Sample collection and preservation devices, systems and methods
AssigneeNextgen Jane, Inc.
InventorsRidhi Tariyal, Stephen K. Gire
Life of this patent
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Abstract
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.
Claims20
A method for assaying for a presence or absence of a vaginal or menstrual microbiome, comprising:
- obtaining a sample collector enclosed in an extractor, wherein the sample collector comprises an absorbent-diffuse material and is configured to collect a biological sample from a vaginal canal of a female subject wherein the biological sample comprises vaginal or menstrual fluid,
- and wherein the vaginal or menstrual fluid is retained on the sample collector;
- releasing or extracting nucleic acid from the sample collector with a solution comprised in the extractor, wherein a moveable compression element closes onto a breakable reagent compartment of the extractor to release the solution, wherein the solution contacts the sample collector when the sample collector is fully enclosed in the extractor, wherein the solution is free to flow between the sample collector and the extractor;
- and
- subjecting the released or extracted nucleic acid to a sequencing analysis, whereby the sequencing analysis detects a presence or absence, or change of expression level of at least one biomarker indicative of a vaginal or menstrual microbiome.
Dependencies are inferred from the claim text.