Abstract: Disclosed herein is a method for improving the precision of a test result from an instrument with an optical system that detects a signal. The method comprises including in the instrument a normalization target disposed directly or indirectly in the optical path of the optical system. Also disclosed are instruments comprising a normalization target, and systems comprising such an instrument and a test device that receives a sample suspected of containing an analyte.

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 method to assess a subject diagnosis is provided. The method includes receiving an image from an image-capturing device, the image comprising an area of interest in a test cartridge, and finding a border of the area of interest of the test cartridge and applying a geometrical transformation on an area delimited by the border of the test cartridge to bring the image of the area of interest in the test cartridge to a selected size and a selected shape. The method also includes identifying a target region within the area of interest of the test cartridge, evaluating a quality of the image based on a characteristic feature of the target region, and providing commands to adjust an optical coupling in the image-capturing device when the quality of the image is lower than a selected threshold.

Abstract: The present invention relates to compositions and methods use in designing immunoassay controls. In various aspects, the invention provides synthetic peptides comprising the sequence CPRRPYIL (SEQ ID NO: 1) or an analog thereof; ELAGLGFAELQC (SEQ ID NO: 4) or an analog thereof; and CDWRKNIDAL (SEQ ID NO: 8) or an analog thereof; specific binding reagents that bind to a CPRRPYIL (SEQ ID NO: 1), ELAGLGFAELQC (SEQ ID NO: 4) or CDWRKNIDAL (SEQ ID NO: 8) peptide; methods of producing such reagents; and assays utilizing such reagents to provide assay controls signals that are unrelated to the measurement of the analyte or analytes of interest in that no reagents used in the analyte assay(s) contribute to the control signal.

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: Separation of the cellular components of whole blood, or other biological fluid, from plasma or serum can be achieved for assay analysis. A device for facilitating separation can include, for example, a capillary tube that accurately draws target blood volume, a pad that chemically interacts with red-blood cells, such that the red blood cells become chemically and/or physically trapped within pad material, a mechanism for plasma recovery from the pad upon diffusion or active mixing, and a dropper tip that facilitates dispensing the mixture onto a test device. The treatment of the cellular components can be performed prior to contact with a buffer solution, so release of the cellular components into the buffer solution is reduced or prevented. Additional filtration can be provided to filter any remaining cellular components in the mixture.

Abstract: Methods for determining the susceptibility or resistance of bacteria to antibiotic agents are provided. In one embodiment, the methods include culturing the bacteria in the presence or absence or the antimicrobial agent to generate a primary culture which is then cultured in the presence or absence of transforming phages. The recombinant phages are specific to the bacteria and comprise a heterologous marker (e.g., a nucleic acid that is expressible as a detectable product such as an RNA or a protein). The susceptibility or resistance of the bacteria to the antimicrobial agent may be determined by assaying the culture for the presence or absence of the heterologous marker, wherein a reduction in the level or activity of the marker in the culture compared to the level or activity of the marker in a comparative culture indicates that the bacteria is sensitive to the antibiotic agent.

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: The present invention relates to compositions and methods use in designing immunoassay controls. In various aspects, the invention provides synthetic peptides comprising the sequence CPRRPYIL or an analog thereof; ELAGLGFAELQC or an analog thereof; and CDWRKNIDAL or an analog thereof; specific binding reagents that bind to a CPRRPYIL, ELAGLGFAELQC or CDWRKNIDAL peptide; methods of producing such reagents; and assays utilizing such reagents to provide assay controls signals that are unrelated to the measurement of the analyte or analytes of interest in that no reagents used in the analyte assay(s) contribute to the control signal.

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 system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device.

Abstract: A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device. The test device and apparatus interact to provide a timer feature for determining a test device specific adjustable cut-off value that is used to ascertain whether signal from a test line in the device corresponds to a positive or negative results, irrespective of the time elapsed since placement of sample on the test device. The adjustable cut-off value renders the system relatively insensitive to incubation time of the test device, where if the incubation time is shorter or longer than needed for accuracy of a test result, the analyzer will report an invalid result, thus preventing the reporting of an incorrect (false negative or false positive) result.

Abstract: Separation of the cellular components of whole blood, or other biological fluid, from plasma or serum can be achieved for assay analysis. A device for facilitating separation can include, for example, a capillary tube that accurately draws target blood volume, a pad that chemically interacts with red-blood cells, such that the red blood cells become chemically and/or physically trapped within pad material, a mechanism for plasma recovery from the pad upon diffusion or active mixing, and a dropper tip that facilitates dispensing the mixture onto a test device. The treatment of the cellular components can be performed prior to contact with a buffer solution, so release of the cellular components into the buffer solution is reduced or prevented. Additional filtration can be provided to filter any remaining cellular components in the mixture.

Abstract: Disclosed herein is a method for improving the precision of a test result from an instrument with an optical system that detects a signal. The method comprises including in the instrument a normalization target disposed directly or indirectly in the optical path of the optical system. Also disclosed are instruments comprising a normalization target, and systems comprising such an instrument and a test device that receives a sample suspected of containing an analyte.

Abstract: A combination of components in a capillary flow channel use capillary forces to passively control the movement of liquid samples within a microfluidic device. To detect a target, a liquid sample introduced to a proximal portion of a capillary channel of a microfluidic device moves by capillary action along the specific components of capillary channel.

Abstract: A system including multiple diagnostic instruments, each diagnostic instrument including a detector that interacts with a test assay is provided. At least one diagnostic instrument is configured to automatically associate the test assay with multiple values to generate a diagnostic. The diagnostic may be stored within a memory of the diagnostic instrument, and the multiple values may be related to one or more of: a test assay identifier, a test assay result, a patient identifier, and a diagnostic instrument identifier. At least one diagnostic instrument in the system may be configured to transmit the diagnostic to a first server for storage. The first server being configured to generate a report based on the diagnostic from each diagnostic instrument for display on a second server or on an end-user workstation. Methods for use the above system are also provided.

Abstract: Devices for use in extracting an analyte of interest from a sample are described. In one embodiment, a device is comprised of a first plurality of chambers, where one or more chambers in the plurality of chambers has a deep end and a shallow end with a depth d1. A channel disposed between at least two adjacent chambers in the plurality of chambers has a depth greater than d1. The dimensions of the chamber and channel provide control of fluid movement in the device, particularly when introducing fluid into the device for its use and during use of the device.

Abstract: Disclosed herein is a method for improving the precision of a test result from an instrument with an optical system that detects a signal. The method comprises including in the instrument a normalization target disposed directly or indirectly in the optical path of the optical system. Also disclosed are instruments comprising a normalization target, and systems comprising such an instrument and a test device that receives a sample suspected of containing an analyte.

Abstract: The present invention relates generally to an assay for detecting and differentiating multiple analytes, if present, in a single fluid sample, including devices and methods therefore.