Abstract: A pathogen detection device is provided. The pathogen detection device may include a pathogen detector circuit configured to detect a target analyte in a patient sample, determine the presence of a pathogen from the target analyte, and generate a detection result including the identity of the pathogen and resistance genes (if any); and a decision support generator circuit configured to generate decision support information for the pathogen by application of user configurable rules to the detection result, wherein each of the configurable rules include a logic expression that indicates the corresponding decision support information of the rule to be included in the detection report.

Abstract: A method for measuring hemoglobin concentration in a whole blood sample is disclosed. The method may include mixing a whole blood sample with a lysing agent, followed by manual agitation, flowing the whole blood or mixture into a reservoir of a sensor, the sensor comprising a transparent portion configured to allow an optical measurement of an absorbance or reflectance of the whole blood sample in the reservoir of the sensor; detecting, using an analyzer into which at least a portion of the sensor has been inserted, the whole blood sample in the reservoir of the sensor; upon detecting the liquid whole blood sample in the reservoir, optically measuring an absorbance or reflectance of the whole blood sample using a light source and a detector in the analyzer; and determining a concentration of hemoglobin in the whole blood sample based on the measured absorbance or reflectance and a calibration curve that relates the absorbance or reflectance to the concentration of hemoglobin in the whole blood sample.

Abstract: M-CSF-specific RX1-based or RX-1 derived antibodies are provided, along with pharmaceutical compositions containing such antibody, kits containing a pharmaceutical composition, and methods of preventing and treating bone loss in a subject afflicted with an osteolytic disease.

Abstract: A model-based method of determining characteristics of a specimen container cap to identify the container cap. The method includes providing a specimen container including a container cap; capturing backlit images of the container cap taken at different exposures lengths and using a plurality of different nominal wavelengths; selecting optimally-exposed pixels from the images at different exposure lengths at each nominal wavelength to generate optimally-exposed image data for each nominal wavelength; classifying the optimally-exposed pixels as at least being one of a tube, a label or a cap; and identifying a shape of the container cap based upon the optimally-exposed pixels classified as being the cap and the image data for each nominal wavelength. Quality check modules and specimen testing apparatus adapted to carry out the method are described, as are numerous other aspects.

Abstract: A method for calibrating an imager of a reagent analyzer, comprises positioning a dry reagent pad at a first read position in a field of view of the imager, the first read position illuminated by an illumination source with a first intensity, detecting a reference optical signal by the imager, indicative of a first reflectance value of the dry reagent pad at the first read position, positioning the dry reagent pad at a second read position, the second read position illuminated with a second intensity different from the first intensity, detecting a first optical signal by the imager, indicative of a second reflectance value of the dry reagent pad at the second read position, and calculating, by a processor, a calibration factor for the dry reagent pad at the second read position based on a difference between the reference optical signal and the first optical signal.

Abstract: Disclosed are methods of measuring moisture. Specifically, methods of measuring moisture on dry or nearly dry surfaces using an electrochemical sensor are disclosed. The method comprises applying a coating comprising an electrolyte to an electrode wherein water in the air can permeate the coating, applying a voltage to the electrode, detecting a current and, determining if the current indicates the presence of moisture. As a voltage is applied, oxygen in the water is reduced and produces a measurable signal. The method includes measuring the amount of or decrease of dissolved oxygen (in the form of water) at the surface of the electrode over time. Reduction of oxygen acts as a surrogate for water/moisture and, as such, the dryness of the surface of the electrode is calculated based on a predetermined relationship between current and dissolved oxygen (in the form of water).

Abstract: The present invention provides processes for determining accurate risk probabilities for chromosome dosage abnormalities. Specifically, the invention provides non-invasive evaluation of genomic variations through chromosome-selective sequencing and non-host fraction data analysis of maternal samples.

Abstract: The invention refers to a method of detecting one or more deoxyribose nucleotide (e.g. DNA) template(s) in a heterogenous sample by generation of template specific surrogate nucleotide sequences. This invention is applied to but not restricted in detecting genetic variations including cancer markers and pathogens.

Abstract: Provided herein are methods, compositions, and kits for diagnosing allograft rejection of organ transplants by identifying the presence of anti-endothelial cell antibodies. Such methods and compositions are independent of external confounders such as recipient age, transplant center, assay, cause of end-stage disease, co-morbidities, immunosuppression usage, and the like.

