Methods and devices are provided for sample collection. In one example, a device is provided comprising at least one capillary tube or collection channel directed to a sample vessel, wherein in a one-step removal step of detaching the sample vessel from the collection channel, a vacuum force is created within the sample vessel, due in part of the pulling of the sealed vessel away from the device, wherein this vacuum force draw out residual sample that may still be resident in the collection channel.
Systems, methods, and devices are provided for clinical laboratory testing using less than 1 mL of sample collected from a subject. Some embodiments collect between 1 mL and about 10 uL of sample from a subject. A method is also provided for analyte testing, wherein a mobile computing device may be used for laboratory test requests and for handling of the analyte testing process.
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
G06Q 10/06 - Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
3.
METHODS, SYSTEMS, AND DEVICES FOR REAL TIME EXECUTION AND OPTIMIZATION OF CONCURRENT TEST PROTOCOLS ON A SINGLE DEVICE
Provided herein are medical testing devices, systems, and methods that integrate multiplex, multi-technology, multi-configuration, multisample, or multi-threading capabilities. These capabilities are achieved using one or more of a level operations and communications architecture, a protocol exection engine, and a machine vision and processing system, method, or device in order to make testing of biologic or other samples more efficient in terms of cost, time, energy, or by prioritizing at least one other objective.
G06F 9/48 - Program initiating; Program switching, e.g. by interrupt
G06F 15/16 - Combinations of two or more digital computers each having at least an arithmetic unit, a program unit and a register, e.g. for a simultaneous processing of several programs
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
H04L 67/10 - Protocols in which an application is distributed across nodes in the network
H04L 67/12 - Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks
4.
MODULAR POINT-OF-CARE DEVICES, SYSTEMS, AND USES THEREOF
The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
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
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
G01N 1/38 - Diluting, dispersing or mixing samples
G01N 33/569 - Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
The present invention provides systems, devices, and methods for point-of-care and/or distributed testing services. The methods and devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device can be modified to allow for more flexible and robust use with the disclosed methods for a variety of medical, laboratory, and other applications. The systems, devices, and methods of the present invention can allow for effective use of samples by improved sample preparation and analysis.
G01N 33/543 - Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
G01N 21/51 - Scattering, i.e. diffuse reflection within a body or fluid inside a container, e.g. in an ampoule
C12Q 1/42 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving phosphatase
C12Q 1/48 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving transferase
C12Q 1/6809 - Methods for determination or identification of nucleic acids involving differential detection
C12Q 1/689 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for bacteria
G01N 33/569 - Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
G01N 33/573 - Immunoassay; Biospecific binding assay; Materials therefor for enzymes or isoenzymes
G01N 33/74 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones
G01N 33/80 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood groups or blood types
G06T 3/40 - Scaling of a whole image or part thereof
A composition is described comprising superparamagnetic particles. Optionally, the particles comprise microbeads. Optionally, the particles comprise nanobeads. Optionally, the particles are non-spherical particles. Optionally, the particles are non-spherical particles suitable for RNA or DNA extraction. A method is described for forming microparticles. Optionally, the method comprises using citrate precipitation. Optionally, a kit comprising one or more of the particles is described. Optionally, a kit for sample preparation for nucleic acid extraction is described comprising non-spherical microparticles or nanoparticles.
This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications. In particular, the medical device reduces interference with an optical signal which is indicative of the presence of an analyte in a bodily sample.
The present invention provides system and methods for detecting an analyte indicative of an influenza viral infection in a sample of bodily fluid. The present invention also provides for systems and method for detection a plurality of analytes, at least two of which are indicative of an influenza viral infection in a sample of bodily fluid.
G01N 33/569 - Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
G01N 33/543 - Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.
Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.
Compositions and methods for measuring coagulation parameters using very small volumes of blood are provided. Advantageously, the methods described herein can be performed from a single drop of blood (about 20 μL) while generally leaving enough sample to perform other measurements, optionally in a multiplexed format. The methods and devices do not require a skilled operator and can be performed at the point of service, which can be an important feature for managing blood coagulation disorders and treatments thereof.
Methods for obtaining a sample from a subject include providing a sample collection room within a retail store; and obtaining a sample from a subject at a retail location. Sample collection rooms may house a sample analysis device or system. Samples may be small, e.g., a finger-stick capillary blood sample.
Assays for rapid measurement of total vitamin D in blood are provided. Vitamin D is measured following the rapid and irreversible release of vitamin D due to denaturation and digestion of vitamin D binding proteins by aspartyl peptidases (e.g., pepsin) under acidic conditions. Such measurements may be made using a vitamin D binder (e.g., an antibody) to measure competition between free vitamin D and added, labeled vitamin D. Synergy between denaturation and degradation is believed to provide more rapid and more complete release of vitamin D than would occur with acid or enzyme alone.
Assays for rapid measurement of total vitamin D in blood are provided. Vitamin D is measured following the rapid and irreversible release of vitamin D due to denaturation and digestion of vitamin D binding proteins by aspartyl peptidases (e.g., pepsin) under acidic conditions. Such measurements may be made using a vitamin D binder (e.g., an antibody) to measure competition between free vitamin D and added, labeled vitamin D. Synergy between denaturation and degradation is believed to provide more rapid and more complete release of vitamin D than would occur with acid or enzyme alone.
These measurements may be made using small amounts of whole blood, serum, or plasma, and are suitable for use in automated devices. These methods provide the advantages of reduced cost, increased speed, reduced discomfort to the subject, and increased availability and ease of use. Reagents, kits, devices, and systems for these assays are also disclosed.
The present invention provides an integrated health care surveillance and monitoring system that provides real-time sampling, modeling, analysis, and recommended interventions. The system can be used to monitor infectious and chronic diseases. When faced with outbreak of an infectious disease agent, e.g., influenza virus, the system can identify active cases through pro-active sampling in high risk locations, such as schools or crowded commercial areas. The system can notify appropriate entities, e.g., local, regional and national governments, when an event is detected, thereby allowing for proactive management of a possible outbreak. The system also predicts the best response for deployment of scarce resources.
