Abstract: A method of training a model of a diagnostic apparatus includes providing one or more first tube assemblies of a first type and one or more second tube assemblies of a second type in a diagnostic apparatus; capturing one or more first images of at least a portion of each of the one or more first tube assemblies and the second tube assemblies using the imaging device. Training the model includes identifying tube assemblies of the first type and tube assemblies of the second type based on the one or more first images and the one or more second images. Tubes assemblies of the first type are grouped into a first group and tube assemblies of the second type are grouped into a second group. Other methods and apparatus are disclosed.

Abstract: Disclosed herein are methods for rapid detection of suspension of a blood sample from a subject and methods for improving the processing time of a point of care blood analysis. Specifically, the disclosed methods provide a rapid detection of hemoglobin concentration, more specifically glycated hemoglobin A1c, and determination of sugar concentration in the blood sample from the subject. Further disclosed herein are methods for rapidly diagnosing diabetes in a subject.

Abstract: A tangent flow hemolysis blood testing assembly, device and method are described herein.

Abstract: A method and a device for determining onset of sepsis are provided. In one aspect, the method includes receiving a medical dataset associated with the patient. Further, the method includes determining if the plurality of medical parameters includes at least one sepsis specific parameter. Additionally, the method includes determining a first output parameter if the plurality of medical parameters does not include at least one sepsis specific parameter. The method also includes determining a second output parameter indicative of onset of sepsis in the patient if the plurality of medical parameters include at least one sepsis specific parameter, wherein the medical parameters associated with the patient are obtained for at least one time instance.

Abstract: In one embodiment, a biological sample analyzer has a housing having at least one outer wall that defines a cavity therein. A receptacle, which can support a consumable holder containing a biological sample, is disposed within the cavity. At least one heater applies heat to the consumable holder when the consumable holder is supported by the receptacle. At least one heater sensor detects a temperature of the receptacle over time. A controller directs the at least one heater to apply an elevated temperature to the consumable holder and reduces an amount of heat applied to the consumable holder before the consumable holder exceeds a target temperature that is less than the elevated temperature. By applying the elevated temperature, the consumable holder can be heated quicker than if it where heated at only the target temperature.

Abstract: Methods of minimizing hook effect interference in an immunoassay are disclosed. Also disclosed are reagents, kits, and immunoassay devices that may be utilized in accordance with the method.

Abstract: A method, device and a system of determining a concentration of one or more analytes in a sample is disclosed. In one aspect of the invention, the method includes introducing the sample through a channel. The method further includes illuminating the sample with light having varying wavelengths. Additionally, the method includes obtaining an image of the illuminated sample at each of the wavelengths. Furthermore, the method includes analyzing the image to determine the concentration of the one or more analytes.

Abstract: A point of care system may comprise a plurality of diagnostic engines and an IDM in electronic communication with each of the plurality of diagnostic engines. Each of the plurality of diagnostic engines may perform testing on a sample inserted into the diagnostic engine. The IDM may be configured to communicate with each of the plurality of diagnostic engines to enable a plurality of tests to be performed on multiple different samples substantially simultaneously by a plurality of users using the plurality of diagnostic engines and to present a single user interface for managing testing by the plurality of diagnostic engines and for receiving the results of tests performed by each of the plurality of diagnostic engines.

Abstract: Fluid analyzation devices, methods, and systems are disclosed including an analyzation device comprising a sample vessel having an outer surface, a microchannel within the confines of the outer surface, a first port extending through the outer surface to the microchannel, and a second port extending through the outer surface to the microchannel; and an piezo transducer bonded to the outer surface of the sample vessel to form a monolithic structure, the piezo transducer configured to emit ultrasonic acoustic waves having a first frequency, a second frequency, and a third frequency into and/or to a blood sample within the microchannel, the first frequency configured to begin separation of red blood cells and plasma in the blood sample, the second frequency configured to complete separation of the red blood cells and plasma, and the third frequency configured to rupture cell walls of the blood cells producing a lysed blood sample.

Abstract: In some embodiments, a method of determining a viewpoint for optically inspecting a sample within a sample container is provided that includes (a) employing a sensor to capture image data of a sample container including a sample, wherein a portion of the sample container includes a label having first and second ends; (b) rotating at least one of the sample container and the sensor about a central axis of the sample container so that the sensor capture s image data including at least the first and second ends of the label; (c) employing the captured image data to generate an unwrapped image of the sample container; (d) processing the unwrapped image to characterize the label and produce label characterization information; and (e) employing the label characterization information to identify a viewpoint through which to optically inspect the sample within the sample container. Numerous other aspects are provided.

