Abstract: Biotin-trap compositions are disclosed that contain particles having an inner polymer coating layer disposed on at least a portion of an outer surface thereof and a biotin-specific binding partner conjugated to the inner polymer coating layer. The biotin-trap compositions may further include an outer polymer coating layer disposed about the biotin-specific binding partner. The biotin-trap compositions specifically bind to free biotin but do not substantially bind to biotin conjugated to other moieties, such as biotinylated assay reagents. Also disclosed are kits and microfluidics devices that include the biotin-trap compositions, as well as methods of producing and using the biotin-trap compositions.

Abstract: The present disclosure relates to methods and compositions to remove or reduce biotin interference from certain assays.

Abstract: A tiltable display screen assembly of a diagnostic analyzer. The tiltable display screen assembly includes a tiltable support interconnectable to a hand-held device including a display screen, a multi-angle adjuster having adjustment features, and a tilting screen mechanism pivotable relative to the tiltable support. The tilting screen mechanism includes a shaft, one or more moveable paddles coupled to the shaft, an adjustment member depending from the shaft configured to engage with the adjustment features of the multi-angle adjuster in order to adjust a tilt angle of the tiltable support and the display screen of the hand-held device. Diagnostic analyzers including the tiltable display screen assembly and methods for adjusting tilt angle of a display screen of a diagnostic analyzer are described, as are other aspects.

Abstract: In one embodiment, a biological sample analyzer has a housing having at least one outer wall that defines a cavity therein, an air intake, and an air exhaust. A plenum is disposed within the cavity and has at least one plenum wall that defines an air duct therein. A receptacle, which can support a consumable holder containing a biological sample, is disposed within the internal cavity. At least a portion of the receptacle is supported within the air duct such that an air gap is defined between the receptacle and the at least one plenum wall. A heater applies heat to the consumable holder so as to heat the consumable holder when the consumable holder is supported by the receptacle. A fan forces air along a path that extends from the air intake, through the air gap, and to the air exhaust so as to cool the heater.

Abstract: Kits containing a multiplexed chemiluminescent detection system and microfluidics devices and methods for detecting the presence and/or concentration of anti-SARS-CoV-2 antibodies in a sample are disclosed. The kits, microfluidics devices, and methods utilize singlet oxygen-activatable chemiluminescent compounds in combination with two or more fluorescent molecules that emit light at different wavelengths. In certain non-limiting embodiments, the kits, microfluidics devices, and methods can distinguish between anti-SARS-CoV-2 antibodies generated in response to vaccination from anti-SARS-CoV-2 antibodies generated in response to infection.

Abstract: Diagnostic immunoassay reagent compositions are disclosed that include liposomes having analyte-specific binding element(s) associated therewith. In particular, the analyte-specific binding element(s) includes a transmembrane domain that anchors the element(s) in the lipid bilayer of the liposome; the analyte-specific binding element(s) further includes an extracellular/extra membrane domain that is exposed on the outer surface of the liposome and that comprises a domain that specifically binds to the target analyte. Also disclosed are kits, devices, and systems that contain the diagnostic immunoassay reagent compositions, as well as methods of producing and using the diagnostic immunoassay reagent compositions.

Abstract: A method (400) and a system (200) for generating a chromatically modified image of one or more components on a microscopic slide (303) is disclosed. In one aspect of the invention, the method includes obtaining the image of the one or more components on the microscopic slide (303). Additionally, the method (400) includes processing the image to identify the one or more components. The method (400) further includes segmenting at least one part of the one or more components identified from the image. Furthermore, the method (400) includes chromatically modifying the at least one part of the one or more components and generating a chromatically modified image of the one or more components.

Abstract: A method of characterizing a specimen to be analyzed in an automated diagnostic analysis system provides an HILN classification (hemolysis, icterus, lipemia, normal) of the specimen along with a basis for that determination. The method includes assigning a hash code to each training image of a sample specimen used in the characterization training process. In response to an HILN determination for a test specimen, the method can retrieve via the hash code one or more of the closest matching training images upon which the HILN classification is based. The one or more of the closest matching training images can be displayed alongside of the one or more images of the test specimen. Quality check modules and systems configured to carry out the method are also described, as are other aspects.

