A sample insertion apparatus enabling a sample to be inserted into a diagnostic analyzer in a hands-free manner. The sample insertion apparatus includes an insertion head having a coupler configured to couple to a sample container having an insertion member, an arm containing a sample probe positioned stationary relative to the arm, and a retraction assembly coupled to the insertion head and configured to cause the sample container to move towards the sample probe to insert the sample probe into the insertion member. Sample insertion and operating methods for hands-free insertion of a sample into a diagnostic analyzer are described, as are other aspects.
A fluidic tubing assembly and method for a blood analyzer comprising a base, a first tube, and a second tube. The base is connectable to the blood analyzer and has a front side, a rear side, a first side, a second side, a top side, and a bottom side. A first connector is supported by the first side. The first end of the first tube is connected to the first connector. A second connector is supported by the top side. The second end of the first tube is connected to the second connector. A third connector is supported by the top side. The first end of the second tube is connected to the third connector. A fourth connector is supported by the bottom side. The second end of the second tube is connected to the fourth connector.
An apparatus and method for transferring a fluid sample from a fluid sample collection apparatus to a liquid sample analyzer. The apparatus includes a barrel having a first end, a second end, a sidewall extending between the first end and the second end, an inner surface defining an internal chamber, and an external surface defining at least a portion of a chromatographic assay chamber in fluid communication with the internal chamber. The first end has an inlet opening with a clot catcher extending across the inlet opening upstream of the passage and the second end has an outlet opening. A chromatographic assay assembly is housed in the chromatographic assay chamber for detecting presence of free hemoglobin in the fluid sample.
An apparatus and method for removing bubbles from a fluid sample. The apparatus has a barrel and a filter member. The barrel has a first end, a second end, a sidewall, and an inner surface defining an internal chamber. The first side has an inlet opening and the second side has an outlet opening. The filter member is slidably disposed within the internal chamber and defines an inlet side and an outlet side of the internal chamber. The filter member has a gas-permeable, liquid-impermeable membrane which permits the gas portion of the fluid sample to pass across the filter member. The barrel has a second gas-permeable, liquid-impermeable membrane which provides a fluid-tight seal across the outlet opening.
An apparatus and method for removing bubbles from a fluid sample. The apparatus has a barrel and a filter member. The barrel has a first end, a second end, a sidewall, and an inner surface defining an internal chamber. The first side has an inlet opening and the second side has an outlet opening. The filter member is disposed within the internal chamber and defines an inlet side and an outlet side of the internal chamber. The filter member has a gas-permeable, liquid-impermeable membrane which permits the gas portion of the fluid sample to pass across the filter member from the inlet side to the outlet side. The gas-permeable, liquid-impermeable membrane provides a fluid-tight seal across the filter member. The filter member is pierceable so a probe may be passed through the filter member to withdraw the liquid portion of the fluid sample from the internal chamber.
B01D 53/22 - Separation of gases or vapours; Recovering vapours of volatile solvents from gases; Chemical or biological purification of waste gases, e.g. engine exhaust gases, smoke, fumes, flue gases or aerosols by diffusion
6.
APPARATUS AND METHOD FOR TRANSFERRING A FLUID SAMPLE FROM A FLUID SAMPLE COLLECTION APPARATUS TO A LIQUID SAMPLE ANALYZER
An apparatus and method for transferring a fluid sample from a fluid sample collection apparatus to a liquid sample analyzer. The apparatus includes a barrel having a first end, a second end, a sidewall extending between the first end and the second end, and an inner surface defining an internal chamber. The first end has an inlet opening and the second end having an outlet opening. The first end of the barrel has a barrel connection portion engageable with a portion of the fluid sample collection apparatus and the second end of the barrel has a tubular portion configured to engage with the liquid sample analyzer so a combination of the fluid sample collection apparatus and the barrel is attachable to the liquid sample analyzer with no additional support.
A method of increasing a concentration of an antigen of a respiratory virus is provided. The method includes preparing a sample containing a first concentration of the antigen; contacting the sample containing the first concentration of the antigen to a first material having a negatively-charged surface, thereby capturing an amount of the antigen with the first material; contacting a second material to the first material to transfer the antigen from the first material to the second material, the second material having an ionic strength sufficient to release the captured antigen from the first material into the second material; and obtaining a resulting solution containing the antigen in a second concentration. The second concentration of the antigen in the resulting solution is higher than the first concentration of the antigen in the sample. Numerous other aspects in accordance with this and other embodiments are provided.
C12Q 1/04 - Determining presence or kind of microorganism; Use of selective media for testing antibiotics or bacteriocides; Compositions containing a chemical indicator therefor
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 33/557 - Immunoassay; Biospecific binding assay; Materials therefor using kinetic measurement, i.e. time rate of progress of an antigen-antibody interaction
A sensor array is disclosed. The sensor array includes a fluid inlet, a fluid outlet, a flow path extending between the fluid inlet and the fluid outlet; and at least one optimization sensor positioned outside of the flow path of the sensor array and configured to provide at least one performance parameter of the sensor array. The at least one performance parameter having performance data of the sensor array.
G01N 37/00 - INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES - Details not covered by any other group of this subclass
G01N 15/00 - Investigating characteristics of particles; Investigating permeability, pore-volume or surface-area of porous materials
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
G01M 3/04 - Investigating fluid tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point
G01N 17/00 - Investigating resistance of materials to the weather, to corrosion or to light
9.
ABSORBANCE SPECTROSCOPY ANALYZER AND METHOD OF USE
Absorbance spectroscopy methods and systems are disclosed including a spectroscopy analyzer, comprising: an optical element device positioned to receive an analysis light that passes through a sample of a fluid specimen from an illumination unit, the analysis light including first light in a first light range and second light in a second light range different than the first light range, the optical element device comprising: a housing assembly that defines an internal space; and a dichroic mirror-reflector within the internal space positioned to receive the analysis light, the dichroic mirror-reflector configured to filter the analysis light such that a first portion of the analysis light in the first light range is reflected off the dichroic mirror-reflector as a spectrometer light, and such that a second portion of the analysis light in the second light range passes through the dichroic mirror-reflector as a detector light.
A lysis device including a sample vessel, at least one piezo element, and a controller is disclosed. The sample vessel has a microchannel formed therein. The sample vessel has at least one port extending through a surface to the microchannel. The piezo element is attached to the surface of the sample vessel. The controller has logic to cause the controller to emit a first signal including a series of frequencies to the at least one piezo element to cause the at least one piezo element to generate ultrasonic acoustic standing waves in the sample vessel, to receive a second signal indicative of measured vibration signals from the sample vessel detected by the at least one piezo element, and to determine a resonant frequency of the sample vessel using the measured vibration signals.
An assembly for use in a medical diagnostic device and system for analysis of one or more samples is disclosed. In one aspect of the invention, the assembly includes at least one extendable sample tray configured to hold the one or more samples. Additionally, the assembly includes at lease one holding unit coupled to the at least one extendable sample tray, wherein the holding unit is configured to hold a calibration marker. Furthermore, the extendable sample tray and the holding unit are arranged in the same plane and when the extendable sample tray is extended, the at least one holding unit is brought in a field of view of an image capturing unit.
