The present disclosure refers to a homogeneous method, apparatus and device for detection of target nucleic acids in a sample. In one aspect, the device includes a magnetic bead. Further, the device includes one or more oligonucleotides bound to the magnetic bead. Additionally, the device includes at least one reporter molecule linked to the one or more oligonucleotides.
Diagnostic immunoassay reagent compositions are disclosed that include liposomes having analyte-specific binding element(s) associated therewith. In particular, the analyte-specific binding element(s) includes a transmembrane domain that anchors the element(s) in the lipid bilayer of the liposome; the analyte-specific binding element(s) further includes an extracellular/extramembrane domain that is exposed on the outer surface of the liposome and that comprises a domain that specifically binds to the target analyte. Also disclosed are kits, devices, and systems that contain the diagnostic immunoassay reagent compositions, as well as methods of producing and using the diagnostic immunoassay reagent compositions.
An automated diagnostic analysis system includes a system controller for system-wide workflow planning and execution of sample analyses and also includes decentralized processing capabilities (e.g., one or more second controllers) for determining a work-around, where possible, to a detected fault affecting an analysis of a particular sample. The system controller communicates with system components via a first communication channel, while the second controller communicates with a subset of the system components via a second communication channel. Where a work-around for a detected fault cannot be determined by the second controller, the detected fault is communicated to the system controller for resolution. Methods of operating an automated diagnostic analysis system are also provided, as are other aspects.
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 33/50 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
4.
DIAGNOSTIC LABORATORY SYSTEMS AND METHODS OF UPDATING
Diagnostic laboratory systems, methods of operating diagnostic laboratory systems, and methods of updating diagnostic laboratory systems are disclosed. A method of operating a diagnostic laboratory system includes identifying data in the system as identified data; identifying change in a data distribution of the identified data; aggregating data instances pertaining to the change in the data distribution; selecting a subset of the aggregated data to update a processing algorithm in the system; and updating the processing algorithm using the subset of the aggregated data. Other systems and methods are disclosed.
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
5.
DIAGNOSTIC LABORATORY SYSTEMS AND METHODS OF IMAGING TUBE ASSEMBLIES
A method of synthesizing an image of a tube assembly includes capturing an image of the tube assembly, wherein the capturing generates a captured image. The captured image is decomposed into a plurality of features in latent space using a trained image decomposition model. One or more of the features in the latent space is manipulated into one or more manipulated features. A synthesized tube assembly image is generated with at least one of the manipulated features using a trained image composition model. Other methods and systems are disclosed.
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
A system (100) and a method (200) for predicting presence of a disease in a subject is disclosed. In one aspect, the system (100) includes one or more processing units (101), a medical database (112) coupled to the one or more processing units (101), and a disease prediction module (110). The module (110) is configured to receive a plurality of parameters associated with the subject. Additionally, the module (110) is configured to determine a threshold for sensitivity and/or specificity associated with a trained machine learning model. Further, the module (110) is configured to predict using the trained machine learning model the presence of the disease in the subject based on the desired sensitivity and specificity and the plurality of parameters associated with the subject and output the prediction on an output unit (105).
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
G16H 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
A method of patient-centric load planning for a diagnostic laboratory having a plurality of instruments includes receiving a list of patient samples, a list of requested tests to be performed for each of the patient samples, and patient-centric information for the patient providing each patient sample. The received data is used to determine a load plan for the instruments, the load plan including a menu of selected tests assigned to each instrument and an ordering of patient samples according to a priority score based on at least a portion of the electronic health record (EHR) of the patient providing the patient sample. A system for patient-centric load planning includes a plurality of instruments controlled by a system controller and computer server to formulate and execute the load plan.
G06Q 10/06 - Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
G06Q 10/0631 - Resource planning, allocation, distributing or scheduling for enterprises or organisations
G06Q 10/0637 - Strategic management or analysis, e.g. setting a goal or target of an organisation; Planning actions based on goals; Analysis or evaluation of effectiveness of goals
8.
SEALING SYSTEM BETWEEN A MANIFOLD AND A LIQUID CONTAINER
A sealing system is provided that includes a liquid container configured to hold a liquid. The liquid container defines an opening having an inner circumferential sealing surface surrounding the opening, a manifold through which liquid is supplied to and/or removed from the liquid container. The manifold includes a sealing protrusion having an outer circumferential sealing surface, which is curved along a longitudinal axis. In a connected state, the manifold is located on the opening to supply liquid to, or to remove liquid from, the liquid container. The sealing protrusion extends into the opening, and the outer circumferential sealing surface contacts the inner circumferential sealing surface to form a seal between the manifold and the liquid container. In an unconnected state, a circumferential length of the outer circumferential sealing surface is larger than a circumferential length of the inner circumferential sealing surface.
A tiltable display screen assembly of a diagnostic analyzer. The tiltable display screen assembly includes a tiltable support interconnectable to a hand-held device including a display screen, a multi-angle adjuster having adjustment features, and a tilting screen mechanism pivotable relative to the tiltable support. The tilting screen mechanism includes a shaft, one or more moveable paddles coupled to the shaft, an adjustment member depending from the shaft configured to engage with the adjustment features of the multi-angle adjuster in order to adjust a tilt angle of the tiltable support and the display screen of the hand-held device. Diagnostic analyzers including the tiltable display screen assembly and methods for adjusting tilt angle of a display screen of a diagnostic analyzer are described, as are other aspects.
F16M 13/00 - Other supports for positioning apparatus or articles; Means for steadying hand-held apparatus or articles
E04G 3/00 - Scaffolds essentially supported by building constructions, e.g. adjustable in height
F16M 11/14 - Means for attachment of apparatus; Means allowing adjustment of the apparatus relatively to the stand allowing pivoting in more than one direction with ball-joint
10.
COMBINED TOTAL IG AND IGG IMMUNOASSAYS FOR SARS-COV-2
Methods for determining if a patient is positive for COVID-19 infection are provided, in which immunoassays are performed to detect the presence of anti-SARS-CoV-2 total immunoglobulin antibodies (tAb) and anti-SARS-CoV-2 IgG antibodies in a patient sample. The two results are combined to provide optimal sensitivity and specificity for the COVID-19 assay. Also disclosed are kits and microfluidic devices for use in the methods.
A sensor assembly for a bodily fluid analyzer includes a reference electrode container containing a reference electrode, a membrane capable or configured to be in fluid communication with the reference electrode container; and a wicking member capable or configured to be in fluid communication with the reference electrode container. The wicking member is configured to draw a reference fluid contained in the reference electrode container towards the membrane when the membrane and the wicking member are exposed to the reference fluid.
