Abstract: The disclosure provides a computer-implemented method for detecting a failure of a device, wherein the device is connected to a sensor, the method comprising: receiving, by a machine learning model, a trace signal from the sensor indicating a status of the device; encoding, by the machine learning model, the trace signal into a plurality of vector representations; and determining, by the machine learning model, whether the trace signal is valid or invalid based on the plurality of vector representations.

Abstract: This invention relates to a method and device for improving the accuracy and performance of detecting or diagnosing sexually transmitted infections (STIs) or STI-causing pathogens. In one embodiment, the present method and device are related to removing one or more interfering molecules such as urea from urine sample, where these interfering molecules alter the performance of Lateral-Flow Immunoassay (LFA). In one embodiment, an aqueous two-phase system (ATPS) embedded entirely within a porous material allows spontaneous phase separation and the target STI-causing pathogens is concentrated in one of the separated phases. In one embodiment, a detection module such as the Lateral-Flow Immunoassay (LFA) is used in connection with other modules so as to detect or diagnose the sexually transmitted infections or the pathogens associated with STIs with an improved performance.

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: Disclosed herein are methods for using modified liposomes or carrier proteins comprising (i) an acridinium ester (AE), and (ii) a first agent encapsulated by the liposomes and/or (iii) a second agent on the surface of the liposomes or the carrier proteins. Specifically, the disclosed methods provide methods of labeling a target of interest, assaying a biological sample for a target antigen, and detecting a target antigen in a biological sample. Further disclosed herein are methods for increasing the strength of a signal detected by an imaging modality.

Abstract: A method for generating a treatment plan in response to medical test results is provided. The method comprises requesting point-of-care (POC) services from a mobile POC unit, receiving at a server confirmation of delivery of POC services to a patient, receiving at the server one or more test results as a result of operation of a medical testing device used in the POC services, wherein the one or more test results includes a determination of the efficacy and dosage level of a medication, generating at the server an updated digital patient record reflecting the one or more test results, and transmitting by the server to a medical entity a treatment plan based on the efficacy and dosage level determined for the medication, wherein the treatment plan is a dosage regimen for the medication.

Abstract: Systems and methods for rapid determination of microorganism growth and antimicrobial agent susceptibility and/or resistance are disclosed.

Abstract: In one aspect of the present disclosure, a tissue marking system is provided that includes a container and an applicator. The applicator is in the container and is removable therefrom. The applicator includes a tip, a reservoir containing sterile tissue marking dye, and a valve. The valve is configured to open and permit sterile tissue marking dye to flow from the reservoir to the tip of the applicator in response to the tip being pressed against a priming surface. In one embodiment, the system includes a substrate that is removable from the container and includes the priming surface. In another embodiment, the container includes a tray having a compartment that receives the applicator. The tray includes a well that includes the priming surface.

Abstract: Methods for image-based detection of the tops of sample tubes used in an automated diagnostic analysis system may be based on a convolutional neural network to pre-process images of the sample tube tops to intensify the tube top circle edges while suppressing the edge response from other objects that may appear in the image. Edge maps generated by the methods may be used for various image-based sample tube analyses, categorizations, and/or characterizations of the sample tubes to control a robot in relationship to the sample tubes. Image processing and control apparatus configured to carry out the methods are also described, as are other aspects.

Abstract: The invention provides methods for determining the MSI status of a patient by liquid biopsy with sample preparation using hybrid capture and non-unique barcodes. In certain aspects, the invention provides a method of detecting microsatellite instability (MSI). The method includes obtaining cell-free DNA (cfDNA) from a sample of blood or plasma from a patient and sequencing portions of the cfDNA to obtain sequences of a plurality of tracts of nucleotide repeats in the cfDNA. A report is provided describing an MSI status in the patient when a distribution of lengths of the plurality of tracts has peaks that deviate significantly from peaks in a reference distribution.

Abstract: A system and method are provided for collection and testing of a biologic sample in a self-diagnostic test. The system and method comprise collecting by a user of a testing device a biologic sample for use with the testing device, assigning correlative values as test results, and receiving the test results at a server disposed on a network. Some aspects include a mobile application operating on a mobile device with which the user interacts. These aspects allow advertisements and other messages to be presented to the user through the mobile application. Some aspects present different messages to the user based on the type of self-diagnostic test the user is conducting.