C12M 1/34 - Measuring or testing with condition measuring or sensing means, e.g. colony counters
C12M 1/40 - Apparatus specially designed for the use of free, immobilised, or carrier-bound enzymes, e.g. apparatus containing a fluidised bed of immobilised enzymes
G01N 23/02 - Investigating or analysing materials by the use of wave or particle radiation, e.g. X-rays or neutrons, not covered by groups , or by transmitting the radiation through the material
G01N 23/04 - Investigating or analysing materials by the use of wave or particle radiation, e.g. X-rays or neutrons, not covered by groups , or by transmitting the radiation through the material and forming images of the material
12.
DEVICES AND METHODS FOR PLASMA SEPARATION AND METERING
Devices, assemblies, and kits are disclosed for separating and/or metering a plasma sample from a patient's liquid test sample. Also disclosed are methods of producing and using same.
A method and biological sample analyzer is described that adjusts airflow within a housing based upon altitude. A first volume of air is moved by at least one fan within a housing of a biological sample analyzer. A temperature of the first volume of air is measured within the biological sample analyzer with a temperature sensor within the housing of the biological sample. Power output of at least one heater positioned within the housing of the biological sample analyzer is measured. The measured power output of the at least one heater is analyzed at the measured temperature within the biological sample analyzer. And, the fan is adjusted to move a second volume of air different from the first volume of air by comparing the measured power output of the at least one heater and expected power output of the at least one heater.
Analyzers and methods of use are disclosed, including a blood analyzer comprising a light source to transmit an optical signal; a detector to generate data indicative of optical signal intensity; a transparent sample vessel between the light source and the detector; a dispensing device to pass a first portion of the blood sample comprising whole blood or lysed blood into the vessel at a first instance of time, and to pass a plasma portion of the blood sample into the vessel at a second instance of time; a controller to cause a processor to obtain first and second data generated by the detector, the first data indicative of the optical signal passing through the first portion of the blood sample and the second data indicative of the optical signal passing through the plasma, to determine a total absorbance spectrum in which the first data is adjusted by the second data.
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using optical sensors, e.g. spectral photometrical oximeters
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
Lysis devices, methods, and systems are disclosed including a lysis device comprising a sample vessel having an outer surface, a microchannel within the confines of the outer surface, a first port extending through the outer surface to the microchannel, and a second port extending through the outer surface to the microchannel; and an acoustic transducer bonded to the outer surface of the sample vessel to form a monolithic structure, the acoustic transducer configured to emit ultrasonic acoustic waves into and/or to induce shear forces into a blood sample within the microchannel, thereby rupturing the blood cells.
Single-use diagnostic consumables for use in performing multiple analyses on a fluid sample are provided. The diagnostic consumables include a first sensing region configured for analysis of at least one analyte in a fluid sample that has been received by the diagnostic consumable. The diagnostic consumable further includes a fluid transport material configured to flow a portion of the fluid sample into a second sensing region fluidically connected to the fluid transport material and configured for performing a second analysis of the fluid sample. Methods for performing multiple analyses of a fluid sample on a single-use diagnostic consumable are also provided.
A magnesium sensing membrane is disclosed for use in a potentiometric ion selective microelectrode that exhibits an increased lower detection limit. Potentiometric ion selective microelectrodes containing said magnesium sensing membranes are also disclosed. Kits containing the microelectrodes are also disclosed, along with methods of production and use of the magnesium sensing membranes and/or potentiometric ion selective microelectrodes.
G01N 27/333 - Ion-selective electrodes or membranes
18.
BIOCIDE FORMULATION COMPRISING HEXAHYDRO 1,3,5-TRIS(2-HYDROXYETHYL)-S-TRIAZINE AND AN ISOTHIAZOLINONE BIOCIDE AND ITS USE FOR THE PRESERVATION OF ANALYTE DETECTION SENSOR(S)
The present invention relates to biocide formulations comprising hexahydro l,3,5-tris(2- hydroxyethyl)-s-triazine and an isothiazolinone-based biocide, and their use to prolong shelf-life of enzymatic assays without impairment of enzymatic activity, and corresponding kits/systems and methods. In embodiments, the isothiazolinone-based biocide is 5-chloro-2-methylisothiazol- 3(2H)-one; or the isothiazolinone-based biocide is selected from the group consisting of methylisothiazolinone, octylisothiazolinone, dichlorooctylisothiazolinone, butylbenzisothiazolinone, and combinations thereof.
A01N 43/707 - 1,2,3- or 1,2,4-Triazines; Hydrogenated 1,2,3- or 1,2,4-triazines
A01N 47/12 - Carbamic acid derivatives, i.e. containing the group —O—CO—N; Thio-analogues thereof containing a —O—CO—N group, or a thio-analogue thereof, neither directly attached to a ring nor the nitrogen atom being a member of a heterocyclic ring
A tangent flow hemolysis blood testing assembly, device and method are described herein. The presently disclosed and claimed inventive concept(s) relate to a device(s), kit(s), and method(s) for injecting a patient's liquid test sample into a reaction vessel. More specifically, the presently disclosed and claimed inventive concept(s) relate to an improved liquid test sample injection device that comprises a plug that forms an airtight seal that facilitates the active injection of a liquid test sample into a reaction vessel, and kits and methods of use related thereto.
The inventive concepts disclosed herein are generally directed to the need to measure a microsample and obtain one or more measurement for one or more analyte in the microsample by configuring a sensor array having one or more first reference signal source interlaced with one or more analyte sensor positioned along the longitudinal axis the sensor body and a second reference signal source positioned downstream of the sensor body along a sample flow path.
G01N 27/26 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by using electrolysis or electrophoresis
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
G01N 27/27 - Association of two or more measuring systems or cells, each measuring a different parameter, where the measurement results may be either used independently, the systems or cells being physically associated, or combined to produce a value for a furthe
G01N 33/483 - Physical analysis of biological material
Disclosed is a sensor assembly including a flow channel; two or more working electrodes located in the flow channel; and one or more reference electrodes located in the flow channel, wherein a total number of working electrodes is greater than a total number of reference electrodes. Volume in the flow channel may be minimized. Liquid testing apparatus and methods of testing test liquids are provided, as are other aspects.
In one embodiment, a biological sample analyzer has a housing having at least one outer wall that defines a cavity therein. A receptacle, which can support a consumable holder containing a biological sample, is disposed within the cavity. At least one heater applies heat to the consumable holder when the consumable holder is supported by the receptacle. At least one heater sensor detects a temperature of the receptacle over time. A controller directs the at least one heater to apply an elevated temperature to the consumable holder and reduces an amount of heat applied to the consumable holder before the consumable holder exceeds a target temperature that is less than the elevated temperature. By applying the elevated temperature, the consumable holder can be heated quicker than if it where heated at only the target temperature.