G16H 50/50 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders
G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
G16H 50/80 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for detecting, monitoring or modelling epidemics or pandemics, e.g. flu
G16Z 99/00 - Subject matter not provided for in other main groups of this subclass
15.
Methods and apparatus for improved sample visualization
Methods and devices are provided for use with a biological sample, wherein in one example, the device comprising a sample holder and an excitation source for providing excitation energy into the light conduit towards the sample holder. In one embodiment, the device comprises an imaging cytometer. Optionally, the device comprises a flow cytometer. Optionally, a light conduit comprises an optical fiber. Optionally, the optical fiber has an outer cross-sectional shape different from an inner optical core cross-sectional shape.
In one embodiment described herein, a cartridge is provided comprising a cartridge frame; a plurality of diluents each in an expandable container; a plurality of reagents each in an expandable container; and a plurality of mixing vessels comprising empty expandable containers.
Devices, systems and methods including a sonicator for sample preparation are provided. A sonicator may be used to mix, resuspend, aerosolize, disperse, disintegrate, or de-gas a solution. A sonicator may be used to disrupt a cell, such as a pathogen cell in a sample. Sample preparation may include exposing pathogen-identifying material by sonication to detect, identify, or measure pathogens. A sonicator may transfer ultrasonic energy to the sample solution by contacting its tip to an exterior wall of a vessel containing the sample. Multipurpose devices including a sonicator also include further components for additional actions and assays. Devices, and systems comprising such devices, may communicate with a laboratory or other devices in a system for sample assay and analysis. Methods utilizing such devices and systems are provided. The improved sample preparation devices, systems and methods are useful for analyzing samples, e.g. for diagnosing patients suffering from infection by pathogens.
C12Q 1/04 - Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor
B01F 11/02 - Mixing by means of ultrasonic vibrations
A composition is described comprising superparamagnetic particles. Optionally, the particles comprise microbeads. Optionally, the particles comprise nanobeads. Optionally, the particles are non-spherical particles. Optionally, the particles are non-spherical particles suitable for RNA or DNA extraction. A method is described for forming microparticles. Optionally, the method comprises using citrate precipitation. Optionally, a kit comprising one or more of the particles is described. Optionally, a kit for sample preparation for nucleic acid extraction is described comprising non-spherical microparticles or nanoparticles.
Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
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
G01N 35/04 - 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 - Details of the conveyor system
G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
B01L 7/00 - Heating or cooling apparatus; Heat insulating devices
C12Q 1/6883 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
G01N 33/569 - Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
G01N 33/80 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood groups or blood types
G01N 21/25 - Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
G01N 33/543 - Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
G01N 21/27 - Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection
C12Q 1/42 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving phosphatase
C12Q 1/52 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving transferase involving transaminase
G01N 33/62 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving urea
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 33/92 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving lipids, e.g. cholesterol
20.
DEVICES FOR SAMPLE COLLECTION AND SAMPLE SEPARATION
Methods and devices are provided for sample collection and sample separation. In one embodiment, a device is provided for use with a formed component liquid sample, the device comprising at least one sample inlet for receiving said sample; at least a first outlet for outputting only a liquid portion of the formed component liquid sample; at least a second outlet for outputting the formed component liquid sample at least a first material mixed therein.
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
A61J 1/05 - Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids
In one embodiment, a method is provided comprising displaying a laboratory test menu on a mobile computing device, where the test menu is variable-based on geographic location; selecting one or more tests from said test menu; and using the mobile computing device to send a laboratory test request to a server.
G16H 40/20 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT 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
G06Q 30/06 - Buying, selling or leasing transactions
Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.
Devices, methods and systems are provided for reducing the sample volume required for analysis. Inserts placed within a sample container, and substitute sample containers having smaller volume sample chambers are provided. Methods are provided for detection and quantification of target substances in reduced volume samples. Methods include placing a small-volume of sample in a small-volume insert. Methods include diluting a small-volume sample, and placing the diluted sample in a small-volume insert. Methods include reducing the volume of sample, and: increasing illumination; increasing dye concentration or amount; increasing the amount of an enzyme substrate; increasing the amounts, concentration, or labeling of antibodies for detection; increasing optical detector sensitivity; increasing the path length of light passing through the sample; decreasing the separation between sample and detector; altering the wavelength, or polarization, or number of wavelengths, passing through the sample; increasing electronic amplification of electrical signals; altering assay temperature; and other alterations.
G01N 21/27 - Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection
Methods and compositions for the amplification of nucleic acids and generation of concatemers are disclosed. Amplification methods provided herein may be performed under isothermal conditions. Methods and compositions may include reagents such as nucleic acid polymerases and primers.
In one nonlimiting example, an automated system is provided for separating one or more components in a biological fluid, wherein the system comprises: (a) a centrifuge comprising one or more bucket configured to receive a container to effect said separating of one or more components in a fluid sample; and (b) the container, wherein the container includes one or more shaped feature that is complementary to a shaped feature of the bucket.
G01D 5/14 - Mechanical means for transferring the output of a sensing member; Means for converting the output of a sensing member to another variable where the form or nature of the sensing member does not constrain the means for converting; Transducers not specially adapted for a specific variable using electric or magnetic means influencing the magnitude of a current or voltage
B04B 15/02 - Other accessories for centrifuges for cooling, heating, or heat insulating
G01P 3/488 - Devices characterised by the use of electric or magnetic means for measuring angular speed by measuring frequency of generated current or voltage of pulse signals delivered by variable reluctance detectors
G01D 5/347 - Mechanical means for transferring the output of a sensing member; Means for converting the output of a sensing member to another variable where the form or nature of the sensing member does not constrain the means for converting; Transducers not specially adapted for a specific variable using optical means, i.e. using infrared, visible or ultraviolet light with attenuation or whole or partial obturation of beams of light the beams of light being detected by photocells using displacement encoding scales
Assays for rapid measurement of total vitamin D in blood are provided. Vitamin D is measured following the rapid and irreversible release of vitamin D due to denaturation and digestion of vitamin D binding proteins by aspartyl peptidases (e.g., pepsin) under acidic conditions. Such measurements may be made using a vitamin D binder (e.g., an antibody) to measure competition between free vitamin D and added, labeled vitamin D. Synergy between denaturation and degradation is believed to provide more rapid and more complete release of vitamin D than would occur with acid or enzyme alone.
