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
-71. (canceled)
A method for assaying for a presence or an absence of an inflammation, comprising:
- (a) 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 a cervicovaginal or a menstrual fluid,
- and wherein the cervicovaginal or the menstrual fluid is retained on the sample collector;
- (b) releasing or extracting a 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
- (c) subjecting the released or extracted nucleic acid to a sequencing analysis, wherein the sequencing analysis detects a presence, an absence, or change of expression level of at least one biomarker indicative of inflammation.
A system for analysis of a vaginal biological sample, said system comprising:
- a sample collector for collecting a vaginal biological sample;
- and
- an extractor comprising:
- a first chamber configured to receive said sample collector via an opening;
- and
- a second chamber adjacent to said first chamber, wherein said second chamber comprises a reagent compartment capable of retaining a solution;
- wherein at least one of said first chamber and said second chamber is breakable in response to a compression force;
- wherein said compression force brings said first chamber in fluid communication with said second chamber, thereby bringing said solution into contact with said vaginal biological sample and to form a mixture of said solution with said vaginal biological sample.
A method for monitoring a health condition of a subject, said method comprising:
- a) using a sample collector to non-invasively collect a vaginal biological sample from a vaginal canal of said subject, wherein said sample collector collects and retains said vaginal biological sample from said vaginal canal;
- b) bringing said sample collector in proximity to an extractor comprising (i) a first chamber configured to receive said sample collector via an opening and (ii) a second chamber adjacent to said first chamber, wherein said second chamber comprises a reagent compartment capable of retaining a solution, wherein at least one of said first chamber and said second chamber is breakable in response to a compression force;
- c) depositing said sample collector through said opening into said first chamber;
- and
- d) applying said compression force to bring said first chamber in fluid communication with said second chamber, thereby bringing said solution into contact with said vaginal biological sample to form a mixture of said solution with said vaginal biological sample.
Dependencies are inferred from the claim text.