Abstract: Methods of detecting and flagging and/or suppressing aberrant results caused by incomplete dispersion of an immunoassay reagent used in a turbidimetric immunoassay are disclosed.

Abstract: Devices and methods for calculating various coagulation characteristics associated with a patients liquid test sample. The presently disclosed and claimed inventive concept(s) relate to an improved device(s) and method(s) for conducting coagulation assays on a patients liquid test sample, including, without limitation, a patients whole blood sample.

Abstract: An image analysis device (BA) is configured to recognize imaged objects. A plurality of training images (TPIC) assigned to an object type (OT) and an object sub-type (OST) are fed into a first neural network module (CNN) to detect image features. Training output data sets (FEA) of the first neural network module are fed into a second neural network module (MLP) to detect object types using the detected image features. For each object type: training images assigned to the object type (OT1, OT2) are fed into the trained first neural network module, the first neural network module training output data set (FEA1, FEA2) generated for the respective training image is assigned to the object sub-type (OST) of the respective training image, and by means of the aforementioned sub-type assignments, a sub-type detection module (BMLP1, BMLP2) is configured to detect object sub-types.

Abstract: A medical diagnosis assistance system, a medical diagnosis assistance method, and a training method for training an artificial intelligence entity are disclosed. The medical diagnosis assistance system includes: an input interface configured to receive medical image data of a patient; a computing device configured to implement: a classification module configured to classify parts of interest, POI, comprising objects of interest, OOI, and/or regions of interest, ROI, within the received medical image data, and to assign a corresponding reliability metric to each of the classified POI; and an analysis module configured to determine, based on the POI and the assigned reliability metric, an analysis of the medical image data; and an output interface configured to output an output signal indicating the analysis.

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: A point of care system is provided that includes an instrument data manager (IDM) configured to communicate with a diagnostic engine and to (1) obtain identification (ID) information of a patient for which a test is to be performed; (2) obtain ID information of a diagnostic consumable to be used to collect a sample from the patient; (3) link the obtained patient ID information with the obtained diagnostic consumable ID information; and (4) restrict testing using the diagnostic engine by (a) prior to performing a test on a sample collected with a diagnostic consumable, determine ID information of the diagnostic consumable at the diagnostic engine; (b) determine whether the diagnostic consumable is linked with patient information within the IDM; and (c) if so, allow the diagnostic engine to perform a test on the sample collected with the diagnostic consumable. Numerous other embodiments are provided.

Abstract: Processes for quantifying an amount of functional groups immobilized on a solid support are described herein. The processes allow for determining whether sufficient functional groups are provided on a solid support for the attachment of a first binding pair member for the detection of a target analyte.

Abstract: A sample insertion apparatus enabling a sample to be inserted into a diagnostic analyzer in a hands-free manner. The sample insertion apparatus includes an insertion head having a coupler configured to couple to a sample container having an insertion member, an arm containing a sample probe positioned stationary relative to the arm, and a retraction assembly coupled to the insertion head and configured to cause the sample container to move towards the sample probe to insert the sample probe into the insertion member. Sample insertion and operating methods for hands-free insertion of a sample into a diagnostic analyzer are described, as are other aspects.

Abstract: Diagnostic laboratory systems, methods of operating diagnostic laboratory systems, and methods of updating diagnostic laboratory systems are disclosed. A method of operating a diagnostic laboratory system includes identifying data in the system as identified data: identifying change in a data distribution of the identified data; aggregating data instances pertaining to the change in the data distribution; selecting a subset of the aggregated data to update a processing algorithm in the system; and updating the processing algorithm using the subset of the aggregated data. Other systems and methods are disclosed.

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: A sensor assembly for a bodily fluid analyzer includes a reference electrode container containing a reference electrode, a membrane capable or configured to be in fluid communication with the reference electrode container; and a wicking member capable or configured to be in fluid communication with the reference electrode container. The wicking member is configured to draw a reference fluid contained in the reference electrode container towards the membrane when the membrane and the wicking member are exposed to the reference fluid.

Abstract: The present disclosure provides methods and kits for identifying and treating individuals at risk of or suffering from amyloid transthyretin cardiomyopathy. In general, detection or measurement of one or more biomarkers, such as TnI, PKM1, PKM2, NT-proBNP, RBP4, DCN, TIMP2, SMOC-2, NfL, or combinations thereof, assists in the identification of amyloid transthyretin cardiomyopathy. The present disclosure also provides methods for selecting patients for treatment of amyloid transthyretin cardiomyopathy, such as with transthyretin stabilizing agents.

Abstract: Kits containing a chemiluminescent detection system and microfluidics devices and methods for determining the concentration of biotin in a sample are disclosed. The kits, microfluidics devices, and methods utilize a sensitizer capable of generating singlet oxygen in its excited state and having avidin or an analog thereof directly or indirectly bound thereto, as well as a singlet oxygen-activatable chemiluminescent compound having biotin or an analog thereof directly or indirectly bound thereto.

Abstract: A wash station for use in a clinical analyzer of an in vitro diagnostics (IVD) environment for cleaning a probe comprises a basin, a vertically-elongated conduit, an inlet port, and a helix insert. The vertically-elongated conduit is attached to the interior of the basin. The inlet port is connected to a bottom portion of the basin. The inlet port is sized to receive and secure a wash feed line that propels a wash fluid upward through the vertically-elongated conduit. The helix insert is positioned within the vertically-elongated conduit and sized to allow insertion of the probe through a center portion of the helix insert for cleaning. The helix insert causes the wash fluid to flow in a helical shape around the probe as it is transported through the vertically-elongated conduit, thereby cleaning the probe.

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: An apparatus, vortex generator assembly and method for automated cell lysis and nucleic acid purification and processing. The vortex generator assembly includes sample holder having a lysis well, at least one wash well, and an elution well. The vortex generator assembly also includes a sample holder cover having a plurality of vibration rods for creating a vortex in the wells of the sample holder. The apparatus includes motor operating a rotating cam to cause the vibration rods to vibrate and create the vortex in a well holding fluid and magnetic beads, wherein the vortexing speed is sufficient to overcome the magnetic attraction between the beads and disperse the beads in solution, to collect nucleic acids such as DNA.

Abstract: A sensor assembly for analysis of physical parameters and chemical constituents of small volume samples of bodily fluids. Disclosed herein is a sensor panel with an upper surface and a lower surface and at least one analyte sensor located on the lower surface. The sensor assembly also includes an optional adhesive layer and a contoured fluid pathway cutout. The upper surface of the adhesive layer is secured to the lower surface of the sensor panel. The sensor assembly also includes a sensor cartridge base with a fluid inlet and outlet and a contoured fluid pathway extending between the inlet and the outlet. The contoured fluid pathway mirrors the shape and span of the contoured fluid pathway cutout of the adhesive layer. As a fluid sample is input at the fluid inlet, the fluid traverses along the fluid pathway in contact with the at least one analyte sensor.

Abstract: A human insulin-like growth factor (IGF) binding protein stock solution and method of making the same include a non-recombinant human IGF binding protein-3 (nr-IGFBP-3) in an aqueous buffered medium. The concentration of the nr-IGFBP-3 in the stock solution ranges from about 16 micrograms per milliliter (?g/ml) to about 40 ?g/ml. A kit includes a set of calibrators for nr-IGFBP-3. The set of calibrators includes the nr-IGFBP-3 in different concentrations.