G01N 31/00 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroups; Apparatus specially adapted for such methods
Methods for obtaining a sample from a subject include providing a sample collection room within a retail store; and obtaining a sample from a subject at a retail location. Sample collection rooms may house a sample analysis device or system. Samples may be small, e.g., a finger-stick capillary blood sample.
Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.
C12Q 1/689 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for bacteria
C12Q 1/04 - Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor
The present invention provides systems, devices, and methods for point-of-care and/or distributed testing services. The methods and devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device can be modified to allow for more flexible and robust use with the disclosed methods for a variety of medical, laboratory, and other applications. The systems, devices, and methods of the present invention can allow for effective use of samples by improved sample preparation and analysis.
C12Q 1/42 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving phosphatase
C12Q 1/48 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving transferase
C12Q 1/6809 - Methods for determination or identification of nucleic acids involving differential detection
C12Q 1/689 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for bacteria
G01N 33/569 - Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
G01N 33/573 - Immunoassay; Biospecific binding assay; Materials therefor for enzymes or isoenzymes
G01N 33/74 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones
G01N 33/80 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood groups or blood types
G06T 3/40 - Scaling of a whole image or part thereof
Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample container for receiving the bodily fluid sample collected in the sample collection channel, the sample container operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the container provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the container.
G01N 1/10 - Devices for withdrawing samples in the liquid or fluent state
A61B 10/00 - Other methods or instruments for diagnosis, e.g. for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
A61B 5/154 - Devices for taking samples of blood specially adapted for taking samples of venous or arterial blood, e.g. by syringes using pre-evacuated means
A61B 5/151 - Devices for taking samples of blood specially adapted for taking samples of capillary blood, e.g. by lancets
A61B 5/155 - Devices for taking samples of blood specially adapted for continuous or multiple sampling, e.g. at predetermined intervals
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
G01N 1/14 - Suction devices, e.g. pumps; Ejector devices
32.
MODULAR POINT-OF-CARE DEVICES, SYSTEMS, AND USES THEREOF
The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.
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 glassware; Droppers
G01N 33/543 - Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
G01N 33/574 - Immunoassay; Biospecific binding assay; Materials therefor for cancer
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
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
G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
B01L 7/00 - Heating or cooling apparatus; Heat insulating devices
G02B 7/09 - Mountings, adjusting means, or light-tight connections, for optical elements for lenses with mechanism for focusing or varying magnification adapted for automatic focusing or varying magnification
G01N 33/487 - Physical analysis of biological material of liquid biological material
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
G01N 21/27 - Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection
G02B 21/16 - Microscopes adapted for ultraviolet illumination
G02B 21/36 - Microscopes arranged for photographic purposes or projection purposes
Improved methods for amplifying target nucleic acid sequences are provided by 1) first amplifying the number of copies of target nucleic acid sequences in a sample by a first nucleic acid amplification method, and then 2) applying a second nucleic amplification method to the amplified sample, or aliquot thereof, further amplifying the number of copies of target sequences. In embodiments, a first nucleic acid amplification method is a thermocycling method, and a second nucleic acid amplification method is an isothermal method.
Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample container for receiving the bodily fluid sample collected in the sample collection channel, the sample container operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the container provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the container.
A61B 5/157 - Devices for taking samples of blood characterised by integrated means for measuring characteristics of blood
A61B 10/00 - Other methods or instruments for diagnosis, e.g. for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
A61B 5/151 - Devices for taking samples of blood specially adapted for taking samples of capillary blood, e.g. by lancets
A61B 5/154 - Devices for taking samples of blood specially adapted for taking samples of venous or arterial blood, e.g. by syringes using pre-evacuated means
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
36.
Systems and methods for analyte testing and laboratory oversight
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
G01N 33/569 - Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
B01L 7/00 - Heating or cooling apparatus; Heat insulating devices
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
37.
UNIFIED DETECTION SYSTEM FOR FLUOROMETRY, LUMINOMETRY AND SPECTROMETRY
The devices and systems disclosed herein provide multiple optical capabilities in a single device or system. Methods for using these devices and systems are provided. These devices and systems are configurable for operation in each of a spectroscopy mode, a fluorescence mode, and a luminescence mode, and are capable of performing spectroscopic, fluorescence, and luminescence observations, measurements, and analyses when operated in the corresponding spectroscopy mode, fluorescence mode, or luminescence mode. These devices and systems include mirror dispersion elements having multiple faces including an optical dispersion element on one face (e.g., a diffraction grating or a prism) and a reflective element on another face (e.g., a mirror). These multiple capabilities eliminate the need to move or load a sample in multiple devices when subjecting a sample to multiple analyses, and thus provide greater accuracy, precision, and speed while reducing complexity and cost of sample analysis.
Methods and devices for cytometric analysis are provided. A cytometry apparatus is provided which may be used with a stationary sample cuvette for analysis of a stationary sample or with a flow sample cuvette for analysis of a flowing sample. The methods and devices provided herein may be used to perform cytometric analysis of samples under a wide range of experimental and environmental conditions.
Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.
G01N 15/00 - Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
G01N 21/00 - Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
G01N 35/04 - 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 - Details of the conveyor system
In one embodiment, a femtowatt sensitivity optical detector is provided using one or more photodiodes, intended as a replacement for the photomultiplier based photon counting unit.
H03F 3/08 - Amplifiers with only discharge tubes or only semiconductor devices as amplifying elements with semiconductor devices only controlled by light
H03M 1/06 - Continuously compensating for, or preventing, undesired influence of physical parameters
In one embodiment, a method is provided comprising displaying a laboratory test menu on a mobile computing device, where the test menu is variable-based on geographic location; selecting one or more tests from said test menu; and using the mobile computing device to send a laboratory test request to a server.
G16H 40/20 - ICT specially adapted for the management or administration of healthcare resources or facilities; ICT 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
G06Q 30/06 - Buying, selling or leasing transactions
Methods, devices, systems and kits for obtaining blood samples are provided. Devices include a cuff, a pressure source, and a timing mechanism. Devices may further include one or more of a: warming mechanism, lancing mechanism; automated sample collection device, automated sample analysis device, and communication unit. Systems include such a device, and may include sample collection, sample analysis, or communication devices.
