Abstract: A method for performing a diagnostic test comprises generating a first visual trigger on a display screen of a mobile device responsive to activation of an application on the mobile device. An image of a diagnostic test presently viewed by a camera incorporated with the mobile device is displayed on the display screen of the mobile device. The diagnostic test has a second visual trigger thereon. The image and the first visual trigger are displayed on the display screen at a same time. An image is captured by the application of the diagnostic test responsive to alignment of the first visual trigger with the second visual trigger on the display screen of the mobile device. The captured image is processed to provide test results for the diagnostic test.

Abstract: An improved system, method and interface for automated rapid antimicrobial susceptibility testing (AST) is disclosed which includes, in one aspect, a carrier population station comprising a workstation having a graphic user interface (GUI). The GUI accepts information from a lab technologist, including information related to a scope of testing to be performed on a patient sample. The GUI controls intelligent assignment of patient samples to test panels in a manner that maximize utilization of the test carrier by grouping together samples of similar tests scopes and advantageously testing those samples using one multiplexed test panel. Customizing workflow in accordance with test scope to facilitate parallel processing of multiple samples advantageously reduces laboratory waste, decreases test latencies, increases AST system throughput and efficiency, and thus lowers the costs to the AST lab.

Abstract: An infusion system may include a strontium-rubidium radioisotope generator that generates a radioactive eluate via elution, a beta detector, a gamma detector, and a controller. The beta detector and the gamma detector may be positioned to measure beta emissions and gamma emissions, respectively, emitted from the radioactive eluate. In some examples, the controller is configured to determine an activity of rubidium in the radioactive eluate based on the beta emissions measured by the beta detector and determine an activity of strontium in the radioactive eluate based on the gamma emissions measured by the gamma detector.

Abstract: The present disclosure is directed to a thin-film element that enables analytes to be analyzed on separate surfaces. In an example, a thin-film element includes a first layer for processing a fluid sample to generate a first analyte and a second analyte. The thin-film element also includes a second layer configured to be impermeable to the first analyte to enable the first analyte to be retained by the first layer and permeable to the second analyte to enable the second analyte to pass through the second layer. The thin-film element further includes a third layer configured to retain the second analyte. The second layer includes a first reflective surface and a second reflective surface to provide reflectance signals indicative of analytes present in the first and third layers to sensors located on opposite sides of the thin-film element.

Abstract: Compounds and methods for use in detecting gabapentin in a sample suspected of containing gabapentin are disclosed. Gabapentin derivatives are used to produce gabapentin conjugates. A gabapentin-immunogenic carrier conjugate may be used as an immunogen for the preparation of an anti-gabapentin antibody. A gabapentin-detectable label may be used in a signal producing system in gabapentin assays.

Abstract: The invention provides analyzers that improve tests for detecting specific cellular, viral, and molecular targets in clinical, industrial, or environmental samples. The invention permits efficient and specific selection and sensitive imaging detection of individual microscopic targets at low magnification. Automated embodiments allow efficient walk-away, on-demand, random-access high-throughput testing. The analyzers perform tests without requiring wash steps thus streamlining engineering and lowering costs. Thus, the invention provides analyzers that can deliver rapid, accurate, and quantitative, easy-to-use, and cost-effective tests for analytes.

Abstract: A microfluidic device has a first substrate, a resilient diaphragm, an actuator, and a second substrate. The first substrate has an opening extending therethrough. The resilient diaphragm is secured to a second side and surrounds the opening. The actuator is secured to a first side and surrounds the opening. The first substrate, the resilient diaphragm, and the actuator cooperate to form a gas-tight chamber. The second substrate has a channel formed therein having a first end and a second end. The second substrate is secured to the first substrate. A volume of gas disposed in the gas-tight chamber pressurizes the gas-tight chamber and expands the resilient diaphragm such that the resilient diaphragm is disposed in the channel between the first end and the second end. The resilient diaphragm retracts from the channel to open the channel from the first end and the second when the gas-tight chamber is depressurized.

Abstract: Devices and methods are provided to detect the presence of bacteria and small microorganisms, and to identify various microbial attributes rapidly.

Abstract: The present disclosure relates generally to methods, compositions, and kits useful for detecting a multiplicity of bacterial genomes present in a sample (e.g., a biological sample obtained from a subject exhibiting one or more signs or symptoms of a bacterial infection). Specifically, the present disclosure relates to nucleic acid primers, primer sets, and multiplicities of primer sets that allow for broad (e.g., species non-specific) detection of bacterial genomes present in such a sample using loop-mediated isothermal amplification (LAMP).