A method for delivering a fluid sample through a channel of a diagnostic consumable is disclosed. The method includes receiving the diagnostic consumable in a reader comprising a delivery system, operatively connecting the delivery system to the channel, and applying pressure pulses to the channel at a predetermined frequency. A reader for reading a diagnostic consumable is also disclosed.
An acoustic analyzer system is provided that includes an acoustic analyzer having a reusable glass flow cell positioned within the acoustic analyzer. A disposable card body may be inserted into the acoustic analyzer and deliver sample fluid to the glass flow cell so that acoustic-wave assisted measurements may be performed on the sample fluid. The disposable card body may also deliver wash fluid to the glass flow cell, and receive waste sample fluid and waste wash fluid from the glass flow cell to prepare the glass flow cell for subsequent sample fluids. Numerous other embodiments are provided.
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
A61B 5/1455 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value using optical sensors, e.g. spectral photometrical oximeters
G01N 33/543 - Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
25.
BIOLOGICAL SAMPLE ANALYZER WITH FORCED AIR CONVECTION PLENUM
In one embodiment, a biological sample analyzer has a housing having at least one outer wall that defines a cavity therein, an air intake, and an air exhaust. A plenum is disposed within the cavity and has at least one plenum wall that defines an air duct therein. A receptacle, which can support a consumable holder containing a biological sample, is disposed within the internal cavity. At least a portion of the receptacle is supported within the air duct such that an air gap is defined between the receptacle and the at least one plenum wall. A heater applies heat to the consumable holder so as to heat the consumable holder when the consumable holder is supported by the receptacle. A fan forces air along a path that extends from the air intake, through the air gap, and to the air exhaust so as to cool the heater.
In one embodiment, a biological sample analyzer has a housing having at least one outer wall that defines a cavity therein. A receptacle, which can support a consumable holder containing a biological sample, is disposed within the internal cavity. At least one heater applies heat to the receptacle when the consumable holder is supported by the receptacle. At least one heater sensor detect temperatures of the receptacle over time. A controller detects whether the consumable holder is below an ambient temperature based on a decrease in temperature of the receptacle when the consumable holder is inserted into the receptacle. The controller also increases an amount of thermal energy transferred from the at least one heater to the consumable holder when the controller detects that the consumable holder is below the ambient temperature so as to heat the consumable holder to a target temperature.
Fluidic devices that include bubble traps are provided. A substrate for a fluidic device includes a first channel to carry a fluid; a chamber, coupled to the first channel, to receive the fluid from the first channel, the chamber having a top and a bottom; a second channel, coupled to the chamber, to receive the fluid from the chamber; and a plurality of barriers adjacent to the top of the chamber. The plurality of barriers inhibit bubbles in the fluid from entering the second channel. Methods for manufacturing and using fluidic devices that include bubble traps are also provided.
Diagnostic consumables for use in the analysis of fluid samples, such as whole blood, plasma or urine, are provided. The diagnostic consumables include a substrate having a sample preparation stage that includes an inlet port for receiving a fluid sample, an outlet port for dispensing a prepared fluid sample, and a channel extending from the inlet port to the outlet port. The channel includes an array of micro-projections extending into the channel to define a plurality of flow paths therebetween along at least a portion of a length of the channel between the inlet port and the outlet port. A material is disposed on the array of micro-projections for mixing with the fluid sample as the fluid sample is flowed through the channel to generate the prepared fluid sample. Methods of operating and manufacturing the diagnostic consumables are also provided.
A fitment device may include a core made of a first material and including a securing portion configured to secure to a chassis and a container portion configured to seal to a container. The fitment device includes an aperture including a first end located at the securing portion and a second end located at the container portion, wherein the aperture is configured to receive a probe in the first end. A plug located in the aperture is movable within the aperture upon contact with the probe to open a passageway between the first end and an interior of the container. Other devices and methods are disclosed.
B67D 7/02 - Apparatus or devices for transferring liquids from bulk storage containers or reservoirs into vehicles or into portable containers, e.g. for retail sale purposes for transferring liquids other than fuel or lubricants
G01N 1/00 - Sampling; Preparing specimens for investigation
G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
30.
FITMENT DEVICES, REAGENT CARTRIDGES CONTAINING FITMENT DEVICES, AND METHODS OF MANUFACTURING AND OPERATING SAME
A fitment device may include a core formed from a first material having a first low permeability of oxygen. The core may include a securing portion configured to secure to a chassis, and a container portion including at least one side portion at least partially coated with a second material configured to seal to a container, wherein the first material is different than the second material and includes a different gas permeability of oxygen. An aperture may extend between the securing portion and the container portion. Reagent cartridges and methods of manufacturing and using fitment devices are also disclosed.
Disclosed is a syringe apparatus. Syringe apparatus has a barrel including an inner surface, an open end, and an inlet end; a plunger including a plunger head received in slidable sealing contact with the inner surface of the barrel and forming a reservoir therein; and an extensible member, optionally including an additive, is contained in the reservoir. Extensible member can be coupled between the inlet end and the plunger head and is extensible in length L as a bio-liquid (e.g., whole blood) is drawn into the reservoir. Methods of mixing or adding an additive such as an anticoagulant, coagulant, or marker, to a bio-liquid are provided, as are other aspects.
A blood testing assembly and method are described. In the method, a blood testing device having a plasma separation membrane and a reagent is connected to a syringe containing blood having blood cells and plasma. A blood sample of the blood is passed from the syringe through a plasma separation membrane within the blood testing device to separate the plasma from the blood cells. A reagent is saturated with the plasma, and then the reagent is colorimetrically analyzed to determine a degree of hemolysis within the blood sample.
Disclosed is a sensor assembly 100 including a sensor body having a flow channel therein configured to receive a test liquid, such as a bio-liquid, one or more moveable walls defining one or more wall portions of the flow channel, the one or more moveable walls configured to be moveable, such as to a first position, a second position, or even an intermediate position, to change a volume of the flow channel 102, and one or more sensor elements positioned in the flow channel. Volume in the flow channel may be minimized for testing neonatal specimens. Liquid testing apparatus and methods of testing test liquids are provided, as are other aspects.
G01N 35/08 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor using a stream of discrete samples flowing along a tube system, e.g. flow injection analysis
G01N 33/48 - Biological material, e.g. blood, urine; Haemocytometers
G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
34.
PATIENT ID AND SAMPLE ID WORKFLOW METHODS AND APPARATUS FOR FACILITATING DIAGNOSTIC TESTING
In point of care system is provided that includes an instrument data manager (IDM) configured to communicate with a diagnostic engine and to (1) obtain identification (ID) information of a patient for which a test is to be performed; (2) obtain ID information of a diagnostic consumable to be used to collect a sample from the patient; (3) link the obtained patient ID information with the obtained diagnostic consumable ID information; and (4) restrict testing using the diagnostic engine by (a) prior to performing a test on a sample collected with a diagnostic consumable, determine ID information of the diagnostic consumable at the diagnostic engine; (b) determine whether the diagnostic consumable is linked with patient information within the IDM; and (c) if so, allow the diagnostic engine to perform a test on the sample collected with the diagnostic consumable. Numerous other embodiments are provided.
