General kits, methods and uses for self-sampling

Abstract

The present invention relates to a self-sampling kit and method for universally sampling at least one specimen, such as cells, cell residues, DMA, RNA, proteins, viruses, bacteria, parasites or fungi, from the vagina and / or rectal cavity of humans and animals, the 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 receiver (50) for storing and transporting the sampling cloth (10). The present invention also relates to the use of the self-sampling cloth (10) for self-sampling at least one specimen from the body cavity of humans and animals, for example, for diagnosing STIs such as HPV infection.

Description

Technical Field

[0001] The present invention relates to the field of self-sampling of specimens, such as cells, cell residues, proteins, DNA, RNA and / or other materials from a body cavity, such as the vaginal or rectal cavity. Background Art

[0002] According to the World Health Organization (WHO), more than 1 million sexually transmitted infections (STIs) are acquired worldwide every day. More than 30 different bacteria, viruses, fungi, and parasites are known to be transmitted through sexual contact. If left untreated, they can cause disease, including cancer, damage to reproductive organs, and infertility. The most widespread STI is infection with the human papillomavirus (HPV), which causes more than 90% of cases of cervical, vaginal, vulvar, and anal cancer. According to the World Health Organization (2008), there are 14 million new HPV infections each year. The incidence of such diseases can be significantly reduced through regular screening. Regular Papanicolau cervical screening tests (also known as Pap tests, Pap smears, or Pap smears) are recommended to identify precancerous changes in cervical cells, which can then be treated to prevent the development of cervical cancer. In addition, regular HPV testing to identify HPV strains is strongly recommended, either together with or separately from the Papanicolau cervical screening test. Before the Pap test and HPV screening, cervical cancer was the most common cancer in women. In countries where regular screening tests are available, the mortality rate from cervical cancer has been greatly reduced. In addition, regular screening for other common STIs (e.g., Trichomonas, Chlamidia, Gonorrhea, Candida, Neisseria, Mycoplasma) will allow for timely treatment of such infections.

[0003] The collection of specimens such as cytology samples, DNA samples, RNA samples and / or biological samples for testing, research and diagnosis of cervical cancer or STI usually requires examination and sampling by a trained professional (physician or nurse). Traditionally, such sampling is performed on female patients by a gynecologist through the following steps, that is, the gynecologist inserts a speculum into the patient's vagina, so that the cervix of the uterus is exposed, and then inserts a cervical scraper (with a swab or brush) for sampling tissue from the endocervical canal and the cervical os. The cervical scraper is designed to scrape the tissue in order to collect a sample of the tissue. Throughout this process, the female patient must remain in a lying (gynecological) position. Finally, the specimen obtained is applied directly to a slide or placed in a container containing a liquid preservative for analysis and evaluation steps. However, in about 30% of cases, this technique fails to collect a satisfactory specimen, resulting in the need to repeat the procedure or erroneous or incomplete results.

[0004] Although regular screening (e.g., annually) is strongly recommended by healthcare standard-setting bodies, many patients, especially in developing countries, do not undergo regular screening due to a variety of reasons, such as the lack of or difficulty in accessing healthcare facilities or the fact that the procedure is painful, uncomfortable, embarrassing, time-consuming, and expensive.

[0005] Some of these problems have been addressed by self-sampling devices, which are devices designed to be used by a patient without the presence and assistance of a medical practitioner.

[0006] EP 2736419 discloses an apparatus, kit and method of use thereof for self-administration and collection of cervical cell tissue samples, for example for use in a cervical smear test. The apparatus comprises an insertion tube, within which a movable cervical alignment tool with an alignment probe is carried, and a cell sampling tool with a cell adhesion surface. The alignment probe and the cell adhesion surface may be selectively movable relative to the insertion tube to improve the accuracy of the test and user safety. The method of collecting vaginal and / or tissue samples comprises: inserting the apparatus into the vagina; advancing a ring from the interior of the tube to perform cervical cap alignment to expand the patient's cervical vault to expose the cervical os; moving the sampling tool (which is provided with a cell adhesion surface, for example, a small brush) to the exterior of the tube and then rotating the cell sampling tool preferably two complete rotations in each direction (clockwise and counterclockwise); moving the elongated sampling tool back to the interior of the tube to shield the sample within the insertion tube; and withdrawing the apparatus. Such an apparatus is difficult and potentially painful for the patient to use. Furthermore, the accuracy (precision) of such a self-test will be even lower than that of a traditional Pap test sampled by a gynecologist, since the sample is collected only in one spot (smaller area) inside the vagina, without any means to ensure that the spot is actually the cervical os or an area suspected of harboring diseased (cancer) cells. Moreover, given its specific and complex structure, the device will have a high production cost, which will make it expensive, especially in developing countries.

[0007] US 6,475,165 provides a cervical self-sampling device for self-sampling of culture materials or specimens used in thin smear techniques, microbiological analysis and epidemiological studies, the device consists of a 15 cm long cotton-like extendable tube, preferably made of medical grade cardboard material coated with wax or polytetrafluoroethylene, and containing a squeezable, retractable sponge. A handle is attached to the sponge to form a screw cap, which is configured to be fixed to a standard tube containing a fixative or preservative. The steps of using this device are: insert the 15 cm long extendable tube into the vagina until resistance is encountered; then, push the handle with the thumb while grasping the tube between the first two fingers to extend the sponge from the tube; then, turn the handle to obtain the specimen; then, retract to return the sponge to the inside of the tube, and then remove the device. Like all other vaginal sampling devices, the important purpose of this device is to protect the sample from vaginal secretions. Although this device is less painful than the previously mentioned devices, it is still relatively difficult to use. Moreover, the accuracy (precision) of such a self-test will be even lower than that of the classic test with sampling by a gynecologist, since the sampling is done only in one point (smaller area) inside the vagina, without any means to ensure that said point is actually the cervical os or an area suspected of having diseased (cancer) cells or infection. Furthermore, the sponge material, which must be absorbent to work ("the vacuum created by the sponge upon insertion should suck cells from the cervical canal"), makes it difficult to extract the sampled cells from this material afterwards, thus reducing the efficiency of the sampling (the final amount of cells and DNA to be analyzed).

[0008] Therefore, there remains a need for an inexpensive, painless, and easy-to-use sampling kit that can be used without the assistance of a trained professional (eg, a physician). Summary of the invention

[0009] The object of the present invention is to provide an inexpensive, painless and easy-to-use self-sampling kit and method, which has high accuracy and efficiency in sampling specimens (e.g., cells, cell residues, DNA, RNA, proteins and / or other substances of interest from the vaginal or rectal cavity).

[0010] This object is achieved by a self-sampling kit according to the invention, comprising a sampling cloth and a suitable receiver. In another aspect, the invention relates to the use of the sampling cloth for self-sampling at least one specimen from a body cavity of a human or animal, in particular from the vaginal or rectal cavity of a human, and to a method for self-sampling and diagnosis.

[0011] Self-sampling refers to a sampling procedure that can be performed by an individual on themselves or on themselves or by an individual on another person without the assistance of a trained professional. For animals, self-sampling will be understood to be performed by a human.

[0012] Specimen refers to any cells, cell residues, DNA, RNA, proteins, viruses, bacteria, parasites, fungi and / or other substances of interest.

