Abstract: A sensor assembly for analysis of physical parameters and chemical constituents of small volume samples of bodily fluids with at least two analyte sensors. The sensor assembly including a separation panel with an upper surface and a lower surface and upper and lower fluid channels disposed within the upper and lower surfaces respectively. The fluid channels extending substantially between the first and second ends and when in an operating mode bodily fluid is in fluid communication with both the upper and lower fluid channels. The sensor assembly including a potentiometric chip positioned atop and an amperometric chip positioned beneath the separation panel with at least one analyte sensor positioned above and beneath each of the fluid channels and when the sensor assembly is in an operating mode the fluid is in fluid communication with the analyte sensors. A bonding media is disposed beneath the amperometric chip.
Abstract: A sensor assembly for analysis of physical parameters and chemical constituents of small volume samples of bodily fluids. Disclosed herein is a sensor panel with an upper surface and a lower surface and at least one analyte sensor located on the lower surface. The sensor assembly also includes an optional adhesive layer and a contoured fluid pathway cutout. The upper surface of the adhesive layer is secured to the lower surface of the sensor panel. The sensor assembly also includes a sensor cartridge base with a fluid inlet and outlet and a contoured fluid pathway extending between the inlet and the outlet. The contoured fluid pathway mirrors the shape and span of the contoured fluid pathway cutout of the adhesive layer. As a fluid sample is input at the fluid inlet, the fluid traverses along the fluid pathway in contact with the at least one analyte sensor.
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 disclosure relates to methods and devices for amplifying a plurality of targets in a single PCR run while distinguishing between clinically relevant amplification and amplification from other sources such as from background contamination. The methods and devices further enable discrimination between gram-positive, gram-negative and fungal infections as wells as identify antimicrobial resistance genes. When applying the methods and devices of the invention, the species or genus of an infection(s), and genus of a fungal co-infection(s) or category of bacterial (gram-positive or negative) co-infection(s) are identified. Species identification of co-infections can also be achieved. Further, when applying the methods and devices of the invention, organisms which are likely to be contaminating organisms from a blood draw are identified.
Type:
Application
Filed:
April 28, 2021
Publication date:
August 12, 2021
Applicant:
Clinical Micro Sensors, Inc. (dba GenMark Diagnostics, Inc.)
Inventors:
Lisa Lynn Freeman-Cook, Christine J. Shaw, Milena Iacobelli Martinez, Anna Maria Al-Khouri, Bradley Adam Brown, John Jay Harvey, Michael Thomas Nguyen
Abstract: Disclosed herein are immunoassays for detecting an antibody in a biological sample from a subject and/or diagnosing an autoimmune disease in a subject. The disclosed immunoassays use a single, direct step to assess the level of antibody in a biological sample from the subject by simultaneously binding the antibody to a capture antigen (e.g. an unlabeled antigen bound to a solid support) and a labeled antigen not bound to the solid support.
Type:
Application
Filed:
July 1, 2019
Publication date:
August 12, 2021
Applicant:
Siemens Healthcare Diagnostics Inc.
Inventors:
James Freeman, Mariah Arcuri, Cheryl Krumm, Eddine Merabet
Abstract: Nanodiamond particles and related devices and methods, such as nanodiamond particles for the detection and/or quantification of analytes, are generally described. In some embodiments, the device comprises a plurality of nanodiamond particles and a species bound to the nanodiamond particles. In certain embodiments, the plurality of nanodiamond particles may be exposed to a sample suspected of containing an analyte. In some cases, the analyte may bind to the species such that the presence of the analyte in the sample may be detected. In some embodiments, the devices, systems, and methods described herein are useful for the detection of an analyte in a sample obtained from a subject for, for example, diagnostic purposes. In some cases, the systems, devices, and methods described herein may be useful for diagnosing, prevent, treating, and/or managing a disease or bodily condition.
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.
Type:
Grant
Filed:
February 28, 2020
Date of Patent:
August 10, 2021
Assignee:
Accelerate Diagnostics, Inc.
Inventors:
Austin Ashby, Wayne Showalter, Jasmin Cote
Abstract: An illumination unit is described that includes a first light source positioned on a first axis and a second light source on a second axis that intersects and is angularly offset with respect to the first axis. The illumination unit includes a reflector having an aperture through which the first axis extends and a reflective surface angled with respect to the first axis and second axis.
