Abstract: Measurement of circulating ST2 and/or IL-33 concentrations is useful for the prognostic evaluation of subjects, in particular for the prediction of adverse clinical outcomes, e.g., mortality, and the detection of severe disease.

Abstract: A rack for a diagnostic robot with at least one support for at least one container; at least one gas-outlet to supply the at least one container with a gas at a predefined but individually adjustable pressure level; a first gas pump to generate a gas at a predefined super-atmospheric pressure level; a second gas pump to generate a gas at a pre-defined sub-atmospheric pressure level; a first tubing system attached to the first gas pump and holding the gas generated by the first gas pump; a second tubing system attached to the second gas pump and holding the gas generated by the second gas pump; and at least one tube bridge, wherein one end of the bridge connects via a first valve into the first tubing system and the other end of the bridge connects via a second valve into the second tubing system, and wherein the at least one gas-outlet is connected to the center of the bridge.

Abstract: This invention provides biochip cartridges and instrument devices for the detection and/or analysis of target analytes from patient samples.

Abstract: A model-based method of inspecting a specimen for presence of one or more interferent, such as Hemolysis, Icterus, and/or Lipemia (HI L) is provided. The method includes generating a pixelated image of the specimen in a first color space, determining color components (e.g., an a-value and a b-value) for pixels in the pixelated image, classifying of the pixels as being either liquid or non-liquid, defining one or more liquid regions based upon the pixels classified as liquid, and determining a presence of one or more interferent within the one or more liquid regions. The liquid classification is based upon a liquid classification model. Pixel classification may be based on a trained multiclass classifier. Interference level for the one or more interferent may be provided. Testing apparatus adapted to carry out the method are described, as are other aspects.

Abstract: An extended wear electrocardiography and physiological sensor monitor is provided. An electrode patch includes an integrated flexible circuit having a single piece of material that includes a longitudinal midsection between upper and lower ends and a mirror image shape of the upper end extending from at least a portion of one side of the upper end that runs substantially parallel to the midsection and folds over the upper end. A receptacle is adhered on an outward surface of the mirror image when the integrated circuit is folded over the upper end. One electrode is positioned on a contact surface of the integrated circuit on the upper end and another electrode is positioned on the contact surface on the lower end. A battery is directly adhered to the outward surface of the mirror image and positioned under the receptacle. A monitor is configured to be removably secured in the receptacle.

Abstract: An analyte testing material web, method of making the analyte testing material web, and an analyzer are disclosed. The analyte testing material web has a material web and a plurality of distinct sample testing devices. The material web has a first surface, a second surface opposite the first surface, a first side, and a second side. The plurality of sample testing devices are positioned on the first surface of the material web. Each of the plurality of sample testing devices has an inlet, an outlet, a fluid channel, and one or more testing elements within the fluid channel and configured to analyze one or more analyte within a sample applied to the inlet of one of the plurality of sample testing devices.

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: Methods and apparatus for publisher-independent auxiliary communications in data router-mediated publisher/subscriber transmission architectures provide faster processing of actionable information by subscribers and increased flexibility to add publishers to a system. Publisher-originated information in a publisher-specific format is used by either the publisher, or a data router coupled to the publisher, to generate information, based on the publisher-originated information, in a publisher-independent format recognized by subscribers, and provided by the data router to subscribers. Publishers may include analyzers such as blood, immuno-assay, and clinical chemistry analyzers, IoT devices, and automation systems.

Abstract: Multi-use biosensors are disclosed that include enzymes coupled to nanobeads; the multi-use biosensors are used to detect analytes in fluidic biological samples, and the biosensors also maintain their enzyme activity after many uses. Multi-sensor arrays are disclosed that include multiple biosensors. Also disclosed are methods of producing and using these devices.

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 amplified 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: Aqueous calibration or quality control reagents that include urea are disclosed; the reagents may further include at least one amino acid-containing composition to provide pH stability thereto. Methods of production and use thereof are also disclosed.

Abstract: A method of characterizing a serum or plasma portion of a specimen in a specimen container provides a fine-grained HILN index (hemolysis, icterus, lipemia, normal) of the serum or plasma portion of the specimen, wherein the H, I, and L classes may each have five to seven sub-classes. The HILN index may also have one un-centrifuged class. Pixel data of an input image of the specimen container may be processed by a deep semantic segmentation network having, in some embodiments, more than 100 layers. A small front-end container segmentation network may be used to determine a container type and boundary, which may additionally be input to the deep semantic segmentation network. A discriminative network may be used to train the deep semantic segmentation network to generate a homogeneously structured output. Quality check modules and testing apparatus configured to carry out the method are also described, as are other aspects.

Abstract: An environmental control system for use in a clinical analyzer module includes an upper deck environmental subsystem comprising a far field sensor, one or more heaters, one or more spine cooling fans, and one or more in-line fluid heat exchangers. The far field sensor is configured to acquire measurements of ambient temperature in the upper deck environmental subsystem. The heaters are configured to generate hot airflow based on the measurements of ambient temperature from the far field sensor. The spine cooling fans are configured to operate in a manner that mixes the hot airflow from the heaters with cool airflow based on the measurements of ambient temperature from the far field sensor. The in-line fluid heat exchangers are configured to heat fluids used in reactions performed on the clinical analyzer module to a constant temperature.

Abstract: Infusion system configurations and assemblies facilitate routing of infusion circuit tubing lines. Tubing lines are routed into and out from compartments of a shielding assembly for the infusion system, at locations which prevent kinking and/or crushing of the lines, and/or provide for ease in assembling the circuit. A plurality of the lines may be held together by a support frame to form a disposable infusion circuit subassembly, that can further facilitate routing of the lines.

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 sensor assembly includes a first sensor substrate with upper surface, lower surface opposite upper surface, and a first set of sensors on the first sensor substrate. The sensor assembly includes a second sensor substrate with upper surface, lower surface in opposite upper surface, and a second set of sensors on the second sensor substrate. The sensor assembly includes a base with upper surface, lower surface opposite upper surface of the base along a vertical direction, a front end, a rear end opposite the front end along a longitudinal direction perpendicular to the vertical direction, a first recess at least partially holds the first sensor substrate, a second recess at least partially holds the second sensor substrate, a first fluid passage for receiving a fluid, and a second fluid passage in series with and open to the first fluid passage. Both sensors are exposed to its corresponding fluid passage.

Abstract: A shielding assembly for an infusion system includes a plurality of compartments and a door for each compartment, and provides a radioactive radiation barrier for the compartments. One of the compartments contains a radioisotope generator of the infusion system and another of the compartments may contain a waste bottle of the infusion system. An opening into each of the generator and waste bottle compartments may be oriented upward, and the opening into the latter may be at a higher elevation than the opening into the former, for example, to facilitate independent removal and replacement of each. A door of at least one of the compartments, other than the generator compartment, when closed, may prevent the door of the generator compartment from being opened. A cabinet structure for the infusion system may enclose the shielding assembly and secure the generator.

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.

Abstract: A method for extracting nucleic acids from a biological sample by isolating nucleic acid-containing particles from the biological sample by one or more centrifugation procedures, performing one or more steps to mitigate adverse factors that prevent or might prevent high quality nucleic acid extraction, and extracting nucleic acids from the isolated particles. The centrifugation procedures are performed at a speed not exceeding about 200,000 g. The extracted nucleic acids contain both 18S and 28S rRNA.