Methods, devices, systems and kits for obtaining blood samples are provided. Devices include a cuff, a pressure source, and a timing mechanism. Devices may further include one or more of a: warming mechanism, lancing mechanism; automated sample collection device, automated sample analysis device, and communication unit. Systems include such a device, and may include sample collection, sample analysis, or communication devices.
Methods include placing a cuff on a digit of a subject, inflating the cuff, and obtaining a small volume blood sample. Methods may further include warming a digit; lancing a digit; pulsing the cuff; and providing a signal indicating the end of the sample collection time period.
Methods, devices, systems and kits for obtaining blood samples are provided. Devices include a cuff, a pressure source, and a timing mechanism. Devices may further include one or more of a: warming mechanism, lancing mechanism; automated sample collection device, automated sample analysis device, and communication unit. Systems include such a device, and may include sample collection, sample analysis, or communication devices.
Methods include placing a cuff on a digit of a subject, inflating the cuff, and obtaining a small volume blood sample. Methods may further include warming a digit; lancing a digit; pulsing the cuff; and providing a signal indicating the end of the sample collection time period.
Kits may include a device, a sample collection vessel, and may include a disposable for use in sample collection.
Methods, devices, systems and kits for obtaining blood samples are provided. Devices include a cuff, a pressure source, and a timing mechanism. Devices may further include one or more of a: warming mechanism, lancing mechanism; automated sample collection device, automated sample analysis device, and communication unit. Systems include such a device, and may include sample collection, sample analysis, or communication devices.
Methods include placing a cuff on a digit of a subject, inflating the cuff, and obtaining a small volume blood sample. Methods may further include warming a digit; lancing a digit; pulsing the cuff; and providing a signal indicating the end of the sample collection time period.
Kits may include a device, a sample collection vessel, and may include a disposable for use in sample collection.
These methods, devices, systems and kits for obtaining blood samples may be used to easily, reliably, and consistently obtain blood samples from subjects.
Methods and compositions for the amplification of nucleic acids and generation of concatemers are disclosed. Amplification methods provided herein may be performed under isothermal conditions. Methods and compositions may include reagents such nucleic acid polymerases and primers.
Devices, systems and methods for optical analysis of cells in microgravity are disclosed.
Devices, systems and methods for optical analysis of cells in microgravity are disclosed.
Effective cellular microscopic and image analysis requires placement of cells into a proper focal plane, region, or volume. Such placement often requires immobilization of the cells. Cell settling onto a substrate is often sufficient for cell immobilization; however, no significant settling occurs in microgravity. Cell immobilization in microgravity may be accomplished by treatment of a substrate, the cells, or both effective that the substrate captures and immobilizes the cells for inspection. Cells may be immobilized in microgravity by adhering magnetic particles to the cells and applying a magnetic field. Cells may be placed in a proper location for viewing in microgravity by placing the cells into a small chamber or narrow channel. Centrifugal force may effect cell settling and aid cell immobilization. Proper placement or immobilization of cells aids cellular microscopic and image analysis in microgravity.
Improved methods for amplifying target nucleic acid sequences are provided by 1) first amplifying the number of copies of target nucleic acid sequences in a sample by a first nucleic acid amplification method, and then 2) applying a second nucleic amplification method to the amplified sample, or aliquot thereof, further amplifying the number of copies of target sequences. In embodiments, a first nucleic acid amplification method is a thermocycling method, and a second nucleic acid amplification method is an isothermal method.
Methods and devices are provided for sample collection. In one example, a device is provided comprising at least one capillary tube or collection channel directed to a sample vessel, wherein in a one-step removal step of detaching the sample vessel from the collection channel, a vacuum force is created within the sample vessel, due in part of the pulling of the sealed vessel away from the device, wherein this vacuum force draw out residual sample that may still be resident in the collection channel.
Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
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
G01N 35/04 - 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 - Details of the conveyor system
G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
B01L 7/00 - Heating or cooling apparatus; Heat insulating devices
C12Q 1/6883 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
G01N 33/569 - Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
G01N 33/80 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood groups or blood types
G01N 21/25 - Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
G01N 33/543 - Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
G01N 21/27 - Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection
C12Q 1/42 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving phosphatase
C12Q 1/52 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving transferase involving transaminase
G01N 33/62 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving urea
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 33/92 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving lipids, e.g. cholesterol
48.
Image analysis and measurement of biological samples
Methods, devices, apparatus, and systems are provided for image analysis. Methods of image analysis may include observation, measurement, and analysis of images of biological and other samples; devices, apparatus, and systems provided herein are useful for observation, measurement, and analysis of images of such samples. The methods, devices, apparatus, and systems disclosed herein provide advantages over other methods, devices, apparatus, and systems.
Devices, systems and methods for optical analysis of cells in microgravity are disclosed.
Effective cellular microscopic and image analysis requires placement of cells into a proper focal plane, region, or volume. Such placement often requires immobilization of the cells. Cell settling onto a substrate is often sufficient for cell immobilization; however, no significant settling occurs in microgravity. Cell immobilization in microgravity may be accomplished by treatment of a substrate, the cells, or both effective that the substrate captures and immobilizes the cells for inspection. Cells may be immobilized in microgravity by adhering magnetic particles to the cells and applying a magnetic field. Cells may be placed in a proper location for viewing in microgravity by placing the cells into a small chamber or narrow channel. Centrifugal force may effect cell settling and aid cell immobilization. Proper placement or immobilization of cells aids cellular microscopic and image analysis in microgravity.
In one embodiment described herein, a cartridge is provided comprising a cartridge frame; a plurality of diluents each in an expandable container; a plurality of reagents each in an expandable container; and a plurality of mixing vessels comprising empty expandable containers.
Systems and methods are provided for collecting, preparing, and/or analyzing a biological sample. A sample collection site may be utilized with one or more sample processing device. The sample processing device may be configured to accept a sample from a subject. The sample processing device may perform one or more sample preparation step and/or chemical reaction involving the sample. Data related to the sample may be sent from the device to a laboratory. The laboratory may be a certified laboratory that may generate a report that is transmitted to a health care professional. The health care professional may rely on the report for diagnosing, treating, and/or preventing a disease in the subject.
