Elution kit, analysis kit, and method for eluting and analyzing biological sample

Abstract

An elution kit (1) for eluting a biological sample in a liquid (2) and dispensing the eluted sample liquid (2 ') onto a test element (102) of an analysis kit (101), the elution kit (1) comprising: a sample collection swab (3) for collecting the biological sample, wherein the sample collection swab (3) comprises a rod-like portion (4) for hand holding and a deformable head portion (5) on the rod-like portion (4) for collecting the biological sample, wherein the head portion (5) is porous for the liquid (2); and an eluent tube (6) comprising: an internal space (7) for accommodating the liquid (2), receiving the sample collection swab (3), and eluting the biological sample in the liquid (2); an insertion opening (10) on a first side of the interior space (7) for inserting the sample collection swab (3) into the interior space (7); a dispensing opening (11) on a second side of the interior space (7) adjacent to the first side for dispensing the eluted sample liquid; a first closing element (12) for sealing the dispensing opening (11) in a water vapor impermeable manner; a second closure element (13) for sealing the insertion opening (10) in a water vapor impermeable manner, where the first closure element (12) and / or the second closure element (13) comprises a foil; and the liquid (2), in which the eluent tube (6) contains the liquid (2), in which the interior space (7) is defined by an inner surface (8) comprising an elution zone (16) with at least one elution portion (9), the at least one elution portion has a minimum side-to-side distance y in a range between about 70% and 140% of a maximum side-to-side distance x of the head portion (5) of the sample collection swab (3) and defines a gap (14) through which the sample collection swab (3) can be pushed and pulled in a closed state of the dispensing opening (11).

Description

Technical Field

[0001] This invention relates to an elution kit for in vitro diagnostics (IVD), an analytical kit including the elution kit, and a method for eluting and analyzing biological samples based on the analytical kit. Background Technology

[0002] During the Covid-19 pandemic, eluting biological samples in liquid was widely practiced when users performed self-testing using lateral flow assays. Test kits used for self-testing typically include: a swab for collecting the biological sample; a vial containing a liquid in which the biological sample can be eluted; and a lateral flow assay comprising a test element, such as a test strip, onto which the liquid containing the eluted sample is applied, and from which a test result can be obtained. The test result provides information about the presence of an analyte, such as the Covid-19 virus, in the sample. The sensitivity and reliability of the test results depend heavily on the proper handling of the test kit and the correct execution of sample elution. Test kits typically include a short manual to guide users through the procedure of performing the test. However, in most cases, test kits leave users some freedom, allowing each user to potentially alter the test's performance, which can lead to poor reliability and reproducibility, and may result in false negatives. Therefore, most test kits requiring elution of biological samples performed by private users cannot guarantee high reliability and reproducibility, as users may deviate from the procedures described in the manual. More specifically, a typical procedure for eluting a sample in a liquid involves immersing the head of a swab in the liquid provided in the vial so that the collected sample can be eluted therein. The swab is then inserted into the vial and rotated inside, while the vial is manually squeezed to provide a degree of friction, thus eluting the collected sample into the liquid. Once the swab has been rotated a predetermined number of times while squeezing the vial, the swab is removed, and the vial is closed with the cap. Typically, the cap has an application function that allows liquid to be added dropwise onto the test element. Therefore, the closed vial is inverted so that the cap is facing down, and the vial is squeezed until a droplet is forced out of the vial through a small opening in the cap, which corresponds to the application function. This procedure is relatively simple but can be improved in terms of repeatability, reliability, and user-friendliness. Summary of the Invention

[0003] Therefore, it is desirable to provide a more reliable elution kit, an analytical kit including the elution kit, and a method for eluting and analyzing biological samples based on the analytical kit. Furthermore, it is desirable to provide an elution kit that can be easily, comfortably, and / or reliably operated by the user.

[0004] At least one of the problems described is solved by the elution kit according to the independent claim, the analytical kit including the elution kit, and the method for eluting and analyzing biological samples based on the analytical kit. Advantageous embodiments are covered by the dependent claims.

[0005] According to one aspect which can be considered a first aspect of this disclosure, an elution kit is provided for eluting biological samples in a liquid and dispensing the eluted sample liquid onto a test element of an analytical kit. The elution kit includes: a sample collection swab for collecting biological samples, wherein the sample collection swab includes a hand-held rod-shaped portion and a deformable head portion on the rod-shaped portion for collecting biological samples, wherein the head portion is porous to the liquid; and an elution liquid tube including: an internal space for containing liquid, receiving the sample collection swab, and eluting the biological sample in the liquid; and an insertion opening in the internal space. On one side, a sample collection swab is inserted into the internal space; a dispensing opening, on a second side of the internal space adjacent to the first side, is used to dispense the eluted sample liquid; a first closure element is used to seal the dispensing opening in a water vapor impermeable manner; a second closure element is used to seal the insertion opening in a water vapor impermeable manner, wherein the first closure element and / or the second closure element comprises a foil; and a liquid, wherein the elution liquid tube contains the liquid, wherein the internal space is defined by an inner surface including an elution zone having at least one elution portion having a minimum side-to-side distance y in the range of approximately 70% to 140% of the maximum side-to-side distance x of the head portion of the sample collection swab, and defining a gap through which the sample collection swab can be pushed and pulled through the dispensing opening in the closed state.

[0006] The elution kit is simple to use and configured for easy manipulation. Liquid is already provided inside the elution liquid tube, which avoids the risk of spillage and / or loss of liquid when the user transfers the liquid into the elution liquid tube. Furthermore, this eliminates the need for the user to perform this step themselves, making the use of the elution kit convenient. A sealing closure element (at least one of which comprises a foil) is required to confine the liquid inside the elution liquid tube and prevent leakage of liquid and / or vapor before use of the elution kit. Furthermore, the closure element prevents contamination of the liquid before one or both closure elements are removed. Placing the foil on the opening is simple and inexpensive, and it can be easily and reliably removed by the user. This is particularly useful when the elution kit is intended for single use. The foil reliably seals the opening in a way that prevents water vapor from penetrating.

[0007] Because the internal space of the elution liquid tube is limited by the side-to-side distance y within approximately the size of the sample collection swab, the air-filled dead space / volume is reduced, allowing a small amount of liquid to be contained within the elution liquid tube without the risk of a large amount of liquid evaporating into the air-filled dead space / volume.

[0008] The inner surface of the elution liquid tube can be considered as the inner wall of the elution liquid tube or a portion thereof. When the sample collection swab is pushed through at least one elution section into the liquid with the dispensing opening closed, the liquid is pressed upward and / or displaced upward through the pores of the head section and / or through the space between the inner wall of the elution zone and the head section (specifically, between the elution section and the head section). A portion of the liquid remains in the pores of the head section. A large amount of the supplied liquid can be mixed and can pass through or through the head section to which the biological sample adheres. High shear forces can be generated by moving the sample collection swab through at least one elution section to efficiently transfer the biological sample into the liquid through physical impact. Therefore, the sample can be eluted efficiently, reliably, and with reproducible results without the user squeezing the tube as is typically done when eluting the sample from the swab into solution (which carries the risk of human error and low effectiveness).

[0009] By using a foil covering the opening, a reliable waterproof / waterproof vapor seal can be achieved in a simple manner requiring minimal material. Furthermore, the foil is easy for the user to remove. This can be particularly advantageous for single-use components, where the opening only needs to be opened and closed once during use, rather than multiple times. This allows for the provision of inexpensive elution kits based on simple concepts, especially for single-use applications. Simultaneously, compared to concepts using caps or other more complex closing elements to seal the opening, elution kits can be manufactured at low cost and with low material consumption, generating less waste. Therefore, improved elution kits can be provided.

[0010] The internal space of the elution liquid tube (which has a substantially tubular shape) includes two openings, sealed by a first closure element and a second closure element, respectively, to confine the liquid within the elution liquid tube and prevent loss of liquid via diffusion and / or leakage. Therefore, the first and second closure elements are specifically water-impermeable and water vapor-impermeable, and are connected to or configured to be connected to the elution liquid tube in a manner preventing loss of liquid via diffusion and / or leakage. Thus, the connection between the first and second closure elements and the elution liquid tube is also water-impermeable and water vapor-impermeable. One opening is for inserting a sample collection swab, and the other opening is for dispensing the sample liquid. Therefore, the insertion opening on a first side of the internal space is configured for inserting a sample collection swab into the internal space, and the dispensing opening on a second side of the internal space adjacent to the first side is configured for dispensing the eluted sample liquid. The second closure element used to seal the insertion opening can be removed first so that the sample collection swab can be introduced into the elution liquid tube. Subsequently, once the sample has been eluted into the liquid by inserting the sample collection swab, the first closing element used to seal the dispensing opening can be removed to dispense the eluted sample liquid. Therefore, when applying the eluted sample liquid to the test element, it is not necessary to flip / rotate and squeeze the elution liquid tube. Thus, the operation of the elution kit is based on a different principle compared to existing systems. The eluted sample liquid is dispensed by moving the sample collection swab toward the open dispensing opening on the second side, so that the eluted sample liquid is pushed out of the internal space through the open dispensing opening and applied to the test element. The dosage can be well controlled manually by the user through the movement and positioning of the sample collection swab. This achieves simple and convenient application without rotating / flipping the elution liquid tube and dispensing the eluted sample liquid through the insertion opening. Therefore, reliable dosing and application of the sample liquid can be achieved.

[0011] The sample collection swab has a porous and / or liquid-permeable head portion, and can therefore be pushed and pulled through the internal space with the dispensing opening closed.

[0012] When used correctly and when the elution fluid tube is held upright, the insertion opening corresponds to the upper opening and the first side corresponds to the upper side, while the dispensing opening corresponds to the lower opening and the second side corresponds to the lower side. More specifically, throughout the entire operation of eluting the sample and dispensing the eluted sample fluid, the insertion opening corresponds to the upper opening and the dispensing opening corresponds to the lower opening.

[0013] The first and second sides are arranged substantially opposite to each other. Therefore, the insertion opening and the dispensing opening can also be arranged substantially opposite to each other, i.e., on a common axis and adjacent to each other. In an alternative embodiment (where the insertion opening and the dispensing opening are not positioned on a common axis), at least one of these openings (most likely the dispensing opening) may, but is not limited to, be arranged on one side of the elution fluid tube. In this case, the openings are not arranged on a common axis, and the sample liquid is not dispensed and / or sprayed along the common axis and / or the axis of the tubular interior space and / or through the openings on the common axis and / or the axis of the tubular interior space, but rather dispensed and / or sprayed toward one side, for example, at an angle of approximately 2° to 45°, specifically approximately 5° to 15°, and more specifically approximately 6° to 10°, formed with the axis of the tubular interior space. However, in a preferred embodiment, the tubular interior space, the insertion opening, and the dispensing opening have a common longitudinal axis defined by their centers aligned with each other. The sample collection swab can then be inserted along and thus aligned with the common longitudinal axis (of the tubular internal space, the insertion opening, and the dispensing opening). The rod-shaped portion of the sample collection swab has a longitudinal axis, and the head portion is positioned at one end of the rod-shaped portion. Therefore, when inserted into the tubular internal space, the longitudinal axis can be aligned with, but is not limited to, the common longitudinal axis (of the tubular internal space, the insertion opening, and the dispensing opening) and corresponds to that common longitudinal axis. Therefore, the internal space can include, but is not limited to, a channel-like and / or tubular volume having a longitudinal axis, along which the longitudinal axis of the rod-shaped portion of the swab can move (and / or parallel to) the longitudinal axis. Therefore, the step of receiving the sample collection swab can be, but is not limited to, receiving the sample collection swab by the internal space and by aligning the longitudinal axis of the sample collection swab with the longitudinal axis of the internal space.

