A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.
A molecular diagnostic test device can include a housing and a sample preparation module within the housing. The sample preparation module defines an input reservoir and a sample input opening through which a biological sample can be loaded into the input reservoir. The sample preparation module includes a solid reagent contained within the input reservoir. The molecular diagnostic test device can include a fluid source within the housing. The fluid source is in fluid communication with the input reservoir such that upon activation of the molecular diagnostic test device, the fluid from the fluid source is injected into the input reservoir to mix the biological sample and the solid reagent within the input reservoir to form an input solution containing a target molecule.
A method includes coupling a molecular diagnostic test device to a power source. A biological sample is conveyed into a sample preparation module. The device is then actuated by only a single action to cause the device to perform the following functions without further user action. First, the device heats the sample via a heater of the sample preparation module to lyse a portion of the sample. Second, the device conveys the lysed sample to an amplification module and heats the sample within a reaction volume of the amplification module to amplify a nucleic acid thereby producing an output solution containing a target amplicon. The device then reacts, within a detection module, each of (i) the output solution and (ii) a reagent formulated to produce a signal that indicates a presence of the target amplicon within the output solution. A result associated with the signal is then read.
An apparatus includes a housing and a sample preparation module disposed within the housing. The sample preparation module has a base including a wall defining a sample reservoir. The apparatus includes a flexible heater having a first end and a second end. The first end of the flexible heater is coupled to a connector to be in electrical communication with a power source. A carrier is coupled to and supports the flexible heater such that the second end of the flexible heater is disposed within the sample reservoir spaced apart from the wall. The apparatus can also include an input retention lid that can be disposed partially within the sample reservoir and includes a retention screen to prevent solid reagents within the sample reservoir from migrating upward.
A stand-alone molecular diagnostic test device includes a housing, a reverse transcription module, an amplification module, and a detection module. The reverse transcription module is configured to heat a biological sample to produce a target cDNA molecule associated with an RNA virus thereby producing an amplification solution. The amplification module defines a reaction volume configured to receive the amplification solution and amplify the target cDNA molecule within the amplification solution to produce an output. The detection module is configured to receive the output from the amplification module and includes one or more probes specific to a polynucleotide sequence of the RNA virus. The one or more probes is designed to facilitate production of a signal indicating the presence of the RNA virus in the biological sample.
C12Q 1/70 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions faisant intervenir des virus ou des bactériophages
C12Q 1/6818 - Tests d’hybridation caractérisés par les moyens de détection impliquant l’interaction de plusieurs marqueurs, p. ex. transfert d’énergie de résonance
C12Q 1/6876 - Produits d’acides nucléiques utilisés dans l’analyse d’acides nucléiques, p. ex. amorces ou sondes
9.
MOLECULAR DIAGNOSTIC DEVICES AND METHODS FOR RETAINING AND MIXING REAGENTS
A molecular diagnostic test device can include a housing and a sample preparation module within the housing. The sample preparation module defines an input reservoir and a sample input opening through which a biological sample can be loaded into the input reservoir. The sample preparation module includes a solid reagent contained within the input reservoir. The molecular diagnostic test device can include a fluid source within the housing. The fluid source is in fluid communication with the input reservoir such that upon activation of the molecular diagnostic test device, the fluid from the fluid source is injected into the input reservoir to mix the biological sample and the solid reagent within the input reservoir to form an input solution containing a target molecule.