[0013] The self-sampling kit according to the present invention comprises: a sampling cloth designed to be inserted into a body cavity; and a sealable receiver for storing and transporting the sampling cloth to a diagnostic facility such as a laboratory. The kit may also include an applicator for inserting the sampling cloth into a body cavity. The kit may also include instructions and / or marking means for using the self-sampling kit.

[0014] The method for self-sampling of the present invention comprises the following steps: (a) inserting a sampling cloth into a body cavity; (b) removing the sampling cloth from the body cavity; (c) placing the sampling cloth in the receiver of the kit; and (d) sealing the receiver.

[0015] The method for diagnosing STI (sexually transmitted infection) of the present invention comprises the following steps: a) self-sampling at least one specimen from the body cavity of a human or animal according to the self-sampling method of the present invention described above; b) determining the presence of STI by analyzing and identifying the at least one specimen from the sampling cloth.

[0016] As previously mentioned, the sampling devices known in the art for sampling cells, nucleic acids or specimens for culture or microbiological assays are designed to reproduce as closely as possible the traditional sampling process performed in a gynecologist's office. Therefore, the sampling devices are concerned with protecting the sampling tool from contact with the body cavity wall and secretions (by keeping the sampling tool in a tube during insertion and withdrawal), and propose how to avoid contamination, i.e. the risk of the sampling tool touching any part of the vagina other than the target part of the vagina. The sampling devices work on the assumption that cells and DNA from the uterus can only be sampled by accurately collecting from the cervical area, and that the sampling devices can only sample specimens from a reduced area of ​​the body cavity. Moreover, the sampling devices work by a complex method that must be correctly performed in order to obtain a specimen of a quality comparable to that of a specimen collected by a gynecologist. The key elements of the method are to try to bring the sampling tool (a small brush or sponge) into direct contact with the cervical os, to manually move the sampling tool in a circular motion, and then immediately retract the sampling tool and withdraw the device.

[0017] In contrast, the use of the sampling cloth according to the present invention is significantly simpler and less traumatic. The whole experience is physically and mentally comfortable, while presenting higher quality results. The sampling cloth can be easily, painlessly and privately introduced into the body cavity. The sampling cloth is easy to wear and can be comfortably left in the body cavity for a period of time before being withdrawn and contained in a separate receiver. Contrary to the teachings of the prior art mentioned above, which indicate that sampling must be performed precisely in the cervical region, we found that the use of the sampling cloth was successful every time cells and nucleic acids were collected from the uterus. In fact, compared with specimens collected in a traditional manner by a doctor or nurse, the specimens collected by using the sampling cloth of the present invention clearly contain more substances of interest such as cells, DNA, proteins, etc., thereby facilitating more complete and accurate detection. These surprising findings have been demonstrated by rigorous experiments, the results of which will be described in more detail later in this specification. These experiments show that the amount of HPV DNA collected from each individual using the sampling cloth of the present invention is up to 10 times the amount of HPV DNA collected from each individual using the traditional sampling process. Likewise, more HPV strains have been diagnosed for each subject tested from samples collected using the self-sampling kit and method of the present invention than from samples collected using traditional sampling methods by trained professionals in a medical facility, thereby making a more accurate and complete diagnosis of HPV infection. In addition, by bringing the sampling cloth into contact with almost the entire surface of the body cavity and external tissues, the sampling cloth can capture each specimen of potential interest (e.g., cells, nucleic acids, proteins, viruses, bacteria, parasites, or fungi) and release when needed.

[0018] The sampling cloth of the present invention can also be used for:

[0019] - Collection of specimens for testing for bacteria (e.g., Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma hominis, Ureaplasma urealyticum, syphilis, Streptococcus), parasites (e.g., Trichomonas vaginalis), or fungi (e.g., Candida albicans).

[0020] - Testing for hemoglobin due to premature rupture of membranes (PROM) during pregnancy, which refers to the rupture of the amniotic sac before the onset of labor. If the rupture occurs before 37 weeks, the rupture is called premature rupture of membranes (PPROM), and both the fetus and the mother are at greater risk of complications. Premature rupture of membranes provides a pathway for bacteria to enter the uterus and puts both the mother and the fetus at risk of life-threatening infections. The lower level of fluid surrounding the fetus also increases the risk of umbilical cord compression and can interfere with the formation of the fetus' lungs and body in early pregnancy. The presence of hemoglobin in the vagina indicates the onset of PROM. Very small amounts of hemoglobin appear in the vagina starting 24 hours before the onset of PROM. Timely detection of such very small amounts of hemoglobin will allow pregnant women to seek medical help and ultimately prevent rupture or contain such effects. Using the self-sampling kit of the present invention, pregnant women at risk of premature rupture of membranes (PPROM) will be able to frequently self-sample hemoglobin and test for the presence of hemoglobin without having to go to a medical facility or be hospitalized.

[0021] - If a sexual assault occurs, the sampling cloth can be used to collect the DNA of the aggressor.

[0022] The sampling cloth according to the present invention is designed to be inserted into the vaginal or rectal cavity of a human or animal with the aid of an applicator. Therefore, an insertion direction is defined, which is an axis oriented from the end of the sampling cloth that last contacts the body cavity or remains outside the body cavity (called the distal end of the sampling cloth) to the end of the sampling cloth that first contacts the body cavity (called the proximal end of the sampling cloth). When viewed along the insertion direction, the top or upper part of the sampling cloth is represented by the end of the sampling cloth including its proximal point; the proximal point is the point that first contacts the body cavity. At the same time, the bottom or lower part of the sampling cloth is represented by the end of the sampling cloth including its distal end; the distal end is the point of the sampling cloth opposite to the proximal point, that is, the bottom or lower part of the sampling cloth is placed at the farthest distance from the proximal point along the insertion direction. In some embodiments, a portion of the sampling cloth may protrude from the vaginal or rectal cavity to the outside. In this case, the bottom of the sampling cloth will also include such a portion of the sampling cloth. Taking into account the above definitions, the lateral sides of the sampling cloth will be the left end and the right end, taking into account the top and bottom as defined above.

[0023] The upper edge of the sampling cloth is the edge on the top of the sampling cloth, and the lower edge of the sampling cloth is the edge located on the bottom of the sampling cloth. According to the present invention, "above", "above" or "above it" refers to a first point or part located closer to the top of the sampling cloth relative to a second reference point, and the second point will be located "below", "below" or "below" the first point or first part, respectively.

[0024] According to the invention, "upward orientation" means orientation towards the top of the sampling cloth, while "downward orientation" means orientation towards the bottom of the sampling cloth. By "forward movement" is understood according to the invention a movement in the direction of insertion of the sampling cloth into the cavity.

[0025] One aspect of the present invention relates to a self-sampling kit comprising a sampling cloth and a sealable receptacle for storing and transporting the sampling cloth.

[0026] Another aspect of the invention relates to the use of a sampling cloth for self-sampling at least one specimen from a body cavity of humans and animals.

[0027] The sampling cloth of the present invention is made of a material suitable for introduction into the vagina or rectum. Therefore, the sampling cloth can be comfortably fitted in the body cavity.