A61B 10/00 - Other methods or instruments for diagnosis, e.g. for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
Kits, microfluidics devices, and methods are disclosed for determining if a patient is positive for COVID-19 infection, in which immunoassays are performed to detect the presence of anti-SARS-CoV-2 antibodies in a patient sample. The kits, microfluidics devices, and methods incorporate the use of a reflex test within the reagent cartridge for the major anti-SARS-CoV-2 antibody assay, wherein the minor assay of the reflex test is employed when the result obtained in the major assay is above a baseline index. The reflex test (i.e., minor assay) utilizes at least one reagent that is different from the reagents utilized in the major assay.
A computer implemented method, an imaging device, an image reconstruction system and a computer program product, for calibrating system parameters of the image reconstruction system are provided, and include obtaining low resolution captured images by illuminating a sample with light source(s), obtaining a high resolution representation of the captured images based on the system parameters and the captured images, generating an approximate function based on the high resolution representation and the captured images, wherein the approximate function is a function of system parameters, and generating an updated set of system parameters by optimizing the approximate function. The computer implemented method, the imaging device, the image reconstruction system, and the computer program product enhance speed of calibration of the image reconstruction system by orders of magnitude, thereby, enabling noise and artifact free microscopic imaging in a robust way for the lifetime of the microscope.
Biotin-trap compositions are disclosed that contain particles having an inner polymer coating layer disposed on at least a portion of an outer surface thereof and a biotin-specific binding partner conjugated to the inner polymer coating layer. The biotin-trap compositions may further include an outer polymer coating layer disposed about the biotin-specific binding partner. The biotin-trap compositions specifically bind to free biotin but do not substantially bind to biotin conjugated to other moieties, such as biotinylated assay reagents. Also disclosed are kits and microfluidics devices that include the biotin-trap compositions, as well as methods of producing and using the biotin-trap compositions.
A vessel transport system in a liquid handler system includes vessel movers that transport a sample vessel using a magnetic base. A track provides a selective magnetic field to propel the magnetic base of each vessel mover along the track using a plurality of multilayer printed circuit boards (PCB) arranged along a transport path. Each PCB has a plurality of multi-layer conductive coils within layers of the PCB and each coil has a plurality of single-layer spirals electrically coupled with one another to form a multilayer coil. A processor is configured to control selective application of currents to the plurality of multi-layer coils to create the selective magnetic field. At least a subset of the multi-layer conductive coils are stacked relative to one another below a surface of the track, such that the selective application of currents selects one of a plurality of branching paths along the track.
A transport track for selectively routing magnetic vessel movers includes a plurality of multilayer printed circuit boards (PCB) arranged adjacent to one another such that a surface of each PCB provides a track surface along which the magnetic vessel movers ride. A plurality of conductive coils are formed within one of the PCBs and include a plurality of single-layer spirals electrically coupled in a stack with one another to form a multilayer coil. A processor is configured to control selective application of currents to the plurality of multi-layer coils to create a magnetic field to propel the magnetic vessel movers along the track. The plurality of conductive coils are arranged adjacent to one another in each PCB to create at least one continuous path for the magnetic vessel movers to move along.
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
H02K 1/12 - Stationary parts of the magnetic circuit
G16H 40/40 - 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 of medical equipment or devices, e.g. scheduling maintenance or upgrades
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.
Immunoassay reagents are disclosed that contain a dehydroepiandrosterone sulphate-fluorescein (DHEAS-FITC) conjugate or a dehydroepiandrosterone sulphate-carboxymethoxylamino-dimethyl acridinium ester (DHEAS-CMO-DMAE) conjugate. Also disclosed are immunoassay kits and devices that contain one or more of the DHEAS conjugates. Methods of making and using the DHEAS conjugates are further disclosed.
A reagent strip is described. The reagent strip includes a substrate and at least one reagent pad positioned on the substrate. The substrate has a storage unit storing control information, such as an authentication code, encoded as a part of a non-visible code. The authentication code may be used to determine if the reagent strip is authentic before testing is done or results are produced.
G06K 7/12 - Methods or arrangements for sensing record carriers by corpuscular radiation using a selected wavelength, e.g. to sense red marks and ignore blue marks
G01N 21/84 - Systems specially adapted for particular applications
G01N 33/487 - Physical analysis of biological material of liquid biological material
A method and system for replenishing refrigerated consumables by a mobile connected autonomous refrigerator includes receiving a notification triggered by a laboratory instrument that a refrigerated consumable used by the laboratory instrument is depleted; autonomously navigating to a refrigerated storage; retrieving the refrigerated consumable and placing it in the mobile refrigerated unit; autonomously moving to the laboratory instrument that triggered the notification; and alerting an operator to retrieve the refrigerated consumable from mobile refrigerated unit and load it into the laboratory instrument.
Lateral flow devices, kits, and methods for detecting the presence and/or concentration of anti‐SARS‐CoV‐2 antibodies in a sample are disclosed. In certain non‐limiting embodiments, the lateral flow devices, kits, and methods can distinguish between anti‐SARS‐CoV‐2 antibodies generated in response to vaccination from anti‐SARS‐CoV‐2 antibodies generated in response to infection.
Kits containing a multiplexed chemiluminescent detection system and microfluidics devices and methods for detecting the presence and/or concentration of anti-SARS-CoV-2 antibodies in a sample are disclosed. The kits, microfluidics devices, and methods utilize singlet oxygen-activatable chemiluminescent compounds in combination with two or more fluorescent molecules that emit light at different wavelengths. In certain non-limiting embodiments, the kits, microfluidics devices, and methods can distinguish between anti-SARS-CoV-2 antibodies generated in response to vaccination from anti-SARS-CoV-2 antibodies generated in response to infection.
The disclosure relates to a method (100) of optically analyzing a blood cell from a blood sample with a device for optically analyzing a blood cell from a blood sample, the device (1) comprising a microfluidic chamber with at least one fluidic flow-through channel, a first inlet (6) port configured to introduce at least a part of the blood sample into the fluidic channel, a first outlet (7) port configured to discharge at least a part of the blood sample from the fluidic channel, a flow generating and stopping device configured to generate a flow of the sample through the channel and to stop the flow while a least a part of the sample comprising at least one blood cell is situated within the channel and wherein after stopping the flow the sample is only influenced by gravity and inertial forces such that blood cells within the sample sediment on a first area of a lower surface of the channel, wherein cells sedimented within the first area of the lower surface can be optically analyzed in the chamber, and to a hematology analyzer.
