Abstract: A method of characterizing a serum or plasma portion of a specimen in a specimen container provides an HILN (hemolysis, icterus, lipemia, normal) determination. Pixel data of an input image of the specimen container is processed by a classification network to identify whether the specimen contains plasma or serum. Pixel data representing a plasma sample are forwarded to a segmentation/classification/regression network trained with plasma samples for HILN determination. Pixel data representing a serum sample are forwarded to a transformation network, wherein the serum sample pixel data is transformed into pixel data that matches pixel data of a corresponding previously-collected plasma sample by changing sample color, contrast, intensity, and/or brightness. The transformed serum sample pixel data are forwarded to the segmentation/classification/regression network for HILN determination. Quality check modules and testing apparatus configured to carry out the method are also described, as are other aspects.

Abstract: A wash system for use in an in vitro diagnostic immunoanalyzer utilizes a bridge having a linear track to move cuvettes from one incubation ring portion to another incubation ring portion. Washing stations along the linear track provide a magnetic field and fluid washing of cuvette contents independent of the size and motion of one or more incubation rings.

Abstract: Devices, kits, and methods separating and metering a plasma sample from a patient's liquid test sample.

Abstract: In one aspect, the inventive concepts disclosed herein are directed to a sensor assembly which contains a first planar substrate and a second planar substrate which respectively support opposing sensor arrays and contains an integrated flow path extending between the first and second substrates.

Abstract: A device that can warm a hand of a user and/or patient to facilitate collection of blood samples (e.g., capillary blood sample collection) is described herein. The device provides controlled amounts of heat directed to the palm of a user and/or patient to facilitate collection of high-quality capillary blood samples. The device is designed in such a way to provide a comfortable resting position for the hand that allows heating the hand of the user and/or patient while simultaneously providing access to the finger of the user and/or patient to carry out one or more steps in preparation for collection of capillary blood samples from the finger. The device will also monitor the temperature to limit the max temperature to a safe level, control the palm temperature to a desired level, and use a conductive material to enable rapid heating.

Abstract: Microbial growth media and methods of growing a microorganism. The microbial growth media may include a growth-stimulating amount of phosphoglucomutase in combination with one or more of a carbon and nitrogen source, a fermentable sugar, and an inorganic salt. The methods of growing a microorganism may include culturing a sample suspected of containing the microorganism in a microbial growth medium containing a growth-stimulating amount of phosphoglucomutase. Microbial growth-stimulating protein compositions and uses of same are also provided.

Abstract: Phenotypic antimicrobial susceptibility testing (AST), the gold-standard diagnostic that indicates whether an antimicrobial will be clinically effective, often suffer the slowest times-to-result for the most resistant pathogens. Here we introduce novel assays to be performed in parallel with standard AST assays that provide additional resistance information and enable rapid, same-shift reporting of AST results for a plurality of pathogens.

Abstract: A method of increasing a concentration of an antigen of a respiratory virus is provided. The method includes preparing a sample containing a first concentration of the antigen; contacting the sample containing the first concentration of the antigen to a first material having a negatively-charged surface, thereby capturing an amount of the antigen with the first material; contacting a second material to the first material to transfer the antigen from the first material to the second material, the second material having an ionic strength sufficient to release the captured antigen from the first material into the second material; and obtaining a resulting solution containing the antigen in a second concentration. The second concentration of the antigen in the resulting solution is higher than the first concentration of the antigen in the sample. Numerous other aspects in accordance with this and other embodiments are provided.

Abstract: Disclosed herein are immunoassays for detecting an anti-thyroid peroxidase antibody in a biological sample from a subject and/or diagnosing a thyroid disease in a subject. The disclosed immunoassays employ a recombinant cynomolgus monkey thyroid peroxidase (rTPO) and assess the level of anti-thyroid peroxidase antibody-induced formation or disruption of complexes comprising a solid support and the rTPO.

Abstract: Phenotypic antimicrobial susceptibility testing (AST), the gold-standard diagnostic that indicates whether an antimicrobial will be clinically effective, often suffer the slowest times-to-result for the most resistant pathogens. Here we introduce novel assays to be performed in parallel with standard AST assays that enable rapid, same-shift reporting of AST results for a plurality of pathogens. The assays developed here are further capable of detecting resistance to carbapenems, the most powerful class of beta-lactams commonly used as “last-resort” antimicrobials.

