Pushing device for test tubes, sampling kit and method for securing a sampling device in a test tube

Abstract

The present invention relates to the handling of sampling devices such as a sampling cloth after sampling, by providing a pushing device (100) for securing a sampling device inside a test tube so that a pipette can be used without hindrance by an automated laboratory robot. The pushing device comprises a hollow, elongated body (1) comprising at least two slots (30) configured to allow fluid communication between the exterior space (80) and interior space (70) of the body, and at least two flaps (5) extending outwardly from the body (1) configured to be elastically such that, upon insertion of the pushing device (100) into a test tube (200) the flaps (5) are constrained by the inner wall of the test tube, causing them to retract inwardly and to exert a force against the inner wall of the test tube, thereby securing the pushing device (100) in a fixed position within the test tube (200). The invention further relates to a sampling kit provided with the pushing device (100) and to methods for securing and processing a sampling device using the pushing device (100).

Description

[0001] Pushing device for test tubes, sampling kit and method for securing a sampling device in a test tube

[0002]

[0001] The present invention relates to a the field of medical testing, and in particular to the handling of sampling devices such as a sampling cloth, or a sampling swab or brush after sampling and during the next steps of securing, transporting and laboratory analysis.

[0003]

[0002] Nowadays, laboratory automation robots are being used to handle a large number of test tubes in clinical examination, being able to work faster, to reduce the errors and to allow for higher safety in manipulating contaminated products or chemical reagents. These robots are able to precisely perform many operations such as pick and place the test tubes, swirl and / or shake about their contents to ensure uniformity of content or of chemical reactions, remove or apply lids to the test tubes, and automated pipetting of the contents of the test tubes, thus aspiring or releasing precise quantities of liquid.

[0004]

[0003] However, for specific tasks such as aspiring the liquid content from a test tube that has other objects inside besides the liquid, it is not possible to use the liquid - handling robots for pipetting. Said other objects may be a sampling device that is used for sampling or self-sampling of specimens such as cells, DNA, bodily fluids containing various biological material, etc, for example a sampling cloth, or a sampling swab or brush, or only the breakable tip of a swab or brush. This sampling device is then stored in a test tube and sent to a laboratory for further processing for analysis. To this aim, a liquid is added and the tube is swirled and / or shaken to allow the specimens in the sampling device to be transferred to the liquid forming a suspension, and then the suspension is aspired and used for analysis, for example by being distributed into several smaller vials. However, the presence of the sampling device in the test tube makes it very difficult to aspire the suspension, because it often either clogs the pipette tip, or, if the robot is programmed to retract from an object in its way, results in failure to perform the task (aspire or release the liquid). For such situations, at present, the lab technician still has to process by hand each and every test tube, removing the lid by hand to add liquid, making sure that the sampling device is not pushed outside by the buoyant force of the liquid during this step and that the lid can be properly secured again for the next step of mixing the contents (i.e. by swirling, vortexing and / or shaking the test tube). Then, the laboratory technician has to open the lid again and to aspire the liquid by hand, often making several attempts to avoid the sampling device clogging the tip of the pipette in order to make sure that the required amount of liquid suspension is retrieved. Finally, the technician will distribute by hand very small amounts of the aspired liquid in several vials, so the risk of errors is high. This is a time-consuming task, often needing repetition for success, with high risk of errors in the aspired quantities and high risk of contamination of the technician.

[0005]

[0004] An attempt has been made to solve these problems by providing, instead of the usual test tubes, a special test recipient in the shape of a cup which has to be large enough such that it is possible to divide its interior into two communicating compartments: a smaller compartment for the sampling device, and a larger compartment for the liquid, such that the centre of the cup falls into the larger room, so a liquid-handling robot can be used to aspire / release liquid from / to this compartment. However, in order to function, this system requires a particular kind of recipients (cups) and a special kind of robot, which are different in shape and dimensions from most of the recipients (test tubes) and robots now on use in laboratories around the world. So, in order to adopt this system, a laboratory would need to perform a costly replacement of their present equipment. Moreover, this system is prone to human errors when the sampling device is introduced in the cup, especially by non-trained users performing self-sampling at home, since it is easy to put the sampling device in the wrong compartment, leading to the robot not being able to perform the task.

[0006]

[0005] The aim of the present invention is to provide a device, kit and method that allows handling of test tubes containing sampling devices to be easy, efficient, secure, not prone to errors and contamination, and to be made by automated laboratory robots adapted for all kinds of test tubes.

[0007]

[0006] This aim is achieved by a pushing device according to the invention. In another aspect, the invention refers to a sampling kit comprising the pushing device of the invention together with a sampling device and a test tube. In another aspect, the present invention refers to the use of the pushing device of the invention and to a method for ensuring unobstructed access to the liquid content of a test tube.

[0008] Definitions

[0009]

[0007] The pushing device of the present invention is configured to be introduced into a test tube and to achieve and maintain a fixed position within the test tube when fully inserted. Thus, a direction of insertion is defined, which is along a longitudinal axis of the pushing device, running in the direction from the end of the device last entering the test tube towards the end of the device first entering the test tube. Thus, considering this the direction of insertion, “lower”, “down”, “downwards” or “below" will refer to a point or region situated in the direction of insertion from a given reference, while “upper”, “up”, upwards” or “above” will refer to a point or region situated opposite from the direction of insertion from a given reference. Accordingly, “oriented upwards” means oriented away from the direction of insertion, while “oriented downwards” means oriented toward the direction of insertion.

[0010] By test tube it is meant a thin hollow cylinder with one end closed, used in chemical and biological experimentation and analysis, usually made of glass or clear plastic. In practice, the test tubes may also have a shape that narrows down toward the closed end, so the diameter at the opening or mouth of the test tube is larger than its diameter at or close to the base or closed end of the test tube. A length of the test tube is defined as the length along its longitudinal axis from the closed end to the mouth or open end of the test tube.

[0011] Disclosure

[0012] Pushing device

[0013]

[0008] One aspect of the invention relates to a self-centring pushing device configured to be introduced and fixed in a test tube, comprising:

[0014] # a hollow, elongated body, comprising:

[0015] - a first end that is open, forming a mouth of said body - a second end opposite from said first end, that is at least partially closed, forming a base of said body

[0016] - a wall extending from said first end to said second end along a longitudinal symmetry axis, the wall delimiting an interior space inside the body from an exterior space outside the body:

[0017] - at least two slots configured to allow fluid communication between said exterior space and interior space, wherein each slot has a first portion which runs radially from the centre of the base to the wall and continues with a second portion running along the tubular body towards but not reaching the open end, thereby said slots separating at least two regions of the body,

[0018] # at least two flaps, distributed around said mouth, wherein each flap:

[0019] - has a first extremity attached to the tubular wall and a second extremity that is free, such that the first extremity is closer to the base B than the second extremity;

[0020] - extends outwardly from the tubular body at an angle of less than 90° in respect to the symmetry axis said flaps being configured to be elastically movable in respect to the tubular body, such that, upon insertion of the pushing device into the test tube, the elastic flaps are constrained by the inner wall of the test tube, causing them to retract inwardly and to exert a force against the inner wall of the test tube, thereby securing the pushing device in a fixed position within the test tube.