G06F 15/16 - Combinations of two or more digital computers each having at least an arithmetic unit, a program unit and a register, e.g. for a simultaneous processing of several programs
Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.
Methods and systems are provided for connecting an electronic device to a network. In some situations, the electronic device connects to a first network provider and pings a first server having a static internet protocol address and a second server having a dedicated uniform resource locator. If the electronic device receives a response from the first and second server, the electronic device maintains its connection to the first network provider. Otherwise, the electronic device connects to a second network provider and pings the first and second servers.
H04L 43/0811 - Monitoring or testing based on specific metrics, e.g. QoS, energy consumption or environmental parameters by checking availability by checking connectivity
G16H 10/20 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
H04W 76/18 - Management of setup rejection or failure
H04L 41/0654 - Management of faults, events, alarms or notifications using network fault recovery
H04L 45/00 - Routing or path finding of packets in data switching networks
H04L 45/28 - Routing or path finding of packets in data switching networks using route fault recovery
H04L 47/726 - Reserving resources in multiple paths to be used simultaneously
H04L 47/74 - Admission control; Resource allocation measures in reaction to resource unavailability
G06F 13/00 - Interconnection of, or transfer of information or other signals between, memories, input/output devices or central processing units
H04L 67/1023 - Server selection for load balancing based on a hash applied to IP addresses or costs
H04L 43/10 - Active monitoring, e.g. heartbeat, ping or trace-route
Methods and devices for cytometric analysis are provided. A cytometry apparatus is provided which may be used with a stationary sample cuvette for analysis of a stationary sample or with a flow sample cuvette for analysis of a flowing sample. The methods and devices provided herein may be used to perform cytometric analysis of samples under a wide range of experimental and environmental conditions.
Systems and methods are provided for processing a biological sample. In one embodiment, the method comprises receiving a sample vessel containing the sample; retrieving information from an information storage unit associated with the sample; using said information for selecting at least one cartridge front at least two or more different cartridges, each configured for use with a sample processing device; loading at least one or more reagents onto the cartridge, wherein the one or more reagents to be added are selected based at least in part on the information or instructions derived from the information; and placing the sample vessel in the cartridge.
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
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
G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
G01N 35/04 - 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 - Details of the conveyor system
56.
Transfer vessel and methods for reducing sample loss
Devices, systems and methods for holding and transferring small volume fluid samples are disclosed. Holding vessels, including holding vessels having two or more internal compartments for holding small volume fluid samples, are disclosed. Transfer vessels for receiving small volume fluid samples from such holding vessels are disclosed. Transfer vessels for combining small volume fluid samples from such holding vessels are disclosed. Methods for providing small volume fluid samples for analysis with small loss of sample are disclosed. Methods for providing small volume fluid samples for analysis using automated sample analysis devices and systems, with small loss of sample, are disclosed.
Reagents, assays, methods, kits, devices, and systems for rapid measurement of cholesterol and cholesterol sub-fractions from a blood sample are provided. Total cholesterol, low density lipoprotein cholesterol, and high density lipoprotein cholesterol can be measured in a single assay using kinetic measurements, under conditions in which cholesterol sub-species are converted to a detectable product at distinct rates. The detectable product is measured at different times after assay initiation. A lipase, cholesterol esterase, cholesterol oxidase and a peroxidase may be used together to produce colored product in amounts directly proportional to the quantity of cholesterol converted. Methods for calculating very-low density lipoprotein cholesterol levels by further including triglyceride measurements are disclosed. Assays may be performed in a single reaction mixture, allowing more accurate and precise cholesterol determinations, including ratios of cholesterol sub-fractions to total cholesterol, at less expense, than would be expected by performing several different assays in different reaction mixtures.
Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample.
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
G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
Bodily fluid sample collection systems, devices, and method are provided. The sample is collected at a first location and subjected to a first sample processing step. The sample may be shipped to a second location and subjected to a second sample processing step that does not introduce contaminants into a plasma portion of the sample formed from the first processing step. The sample may also be mixed with other material(s) in the collection device.
A61B 5/151 - Devices for taking samples of blood specially adapted for taking samples of capillary blood, e.g. by lancets
A61B 5/154 - Devices for taking samples of blood specially adapted for taking samples of venous or arterial blood, e.g. by syringes using pre-evacuated means
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
61.
Methods and devices for improved signal detection from biological samples
Methods and devices are provided to provide clean signals even in the presence of spectral interference. At least some of these methods can be applied for cases when interfering signals are to be accounted for. These cases include, but are not limited to, hemolysis detection, icterus detection, and assays. They can be implemented in with data collected with spectrophotometers, instruments that can collect absorbance values at the few wavelengths of interest, and, in the case of the method based on background subtraction, simple imaging setups with only two filters (such as but not limited to narrow-band and wide-band) per absorption peak of interest.
G01N 21/33 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using ultraviolet light
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
62.
DEVICES, SYSTEMS, METHODS, AND KITS FOR RECEIVING A SWAB
Methods, devices, systems, and kits useful for the collection and analysis of samples obtained by swabs are disclosed. Swab containers configured for receiving a swab containing a sample; cartridges for holding one or more of: a swab container, a swab, assay units, pipette tips, vessels, transport units, and implements; systems (which may include a sample processing device); kits; and methods for their use are disclosed. A swab container may include an entry port; an assay chamber having an assay port; a conduit comprising an interior channel connecting the entry port; and an interior channel providing fluidic communication between the entry port and assay chamber. An interior channel may be configured to squeeze a portion of a swab placed in or through the conduit. A cartridge may include a cartridge frame configured to receive one or more of swab containers, assay units, transport units, pipette tips, vessels or implements.
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
A61B 10/00 - Other methods or instruments for diagnosis, e.g. for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
In one embodiment described herein, a bodily fluid separation material is provided comprising a formed component capture region and a bodily fluid pass-through region. The pass-through region has structures with a reduced liquid leaching quality relative to than the capture region, wherein during separation material use, bodily fluid enters the capture region prior to entering the pass-through region. Optionally, a bodily fluid pass-through region has a reduced amount of liquid leaching material relative to than the capture region.