Abstract: A microfluidic device has a first substrate, a resilient diaphragm, an actuator, and a second substrate. The first substrate has an opening extending therethrough. The resilient diaphragm is secured to a second side and surrounds the opening. The actuator is secured to a first side and surrounds the opening. The first substrate, the resilient diaphragm, and the actuator cooperate to form a gas-tight chamber. The second substrate has a channel formed therein having a first end and a second end. The second substrate is secured to the first substrate. A volume of gas disposed in the gas-tight chamber pressurizes the gas-tight chamber and expands the resilient diaphragm such that the resilient diaphragm is disposed in the channel between the first end and the second end. The resilient diaphragm retracts from the channel to open the channel from the first end and the second when the gas-tight chamber is depressurized.

Abstract: In some aspects, automated rapid antimicrobial susceptibility testing systems for performing a multi-assay testing sequence can include an automated incubation assembly having a nest assembly adapted to house at least one test panel having a plurality of wells for receiving a sample comprising microorganisms originating from a clinical sample, the incubation assembly facilitating incubation of one or more test panels in order to undergo the multi-assay testing sequence; a robotic handling assembly configured to accept one or more incoming test panels and move them to and from the incubation assembly for incubation between each assay of the multi-assay testing sequence; an automated liquid handling assembly configured to exchange one or more fluids in the plurality of wells of the test panels; and an optical assembly for interrogation and readout of each assay of the multi-assay testing sequence being performed in the plurality of wells.

Abstract: A system and method for physiological data classification for use in facilitating diagnosis is provided. A physiological monitor includes a feedback button and physiological data obtained via the physiological monitor is stored in a database. The physiological data is divided into segments and one or more data segments are classified as noise. A determination is made that at least one of the data segments classified as noise includes a marker indicating a press of the feedback button on the physiological monitor. A set of the physiological data including and surrounding the physiological data occurring during the press of the feedback button is identified within the data segment classified as noise. The identified set of physiological data is provided with the data segments classified as valid for analysis.

Abstract: An image analysis system, a method and a point of care device are provided for determining, from an image of a cassette containing a sample, a concentration of one or more target analytes in the sample. The method includes identifying a region of interest (ROI) from the image corresponding to a result viewing area of the cassette, generating a unidimensional (1D) profile of the ROI, and probabilistically determining from the 1D profile, the concentration of the target analyte(s) in the sample based on a statistical model having one or more parameters of the 1D profile varying with respect to time and/or the concentration of the target analyte(s) in the sample.

Abstract: The present invention relates to methods of detecting novel mutations in a PKD1 and/or PKD2 gene that have been determined to be associated with autosomal dominant polycystic kidney disease (ADPKD) in order to detect or predict the occurrence of ADPKD in an individual.

Abstract: The present invention is directed to membranes, sensors, systems and process for the detection of magnesium ions in protein-containing samples. The novel membranes, sensors, systems, and processes are based upon the discovery that the lipophilicity of the plasticizer (or blend of plasticizers) utilized in the formulation of magnesium ion selective membranes for clinical use is inversely proportional to the sensitivity of the plasticizer(s) and directly proportional to the use life thereof.

Abstract: There is provided a chloride selective membrane including an epoxide-based matrix reacted with a stoichiometric amount of an amino compound and an activator such that the epoxide-based matrix comprises a number of quaternary ammonium groups.

Abstract: Methods of troubleshooting non-event malfunctions. The methods include providing a database including pre-populated non-event issues and associated corrective actions, inputting search criteria regarding a particular non-event issue via entry of a search string at the user interface, parsing and normalizing the search string into a meta-data schema to produce a normalized search string, searching the database with the normalized search string to generate a listing of one or more particular corrective actions, and receiving the listing of one or more particular corrective actions that are associated with the normalized search string. Apparatus configured to carry out the methods are provided, as are other aspects.

Abstract: A method of detecting a level of a liquid in a well of a container. The method includes looking up an expected liquid level of the liquid in the well of a container; measuring and recording a measured liquid level of the liquid in the well; changing a level of the liquid in the well based upon an expected amount of the liquid to be added or removed; and calculating a next expected liquid level at least in part based on multi-point filtering. Apparatus for carrying out the method are provided, as are other aspects.

Abstract: A quality check module for characterizing a specimen and/or a specimen container including stray light compensation. The quality check module includes an imaging location within the quality check module configured to receive a specimen container containing a specimen, one or more image capture devices configured to capture images of the imaging location from one or more viewpoints, and one or more light sources configured to provide back lighting for the one or more image capture devices, and one or more stray light patches located in an area receiving stray light from the one or more light sources enabling stray light affecting the images to be compensated for and to provide a stray light compensated image. Calibration methods, methods of characterizing a specimen, specimen testing apparatus including a quality check module, and specimen container carriers including one or more stray light patches are provided, as are other aspects.