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: The present disclosure relates to compositions and methods for detection, identification and quantification of human papillomaviruses (HPV) and clinically significant sexually transmitted infections (STI) in a single amplification reaction. The disclosed method utilizes next-generation sequencing (NGS) to sequence amplified products. The present disclosure is also directed to kits containing primers specific to multiple HPV and STI targets.

Abstract: The present invention relates to the methods and products for detection of colorectal cancer. Additionally, the present invention relates to methods and products for determining the probability, risk or incidence of colorectal cancer and of colorectal cancer metastasis. The products and methods of the present invention include detecting the level of expression of COL10A1 or MMP11, in combination, from samples, including tissue samples, from humans who currently have been diagnosed with cancer or who were previously diagnosed with cancer and those who are thought to have cancer and are undergoing diagnosis.

Abstract: Embodiments of a portable and compact centrifugal system are described, comprising a centrifuge body comprising a motor; and a monolithic rotor, suitable for manufacturing in a straight-pull injection mold, with an attachment hub, fixed retainer for exactly one sample tube, arms for the retainer, and a thin, aerodynamic counterweight. Embodiments include a rotor with a counterweight and wherein the tube retainer and the counterweight are angled downward; a central clearance volume for manual placement of a sample tube; and dimensions optimized to just fill a fixed rotational circle. Embodiments include a centrifuge with: an enclosure, hinged lid, lid-closure sensor, motor, and automatic timer; free of both user controls and user displays.

Abstract: Disclosed is a covalently-linked multilayered three-dimensional matrix comprising capture molecules, linkers and spacers (referred to as a Molecular Net) for specific and sensitive analyte capture from a sample. Also disclosed herein is a Molecular Net comprising covalently-linked multilayered three-dimensional matrix comprising more than one type of capture molecule and more than one type of linker and may comprise one or more spacer for specific and sensitive capture of more than one type of analyte from a sample. A Molecular Net may comprise a pseudorandom nature. Use of various capture molecules, linkers and spacers in a Molecular Net may confer unique binding properties to a Molecular Net. Porosity, binding affinity, size exclusion abilities, filtration abilities, concentration abilities and signal amplification abilities of a Molecular Net may be varied and depend on the nature of components used in its fabrication.

Abstract: Embodiments are directed to a combination of an automation system that continuously tracks the identity and positions of all of its pucks with a single sample identification station and covers/interlocks in order to provide sample chain of custody without the need to re-identify the sample at points of interaction (aspiration, de-capping, etc.). This eliminates the need to have sample identification stations at each interaction point. This reduction of hardware allows the system to be cheaper, smaller, and more reliable. It also allows not only the automation system, but also existing pre-analytical/analytical equipment connected to the automation system, to run more efficiently.

Abstract: A method for managing sample exposure to air on an automation system for performing clinical laboratory in-vitro diagnostics (IVD) includes receiving a sample in a capped container and loading the capped container onto a sample carrier. A plurality of test requests corresponding to the sample is received. Optionally, the capped container may be parked on a sample handler pending readiness of the system to process the test requests. Each test request is associated with one or more analytical modules included in an automated IVD system. In response to determining that the first analytical module is available to perform the first test request, the capped container is reloaded from the sample handler, if necessary, and decapped. Next the system performs prioritized delivery of the decapped container to the analytical modules in order to optimize performance of the assays with respect to the stability of the sample's analytes.

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

Abstract: Disclosed herein are methods of detecting ascorbic acid in a urine sample from a subject. The methods comprise contacting at least a portion of the urine sample with a test strip comprising a reagent pad and detecting whether ascorbic acid is present in the urine sample. The detecting comprises measuring an intensity of color on the reagent pad, wherein a reduction in the intensity of color on the reagent pad indicates the presence of ascorbic acid.

