VAGINAL DETECTION METHODS AND KITS USING A TAMPON
The present invention relates to methods of obtaining a biological sample from the vagina and detecting various conditions (e.g., detecting a sexually transmitted infection, determining the composition of the vaginal microbiome, and detecting dysbiosis) using a tampon. The present invention also relates to kits containing a tampon for use in such methods.
1 . A method for obtaining a biological sample from a subject, comprising obtaining a biological sample from a tampon comprising (i) an absorbent tampon body and (ii) a protective sock around the tampon body; wherein said tampon having been administered to the subject vaginally for a time sufficient to obtain a biological sample on the protective sock.
2 . A method for obtaining a biological sample from a subject, comprising:
(a) obtaining a tampon comprising (i) an absorbent tampon body and (ii) a protective sock around the tampon body; wherein said tampon having been administered to the subject vaginally for a time sufficient to obtain a biological sample on the protective sock; and
(b) obtaining the biological sample from the protective sock.
3 . The method of claim 1 or 2 , further comprising separating the protective sock from the tampon before obtaining the biological sample from the protective sock.
4 . A method for obtaining a biological sample from a subject, comprising:
(a) administering a tampon to the subject vaginally; wherein the tampon comprises (i) an absorbent tampon body and (ii) a protective sock around the tampon body; and
(b) maintaining the tampon in the vagina for a time sufficient to obtain a biological sample on the protective sock.
5 . The method of claim 4 , further comprising (c) removing the tampon from the vagina.
6 . The method of claim 5 , further comprising (d) separating the protective sock from the tampon.
7 . The method of claim 6 , further comprising (e) obtaining the biological sample from the protective sock.
8 . The method of claim 7 , wherein the protective sock is made of industrial hemp fiber.
9 . The method of claim 7 , wherein the protective sock is made of rayon, cotton, or a mixture thereof
10 . The method of any one of claims 1 - 9 , wherein the tampon body is made of industrial hemp fiber.
11 . The method of any one of claims 1 - 9 , wherein the tampon body is made of rayon, cotton, or a mixture thereof.
12 . The method of any one of claims 1 - 11 , wherein the tampon further comprises a pharmaceutical composition comprising an effective amount of cannabidiol (CBD).
13 . The method of any one of claims 1 - 12 , wherein the tampon is maintained in the vagina for at least 20 minutes.
14 . The method of any one of claims 1 - 13 , wherein the biological sample is obtained at least 5 days after the tampon is removed from the vagina.
15 . The method of any one of claims 1 - 14 , wherein the protective sock is stored at room temperature after the tampon is removed from the vagina.
16 . A method to detect a sexually transmitted infection (STI) in a subject, comprising performing a nucleic acid assay on a biological sample to detect and/or quantify the presence of an STI marker; wherein said detecting and/or quantifying of the marker is indicative of an STI in the subject; wherein the biological sample is present on a tampon comprising (i) an absorbent tampon body and (ii) a protective sock around the tampon body; and wherein said tampon having been administered to the subject vaginally for a time sufficient to obtain a biological sample on the protective sock.
17 . A method to detect an STI in a subject, comprising:
(a) obtaining a tampon comprising (i) an absorbent tampon body and (ii) a protective sock around the tampon body; wherein said tampon having been administered to the subject vaginally for a time sufficient to obtain a biological sample on the protective sock; and
(b) performing a nucleic acid assay on the biological sample to detect and/or quantify the presence of an STI marker;
wherein said detecting and/or quantifying of the marker is indicative of an STI in the subject.
18 . A method to detect an STI in a subject, comprising:
(a) administering a tampon to the subject vaginally; wherein the tampon comprises (i) an absorbent tampon body and (ii) a protective sock around the tampon body;
(b) maintaining the tampon in the vagina for a time sufficient to obtain a biological sample on the protective sock; and
(c) performing a nucleic acid assay on the biological sample to detect and/or quantify the presence of an STI marker;
wherein said detecting and/or quantifying of the marker is indicative of an STI in the subject.
19 . The method of any one of claims 16 - 18 , further comprising separating the protective sock from the tampon before performing the nucleic acid assay.
20 . The method of any one of claims 16 - 18 , further comprising isolating the biological sample from the protective sock before performing the nucleic acid assay.
21 . The method of any one of claims 16 - 20 , wherein the nucleic acid assay is polymerase chain reaction (PCR).
22 . The method of claim 21 , wherein the PCR is real-time PCR or quantitative PCR.
23 . The method of claim 21 or 22 , wherein the PCR comprises isolation of DNA from the biological sample, amplification of a DNA sequence of an STI marker, and detection and/or quantification of the amplified sequence.
24 . The method of any one of claims 21 - 23 , wherein the PCR further comprises comparison of the quantified amount of the STI marker to a reference amount of the STI marker.
25 . The method of claim 24 , wherein the STI marker is an aerobic microorganism.