[0028] The suitable material will be flexible, by which it is to be understood that a material will and will not bend to follow the shape of the vagina or rectum. Likewise, the suitable material will preferably be atraumatic, by which it is to be understood that a material can be brought into contact with or slid or wiped on a body membrane surface such as the vaginal or rectal mucosa without causing any injury or discomfort, e.g. irritation, pain, etc., preferably a fabric with a soft, coarse, smooth surface. The use of a sampling cloth made of such a flexible, atraumatic material has the advantage that irritation, pain and discomfort of the vaginal cavity during insertion, which is usually associated with the use of devices from the prior art, is avoided. Preferably, when the sampling cloth is introduced into the vagina with the help of an applicator, the sampling cloth above and around the applicator will protect the vaginal mucosa from direct contact with the hard material of the applicator.

[0029] Advantageously, a suitable material for the sampling cloth is a material that can capture a specimen from the body cavity and preferably retain the specimen on its surface, while being able to subsequently easily release the specimen so that the specimen can be analyzed. Therefore, advantageously, the sampling cloth has a surface that contacts the body cavity, but the surface has a small absorbency or no absorbency, so that only a small amount of the specimen is absorbed into the fabric of the sampling cloth. According to the present invention, the absorbency measured using the Syngina protocol for measuring the absorbency of cotton strips should be less than 3.5g / g, preferably less than 3g / g, and more preferably less than 2g / g. For example, an absorbency of 3.5g / g means that 3.5 grams of liquid are absorbed per 1 gram of material. Preferably, the sampling cloth is made of a fabric with a small thickness. A sampling cloth with a small thickness will be able to capture a specimen on its surface, but the sampling cloth will not be able to or only rarely transfer, collect and retain the specimen within the depth of the sampling cloth. Such a sampling cloth has the advantage that, unlike a sponge or a cotton strip, the sampling cloth will not retain the collected specimen (cells, proteins, DNA, etc.) during the analysis and evaluation steps. Instead, the sampling cloth will easily release the sample from the sampling cloth, so the final number of specimens to be analyzed is maximized, which improves the accuracy (precision) of the sampling test. The thickness of the sampling cloth should be 3 mm or less, preferably 2 mm or less, more preferably 1 mm or less, and even more preferably 0.6 mm or less, which means that the thickness of the sampling cloth is much smaller than that of an ordinary cotton strip. Advantageously, the material of the sampling cloth has a density of about 60 g / m 2 The basis weight.

[0030] The material of the sampling cloth suitable for comfortable insertion into the body cavity can be selected from the group consisting of woven or non-woven textiles, such as synthetic fibers (e.g., polyester, polypropylene, polyethylene, polyamide, polyacetate, polyvinyl acetate), semi-synthetic fibers (e.g., viscose, modal, lyocell), plant fibers (e.g., cotton), animal fibers (e.g., silk) or combinations thereof. In a preferred embodiment, the material is biodegradable, thereby reducing the impact on the environment. Preferably, the material is a non-woven textile made of synthetic fibers, because such a material is damage-resistant and has a desired lower absorbency. Moreover, such a product would have a lower production cost. In a preferred embodiment, the material is also heat-fusible so that it can be welded. In a preferred embodiment, the sampling cloth is made of a non-woven fabric with a soft, coarse, smooth surface, comprising a non-woven polyethylene / polyester bicomponent. Preferably, this material has the following properties:

[0031] - Average basis weight (mass per unit area), measured by WSP 130.1 test method, the average basis weight is about 59.20 g / m2 ,

[0032] - Average tensile strength MD, which represents the force per unit width required to rupture a sample oriented in the machine direction, measured by a test method following WSP 110.4 using a sample width of 25.4 mm (1 inch), a clamping distance of 127 mm (5 inches), and a speed of 500 mm / min (19.7 inches / min), the average tensile strength MD is about 48.86 N / in

[0033] - Average elongation at F-max MD, which represents the relative increase in length at the maximum force applied on a sample oriented in the machine direction, the average elongation at F-max MD is measured by a test method following WSP 110.4 using a sample width of 25.4 mm (1 inch), a clamping distance of 127 mm (5 inches) and a speed of 500 mm / min (19.7 inches / min), and the average elongation at F-max MD is about 38.40%.

[0034] In a preferred embodiment, the sampling cloth according to the present invention may have an area having a rougher surface than the rest of the sampling cloth (e.g., a coarser check of organic cotton, linen or burlap), the area preferably being placed so that it is most likely to reach the target area of ​​the body cavity and collect samples from the target area of ​​the body cavity by scraping the tissue. For example, in order to collect samples from the cervical os, a rougher fabric may be placed at the top of the sampling cloth. The rougher fabric may be attached to the fabric of the sample cloth, for example, by any suitable means such as gluing, welding, sewing, etc., or the rougher fabric may be an integral part of the sample cloth. A sampling cloth having such an area with a rougher surface will be able to collect specimens from the target area in less time.

[0035] The sampling cloth according to the present invention is suitable for insertion into the vaginal or rectal cavity of a human or animal. Therefore, those skilled in the art will understand that the size of the sampling cloth is selected to be suitable for the size of the body cavity into which the sampling cloth is to be inserted.

[0036] The vagina and rectum are open cavities in the form of fibromuscular tubes with walls that are easily expanded. The vagina is in the form of a tube with an external opening (vaginal opening) and an internal opening (which is connected to the uterus) at the end. The rectum is in the form of a tube with an external opening (anus) and an internal opening (which is connected to the large intestine) at the end; near the external opening, the rectum has an enlarged part, i.e., the rectal ampulla, where it is meant to accommodate the sampling cloth according to the present invention. The external opening of the vagina and rectum is substantially circular. The width (diameter) of the tube (vagina and rectum) varies over its entire length, with the minimum width at the external opening of the body cavity. For example, the vagina or rectum of an adult at rest has a width of about 2.5 cm at the external opening.

[0037] Regardless of the shape of the sampling cloth when it is outside the body cavity, due to the fact that the sampling cloth is made of flexible fabric, when the sampling cloth is inserted into the body cavity by pushing the sampling cloth through the substantially circular external opening into the body cavity, the sampling cloth will collapse, for example, deform, fold, tighten and / or twist to pass through the external opening, and will then unfold to roughly follow the shape of the cavity. Therefore, the size of the sampling cloth for insertion into the vaginal or rectal cavity of a person will be selected so that the maximum width of the sampling cloth in the collapsed position will be less than 2.5 cm, so that the sampling cloth can be comfortably inserted into the body cavity. In a preferred embodiment, when a sampling cloth of substantially rectangular shape is used, the width of the rectangle can be selected to be, for example, between 2 cm and 6 cm.

[0038] When the sampling cloth is inserted into the body cavity, this means that after the sampling cloth has been pushed into the body cavity, the sampling cloth will preferably take a shape having a proximal end closest to the internal opening of the body cavity and a distal end closest to the external opening of the body cavity, and the sampling cloth will occupy a generally tubular space. The distance from the proximal end to the distal end of the sampling cloth defines the length of the sampling cloth. Therefore, a person skilled in the art will be able to shape / select the size of the sampling cloth so that when the sampling cloth is inserted into the body cavity, the length of the sampling cloth preferably reaches the maximum length of the vagina or rectal ampulla. In a preferred embodiment, after the sampling cloth is inserted into the body cavity, the length of the sampling cloth is equal to or slightly less than the length of the body cavity, so that specimens can be sampled from almost all surfaces of the body cavity. In another embodiment, the length of the sampling cloth may be greater than the maximum length of the body cavity, so that a portion of the sampling cloth protrudes outside the body cavity so as to collect specimens from an area outside the body cavity (e.g., the vulva or anal orifice). Preferably, the portion of the sampling cloth protruding to the outside can be used as a removal device for withdrawing the sampling cloth from the body cavity and also for sampling specimens from external areas or even from other body cavities.