Abstract: Analytical assay reaction cartridges are disclosed that include a reagent tray containing a liquid reagent disposed therein and a flexible cover removably attached thereto. The flexible cover has a portion that extends beyond the reagent tray and that forms a tab portion extends through an opening in a lid member of the cartridge in order to facilitate removal of at least a portion of the cover and release of the liquid reagent. Also disclosed are analytical assay reaction kits that include the cartridges and diagnostic instruments for use with the analytical assay reaction cartridges/kits, as well as methods of making and using the cartridges/kits.

Abstract: Fluidic devices that include bubble traps are provided. A substrate for a fluidic device includes a first channel to carry a fluid; a chamber, coupled to the first channel, to receive the fluid from the first channel, the chamber having a top and a bottom; a second channel, coupled to the chamber, to receive the fluid from the chamber; and a plurality of barriers adjacent to the top of the chamber. The plurality of barriers inhibit bubbles in the fluid from entering the second channel. Methods for manufacturing and using fluidic devices that include bubble traps are also provided.

Abstract: Disclosed herein are immunoassays for detecting an antibody in a biological sample from a subject and/or diagnosing an autoimmune disease in a subject. The disclosed immunoassays use a single, direct step to assess the level of antibody in a biological sample from the subject by simultaneously binding the antibody to a capture antigen (e.g. an unlabeled antigen bound to a solid support) and a labeled antigen not bound to the solid support.

Abstract: Methods and systems for detecting an obstruction on a sensor of a fluid analyzer, including a method comprising causing a first calibration fluid to contact the sensor to generate signals indicative of a first electric potential of the first calibration fluid; causing a second calibration fluid to contact the sensor to generate signals indicative of a second electric potential of the second calibration fluid; storing a first response slope; causing the first calibration fluid to contact the sensor to generate signals indicative of a third electric potential of the first calibration fluid; causing the second calibration fluid to contact the sensor to generate signals indicative of a fourth electric potential of the second calibration fluid; storing a second response slope; and storing data indicative of an obstruction on the sensor in response to a difference between the first response slope and the second response slope being beyond a threshold.

Abstract: Composition(s), device(s), kit(s), and method(s) for improved biocide formulations that remove contaminants (and the effects related thereto) from at least one analyte detection sensor, while simultaneously preserving and/or extending the functional life of the at least one analyte detection sensor.

Abstract: Antibodies that specifically bind naloxone and/or naltrexone are disclosed. Also disclosed are conjugates used in the production of the antibodies, as well as methods of producing the antibodies. Also disclosed are methods of using the antibodies in direct assays for naloxone and/or naltrexone. Further disclosed are methods of reducing naloxone and/or naltrexone interference in opiate assays using the antibodies.

Abstract: A probe assembly for aspirating and delivering liquids includes a liquid line having a liquid line end and a pipette configured to be in fluid communication with the liquid line, the pipette configured to aspirate and dispense liquids when the probe assembly is devoid of connections to external liquid sources other than liquids being aspirated or dispensed, the liquid line end having a first portion of a dynamic coupler configured to be dynamically coupled to a second portion of a dynamic coupler, and the second portion of the dynamic coupler configured to be in fluid communication with a liquid source external to the probe assembly. Other probe assemblies, testing apparatus, and methods are disclosed.

Abstract: A blood testing device for detecting hemolysis in a blood sample is described. The blood testing device comprises an housing for containing the blood sample. The housing has a treatment window and an optical zone formed therein. The blood testing device further includes an acoustic transducer positioned to selectively generate acoustic forces directed into the treatment window of the housing and a control unit for selectively actuating and deactuating the acoustic transducer to permit colorimetric analysis of plasma within the blood sample.

Abstract: Disclosed herein are immunoassay methods and reagents for detecting anti-Zika IgM antibody in a biological sample from a subject and/or diagnosing Zika virus infection in a subject. Also disclosed are algorithms for implementing the disclosed methods. The disclosed immunoassay methods, reagents, and algorithms enable efficient and reliable qualitative detection of anti-Zika virus antibodies and rapid determination of presumptive positive results for Zika virus infection in human subjects.

Abstract: A method of synthesizing an image of a tube assembly includes capturing an image of the tube assembly, wherein the capturing generates a captured image. The captured image is decomposed into a plurality of features in latent space using a trained image decomposition model. One or more of the features in the latent space is manipulated into one or more manipulated features. A synthesized tube assembly image is generated with at least one of the manipulated features using a trained image composition model. Other methods and systems are disclosed.