05 - Produits pharmaceutiques, vétérinaires et hygièniques
10 - Appareils et instruments médicaux
Produits et services
Omic specimen collection kits comprised primarily of swabs for medical purposes and also including collection tube, gloves, specimen container, tube holder, power adapter, instructions, and screening device for use in diagnosing and screening various medical conditions; Medical specimen collection kits comprised primarily of swabs and also including collection tube, gloves, specimen bag, tube holder, power adapter, instructions, and device for use in screening various medical conditions Medical diagnostic apparatus for the detection of infectious diseases, cancers, and neurological diseases and conditions; medical diagnostic apparatus for testing for infectious diseases, cancers and non-infectious neurological diseases and conditions; medical diagnostic apparatus for testing for bacterial infections, viral infections, sexually transmitted infections, and infectious diseases; medical diagnostic apparatus for the detection of and testing for cancers and non-infectious neurological diseases and conditions
05 - Produits pharmaceutiques, vétérinaires et hygièniques
10 - Appareils et instruments médicaux
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
Omic specimen collection kits comprised primarily of swabs for medical purposes and also including collection tube, gloves, specimen container, tube holder, power adapter, instructions, and screening device for use in diagnosing and screening various medical conditions; Medical specimen collection kits comprised primarily of swabs and also including collection tube, gloves, specimen bag, tube holder, power adapter, instructions, and device for use in screening various medical conditions Medical diagnostic apparatus for the detection of infectious diseases, cancers, and neurological diseases and conditions; medical diagnostic apparatus for testing for infectious diseases, cancers and non-infectious neurological diseases and conditions; medical diagnostic apparatus for testing for bacterial infections, viral infections, sexually transmitted infections, and infectious diseases; medical diagnostic apparatus for the detection of and testing for cancers and non-infectious neurological Consultation services in the field of health care and the detection and diagnosis of infectious and non-infectious diseases and conditions
12.
Devices and methods for antibiotic susceptibility testing
The disclosure relates generally to molecular diagnostic devices configured to amplifying a single nucleotide polymorphism (SNP) locus and discriminate between two or more allelic variants of the SNP, indicating presence or absence of a target allele. In some embodiments, the molecular diagnostic devices are capable of detecting, at point-of-care, SNPs associated with resistance or susceptibility to antibiotic treatment of organism infections. In other aspects, the disclosure provides methods of treatment for disease or disorders (e.g. organism infections) where treatment is guided by presence or absence of an allele at a SNP locus as determined by such molecular diagnostic devices.
C12P 19/34 - Polynucléotides, p. ex. acides nucléiques, oligoribonucléotides
C12Q 1/04 - Détermination de la présence ou du type de micro-organismeEmploi de milieux sélectifs pour tester des antibiotiques ou des bactéricidesCompositions à cet effet contenant un indicateur chimique
C12Q 1/18 - Test de l'activité antimicrobienne d'un matériau
C12Q 1/689 - Produits d’acides nucléiques utilisés dans l’analyse d’acides nucléiques, p. ex. amorces ou sondes pour la détection ou l’identification d’organismes pour les bactéries
13.
Molecular diagnostic devices with digital detection capability and wireless connectivity
In some embodiments, a stand-alone molecular diagnostic test device includes a detection circuit that includes a light emitting device and a light receiving device (e.g., a photodiode) that are arranged to produce an electronic signal associated with a colorimetric output produced by the stand-alone molecular diagnostic test.
Disclosed herein are methods and devices for preparing a sample of nucleic acid molecules from a biological sample. The methods and devices may perform similarly to or better than standard sample preparation methods. The nucleic acid molecules prepared using the methods and devices provided herein may be utilized for downstream applications, including polymerase chain reaction (PCR).
C12N 15/10 - Procédés pour l'isolement, la préparation ou la purification d'ADN ou d'ARN
C12Q 1/6806 - Préparation d’acides nucléiques pour analyse, p. ex. pour test de réaction en chaîne par polymérase [PCR]
C12Q 1/00 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions
G01N 33/48 - Matériau biologique, p. ex. sang, urineHémocytomètres
B01L 3/00 - Récipients ou ustensiles pour laboratoires, p. ex. verrerie de laboratoireCompte-gouttes
C12Q 1/37 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions faisant intervenir une hydrolase faisant intervenir une peptidase ou une protéinase
C12Q 1/686 - Réaction en chaine par polymérase [PCR]
15.
