The present disclosure relates to devices, apparatus and methods of improving the accuracy of an image-based assay. One aspect of the present invention is to sandwich a sample between two plates and add reference marks in the sample areas of the plates, with at least one of the geometric and/optical properties of the reference marks being predetermined and known, and taking images of the sample with the reference marks, and applying a machine learning model in the analysis of the image-based assay.
The present invention is related to, among other things, the devices and methods that improve the accuracy and reliability of an assay, even when the assay device and/or the operation of the assay device has certain errors, and in some embodiments the errors are random.
The present invention provides, among other things, the devices and methods that can rapidly change or cycle (i.e. heat and cool) a sample temperature with high speed, less heating energy, high energy efficiency, a compact and simplified apparatus (e.g. handheld), easy and fast operation, and/or low cost.
The present invention provides devices, systems, and methods for rapid sample thermal cycle changes for the facilitation of reactions such as but not limited to PCR.
Among other things, the present invention is related to devices and methods of performing biological and chemical assays, such as but not limited to immunoassays and nucleic assay acid, particularly the homogeneous assay that does not use the step of wash and that is fast (e.g. 60 seconds from dropping a sample to displaying results).
The disclosure provides a kit and method using the kit for analyzing a sample, particularly blood. The kit may comprise a device (a) for sample collecting, mixing, staining, and transferring and a device (b) for sample distribution and imaging device. The device (a) comprises part (1) and an optional part (2) connected to each other. The part (1) is a capillary tube with reagent coated inside. The part (2) is used for providing an external force to suck in and/or push out the sample. The device (b) comprises two plates opposing to each other and defining an interior cavity, and a sample inlet. The interior cavity is in fluid communication with the exterior liquid sample contact area. The liquid sample flows into the spacing between the two plates through the sample inlet and a sample landing Zone that is at the exterior location of the device (b).
G01N 33/80 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood groups or blood types
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G01N 33/72 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood pigments, e.g. hemoglobin, bilirubin
The present invention provides, among other things, QMAX card based assays in different forms for various analytes, offering simpler, fast, more sensitive assaying.
G01N 21/69 - 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 specially adapted for fluids
The disclosure provides an apparatus, a device, and methods for improving optical analysis of a thin layer of a sample between two plates, particularly for multiple wavelengths.
G01N 21/31 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G01N 21/29 - ColourSpectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using visual detection
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing
The present invention is related to the field of bio/chemical sampling, sensing, assays and applications. Particularly, the present invention is related to how to make the sampling/sensing/assay become simple to use, fast to results, highly sensitive, easy to use, using tiny sample volume (e.g. 0.5 uL or less), operated by a person without any professionals, reading by mobile-phone, or low cost, or a combination of them.
G01N 15/01 - Investigating characteristics of particlesInvestigating permeability, pore-volume or surface-area of porous materials specially adapted for biological cells, e.g. blood cells
G01N 15/14 - Optical investigation techniques, e.g. flow cytometry
G01N 21/69 - 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 specially adapted for fluids
A homogeneous assay method that employs a device is provided. In some embodiments, the device contains a pair of plates that can be opened and closed. The sample is placed between two plates. In some embodiments, the thickness of the sample in a closed configuration, the concentration of labels, and amplification factor of the amplification surface are configured to make the label(s) bound on the amplification surface visible without washing away of the unbound labels.
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 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
G01N 33/58 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving labelled substances
13.
OPTICAL TRANSMISSION SAMPLE HOLDER AND ANALYSIS, PARTICULARLY FOR HEMOGLOBIN
Among other things, the present invention is related to devices and methods for improving optical analysis of a thin layer of a sample sandwiched between containing between two plates.
C12N 15/113 - Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides
A61K 31/7088 - Compounds having three or more nucleosides or nucleotides
A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting 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
The disclosure provides a device and a method to press a QMAX-Card to form a liquid layer. A device comprises a first arm including a pressing block and a second arm including a compartment for accommodating the QMAX-Card. Each of the first arm and the second arm comprises a first end and a second end opposing the first end, and the first arm and the second arm are joined by a hinge at the first end. The first arm is capable of rotating around the hinge toward the second arm 500 from an open position to a close position. The pressing block and the compartment face each other and are disposed at the second end. The pressing block press the QMAX-Card so that the QMAX-Card changes a closed configuration to compress a liquid sample in the QMAX-Card into a substantially uniform thin layer.
Described are methods and devices that can accelerate the process and quantify the parameters for bio/chemical material samples. In some embodiments, a QMAX (Q: quantification; M: magnifying; A: adding reagents; X: acceleration) device having two or more electrodes capable of accelerating the electrical measurement process of the samples. In addition, the electrical measurement technology of the QMAX device enables for extraction, separation, and purification of sample components, such as but not limited to nucleic acids. In some embodiments, the QMAX device includes a plate for hosting a small sensing chip to facilitate a bio/chemical sensing of the sensing chip.
