Abstract: Provided herein are dye compounds having improved properties, such as aqueous solubility, stability, and fluorescence, as well as methods of detecting the presence or absence of an analyte in a test sample using said dye compounds.

Abstract: Apparatuses, methods, and systems for generating signatures based on sensing one or more gas concentration conditions are disclosed. One method includes sensing, by one or more sensors, levels of a gas over time for a plurality of gas concentration conditions, receiving, by a controller, the sensed levels of gas over time for the plurality of gas concentration conditions, and generating, by the controller, a plurality of signatures, wherein one or more signatures is generated for one or more gas concentration conditions based on the sensed levels of gas over time, and determining whether to take action or not to take action.

Abstract: Apparatuses, methods, and systems for detecting a sample are disclosed. One method includes generating, by a tunable light source, a beam of electro-magnetic radiation, wherein a wavelength of the beam of electro-magnetic radiation is tuned to operate at a plurality of wavelengths. At least a portion of the beam of electro-magnetic radiation is directed to pass through the sample and a reference substance. The system detector is configured to sense at least the portion of the beam of electro-magnetic radiation after passing through the sample and the reference substance. The processor operates to receive information related to intensity or amplitude of the sensed beam of electro-magnetic radiation after passing through the sample and the reference substance and detect an amount of the sample based on the received information related to the intensity or amplitude of the sensed beam of the electro-magnetic radiation.

Abstract: Apparatuses, methods, and systems for detecting a sample are disclosed. One method includes generating, by a tunable light source, a beam of electro-magnetic radiation, wherein a wavelength of the beam of electro-magnetic radiation is tuned to operate at a plurality of wavelengths. At least a portion of the beam of electro-magnetic radiation is directed to pass through the sample and a reference substance. The system detector is configured to sense at least the portion of the beam of electro-magnetic radiation after passing through the sample and the reference substance. The processor operates to receive information related to intensity or amplitude of the sensed beam of electro-magnetic radiation after passing through the sample and the reference substance and detect an amount of the sample based on the received information related to the intensity or amplitude of the sensed beam of the electro-magnetic radiation.

Abstract: Aspects of the disclosure relate to compositions and methods for amplifying and/or detecting one or more target nucleic acid sequences (e.g., a nucleic acid sequence of one or more pathogens) in a biological sample obtained from a subject. In some embodiments, the pathogens are viral, bacterial, fungal, parasitic, or protozoan pathogens, such as SARS-CoV-2 or an influenza virus. In some embodiments, the methods comprise isothermal amplification of a target nucleic acid and subsequent detection of the amplification products.

Abstract: The present disclosure describes Bst polymerase variants which exhibit DNA-dependent DNA polymerase and reverse transcriptase activity, and methods of use thereof. The Bst polymerase variants of the disclosure may be combined with a separate enzyme having reverse transcriptase activity to amplify target RNA sequences; however, the addition of a separate enzyme having reverse transcriptase activity is not necessary for the successful amplification of RNA targets using the Bst polymerase variants of the disclosure. Target DNA sequences may also be amplified using Bst polymerase variants of the disclosure.

Abstract: Aspects of the disclosure relate to compositions and methods for amplifying and/or detecting one or more target nucleic acid sequences (e.g., a nucleic acid sequence of one or more pathogens) in a biological sample obtained from a subject. In some embodiments, the pathogens are viral, bacterial, fungal, parasitic, or protozoan pathogens, such as SARS-CoV-2 or an influenza virus. In some embodiments, the methods comprise isothermal amplification of a target nucleic acid and subsequent detection of the amplification products.

Abstract: Provided herein, in some embodiments, are rapid diagnostic tests to detect one or more target nucleic acid sequences (e.g., a nucleic acid sequence of one or more pathogens). In some embodiments, the pathogens are viral, bacterial, fungal, parasitic, or protozoan pathogens, such as SARS-CoV-2 or an influenza virus. Further embodiments provide methods of detecting genetic abnormalities. Diagnostic tests comprising a sample-collecting component, one or more reagents (e.g., lysis reagents, nucleic acid amplification reagents), and a detection component (e.g., a component comprising a lateral flow assay strip) are provided.

