Disclosed herein are assay methods and kits for assessing the strength of the immune response to SARS-CoV-2 virus in a subject by allowing for rapid and efficient detection of neutralizing antibodies (NAbs) from serum of vaccinated and non-vaccinated subjects. The assay method can be conducted in a biosafety level 2 setting, and uses highly-purified, monomeric SARS-Cov-2-Spike1 which leads to improved sensitivity and specificity over current state of the art assays.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Medical diagnostic rapid point-of-care test kits comprised
of medical diagnostic reagents and assays for testing of
bodily fluids for use in disease detection, namely,
hepatitis C (HCV), hepatitis B sAg (HBsAg), syphilis,
syphilis/HIV combination and malaria; medical diagnostic
rapid point-of-care test kits comprised of medical
diagnostic reagents and assays for testing of bodily fluids
for detection of pregnancy.
The invention relates to a direct sample collection pad for assay diagnosis of a sample without introducing an additional sampling device into the assay method. This simplifies the system and method of sample collection and assay diagnosis, thus reducing waste and potential for patient irritation or injury during diagnosis.
An oral fluid collection device includes a plunger and funnel to simultaneously collect and split a single specimen into metered doses for drug testing. The device may be used with collection tubes for collection of the metered doses and later testing. The device, when used, drives the metered dose into the collection tubes and removes bubbles in the specimen to provide improved accuracy in testing.
A61B 10/00 - Instruments for taking body samples for diagnostic purposesOther methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determinationThroat striking implements
6.
PRODUCTS AND METHODS FOR MONITORING ADHERENCE TO NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR THERAPY
The invention provides novel compounds, reagents, systems, and methods for detecting a metabolite related to a NRTI in a biological sample and use thereof in monitoring adherence to pre-exposure prophylaxis or anti-retroviral treatment. Such reagents comprise NRTI derivatives, analogs, NRTI derivatives conjugates, along with antibodies directed to same, which are useful for antibody-based methods, such as a lateral flow immunoassay and other point of care devices.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Medical diagnostic rapid point-of-care test kits comprised of medical diagnostic reagents and assays for testing of bodily fluids for use in disease detection, namely, hepatitis C (HCV), hepatitis B sAg (HBsAg), syphilis, syphilis/HIV combination and malaria; Medical diagnostic rapid point-of-care test kits comprised of medical diagnostic reagents and assays for testing of bodily fluids for detection of pregnancy
Disclosed herein are assay methods and kits for for assessing the strength of the immune response to SARS-CoV-2 virus in a subject by allowing for rapid and efficient detection of neutralizing antibodies (NAbs) from serum of vaccinated and non-vaccinated subjects. The assay method can be conducted in a biosafety level 2 setting, and uses highly-purified, monomeric SARS-Cov-2-Spikel which leads to improved sensitivity and specificity over current state of the art assays.
G01N 33/569 - ImmunoassayBiospecific binding assayMaterials therefor for microorganisms, e.g. protozoa, bacteria, viruses
A61K 39/215 - Coronaviridae, e.g. avian infectious bronchitis virus
C07K 14/165 - Coronaviridae, e.g. avian infectious bronchitis virus
C07K 16/10 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material from viruses from RNA viruses
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving virus or bacteriophage
13.
DIRECT SAMPLE COLLECTION PAD AND METHOD OF USE FOR ASSAY DIAGNOSIS
The invention relates to a direct sample collection pad for assay diagnosis of a sample without introducing an additional sampling device into the assay method. This simplifies the system and method of sample collection and assay diagnosis, thus reducing waste and potential for patient irritation or injury during diagnosis.
An oral fluid collection device includes a plunger and funnel to simultaneously collect and split a single specimen into metered doses for drug testing. The device may be used with collection tubes for collection of the metered doses and later testing. The device, when used, drives the metered dose into the collection tubes and removes bubbles in the specimen to provide improved accuracy in testing.
A61B 10/00 - Instruments for taking body samples for diagnostic purposesOther methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determinationThroat striking implements
B01L 99/00 - Subject matter not provided for in other groups of this subclass
The invention relates to a direct sample collection pad for assay diagnosis of a sample without introducing an additional sampling device into the assay method. This simplifies the system and method of sample collection and assay diagnosis, thus reducing waste and potential for patient irritation or injury during diagnosis.
An oral fluid collection device includes a plunger and funnel to simultaneously collect and split a single specimen into metered doses for drug testing. The device may be used with collection tubes for collection of the metered doses and later testing. The device, when used, drives the metered dose into the collection tubes and removes bubbles in the specimen to provide improved accuracy in testing.