A multi-mode illumination system, including: a first illumination module; a second illumination module; and a third illumination module, as disclosed herein.
Among other things, the present invention is related to devices and methods for improving optical analysis of a thin layer of a sample sandwiched between two plates.
A61K 31/7088 - Compounds having three or more nucleosides or nucleotides
A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
A61K 47/54 - Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additivesTargeting 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
A method of assaying an analyte in a sample is disclosed. The method includes having a sample holder with a sample contact area for contacting a sample with an analyte, having a plurality of calibration structures on the sample contact area of the sample holder, imaging a part of the sample contact area that has the calibration structures, and using an algorithm that includes an image, calibration structures in the image, and artificial intelligence and/or machine learning to identify the analyte and/or determine the analyte concentration.
The disclosure provides an apparatus for high throughput analysis of samples and a method of making an assay card and performing an assay using the apparatus. The apparatus can include a transporter to position and advance a first plate of the QMAX card, a first dispenser to deposit a sample on the first plate, a second dispenser to dispense a reagent to contact the sample, a press to compress the sample between the first and second plates of the QMAX card into a uniformly thick layer, and an imager to image the uniformly thick layer.
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
21.
ENHANCED, RAPID, HOMOGENEOUS, CELL STAINING AND ASSAY
The present invention provides, among other things, devices, kits, apparatus, and methods for rapid homogenous cell staining and imaging. Particularly, in some embodiments, the present invention can immunochemically stain a cell or a tissue in less than 60 seconds without washing. In some embodiments, the present invention stains and observes analyte (protein or nucleic acid) inside a cell in 60 seconds without washing.
The present disclosure relates to devices, apparatus and methods of improving the accuracy of image-based assay, that uses imaging system having uncertainties or deviations (imperfection) compared with an ideal imaging system. One aspect of the present invention is to add the monitoring marks on the sample holder, with at least one of their geometric and/optical properties of the monitoring marks under predetermined and known, and taking images of the sample with the monitoring marks, and train a machine learning model using the images with the monitoring mark.
A device for liquid sample collection and liquid sample analysis, including: a base plate having: at least one pedestal area in at least a portion of a sample image area; and at least one recessed area, wherein at least of a portion of the at least one pedestal area is adjacent to the at least one recessed area; a cover plate that opposes the base plate; a plurality of spacers attached to one of the base plate, the cover plate, or both, and the spacers are situated between the opposable plates; and an exterior liquid sample contact area on an exterior location of the device; wherein the base plate and the cover plate define an interior cavity in fluid communication with the exterior liquid sample contact area. Also disclosed are an apparatus including the device, a method of making the device, and a method of using the device.
The present invention is related to correct the errors in instruments, operation, and others using intelligent monitoring structures and machine learning, and others.
The disclosure provides a method for identifying a bio-entity including a cell type and count in a sample. The method includes: providing a device comprising a first plate, a second plate, and a patterned structural element; depositing the sample between the first and second plates; reducing the spacing of the first and second plates so that the first and second plates are in a closed configuration to compress the sample into a layer; and imaging the sample to obtain an image; and measuring and analyzing the image against a database generated with a machine learning model to obtain the bio-entity of the sample. The sample can be a blood sample, and the method can be a white blood cell differential test conducted with a mobile phone.
Among other things, the disclosure of the present invention is related to make pathology and cytology faster, better, and lower cost, as well as to using fast cytology to quickly determine the concentration of the analyte outside a cell in a sample. The present invention is also related to rapid intra-cellular assays.
G01N 33/569 - ImmunoassayBiospecific binding assayMaterials therefor for microorganisms, e.g. protozoa, bacteria, viruses
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving virus or bacteriophage
The present invention is related to, among other things, the devices and methods that improve the accuracy and reliability of an assay, even when the assay device and/or the operation of the assay device has certain errors, and in some embodiments, the errors are random. One aspect of the present invention is to overcome the random errors or imperfections of an assay device or the operation of the assay device by measuring, in addition to measuring the analyte in a sample to generate an analyte test result, the trustworthiness of the analyte test result. The analyte test result will be reported, only when the trustworthiness meets a predetermined threshold, otherwise the analyte test result will be discarded. Various of parameter variation have been used for test trustworthy determination.
One aspect of the present invention is to provide the device and methods for performing an assay that uses the multiplexing of sample thicknesses on the same plate. The sample thickness multiplexing can offer many information that is unavailable in using a single sample thickness.
The present invention is to provide methods and devices that monitoring health and diagnosing a disease by directly measuring the biomarkers inside a cell (intra-cellular detection) rapidly and easily.
Cell analysis in body fluids, particularly blood using a sample card with multiple spacer sets having at least two distinct substantially uniform heights
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
G02B 17/00 - Systems with reflecting surfaces, with or without refracting elements
G06V 10/143 - Sensing or illuminating at different wavelengths
G06V 20/69 - Microscopic objects, e.g. biological cells or cellular parts
G01N 15/01 - Investigating characteristics of particlesInvestigating permeability, pore-volume or surface-area of porous materials specially adapted for biological cells, e.g. blood cells
Disclosed is an apparatus and method for imaging: a side-view of a object on a surface, a Contact Angle of a liquid object, the color of an object, or combinations thereof.