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16H 10/00 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
35.
SOLUTION COLLECTION DEVICE WITH EVALUATION ELEMENT
A blood testing device for detecting hemolysis in a blood sample is described. The blood testing device comprises an housing for containing the blood sample. The housing has a treatment window and an optical zone formed therein. The blood testing device further includes an acoustic transducer positioned to selectively generate acoustic forces directed into the treatment window of the housing and a control unit for selectively actuating and deactuating the acoustic transducer to permit colorimetric analysis of plasma within the blood sample.
A device including a housing, a zone and a means for testing a fluid sample within the housing is disclosed. The housing is constructed of a fluid impermeable material, and defines a first fluid port, and a second fluid port. The first fluid port is configured to connect to a fluid collection device to receive a fluid sample from the fluid collection device into the housing. The second port is configured to pass the fluid sample from the housing into a testing instrument. The zone is formed in the housing. The zone is constructed of a material that allows an analysis of the fluid sample positioned within the housing, and located adjacent to the zone.
Devices and methods for the hook effect detection associated with analytes of interest in the conductance of one or more diagnostic assays, including, without limitation, immunoassays.
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
Improved analyte detection system within a blood gas analyzer, the improved system comprising and/or consisting of at least one CO-oximetry system that is formed as an integrated, unitary structure(s) with an electrochemical sensor module, and methods of use related thereto.
G01N 27/06 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance of a liquid
G01N 27/27 - Association of two or more measuring systems or cells, each measuring a different parameter, where the measurement results may be either used independently, the systems or cells being physically associated, or combined to produce a value for a furthe
A method and system for determining a concentration of one or more analytes in whole blood is provided. In one aspect of the invention, the system includes a channel configured to carry whole blood. The system further includes a light source configured to emit light on the channel. Additionally, the system includes an actuation module associable with the channel, wherein the actuation module is configured to generate a cell-free plasma layer in the channel. Furthermore, the system includes an optical module associable with the channel.
A composition of a bilirubin stock and a method of preparation are provided. In one aspect of the invention, the composition includes a base solution. The composition further includes a carbonate salt. Additionally, the composition includes bilirubin. Furthermore, the composition includes human serum albumin.
C12N 5/00 - Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
A61K 31/409 - Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having four such rings, e.g. porphine derivatives, bilirubin, biliverdine
A method, device and a system of determining a concentration of one or more analytes in a sample is disclosed. In one aspect of the invention, the method includes introducing the sample through a channel. The method further includes illuminating the sample with light having varying wavelengths. Additionally, the method includes obtaining an image of the illuminated sample at each of the wavelengths. Furthermore, the method includes analyzing the image to determine the concentration of the one or more analytes.
G01N 21/17 - Systems in which incident light is modified in accordance with the properties of the material investigated
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 21/35 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry using infrared light
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
42.
METHOD AND DEVICE FOR DETERMINING THE CONCENTRATION OF ANALYTES IN A SAMPLE
A method and a device for determining a concentration of one or more analytes in a whole blood sample is disclosed. In one aspect of the invention, the method includes introducing the sample in a channel. The method further includes generating a cell-free plasma region in the channel, wherein the cell-free plasma region is generated in the channel based on rouleaux effect. The method further includes illuminating the sample with light having varying wavelengths. Additionally, the method includes obtaining an image of the illuminated sample at each of the wavelengths. Furthermore, the method includes analyzing the image to determine the concentration of the one or more analytes.
G01N 1/00 - Sampling; Preparing specimens for investigation
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
43.
MICROALBUMIN CREATININE ASSAY DETECTION FLAG AND METHODS OF PRODUCTION AND USE RELATED THERETO
Devices, kits, and methods related to embodiments of an improved liquid test sample injection device comprising a sample mixture that comprises at least one sample flag compound for detecting the presence or non-presence of a patient's liquid test sample upon being interrogated by a pre-determined wavelength of light.
A sensor assembly for analysis of physical parameters and chemical constituents of small volume samples of bodily fluids with at least two analyte sensors. The sensor assembly including a separation panel with an upper surface and a lower surface and upper and lower fluid channels disposed within the upper and lower surfaces respectively. The fluid channels extending substantially between the first and second ends and when in an operating mode bodily fluid is in fluid communication with both the upper and lower fluid channels. The sensor assembly including a potentiometric chip positioned atop and an amperometric chip positioned beneath the separation panel with at least one analyte sensor positioned above and beneath each of the fluid channels and when the sensor assembly is in an operating mode the fluid is in fluid communication with the analyte sensors. A bonding media is disposed beneath the amperometric chip.
A sensor assembly includes a first sensor substrate with upper surface, lower surface opposite upper surface, and a first set of sensors on the first sensor substrate. The sensor assembly includes a second sensor substrate with upper surface, lower surface opposite upper surface, and a second set of sensors on the second sensor substrate. The sensor assembly includes a base with upper surface, lower surface opposite upper surface of the base along a vertical direction, a front end, a rear end opposite the front end along a longitudinal direction perpendicular to the vertical direction, a first recess at least partially holds the first sensor substrate, a second recess at least partially holds the second sensor substrate, a first fluid passage for receiving a fluid, and a second fluid passage in series with and open to the first fluid passage. Both sensors are exposed to its corresponding fluid passage.
A sensor assembly for analysis of physical parameters and chemical constituents of small volume samples of bodily fluids. Disclosed herein is a sensor panel with an upper surface and a lower surface and at least one analyte sensor located on the lower surface. The sensor assembly also includes an optional adhesive layer and a contoured fluid pathway cutout. The upper surface of the adhesive layer is secured to the lower surface of the sensor panel. The sensor assembly also includes a sensor cartridge base with a fluid inlet and outlet and a contoured fluid pathway extending between the inlet and the outlet. The contoured fluid pathway mirrors the shape and span of the contoured fluid pathway cutout of the adhesive layer. As a fluid sample is input at the fluid inlet, the fluid traverses along the fluid pathway in contact with the at least one analyte sensor.
An illumination unit is described that includes a first light source positioned on a first axis and a second light source on a second axis that intersects and is angularly offset with respect to the first axis. The illumination unit includes a reflector having an aperture through which the first axis extends and a reflective surface angled with respect to the first axis and second axis.
Disclosed herein are compositions comprising oxygen, a sugar or sugar alcohol, and an amino acid, wherein the amino acid is present in an amount sufficient to stabilize the oxygen. Also provided are aqueous diagnostic quality controls or calibration reagents and methods of stabilizing oxygen in a liquid solution.
