Abstract
The present invention relates to a self-sampling kit and method for the universal sampling of at least one specimen such as a cell, cell residue, DMA, RNA, protein, virus, bacterium, parasite or fungus from the vaginal and/or rectal cavities of humans and animals, said kit comprising a self-sampling cloth (10) made of a flexible fabric with an absorbancy of 3.5 g/g or less and a sealable recipient (50) for storing and transporting said sampling cloth (10). The present invention also relates to the use of the self-sampling cloth (10) for self-sampling of at least one specimen from bodily cavities of humans and animals, for instance for diagnosing an STI, such as an HPV infection.
Claims
1-44. (canceled)
45. Self-sampling kit for self sampling at least one specimen from bodily cavities of humans and animals comprising a sampling cloth (10) made of a flexible fabric with an absorbancy of 3.5 g/g or less and a sealable recipient (50) for storing and transporting said sampling cloth (10).
46. Self-sampling kit according to claim 45, wherein said at least one specimen is a cell, cell residue, DNA, RNA, protein, virus, bacterium, parasite, or fungus.
47. Self-sampling kit according to claim 45, wherein, wherein said bodily cavities are the vaginal cavity (30) and/or the rectal cavity (40).
48. Self-sampling kit according to claim 45, wherein said sampling cloth (10) is made of a fabric with a thickness of 3 mm or less, preferably 2 mm or less, more preferably 1 mm or less, most preferably 0.6 mm or less.
49. Self-sampling kit according to claim 45, wherein said sampling cloth (10) has dimensions so that, after insertion, part of said sampling cloth (10) protrudes outside the bodily cavity.
50. Self-sampling kit according to claim 45, wherein said sampling cloth (10) is made of at least one sheet of fabric (1) and/or comprise one or more fringes (2), such as stripes or cords.
51. Self-sampling kit according to claim 50, wherein said sampling cloth (10) comprises a multitude of fringes (2) or at least one fringe (2), which is folded to form a multitude of fringes (2), together with means to hold said fringes (2) together.
52. Self-sampling kit according to claim 51, wherein at least one of the fringes (12) has a length sufficient to protrude outside the bodily cavity.
53. Self-sampling kit according to claim 45, wherein said sampling cloth (10) is further provided with means of removal (16) for removing said sampling cloth (10) from the bodily cavity, such as at least one thread, string, strip, ribbon, wire.
54. Self-sampling kit according to claim 45, wherein the sealable recipient (50) has the dimensions adapted to house the entire sampling cloth.
55. Self-sampling kit according to claim 45, wherein the sealable recipient (50) further contains means for preserving or preparing the specimen, such as saline water or culture medium.
56. Self-sampling kit according to claim 45, wherein the sealable recipient (50) is a plastic jar or tube provided with a thread cap.
57. Self-sampling kit according to claim 45, wherein the sealable recipient (50) is a syringe, comprising a barrel (51), a piston (52), a discharge orifice (53) provided with sealing means (54), and stopping elements (55) for fixing and sealing the piston (52) into place inside the barrel (51).
58. Method of using a sampling cloth (10), comprising self sampling at least one specimen from bodily cavities of humans or animals, wherein said sampling cloth (10) is made of a flexible fabric with an absorbency of less than 3.5 g/g.
59. Method for self-sampling at least one specimen from bodily cavities of humans or animals comprising the steps: a) inserting a sampling cloth (10) made of a flexible fabric with an absorbancy of 3.5 g/g or less into the bodily cavity of a human or animal; b) removing the sampling cloth (10) from the bodily cavity.
60. Method for self-sampling according to claim 59, further comprising the steps: c) placing the sampling cloth (10) inside a sealable recipient; d) sealing the recipient.
61. Method for self-sampling according to claim 60, wherein the sampling cloth (10) is left inserted into the bodily cavity for a period of time of at least 2 minutes, preferably for 30 minutes, 1 hour, 2 hours, 3 hours or more.
62. Method for diagnostic of STIs (Sexually Transmitted Diseases) comprising the steps of: a) self-sampling at least one specimen from bodily cavities of humans and animals according to the method of claim 59, b) determining the presence of a STI by analyzing and identifying said at least one specimen from the sampling cloth (10).
