Abstract: An apparatus useful for the rapid collection of blood from a subject (e.g., a blood vessel, such as the vein, artery or capillary bed of a bovine subject) and dispensing the blood therefrom into a test or collection device. In general, the apparatus comprises: (a) a body having a chamber formed therein, said chamber having an inlet and outlet, with said chamber configured to draw blood therein; (b) a hollow barrel connected to said chamber outlet; (c) an ejector operatively associated with said barrel; (d) a hollow needle connected to said body, with said hollow needle in fluid communication with said chamber through said inlet, so that blood can be rapidly drawn into said chamber through said needle. The needle is optionally removed and blood dispensed from the body into a test or collection device by actuating the ejector.

Abstract: Barcode tag conditions on sample tubes are detected utilizing side view images of sample tubes for streamlining handling in clinical laboratory automation systems. The condition of the tags may be classified into classes, each divided into a list of additional subcategories that cover individual characteristics of the tag quality. According to an embodiment, a tube characterization station (TCS) is utilized to obtain the side view images. The TCS enables the simultaneous or near-simultaneous collection of three images for each tube, resulting in a 360 degree side view for each tube. The method is based on a supervised scene understanding concept, resulting in an explanation of each pixel into its semantic meaning. Two parallel low-level cues for condition recognition, in combination with a tube model extraction cue, may be utilized. The semantic scene information is then integrated into a mid-level representation for final decision making into one of the condition classes.

Abstract: Provided herein are antibodies and antigen-binding antibody fragments that bind to human soluble Growth Stimulation-Expressed Gene 2 (ST2) protein, kits containing these antibodies and antibody fragments, and methods of using these antibodies and antibody fragments.

Abstract: A fluid analyzer for analyzing fluid samples comprising one or more analytes and a method of calibrating such. The fluid analyzer includes a control system to control at least one automated valve to pass at least three calibration reagents through a fluid channel to a secondary ion selective electrode, a primary ion selective electrode, and a reference electrode, and determine calibration information using calibration logic from signals generated by a meter, control the at least one automated valve to selectively pass different subsets of the at least three calibration reagents through the fluid channel to the secondary ion selective electrode, the primary ion selective electrode, and the reference electrode, and determine re-calibration information using the signals generated by the meter and at least one of the calibration information and re-calibration logic.

Abstract: In one aspect, the inventive concepts disclosed herein are directed to a sensor assembly which contains a first planar substrate and a second planar substrate which respectively support opposing sensor arrays and contains an integrated flow path extending between the first and second substrates. Sensor assembly contains a first planar substrate having a base layer, and a conductive layer formed on a first planar surface of the base layer. Base layer may be made from, for example, ceramic, polymer, foil, or any other type of material known to someone of ordinary skill in the art. Conductive layer contains at least at least two electrically isolated electrical contacts made, for example, using a thick film approach (e.g., screen printing, rotogravure, pad printing, stenciling conductive material such as carbon, Cu, Pt, Pd, Au, and/or Nanotubes, etc.) or a thin firm approach (e.g., by sputtering, thermal spraying, and/or cold spraying conductive material).

Abstract: A model-based method of inspecting a specimen for presence of an interferent (H, I, and/or L). The method includes capturing images of the specimen at multiple different exposures times and at multiple spectra having different nominal wavelengths, selection of optimally-exposed pixels from the captured images to generate optimally-exposed image data for each spectra, identifying a serum or plasma portion of the specimen, and classifying whether an interferent is present or absent within the serum or plasma portion. Testing apparatus and quality check modules adapted to carry out the method are described, as are other aspects.

Abstract: The present disclosure relates to methods and devices for amplifying a plurality of targets in a single PCR run while distinguishing between clinically relevant amplification and amplification from other sources such as from background contamination. The methods and devices further enable discrimination between gram-positive, gram-negative and fungal infections as wells as identify antimicrobial resistance genes. When applying the methods and devices of the invention, the species or genus of an infection(s), and genus of a fungal co-infection(s) or category of bacterial (gram-positive or negative) co-infection(s) are identified. Species identification of co-infections can also be achieved. Further, when applying the methods and devices of the invention, organisms which are likely to be contaminating organisms from a blood draw are identified.

Abstract: Measurement of circulating ST2 and natriuretic peptide (e.g., NT-proBNP) concentrations is useful for the prognostic evaluation of subjects, in particular for the prediction of adverse clinical outcomes, e.g., mortality, transplantation, and heart failure.

Abstract: An apparatus configured for displacing fluid from a fluid container comprises first and second actuators configured to be movable together until the first actuator compresses a first part of the fluid container and then moveable independently until the second actuator compresses a second part of the fluid container. Fluid containers comprise a first vessel, a second vessel, and a sealing partition preventing fluid flow from the second vessel and further include a piercing point for piercing the sealing partition to permit fluid flow from the second vessel. A fluid container comprises a vessel configured to be collapsed to displace fluid from the vessel, a housing surrounding at least a portion of the vessel, and a floating compression plate movably disposed within the housing and configured to permit an external actuator to press the compression plate into the vessel to collapse the vessel and displace the fluid contents therefrom.

