The present disclosure provides a device for collection of an endocervical or vaginal sample, as well as a method of using the device to collect a sample a subject and perform an assay. The collection device includes a resiliently deformable ring, a flexible membrane coupled to the ring which defines a collection reservoir, and a retrieval element configured for removal of the device.

A swab device, according to an example, includes a handle shaft, and a collection element positioned at a distal end of the handle shaft to collect a biological sample. The swab device includes an embedded test element to perform a test on the collected sample and provide an indication of a result of the test.

The present invention relates to the field of medical diagnostics and more specifically, to identification of amniotic fluid.

A kit and method for collecting body fluid for medical diagnosis. In some embodiments, the method includes collecting a sufficient amount of body fluid and cells comprising nucleic acid, and applying a nucleic acid assay to detect pathogenic genomic material such as human papillomavirus mRNA and/or human papillomavirus DNA. In some embodiments, by testing fluid and cells, a sensitivity of the test is improved. In some embodiments, the method includes inserting an absorbing member into a body orifice, such as the vagina, for a time period such as 1-2 hours; retrieving the absorbing member and placing it in a sample container; extracting fluid from the absorbing member using a fluid extraction device, and testing the fluid. In some embodiments, the kit is a home use kit and the sample is self collected by a user.

The present invention discloses a vaginal microbiota collection device and modular preservation unit comprising a means to collect and preserve the vaginal microbiota from an individual, a means to distribute the harvested microbiota, or both. The means to distribute the harvested microbiota comprises a collection apparatus with one or more modular components. The vaginal microbiota is distributed based on need or validation. The collection and preservation of the vaginal microbiota is accomplished by a piston mechanism. The present invention also discloses a method of harvesting vaginal microbiota using the device disclosed herein.

A method of analyzing vaginal fluid includes collecting vaginal fluid in a vaginal fluid collecting system and transporting the collected vaginal fluid to a location for analysis. The analysis can be stored in and retrieved from a secure cloud storage data base.

Provided herein are methods and devices for the detection of conditions or disorders by detecting altered levels of stress response pathway biomarkers. Also provided are methods and reagents for identifying panels of biomarkers associated with a condition or disorder.

The present disclosure relates to gastrointestinal (GI) tract detection methods, devices and systems.

Disclosed herein are methods and kits for performing microbiome analysis in the field of microbiology. More specifically, disclosed herein are methods and kits for remote sample collection and sample preservation so that analysis may be performed on the sample in a laboratory.

The present invention provides devices and systems for use at the point of care. The methods devices of the invention are directed toward automatic detection of analytes in a bodily fluid. The components of the device are modular to allow for flexibility and robustness of use with the disclosed methods for a variety of medical applications.