Lateral flow device

Abstract

A lateral flow device comprising a body portion and a removable swab, where the swab comprises a shaft having a proximal end and a distal end with an absorbent head at the distal end, and the body portion comprises: an inlet region for receiving the swab prior to use and for receiving the swab in use during a lateral flow test; a fluid chamber containing an amount of extract; an outlet conduit; and a lateral flow test strip; wherein the fluid chamber is arranged to open in use when the absorbent head is forcibly inserted through the inlet region into the body portion, such that the extraction liquid treats the absorbent head and enters the outlet conduit; and wherein the outlet conduit comprises or is in fluid communication with the proximal end of the lateral flow test strip such that, in use, extract entering the outlet conduit can reach the proximal end of the lateral flow test strip and then flow along the lateral flow test strip for lateral flow testing. The invention also provides a method for carrying out a flow measurement test by using the flow measurement device.

Description

Field of the Invention

[0001] The present invention relates to a lateral flow device for performing a lateral flow test on a liquid sample to detect the presence (or absence) of a target substance therein. The liquid may be, for example, an oral or nasal fluid (e.g., saliva or mucosal excretions) or a sample of blood, urine, or another body fluid. The target substance may be, for example, an antigen, such as a viral protein.

[0002] The invention is particularly suitable for determining the presence (or absence) of the SARS-CoV-2 virus in members of the general population by detecting the presence (or absence) of Covid-19 antigens, for example, as part of a national "test yourself" testing program. However, the invention is by no means limited to this purpose, but can be used to detect the presence (or absence) of other pathogens, antigens, proteins, target molecules (such as hormones) or other target substances. Background of the Invention

[0004] Lateral flow devices can be used to test body fluid samples from people (subjects) to provide rapid indications of the presence (or absence) of target substances therein. Test results are typically obtained from the lateral flow device itself within a few minutes without the need for additional equipment or laboratory-based processing. The sample can be obtained by the test tube user in terms of himself as a subject (as in the case of "self-testing"), or from another person (e.g., from an adult in terms of a child, or from a healthcare professional in terms of a patient, etc.).

[0005] Particularly for testing oral or nasal fluids, for example for the presence of the SARS-CoV-2 virus, lateral flow devices are often provided as part of a "rapid antigen" lateral flow test kit, for example for detecting the presence of Covid-19 antigens. Such test kits typically include as separate articles:

[0006] an extraction tube (which usually includes a cap with a dropper function),

[0007] the container of the extract (e.g. a sachet or bottle),

[0008] a swab (with an absorbent tip on the end of the shaft), and

[0009] The lateral flow device itself (which typically comprises a lateral flow test strip mounted within a plastic housing).

[0010] The swab is typically provided in its own sealed packaging, and similarly, the lateral flow device is typically provided in its own sealed packaging to ensure that nothing is contaminated prior to use. The extraction tube may also be provided in its own separate packaging.

[0011] At the time of use, the lateral flow device is removed from its packaging and placed on a clean flat surface, ready for use. The extraction tube is also removed from any packaging and placed on a clean surface or support (e.g., using a tube holder provided as part of the kit). The extraction solution (also referred to as "buffer") is transferred from its container into the extraction tube, with the user being careful not to spill any solution or contaminate the solution or tube.

[0012] The swab is then removed from its packaging material, with the user being careful not to touch or otherwise contaminate the absorbent tip. The swab is then used to collect a fluid sample from a subject, such as from the subject's nasal passages and / or the back of their throat, using the absorbent tip.

[0013] The absorber head is then introduced into the extract in the extraction tube, and the user presses or squeezes the absorber head against the wall of the extraction tube to transfer the collected fluid sample (including the target substance (e.g., Covid-19 antigen) if present) into the extract. The resulting solution containing the fluid sample may be referred to herein as a test solution. Again, care should be taken not to contaminate the extract or the resulting test solution during this process.

[0014] A specific amount (e.g., a few drops) of the test fluid is then transferred from the extraction tube to the inlet of the lateral flow device (e.g., through a dropper cap on the extraction tube, if such a cap is provided), again taking care not to contaminate the test fluid or the lateral flow device, or lose the test fluid, in the process.

[0015] The test fluid is then transferred from the inlet of the lateral flow device by capillary flow along the test strip from the proximal end of the test strip (coinciding with the inlet) toward the distal end of the test strip. If the target substance (e.g., Covid-19 antigen) is present, a positive test line is generated in the first indicator area along the test strip, and a control line is usually generated in the second indicator area along the test strip to confirm that the test fluid is flowing correctly along the test strip.

[0016] More generally, a test strip has a proximal end (for receiving a solution to be tested), a distal end (towards which the solution flows), and one or more indicator regions therebetween for determining the presence (or absence) of a target substance.

[0017] In practice, as will be understood by those skilled in the art, the composition of the test strip will vary according to the target substance to be detected in the test solution. Suitable test strip compositions are well known to those skilled in the art and need not be described in detail herein. However, in general, such test strips are designed to transmit the test solution along the surface of the pad with reactive molecules that display visual positive or negative results. The pad is based on a series of capillary beds, such as a sheet of porous paper or polymer (e.g., microstructured polymer or sintered polymer), and can spontaneously transport the test solution. Typically, the test strip includes a sample pad, a conjugate pad, and a wicking pad in sequence. The sample pad at the proximal end of the test strip and overlapping with the inlet is used to absorb the test solution and accommodate excess test solution. From there, the test solution flows to the conjugate pad with a conjugate in a salt-sugar matrix, wherein the conjugate generally comprises freeze-dried bioactive particles. The conjugate pad has the necessary reagents to produce a chemical reaction between the target substance (e.g., antigen) and the chemical partner (e.g., antibody) of the target substance that has been fixed on the particle surface. This marks that the target particles pass through the pad as they continue to pass through the test line and control line in the corresponding indicator area. The test line provides a colored indication if the target substance is present. The control line contains an affinity ligand that indicates whether the test fluid has flowed through and whether the particles in the conjugate pad are active. After passing through these reaction zones, the test fluid enters a wicking pad, which essentially serves as a waste container.