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0066] FIG. 1 represents a front view of preferred embodiments according to the invention wherein the sampling cloth is in the form of a single-sheet
[0067] FIG. 2 represents a front view of other preferred embodiments of the invention wherein the sampling cloth is in the form of a single-sheet fabric having a folded area.
[0068] FIG. 3 represents a front view of different embodiments according to the invention wherein the sampling cloth is in the form of a single-sheet fabric having a folded area and guiding elements, together with applicators.
[0069] FIG. 4 represents a front view of different embodiments according to the invention wherein the sampling cloth is in the form of a multitude of fringes.
[0070] FIG. 5 represents sectional views of some preferred embodiments according to the invention, with a sampling cloth being inserted into a bodily cavity with an applicator, and various positions of the sampling cloth after removal of the applicator.
[0071] FIG. 6 represents views of the steps according to an embodiment of the invention for placing the sampling cloth within a syringe-shaped recipient, closing and securing said recipient.
[0072] FIG. 7 represents a table showing trial results obtained by using the sampling cloth of the invention for detection of HPV strains as compared with conventional methods of sampling by a trained professional.
[0073] FIGS. 1a and 1b depict two embodiments of a sampling cloth (10) according to the invention wherein the sampling cloth (10) is in the form of rectangular fabric consisting of a sheet (1) of fabric and is provided with a pushing area (11) which has with an orifice (12), preferably in a central position with respect to the pushing area. As shown in FIGS. 1a and 1b, said pushing area may be placed at different positions along the length of the sampling cloth (10), preferably closer to the proximal end of the sampling cloth (10).
[0074] In a preferred embodiment, the sampling cloth (10) in the form of a rectangle has a length of about 18 to 22 cm; and a width of about 3 to 6 cm.
[0075] An applicator (20) for the insertion of the sampling cloth (10) inside the bodily cavity is also depicted, and the position of the sampling cloth (10) on the applicator (20) before insertion into the bodily cavity. Said applicator (20) is substantially in the form of a rod, and has a proximal end which is the end that will be inserted into the bodily cavity, and a distal end, which is the end that remains outside the bodily cavity. The proximal end of the applicator (20) is provided with a protuberance (22). The protuberance (22) has a diameter less that the diameter of the orifice (12), such that it can reversibly protrude through the orifice (12), while the proximal end of the applicator has a diameter larger that the diameter of the orifice (12), so that it cannot protrude through the orifice (12). Therefore, the proximal end of the applicator (20) will be able to push the sampling cloth (10) within the bodily cavity, while the protuberance (22) passing through the orifice (12) will keep the applicator (20) connected with the sampling cloth (10). The distal end of the applicator (20) is provided with a gripping area (21) consisting, in this example, in a series of recesses in the material of the applicator. In a preferred embodiment, the length of the applicator (20) is of about 12 cm.
[0076] FIG. 2 depicts further embodiments of the sampling cloth (10) of the invention made from a single sheet (1) of fabric. FIG. 2a represents a front view of a rectangular sampling cloth (10) from which the preferred embodiments depicted in FIGS. 2b and 2c may be obtained by folding once the proximal end of the sampling cloth (10) along a folding line (13) and welding the folded area to the rest of the sheet (1) along guiding lines (14), thus defining pocket areas (15) for the insertion of an applicator. Preferably, the folding line (13) is substantially parallel with the short sides of said rectangular sampling cloth (10). In the embodiment of FIG. 2b, the pocket area (15) is delimited by two guiding elements (14) and the folded line (13), while in the embodiment of FIG. 2c the pocket area (15) is delimited by three guiding elements (14). In a preferred embodiment, the sampling cloth (10) in FIG. 2 has a length of more than 14 cm, preferably more than 16 cm, more preferably more than 18 cm; and a width of less than 6 cm, preferably less than 5 cm. In a preferred example, the folding line (13) is at a distance of about 2 cm to about 4 cm from the proximal end of the sampling cloth (10), thus obtaining a pocket (15) with dimensions sufficient to maintain the applicator (20) in place during insertion while at the same time maximizing the surface of the sample cloth (10) that remains in the form of one single sheet. The guiding elements (14) are placed so that the maximum distance between them is about 2-6 mm bigger than the diameter of the applicator (20), for a smooth insertion and removal of the applicator (20). In a preferred embodiment, for a sampling cloth (10) for vaginal use, the sampling cloth as depicted in FIG. 2 has, along the folding line (13), an area consisting of a rough material (not represented in the figure). Placing the rough material along the folding line (13) has the advantage that the rough material will have better chances of coming into contact with and sampling cells from the cervix.
