The present disclosure provides systems, methods, devices, and kits for analysis of vaginal biological samples. A device for the analysis of vaginal biological samples can include a sample collector, an extractor, and an assay cartridge. A method for the analysis of vaginal biological samples can include detecting the presence or absence of a pathology, a disease, an immune disorder, a reproductive disorder of a subject. The method may further comprise preserving, storing, or transporting the vaginal biological samples. A kit for the analysis of vaginal biological samples can include probe, reagents and instructions for detecting a nucleic acid in the vaginal biological samples.

The invention relates to a vaginal fluid monitoring device embedded into a feminine sanitary pad, said device comprising a stack of the following elements: An absorbent layer (100) configured to be in proximity to, and collect, a vaginal fluid; and A biosensing system (1000) in fluidic connection with said absorbent layer (100), said biosensing system (1000) comprising: A microfluidic chip (200) configured to perform an immunoassay to detect the presence and/or the concentration of at least one target biomarker comprised in a vaginal fluid; Means (300) for providing a readout of the presence and/or the concentration of said at least one target biomarker; and An electrode array (400) located along the microfluidic chip (200) configured to detect and analyze the flow of said vaginal fluid by impedance means; wherein said immunoassay is configured to detect the presence and/or the concentration of at least one target biomarker indicative of a pre-term birth (PTB) risk and/or premature rupture of membrane (PROM) risk. The invention also relates to a method for detecting at least one target biomarker comprised in a vaginal fluid.

A personal hygiene swab includes a handle and an absorbent material secured to the handle. The handle is elongated and has a first end and a second end. The absorbent material includes an open-cell foam and covers a first end of the handle. The second end of the handle extends from the absorbent material. Another personal hygiene swab includes an absorbent material having a central cavity defining an opening at one end of the absorbent material. The absorbent material is stretchable, and a diameter of the central cavity is configured to accept a finger of a user. Removing fluid from a bodily cavity includes inserting a swab through a bodily orifice and into the bodily cavity, rotating the swab in the bodily cavity to absorb fluid in the bodily cavity, and removing the swab from the bodily cavity through the bodily orifice.

The present disclosure relates to methods for predicting time-to-delivery in pregnant women. The methods include predicting that a pregnant woman will deliver within a predetermined time frame if PAMG-1 is determined to be present at a level above a predetermined detection threshold in a vaginal fluid sample obtained from the pregnant woman. Also provided are methods for determining a patient's risk of preterm labor and/or spontaneous rupture of the chorioamniotic membrane.

A device for the collection of biological samples comprising a cylindrical body with a proximal end and a distal end. In addition, the cylindrical body includes a tab located within the cylindrical body, between the proximal end and the distal end; and a stop located on the inner surface of the cylindrical body between the proximal end and the distal end. In addition, the device includes a rod located within the cylindrical body, wherein the rod has a proximal tip and a distal tip sticking out from the distal end of the cylindrical body; and a tab located between the proximal tip and the distal tip. Also, the device includes a brush with a distal connection connected to the proximal tip of the rod, wherein the distal connection is located apart from the stop in the proximal direction. On the other hand, when the rod moves longitudinally along the cylindrical body in the proximal direction, the rod connects the flange to the tab. Furthermore, when the rod moves longitudinally along the cylindrical body in the distal direction, it causes the distal connection of the brush to strike against the cylindrical body stop, causing the brush to detach from the rod.

An at-home medical diagnostic test kit container including a plurality of at-home medical diagnostic test kits is provided herein. In particular, the medical diagnostic test kit container may include a machine-readable code (e.g., QR code) configured to facilitate an augmented reality experience associated with the at-home medical diagnostic test kit container. In some embodiments, a testing and diagnostic platform may facilitate tracking of inventory within the at-home medical diagnostic test kit container and/or may facilitate coordination of prescription medication order fulfillment and delivery upon indication of a medical condition that could benefit from taking prescription medication.

A device for collecting cervical cells for analysis includes a thin saucer-shaped base portion having two opposite concave and convex side faces and having an outer edge which is oval in shape and elongate in form. In addition, the base portion is insertable into the vaginal canal of a female for cell-collecting purposes and includes a leading end which first enters the vaginal canal when the device is directed therein and an opposite trailing end. Furthermore, a plurality of bristles are joined to and extend away from the concave side of the base portion so that by inserting the device along the vaginal canal, the bristles of the device move across and collect cervical cells from the surface of the cervix.

The present disclosure, in certain embodiments, relates to a flexible and non-absorbent vaginal insert device that is easier to insert and remove and is for use in improving and preventing symptoms associated with pelvic organ prolapse and urinary and/or fecal incontinence when the device is inserted. In certain embodiments, the device has an optionally cone-shaped upper portion that provides pelvic organ support and a removal portion or stem that facilitates insertion and removal of the device.

The present disclosure, in certain embodiments, relates to a flexible and non-absorbent vaginal insert device that is easier to insert and remove and is for use in improving and preventing symptoms associated with pelvic organ prolapse and urinary and/or fecal incontinence when the device is inserted. In certain embodiments, the device has an optionally cone-shaped upper portion that provides pelvic organ support and a removal portion or stem that facilitates insertion and removal of the device.

A collection device for a biological sample to capture target compounds such as viruses or other pathogens or particles for testing from within the sample and move the captured target compound to a separate chamber for subsequent processing. The collection device can include an openable substance blister including capture particles located in a cup interior. Capture particles can attract and bind the target compounds from the sample. An extraction tube extracts any nucleic acid from the target compound for storage or subsequent amplification and testing to confirm presence of known microorganisms. The extraction tube can comprise a heat-deformable material and can be connected to a microfluidic cartridge for further processing of nucleic acid including, amplification and detection. The microfluidic cartridge includes valves and a plurality of chambers for amplification.