[0039] For example, the length of the vagina of an adult at rest varies from about 5 cm to about 14 cm, and the length of the rectal ampulla of an adult varies from about 4 cm to about 6 cm. A person skilled in the art will preferably select the size of the sampling cloth for full insertion into the human vagina so that when the sampling cloth is inserted, the length of the sampling cloth will be approximately equal to or slightly less than the length of the human vagina, so that the sampling cloth can collect specimens from all parts of the vagina. Therefore, a person skilled in the art will select a sampling cloth having a length of less than 14 cm in this case, such as about 12 cm, about 10 cm, about 8 cm or shorter, preferably about 10 cm.

[0040] In order to insert the sampling cloth into the rectum of a person, the sampling cloth will be smaller so as to stay in the rectal ampulla, for example, the sampling cloth has a length of less than 5 cm, preferably less than 3.5 cm.

[0041] In another preferred embodiment, the length of the sampling cloth is selected to be longer than the human vagina (i.e., longer than 12 cm, preferably about 14 cm, about 16 cm, about 18 cm, about 20 cm, about 22 cm or longer) so that the sampling cloth will protrude to the outside of the human vagina during use. A sampling cloth that protrudes to the outside of the human vagina will have the following advantages, namely, the sampling cloth will be able to collect specimens from the end of the vaginal cavity, on the vulva, around the anal orifice, and if necessary, the sampling cloth can also be introduced into the anus so that the sampling cloth also collects from this area. In this way, the sampling cloth will capture specimens from infections (e.g., genital warts) that are outside the vagina. Moreover, the sampling cloth that protrudes to the outside of the vagina has the following advantages, namely, the sampling cloth can be extracted from the vagina by pulling the segment left outside the vagina; therefore, the sampling cloth will not require any device for removal, making the sampling cloth simpler, cheaper, and less harmful to produce, such as not requiring a device for removal to be attached to the sampling cloth, thereby not creating hard points.

[0042] The sampling cloth can be made of at least one fabric having any suitable shape; preferably, the sampling cloth can have a shape such as a substantially rectangular, square, trapezoidal, parallelepipedic, elliptical or circular shape. Alternatively, the sampling cloth can include one or more stripes or cords, such as strips or cords.

[0043] In a preferred embodiment, the sampling cloth of the kit of the present invention is substantially in the form of a single piece of fabric, so that the surfaces of both sides of the fabric sheet will be in direct contact with the body cavity, thereby maximizing the contact surface of the collected specimen. Such a sample cloth will also allow for easier release of the collected specimen (cells, proteins, DNA, etc.) from the sample cloth during the analysis and evaluation steps. The sampling cloth formed substantially in the form of a single piece is efficient because this minimizes the surface of the folded area, which is the area where a part of the sampling cloth is not in direct contact with the wall of the body cavity; moreover, this does not form a small pocket in the fabric of the sampling cloth, where the specimen of interest will potentially remain captured and not be easily released.

[0044] For example, the sampling cloth formed in a single-piece form can include a single piece of fabric having a push area with increased strength for contacting and maintaining the applicator in a substantially fixed position during the insertion of the sampling cloth into the body cavity. The push area can, for example, be composed of a welding area, which provides strength and resistance to the push area and is also used as a rougher surface for sampling specimens, as described above. Alternatively, the push area can include an adhesive material, such as a rubberized material, for maintaining contact with the applicator. Such a push area is preferably placed along the symmetry axis of the sampling cloth. In a preferred embodiment, in order to even more reliably and permanently fix the applicator during insertion, the push area is also provided with an orifice, wherein the orifice is small enough to make the applicator unable to protrude through the orifice. More preferably, this sampling cloth will be used with an applicator having a protrusion that can fit into the orifice of the push area to allow the applicator to be better fixed to the sampling cloth during insertion.

[0045] In another preferred embodiment, the sampling cloth is formed by a fabric sheet having a folded area at the proximal end by folding the sheet through a folding line. The folding area is provided with a guiding element for guiding and holding the applicator in the folding area during insertion, and also for holding the folding area in a suitable position. For example, the guiding element can be in the form of a welding line along which the fabric is welded together on both sides of the folding line. The guiding element defines a pocket-like area of ​​the folding area, in which the applicator is placed during the insertion of the sampling cloth into the body cavity. The guiding element will be placed so that the applicator is guided towards the folding line and held in a substantially fixed position in the pocket-like area during the insertion of the sampling cloth into the body cavity, and so that after insertion the applicator will be easily released from the pocket-like area and removed from the body cavity by moving the applicator in a direction opposite to the insertion direction, again without removing the sampling cloth. To this end, the guiding elements are placed so that the maximum distance between them is about 2 mm to 6 mm larger than the maximum segment (e.g. diameter) of the head (proximal end) of the applicator, for smooth insertion and removal of the applicator. In a preferred embodiment, the sampling cloth with the folding area has a substantially rectangular shape, wherein the proximal end is folded once and provided with a welded guide element. In another preferred embodiment, the shape of the sampling cloth before folding the proximal end is substantially parallelogram or isosceles trapezoidal, so that the tip of one substantially triangular shape can be folded to form the folding area, and the area of ​​another substantially triangular shape forms the distal end of the sampling cloth, which is placed at a narrower area of ​​the body cavity or outside the body cavity. The advantage of this shape is that less raw material is used to produce a sampling cloth with substantially the same capture surface.

[0046] In another embodiment, the sampling cloth of the present invention comprises one or more stripes, for example, strips, cords or ropes. Advantageously, when the sampling cloth is made of a rope, the thickness of the rope can be greater than 3 mm, preferably 10 mm or less, as long as the ability to capture and release the specimen is not impaired. In a preferred embodiment, the sampling cloth comprises multiple stripes, for example, strips and / or cords. In another preferred embodiment, the sampling cloth can be made of at least one strip or rope, and the at least one strip or rope is folded to form multiple stripes. Such a sampling cloth will advantageously maximize the contact surface between the sampling cloth and the target tissue, and allow the sampling cloth to reach different areas of the body cavity. The strips or cords can optionally have various lengths, preferably the strips or ropes have gradually increasing lengths. More preferably, at least one of the strips and / or cords has a length sufficient to protrude outside the body cavity, so that specimens can be collected from external areas and optionally from another body cavity, and can also be used as a removal device. The stripes are provided with a device to keep them together, for example, a welding point, a gluing point, a knotting point or a connecting element. For example, such a connecting element may be made of the same material as the sampling cloth or of another material such as plastic.

[0047] The sampling cloth according to the present invention may be provided with a removal device, which is used to remove the sampling cloth from the body cavity after use. The removal device may be, for example, at least one silk thread, rope, strap, ribbon, wire, etc., the length of which is suitable for extracting the sampling cloth from the body cavity or longer (suitable for reaching another body cavity and collecting specimens from the other body cavity). The sampling cloth may be made of any material that does not tear when the force necessary to extract the sampling cloth from the body cavity is applied to the sampling cloth. Preferably, the fracture resistance of such a device is higher than 50N. The preferred removal device is cotton yarn with a metric yarn count of 16 / 4Nm.

