49 results about "Rapid screening test" patented technology

A hand-held optoelectronic test system comprising a cartridge including at least one light source and sensors prealigned to permit acquisition of electro-optic data from a fluid sample reacted with a reagent, such as upon a test membrane in a reaction zone, and a reader which processes the acquired data to identify a physical change in the fluid sample. The cartridge and reader are operable for separate predetermined or controllable finite numbers of tests before becoming disposable.

A device and method for performing a point of care diagnostic test for detecting and quantifying at least one analyte in a biological sample (e.g., a body fluid). A device may include an immunoassay apparatus and a holder with an adjustable variable angle stage for positioning the immunoassay apparatus relative to a light source and a detector device so as to optimize the angle of incidence and angle of radiation to optimize an elastic light scattering signal from the immunoassay apparatus. The elastic light scattering signal may be used to quantify the amount of the analyte(s) of interest present in the sample. The device is based upon elastic light scattering, so the variation in the angle of incidence and angle of reflection are optimized to maximize signal generation due to elastic light scattering.

A handheld diagnostic test device includes a port to removably receive a test cartridge, an element connected with an electronic device, and sensors for detection of test data from a biological or environment sample after reaction with reagents onboard the cartridge. The test device also includes memory storing algorithms for upload to the electronic device to enable a processor thereof: to await elapse of a pre-determined time following reaction of the sample with the reagents; to thereafter instruct the sensors to detect the test data; to generate presentation data based on the test data; and to present the presentation data from a presentation element of the electronic device to a user. A related method includes a connecting step, an up-loading step, a presentation step, a cartridge inserting step, a waiting step, a sensing step, and an electronic device processing step.

A rapid diagnostic testing device for testing of a biological sample is provided. The device comprises a channeled construct, at least one lateral flow unit, and a cassette housing. The channeled construct is configured to receive a biological sample to form at least partially purified biological sample. The lateral flow unit is at least partially disposed in the cassette housing. The lateral flow unit comprises: a sample receiving zone, a conjugate zone and a detection zone. The sample receiving zone is operatively coupled to the channeled construct for receiving the partially purified biological sample comprising at least one analyte. The conjugate zone comprising a conjugate particle to bind the analyte is disposed adjacent to the first side of the sample receiving zone. The detection zone is disposed adjacent to the second side of the sample receiving zone and comprises at least one binding agent for detecting the analyte.

An improved rapid diagnostic device, assay and multifunctional buffer reagent are provided for the detection of a target analyte in a fluid test sample. The 2-step assay utilizes a dual component flow-through device comprising a test unit and a dried indicator reagent delivery unit capable of receiving the fluid sample and multifunctional buffer, respectively. The test unit comprises a reaction zone containing immobilized capture reagent that can specifically bind to the target analyte, an absorbent zone supporting the reaction zone, and optionally, a blood separation zone in lateral fluid communication with the reaction zone. The dried indicator reagent delivery unit comprises a label zone permeated with a dried indicator reagent which is capable of being placed in transient fluid communication with the reaction zone of the test unit during the assay procedure. The rapid diagnostic assay system reduces the number of assay reagents, method steps and time required for performance compared to other conventional assays.

An improved rapid diagnostic device, assay and multifunctional buffer reagent are provided for the detection of a target analyte in a fluid test sample. The 2-step assay utilizes a dual component flow-through device comprising a test unit and a dried indicator reagent delivery unit capable of receiving the fluid sample and multifunctional buffer, respectively. The test unit comprises a reaction zone containing immobilized capture reagent that can specifically bind to the target analyte, an absorbent zone supporting the reaction zone, and optionally, a blood separation zone in lateral fluid communication with the reaction zone. The dried indicator reagent delivery unit comprises a label zone permeated with a dried indicator reagent which is capable of being placed in transient fluid communication with the reaction zone of the test unit during the assay procedure. The rapid diagnostic assay system reduces the number of assay reagents, method steps and time required for performance compared to other conventional assays.