A point of care system may comprise a plurality of diagnostic engines and an IDM in electronic communication with each of the plurality of diagnostic engines. Each of the plurality of diagnostic engines may perform testing on a sample inserted into the diagnostic engine. The IDM may be configured to communicate with each of the plurality of diagnostic engines to enable a plurality of tests to be performed on multiple different samples substantially simultaneously by a plurality of users using the plurality of diagnostic engines and to present a single user interface for managing testing by the plurality of diagnostic engines and for receiving the results of tests performed by each of the plurality of diagnostic engines.
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 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
G16B 50/00 - ICT programming tools or database systems specially adapted for bioinformatics
G01N 33/48 - Biological material, e.g. blood, urine; Haemocytometers
The present disclosure describes a method in which a sample is passed through a fluid flow path of a sensor assembly such that the sample intersects at least one sensor comprising at least three electrodes arranged such that two or more electrodes are opposing and two or more electrodes are beside one another. The sensor is read by a reader monitoring changes to the sensor due to the presence of the sample. The reader measures the presence and/or concentration of one or more analytes within the sample based upon data obtained by the reader.
G01F 1/64 - Measuring the volume flow or mass flow of fluid or fluent solid material wherein the fluid passes through a meter in a continuous flow by using electric or magnetic effects by measuring electrical potential generated by the fluid flow, e.g. by electrochemical, contact, or friction effects
G01F 1/688 - Structural arrangements; Mounting of elements, e.g. in relation to fluid flow using a particular type of heating, cooling or sensing element
G01N 27/00 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
A point of care system may comprise a plurality of diagnostic engines and an IDM in electronic communication with each of the plurality of diagnostic engines. Each of the plurality of diagnostic engines may perform testing on a sample inserted into the diagnostic engine. The IDM may be configured to communicate with each of the plurality of diagnostic engines to enable a plurality of tests to be performed on multiple different samples substantially simultaneously by a plurality of users using the plurality of diagnostic engines and to present a single user interface for managing testing by the plurality of diagnostic engines and for receiving the results of tests performed by each of the plurality of diagnostic engines.
G01N 37/00 - INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES - Details not covered by any other group of this subclass
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 10/60 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
A61B 5/00 - Measuring for diagnostic purposes ; Identification of persons
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
52.
ADHESIVE-POLYMER CONTAINING MEMBRANES FOR IN VITRO DIAGNOSTIC DEVICES
In vitro diagnostic sensors are disclosed that include membranes formed of a polymer matrix that has been modified to contain surface adhesion functional group(s) that enables attachment of the membrane to a substrate of the sensor. Also disclosed are membranes of these sensors as well as multi-sensor arrays that include multiple sensors. In addition, methods of producing and using these membranes, sensors, and arrays are disclosed.
G01N 33/48 - Biological material, e.g. blood, urine; Haemocytometers
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
G01N 33/483 - Physical analysis of biological material
53.
SCAVENGER PROTEIN(S) FOR IMPROVED PRESERVATION OF ANALYTE DETECTION SENSOR(S) AND METHOD(S) OF USE THEREOF
Composition(s), device(s), kit(s), and method(s) for an improved analyte detection sensor(s) comprising at least one scavenger protein and method(s) of preserving the functioning and functional life of the improved analyte detection sensor(s).
A01N 43/80 - Biocides, pest repellants or attractants, or plant growth regulators containing heterocyclic compounds having rings with nitrogen atoms and oxygen or sulfur atoms, as ring hetero atoms five-membered rings with one nitrogen atom and either one oxygen atom or one sulfur atom in positions 1,2
A01P 1/00 - Disinfectants; Antimicrobial compounds or mixtures thereof
C12M 1/34 - Measuring or testing with condition measuring or sensing means, e.g. colony counters
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
C12Q 1/26 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving oxidoreductase
C12Q 1/37 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase involving peptidase or proteinase
Compositions, devices, kits, and methods for calibrating at least one oxygen sensor in a blood gas, electrolyte, and/or metabolite instrument utilizing a calibration fluid comprising a pyrogallol oxygen scavenger.
A method and a device for determining the concentration of an analyte in whole blood is disclosed. In one embodiment, the method includes generating a plasma layer in the whole blood sample. Furthermore, the method includes exposing the plasma layer to light. The method also includes capturing light reflected from the plasma layer. Additionally, the method includes analyzing the reflected light to determine the concentration of the analyte.
A method and a device for determining the concentration of an analyte in whole blood is disclosed. In one embodiment, the method includes generating a plasma layer in the whole blood sample. Furthermore, the method includes exposing the plasma layer to light. The method also includes capturing light reflected from the plasma layer. Additionally, the method includes analyzing the reflected light to determine the concentration of the analyte.
Disclosed are internal electrolyte layers for ion selective electrodes, wherein the internal electrolyte layers contain carbon paste doped with a metal salt. Also disclosed are ion selective electrodes and sensor array assemblies containing the internal electrolyte layers. Also disclosed are methods of producing and using the internal electrolyte layers, ion selective electrodes, and sensor array assemblies.
Multi-use biosensors are disclosed that include enzymes that have been modified to reduce the solubility thereof; the multi-use biosensors are used to detect analytes in fluidic biological samples, and the biosensors also maintain their enzyme activity after many uses. Multi-sensor arrays are disclosed that include multiple biosensors. Also disclosed are methods of producing and using these devices.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
G01N 33/487 - Physical analysis of biological material of liquid biological material
Multi-use biosensors are disclosed that include enzymes coupled to nanobeads; the multi-use biosensors are used to detect analytes in fluidic biological samples, and the biosensors also maintain their enzyme activity after many uses. Multi-sensor arrays are disclosed that include multiple biosensors. Also disclosed are methods of producing and using these devices.
C12Q 1/58 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving urea or urease
A sample receiving assembly capable of receiving a fluid sample from sample containers having different sizes and shapes includes an arm, an arm holder, a sample probe, and a support member, the support member having a bore therethrough and a plurality of linear grooves. The ann is disposed within the arm holder and the sample probe is disposed within the ann. The arm holder includes a hollow pivot pin insertable through the bore in the support member. The sample probe has a first portion extendable through a distal end of the arm, and a second portion extending axially through the hollow pivot pin. The plurality of linear grooves in the support member are sized and positioned to receive a guide pin on the arm and guide retraction of the arm into the arm holder from an extended position to a retracted position.
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
G01N 1/00 - Sampling; Preparing specimens for investigation
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
61.
SIMULTANEOUS MEASUREMENT OF MULTIPLE ANALYTES OF A LIQUID ASSAY
Analyzers and methods for making and using analyzers are described such as a method in which multiple absorption readings of a liquid assay are obtained by a photodetector using multiple light sources having at least three separate and independent wavelength ranges and with each of the absorption readings taken at a separate instant of time. Using at least one processor and calibration information of the liquid assay, an amount of at least two analytes within the liquid assay using the multiple absorption readings is determined.
G01N 21/31 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
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 21/17 - Systems in which incident light is modified in accordance with the properties of the material investigated
G01N 21/62 - Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
G01N 21/75 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
G01N 30/30 - Control of physical parameters of the fluid carrier of temperature
62.
