Abstract: This disclosure relates to a magnetic mixing apparatus that mixes a sample contained in a mixing chamber using a stir bar, while minimizing the amount of contact between the stir bar and walls of the mixing chamber. In one aspect, the apparatus comprises a ferromagnetic stir bar contained in the mixing chamber, and a driving magnet and a driven magnet located on opposite sides of the mixing chamber. The driving magnet, the driven magnet, and the ferromagnetic stir bar are each capable of rotating about a respective axis. The driving magnet, the driven magnet, and the ferromagnetic stir bar are magnetically coupled such that rotation of the driving magnet induces rotation of the driven magnet and rotation of the driving magnet and the driven magnet induce rotation of the ferromagnetic stir bar. In some embodiments, rotation of the ferromagnetic stir bar within the mixing chamber mixes the sample contained within the mixing chamber.

Abstract: Methods and systems are provided for point-of-care nucleic acid amplification and detection. One embodiment of the point-of-care molecular diagnostic system includes a cartridge and an instrument. The cartridge can accept a biological sample, such as a urine or blood sample. The cartridge, which can comprise one or more of a loading module, lysis module, purification module and amplification module, is inserted into the instrument which acts upon the cartridge to facilitate various sample processing steps that occur in order to perform a molecular diagnostic test.

Abstract: Rotary valves and methods of using, manufacturing, and storing the same are provided herein. The rotary valve includes a rotor and a stator, biased toward one another to form a fluid tight seal. In some implementations, the rotor comprises an integrated flow channel containing a porous solid support. Frequently, the interface between rotor and stator is made fluid-tight using a gasket. Some implementations of the rotary valve include a displaceable spacer to prevent the gasket from sealing against at least one of the rotor and stator prior to operation, wherein when the spacer is displaced, the gasket seals the rotor and stator together in a fluid-tight manner.

Abstract: Disclosed herein are primers and probes related to the detection of beta actin [Homo sapiens (human)] via nucleic acid amplification testing (NAAT), for example to amplify and determine the presence of ?-actin present in test samples. Specifically, the present disclosure describes primers and probes that bind to the beta actin gene for detection via loop mediated isothermal amplification (LAMP) and molecular beacon hybridization.

Abstract: This disclosure relates to an apparatus for simultaneously filling a plurality of sample chambers. In one aspect, the apparatus comprises a common fluid source and a plurality of independent, continuous fluidic pathways. Each independent, continuous fluidic pathway comprises a sample chamber and a pneumatic compartment. The sample chamber is connected to the common fluid source, and the pneumatic compartment is connected to the sample chamber. The sample chamber comprises, in part, an assay chamber. The assay chamber comprises a monolithic substrate and a plug having optically transmissive properties. In some embodiments, the assay chamber contains a magnetic mixing element. In some embodiments, the assay chamber is a double tapered chamber. In some embodiments, a ratio of a volume of the sample chamber to a volume of the pneumatic compartment is substantially equivalent for each fluidic pathway of the plurality of fluidic pathways.

Abstract: Disclosed herein are primers and probes related to the detection of beta actin [Homo sapiens (human)] via nucleic acid amplification testing (NAAT), for example to amplify and determine the presence of ?-actin present in test samples. Specifically, the present disclosure describes primers and probes that bind to the beta actin gene for detection via loop mediated isothermal amplification (LAMP) and molecular beacon hybridization.

Abstract: Disclosed herein are methods and devices for rapid assessment of whether a microorganism present in a sample is susceptible or resistant to a treatment.

Abstract: The invention provides methods and compositions for the detection of Chlamydia trachomatis in a test sample. Its presence or absence in the sample is determined by nucleic acid based testing methods using primers and/or probes and or molecular beacons that bind to the 23S ribosomal genes or gene transcripts.

Abstract: This disclosure relates to an apparatus for simultaneously filling a plurality of sample chambers. In one aspect, the apparatus comprises a common fluid source and a plurality of independent, continuous fluidic pathways. Each independent, continuous fluidic pathway comprises a sample chamber and a pneumatic compartment. The sample chamber is connected to the common fluid source, and the pneumatic compartment is connected to the sample chamber. The sample chamber comprises, in part, an assay chamber. The assay chamber comprises a monolithic substrate and a plug having optically transmissive properties. In some embodiments, the assay chamber contains a magnetic mixing element. In some embodiments, the assay chamber is a double tapered chamber. In some embodiments, a ratio of a volume of the sample chamber to a volume of the pneumatic compartment is substantially equivalent for each fluidic pathway of the plurality of fluidic pathways.

Abstract: Disclosed herein are primers and probes related to the detection of SARS-CoV-2 via nucleic acid amplification testing (NAAT), for example to amplify and determine the presence of SARS-CoV-2 in test samples and/or to diagnose Covid-19. Specifically, the present disclosure describes primers and probes that bind to the N gene, ORF1ab, or E gene of SARS-CoV-2 coronavirus for detection via loop mediated isothermal amplification (LAMP) and molecular beacon hybridization.

