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: 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: 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: 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: 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: 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 system and method for a multi-function remote ambulatory cardiac monitoring system. The system includes a housing and a microprocessor disposed within the housing. The microprocessor controls the remote ambulatory cardiac monitoring system. The system also includes an electrode for sensing ECG signals and the electrode being in communication with the microprocessor. An integrated cellular module also is included in the system, and the cellular module is connected to the microprocessor and disposed within the housing. The integrated cellular module transmits ECG signals to a remote center.

Abstract: Systems and methods are disclosed herein for adjusting flash intensity based on retinal pigmentation. In an embodiment, a processor determines a retinal pigmentation of a retina of an eye positioned at an imaging device. The processor commands the imaging device to adjust an intensity of a flash component from a first intensity to a second intensity based on the retinal pigmentation. The processor commands the imaging device to capture an image that is lit by the flash component at the second intensity, and receives the image from the imaging device.

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: Techniques for administering a care plan for a patient. A monitoring device is selected, at a care plan management system based on a care plan, to use in administering the care plan. The care plan specifies biometric data to monitor for a patient. The monitoring device is configured to collect the biometric data, based on the care plan. The biometric data collected using the monitoring device is received at the care plan management system. The biometric data includes a first event initially classified as a first type of event using the monitoring device. The first event is selected for reclassification, based on the initial classification, and in response the first event is reclassified as a second type of event using the care plan management system. The patient is treated based on the care plan and the reclassified first event.

Abstract: A machine learning system and method for somatic mutation discovery are provided that provides improved identification of tumor-specific mutations. The improved identification of tumor-specific mutations may affect discovery of alterations and therapeutic management of cancer patients.

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: The present invention, in some embodiments thereof, generally relates to methods and devices for determining the health status of a subject, e.g., whether the subject has a disease or other condition. In some embodiments, a plurality or mixture of species may be differentially solubilized in a single two-phase aqueous system, or other multi-phase aqueous system. The nature or degree of the solubilization of the species may be used to determine the health status of a subject. For example, some embodiments are directed to devices and methods for determining a disease or other condition as a function of the changes to the structure of two or more species. The species may be selected based on their differential solubility behavior in a two-phase or other multi-phase aqueous system.

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: 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 system for recording, storing and processing diagnostic information, including: a computer implementing a computer-readable media including digital data and ground truth; a registry constructed and arranged to store and associate transactions or accesses on the data; and a machine learning system that considers each learning step modification a microtransaction for the data used in that step and which is recorded in the transaction registry. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

Abstract: An insertable cardiac monitor (ICM) with induction-based recharging capabilities and a transmitting coil for recharging the same are disclosed. The length of the monitoring performed by the ICM is extended and the functionality of the ICM enhanced, by including an internal energy harvesting module that allows for charging the ICM at a high speed without burning the patient or overheating components of the ICM. Internally, the energy harvesting module includes at least two overlapping receiving coils that are spaced to be orthogonal to each other and that have a tilt angle of substantially 45°. Such overlapping wire combination allows to minimize mutual inductance of the solenoid coils and increase the rate at which energy can be provided to the energy harvesting module. Further, the rate at which the energy is transmitted from the outside can be increased by defining in a transmitting coil a substantially triangular gap.