Abstract: An integrated microfluidic unit with pipette adaptation. The integrated microfluidic unit may be accommodated within a pipette tip rack for storage prior to use and may be received by a translating pipette head during use. The number of components required within the laboratory instrument is reduced compared to processes employing discrete microfluidic chips and pipette tips. Processes involving microfluidic devices integrated into the presently disclosed unit are streamlined at least by the elimination of discrete manipulation steps associated with aspirating sample fluid into a pipette tip, then using a discrete chip feeder or manipulator to bring the chip and pipette tip into fluidic communication for transfer of the sample to the chip. The number of consumables is also reduced by the integration of microfluidics with physical features enabling fluid aspiration and unit conveyance. A variety of microfluidic devices and channel configurations may be accommodated.

Abstract: Systems and methods for use in an in vitro diagnostics setting incorporating magnetic shielding to reduce exposure of any of samples, reactants, devices or people from exposure or prolonged exposure to magnetic or electromagnetic fields generated with the system.

Abstract: Disclosed is a sensor assembly 100 including a sensor body having a flow channel therein configured to receive a test liquid, such as a bio-liquid, one or more moveable walls defining one or more wall portions of the flow channel, the one or more moveable walls configured to be moveable, such as to a first position, a second position, or even an intermediate position, to change a volume of the flow channel 102, and one or more sensor elements positioned in the flow channel. Volume in the flow channel may be minimized for testing neonatal specimens. Liquid testing apparatus and methods of testing test liquids are provided, as are other aspects.

Abstract: Methods of detecting aberrant results caused by delivery issues for a polyhapten reagent in the context of immunoassays are disclosed.

Abstract: A fitment device may include a core made of a first material and including a securing portion configured to secure to a chassis and a container portion configured to seal to a container. The fitment device includes an aperture including a first end located at the securing portion and a second end located at the container portion, wherein the aperture is configured to receive a probe in the first end. A plug located in the aperture is movable within the aperture upon contact with the probe to open a passageway between the first end and an interior of the container. Other devices and methods are disclosed.

Abstract: Embodiments are directed to transferring and opening reagent containers for use in a clinical analyzer in an in vitro diagnostics (IVD) environment. Contents of a reagent container may be automatically recorded, and the container is positioned and opened, making available its contents to a transfer probe. A set of mechanical fingers open and close relative to one another, to release and grip the reagent container on opposite sides thereof for transferring the container. Once the container is positioned, the mechanical fingers raise and are positioned above a seal concealing the contents of the reagent container. The fingers are configured to close together and travel in a downward trajectory to pierce the seal. The reagent container is originally presented as an un-opened package to prevent spillage and to control reagent life expectancy. According to an embodiment, a method of performing a cycle unload, transfer, and load, without operator intervention, is provided.

Abstract: A fitment device may include a core formed from a first material having a first low permeability of oxygen. The core may include a securing portion configured to secure to a chassis, and a container portion including at least one side portion at least partially coated with a second material configured to seal to a container, wherein the first material is different than the second material and includes a different gas permeability of oxygen. An aperture may extend between the securing portion and the container portion. Reagent cartridges and methods of manufacturing and using fitment devices are also disclosed.

Abstract: A breath collection system, includes a vacuum reservoir; a vacuum connected to the vacuum reservoir; a breath collection reservoir configured to be located inside the vacuum reservoir during a breath collection and removed after a breath is collected from a patient; and a patient interface device connected to the breath collection reservoir to collect the breath from the patient.

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.

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: The current disclosure provides methods for detecting and analyzing K17 expression in a bladder sample obtained from a subject. The current disclosure also pertains to methods and kits for identifying a mammalian subject with bladder cancer by detecting the expression of K17 in a sample. The present methods include both cell-based and cell-free methods for determining the level of keratin 17 in a sample obtained from the bladder of a subject.

