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: Methods of troubleshooting non-event malfunctions include providing a database including pre-populated non-event issues and associated corrective actions, receiving search criteria regarding a particular non-event issue via entry of a search string at a 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: Labels that include dibromopyridazinedione attached to signal molecules are disclosed, along with methods of producing and using same. Also disclosed are conjugates of the label attached to an analyte-specific binder, as well as methods of producing and using same. Kits containing the labels and/or conjugates are also disclosed, along with microfluidics devices containing same.

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

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: 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 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: 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: 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 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: The invention relates to a method for detecting a dengue infection in a patient blood sample, comprising the steps: a) Performing an analysis of prespecified parameters of blood platelets and prespecified types of blood cells in the sample and determining parameter values for the prespecified parameters of the platelets and the prespecified types of cells; b) Obtaining sample parameters from the values determined in step a); and c) Evaluating the sample parameters in relation to a prespecified criterion, wherein, if the criterion is fulfilled, a dengue infection is present.

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.

Abstract: Provided herein are antigenic molecules that can be used to generate antibodies capable of binding to a vitamin D derivative, such as 25-hydroxyvitamin D2 and/or 25-hydroxyvitamin D3, or a 25-hydroxyvitamin D analog, such as a vitamin D-C22 immunogenic molecule or compound. Antibodies produced using these antigenic molecules, and related antigenic compounds, are also described. In addition, disclosed herein are methods for detecting vitamin D deficiency in a subject, methods for treating a subject suspected of having a vitamin D deficiency, methods for monitoring progression of vitamin D deficiency in a subject, and methods for monitoring treatment of vitamin D deficiency in a subject in need thereof. The methods involve the detection or quantification of 25-hydroxyvitamin D2 and D3.

Abstract: A quality check module for characterizing a specimen and/or a specimen container. 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 cameras located at one or more viewpoints adjacent to the imaging location, and one or more spectrally-switchable light source including a light panel assembly located adjacent the imaging location and configured to provide lighting for the one or more cameras, the spectrally-switchable light source configured to be operatively switchable between multiple different spectra. Methods of imaging a specimen and/or specimen container and specimen, and specimen testing apparatus including a quality check module adapted to carry out the method are described herein, as are other aspects.