Abstract: A method of characterizing a specimen to be analyzed in an automated diagnostic analysis system provides a segmentation determination and/or an HILN (hemolysis, icterus, lipemia, normal) determination of the specimen while providing characterization training updates based on the accuracy and/or confidence in the determinations. The method includes identifying an incorrect or low confidence segmentation or HILN determination, forwarding the incorrect or low confidence determination from the HILN network to a database, and providing one or more training images to the HILN network based on the incorrect or low confidence determination. Quality check modules and systems configured to carry out the method are also described, as are other aspects.

Abstract: Reagents, kits, and microfluidics devices are disclosed for detecting the presence and/or concentration of antibodies directed to microorganisms in human biological samples. Also disclosed are methods of production and use of the reagents, kits, and microfluidics devices. Anti-human immunoglobulin antibodies are utilized as a reagent in a bridging immunoassay for detection of the microorganisms.

Abstract: A method of characterizing a specimen and specimen container to be analyzed in an automated diagnostic analysis system. The method can provide a segmentation determination and/or an HILN determination (hemolysis, icterus, lipemia, or normal) of the specimen while protecting patient information. The method includes capturing an image of a specimen container via an image capture device, identifying a label affixed to the specimen container in the captured image via an anonymization network, and editing the captured image via the anonymization network to mask some or all information present in the label so that it is removed from the captured image. Quality check modules and systems configured to carry out the method are also described, as are other aspects.

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: The present disclosure relates to oligonucleotide sequences for amplification primers and their use in performing nucleic acid amplifications of HCV, in particular regions that encode the NS3 polypeptide. In some embodiments the primers are used in nested PCR methods for the detection or sequencing of HCV NS3. The oligonucleotide sequences are also provided assembled as kits that can be used to amplify and detect or sequence HCV NS3.

Abstract: Methods are disclosed for a sandwich assay for a small molecule having a molecular weight of about 500 to about 2,500. The method comprises the use of a first antibody that binds to the small molecule and a second antibody that binds to the small molecule at a portion of the small molecule other than a portion to which the first antibody binds. The second antibody is prepared from an immunogen that comprises a hapten that is not the small molecule or a derivative of the small molecule wherein the hapten comprises a moiety that is structurally similar to that of the second portion of the small molecule. The antibodies may be employed in sandwich assays for the small molecule.

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 heath checking the calibration and apparatus used to carry out the calibration are provided as well as other aspects.

Abstract: A status visualization method of a diagnostic laboratory system. The status visualization method includes receiving, at a system controller, computer-readable data comprising analyzers included within the diagnostic laboratory system, and test demand for types of tests and number of the tests to be performed on samples by the analyzers, wherein the analyzers each include consumable items and maintenance items. The method further includes determining, via a walk-away time estimation module executing on the system controller, an estimated walk-away time for the analyzers based upon the test demand and status of the consumable items and maintenance items. Diagnostic laboratory systems with walk-away time estimation are disclosed, as are other aspects.

Abstract: A method and a device for determining a concentration of one or more analytes in a whole blood sample is disclosed. In one aspect of the invention, the method includes introducing the sample in a channel. The method further includes generating a cell-free plasma region in the channel, wherein the cell-free plasma region is generated in the channel based on rouleaux effect. 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: Devices, kits, and methods related to embodiments of an improved liquid test sample injection device comprising a sample mixture that comprises at least one sample flag compound for detecting the presence or non-presence of a patient's liquid test sample upon being interrogated by a pre-determined wavelength of light.

Abstract: The present invention relates to the methods and products for detection of colorectal cancer. Additionally, the present invention relates to methods and products for determining the probability, risk or incidence of colorectal cancer and of colorectal cancer metastasis. The products and methods of the present invention include detecting the level of expression of COL10A1 or MMP11, in combination, from samples, including tissue samples, from humans who currently have been diagnosed with cancer or who were previously diagnosed with cancer and those who are thought to have cancer and are undergoing diagnosis.

Abstract: A method of aligning a component to a structure in a diagnostic laboratory system. The method includes aligning a position sensor to the structure; sensing a position of the component using the position sensor; and calculating the position of the component relative to the structure based at least in part on the sensing. Other methods, apparatus, and systems are disclosed.

Abstract: A method of determining a 3D center location of a specimen container on a track. The method includes providing a calibration object on the track; providing an initially calibrated image capture device adjacent to the track; moving the calibration object to at least two different longitudinal positions along the track; capturing a first image with the calibration object located at the first longitudinal position; capturing a second image with the calibration object located at the second longitudinal position; and determining a three-dimensional path trajectory of a center location along the track based at least upon the first image and the second image. The method can be used to determine a 3D center location of a specimen container imaged anywhere within a viewing area. Characterization apparatus and specimen testing apparatus adapted to carry out the methods are described, as are other aspects.

Abstract: The present disclosure includes compounds, kits, and assay procedures for use in determining the levels of certain types of drugs in samples that contain specific binding proteins for the drugs. The present disclosure includes analog compounds useful for displacing the drugs from their endogenous binding proteins, and kits including same, as well as methods that utilize these displacers as binding competitors in pharmaceutical assays.

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: Apparatus for robotic arm alignment in an automated sample analysis system includes a robotic arm, a sample tube carrier, a plurality of optical components (including, e.g., one or more cameras), and a controller. The controller is operative to process images received from the optical components to determine a first set of coordinates of a first marker relative to the sample tube carrier and determine a second set of coordinates of a second marker relative to the robotic arm. The controller is further operative to adjust the position of the robotic arm and/or the sample tube carrier in response to an excessive offset between the first and second sets of coordinates. In some embodiments, a positioning tool includes the first and second markers thereon. Methods of robotic arm alignment with a sample tube carrier in an automated sample analysis system are also provided, as are other aspects.

Abstract: Methods of predicting a fault in a diagnostic laboratory system include providing one or more sensors; generating data using the one or more sensors; inputting the data into an artificial intelligence algorithm, the artificial intelligence algorithm configured to predict at least one fault in the diagnostic laboratory system in response to the data; and predicting at least one fault in the diagnostic laboratory system using the artificial intelligence algorithm. Other methods, systems, and apparatus are also disclosed.

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: 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: Systems and methods for determining an evaluation of one or more patients is provided. User input for evaluating one or more patients is received. A commit bundle is retrieved from a commit database. An evaluation of the one or more patients is determined based on the user input using a medical ontology configured with the retrieved commit bundle. The medical ontology is separate from the commit database. Results of the evaluation of the one or more patients are output.