[0077] The embodiments of FIGS. 2b and 2c are also depicted in FIGS. 3a and 3b, respectively, this time together with applicators. FIGS. 3a and 3b show how the sampling cloths (10) of the two embodiments are positioned on the applicators (20) before insertion into the bodily cavity. FIG. 3b further depicts another embodiment, wherein the sampling cloth (10) is provided with means for removal (16), for removing the sampling cloth (10) from the bodily cavity and also for sampling specimens from outside the bodily cavity. The means for removal (16) may consist of at least one thread or stripe.
[0078] As shown in FIG. 3b, the placing of the guiding elements (14) such that the proximal limit of the pocket (15) consists of a guiding line (14) placed underneath the folding line (13) has the advantage that a loop (18) of fabric is formed by the material of the sampling cloth (10) above the pocket (15). This loop (18) has the advantage that it better protects the bodily cavity from the impact of the applicator (20) at the moment of insertion and that it is also able to more thoroughly sample the specimens of the cervix. As mentioned before, a rougher material may be placed in the area of this loop (18) in order to efficiently sample specimens from the cervical area.
[0079] FIG. 4 depicts several embodiments according to the invention wherein the sampling cloth (10) is in the form of a multitude of fringes (2) of various lengths or of the same length, held together by a joining element (17), as well as an applicator (20) adapted for inserting such sample cloths (10) within a bodily cavity.
[0080] In the embodiment according to FIG. 4a, the fringes (2) have gradually increasing lengths, with one of the fringes (2) being long enough to protrude outside the bodily cavity and to be used as means of removal (16). In a preferred embodiment, the fringes (2) have lengths increasing gradually from about 4 cm to about 22 cm. Said fringes (2) are provided with means to hold them together in the form of joining elements (17).
[0081] FIG. 4d shows an applicator (20) having a proximal end provided with a depression for housing the fringes (2) of the sampling cloth during insertion.
[0082] FIG. 5 represents sectional views of various embodiments according to the invention, showing the positioning of a sampling cloth (10) into the bodily cavity(es). FIG. 5a shows a sampling cloth (10) as depicted in FIG. 1 at the moment of insertion inside the vaginal cavity (30). It can be seen that the protuberance (22) of the applicator (20) protrudes from the orifice (12) of the pushing area (11) of the sampling cloth (10). Part of the sampling cloth (10) protrudes outside the vaginal cavity (30) and can be held in place together with the applicator (20) at the gripping area (21) of the applicator. FIG. 5b shows the position taken by the sampling cloth within the vaginal cavity (30) after removing the applicator (20). FIG. 5c depicts the sampling cloth (10) having a length sufficient to reach the anal orifice, while FIG. 5d shows the sampling cloth (10) inserted into the vaginal cavity (30) and having a length sufficient to be also inserted into the rectal cavity (40).
[0083] FIG. 6 represents views of the steps according to an embodiment of the invention for placing the sampling cloth (10) within a syringe-shaped recipient (50), closing and securing said recipient (50).
[0084] In a preferred embodiment depicted in FIG. 6, after removing the sample cloth (10) from the bodily cavity, it is placed in a recipient (50) having the shape of a syringe. Said recipient (50) comprises a barrel (51), a piston (52) and a discharge orifice (53) provided with sealing means (54). Also, the recipient (50) is further provided with stopping elements (55). FIG. 6a depicts the introducing of the sampling cloth (10) into the barrel (51) of the recipient (50). In FIG. 6b it is shown how the piston (52) of the syringe-like recipient (50) is inserted into the barrel (51). FIG. 6c illustrates a preferred embodiment wherein the recipient (50) is further provided with stopping elements for sealing the piston (52) in a closed position inside the barrel (51). In FIG. 6c, said stopping elements consist of an adjustable plastic strip (55) adapted to pass through an orifice (56) provided in the barrel (51) as well as through an orifice (57) provided in the piston (52), for example at its end. After the piston (52) is inserted into the barrel (51), the adjustable plastic strip (55) is passed through the orifices (56) and (57) and is closed in position (the length of its loop is adjusted to the desired length), thus sealing together the piston (52) and barrel (51) in the desired position. The use of such an adjustable strip (55) ensures that the piston (52) cannot exit the barrel (51) by accident, and it will function as an alarm signal (evidence) in case the recipient is tampered with.
