Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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, SN Ps 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.

Abstract: 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.

Abstract: 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).

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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).

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.