[0018] It will be appreciated that there are a number of potential drawbacks or disadvantages associated with the use of conventional lateral flow devices of the type described above, including:

[0019] - The test kit consists of multiple individual items that may be bulky to store and not convenient for one person to carry;

[0020] - the need to unpack the various individual items that make up the kit, which can be awkward (e.g. for people with poor manual dexterity) and time consuming, and can result in the generation of large amounts of packaging waste;

[0021] - A clean flat surface needs to be prepared on which to place the lateral flow device and extraction tube;

[0022] -The extraction fluid needs to be carefully transferred from its container to the extraction tube without spilling any solution or contaminating the extraction fluid or tube;

[0023] - the need to transfer the collected fluid sample from the swab to the extraction fluid (e.g. by expression) without contaminating the extraction fluid or the resulting test fluid; and

[0024] - A specific amount (ie a specific number of drops) of a test fluid needs to be transferred to a lateral flow device without contaminating the test fluid or the lateral flow device and without losing the test fluid.

[0025] Due to the above shortcomings, conventional lateral flow tests cannot be easily carried out in a position away from home (or similar) environment. In particular, when the user is standing, for example, in an airport, railway station, theater, cinema, concert hall, conference hall, retail store, religious worship place, sports venue, bar, nightclub, dance hall or other place where many other people may be present, the traditional lateral flow test cannot be easily carried out by the user away from home, if the user is infected with the virus (such as SARS-CoV-2), there will be a risk of spreading the virus to other people (maybe many other people) in the place. It will be recognized that in these places, it is hoped that it can be determined by on-site lateral flow tests whether people are infected with the virus, if so, then they are not allowed to enter the place. On the contrary, it is determined that the people in the place are not infected with the virus, so that they can communicate more freely and comfortably in the place, and the risk of spreading or catching the virus is low.

[0026] Furthermore, as will be appreciated from the above, conventional lateral flow tests are susceptible to contamination or other problems (e.g., loss of fluid) when performing the test, which in turn may affect the accuracy of the results. Furthermore, the need to develop the various articles that make up the test kit may be difficult and may result in the generation of a considerable amount of waste.

[0027] Therefore, there is a need for a lateral flow device that people can use to test themselves for the presence (or absence) of a target substance (e.g., the SARS-CoV-2 virus) that overcomes one or more of the above-mentioned disadvantages and enables users (including outside of home) to more easily perform the test. SUMMARY OF THE INVENTION

[0029] According to a first aspect of the present invention, there is provided a lateral flow device as defined in claim 1 of the accompanying claims. There is also provided a method of performing a lateral flow test using such a lateral flow device. Optional features and details of certain embodiments are set out in the accompanying dependent claims.

[0030] Thus, according to a first aspect of the present invention, there is provided a lateral flow device comprising a main body portion and a removable swab, wherein the swab comprises a stem having a proximal end and a distal end, with an absorbent head at the distal end, and the main body portion comprises:

[0031] an inlet region for receiving a swab prior to use and for receiving the swab during use during performance of a lateral flow test;

[0032] a fluid chamber containing a volume of extraction fluid (also referred to herein as "buffer");

[0033] an outlet conduit; and

[0034] lateral flow test strips;

[0035] wherein the fluid chamber is arranged to open, in use, upon forced insertion of the absorbent tip into the main body portion through the inlet region, to allow extraction fluid to process the absorbent tip (thereby mixing the extraction fluid with the fluid sample collected on the absorbent tip) and to allow the extraction fluid (with the fluid sample mixed therein) to enter the outlet conduit; and

[0036] The outlet conduit includes the proximal end of the lateral flow test strip or is connected to the proximal fluid of the lateral flow test strip, so that when in use, the extraction liquid (including the fluid sample) entering the outlet conduit can reach the proximal end of the lateral flow test strip and then flow along the lateral flow test strip to perform a lateral flow test.

[0037] Therefore, before use, main body and swab can be conveniently provided as single portable article.In addition, by including fluid chamber and lateral flow test strip, main body integrates all parts required for lateral flow test to the fluid sample collected by the absorption head of swab.Therefore, this device is fast and easy to use, and does not need to place the clean flat surface of this device thereon.In turn, this enables this equipment to be used away from the home of the user, including when the user stands, such as when queuing in airports, railway stations, theaters, cinemas, concert halls, conference halls, retail stores, religious worship places, sports venues, bars, nightclubs, dance halls or other such places.In addition, as a result of the mode of automatically conveying fluid in the device, the user does not need to carry out complicated processing steps by himself, and significantly reduces the risk of (fluid sample, extract, swab or other parts) contamination.

[0038] The fluid chamber may have a first rupturable seal at the proximal end of the fluid chamber and a second rupturable seal at the distal end of the fluid chamber; wherein, in use, the first seal of the fluid chamber is arranged to be penetrated and ruptured by the absorbent head of the swab when the swab portion is inserted into the main body portion; the second seal of the fluid chamber is arranged to be penetrated and ruptured by the absorbent head of the swab when the swab is further inserted into the main body portion; and the second seal of the fluid chamber is adjacent to the outlet conduit, so that when the second seal is ruptured in use, the extraction liquid can flow from the fluid chamber into the outlet conduit. Therefore, such a fluid chamber can be easily opened in use, simply by the user inserting the swab (preferably simply driving the swab completely back into the main body portion), thereby causing the first seal and the second seal to rupture.