Portable molecular diagnostic device and methods for the detection of target viruses
A method includes coupling a molecular diagnostic test device to a power source. A biological sample is conveyed into a sample preparation module. The device is then actuated by only a single action to cause the device to perform the following functions without further user action. First, the device heats the sample via a heater of the sample preparation module to lyse a portion of the sample. Second, the device conveys the lysed sample to an amplification module and heats the sample within a reaction volume of the amplification module to amplify a nucleic acid thereby producing an output solution containing a target amplicon. The device then reacts, within a detection module, each of (i) the output solution and (ii) a reagent formulated to produce a signal that indicates a presence of the target amplicon within the output solution. A result associated with the signal is then read.
42 - Services scientifiques, technologiques et industriels, recherche et conception
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
(1) Medical diagnostic apparatus for the detection of infectious diseases, cancers, and neurological diseases and conditions; medical diagnostic apparatus for testing for infectious diseases, cancers and non-infectious neurological diseases and conditions; medical diagnostic apparatus for testing for bacterial infections, viral infections, sexually transmitted infections, and infectious diseases; medical diagnostic apparatus for the detection of and testing for cancers and non-infectious neurological diseases and conditions; Omics analysis kits containing collection swab, collection tube, gloves, specimen container, tube holder, power adapter, instructions, and screening device for use in diagnosing, screening, researching or monitoring various medical conditions; Omic surveillance kits containing collection swab, collection tube, gloves, specimen bag, tube holder, power adapter, instructions, and surveillance device for use in screening and for monitoring various medical conditions; Medical testing kits containing collection swab, collection tube, gloves, specimen bag, tube holder, power adapter, instructions, and device for use in screening and for monitoring various medical conditions; Omic testing kits containing medical instruments for taking samples for diagnosing, screening, monitoring or researching various medical conditions (1) Electronic data collection and data submission services for business purposes in the field of healthcare; electronic data collection and data submission services for business purposes in the fields of infectious and non-infectious diseases and conditions
(2) Data automation and collection service using proprietary software to evaluate, analyze, and collect health care data; electronic data storage in the field of healthcare; data automation and collection service using proprietary software to evaluate, analyze, and collect data regarding infectious and non-infectious diseases and conditions; electronic data storage in the field of infectious and non-infectious diseases and conditions; consultation services regarding the design and development of medical diagnostic devices
(3) Consultation services in the field of health care and the detection and diagnosis of infectious and non-infectious diseases and conditions
17.
Devices and methods for molecular diagnostic testing
A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.
A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.
The disclosure relates generally to molecular diagnostic devices configured to amplifying a single nucleotide polymorphism (SNP) locus and discriminate between two or more allelic variants of the SNP, indicating presence or absence of a target allele. In some embodiments, the molecular diagnostic devices are capable of detecting, at point-of-care, SNPs associated with resistance or susceptibility to antibiotic treatment of bacterial infections. In other aspects, the disclosure provides methods of treatment for disease or disorders (e.g. bacterial infections) where treatment is guided by presence or absence of an allele at a SNP locus as determined by such molecular diagnostic devices.
B01L 7/00 - Appareils de chauffage ou de refroidissementDispositifs d'isolation thermique
C12Q 1/6827 - Tests d’hybridation pour la détection de mutation ou de polymorphisme
C12Q 1/689 - Produits d’acides nucléiques utilisés dans l’analyse d’acides nucléiques, p. ex. amorces ou sondes pour la détection ou l’identification d’organismes pour les bactéries
20.
DEVICES AND METHODS FOR DETECTION OF TARGET VIRUSES
A stand-alone molecular diagnostic test device includes a housing, a reverse transcription module, an amplification module, and a detection module. The reverse transcription module is configured to heat a biological sample to produce a target cDNA molecule associated with an RNA virus thereby producing an amplification solution. The amplification module defines a reaction volume configured to receive the amplification solution and amplify the target cDNA molecule within the amplification solution to produce an output. The detection module is configured to receive the output from the amplification module and includes one or more probes specific to a polynucleotide sequence of the RNA virus. The one or more probes is designed to facilitate production of a signal indicating the presence of the RNA virus in the biological sample.
C12Q 1/70 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions faisant intervenir des virus ou des bactériophages
21.