[0014] The sample collection swab received by the internal space has the following effect: the head portion is immersed in and wetted in the liquid, and thus the biological sample is at least partially eluted in the liquid. The liquid may be, but is not limited to, an aqueous solution, specifically an aqueous buffer solution and / or another saline aqueous solution. Alternatively or additionally, the liquid may contain a non-aqueous solvent.

[0015] The head portion may include, but is not limited to, sponges or sponge-like elements, tissue paper, cotton, fibers, etc. The head portion is deformable and may be soft, elastic, flexible, and / or compressible. The head portion is porous for liquids, meaning that liquids can flow through the pores and / or empty spaces defined by the structure and / or substructures of the head portion. For example, a sponge provides substantially random substructures containing material with gas-filled spaces. These gas-filled spaces are considered pores. Pores should not be completely closed (sealed) by the material and should therefore allow fluid to enter and / or pass through. This has the effect that when the head portion is pushed downwards along a tube (with the same diameter as or even smaller than the head portion) through its internal space, liquid below the head portion can pass through the center of the head portion and also along the sides of the head portion due to its porous structure. If the tube of the internal space has a smaller diameter than the head portion in its dry state (however, the size of the head portion is determined in the dry state before wetting), it is feasible to compress the head portion into the tube, as the head portion is deformable. Therefore, the head portion can be considered compressible and / or flexible. In this case, the size of the head portion, i.e., the maximum side-to-side distance x (which can be the diameter of the head portion), deforms and contracts in its cross-section to the size and shape of the internal space.

[0016] The head portion may, but is not limited to, have a porous structure, such as a fibrous and / or sponge-like structure, which generates capillary forces. Therefore, the fibrous and / or sponge-like material can attract liquid by van der Waals forces, such that the gas-filled and / or air-filled spaces between the material portions are filled with liquid. Thus, the gas-filled spaces can, but are not limited to, be very small, i.e., in the range of micrometers to millimeters. Within this range, capillary forces can be generated, and specifically, aqueous solutions can be absorbed by the head portion. Further, specifically in this case, when the tube of the internal space, in the wetted state of the head portion, has substantially the same size as or is smaller than the head portion, capillary forces can also be generated between the sidewall of the elution liquid tube and the head portion. Depending on the liquid content / composition, the head portion may contain hydrophilic and / or hydrophobic materials. Hydrophilic materials increase the attraction to aqueous solutions, which facilitates the absorption of liquid by the head portion. For example, hydrophobic materials will have the opposite effect on aqueous solutions but may have the same effect on nonpolar solvents. Therefore, since aqueous solutions are typically used to elute biological samples, it is preferable to provide a hydrophilic material to form the head portion.

[0017] The elution fluid tube may, but is not limited to, be substantially stable in shape. Alternatively, the elution fluid tube may be slightly flexible. The rod-shaped portion of the sample collection swab may, but is not limited to, be substantially stable in shape. Alternatively, the rod-shaped portion of the sample collection swab may be slightly flexible. In all cases, the elution fluid tube and the rod-shaped portion of the sample collection swab are substantially stable in shape when used conventionally according to their intended purpose. For example, the rod-shaped portion may be slightly bent when the sample collection swab is inserted into a body opening such as the nose.

[0018] Biological samples can be collected from body parts (specifically, body openings such as the nose).

[0019] The internal space of the elution liquid tube is defined, i.e. specifically surrounded, by an inner surface including an elution zone having at least one elution portion having a minimum side-to-side distance y in the range of approximately 70% to 140% of the maximum side-to-side distance x of the head portion of the sample collection swab, and defining a gap through which the sample collection swab can be pushed and pulled when the dispensing opening is closed (i.e., when the dispensing opening is closed).

[0020] The elution zone is a region and / or area within the internal space of the elution fluid tube, in which the sample collection swab can come into contact with the sample fluid. This region may, but is not limited to, be substantially tubular. The elution zone may, but is not limited to, have a smooth surface, i.e., one or more substantially smooth walls (substantially unstructured), because the inner surface of the elution zone is homogeneous, for example, corresponding to the inner surface of the tube without any irregularities. In this case, the entire elution zone may, but is not limited to, correspond to an elution portion defined by the aforementioned ratio between its minimum side-to-side distance y and the maximum side-to-side distance x of the head portion (the minimum side-to-side distance y of the elution portion is in the range of approximately 70% to 140% of the maximum side-to-side distance x of the head portion of the sample collection swab). Alternatively or additionally, the inner surface of the elution fluid tube in the elution zone may be structured and / or may have one or more elements corresponding to the elution portion. Specifically, the inner surface of the elution portion may include one or more elution portions. The structure and / or elution portion may include, but is not limited to, another structured surface of the inner surface of ribs, ribbed structures, conical structures and / or internal spaces, such as, for example, a honeycomb structure or its surface structure, a clamping structure, a block structure, a twisted structure / spiral structure, etc.

[0021] The elution zone can refer to, but is not limited to, a substantially rigid portion of the elution fluid tube that forms and / or defines a portion of the internal space of the elution fluid tube. Therefore, the elution zone can be substantially stable in shape. If, as previously mentioned, the elution fluid tube is slightly flexible, then the elution portion can be slightly flexible.

[0022] As mentioned herein without further explanation, the maximum side-to-side distance x of the head portion is defined in the (original) dry and relaxed state (i.e., the head portion is not wetted, deformed, compressed, and / or twisted). The maximum side-to-side distance x in the dry state (also referred to as the "original state") can be defined more easily, better, and / or more precisely than in the wetted state, and therefore, it is referred to as the maximum side-to-side distance x in the dry state. The maximum side-to-side distance x of the head portion may vary upon expansion and / or compression. The variation in this measure due to expansion and / or compression will be compared with the original maximum side-to-side distance x defined for the head portion in the dry and relaxed state. As already mentioned, when the head portion of the sample collection swab is pushed into the liquid provided within the elution liquid tube, the head portion may expand as permitted by the dimensions of the internal space of the elution liquid tube. The maximum side-to-side distance x of the head portion of the sample collection swab is defined in a dry state and can correspond to a range of values ​​for a given number of swabs. For example, the range can be, but is not limited to, allowing deviations from the average and / or predetermined value of the maximum side-to-side distance x of the head portion by up to approximately + / - 20%, specifically approximately + / - 15%, and more specifically approximately + / - 5%. Expansion generally increases the original side-to-side distance x of the head portion because the air-filled space is filled with liquid that is slightly larger than the volume of air, and compression reduces the original side-to-side distance x of the head portion in order to expel the liquid from the head portion. When referring to "maximum side-to-side distance x of the head portion," it means the original maximum side-to-side distance x of the head portion in a dry and relaxed / uncompressed state. The head portion of the sample collection swab can expand by approximately 0.2% to 20%, specifically approximately 0.5% to 10%, and more specifically approximately 1% to 8%. Each head portion can have its own individual expansion behavior.

[0023] According to this embodiment, the external force and / or mechanical force typically applied to the head portion by the user can be well controlled and / or predetermined by the elution section, making the elution process highly reliable, efficient, and reproducible. If the minimum side-to-side distance y of the elution section is less than the maximum side-to-side distance x of the head portion in its original and / or wetted state, the head portion is squeezed during insertion, and the liquid that can be absorbed by the head portion can be at least partially scraped off and mixed with the rest of the liquid. In other words, the head portion, such as a sponge-like head portion, can be squeezed and / or pressed by being pushed through the gap of the elution section. Therefore, the specifications of the elution zone, specifically the specifications of the elution section, can have several effects, namely, the mixing of liquids and the squeezing and / or scraping of liquid inside and / or on the head portion. A manual, which can be provided to the user with the analytical kit, can determine (predetermine) and / or recommend the number of times the sample collection swab is pushed and / or pulled through the elution zone and / or elution section. This allows for highly reliable, reproducible, and simple testing by the user. The eluent tube may also include at least one mark on its outer and / or inner walls to provide visual indication of the location to which the head portion can be pushed and / or pulled and / or where the head portion can be placed.

[0024] In the case where the elution section has an annular shape and defines a substantially circular gap / opening that passes through the tubular interior space, the minimum side-to-side distance y of the elution section can, for example, correspond to the diameter of the elution section at its narrowest point. The gap / opening of the elution section can be considered as a narrowing and / or constriction relative to other areas of the tubular interior space and / or relative to another area in the elution zone.

[0025] The common longitudinal axis of the tubular internal space, insertion opening, and dispensing opening can be centered within the gap of the elution section (e.g., a circular opening, but not limited to this). Therefore, the longitudinal axis of the tubular internal space, insertion opening, and dispensing opening can correspond to the common longitudinal axis in the case of a gap in the elution section. The gap of the elution section can be uniform or tapered along the common longitudinal axis. If the gap is tapered, the minimum side-to-side distance y of the elution section corresponds to the minimum diameter of the tapered gap. The tapered elution section can extend from the inner wall of the tubular internal space. The tapered elution section avoids sharp edges and therefore prevents damage and / or tearing of the head portion. Furthermore, the tapered elution section can guide the head portion toward its predetermined position while the user pushes and / or pulls the swab essentially in a single direction (e.g., along the common axis). In other words, the user does not need to carefully position the swab perpendicular to the common longitudinal direction (i.e., essentially the pushing and / or pulling direction).

[0026] The elution section may, but is not limited to, define a gap / opening of any possible shape (such as circular, polygonal, square, oval, substantially star-shaped, or similar). The shape may, but is not limited to, be point-symmetric. Generally, the elution section may be tapered, as previously mentioned, specifically tapered along the longitudinal axis toward the application opening, which produces the effect that the user does not miss the opening when inserting and pushing the sample collection swab through the elution section. Alternatively or additionally, the elution section may be tapered along the longitudinal axis toward the insertion opening, which produces the effect that the user does not miss the opening when pulling the sample collection swab through the elution section. Generally, but not limited to, edges, specifically sharp edges, may be avoided.

[0027] The elution section can alternatively and / or additionally act as a decelerator for the sample collection swab. It can alternatively and / or additionally provide tactile feedback to the user due to the increased mechanical resistance when pushed or pulled through, and it can provide information about where to stop pushing and / or pulling. The elution section can alternatively and / or additionally act as a holder that can rest the head section, in which case the sample collection swab no longer needs to be held by the user to prevent it from sliding down the internal space of the elution fluid tube.