[0039] Preferably, the inlet region, the fluid chamber and the outlet conduit are colinearly arranged within the body portion to allow the absorbent head of the swab to be inserted in a linear manner along the inlet region, through the fluid chamber and into the outlet conduit.

[0040] Advantageously, the inlet region and outlet conduit may be integrally formed within the body portion, and the fluid chamber may be formed as a substantially separate pre-filled component (substantially a cartridge) that is inserted into the body portion during manufacture. This facilitates manufacture of the lateral flow device, particularly in terms of introducing the extraction fluid into the device. This also enables sterility of the extraction fluid to be ensured, as it enables the fluid chamber to be pre-filled and sealed under carefully controlled sterile conditions.

[0041] Advantageously, in order to limit the extent to which the swab enters the main body portion when the swab is fully inserted (i.e. driven back) within the main body portion, the shaft may include a radial projection (e.g. a flange) and the entry region or fluid chamber may include a stop (or other detent) against which an adjacent radial projection of the swab abuts (or engages) when the swab is fully inserted into the main body portion in use.

[0042] Advantageously, the length of the swab from the protruding portion to the tip of the absorbent head may correspond to the distance along the main body portion from the stopper to a point along the outlet conduit. As a result, when the swab is fully inserted into the main body portion, the absorbent head will pass through the fluid chamber and enter the outlet conduit.

[0043] Preferably, the inlet region and fluid chamber are cylindrical, so that a swab (having a circular cross-section) can be inserted in any orientation about its axis.

[0044] Alternatively, the inner diameter of the fluid chamber may be smaller than the diameter of the absorbent tip, so that the absorbent tip is radially compressed when entering the fluid chamber, thereby facilitating the release of the fluid sample collected by the absorbent tip during use.

[0045] Preferably, the proximal end of the rod includes a handle head, through which the user can push the swab into the main body portion during use. The handle head may have a wider diameter than the entrance area, and the handle head has an underside that is shaped to abut the opening of the entrance area when the swab is fully inserted into the main body portion during use. In addition, the underside of the handle head may be shaped to plug the opening of the entrance area when the swab is fully inserted into the main body portion during use.

[0046] Preferably, the rod and / or the inlet region include sealing means for forming a seal between the rod and the inlet region when the absorbent head is inserted into the main body portion (particularly into or beyond the fluid chamber) in use. For example, the sealing means may include one or more fins formed on the rod.

[0047] In a currently preferred embodiment, the body portion further comprises a housing in which at least a majority of the lateral flow test strip is contained. The housing may have one or more openings through which one or more indicator regions of the lateral flow test strip may be viewed.

[0048] Preferably, the housing is arranged relative to the rest of the body portion in a manner substantially similar to that of a pen clip relative to the rest of a pen. That is, the housing (and the test strip therein) is folded back over the rest of the body portion, making the entire device more compact and also enabling the entire device to be clipped into a pocket before or after use. In fact, the dimensions of the device may also be substantially similar to a typical pen.

[0049] Preferably, the device also includes a removable sheath that surrounds at least the absorbent head of the swab before use, thereby keeping the absorbent head clean and sterile before use. The sheath may include a barrier film packaging material, but in alternative embodiments, the sheath may be substantially rigid. The rod of the swab may include one or more ridges or fins (preferably multiple ridges or fins), around which the proximal end of the sheath may engage before use. The proximal end of the sheath may be formed as a collar around one or more protrusions, ridges or fins.

[0050] Advantageously, the proximal end of the sheath may be provided with tabs and / or perforations through which the sheath may be torn to enable it to be easily removed from the swab prior to use. The one or more projections, ridges or fins around which the collar is formed may also serve as sealing means for forming a seal between the shaft and the inlet region when the absorbent head is inserted into the main body portion in use.

[0051] Preferably, the diameter of the collar is greater than the diameter of the inlet region to retain the sheath relative to the inlet region prior to use, and the length of the sheath from the underside of the collar to the distal end of the sheath is less than the length of the main body from the opening of the inlet region to the fluid chamber to retain the swab away from the fluid chamber prior to use.

[0052] Preferably, the swab and / or the inlet region comprises a clamping means for releasably clamping the swab in the inlet region prior to use.For example, the clamping means may comprise one or more ridges or fins (preferably a plurality of ridges or fins) formed on the shaft.

[0053] According to a second aspect of the present invention, there is provided a method for performing a lateral flow test using a lateral flow device according to the first aspect of the present invention, the method comprising:

[0054] Remove the swab from the entry area of ​​the main body;

[0055] collecting a fluid sample using an absorbent tip; and

[0056] The absorbent tip is forcibly inserted into the main body portion, thereby opening the fluid chamber, and the extraction liquid of the absorbent tip and the extraction liquid containing the fluid sample enter the outlet conduit, reach the proximal end of the lateral flow test strip, and then flow along the lateral flow test strip to perform a lateral flow test.

[0057] When using the fluid chamber as described above, there is a first rupturable seal at the proximal end of the fluid chamber and a second rupturable seal at the distal end of the fluid chamber. When the swab portion is inserted into the main body portion, the first seal of the fluid chamber is penetrated and ruptured by the absorbent head of the swab; and when the swab is further inserted into the main body portion, the second seal of the fluid chamber is penetrated and ruptured by the absorbent head of the swab.

[0058] Where the swab is initially sheathed, the method further comprises removing the sheath from the swab after the swab is removed from the access region of the body portion and before collecting the fluid sample with the absorbent tip.