Abstract: Diagnostic devices for performing diagnostic tests are provided, as well as methods that utilize the diagnostic devices, methods for manufacturing the diagnostic devices, and test kits for performing the diagnostic tests. The diagnostic devices may include a sample chamber; a fluid chamber connected to the sample chamber by a conduit; and a test chamber separated from the sample chamber by a breakable seal. A movable liner may form a portion of an inner surface of the sample chamber. The sample chamber may be configured to receive a sample swab, which may move in a first direction when being inserted in the sample chamber to an inserted position, and which may to move in a second direction to cause the breakable seal to break. Movement of the sample swab in the second direction may cause the liner to move in the second direction to break the breakable seal.

Abstract: Provided herein, in some embodiments, are rapid diagnostic tests to detect one or more target nucleic acid sequences (e.g., a nucleic acid sequence of one or more pathogens). In some embodiments, the pathogens are viral, bacterial, fungal, parasitic, or protozoan pathogens, such as SARS-CoV-2 or an influenza virus. Further embodiments provide methods of detecting genetic abnormalities. Diagnostic tests comprising a sample-collecting component, one or more reagents (e.g., lysis reagents, nucleic acid amplification reagents), and a detection component (e.g., a component comprising a lateral flow assay strip and/or a colorimetric assay) are provided.

Abstract: Diagnostic devices for performing diagnostic tests are provided, as well as methods that utilize the diagnostic devices, methods for manufacturing the diagnostic devices, and test kits for performing the diagnostic tests. The diagnostic devices include a vial, a rupturable container disposed in an internal cavity of the vial and containing a fluid, and a test and readout device in fluid communication with the internal cavity of the vial. The rupturable container is configured to rupture during a test procedure of the diagnostic test to enable the fluid to flow into the internal cavity of the vial. The rupturable container may include a rupturable ampoule or a frangible seal. The rupturable container may be ruptured by deformation of the vial or by piercing caused by a sharp object in the vial or a sample swab inserted in the vial.

Abstract: Described herein in an embodiment is a lateral flow assay strip for detecting the presence of one or more target nucleic acid sequences (e.g., one or more nucleic acid sequences of a pathogen, such as a coronavirus or an influenza virus). The lateral flow assay strip may comprise a first test line configured to detect a first target nucleic acid sequence and a flow control line configured to detect a liquid. In some cases, the first test line comprises a biological capture reagent (e.g., an immobilized antibody). In some cases, the flow control line comprises a non-biological fluid indicator (i.e., a non-antibody reagent). The non-biological fluid indicator may, for example, comprise a pH-sensitive material, a moisture-sensitive material, and/or a chemically-sensitive material. The flow control line may provide a visual indication of whether a fluidic sample was successfully transported from a first end of the lateral flow assay strip to the first test line.

Abstract: Aspects of the disclosure relate to compositions and methods for amplifying and/or detecting one or more target nucleic acid sequences (e.g., a nucleic acid sequence of one or more pathogens), and use of a trap region or reagent to reduce the level of one or more target nucleic acid analytes in an amplified sample prior to or in conjunction with detection. In some embodiments, the pathogens are viral, bacterial, fungal, parasitic, or protozoan pathogens, such as SARS-CoV-2 or an influenza virus. In some embodiments, the methods comprise isothermal amplification of a target nucleic acid and subsequent reduction in the level of one or more target nucleic acid analytes and detection of the amplification products.