Embodiments provide a tube retainer system, including: an outer body; a diaphragm having a circular opening; a valve including a valve head and a valve stem attached to the valve head; a cam; a camshaft extending through the cam; a drive gear attached to the camshaft; a restraint gear attached to the camshaft; a push bar located below the diaphragm; and a pawl. The diaphragm, the cam, the drive gear, the restraint gear, the push bar, and the pawl are all provided in the outer body, when a bottom of a tube is inserted into the circular opening and a downward pressure is applied on the diaphragm, the cam is oriented to close the valve to form a partial vacuum in the outer body to secure the bottom of the tube within the circular opening.
The present disclosure provides methods and kits for identifying and treating individuals at risk of or suffering from amyloid transthyretin cardiomyopathy. In general, detection or measurement of one or more biomarkers, such as TnI, PKM1, PKM2, NT-proBNP, RBP4, DCN, TIMP2, SMOC-2, NfL, or combinations thereof, assists in the identification of amyloid transthyretin cardiomyopathy. The present disclosure also provides methods for selecting patients for treatment of amyloid transthyretin cardiomyopathy, such as with transthyretin stabilizing agents.
A method of performing a study using one or more laboratory analyzers includes displaying on a display one or more evaluation studies performable on the one or more laboratory analyzers; receiving a selected evaluation study to be performed on the one or more laboratory analyzers from the one or more evaluation studies; generating, by a processor, instructions configured to operate the one or more laboratory analyzers to perform the evaluation study; and executing the instructions in the one or more laboratory analyzers. The instructions cause the one or more laboratory analyzers to perform an analysis using one or more test materials in response to the selected evaluation study. Other methods and apparatus are disclosed.
G16H 10/40 - ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
G16H 40/20 - ICT specially adapted for the management or administration of healthcare resources or 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
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.
A dynamometer includes a torque measuring device configured to measure torque applied to the torque measuring device; a clutch having a clutch input and a clutch output, the clutch output coupled to the torque measuring device and the clutch input configured to be coupled to a motor under test; wherein friction between the clutch input and the clutch output is variable; and a dampening mechanism configured to dampen the friction between the clutch input and the clutch output. Other dynamometers and methods of measuring torque are disclosed.
F16F 9/00 - Springs, vibration-dampers, shock-absorbers, or similarly-constructed movement-dampers using a fluid or the equivalent as damping medium
G01L 3/14 - Rotary-transmission dynamometers wherein the torque-transmitting element is other than a torsionally-flexible shaft
G01L 5/00 - Apparatus for, or methods of, measuring force, work, mechanical power, or torque, specially adapted for specific purposes
G01L 5/26 - Apparatus for, or methods of, measuring force, work, mechanical power, or torque, specially adapted for specific purposes for determining the characteristic of torque in relation to revolutions per unit of time
G01L 3/00 - Measuring torque, work, mechanical power, or mechanical efficiency, in general
30.
APPARATUS AND METHOD FOR REMOVING BUBBLES FROM 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 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.
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.
The disclosure relates to a device and method for analyzing a blood sample, particularly including pre-analytical (qualification), analytical and post-analytical (verification) testing. More particularly the disclosure relates in certain embodiments to a device configured for collecting, imaging and lysing blood cells in a sample vessel by means of ultrasonic acoustic waves, generated in the vessel by an acoustic transducer driven at one particular excitation frequency or more particular excitation frequencies, or one range of frequency or ranges of frequencies. In some non-limiting embodiments, the ultrasonic acoustic waves are generated by a single acoustic transducer. Further on, according to certain embodiments, the device and workflow are configured for three analytical steps in single device, comprising pre-analytical (qualification), analytical and post-analytical (verification) testing.
Methods of early real-time detection or prediction of aspiration faults in an automated diagnostic analysis system include an artificial intelligence algorithm configured to use either cluster analysis or probabilistic graphical modeling based on an aspiration pressure measurement signal waveform. Aspiration faults may include short-volume aspiration and unwanted gel pick-up. These methods may allow for timely termination of an aspiration process so as to avoid or minimize possible detrimental downstream consequences such as faulty sample test results and/or instrument downtime for servicing and cleanup. Apparatus for early real-time detection or prediction of aspiration faults are provided as are other aspects.
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
Methods of real-time detection of short-sample aspiration faults in an automated diagnostic analysis system include spectral analysis of a pressure slope waveform based on aspiration pressure measurement signals. The spectral analysis may include using a moving average filter or a wavelet transform, such as, e.g., a continuous wavelet transform (CWT) or a discrete wavelet transform (DWT), to identify distinct transient behavior in the pressure slope waveform. These methods accurately identify short-sample aspiration faults such that an automated diagnostic analysis system can timely terminate an analysis of a detected short sample to avoid a possibly erroneous sample test result. Apparatus for real-time detection of short-sample aspiration faults is also provided, as are other aspects.
G01F 22/02 - Methods or apparatus for measuring volume of fluids or fluent solid material, not otherwise provided for involving measurement of pressure
G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
36.
DETECTION OF ABNORMAL HEAT EXCHANGER OPERATING CONDITION
A method for detecting an abnormal operating condition of a heat exchanger is provided. The method includes determining the actual current through a heat exchanger, using the actual current to indicate an abnormal operating condition, and declaring a fault state. A step of comparing the baseline current to the actual current includes normalizing the actual current, calculating a difference between the normalized actual current and the baseline current, and determining that difference is less than zero.
Methods of characterizing a sample container or a biological sample in an automated diagnostic analysis system using an artificial intelligence (AI) algorithm include retraining of the AI algorithm in response to characterization confidence levels determined to be unsatisfactory. The AI algorithm is retrained with data (including image data and/or non-image data) having features prevalent at the site where the automated diagnostic analysis system is operated, which were not sufficiently or at all included in training data used to initially train the AI algorithm. Systems for characterizing a sample container or a biological sample using an AI algorithm are also provided, as are other aspects.
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
A method of characterizing a specimen container or a specimen in an automated diagnostic system includes capturing an image of a specimen container containing a specimen using an imaging device. The method further includes characterizing the image using a first AI model and determining whether a characterization confidence of the image is below a pre-selected threshold. The first AI model is retrained with the image having the characterization confidence below the pre-selected threshold to a second AI model, wherein the retraining includes data selected from one or more of a group of: non-image data, and text data. Quality check modules and systems configured to perform the method are also described, as are other aspects.