[0021]

[0009] Thus, the pushing device is adapted to be introduced into a test tube, such that it can push inside a thin object such as sampling device that is placed inside the test tube or is placed over the opening of the test tube, securing the object in a position in the test tube that is outside the pushing device, for example at the bottom of the test tube and / or between the outside of the wall of the pushing device and the inner wall of the test tube, accessible to a liquid poured inside the test tube. Consequently, an interior space inside the elongated body of the pushing device remains free of any object so that it can be easily and unimpeded accessible through the mouth of the pushing device for aspiring / releasing liquid from / into it. Thus, this free space is easily accessible for pipetting by a lab technician and, importantly, by a laboratory robot, which results in an efficient and precise process.

[0022]

[0010] In a preferred embodiment, the pushing device further comprises at least two spacers placed on an outer surface of the wall, for maintaining a distance between the wall of the pushing device and the inner wall of a test tube, said spacers being arranged on said regions.

[0023]

[0011] The pushing device may also advantageously comprise at least one spike extending from the base downwards in the exterior space, for creating a space between the base of the pushing device and the bottom of the test tube.

[0024] Furthermore, the pushing device may further comprise at least one stopping element placed on the inside surface of the wall of said regions, close to the base. The stopping elements prevent the sampling device to enter the interior space of the pushing device, for example if the covering of the base is smaller or less rigid, or if the sampling device is too thin, so the movement of said regions with respect to each other might results in the sampling device being able to pass through. Furthermore, these stopping elements may allow the pushing device to be manufactured from a thinner material, by lending it resilience toward the base, where the sampling device is being pushed. In preferred embodiments, each region has a stopping element.

[0025] Material

[0026]

[0012] The pushing device of the invention can be made of any suitable material or combination of materials, such as plastic, metal (preferably resistant to corrosion in liquids such as stainless steel or titanium), wood or compressed paper. The specialist is aware of the materials that are suitable for coming into contact with sampling devices and with the liquids and reagents used for analysis.

[0027]

[0013] Since the flaps of the device are configured to be elastically movable in respect to the tubular body, at least the flaps are preferably made by an elastic material, such that they can retract when introduced into the test tube and exert an elastic force on the inner wall of the test tube sufficient to maintain the device fixed in place inside the test tube, even when the buoyant force when there is liquid inside the tube with the pushing device would act to push it outwards. Alternatively, the flaps could be attached to the body by an elastic attachment (such as, for example, an elastic hinge) that would provide the necessary elastic force.

[0028]

[0014] Preferably the material of the body of the pushing device has also a degree of elasticity or flexibility, so that when the device is introduced into the test tube, the regions separated by the slots may draw near each other and / or slide on each other in order to make room for and accommodate the presence of the sampling device between the pushing device and the test tube.

[0029]

[0015] Of the above materials, plastic is preferred, since it is cheaper, recycled plastic can be used for environmental-friendly devices, and it is easy to manufacture a device with any wished degree of elasticity and thickness of the material. Preferably, the material is chosen such that the pushing device is re-usable and / or recyclable. Preferably, the pushing device is made of low density polyethylene PE-LD, which has low production costs, good elasticity / flexibility, low weight, and can be cleaned and re-used.

[0030] Dimensions

[0031]

[0016] The pushing device of the invention is configured to be introduced in a test tube and to be securely and reversibly fastened in a position inside a test tube of any dimensions. Therefore, the dimensions of the pushing device of the invention can be adapted to work with a test tube of any dimensions. As mentioned, the dimensions of the pushing device are chosen such that the outer diameter of the elongated body is smaller than the inner diameter of the test tube, such that the body of the pushing device can be fitted into the test tube without getting stuck midway, even when the sampling device gets between the pushing device and the inner wall of the test tube, and even considering that the inner diameter of some test tubes gets smaller towards their base. For example, the dimensions of the pushing device are adapted so that, when a sampling device in the shape of a sampling cloth is introduced into the test tube together with the pushing device, it has sufficient space so the entire sampling cloth fits along one side of the wall of the test tube but it also has sufficient space for the sampling cloth to bend over and occupy space on two sides or around the wall. In preferred examples, the outer diameter of the hollow, elongated body is 1 to 5mm less than the inner diameter of the test tube.

[0032]

[0017] On the other hand, the dimensions of the flaps and the value of the angle 0 they make to the tubular wall are chosen so that the flaps exert an elastic force on the inner wall of the test tube, so a maximum distance determined by the flaps when not constrained is bigger than the diameter of the test tube. Consequently, when introduced into the test tube, the pushing device cannot simply fall into the test tube, but instead the elastic flaps remain partially outside and a force is needed to push them inside, such as pushing with a finger, or a palm, or a lid. Further to this force being applied, the flaps become constrained by the inner wall of the test tube, causing them to retract inwardly and to exert in turn an elastic force against the inner wall of the test tube, sufficient to secure the pushing device in a fixed position, centred within the test tube. By said maximum distance determined by the flaps when not constrained is meant the maximum distance between two points of the flaps measurable in transverse plane (a plane perpendicular to the longitudinal axis). For example, if the device has two flaps of the same length L (from first to second extremities) and forming a similar angle 0 with the body of the pushing device, the maximum distance would be calculated between points at the ends of the flaps, and would be the sum of the diameter of the elongated body plus two times L sin 0. For a device having three or more flaps arranged around its mouth, said maximum distance could be, for example, the diameter of the biggest circle formed in a transverse plane by said flaps. It would be obvious for the specialist in the art to choose the dimensions of the flaps and of their angles such that it is possible to easily push and secure the pushing device inside the test tube.

[0033] The specialist in the art will also know to choose the length of the pushing device such that it can be completely inserted within the desired test tube. In preferred embodiments, the length of the pushing device should be at least 15mm shorter that the length of the test tube.

[0034]

[0018] At the same time, the length of the hollow, elongated body is chosen such that a dispensing device, such as a pipette, can have unobstructed and sufficient access the interior space. Also, the specialist will be aware that the minimum inside diameter of the tubular wall W of the elongated body has to be sufficient so a pipette can be easily introduced in the interior space, so the specialist will be able to adapt this diameter to the dimensions of the pipette to be used or to the diameter of the usual laboratory liquid dispensers.

[0035]

[0019] Similarly, the thickness of the wall and of the flaps of the pushing device can be chosen by the specialist such that the device is sufficiently resilient while at the same time sufficiently flexible and every element is able to fulfil its function.