[0059] BRIEF DESCRIPTION OF THE DRAWINGS

[0060] Embodiments of the present invention will now be described, by way of example only, and with reference to the accompanying drawings, in which:

[0061] Figure 1 is a partial cross-sectional view of a lateral flow device prior to use, the lateral flow device comprising a removable swab and a body portion having an integral lateral flow test strip, the swab being sheathed and releasably retained within an inlet region of the body portion prior to use;

[0062] Figure 2 and Figure 3 yes Figure 1 A perspective view of a lateral flow device prior to use;

[0063] Figure 4 , Figure 5 and Figure 6 They are Figure 1 A side view, a top view, and a bottom view of a lateral flow device before use;

[0064] Figure 7 and Figure 8 yes Figure 1 An end view of a lateral flow device prior to use;

[0065] Fig. 9 When in use Figure 1 A partial cross-sectional view of a lateral flow device of claim 1, wherein the swab has been removed from the sheath and partially inserted into the body portion after collecting a fluid sample;

[0066] Fig.10 When in use Figure 1 A partial cross-sectional view of a lateral flow device, Fig. 9 A later time period depicted in FIG. 1 , wherein the swab has been fully inserted into the body portion;

[0067] Fig.11 yes Figure 1 of (and corresponding to) a cross-sectional view of a lateral flow device prior to use;

[0068] Fig.12 When in use Fig.10 of (and corresponding to) a cross-sectional view of a lateral flow device; and

[0069] Fig.13 and Fig.14 They are Fig.10 and Fig.12 Perspective and side views of a lateral flow device in use.

[0070] In the drawings, like elements are always denoted by like reference numerals.

[0071] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0072] The embodiments of the present invention represent the best ways known to the applicant to put the invention into practice. However, they are not the only ways in which this can be accomplished.

[0073] Preliminary Overview

[0074] First reference Figure 1 , the present disclosure provides a lateral flow device 10, which includes a body portion 30 and a removable swab 20. Briefly go to Fig. 9 and Fig.10 (Since swab 20 is Figure 1 The swab 20 is partially covered by a sheath 50 in the swab 20, thereby hiding some features of the swab 20, and the swab 20 includes a rod 21, 25 having a proximal end and a distal end. An absorbent head 26 is disposed at the distal end of the swab 20 and is suitable for collecting a fluid sample (e.g., nasal and / or oral fluid from the user's nasal passages and / or the back of their throat, wherein the fluid sample may contain a target substance, such as a specific antigen, if present).

[0075] exist Figure 1 In the illustrated embodiment, the lateral flow device 10 is preferably provided to the user with the swab 20 partially inserted into the inlet region 34 of the body portion 30 , wherein the swab 20 is partially covered by the removable sheath 50 .

[0076] Alternatively, the swab 20 may in principle be provided separately from the body portion 30, although providing the swab 20 partially inserted into the body portion 30 provides the advantage of conveniently providing the user with a single integral device 10, including the body portion 30 and the swab 20, ready for use when required.

[0077] like Figure 1 As shown, the lateral flow device 10 is preferably provided to the user, wherein at least the absorbent head 26 of the swab 20 is covered by a removable sheath 50 to keep the absorbent head 26 sterile and clean before use. Just before the user uses the swab 20 to collect a fluid sample using the absorbent head 26, the user removes the sheath 50.

[0078] Meanwhile, the main body portion 30 integrates all components required for performing a lateral flow test on the fluid sample collected by the absorbent head 26 of the swab 20 , including a certain amount of extraction fluid 39 and a lateral flow test strip 40 .

[0079] In more detail, the main body 30 includes four main parts in sequence, namely:

[0080] an inlet region 34 (having an opening 32) for accommodating a swab 20 prior to use and for receiving a swab 20 during use for performing a lateral flow test;

[0081] A fluid chamber 36 , which is pre-filled with a certain amount of extraction fluid (also called “buffer”) 39 during manufacture;

[0082] an outlet conduit 38; and

[0083] Lateral flow test strip 40.

[0084] The entire device 10 preferably has an overall slender and compact configuration, generally similar to that of a pen, so that a user can conveniently carry the device 10 about their body (e.g., in a jacket or coat pocket or handbag, etc.). Therefore, the entire device 10 is well suited for on-site testing by users away from home, for example, while waiting in line at an airport, train station, theater, cinema, concert hall, conference hall, retail store, place of religious worship, sports venue, bar, nightclub, dance hall, or other location where many other people may be present, and if the user is infected with a virus (such as SARS-CoV-2), there is a risk of transmitting the virus to others in the location (which may be many other people).

[0085] In a general sense, and as Fig. 9 , Fig.10 and Fig.12 As shown in the example in FIG. 1 , the fluid chamber 36 is arranged to open when the absorbent tip 26 of the swab 20 is forcibly inserted into the main body portion 30 through the inlet region 34 during the test to allow the extraction fluid 39 to process the absorbent tip 26. This has the effect of transferring the fluid sample collected by the absorbent tip 26 (including the target substance, such as antigen, if present) into the extraction fluid 39.

[0086] like Fig.10 and Fig.12 As shown, the extraction fluid 39 (including the target substance, if present) also enters the outlet conduit 38. The outlet conduit 38 includes the proximal end of the lateral flow test strip 40 or is in fluid communication with the proximal end of the lateral flow test strip 40, so that in use, the extraction fluid 39 entering the outlet conduit 38 can reach the proximal end of the test strip 40 and then flow along the test strip 40 to perform a lateral flow test.

[0087] In the illustrated embodiment, the fluid chamber 36 is initially manufactured as a separate component, essentially in the form of a cartridge prefilled with an extraction liquid 39. The prefilled fluid chamber 36 is then inserted into the main body portion 30 during manufacture. The fluid chamber 36, which is rectangular in cross section, has a tubular sidewall, a first breakable seal 37a at one end (the proximal end when installed in the main body portion) and a second breakable seal 37b at the other end (the distal end when installed in the main body portion). The sidewalls of the fluid chamber 36 can be made of any suitable plastic material, such as polypropylene. The first seal 37a and the second seal 37b can be made of, for example, a metallized polymer film (e.g., metallized polypropylene or metallized polyethylene terephthalate). For example, aluminum can be used to metallize these films. The extraction liquid 39 is contained between the first seal 37a and the second seal 37b. Preferably, the fluid chamber 36 is substantially filled with the extraction liquid 39. The volume of the extraction liquid can be about 1mL (1cm 3 ).