MULTIPLE SEQUENTIAL WAVELENGTH MEASUREMENT OF A LIQUID ASSAY
Analyzers and methods for making and using analyzers are described such as a method in which multiple absorption readings of a liquid assay are obtained by a photodetector using multiple light sources having respective first and second wavelengths within at least two separate and independent wavelength ranges and with each of the absorption readings taken at a separate instant of time. Using at least one processor and calibration information of the liquid assay, an amount of at least one analyte within the liquid assay using the multiple absorption readings is determined.
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 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
Disclosed herein are methods of detecting ascorbic acid in a urine sample from a subject. The methods comprise contacting at least a portion of the urine sample with a test strip comprising a reagent pad and detecting whether ascorbic acid is present in the urine sample. The detecting comprises measuring an intensity of color on the reagent pad, wherein a reduction in the intensity of color on the reagent pad indicates the presence of ascorbic acid.
G01N 21/78 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
G01N 31/22 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroups; Apparatus specially adapted for such methods using chemical indicators
G01N 33/52 - Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper
64.
LIQUID ANALYTICAL REAGENT DISPENSING APPARATUS AND ANALYTICAL KITS AND METHODS OF USE RELATED THERETO
An analyzer system for in vitro diagnostics includes a sample handler module having a robot arm that delivers samples from drawers into carriers on a linear synchronous motor automation track. Samples are delivered via the automation track to individual track sections associated with individual analyzer modules. Analyzer modules aspirate sample portions directly from the sample carriers and perform analysis thereon.
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 1/00 - Sampling; Preparing specimens for investigation
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
66.
BIOFOULING PREVENTION OF WEARABLE SENSORS AND METHODS OF USE AND CALIBRATION RELATED THERETO
Devices, kits, and methods for (a) determining the presence and/or concentration of at least one analyte(s) of interest present in a patient's fluid sample and devices and methods of calibration related thereto, and (b) preventing, mitigating, and/or eliminating biofouling of an indwelling, wearable biosensor are disclosed and/or claimed herein.
G01N 21/78 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
G01N 33/48 - Biological material, e.g. blood, urine; Haemocytometers
G01N 33/52 - Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper
A method and system is described that includes obtaining a whole blood sample and obtaining a first light absorbance profile of the whole blood sample. Next, the whole blood sample is hemolyzed to generate a hemolyzed sample of blood and a second light absorbance profile of the hemolyzed sample of blood is obtained. The level of hemolysis in the whole blood sample is determined by comparing the first light absorbance profile and the second light absorbance profile.
An embodiment of the present disclosure is a sample vessel for a holding a sample for analysis by a sample analyzer. The sample vessel includes a body that includes a bottom, an open top spaced from the bottom along a first axis, a side wall that extends from the open top to the bottom, and an interior chamber for holding a sample and that extends from the open top toward the bottom along the first axis. The body includes an opaque portion, a first translucent portion, and a second translucent portion spaced from the first translucent portion a distance that extends along a second axis that is perpendicular to the first axis. The first and second translucent portions are each disposed along the bottom of the body.
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
70.
FLUID ANALYZER FOR MEASURING A TARGET ANALYTE AND METHOD OF CALIBRATING AN AMPEROMETRIC SENSOR
A control system for a fluid analyzer is described. The control system has a processor executing processor executable code to: control a potentiostat to apply a first voltage potential sufficient to induce a first electrochemical reaction of a target analyte or a reaction byproduct of the target analyte in a sample of the calibration reagent and receive a first reading from the potentiostat; control the potentiostat to apply a second voltage potential insufficient to induce a second electrochemical reaction of the target analyte or a reaction byproduct of the target analyte in the sample of the calibration reagent and receive a second reading from the potentiostat; calculate calibration parameters using the first reading, the second reading and a multi-point calibration algorithm; and measure a target analyte concentration within the fluid sample using the calibration parameters.
Devices, methods, and kits for detecting at least two analytes present within a small volume single fluid sample obtained from patient for the creation of a multiplexed panel of the various analytes present within the single fluid sample are disclosed.
Devices, methods, and kits for detecting at least two analytes present within a small volume single fluid sample obtained from patient for the creation of a multiplexed panel of the various analytes present within the single fluid sample are disclosed.
Sensing devices are provided which may be implemented to test various biological and chemical samples. The test devices include opposing sensor arrays, a flow channel, electrodes, multiple planar substrates, and integrated heating elements such that a sample may be thermally controlled for increased testing accuracy and controlled flow.
A fluid analyzer for analyzing fluid samples comprising one or more analytes and a method of calibrating such. The fluid analyzer includes a control system to control at least one automated valve to pass at least three calibration reagents through a fluid channel to a secondary ion selective electrode, a primary ion selective electrode, and a reference electrode, and determine calibration information using calibration logic from signals generated by a meter, control the at least one automated valve to selectively pass different subsets of the at least three calibration reagents through the fluid channel to the secondary ion selective electrode, the primary ion selective electrode, and the reference electrode, and determine re-calibration information using the signals generated by the meter and at least one of the calibration information and re-calibration logic.
The present invention is based in part on the present inventors' appreciation that certain sequences within an HIV genome are more likely to successfully detect HIV across a breadth of HIV variants. The ability to detect and/or quantify the presence and/or load of HIV in a subject is important to, among other things, the diagnosis and treatment of infected individuals. The present invention is based, in part, on the discovery of oligonucleotide reagents that detectably amplify sequences from a greater breadth of HIV samples than certain prior reagents and/or that generate amplicons from HIV genomes from which certain prior reagents would not have generated amplicons. Oligonucleotide reagents as described herein provide unexpected benefits in the detection and/or quantification of the presence and/or load of HIV in a subject, and thereby in the diagnosis and treatment of HIV.
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
C07H 21/02 - Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids with ribosyl as saccharide radical
Barcode tag conditions on sample tubes are detected utilizing side view images of sample tubes for streamlining handling in clinical laboratory automation systems. The condition of the tags may be classified into classes, each divided into a list of additional subcategories that cover individual characteristics of the tag quality. According to an embodiment, a tube characterization station (TCS) is utilized to obtain the side view images. The TCS enables the simultaneous or near-simultaneous collection of three images for each tube, resulting in a 360 degree side view for each tube. The method is based on a supervised scene understanding concept, resulting in an explanation of each pixel into its semantic meaning. Two parallel low-level cues for condition recognition, in combination with a tube model extraction cue, may be utilized. The semantic scene information is then integrated into a mid-level representation for final decision making into one of the condition classes.
G06K 7/14 - Methods or arrangements for sensing record carriers by corpuscular radiation using light without selection of wavelength, e.g. sensing reflected white light
G06V 10/80 - Fusion, i.e. combining data from various sources at the sensor level, preprocessing level, feature extraction level or classification level
G01N 37/00 - INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES - Details not covered by any other group of this subclass
A method of tube slot localization is provided using a tray coordinate system and a camera coordinate system. The method includes receiving, a series of images from at least one camera of a tray comprising tube slots arranged in a matrix of rows and columns. Each tube slot is configured to receive a sample tube. The method also includes automatically detecting fiducial markers disposed on cross sectional areas between the tube slots on the tray and receiving an encoder value indicating when each row of the tray is substantially at the center of the camera's field of view. The method further includes determining calibration information to provide mapping of locations from the tray coordinate system to locations from the camera coordinate system and automatically aligning the tray based on the encoder value and calibration information.