[0048] Advantageously, the removal device will also be able to capture specimens from outside the body cavity. For example, the device for removing the vaginal cloth will capture specimens from the end of the vaginal cavity, on the vulva, around the anal orifice, and if necessary can also be introduced into the anus so that it can also collect specimens from this area. Since the entire sampling cloth including the removal device is accommodated in the receptacle of the kit and then subjected to the same treatment for releasing the specimen therefrom, the surface of the removal device will advantageously be able to capture and release samples from different areas. To this end, the removal device will advantageously not undergo the treatments known in the art for making them hydrophobic (e.g., treating the removal device with a waterproof substance, for example, covering the removal device with a waterproof wax). In this way, the removal device of the present invention will be safer to use and will also be able to sample specimens.

[0049] The removal device can be attached to the sampling cloth in any suitable manner known in the art that will allow good fixation, for example by welding, sewing, sticking, stapling, buttoning, knotting or gluing, without the need for detachment from the sampling cloth during use or removal.

[0050] In a preferred embodiment, the removal device can be attached at one or more points located on the axis of symmetry of the sampling cloth, which is substantially parallel to the direction of insertion into the vagina or rectum or forms an angle of no more than 45° with the insertion direction.

[0051] The sampling cloth according to the present invention can be inserted into the body cavity by using an applicator, which can be a finger or a pushing tool. The pushing tool or applicator will have a shape and size suitable for its intended body cavity and the strength required to be able to push the sampling cloth into the body cavity. The applicator can be disposable (used only once) or reusable. The applicator can be made of any suitable material, for example, plastic, silicon, wood, metal (for example, stainless steel, titanium or gold-plated), cardboard, etc. Preferably, the applicator is made of low-density polyethylene PE-LD, which has a low production cost, good flexibility, light weight and can be cleaned and reused.

[0052] The applicator can be releasably inserted into a dedicated pocket that is centered or eccentric to the sampling cloth. Preferably, the width of the pocket is 2mm to 6mm larger than the diameter of the applicator for smooth insertion and removal of the applicator. Optionally, the applicator can have a gripping area for gripping during insertion of the sampling cloth and during removal of the applicator from the body cavity. The gripping area can have an adhesive surface, or can be shaped so that the gripping area can be easily and securely held by a person's hand. For example, the applicator can have a series of recesses or protrusions along the gripping area.

[0053] For example, the pushing tool can be made in the form of a tubular body having a proximal end (head) and a distal end, the proximal end being the end that first enters the body cavity, the distal end being the end that remains outside the body cavity and optionally provided with a gripping device. For human use, such an applicator can have a length of about 120 mm (the height of the tube) and a width of about 11 mm (the diameter of the tube).

[0054] In another preferred embodiment, for the sampling cloth in the form of multiple stripes, the applicator is advantageously in the form of a tubular body having a proximal end provided with a recess for accommodating the stripes of the sampling cloth during insertion, or alternatively, for receiving a connecting element of the sampling cloth during insertion.

[0055] The self-sampling kit of the present invention comprises a sampling cloth as described above and a suitable sealable receiver for storing and transporting the sampling cloth to a diagnostic facility. The kit may also include an applicator as described above for inserting the sampling cloth into a body cavity. The kit may also include instructions for using the self-sampling kit and / or a labeling tool for attaching a label to the receiver.

[0056] The receiver of the self-sampling kit is made of a suitable standard material such as plastic and has a size suitable for accommodating the entire sampling cloth. The receiver is provided with at least one opening provided with a sealing device. The size of at least one of the openings of the receiver is sufficient to allow the user of the kit to easily place the sampling cloth in the receiver, preferably without squeezing the sampling cloth, which may result in the removal of part of the collected specimen. Therefore, the size of the opening will depend on the width of the sampling cloth. For example, the receiver can be in the form of a plastic jar or a plastic tube provided with a threaded lid.

[0057] Optionally, the receptacle may include means for preserving the specimen or further preparing the specimen for subsequent examination as desired, e.g., saline, culture medium (for bacterial analysis), KOH solution (for fungal analysis), and the like.

[0058] In a preferred embodiment, the receiver is a syringe, which includes a barrel, a piston and a discharge port provided with a sealing device such as a cap. The advantage of a receiver shaped like a syringe is that, when arriving at the inspection facility (laboratory), the receiver can be used to directly draw convenient substances (e.g., saline solution) into the receiver. Moreover, the piston can be repeatedly moved in and out of the barrel to stir the contents and separate the specimen from the sampling cloth. Moreover, when discharging the specimen, the piston can be pushed as far as possible, thereby thoroughly beating the wall of the barrel and squeezing the sampling cloth so that the maximum possible number of specimens will be discharged from the barrel through the discharge port. As a result, no other equipment and manipulation are required to discharge the specimen from the receiver, and very few specimens are lost, resulting in very efficient processing and a large number of specimens to be inspected. After the sampling cloth is introduced into the receiver, the piston of the syringe-shaped receiver will be used to seal the opening of the barrel. Preferably, the receiver will be further provided with a stop element for fixing and sealing the piston in a suitable position in the barrel. For example, such a stopper element may include an adjustable plastic strap adapted to pass through apertures provided in the piston and the barrel, thereby sealing the piston and barrel together in a desired position. Such a stopper element ensures that the receiver remains sealed until it reaches the laboratory, and any tampering or damage to the receiver will be apparent.

[0059] Optionally, the receiver may be provided with marking means, for example a label for writing the data of the patient from whom the sample was taken.

[0060] The method for self-sampling of the present invention comprises the following steps: (a) inserting a sampling cloth into a body cavity; (b) removing the sampling cloth from the body cavity; and optionally (c) placing the sampling cloth in a sealable receptacle, and (d) sealing the receptacle. Thus, the sampling cloth can be directly tested or placed in a sealable receptacle, which can then be taken or sent to a testing facility such as a laboratory for analysis and diagnosis.

[0061] The sampling cloth of the present invention can be kept inserted into the body cavity for a period of time depending on the specific situation (e.g., humidity in the user's body cavity, target specimen, type of sampling cloth used, etc.) The sampling cloth of the present invention is advantageously very comfortable to wear in the body cavity.

[0062] In a preferred embodiment, in order to collect HPV DNA from the human vagina, the sampling cloth of the present invention can be kept inserted into the vagina for at least 2 minutes, preferably 30 minutes, 1 hour, 2 hours, 3 hours or longer.

[0063] Our tests have shown that significantly more specimens are sampled by using the self-sampling method of the present invention than by using traditional sampling methods (sampling by a trained professional such as a doctor or nurse) or by using self-sampling devices known in the art.

[0064] The method for diagnosing STI (sexually transmitted infection) of the present invention comprises the following steps: a) self-sampling at least one specimen from the body cavity of a human or animal according to the self-sampling method of the present invention described above; b) determining the presence of STI by analyzing and identifying the at least one specimen from the sampling cloth.