[0088] like Fig. 9 , 10 As shown in Figure 12, for this cylindrical fluid chamber 36, when in use, the first seal 37a and the second seal 37b are broken by the absorbent head 26, and the swab 20 is quickly and forcibly inserted into the main body 30 to the maximum extent allowed by the structure of the device, in other words, by pushing the swab 20 completely back into the main body 30, so as to achieve the above-mentioned opening of the fluid chamber. The forced insertion of the swab 20 is preferably performed as a single uninterrupted unidirectional insertion action, usually within one or two seconds, so that the swab 20 is driven or impacted into the main body 30.

[0089] More specifically, as the swab 20 is gradually inserted into the main body portion 30, the absorbent head 26 is first forced into the fluid chamber 36, penetrating the first seal 37a (and thus Fig. 9 The tip of the absorbent head 26 is then forced out of the opposite end of the fluid chamber 36, penetrating the second seal 37b (and thus Fig.10 The numerals 37b) are shown using a through line.

[0090] In other words, when the swab 20 is partially inserted into the main body portion 30, the first seal 37a of the fluid chamber 36 is broken or burst by the absorbent head 26, and then when the swab 20 is further inserted into the main body portion 30 (i.e., when the swab 20 is fully pushed back into place), the second seal 37b of the fluid chamber 36 is broken or burst by the absorbent head 26.

[0091] In the present embodiment, the rupture of the first seal 37a and the second seal 37b of the fluid chamber 36 is due to the absorbent head 26 sequentially contacting each of the seals 37a, 37b and exerting pressure on each of the seals 37a, 37b due to the gradual advancement of the swab 20. However, in alternative embodiments, the rupture of the second seal 37b may occur due to the accumulation of pressure in the extraction fluid 39 before the absorbent head 26 actually reaches the second seal 37b.

[0092] The second seal 37b of the fluid chamber 36 is adjacent to the outlet conduit 38 so that when the second seal 37b is ruptured in use, the extraction fluid 39 (including the collected fluid sample) can flow from the fluid chamber 36 into the outlet conduit 38 and thence to the integrated lateral flow test strip 40.

[0093] As shown, the inlet region 34 , fluid chamber 36 , and outlet conduit 38 are preferably co-linearly arranged within the body portion 30 to allow the absorbent head 26 of the swab 20 to be inserted in a linear manner along the inlet region 34 , through the fluid chamber 36 , and into the outlet conduit 38 .

[0094] However, it should be noted that the above use of a cylindrical fluid chamber 36 having a rupturable first seal 37a and a second seal 37b at each end is only one way in which the fluid chamber can be arranged to open when the swab 20 is inserted into the main body portion 30. Alternative configurations are also possible, by which the insertion of the swab 20 into the main body portion 30 will cause the fluid chamber to open, thereby treating the absorbent head 26 with the extraction liquid from the fluid chamber. For example, a mechanical arrangement can be provided whereby the insertion of the swab 20 into the main body portion 30 causes the flap on the fluid chamber to open, thereby releasing the extraction liquid therein. Such flaps can be pushed open directly by the inserted swab 20, or can be opened, for example, by a lever device actuated by the swab 20 when the main body portion 30 is inserted. In another example, the fluid chamber can take the form of a rupturable capsule filled with an extraction liquid, which, for example, ruptures when the swab 20 is inserted.

[0095] It should also be noted that while the illustrated embodiment uses a fluid chamber 36 that is arranged to be open at both ends (by rupturing the first seal 37a and then the second seal 37b as the swab 20 is gradually inserted into the body portion 30 and the absorbent tip 26 passes through the fluid chamber 36), in an alternative arrangement, a single opening may be provided through which the extraction fluid within the fluid chamber is released as the swab 20 is inserted into the body portion 30. To allow the extraction fluid to be processed, the absorbent tip 26 of the swab 20 is disposed, and the extraction fluid (containing the collected fluid sample) is allowed to enter the outlet conduit 38, thereby reaching the integrated lateral flow test strip 40.

[0096] More details about Swab 20

[0097] As mentioned above, and for example Fig. 9 and Fig.10 As shown, the swab 20 includes a rod 21, 25 having a proximal end and a distal end. The rods 21, 25 are preferably cylindrical / rod-shaped, i.e., circular in cross-section, so that they can be used (and inserted into the main body 30) in any direction around their axis. An absorbent head 26 is provided at the distal end of the swab 20 (i.e., the region 25 attached to the rod), which is suitable for collecting fluid samples (e.g., nasal and / or oral fluids, from the user's nasal passages and / or the back of their throat) when in use. In addition, in the illustrated embodiment, a handle head 24 is provided at the proximal end of the swab 20 (i.e., the region 21 attached to the rod), through which the user can force the swab 20 into the main body 30 for lateral flow testing.

[0098] The absorbent head 26 may be made of any suitable material, such as foam or cotton. Fig.11 and 12 As shown, in the embodiment shown, the rods 21, 25 are hollow and the absorbent head 26 is mounted around a core 25' which is a continuation of the smaller diameter of the region 25 of the rod. This core 25' reinforces the absorbent head 26, providing it with a degree of rigidity, which in turn facilitates penetration of the first seal 37a and the second seal 37b during testing. However, in alternative embodiments, the absorbent head 26 can be formed without a reinforcing core 25'.