G01N 37/00 - INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES - Details not covered by any other group of this subclass
G06T 7/73 - Determining position or orientation of objects or cameras using feature-based methods
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
78.
LOCALITY-BASED DETECTION OF TRAY SLOT TYPES AND TUBE TYPES IN A VISION SYSTEM
A method for detecting properties of sample tubes is provided that includes extracting image patches substantially centered on a tube slot of a tray or a tube top in a slot. For each image patch, the method may include assigning a first location group defining whether the image patch is an image center, a comer of an image or a middle edge of an image, selecting a trained classifier based on the first location group and determining whether each tube slot contains a tube. The method may also include assigning a second location group defining whether the image patch is from an image center, a left comer of the image, a right comer of the image, a left middle of the image; a center middle of the image or a right middle of the image, selecting a trained classifier based on the second location group and determining a tube property.
A model-based method of inspecting a specimen for presence of one or more interferent, such as Hemolysis, Icterus, and/or Lipemia (HI L) is provided. The method includes generating a pixelated image of the specimen in a first color space, determining color components (e.g., an a-value and a b-value) for pixels in the pixelated image, classifying of the pixels as being either liquid or non-liquid, defining one or more liquid regions based upon the pixels classified as liquid, and determining a presence of one or more interferent within the one or more liquid regions. The liquid classification is based upon a liquid classification model. Pixel classification may be based on a trained multiclass classifier. Interference level for the one or more interferent may be provided. Testing apparatus adapted to carry out the method are described, as are other aspects.
Embodiments are directed to classifying barcode tag conditions on sample tubes from top view images to streamline sample tube handling in advanced clinical laboratory automation systems. The classification of barcode tag conditions leads to the automatic detection of problematic barcode tags, allowing for a user to take necessary steps to fix the problematic barcode tags. A vision system is utilized to perform the automatic classification of barcode tag conditions on sample tubes from top view images. The classification of barcode tag conditions on sample tubes from top view images is based on the following factors: (1) a region-of-interest (ROI) extraction and rectification method based on sample tube detection; (2) a barcode tag condition classification method based on holistic features uniformly sampled from the rectified ROI; and (3) a problematic barcode tag area localization method based on pixel-based feature extraction.
Systems and methods are provided that employ image-based tube top circle detection techniques to determine, within in-vitro diagnostics environments, tube characteristics in a more efficient and streamlined manner, which results in a reduced setup footprint and lower maintenance costs. Embodiments provide a method of using image-based tube top circle detection that includes extracting, from one of a series of images of a tube tray, a region of interest (ROI) patch having a target tube top circle and boundaries constrained by two dimensional (2D) projections of different types of tube top circle centers. The method includes calculation of an edge gradient magnitude map of the ROI patch and the use of weighted votes from edge points along edge point gradient directions to construct a 3D map for selecting target tube top circle based on the greatest accumulated votes.
G01B 11/08 - Measuring arrangements characterised by the use of optical techniques for measuring diameters
G06V 10/25 - Determination of region of interest [ROI] or a volume of interest [VOI]
G06V 10/44 - Local feature extraction by analysis of parts of the pattern, e.g. by detecting edges, contours, loops, corners, strokes or intersections; Connectivity analysis, e.g. of connected components
G06V 10/74 - Image or video pattern matching; Proximity measures in feature spaces
The present invention is directed to membranes, sensors, systems and process for the detection of magnesium ions in protein-containing samples. The novel membranes, sensors, systems, and processes are based upon the discovery that the lipophilcity of the plasticizer (or blend of plasticizers) utilized in the formulation of magnesium ion selective membranes for clinical use is inversely proportional to the sensitivity of the plasticizer(s) and directly proportional to the use life thereof.
There is described a process for improving precision in an analytical test for a target analyte in a sample. The process includes prior to analyzing the sample for a target analyte via a biosensor, introducing to an analytical zone defined by the biosensor a fluid comprising an effective amount of the target analyte.
This disclosure relates to the detection of whole blood hemolysis in a sample of whole blood. More specifically, this disclosure describes detecting hemolysis using one or more novel ratios of intercellular concentrations of whole blood analytes.
G01N 27/49 - Systems involving the determination of the current at a single specific value, or small range of values, of applied voltage for producing selective measurement of one or more particular ionic species
G01N 33/48 - Biological material, e.g. blood, urine; Haemocytometers
85.
SENSOR ARRAY WITH ANTI-DIFFUSION REGION(S) TO EXTEND SHELF LIFE
The inventive concepts disclosed herein are generally directed to a sensor array device that has a prolonged shelf life but requires only a minimal amount of sample volume in order to test two or more analytes concurrently. In order to ensure the sensor array has a sufficient shelf life, anti-diffusion regions are positioned among the reaction wells in order to slow the processes of diffusion. The use of anti-diffusion regions, as described herein, can be used to optimize the number of sensors that can be fit into a sensor array designed for reduced sample liquid volumes (e.g., less than 100 µL) as well as extending the test strip's shelf life.
G01N 27/27 - Association of two or more measuring systems or cells, each measuring a different parameter, where the measurement results may be either used independently, the systems or cells being physically associated, or combined to produce a value for a furthe
Aspects of the present invention are directed to devices, systems and methods that enable the quick and reliable detection of hemolysis in a sample such that a sample which exhibits an unacceptable level of hemolysis can be flagged or disregarded in an associated diagnostic test.
G01N 33/483 - Physical analysis of biological material
A61M 1/34 - Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration, diafiltration
B01D 61/00 - Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
G01N 33/72 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. hemoglobin, bilirubin
G01N 33/84 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving inorganic compounds or pH
87.
PHASE-MODULATED STANDING WAVE MIXING APPARATUS AND METHODS
Disclosed are mixing apparatus adapted to provide mixing of components in an automated analyzer. The mixing apparatus includes a reservoir configured to contain a coupling liquid, a transducer configured to be driven at a frequency and communicate with the coupling liquid, and a signal generation unit configured to provide a phase modulatable drive signal to the transducer. In some embodiments, improved patient sample and reagent mixing may be provided. Systems and methods are provided, as are other aspects.
This disclosure relates to creatinine biosensors and the uses thereof. More specifically, this disclosure describes potentiometric creatinine sensors which utilizes one or both of a type of enzyme capable of directly producing ammonium ions (NH4+) as a consequence of coming into contact with a liquid sample and an internal fill solution with a low free ammonium ion concentration.