[0028] The elution kit includes: a first closure element for sealing the internal volume of the elution liquid tube by covering the application opening; and / or a second closure element for sealing the internal volume of the elution liquid tube by covering the insertion opening. In other words, the first closure element is configured to seal the application opening, and the second closure element is configured to seal the insertion opening. The elution kit includes a liquid, wherein the elution liquid tube contains the liquid, and the first and second closure elements constrain the liquid together with the elution liquid tube in a sealed manner (specifically, liquid-sealed, liquid vapor-sealed, and / or water vapor-sealed) within the internal volume of the elution liquid tube.

[0029] The elution kit may include, but is not limited to: a first closure element for opening and closing the application opening; and / or a second closure element for opening and closing the insertion opening, wherein the closure element is also configured to provide a sealed closure to the interior of the elution liquid tube.

[0030] The first closing element may include, but is not limited to, a plug, a cap, a foil, and / or a membrane, and may close (specifically seal) the dispensing opening, i.e., cover the dispensing opening in a sealed manner. The foil and / or membrane may be welded and / or laminated onto the eluent tubing over the dispensing opening (e.g., from below). The plug and / or cap may be configured, but not limited to, to repeatedly open and close the dispensing opening, while the foil and / or membrane may be configured to close and open the dispensing opening at least once.

[0031] The second closure element may include a plug, cap, foil, and / or membrane, and may specifically seal the insertion opening, i.e., cover the insertion opening in a sealed manner. The foil and / or membrane may be welded and / or laminated onto the eluent tube (e.g., from above) over the insertion opening. The plug and / or cap may be configured to repeatedly open and close the dispensing opening, while the foil and / or membrane may be configured to close and open the dispensing opening at least once.

[0032] The elution kit is provided with the elution liquid tube already containing liquid. Therefore, the internal space is sealed by a first closure element and a second closure element to prevent liquid leakage and / or diffusion outside the elution liquid tube. Furthermore, the closure elements prevent contamination of the internal space. If the elution liquid tube is not already filled with liquid, the elution liquid tube may have a first closure element for sealing the dispensing opening after liquid is filled into the elution liquid tube, and may or may not have a second closure element.

[0033] The term "seal" refers to a watertight (and in most cases airtight) closure that prevents any leakage or contamination. The term "seal" also refers to a closure that is impermeable to water vapor. This can be achieved by using gaskets, O-rings, or other sealing mechanisms to ensure a safe and reliable closure. For example, a cap as described herein may include an O-ring to seal the internal volume of a chamber. Furthermore, a seal may refer to a foil, membrane, plate, or diaphragm that is heat-welded, welded, or otherwise bonded and impermeable to water vapor.

[0034] The volume of the internal space of the elution fluid tube may, but is not limited to, be designed to accommodate a liquid volume of less than 1 ml, specifically less than 500 µl and more specifically less than 10 µl, wherein the ratio of “volume of internal space” to “liquid volume” may be in the range of less than about 10; and / or the ratio of “liquid volume” to “liquid volume absorbed by the wetted head portion” may be in the range of about 1 to 10.

[0035] Therefore, the elution liquid tube can be, but is not limited to, configured to contain a small volume of liquid, i.e., a small amount of liquid, and the head portion can be configured to absorb a portion of the entire amount of liquid. Elution kits that allow manipulation of small volumes of liquid have the effect that samples can be eluted with a small volume, thereby achieving a high "sample volume" / "liquid volume" ratio. This allows test kits / analytical kits using this elution kit to provide high sensitivity because the sample is only slightly diluted and remains at a high concentration. Therefore, the internal space of the elution liquid tube can, but is not limited to, have a small side-to-side distance and / or diameter compared to the side-to-side distance and / or diameter defined by the outer wall of the elution liquid tube. This allows the elution liquid tube to be easily held in place by the outer periphery of the elution liquid tube when manipulating a very small amount of liquid stored within the internal space.

[0036] The elution section may include at least one of the following: at least one elution region having a length between 10% and 98% of the length of the elution liquid tube, measured along the (common) longitudinal axis of the insertion opening; at least one elution protrusion having a length less than 10% of the length of the elution liquid tube, measured along the (common) longitudinal axis of the insertion opening; and / or at least one helical thread-like protrusion. The elution region differs from the elution protrusion in the length measured along the (common) longitudinal axis of the insertion opening.

[0037] The elution zone may correspond to a region within the elution area where the inner tube diameter satisfies the requirement that the minimum side-to-side distance y is within approximately 70% to 140% of the maximum side-to-side distance x of the head portion of the sample collection swab, and this region defines a gap through which the sample collection swab can be pushed and pulled when the dispensing opening is closed (i.e., when the dispensing opening is closed). The elution zone may have a length within approximately 10% to 98% of the length of the elution liquid tube. The elution zone may, but is not limited to, correspond to the entire elution area, where the sample can be eluted uniformly, i.e., the pressure applied from the side to the head portion can be uniform across the entire elution area. The elution zone may, but is not limited to, be within approximately 50% to 100% of the length of the elution zone of the elution liquid tube.

[0038] Elution protrusions having a length of less than 10% corresponding to the length of the elution liquid tube and / or at least one helical thread-like protrusion may, but are not limited to, have the specific effect of scraping the absorbed liquid from the head portion. These two variations of the elution portion may alternatively or additionally have the effect that the liquid can be well mixed. Specifically, the helical thread-like protrusions can, on the one hand, very efficiently expel the head portion when pushed or pulled through, and on the other hand, the liquid can be well distributed by being guided along the helical ridge. The elution protrusions may have a length of less than 50% corresponding to the length of the elution liquid zone.

[0039] The gaps, openings, and / or through-holes defined by the elution section, elution zone, and / or any other area or region in the elution liquid tube may, but are not limited to, have a cross-sectional shape including at least one of the following:

[0040] - A circle with a minimum side-to-side distance y, which corresponds to its diameter.

[0041] - Polygonal, specifically a square.

[0042] -Oval shape.

[0043] The eluent tube may include, at and / or on the dispensing opening and / or on the side of the dispensing opening: a dispensing nozzle defining the dispensing opening; and / or an edge configured to position the eluent tube on a planar surface in an upright orientation. The edge may include elements of a coupling mechanism for coupling the eluent tube to a test element, optionally including a threaded mechanism, a bayonet, and / or a Luer lock mechanism. Specifically, without an edge, the eluent tube may include elements of a coupling mechanism for coupling the eluent tube to a test element, optionally including a threaded mechanism, a bayonet, and / or a Luer lock mechanism. This element of the coupling mechanism may be positioned, for example, on the outer wall of the eluent tube.

[0044] For example, a dispensing nozzle defining the dispensing opening allows for precise positioning of the dispensing opening and the droplets of liquid sprayed from it onto the test strip. The dispensing nozzle may, but is not limited to, be aligned with the common longitudinal axis of the insertion opening, the tubular interior space, and the dispensing opening. Alternatively, the dispensing nozzle may be parallel to the (common) longitudinal axis of the insertion opening and / or the tubular interior space, but off-center. The dispensing nozzle may also be slightly inclined relative to the (common) longitudinal axis of the insertion opening and / or the tubular interior. The external length of the elution fluid tube may, but is not limited to, be approximately 3 to 20 times, specifically approximately 5 to 15 times, and more specifically approximately 8 to 12 times the length of the dispensing nozzle. The dispensing nozzle may, but is not limited to, be in the range of approximately 0.5 cm to 10 cm, specifically approximately 1 cm to 8 cm, and more specifically approximately 2 cm to 5 cm. The application nozzle can be permanently attached to the eluent line, or it can be detachably attached to the eluent line via a coupling and / or locking mechanism (such as a Luer locking mechanism).

[0045] The edge can have the following main effect: allowing the eluent tube to be positioned in an upright orientation, such that the eluent tube can be placed and erected, for example, on a table. In some cases, an edge may be provided in addition to the dispensing nozzle. The edge may extend from the eluent tube parallel to the dispensing nozzle. Alternatively, the edge may extend from the eluent tube obliquely relative to the dispensing nozzle (e.g., in a tapered manner) and / or the (common) longitudinal axis of the insertion opening and / or the tubular internal space. Specifically, the permanently attached dispensing nozzle may not extend beyond the edge along the (common) longitudinal axis of the insertion opening (at its lower end) and / or the tubular internal space. When the edge and the dispensing nozzle extend parallel to each other, the edge may have the same length as the dispensing nozzle. The external length of the eluent tube may, but is not limited to, approximately 2 to 20 times, specifically approximately 4 to 15 times, and more specifically approximately 6 to 12 times, the length of the edge. The edge may be, but is not limited to, between approximately 0.5 cm and 11 cm, specifically between approximately 1 cm and 10 cm, and more specifically between approximately 2 cm and 6 cm. The edge may be permanently attached to the elution fluid tube, or may be detachably attached to the elution fluid tube by means of a coupling and / or locking mechanism.

[0046] The edge and / or eluent tube may include elements of a coupling and / or locking mechanism for coupling the eluent tube to the test element. The coupling mechanism may include a threaded mechanism, a bayonet, and / or a Luer lock mechanism. One element of the coupling and / or locking mechanism may be disposed on the inner and / or outer surface of the edge, and another element may be disposed on the test element.

[0047] The eluent tube may include a filter, which may be located in the lower portion of the eluent tube, for example, before or after the dispensing opening. The filter may be configured to remove particles by a predetermined bias. In this case, only the eluted and filtered sample liquid (which is substantially free of particles or contains only particles below the predetermined bias) can be sprayed and / or dispensed.

[0048] The elution fluid tube may include, but is not limited to, at least one flexible, elastic, and / or deformable member (such as a lip and / or flaps) within the elution zone, specifically an annular member with a central gap and / or opening, wherein the flexible member may be arranged perpendicular to a common longitudinal axis, or the flexible member may be tapered and / or inclined relative to the common longitudinal axis. The effect of the flexible annular member in the lower region of the elution zone is that it can pull the sample collection swab through the gap of the member and can scrape the liquid contained in and / or absorbed in the head portion from the head portion. The effect of such a member in the higher region of the elution zone is that it can prevent liquid from overflowing from the insertion opening when the sample collection swab is inserted. Further, such a flexible annular member can help center the sample collection swab and align its longitudinal axis with the common longitudinal axis (of the insertion opening, the tubular internal space, and the dispensing opening). In addition, the flexible annular member can provide a degree of friction to stop and / or fix the position of the sample collection swab, so that the sample collection swab does not slide downwards along the tubular internal space without applied force. Therefore, the flexible annular member can act as a stopper. However, the flexible annular member can substantially correspond in shape and function to the elution section; the flexible annular member can provide a high degree of flexibility and therefore can bend, allowing the liquid to be smoothly scraped from the head section. Furthermore, due to its flexibility, the gap defined by the flexible annular member can extend when pressure is applied with the head section. In other words, the flexible annular member can be flexible and / or elastic, which is not typically the case with the elution section.