[0099] The stems 21, 25 (and core 25') are preferably made of a plastic material (e.g., by injection molding) and may include a recess 22 (in region 21 of the stem) that serves as a finger grip to facilitate manipulation of the swab 20 when collecting a fluid sample. The handle head 24 may be integrally formed with the rest of the stems 21, 25.

[0100] like Figure 1 and 11 As shown, during the manufacturing process, the swab 20 is equipped with a removable sheath 50 that surrounds at least the absorbent head 26 of the swab 20 to keep the absorbent head 26 clean and sterile before use. In the embodiment shown, the sheath 50 comprises a barrier film packaging material. In order to fix the film packaging sheath 50, the stem 21 of the swab 20 includes one or more ridges or annular fins 27 or other protrusions, around which the proximal end of the sheath 50 engages before use. In the embodiment shown, a plurality (a first group) of such fins 27 are provided. In practice, the proximal end of the film packaging sheath 50 is formed as a collar 52 around the fins 27 (or ridges or other protrusions).

[0101] The diameter of the collar 52 of the sheath 50 is greater than the diameter of the opening 32 of the inlet region 34, so that the sheath 50 is accommodated relative to the inlet region 34 before use (retained outside the opening 32 of the inlet region 34 by the collar 52). In addition, the length of the sheath 50 from the underside of the collar 52 to the distal end of the sheath 50 is less than the length of the main body portion 30 from the opening 32 of the inlet region 34 to the first seal 37a of the fluid chamber 36. Therefore, when the sheath 50 is in place, the swab 20 is kept away from the first seal 37a and there is no risk of rupturing it.

[0102] refer to Fig. 9 , 10 , 11 and 12, when the absorbent head 26 is inserted into the fluid chamber 36 during testing, one or more ridges or fins 27 (or other protrusions) forming the collar 52 around it can also be used as a sealing device for forming a seal between the rods 21, 25 and the inlet area 34. In use, the seal created by the ridges or fins 27 (or the like) ensures that once the first seal 37a is broken, the extraction liquid 39 will not leak. In addition, when the first seal 37a is broken and the swab 20 is pushed further into the main body portion 30, the ridges or fins 27 (or the like) can also be advantageously used as a pressure relief valve.

[0103] Special References Fig.11 The swab 20 and / or the inlet area 34 may also include a clamping device for releasably clamping (i.e., temporarily holding) the sheathed swab 20 within the inlet area 34, for example at the opening 32 of the inlet area 34, prior to use. With the aid of such clamping components, the swab 20 and the main body 30 are held together as a single article 10 until the user is ready to remove the swab 20 to begin a lateral flow test. As shown, the clamping device may include one or more ridges or annular fins 28 formed on the rods 21, 25. Preferably, the one or more ridges or fins 28 are molded as an integral part of the rods 21, 25. In the illustrated embodiment, a plurality of ridges or fins 28 are provided and may be considered to be a second group (in addition to the first group 27 described above). As shown in the figure Fig.11 As shown, these ridges or fins 28 provide a light friction fit between themselves and the opening 32 of the inlet region 34, for example, due to a small amount of elastic deformation of the ridges or fins 28. Fig.11As shown, this clamping effect still occurs despite the presence of the membrane sheath 50 around the ridges or fins 28. In fact, the presence of the sheath 50 can assist the clamping effect. Conversely, when the sheath 50 is subsequently removed in use, the clamping effect caused by the ridges or fins 28 alone can be reduced, allowing the swab 20 to be more easily inserted into the main body portion 30 when performing a lateral flow test. In use, the ridges or fins 28 can also serve as an additional sealing device for forming a seal between the rods 21, 25 and the inlet area 34 when the absorbent head 26 is inserted into the fluid chamber 36 during the test.

[0104] To prepare for use of the device 10 , the user first removes the sheathed swab 20 from the body portion 30 (overcoming the aforementioned gripping effect provided by the ridges or fins 28 ), and then removes the sheath 50 from the swab 20 to expose the absorbent tip 26 .

[0105] In the illustrated embodiment, a tab 54 and a series of perforations 56 are provided through the proximal end (loop 52) of the sheath 50 to facilitate removal of the film-wrapped sheath 50 from the swab 20, for example, as Figure 1 By pulling the tab 54 and rupturing the membrane between the perforations 56, the sheath 50 can be easily torn off the swab 20 and subsequently discarded.

[0106] Once unsheathed, the swab 20 can be used to collect a fluid sample at the absorbent tip 26, with the user holding the swab 20 by the stem 21 (with the aid of the recessed / finger grip 22) and naturally being careful not to contaminate the absorbent tip 26 during the collection process.

[0107] For example Fig. 9 As shown, in the illustrated embodiment, the swab 20 also includes a flange 29 (or other radial projection) on the stem 25 .

[0108] Preferably, the flange 29 is molded as an integral part of the stem 25. The position of the flange 29 defines the extent to which the swab 20 enters the body portion 30 when the swab 20 is fully inserted (i.e., driven back) because the flange 29 abuts a stop 33 provided in the body portion 30, such as Fig.10 and 12 A stop mechanism may also be provided, potentially producing an audible click when the swab 20 is fully driven into the body portion 30 .

[0109] from Fig.10 and Fig.12 It will also be appreciated that the length of the swab 20 from the flange 29 (or other radial projection) to the tip of the absorbent head 26 corresponds to the distance along the main body portion 30 from the stop 33 to a point along the outlet conduit 38 (i.e. beyond the second seal 37b).

[0110] Thus, the second seal 37b (as well as the first seal 37a)) is broken when the swab 20 is fully inserted into the body portion 30. Upon breaking the second seal 37b, any pressure accumulated in the fluid chamber 36 (due to the gradual advancement of the swab 20) is released, and the extraction fluid 39 (containing the collected fluid sample) is forced into the outlet conduit 38, from which the extraction fluid 39 will then reach the proximal end of the lateral flow test strip 40 and then travel along the test strip 40.