A multiplex assay device including: a separation structure on a first plate; and a sample contact area on the surface of the first plate. Also disclosed is a method for fabricating a multiplex assay, including: making a reagent into a non-liquid reagent particle; creating a well on a sample contact area of a plate of a Q-card two plate sample card; and dropping one or more of the non-liquid reagent particles into at least one well.
C12Q 1/18 - Testing for antimicrobial activity of a material
G16H 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
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 30/40 - ICT specially adapted for the handling or processing of medical images for processing medical images, e.g. editing
G16H 80/00 - ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
C12M 1/34 - Measuring or testing with condition measuring or sensing means, e.g. colony counters
The present invention is related to, among other things, the devices and methods that improve the accuracy and reliability of an assay, even when the assay device and/or the operation of the assay device has certain errors, and in some embodiments the errors are random.
One aspect of the present invention is to provide systems and methods that improve the accuracy of an assay that comprise at least one or more parameters each having a random error.
G06V 10/34 - Smoothing or thinning of the patternMorphological operationsSkeletonisation
G06V 10/44 - Local feature extraction by analysis of parts of the pattern, e.g. by detecting edges, contours, loops, corners, strokes or intersectionsConnectivity analysis, e.g. of connected components
G06V 20/69 - Microscopic objects, e.g. biological cells or cellular parts
G06F 18/2413 - Classification techniques relating to the classification model, e.g. parametric or non-parametric approaches based on distances to training or reference patterns
G06V 10/764 - Arrangements for image or video recognition or understanding using pattern recognition or machine learning using classification, e.g. of video objects
G06V 10/82 - Arrangements for image or video recognition or understanding using pattern recognition or machine learning using neural networks
Among other things, the present disclosure is related to devices and methods of performing biological and chemical assays, such as but not limited to immunoassays and nucleic assay acid, particularly a homogeneous assay that does not use a wash step and that is fast (e.g., 60 seconds from dropping a sample to displaying results). The present disclosure is related to both competitive and non-competitive homogeneous assays.
The present invention provides diagnostic devices and methods for quantifying the amounts of an acute phase reactant (e.g., C-reactive protein (CRP) or serum amyloid A (SAA)) in a body fluid sample and/or white blood cell counts in blood sample. In particular, the present invention provides a rapid assay to detect CRP, SAA, and/or white blood cells in blood with high sensitivity and specificity.
The disclosure relates to a device and method of using the device for performing biological and chemical assays that require an easy sample manipulation and/or a rapid change or a rapid thermal cycling of a sample temperature (e.g., Polymerase Chain Reaction (PCR) for amplifying nucleic acids). The device includes a first plate, a second plate, a plurality of spacers, and at least one clamp. The method includes obtaining the device, depositing a sample onto a sample contact area of at least one of the first and second plates of the device in an open configuration, closing the two plates into a closed configuration and placing the clamp in the active mode, and rapidly changing the temperature of the sample portion encircled by rings.
The present disclosure relates to devices, apparatus and methods of improving the accuracy of image-based assay, that uses imaging system having uncertainties or deviations (imperfection) compared with an ideal imaging system. One aspect of the present invention is to add the monitoring marks on the sample holder, with at least one of their geometric and/optical properties of the monitoring marks under predetermined and known, and taking images of the sample with the monitoring marks, and train a machine learning model using the images with the monitoring mark.
G06T 7/70 - Determining position or orientation of objects or cameras
G06V 10/22 - Image preprocessing by selection of a specific region containing or referencing a patternLocating or processing of specific regions to guide the detection or recognition
41.
ASSAY SAMPLE PREPARATION FOR REAGENT UNIFORMITY, PARTICULARLY BLOOD
The disclosure provides a kit and method using the kit for analyzing a sample, particularly blood. The kit may comprise a device (a) for sample collecting, mixing, staining, and transferring and a device (b) for sample distribution and imaging device. The device (a) comprises part (1) and an optional part (2) connected to each other. The part (1) is a capillary tube with reagent coated inside. The part (2) is used for providing an external force to suck in and/or push out the sample. The device (b) comprises two plates opposing to each other and defining an interior cavity, and a sample inlet. The interior cavity is in fluid communication with the exterior liquid sample contact area. The liquid sample flows into the spacing between the two plates through the sample inlet and a sample landing Zone that is at the exterior location of the device (b).
The present invention relates to provide, among other things, the methods, devices, and systems that can simply and quickly collecting and analyzing a tiny amount of vapor condensates (e.g. exhaled breath condensate (EBC)).