Abstract: A method of characterizing a serum or plasma portion of a specimen in a specimen container includes capturing a plurality of images of the specimen container from multiple viewpoints, stacking the multiple viewpoint images along a channel dimension into a single stacked input, and processing the stacked input with a single deep convolutional neural network (SDNN). The SDNN includes a segmentation convolutional neural network that receives the stacked input and outputs multiple label maps simultaneously. The SDNN also includes a classification convolutional neural network that processes the multiple label maps and outputs an HILN determination (Hemolysis, Icterus, and/or Lipemia, or Normal) of the serum or plasma portion of the specimen. Quality check modules and testing apparatus configured to carry out the method are also described, as are other aspects.

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 lipophilcity 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: Automated diagnostic analysis apparatus for analyzing patient specimens may include a probe to aspirate and dispense a bio-liquid. A probe tip on the probe may require replacement after contact with each bio-liquid. The automated diagnostic analysis apparatus may include a probe tip eject device and a waste chute for controlled removal and disposal of the probe tip to mitigate splattering or splashing of any residual bio-liquid in the probe tip as it is removed from the probe. A sloped ramp in the probe tip eject device may engage and remove the probe tip as it rotates through the probe tip eject device. The waste chute may include guides to transfer a removed probe tip directly into a waste bin without any surface contact by the probe tip. Methods of removing and disposing of a probe tip in an automated diagnostic analysis apparatus are described, as are other aspects.

Abstract: Methods of treating a subject having a cardiovascular disease, selecting a therapy for a subject having a cardiovascular disease, identifying a subject having a cardiovascular disease that will benefit or not benefit from exercise therapy, determining whether a subject having a cardiovascular disease should begin, continue, not begin, discontinue, or avoid exercise therapy, determining whether a subject having a cardiovascular disease should continue, discontinue, or avoid exercise therapy, reducing the risk of an adverse outcome (e.g., death) in a subject having a cardiovascular disease, and predicting the efficacy of exercise therapy in a subject having a cardiovascular disease. These methods include determining a level of soluble ST2 in a subject.

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, methods, and kits for detecting at least two analytes present within a small volume single fluid sample obtained from patient for the creation of a multiplexed panel of the various analytes present within the single fluid sample are disclosed.

Abstract: Devices, kits, and methods for conducting a plurality of diagnostic assays on a patient's single liquid test sample within a single reaction cassette.

Abstract: A method of characterizing a specimen for HILN (H, I, and/or L, or N). The method includes capturing images of the specimen at multiple different viewpoints, processing the images to provide segmentation information for each viewpoint, generating a semantic map from the segmentation information, selecting a synthetic viewpoint, identifying front view semantic data and back view semantic data for the synthetic viewpoint, and determining HILN of the serum or plasma portion based on the front view semantic data with an HILN classifier, while taking into account back view semantic data. Testing apparatus and quality check modules adapted to carry out the method are described, as are other aspects.

Abstract: Asset data is collected from one or more asset managers and stored in a known asset database. The known asset database enables tracking and maintenance of assets associated with each asset manager. One or more field technicians may also be associated with assets in the known asset database. A field technician is provided with access to a field asset management application on a mobile device, which allows the field technician to provide data associated with asset samples. Asset sample data is then correlated with asset data. Once an asset sample has been correlated with an asset, a field technician or other party is presented with an interface through an asset management application, allowing the party to place one or more requests for tests to be performed on one or more asset samples. Once the one or more tests are performed, test results data is provided.

Abstract: A centrifugal cartridge or disk used for extraction of light supernatant fractions from fluid samples is described, particularly for non-homogenous fluid biological samples such as whole blood. The device may be used to collect cell-free blood plasma or a fraction of whole blood containing target cells such as leukocytes. Single or multiple channels are described, including channels with passive valves, gaskets, receiving cavities, inlet holes, capillary wicking ridges, distal cavities for cell retention, separator gel, and density medium. Centrifugal action causes whole blood in a receiving cavity to pass into one or more channels where it separates into blood cells, plasma and optionally fractions of an intermediate density. After spin, the plasma returns to the receiving cavity by way of the one or more channels for extraction through the inlet hole or other inwardly located hole.

Abstract: Apparatus configured to control chamber pressure during pipette rinsing having lower pressure recovery time. Pressure control apparatus includes pipettes to dispense liquid, a manifold chamber to supply liquid to the pipettes, a flow control valve in each flow path, a pump to supply the liquid, a pressure sensor to provide measured pressure, and a flow controller, which in a calibration mode, decreases a pump drive setting if measured pressure is high, increases the setting if measured pressure is low, and stores the pump drive setting for the individual combined operational state if the pressure is within predetermined pressure threshold limits, or in a testing mode, determines if the measured pressure is within the threshold limits for a previously-commanded state combination, and adjusts the pump drive setting if not within the threshold limits for a next time. Methods for operating pressure control apparatus are described, as are other aspects.