[0036]

[0020] In a particularly preferable example, the dimensions of the pushing device are chosen such that it works with the test tubes that are usually employed together with sampling devices. At present, most sampling devices are collected in test tubes having an inner diameter of about 10 to 16 mm and a length of 75 to 120mm. The laboratory automation robots currently employed and produced are designed to work with test tubes of these dimensions. For using with such test tubes, the pushing device in this preferred example may have a length of about 60 to about 1 15mm, and the maximum distance determined by the flaps when not constrained can vary from 10.5 to 20mm. Body

[0037]

[0021] As mentioned, the hollow, elongated body of the pushing device has an open end (a mouth), so that a dispensing head (such as a pipette) can enter freely in the interior space formed inside the hollow body of the pushing device. For simplicity of manufacture, said mouth may be an opening in transverse plane, positioned such that its centre coincides substantially with the centre of the tubular body.

[0038]

[0022] The wall of the hollow, elongated body extends along a longitudinal symmetry axis X from the mouth of the body to the base of the body in a substantially tubular shape. By tubular shape it is meant a hollow, longer than wider shape, wherein the transverse section can be, for example, a circle or a regular polygon (such as a hexagon, an octagon, etc.). So, by the diameter of the body or of the wall it is meant either the diameter of its transverse circular section or the diameter of the circle circumscribing said regular polygon. Furthermore, in preferred embodiments, said diameter of the body or of the wall narrows down from the first end towards the second end of the elongated body, in order to better fit in by following the shape of the test tube.

[0039]

[0023] Preferably, the wall of the body continues on the base to form also the base of the body, so that the base of the body is at least partially covered, thus preventing the sampling device from entering into the interior space of the body.

[0040] Slots

[0041]

[0024] Slots, i.e. long, narrow apertures, slits or cut-outs are made in the wall starting from the centre of the base and running radially to the edge(s) of the base, and then continuing along the body towards but not reaching the mouth. These slots are narrow, i.e. significantly narrower than the wall, so that a sampling device such as a sampling cloth (usually made of one or two sheets of woven or non-woven textile) or the breakable tip of a sampling swab or brush cannot pass through said slots into the interior space of the pushing device. For example a slot may have a width of 1 to 3 mm. The width of a slot may be the same along the entire length of the slot, or it may vary, for example from 1 mm at a lower end to 3mm at an upper end of the slot. Said slots or cut-outs allow liquid communication between the interior and exterior space of the body, so that when a liquid is introduced in the interior space of the pushing device, it can flow easily outside the pushing device and into the test tube to reach the sampling device in order to extract the specimens therefrom, and then the liquid together with the specimens suspended therein may flow freely inside the pushing device, so it can be aspired and analyzed. Advantageously, this means that an automated robot may directly process a test tube having inside the pushing device of the invention and a sampling device: it may open the lid, insert liquid therein, swirl or shake the test tube to extract the specimens from the sampling device, add further reagents and / or aspire the resulted suspension and dispense it into one or more vials for analysis. Moreover, the advantage of said slots is that they allow the pushing device to change shape when the regions formed in the elongated body draw near each other or slide about each other, so it can adapt to the shape of the test tube (even when it narrows down toward the base) also allowing space for the sampling device.

[0042]

[0025] The at least two, preferably three or four slots made in the elongated body of the pushing device separate a corresponding number of regions at the lower part of the body. In preferred embodiments, due to the flexibility of the material of the body, these regions may slide in respect to each other when a force acts upon them, so that they will be able to better accommodate the sampling device in the space between the pushing device and the test tube.

[0043]

[0026] In some embodiments, said slots have equal lengths. The advantage of this arrangement is the ease of fabrication. Also for ease of fabrication the slots may be evenly distributed around the elongated body. For example, the slots may reach to about 1 / 3, 1 / 2, 2 / 3, 3 / 4 of the length of the elongated body. Preferably, the slots reach to maximum 1 cm from the mouth.

[0044]

[0027] In other embodiments, said slots may have different lengths. The advantage of this arrangement is that it allows pressure (from the sampling device fitting between the test tube and the pushing device) to distribute unevenly along the elongated body, so less pressure is concentrated in the same area of the pushing device, so the pushing device will be more flexible, and can be made of a less resistant material, or can be thinner.

[0045] Flaps

[0046]

[0028] The pushing device is provided with at least two flaps, preferably three or four flaps, distributed around said mouth, for securing the pushing device in place within the test tube. The flaps are configured to be elastically movable in respect to the tubular body, either due to the elasticity of their material or to the elasticity of the hinge between the flaps and the wall, such that, upon insertion of the pushing device into the test tube, the elastic flaps are constrained by the inner wall of the test tube, causing them to retract inwardly and to exert a force against the inner wall of the test tube. This force should be sufficient to secure the pushing device in place such that it is not pushed out by the buoyant force of a liquid that is introduced in the test tube, or by turning the test tube upside down.

[0047]

[0029] Advantageously, the shape of the flaps and the fact that the maximum distance determined by the flaps is bigger than the diameter of the test tube ensures that the user cannot insert the pushing device the wrong way in the test tube, thus eliminating the risk of human errors in using the device.

[0048]

[0030] In preferred embodiments, the flaps are distributed evenly around the mouth of the pushing device, so that the constraining forces are also evenly distributed and the pushing device is secured in a central position inside the test tube, ensuring good access by a pipetting robot.

[0049]

[0031] In preferred embodiments, the flaps have the same length, meaning the same distance from the first to the second extremities. This arrangement is easier to produce and results also in equilibrating the forces around the pushing device.

[0050]

[0032] Each flap extends outwardly from the tubular body at an angle 0 of 0° to 90° in respect to the symmetry axis.

[0051]

[0033] In some embodiments, the angles 0 of all the flaps are equal. This is easy to manufacture and results in an even distribution of the constraining forces that ensure a central position of the elongated body in the test tube.

[0052] In other preferred embodiments, the pushing device is further provided with at least one straight, longer pushing flap for pushing besides said at least two flaps for fixing the pushing device in the test tube. Said pushing flap is substantially straight, meaning that it has the value of angle p of 0° or close to 0°, and it is taller than the other flaps, meaning that it has dimensions such that the second extremity of the pushing flap reaches to a point that is above the second extremities of the other fixing flaps, both when the fixing flaps are in constrained, retracted position or when they are not retracted. This embodiment has the advantage that, when the pushing device is pushed downwards into a test tube, either with a finger, palm or a cap, the straight pushing flap being slightly longer than the fixing flaps, when the pushing flap has entered the test tube, this ensures that all the fixing flaps are deeper inside, firmly fixed in a position lower than the mouth of the test tube, so they cannot go out when opening the test tube.

[0053]

[0034] In some embodiments, the pushing device of the invention is configured to be removably attached inside a lid or cap of a test tube. Such pre-assembled pushing device- and-cap assemblies are easier to use and prevent contamination by handling the device with the hand.