26 . The method of claim 24 , wherein the STI marker is an anaerobic microorganism.
27 . The method of claim 24 , wherein the STI marker is a bacteria, virus, yeast, mycoplasma, or ureaplasma.
28 . The method of claim 24 , wherein the STI marker is a bacteria of the phyla Firmicutes, Actinobacteria, Bacteroidetes, Fusobacteria, or Proteobacteria.
29 . The method of claim 24 , wherein the STI is chlamydia, herpes, genital herpes, HSV-1, HSV-2, hepatitis B, trichomoniasis, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), human papilloma virus (HPV), CMV, chancroid, molluscum contagiosum, scabies, syphilis, gonorrhea, or crabs.
30 . The method of any one of claims 16 - 29 , wherein the protective sock is made of industrial hemp fiber.
31 . The method of any one of claims 16 - 29 , wherein the protective sock is made of rayon, cotton, or a mixture thereof.
32 . The method of any one of claims 16 - 31 , wherein the tampon body is made of industrial hemp fiber.
33 . The method of any one of claims 16 - 31 , wherein the tampon body is made of rayon, cotton, or a mixture thereof.
34 . The method of any one of claims 16 - 33 , wherein the tampon further comprises a pharmaceutical composition comprising an effective amount of CBD.
35 . The method of any one of claims 16 - 34 , wherein the tampon is maintained in the vagina for at least 20 minutes.
36 . The method of any one of claims 16 - 35 , wherein the biological sample is obtained at least 5 days after the tampon is removed from the vagina.
37 . The method of any one of claims 16 - 36 , wherein the protective sock is stored at room temperature after the tampon is removed from the vagina.
38 . A method to determine the composition of the vaginal microbiome of a subject, comprising performing a nucleic acid assay on a biological sample to determine and/or quantify the vaginal microbiome of the subject; wherein the dominant species of bacteria in the biological sample is indicative of the composition of the vaginal microbiome of the subject; wherein the biological sample is present on a tampon comprising (i) an absorbent tampon body and (ii) a protective sock around the tampon body; and wherein said tampon having been administered to the subject vaginally for a time sufficient to obtain a biological sample on the protective sock.
39 . A method to determine the composition of the vaginal microbiome of a subject, comprising:
(a) obtaining a tampon comprising (i) an absorbent tampon body and (ii) a protective sock around the tampon body; wherein said tampon having been administered to the subject vaginally for a time sufficient to obtain a biological sample on the protective sock; and
(b) performing a nucleic acid assay on the biological sample to determine and/or quantify the vaginal microbiome of the subject; wherein the dominant species of bacteria in the biological sample is indicative of the composition of the vaginal microbiome of the subject.
40 . A method to determine the composition of the vaginal microbiome of a subject, comprising:
(a) administering a tampon to the subject vaginally; wherein the tampon comprises (i) an absorbent tampon body and (ii) a protective sock around the tampon body;
(b) maintaining the tampon in the vagina for a time sufficient to obtain a biological sample on the protective sock; and
(c) performing a nucleic acid assay on the biological sample to determine and/or quantify the vaginal microbiome of the subject;
wherein the dominant species of bacteria in the biological sample is indicative of the composition of the vaginal microbiome of the subject.
41 . The method of any one of claims 38 - 40 , further comprising separating the protective sock from the tampon before performing the nucleic acid assay.
42 . The method of any one of claims 38 - 41 , further comprising isolating the biological sample from the protective sock before performing the nucleic acid assay.
43 . The method of any one of claims 38 - 42 , wherein the nucleic acid assay is PCR.
44 . The method of claim 43 , wherein the PCR is real-time PCR or quantitative PCR.
45 . The method of claim 43 or 44 , wherein the PCR comprises isolation of DNA from the biological sample, amplification of total bacterial DNA from the biological sample, and detection and/or quantification of the dominant species of bacteria in the biological sample.
46 . The method of any one of claims 38 - 45 , wherein the protective sock is made of industrial hemp fiber.
47 . The method of any one of claims 38 - 45 , wherein the protective sock is made of rayon, cotton, or a mixture thereof.
48 . The method of any one of claims 38 - 47 , wherein the tampon body is made of industrial hemp fiber.
49 . The method of any one of claims 38 - 47 , wherein the tampon body is made of rayon, cotton, or a mixture thereof.
50 . The method of any one of claims 38 - 49 , wherein the tampon further comprises a pharmaceutical composition comprising an effective amount of CBD.
51 . The method of any one of claims 38 - 50 , wherein the tampon is maintained in the vagina for at least 20 minutes.
52 . The method of any one of claims 38 - 51 , wherein the biological sample is obtained at least 5 days after the tampon is removed from the vagina.
53 . The method of any one of claims 38 - 52 , wherein the protective sock is stored at room temperature after the tampon is removed from the vagina.