Abstract: One embodiment provides a quick-connect and rotation system for impeller coupling including: an impeller comprising: a mixer end; and a first attachment end; the first attachment end comprising a first member that is diametrically magnetized; and an motor comprising: a rotational shaft with a second attachment end comprising a second member that is diametrically magnetized; wherein the first attachment end and the second attachment end are complementary to each other; and wherein the motor imparts rotational torque, via a magnetic field between the first member and the second member, on the first attachment end when the first attachment end and the second attachment end are connected.

Abstract: In one embodiment, a biological sample analyzer has a housing having at least one outer wall that defines a cavity therein, an air intake, and an air exhaust. A plenum is disposed within the cavity and has at least one plenum wall that defines an air duct therein. A receptacle, which can support a consumable holder containing a biological sample, is disposed within the internal cavity. At least a portion of the receptacle is supported within the air duct such that an air gap is defined between the receptacle and the at least one plenum wall. A heater applies heat to the consumable holder so as to heat the consumable holder when the consumable holder is supported by the receptacle. A fan forces air along a path that extends from the air intake, through the air gap, and to the air exhaust so as to cool the heater.

Abstract: The present disclosure relates to methods for treating glioblastoma in a subject in need thereof using gene signatures in exosomal RNA derived from the subject. The gene signatures comprise: at least one of FAM229B, ZNF35, CTD-2647L4.4, CABP5, CYP20A1, CEP126, DTX2P1-UPK3BP1-PMS2P11, RP11-507K12.1, KRBA2, CALD1, LRFN1, RP2, SLC2A13, CDKL3, SLC8A3, ANTXR2, TIGD5, AC074289.1 RP11-932O9.7; at least one of tRNA-Lys-CTT-2-2, tRNA-Pro-AGG-2-7, LAMTOR2, RAD51AP1, DENND2A, A1BG, THSD1, CSF1, RP11-332M2.1, ZNF717, ZNF860, ORC6, Clorf50, PSPH, HIST1H4C, CYP2U1, THAP8, TMEM192, NAA20; or at least one of CREBBP, CXCR2 and S100A9. The treatment methods comprise measuring the expression level of at least one of the aforementioned genes in exosomal RNA from a subject and administering to the subject a glioblastoma treatment based on the expression level(s).

Abstract: A remote control warning device enabling communication of warnings and/or communication of information with a remote operation device. The remote control warning device includes a housing, a proximity sensor coupled to the housing configured to sense a presence of a person located within a safety zone, one or more warning devices coupled to the housing and configured to display and/or sound a warning to the person, a user interface coupled to the housing and configured to display information and/or allow input by a local operator, and a communication interface operatively coupleable with a communication network to provide communication with the remote operator. Warnings may be provided to the local operator. Automated processing systems including the remote control warning device and methods of operation are provided, as are other aspects.

Abstract: A system for automated microorganism identification and antibiotic susceptibility testing comprising a reagent cartridge, a reagent stage, a cassette, a cassette, stage, a pipettor assembly, an optical detection system, and a controller is disclosed. The system is designed to dynamically adjust motor idle torque to control heat load and employs a fast focus process for determining the true focus position of an individual microorganism. The system also may quantify the relative abundance of viable microorganisms in a sample using dynamic dilution, and facilitate growth of microorganisms in customized media for rapid, accurate antimicrobial susceptibility testing.

Abstract: Disclosed herein are methods for rapid detection of suspension of a blood sample from a subject and methods for improving the processing time of a point of care blood analysis. Specifically, the disclosed methods provide a rapid detection of hemoglobin concentration, more specifically glycated hemoglobin A1c, and determination of sugar concentration in the blood sample from the subject. Further disclosed herein are methods for rapidly diagnosing diabetes in a subject.

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: Non-limiting embodiments of a modified solid reagent zone comprising at least hydrophilic polysaccharide and/or at least one hydrophilic non-polysaccharide polymer for use in the conductance of at least one diagnostic assay, as well as kits and methods of use and production related thereto.