Printed circuit board heater for an amplification module
An apparatus includes a substrate, a first heating element, and a second heating element. The substrate includes a first portion, a second portion, and a third portion that is between the first portion and the second portion. The first portion is characterized by a first thermal conductivity, the second portion is characterized by a second thermal conductivity, and the third portion is characterized by a third thermal conductivity. The third thermal conductivity is less than the first thermal conductivity and the second thermal conductivity. The first heating element is coupled to the first portion of the substrate, and is configured to produce a first thermal output. The second heating element is coupled to the second portion of the substrate, and configured to produce a second thermal output. The second thermal output is different from the first thermal output.
B01L 7/00 - Appareils de chauffage ou de refroidissementDispositifs d'isolation thermique
H05B 1/02 - Dispositions de commutation automatique spécialement adaptées aux appareils de chauffage
B01L 99/00 - Matière non prévue dans les autres groupes de la présente sous-classe
H05B 3/26 - Éléments chauffants ayant une surface s'étendant essentiellement dans deux dimensions, p. ex. plaques chauffantes non flexibles le conducteur chauffant monté sur une base isolante
C12Q 1/686 - Réaction en chaine par polymérase [PCR]
22.
Printed circuit board heater for an amplification module
An apparatus includes a substrate, a first heating element, and a second heating element. The substrate includes a first portion, a second portion, and a third portion that is between the first portion and the second portion. The first portion is characterized by a first thermal conductivity, the second portion is characterized by a second thermal conductivity, and the third portion is characterized by a third thermal conductivity. The third thermal conductivity is less than the first thermal conductivity and the second thermal conductivity. The first heating element is coupled to the first portion of the substrate, and is configured to produce a first thermal output. The second heating element is coupled to the second portion of the substrate, and configured to produce a second thermal output. The second thermal output is different from the first thermal output.
B01L 7/00 - Appareils de chauffage ou de refroidissementDispositifs d'isolation thermique
C12Q 1/686 - Réaction en chaine par polymérase [PCR]
H05B 1/02 - Dispositions de commutation automatique spécialement adaptées aux appareils de chauffage
H05B 3/26 - Éléments chauffants ayant une surface s'étendant essentiellement dans deux dimensions, p. ex. plaques chauffantes non flexibles le conducteur chauffant monté sur une base isolante
23.
Devices and methods for antibiotic susceptability testing
The disclosure relates generally to molecular diagnostic devices configured to amplifying a single nucleotide polymorphism (SNP) locus and discriminate between two or more allelic variants of the SNP, indicating presence or absence of a target allele. In some embodiments, the molecular diagnostic devices are capable of detecting, at point-of-care, SNPs associated with resistance or susceptibility to antibiotic treatment of organism infections. In other aspects, the disclosure provides methods of treatment for disease or disorders (e.g. organism infections) where treatment is guided by presence or absence of an allele at a SNP locus as determined by such molecular diagnostic devices.
C12P 19/34 - Polynucléotides, p. ex. acides nucléiques, oligoribonucléotides
C12Q 1/689 - Produits d’acides nucléiques utilisés dans l’analyse d’acides nucléiques, p. ex. amorces ou sondes pour la détection ou l’identification d’organismes pour les bactéries
C12Q 1/18 - Test de l'activité antimicrobienne d'un matériau
C12Q 1/04 - Détermination de la présence ou du type de micro-organismeEmploi de milieux sélectifs pour tester des antibiotiques ou des bactéricidesCompositions à cet effet contenant un indicateur chimique
24.
DEVICES AND METHODS FOR ANTIBIOTIC SUSCEPTIBILITY TESTING
e.g.e.g. organism infections) where treatment is guided by presence or absence of an allele at a SNP locus as determined by such molecular diagnostic devices.
C12Q 1/18 - Test de l'activité antimicrobienne d'un matériau
B29C 45/00 - Moulage par injection, c.-à-d. en forçant un volume déterminé de matière à mouler par une buse d'injection dans un moule ferméAppareils à cet effet
C12N 11/04 - Enzymes ou cellules microbiennes immobilisées sur ou dans un support organique piégées à l’intérieur du support, p. ex. dans un gel ou dans des fibres creuses
25.