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
A method (200), and a system (100) for processing medical images is provided. In one aspect, the method (200) includes receiving the medical image, wherein the medical image comprises a plurality of objects, wherein the medical image is a low-resolution image. Further, the method (200) includes segmenting at least one object from the plurality of objects from the medical image. Additionally, the method (200) includes identifying at least one region of interest in the medical image, wherein the region of interest comprises the at least one object, wherein the at least one object is clinically relevant. Furthermore, the method (200) includes generating a high-resolution image of the region of interest. The method also includes displaying the high-resolution image of the region of interest on a display unit.
A method of monitoring a specimen container or specimen in a diagnostic laboratory system includes moving the specimen container on a track within the diagnostic laboratory system; moving a sensor module on the track; and monitoring at least one characteristic of the specimen container or a specimen located in the specimen container using the sensor module. Other methods, sensor modules, and diagnostic laboratory systems are disclosed.
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 29/26 - Arrangements for orientation or scanning
G01N 29/275 - Arrangements for orientation or scanning by moving both the sensor and the material
An automated analyzer is described. The analyzer includes a housing, a consumable insert, a consumable support device, a reader and a control system. The housing has a sample port. The consumable insert has a consumable insert type and an identification component and receives a consumable. The consumable support device is disposed within the sample port, supports the consumable insert, and is moveable to a testing position within the internal cavity. The consumable support device has an identifier component configured to identify the consumable insert type based in part on the identification component and configured to output a first data signal indicative of the consumable insert type. The reader outputs a second data signal indicative of a reading from the consumable. The control system receives the first and second data signals, and interprets the second data signal based on the first data signal.
Reagents, kits, and microfluidics devices are disclosed for detecting the presence and/or concentration of antibodies directed to microorganisms in human biological samples. Also disclosed are methods of production and use of the reagents, kits, and microfluidics devices. Anti-human immunoglobulin antibodies are utilized as a reagent in a bridging immunoassay for detection of the microorganisms.
A method of operating a diagnostic instrument includes illuminating an imaging location of the diagnostic instrument with first light having a first spectrum for a first period and capturing a first image of the imaging location illuminated by the first light. The method further includes illuminating the imaging location of the diagnostic instrument with second light having a second spectrum for a second period, the second spectrum being more destructive to a chemical configured to be received in the diagnostic instrument than the first spectrum; and capturing a second image of the imaging location illuminated by the second light. Other methods and diagnostic instruments are disclosed.
Diagnostic instruments and methods of operating diagnostic instruments are provided. Methods of operating a diagnostic instrument includes providing the diagnostic instrument having one or more modules, wherein the one or more modules are configured to analyze specimens; providing a specimen sorter coupled to the diagnostic instrument; and sorting specimens into at least first group and a second group, wherein specimens in the first group are to be analyzed by at least one of the one or more modules, and specimens in the second group are not to be analyzed by any of the one or more modules. Other sorting methods and diagnostic instruments are provided.
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
G01N 21/66 - Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light electrically excited, e.g. electroluminescence
G01N 33/58 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
An analyzer control product provided with a sealed rack tube containing a preconfigured volume of analyzer control fluid is described. In particular, the rack tube is provided with a base portion; a top portion; and a sidewall extending from the base portion to the top portion, the sidewall having an inner peripheral surface and an outer peripheral surface, at least one of the inner peripheral surface and the outer peripheral surface in contact with the base portion to form a control fluid void. The analyzer control fluid is within the control fluid void. The analyzer control fluid has a preconfigured volume. A sealing member is attached to the top portion to seal the control void.
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 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
46.
METHOD, DEVICE AND SYSTEM FOR ENHANCING IMAGE QUALITY
A method, device and system for enhancing image quality of an image is provided. In one aspect, the method includes illuminating a sample with a light source associated with an imaging device. Further, the method includes simulating a transmission wave at a sensor plane of the imaging device for a light wave from illuminating the sample. Additionally, the method includes determining a phase and amplitude information associated with the light wave based on the transmission wave. The method also includes determining at least one microscope transfer function associated with the imaging device based on the phase and amplitude information. Furthermore, the method includes generating a modified mi-croscope transfer function using a Zernike function based on the at least one microscope transfer function in an iterative procedure and enhancing the image quality associated with the im-age using the modified microscope transfer function.
Methods of operating a diagnostic laboratory system include providing a module configured to perform a function on an item in the diagnostic laboratory system; providing a plurality of sensors, each of the plurality of sensors configured to monitor the function or the item and generate sensor data in response to the monitoring; checking an operational status of a first sensor of the plurality of sensors; receiving sensor data from at least one of the plurality of sensors; and scaling sensor data from the first sensor in response to the operational status and the sensor data to generate revised sensor data. Systems including a middleware server configured to carry out the methods are provided as are other aspects.
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
G01N 21/13 - Moving of cuvettes or solid samples to or from the investigating station
G01F 22/00 - Methods or apparatus for measuring volume of fluids or fluent solid material, not otherwise provided for
G01F 22/02 - Methods or apparatus for measuring volume of fluids or fluent solid material, not otherwise provided for involving measurement of pressure
48.
METHODS AND APPARATUS ADAPTED TO IDENTIFY 3D CENTER LOCATION OF A SPECIMEN CONTAINER USING A SINGLE IMAGE CAPTURE DEVICE
A method of determining a 3D center location of a specimen container on a track. The method includes providing a calibration object on the track; providing an initially calibrated image capture device adjacent to the track; moving the calibration object to at least two different longitudinal positions along the track; capturing a first image with the calibration object located at the first longitudinal position; capturing a second image with the calibration object located at the second longitudinal position; and determining a three-dimensional path trajectory of a center location along the track based at least upon the first image and the second image. The method can be used to determine a 3D center location of a specimen container imaged anywhere within a viewing area. Characterization apparatus and specimen testing apparatus adapted to carry out the methods are described, as are other aspects.
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
Methods of utilizing sample lysis reagent compositions in the handling of samples containing viruses, such as (but not limited to) severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), are disclosed. Kits containing the sample lysis reagent compositions are also disclosed.
Apparatus for robotic arm alignment in an automated sample analysis system includes a robotic arm, a sample tube carrier, a plurality of optical components (including, e.g., one or more cameras), and a controller. The controller is operative to process images received from the optical components to determine a first set of coordinates of a first marker relative to the sample tube carrier and determine a second set of coordinates of a second marker relative to the robotic arm. The controller is further operative to adjust the position of the robotic arm and/or the sample tube carrier in response to an excessive offset between the first and second sets of coordinates. In some embodiments, a positioning tool includes the first and second markers thereon. Methods of robotic arm alignment with a sample tube carrier in an automated sample analysis system are also provided, as are other aspects.
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
51.