54 . A method to detect dysbiosis in a subject, comprising performing a nucleic acid assay on a biological sample to detect dysbiosis in the subject; wherein the biological sample is present on a tampon comprising (i) an absorbent tampon body and (ii) a protective sock around the tampon body; and wherein said tampon having been administered to the subject vaginally for a time sufficient to obtain a biological sample on the protective sock.
55 . A method to detect dysbiosis in a subject, comprising:
(a) obtaining a tampon comprising (i) an absorbent tampon body and (ii) a protective sock around the tampon body; wherein said tampon having been administered to the subject vaginally for a time sufficient to obtain a biological sample on the protective sock; and
(b) performing a nucleic acid assay on the biological sample to detect dysbiosis in the subject.
56 . A method to detect dysbiosis in a subject, comprising:
(a) administering a tampon to the subject vaginally; wherein the tampon comprises (i) an absorbent tampon body and (ii) a protective sock around the tampon body;
(b) maintaining the tampon in the vagina for a time sufficient to obtain a biological sample on the protective sock; and
(c) performing a nucleic acid assay on the biological sample to detect dysbiosis in the subject.
57 . The method of any one of claims 54 - 56 , further comprising separating the protective sock from the tampon before performing the nucleic acid assay.
58 . The method of any one of claims 54 - 57 , further comprising isolating the biological sample from the protective sock before performing the nucleic acid assay.
59 . The method of any one of claims 54 - 58 , wherein the nucleic acid assay is PCR.
60 . The method of claim 59 , wherein the PCR is real-time PCR or quantitative PCR.
61 . The method of claim 59 or 60 , wherein the PCR comprises isolation of DNA from the biological sample, amplification of a DNA sequence of a marker for dysbiosis, and detection and/or quantification of the amplified sequence.
62 . The method of any one of claims 59 - 61 , wherein the PCR further comprises comparison of the quantified amount of the amplified sequence of the dysbiosis marker to a reference amount of the dysbiosis marker.
63 . The method of any one of claims 54 - 62 , wherein dysbiosis is indicated in the subject when less than about 80% of bacteria in the biological sample is Lactobacillus.
64 . The method of claim 63 , wherein the Lactobacillus is L. crispatus, L. iners, L. gasseri , or L. jensenii.
65 . The method of any one of claims 54 - 64 , wherein the dysbiosis is moderate dysbiosis.
66 . The method of claim 65 , wherein moderate dysbiosis is indicated in the subject when from about 20% to about 80% of bacteria in the biological sample is Lactobacillus.
67 . The method of any one of claims 54 - 64 , wherein the dysbiosis is apparent dysbiosis.
68 . The method of claim 67 , wherein apparent dysbiosis is indicated in the subject when less than about 20% of bacteria in the biological sample is Lactobacillus.
69 . The method of any one of claims 54 - 64 , wherein the dysbiosis is apparent mixed dysbiosis, moderate mixed dysbiosis, apparent anaerobic dysbiosis, or moderate anaerobic dysbiosis.
70 . The method of any one of claims 54 - 69 , wherein the protective sock is made of industrial hemp fiber.
71 . The method of any one of claims 54 - 69 , wherein the protective sock is made of rayon, cotton, or a mixture thereof.
72 . The method of any one of claims 54 - 71 , wherein the tampon body is made of industrial hemp fiber.
73 . The method of any one of claims 54 - 71 , wherein the tampon body is made of rayon, cotton, or a mixture thereof.
74 . The method of any one of claims 54 - 73 , wherein the tampon further comprises a pharmaceutical composition comprising an effective amount of CBD.
75 . The method of any one of claims 54 - 74 , wherein the tampon is maintained in the vagina for at least 20 minutes.
76 . The method of any one of claims 54 - 75 , wherein the biological sample is obtained at least 5 days after the tampon is removed from the vagina.
77 . The method of any one of claims 54 - 76 , wherein the protective sock is stored at room temperature after the tampon is removed from the vagina.
78 . A kit, comprising:
(a) a tampon comprising (i) an absorbent tampon body and (ii) a protective sock around the tampon body; and
(b) instructions for obtaining a biological sample with the tampon.
79 . The kit of claim 78 , further comprising a container for storing the tampon after the biological sample is collected.
80 . The kit of claim 78 or 79 , further comprising a self-assessment survey.
81 . The kit of any one of claims 78 - 80 , further comprising a mailing envelope for shipping the tampon after the biological sample is collected.
82 . The kit of any one of claims 78 - 81 , wherein the protective sock is made of industrial hemp fiber.
83 . The kit of any one of claims 78 - 81 , wherein the protective sock is made of rayon, cotton, or a mixture thereof.
84 . The kit of any one of claims 78 - 83 , wherein the tampon body is made of industrial hemp fiber.
85 . The kit of any one of claims 78 - 83 , wherein the tampon body is made of rayon, cotton, or a mixture thereof.
86 . The kit of any one of claims 78 - 85 , wherein the tampon further comprises a pharmaceutical composition comprising an effective amount of CBD.