Portable molecular diagnostic device and methods for the detection of target viruses
A method includes coupling a molecular diagnostic test device to a power source. A biological sample is conveyed into a sample preparation module. The device is then actuated by only a single action to cause the device to perform the following functions without further user action. First, the device heats the sample via a heater of the sample preparation module to lyse a portion of the sample. Second, the device conveys the lysed sample to an amplification module and heats the sample within a reaction volume of the amplification module to amplify a nucleic acid thereby producing an output solution containing a target amplicon. The device then reacts, within a detection module, each of (i) the output solution and (ii) a reagent formulated to produce a signal that indicates a presence of the target amplicon within the output solution. A result associated with the signal is then read.
Medical diagnostic apparatus for the detection of infectious diseases, cancers, and neurological diseases and conditions; medical diagnostic apparatus for testing for infectious diseases, cancers and non-infectious neurological diseases and conditions; medical diagnostic apparatus for testing for bacterial infections, viral infections, sexually transmitted infections, and infectious diseases; medical diagnostic apparatus for the detection of and testing for cancers and non-infectious neurological diseases and conditions
42 - Services scientifiques, technologiques et industriels, recherche et conception
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
Electronic data collection and data submission services for business purposes in the field of healthcare; electronic data collection and data submission services for business purposes in the fields of infectious and non-infectious diseases and conditions Data automation and collection service using proprietary software to evaluate, analyze, and collect health care data; electronic data storage in the field of healthcare; data automation and collection service using proprietary software to evaluate, analyze, and collect data regarding infectious and non-infectious diseases and conditions; electronic data storage in the field of infectious and non-infectious diseases and conditions; consultation services regarding the design and development of medical diagnostic devices Consultation services in the field of health care and the detection and diagnosis of infectious and non-infectious diseases and conditions
28.
MOLECULAR DIAGNOSTIC DEVICES WITH DIGITAL DETECTION CAPABILITY AND WIRELESS CONNECTIVITY
In some embodiments, a stand-alone molecular diagnostic test device includes a detection circuit that includes a light emitting device and a light receiving device (e.g., a photodiode) that are arranged to produce an electronic signal associated with a colorimetric output produced by the stand-alone molecular diagnostic test.
B01L 3/00 - Récipients ou ustensiles pour laboratoires, p. ex. verrerie de laboratoireCompte-gouttes
C12N 15/10 - Procédés pour l'isolement, la préparation ou la purification d'ADN ou d'ARN
B01L 7/00 - Appareils de chauffage ou de refroidissementDispositifs d'isolation thermique
C12Q 1/37 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions faisant intervenir une hydrolase faisant intervenir une peptidase ou une protéinase
29.
DEVICES AND METHODS FOR ANTIBIOTIC SUSCEPTIBILITY TESTING
The disclosure relates generally to molecular diagnostic devices configured to amplifying a single nucleotide polymorphism (SNP) locus and discriminate between two or more allelic variants of the SNP, indicating presence or absence of a target allele. In some embodiments, the molecular diagnostic devices are capable of detecting, at point-of-care, SNPs associated with resistance or susceptibility to antibiotic treatment of bacterial infections. In other aspects, the disclosure provides methods of treatment for disease or disorders (e.g. bacterial infections) where treatment is guided by presence or absence of an allele at a SNP locus as determined by such molecular diagnostic devices.
B01L 3/00 - Récipients ou ustensiles pour laboratoires, p. ex. verrerie de laboratoireCompte-gouttes
C12Q 1/6827 - Tests d’hybridation pour la détection de mutation ou de polymorphisme
C12Q 1/689 - Produits d’acides nucléiques utilisés dans l’analyse d’acides nucléiques, p. ex. amorces ou sondes pour la détection ou l’identification d’organismes pour les bactéries
42 - Services scientifiques, technologiques et industriels, recherche et conception
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
Electronic data collection and data submission services for
business purposes in the field of healthcare; electronic
data collection and data submission services for business
purposes in the fields of infectious and non-infectious
diseases and conditions. Data automation and collection service using proprietary
software to evaluate, analyze, and collect health care data;
electronic data storage in the field of healthcare; data
automation and collection service using proprietary software
to evaluate, analyze, and collect data regarding infectious
and non-infectious diseases and conditions; electronic data
storage in the field of infectious and non-infectious
diseases and conditions; consultation services regarding the
design and development of medical diagnostic devices. Consultation services in the field of health care and the
detection and diagnosis of infectious and non-infectious
diseases and conditions.
