Abstract: Disclosed is a system for qualifying medical images submitted by user for diagnostic analysis comprising: an image input module, configured to receive one or more image input by a user; an image protocol conformation module, configured to receive the one or more images from the image input module, and further configured to analyze each of the one or more images for conformity with a predefined protocol and wherein images that do not conform to the predefined protocol are flagged as non-conforming images; an image output module, configured to identify to the user each of the one or more images flagged as non-conforming and prompting the user to resubmit a new image for each of the non-conforming images; and an image resubmission module, configured to receive the user resubmitted image and provide the resubmitted image to the image protocol conformation module.

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: Processes for quantifying an amount of functional groups immobilized on a solid support are described herein. The processes allow for determining whether sufficient functional groups are provided on a solid support for the attachment of a first binding pair member for the detection of a target analyte.

Abstract: A point of care system is provided that includes an instrument data manager (IDM) configured to communicate with a diagnostic engine and to (1) obtain identification (ID) information of a patient for which a test is to be performed; (2) obtain ID information of a diagnostic consumable to be used to collect a sample from the patient; (3) link the obtained patient ID information with the obtained diagnostic consumable ID information; and (4) restrict testing using the diagnostic engine by (a) prior to performing a test on a sample collected with a diagnostic consumable, determine ID information of the diagnostic consumable at the diagnostic engine; (b) determine whether the diagnostic consumable is linked with patient information within the IDM; and (c) if so, allow the diagnostic engine to perform a test on the sample collected with the diagnostic consumable. Numerous other embodiments are provided.

Abstract: A sample insertion apparatus enabling a sample to be inserted into a diagnostic analyzer in a hands-free manner. The sample insertion apparatus includes an insertion head having a coupler configured to couple to a sample container having an insertion member, an arm containing a sample probe positioned stationary relative to the arm, and a retraction assembly coupled to the insertion head and configured to cause the sample container to move towards the sample probe to insert the sample probe into the insertion member. Sample insertion and operating methods for hands-free insertion of a sample into a diagnostic analyzer are described, as are other aspects.

Abstract: Diagnostic laboratory systems, methods of operating diagnostic laboratory systems, and methods of updating diagnostic laboratory systems are disclosed. A method of operating a diagnostic laboratory system includes identifying data in the system as identified data: identifying change in a data distribution of the identified data; aggregating data instances pertaining to the change in the data distribution; selecting a subset of the aggregated data to update a processing algorithm in the system; and updating the processing algorithm using the subset of the aggregated data. Other systems and methods are disclosed.

Abstract: The present disclosure involves ctDNA assays that interrogate many regions from a single sample with high precision and accuracy, while evaluating multiple forms of cancer-related genomic alterations including sequence mutations and structural alterations. The disclosure provides simplified yet robust methods that achieve high sensitivity and specificity by analyzing cancer genes using a limited pool of non-unique barcodes in combination with endogenous barcodes. Samples are captured and sequenced using high coverage next-generation sequencing to allow tumor-specific somatic mutations, amplifications, and translocations to be identified.

Abstract: The present invention is directed to membranes, sensors, systems and process for the detection of magnesium ions in protein-containing samples. The novel membranes, sensors, systems, and processes are based upon the discovery that the lipophilicity of the plasticizer (or blend of plasticizers) utilized in the formulation of magnesium ion selective membranes for clinical use is inversely proportional to the sensitivity of the plasticizer(s) and directly proportional to the use life thereof.

Abstract: A method of treating a tissue exhibiting eosinophil-related inflammation in a subject is disclosed. The method includes administering a composition to the subject that contains a therapeutically effective amount of a polymer and a pharmaceutically acceptable excipient. The polymer is formed from an acidic amino acid, e.g., aspartate and/or glutamate, or a pharmaceutically acceptable salt thereof. The polymer has an average molecular weight of at least about 5 kDa. The polymer binds to one or more eosinophil granule proteins in the tissue to neutralize the eosinophil granule proteins and treat the eosinophil-related inflammation.

Abstract: A sensor assembly for a bodily fluid analyzer includes a reference electrode container containing a reference electrode, a membrane capable or configured to be in fluid communication with the reference electrode container; and a wicking member capable or configured to be in fluid communication with the reference electrode container. The wicking member is configured to draw a reference fluid contained in the reference electrode container towards the membrane when the membrane and the wicking member are exposed to the reference fluid.