Abstract: An acoustophoresis device having a sample vessel and a piezo transducer is described. The sample vessel has an outer surface, a microchannel within 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, such that a blood sample is insertable through the first port into the microchannel. The sample vessel has conductive traces on the outer surface. The piezo transducer is bonded to the outer surface of the sample vessel to form a monolithic structure. The piezo transducer contacts at least one of the conductive traces, the piezo transducer is configured to generate ultrasonic waves inside a sample in the microchannel. The piezo transducer has an excitation signal input and response signal output electrically connected to the at least one of the conductive traces.

Abstract: Hydrophilic, high quantum yield, chemiluminescent acridinium compounds with increased light output, improved stability, fast light emission and decreased non specific binding are disclosed. The chemiluminescent acridinium esters possess hydrophilic, branched, electron-donating functional groups at the C2 and/or C7 positions of the acridinium nucleus.

Abstract: Embodiments provide a tube retainer system, including: an outer body; a diaphragm having a circular opening; a valve including a valve head and a valve stem attached to the valve head; a cam; a camshaft extending through the cam; a drive gear attached to the camshaft; a restraint gear attached to the camshaft; a push bar located below the diaphragm; and a pawl. The diaphragm, the cam, the drive gear, the restraint gear, the push bar, and the pawl are all provided in the outer body, when a bottom of a tube is inserted into the circular opening and a downward pressure is applied on the diaphragm, the cam is oriented to close the valve to form a partial vacuum in the outer body to secure the bottom of the tube within the circular opening.

Abstract: The present invention provides compounds used in the synthesis of chemiluminescent acridinium compounds and methods of producing these compounds. Specifically, methods are provided for the N-alkylation of acridan compounds using alkylating reagents. Typically, these alkylating reagents comprise a protected sulfonate group protected with an acid-labile protecting group.

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: The present disclosure relates to a device comprising a container having an inner wall and at least one opening, containing a mixture containing at least one reagent, and at least one additive, a method of producing this device, and a method of extracting a substance from a sample, enriching a substance in a sample, and/or detecting a substance in a sample using the device.

Abstract: A sample probe system has a sample probe assembly, an air supply assembly, and a control system. The sample probe assembly has a transducer and a sample probe. The air supply assembly has a piezoelectric pump configured to supply an air flow to the sample probe assembly such that the air flow exits the sample probe. The control system determines a relative location of the sample probe based on pressure changes in the air flow detected by the transducer.

Abstract: Disclosed herein are compositions and methods for removing interfering substances from biological samples, biochemical assays, or reagents used in biological samples using porous liposomes that capture and in some instances enrich said interfering substances within the liposomes.

Abstract: The present invention relates to methods and compositions to remove or reduce biotin interference from certain assays.

Abstract: A method of patient-centric load planning for a diagnostic laboratory having a plurality of instruments includes receiving a list of patient samples, a list of requested tests to be performed for each of the patient samples, and patient-centric information for the patient providing each patient sample. The received data is used to determine a load plan for the instruments, the load plan including a menu of selected tests assigned to each instrument and an ordering of patient samples according to a priority score based on at least a portion of the electronic health record (EHR) of the patient providing the patient sample. A system for patient-centric load planning includes a plurality of instruments controlled by a system controller and computer server to formulate and execute the load plan.

Abstract: A calibration method is provided including identifying the imaging area on each light panel with respect to each imaging device. A center position of the imaging area of each light panel for each imaging device is determined. An optimal optical center of the imaging apparatus using the center position of the imaging area of each imaging device is determined. A tube calibration tool is installed in a carrier on a track, and the carrier is moved on the track so that a center of the tube calibration tool is located at a closest location to the optimal optical center of the imaging apparatus. The center of the tube calibration tool is used to determine a center of a region of interest (ROI) for backlight calibration. Methods for health checking the calibration and apparatus used to carry out the calibration are provided as well as other aspects.

Abstract: Embodiments provide a method of using image-based tube top circle detection based on multiple candidate selection to localize the tube top circle region in input images. According to embodiments provided herein, the multi-candidate selection enhances the robustness of tube circle detection by making use of multiple views of the same tube to improve the robustness of tube top circle detection. With multiple candidates extracted from images under different viewpoints of the same tube, the multi-candidate selection algorithm selects an optimal combination among the candidates and provides more precise measurement of tube characteristics. This information is invaluable in an IVD environment in which a sample handler is processing the tubes and moving the tubes to analyzers for testing and analysis.