In one embodiment described herein, a cartridge is provided comprising a cartridge frame; a plurality of diluents each in an expandable container; a plurality of reagents each in an expandable container; and a plurality of mixing vessels comprising empty expandable containers.
Methods, devices, apparatus, and systems are provided for image analysis. Methods of image analysis may include observation, measurement, and analysis of images of biological and other samples; devices, apparatus, and systems provided herein are useful for observation, measurement, and analysis of images of such samples. The methods, devices, apparatus, and systems disclosed herein provide advantages over other methods, devices, apparatus, and systems.
G01N 33/569 - Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
G02B 7/09 - Mountings, adjusting means, or light-tight connections, for optical elements for lenses with mechanism for focusing or varying magnification adapted for automatic focusing or varying magnification
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
G02B 21/36 - Microscopes arranged for photographic purposes or projection purposes
G02B 21/16 - Microscopes adapted for ultraviolet illumination
G01N 21/27 - Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection
G01N 33/487 - Physical analysis of biological material of liquid biological material
Applicant discloses herein kits for identifying the presence of Zika virus in a sample. In embodiments, these kits comprise reagents disclosed herein. Applicant further provides kits for use in detecting ZIKV in a sample, the kits comprising reagents disclosed herein. In embodiments, kits include primers directed to Zika virus (ZIKV) nucleic acid sequences, the primers capable of hybridizing to ZIKV nucleic acids and to copies of ZIKV nucleic acids (including to cDNA copies of ZIKV nucleic acids). Applicant discloses herein reagents for detecting Zika virus (ZIKV) in a sample, the reagents including one or more nucleic acid primers that are capable of hybridizing to a ZIKV nucleic acid (including to cDNA copies of ZIKV nucleic acids).
A61K 39/295 - Polyvalent viral antigens; Mixtures of viral and bacterial antigens
C12N 15/10 - Processes for the isolation, preparation or purification of DNA or RNA
C12N 7/00 - Viruses, e.g. bacteriophages; Compositions thereof; Preparation or purification thereof
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
Provided herein are methods for extracting blood from a subject's digit, such as a finger. Methods provided herein may release relatively large quantities of blood from a pierced finger. Pressure can be applied at selected locations on the subject's digit to increase blood flow released from the subject.
Methods, compositions, systems, and devices are provided for performing and analyzing agglutination assays. In one aspect, methods for image analysis of agglutination assays are provided. In another aspects, methods for performing agglutination assays are provided. In one aspect, the methods may be used for the detection of various molecules, including viruses or antibodies against a virus. In another aspect, the methods can be used to determine effective immunization of a subject.
Methods for improving assays of biological samples are provided, including assays of small volume biological samples, such as blood samples obtained from a fingerstick. The methods include steps of selecting a baseline assay; providing a first revised assay by altering an aspect, a reagent, or a step of the baseline assay; comparing the results of the baseline assay and first revised assay; and identifying the first revised assay as an improved assay if the results of the first revised assay are similar to, are substantially the same as, or are better than, the results of the baseline assay. The methods may be iterated. Alterations include reducing sample volume; setting temperature; reducing step number and duration; altering reagent composition and number; and altering detection. Improved assays may reduce the duration, cost, or complexity of the assay, may improve assay sensitivity, accuracy, or reliability, and may provide synergistic improvements.
Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample vessel for receiving the bodily fluid sample collected in the sample collection channel, the sample vessel operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the vessel and/or another source provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the vessel.
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
G06Q 10/08 - Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
Devices, methods and systems are provided for reducing the sample volume required for analysis. Inserts placed within a sample container, and substitute sample containers having smaller volume sample chambers are provided. Methods are provided for detection and quantification of target substances in reduced volume samples. Methods include placing a small-volume of sample in a small-volume insert. Methods include diluting a small-volume sample, and placing the diluted sample in a small-volume insert. Methods include reducing the volume of sample, and: increasing illumination; increasing dye concentration or amount; increasing the amount of an enzyme substrate; increasing the amounts, concentration, or labeling of antibodies for detection; increasing optical detector sensitivity; increasing the path length of light passing through the sample; decreasing the separation between sample and detector; altering the wavelength, or polarization, or number of wavelengths, passing through the sample; increasing electronic amplification of electrical signals; altering assay temperature; and other alterations.
Devices, systems and methods including a sonicator for sample preparation are provided. A sonicator may be used to mix, resuspend, aerosolize, disperse, disintegrate, or de-gas a solution. A sonicator may be used to disrupt a cell, such as a pathogen cell in a sample. Sample preparation may include exposing pathogen-identifying material by sonication to detect, identify, or measure pathogens. A sonicator may transfer ultrasonic energy to the sample solution by contacting its tip to an exterior wall of a vessel containing the sample. Multipurpose devices including a sonicator also include further components for additional actions and assays. Devices, and systems comprising such devices, may communicate with a laboratory or other devices in a system for sample assay and analysis. Methods utilizing such devices and systems are provided. The improved sample preparation devices, systems and methods are useful for analyzing samples, e.g. for diagnosing patients suffering from infection by pathogens.
G01N 1/38 - Diluting, dispersing or mixing samples
C12Q 1/04 - Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor
B01F 11/02 - Mixing by means of ultrasonic vibrations
Devices and methods are described for measuring formed blood component sedimentation rate. Some of the methods may use (1) centrifugal techniques for separating red blood cells from plasma and (2) video and/or still imaging capability. Both may be used alone or in combination to accelerate formed blood component sedimentation and to measure its rate. In one example, the method may advantageously enable rapid measurement of sedimentation rate using small blood sample volumes. Automated image analysis can be used to determine both sedimentation rate and hematocrit. Automated techniques may be used to compensate for effects of hematocrit on uncorrected sedimentation rate data.