The invention provides reagents and methods for multivalent binding and quantitative capture of components in a sample. In one aspect, reagents and methods for diagnostic assay for antigen, ligand, binding agent, or antibody are provided. Compositions of a non-natural or deliberately constructed nucleic acid-like polymeric scaffold are provided, to which multiple antibodies, peptides or other binding agents can be affixed by hybridization of a oligonucleotide: binding agent complex such that the nucleic acid: binding agent construction displays multivalent behavior when interacting with a multivalent analyte. Methods for constructing and using the scaffolds are described. Such compositions may include assembly of mixed specificity binding agents such that the composition displays multivalent binding behavior against a target containing mixed analytes which can be bound by the construct to effect a binding affinity increase such as is observed in avidity reagents against single analytes expressed multiply on the target analyte. A manufacturing method for producing rapid diagnostic assays in a decentralized manner is also described. The method generates net economic advantages over conventional diagnostic manufacturing practices.

A package which incorporates, integrated in the composition of one of the components of the test's package, a plastic base (1), a moisture absorbing agent, so that this does not affect them, in combination with one or more polymers, which may be packaged in a blister produced by a base sheet (7) with structures which give rise to cavities (9), in each one whereof a rapid diagnostic test (5) is placed, whose base sheet (7) is complemented with a cover sheet (8) which seals the previous by heat fusion, achieving the hermeticity of each cavity.

The invention discloses a portable fluorescence immunity analyzer. The portable fluorescence immunity analyzer comprises a test strip bin, an excitation light source, a camera, a communication moduleand a processing module, wherein the test strip bin is used for being inserted with a fluorescence chromatography rapid diagnosis test strip; the excitation light source is arranged right above a color developing region of the fluorescence chromatography rapid diagnosis test strip and used for exciting a fluorescent substance on the fluorescence chromatography rapid diagnosis test strip to producefluorescence emitting lights; the camera is arranged at an entrance above an acquisition channel on the excitation light source and used for acquiring the fluorescence emitting lights of a fluorescence test strip; the communication module is used for sending an image acquired by the camera; and the processing module is used for controlling the excitation light source, the camera and the communication to work harmoniously.

This invention relates to a test for detecting a Mycobacterium tuberculosis (tuberculosis or TB) infection in a patient or subject, specifically a diagnostic test, including a breath test, whereby patients are provided a small dose of an isotopically labeled TB drug, Isoniazid (INH) orally or directly to the lungs of the patient or subject. If TB is present, a TB enzyme mycobacterial peroxidase KatG oxidizes the INH; and KatG specific metabolites, in particular, isotopically labeled nitric oxide (NO), nitrites, nitrates, carbon monoxide (CO) or carbon dioxide converted from carbon monoxide of INH cleavage are measured. Other embodiments relate to a diagnostic breath test for detecting TB utilizing isotopically labeled urea (preferably, carbon-13 labeled urea), alone or in combination with isotopically labeled isoniazid (preferably, nitrogen-15 labeled isoniazid), wherein M. tuberculosis organism, if present in the patient or subject's lungs (or other tissues), will metabolize the isotopically labeled urea to isotopically labeled carbon dioxide (CO2) such that a determination of the residence of M. tuberculosis, including residence of an isoniazid resistant strain of M. tuberculosis, may be made.

The present invention provides a multiplexed immunoassay which leverages stockpiled antibodies to detect whether a patient has been infected with an emerging disease which does not have specific antibodies raised against it (FIG. 1). The assay is preferably designed as a paper-based assay, which allows diagnosis at point of care (POC) and readout by eye or mobile phone. Paper-based rapid diagnostic tests (RDTs) are convenient, robust, and can be read out within minutes. The immunoassay of the invention combines the strategic use of nanoparticles of assorted colors with readily available stockpiled antibodies to one or more biomarkers of disease, particularly viral diseases.

A device, system, method, and computer readable medium is provided for universal analysis of immunoassay rapid diagnostic tests. They permit different tests, from varied manufacturers, to be read even though such tests may be associated with reflection and / or emission types of signals. The device, system, method, and computer readable medium use one or more rapid diagnostic test databases, including information on products commercially available on the market and on customized rapid tests. The device, system, method, and computer readable medium identify the type of test to be analyzed by matching it with the test database(s). They capture a corresponding reflection and / or emission signal from the test, as appropriate. The device, system, method, and computer readable medium may transform the signal to an image, or vice-versa, and / or analyze the image to interpret the test result.

