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 lipophilcity 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 characterizing a serum or plasma portion of a specimen in a specimen container includes capturing a plurality of images of the specimen container from multiple viewpoints, stacking the multiple viewpoint images along a channel dimension into a single stacked input, and processing the stacked input with a single deep convolutional neural network (SDNN). The SDNN includes a segmentation convolutional neural network that receives the stacked input and outputs multiple label maps simultaneously. The SDNN also includes a classification convolutional neural network that processes the multiple label maps and outputs an HILN determination (Hemolysis, Icterus, and/or Lipemia, or Normal) of the serum or plasma portion of the specimen. Quality check modules and testing apparatus configured to carry out the method are also described, as are other aspects.

Abstract: Devices, methods, and kits for detecting at least two analytes present within a small volume single fluid sample obtained from patient for the creation of a multiplexed panel of the various analytes present within the single fluid sample are disclosed.

Abstract: A method and a device for determining a concentration of one or more analytes in a whole blood sample is disclosed. In one aspect of the invention, the method includes introducing the sample in a channel. The method further includes generating a cell-free plasma region in the channel, wherein the cell-free plasma region is generated in the channel based on rouleaux effect. 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 wavelengths. Furthermore, the method includes analyzing the image to determine the concentration of the one or more analytes.

Abstract: Automated diagnostic analysis apparatus for analyzing patient specimens may include a probe to aspirate and dispense a bio-liquid. A probe tip on the probe may require replacement after contact with each bio-liquid. The automated diagnostic analysis apparatus may include a probe tip eject device and a waste chute for controlled removal and disposal of the probe tip to mitigate splattering or splashing of any residual bio-liquid in the probe tip as it is removed from the probe. A sloped ramp in the probe tip eject device may engage and remove the probe tip as it rotates through the probe tip eject device. The waste chute may include guides to transfer a removed probe tip directly into a waste bin without any surface contact by the probe tip. Methods of removing and disposing of a probe tip in an automated diagnostic analysis apparatus are described, as are other aspects.

Abstract: A method of characterizing a specimen for HILN (H, I, and/or L, or N). The method includes capturing images of the specimen at multiple different viewpoints, processing the images to provide segmentation information for each viewpoint, generating a semantic map from the segmentation information, selecting a synthetic viewpoint, identifying front view semantic data and back view semantic data for the synthetic viewpoint, and determining HILN of the serum or plasma portion based on the front view semantic data with an HILN classifier, while taking into account back view semantic data. Testing apparatus and quality check modules adapted to carry out the method are described, as are other aspects.

Abstract: Devices, kits, and methods for conducting a plurality of diagnostic assays on a patient's single liquid test sample within a single reaction cassette.

Abstract: Apparatus configured to control chamber pressure during pipette rinsing having lower pressure recovery time. Pressure control apparatus includes pipettes to dispense liquid, a manifold chamber to supply liquid to the pipettes, a flow control valve in each flow path, a pump to supply the liquid, a pressure sensor to provide measured pressure, and a flow controller, which in a calibration mode, decreases a pump drive setting if measured pressure is high, increases the setting if measured pressure is low, and stores the pump drive setting for the individual combined operational state if the pressure is within predetermined pressure threshold limits, or in a testing mode, determines if the measured pressure is within the threshold limits for a previously-commanded state combination, and adjusts the pump drive setting if not within the threshold limits for a next time. Methods for operating pressure control apparatus are described, as are other aspects.

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: 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 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: 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: 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: 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: 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: 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 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 sample probe system has a sample probe assembly, an air supply assembly, and a control system. The sample probe assembly has a transducer and a sample probe. The air supply assembly has a piezoelectric pump configured to supply an air flow to the sample probe assembly such that the air flow exits the sample probe. The control system determines a relative location of the sample probe based on pressure changes in the air flow detected by the transducer.

Abstract: Reagents are disclosed for use with potentiometric magnesium ion selective electrodes, along with kits containing same as well as methods of use thereof.