[0049] The internal space may include, but is not limited to: an insertion region; a elution region; and a mating region, optionally, but not limited to, a maximum diameter of the internal space in the insertion region greater than the maximum diameter of the internal space in the elution region and / or a maximum diameter of the internal space in the mating region greater than the maximum diameter of the internal space in the mating region. Further, the minimum diameter of the internal space in the insertion region may be greater than the minimum and / or maximum diameter of the internal space in the elution region, and / or the minimum diameter of the internal space in the elution region greater than the minimum and / or maximum diameter of the internal space in the mating region. If the shape of the corresponding gap is not circular, the above features apply to the minimum or maximum side-to-side distance, not the diameter.

[0050] The maximum or minimum diameter of the internal space in the insertion zone may be, but is not limited to, approximately 1.2 to 10 times, specifically approximately 2 to 8 times, and more specifically approximately 3 to 5 times, the minimum or maximum diameter of the internal space in the elution zone. The maximum or minimum diameter of the internal space in the elution zone may be, but is not limited to, approximately 1.5 to 20 times, specifically approximately 2 to 10 times, and more specifically approximately 5 to 8 times, the minimum or maximum diameter of the internal space in the preparation zone. The diameter of the internal space in the insertion zone may be, but is not limited to, between approximately 0.8 cm and 3 cm, specifically between approximately 0.9 cm and 2.5 cm, and more specifically between approximately 1 cm and 2 cm. The diameter of the internal space in the elution zone may be, but is not limited to, between approximately 0.2 cm and 1 cm, specifically between approximately 0.3 cm and 0.8 cm, and more specifically between approximately 0.4 cm and 0.5 cm. The diameter of the internal space in the application area may, but is not limited to, be between approximately 0.05 cm and 0.3 cm, specifically between approximately 0.08 cm and 0.2 cm, and more specifically between approximately 0.1 cm and 0.15 cm.

[0051] In other words, the internal space of the elution fluid tube is tapered from the insertion zone (where the sample collection swab is inserted) towards the dispensing zone (where the eluted sample fluid is dispensed). This has the following advantages: insertion of the sample collection swab is simple and uncomplicated for the user because the insertion zone is large enough to easily position the swab within the internal space of the elution fluid tube. The elution zone allows the sample collection swab to come into contact with a small amount of fluid, and the dispensing zone does not retain large amounts of fluid and allows for precise dispensing.

[0052] The outer diameter of the elution liquid tube may be about 3 times or more the side-to-side distance y of the elution portion of the internal space in the elution zone, specifically about 8 times or more the side-to-side distance y of the elution portion of the internal space in the elution zone, and more specifically 20 times or more the side-to-side distance y of the elution portion of the internal space in the elution zone.

[0053] This allows for manipulation of very small amounts of liquid stored inside the internal space, while the elution liquid tube is large enough to be easily grasped and held in the hand.

[0054] According to another aspect, which can be considered a second aspect of this disclosure, an analytical kit for analyzing biological samples is provided, the analytical kit comprising: an elution kit according to one embodiment of the embodiments described herein; and a test element comprising at least an application function, a test reaction function, and a test detection function.

[0055] An analytical kit having an elution kit according to any of the embodiments described herein allows a user to analyze biological samples. Specifically, it allows a user to detect predetermined analytes, such as at least one of the following and / or fragments thereof: viruses, DNA, RNA, hormones, bacteria, and / or another biomolecule. All the advantages and technical effects applicable to the elution kit included in the analytical kit also apply to the analytical kit.

[0056] Specifically, in some embodiments, a more reliable analytical kit may be provided. Further, in some embodiments, an analytical kit may be provided that can be easily, comfortably, and / or reliably operated by a user.

[0057] Test elements may include a test element housing and / or an LFA core (side flow measurement (core) bar).

[0058] Generally, LFAs (such as LFA strips or dipstick tests) can be used for diagnostic applications. Test sheets that can be used for such tests may contain, but are not limited to, silicone, plastic, glass, fiberglass, aluminum foil, paper, and / or other hydrophilic or hydrophobic porous cellulose and rayon compounds. Specific lines can be applied to a sheet containing a specific chemical trapping reagent or compound designed to react with and bind to a predetermined analyte, specifically a biomarker that can be present in a test sample liquid (such as, but not limited to, sputum, urine, blood, water, liquefied food samples, and surface swab samples). A specific example of an LFA is a rapid antigen test used to detect the presence of an analyte (such as a fragment of a virus from an infectious disease in a biological sample). Generally, LFA test units can be used in the form of test strips (such as, for example, pregnancy test strips, drug test strips, influenza and / or Covid-19 tests, and / or rapid allergen tests).

[0059] When the sample liquid is applied to the application area of ​​the LFA test strip, the sample liquid is drawn in by capillary force along the longitudinal axis of the membrane (also known as the membrane analyte assay strip). The presence of the predetermined analyte can be indicated by the migration of enzymes, target proteins, and / or biomarkers corresponding to these analytes along the membrane and their interaction with chemically trapped reagents in the stripes of the membrane, thereby generating a measurable and detectable signal / change in the analyte assay test area. The detectable and measurable signal obtained at the stripe area can be, but is not limited to, caused by binding to colloidal gold, carbon beads, latex-stained beads, magnetic or paramagnetic beads, and / or reagents or particles capable of emitting fluorescence, autofluorescence, cryoluminescence, phosphorescence, or chemiluminescence.

[0060] The test element housing is configured to at least partially house the test element. The test element housing may have a certain rigidity and / or stability configured to provide protection to the test element. The test element housing may house some or all of the components of the elution kit. Specifically, the test element housing may at least partially house the test element and the elution fluid tubing. The test element housing may be substantially rigid in shape, i.e., inflexible. Alternatively, the housing may have a foldable, bendable, and / or flexible sheath-like structure. Thus, in some embodiments, the housing may include, for example, cardboard and / or plastic components. For example, the elution fluid tubing may include a plastic tube fixed, attached, and / or coupled to the cardboard element. The cardboard element may directly or indirectly house and / or support the test element. For example, the test element may be at least partially housed in a particular test element housing, such as a plastic element, and the plastic element may be at least partially housed and / or supported in or on the cardboard.

[0061] Specifically, the test element may include an LFA strip that allows the detection of molecular fragments and / or molecules of a predetermined analyte in a side-flow assay.

[0062] The elution liquid tube and test element of the elution kit may be arranged in a fixed relationship with each other, specifically fixedly attached to each other, and / or housed in a single unit and / or housing, and / or formed as a single unit; and / or the analytical kit may include a fluid path permanently disposed between the elution liquid tube and the test element and include a fluid path closure element configured to prevent fluid from being transferred from the elution kit to the elution liquid application area when the fluid path is closed, and to allow fluid from the elution liquid tube to the elution liquid application area when the fluid path is open.

[0063] The term “fixedly attached to each other” means that two or more components are formed as a single piece, for example by injection molding or additive manufacturing, or that two or more components are permanently attached to each other after production (e.g. by thermal welding, bonding, fusion, etc.) and will not abut against each other or separate and / or move relative to each other at the connection location without damaging at least one of the two or more components and / or losing the actual full function of that component.

[0064] The elution fluid tubing and test element of the elution kit can be arranged in a fixed relationship with each other, which has the following effects: the user does not need to arrange the elution fluid tubing relative to the test element. Furthermore, the elution fluid tubing or test element is not easily lost. Specifically, the elution fluid tubing and test element of the elution kit can be fixedly attached to each other, which can provide a permanent connection between them. The elution fluid tubing and test element of the elution kit can be located in one housing or two separate housings attached, connected, and / or fixed to each other, and housed by, fixed to, and / or attached to, one housing or two separate housings, wherein in some cases the housing may correspond to the aforementioned test element housing.

[0065] The elution fluid tubing and test elements of the elution kit can be formed as a single unit and / or housed within that single unit, and / or housed in a single housing, which can provide a permanent, substantially rigid, and predefined connection between them. The housing can be formed as a single piece, or alternatively, it can be composed of several pieces. The single-piece housing housing the elution fluid tubing and / or test elements of the elution kit can be efficiently manufactured by injection molding or additive manufacturing. Assembly of the elution kit including the single-piece housing can be rapid and / or efficient.

[0066] The analytical kit may include a fluid path permanently positioned between the eluent tube and the test element and includes a fluid path closure element configured to...

[0067] ●Prevent liquid from being transferred from the elution kit to the elution buffer application area while the fluid path is closed; and

[0068] ● With the fluid path open, liquid can be transferred from the eluent tube to the eluent application area.

[0069] Permanent fluid paths (such as tubes that can fluidly connect the eluent tube to the test element in an open state) are very user-friendly because the user does not need to establish the fluid path themselves. It may only be necessary to establish an open state for fluidly connecting the eluent tube to the test element. This step can be performed once the biological sample has been eluted in the liquid. The open state for fluidly connecting the eluent tube to the test element can be established by pulling, rotating, and / or pushing a fluid path closing element or a portion thereof. For example, a plug can be pulled. In an alternative embodiment, a swab can be pushed through a membrane. In another alternative embodiment, a valve can be rotated.

[0070] The fluid path closure element may include: a valve element configured to mechanically transition from an open state to a closed state of the fluid path; a pullable plug and / or a ruptureable barrier, which may have an intact state corresponding to the closed state or a ruptured state corresponding to the open state.

[0071] Rotary fluid path closure elements (such as valves) can reversibly open and / or close the fluid path. The same applies to pull-type fluid path closure elements, such as plugs. Rupture barriers (such as diaphragms) can be configured to open the fluid path only once. Rupture barriers can have the advantage of being inexpensive components and / or easily manufactured and / or assembled with the housing.

[0072] The elution liquid tube and the test element can be or correspond to individual elements and / or units, optionally wherein the elution liquid tube and the test element can be connected to each other, specifically in fluid connection, to transfer the eluted sample liquid onto the test element.

[0073] If the elution fluid tube and test element are or correspond to separate elements, this provides a high degree of versatility because the elution fluid tube and test element can be interchangeably connected, meaning a specific elution fluid tube can be arbitrarily connected to a test element. Furthermore, the production of such analytical kits can be simple and / or efficient.

[0074] The elution liquid tubing and test element may include a coupling mechanism for connecting the elution liquid tubing to the test element and specifically configured to allow the eluted sample liquid to be transferred to the elution application area of ​​the test element without spillage.

[0075] The coupling mechanism enables the user to correctly establish a fluid connection between the eluent tubing and the test element. The coupling mechanism may include locking mechanisms, threaded mechanisms, hooks and / or springs and recesses, Luer locking mechanisms, etc. The coupling mechanism guides the user in attempting to establish a fluid connection between the eluent tubing and the test element. Furthermore, the coupling mechanism allows the user to focus on transferring liquid to the test element while ensuring a secure connection between the eluent tubing and the test element, and the user does not need to permanently hold both elements to establish the fluid connection. In certain embodiments, the transfer of fluid from the eluent tubing to the test element is spill-free, and small amounts / volumes of liquid can be safely transferred without the risk of loss of any portion of the liquid due to spillage and / or evaporation.