Abstract: Rotary valves and methods of using, manufacturing, and storing the same are provided herein. The rotary valve includes a rotor and a stator, biased toward one another to form a fluid tight seal. In some implementations, the rotor comprises an integrated flow channel containing a porous solid support. Frequently, the interface between rotor and stator is made fluid-tight using a gasket. Some implementations of the rotary valve include a displaceable spacer to prevent the gasket from sealing against at least one of the rotor and stator prior to operation, wherein when the spacer is displaced, the gasket seals the rotor and stator together in a fluid-tight manner.

Abstract: Methods and systems are provided for point-of-care nucleic acid amplification and detection. One embodiment of the point-of-care molecular diagnostic system includes a cartridge and an instrument. The cartridge can accept a biological sample, such as a urine or blood sample. The cartridge, which can comprise one or more of a loading module, lysis module, purification module and amplification module, is inserted into the instrument which acts upon the cartridge to facilitate various sample processing steps that occur in order to perform a molecular diagnostic test.

Abstract: Rotary valves and methods of using, manufacturing, and storing the same are provided herein. The rotary valve includes a rotor and a stator, biased toward one another to form a fluid tight seal. In some implementations, the rotor comprises an integrated flow channel containing a porous solid support. Frequently, the interface between rotor and stator is made fluid-tight using a gasket. Some implementations of the rotary valve include a displaceable spacer to prevent the gasket from sealing against at least one of the rotor and stator prior to operation, wherein when the spacer is displaced, the gasket seals the rotor and stator together in a fluid-tight manner.

Abstract: Disclosed herein are primers and probes related to the detection of Neisseria gonorrhoeae via nucleic acid amplification testing (NAAT), for example to amplify and determine the presence of N. gonorrhoeae nucleic acids present in test samples. Specifically the present disclosure describes primers and probes that bind to Cytochrome C or ccpA gene of N. gonorrhoeae for detection via loop mediated isothermal amplification (LAMP) and molecular beacon hybridization.

Abstract: This disclosure relates to an apparatus for simultaneously filling a plurality of sample chambers. In one aspect, the apparatus comprises a common fluid source and a plurality of independent, continuous fluidic pathways. Each independent, continuous fluidic pathway comprises a sample chamber and a pneumatic compartment. The sample chamber is connected to the common fluid source, and the pneumatic compartment is connected to the sample chamber. The sample chamber comprises, in part, an assay chamber. The assay chamber comprises a monolithic substrate and a plug having optically transmissive properties. In some embodiments, the assay chamber contains a magnetic mixing element. In some embodiments, the assay chamber is a double tapered chamber. In some embodiments, a ratio of a volume of the sample chamber to a volume of the pneumatic compartment is substantially equivalent for each fluidic pathway of the plurality of fluidic pathways.

Abstract: This disclosure relates to an assembly for loading a sample liquid. The assembly comprises an entry port comprising an inlet and a gas vent, and a reservoir. The reservoir comprises a distal wall, a fin, and a continuous fluidic pathway. The fin comprises first and second surfaces and extends from the inlet towards the distal wall. The continuous fluidic pathway comprises a converging channel that is in fluidic communication with the inlet and is defined by the second surface of the fin, and a diverging channel that is defined by the first surface of the fin and is in fluidic communication with the gas vent. At a distal end of the fin, a width of the converging channel at most equals a width of the diverging channel, and the width of the converging channel at most equals a distance between the distal end of the fin and the distal wall.

Abstract: This disclosure relates to a magnetic mixing apparatus that mixes a sample contained in a mixing chamber using a stir bar, while minimizing the amount of contact between the stir bar and walls of the mixing chamber. In one aspect, the apparatus comprises a ferromagnetic stir bar contained in the mixing chamber, and a driving magnet and a driven magnet located on opposite sides of the mixing chamber. The driving magnet, the driven magnet, and the ferromagnetic stir bar are each capable of rotating about a respective axis. The driving magnet, the driven magnet, and the ferromagnetic stir bar are magnetically coupled such that rotation of the driving magnet induces rotation of the driven magnet and rotation of the driving magnet and the driven magnet induce rotation of the ferromagnetic stir bar. In some embodiments, rotation of the ferromagnetic stir bar within the mixing chamber mixes the sample contained within the mixing chamber.

Abstract: Methods and systems are provided for point-of-care nucleic acid amplification and detection. One embodiment of the point-of-care molecular diagnostic system includes a cartridge and an instrument. The cartridge can accept a biological sample, such as a urine or blood sample. The cartridge, which can comprise one or more of a loading module, lysis module, purification module and amplification module, is inserted into the instrument which acts upon the cartridge to facilitate various sample processing steps that occur in order to perform a molecular diagnostic test.

Abstract: This disclosure relates to an apparatus for simultaneously filling a plurality of sample chambers. In one aspect, the apparatus comprises a common fluid source and a plurality of independent, continuous fluidic pathways. Each independent, continuous fluidic pathway comprises a sample chamber and a pneumatic compartment. The sample chamber is connected to the common fluid source, and the pneumatic compartment is connected to the sample chamber. The sample chamber comprises, in part, an assay chamber. The assay chamber comprises a monolithic substrate and a plug. In some embodiments, the assay chamber contains a magnetic mixing element. In some embodiments, the assay chamber is a double tapered chamber. In some embodiments, a ratio of a volume of the sample chamber to a volume of the pneumatic compartment is substantially equivalent for each fluidic pathway of the plurality of fluidic pathways.