[0065] As mentioned above, compared with sampling specimens by using other methods, more samples can be sampled by using the self-sampling method of the present invention, so the diagnostic method of the present invention will be more accurate. BRIEF DESCRIPTION OF THE DRAWINGS

[0066] Figure 1 A front view of a preferred embodiment according to the present invention is shown, wherein the sampling cloth is in the form of a single piece.

[0067] Figure 2 A front view of another preferred embodiment of the present invention is shown, wherein the sampling cloth is in the form of a single piece of fabric having a folded area.

[0068] Figure 3 A front view is shown of a different embodiment according to the invention, wherein the sampling cloth is in the form of a single piece of fabric with folded areas and guide elements and an applicator.

[0069] Figure 4A front view is shown according to a different embodiment of the present invention, wherein the sampling cloth is in the form of a plurality of stripes.

[0070] Figure 5 sectional views are shown according to some preferred embodiments of the present invention, in which a sampling cloth is inserted into a body cavity with the aid of an applicator, and the figure shows various positions of the sampling cloth after the applicator is removed.

[0071] Figure 6 Views showing steps for placing a sampling cloth in a syringe-shaped receiver, closing the receiver, and securing the receiver according to an embodiment of the present invention.

[0072] Figure 7 A table showing test results obtained by detecting HPV virus strains using the sampling cloth of the present invention as compared with a conventional sampling method performed by trained professionals is shown. DETAILED DESCRIPTION

[0073] Figure 1 a and Figure 1 b shows two embodiments of a sampling cloth (10) according to the invention, wherein the sampling cloth (10) is in the form of a rectangular fabric, which is composed of a fabric piece (1) and is provided with a push area (11), the push area (11) having an orifice (12), the orifice (12) preferably being in a central position relative to the push area. Figure 1 a and Figure 1 As shown in FIG. 1 , the pushing area can be placed at different positions along the length of the sampling cloth (10), preferably closer to the proximal end of the sampling cloth (10). In a preferred embodiment, the sampling cloth (10) in a rectangular form has a length of about 18 cm to 22 cm; and a width of about 3 cm to 6 cm.

[0074] Also shown is an applicator (20) for inserting a sampling cloth (10) into a body cavity, and the position of the sampling cloth (10) on the applicator (20) before insertion into the body cavity. The applicator (20) is basically in the form of a rod and has a proximal end and a distal end, the proximal end being the end to be inserted into the body cavity, and the distal end being the end to be retained outside the body cavity. The proximal end of the applicator (20) is provided with a protrusion (22). The protrusion (22) has a diameter smaller than the diameter of the orifice (12) so that it can reversibly protrude through the orifice (12), while the proximal end of the applicator has a diameter larger than 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) into the body cavity, while the protrusion (22) passing through the orifice (12) will keep the applicator (20) connected to the sampling cloth (10). The distal end of the applicator (20) is provided with a gripping area (21) which in this example comprises a series of recesses in the material of the applicator.In a preferred embodiment, the length of the applicator (20) is approximately 12 cm.

[0075] Figure 2 Still further embodiments of the sampling cloth (10) of the present invention made of a single piece of fabric (1) are shown. Figure 2 a shows a front view of a rectangular sampling cloth (10), from which a sample can be obtained by the following steps: Figure 2 b and Figure 2 c, that is, the step is to fold the proximal end of the sampling cloth (10) once along the folding line (13) and weld the folded area to the rest of the sheet (1) along the guide line (14), thereby defining a pocket area (15) for inserting the applicator. Preferably, the folding line (13) is substantially parallel to the short side of the rectangular sampling cloth (10). Figure 2 b, the pocket region (15) is delimited by two guide elements (14) and the folding line (13), while in Figure 2 c, the pocket region (15) is delimited by three guide elements (14). Figure 2The sampling cloth (10) in the embodiment of the present invention has a length greater than 14 cm, preferably greater than 16 cm, more preferably greater than 18 cm; and has a width 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 4 cm from the proximal end of the sampling cloth (10), thereby obtaining a pocket (15) of sufficient size to maintain the applicator (20) in place during insertion while maximizing the surface of the sample cloth (10) that remains in the form of a single piece. The guide elements (14) are placed so that the maximum distance between them is about 2 mm to 6 mm greater than the diameter of the applicator (20) for smooth insertion and removal of the applicator (20).

[0076] In a preferred embodiment, for the vaginal sampling cloth (10), as Figure 2 The sampling cloth shown in has an area of ​​rough material (not shown in the figure) along the fold line (13). The advantage of placing the rough material along the fold line (13) is that the rough material will have a better chance of contacting the cervix and sampling cells from the cervix.

[0077] exist Figure 3 a and Figure 3 b also shows Figure 2 b and Figure 2 c, this time shown together with the applicator. Figure 3 a and Figure 3 b shows how the sampling cloth (10) of the two embodiments is positioned on the applicator (20) before being inserted into the body cavity. Figure 3 b further shows another embodiment, in which the sampling cloth (10) is provided with a device for removal (16), which is used to remove the sampling cloth (10) from the body cavity and also to collect a sample from outside the body cavity. The device for removal (16) can be composed of at least one thread or strip.

[0078] like Figure 3 As shown in Fig. 1, the guide element (14) is placed so that the proximal limit of the bag (15) is formed by the guide line (14) placed below the fold line (13), which has the advantage that the loop (18) of fabric is formed by the material of the sampling cloth (10) above the bag (15). The advantage of this loop (18) is that it better protects the body cavity from the impact of the applicator (20) at the moment of insertion, and the ring (18) also allows a more thorough sampling of the specimen of the cervix. As mentioned above, a rougher material can be placed in the area of ​​this loop (18) in order to efficiently sample the specimen from the cervical area.

[0079] Figure 4Several embodiments according to the present invention are shown, in which the sampling cloth (10) is in the form of multiple stripes (2) of various lengths or the same length held together by connecting elements (17), and an applicator (20) is shown, which is suitable for inserting such a sample cloth (10) into a body cavity.

[0080] In accordance with Figure 4 In an embodiment of the invention, the stripes (2) have a gradually increasing length, wherein one of the stripes (2) is long enough to protrude outside the body cavity and serve as a removal device (16). In a preferred embodiment, the stripes (2) have a length that gradually increases from about 4 cm to about 22 cm. The stripes (2) are provided with means in the form of connecting elements (17) that hold them together.

[0081] Figure 4 d shows an applicator (20) having a proximal end provided with a recess for accommodating the stripe (2) of the sampling cloth during insertion.

[0082] Figure 5 A cross-sectional view is shown illustrating positioning of a sampling cloth (10) into one or more body cavities according to various embodiments of the present invention. Figure 5 a shows the moment of insertion into the vaginal cavity (30). Figure 1 The sampling cloth (10) is shown. It can be seen that the protrusion (22) of the applicator (20) protrudes from the orifice (12) of the push area (11) of the sampling cloth (10). A portion of the sampling cloth (10) protrudes outside the vaginal cavity (30) and can be held in place with the applicator (20) at the gripping area (21) of the applicator. Figure 5 b shows the position occupied by the sampling cloth within the vaginal cavity (30) after removal of the applicator (20). Figure 5 c shows a sampling cloth (10) having a length sufficient to reach the anal orifice, while Figure 5 d shows the sampling cloth (10) inserted into the vaginal cavity (30) and having a length sufficient to also be inserted into the rectal cavity (40).

