Abstract: A device for determining presence or absence of infection due to an infectious agent is described. The device comprises a sample receiving zone configured to receive a liquid sample from a subject suspected of having an infection due to an infectious agent, the sample receiving zone positioned to distribute the sample along a first fluid flow path to a first label zone and along a second fluid flow path to a second label zone. Test lines in each fluid flow path capture a mobile detectable species as an indicator of presence or absence of the infectious agent. The device also comprises a reference line positioned in the one of the fluid flow paths. The bidirectional fluid flow paths emanate from a common sample zone and provide an efficient approach to detection and differentiate two species as indicators of the same infectious agent or as indicators of two different infectious agents.

Abstract: An enzymatic extraction agent, as well as methods, compositions and kits for detecting Group A streptococcus in a biological sample, which involve the enzymatic agent, are described.

Abstract: A device for determining presence or absence of infection due to an infectious agent is described. The device comprises a sample receiving zone configured to receive a liquid sample from a subject suspected of having an infection due to an infectious agent, the sample receiving zone positioned to distribute the sample along a first fluid flow path to a first label zone and along a second fluid flow path to a second label zone. Test lines in each fluid flow path capture a mobile detectable species as an indicator of presence or absence of the infectious agent. The device also comprises a reference line positioned in the one of the fluid flow paths. The bidirectional fluid flow paths emanate from a common sample zone and provide an efficient approach to detection and differentiate two species as indicators of the same infectious agent or as indicators of two different infectious agents.

Abstract: Lateral flow immunoassays that reliably detect human antibodies, including IgG and/or IgM antibodies, specific for severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) are described herein. Devices, methods and kits for analysis of samples, such as liquid blood, serum or plasma, for the presence of human antibodies, such as IgG and/or IgM antibodies, specific for SARS CoV-2 proteins, such as SARS CoV-2 N and/or S proteins are provided.

Abstract: An enzymatic extraction agent, as well as methods, compositions and kits for detecting Group A Streptococcus in a biological sample, which involve the enzymatic agent, are described.

Abstract: Embodiments of the present disclosure relate to chimeric antibodies which specifically bind to Borrelia decorin-binding protein A (DbpA) antigens and compositions or kits comprising such antibodies. The disclosure further relates to use of such antibodies in the detection of Borrelia sp. in samples, e.g., biological samples such as human blood and/or tissues of deer, ticks and other carriers of Borrelia. Embodiments of the disclosure further relate to diagnosis and/or therapy of Lyme disease using the chimeric antibodies and/or compositions containing the chimeric antibodies.

Abstract: A substrate structured to define thereon a fluid flow channel and/or a fluid control feature is described. The substrate may additionally comprise a capture zone and/or a test zone, for use as a test strip for determining presence or absence of an analyte of interest, such as an infectious agent or a biomarker. Reagents are deposited in the capture zone and/or test zone as an array of drops.

Abstract: A substrate structured to define thereon a fluid flow channel and/or a fluid control feature is described. The substrate may additionally comprise a capture zone and/or a test zone, for use as a test strip for determining presence or absence of an analyte of interest, such as an infectious agent or a biomarker. Reagents are deposited in the capture zone and/or test zone as an array of drops.

Abstract: Methods, compositions and kits for detecting Group A Streptococcus in a biological sample are described. More particularly, the present disclosure provides an immunoassay in which the specificity of detection of Group A Streptococcus is enhanced by addition of N-acetyl-D-glucosamine. These methods, compositions and kits are useful in convenient, reliable and early diagnosis of streptococcal infection in a human subject.

Abstract: A device for determining presence or absence of infection due to an infectious agent is described. The device comprises a sample receiving zone configured to receive a liquid sample from a subject suspected of having an infection due to an infectious agent, the sample receiving zone positioned to distribute the sample along a first fluid flow path to a first label zone and along a second fluid flow path to a second label zone. Test lines in each fluid flow path capture a mobile detectable species as an indicator of presence or absence of the infectious agent. The device also comprises a reference line positioned in the one of the fluid flow paths. The bidirectional fluid flow paths emanate from a common sample zone and provide an efficient approach to detection and differentiate two species as indicators of the same infectious agent or as indicators of two different infectious agents.