[0085] FIG. 7 represents a comparative table, showing a representative comparison between results obtained for detecting HPV strains by using the sampling cloth (10) and self-sampling method according to the invention compared with the results obtained by using traditional (physician-collected) samples.
[0086] A lot of 91 women were using both the self-sampling method of the invention, and the traditional (physician-collected) sampling. The self-sampling method of the invention was performed using a sampling cloth (10) similar to the one depicted in FIG. 2b. Said sampling cloth (10) was made of a non-woven textile with a soft carded smooth surface comprising polyethylene and polyester, having an absorbency of 1.6 g/g as measured using Syngina protocol; a thickness of 0.25 mm, and dimensions of about 17045 mm before being folded. The recipient (50) of the self-sampling kit was a plastic jar with a threaded cap. The women were advised to maintain the sampling cloth inside the vagina for about 3 hours.
[0087] The first line of the table in FIG. 7 shows all the known strains of HPV. The high-risk strains known to be responsible for causing cancer are marked with a letter c.
[0088] The second line of the table in FIG. 7 shows (marked with the letter x) the strains of HPV against which Vaccine G4 is effective.
[0089] The third line of the table in FIG. 7 shows (marked with the letter x) the strains of HPV against which Vaccine G9 is effective.
[0090] The following six lines of the table in FIG. 7 show the results obtained by testing women using the traditional method (of sampling by a gynecologist using a vaginal scraper with a swab). Marked with the sign+are the strains of HPV thus detected.
[0091] The next three lines of the table in FIG. 7 show the results obtained by testing the same women using the self-sampling kit and method of the invention as detailed above. Marked with the sign+are the strains of HPV detected by using self-sampling kit and method which have also been detected by the traditional method. It is evident that all the HPV strains detected by the traditional method where also detected in the samples obtained by using the kit and method of the invention. Moreover, by using the self-sampling kit and method according to the invention have been detected (marked with the sign ++) strains of HPV which have not been detected by the traditional method, including, for patient #006, the very dangerous HPV strain 16.
[0092] The total findings for all 91 patients have been compiled in the comparative Table 1 below.
TABLE-US-00001 TABLE 1 Results obtained using Results obtained the sampling made by using the self- a trained specialist sampling method using a cervical and kit of the Specimens to be detected scraper (swab) invention Total number of patients tested 91 91 HPV - number of patients with both low-risk 20 33 and high risk strains of HPV detected HPV - Average number of HPV detected - 0.50/sample 0.80/sample both low-risk and high risk strains - HPV - number of patients with high-risk 14 27 strains of HPV detected HPV - Average number of HPV strains 0.35/sample 0.51/sample detected - high risk strains only - Number of patients for which 91 91 Ubiquitous cellular genes - cellular DNA was detected number of patients detected with 1 1 Chlamidia trachomatis number of patients detected with 1 1 Neisseria gonorrheae number of patients detected with 3 3 Mycoplasma genitalium number of patients detected with 7 9 Mycoplasma hominis number of patients detected with 9 11 Ureaplasma urealyticum number of patients detected with 40 41 Ureaplasma parvum number of patients detected with 1 1 Trichomonas vaginalis number of patients detected with 62 67 Vaginal bacteria
[0093] The data in the table show that in ail cases the use of the method and kit of the invention resulted in a better detection than by using the traditional method (or at least similar detection). Especially for the detection of HPV strains the method and kit of the invention has yielded significantly better results. For example, the number of patients for which high-risk HPV strains have been detected by using the method and kit of the invention is almost double than the number of patients for which such strains have been detected using the traditional method (27 patients vs. 14 patients). Also, the figures show that by using the self-sampling method and kit of the invention, cervical cells (cellular DNA) is detected in every case (91 patients out of 91). Thus, surprisingly, the self-sampling method and kit of the invention is one hundred percent successful in sampling cervical cells of a quality necessary for diagnosis of cervical cancer, and the same sample can be also used for a very effective detection of HPV and other specimens.
[0094] While the present invention has been described with reference to exemplary embodiments, it is to be understood that the invention is not limited to the disclosed exemplary embodiments. The scope of the claims is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions.