[0054]

[0035] In one example, a pushing device configured to be placed inside a thread cap has equally spaced-apart flaps having the same length and the same angle p with the elongated body. Such a pushing device can be arranged inside a thread cap with the second extremities of the flaps placed at the inner edge of the thread cap such that the flaps are constrained by the inner wall of the cap, thus securing the pushing device therein. In this arrangement, the user can grip the cap having the pushing device secured within and use it to introduce the pushing device within the test tube and then the user can thread the cap. By threading the cap, the edge of the wall of the test tube forces out and replaces the second extremities of the flaps at the inner edge of the cap, so the second extremities of the flaps are transferred to press against the inner wall of the test tube.

[0055] In a preferred embodiment, the pushing device has two, three or more equally spaced-apart fixing flaps having the same length and the same angle [3 with the elongated body, and one pushing flap that is substantially straight (angle p of about 0°) and that is configured to abut the bottom or any element of the cap, such as a fixing element protruding from the bottom of the cap that is directly above the straight pushing flap. Consequently, because the straight pushing flap reaches to a point slightly above the other, fixing flaps, it pushes on the device when threading the cap on and ensures that the fixing flaps fully enter into the test tube so they can secure it in a fixed position. Furthermore, the straight pushing flap ensures that the pushing device follows a straight trajectory during entering in the test tube while threading of the cap, so the threading does not force it in an unbalanced, helicoidal trajectory that could result in an off-centre position.

[0056]

[0036] In another example, the pushing device is configured to be placed inside a “snap-on” cap. Similarly to the previous example, the pushing device preferably has equally spaced- apart flaps having the same length and the same angle p with the elongated body, so the flaps can fix the pushing device by compressing against the snap-on cap. Furthermore, a snap-on cap has inside a fixing element, usually elastic, protruding from the bottom of the cap so the walls of the test tube can snap into a fixed position between the cap and the fixing element. Therefore, the pushing device can be arranged inside a snap-on cap with the second extremities of the flaps being at least partially caught and retained in the space between the cap and the fixing element, thus removably attaching the pushing device to the snap-on cap. For a more secure attachment, in one example, one or more points of superficial welding may be made between the flaps and the cap, such that this welding is broken in the process of pushing and securing the cap on the test tube. Alternatively, the pushing device may be removably attached to the snap-on cap by one or more points of superficial welding without the flaps going into the space between the fixing element and the wall of the cap.

[0057]

[0037] In any of these arrangements, the user can grip the cap with the pushing device secured within and use it to introduce the pushing device within the test tube and then push the cap on. By pushing the cap on the test tube, the edge of the wall of the test tube breaks any welding points and / or forces out and replaces the second extremities of the flaps from their position against the cap or in the space between the cap and the round fixing element, so the second extremities of the flaps are transferred to press against the inner wall of the test tube.

[0058] In an alternative example, the pushing device has two, three or more equally spaced-apart fixing flaps having the same length and the same angle p with the elongated body, and one pushing flap that is substantially straight (angle p of about 0°), which pushing flap is placed with the second extremity against the bottom of the cap or against said fixing element. Since it reaches to a point slightly above the other flaps, when the cap is pushed down, the straight pushing flap pushes on the pushing device and ensures that the fixing flaps fully enter into the test tube so they can secure it in a fixed position.

[0059] Spacers

[0060]

[0038] The pushing device of the present invention may optionally be further provided with at least one spacer arranged on the exterior of the wall of said regions of the elongated body, for maintaining a distance between the wall of the elongated body and the inner wall of the test tube, in order to ensure that the elongated body does not abut with the inner wall of the test tube and in doing so impedes free circulation of liquid around the pushing device. Free circulation of liquid is important for a better extraction of specimens of interest from the sampling device and for a better homogenization of the specimens in the liquid. Furthermore, said spacers may help maintain the pushing device secured inside the test tube, by adding their force of compression against the wall of the test tube to the force of the flaps. Preferably, each region of the elongated body is provided with a spacer, to help maintain the pushing device secured in a central position inside the test tube.

[0061]

[0039] In preferred embodiments, said spacers are placed on said regions of the body close to the base of the elongated body, so they help to catch and push the sampling device inside the test tube when the pushing device is introduced in the test tube. When the sampling device is a sampling cloth, the spacers may also ensure that the sampling cloth remains compressed inside the test tube and does not float to the surface, so it can be entirely covered with liquid for a better extraction of specimens.

[0062] Said spacers may be made of the same material as the wall of the elongated body, for ease of manufacture. They may have any shape and dimensions that allow them to fulfil their functions, such as a cube, prism, hemisphere, etc. In a preferred embodiment, said spacers are in the shape of elongated solids that are narrower near the base of the body and wider in the opposite direction, to adapt to the shape of the test tubes that usually narrows down toward their base. Spikes

[0063]

[0040] The pushing device may also advantageously comprise at least one spike, preferably one for each region of the elongated body, extending from the base downwards in the exterior space, for pushing the sampling device, and for creating a space for it and for circulation of liquid between the base of the pushing device and the bottom of the test tube. The spikes are preferably pointy, the better to be able to hook and keep a sampling cloth, no matter how this is placed in or over the test tube. For example, in one embodiment, it is preferred to use a sampling cloth having a width larger than the diameter of the test tube, making it difficult to introduce the sampling cloth in the test tube without contamination. For this embodiment, the user can place the sampling cloth over the opening of the test tube and push it inside with the pushing device. The spikes are especially useful for this embodiment, making sure that the pushing device does not slide along the sampling cloth, but is able to catch it and handle it as intended. Moreover, pointy spikes also function as a preventative measure impeding the user from misuse of the device by trying to push it upside down in the test tube.

[0064]

[0041] Said spikes may be made of the same material as the wall of the elongated body, for ease of manufacture. For using with a test tube of 75mm length, spikes can have, for example, a length of between 1 and 5 mm.

[0065] Stopping elements

[0066]

[0042] The pushing device may also comprise at least one stopping element placed on the inside surface of the wall in said regions of the elongated body, close to the base. In preferred embodiments, each region has a stopping element. The purpose of such stopping elements is to prevent the sampling device to enter through the slots in the interior space of the elongated body, for example if the sampling device is very thin as compared with the width of the slots, or if the flexibility of the elongated body is such that movement of said regions with respect to each other might results in the sampling device being able to pass through the opening made between said regions. As mentioned, the first portions of the slots separate the wall of the base in radial sections. For the case that these radial sections of the wall of the base B are too small or not rigid enough to stop an object such as a thin cloth or a swab from entering into the interior space of the elongated body, the stopping elements may be provided preferably on the interior of the wall W of each region, as near as possible to the base B.

[0067]

[0043] These stopping elements may also act as reinforcements of the wall, allowing the pushing device to be manufactured from a thinner material, by lending resilience to the wall toward the base, where the sampling device is being pushed against the sampling device. For ease of manufacture, said stopping elements may be made by the same material as the wall of the elongated body. They may have any shape and dimensions that allow them to fulfil their functions. In a preferred embodiment, said stopping elements are placed along the inside wall of each region and have a substantially triangular shape, with the base of the triangle at or very near the base of the elongated body, and the height along the wall of the elongated body. This shape allows the base of the stopping elements to prevent a sampling device from entering the interior of the elongated body. Kit

[0068]

[0044] In another aspect, the present invention refers to a sampling or self-sampling kit comprising the pushing device of the invention, as described above, together with a sampling device and a sealable test tube.