A diagnostic device 10 for screening for a target analyte in a sample is provided. The diagnostic device 10 comprises a substrate 12 and a hydrophobic material 20 disposed on the substrate. The hydrophobic material 20 is selected to be converted from the hydrophobic material 20 to a hydrophilic material 22 upon contact with a conversion component within or derived from a sample introduced to the device 10.
C12Q 1/00 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
C12M 1/34 - Measuring or testing with condition measuring or sensing means, e.g. colony counters
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
G01N 33/52 - Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper
A plasma separation system and process for providing filtered plasma from a blood sample is described. The system may include a blood separation well having a separation membrane for filtering the blood sample. The filtering process may be aided by the use of a negative or positive pressure source attached to the plasma separation system.
In one illustrative embodiment, a test strip with a first planar substrate has coplanar electrodes on a first planar surface and a second planar substrate (which opposes the first surface of the first planar substrate) has coplanar electrodes on a second planar surface. The first planar surface of the first planar substrate having a first sensing area electrically connected to a first electrical contact. The second planar surface of the second planar substrate having a second electrical contact electrically connected to the first electrical contact via a conductive element, the conductive element extending between the first surface of the first planar substrate and the second surface of the second planar substrate without passing through the first planar substrate, the second planar substrate, or any intermediate layers.
81801963 ABSTRACT In one aspect, the inventive concepts disclosed herein are directed to a sensor assembly which contains a first planar substrate and a second planar substrate which respectively support opposing sensor arrays and contains an integrated flow path extending between the first and second substrates. Sensor assembly contains a first planar substrate having a base layer, and a conductive layer formed on a first planar surface of the base layer. Base layer may be made from, for example, ceramic, polymer, foil, or any other type of material known to someone of ordinary skill in the art. Conductive layer contains at least two electrically isolated electrical contacts made, for example, using a thick film approach (e.g., screen printing, rotogravure, pad printing, stenciling conductive material such as carbon, Cu, Pt, Pd, Au, and/or Nanotubes, etc.) or a thin firm approach (e.g., by sputtering, thennal spraying, and/or cold spraying conductive material). Date Recue/Date Received 2020-11-03
G01N 1/20 - Devices for withdrawing samples in the liquid or fluent state for flowing or falling materials
G01N 27/00 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
H01L 23/485 - Arrangements for conducting electric current to or from the solid state body in operation, e.g. leads or terminal arrangements consisting of lead-in layers inseparably applied to the semiconductor body consisting of layered constructions comprising conductive layers and insulating layers, e.g. planar contacts
93.
MICROFLUIDIC DEVICE WITH DEGASSING MEMBRANE AND OPTICAL MEASUREMENT CHAMBER
A fluidic device and a method for degassing a fluidic device are presented. The fluidic device includes a plurality of fluidic components such as channels, chambers, and integrated valves and pumps, etc. A porous membrane is disposed on a degassing area of the fluidic device for removing gas (such as, for example, bubbles) contained in a liquid. A fluid control device monitors a pressure profile indicating a pressure in the fluidic device over time and applies a pressure differential between two sides of the membrane when activated. The membrane is permeable to gas in the fluidic device and is impermeable to liquids through the pores under the pressure differential. The disclosed method enables degassing large volume of gas at a high flow rate and provides a bubble free filling in a fluidic device which is critical to precision sample metering, mixing, fluid control, reaction, and detection, etc.
Disclosed herein is a kit comprising a potentiometric ion selective electrode comprising a solid-state planar magnesium sensing membrane for installation within a clinical diagnostic instrument in combination with three calibration reagents that are designed for use with the solid-state planar magnesium sensing membrane for the potentiometric ion selective electrode to provide the electrode with a stable uselife of at least four weeks. The potentiometric ion selective electrode detects ionized magnesium in a biological sample, and the potentiometric ion selective electrode comprises a solid-state planar magnesium sensing membrane. The first, second, and third calibration reagents comprise calcium ions and magnesium ions that are both present at different concentrations from the concentrations found in each of the other two calibration reagents; however, the calcium and magnesium ions are present in each of the calibration reagents at a calcium:magnesium molar ratio in a range of from about 1.5:1 to about 3.25:1.
Methods and systems for detecting properties of sample tubes in a laboratory environment include a drawer vision system that can be trained and calibrated. Images of a tube tray captured by at least one camera are analyzed to extract image patches that allow a processor to automatically determine if a tube slot is occupied, if the tube has a cap, and if the tube has a tube top cup. The processor can be trained using a random forest technique and a plurality of training image patches. Cameras can be calibrated using a three-dimensional calibration target that can be inserted into the drawer.
In one aspect, the inventive concepts disclosed herein are directed to a chromatographic assay device for detecting the presence of free hemoglobin in a whole blood sample. The device comprising a chromatographic detection pad with a sample application site and a detection side. The chromatographic detection pad defines a path for capillary fluid flow. The chromatographic detection pad has a pore size. The sample application site on the chromatographic detection pad is for application of a portion of the whole blood sample. The detection site on the chromatographic detection pad is spaced apart from the application site and is downstream of the sample application site. The chromatographic detection pad is devoid of a compound located downstream of the application site that is reactive to the whole blood sample.
A microfluidic device 10 is provided that includes a porous substrate 12 and a plurality of reaction channels 14 disposed on a first side 36 of the porous substrate 12. The reaction channels 14 are defined by a barrier material 16 disposed on the substrate 12 in a user-defined pattern 13. At least one reagent 18 is disposed within each reaction channel 14 in an amount effective to test for the presence of at least one analyte or property in a sample introduced to the device 10.
An insert for a sample collection tube includes a generally hollow tubular body insertable into the sample collection tube. The tubular body is open at least at one end. The tubular body of the insert has an internal cross-sectional area dimensioned to accommodate a width of test strip which comprises a plurality of test areas arranged along its length. The internal cross-sectional area of the tubular body is further dimensioned such that volume of 2.5mL of a liquid sample inside the insert occupies a height which is at least sufficient to wet all of the test areas of the test strip when the strip is inserted lengthwise into insert containing the liquid sample.
G01N 21/78 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
G01N 1/20 - Devices for withdrawing samples in the liquid or fluent state for flowing or falling materials
99.
MAGNESIUM SENSING MEMBRANE FOR POTENTIOMETRIC ION SELECTIVE ELECTRODE FOR MEASURING IONIZED MAGNESIUM AND METHODS OF PRODUCTION AND USE THEREOF
A magnesium sensing membrane is disclosed for use in a potentiometric ion selective electrode that exhibits improved stability upon exposure to surfactant-containing reagents. Kits containing same are disclosed, along with methods of production and use of the magnesium sensing membrane.
A chemiluminescent detection system, as well as kits and microfluidics devices containing same, are disclosed. Methods of using the system, kits, and devices are also disclosed. The first, second, and third antibodies or binding fragments thereof may be provided in any form that allows these antibodies/binding fragments to function in accordance with the presently disclosed and claimed inventive concept(s). For example, each of the first, second, and third antibodies/binding fragments may be a polyclonal antibody/binding fragment or a monoclonal antibody/binding fragment.
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