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
G01N 33/497 - Physical analysis of biological material of gaseous biological material, e.g. breath
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 40/67 - ICT specially adapted for the management or administration of healthcare resources or facilitiesICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
G01N 21/01 - Arrangements or apparatus for facilitating the optical investigation
G01N 21/27 - ColourSpectral 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 21/78 - 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
43.
Device and system for analyzing a sample, particularly blood, as well as methods of using the same
The present invention is related to the field of bio/chemical sampling, sensing, assays and applications. Particularly, the present invention is related to how to make the sampling/sensing/assay become simple to use, fast to results, highly sensitive, easy to use, using tiny sample volume (e.g., 0.5 μL or less), operated by a person without any professionals, reading by mobile-phone, or low cost, or a combination of them.
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
G16B 25/00 - ICT specially adapted for hybridisationICT specially adapted for gene or protein expression
G16B 50/00 - ICT programming tools or database systems specially adapted for bioinformatics
G16H 80/00 - ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
Device, systems, and methods are provided that can be used to monitor, examine, and/or analyze hair conditions and make suggestions to improve the hair conditions.
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
G16H 50/20 - ICT specially adapted for medical diagnosis, medical simulation or medical data miningICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
The disclosure provides a spacing-changeable device and a method using both lateral flow and compressed open flow for assaying a liquid sample. The device includes a first plate, a second plate, and an exterior liquid sample contact area. The spacing between the two plates are changeable to form different configurations including a first and second configurations. In the first configuration, the two plates face each other and form at least two gaps including a spacing-1 and a spacing-1′. The spacing height of the spacing-1′ has a size that allows a liquid sample to flow into the spacing-1′. In the second configuration, the two plates are pressed, which changes spacing-1 and spacing-1′ to spacing-2 and spacing-2′, respectively, and the spacing-2′ has a spacing height larger than that of spacing-2. In the second configuration, the sample flows and spreads in areas of spacing-2 and spacing-2′.
Devices and systems are provided herein relating to a novel and rapid assay for tissue staining. Methods for using the devices and systems for analyzing tissue samples are also disclosed.
G01N 1/36 - Embedding or analogous mounting of samples
H04M 1/72409 - User interfaces specially adapted for cordless or mobile telephones with means for local support of applications that increase the functionality by interfacing with external accessories
G06V 20/69 - Microscopic objects, e.g. biological cells or cellular parts
The present invention is to provide methods and devices that monitoring health and diagnosing a disease by directly measuring the biomarkers inside a cell (intra-cellular detection) rapidly and easily.
A method for sample analysis that employs a signal-amplifying nanosensor is provided. An implementation of the present method may include a) obtaining a sample, b) applying the sample to a signal-amplifying nanosensor containing a capture agent that binds to an analyte of interest, under conditions suitable for binding of the analyte in a sample to the capture agent, c) washing the signal-amplifying nanosensor, and d) reading the signal-amplifying nanosensor, thereby obtaining a measurement of the amount of the analyte in the sample. In some embodiments, the analyte may be a biomarker, an environmental marker, or a foodstuff marker. Also provided herein are kits that find use in performing the present method.
The disclosure provides an apparatus for high throughput analysis of samples and a method of making an assay card and performing an assay using the apparatus. The apparatus can include a transporter to position and advance a first plate of the QMAX card, a first dispenser to deposit a sample on the first plate, a second dispenser to dispense a reagent to contact the sample, a press to compress the sample between the first and second plates of the QMAX card into a uniformly thick layer, and an imager to image the uniformly thick layer.
The present disclosure relates to devices, apparatus and methods of improving the accuracy of an image-based assay. One aspect of the present invention is to sandwich a sample between two plates and add reference marks in the sample areas of the plates, with at least one of the geometric and/optical properties of the reference marks being predetermined and known, and taking images of the sample with the reference marks, and applying a machine learning model in the analysis of the image-based assay.
Disclosed is a device including a substrate having a plurality of detection areas to receive at least a portion of a sample having an analyte or suspected of having an analyte and at least one reference marker adjacent to at least one of the detection areas, wherein each of the detection areas detects a specific analyte and the at least one reference marker defines a scale mark, a shape mark, a color mark, or a combination thereof. Also disclosed is an imaging system and method for using the device and imaging system.
G01N 33/52 - Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper
G01N 21/25 - ColourSpectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
G01N 21/27 - ColourSpectral 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 21/78 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
The disclosure provides a device and a method to press a QMAX-Card to form a liquid layer. A device comprises a first arm including a pressing block and a second arm including a compartment for accommodating the QMAX-Card. Each of the first arm and the second arm comprises a first end and a second end opposing the first end, and the first arm and the second arm are joined by a hinge at the first end. The first arm is capable of rotating around the hinge toward the second arm 500 from an open position to a close position. The pressing block and the compartment face each other and are disposed at the second end. The pressing block press the QMAX-Card so that the QMAX-Card changes a closed configuration to compress a liquid sample in the QMAX-Card into a substantially uniform thin layer.