Abstract: A concentrated sample having enhanced concentration of the one or more different populations of target rare molecules is incubated with, for each different population of target rare molecules, a particulate or non-particulate affinity agent that comprises a specific binding partner that is specific for and binds to a target rare molecule. The affinity agent comprises a mass spectrometry (MS) label precursor or a first alteration agent, which either facilitates the formation of an MS label from the MS label precursor or releases an entity that comprises the MS label precursor from the affinity agent. The MS label corresponds to one of the populations of target rare molecules. A second alteration agent is employed if the first alteration agent does not facilitate the formation of an MS label from the MS label precursor. MS analysis is used to determine each different MS label.

Abstract: The present disclosure relates to normalization of biological samples, particularly samples comprising nucleic acids to be sequenced. The normalization protocols described herein may be utilized across multiple samples to cap total stoichiometric input and minimize variations in transcript abundance on a per-sample basis in a multiplexed fashion to dramatically increase the accuracy, capacity and efficiency of nucleic acid sequencing.

Abstract: The invention provides novel methods and kits for fully automated high-throughput method for isolation of extracellular vesicles and co-isolation of cell-free DNA from biofluids, including cell-free DNA and/or cell-free DNA and nucleic acids including at least RNA from microvesicles, novel methods and kits for isolation of extracellular vesicles and co-isolation of cell-free DNA from biofluids, including cell-free DNA and/or cell-free DNA and nucleic acids including at least RNA from microvesicles that do not require the use of phenol or chloroform, and for extracting nucleic acids from the extracellular vesicles and/or from the biological samples.

Abstract: An extended wear electrocardiography patch is provided. A flexible backing includes an elongated strip of stretchable material. An electrocardiographic electrode is respectively affixed to and conductively exposed on each end of the elongated strip. A flexible circuit is affixed on each end to the elongated strip and includes a pair of circuit traces each originating within one of the ends of the elongated strip and coupled to one of the electrocardiographic electrodes. A non-conductive receptacle securely adhered on the one end of the elongated strip and includes electrode terminals aligned to interface the pair of circuit traces to an electrocardiography monitor to obtain electrocardiographic signals through the electrocardiographic electrodes.

Abstract: A system for facilitating a cardiac rhythm disorder diagnosis with the aid of a digital computer is provided. A download station retrieves cutaneous action potentials of a patient recorded over a time by an ECG device as ECG data. An R-R interval plot of the ECG data includes R-R intervals plotted along an x-axis of the plot and heart rates associated with the R-R intervals plotted along a y-axis. The R-R intervals are calculated as a difference between recording times of successive pairs of R-wave peaks. Each heart rate is associated with each time difference. One or more portions of the R-R intervals are identified in the plot. Each portion of the R-R intervals includes a cardiac event. Report strips are generated and each includes one portion of the R-R intervals and a portion of the ECG data. The report strips are included in a cardiac report for the patient.

Abstract: Methods and apparatus configured and adapted to provide less carryover in an automated clinical analyzer are disclosed. The methods include aspirating a scavenger segment (e.g., a buffer- and surfactant-containing segment) into the interior of a pipette along with the specimen or reagent. The scavenger film aids in preventing adherence of the specimen or reagent to the interior of the pipette. Apparatus configured to carry out the methods are provided, as are other aspects.

Abstract: The invention, depending on aspect and embodiment, relates to capture probe controls, and capture and signal probe configurations and combinations of configurations that can facilitate accurate and efficient multiplex analyte detection, especially in electrochemical detection schemes.

Abstract: The present disclosure provides method and products for the selective enrichment of one population of DNA in a mixed sample comprising multiple populations of DNA. In some embodiments, the mixed sample comprises one or more populations of microbial DNA and the mammalian host DNA, particularly including pathogenic microbial DNA mixed with mammalian host DNA in a clinical sample from an infected individual.

Abstract: The timing of the reaction of moisture-sensitive reagents for detecting the presence of analytes, e.g. leukocytes in urine samples, is used to detect when the reagents have been compromised by excess humidity. The ratio of light reflectance at wavelengths characteristic of the products of reaction between the reagents and the analyte and an infra-red reference dye is measured at two preset times after a urine sample has been applied to a test strip and used to determine whether the reagents have been compromised by excessive humidity. The presence of unusually dark samples is determined from the reflected light at 470 and 625 nm in order to confirm that the test strips are humidity-compromised.

Abstract: The invention relates generally to a process for isolating subpopulations of EVs to identify biomarkers useful identifying, determining the progression of, and/or prognosing a disease, including a neurological disease. More particularly, the present invention relates to detection technology of various exosomal biomarkers including proteins, protein modifications, sugars, RNA, DNA, lipids, and metabolites, and combinations thereof.