Disclosed is a covalently-linked multilayered three-dimensional matrix comprising capture molecules, linkers and spacers (referred to as a Molecular Net) for specific and sensitive analyte capture from a sample. Also disclosed herein is a Molecular Net comprising covalently-linked multilayered three-dimensional matrix comprising more than one type of capture molecule and more than one type of linker and may comprise one or more spacer for specific and sensitive capture of more than one type of analyte from a sample. A Molecular Net may comprise a pseudorandom nature. Use of various capture molecules, linkers and spacers in a Molecular Net may confer unique binding properties to a Molecular Net. Porosity, binding affinity, size exclusion abilities, filtration abilities, concentration abilities and signal amplification abilities of a Molecular Net may be varied and depend on the nature of components used in its fabrication. Uses of a Molecular Net may include analyte capture, analyte enrichment, analyte purification, analyte detection, analyte measurement and analyte delivery. Molecular Nets may be used in liquid phase or on solid phases such as nanomaterials, modified metal surfaces, nanospheres, microspheres, microtiter plates, slides, pipettes, cassettes, cartridges, discs, probes, lateral flow devices, microfluidics devices, microfluidics devices, optical fibers and others.

The present invention is directed to a biosensor (10) having a photonic sensing device (20), a sheet of a porous material (60), and an optically clear cover layer (70). The optically clear cover layer (70) may be removable and replaceable, whereby the sheet of porous material (60) can be replaced, and the photonic sensing device (20) can be re-used. Detection devices (810, 910) that include the biosensor (10), as well as methods of making and using the biosensor (10) are also disclosed.

Test devices to detect pregnancy in a human female subject are provided. In various embodiments, test devices include an assay means to measure the absolute or relative amount of hCG in a sample from the subject; an assay means to measure the absolute or relative amount of FSH in a sample from the subject; and an assay means to measure the absolute or relative amount of one or more progesterone metabolites in a sample from the subject.

Disclosed herein are devices, systems, methods and kits for performing immunoassay tests to detect for at least progesterone or analytes of progesterone on a sample in association with diagnosing problems and issues associated with corpus luteum functionality. The immunoassay devices and methods may be used in conjunction with diagnostic reader systems and/or a base unit for obtaining a sensitive read-out of the immunoassay results. The immunoassay devices and methods may utilize a competitive binding-like assay and a sandwich binding assay to detect at least progesterone or analytes of progesterone in a sample.

Disclosed herein are devices, systems, methods and kits for performing immunoassay tests to detect for at least progesterone or analytes of progesterone on a sample in association with diagnosing problems and issues associated with corpus luteum functionality. The immunoassay devices and methods may be used in conjunction with diagnostic reader systems and/or a base unit for obtaining a sensitive read-out of the immunoassay results. The immunoassay devices and methods may utilize a competitive binding-like assay and a sandwich binding assay to detect at least progesterone or analytes of progesterone in a sample.

An improved electronic diagnostic device for detecting the presence of an analyte in a fluid sample comprises a casing having a display, a test strip mounted in the casing, a processor mounted in the casing, and a first sensor mounted in the casing and operatively coupled to the processor. The processor is configured to receive a signal from the first sensor when the device is exposed to ambient light thereby causing the device to become activated. The device includes a light shield that exerts pressure across a width of the test strip to prevent fluid channeling along the length of the test strip. The processor is configured to present an early positive test result reading when a measured value exceeds a predetermined early reading threshold value at any time after a predetermined early testing time period.

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 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.

The present invention describes a whole blood assay chip that enables separation of the cellular compartment from surrounding plasma, facilitating multiplexed measurement of otherwise difficult to detect soluble factors produced upon cellular stimulation. The invention is a microfluidic chip with an incubation chamber comprising an inlet, an outlet, and a fluidic barrier. Using this platform, the cellular compartment can be stimulated with various substances and levels of immunologic biomarkers could be measured. Through a proprietary immunologic algorithm described herein, this would allow for the diagnosis of an allergic response to foods, antibiotics, and/or other drugs. Additional applications of the invention besides allergy testing could include pregnancy testing, blood type, and medical applications requiring whole blood cellular stimulation readouts.

The present disclosure is on a premise that the inventors of the present disclosure surprisingly observed that an electrode attached with graphene-polypyrrole based nano-composites can significantly improve the conductivity of the electrode, which in turn can significantly improve limit of detection (LOD) of the electrochemical device enabling quantitative detection of biological target in a sample to the tune of 0.5 fg/mL. Accordingly, an aspect of the present disclosure relates to an improved electrode for an electrochemical device, the electrochemical device capable of detecting a biological target in a sample, wherein at least part of a surface of the electrode is attached with a graphene-polypyrrole based composite, and wherein the graphene-polypyrrole based composite is attached with at least one biological targeting moiety. Aspects of the present disclosure also provide a method of the fabrication of the advantageous electrode of the present invention, an electrochemical device including the advantageous electrode and method of detection of a biological target.