A61B 10/00 - Instruments for taking body samples for diagnostic purposesOther methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determinationThroat striking implements
The invention relates to a direct sample collection pad for assay diagnosis of a sample without introducing an additional sampling device into the assay method. This simplifies the system and method of sample collection and assay diagnosis, thus reducing waste and potential for patient irritation or injury during diagnosis.
An oral fluid collection device includes a plunger and funnel to simultaneously collect and split a single specimen into metered doses for drug testing. The device may be used with collection tubes for collection of the metered doses and later testing. The device, when used, drives the metered dose into the collection tubes and removes bubbles in the specimen to provide improved accuracy in testing.
A61B 10/00 - Instruments for taking body samples for diagnostic purposesOther methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determinationThroat striking implements
19.
REAGENTS, METHODS, AND SYSTEMS FOR DETECTING THERAPEUTIC AGENTS TO MONITOR ADHERENCE TO NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR METABOLITES
The invention provides novel compounds, reagents, systems, and methods for detecting a metabolite related to a NRTI in a biological sample, and uses thereof in monitoring adherence to pre-exposure prophylaxis. Such reagents comprise NRTI derivatives, analogs, NRTI derivatives conjugates, along with antibodies directed to same, which are useful for antibody-based methods, such as a lateral flow immunoassay and other point of care devices.
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
C07K 16/44 - Immunoglobulins, e.g. monoclonal or polyclonal antibodies against material not provided for elsewhere
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing
20.
REAGENTS, METHODS, AND SYSTEMS FOR DETECTING THERAPEUTIC AGENTS TO MONITOR ADHERENCE TO NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR METABOLITES
The invention provides novel compounds, reagents, systems, and methods for detecting a metabolite related to a NRTI in a biological sample, and uses thereof in monitoring adherence to pre-exposure prophylaxis. Such reagents comprise NRTI derivatives, analogs, NRTI derivatives conjugates, along with antibodies directed to same, which are useful for antibody-based methods, such as a lateral flow immunoassay and other point of care devices.
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
21.
Reagents, methods, and systems for detecting therapeutic agents to monitor adherence to nucleoside reverse transcriptase inhibitor metabolites
The invention provides novel compounds, reagents, systems, and methods for detecting a metabolite related to a NRTI in a biological sample, and uses thereof in monitoring adherence to pre-exposure prophylaxis. Such reagents comprise NRTI derivatives, analogs, NRTI derivatives conjugates, along with antibodies directed to same, which are useful for antibody-based methods, such as a lateral flow immunoassay and other point of care devices.
The invention provides a developer solution vial and methods of its use to diagnose diseases using a sampling and/or assay device, for example, for use with a lateral flow assay (LFA) device. The developer solution vial may include any container that is capable of holding developer solution. The developer solution vial is keyed to the sampling and/or assay device. The developer solution vial minimizes the amount of developer solution required for accurate fluid flow assay testing.
The invention provides a developer solution vial and methods of its use to diagnose diseases using a sampling and/or assay device, for example, for use with a lateral flow assay (LFA) device. The developer solution vial may include any container that is capable of holding developer solution. The developer solution vial is keyed to the sampling and/or assay device. The developer solution vial minimizes the amount of developer solution required for accurate fluid flow assay testing.
Disclosed are lateral flow assay methods, lateral flow assay test strips, and devices for detection of antibody classes associated with acute immune responses. The invention generally relates to assay methods, in particular, lateral flow assay methods for detection of an antibody isotype associated with acute infection, and to lateral flow assay strips for use in the methods of the invention.
Medical device for analyzing and checking adherence to prescribed medication regimens, detecting non-compliance with medical treatment plans and medication regimens, and alerting users when a non-compliance with medical adherence is detected
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Medical diagnostic rapid point-of-care test kits being specimen collection kits for use in virus testing, comprised primarily of nasal swabs for medical purposes, and also including plastic bags and boxes for oral fluid collection, as well as printed instructions for use, all for the detection of antibodies, antigen and viruses
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Medical diagnostic rapid point-of-care test kits being specimen collection kits for use in virus testing, comprised primarily of nasal swabs for medical purposes, and also including plastic bags and boxes for oral fluid collection, as well as printed instructions for use, all for the detection of antibodies, antigen and viruses
Disclosed herein are assay methods, lateral flow assay test strips, and devices for improved analyte detection. Analyte binding to target is performed both in solution phase and with a target immobilized on a surface, resulting in improved analyte detection.