Abstract: An analyte detection apparatus is disclosed and configured for testing a substance for the presence or absence of at least one target analyte. In at least one embodiment, a housing provides a mixing chamber and a testing chamber in selective fluid communication with the mixing chamber. During use of the apparatus, an end cap is disengaged from the housing, a volume of the substance is collected via a collection scoop provided by the end cap, the end cap is re-engaged with the housing, thereby introducing the substance from the collection scoop into the mixing chamber, the substance is mixed with a delivery fluid within the mixing chamber, and a mixing valve is rotated into an open position, allowing the substance to travel into the testing chamber and come into contact with a test medium, with a resulting visual indication from the test medium being viewable via a result window.

Abstract: The present disclosure provides methods and kits for identifying and treating individuals at risk of or suffering from amyloid transthyretin cardiomyopathy. In general, detection or measurement of one or more biomarkers, such as TnI, PKM1, PKM2, NT-proBNP, RBP4, DCN, TIMP2, SMOC-2, NfL, or combinations thereof, assists in the identification of amyloid transthyretin cardiomyopathy. The present disclosure also provides methods for selecting patients for treatment of amyloid transthyretin cardiomyopathy, such as with transthyretin stabilizing agents.

Abstract: Kits containing a chemiluminescent detection system and microfluidics devices and methods for determining the concentration of biotin in a sample are disclosed. The kits, microfluidics devices, and methods utilize a sensitizer capable of generating singlet oxygen in its excited state and having avidin or an analog thereof directly or indirectly bound thereto, as well as a singlet oxygen-activatable chemiluminescent compound having biotin or an analog thereof directly or indirectly bound thereto.

Abstract: A wash station for use in a clinical analyzer of an in vitro diagnostics (IVD) environment for cleaning a probe comprises a basin, a vertically-elongated conduit, an inlet port, and a helix insert. The vertically-elongated conduit is attached to the interior of the basin. The inlet port is connected to a bottom portion of the basin. The inlet port is sized to receive and secure a wash feed line that propels a wash fluid upward through the vertically-elongated conduit. The helix insert is positioned within the vertically-elongated conduit and sized to allow insertion of the probe through a center portion of the helix insert for cleaning. The helix insert causes the wash fluid to flow in a helical shape around the probe as it is transported through the vertically-elongated conduit, thereby cleaning the probe.

Abstract: A diagnosis system trains a set of machine-learned diagnosis models that are configured to receive an image of a patient and generate predictions on whether the patient has one or more health conditions. In one embodiment, the set of machine-learned models are trained to generate predictions for images that contain two or more underlying health conditions of the patient. In one instance, the symptoms for the two or more health conditions are shown as two or more overlapping skin abnormalities on the patient. By using the architectures of the set of diagnosis models described herein, the diagnosis system can generate more accurate predictions for images that contain overlapping symptoms for two or more health conditions compared to existing systems.

Abstract: Methods, compositions and kits are disclosed directed at levetiracetam derivatives, immunogens, signal generating moieties, antibodies that bind levetiracetam and immunoassays for detection of levetiracetam.

Abstract: A method for positioning a portable multispectral imaging device within a target distance range relative to a surface for imaging a region of interest (ROI) of the surface. The method generally involves determining a distance between the portable multispectral imaging device and the ROI of the surface determining whether the distance is within the target distance range generating a signal indicating to a user that the portable multispectral imaging device is not within the target distance range and providing instructions to the user to guide that the user for repositioning the portable multispectral imaging device; and triggering an image capturing sequence when the portable multispectral imaging device is within the target distance range. A method for calibrating a light source unit of the portable multispectral imaging device and a portable multispectral imaging device are also described.

Abstract: Examples of a mitral heart valve apparatus are described. In one example, the apparatus has an annular body made of a first material, and a plurality of first anchor members and at least two paddles made of a second material extending from the annular body. In a compressed state, the first anchor members extend substantially longitudinally from the first end of the annular body, and the paddles extend substantially longitudinally from the second end of the annular body. In an expanded state, the annular body has a larger diameter, the first anchor members extend outward from the first end for engaging an upstream portion of a mitral valve annulus to resist displacement of the annular body towards a left ventricle, and the paddles extend outward from the second end for engaging chordae tendineae. In another example, the annular body, anchor members, and paddles are made of the same material.