[0076] At least one component of the analytical kit can be configured for single use, which can allow for the provision of relatively environmentally friendly analytical kits, specifically where at least some components of the analytical kit are compostable and / or require potentially environmentally unfriendly cleaning procedures. Furthermore, single-use components can be provided at low cost and are easy to handle and dispose of after use.

[0077] At least one element of the analytical kit can be configured for multiple / reusable uses, which can allow for the provision of environmentally friendly analytical kits, specifically where the cleaning procedures that may be required to clean at least one element of the analytical kit are also environmentally friendly.

[0078] According to another aspect, which can be considered a third aspect of this disclosure, a method for eluting and analyzing a biological sample includes the following steps: providing an analytical kit according to any of the embodiments described herein, wherein liquid is provided in the internal space of an elution liquid tube; collecting a biological sample with the head portion of a sample collection swab; inserting the sample collection swab into the internal space through an insertion opening with the head portion facing forward; pushing the head portion into an elution zone at least partially across at least one elution portion toward a dispensing opening and wetting the head portion of the sample collection swab with liquid; pulling the sample collection swab toward the insertion opening at least partially across at least one elution portion within the elution zone; opening the dispensing opening while the sample collection swab is held in one position; pushing the sample collection swab toward the dispensing opening to dispense the eluted sample liquid onto a test element; and analyzing the biological sample by reading the result from a test detection zone.

[0079] The method can be simple, reliable, safe, and / or repeatable. Specifically, all steps can be easily performed at home by non-professional users. In alternative embodiments, at least one step of the method can be configured to be performed by professional healthcare workers and / or diagnostic machines / devices.

[0080] Analyzing biological samples may include detecting the presence of at least one specific predetermined analyte in the biological sample, such as, for example, a molecule or fragment of a molecule, such as an antigen, antibody, protein, DNA, or another molecule, or a corresponding fragment thereof.

[0081] The liquid supplied in the internal space of the elution liquid tube may correspond to a buffer solution, an aqueous solution containing salt, a detergent, a solubilizer, a stabilizer, a solvent, and / or a lipid.

[0082] Collecting biological samples using the head portion of a sample collection swab can include collecting samples from the nose or another body part. Biological samples can specifically include: at least one bodily fluid; molecules produced by the body and / or organisms on the body; and / or cells of the body. This step can specifically be performed manually.

[0083] Inserting the sample collection swab into the internal space through the insertion opening with the head portion facing forward can include advancing the sample collection swab with the longitudinal axis of its rod-shaped portion aligned with the longitudinal axis of the internal space. This step can be performed manually. In an alternative embodiment, this step can be performed by a machine / device.

[0084] Pushing the head portion of the sample collection swab into the elution zone at least partially across at least one elution section toward the application opening and wetting the head portion with liquid can specifically be performed manually. This step can specifically be performed manually. In an alternative embodiment, this step can be performed by a machine / device.

[0085] Pulling the sample collection swab toward the insertion opening, at least partially across at least one elution section within the elution zone, can be performed manually. In an alternative embodiment, this step can be performed by a machine / device.

[0086] The pushing and pulling can be performed a predetermined number of times. The pushing and pulling can be performed once, twice, three times, four times, five times, six times, or more. The more times the pushing and pulling are performed, the higher the amount of biological sample eluted, and the more sensitive the test. To increase the reliability of the test, a precise or minimum number of pushing and / or pulling is predetermined. The pushing and / or pulling can be performed between two specific and / or predetermined locations, to which the head portion of the sample collection swab can or must be pushed and / or pulled. These locations can be marked by markings inside or outside the sample collection tube. Instead of markings, or in addition to markings, at least one protrusion can be provided inside the elution fluid tube. The protrusion can provide the user with a visible and tactile reference, allowing the user to receive feedback on where the sample collection swab stops when pushing and pulling. This step or these steps can specifically be performed manually. In alternative embodiments, at least some of these steps can be performed by a machine / device.

[0087] Fixing and / or adjusting the position of the sample collection swab can precede the step of opening the dispensing opening while the sample collection swab is held in one position. The sample collection swab, along with the liquid surrounding and / or filling it, can seal and / or plug the tube between the insertion opening and the dispensing opening to prevent air from entering, ensuring that when the dispensing opening is opened and the sample collection swab is held in the fixed position, the liquid inside the eluent tube remains inside the eluent tube and does not "fall out" due to gravity. This step can be performed manually. In an alternative embodiment, this step can be performed by a machine / device.

[0088] After opening the application opening, the following can be performed: establishing a fluid connection between the application opening and the eluent application area of ​​the test element and / or positioning the application opening above the eluent application area of ​​the test element. Before elution is complete, the fluid connection between the application opening and the eluent application area can be sealed to achieve high elution and thus high sensitivity before testing begins. This step can be performed manually. In an alternative embodiment, this step can be performed by a machine / device.

[0089] The step of pushing the sample collection swab toward the dispensing opening to dispense the eluted sample liquid onto the test element allows for the spraying and / or dosing of the eluted sample liquid. Pushing can be performed to a specific and / or predetermined position, to which the head portion of the sample collection swab can or must be pushed. This position can be marked by markings inside or outside the sample collection tube, by markings that prevent movement of the sample collection swab, and / or by raised and / or tapered openings. This step, or these steps, can be performed manually. In alternative embodiments, at least some of these steps can be performed by a machine / device.

[0090] The analysis of biological samples by reading results from the test detection area can specifically be performed by the user. A negative result (i.e., the analyte is absent and therefore not detected in most cases) can be indicated by the presence of a control line while the test line is absent. A positive result (i.e., the analyte is present and therefore detected in most cases) can be indicated by the presence of both a control line and a test line. Alternatively or additionally, the machine and / or sensor can detect and / or read the results from the test element (specifically, the test strip). Test results can also or alternatively be indicated in different ways, such as, for example, fluorescence or another type of indication. Detailed Implementation

[0091] In the following description, some exemplary embodiments will be described in detail, wherein the invention should not be construed as limited to the described exemplary embodiments. The following examples and drawings are provided to aid in understanding the invention, the true scope of which is set forth in the appended claims. Individual features described in particular embodiments may be combined arbitrarily, as long as they are not mutually exclusive. Furthermore, the different features provided together in the exemplary embodiments should not be considered as limiting the invention. Those skilled in the art will understand that the elements in the drawings are shown for simplicity and clarity and are not necessarily drawn to scale. For example, the dimensions of some elements in the figures may be enlarged relative to other elements, and other elements may have been omitted or represented by reduced quantities to enhance clarity and improve understanding of aspects of this disclosure. The same reference numerals are used for the same or similar elements or elements having similar or identical effects in different embodiments and examples. Attached Figure Description

[0092] Figure 1 is a schematic diagram of an elution kit having an elution liquid tube and a sample collection swab according to one embodiment;

[0093] Figures 2a) to 2c) are schematic diagrams of the elution kit during operation according to one embodiment and in three different operating states, and a detailed view of Figure 2b).

[0094] Figures 3a) to 3f) are schematic diagrams of elution kits according to six different embodiments;

[0095] Figures 4a) to 4f) are schematic cross-sectional views of the elution section according to six different embodiments;

[0096] Figures 5a) to 5c) are schematic diagrams of sample collection swabs according to three different embodiments;

[0097] Figures 6a) and 6b) are schematic diagrams of the elution liquid tubes according to the two embodiments;

[0098] Figure 7 is a schematic diagram of an analytical kit including test elements and an elution kit having an elution liquid tube and a sample collection swab according to one embodiment;

[0099] Figure 8 is a schematic diagram of an analytical kit including test elements and an elution kit having an elution liquid tube and a sample collection swab according to another embodiment;

[0100] Figure 9 is a schematic diagram of an analytical kit including test elements and an elution kit having an elution liquid tube and a sample collection swab according to another embodiment; and

[0101] Figure 10 is a flowchart of the method for eluting and analyzing biological samples.

[0102] Figure 1 is a schematic diagram of an elution kit 1 according to one embodiment, having an elution liquid tube 6 and a sample collection swab 3. The elution kit 1 is configured to elute biological samples in a liquid 2 (see, for example, Figure 2) and to apply the eluted sample liquid 2' (see, for example, Figure 2) to a test element 102 of an analytical kit 101 (see, for example, Figures 7 to 9). The elution kit 1 includes a sample collection swab 3 for collecting biological samples, wherein the sample collection swab 3 includes a stick-shaped portion 4 for holding and a deformable head portion 5 on the stick-shaped portion 4 for collecting biological samples, wherein the head portion 5 is porous to the liquid 2. The elution liquid tube 6 is shown on the left, and the sample collection swab 3 is shown on the right.

[0103] The sample collection swab 3 includes a long, rod-shaped portion 4 for holding, and a head portion 5 is attached to one end of the rod-shaped portion 4. The head portion 5 may be soft to avoid injury to body parts (such as the inside of the user's and / or patient's nose) that come into contact with the head portion 5. Further, the head portion 5 may comprise at least one of the following: sponge, sponge-like material, tissue paper, wool, cotton, polymer, fabric, fiber, etc. The head portion may be soft, elastic, and / or flexible. The rod-shaped portion 4 may comprise at least one of the following: polymer, thermoplastic material, wood chip, organic material, metal, etc.

[0104] The elution liquid tube 6 includes an internal space 7 for containing liquid 2, receiving a sample collection swab 3, specifically along the longitudinal axis 26 of the elution liquid tube 6, and immersing and wetting the head portion 5 in the liquid 2, thereby eluting the biological sample in the liquid 2. The liquid may, for example, correspond to an aqueous buffer solution. Further, the elution liquid tube 6 includes: an insertion opening 10 on a first side (here, the upper side) of the internal space 7 for inserting the sample collection swab 3 into the internal space 7; and a dispensing opening 11 on a second side (here, the lower side) of the internal space 7 adjacent to the first side for dispensing the eluted sample liquid. The internal space 7 may be substantially channel-shaped, i.e., a long tube extending substantially from the insertion opening 10 toward the dispensing opening 11, and has a longitudinal axis 26 that may correspond to a common longitudinal axis 26 passing through the internal space 7, the dispensing opening 11, and the insertion opening 10. Sample collection swabs can be received along a common longitudinal axis 26 that is substantially centered in the interior space 7, such that the common longitudinal axes 26, 27 correspond to and / or align with the longitudinal axis 27 of the sample collection swab 3 when it is at least partially inserted.

[0105] The eluent tube 6 may comprise at least one of the following: a transparent material, a polymeric material, a duroplast, glass, metal, etc. The transparent material may include polymers and / or glass. The eluent tube 6 may be substantially rigid and / or stable in shape. Alternatively, the eluent tube 6 may be (slightly) deformable, meaning that, for example, the eluent tube 6 can be pressed together with, for example, two fingers. The eluent tube 6 may be stable in shape in all cases if no force is applied by the user.

