Abstract: The present disclosure relates to the use of anti-PAD IgA as a clinical biomarker for diagnostic and prognostic information in rheumatoid arthritis (RA) patients. The disclosure further provides methods and compositions for the detection anti-PAD IgA in a biological sample.

Abstract: Analyzers and methods of use are disclosed, including a blood analyzer comprising a light source to transmit an optical signal; a detector to generate data indicative of optical signal intensity; a transparent sample vessel between the light source and the detector; a dispensing device to pass a first portion of the blood sample comprising whole blood or lysed blood into the vessel at a first instance of time, and to pass a plasma portion of the blood sample into the vessel at a second instance of time; a controller to cause a processor to obtain first and second data generated by the detector, the first data indicative of the optical signal passing through the first portion of the blood sample and the second data indicative of the optical signal passing through the plasma, to determine a total absorbance spectrum in which the first data is adjusted by the second data.

Abstract: A method of characterizing a specimen and specimen container to be analyzed in an automated diagnostic analysis system. The method can provide a segmentation determination and/or an HILN determination (hemolysis, icterus, lipemia, or normal) of the specimen while protecting patient information. The method includes capturing an image of a specimen container via an image capture device, identifying a label affixed to the specimen container in the captured image via an anonymization network, and editing the captured image via the anonymization network to mask some or all information present in the label so that it is removed from the captured image. Quality check modules and systems configured to carry out the method are also described, as are other aspects.

Abstract: A method for performing a lateral flow assay is provided. The method includes inserting a sample cartridge (201) in a dark chamber (220) and activating a light emitter (251) in the dark chamber (220). The method includes focusing an optical coupling mechanism (115a, 115b) in an image-capturing device (100a, 100b) to optimize an image of a sensitive area (202) in the sample cartridge (201) and capturing, with an image capturing device (100a, 100b), an image of a sensitive area (202) in the sample cartridge (201) after a selected period of time. The method also includes providing the image of the sensitive area (202) to a processor, wherein the processor comprises an image-capturing application (122). A system and a computer-implemented method to perform at least partially the above method are also provided.

Abstract: The techniques described herein relate to systems and methods for diagnosing diseases in animal patients. In some cases, a method includes providing a set of global data to a global data center and processing the set of global data and categorizing it into data clusters, where each data cluster corresponds to a diagnostic indicator for assessment of a physiological or pathological condition. The method can further include measuring data of a local patient using measurement equipment of a local autonomous cell and communicating the local measurement data from the local autonomous cell to the global data center. The local measurement data can be processed, and the processed local measurement data can be compared with the data clusters to determine a local diagnostic indicator for the local patient. The local diagnostic indicator can then be communicated from the global data center to the local autonomous cell.

Abstract: Biotin-trap compositions are disclosed that contain particles having an inner polymer coating layer disposed on at least a portion of an outer surface thereof and a biotin-specific binding partner conjugated to the inner polymer coating layer. The biotin-trap compositions may further include an outer polymer coating layer disposed about the biotin-specific binding partner. The biotin-trap compositions specifically bind to free biotin but do not substantially bind to biotin conjugated to other moieties, such as biotinylated assay reagents. Also disclosed are kits and microfluidics devices that include the biotin-trap compositions, as well as methods of producing and using the biotin-trap compositions.

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

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: A tiltable display screen assembly of a diagnostic analyzer. The tiltable display screen assembly includes a tiltable support interconnectable to a hand-held device including a display screen, a multi-angle adjuster having adjustment features, and a tilting screen mechanism pivotable relative to the tiltable support. The tilting screen mechanism includes a shaft, one or more moveable paddles coupled to the shaft, an adjustment member depending from the shaft configured to engage with the adjustment features of the multi-angle adjuster in order to adjust a tilt angle of the tiltable support and the display screen of the hand-held device. Diagnostic analyzers including the tiltable display screen assembly and methods for adjusting tilt angle of a display screen of a diagnostic analyzer are described, as are other aspects.