The invention relates to an ingestible, implantable or wearable medical device comprising a microarray which comprises a bioactive agent capable of interacting with a disease marker biological analyte; a reservoir which comprises at least one therapeutic agent and is capable of releasing the therapeutic agent(s) from the medical device; and a plurality of microchips comprising a microarray scanning device capable of obtaining physical parameter data of an interaction between the disease marker biological analyte with the bioactive agent; a biometric recognition device capable of comparing the physical parameter data with an analyte interaction profile; optionally a therapeutic agent releasing device capable of controlling release of the therapeutic agent from the reservoirs; an interface device capable of facilitating communications between the microarray scanning device, biometric recognition device and the therapeutic agent releasing device; and an energy source to power the medical device. Specifically, the invention relates to a medical device capable of detecting an analyte in a bodily fluid comprising at least one microneedle capable of obtaining a sample of a bodily fluid, a first microchannel through which the sample flows and is in fluid communication with the at least one microneedle, a second microchannel in fluid communication with the first microchannel, through which a buffer flows, wherein the second channel comprises a microarray with a bioactive agent, a microarray scanning device to detect an interaction between the bioactive agent and the analyte in the bodily fluid; and an interface device.
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/157 - Devices for taking samples of blood characterised by integrated means for measuring characteristics of blood
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
A61M 37/00 - Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
A61B 5/1477 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means non-invasive
A61B 5/1473 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using chemical or electrochemical methods, e.g. by polarographic means invasive, e.g. introduced into the body by a catheter
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using optical sensors, e.g. spectral photometrical oximeters
76.
Methods and devices for sample collection and stabilization
Methods and devices are provided for sample collection. In one example, a device is provided comprising at least one capillary tube or collection channel directed to a sample vessel, wherein in a one-step removal step of detaching the sample vessel from the collection channel, a vacuum force is created within the sample vessel, due in part of the pulling of the sealed vessel away from the device, wherein this vacuum force draw out residual sample that may still be resident in the collection channel.
Methods and compositions for the amplification of nucleic acids and generation of concatemers are disclosed. Amplification methods provided herein may be performed under isothermal conditions. Methods and compositions may include reagents such as nucleic acid polymerases and primers.
Devices and methods are described for measuring formed blood component sedimentation rate. Some of the methods may use (1) centrifugal techniques for separating red blood cells from plasma and (2) video and/or still imaging capability. Both may be used alone or in combination to accelerate formed blood component sedimentation and to measure its rate. In one example, the method may advantageously enable rapid measurement of sedimentation rate using small blood sample volumes. Automated image analysis can be used to determine both sedimentation rate and hematocrit. Automated techniques may be used to compensate for effects of hematocrit on uncorrected sedimentation rate data.
Applicant discloses herein kits for identifying the presence of Zika virus in a sample. In embodiments, these kits comprise reagents disclosed herein. Applicant further provides kits for use in detecting ZIKV in a sample, the kits comprising reagents disclosed herein. In embodiments, kits include primers directed to Zika virus (ZIKV) nucleic acid sequences, the primers capable of hybridizing to ZIKV nucleic acids and to copies of ZIKV nucleic acids (including to cDNA copies of ZIKV nucleic acids). Applicant discloses herein reagents for detecting Zika virus (ZIKV) in a sample, the reagents including one or more nucleic acid primers that are capable of hybridizing to a ZIKV nucleic acid (including to cDNA copies of ZIKV nucleic acids).
A61K 39/00 - Medicinal preparations containing antigens or antibodies
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
C12N 7/00 - Viruses, e.g. bacteriophages; Compositions thereof; Preparation or purification thereof
A61K 39/295 - Polyvalent viral antigens; Mixtures of viral and bacterial antigens
80.
Methods for the Detection of Analytes in Small-Volume Blood Samples
This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications.
G01N 33/92 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving lipids, e.g. cholesterol
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
G01N 21/27 - Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection
G01N 21/31 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
Methods and devices for cytometric analysis are provided. A cytometry apparatus is provided which may be used with a stationary sample cuvette for analysis of a stationary sample or with a flow sample cuvette for analysis of a flowing sample. The methods and devices provided herein may be used to perform cytometric analysis of samples under a wide range of experimental and environmental conditions.
Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample vessel for receiving the bodily fluid sample collected in the sample collection channel, the sample vessel operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the vessel and/or another source provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the vessel.
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
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)
In one embodiment, a femtowatt sensitivity optical detector is provided using one or more photodiodes, intended as a replacement for the photomultiplier based photon counting unit.
H03F 3/08 - Amplifiers with only discharge tubes or only semiconductor devices as amplifying elements with semiconductor devices only controlled by light
H03M 1/06 - Continuously compensating for, or preventing, undesired influence of physical parameters
Methods and devices are provided for sample collection and sample separation. In one embodiment, a device is provided for use with a formed component liquid sample, the device comprising at least one sample inlet for receiving said sample; at least a first outlet for outputting only a liquid portion of the formed component liquid sample; at least a second outlet for outputting the formed component liquid sample at least a first material mixed therein.
A61J 1/05 - Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids
The present invention provides an integrated health care surveillance and monitoring system that provides real-time sampling, modeling, analysis, and recommended interventions. The system can be used to monitor infectious and chronic diseases. When faced with outbreak of an infectious disease agent, e.g., influenza virus, the system can identify active cases through pro-active sampling in high risk locations, such as schools or crowded commercial areas. The system can notify appropriate entities, e.g., local, regional and national governments, when an event is detected, thereby allowing for proactive management of a possible outbreak. The system also predicts the best response for deployment of scarce resources.
G16H 50/50 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders
G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
G16H 50/80 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for detecting, monitoring or modelling epidemics or pandemics, e.g. flu
G16Z 99/00 - Subject matter not provided for in other main groups of this subclass
86.
Integrated health data capture and analysis system
The present invention provides an integrated health care surveillance and monitoring system that provides real-time sampling, modeling, analysis, and recommended interventions. The system can be used to monitor infectious and chronic diseases. When faced with outbreak of an infectious disease agent, e.g., influenza virus, the system can identify active cases through pro-active sampling in high risk locations, such as schools or crowded commercial areas. The system can notify appropriate entities, e.g., local, regional and national governments, when an event is detected, thereby allowing for proactive management of a possible outbreak. The system also predicts the best response for deployment of scarce resources.