APPARATUS AND METHODS OF ALIGNING COMPONENTS OF DIAGNOSTIC LABORATORY SYSTEMS
A method of aligning a component to a structure in a diagnostic laboratory system. The method includes aligning a position sensor to the structure; sensing a position of the component using the position sensor; and calculating the position of the component relative to the structure based at least in part on the sensing. Other methods, apparatus, and systems are disclosed.
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
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
52.
APPARATUS AND METHODS OF DETECTING DEFECTS IN MACHINE VISION SYSTEMS
Methods of identifying a defect in a machine vision system. Embodiments of the method include providing a first imaging device having a first field of view; moving a reflective tool through the first field of view; capturing a plurality of images of the reflective tool at different locations in the first field of view using the first imaging device; and analyzing at least one of the plurality of images to identify one or more defects in the machine vision system. Systems and apparatus configured to carry out the methods are provided, as are other aspects.
A luminescence detection system for use in immunoassay testing. Luminescence detection system comprises a sample holder configured to hold a test sample including labeled components, wherein the labeled components in the test sample undergo a chemiluminescent reaction and emit luminescent emissions over a first wavelength range, a photodetector having a light entrance window configured to receive light emissions, the photodetector having a maximum detection efficiency wavelength range, and a conversion member provided adjacent the light entrance window that operates to cause conversion of the luminescent emissions over the first wavelength range to incident emissions of a second wavelength range wherein an incident peak of the incident emissions falls within the maximum detection efficiency wavelength range where the quantum efficiency of the photodetector is 10% or more. Methods of luminescence detection are provided, as are other aspects.
Methods of predicting a fault in a diagnostic laboratory system include providing one or more sensors; generating data using the one or more sensors; inputting the data into an artificial intelligence algorithm, the artificial intelligence algorithm configured to predict at least one fault in the diagnostic laboratory system in response to the data; and predicting at least one fault in the diagnostic laboratory system using the artificial intelligence algorithm. Other methods, systems, and apparatus are also disclosed.
G01B 7/00 - Measuring arrangements characterised by the use of electric or magnetic techniques
G06F 11/07 - Responding to the occurrence of a fault, e.g. fault tolerance
H02H 3/04 - Emergency protective circuit arrangements for automatic disconnection directly responsive to an undesired change from normal electric working condition, with or without subsequent reconnection - Details with warning or supervision in addition to disconnection, e.g. for indicating that protective apparatus has functioned
55.
LABELS COMPRISING DIBROMOPYRIDAZINEDIONES FOR IMMUNOASSAYS AND METHODS OF PRODUCTION AND USE THEREOF
Labels that include dibromopyridazinedione attached to signal molecules are disclosed, along with methods of producing and using same. Also disclosed are conjugates of the label attached to an analyte-specific binder, as well as methods of producing and using same. Kits containing the labels and/or conjugates are also disclosed, along with microfluidics devices containing same.
A61K 31/501 - Pyridazines; Hydrogenated pyridazines not condensed and containing further heterocyclic rings
C09B 62/12 - Reactive dyes, i.e. dyes which form covalent bonds with the substrates or which polymerise with themselves with the reactive group directly attached to a heterocyclic ring to a pyridazine ring
A61K 47/50 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
A61K 47/51 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic compound
A61K 47/62 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
56.
COMPUTATIONALLY-EFFICIENT LOAD PLANNING SYSTEMS AND METHODS OF DIAGNOSTIC LABORATORIES
Systems and methods include an optimization-based load planning module including a data-reduction scheme for analyzers of bio-fluid samples. The optimization-based load planning module is executable on a computer server and is configured to optimize assay type assignments across a large number of analyzers based on one or more objectives, such as: load balancing, efficient reagent usage, reduced turn-around-time, reduced quality assurance costs, and/or improved system robustness. The optimization-based load planning module uses a data-reduction scheme to generate a load plan comprising computer-executable instructions configured to cause a system controller of a diagnostic laboratory system to assign each of the requested test types to be performed over the planning period to one or more selected analyzers in accordance with the one or more preferences or priorities. Other aspects are also described.
A microfluidic device has a first substrate, a resilient diaphragm, an actuator, and a second substrate. The first substrate has an opening extending therethrough. The resilient diaphragm is secured to a second side and surrounds the opening. The actuator is secured to a first side and surrounds the opening. The first substrate, the resilient diaphragm, and the actuator cooperate to form a gas-tight chamber. The second substrate has a channel formed therein having a first end and a second end. The second substrate is secured to the first substrate. A volume of gas disposed in the gas-tight chamber pressurizes the gas-tight chamber and expands the resilient diaphragm such that the resilient diaphragm is disposed in the channel between the first end and the second end. The resilient diaphragm retracts from the channel to open the channel from the first end and the second when the gas-tight chamber is depressurized.
Methods of controlling diagnostic laboratory systems include providing one or more modules, each of the one or more modules configured to process a specimen container and/or analyze a specimen; providing middleware configured to communicate with the one or more modules, wherein the middleware is configured to generate instructions to change an operational state of at least one of the one or more modules to enabled or disabled; generating, by the middleware, one or more instructions to change the operational state of at least one of the one or more modules; and changing the operational state of at least one of the one or more modules in response to one or more instructions generated by the middleware. Systems including a middleware server configured to carry out the methods are provided as are other aspects.
G05B 19/418 - Total factory control, i.e. centrally controlling a plurality of machines, e.g. direct or distributed numerical control (DNC), flexible manufacturing systems (FMS), integrated manufacturing systems (IMS), computer integrated manufacturing (CIM)
59.
SAMPLE STATUS VISUALIZATION METHODS AND DIAGNOSTIC LABORATORY SYSTEMS INCLUDING SAME
Methods of visualizing sample status within a diagnostic laboratory system are provided. The methods include displaying on a display screen, a visual image representing a layout of a plurality of laboratory analyzers included within the diagnostic laboratory system, and further to display on the visual image, for a particular selected sample scheduled for testing, status indicators located proximate to the visual images of the analyzers on which the tests are scheduled. The status indicators denote: the testing is completed on one or more analyzers (processed), the testing is currently being conducted on one or more analyzers (current), or the testing has not yet been received on the one or more analyzers (to do). Systems including such sample status indicators are provided as are other aspects.
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
61.
MULTI-POINT FILTERING LIQUID LEVEL DETECTION METHODS AND APPARATUS
A method of detecting a level of a liquid in a well of a container. The method includes looking up an expected liquid level of the liquid in the well of a container; measuring and recording a measured liquid level of the liquid in the well; changing a level of the liquid in the well based upon an expected amount of the liquid to be added or removed; and calculating a next expected liquid level at least in part based on multi-point filtering. Apparatus for carrying out the method are provided, as are other aspects.