Abstract: Negative outcomes experienced by a user in a live software system can be automatically, deterministically, and contemporaneously traced back to the root conditions that caused those outcomes, by generating causal event entries in a database for those root conditions as they occur, assigning unique causal IDs to those causal events, and propagating causal IDs alongside the software system state changes that are known to produce negative outcomes and which are effected by those root conditions. By selectively passing causal IDs based on the input and output values of the operation, subsequent causal events and negative outcomes can be linked accurately to causal IDs of parent events, making it simpler to trace negative outcomes for the user back to their root cause events in a software system.

Abstract: An optical discrimination apparatus adapted for use in PCR testing and the like. The apparatus includes a multi-color light emitter to emit excitation light, a sample holder configured to hold dye-marked nucleic acid fragments in a PCR solution at a position configured to receive the excitation light along a first direction, light emission collection optics configured to collect scattered excitation light and light emission (fluorescent emission) from the sample holder along a second direction that is approximately orthogonal to the first direction, a spectrally-dispersive element configured to spectrally disperse scattered light and emission light, and a spectral detector configured to receive the separated emission light and excitation light on different photosites of the spectral detector. Systems and methods are provided, as are other aspects.

Abstract: Methods and reagents are disclosed for minimizing a false result in an assay measurement for determining a concentration of an analyte in a sample suspected of containing the analyte. The method comprises pretreating both an antibody and a sample to be subjected to a non-agglutination immunoassay. In the method the antibody and the sample are combined with a pretreatment agent selected from the group consisting of hydroxyphenyl-substituted C1-C5 carboxylic acids and metallic salts thereof and halogen-substituted C1-C5 carboxylic acids and metallic salts thereof in an amount effective to enhance the accuracy of the non-agglutination immunoassay.

Abstract: A system and method are provided for collection and testing of a biologic sample. The system and method comprise collecting by a user of a testing device a biologic sample for use with the testing device, assigning correlative values as test results, and receiving the test results at a server disposed on a network. Some aspects further include presenting advertisements and other messages to users through a mobile application operating on a mobile device. These aspects take into account the results of the self-diagnostic test and present different advertisements to the user based on the results of the test.

Abstract: An apparatus, vortex generator assembly and method for automated cell lysis and nucleic acid purification and processing. The vortex generator assembly includes sample holder having a lysis well, at least one wash well, and an elution well. The vortex generator assembly also includes a sample holder cover having a plurality of vibration rods for creating a vortex in the wells of the sample holder. The apparatus includes motor operating a rotating cam to cause the vibration rods to vibrate and create the vortex in a well holding fluid and magnetic beads, wherein the vortexing speed is sufficient to overcome the magnetic attraction between the beads and disperse the beads in solution, to collect nucleic acids such as DNA.

Abstract: A sample holder for PCR processing. The sample holder includes a body with an inlet and outlet grooves formed alongside each other, a detection recess that is connected to the inlet and outlet grooves, and a fill port interconnected to both the inlet and outlet grooves, and a cover interfacing with the body to form an inlet channel interconnected to the fill port, a detection region interconnected to the inlet channel, and an outlet channel interconnected to the detection region and the fill port. The detection region is configured to receive a PCR solution from the fill port and replication occurs within the detection region via heating and cooling cycles. Thereafter, fluorescent emissions from tagged replicated DNA/RNA in the detection region are detected and measured. PCR stations, PCR station assemblies, PCR testing systems, and methods of operating a PCR testing systems are provided, as are other aspects.

Abstract: A method for a microfluidic testing device includes pumping a portion of a biologic sample into each of a first plurality of parallel pathways from the first reservoir using a micro-pump, applying a separate treatment agent of the plurality of treatment agents within each of the first plurality of parallel pathways to the portion of the biologic sample within the parallel pathway, pumping a second portion of the biologic sample into a selected second parallel pathway associated with a determined treatment agent of a second plurality of parallel pathways from the first reservoir using a second micro-pump, applying the determined treatment agent at a plurality of different dosage levels within the selected second parallel pathway to the second portion of the biologic sample within the selected second parallel pathway, and determining a dosage level of the plurality of different dosage levels of the determined treatment agent providing the treatment efficacy.

Abstract: A system for transporting a sample in a clinical analysis system includes a sample container holding the sample, a ferromagnetic base connected to a bottom portion of the sample container, and a puck. The puck is used for transporting the sample container in the clinical analysis system. The puck comprises an embedded magnet for securing the sample container to the puck using the ferromagnetic base.

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: 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.