Abstract: A device for determining presence or absence of infection due to an infectious agent is described. The device comprises a sample receiving zone configured to receive a liquid sample from a subject suspected of having an infection due to an infectious agent, the sample receiving zone positioned to distribute the sample along a first fluid flow path to a first label zone and along a second fluid flow path to a second label zone. Test lines in each fluid flow path capture a mobile detectable species as an indicator of presence or absence of the infectious agent. The device also comprises a reference line positioned in the one of the fluid flow paths. The bidirectional fluid flow paths emanate from a common sample zone and provide an efficient approach to detection and differentiate two species as indicators of the same infectious agent or as indicators of two different infectious agents.

Abstract: Antibody fusions comprising any antibody or fragment thereof, operably linked, and expressed as a fusion with a label of interest are provided. Plasmids, vectors, host cells, methods, and kits related to the described antibody fusions are also provided. The antibody fusions are useful at least in the diagnostic and reagent setting.

Abstract: A system including a sample receptacle configured to receive a test sample and a test strip coupled to the sample receptacle is provided. The test strip configured to generate a signal based on a concentration of a target analyte in the test sample. The system also includes a detector to generate a transduced signal based on the signal and a computer to receive a transduced signal. The computer further determines the concentration of the target analyte in the test sample. For this, the computer retrieves the transduced signal from the detector at multiple time points to determine a signal rate based on a signal value for the time points, and to determine the concentration of the target analyte based on the signal rate and a model. A method and a non-transitory, computer-readable medium storing instructions to use the above system are also provided.

Abstract: An enzymatic extraction agent, as well as methods, compositions and kits for detecting Group A streptococcus in a biological sample, which involve the enzymatic agent, are described.

Abstract: Embodiments of the present disclosure relate to chimeric antibodies which specifically bind to Borrelia decorin-binding protein A (DbpA) antigens and compositions or kits comprising such antibodies. The disclosure further relates to use of such antibodies in the detection of Borrelia sp. in samples, e.g., biological samples such as human blood and/or tissues of deer, ticks and other carriers of Borrelia. Embodiments of the disclosure further relate to diagnosis and/or therapy of Lyme disease using the chimeric antibodies and/or compositions containing the chimeric antibodies.

Abstract: Methods, compositions and kits for detecting Group A streptococcus in a biological sample are described. More particularly, the present disclosure provides an immunoassay in which the specificity of detection of Group A streptococcus is enhanced by addition of N-acetyl-D-glucosamine. These methods, compositions and kits are useful in convenient, reliable and early diagnosis of streptococcal infection in a human subject.

Abstract: Methods, compositions and kits for detecting Group A streptococcus in a biological sample are described. More particularly, the present disclosure provides an immunoassay in which the specificity of detection of Group A streptococcus is enhanced by addition of N-acetyl-D-glucosamine. These methods, compositions and kits are useful in convenient, reliable and early diagnosis of streptococcal infection in a human subject.

Abstract: A substrate structured to define thereon a fluid flow channel and/or a fluid control feature is described. The substrate may additionally comprise a capture zone and/or a test zone, for use as a test strip for determining presence or absence of an analyte of interest, such as an infectious agent or a biomarker. Reagents are deposited in the capture zone and/or test zone as an array of drops.

Abstract: A device for determining presence or absence of infection due to an infectious agent is described. The device comprises a sample receiving zone configured to receive a liquid sample from a subject suspected of having an infection due to an infectious agent, the sample receiving zone positioned to distribute the sample along a first fluid flow path to a first label zone and along a second fluid flow path to a second label zone. Test lines in each fluid flow path capture a mobile detectable species as an indicator of presence or absence of the infectious agent. The device also comprises a reference line positioned in the one of the fluid flow paths. The bidirectional fluid flow paths emanate from a common sample zone and provide an efficient approach to detection and differentiate two species as indicators of the same infectious agent or as indicators of two different infectious agents.

Abstract: Embodiments include methods that may be used to optically obtain the precise three-dimensional location of multiple objects from one or more two dimensional images. An optical point spread function having a transverse shape which varies with axial distance may be implemented to obtain depth information. The transverse variation in the PSF with depth may be produced using a cylindrical lens. The objects may be imaged by a focal plane array detector. One or more 2D images may be used to find the 3D location of the objects using sparse signal reconstruction methods.