G01F 23/00 - Indicating or measuring liquid level or level of fluent solid material, e.g. indicating in terms of volume or indicating by means of an alarm
G01N 35/10 - Devices for transferring samples to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
62.
SYSTEM, METHOD AND POINT OF CARE DEVICE FOR IMAGE ANALYSIS OF DIAGNOSTIC ASSAYS
An image analysis system, a method and a point of care device are provided for determining, from an image of a cassette containing a sample, a concentration of one or more target analytes in the sample. The method includes identifying a region of interest (ROI) from the image corresponding to a result viewing area of the cassette, generating a unidimensional (1D) profile of the ROI, and probabilistically determining from the 1D profile, the concentration of the target analyte(s) in the sample based on a statistical model having one or more parameters of the 1D profile varying with respect to time and/or the concentration of the target analyte(s) in the sample.
A reagent strip is described. The reagent strip includes a substrate and at least one reagent pad positioned on the substrate. The substrate has a storage unit storing an authentication code. The authentication code has a lot value and a secondary value related to the lot value by a predetermined function assigned to the lot value.
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.
A reagent analyzer comprising an imaging system having a first field of view of a reagent test device and a second field of view of a fluid sample information indicator, and configured to capture a first image depicting the reagent test device and a second image depicting the information indicator; a mirror moveable between a first position outside the first field of view and a second position inside the first field of view and located between the imaging system and the reagent test device, the mirror in the second position reflecting light to produce the second field of view; and a processor executing instructions to: receive the first and second images; analyze the first image to determine calibration information from the information indicator; and analyze the second image to determine constituent presence/absence in the fluid sample applied to the reagent test device, using, in part, the determined calibration information.
Systems and methods for determining an assessment of a patient for a medical condition are provided. Input medical data of a patient is received. A vector representing a state of the patient is generated based on the input medical data. An assessment of the patient for a medical condition is determined using a machine learning based network based on the vector. The assessment of the patient is output.
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 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
67.
ESTIMATING PATIENT RISK OF CYTOKINE STORM USING KNOWLEDGE GRAPHS
Systems and methods for determining an assessment of a patient for a medical condition are provided. Input medical data of a patient is received. A knowledge graph is computed based on the input medical data. A vector representing a state of the patient is generated based on the knowledge graph. An assessment of the patient for a medical condition is determined using a machine learning based network based on the vector. The assessment of the patient is output.
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 50/30 - ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for individual health risk assessment
A reagent analyzer having a circuit board, an imaging system and a processor is disclosed. The circuit board has a substrate, and a plurality of conductive leads. The substrate has a first and a second major surface. The first major surface is opposite the second major surface. The substrate has an opening extending between the first major surface and the second major surface. The reagent analyzer also includes an imaging system having a field of view extending through the opening formed in the substrate and configured to capture an image of a wet reagent test device positioned at a read position in the field of view, the image having a plurality of pixels. The processor is configured to receive the image, and to analyze pixels of the image to determine a presence or an absence of a target constituent being in a sample applied to the wet reagent pad.
F21L 4/00 - Electric lighting devices with self-contained electric batteries or cells
F21V 29/507 - Cooling arrangements characterised by the adaptation for cooling of specific components of means for protecting lighting devices from damage, e.g. housings
F21V 29/70 - Cooling arrangements characterised by passive heat-dissipating elements, e.g. heat-sinks
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.
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 wash station for use in a clinical analyzer of an in vitro diagnostics (IVD) environment for cleaning a probe comprises a basin, a vertically-elongated conduit, an inlet port, and a helix insert. The vertically-elongated conduit is attached to the interior of the basin. The inlet port is connected to a bottom portion of the basin. The inlet port is sized to receive and secure a wash feed line that propels a wash fluid upward through the vertically-elongated conduit. The helix insert is positioned within the vertically-elongated conduit and sized to allow insertion of the probe through a center portion of the helix insert for cleaning. The helix insert causes the wash fluid to flow in a helical shape around the probe as it is transported through the vertically-elongated conduit, thereby cleaning the probe.
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups ; Handling materials therefor
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
72.
ASSEMBLY FOR USE IN MEDICAL DIAGNOSTIC DEVICE AND SYSTEM FOR ANALYSIS OF SAMPLES
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
73.
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.
Embodiments provide a fluid metering device, including: a first fluid supply port for receiving a first fluid; a first fluid dispense port for dispensing the first fluid; a second fluid supply port for receiving a second fluid; a second fluid dispense port for dispensing the second fluid; a waste discharge port for discharging a mixture of the first fluid and the second fluid; a valve assembly including a plurality of valves; a manifold connected to the metering pump, wherein the manifold includes a plurality of fluid channels, and the manifold is used for communicating between the valve assembly and each port; a first tube connected between the second valve and the third valve for accommodating the mixture or the first fluid; and a second tube connected between the third valve and the fourth valve for accommodating the second fluid.
G01F 1/34 - 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 mechanical effects by measuring pressure or differential pressure
G01F 7/00 - Volume-flow measuring devices with two or more measuring ranges; Compound meters
G01F 11/12 - Apparatus requiring external operation adapted at each repeated and identical operation to measure and separate a predetermined volume of fluid or fluent solid material from a supply or container, without regard to weight, and to deliver it with measuring chambers moved during operation of the valve type, i.e. the separating being effected by fluid-tight or powder-tight movements
G01F 13/00 - Apparatus for measuring by volume and delivering fluids or fluent solid materials, not provided for in the preceding groups
G01F 15/00 - MEASURING VOLUME, VOLUME FLOW, MASS FLOW, OR LIQUID LEVEL; METERING BY VOLUME - Details of, or accessories for, apparatus of groups insofar as such details or appliances are not adapted to particular types of such apparatus
G01F 22/02 - Methods or apparatus for measuring volume of fluids or fluent solid material, not otherwise provided for involving measurement of pressure
76.
ANALYTICAL ASSAY REACTION CARTRIDGE CONTAINING MAGNETIC CAPTURE BEADS AND METHODS OF PRODUCTION AND USE THEREOF
Analytical assay reaction cartridges, kits containing same, and methods of production and use thereof are disclosed. These cartridges include a magnetic assembly that surrounds at least a portion of a sample read window on the cartridge. The cartridge also includes an analytical reagent positioned therewithin, wherein the analytical reagent comprises magnetic beads coated with at least one anti-red blood cell antibody.