The disclosure provides an apparatus, a device, and methods for improving optical analysis of a thin layer of a sample between two plates, particularly for multiple wavelengths.
G01N 21/31 - Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
Among other things, the present invention is related to devices and methods for improving optical analysis of a thin layer of a sample sandwiched between containing between two plates.
The disclosure provides a method for identifying a bio-entity including a cell type and count in a sample. The method includes: providing a device comprising a first plate, a second plate, and a patterned structural element; depositing the sample between the first and second plates; reducing the spacing of the first and second plates so that the first and second plates are in a closed configuration to compress the sample into a layer; and imaging the sample to obtain an image; and measuring and analyzing the image against a database generated with a machine learning model to obtain the bio-entity of the sample. The sample can be a blood sample, and the method can be a white blood cell differential test conducted with a mobile phone.
The disclosure provides a method for monitoring, testing, and/or correcting an imperfection in an apparatus used for an image-based assay. The method includes obtaining a test image of the sample or reference using the device or apparatus, detecting a light-field contour from the test image, determining parameters of the light-field contour, and determining if one or more of the parameters fall with respective work or desired ranges. The parameters include a shape, center, pixel size, brightness, and/or color toning of the light-field contour. The method also
The present invention is related to correct the errors in instruments, operation, and others using intelligent monitoring structures and machine learning, and others.
The present invention is related to the field of bio/chemical sampling, sensing, assays and applications. Particularly, the present invention is related to how to make the sampling/sensing/assay become simple to use, fast to results, highly sensitive, easy to use, using tiny sample volume (e.g. 0.5 uL or less), operated by a person without any professionals, reading by mobile-phone, or low cost, or a combination of them.
G01N 15/01 - Investigating characteristics of particlesInvestigating permeability, pore-volume or surface-area of porous materials specially adapted for biological cells, e.g. blood cells
G01N 15/14 - Optical investigation techniques, e.g. flow cytometry
G01N 21/69 - 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 specially adapted for fluids
Among other things, the present disclosure provides devices and methods for improving a homogeneous assay, particularly in improving accuracy, reduce noises, none-perfect conditions, multiplexing, etc.
Disclosed is a method for correlating a biomarker in a non-blood bodily fluid with the same biomarker in the blood of an individual, including: measuring, in a first period in time, the biomarker in non-blood bodily fluid and measuring the same biomarker in the blood of the same individual to establish an R ratio of [NBBF1]/[BB1], where [NBBF1] is the biomarker concentration in non-blood bodily fluid in the first period in time, and [BB1] is the biomarker concentration in the blood in the first period in time; storing the ratio in a memory; measuring, in a second period in time, the biomarker in non-blood bodily fluid to determine [NBBF2], where [NBBF2] is the biomarker concentration in the non-blood bodily fluid in the second period in time; and correlating the measured [NBBF2] with the R ratio to generate a correlated [BB2] biomarker concentration in the blood of the individual in the second period in time. Also disclosed is a device, apparatus, and method for correlating the glucose concentration in a non-blood bodily fluid such as saliva with the glucose in the blood of an individual.
The present invention relates to the methods, devices, and systems that make bio/chemical sensing (including, not limited to, immunoassay, nucleic assay, electrolyte analysis, etc.) faster, more sensitive, less steps, easy to perform, smaller amount of samples required, less or reduced (or no) needs for professional assistance, and/or lower cost, than many current sensing methods and devices. The present invention also allows a test performed by a smartphone.
The present disclosure relates to devices, apparatus and methods of improving the accuracy of image-based assay, that uses imaging system having uncertainties or deviations (imperfection) compared with an ideal imaging system. One aspect of the present invention is to add the monitoring marks on the sample holder, with at least one of their geometric and/optical properties of the monitoring marks under predetermined and known, and taking images of the sample with the monitoring marks, and train a machine learning model using the images with the monitoring mark.
G01N 21/17 - Systems in which incident light is modified in accordance with the properties of the material investigated
G01N 21/77 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
G01N 21/84 - Systems specially adapted for particular applications
G01N 33/483 - Physical analysis of biological material
Provided herein is a method and device for performing a homogeneous nucleic acid detection assay. The device can contain a pair of plates where one of the plates comprises (i) surface amplification surface; and (ii) target-specific nucleic acid probes that are immobilized on said amplification surface and that specifically binds to a part of the target nucleic acid; and the second plate comprises a sample contact area comprising a reagent storage site that comprises target-specific nucleic acid detection agents that specifically binds to another part of the target nucleic acid. In some embodiments, the device can be read without a washing unbound label from the surface of the device.
A device for liquid sample collection and liquid sample analysis, including: a base plate having: at least one pedestal area in at least a portion of a sample image area; and at least one recessed area, wherein at least of a portion of the at least one pedestal area is adjacent to the at least one recessed area; a cover plate that opposes the base plate; a plurality of spacers attached to one of the base plate, the cover plate, or both, and the spacers are situated between the opposable plates; and an exterior liquid sample contact area on an exterior location of the device; wherein the base plate and the cover plate define an interior cavity in fluid communication with the exterior liquid sample contact area. Also disclosed are an apparatus including the device, a method of making the device, and a method of using the device.