[0083] Figure 6 A view showing steps for placing a sampling cloth (10) in a syringe-shaped receiver (50), closing the receiver (50), and fixing the receiver (50) according to an embodiment of the present invention.

[0084] exist Figure 6In the preferred embodiment shown, after removing the sample cloth (10) from the body cavity, the sample cloth (10) is placed in a receiver (50) having a syringe shape. The receiver (50) includes a barrel (51), a piston (52) and a discharge port (53) provided with a sealing device (54). In addition, the receiver (50) is also provided with a stopper element (55). Figure 6 a shows the introduction of the sampling cloth 10 into the tube 51 of the receiver 50. Figure 6 b shows how the piston (52) of the syringe-like receiver (50) is inserted into the barrel (51). Figure 6 c shows a preferred embodiment, in which the receiver (50) is also provided with a stop element for sealing the piston (52) in a closed position within the tube (51). Figure 6 c, the stop element consists of an adjustable plastic strip (55) adapted to pass through an orifice (56) provided in the barrel (51) and through an orifice (57) provided, for example, at its end in the piston (52). After the piston (52) is inserted into the barrel (51), the adjustable plastic strip (55) passes through the orifice (56) and the orifice (57) and closes in the appropriate position (the length of its loop being adjusted to the desired length), thereby sealing the piston (52) and the barrel (51) together in the desired position. The use of such an adjustable strip (55) ensures that the piston (52) cannot accidentally leave the barrel (51) and will serve as an alarm signal (evidence) if the receiver has been tampered with.

[0085] Figure 7 A comparison table is shown showing a representative comparison between the results obtained by detecting HPV strains using the sampling cloth (10) and the self-sampling method according to the present invention and the results obtained by using traditional (doctor-collected) specimens.

[0086] 91 women used both the self-sampling method of the present invention and the traditional (doctor-collected) sampling method. Figure 2 b. The sampling cloth (10) is performed by a sampling cloth similar to the sampling cloth shown in b. The sampling cloth (10) is made of a non-woven fabric with a soft, coarse and smooth surface, the non-woven fabric comprising polyethylene and polyester, which has an absorbency of 1.6 g / g as measured using the Syngina protocol; a thickness of 0.25 mm before being folded and a size of approximately 170 mm×45 mm. The receiver (50) of the self-sampling kit is a plastic jar with a threaded lid. It is recommended that women keep the sampling cloth in the vagina for about 3 hours.

[0087] exist Figure 7 The first row of the table in shows all known HPV strains. High-risk strains known to be the cause of cancer are marked with the letter c.

[0088] exist Figure 7 The second row of the table in shows (marked with the letter x) the HPV strains for which the vaccine G4 is effective.

[0089] exist Figure 7 The third row of the table in shows (marked with the letter x) the HPV strains for which the vaccine G9 is effective.

[0090] exist Figure 7 The following six rows of the table in show the results obtained by testing women using the traditional method (sampling by a gynecologist using a vaginal scraping with a swab). The HPV strains thus detected are marked with the symbol +.

[0091] exist Figure 7 The next three rows of the table in show the results obtained by testing the same women using the self-sampling kit and method of the present invention as described above. The HPV strains detected by using the self-sampling kit and method are marked with the symbol +, which have also been detected by conventional methods. It is obvious that all HPV strains detected by conventional methods, all of which were also detected in the samples obtained by using the kit and method of the present invention. In addition, by using the self-sampling kit and method according to the present invention, HPV strains that have not been detected by conventional methods have been detected (marked with the symbol ++), including the very dangerous HPV strain 16 for patient #006.

[0092] The overall findings for all 91 patients have been compiled in the following comparative Table 1 .

[0093]

[0094]

[0095] The data in this table show that in all cases, the use of the methods and kits of the present invention resulted in better detection (or at least similar detection) than when using traditional methods. In particular, for the detection of HPV strains, the methods and kits of the present invention have produced significantly better results. For example, the number of patients in whom higher-risk HPV strains have been detected using the methods and kits of the present invention is almost twice the number of patients in whom such strains have been detected using traditional methods (27 patients vs. 14 patients). Moreover, these figures show that cervical cells (cellular DNA) were detected in every case (91 out of 91 patients) using the self-sampling methods and kits of the present invention. Therefore, surprisingly, the self-sampling methods and kits of the present invention are 100% successful in collecting cervical cells of the quality necessary for diagnosing cervical cancer, and the same samples can also be used to detect HPV and other specimens very efficiently.

[0096] 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 following claims is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions.

Claims

1. A self-sampling kit for self-sampling at least one specimen from a body cavity of a human or animal, the self-sampling kit comprising: a sampling cloth (10) adapted to be introduced into the body cavity, to remain in the body cavity for a period of time, and to be withdrawn and accommodated in a sealable receptacle (50), and - the sealable receiver (50), the sealable receiver is used to store and transport the sampling cloth (10), Characterized in that the sampling cloth (10) is made of a flexible fabric having an absorbency of 3.5 g / g or less, and the sealable receiver (50) is provided with at least one opening, wherein each opening of the sealable receiver (50) is provided with a sealing device (54), The self-sampling kit further comprises an applicator (20) for inserting the sampling cloth (10) into the body cavity, wherein the applicator (20) is configured to leave the sampling cloth in the body cavity after the applicator (20) is removed, and wherein the applicator (20) has a proximal end and a distal end, wherein the proximal end is the end that first enters the body cavity, and the distal end is the end that remains outside the body cavity.

2. The self-sampling kit according to claim 1, wherein: The distal end is provided with a gripping area (21).

3. The self-sampling kit according to claim 1 or 2, wherein: The at least one specimen is a cell, cell residue, DNA, RNA, protein, virus, bacteria, parasite or fungus.

4. The self-sampling kit according to claim 1 or 2, wherein: The body cavity is the vaginal cavity (30) and / or the rectal cavity (40).

5. The self-sampling kit according to claim 1 or 2, wherein: The sampling cloth (10) is made of fabric, and the fabric has a thickness of 3 mm or less.

6. The self-sampling kit according to claim 5, wherein: The fabric has a thickness of 2 mm or less.

7. The self-sampling kit according to claim 5, wherein: The fabric has a thickness of 1 mm or less.

8. The self-sampling kit according to claim 5, wherein: The fabric has a thickness of 0.6 mm or less.

9. The self-sampling kit according to claim 1 or 2, wherein: The sampling cloth is made of about 60 g / m 2 Made of fabric with a basis weight of .

10. The self-sampling kit according to claim 1, wherein: The sampling cloth (10) is made of woven or non-woven textiles, and the woven or non-woven textiles are made of synthetic fibers, semi-synthetic fibers, plant fibers, animal fibers or a combination thereof.

11. The self-sampling kit according to claim 10, wherein: The sampling cloth (10) is made of a fabric comprising polyester, polypropylene, polyethylene, polyamide, polyacetate, polyvinyl acetate, viscose fiber, modal fiber, lyocell fiber, cotton, silk or a combination thereof.

12. The self-sampling kit according to claim 10 or 11, wherein: The sampling cloth (10) is made of a non-woven textile having a soft, rough and smooth surface containing polyethylene and polyester.