The invention provides novel compounds, reagents, systems, and methods for detecting a metabolite related to a NRTI in a biological sample, and use thereof in monitoring adherence to pre-exposure prophylaxis or anti-retroviral treatment. Such reagents comprise NRTI derivatives, analogs, NRTI derivatives conjugates, along with antibodies directed to same, which are useful for anti-body-based methods, such as a lateral flow immunoassay and other point of care devices.
G01N 33/543 - ImmunoassayBiospecific binding assayMaterials therefor with an insoluble carrier for immobilising immunochemicals
C07F 9/6561 - Heterocyclic compounds, e.g. containing phosphorus as a ring hetero atom containing systems of two or more relevant hetero rings condensed among themselves or condensed with a common carbocyclic ring or ring system, with or without other non-condensed hetero rings
A61K 47/64 - Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
30.
LATERAL FLOW ASSAYS FOR DIFFERENTIAL ISOTYPE DETECTION
Disclosed are lateral flow assay methods, lateral flow assay test strips, and devices for detection of antibody classes associated with acute immune responses. The invention generally relates to assay methods, in particular, lateral flow assay methods for detection of an antibody isotype associated with acute infection, and to lateral flow assay strips for use in the methods of the invention.
Disclosed are lateral flow assay methods, lateral flow assay test strips, and devices for detection of antibody classes associated with acute immune responses. The invention generally relates to assay methods, in particular, lateral flow assay methods for detection of an antibody isotype associated with acute infection, and to lateral flow assay strips for use in the methods of the invention.
Disclosed herein are assay methods, lateral flow assay test strips, and devices for improved analyte detection. Analyte binding to target is performed both in solution phase and with a target immobilized on a surface, resulting in improved analyte detection.
Disclosed herein are assay methods, lateral flow assay test strips, and devices for improved analyte detection. Analyte binding to target is performed both in solution phase and with a target immobilized on a surface, resulting in improved analyte detection.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Medical diagnostic test kit comprised of diagnostic preparation for detection of drugs in the body; medical diagnostic saliva pads; medical diagnostic saliva vials.
05 - Pharmaceutical, veterinary and sanitary products
Goods & Services
Medical diagnostic test kit comprised of diagnostic preparation for detection of drugs in the body; medical diagnostic saliva pads; medical diagnostic saliva vials.
A sample collection kit includes a sample collector, a polycarbonate container, and a preservative solution. The sample collector includes an absorbent pad with a collecting element that receives a sample of oral fluid. The absorbent pad also includes an interior portion that extends into a handle. The handle includes an upper casing and a lower casing. The collecting element can be treated with a surfactant to optimize recovery of analytes from the oral sample and/or their absorbance onto the absorbent pad. A polycarbonate container receives the absorbent pad or the sample collector and stores it for testing of analytes. A dextran sulfate preservative solution is included in the polycarbonate container that inhibits enzymatic activity on a collected sample.
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
Goods & Services
Diagnostic preparations for medical purposes; chemicals for medical purposes and for analytical purposes; reagent preparations for medical purposes; reagents for laboratory use (medical) and analysis; testing kits comprised of medical diagnostic reagents and assays. Testing apparatus for medical purposes; analytical apparatus for medical purposes; diagnostic test kits; diagnostic instruments and apparatus for medical purposes; medical diagnostic test kits primarily consisting of oral fluid collection pads, and vials; parts and fittings for the aforesaid goods.
A cryo-surgical system may comprise a container containing a refrigerant, a delivery tube having a first end configured to be in flow communication with the container and a second end opposite the first end. The system may further include a plurality of flexible finger portions disposed proximate a second end of the delivery tube opposite the first end, an applicator bud having a body portion disposed within the plurality of flexible finger portions and a contact surface extending from the plurality of flexible finger portions. An adjustment ring may be disposed along the delivery tube adjacent to the plurality of flexible finger portions. The contact surface of the bud may be changeable by adjustment of the adjustment ring.
A61B 18/02 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
47.
CRYO-SURGICAL SYSTEMS AND METHODS OF USING THE SAME
A cryo-surgical system may com-prise a container containing a refrigerant, a deliv-ery tube having a first end configured to be in flow communication with the container and a second end opposite the first end. The system may further include a plurality of flexible finger portions disposed proximate a second end of the delivery tube opposite the first end, an applicator bud having a body portion disposed within the plurality of flexible finger portions and a contact surface extending from the plurality of flexible finger portions. An adjustment ring may be dis-posed along the delivery tube adjacent to the plu-rality of flexible finger portions. The contact sur-face of the bud may be changeable by adjustment of the adjustment ring.