Among other things, the present invention provides devices and methods that stain a sample simply (e.g. one step) and quickly (e.g. <60 seconds), image it without wash, and generate, by a machine learning algorithm, a final image similar to a standard staining with wash.
Among other things, the disclosure of the present invention is related to make pathology and cytology faster, better and lower cost. The present invention also related to rapid intracellular assay.
Among other things, the disclosure of the present invention is related to make pathology and cytology faster, better, and lower cost, as well as to using fast cytology to quickly determine the concentration of the analyte outside a cell in a sample. The present invention is also related to rapid intra-cellular assays.
G01N 21/69 - 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 specially adapted for fluids
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
One of the aspects of the present invention is the devices and methods that simplify the steps (hence the time and cost) in an assay that uses beads to capture an analyte, and in achieving a high sensitivity. One of the features of the present invention is to use barrier selector to facilitate and simply an assay.
The present invention is related to, among other things, the devices and methods that improve the accuracy and reliability of an assay, even when the assay device and/or the operation of the assay device has certain errors, and in some embodiments, the errors are random. One aspect of the present invention is to overcome the random errors or imperfections of an assay device or the operation of the assay device by measuring, in addition to measuring the analyte in a sample to generate an analyte test result, the trustworthiness of the analyte test result. The analyte test result will be reported, only when the trustworthiness meets a predetermined threshold, otherwise the analyte test result will be discarded. Various of parameter variation have been used for test trustworthy determination.
Disclosed is a method for correlating a biomarker in a non-blood bodily fluid with the same biomarker in the blood of an individual, including: measuring, in a first period in time, the biomarker in non-blood bodily fluid and measuring the same biomarker in the blood of the same individual to establish an R ratio of [NBBF1]/[BB1], where [NBBF1] is the biomarker concentration in non-blood bodily fluid in the first period in time, and [BB1] is the biomarker concentration in the blood in the first period in time; storing the ratio in a memory; measuring, in a second period in time, the biomarker in non-blood bodily fluid to determine [NBBF2], where [NBBF2] is the biomarker concentration in the non-blood bodily fluid in the second period in time; and correlating the measured [NBBF2] with the R ratio to generate a correlated [BB2] biomarker concentration in the blood of the individual in the second period in time. Also disclosed is a device, apparatus, and method for correlating the glucose concentration in a non-blood bodily fluid such as saliva with the glucose in the blood of an individual.
G01N 33/66 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving blood sugars, e.g. galactose
G01N 33/49 - Physical analysis of biological material of liquid biological material blood
G01N 33/58 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving labelled substances
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 1/22 - Devices for withdrawing samples in the gaseous state
74.
ASSAY SAMPLE CARDS AND ADAPTORS AND USE OF THE SAME (II)
A device for sample analysis, including: a first plate, a second plate, spacers, a hinge, and an adhesive, wherein the first plate and the second plate are connected by the hinge and movable relative to each other around the axis of the hinge into different configurations, including an open configuration and a closed configuration as disclosed herein. Also disclosed are a kit, a system, and a method including the device.
G01N 31/00 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroupsApparatus specially adapted for such methods
A device, including: an end-emitting optical fiber including a first end and a second end; a light extraction plate including a light scattering structure; and a light diffuser film disposed above the light scattering structure. Also disclosed are systems including the device.
A multi-mode illumination system, including: a first illumination module; a second illumination module; and a third illumination module, as disclosed herein.
The present disclosure relates to devices, apparatus and methods of improving the accuracy of image-based assay, that uses imaging system having uncertainties or deviations (imperfection) compared with an ideal imaging system. One aspect of the present invention is to add the monitoring marks on the sample holder, with at least one of their geometric and/optical properties of the monitoring marks under predetermined and known, and taking images of the sample with the monitoring marks, and train a machine learning model using the images with the monitoring mark.
G06T 7/70 - Determining position or orientation of objects or cameras
G06V 10/22 - Image preprocessing by selection of a specific region containing or referencing a patternLocating or processing of specific regions to guide the detection or recognition
Among other things, the present disclosure is related to devices and methods of performing biological and chemical assays, such as but not limited to immunoassays and nucleic assay acid, particularly a homogeneous assay that does not use a wash step and that is fast (e.g., 60 seconds from dropping a sample to displaying results). The present disclosure is related to both competitive and non-competitive homogeneous assays.
The present disclosure relates to devices, apparatus and methods of improving the accuracy of an image-based assay. One aspect of the present invention is to sandwich a sample between two plates and add reference marks in the sample areas of the plates, with at least one of the geometric and/optical properties of the reference marks being predetermined and known, and taking images of the sample with the reference marks, and applying a machine learning model in the analysis of the image-based assay.
