Abstract: Methods of mitigating lipoprotein interference in in vitro diagnostic assays for target hydrophobic analytes are disclosed, as well as compositions, kits, and devices useful in said methods. A pretreatment reagent is utilized that includes at least one enzyme that digests lipoprotein.

Abstract: A computer-implemented method for detecting a failure of a device connected to a sensor is disclosed. The method includes a machine learning model receiving a trace signal from the sensor indicating a status of the device, the machine learning model encoding the trace signal into a plurality of vector representations, and the machine learning model determining whether the trace signal is valid or invalid based on the plurality of vector representations.

Abstract: An apparatus and method for removing bubbles from a fluid sample. The apparatus has a barrel and a filter member. The barrel has a first end, a second end, a sidewall, and an inner surface defining an internal chamber. The first side has an inlet opening and the second side has an outlet opening. The filter member is slidably disposed within the internal chamber and defines an inlet side and an outlet side of the internal chamber. The filter member has a gas-permeable, liquid-impermeable membrane which permits the gas portion of the fluid sample to pass across the filter member. The barrel has a second gas-permeable, liquid-impermeable membrane which provides a fluid-tight seal across the outlet opening.

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: Methods of real-time detection of short-sample aspiration faults in an automated diagnostic analysis system include spectral analysis of a pressure slope waveform based on aspiration pressure measurement signals. The spectral analysis may include using a moving average filter or a wavelet transform, such as, e.g., a continuous wavelet transform (CWT) or a discrete wavelet transform (DWT), to identify distinct transient behavior in the pressure slope waveform. These methods accurately identify short-sample aspiration faults such that an automated diagnostic analysis system can timely terminate an analysis of a detected short sample to avoid a possibly erroneous sample test result. Apparatus for real-time detection of short-sample aspiration faults is also provided, as are other aspects.

Abstract: An apparatus and method for removing bubbles from a fluid sample. The apparatus has a barrel and a filter member. The barrel has a first end, a second end, a sidewall, and an inner surface defining an internal chamber. The first side has an inlet opening and the second side has an outlet opening. The filter member is disposed within the internal chamber and defines an inlet side and an outlet side of the internal chamber. The filter member has a gas-permeable, liquid-impermeable membrane which permits the gas portion of the fluid sample to pass across the filter member from the inlet side to the outlet side. The gas-permeable, liquid-impermeable membrane provides a fluid-tight seal across the filter member. The filter member is pierceable so a probe may be passed through the filter member to withdraw the liquid portion of the fluid sample from the internal chamber.

Abstract: Embodiments provide a tube retainer system, including: an outer body; a diaphragm having a circular opening; a valve including a valve head and a valve stem attached to the valve head; a cam; a camshaft extending through the cam; a drive gear attached to the camshaft; a restraint gear attached to the camshaft; a push bar located below the diaphragm; and a pawl. The diaphragm, the cam, the drive gear, the restraint gear, the push bar, and the pawl are all provided in the outer body, when a bottom of a tube is inserted into the circular opening and a downward pressure is applied on the diaphragm, the cam is oriented to close the valve to form a partial vacuum in the outer body to secure the bottom of the tube within the circular opening.

Abstract: Improved analyte detection system within a blood gas analyzer, the improved system comprising and/or consisting of at least one CO-oximetry system that is formed as an integrated, unitary structure(s) with an electrochemical sensor module, and methods of use related thereto.

Abstract: Methods and reagents are disclosed for minimizing a false result in an assay measurement for determining a concentration of an analyte in a sample suspected of containing the analyte. The method comprises pretreating both an antibody and a sample to be subjected to a non-agglutination immunoassay. In the method the antibody and the sample are combined with a pretreatment agent selected from the group consisting of hydroxyphenyl-substituted C1-C5 carboxylic acids and metallic salts thereof and halogen-substituted C1-C5 carboxylic acids and metallic salts thereof in an amount effective to enhance the accuracy of the non-agglutination immunoassay.

Abstract: Reagents are disclosed for use with potentiometric magnesium ion selective electrodes, along with kits containing same as well as methods of use thereof.

Abstract: Methods of early real-time detection or prediction of aspiration faults in an automated diagnostic analysis system include an artificial intelligence algorithm configured to use either cluster analysis or probabilistic graphical modeling based on an aspiration pressure measurement signal waveform. Aspiration faults may include short-volume aspiration and unwanted gel pick-up. These methods may allow for timely termination of an aspiration process so as to avoid or minimize possible detrimental downstream consequences such as faulty sample test results and/or instrument downtime for servicing and cleanup. Apparatus for early real-time detection or prediction of aspiration faults are provided as are other aspects.

Abstract: A method for detecting an abnormal operating condition of a heat exchanger is provided. The method includes determining the actual current through a heat exchanger, using the actual current to indicate an abnormal operating condition, and declaring a fault state. A step of comparing the baseline current to the actual current includes normalizing the actual current, calculating a difference between the normalized actual current and the baseline current, and determining that difference is less than zero.

Abstract: Methods of characterizing a sample container or a biological sample in an automated diagnostic analysis system using an artificial intelligence (AI) algorithm include retraining of the AI algorithm in response to characterization confidence levels determined to be unsatisfactory. The AI algorithm is retrained with data (including image data and/or non-image data) having features prevalent at the site where the automated diagnostic analysis system is operated, which were not sufficiently or at all included in training data used to initially train the AI algorithm. Systems for characterizing a sample container or a biological sample using an AI algorithm are also provided, as are other aspects.

Abstract: Kits containing a multiplexed chemiluminescent detection system and microfluidics devices and methods for detecting the presence and/or concentration of biotin and at least one target analyte in a sample are disclosed. The kits, microfluidics devices, and methods utilize singlet oxygen-activatable chemiluminescent compounds in combination with two or more fluorescent molecules that emit light at different wavelengths.

Abstract: The present invention relates to methods and compositions to remove or reduce biotin interference from certain assays.

Abstract: Methods of operating a diagnostic laboratory system include providing a module configured to perform a function on an item in the diagnostic laboratory system; providing a plurality of sensors, each of the plurality of sensors configured to monitor the function or the item and generate sensor data in response to the monitoring; checking an operational status of a first sensor of the plurality of sensors; receiving sensor data from at least one of the plurality of sensors; and scaling sensor data from the first sensor in response to the operational status and the sensor data to generate revised sensor data. Systems including a middleware server configured to carry out the methods are provided as are other aspects.

Abstract: An analyzer control product provided with a sealed rack tube containing a preconfigured volume of analyzer control fluid is described. In particular, the rack tube is provided with a base portion; a top portion; and a sidewall extending from the base portion to the top portion, the sidewall having an inner peripheral surface and an outer peripheral surface, at least one of the inner peripheral surface and the outer peripheral surface in contact with the base portion to form a control fluid void. The analyzer control fluid is within the control fluid void. The analyzer control fluid has a preconfigured volume. A sealing member is attached to the top portion to seal the control void.

Abstract: Methods of utilizing sample lysis reagent compositions in the handling of samples containing viruses, such as (but not limited to) severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), are disclosed. Kits containing the sample lysis reagent compositions are also disclosed.

Abstract: There is provided a chloride selective membrane including an epoxide-based matrix reacted with a stoichiometric amount of an amino compound and an activator such that the epoxide-based matrix comprises a number of quaternary ammonium groups.