Abstract: Disclosed are optical interrogation apparatus that can produce lens-free images using an optoelectronic sensor array to generate a holographic image of sample objects, such as microorganisms in a sample. Also disclosed are methods of detecting and/or identifying microorganisms in a biological sample, such as microorganisms present in low levels. Also disclosed are methods of using systems to detect microorganisms in a biological sample, such as microorganisms present in low levels. In addition or as an alternative, the methods of using systems may identify microorganisms present in a sample and/or determine antimicrobial susceptibility of such microorganisms.
Abstract: Devices and kits for detecting molecular targets involved in the onset of parturition are presented, as are methods of using the same. The devices and kits include one or more associators specific for molecular targets, such as microRNAs and proteins and peptide fragments thereof. The associators, such as aptamers or antibodies, bind their targets, when such targets are present in a fluid sample from a pregnant woman, to produce a detectable signal. The signal may be produced in a lateral flow device.
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: A chemiluminescent detection system, as well as kits and microfluidics devices containing same, are disclosed. Methods of using the system, kits, and devices are also disclosed.
Type:
Application
Filed:
January 22, 2021
Publication date:
July 29, 2021
Applicant:
Siemens Healthcare Diagnostics Inc.
Inventors:
Jay J. Li, David J. Ledden, Eric Scott Cowden, Donglai Lu
Abstract: A plasma separation system and process for providing filtered plasma from a blood sample is described. The system may include a blood separation well having a separation membrane for filtering the blood sample. The filtering process may be aided by the use of a negative or positive pressure source attached to the plasma separation system.
Type:
Application
Filed:
April 9, 2021
Publication date:
July 29, 2021
Applicant:
Siemens Healthcare Diagnostics Inc.
Inventors:
Michael S. Wilson, Jay Li, Kenneth P. Galano
Abstract: A plasma separation system and process for providing filtered plasma from a blood sample is described. The system may include a blood separation well having a separation membrane for filtering the blood sample. The filtering process may be aided by the use of a negative or positive pressure source attached to the plasma separation system.
Type:
Application
Filed:
April 9, 2021
Publication date:
July 29, 2021
Applicant:
Siemens Healthcare Diagnostics Inc.
Inventors:
Michael S. Wilson, Jay Li, Kenneth P. Galano
Abstract: The present invention provides compounds used in the synthesis of chemiluminescent acridinium compounds and methods of producing these compounds. Specifically, methods are provided for the N-alkylation of acridan compounds using alkylating reagents. Typically, these alkylating reagents comprise a protected sulfonate group protected with an acid-labile protecting group.
Abstract: A characterization apparatus including pattern generation. The characterization apparatus is configured to characterize a specimen and/or a specimen container in some embodiments. The characterization apparatus includes an imaging location configured to receive a specimen container containing a specimen, one or more image capture devices located at one or more viewpoints adjacent to the imaging location, and one or more light panel assemblies including pattern generation capability located adjacent to the imaging location and configured to provide back lighting. Methods of imaging a specimen and/or specimen container using the pattern generation are described herein, as are other aspects.
Type:
Grant
Filed:
November 13, 2017
Date of Patent:
July 27, 2021
Assignee:
Siemens Healthcare Diagnostics Inc.
Inventors:
Patrick Wissmann, Ludwig Listl, Benjamin S. Pollack
Abstract: One embodiment provides systems and methods for masking the effects of a flash on an operator including: a drawer system configured to receive a tray comprising one or more laboratory containers, wherein upon receiving the tray, the drawer system centers the tray underneath an image capture device; a flash device configured to activate, based on said centering, to illuminate the one or more laboratory containers; and an image capture device configured to capture an illuminated image of the one or more laboratory containers.
Abstract: Embodiments are directed to a simple, tool-less, and automated connection between a transfer probe and a capacitive liquid level detection printed circuit assembly (PCA) for use in a clinical analyzer in an in vitro diagnostics (IVD) environment in a hospital or laboratory setting. Advantageously, a single user connection is required: a fitting that is used to attach fluid tubing of the transfer arm to a probe, resulting in a mechanical, fluid, and electrical connection between the probe and the transfer arm. A PCA comprises a plurality of spring-loaded pins and capacitive liquid level detection circuity. A probe comprises a primary tube nested within a secondary tube, wherein the primary tube and the secondary tube comprise respective heads at respective top portions thereof forming a set of electrically isolated surfaces. The fitting secures the probe within a transfer arm and establishes the connection between the PCA and the probe.
Type:
Application
Filed:
May 10, 2017
Publication date:
July 22, 2021
Applicant:
Siemens Healthcare Diagnostics Inc.
Inventors:
William D. Dunfee, Amanda H. Schaffers, Stephen Krufka