The present invention provides diagnostic devices and methods for quantifying the amounts of an acute phase reactant (e.g., C-reactive protein (CRP) or serum amyloid A (SAA)) in a body fluid sample and/or white blood cell counts in blood sample. In particular, the present invention provides a rapid assay to detect CRP, SAA, and/or white blood cells in blood with high sensitivity and specificity.
The present invention is related to, among other things, the devices and methods that improve the accuracy and reliability of an assay, even when the assay device and/or the operation of the assay device has certain errors, and in some embodiments the errors are random.
The present invention is related to the field of bio/chemical sampling, sensing, assays and applications. More particularly, one aspect of the present invention is related to bio/chemical assays, including how to separate two plates, how to separate a certain component from a composite liquid sample and obtain a liquid sample free of the component therein, and how to deposit sample and how operate plates for facilitating assaying.
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Medical diagnostic apparatus for testing cells, tissue, biomolecules, proteins, small molecules, and nucleotides; Medical devices for obtaining bodily fluid samples; Medical diagnostic instruments for the analysis of bodily fluids; Medical apparatus for diagnostic use, namely, medical apparatus for diagnostic testing of health conditions, diseases, or abnormalities, namely, cancer, blood abnormalities, immune diseases, neurological diseases, cardiovascular diseases, infectious diseases, viral diseases, genetic diseases, and endocrine diseases, and other tissue-based diagnostic testing, cytology, and cell based testing; Medical apparatus, devices, and instruments for wellness testing, health condition testing, and healthcare testing, namely, point-of-care diagnostic devices, at-home diagnostic devices, and portable health monitoring devices that detect health conditions and diseases in the nature of cancers, blood abnormalities, immune diseases, neurological diseases, cardiovascular diseases, infectious diseases, viral diseases and genetic diseases; Medical apparatus, devices, and instruments for the detection and identification of nucleic acids, namely, DNA and RNA in a sample, in the nature of apparatus for DNA and RNA testing for medical purposes; Medical diagnostic instruments for the analysis of body fluids in the nature of biological and chemical test kits for the detection and identification of nucleic acids, namely, DNA and RNA in a sample Medical services; Medical assistance; Medical consultations; Medical counseling; Medical information; Healthcare services in the field of digital healthcare services, namely, the diagnosis of diseases, namely, cancer, blood abnormalities, immune diseases, neurological diseases, cardiovascular diseases, infectious diseases, viral diseases, and genetic diseases; Diagnostic services, namely, medical testing for diagnostic purposes; Wellness services, namely, providing wellness information in the nature of providing information in the fields of health and wellness; Medical testing services for the detection and identification of cells, proteins, small molecules, and nucleic acids in a sample in the nature of medical testing for diagnostic or treatment purposes
One aspect of the present invention is to provide systems and methods that improve the accuracy of an assay that comprise at least one or more parameters each having a random error.
G06V 10/34 - Smoothing or thinning of the patternMorphological operationsSkeletonisation
G06V 10/44 - Local feature extraction by analysis of parts of the pattern, e.g. by detecting edges, contours, loops, corners, strokes or intersectionsConnectivity analysis, e.g. of connected components
G06V 20/69 - Microscopic objects, e.g. biological cells or cellular parts
G06F 18/2413 - Classification techniques relating to the classification model, e.g. parametric or non-parametric approaches based on distances to training or reference patterns
G06V 10/764 - Arrangements for image or video recognition or understanding using pattern recognition or machine learning using classification, e.g. of video objects
G06V 10/82 - Arrangements for image or video recognition or understanding using pattern recognition or machine learning using neural networks
01 - Chemical and biological materials for industrial, scientific and agricultural use
10 - Medical apparatus and instruments
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Assays for research purposes; Biological and chemical reagents used for non-medical research and laboratory purposes, namely, in vitro and in vivo scientific use, the testing of bodily fluids, and the detecting and analyzing of cells, proteins, small molecules, and nucleotides; Biological and chemical test kits comprised of biological, chemical, and diagnostic reagents for the detection and identification of nucleic acids, namely, DNA and RNA in a sample, for laboratory and research use Medical diagnostic apparatus for testing cells, tissue, biomolecules, proteins, small molecules, and nucleotides; Medical devices for obtaining bodily fluid samples; Medical diagnostic instruments for the analysis of bodily fluids; Medical apparatus for diagnostic use, namely, medical apparatus for diagnostic testing of health conditions, diseases, or abnormalities, namely, cancer, blood abnormalities, immune diseases, neurological diseases, cardiovascular diseases, infectious diseases, viral diseases, genetic diseases, and endocrine diseases, and other tissue-based diagnostic testing, cytology, and cell based testing; Medical apparatus, devices, and instruments for wellness testing, health condition testing, and healthcare testing, namely, point-of-care diagnostic devices, at-home diagnostic devices, and portable health monitoring devices that detect health conditions and diseases in the nature of cancers, blood abnormalities, immune diseases, neurological diseases, cardiovascular diseases, infectious diseases, viral diseases and genetic diseases; Medical apparatus, devices, and instruments for the detection and identification of nucleic acids, namely, DNA and RNA in a sample, in the nature of apparatus for DNA and RNA testing for medical purposes; Medical diagnostic instruments for the analysis of body fluids in the nature of biological and chemical test kits for the detection and identification of nucleic acids, namely, DNA and RNA in a sample Medical services; Medical assistance; Medical consultations; Medical counseling; Medical information; Healthcare services in the field of digital healthcare services, namely, the diagnosis of diseases, namely, cancer, blood abnormalities, immune diseases, neurological diseases, cardiovascular diseases, infectious diseases, viral diseases, and genetic diseases; Diagnostic services, namely, medical testing for diagnostic purposes; Wellness services, namely, providing wellness information in the nature of providing information in the fields of health and wellness; Medical testing services for the detection and identification of cells, proteins, small molecules, and nucleic acids in a sample in the nature of medical testing for diagnostic or treatment purposes
88.