[0069]

[0045] The sampling device may be a sampling cloth, such as, for example, the sampling cloth described in document WO2019 / 106408, hereby incorporated by reference. This is a thin, flexible sampling cloth made from a material chosen from the group of a woven or nonwoven textile, for example made of synthetic fibers (such as polyester, polypropylene, polyethylene, polyamide, polyacetate, polyvinyl acetate), semi-synthetic fibers (such as viscose, modal, lyocell), plant fibers (such as cotton), animal fibers (such as silk), or combinations thereof. This material has little or no absorbency, so that only a small amount of the specimens are absorbed into the fabric of the sampling cloth. The absorbency should be less than 3.5 g / g, preferably less than 3 g / g, more preferably less than 2 g / g measured using the Syngina protocol for measuring the absorbency of tampons. The thickness of the sampling cloth should be of 3mm or less, preferably 2 mm or less, more preferably 1 mm or less, even more preferably 0.6 mm or less. The material of the sampling cloth has a basisweight of approximately 60 g / m2.

[0070]

[0046] Thus, the sampling cloth of the kit is made of a thin, flexible textile material, such that it will be possible to fit inside the test tube but outside the pushing device, either compressed at the bottom and / or along the walls. The dimensions (length and width) of the sampling cloth may vary with its different shapes and configurations; however, it has dimensions adapted to its functions and to the dimensions of the sealed recipient wherein it is placed. For example, for a standard test tube of 12 to 16 mm diameter and 75mm length, the sampling cloth may have a length of 80 mm or less, and a width of about 12 to 14 mm. If the length or width of the sampling cloth is greater than those of the test tube, the sampling cloth may be easily introduced into the test tube by placing it across the opening of the test tube and pushing it inside with the pushing device of the present invention.

[0071]

[0047] The sampling device of the kit may also be a breakable sampling swab or brush. After sampling, the tip comprising the swab or brush is broken off, and this broken-off tip will represent the sampling device to be placed inside the test tube. Again, considering the usual dimensions of such swabs or brushes, they are made of a very thin stick with a small absorbent tip which gets even smaller after sampling, so they will fit within the space ar the bottom and / or along the walls of the test tube.

[0072]

[0048] The kit further comprises the pushing device of the invention and a corresponding sealable test tube for storing and transporting said sampling device to a laboratory. In order to be sealable, the test tube is provided with a lid or cap. Preferably, the sealable test tube is suitable for being used directly as a working test tube at the laboratory, so the usual laboratory robots can work with it in the usual analysis systems. By a corresponding test tube is meant that the pushing device and the test tube have dimensions adapted to function together, namely such that the pushing device can be entirely enclosed and securely fixed within the test tube, together with the sampling device.

[0073]

[0049] In preferred embodiments, the kit comprises the pushing device pre-assembled with the cap of the test tube. For these embodiments, the kit comprises a test tube having a cap that is not attached, or not attached all the way to the test tube. As explained above, in these embodiments, the flaps of the pushing device are adapted to removably fix the pushing device inside the cap of the test tube, such that, upon putting the cap on the test tube, for example by screwing the cap all the way or by snapping the cap on, the pushing device is transferred into the test tube. For such embodiments, the kit of the invention may comprise the cap-and-pushing device assembly separate from the test tube, or the cap- and-pushing device assembly loosely introduced into the test tube. The advantages of these embodiments are that the user does not have to touch the pushing device in order to fix it inside de test tube, so the risk of contamination is reduced. Also, it will be easier and clearer for the user how to insert the pushing device into the test tube, eliminating human errors. Moreover, it will be easier for the user to insert the pusing device into the test tube by using the cap, especially for the embodiments where the pushing device is equipped with a pushing flap.

[0074]

[0050] The kit of the invention may of course comprise further elements, adapted for the type of sampling to be performed, such as an applicator for inserting a sampling cloth in a bodily cavity, preserving liquid which may be stored in the test tube or separately, labeling means, instructions for use, etc.

[0075] Methods

[0076]

[0051] In another aspect, the present invention refers to a method of securing a sampling device inside a test tube comprising the steps of a) placing a sampling device in a test tube or across the mouth of a test tube, b) introducing and fixing the pushing device of the invention within the test tube, thereby securing said sampling device in a position that is inside the test tube and outside the pushing device. For cases when immediate analysis is not possible, and the storage and transport of the sampling device are needed, a further step is added to the method, of c) putting on a lid or cap to seal the test tube. Alternatively, steps b) and c) may be performed at the same time, when the pushing device of the invention is pre-assembled with the cap of the test tube, as described above. In another alternative, the sampling device may be first placed in the test tube and then the cap may be put on the test tube for storage and transport to a laboratory, where a technician may open the cap and insert the pushing device. In another alternative, a further step d) may be added at any time before step c), of placing a substance, for example a preservative liquid or extraction liquid such as physiological serum inside the test tube.

[0077]

[0052] The advantage of storing a sampling device according to this method is that it becomes possible for a laboratory robot to directly process the sampling device for analysis. At present, a lab technician needs to open by hand the cap of a test tube having a sampling device inside, and carefully perform any further steps making sure that the sampling device is not pushed out by the liquid, so that no contamination occurs and the cap can be secured again after adding or taking liquid from the test tube. Then, the lab technician has to work around the sampling device trying to manipulate the right amounts of extraction liquid, reagents, or suspension into and out of the test tube. However, when the method according to the invention is performed, the sampling device arrives at the laboratory securely stored in the test tube, so a robot or automated system can perform immediately, efficiently, safely and rapidly any of the necessary tasks such as taking off the cap, pipetting a substance into the test tube, vortexing the tube to extract specimens from the sampling device into a liquid, aspiring a precise quantity of liquid without the pipette becoming clogged or retracting from the sampling device, etc. Of course, the method also allows a laboratory technician, even in the absence of a lab robot or automated system, to work easier and safer.

[0078]

[0053] A sampling device suitable to be used for this method may be a sampling cloth or a sampling swab or brush or the breakable tip thereof as described above. Also as described above, in step a) a sampling cloth may be introduced inside the test tube by the user or, if the width of the sampling cloth is bigger that the width of the test tube, the sampling cloth may be placed on the opening of the test tube, for example it is laid in equilibrium on the mouth of the test tube, in a transverse position. In this arrangement, when inserting the pushing device into the test tube, the pushing device will also push the sampling cloth inside.

[0079]

[0054] Preferably, the test tube used for this method is sealable, meaning that it has means for sealing the opening of the test tube, such as a cap. Advantageously, elements on the bottom of the test tube cap such as, for example, fixing elements for securing the cap on the test tube can push down the flaps of the pushing device when putting the cap on, making it even more securely attached to the test tube.