Medical diagnostic devices; medical diagnostic devices for
use in testing for infectious and non-infectious diseases
and conditions; medical diagnostic devices for testing for
bacterial infections, viral infections, sexually transmitted
infections, and other types of infections and conditions;
medical diagnostic devices for testing for non-infectious
diseases and conditions.
42 - Services scientifiques, technologiques et industriels, recherche et conception
44 - Services médicaux, services vétérinaires, soins d'hygiène et de beauté; services d'agriculture, d'horticulture et de sylviculture.
Produits et services
(1) Electronic data collection and data submission services for business purposes, namely database management in the field of healthcare; electronic data collection and data submission services for business purposes, namely database management in the fields of infectious and non-infectious diseases and conditions.
(2) Software as a service for data automation and collection service to evaluate, analyze, and collect health care data in the field of healthcare business management; electronic data storage, namely, cloud computing provider services for general storage of data in the field of healthcare; Software as a service for data automation and collection service to evaluate, analyze, and collect data regarding infectious and non-infectious diseases and conditions; cloud computing provider services for general storage of data in the field of infectious and non-infectious diseases and conditions; consultation services regarding the design and development of medical diagnostic devices.
(3) Consultation services in the field of health care, namely, health risk assessment and the detection and diagnosis of infectious and non-infectious diseases and conditions.
(1) Medical diagnostic devices for the qualitative detection of COVID-19 and other coronavirus antibodies in human specimens collected as plasma or dried blood spots; medical diagnostic devices using polymerase chain reaction (PCR) for testing pathogenic bacteria in human RNA and DNA; medical diagnostic devices for testing for bacterial infections, viral infections, sexually transmitted infections, urinary tract infections, and skin infections; medical diagnostic devices for testing for non-infectious diseases and conditions in the field of cancer, diabetes, and cardiovascular disease.
Cartridge-based thermocyclers can include cartridges that are configured to move a fluid between distinct chambers. In some cases, the cartridge-based thermocyclers can be used for thermocycling a sample fluid comprising a deoxyribonucleic acid (DNA) target to perform polymerase chain reaction (PCR). Individual chambers can be heated, cooled, and/or compressed to mix fluid within the chamber or to propel fluid in the chamber into another chamber. The cartridges can have a laminate construction. The cartridges can be configured to enable multiplexed thermocycling and/or detection.
A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.
A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.
A method includes coupling a molecular diagnostic test device to a power source. A biological sample is conveyed into a sample preparation module. The device is then actuated by only a single action to cause the device to perform the following functions without further user action. First, the device heats the sample via a heater of the sample preparation module to lyse a portion of the sample. Second, the device conveys the lysed sample to an amplification module and heats the sample within a reaction volume of the amplification module to amplify a nucleic acid thereby producing an output solution containing a target amplicon. The device then reacts, within a detection module, each of (i) the output solution and (ii) a reagent formulated to produce a signal that indicates a presence of the target amplicon within the output solution. A result associated with the signal is then read.
A method includes conveying a detection solution containing a target amplicon into a detection module of a molecular diagnostic test device. The detection module includes a detection surface including a series of capture probes to which a first portion of the target amplicon is bound when the detection solution is conveyed. A first reagent formulated to produce a visible signal indicating a presence of the target amplicon is then conveyed into the detection module. The first reagent is bound to a second portion of the target amplicon when the first reagent is conveyed. A second reagent is conveyed into the detection module. The second reagent includes a precipitating substrate formulated to catalyze the production of the visible signal by producing an insoluble colored product when the second reagent is in contact with the first reagent. The method includes viewing the visible signal via a transparent portion of the detection module.