[0111] In view of the above, when the absorbent head 26 of the swab 20 is advanced through the double-ended cylindrical fluid chamber 36, the present device can be considered to employ the "positive pressure displacement" principle.

[0112] For example Figure 1 As shown, the handle head 24 may be provided with a dome-shaped end 23 and may be slightly enlarged relative to the rest of the swab 20. This facilitates the user's action of forcibly (but still comfortably) pushing the swab 20 into the body portion 10 during use.

[0113] It should also be noted that in the illustrated embodiment, the handle head 24 has a wider diameter than the opening 32 of the entry region 34. Fig.10 and Fig.12 As best shown in the figure, the handle head 24 has a lower side 24a and a portion 24b, the lower side 24a being shaped to abut the opening 32 of the entrance area 34 when the swab 20 is fully inserted into the body portion in use, and the portion 24b being shaped to plug the opening 32 of the entrance area 34. To this end, in the illustrated embodiment, the shape of the lower side 24a of the handle head 24 is substantially stepped so that it can directly abut the open end of the entrance area 34. The portion 24b is tapered to guide the handle head 24 to be centrally (coaxially) aligned with the opening 32 of the entrance area 34 and plug the opening 32.

[0114] Thus, in the illustrated embodiment, when the swab 20 is fully inserted into the body portion 30 (i.e., pushed back into place), two abutments occur simultaneously - the flange 29 abuts against the stop 33, and the underside 24a of the handle head 24 abuts against the opening 32 of the entry region 34. Fig.10 and 12 As shown, when the swab 20 is fully inserted into the main body portion 30, this causes the entire device 10 to adopt a well-defined configuration in a well-controlled manner, wherein the range of longitudinal travel of the swab 20 relative to the main body portion 30 is precisely limited, and the swab 20 is concentrically (coaxially) aligned within the main body portion 30.

[0115] In addition, from Fig.10 and Fig.12It can be seen that when the swab 20 is fully inserted into the main body portion 30, the absorbent head 26 has passed through the first seal 37a and the second seal 37b of the fluid chamber 36, with some of the absorbent head 26 remaining in the fluid chamber 36, and the distal tip of the absorbent head 26 enters the outlet region 38. In this configuration, the extraction liquid 39 from the fluid chamber 36 mixes with the fluid sample collected by the absorbent head 26, enters the outlet region 38, and thus reaches the proximal end of the lateral flow test strip 40, which is in the outlet region 38 (or is in fluid communication with the outlet region 38). The lateral flow test is then performed by the extraction liquid 39 (containing the collected fluid sample) flowing along the capillary of the test strip 40.

[0116] More details about the main part 30

[0117] As mentioned above, the main body portion 30 includes four main parts in sequence, namely:

[0118] an inlet region 34 (having an opening 32) for accommodating a swab 20 prior to use, and for receiving a swab 20 when in use during the performance of a lateral flow test;

[0119] A fluid chamber 36 , which is pre-filled with a certain amount of extraction fluid (also called “buffer”) 39 during manufacture;

[0120] an outlet conduit 38; and

[0121] Lateral flow test strip 40.

[0122] In the embodiment shown, the inlet area 34 and the fluid chamber 36 are cylindrical (i.e., have a circular inner cross section), and are coaxially aligned with each other to allow the swab 20 (which has a circular cross section) to be inserted in any direction around its axis. The shape of the outlet conduit 38 can also be roughly cylindrical. In use, when the first seal 37a and the second seal 37b of the fluid chamber 36 are broken, the inlet area 34, the fluid chamber 36 and the outlet conduit 38 coaxially form a continuous tubular channel through which the swab 20 passes. It should be understood that the continuous tubular channel may not have a constant inner diameter. In particular, as shown in the figure, the fluid chamber 36 can have an inner diameter smaller than the inlet area 34 and the outlet conduit 38, mainly because the fluid chamber 36 is formed as a pre-filled component for initial separation.

[0123] In alternative embodiments, at least a portion of the swab 20 and the interior cross-section of the inlet region 34 and / or the fluid chamber 36 may have a non-circular shape, such as a square or rectangular shape.

[0124] As mentioned above, the swab 20 may be provided with sealing means, such as ridges or fins 27, 28. Alternatively or additionally, sealing means, such as one or more O-rings, may be provided along the inlet region 34 and / or the fluid chamber 36 (particularly along the inlet region 34) to provide further sealing between the stem 21 and the inner wall of the inlet region 34, or possibly between the shaft 25 and the inner wall of the fluid chamber 36.

[0125] Furthermore, in the illustrated embodiment, the inlet region 34 (with the stopper 33) and the outlet conduit 38 are integrally molded within the body portion 30, sharing a common outer wall 31, whereas, as described above, the fluid chamber 36 is formed as an initially separate pre-filled component that is inserted into the body portion 30 in the manner of a cartridge during the manufacturing process. Fig.11 As shown, suitable moldings may be provided in the wall 31 of the body portion 30 to secure the fluid chamber 36 in place, for example, to retain the fluid chamber 36 in a press-fit manner. The wall of the fluid chamber 36 may also include annular fins 36a, 36b, by means of which the fluid chamber 36 may be coaxially clamped within the wall 31 of the body portion 30. Thus, as shown, the inner diameter of the fluid chamber 36 may be smaller than the inner diameter of the inlet region 34 and the outlet conduit 38 or the common outer wall 41.