[0106] The elution kit 1 includes: a first closure element 12a (which may correspond to a plug and / or sealing foil, but is not limited thereto) for opening and closing the dispensing opening 11 (on the lower side); and a second closure element 13 for opening and closing the insertion opening 10 (on the upper side). The second closure element 13 is shown in a position where it is used to completely close the insertion opening 10. The second closure element 13 is indicated as a plug 13 having an upper plate that is slightly larger circumferentially than the central portion of the plug 13. The plug 13 is configured to be inserted into the insertion region 15 of the elution fluid tube 6. Further, the second closure element 13 is shown having a tapered lower end that engages with the tapered portion indicated on the insertion region 15 of the elution fluid tube 6. The second closure element 13 is shown partially inserted into the internal space 7 in the insertion region 15. The first closing element 12a corresponds to the plug configured to be inserted into the internal space 7 in the dispensing area 17. In the schematic diagram shown in Figure 1, the first closing element 12a has not yet been inserted into the internal space 7, and therefore, the dispensing opening 11 is in the open state.

[0107] In this embodiment, the first closing element 12a and the second closing element 13 correspond to the plug. Alternatively, at least one of the closing elements 12a and 13 may include at least one of the following: a membrane, a sheet, a foil, a diaphragm, a plate, or a cap.

[0108] In this embodiment, the tapered insertion region 15 allows the sample collection swab 3 to be guided into the internal space 7 of the elution region 16, which has a smaller diameter than the internal space 7 of the insertion region 15. This allows the sample collection swab 3 to be easily inserted into the compact internal space 7 of the elution region 16 while providing a relatively large insertion opening 10. By providing a tapered structure, the sample collection swab 3 can easily slide into the internal space 7 with a reduced diameter. The lowest portion of the internal space 7 in the elution region 16 (i.e., the portion furthest from the insertion opening 10) is also tapered in this embodiment to smoothly further reduce the diameter of the internal space 7 towards the internal space 7 of the preparation region 17, which ends at the preparation opening 11. The preparation opening 11 and the insertion opening 10 are opposite / adjacent to each other and are fluidly connected through the internal space 7. In this embodiment, the diameter of the internal space 7 in the insertion zone 15 is larger than the diameter of the internal space 7 in the elution zone 16, and the diameter of the internal space 7 in the elution zone 16 is larger than the diameter of the internal space 7 in the application zone 17. In the application zone 17 of this embodiment, the internal space 7 has a diameter that can be configured to prevent the sample collection swab 3 from passing through. The tapered lower portion of the internal space 7 in the elution zone 16 can smoothly prevent the sample collection swab 3 from passing through the lower channel portion. The head portion 5 can rest on the tapered portion.

[0109] The internal space 7 is defined by an inner surface 8 that provides / surrounds a gap that can be considered a channel, and the inner surface includes an elution zone 16 having at least one elution portion 9, 9a, the at least one elution portion having a minimum side-to-side distance y in the range of approximately 70% to 140% of the maximum side-to-side distance x of the head portion 5 of the sample collection swab 3. The inner surface 8 defines a gap 14 through which the sample collection swab 3 can be pushed and pulled, at least in the elution zone 16 and the insertion zone 15, while the dispensing opening 11 is closed.

[0110] In the embodiment of Figure 1, the elution portion 9 has a minimum side-to-side distance y (here, diameter) in the range of approximately 95% to 105% of the maximum side-to-side distance x (here, diameter) of the head portion 5 of the sample collection swab 3.

[0111] In the embodiment of Figure 1, elution sections 9, 9a are indicated to be substantially uniform across the entire elution zone 16. Elution sections 9, 9a include elution regions that may have a length ranging from approximately 10% to 98% of the length of the elution liquid tube. In this specific embodiment, the length of the elution region ranges from approximately 75% to 85% of the length of the elution liquid tube 6.

[0112] The eluent tube 6 can be circular externally and / or internally. Specifically, in this embodiment, the cross-section of the internal space 7, and more specifically the gap 14 defined by the eluent portions 9, 9a (in the cross-section), can be circular. Therefore, the minimum side-to-side distance y of the eluent portions 9, 9a can correspond to the diameter. The same applies to the head portion 5 of the sample collection swab 3, which can be circular in its cross-section, and therefore the maximum side-to-side distance x of the head portion 5 can correspond to its diameter (at its widest position along the horizontal axis perpendicular to the length axis of the rod-shaped portion).

[0113] Figures 2a) to 2c) are schematic diagrams of the elution kit 1 during operation according to the embodiment of Figure 1, where Figures 2a) to 2c) correspond to three different operating states, and a detailed view of Figure 2b) is shown. The elution liquid tube 6 has a closed dispensing opening 11 and an open insertion opening 10. In other words, the dispensing opening 11 is closed by a first closing element 12a, and the insertion opening is open because the second closing element 13 is removed. The first closing element 12a is inserted into the internal space 7 and substantially reaches therein to seal the entire length of the dispensing area 17.

[0114] In Figure 2a), the sample collection swab 3 is inserted into the internal space 7, with the head portion 5 extending downwards to half of the elution zone 16. The sample collection swab 3 is being pushed downwards toward the application opening 11 (indicated by the arrow at the top). The head portion 5 has approximately the same diameter as the elution zone, which is the area where the internal space 7 has a smaller diameter compared to the insertion portion. In Figure 2a), the sample collection swab 3 is in a position where it has not yet reached the liquid 2 and is therefore still dry. It is possible that the head portion is somewhat compressed into the internal space 7 in the elution zone 16, specifically when the diameter of the head portion 5 (at its widest position along the horizontal axis perpendicular to the length axis of the rod-shaped portion) exceeds the diameter of the internal space 7 in the elution zone 16.

[0115] In Figure 2b), the sample collection swab 3 is inserted into the internal space 7, where, compared to the case in Figure 2a), the head portion 5 reaches further down in the elution zone 16 (indicated by the top arrow). The head portion 5 actually reaches the liquid in the lower portion of the elution zone 16. As can be seen in the unfolded view of Figure 2b), the head portion 5 is immersed in the liquid 2, and a portion of the liquid 2 passes upward through and / or around the head portion 5 (indicated by the curved arrow), while another portion is drawn into the pores of the head portion 5. By passing through (around) the head portion 5, the liquid 2 comes into contact with the biological sample. The biological sample is eluted in the liquid 2, and then the liquid 2 corresponds to the eluted sample liquid 2', i.e., the liquid containing at least some of the sample previously adhered to the sample collection swab 3.

[0116] In Figure 2c), the sample collection swab 3 is pulled upward again toward the insertion opening 10 (indicated by the arrow at the top). The sample liquid 2', at least partially eluted, is then pulled downward toward the application opening 11, passing (around) the head portion 5 (indicated by the curved arrow).

[0117] Each time the sample collection swab 3 is pushed or pulled, the liquid 2 or the eluted sample liquid 2' bypasses and / or passes through the head portion 5, and the biological sample is eluted more and more thoroughly. Therefore, pushing and pulling the sample collection swab 3 through the liquid 2 multiple times increases the amount of biological sample eluted in the liquid 2, making the eluted sample liquid 2' more concentrated. This has the following effect: the test becomes more sensitive due to the increased sample concentration in the liquid 2.

[0118] Figures 3a) to 3f) are schematic diagrams of elution kits according to six different embodiments. In Figure 3a), an elution kit according to Figures 1 and 2 is shown. Elution portions 9, 9a include an elution region having a length 22, which is between approximately 10% and 98% of the length of the elution liquid tube 6, in this example between approximately 75% and 90%, and is 100% of the length of the elution region 16. In other words, elution portions 9, 9a are substantially over the entire length of the elution region 16. The cross-section of the elution portions 9, 9a (or any other portion of the elution liquid tube 6), for example indicated by line AA', may correspond to any of the shapes shown in Figures 4a) to 4f), which are further described below. The primary function of the elution portions 9, 9a according to this embodiment is to allow the liquid to bypass and / or pass through the head portion 5 when the sample collection swab 3 is pushed and pulled. The narrow, tubular / channel-like volume of the internal space 7 allows for the handling of small amounts of liquid. The conical portion in the insertion area 15 assists the user by centering the sample collection swab and locating the tubular / channel-like volume of the internal space 7. The head portion 5 of the sample collection swab 5 can slide along the sidewall of the conical portion into the internal space 7 of the elution area 16. A pushing force may be required to move the head portion 5 downwards.

[0119] Figure 3b) illustrates an elution kit 1 according to another embodiment. The elution liquid tube 6 has conical elution portions 9, 9a, which include an elution region having a length 23, the length ranging from approximately 10% to 98%, or in this example, approximately 10% to 13%, of the length of the elution liquid tube 6. The elution portions 9, 9a are located in the lower half of the elution zone 16 and the elution liquid tube 6, specifically in the lower third of the elution zone and the elution liquid tube. The remaining portion of the internal space 7 in the elution zone 16 is wider in diameter than the elution portions 9, 9a. The function of the elution portion 9a according to this embodiment is to allow liquid to bypass and / or pass through the head portion 5 when the sample collection swab 3 is pushed and pulled, and to scrape away a portion of the biological sample and / or liquid retained / absorbed in the head portion 5 of the sample collection swab 3. In the region above and / or below the elution section 9a, liquid can be drawn into the head section 5, and at least a portion of the liquid drawn into the head section 5 can be scraped off as it passes through the elution section 9a. Furthermore, biological samples remaining on and / or in the head section 5 of the sample collection swab 3 can also be scraped off, allowing the biological samples to be easily eluted into the liquid.

[0120] For simplicity, the aforementioned closing element and liquid are not shown in the accompanying drawings. The cross-section of the elution portions 9, 9a, for example, indicated by line BB', can correspond to any of the shapes shown in Figures 4a) to 4f), which are described further below.

[0121] In Figure 3c), an elution kit 1 according to another embodiment is shown. The elution liquid tube 6 has conical elution portions 9, 9b corresponding to the elution protrusion 9b. The elution protrusion 9b is located in the lower third of the elution zone 16 and the elution liquid tube 6. In this example, the elution protrusion 9b may be shorter in length by about 10% of the length l of the elution liquid tube 6, for example, about 0.5% to 5% of the length l of the elution liquid tube 6. The remaining portion of the elution zone 16 is wider in diameter than the elution portion 9b and in some cases may at least partially correspond to the elution zone as described with respect to Figure 4a). The primary function of the elution portion 9b according to this embodiment is to scrape away a portion of the liquid retained / absorbed in the head portion 5 of the sample collection swab 3. Further, it may also be a function for the liquid to bypass and / or pass through the head portion 5 when the sample collection swab 3 is pushed and pulled. The cross section of the elution section 9b, for example indicated by line CC', can correspond to any of the shapes shown in Figures 4a) to 4f), which are described further below.

