Abstract: A method and biological sample analyzer is described that adjusts airflow within a housing based upon altitude. A first volume of air is moved by at least one fan within a housing of a biological sample analyzer. A temperature of the first volume of air is measured within the biological sample analyzer with a temperature sensor within the housing of the biological sample. Power output of at least one heater positioned within the housing of the biological sample analyzer is measured. The measured power output of the at least one heater is analyzed at the measured temperature within the biological sample analyzer. And, the fan is adjusted to move a second volume of air different from the first volume of air by comparing the measured power output of the at least one heater and expected power output of the at least one heater.

Abstract: Non-limiting embodiments of a methodology of validating accuracy and precision determinations of a new urine sediment analyzer, and method(s) related thereto.

Abstract: Systems and methods include an optimization-based load planning module for laboratory analyzers of bio-fluid samples. The optimization-based load planning module is executable on a computer server and is configured to optimize assay (lab test) assignments across a large number of laboratory analyzers based on one or more of the following user selected and weighted objectives: reduced turn-around-time, load balancing, efficient reagent usage, lower quality assurance costs, and/or improved system robustness. The optimization-based load planning module outputs a load plan comprising computer executable instructions configured to cause a system controller of a laboratory analyzer system to schedule and direct each requested test to be performed at one or more selected laboratory analyzers of the laboratory analyzer system in accordance with the user selected and weighted objectives. Other aspects are also described.

Abstract: A device and method for separating serum or plasma from blood cells in a whole blood specimen. The present invention uses a cap with a reservoir, such that blood cells are packed into the cap when the specimen container is centrifuged. When the cap is removed, the blood cells are also removed, and the serum or plasma is left in the specimen tube where it can be readily extracted by a pipette which is able to reach all the way to the bottom of the specimen tube minimizing the dead volume.

Abstract: An implantable medical device is disclosed. A housing includes a hollow body forming a first electrode on an outer surface with end caps affixed to opposite ends, one end cap forming a second electrode. A microcontroller circuit is provided and includes a microcontroller operable under program instructions stored within a non-volatile memory device. An analog front end is interfaced to the electrodes to sense electrocardiographic signals. A transceiver circuit is operable to wirelessly communicate with an external data device. The program instructions define instructions to continuously sample the electrocardiographic signals into the non-volatile memory device and to offload the non-volatile memory device to the external data device. A receiving coil and a charging circuit are operable to charge an onboard power source for the microcontroller circuit.

Abstract: A lysis device including a sample vessel, at least one piezo element, and a controller is disclosed. The sample vessel has a microchannel formed therein. The sample vessel has at least one port extending through a surface to the microchannel. The piezo element is attached to the surface of the sample vessel. The controller has logic to cause the controller to emit a first signal including a series of frequencies to the at least one piezo element to cause the at least one piezo element to generate ultrasonic acoustic standing waves in the sample vessel, to receive a second signal indicative of measured vibration signals from the sample vessel detected by the at least one piezo element, and to determine a resonant frequency of the sample vessel using the measured vibration signals.

Abstract: Compositions and methods of treating COVID-19 are disclosed. The compositions comprise heparin and/or one or more other negatively charged molecules.

Abstract: Analytical assay reaction cartridges are disclosed that include a reagent tray containing a liquid reagent disposed therein and a flexible cover removably attached thereto. The flexible cover has a portion that extends beyond the reagent tray and that forms a tab portion extends through an opening in a lid member of the cartridge in order to facilitate removal of at least a portion of the cover and release of the liquid reagent. Also disclosed are analytical assay reaction kits that include the cartridges and diagnostic instruments for use with the analytical assay reaction cartridges/kits, as well as methods of making and using the cartridges/kits.

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: A method for using saliva to measure at least one substance or physiological parameter of a human or animal subject may involve inserting a first end of a sensor into a handheld saliva testing device. The method may also involve receiving saliva from the subject on a second end of the sensor, moving the saliva from the second end of the sensor to the first end, and processing the saliva with the handheld saliva testing device to provide initial saliva data related to the at least one substance or physiological parameter of the subject. In some embodiments, the sensor remains inserted in the handheld device while the subject deposits saliva on the opposite, free end of the sensor.