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: The present invention features a method and kit for isolating microvesicles or extracting microvesicle nucleic acids from a biological sample by using a control particle. The present invention provides control particles that are viruses or virus-like particles, such as bacteriophages, that contain control nucleic acids that can be detected to assess the accuracy, reliability, and efficiency of the microvesicle isolation or nucleic acid extraction steps. The methods described herein may further comprise the analysis of the presence, absence, or level of at least one biomarker associated with a disease or medical condition for diagnosing, prognosing, or monitoring the disease or medical condition.

Abstract: Methods, systems, and kits for detection, diagnosis, monitoring, and/or treatment of viral infections such as represented by the COVID-19 disease are described. The methods, systems, and kits are capable of detection of salivary biomarkers which correlate with, and are indicative of, COVID-19 in a subject. Detection of the biomarkers in a saliva sample provides opportunities for a COVID-19 or other viral detection assay which is non-invasive, produces rapid results, and can be implemented in the field on a wide geographic basis for individualized screening or mass screenings for COVID-19 or other viral infections.

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: A method for calibrating an imager of a reagent analyzer, comprises positioning a dry reagent pad at a first read position in a field of view of the imager, the first read position illuminated by an illumination source with a first intensity, detecting a reference optical signal by the imager, indicative of a first reflectance value of the dry reagent pad at the first read position, positioning the dry reagent pad at a second read position, the second read position illuminated with a second intensity different from the first intensity, detecting a first optical signal by the imager, indicative of a second reflectance value of the dry reagent pad at the second read position, and calculating, by a processor, a calibration factor for the dry reagent pad at the second read position based on a difference between the reference optical signal and the first optical signal.

Abstract: The disclosure provides an in vitro diagnostic method that is sensitive and accurate for detection and quantification of targets of interest that are associated with disease. There is an ongoing need for a highly sensitive detection system. In addition to the methods, stable complexes and kits comprising the components necessary to perform the disclosed detection methods are described.

Abstract: Devices, kits, and methods related to embodiments of an improved liquid test sample injection device comprising a sample mixture that comprises at least one sample flag compound for detecting the presence or non-presence of a patient's liquid test sample upon being interrogated by a pre-determined wavelength of light.

Abstract: A method and system for determining a concentration of one or more analytes in whole blood is provided. In one aspect of the invention, the system includes a channel configured to carry whole blood. The system further includes a light source configured to emit light on the channel. Additionally, the system includes an actuation module associable with the channel, wherein the actuation module is configured to generate a cell-free plasma layer in the channel. Furthermore, the system includes an optical module associable with the channel.

Abstract: The invention relates to a heating device for a rack of a diagnose robot comprising: -a polygonal, oval or cylindrical ring (221) defining a polygonal, oval or cylindrical closed wall, having a bottom opening (222) and a top opening (223) -wherein the bottom opening matches the size and form of a filter membrane and/or supporting body (2, 3) of a carrier (1) of a filtration assembly; and -one or more heating elements (224) selected from -a heating element which is integrated into the ring, -a heating element which is arranged on the outer and/or inner surface of the wall defining the ring, and -a heating element arranged in or on a lid, wherein the lid matches the size and form of the opening of the ring.

Abstract: A method, device and a system of determining a concentration of one or more analytes in a sample is disclosed. In one aspect of the invention, the method includes introducing the sample through a channel The method further includes illuminating the sample with light having varying wavelengths. Additionally, the method includes obtaining an image of the illuminated sample at each of the wavelength. Furthermore, the method includes analyzing the image to determine the concentration of the one or more analytes.

Abstract: A location based dynamic information provision system integrates operator positional awareness within a laboratory environment with a laboratory environment asset site map. At least one operator proximity metric, defining a distance threshold for establishing whether an operator within the laboratory is proximate to a respective asset, is defined for each asset. Operator detection and position is provided by an indoor positioning system. A signaling device associated with each operator is in communication with a laboratory process management platform for receiving operator information contingent upon the respective operator being within the proximity metric for a respective laboratory asset and the asset having communicated status of a given urgency to the process management platform. The signaling device may enable the operator to communicate with the process management platform and may provide a tactile or other attention attracting signal to the operator.