the exterior surface of the tip to form an aperture (30) in the exterior surface. The lance has a length extending between an operating end (32) and a sample end (34). The lance includes a seal segment (38) contiguous with the sample end. The seal segment extends a distance lengthwise and has a constant cross-sectional geometry. The transfer device is selectively disposable in an empty volume position and a sample volume position by relative lengthwise movement between the outer casing and the lance. In the empty volume position, the sample end extends outside of the- aperture. In the sample volume position, the sample end of the lance is disposed within the bore a distance away from the aperture. The seal segment of the lance forms an interference fit with the bore, which interference fit is operable to create a seal between the seal segment and the bore.
The invention is directed to methods and devices for reducing interference from heterophile antibodies in an analyte immunoassay. In one embodiment, the invention is to a method comprising the steps of (a) amending a biological sample such as a whole blood sample with non-human IgM or fragments thereof by dissolving into said sample a dry reagent to yield a non-human IgM concentration of at least about 20 µg/mL or equivalent fragment concentration; and (b) performing an electrochemical immunoassay on the amended sample to determine the concentration of said analyte in said sample. Preferably, the sample is amended with IgG or fragments thereof in addition to the IgM of fragments thereof.
A composition of matter for use in an immunoassay devices and method comprising a signal antibody, e.g., FAB fragment, covalently linked to a first nucleotide; and one or more signal elements, e.g., signal enzymes such as ALP or fluorescent dyes, each covalently linked to a second nucleotide, wherein the first nucleotide has one or more repeated sequences, and the second nucleotide is bound to one of the one or more repeated sequences on said first nucleotide, and wherein the ratio of the signal antibody to the signal element is controlled by the number of repeated sequences.
The invention is directed to fluid-containing pouches and to methods for forming fluid-containing pouches. In one embodiment, the invention is to a fluid-containing pouch, comprising first and second opposing sheets, and a fluid (e.g., a calibrant fluid, a reactant fluid or a wash fluid) disposed between the first and second opposing sheets. The first sheet and the second sheet have a substantially liquid and gas impermeable perimeter seal. The sheets may be sealed, for example, by one or more of heat crimping, pressure crimping, heat and pressure crimping, ultrasonic welding, metal-to-metal welding or laser welding. Fluid-containing pouches sealed according to the disclosed methods and apparatuses show substantially improvement in terms of reduced gas exchange, notably CO2 pressurization levels.
B29C 65/18 - Joining of preformed parts; Apparatus therefor by heating, with or without pressure using heated tool
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
B65B 51/22 - Applying or generating heat or pressure or combinations thereof by friction or ultrasonic or high-frequency electrical means
B65B 9/04 - Enclosing successive articles, or quantities of material, between opposed webs one or both webs being formed with pockets for the reception of the articles, or of the quantities of material
B65B 51/14 - Applying or generating heat or pressure or combinations thereof by reciprocating or oscillating members
B65D 75/32 - Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
93.
METHOD OF DETECTING VERY LOW LEVELS OF ANALYTE WITHIN A THIN FILM FLUID SAMPLE CONTAINED IN A THIN THICKNESS CHAMBER
A method and apparatus for the detection and quantification of very low levels of a target analyte using an imaging system is provided. In the case of some analytes such as certain hormones, for example TSH, their levels may be as low as several tens of thousands of molecules per micro liter. These extremely low levels can be measured by using the present invention to count the individual molecules of analyte. The invention also has the advantage of being a primary quantitative method, which is one which needs no standardization.
A method for determining the area of an analysis chamber covered by a biologic fluid sample quiescently residing within the chamber is provided. The chamber has a first panel with an interior surface, and a second panel with an interior surface, both of which panels are transparent. The method includes the steps of: a) illuminating the sample residing within the analysis chamber at one or more wavelengths operable to highlight interfaces between the sample and air, and to highlight a constituent within the sample; b) imaging the sample along the one or more wavelengths, and producing image signals representative of the interaction of the one or more wavelengths with the sample; c) determining a location of at least one interface between the sample and air, using the image signals; d) determining a location of one or more constituents within the sample relative to the at least one sample-air interface using the image signals; and e) determining an area of the chamber containing the sample, using the location of the one or more constituents and the at least one sample-air interface.