[0122] In Figure 3d), an elution kit 1 according to another embodiment is shown. The elution liquid tube 6 has elution portions 9, 9c corresponding to helical threaded protrusions 9c. The helical threaded protrusions 9c are positioned in the lower third of the elution zone 16 and the elution liquid tube 6. The remaining portion of the elution zone 16 is wider in diameter than the elution portions 9, 9c and in some cases may at least partially correspond to the elution region as described with respect to Figure 4a). The helical threaded protrusions 9c may specifically function to mix liquids along and / or along the threaded ridges and / or grooves. Further, the helical threaded protrusions 9c may function to efficiently scrape away at least a portion of the biological sample and / or the aspirated liquid from the head portion 5. More specifically, pushing the head portion 5 through the helical threaded protrusions 9c can repeatedly squeeze and / or press the head portion 5, and thus efficiently scrape away material in and / or on the head portion 5. The cross-section of the elution portions 9, 9c, for example, indicated by line DD', can correspond to any of the shapes shown in Figures 4a) to 4f), which are described further below.

[0123] In Figure 3e), an elution kit 1 according to another embodiment is shown. The elution liquid tube 6 has two elution portions 9, 9a, 9b, respectively corresponding to the elution protrusion 9b and the elution region 9a having a length of 24, the length of which is between approximately 10% and 98% of the length of the elution liquid tube 6, and in this example, approximately 10% to 13%. The elution portions 9a, 9b are located in the lower third of the elution region 16 and the elution liquid tube 6. The remaining portion of the elution region 16 is wider in diameter than the elution portions 9a, 9b, and in some cases may at least partially correspond to the elution region as described with respect to Figure 4a). The cross-sections of the elution portions 9a, 9b, for example, indicated by lines FF' and EE' respectively, may correspond to any of the shapes shown in Figures 4a) to 4f), which are further described below. The elution protrusion 9b is positioned above the elution region 9a and has a very short length, for example, approximately 0.5% of the length l of the elution liquid tube 6. The elution protrusion 9b provides the primary function of scraping liquid from the head portion 5, while the elution region 9a provides the primary function of mixing the liquid by passing through and / or around the head portion 5. This can produce a synergistic effect between the two elution portions 9a, 9b, resulting in improved elution of biological samples. In this embodiment, the dispensing opening 11 is tapered in diameter from the outside towards the inside (i.e., upwards). This allows, for example, easy insertion of extensions of the dispensing tip, plug, and / or cap into the dispensing opening 11.

[0124] In Figure 3f), an elution kit 1 according to another embodiment is shown. The elution liquid tube 6 has two elution portions 9, 9a, 9b, respectively corresponding to an elution protrusion 9b and an elution region 9a having a length of 25, the length of which is between approximately 10% and 98% of the length of the elution liquid tube 6, specifically between approximately 10% and 15%. The elution portions 9a, 9b are substantially located in the lower half of the elution region 16 of the elution liquid tube 6. The remaining portion of the elution region 16 is wider in diameter than the elution portions 9, 9b, and in some cases may at least partially correspond to, as for... Figure 4a) The described elution area. The elution protrusion 9b is positioned at or slightly below the midpoint of the elution fluid tube 6 relative to its length axis. This allows for prevention of liquid overflow towards the insertion opening. Additional elements for preventing liquid overflow from the elution fluid tube 6 are provided in a diaphragm and / or splash guard 19, which leaves only a small gap for inserting the sample collection swab 3. The diaphragm 19 can therefore be elastic and / or flexible. In an alternative embodiment, instead of the diaphragm 19, a plate, sheet, and / or another element with a small gap allowing insertion of the sample collection swab 3 can be provided.

[0125] The cross sections of the elution portions 9a and 9b, for example, indicated by lines HH' and GG' respectively, can correspond to any of the shapes shown in Figures 4a) to 4f), which are described further below.

[0126] Additional functions of all or at least some of the described elution portions 9, 9a, 9b, 9c may prevent liquid from overflowing upwards. Furthermore, the functions of all or at least some of the described elution portions 9, 9a, 9b, 9c may correspond to stopping and / or slowing down the sample collection swab 3 due to increased mechanical resistance as the head portion 5 passes. Additionally, the functions of all or at least some of the described elution portions 9, 9a, 9b, 9c may address the possibility that the sample collection swab 3 may be held in a certain position due to increased mechanical resistance. In this case, the user can leave the head portion 5 in the position of the corresponding elution portion 9, 9a, 9b, 9c, and the sample collection swab will remain there, and will not slide downwards under gravity even if the user does not hold it. If the head portion 5 is submerged in liquid at this position, the passage between the insertion opening 10 and the dispensing opening 11 is blocked, and liquid will not leave the internal space 7 of the elution liquid tube 6 when the dispensing opening 11 is open. At least some of the described elution portions 9a, 9b, 9c (Figs. 3b) to 3f) are indicated to be tapered on their upper and lower sides so that the head portion 5 is smoothly guided toward the gap 14 defined by the respective elution portions 9a, 9b, 9c when the sample collection swab 3 is pushed and pulled. Furthermore, by smoothly guiding the head portion 5 along the tapered surface, damage to the head portion can be prevented because sharp edges that could potentially damage the head portion 5 can be avoided.

[0127] The elution portions 9, 9a, 9b, and 9c shown in the embodiments of all the accompanying drawings can be combined in any way that is structurally possible and not contradictory.

[0128] Figures 4a) to 4f) are schematic cross-sectional views of the elution portions according to six different embodiments, but are not limited thereto. The cross-sections correspond to the gaps 14 defined by the respective elution portions 9, 9a, 9b, and 9c. In Figure 4a), the shape of the gap 14 corresponds to a circular shape, and the minimum side-to-side distance y of the elution portion corresponds to the diameter of the circular shape. Figure 4 In Figure 4b), the shape of gap 14 corresponds to a square shape, and the minimum side-to-side distance y of the elution portion corresponds to the distance between the two parallel sides of the square shape. In Figure 4c), the shape of gap 14 corresponds to a rectangular non-square shape, and the minimum side-to-side distance y of the elution portion corresponds to the distance between the two longer parallel sides of the rectangular shape. Figure 4 In Figure d), the shape of gap 14 corresponds to a hexagonal shape, and the minimum side-to-side distance y of the elution portion corresponds to the distance between two parallel sides of the hexagonal shape. In Figure 4e), the shape of gap 14 corresponds to an elliptical shape, and the minimum side-to-side distance y of the elution portion corresponds to the shortest distance between two sides of the elliptical shape. In Figure 4f), the shape of gap 14 corresponds to a cross shape in the circular support of elution portions 9, 9a, 9b, 9c, and the minimum side-to-side distance y of the elution portion corresponds to the shortest distance between two edges of the cross shape. The edges may be rounded to avoid damaging the head portion 5. The example given herein for gap 14 does not limit the possibility of choosing a shape. Furthermore, the example given herein can also be applied to the cross-section of the internal space 7, i.e., gaps in other areas (such as insertion area 15, elution area 16 in which no elution portion is provided, and / or dispersion area 17).

[0129] Figures 5a) to 5c) are schematic diagrams of sample collection swab 3 according to three different embodiments. Figure 5In Figure 5a), the head portion 5 has a rectangular shape in its cross-section (indicated by the dashed tangent), as shown in the diagram to the right of sample collection swab 3 in Figure 5a). The head portion also has a rectangular shape along the longitudinal axis 27. In Figure 5b), the head portion 5 has a substantially teardrop shape along its longitudinal axis 27 and a circular shape in its cross-section (indicated by the dashed tangent), as shown in the diagram to the right of sample collection swab 3 in Figure 5b). The maximum side-to-side distance x of the head portion in this embodiment corresponds to the diameter of the head portion 5 at its widest position along the horizontal axis perpendicular to the length of the rod portion 4 / longitudinal axis 27. In Figure 5c), the head portion 5 has a long and extended shape along its longitudinal axis 27 and a rounded tip at its end, and a circular shape in its cross-section (indicated by the dashed tangent), as shown in the diagram to the right of sample collection swab 3 in Figure 5c. The rounded and / or circular shape of the head portion 5 allows for smooth insertion into gaps and / or body openings, and the smooth and / or soft surface helps prevent injury to the patient. Generally, the maximum side-to-side distance x of the head portion 5 can be measured at its widest point. It can correspond to the diameter of the circular shape (see Figures 5b and 5c) or the distance between two parallel sides (at the maximum distance between the two surfaces) (see Figure 5a). The examples of the shape of the head portion 5 given herein do not limit the possibilities for shape selection.

[0130] Figures 6a) and 6b) are schematic diagrams of the eluent tube 6 according to two embodiments. In Figure 6a), a dispensing nozzle 18 in the form of an extended tip is provided on the dispensing opening 11 to precisely apply the eluted sample liquid to a target (such as a field of a test element). The dispensing nozzle 18 may be permanently provided on the eluent tube 6, or may be attached to and detached from it. The dispensing opening 11 can be closed by a plug 12a. Similar to Figures 6a) and also similar to Figure 6b), the dispensing nozzle 18 in the form of an extended tip is provided on the dispensing opening 11. Further, an edge 28 is provided on the outer periphery, which allows the user to stand the eluent tube 6 upright on a flat surface. The edge 28 is longer than the dispensing nozzle 18. The dispensing opening 11 can be closed by a cap 12b. In this embodiment of the cap 12b, the dispensing nozzle 18 is received by an extension at the center of the cap 12b, the extension having a recess / cavity. Alternatively, the cap 12b may have an extension at its center configured to insert into the dispensing opening 11. On the side of the cap 12b, a circular receiving recess is provided for receiving the edge 28 and securing the cap 12b to the eluent tube 6. The cap 12b can be implemented according to alternative structures. The cap 12b and / or the plug 12a can be secured to the eluent tube 6, for example, by a strap and / or wire.

[0131] Figure 7 is a schematic diagram of an analytical kit 101 including a test element 102 and an elution kit 1 having an elution liquid tube 6 and a sample collection swab 3 according to one embodiment. The elution kit 1 can be any of the elution kits 1 described herein. The situation depicted in the figure is such that the sample has been eluted in the liquid 2, the plug 12a is removed, and the sample collection swab 3 is pushed down as indicated by the upper arrow to dispense and / or spray the eluted sample liquid 2'. Droplets sprayed through the dispensing nozzle 18 of the elution liquid tube 6 are directed to pass through the sample application recess 112 of the test element housing 103 of the test element 102 and transfer to the LFA core 111 housed therein. The LFA core 111 includes a base 113 (or a liner), a region 104 for applying eluent (corresponding to a sample pad to which the eluted sample liquid 2' can be applied), a region 105 for testing the reaction (corresponding to a conjugate release pad), a region 106 for testing the detection (corresponding to a membrane, such as a nitrocellulose pad), and a region 107 for collecting the sample (corresponding to an adsorbent pad). On the membrane, test lines 108a and control lines 108b are provided so that the test results are visible to a user who can see through the recess in the housing 103 to read the test results from the LFA core 111.

