Devices and methods for the detection of analytes are disclosed. Devices and methods for detecting food-borne pathogens are disclosed.

A system and method are provided for presenting self-diagnostic test instructions in the form of audiovisual messages. The system and method include collecting by a user of a testing device a biologic sample for use with a testing device, assigning correlative values as test results, and receiving the test results at a server disposed on a network. Some aspects of the system and method present test instructions to the user in the form of audiovisual messages. The audiovisual messages are provided to the user as a response to an interaction with a retail diagnostic product. In some aspects, the complete audiovisual message is presented before the user may complete a self-diagnostic test.

A method for providing immunoassay test results includes collecting at least one biologic with a testing device, conjugating the biologic with particles on a conjugate pad of a test strip to create an immune complex, binding antigens or antibodies of the immune complex to antigens or antibodies of a test line, providing a software application to be stored on a mobile device having a camera; capturing an image of the testing device, including a color mosaic having at least one color value corresponding to a positive test result, comparing the color values of the test line image to the color values of the image of the color mosaic, determining if the color values of the image of the test line are within a predetermined range of the at least one color value of the image of the color mosaic corresponding to a positive test result; and presenting test results on the viewing screen.

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.

A secure assay device is disclosed herein that provides: an assay or a test device that provides at least one result, wherein the assay or test device comprises at least one surface which exhibits optical change in response to at least one target particle, at least one marker or a combination thereof; and at least one multi-layer coating that at least partially covers the assay membrane, the assay device or a combination thereof, wherein the multi-layer coating blocks or impairs the user visualization of the optical change, the at least one result or a combination thereof. A secure reader and method of utilizing the secure assay device and secure reader are disclosed herein.

An immunoassay device that authenticates a biological sample while performing an assay for an analyte or analytes of interest is provided. The device includes a sample receiving zone to receive the biological sample; a validation zone placed before or after the sample receiving zone to validate the biological sample; a conjugate zone having labels conjugated with primary antibodies or reagents specific to a plurality of characteristic markers of the biological sample and the analytes of interest; and a reaction zone having secondary antibodies or antigens or reagents specific to the primary antibodies or reagents that bind with the plurality of characteristic markers of the biological sample and analytes of interest.

It was discovered that hydrogel scaffolds can be used to induce phase separation as aqueous two-phase systems (ATPSs) pass through and/or rehydrate the scaffolds, allowing for concentration of target analyte(s) (e.g., biomolecule(s)) into a particular phase of the ATPS or into a leading front. Accordingly, in various embodiments methods and devices are provided that utilize aqueous two-phase systems and hydrogel scaffolds to improve the sensitivity of assays (e.g., of point-of-care assays) without sacrificing cost or ease of use.

Multilayer diagnostic microfluidic devices for the capture of a present or past SARS-CoV-2 infection and/or COVID-19 disease from a fluid sample using a multiplexed ELISA-based assay and their methods of use are described herein. The devices comprise a sample application layer comprising a sample application zone: a conjugation layer comprising a conjugation reagent in a conjugation zone, wherein the conjugation reagent comprises a detectable marker; a capture layer comprising a capture reagent in a capture zone; and an absorbent layer. The layers above tire capture layer are removable to expose a detectable signal in the capture zone. Detectable analytes include a SARS-CoV-2 protein or an antigenic fragment thereof, an IgM, IgG, or IgA antibody associated with a SARS-CoV-2 infection and or COVID-19 disease, or an inflammatory biomarker associated with a SARS-CoV-2 infection and/or COVID-19 disease.

Diagnostic devices for performing diagnostic tests are provided, as well as methods that utilize the diagnostic devices, methods for manufacturing the diagnostic devices, and test kits for performing the diagnostic tests. The diagnostic devices include a vial, a rupturable container disposed in an internal cavity of the vial and containing a fluid, and a test and readout device in fluid communication with the internal cavity of the vial. The rupturable container is configured to rupture during a test procedure of the diagnostic test to enable the fluid to flow into the internal cavity of the vial. The rupturable container may include a rupturable ampoule or a frangible seal. The rupturable container may be ruptured by deformation of the vial or by piercing caused by a sharp object in the vial or a sample swab inserted in the vial.

The invention relates to systems and methods for the determination of degree and distribution of pectin homogalacturonan (HG) methyl-esterification. The systems comprise a sheet, at least one labeled anti-pectin detection antibody, and a Template Guide. The sheet may comprise an absorbent portion and a membrane portion; an absorbent portion, a membrane portion, and a conjugate portion; or an absorbent portion, a membrane portion, a conjugate portion, and a sample portion. The membrane portion comprises a Control Zone with at least one immobilized unlabeled capture reagent and a Test Zone with at least one immobilized unlabeled anti-pectin capture antibody. When the sheet comprises a conjugate portion, the at least one labeled anti-pectin detection antibody is on the conjugate portion. The system may optionally comprise a container with the at least one labeled anti-pectin detection antibody.