This invention relates to a test for detecting a Mycobacterium tuberculosis (tuberculosis or TB) infection in a patient or subject, specifically a diagnostic test, including a breath test, whereby patients are provided a small dose of an isotopically labeled TB drug, Isoniazid (INH) orally or directly to the lungs of the patient or subject. If TB is present, a TB enzyme mycobacterial peroxidase KatG oxidizes the INH; and KatG specific metabolites, in particular, isotopically labeled nitric oxide (NO), nitrites, nitrates, carbon monoxide (CO) or carbon dioxide converted from carbon monoxide of INH cleavage are measured. Other embodiments relate to a diagnostic breath test for detecting TB utilizing isotopically labeled urea (preferably, carbon-13 labeled urea), alone or in combination with isotopically labeled isoniazid (preferably, nitrogen-15 labeled isoniazid), wherein M. tuberculosis organism, if present in the patient or subject's lungs (or other tissues), will metabolize the isotopically labeled urea to isotopically labeled carbon dioxide (CO2) such that a determination of the residence of M. tuberculosis, including residence of an isoniazid resistant strain of M. tuberculosis, may be made.

Quality control (QC) sensor methods, systems and devices are for use with biological / environmental rapid diagnostic test (RDT) devices and provide for automatic timers, reminders and RDT cassette images. Sensors are calibrated and optimized, and provide for quality control of the RDT devices. Image analysis identifies cassette and patient information, and evaluates the processing and conditions of the RDT devices, cassettes and RDTs. Results may be accessed and analyzed remotely from the RDT devices. RDT chain of custody and workflow, incubation and reading sequences are tracked. A QC score for each unique patient RDT is determined based on QC criteria.

A package which incorporates, integrated in the composition of one of the components of the test package, a plastic support (1), a moisture absorbing agent, so that this does not affect them, in combination with one or more polymers, which may be packaged in a blister produced by a base sheet (7) with cavities (9), in each one whereof a rapid diagnostic test (5) is placed, whose base sheet (7) is complemented with a cover sheet (8) which seals the base sheet by heat fusion, achieving the hermeticity of each cavity.

Quality control (QC) sensor methods, systems and devices are for use with biological / environmental rapid diagnostic test (RDT) devices and provide for automatic timers, reminders and RDT cassette images. Sensors are calibrated and optimized, and provide for quality control of the RDT devices. Image analysis identifies cassette and patient information, and evaluates the processing and conditions of the RDT devices, cassettes and RDTs. Results may be accessed and analyzed remotely from the RDT devices. RDT chain of custody and workflow, incubation and reading sequences are tracked. A QC score for each unique patient RDT is determined based on QC criteria.

A cassette device for rapid diagnostic test in a single step. More specifically, an immunochromatographic rapid test for identifying antibodies present in a biological sample, such as human blood, is disclosed. The device has a lower cassette (1) and an upper cassette (7) containing a capillary-tube-shaped structure (8). The capillary-shaped structure holds the sample amount needed for the rapid test, preventing waste and sample dilution. Lower (1) and upper (7) cassettes are attached by a movable cover (9), which when pressed causes the capillary-tube-shaped structure closure (8), and a disruption of a capsule (5) containing buffer solution by pressing thereof using a spear-shaped structure (6). Disruption of the capsule (5) by this mechanism allows the buffer solution to be poured in a controlled manner over an absorbent pad (3) located on a test strip (2) in a point anterior the point receiving the sample (10).

A three-in-one apparatus for analyzing liquids, such as some body fluids, uses labeled molecular affinity binding, such as immunochromatography. The multi-functional diagnostic test device can detect an analyte, such as an antibody or antigen, which may indicate a particular condition. The multi-functional diagnostic test device provides multi-functional formats to apply in multiple different sampling methods, including the “dip”, “cassette” and “collection” formats. The diagnostic test device can accommodate a plurality of test strips, such as 18 test strips for analyzing up to 90 analytes.