G16H 50/50 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for simulation or modelling of medical disorders
G16H 50/70 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for mining of medical data, e.g. analysing previous cases of other patients
G16H 50/80 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for detecting, monitoring or modelling epidemics or pandemics, e.g. flu
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
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)
Assays for rapid measurement of total vitamin D in blood are provided. Vitamin D is measured following the rapid and irreversible release of vitamin D due to denaturation and digestion of vitamin D binding proteins by aspartyl peptidases (e.g., pepsin) under acidic conditions. Such measurements may be made using a vitamin D binder (e.g., an antibody) to measure competition between free vitamin D and added, labeled vitamin D. Synergy between denaturation and degradation is believed to provide more rapid and more complete release of vitamin D than would occur with acid or enzyme alone. These measurements may be made using small amounts of whole blood, serum, or plasma, and are suitable for use in automated devices. These methods provide the advantages of reduced cost, increased speed, reduced discomfort to the subject, and increased availability and ease of use. Reagents, kits, devices, and systems for these assays are also disclosed.
G01N 31/00 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroups; Apparatus specially adapted for such methods
The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
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
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
G01N 1/38 - Diluting, dispersing or mixing samples
G01N 33/569 - Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
A61B 5/151 - Devices for taking samples of blood specially adapted for taking samples of capillary blood, e.g. by lancets
G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
B01L 7/00 - Heating or cooling apparatus; Heat insulating devices
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 33/94 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving narcotics
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
G01N 33/574 - Immunoassay; Biospecific binding assay; Materials therefor for cancer
A61B 10/00 - Other methods or instruments for diagnosis, e.g. for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
A61B 10/02 - Instruments for taking cell samples or for biopsy
This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications. In particular, the medical device reduces interference with an optical signal which is indicative of the presence of an analyte in a bodily sample.
The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
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
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
G01N 1/38 - Diluting, dispersing or mixing samples
G01N 33/569 - Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
A61B 5/151 - Devices for taking samples of blood specially adapted for taking samples of capillary blood, e.g. by lancets
B01L 7/00 - Heating or cooling apparatus; Heat insulating devices
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 33/94 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving narcotics
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
G01N 33/574 - Immunoassay; Biospecific binding assay; Materials therefor for cancer
A61B 10/00 - Other methods or instruments for diagnosis, e.g. for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
A61B 10/02 - Instruments for taking cell samples or for biopsy
This invention is in the field of medical devices. Specifically, the present invention provides portable medical devices that allow real-time detection of analytes from a biological fluid. The methods and devices are particularly useful for providing point-of-care testing for a variety of medical applications. In particular, the medical device reduces interference with an optical signal which is indicative of the presence of an analyte in a bodily sample.
Devices, systems and methods for holding and transferring small volume fluid samples are disclosed. Holding vessels, including holding vessels having two or more internal compartments for holding small volume fluid samples, are disclosed. Transfer vessels for receiving small volume fluid samples from such holding vessels are disclosed. Transfer vessels for combining small volume fluid samples from such holding vessels are disclosed. Methods for providing small volume fluid samples for analysis with small loss of sample are disclosed. Methods for providing small volume fluid samples for analysis using automated sample analysis devices and systems, with small loss of sample, are disclosed.
Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample container for receiving the bodily fluid sample collected in the sample collection channel, the sample container operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the container provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the container.
A61B 10/00 - Other methods or instruments for diagnosis, e.g. for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
Bodily fluid sample collection systems, devices, and method are provided. The device may comprise a first portion comprising at least a sample collection channel configured to draw the fluid sample into the sample collection channel via a first type of motive force. The sample collection device may include a second portion comprising a sample container for receiving the bodily fluid sample collected in the sample collection channel, the sample container operably engagable to be in fluid communication with the collection channel, whereupon when fluid communication is established, the container provides a second motive force different from the first motive force to move a majority of the bodily fluid sample from the channel into the container.
A61B 5/157 - Devices for taking samples of blood characterised by integrated means for measuring characteristics of blood
A61B 10/00 - Other methods or instruments for diagnosis, e.g. for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
A61B 5/151 - Devices for taking samples of blood specially adapted for taking samples of capillary blood, e.g. by lancets
A61B 5/154 - Devices for taking samples of blood specially adapted for taking samples of venous or arterial blood, e.g. by syringes using pre-evacuated means
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
The present invention provides system and methods for detecting an analyte indicative of an influenza viral infection in a sample of bodily fluid. The present invention also provides for systems and method for detection a plurality of analytes, at least two of which are indicative of an influenza viral infection in a sample of bodily fluid.
A61K 39/145 - Orthomyxoviridae, e.g. influenza virus
G01N 33/569 - Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
G01N 33/543 - Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
Methods and devices for cytometric analysis are provided. A cytometry apparatus is provided which may be used with a stationary sample cuvette for analysis of a stationary sample or with a flow sample cuvette for analysis of a flowing sample. The methods and devices provided herein may be used to perform cytometric analysis of samples under a wide range of experimental and environmental conditions.
The devices and systems disclosed herein provide multiple optical capabilities in a single device or system. Methods for using these devices and systems are provided. These devices and systems are configurable for operation in each of a spectroscopy mode, a fluorescence mode, and a luminescence mode, and are capable of performing spectroscopic, fluorescence, and luminescence observations, measurements, and analyses when operated in the corresponding spectroscopy mode, fluorescence mode, or luminescence mode. These devices and systems include mirror dispersion elements having multiple faces including an optical dispersion element on one face (e.g., a diffraction grating or a prism) and a reflective element on another face (e.g., a mirror). These multiple capabilities eliminate the need to move or load a sample in multiple devices when subjecting a sample to multiple analyses, and thus provide greater accuracy, precision, and speed while reducing complexity and cost of sample analysis.
In one embodiment described herein, a bodily fluid separation material is provided comprising a formed component capture region and a bodily fluid pass-through region. The pass-through region has structures with a reduced liquid leaching quality relative to than the capture region, wherein during separation material use, bodily fluid enters the capture region prior to entering the pass-through region. Optionally, a bodily fluid pass-through region has a reduced amount of liquid leaching material relative to than the capture region.
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