[0080]

[0055] In another aspect, the present invention refers to a method for automated processing and analysis of a sampling device, comprising at least the step of i) a dispensing device, for example a pipette, of a liquid handling robot entering a test tube having a sampling device secured inside by the above method to aspire liquid from or to release liquid into it.

[0081]

[0056] A very important advantage of the pushing device of the present invention is that it is secured in a fixed position, centred within the test tube. This makes it possible for a robotic arm equipped with a pipette to have unimpeded access to the liquid inside, because the lab robots are designed to go to the centre of a test tube. So, because the elongated body of the pushing device is aligned along the centre of the test tube, and because the sampling device is kept by the pushing device to the exterior of the elongated body, the interior space inside the elongated body is easily accessible to a pipette coming down about the centre of the test tube. Therefore, by using the method of the invention, the processing and analysis of the specimens sampled by a sampling device can be automated, and thus becomes fast, efficient, safe, and free of errors.

[0082]

[0057] The method for automated processing and analysis of the invention may comprise also other steps, the order of which will be determined by the workflow of the system implemented in a laboratory: ii) opening or closing the lid of the test tube, iii) gripping and moving the test tube from a position to another, iv) mixing the contents of the test tube for example by vortexing and / or shaking, etc.

[0083] Advantages

[0084]

[0058] The advantages of the pushing device, kit and methods of the invention are as follows: - they can be used with existing laboratory equipment, so there is no need for any costly replacement of test tubes, lab robots or systems;

[0085] - the results of the laboratory tests can be obtained faster (no multiple tries needed, use of laboratory robots possible) and more reliably (robots can operate a great number of tests in exactly the same way);

[0086] - reduction of errors - during securing the sampling cloth in the recipient (test tube) - the pushing device is configured to ensure that the user places the sampling device in the correct space and the pushing device is introduced correctly

[0087] - during manipulation for analysis - the fact that a robot is being used eliminates errors of mislabelling, quantities of liquids being dispensed, other human errors

[0088] - increased safety by allowing a robot to manipulate chemical reagents and / or contaminated contents instead of a lab technician.

[0089] Brief description of the drawings

[0090]

[0059] Figure 1 represents a front view of one embodiment of the pushing device according to the invention having 4 flaps and 4 equal slots and spacers.

[0091] Figures 2a and 2b represent views from above into a test tube, before and after the pushing device according to the embodiment of Fig. 1 has been secured in place in the test tube.

[0092] Figure 3 represents a view of another embodiment of the pushing device according to the invention having the slots and spacers of different sizes.

[0093] Figure 4 represents a view from bellow and lateral of another embodiment of the pushing device of the invention having 3 flaps, 3 slots and 3 spikes.

[0094] Figures 5a and 5b represent views of an assemble of a pushing device and a snap-on cap before and after the pushing device is releasably secured inside said snap-on cap.

[0095] Figure 6 represents a longitudinal section through of test tube with thread cap and a pushing device after the pushing device has been inserted, wherein the pushing device has a straight flap.

[0096] Figure 7 depicts a kit and a method of of securing a sampling device inside a test tube according to one embodiment of the present invention, wherein the sampling device is a sampling cloth having a length and width smaller than the length and width of the test tube. Figure 8 depicts a kit and a method of of securing a sampling device inside a test tube according to another embodiment of the present invention, wherein the sampling device is a sampling cloth having a length and width bigger than the length and width of the test tube.

[0097]

[0060] Figure 1 depicts a pushing device (100) according to an embodiment of the invention, wherein the pushing device (100) has four slots (30), out of which only two are visible, configured to allow fluid communication between the exterior space (80) and interior space (70) of the elongated body (1 ) of the pushing device (100). The slots (30) are equal, symmetrical and parallel to the longitudinal symmetry axis X of the pushing device (100). This arrangement is easy to manufacture and ensures that the forces distribute uniformly around the pushing device (100), so it will take a position in the centre of the test tube. The second portion (34) of the slots (30) reaches to about one third from the base B to about one half of the length of the elongated body (1 ), which ensures that there is sufficient space for the fluid communication and, at the same time, the pushing device has sufficient resilience. The pushing device (100) of the present embodiment is made of a flexible plastic material, so the regions (40) can draw near each other or slide on each other to adjust to the shape of the test tube and also accommodate a sampling device (300) in the space between the pushing device (100) and the inner wall of the test tube (200). The pushing device (100) of Fig. 1 has 4 flaps (5), evenly distributed around its open end (10), wherein all four flaps (5) have similar shapes and dimensions and form the same angle |3 of about 5° to 45°, preferably about 10° to 25°, most preferably about 15° in respect to the symmetry axis X. This configuration also has the advantage that ensures that the pushing device easily self-centres when pushed inside the test tube.

[0098]

[0061] Furthermore, the pushing device (100) of the present embodiment is provided with four elongated spacers (2), out of which three are visible, said spacers (2) being substantially equal to each other and being placed on the four regions (40) formed by the four slots (30) such that the thickest area of the spacers (2) is the furthest from the basis B. This arrangement allows the pushing device (100) to conform to different shapes of a test tube (200), while still ensuring that a liquid can flow freely to extract specimens of interest from a sampling device (300).

[0099]

[0062] Figure 1 also shows that the pushing device (100) is provided with 4 spikes (3), out of which only three are visible. Said spikes (3) start from the base B where they are fixed on the wall of the base (B), on each of the four regions (40).

[0100] Although this example depicts a pushing device (100) symmetrically divisible in four sections, it will be obvious to the specialist that the same advantages will occur if the pushing device (100) is symmetrically divisible in two, three or more sections.

[0101]

[0063] Figures 2a and 2b depict views from above into a test tube (200). In figure 2a the pushing device has been partially introduced into the test tube, but has not yet been pushed and secured within. It can be seen that Df, the maximum distance between the flaps, is bigger than Dt, the diameter of the test tube, so the pushing device cannot fall in the test tube, it has to be forcibly pushed inside. The sampling device (300), which in this case is a thin sampling cloth, is depicted in the space (80) that is outside the elongated body (1 ) and inside the test tube (200). Because the inside of the elongated body (1 ) is empty, the inside view of the base B can be seen from above, so the four slots (3) are visible, namely their first portions (32) starting from the centre of the base B and reaching to the edge of the base B, from where they continue with the second portions (34). Also depicted are four stopping elements (4), which in this example are elongated solids attached to the inside of the wall W such that they are wider near the base B and narrow down toward the mouth M. So from above, the stopping elements (4) appear rectangular since their bases, which represent their widest areas, and are placed at or near the base B, are rectangles with the length of about 75% of the radius of the base B, while from a side they appear triangular. The wide base of the stopping elements (4) ensures that the sampling device cannot enter into the interior space of the elongated body (1 ). Furthermore, the elongated shape of the stopping elements (4) allows them to lend strength to the wall W, so the thickness of the wall may be reduced, thus reducing waste of materials and costs.