Detection and characterization of immunologically detected substances are performed electronically on human and animal biological fluids such as whole blood, serum, plasma, urine, milk, pleural and peritoneal fluids, and semen, which fluids are contained in a thin chamber forming a quiescent fluid sample, which chamber has at least two parallel planar walls, at least one of which is transparent.
A method and apparatus for measuring antibody titers in a thin film sample in an automated system which does not require multiple dilutions. The system provides a simple method for creating an in-situ dilution within a sample analysis chamber without the use of any precision fluid-handling components, and further, to use the same principles to provide a wide range of sample dilutions within the chamber so as to obviate the need for additional dilution steps when dealing with samples possibly containing wide ranges of analyte concentrations.
A method and system for performing a serological agglutination assay in a liquid sample. The system provides a simple method for creating an in-situ sample/reagent admixture within a sample analysis chamber without the use of any precision fluid-handling components.
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
98.
METHOD AND APPARATUS FOR DETERMINING THE HEMATOCRIT OF A BLOOD SAMPLE UTILIZING THE INTRINSIC PIGMENTATION OF HEMOGLOBIN CONTAINED WITHIN THE RED BLOOD CELLS
A method for determining the hematocrit of a blood sample is provided that includes the steps of : 1) depositing the sample into an analysis chamber (10) adapted to quiescently hold the sample for analysis, the chamber defined by the interior surfaces (14, 18) of first and second panels (12, 16) and a height (20) extending there between, wherein both panels are transparent, and the height is such that at least some of the red blood cells (22) within the sample contact both interior surfaces of the panels and one or more lacunae (24) within the quiescent sample extend between the interior surfaces; 2) imaging at least a portion of the quiescent sample, which sample portion contains the red blood cells and one or more lacunae to determine an optical density of the imaged portion of the sample on a per image unit basis; 3) selecting and averaging the optical density values of the image units aligned with the red blood cells contacting the interior surfaces, and assigning an upper boundary value of 100% to the average optical density value of those image units; 4) selecting the optical density values of the image units aligned with the one or more lacunae, and assigning a lower boundary value of 0% to the optical density values of those image units; and 5) determining the hematocrit of the sample by assigning relative values to the optical density value of each image of the imaged sample portion as a function of the upper and lower boundary values, and averaging the relative values.
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
99.
METHOD AND APPARATUS FOR DETERMINING RED BLOOD CELL INDICES OF A BLOOD SAMPLE UTILIZING THE INTRINSIC PIGMENTATION OF HEMOGLOBIN CONTAINED WITHIN THE RED BLOOD CELLS
Method and apparatus for determining the concentration of haemoglobin within red blood cells. An undiluted, whole blood sample is deposited into a transparent analysis chamber (10) whose height is such that the red blood cells are in contact with both surfaces (14, 18). Then the optical density of a portion of the red blood cells in contact with both' surf aces is measured. The haemoglobin concentration of the red blood cell is calculated from the optical density and the known distinction coefficient of haemoglobin. This is repeated with other cells until an average haemoglobin concentration can be determined with confidence. Dependent claims include use of zwitterionic isovolumetric sphering agent make the measurement independent of a geometrical form factor.
A method and apparatus for focusing a device for imaging a biologic sample is provided. A method aspect of the disclosure includes the steps of: 1) disposing lenslets within a field of a biologic sample, which lenslets have a height, and have a refractive index and which refractive index is different from that of the sample, wherein one or both of the imaging device and the sample are relatively locatable so a focal position of the imaging device can be moved along the height of the lenslets; 2) imaging at least a portion of the sample including a plurality of lenslets using transmittance at one or more predetermined wavelengths; 3) determining an average light transmittance intensity of the sample at the wavelengths; 4) determining an average light transmittance intensity of a region of each lenslet at the wavelengths; and 5) determining the focal position of the imaging device using the average light transmittance intensity of the sample and the average light transmittance intensity of the region of the lenslets.
patents