[0132] Figure 8 is a schematic diagram of an analytical kit 101 including a test element 102 and an elution kit 1 having an elution liquid tube 6 and a sample collection swab 3 according to another embodiment. However, the analytical kit 101 of Figure 8 differs from the analytical kit of Figure 7 in that a cap 12b is used instead of a plug 12a, and the elution liquid tube includes an edge 28 and a coupling mechanism 109 having two parts / elements 109a, 109b for connecting the elution liquid tube 6 to the housing 103 of the test element 102. The coupling mechanism 109 shown in this embodiment relies on the thread 109a in the sample application recess 112 of the housing 103 and the reverse element 109b on the thread on the edge 28 of the elution liquid tube 6. The coupling mechanism 109 allows the elution liquid tube 6 to be connected and disconnected from the housing 103, so that the eluted sample liquid can be safely and / or without spillage transferred to the test element 102.

[0133] Figure 9 is a schematic diagram of an analytical kit 101 including a test element 103 and an elution kit 1 having an elution liquid tube 6 and a sample collection swab 3 according to another embodiment. The elution liquid tube 6 and the test element 103 are fixed to each other. Specifically, the elution liquid tube 6 and the test element 103 may be disposed in a common housing 115 and / or on a common support 115. If the elution liquid tube 6 and the test element 103 are disposed in the common housing 115, liquid that may leak from the elution liquid tube 6 can be collected in a groove 116 and / or a portion of the housing 115 that functions similarly to a groove. In the embodiment where the housing 115 is disposed, high stability can be achieved. In the embodiment where the common support 115 is disposed, inexpensive and / or simple production of the analytical kit 109 can be achieved.

[0134] The elution liquid tube 6 and the test element 103 are also connected via a fluid path 21, which is closed before the test begins and before the biological sample is eluted in the liquid. When the biological sample is eluted in the liquid, the fluid path closure element 20, such as a membrane and / or plug, can be broken and / or removed to establish a fluid connection between the elution liquid tube 6 and the test element 103 (specifically, the sample pad 104 of the test element 103).

[0135] Typically, the test element / test strip that can be used with this invention or any embodiment thereof may differ from the test element shown. For example, if the reaction is carried out outside of, for example, the test strip may not have a substrate, or may only have a membrane and a sample collection pad, without a sample pad and a conjugate pad.

[0136] Figure 10 is a flowchart of a method 200 for eluting and analyzing biological samples. The method 200 for eluting and analyzing biological samples includes the following steps:

[0137] a. Provide 201 an analytical kit as described herein as one embodiment of these embodiments, wherein liquid is inserted by the user into the internal space 7 by 202, or liquid has been provided in the internal space 7 of the elution liquid tube 6;

[0138] b. Collect 203 biological samples using the head portion 5 of sample collection swab 3;

[0139] c. With the head portion 5 facing forward, insert the sample collection swab 3 through the insertion opening 10 and into the internal space 7 via 204;

[0140] d. Push the head portion 5 205 into the elution zone 16 at least partially across at least one elution portion 9 toward the application opening 11, and wet 206 the head portion 5 of the sample collection swab 3 with liquid 2;

[0141] e. Pull 207 sample collection swab 3 towards the insertion opening 10, at least partially across at least one elution section 9 inside the elution zone 16;

[0142] f. With the sample collection swab 3 held in one position and / or resting in one position, open the 208 application opening 11;

[0143] g. Push the sample collection swab 3 towards the application opening 11 to apply the eluted sample liquid onto the test element 102; and

[0144] h. Analyze 212 biological samples by reading the results from test detection area 106.

[0145] Steps d. and e., which involve pushing and pulling, may be repeated a predetermined number of times, such as 3, 4, 5, 6, 7, 8, or more. The specific predetermined number of pushes and pulls ensures that critical and / or minimum amounts of biological sample are eluted in the liquid, resulting in reversible and / or reliable results and reducing the risk of false negatives.

[0146] Based on the above description, modifications and variations to the disclosed aspects are of course possible. Therefore, it should be understood that, within the scope of the appended claims, the invention can be practiced in ways different from the specific designs described in the above examples.

[0147] In particular, it should be understood that at least some of the accompanying drawings or parts are merely illustrative and provided only as examples. Furthermore, the relationships between elements may differ from those shown, and portions irrelevant to the purpose of this disclosure have been omitted.

[0148] Furthermore, throughout this specification, references to "an aspect," "an aspect," "an instance," "an embodiment," or "an embodiment" refer to a specific feature, structure, or characteristic described in connection with that aspect, instance, or embodiment being included in at least one aspect, instance, or embodiment. Therefore, the phrases "in an aspect," "in a aspect," "an instance," "an embodiment," or "an embodiment" appearing throughout this specification do not necessarily refer to the same aspect, instance, or embodiment.

[0149] Furthermore, specific features, structures, or characteristics may be combined in any suitable combination and / or sub-combination in one or more aspects, examples, or embodiments.

[0150] List of reference numerals

[0151]

Claims

1. An elution kit (1) for eluting biological samples in a liquid (2) and dispensing the eluted sample liquid (2') onto a test element (102) of an analytical kit (101), said elution kit (1) comprising: A sample collection swab (3) for collecting the biological sample, wherein the sample collection swab (3) includes a rod-shaped portion (4) for holding and a deformable head portion (5) on the rod-shaped portion (4) for collecting the biological sample, wherein the head portion (5) is porous for the liquid (2); as well as The eluent tube (6) includes: An internal space (7) is provided for containing the liquid (2), receiving the sample collection swab (3), and eluting the biological sample in the liquid (2); An insertion opening (10) is provided on the first side of the internal space (7) for inserting the sample collection swab (3) into the internal space (7); A dispensing opening (11) is provided on a second side of the interior space (7) adjacent to the first side for dispensing the eluted sample liquid; The first closing element (12) is used to seal the application opening (11) in a way that prevents water vapor from penetrating; A second closing element (13) for sealing the insertion opening (10) in a water vapor impermeable manner, wherein the first closing element (12) and / or the second closing element (13) comprises a foil; and The liquid (2), wherein the elution liquid tube (6) contains the liquid (2), The internal space (7) is defined by an inner surface (8) including an elution zone (16) having at least one elution portion (9) having a minimum side-to-side distance y in the range of approximately 70% to 140% of the maximum side-to-side distance x of the head portion (5) of the sample collection swab (3), and defining a gap (14) through which the sample collection swab (3) can be pushed and pulled through the application opening (11) in the closed state.

2. The elution kit (1) according to claim 1, wherein the volume of the internal space (7) of the elution liquid tube (6) is sized to accommodate a liquid volume of less than 1 ml, specifically less than 500 µl and more specifically less than 10 µl, and wherein The ratio of "volume of the internal space (7)" to "liquid volume" is less than 10; and / or The ratio of "liquid volume" to "liquid volume absorbed by the wetted head portion (5)" is between 1 and 10.

3. The elution kit (1) according to any one of the preceding claims, wherein the elution portion (9) comprises at least one of the following: At least one elution zone (9a) having a length between 10% and 98% of the length (l) of the elution liquid tube (6); At least one elution protrusion (9b) having a length corresponding to less than 10% of the length (l) of the elution liquid tube (6); and / or At least one spiral thread-like protrusion (9c).

4. The elution kit (1) according to any one of the preceding claims, wherein the elution liquid tube (6) comprises on the side where the application opening (11) is located: Application nozzle (18) that defines the application opening (11); And / or An edge, configured to position the eluent tube (6) in an upright orientation, optionally wherein the edge includes elements of a coupling mechanism (109a, 109b) for coupling the eluent tube (6) to a test element (102), optionally wherein the coupling mechanism (109a, 109b) includes a threaded mechanism (109b), a bayonet, and / or a Luer lock mechanism.

5. The elution kit (1) according to any one of the preceding claims, wherein the internal space (7) comprises: Insertion area (15); The elution zone (16); and The application area (17) optionally has a maximum diameter (Rb) of the internal space (7) in the insertion area (15) that is greater than the maximum diameter (Rc) of the internal space (7) in the elution area (16) and / or the maximum diameter (Rc) of the internal space (7) in the elution area (16) that is greater than the maximum diameter (Rd) of the internal space (7) in the application area (17).

6. The elution kit (1) according to any one of the preceding claims, wherein the outer diameter of the elution liquid tube (6) is 3 or more times, specifically 8 or more times, and more specifically 20 or more times the side-to-side distance y of the elution portion (9) of the internal space (7).

7. An analytical kit (100) for analyzing biological samples, the analytical kit comprising: Elution kit (1) according to any one of the preceding claims; as well as The test element (102) includes at least an application function (104), a test response function (105), and a test detection function (106).

8. The analytical kit (100) according to claim 7, wherein the test element (102) comprises a test element housing (103) and / or an LFA core strip (111).

9. The analytical kit (101) according to claim 7 or 8, The elution liquid tube (6) and the test element (102) of the elution kit (1) are fixed to each other, specifically fixedly attached to each other, and / or supported or housed in a single unit, specifically supported jointly and at least partially by a cardboard; and / or the analytical kit (101) includes a fluid path (21) permanently disposed between the elution liquid tube (6) and the test element (102) and includes a fluid path closure element (20) configured to prevent the liquid from being transferred from the elution kit (1) to the elution application area (104) when the fluid path (21) is closed, and to allow the liquid to be transferred from the elution liquid tube to the elution application area (104) when the fluid path (21) is open.

10. The analytical kit (101) according to claim 9, wherein the fluid path closure element (20) comprises: A valve element configured to mechanically transition from the open state of the fluid path (21) to the closed state; And / or A breakable barrier that can have a complete state corresponding to the closed state or a broken state corresponding to the open state.

11. The analytical kit (100) according to claim 7 or 8, wherein the elution liquid tube (6) and the test element (102) are separate elements, optionally wherein the elution liquid tube (6) and the test element (102) are fluidly connected to each other to transfer the eluted sample liquid onto the test element (102).

12. The analytical kit (100) of claim 11, wherein the elution liquid tube (6) and the test element (102) include coupling mechanisms (109a, 109b) for coupling the elution liquid tube (6) to the test element (102) and configured to allow the eluted sample liquid to be transferred without spillage to the elution application area (104) of the test element (102).

13. A method (200) for eluting and analyzing biological samples, the method comprising the following steps: Provide (201) the analytical kit according to any one of claims 7 to 12, wherein the liquid is provided in the internal space (7) of the elution liquid tube (6); The biological sample is collected (203) by the head portion (5) of the sample collection swab (3); With the head portion (5) facing forward, the sample collection swab (3) is inserted (204) through the insertion opening (10) into the internal space (7); At least partially across the at least one elution portion (9) toward the application opening (11), the head portion (5) is pushed (205) into the elution zone (16), and the head portion (5) of the sample collection swab (3) is wetted (206) with the liquid (2); The sample collection swab (3) is pulled (207) toward the insertion opening (10) at least partially across the at least one elution section (9) inside the elution zone (16); While the sample collection swab (3) is held in one position, open (208) the application opening (11); Push (211) the sample collection swab (3) toward the application opening (11) to apply the eluted sample liquid onto the test element (102); as well as The biological sample is analyzed (212) by reading the results from the test detection area (106).

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