Abstract: Methods and apparatus for rapid and accurate detection of nucleic acid in a single reaction chamber are provided. In one aspect, a patient specimen suspected of comprising a first nucleic acid is used to form a crude lysate which is combined with an infrared absorbing material, a detecting nucleic acid, and at least one reporter molecule in the single reaction chamber and heated by irradiating the reaction mixture with infrared light. Another aspect is directed to an apparatus for detecting a presence or absence of a plurality of different molecules within a reaction container. The apparatus comprises an infrared light source aimed to illuminate contents of the reaction container; an excitation light source positioned to illuminate contents of the reaction container; and a spectrometer positioned to detect emission light emanating from the reaction container.

Abstract: Analytical assay reaction cartridges, kits containing same, and methods of production and use thereof are disclosed. These cartridges include a magnetic assembly that surrounds at least a portion of a sample read window on the cartridge. The cartridge also includes an analytical reagent positioned therewithin, wherein the analytical reagent comprises magnetic beads coated with at least one anti-red blood cell antibody.

Abstract: Embodiments provide a fluid metering device, including: a first fluid supply port for receiving a first fluid; a first fluid dispense port for dispensing the first fluid; a second fluid supply port for receiving a second fluid; a second fluid dispense port for dispensing the second fluid; a waste discharge port for discharging a mixture of the first fluid and the second fluid; a valve assembly including a plurality of valves; a manifold connected to the metering pump, wherein the manifold includes a plurality of fluid channels, and the manifold is used for communicating between the valve assembly and each port; a first tube connected between the second valve and the third valve for accommodating the mixture or the first fluid; and a second tube connected between the third valve and the fourth valve for accommodating the second fluid.

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 system and method for remote ECG data streaming in real-time is provided. A continuous connection is established between a cloud-based server and a physiological monitor. The physiological monitor includes at least two electrodes and is affixed to a chest of a patient or implanted within the patient. ECG data is collected via one or more of the electrodes and encrypted via a wireless interface on the physiological monitor using a secret key stored on the physiological monitor. The encrypted ECG data is transmitted from the cloud-based server and received on a computing device in real-time.

Abstract: The present disclosure relates to methods of enzymatic treatment of double-stranded PCR amplified products for eliminating or minimizing primer-dimers in multiplex PCR reactions and for the efficient ligation of adapters. The present disclosure relates to methods and compositions that allow more efficient highly multiplex target amplification compared to conventional methods, compositions and kits by minimizing laboratory steps, eliminating primer-dimers and increasing the efficiency of adapter ligation. The disclosed methods use multiple target-specific primers for specific and selective amplification of targets in a subject's genome. The disclosed methods can be used for numerous downstream procedures and analysis, including DNA sequencing.

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 test element for an assay includes: a cartridge having a housing which includes a priming pad capable of containing a liquid fluid, a wash port having an opening in the housing, and an opening for directly or indirectly applying a sample; and an assay device positioned within the cartridge in fluid communication with the wash port containing an analytical reagent.

Abstract: A noise-separating cardiac monitor is provided. An implantable housing includes an external surface. A wireless antenna is shaped to wrap around an interior periphery of the implantable housing. Electrodes are provided on a ventral surface of the implantable housing to capture P-wave signals and R-wave signals. Electronic circuitry is provided within the wearable housing and includes a low power microcontroller. A front end circuit includes a signal lead operable to sense cardiac electrical potentials through one of the electrodes, a reference lead operable to sense the cardiac electrical potentials through another electrode, and a reference generator configured to inject a driven reference to the reference lead. The signal lead includes a coupling capacitor and a protection resistor associated with thermal noise. The thermal noise is not contained in the driven reference and not introduced to the reference lead. A non-volatile memory is electrically interfaced with the microcontroller.