B03C 1/005 - Pretreatment specially adapted for magnetic separation
G01N 15/06 - Investigating concentration of particle suspensions
G01N 27/74 - Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating magnetic variables of fluids
G01N 33/487 - Physical analysis of biological material of liquid biological material
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
G01N 33/537 - Immunoassay; Biospecific binding assay; Materials therefor with immune complex formed in liquid phase with separation of immune complex from unbound antigen or antibody
77.
METHODOLOGY OF ACCURACY AND PRECISION DETERMINATION FOR A NEW URINE SEDIMENT ANALYZER
Non-limiting embodiments of a methodology of validating accuracy and precision determinations of a new urine sediment analyzer, and method(s) related thereto.
A reagent strip and a reagent analyzer for reading the reagent strip is described. The reagent strip includes a substrate, at least one reagent pad positioned on the substrate, and a photo luminescent phosphor spot positioned at a fixed location on the substrate. The photo luminescent phosphor spot is formulated to exhibit a predetermined addressable attribute.
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
A61B 5/145 - Measuring characteristics of blood in vivo, e.g. gas concentration, pH-value
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 33/49 - Physical analysis of biological material of liquid biological material blood
A method and a kit for detecting one or more analytes in a sample is disclosed. In one aspect, the method includes introducing the sample to a surface bound to at least one portion of a first antibody to form a first antibody-analyte complex. The method further includes incubating the first antibody-analyte complex with a set of second antibodies to form a first antibody-analyte-second antibody complex, wherein one second antibody is conjugated with a nucleic acid fragment comprising an exposed 3' hydroxyl group and another second antibody is conjugated with an exposed 5' phosphate group. Additionally, the method includes ligating the nucleic acid fragment comprising the exposed 3' hydroxyl group and the nucleic acid fragment comprising the exposed 5' phosphate group. Furthermore, the method includes separating the ligated nucleic acid fragments from the first antibody-analyte-second antibody complex.
C12Q 1/34 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving hydrolase
C12Q 1/25 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving enzymes not classifiable in groups
Embodiments provide a fitting for tubing connection, a male fitting assembly, and a torque adaptor. The fitting for tubing connection includes a head including a plurality of first gripping portions, each first gripping portion extending from a top of the head; and a shaft attached to the head, wherein the shaft comprises a plurality of external threads.
F16L 19/02 - Pipe ends provided with collars or flanges, integral with the pipe or not, pressed together by a screwed member
F16L 19/025 - Pipe ends provided with collars or flanges, integral with the pipe or not, pressed together by a screwed member the pipe ends having integral collars or flanges
B25B 13/48 - Spanners; Wrenches for special purposes
B25B 13/50 - Spanners; Wrenches for special purposes for operating on work of special profile, e.g. pipes
F16L 47/04 - Connecting arrangements or other fittings specially adapted to be made of plastics or to be used with pipes made of plastics with a swivel nut or collar engaging the pipe
F16L 37/24 - Couplings of the quick-acting type in which the connection is made by inserting one member axially into the other and rotating it to a limited extent, e.g. with bayonet-action
82.
INTERFERING FLAG TO REDUCE FALSES DIAGNOSIS DUE TO INTERFERING CONDITIONS IN MICROSCOPIC MORPHOLOGY BASED SEDIMENT URINALYSIS
Non-limiting embodiments of a system(s) of generating interfering flags to reduce false diagnosis due to interfering conditions present in urinalysis results, and method(s) related thereto.
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.
An apparatus, a method and a device for calibrating the apparatus is disclosed. The apparatus comprises one or more light sources, at least one image acquisition device for acquiring images; and a device. The device comprises a processing unit, a memory coupled to the processing unit. The memory comprising a calibration module configured to obtain a value of current flowing through each of one or more light sources in real-time, compare the value of current flowing through each of the one or more light sources with a predefined threshold current value, and calibrate color gain value associated with at least one image acquisition device, if the determined value of current for each of the one or more light sources is above the predefined threshold current value.
H04N 9/31 - Projection devices for colour picture display
H04N 9/64 - Circuits for processing colour signals
H04N 9/73 - Colour balance circuits, e.g. white balance circuits or colour temperature control
H05B 45/22 - Controlling the colour of the light using optical feedback
G09G 5/02 - Control arrangements or circuits for visual indicators common to cathode-ray tube indicators and other visual indicators characterised by the way in which colour is displayed
85.
AUTOMATIC LIQUID ANALYTICAL REAGENT DISPENSING APPARATUS, ANALYTICAL ASSAY REACTION CARTRIDGES AND KITS, AND METHODS OF USE RELATED THERETO
Analytical assay reaction cartridges are disclosed that include a reagent tray containing a liquid reagent disposed therein and a flexible cover removably attached thereto. The flexible cover has a portion that extends beyond the reagent tray and that forms a tab portion extends through an opening in a lid member of the cartridge in order to facilitate removal of at least a portion of the cover and release of the liquid reagent. Also disclosed are analytical assay reaction kits that include the cartridges and diagnostic instruments for use with the analytical assay reaction cartridges/kits, as well as methods of making and using the cartridges/kits.
B65D 17/34 - Arrangement or construction of pull or lift tabs
B65D 51/28 - Closures not otherwise provided for combined with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials
B65D 73/00 - Packages comprising articles attached to cards, sheets or webs
86.
BIOLOGICAL SAMPLE PREPARATION AND REVERSE CROSSLINK TREATMENT BUFFER FOR MOLECULAR DIAGNOSTIC APPLICATIONS AND METHODS OF PRODUCTION AND USE THEREOF
A biological sample preparation and reverse crosslink treatment reagent is disclosed in which all molecular pre-analytical and sample preparation steps can be performed on the biological sample in the single reagent. Also disclosed are kits containing the treatment reagent and methods of producing and using the treatment reagent.
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
C07H 21/00 - Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
C12P 19/34 - Polynucleotides, e.g. nucleic acids, oligoribonucleotides
87.
CLINICAL SPECIMEN COLLECTION SWABS FOR MOLECULAR DIAGNOSTIC APPLICATIONS AND METHODS OF PRODUCTION AND USE THEREOF
A biological sample collection swab is disclosed that can be utilized for sample collection, storage, washing, nucleic acid elution, and molecular diagnostic applications. The biological sample collection swab maintains the stability of nucleic acid present in the biological sample so that one or more nucleic acid assay target(s) present in the biological sample is not substantially degraded during storage and shipping. Also disclosed are kits containing the biological sample collection swabs and methods of producing and using the biological sample collections swabs.