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: A substrate structured to define thereon a fluid flow channel and/or a fluid control feature is described. The substrate may additionally comprise a capture zone and/or a test zone, for use as a test strip for determining presence or absence of an analyte of interest, such as an infectious agent or a biomarker. Reagents are deposited in the capture zone and/or test zone as an array of drops.

Abstract: Diagnostic immunoassay reagent compositions are disclosed that include liposomes having analyte-specific binding element(s) associated therewith. In particular, the analyte-specific binding element(s) includes a transmembrane domain that anchors the element(s) in the lipid bilayer of the liposome; the analyte-specific binding element(s) further includes an extracellular/extra membrane domain that is exposed on the outer surface of the liposome and that comprises a domain that specifically binds to the target analyte. Also disclosed are kits, devices, and systems that contain the diagnostic immunoassay reagent compositions, as well as methods of producing and using the diagnostic immunoassay reagent compositions.

Abstract: Kits containing a multiplexed chemiluminescent detection system and microfluidics devices and methods for detecting the presence and/or concentration of anti-SARS-CoV-2 antibodies 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. In certain non-limiting embodiments, the kits, microfluidics devices, and methods can distinguish between anti-SARS-CoV-2 antibodies generated in response to vaccination from anti-SARS-CoV-2 antibodies generated in response to infection.

Abstract: A system for recording, storing and processing diagnostic information, including: a computer implementing a computer-readable media including digital data and ground truth; a registry constructed and arranged to store and associate transactions or accesses on the data; and a machine learning system that considers each learning step modification a microtransaction for the data used in that step and which is recorded in the transaction registry. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

Abstract: The disclosure provides cartridges that are pre-loaded with reagents for performing antimicrobial susceptibility testing (AST) and FISH testing. Cartridges of the disclosure include various incubation wells loaded with different antimicrobial agents for differential growth analysis. Imaging wells with species-specific microbial probes, fluorescent tags, magnetic particles and dye-cushion layers allow for tagging and imaging of target microbes for differential growth analysis.

Abstract: Described herein are clinical diagnostics and more specifically to a lateral-flow assay devices.

Abstract: A method (400) and a system (200) for generating a chromatically modified image of one or more components on a microscopic slide (303) is disclosed. In one aspect of the invention, the method includes obtaining the image of the one or more components on the microscopic slide (303). Additionally, the method (400) includes processing the image to identify the one or more components. The method (400) further includes segmenting at least one part of the one or more components identified from the image. Furthermore, the method (400) includes chromatically modifying the at least one part of the one or more components and generating a chromatically modified image of the one or more components.

Abstract: A method of characterizing a specimen to be analyzed in an automated diagnostic analysis system provides an HILN classification (hemolysis, icterus, lipemia, normal) of the specimen along with a basis for that determination. The method includes assigning a hash code to each training image of a sample specimen used in the characterization training process. In response to an HILN determination for a test specimen, the method can retrieve via the hash code one or more of the closest matching training images upon which the HILN classification is based. The one or more of the closest matching training images can be displayed alongside of the one or more images of the test specimen. Quality check modules and systems configured to carry out the method are also described, as are other aspects.

Abstract: Apparatus and methods for eye tracking using an optical coherence tomography (OCT) device are disclosed. Such eye tracking may be performed by using information about the shape of the cornea and the corneal apex or using the iris/pupil border obtained using the OCT device.

Abstract: An acoustophoresis device having a sample vessel and a piezo transducer is described. The sample vessel has an outer surface, a microchannel within 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, such that a blood sample is insertable through the first port into the microchannel. The sample vessel has conductive traces on the outer surface. The piezo transducer is bonded to the outer surface of the sample vessel to form a monolithic structure. The piezo transducer contacts at least one of the conductive traces, the piezo transducer is configured to generate ultrasonic waves inside a sample in the microchannel. The piezo transducer has an excitation signal input and response signal output electrically connected to the at least one of the conductive traces.