US-12616454-B2 - Self sampling universal kit, methods and use

US12616454B2US 12616454 B2US12616454 B2US 12616454B2US-12616454-B2

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 absorbency 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.

Inventors

Bernard Chaffringeon

Assignees

V-VEIL-UP PHARMA LTD.

Dates

Publication Date: 20260505
Application Date: 20171128

Claims (17)

1 . A method of using a sampling cloth ( 10 ), comprising self-sampling at least one specimen from bodily cavity side walls of humans or animals for diagnosis, wherein said sampling cloth ( 10 ) consists of a single sheet of flexible fabric with a total absorbency of less than 2.8 g and a thickness of 2 mm or less.
2 . A method for self-sampling at least one specimen from bodily cavities of humans or animals for diagnosis, the method comprising the steps: a) inserting a sampling cloth ( 10 ) consisting of a single sheet of flexible fabric with a total absorbency of less than 2.8 g and thickness of 2 mm or less into a bodily cavity of a human or animal to collect specimen material from a side wall of the bodily cavity; b) removing the sampling cloth ( 10 ) from the bodily cavity; and c) taking or sending the sampling cloth ( 10 ) to a testing facility for diagnosis.
3 . The method for self-sampling according to claim 2 , further comprising the steps: a) placing the sampling cloth ( 10 ) inside a sealable recipient; and b) sealing the sealable recipient after placing the sampling cloth ( 10 ) inside the sealable recipient and before taking or sending the sampling cloth ( 10 ) to the testing facility.
4 . The method for self-sampling according to claim 3 , wherein the sampling cloth ( 10 ) is left inserted into the bodily cavity for a period of time of at least 30 minutes.
5 . A 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 2 , and b) determining a presence of a STI by analyzing and identifying said at least one specimen from the sampling cloth ( 10 ).
6 . The method of claim 5 , wherein said sampling cloth ( 10 ) has dimensions so that, after insertion, part of said sampling cloth ( 10 ) protrudes outside the bodily cavity.
7 . The method of claim 5 , wherein said sampling cloth ( 10 ) is made of at least one sheet of fabric ( 1 ) and/or comprises one or more fringes ( 2 ).
8 . The method of claim 7 , wherein at least one of the fringes ( 12 ) has a length sufficient to protrude outside the bodily cavity.
9 . The method of claim 5 , wherein said sampling cloth ( 10 ) is further provided with at least one thread, string, strip, ribbon, or wire for removing said sampling cloth ( 10 ) from the bodily cavity.
10 . The method of claim 5 , wherein the sampling cloth ( 10 ) has a region having a rougher surface than an area of the sampling cloth outside the region, the region having the rougher surface being situated to collect specimen material.
11 . The method of claim 10 , wherein the region having the rougher surface is integrally formed with the area of the sampling cloth outside the region.
12 . The method of claim 10 , wherein the region having the rougher surface is attached to the area of the sampling cloth outside the region by gluing, welding or sewing.
13 . The method of claim 10 , wherein the sampling cloth ( 10 ) is made of a non-woven textile made of synthetic fibers.
14 . The method of claim 13 , wherein the non-woven textile is thermo-fusible.
15 . The method of claim 14 , wherein the non-woven textile comprises a polyethylene-polyester bicomponent.
16 . The method for self-sampling according to claim 2 , wherein the flexible fabric has an absorbency of less than 2 g/g.
17 . The method for self-sampling according to claim 2 , wherein the single sheet of flexible fabric is in a rectangular shape having a width of from 2 cm to 6 cm, a length of from 3.5 cm to 22 cm, and an absorbency of less than 3 g/g.

Description

The present invention relates to the field of self-sampling for specimens such as cells, cell residues, proteins, DNA, RNA, and/or other material from bodily cavities such as the vaginal or rectal cavity. BACKGROUND According to the World Health Organization (WHO), more than 1 million sexually transmitted infections (STIs) are acquired every day worldwide. More than 30 different bacteria, viruses, fungi and parasites are known to be transmitted through sexual contact. Left untreated, they can lead to diseases, including cancer, damage of the reproductive organs and infertility. The most widespread STI, the Human papillomavirus (HPV) infection, causes more than 90% of cervical, vaginal, vulvar and anal cancer cases. 14 million new HPV infections occur every year according to the report of World Health Organization (2008). The incidence of such diseases can be significantly reduced by regular screenings. A regular Papanicolau cervical screening test (also known as Pap test, Pap smear or cervical smear) is recommended to identify pre-cancerous changes of the cells of the cervix, which can then be treated, preventing cervical cancer from developing. Also, a regular HPV testing is strongly recommended together with or separately from the Papanicolau test to determine the HPV strains. Prior to the Pap test and HPV screening, cervical cancer was the most common cancer in women. In countries where regular screening tests are available, mortality from cervical cancer has drastically reduced. Also, a regular screening for the other common STIs (such as Trichomonas, Chlamydia, Gonorrhea, Candida, Neisseria, Mycoplasma) will permit the timely treatment of such infections. Collecting specimens such as cytological, DNA, RNA and/or biologic samples for testing, study and diagnosis of cervical cancer or STIs usually requires an examination and sampling made by a trained specialist (physician or nurse). Such samplings are traditionally performed on women by a gynecologist by inserting a speculum into the patient's vagina in a manner to expose the cervix of the uterus and then inserting a cervical scraper (with a swab or a brush) for sampling tissue from the endocervical canal and cervical os. The cervical scrapers are designed to scratch the tissue in order to take samples of tissue. Throughout this process, the woman must remain in a reclining (gynecological) position. Finally, the obtained specimen is applied directly on a glass slide, or placed into a recipient containing a liquid preservative in order to go through the analysis and evaluation steps. However, in about 30% of cases, unsatisfactory specimens are collected by this technique, leading to the need to repeat the procedure or to false or incomplete results. Although regular screening (e.g annual) is highly recommended by health care standards-setting organizations, many patients do not screen regularly, especially in developing countries, due to different causes such as no or difficult access to a healthcare facility, or the fact that the procedure is painful, uncomfortable and embarrassing, time-consuming and expensive. Some of these issues have been addressed by self-sampling devices, which are devices designed to be used by the patient without the presence and aid of a medical practitioner. EP 2736419 discloses a device, a kit, and a method of use thereof, for self-administration and collection of cervical cell tissue samples such as for Pap smear testing. The device comprises an insertion tube, within which is carried a movable cervical aligning tool with an aligning probe, and a cellular sampling tool with a cellular adhesion surface. The aligning probe and cellular adhesion surface can be selectively movable relative to the insertion tube to improve accuracy of the testing and user safety. The method of collecting a vaginal and/or tissue sample consists of inserting the device into the vagina, advancing a ring from the inside of a tube for cervical cap alignment to enlarge the cervical fornix of the patient in order to expose the os, moving the sampling tool (provided with a cellular adhesion surface such as a small brush) outside the tube and then rotating the cellular sampling tool preferably two full rotations in each direction (clockwise and counter-clockwise), moving the elongated sampling tool back inside the tube to shield the sample within the insertion tube and withdrawing the device. Such a device is difficult to use by the patients and potentially painful. Moreover, the precision rate (accuracy) of such a self-test will be even more reduced than that of the classical Pap test sampled by the gynecologist, since the collecting is made in only one point (small area) inside the vagina, without any means to ensure that said point is actually the cervical os or an area under suspicion of having modified (cancerous) cells. Also, given the specific and complex structure of the device, it will have high productions costs, which will make it expensive and