Systems and methods for providing a universal platform for at-home health testing and diagnostics are provided herein. In particular, a health testing and diagnostic platform is provided to connect medical providers with patients and to generate a unique, private testing environment. In some embodiments, the testing environment may facilitate administration of a medical test to a patient with the guidance of a proctor. In some embodiments, the patient may be provided with step-by-step instructions for test administration by the proctor within a testing environment. The platform may display unique, dynamic testing interfaces to the patient and proctor to ensure proper testing protocols and accurate test result verification.

A method is provided for testing for presence of a particulate selected from the group consisting of: a microorganism, a fungus, a bacteria, a spore, a virus, a mite, a biological cell, a biological antigen, a protein, a protein antigen, and a carbohydrate antigen. The method includes (a) collecting, in a tube (22), fluid that potentially contains the particulate, (b) using a plunger (24) to push the fluid through a filter (26) disposed at a distal portion of the tube or at a distal end of the plunger, and subsequently, (c) while the filter is inside the tube, ascertaining if any of the particulate was trapped by the filter by applying a particulate-presence-testing-facilitation solution to the filter. Other embodiments are also described.

The invention relates to a respiratory secretion sample collection device that includes a collection reservoir for directly receiving a sample of a respiratory secretion, a displacement member for insertion into the collection reservoir and displacing the sample within the collection reservoir, a container of a diluent for fluid communication with the sample for mixing the diluent with the sample, and an outlet for discharging the mixture of the diluent and the sample to an assay device. In embodiments, the precise volumes of the sample and the diluent are effectively mixed to enable the conduct of assays for which the relative concentration of diluent and sample is critical.

Improved assessment of brain injuries, and improved brain injury management, is achieved using a combination of impact-related data derived from instrumented mouthguard devices, human function performance testing, and biomarkers derived from biological fluid (such as saliva and/or blood). The human function performance testing may include brain function performance testing, and/or other forms of human function performance testing. This involves combining a data-driven understanding of a head impact event (based on data collected via an instrumented mouthguard device) with a data-driven understanding of human function performance following that head impact event. The biomarkers may include salivary mRNA and/or ncRNA, and/or blood proteins (for example via a FDA-approved Brain Trauma Indicator test).

The disclosure relates to devices, solutions and methods for collecting and processing samples of bodily fluids containing cells (as well as embodiments for the collection, and processing and/or analysis of other fluids including toxic and/or hazardous substances/fluids). In addition, the disclosure relates generally to function genomic studies and to the isolation and preservation of cells from saliva and other bodily fluids (e.g., urine), for cellular analysis. With respect to devices for collection of bodily fluids, some embodiments include two mating bodies, a cap and a tube (for example), where, in some embodiments, the cap includes a closed interior space for holding a sample preservative solution and mates with the tube to constitute the (closed) sample collection device. Upon mating, the preservation solution flows into the closed interior space to preserve cells in the bodily fluid. The tube is configured to receive a donor sample of bodily fluid (e.g., saliva, urine), which can then be subjected to processing to extract a plurality of cells. The plurality of cells can be further processed to isolate one and/or another cell type therefrom. The plurality of cells, as well as the isolated cell type(s), can be analyzed for functional genomic and epigenetic studies, as well as biomarker discovery.

The disclosure relates to devices, solutions and methods for collecting and processing samples of bodily fluids containing cells (as well as embodiments for the collection, and processing and/or analysis of other fluids including toxic and/or hazardous substances/fluids). In addition, the disclosure relates generally to function genomic studies and to the isolation and preservation of cells from saliva and other bodily fluids (e.g., urine), for cellular analysis. With respect to devices for collection of bodily fluids, some embodiments include two mating bodies, a cap and a tube (for example), where, in some embodiments, the cap includes a closed interior space for holding a sample preservative solution and mates with the tube to constitute the (closed) sample collection device. Upon mating, the preservation solution flows into the closed interior space to preserve cells in the bodily fluid. The tube is configured to receive a donor sample of bodily fluid (e.g., saliva, urine), which can then be subjected to processing to extract a plurality of cells. The plurality of cells can be further processed to isolate one and/or another cell type therefrom. The plurality of cells, as well as the isolated cell type(s), can be analyzed for functional genomic and epigenetic studies, as well as biomarker discovery.

Example embodiments of the present invention include various compositions that include a pH modifier composition and/or a buffering capacity modifier composition. In some examples, the pH modifier compositions include a dose of pH modifier to raise the pH in a patient's mouth from about 1 to about 2 pH levels. The compositions are then incorporated into various confections for oral ingestion or application that allow a patient to easily use the composition with the pH and/or buffering capacity modifiers. For example, compositions with the pH and/or buffering capacity modifiers can be incorporated within chewing gum, tablets, lozenges, breath strips, hard candy, oral sprays, and other confections. Another embodiment of the invention includes a testing device to test the pH and buffering capacity within a patient's mouth.

One or more methods for sampling gingival metabolites and biomarkers.

A device for determining the presence and/or quantity of one or more analytes in a sample of human body fluid has a container for receiving a sample of body fluid, with an interior that is delimited by a base and by a circumferential surface. It further comprises at least one test strip and a holding element for receiving and holding the one or more test strips. The holding element is designed such that it has a shape corresponding and adapted to the peripheral circumferential surface of the container. The device further comprises an elongate sampling element having an absorbent sampler that takes up the sample of body fluid and by means of which the sample of body fluid is transferred into the container. The sampling element can include an indicator strip for determining whether the amount of liquid sample sufficient for carrying out an assay.

The present invention generally relates to collecting, determining and/or transmitting information associated with the process of receiving bodily fluid through a device opening and/or delivering substances to a subject. In one aspect, the device includes an information collecting portion and a fluid receiving portion. In another aspect, the two portions are constructed and designed to attach to one another. In one embodiment, actuation of one of the portions causes the other portion to actuate. Methods of time keeping and information transmission are also discussed.