[0064] Figure 2b depicts a view from above of the test tube (200), the pushing device (100) and the sampling cloth (300) after the pushing device (100) has been pushed inside the test tube (200) and secured in place by the flaps (5). It can be seen that, due to the elasticity of the material of the test tube, the regions (40) have come closer to each other to accommodate the sampling cloth (300), so the slots (30) have become narrower. It can also be seen that the flaps (5) have been constrained against the inner wall of the test tube (200) until they have been completely enclosed within the test tube (200), so a cap can be put on the tube.

[0102]

[0065] Figure 3 depicts a pushing device (100) according to another embodiment of the invention, wherein the pushing device (100) has four slots (30), out of which only two are visible. The slots (30) of this embodiments are placed symmetrically around the wall W, but they have different lengths, so the pressure around the elongated tube is distributed helicoidally, making it more flexible. The pushing device (100) also has 4 spacers (2) that have also increasing lengths, to contribute to this technical effect.

[0103]

[0066] Figure 4 represents a view from bellow and lateral of another embodiment of the pushing device (100) of the invention having 3 flaps, 3 slots and 3 spikes. From this view the base B of the elongated body (1 ) is visible from outside, so it can be seen how the three slots (30) start from the centre of the base B and go radially to the edge of the base B forming the first portion (32) of the slots (30), which continues on the wall W of the elongated body with the second portion (34) of the slots (30).

[0104]

[0067] Figures 5a and 5b represent longitudinal sections of an assemble of a pushing device (100) and a snap-on cap (250) of a test tube (200).

[0105]

[0068] Figure 5a depicts a pushing device (100) having three equally spaced-apart flaps (5) that have the same length and the same angle p with the elongated body, placed inside a sanp-on cap (250). The snap-on cap (250) has inside an fixing element (254) arranged so the walls of the test tube (200) can be fixed between the cap (250) and the fixing element (254). The pushing device (100) is removably attached to the snap-on cap (250) by one or more points of superficial welding (56), without the flaps (5) going into the space between the fixing element (254) and the wall of the cap (250). So, the user can grip the cap (250) with the pushing device (100) fixed within by the welding point(s) (56) and use it to introduce the pushing device (100) within the test tube (200) by breaking the point(s) of superficial welding (56), and then push the cap (250) securely on.

[0106]

[0069] In figure 5b, the pushing device (100) is arranged inside a snap-on cap (250) with the second extremities (54) of the flaps (5) being at least partially caught and retained in the space between the cap (250) and the fixing element (254), thus removably attaching the pushing device (100) to the snap-on cap (250). For a more secure attachment, in this example, one or more points of superficial welding (56) have been made between the flaps (5) and the cap (250) The cap (250) is then used as a handler to manipulate the pushing device (100) inside the test tube (200), and then the cap is pushed on with a force sufficient to break the superficial welding points (56) and for the edge of the wall of the test tube (200) to force out and replaces the flaps (5) in the space between the cap (200) and the round fixing element (254), so the second extremities (54) of the flaps (5) are transferred to press against the inner wall of the test tube (200).

[0107]

[0070] Figure 6 represents a longitudinal section through an embodiment comprising a test tube (200) with thread cap (250) and a pushing device (100) after the pushing device (100) has been inserted and the cap (250) has been thread on, wherein the pushing device (100) has a straight pushing flap (5’). It is visible that the wall of the test tube (200) has been secured in the space between the cap (250) and a round fixing element (254) protruding from the bottom of the cap (250), more specifically in the space between thread elements (258) of the cap (250) and the fixing elements (254). In this embodiment, a section of the straight flap (5) is shown abutting the fixing element (254) at a point that is upwards from the free end (54) of the other flaps (5), out of which only one is visible in this section. Consequently, when the pushing device (100) is pushed down either by hand or by threading the cap (250), this longer, straight pushing flap (5’) pushes on the device (100) and ensures that the other flaps (5) enter into the test tube (200) up to a lower point. So, in this embodiment, the pushing device (100) is secured in a lower fixed position, so it will have no possibility to get out of the test tube (200) when the cap (250) is taken off. Furthermore, in an embodiment where the pushing device (100) is pre-assembled with the cap (250), the straight fixing flap (5’) ensures that the pushing device (100) follows a straight trajectory while the cap is thread on, so the circular movements of the threading do not force it in an unbalanced, helicoidal trajectory that could result in an off-centre position.

[0108]

[0071] Figure 7 depicts a kit according to an embodiment of the invention and a corresponding method of securing a sampling device (300) inside a test tube (200). According to this embodiment, and as shown in figure 7a, the kit comprises a sealable test tube (200), a sampling device (300) that is a sampling cloth having a width that is smaller than the width of the test tube (200) and a pushing device (100).

[0109] The method for securing the sampling cloth (300) inside the test tube (200) is depicted in the next figures, as follows: Figure 7b shows that the user drops the sampling cloth (300) inside the test tube (200). Because of their comparative dimensions, this is easy to do. For example, the sampling cloth (300) may have a width of about 10 to 12 mm, while the test tube (200) may have a diameter of about 14 to 16 mm. Figure 7c shows the sampling cloth (300) after was dropped in the test tube (200), so we can see that, in this example, the sampling cloth (300) can be longer than the test tube (200). Figure 7d shows the user preparing to use a pushing device (100). The user holds the test tube (200) having the sampling cloth (300) with one hand, and the pushing device (100) in the other hand. Figure 7e shows the user introducing the pushing device (100) in the test tube (200), and we can see that the pushing device (100) has pushed the sampling cloth (300) inside the test tube (200) and has compressed it against the wall of the test tube (200). Figure 7f shows the user using a finger to force the flaps (5) of the pushing device (100) in the test tube (200). Finally, figure 7g shows the user putting the cap (250) on the test tube (200), thus securing the tube for sending to the laboratory. Especially for a snap-on cap, the elements on the bottom of the cap (250) such as, for example, fixing elements (254), will continue to push down the flaps (5) of the pushing device (100), making it even more securely attached to the test tube (200)

[0110]

[0072] Figure 8 depicts a kit according to another embodiment of the invention and a corresponding method of securing a sampling device (300) inside a test tube (200). According to this embodiment, and as shown in figure 8a, the kit comprises a sealable test tube (200), a sampling device (300) that is a sampling cloth having a width that is bigger than the width of the test tube (200) and a pushing device (100).