Abstract: A method of characterizing a serum or plasma portion of a specimen in a specimen container provides an HILN (hemolysis, icterus, lipemia, normal) determination. Pixel data of an input image of the specimen container is processed by a classification network to identify whether the specimen contains plasma or serum. Pixel data representing a plasma sample are forwarded to a segmentation/classification/regression network trained with plasma samples for HILN determination. Pixel data representing a serum sample are forwarded to a transformation network, wherein the serum sample pixel data is transformed into pixel data that matches pixel data of a corresponding previously-collected plasma sample by changing sample color, contrast, intensity, and/or brightness. The transformed serum sample pixel data are forwarded to the segmentation/classification/regression network for HILN determination. Quality check modules and testing apparatus configured to carry out the method are also described, as are other aspects.

Abstract: A wash system for use in an in vitro diagnostic immunoanalyzer utilizes a bridge having a linear track to move cuvettes from one incubation ring portion to another incubation ring portion. Washing stations along the linear track provide a magnetic field and fluid washing of cuvette contents independent of the size and motion of one or more incubation rings.

Abstract: Devices, kits, and methods separating and metering a plasma sample from a patient's liquid test sample.

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.

Abstract: A device that can warm a hand of a user and/or patient to facilitate collection of blood samples (e.g., capillary blood sample collection) is described herein. The device provides controlled amounts of heat directed to the palm of a user and/or patient to facilitate collection of high-quality capillary blood samples. The device is designed in such a way to provide a comfortable resting position for the hand that allows heating the hand of the user and/or patient while simultaneously providing access to the finger of the user and/or patient to carry out one or more steps in preparation for collection of capillary blood samples from the finger. The device will also monitor the temperature to limit the max temperature to a safe level, control the palm temperature to a desired level, and use a conductive material to enable rapid heating.

Abstract: Microbial growth media and methods of growing a microorganism. The microbial growth media may include a growth-stimulating amount of phosphoglucomutase in combination with one or more of a carbon and nitrogen source, a fermentable sugar, and an inorganic salt. The methods of growing a microorganism may include culturing a sample suspected of containing the microorganism in a microbial growth medium containing a growth-stimulating amount of phosphoglucomutase. Microbial growth-stimulating protein compositions and uses of same are also provided.

Abstract: Phenotypic antimicrobial susceptibility testing (AST), the gold-standard diagnostic that indicates whether an antimicrobial will be clinically effective, often suffer the slowest times-to-result for the most resistant pathogens. Here we introduce novel assays to be performed in parallel with standard AST assays that provide additional resistance information and enable rapid, same-shift reporting of AST results for a plurality of pathogens.

Abstract: A method of increasing a concentration of an antigen of a respiratory virus is provided. The method includes preparing a sample containing a first concentration of the antigen; contacting the sample containing the first concentration of the antigen to a first material having a negatively-charged surface, thereby capturing an amount of the antigen with the first material; contacting a second material to the first material to transfer the antigen from the first material to the second material, the second material having an ionic strength sufficient to release the captured antigen from the first material into the second material; and obtaining a resulting solution containing the antigen in a second concentration. The second concentration of the antigen in the resulting solution is higher than the first concentration of the antigen in the sample. Numerous other aspects in accordance with this and other embodiments are provided.

Abstract: Disclosed herein are immunoassays for detecting an anti-thyroid peroxidase antibody in a biological sample from a subject and/or diagnosing a thyroid disease in a subject. The disclosed immunoassays employ a recombinant cynomolgus monkey thyroid peroxidase (rTPO) and assess the level of anti-thyroid peroxidase antibody-induced formation or disruption of complexes comprising a solid support and the rTPO.

Abstract: Phenotypic antimicrobial susceptibility testing (AST), the gold-standard diagnostic that indicates whether an antimicrobial will be clinically effective, often suffer the slowest times-to-result for the most resistant pathogens. Here we introduce novel assays to be performed in parallel with standard AST assays that enable rapid, same-shift reporting of AST results for a plurality of pathogens. The assays developed here are further capable of detecting resistance to carbapenems, the most powerful class of beta-lactams commonly used as “last-resort” antimicrobials.

Abstract: A microfluidic device has a first substrate, a resilient diaphragm, an actuator, and a second substrate. The first substrate has an opening extending therethrough. The resilient diaphragm is secured to a second side and surrounds the opening. The actuator is secured to a first side and surrounds the opening. The first substrate, the resilient diaphragm, and the actuator cooperate to form a gas-tight chamber. The second substrate has a channel formed therein having a first end and a second end. The second substrate is secured to the first substrate. A volume of gas disposed in the gas-tight chamber pressurizes the gas-tight chamber and expands the resilient diaphragm such that the resilient diaphragm is disposed in the channel between the first end and the second end. The resilient diaphragm retracts from the channel to open the channel from the first end and the second when the gas-tight chamber is depressurized.