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: 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: 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.

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: 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: 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: Disclosed are optical interrogation apparatus that can produce lens-free images using an optoelectronic sensor array to generate a holographic image of sample objects, such as microorganisms in a sample. Also disclosed are methods of detecting and/or identifying microorganisms in a biological sample, such as microorganisms present in low levels. Also disclosed are methods of using systems to detect microorganisms in a biological sample, such as microorganisms present in low levels. In addition or as an alternative, the methods of using systems may identify microorganisms present in a sample and/or determine antimicrobial susceptibility of such microorganisms.

Abstract: Presented herein are systems and methods that provide for improved computer aided display and analysis of nuclear medicine images. In particular, in certain embodiments, the systems and methods described herein provide improvements to several image processing steps used for automated analysis of bone scan images for assessing cancer status of a patient. For example, improved approaches for image segmentation, hotspot detection, automated classification of hotspots as representing metastases, and computation of risk indices such as bone scan index (BSI) values are provided.

Abstract: The present invention relates to a method and/or device for improving the separation behaviors and performance of aqueous two-phase system (ATPS) for the isolation and/or concentration of one or more target analytes from a sample. In one embodiment, the present method and device comprise ATPS components within a porous material and one or more phase separation behavior modifying agents that improve the separation behavior and performance characteristics of ATPS, including but not limited to the increasing the stability or reducing fluctuations of ATPS thought the adjustment of total volume of a sample solution that undergoes phase separation, volume ratio of the two phases of the ATPS, fluid flow rates, and concentrations of ATPS components.

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.

Abstract: A system and method are provided for collection and testing of a biologic sample. The system and method comprise collecting by a user of a testing device a biologic sample for use with the testing device, assigning correlative values as test results, and receiving the test results at a server disposed on a network. Some aspects further include presenting advertisements and other messages to users through a mobile application operating on a mobile device. These aspects take into account the results of the self-diagnostic test and present different advertisements to the user based on the results of the test.

Abstract: A lateral-flow assay device includes a substrate having a sample addition zone and a wash addition zone downstream thereof along a fluid flow path through which a sample flows. The fluid flow path is configured to receive a wash fluid in the wash addition zone. A hydrophilic surface is arranged in the wash addition zone. Flow constriction(s) are spaced apart from the fluid flow path and arranged to define, with the hydrophilic surface, a reservoir configured to retain the wash fluid by formation of a meniscus between the hydrophilic surface and the flow constriction(s). The fluid flow path draws the wash fluid from the reservoir by capillary pressure. Apparatus for analyzing a fluidic sample and methods of displacing a fluidic sample in a fluid flow path of an assay device are also described.

Abstract: A method, device and system for enhancing image quality of an image is provided. In one aspect, the method includes illuminating a sample with a light source associated with an imaging device. Further, the method includes simulating a transmission wave at a sensor plane of the imaging device for a light wave from illuminating the sample. Additionally, the method includes determining a phase and amplitude information associated with the light wave based on the transmission wave. The method also includes determining at least one microscope transfer function associated with the imaging device based on the phase and amplitude information. Furthermore, the method includes generating a modified mi-croscope transfer function using a Zernike function based on the at least one microscope transfer function in an iterative procedure and enhancing the image quality associated with the im-age using the modified microscope transfer function.

Abstract: Aspects of the present disclosure relate generally to methods, compositions, and kits for in situ whole cell or single cell barcoding. Aspects of the present disclosure also include a computer readable-medium and a processor to carry out the steps of the method described herein. In some embodiments, the disclosure relates to whole cell or single cell barcoding performed in situ.