B01L 3/00 - Récipients ou ustensiles pour laboratoires, p. ex. verrerie de laboratoireCompte-gouttes
C12Q 1/686 - Réaction en chaine par polymérase [PCR]
B01L 7/00 - Appareils de chauffage ou de refroidissementDispositifs d'isolation thermique
C12Q 1/68 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions faisant intervenir des acides nucléiques
Disclosed herein are methods and devices for preparing a sample of nucleic acid molecules from a biological sample. The methods and devices may perform similarly to or better than standard sample preparation methods. The nucleic acid molecules prepared using the methods and devices provided herein may be utilized for downstream applications, including polymerase chain reaction (PCR).
C12Q 1/6806 - Préparation d’acides nucléiques pour analyse, p. ex. pour test de réaction en chaîne par polymérase [PCR]
C12N 15/10 - Procédés pour l'isolement, la préparation ou la purification d'ADN ou d'ARN
C12Q 1/00 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions
G01N 33/48 - Matériau biologique, p. ex. sang, urineHémocytomètres
B01L 3/00 - Récipients ou ustensiles pour laboratoires, p. ex. verrerie de laboratoireCompte-gouttes
C12Q 1/37 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions faisant intervenir une hydrolase faisant intervenir une peptidase ou une protéinase
C12Q 1/686 - Réaction en chaine par polymérase [PCR]
Medical diagnostic apparatus for the detection of infectious diseases, cancers, and neurological diseases and conditions; medical diagnostic apparatus for testing for infectious diseases, cancers and non-infectious neurological diseases and conditions; medical diagnostic apparatus for testing for bacterial infections, viral infections, sexually transmitted infections, and infectious diseases; medical diagnostic apparatus for the detection of and testing for cancers and non-infectious neurological diseases and conditions
41.
Devices and methods for molecular diagnostic testing
A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.
A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.
A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.
An apparatus includes a substrate, a first heating element, and a second heating element. The substrate includes a first portion, a second portion, and a third portion that is between the first portion and the second portion. The first portion is characterized by a first thermal conductivity, the second portion is characterized by a second thermal conductivity, and the third portion is characterized by a third thermal conductivity. The third thermal conductivity is less than the first thermal conductivity and the second thermal conductivity. The first heating element is coupled to the first portion of the substrate, and is configured to produce a first thermal output. The second heating element is coupled to the second portion of the substrate, and configured to produce a second thermal output. The second thermal output is different from the first thermal output.
B01L 7/00 - Appareils de chauffage ou de refroidissementDispositifs d'isolation thermique
H05B 3/26 - Éléments chauffants ayant une surface s'étendant essentiellement dans deux dimensions, p. ex. plaques chauffantes non flexibles le conducteur chauffant monté sur une base isolante
C12Q 1/686 - Réaction en chaine par polymérase [PCR]
H05B 1/02 - Dispositions de commutation automatique spécialement adaptées aux appareils de chauffage
A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.
A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.
Cartridge-based thermocyclers can include cartridges that are configured to move a fluid between distinct chambers. In some cases, the cartridge-based thermocyclers can be used for thermocycling a sample fluid comprising a deoxyribonucleic acid (DNA) target to perform polymerase chain reaction (PCR). Individual chambers can be heated, cooled, and/or compressed to mix fluid within the chamber or to propel fluid in the chamber into another chamber. The cartridges can have a laminate construction. The cartridges can be configured to enable multiplexed thermocycling and/or detection.
A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.
B01L 7/00 - Appareils de chauffage ou de refroidissementDispositifs d'isolation thermique
C12Q 1/68 - Procédés de mesure ou de test faisant intervenir des enzymes, des acides nucléiques ou des micro-organismesCompositions à cet effetProcédés pour préparer ces compositions faisant intervenir des acides nucléiques
B01L 3/00 - Récipients ou ustensiles pour laboratoires, p. ex. verrerie de laboratoireCompte-gouttes
