Abstract: A reagent carrier includes: a cap configured to fit on an opening of a reaction vessel; and a reagent confined by the cap. The cap may be configured to release the reagent when a user manipulates the cap while the cap is fitted on the opening of the reaction vessel. For example, the reagent may be released when the user twists the cap from a first position to a second position or when the user pushes on a surface of the cap. The cap may be configured to seal the opening of the reaction vessel when the cap is fitted on the opening of the reaction vessel. In some implementations, the cap may be a blister cap containing the reagent. In some implementations, the cap may include a cage containing the reagent. In some implementations, the cap may include a deformable structure containing the reagent.

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: 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: 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) having a seal component. 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), a seal component, and a detection component (e.g., a component comprising a lateral flow assay strip and/or a colorimetric assay) are provided.

Abstract: Provided herein are rapid diagnostic tests, systems, and methods for detecting one or more target nucleic acid sequences (e.g., a nucleic acid sequence of one or more pathogens, such as SARS-CoV-2 or an influenza virus) using isothermal nucleic acid amplification. The tests, systems, and methods described herein may be performed in a point-of-care setting or a home setting without specialized equipment.

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: Provided herein, in some embodiments, are rapid diagnostic tests comprising a lateral flow strip and an integrated swab head. The tests may be used to detect, for example, one or more pathogens, such as viral, bacterial, fungal, parasitic, or protozoan pathogens. Further embodiments provide methods of detecting genetic abnormalities. Nucleic acid tests using the diagnostic tests are provided.

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.