13. The self-sampling kit according to claim 1 or 2, wherein: The size of the sampling cloth (10) is designed to allow the sampling cloth (10) to be completely accommodated in the vaginal cavity or rectal cavity (30, 40) of the human or animal.

14. The self-sampling kit according to claim 1 or 2, wherein: The size of the sampling cloth (10) is designed so that a portion of the sampling cloth (10) protrudes outside the body cavity after insertion.

15. The self-sampling kit of claim 1, wherein: The sampling cloth (10) is made of at least one fabric sheet (1) and / or comprises one or more stripes (2).

16. The self-sampling kit according to claim 15, wherein: The stripes (2) are strips or cords.

17. The self-sampling kit according to claim 15 or 16, wherein: The sampling cloth (10) is made of a fabric sheet (1).

18. The self-sampling kit according to claim 17, wherein: The fabric sheet (1) has a substantially rectangular, square, trapezoidal, parallelepipedal, elliptical or circular shape in an unfolded state.

19. The self-sampling kit of claim 17, wherein: The fabric sheet (1) has a push area (11) having increased strength for contacting and holding an applicator.

20. The self-sampling kit of claim 19, wherein: The pushing area (11) is a welding area or a glue coating area.

21. The self-sampling kit of claim 19, wherein: The push area (11) has an orifice (12) whose size is designed so that the applicator (20) cannot protrude through the orifice (12).

22. The self-sampling kit of claim 21, wherein: The orifice is placed in a substantially central position of the pushing area (11).

23. The self-sampling kit of claim 17, wherein: The fabric sheet (1) is folded along a fold line (13) to form a folded area, the folded area being secured by a guide element (14), the guide element defining a pocket area (15) for guiding the applicator (20) toward the fold line (13) during insertion and retaining the applicator (20) within the pocket area (15), wherein the guide elements (14) are positioned so that the maximum distance between them is approximately 2 mm to 6 mm greater than the diameter of the proximal end of the applicator (20).

24. The self-sampling kit of claim 23, wherein: The guiding element (14) is a welding wire.

25. The self-sampling kit according to claim 23 or 24, wherein The fabric sheet (1) has a substantially rectangular shape, and the folding line (13) is substantially parallel to the short sides of the rectangle.

26. The self-sampling kit of claim 25, wherein: The guide element (14) is positioned so that the folding line (13) forms one side of the pocket region (15).

27. The self-sampling kit of claim 25, wherein: The guide elements (14) are positioned such that one of the guide elements (14) is parallel to the fold line (13), thereby forming a loop (18) of fabric over the pocket region (15).

28. The self-sampling kit of claim 27, wherein: The ring (18) has a coarser texture than the rest of the sampling cloth (10).

29. The self-sampling kit of claim 28, wherein: The ring (18) has coarse-grid organic cotton.

30. The self-sampling kit according to claim 23 or 24, wherein The fabric sheet (1) is substantially in the form of an isosceles trapezoid, and the folding line (13) is substantially perpendicular to the parallel sides of the isosceles trapezoid.

31. The self-sampling kit of claim 30, wherein: The folding line (13) is placed so that the tip of a triangle of the isosceles trapezoid is folded.

32. The self-sampling kit according to claim 23 or 24, wherein The fabric sheet (1) is substantially in the form of a parallelogram, and the folding line (13) is substantially perpendicular to the longer sides of the parallelogram.

33. The self-sampling kit of claim 32, wherein: The folding line (13) is placed so that the tip of one triangle of the parallelogram is folded.

34. The self-sampling kit according to claim 15 or 16, wherein: The sampling cloth (10) comprises a plurality of stripes (2) or at least one stripe (2) folded to form a plurality of stripes (2) and a device for holding the stripes (2) together.

35. The self-sampling kit of claim 34, wherein: The stripes (2) have substantially the same length.

36. The self-sampling kit of claim 34, wherein: The stripes (2) have different lengths.

37. The self-sampling kit of claim 36, wherein: The stripes (2) have a gradually increasing length.

38. The self-sampling kit of claim 34, wherein: At least one of the stripes (2) has a length sufficient to protrude outside the body cavity.

39. The self-sampling kit of claim 34, wherein: The means for holding the stripes (2) together are welding points, gluing points, knotting points or connecting elements which can be made of the same material as the sampling cloth (10) or of another material.

40. The self-sampling kit of claim 39, wherein: The other material is plastic.

41. The self-sampling kit according to claim 1 or 2, wherein: The sampling cloth (10) is also provided with a removal device (16) for removing the sampling cloth (10) from the body cavity.

42. The self-sampling kit of claim 41, wherein The removal device is at least one thread, rope, strap, ribbon or wire.

43. The self-sampling kit of claim 41, wherein: The removal device (16) is not covered with a waterproof substance.

44. The self-sampling kit according to claim 1 or 2, wherein: The applicator (20) can be a finger or a pressing tool.

45. The self-sampling kit of claim 21 or 22, wherein: The applicator (20) is provided with a protrusion (22) at its proximal end, wherein the protrusion (22) has a diameter smaller than the diameter of the orifice (12).

46. ​​The self-sampling kit according to claim 1 or 2, wherein: The sealable receiver (50) has a size capable of accommodating the entire sampling cloth.

47. The self-sampling kit according to claim 1 or 2, wherein: The sealable receptacle (50) further comprises means for storing or preparing the specimen.

48. The self-sampling kit of claim 47, wherein: The device for preserving or preparing the specimen is saline or culture medium.

49. The self-sampling kit of claim 1, wherein: The sealable receiver (50) is a plastic jar or tube provided with a threaded cap.

50. The self-sampling kit of claim 1, wherein: The sealable receiver (50) is a syringe comprising a barrel (51), a piston (52) and a discharge port (53) provided with a sealing device (54).

51. The self-sampling kit of claim 50, wherein: The sealable receptacle (50) is also provided with a stop element (55) for securing and sealing the piston (52) in position within the barrel (51).

52. The self-sampling kit of claim 51, wherein: The stop element (55) is formed by an adjustable plastic strip which can be passed through an opening (57) provided in the piston (52) and through an opening (56) provided in the tube (51), thereby sealing the piston (51) and the tube (52) together in a desired position.

53. The self-sampling kit according to claim 1 or 2, further comprising labeling means and / or instructions for using the self-sampling kit.

54. The self-sampling kit of claim 53, wherein: The marking means is a label for writing the data of the patient from whom the sample was taken.

55. The self-sampling kit of claim 1, wherein: The sampling cloth (10) remains inserted into the body cavity for a period of at least 2 minutes.

56. The self-sampling kit of claim 55, wherein: The sampling cloth (10) is kept inserted into the body cavity for a period of at least 30 minutes, 1 hour, 2 hours, 3 hours or more.

57. Use of a sampling cloth (10) for preparing a self-sampling kit according to claim 1, wherein: The sampling cloth (10) is made of a flexible fabric having an absorbency of less than 3.5 g / g.

58. The method for using the self-sampling kit according to claim 1, comprising the following steps: a) placing the sampled sampling cloth (10) in a sealable receiver; b) sealing the receptacle; c) taking or delivering the sampled sampling cloth (10) to a testing facility for analysis, wherein the sampling cloth (10) is made of a flexible fabric having an absorbency of 3.5 g / g or less.

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