Abstract: The disclosure relates, in some aspects, to compositions and methods for amplifying nucleic acids. In some embodiments, the disclosure describes solid compositions comprising a first enzyme (e.g., a reverse transcriptase) and a second enzyme (e.g., a polymerase), and optionally a third enzyme (e.g., a Uracil-DNA glycosylase), where each enzyme is under the control of a molecular switch. In some embodiments, solid compositions described by the disclosure allow for single-tube, temperature-controlled lysis, decontamination, and amplification of nucleic acid s (e.g., DNA or RNA) from a biological sample without the need to add additional reaction components or transfer the reaction mixture from one container to another.

Abstract: Provided herein, in some embodiments, are rapid diagnostic tests to detect one or more target nucleic acid sequences (e.g., a nucleic acid sequence of one or more pathogens). In some embodiments, the pathogens are viral, bacterial, fungal, parasitic, or protozoan pathogens, such as SARS-CoV-2 or an influenza virus. In one embodiment, a diagnostic system is provided comprising a control device configured to control one or more parameters and/or actions of a diagnostic test, and a test kit component comprising a physical encoding of control information for the control device. In one embodiment, the control device is configured to receive the control information of the physical encoding and perform one or more actions based at least in part on the control information. In one embodiment, the control device can control one or more temperatures at which a biological sample is to be processed as part of the diagnostic test.

Abstract: Aspects of the disclosure relate to compositions and methods for amplifying and/or detecting one or more target nucleic acid sequences (e.g., a nucleic acid sequence of one or more pathogens) in a biological sample obtained from a subject. In some embodiments, the pathogens are viral, bacterial, fungal, parasitic, or protozoan pathogens, such as SARS-CoV-2 or an influenza virus. In some embodiments, the methods comprise isothermal amplification of a target nucleic acid and subsequent detection of the amplification products.

Abstract: Provided herein, in some embodiments, are breakable swabs for sample collection. In some embodiments, the swabs may be used in rapid diagnostic tests to detect one or more target nucleic acid sequences (e.g., a nucleic acid sequence of one or more pathogens). In some embodiments, the pathogens are viral, bacterial, fungal, parasitic, or protozoan pathogens, such as SARS-CoV-2 or an influenza virus. The swab may include a stem portion for handling and a head portion for collecting and/or holding a sample. After sample collection, the head portion may be inserted into a reaction tube or any other sample-receiving device. The stem portion of the swab may then be separated or detached from the head portion along a breakable portion.

Abstract: A system and method for detecting degradation of a fiber optic in a strap of a body-worn device that is removably attached to an appendage or other location of a person or animal. A fiber optic is embedded within the strap. A light source emits light energy through the optical interface and into the fiber optic and a light sensor receives and detects light energy from the fiber optic. If the light energy is not received and detected from the fiber optic, the light energy is increased until the light energy is received and detected or reaches a maximum light energy at which time tampering is declared. If the light energy reaches a pre-determined threshold which is less than the maximum light energy, it is declared that the body-worn device requires servicing.

Abstract: Described herein in one embodiment is software, which may be downloaded to a device, to guide a user through administration of a test. Test results may be uploaded, manually or automatically, to a device or communicated remotely through a network. In an embodiment, the test is a rapid test. In an embodiment, the rapid test detects presence of COVID-19. In an embodiment, the rapid test detects COVID-19 or influenza. In an embodiment, the rapid test detects influenza A or influenza B. In an embodiment, the rapid test detects a target nucleic acid. In an embodiment, the target nucleic acid represents one of a viral, bacterial, fungal, parasitic or protozoan pathogen. Each of the rapid tests may be self administrable.

Abstract: Provided herein, in some embodiments, are rapid diagnostic tests to detect one or more target nucleic acid sequences (e.g., a nucleic acid sequence of one or more pathogens). In some embodiments, the pathogens are viral, bacterial, fungal, parasitic, or protozoan pathogens, such as SARS-CoV-2 or an influenza virus. Further embodiments provide methods of detecting genetic abnormalities. Diagnostic tests comprising a sample-collecting component, one or more reagents (e.g., lysis reagents, nucleic acid amplification reagents), and a detection component (e.g., a component comprising a lateral flow assay strip) are provided.