A61B 18/02 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
48.
Container and method for supporting home testing and diagnosis of infectious diseases
A container is configured to provide sequential access to contents therein, and includes an upper portion and a lower portion connected to the upper portion by a hinged portion, the lower portion defining an interior space bearing a moveable tray and an opening through which the moveable tray may move, the moveable tray defining an interior volume configured to receive at least one device therewithin. The container also includes at least one device borne by the moveable tray, at least one cavity for receiving the at least one device disposed in the upper portion and at least one insert located between the upper and lower portions, the at least one insert comprising at least written indicia thereon.
G01N 15/06 - Investigating concentration of particle suspensions
G01N 33/00 - Investigating or analysing materials by specific methods not covered by groups
G01N 33/48 - Biological material, e.g. blood, urineHaemocytometers
G01N 21/75 - Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
G01N 31/22 - Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroupsApparatus specially adapted for such methods using chemical indicators
G01N 33/52 - Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper
B01L 3/00 - Containers or dishes for laboratory use, e.g. laboratory glasswareDroppers
B01L 99/00 - Subject matter not provided for in other groups of this subclass
A collector includes a collecting element that receives a sample of bodily fluid. The collecting element may be an absorbent pad that has been treated with a surfactant to optimize recovery of analytes from the sample and/or their absorbancc onto the absorbent material. An extractor is operably connected to a container and receives the collector to provide fluid communication between the collector and the container. The collector, when received by the extractor, is operable to release a volume of the sample into the container.
B65D 81/00 - Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
50.
CONTAINER AND METHOD FOR SUPPORTING HOME TESTING AND DIAGNOSIS OF INFECTIOUS DISEASES
A container is configured to provide sequential access to contents therein, and includes an upper portion and a lower portion connected to the upper portion by a hinged portion, the lower portion defining an interior space bearing a moveable tray and an opening through which the moveable tray may move, the moveable tray defining an interior volume configured to receive at least one device therewithin. The container also includes at least one device borne by the moveable tray, at least one cavity for receiving the at least one device disposed in the upper portion and at least one insert located between the upper and lower portions, the at least one insert comprising at least written indicia thereon.
A61B 50/30 - Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments
A container is configured to provide sequential access to contents therein, and includes an upper portion and a lower portion connected to the upper portion by a hinged portion, the lower portion defining an interior space bearing a moveable tray and an opening through which the moveable tray may move, the moveable tray defining an interior volume configured to receive at least one device therewithin. The container also includes at least one device borne by the moveable tray, at least one cavity for receiving the at least one device disposed in the upper portion and at least one insert located between the upper and lower portions, the at least one insert comprising at least written indicia thereon.
A cryosurgery device for dispensing a liquid refrigerant from a container having a valve stem extending outwardly therefrom. The device includes an actuator adapted to seat on the valve stem of the container in order to depress the valve stem to release the refrigerant from the container. The actuator includes an inner passageway having opposed ends disposed therein, one of the ends of the passageway being in fluid communication with the valve stem. An applicator tube is mounted to the actuator at the other end of the inner passageway. A cap is disposed on the top of the container. The actuator is movably positioned on the cap and a shield is attached to the cap to completely receiving the applicator tube. Liquid refrigerant can only be dispensed when the actuator is positioned properly and the applicator tube is disposed within the shield means.
A61B 18/02 - Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
F25D 17/02 - Arrangements for circulating cooling fluidsArrangements for circulating gas, e.g. air, within refrigerated spaces for circulating liquids, e.g. brine
Medical diagnostic rapid point-of-care testing apparatus using oral fluid, finger-stick or venipuncture whole blood, plasma, serum or other specimen types for use in detecting antibodies, antigen, viruses, drugs of abuse or other markers, substances or conditions.
medical diagnostic rapid point-of-care test kits comprised of collection pads or swabs, collection loops or vials, test strips capable of visual or instrument read-out of test results, and/or vials of developer solution or reagents, which use oral fluid, finger stick or venipuncture whole blood, plasma, serum, and other bodily fluids and specimens for use in detecting antibodies, antigen, viruses, drugs of abuse, diseases, nucleic acids, pathogens, proteins, toxins and chemicals