Optical transmission sample holder and analysis, particularly for hemoglobin
Among other things, the present invention is related to devices and methods for improving optical analysis of a thin layer of a sample sandwiched between two plates.
Disclosed are devices and methods for performing biological and chemical assays, such as immunoassays and nucleic acid assays, more particularly a homogeneous assay that does not use a wash step by using the aggregation and de-aggregation processes of microparticles or nanoparticles.
The present invention provides, among other things, devices, kits, apparatus, and methods for rapid homogenous cell staining and imaging. Particularly, in some embodiments, the present invention can immunochemically stain a cell or a tissue in less than 60 seconds without washing. In some embodiments, the present invention stains and observers analyte (protein or nucleic acid) inside a cell in 60 seconds without wash.
The present invention is to provide methods and devices that monitoring health and diagnosing a disease by directly measuring the biomarkers inside a cell (intra-cellular detection) rapidly and easily.
A multiplex assay device including: a separation structure on a first plate; and a sample contact area on the surface of the first plate. Also disclosed is a method for fabricating a multiplex assay, including: making a reagent into a non-liquid reagent particle; creating a well on a sample contact area of a plate of a Q-card two plate sample card; and dropping one or more of the non-liquid reagent particles into at least one well.
The present invention is related to correct the errors in instruments, operation, and others using intelligent monitoring structures and machine learning, and others.
The present disclosure relates to devices, apparatus and methods of improving the accuracy of image-based assay, that uses imaging system having uncertainties or deviations (imperfection) compared with an ideal imaging system. One aspect of the present invention is to add the monitoring marks on the sample holder, with at least one of their geometric and/optical properties of the monitoring marks under predetermined and known, and taking images of the sample with the monitoring marks, and train a machine learning model using the images with the monitoring mark.
One aspect of the present invention is to provide the device and methods for performing an assay that uses the multiplexing of sample thicknesses on the same plate. The sample thickness multiplexing can offer many information that are unavailable in using a single sample thickness.
The present invention is related to the field of bio/chemical sampling, sensing, assays and applications. Particularly, the present invention is related to how to make the sampling/sensing/assay become simple to use, fast to results, highly sensitive, easy to use, using tiny sample volume (e.g. 0.5 uL or less), operated by a person without any professionals, reading by mobile-phone, or low cost, or a combination of them.
G01N 15/14 - Optical investigation techniques, e.g. flow cytometry
G01N 21/69 - 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 specially adapted for fluids
The present invention is to provide methods and devices that monitoring health and diagnosing a disease by directly measuring the biomarkers inside a cell (intra-cellular detection) rapidly and easily.
A microscopy imaging system comprising: a sample card holder; a sample card for holding a liquid sample or a solid sample in a uniformly thick layer between two opposable plates, the plates are separated by a plurality of evenly separated spacers of uniform height, and the horizontal in-plane cross-section of the plurality of spacers provide a plurality of calibration marks; a camera module having an image sensor and an internal lens; and an external lens situated between the camera module and the sample card device.
Disclosed is a method for correlating a biomarker in a non-blood bodily fluid with the same biomarker in the blood of an individual, including: measuring, in a first period in time, the biomarker in non-blood bodily fluid and measuring the same biomarker in the blood of the same individual to establish an R ratio of [NBBF1]/[BB1], where [NBBF1] is the biomarker concentration in non-blood bodily fluid in the first period in time, and [BB1] is the biomarker concentration in the blood in the first period in time; storing the ratio in a memory; measuring, in a second period in time, the biomarker in non-blood bodily fluid to determine [NBBF2], where [NBBF2] is the biomarker concentration in the non-blood bodily fluid in the second period in time; and correlating the measured [NBBF2] with the R ratio to generate a correlated [BB2] biomarker concentration in the blood of the individual in the second period in time. Also disclosed is a device, apparatus, and method for correlating the glucose concentration in a non- blood bodily fluid such as saliva with the glucose in the blood of an individual.