A transport medium is disclosed that can be utilized for both sample collection and molecular diagnostic applications. The transport medium can be utilized with multiple types of biological samples and maintains the stability of nucleic acid present in the biological samples so that one or more nucleic acid assay target(s) present in the biological sample is not substantially degraded during storage and shipping. Also disclosed are kits containing the transport medium, mixtures that include a biological sample disposed in the transport medium, and methods of producing and using the medium.
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 10/00 - Other methods or instruments for diagnosis, e.g. for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
89.
CALIBRATION AND QUALITY CONTROL REAGENTS FOR USE WITH IMMUNOASSAYS FOR ANTIBODIES
Calibration and/or quality control reagents are disclosed for use in serology immunoassays for antibodies to a microorganism. In the reagents, antibodies specific to an antigen of the microorganism are complexed with anti-human Ig antibody to form a complex. Kits and microfluidics devices containing the reagents are also disclosed, along with methods of producing and using the reagents.
Reagents, kits, and microfluidics devices are disclosed for detecting the presence and/or concentration of antibodies directed to microorganisms in human biological samples. Also disclosed are methods of production and use of the reagents, kits, and microfluidics devices. Anti-human immunoglobulin antibodies are utilized to enhance the signal produced by the assay.
A61K 48/00 - Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
A61P 1/16 - Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
A61P 25/00 - Drugs for disorders of the nervous system
A random access automated molecular testing system and method is used with a planar polymerase chain reaction (PCR) chip to provide molecular detection covering a wide variety of assays/tests in a small footprint. An automated transport mechanism moves the PCR chip between a pipette loading station, a sealing station and an amplification and detection module to provide batchless and random-access amplification and detection of a biological sample fluid. The PCR chip a planar rectangular body, a U-shaped channel for receiving sample fluid from an inlet port and a gripping feature laterally extending from an upper surface of the body above the inlet port for use by the automated transport mechanism. An amplification and detection module includes a heating block, a clip with a viewing window for retaining the PCR chip and a detection platform for identifying a content characteristic of interest of the sample fluid.
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
B01L 7/00 - Heating or cooling apparatus; Heat insulating devices
93.
SAMPLE HOLDERS, PCR STATION ASSEMBLIES, AND METHODS OF OPERATING PCR TESTING SYSTEMS
A sample holder for PCR processing. The sample holder includes a body with an inlet and outlet grooves formed alongside each other, a detection recess that is connected to the inlet and outlet grooves, and a fill port interconnected to both the inlet and outlet grooves, and a cover interfacing with the body to form an inlet channel interconnected to the fill port, a detection region interconnected to the inlet channel, and an outlet channel interconnected to the detection region and the fill port. The detection region is configured to receive a PCR solution from the fill port and replication occurs within the detection region via heating and cooling cycles. Thereafter, fluorescent emissions from tagged replicated DNA/RNA in the detection region are detected and measured. PCR stations, PCR station assemblies, PCR testing systems, and methods of operating a PCR testing systems are provided, as are other aspects.
A61J 1/05 - Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids
A multi-site sample holder for PCR processing. In one aspect, the multi-site sample holder includes a body with an inlet and outlet grooves formed alongside each other, a detection recess, and a cover interfacing with the body to form an inlet channel, a detection region interconnected to the inlet channel, and an outlet channel interconnected to the detection region. The detection region includes multiple sites and is configured to receive a PCR solution and replication occurs within the detection region via heating and cooling cycles. Thereafter, fluorescent emissions from tagged replicated DNA (or RNA) in the multiple sites may be individually (or in groups of less than all the sites) detected and measured. PCR station assemblies, PCR testing systems, and methods of operating a PCR testing systems are provided, as are other aspects.
A clinical diagnostics system provides at least one biochemical analyzer and a track with one or more carriers for clinical samples, wherein the track and carriers are configured to effect carrier motion in a horizontal plane and the biochemical analyzer is arranged above the track and the one or more carriers.
G01N 1/00 - Sampling; Preparing specimens for investigation
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
96.
OPTICAL DISCRIMINATION APPARATUS AND METHODS ADAPTED TO MONITOR REACTIONS
An optical discrimination apparatus adapted for use in PCR testing and the like. The apparatus includes a multi-color light emitter to emit excitation light, a sample holder configured to hold dye-marked nucleic acid fragments in a PCR solution at a position configured to receive the excitation light along a first direction, light emission collection optics configured to collect scattered excitation light and light emission (fluorescent emission) from the sample holder along a second direction that is approximately orthogonal to the first direction, a spectrally-dispersive element configured to spectrally disperse scattered light and emission light, and a spectral detector configured to receive the separated emission light and excitation light on different photosites of the spectral detector. Systems and methods are provided, as are other aspects.
An apparatus, vortex generator assembly and method for automated cell lysis and nucleic acid purification and processing. The vortex generator assembly includes sample holder having a lysis well, at least one wash well, and an elution well. The vortex generator assembly also includes a sample holder cover having a plurality of vibration rods for creating a vortex in the wells of the sample holder. The apparatus includes motor operating a rotating cam to cause the vibration rods to vibrate and create the vortex in a well holding fluid and magnetic beads, wherein the vortexing speed is sufficient to overcome the magnetic attraction between the beads and disperse the beads in solution, to collect nucleic acids such as DNA.
A computer-implemented method for analyzing log files generated by complex physical equipment includes receiving one or more log file generated by one or more components of physical equipment. Each of the log files comprises one or more log entries. A plurality of templates are extracted from each log file describing fixed portions of the log entries. The log entries are grouped in log files into a plurality of instances. Each instance corresponds to one of a plurality of partitions along one or more dimensions describing data in the log entries. A representation of each instance is created that describes a set of the templates included in the instance. A plurality of clusters are generated by applying a clustering process to the representations of the instances. A visual depiction of the clusters and the instances may then be created in a graphical user interface (GUI).
Disclosed herein are methods for using modified liposomes or carrier proteins comprising (i) an acridinium ester (AE), and (ii) a first agent encapsulated by the liposomes and/or (iii) a second agent on the surface of the liposomes or the carrier proteins. Specifically, the disclosed methods provide methods of labeling a target of interest, assaying a biological sample for a target antigen, and detecting a target antigen in a biological sample. Further disclosed herein are methods for increasing the strength of a signal detected by an imaging modality.
Disclosed herein are compositions and methods for using modified liposomes comprising (i) an encapsulated hydrophilic acridinium ester (AE), and (ii) a first agent encapsulated by the liposomes and/or (iii) a second agent on the surface of the liposomes. Specifically, the disclosed methods provide methods of labeling a target of interest, assaying a biological sample for a target antigen, and detecting a target antigen in a biological sample. Further disclosed herein are methods for increasing the strength of a signal detected by an imaging modality.
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