Abstract: Lysis devices, methods, and systems are disclosed including a lysis device comprising a sample vessel having an outer surface, a microchannel within the confines of the outer surface, a first port extending through the outer surface to the microchannel, and a second port extending through the outer surface to the microchannel; and an acoustic transducer bonded to the outer surface of the sample vessel to form a monolithic structure, the acoustic transducer configured to emit ultrasonic acoustic waves into and/or to induce shear forces into a blood sample within the microchannel, thereby rupturing the blood cells.

Abstract: The invention relates to a system with a seal between a manifold and a liquid container in which a sealing without an elastomer material is used, wherein the sealing properties of the seal are independent of the rotational position of the manifold in relation to the container

Abstract: Methods of visualizing performance of a diagnostic laboratory system are provided. The methods include displaying on a display, an image representing a layout of a plurality of laboratory analyzers included within the diagnostic laboratory system, and overlaying the image with a dynamically-changeable color overlay that indicates a performance for the plurality of laboratory analyzers over a period of time via using changeable colors. Systems including color-changeable overlays are provided as are other aspects.

Abstract: Methods of minimizing hook effect interference in an immunoassay are disclosed. Also disclosed are reagents, kits, and immunoassay devices that may be utilized in accordance with the method.

Abstract: Systems, apparatus, and methods for conducting amplification-based analyses, including PCR testing. In one illustrative embodiment, a system may include a testing container assembly and a testing unit. The testing container assembly may include a sample collection port, a sample preparation chamber, and a reaction chamber. The sample collection port may include a bottom opening sealed by a plug member. In use, the testing container assembly may be placed in a seat of the testing unit with a sample in the sample collection port, closed by a lid. A plunger may dislodge the plug member and the sample drawn into the sample preparation chamber. Once sample preparation is complete, a channel may be opened, and the prepared sample flows into the reaction chamber which is then sealed. Testing including amplification reactions, may then be performed, followed by detection, as by detecting fluorescent emissions in the reaction chamber.

Abstract: A diagnostic device has a sample probe for receiving sample material from one or more containers, a sample line for delivering the sample material to one or more reaction containers, a reagent supply and reagent supply line for supplying reagent to the one or more reaction containers, an incubation ring for receiving the reaction containers and incubating a mixture of the sample material and the reagent for a period of time, and a heating system for heating one or more areas or components of the device. The heating system has one or more positive temperature coefficient heaters.

Abstract: The present disclosure provides, among other things, primers and probes for detecting shedding of an AAV construct or fragment thereof in a subject. In some embodiments the primers are selected to generate an amplicon that comprises (i) a first strand comprising (1) a nucleotide sequence corresponding to the forward primer, and (2) a nucleotide sequence corresponding to a portion of the AAV construct or fragment thereof, (ii) a second strand comprising (1) a nucleotide sequence of the reverse primer, and (2) a nucleotide sequence that is complementary to the portion of the AAV construct or fragment thereof, or (iii) a combination thereof, where the portion of the AAV construct or fragment thereof comprises a nucleotide sequence that spans a junction between a regulatory element and the therapeutic gene of interest.

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: A method and a device for determining the concentration of an analyte in whole blood is disclosed. In one embodiment, the method includes generating a plasma layer in the whole blood sample. Furthermore, the method includes exposing the plasma layer to light. The method also includes capturing light reflected from the plasma layer. Additionally, the method includes analyzing the reflected light to determine the concentration of the analyte.

Abstract: The present disclosure relates to water dispersible or soluble diagnostic assay methods, devices, kits, and methods of manufacture.

Abstract: An apparatus, multi-well plate and method for automated cell lysis and nucleic acid purification and processing. The plate includes a lysis well, at least one wash well, and an elution well. The apparatus includes a vertically aligned rotor mixer comprising a magnetic tip and actuators for moving the rotor mixer in a vertical and horizontal directions, to transfer magnetic beads from well to well. The rotor mixer is used to vortex lysis mixtures, wherein the vortexing speed is sufficient to overcome the magnetic attraction between the beads and mixer tip and disperse the beads in solution, to collect nucleic acids such as DNA.