Disclosed herein is an information-augmented rapid diagnostic test in which control and test modules of a barcode, such as a QR code, are responsive to biomarkers in an analyte to become visible and form at least a portion of the barcode upon detection of the presence of such biomarkers. The barcode embeds test manufacturing details, serves as a trigger for image capture, enables registration for image analysis, and corrects for lighting effects. An accompanying mobile application preferably automatically captures an image of the test when the QR code is recognized, decodes the QR code, performs image processing to determine the concentration of the particular biomarker that is being diagnosed, and transmits the test results and QR code payload to a secure web portal.

A progressive compression driven flow cartridge for analyzing liquids is coupled with convenient sampling methods for different applications. A one-step device provides for direct sample collection upon a sample pad annexed to the cartridge. The sample pad can deliver sample to the test strips, while saving a portion of the sample pad for further laboratory confirmation use. If the sample collecting pad is not suitable to collect the sample, such as the case of biological substances inside the human body, such as within the nose or throat, a two-step device can include a long-arm swab applicator and a specialized chamber in which some amount of liquid can dissolve biological substances as specimen. The specimen can then be transferred onto the cartridge, either by application to the sample pad, or into the device through a sample window. Each method provides a qualitative analysis much faster than traditional rapid diagnostic devices.

The invention belongs to the field of bioengineering technology. Based on the common problems in the field of rapid antibody detection at home and abroad, such as poor antigen water solubility, weak detection signal, low sensitivity, and poor specificity, the invention proposes to directly use the overall fusion protein carrying a fusion label to detect the analyte Rapid detection of planar flow type. 1. The main points of the present invention are: constructing the recombinant gene of the fusion protein; expressing and purifying the recombinant fusion protein; preparing detection reagents and capture reagents with the recombinant fusion protein. 2. The present invention shows that the fusion protein has the advantages of good water solubility, easy purification, natural configuration, high activity, and high labeling efficiency, and the rapid detection reagent made from it has high sensitivity and specificity. 3. The rapid detection reagent constructed according to the present invention can detect one or two analytes simultaneously. 4. The present invention has broad application prospects in the field of application and basic research such as disease diagnosis, epidemiological survey, medical identification, new drug development, agriculture, animal husbandry and veterinary medicine.

A rapid diagnostic test device uses driven flow technology to significantly expedite the testing time of a sample. The rapid diagnostic test device can be used to analyze liquids, such as some body fluids, by using labeled molecular affinity binding, such as immunochromatography. The test device can detect an analyte, such as an antibody or antigen, which may indicate a particular condition, the presence of a particular drug, or the like. The device includes a cover and base that combine to form an internal cavity for receiving a test strip. Compression bars in the cover and a compression cushion in the base sandwich a conjugate pad of the test strip to accelerate chemical mixtures to flow from the conjugate pad of the test strip toward fixed sites along the strip from which readings are taken.

Provided herein are integrated devices that improve sensitivity of rapid diagnostic tests. The devices described herein integrate sample separation with rapid diagnostic tests and improve signal intensity of the rapid diagnostic tests.

The disclosed embodiments are generally directed to improving feature detection of rapidly acquired images using camera-enabled mobile devices involving a 2-D decal code, such as a QR code, for improving the reading accuracy of a rapid diagnostic antigen or antibody or enzymatic colorimetric directed test, such as for COVID-19 diagnosis. One primary issue with evaluating a Covid-19 rapid test is detecting and quantifying positive test lines from sampled test strips based on digital images of the test strip. Aspects of the present invention contemplate masking a QR code to improve the sample image resolution and contrast. Other aspects of the present invention contemplate methods and techniques to evaluate a test line on the sample image by enhancing an intensity curve along the test line and control line containing area by way of calculating the instantaneous change in pixel intensity and evaluating the position and intensity of those signals.

Assay cassettes and testing devices that can be used to provide rapid, accurate, affordable, laboratory-quality testing at the point of care. Such assay cassettes and testing devices are designed to provide rapid, quantitative test results in a point-of-care setting or the like. Likewise, such assay cassettes and testing devices may eliminate or replace expensive, centralized clinical testing equipment and technical personnel. Such testing device may include automated data reporting and decision support. Methods for performing point of care diagnostic tests are also disclosed.