[0111] The method for securing the sampling cloth (300) inside the test tube (200) is depicted in the next figures, as follows: Figure 8b shows that the user places the sampling cloth (300) across the opening of the test tube (200). Because of their comparative dimensions, the sampling cloth (300) can be laid in equilibrium on the opening of the test tube (200), as shown. For example, the sampling cloth (300) may have a width of about 14 mm, while the test tube (200) may have a diameter of about 10 to 12 mm. Figure 8c shows the user on the point of using a pushing device (100). The user holds the test tube (200) having the sampling cloth (300) laid across with one hand, and the pushing device (100) in the other hand. Figure 8d shows the user introducing the pushing device (100) in the test tube (200) together with the sampling cloth (300). The next steps of the method (not shown) are forcing the flaps (5) of the pushing device (100) to fully enter the test tube (200), for example by pushing with a finger or the palm, and then putting the cap (250) on the test tube (200), thus securing the tube for sending to the laboratory.

Claims

Claims1. Pushing device (100) configured to be introduced and fixed in a test tube (200), comprising:# a hollow, elongated body (1 ), comprising:- a first end (10) that is open, forming a mouth M of said body (1 )- a second end (20) opposite from said first end (10), forming a base (B) of said elongated body (1 ) that is at least partially covered- a wall (W) extending from said first end (10) to said second end (20) along a longitudinal symmetry axis (X), the wall W delimiting an interior space (70) inside the elongated body (1 ) from an exterior space (80) outside the elongated body (1 ):- at least two slots (30) configured to allow fluid communication between said exterior space (80) and interior space (70), wherein each slot (30) has a first portion (32) which runs radially from the centre of the base B to the wall (W) and continues with a second portion (34) running along the elongated body (1 ) towards but not reaching the open end (10), thereby said slots (30) separating at least two regions (40) of the elongated body (1 ), at least two flaps (5), distributed around said mouth (10), wherein each flap (5):- has a first extremity (52) attached to the wall (W) and a second extremity (54) that is free, such that the first extremity (52) is closer to the base B than the second extremity (54);- extends outwardly from the tubular body (1 ) at an angle p of less than 90 ° in respect to the longitudinal symmetry axis X said flaps (5) being configured to be elastically movable in respect to the elongated body (1), such that, upon insertion of the pushing device (100) into the test tube (200) the flaps (5) are constrained by the inner wall of the test tube (200), causing them to retract inwardly and to exert a force against the inner wall of the test tube (200), thereby securing the pushing device (100) in a fixed position within the test tube (200).2 Pushing device (100) according to claim 1 , further comprising at least two spacers (2) for maintaining a distance between the wall W of the pushing device (100) and the inner wall of a test tube (200), the spacers (2) being placed on an outer surface of the wall (W) between said at least two slots (30).3 Pushing device (100) according to any of the preceding claims, further comprising at least one spike (3) extending downward from the base B in the exterior space (80), for maintaining a distance between the closed end of the test tube (200) and the base B of the pushing device (100).4 Pushing device (100) according to any of the preceding claims, further comprising at least one stopping element (4) for preventing an object such as a sampling device (300) from passing into the interior space (70) through an opening in the base B, said at least one stopping element (4) being placed on the inside surface of the wall W of the elongated body (1 at or close to the base B.

5. Pushing device (100) according to any of the preceding claims, wherein said at least two slots (30) are substantially parallel to the symmetry axis X and equally spaced-apart.

6. Pushing device (100) according to any of the preceding claims, wherein said at least two flaps (5) are distributed evenly around the mouth, and have the same angles p in respect to the longitudinal symmetry axis X.

7. Pushing device (100) according to any of claims 1 to 5, further comprising a pushing flap (5’) which forms an angle of 0° or substantially 0° in respect to the longitudinal symmetry axis X, configured to be pushed during the insertion of the pushing device (100) inside the test tube (200) such that said at least two flaps (5) are completely enclosed in the test tube (200).

8. A sampling or self-sampling kit comprising:- the pushing device (100) according to any of the preceding claims,- a sealable test tube (200) having an inner wall with dimensions such that, upon insertion of the pushing device (100) into the test tube (200), the at least two flaps (5) are constrained by the inner wall of the test tube, causing the at least two flaps (5) to retract inwardly and to exert a force against the inner wall of the test tube (200), thereby securing the pushing device (100) in a fixed position within the test tube (200), and- optionally a sampling device (300).

9. A sampling or self-sampling kit according to claim 8, wherein said sampling device (300) is a sampling cloth, a sampling swab, a sampling brush or a part thereof.

10. A sampling or self-sampling kit according to any of claims 8 or 9, wherein the pushing device (100) is removably attached inside a lid or cap (250) of the test tube (200) by placing the free extremities (54) of the flaps inside the cap (250) such that the pushing device (100) can be manipulated by gripping and handling the cap (250), and such that, by pushing the cap (250) onto the test tube (200), the wall of the test tube (200) passes between the cap (250) and the flaps (5) detaching the flaps (5) from their position inside the cap (250) and transferring the flaps (5) to push against the inner wall of the test tube (200).

11. A sampling or self-sampling kit according to claim 10, wherein the pushing device (100) is attached inside the cap (250) by the flaps (5) being constrained against the inner wall of the cap (250), causing them to retract inwardly and to exert a force against the inner wall of the cap (250) and / or by the flaps (5) being fused to the cap (250) in at least one breakable welding point (56) and / or by the flaps (5) being placed with their free extremities (54) at least partially caught and retained in the space between the wall of the cap (250) and an fixing element (254) arranged so the walls of the test tube (200) get fixed between the cap (250) and the fixing element (254).

12. A method of securing a sampling device (300) inside a test tube (200) by means of a pushing device according to any of claims 1 to 7, comprising the steps of:a) placing at least part of a sampling device (300) in a test tube (200) or across the mouth of a test tube (200); b) introducing and fixing the pushing device (100) within the test tube (200), thereby securing said sampling device (300) in a position that is between the inner wall of the test tube (200) and an outer wall of the pushing device (100) and / or at the bottom of the test tube (200).

13. A method of securing a sampling device (300) inside a test tube (200) according to claim 12, further comprising the step c) putting on a lid or cap (250) to seal the test tube (200).

14. A method of securing a sampling device (300) inside a test tube (200) according to claims 12 and 13 by using a kit according to claims 10 or 1 1 , wherein steps b) and c) are performed at the same time.

15. A method of securing a sampling device (300) inside a test tube (200) according to claim 12 comprising the following steps: i) placing a sampling device (300) in a test tube (200) ii) putting on a cap (250) to seal the test tube (200) iii) transporting the test tube (200) from step ii) to a laboratory iv) opening the cap (250) of the test tube (200) v) introducing and fixing the pushing device (100) according to claims 1 to 7 within the test tube (200).

16. A method of securing a sampling device (300) inside a test tube (200) according to any of claims 12 to 15, wherein a further step d) is added of placing a substance, for example a preservative liquid or extraction liquid such as physiological serum inside the test tube (200).

17. A method for automated processing and analysis of a sampling device (300), comprising at least the step of: i) accessing the contents of a test tube (200) by a liquid handling laboratory robot by means of a liquid dispensing device such as a pipette to aspire liquid from or to release liquid into it, wherein said test tube (200) has inside a sampling device (300) secured by using the pushing device (100) according to any of claims 1 to 7.

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