Abstract: A method for determining a subject's risk for developing hemophilia A, hemophilia B, or von Willebrand disease (VWD) is described. The method involves obtaining a sample of genetic material from the subject. The genetic material is amplifed using primers specific for the genes underlying hemophilia A, hemophilia B and VWD. The DNA sequence of the amplified genetic material is determined and compared with a DNA sequence from a normal control subject. One or more DNA sequence alterations in the amplified genetic material not present in the DNA sequence from the normal control subject indicates that the subject is at risk for developing hemophilia A, hemophilia B, or VWD.

Abstract: Anti-hog TCN1 monoclonal antibodies are disclosed, along with epitopes recognized by same. Also disclosed are kits containing the monoclonal antibodies and methods of producing the antibodies. Further disclosed are methods of using the monoclonal antibodies, such as (but not limited to) in methods of estimating and/or removing TCN1 from hog intrinsic factor preparations.

Abstract: An apparatus, multi-well plate and method for automated cell lysis and nucleic acid purification and amplification. The plate includes a lysis well, at least one wash well, an elution well, and a PCR chip. The apparatus includes a vertically aligned rotor mixer comprising a magnetic tip and actuators for moving the rotor mixer in a vertical and horizontal directions, to transfer magnetic beads from well to well. The rotor mixer is used to vortex lysis mixtures, wherein the vortexing speed is sufficient to overcome the magnetic attraction between the beads and mixer tip and disperse the beads in solution, to collect nucleic acids such as DNA in an elution solution that is transferred to the PCR chip for amplification of target sequences.

Abstract: Methods for setting up, maintaining and operating a radiopharmaceutical infusion system, that includes a radioisotope generator, are facilitated by a computer of the system. The computer may include pre-programmed instructions and a computer interface, for interaction with a user of the system, for example, in order to track contained volumes of eluant and/or eluate, and/or to track time from completion of an elution performed by the system, and/or to calculate one or more system and/or injection parameters for quality control, and/or to perform purges of the system, and/or to facilitate diagnostic imaging.

Abstract: In order to address an inability to separate portions of a sample and/or substance, in some embodiments, methods and apparatuses for separating components and/or portions of a sample are provided. For example, a sample collection container may comprise two areas within the container, one which is configured to contain a first volume of the sample, and one which is configured to contain a second volume of the sample. A float device may be configured to seal the portion of the container collecting the first volume from the portion of the container collecting the second volume, after the former portion of the container has been filled. The sample collection container may further comprise a top cap configured to further seal the two portions of the container, and to prevent leakage and/or spilling of the sample from the sample collection container.

Abstract: Disclosed is an antibody which binds to a symmetrically dimethylated arginine analyte that can be used to detect a symmetrically dimethylated arginine analyte in a sample, such as in a homogeneous enzyme immunoassay method.

Abstract: Physiological monitoring can be provided through a lightweight wearable monitor that includes two components, a flexible extended wear electrode patch and a reusable monitor recorder that removably snaps into a receptacle on the electrode patch. The wearable monitor sits centrally on the patient's chest along the sternum oriented top-to-bottom. The placement of the wearable monitor in a location at the sternal midline, with its unique narrow “hourglass”-like shape, significantly improves the ability of the wearable monitor to cutaneously sense cardiac electrical potential signals, particularly the P-wave and the QRS interval signals indicating ventricular activity in the ECG waveforms. In particular, the ECG electrodes on the electrode patch are tailored to be positioned axially along the midline of the sternum for capturing action potential propagation in an orientation that corresponds to the aVF lead used in a conventional 12-lead ECG that is used to sense positive or upright P-waves.

Abstract: A composition of a bilimbin stock and a method of preparation are provided. In one aspect of the invention, the composition includes a base solution. The composition further includes a carbonate salt. Additionally, the composition includes bilimbin. Furthermore, the composition includes human serum albumin.

Abstract: Devices, kits, and methods are disclosed for use in detecting a concentration of an analyte of interest in a patient's liquid test sample. The devices, kits, and methods employ the use of one or more solid reagent zones that includes at least one analytical reagent for detection of an analyte of interest. The solid reagent zone(s) also includes at least one dye for determining whether results obtained from the diagnostic assay for the at least one analyte of interest are biased or inaccurate due to a loss of volume of a liquid reagent during the dispensing of the liquid reagent.