[0126] like Fig. 9 As shown, the inner diameter of the fluid chamber 36 can be smaller than the diameter of the absorber head 26, so that the absorber head 26 is radially compressed when entering the fluid chamber 36. This radial compression of the absorber head 26 helps release the collected fluid sample from the absorber head 26, and the mixing of the fluid sample in the fluid chamber 36 (and released from the fluid chamber 36) with the extraction liquid 39.

[0127] The outlet conduit 38 includes the proximal end of the lateral flow test strip 40 or is connected to the proximal fluid of the lateral flow test strip 40, so that when in use, the extraction liquid 39 (including the collected fluid sample) entering the outlet conduit 38 can reach the proximal end of the test strip 40 and then flow along the test strip 40 to perform a lateral flow test.

[0128] The body portion 30 also includes a housing 42 in which at least a majority of the lateral flow test strip 40 is contained. In other words, all of the test strip 40 may be contained within the housing 42; or substantially all of the test strip 40 may be contained within the housing 42, except for a proximal portion within (or exposed to) the outlet conduit 38. The housing 42 has one or more openings 44 through which one or more indicator regions of the lateral flow test strip 40 may be viewed.

[0129] In terms of structure, Fig.11 and 12As shown, the housing 42 can be formed into a first portion 42a and a second portion 42b opposite each other, and the test strip 40 is mounted between the first portion 42a and the second portion 42b. In the embodiment shown, the housing 42 is connected to the rest of the body portion 30 by means of the end portion 41 and the bridge portion 42'. The end portion 41 also serves as the end wall of the outlet conduit 38.

[0130] In design, the housing 42 is arranged relative to the rest of the body portion 30 in a manner similar to a pen clip (e.g., a pen clip) relative to the rest of a pen. That is, the housing 42 (and the test strip 40 therein) is folded back on the rest of the body portion 30, making the entire device 10 more compact and also enabling the entire device 10 to be clipped into a user's pocket (e.g., a jacket or coat pocket) before or after use.

[0131] The device is also roughly similar in size to a typical pen. Figure 1 In the configuration shown, the length of the entire device may be about 100 mm to 150 mm, and may preferably be about 120 mm in length. The outer diameter of the main body portion may be about 10 mm to 15 mm, and may preferably be about 12 mm.

[0132] The lateral flow test strip 40 may have any suitable composition taking into account the target substance being detected. For example, it may have a composition as outlined in the "Background Technology" section above. The indicator area of ​​the test strip 40 visible through the opening 44 may include a first indicator area in which a positive test line is generated if the target substance (e.g., target antigen) is present in the extract, and generally further along the test strip, a second indicator area is included in which a control line is generated to confirm that the extract has properly flowed along the test strip 40.

[0133] A QR code 46 or other test identification device and / or instructional or explanatory text or images (eg, regarding the meaning of the test lines) may also be provided on the housing 42 or elsewhere on the main body portion 32 .

[0134] How to use

[0135] To perform a lateral flow test, the method performed by the user simply involves:

[0136] Remove the sheathed swab 20 from the main body portion 30;

[0137] Removing the sheath 50 from the swab 20, such as by pulling the tab 54 and tearing the sheath 50 using the perforations 56 to expose the absorbent tip 26;

[0138] Collecting a fluid sample (e.g., oral or nasal fluid) using an absorbent tip 26;

[0139] The absorbent head 26 is then forcibly inserted into the main body portion 30 (e.g., via Fig. 9 The structure shown, enter Fig.10 and Fig.12 The structure shown in the figure) allows the fluid chamber 36 to be opened, the extraction liquid 39 processes the absorption head 26, and the extraction liquid 39 contains the collected fluid sample to enter the outlet conduit 38, reach the proximal end of the lateral flow test strip 40, and then flow along the test strip 40 (through capillary flow) to perform the lateral flow test. Then, after a given period of time, the test result is displayed by means of one or more indicator areas in the opening 44 on the housing 42.

[0140] More specifically, when the above-mentioned fluid chamber 36 having a first rupturable seal 37a at the proximal end of the fluid chamber 36 and a second rupturable seal 37b at the distal end of the fluid chamber is used, the first seal 37a is penetrated and ruptured by the absorbent head 26 when the swab 20 is partially inserted into the main body portion 30; and the second seal 37b is penetrated and ruptured by the absorbent head 26 when the swab 20 is further (i.e., completely) inserted into the main body portion 30.

[0141] After the lateral flow test is performed, when the device 10 is in the Fig.10 and Fig.12 (as well as Fig.13 and Fig.14 ), the device 10 is self-sealing by means of the sealing means 27, 28 and the plug portion 24b of the handle head 24 described above. This prevents leakage of the extraction solution 29 and enables the device 10 to be returned to a pocket or the like once the test has been performed. This also prevents the device 10 from drying out over time, as the solution 29 is well contained within the device 10.

[0142] It will be appreciated that once a lateral flow test is performed, the test result remains visible in the indicator region of the test strip 40 within the opening 44. Thus, if the test result is negative, the user will be able to easily display the completed test device 10 to others to provide evidence of the user's negative status.

[0143] Advantages Overview

[0144] Compared to conventional lateral flow devices as outlined in the “Background of the Invention” section above, the present lateral flow device 10 provides the following advantages:

[0145] - The device 10 is a single item (e.g. Figure 1 ) provides the user with a single item that is compact to store, convenient to carry by one person, and quick and easy to use;

[0146] - the user does not need to unfold multiple separate items before use, which helps make the device 10 quick and easy to use (e.g., for people with poor manual dexterity) and significantly reduces packaging waste (because only the sheath 50 needs to be removed before use);

[0147] - there is no need to prepare a clean flat surface on which to place the device 10 for use - rather it can be used essentially anywhere, including when the user is standing, e.g. away from home;

[0148] - the user does not need to transfer the extraction liquid from a separate container to the device 10, thereby eliminating any risk of spilling the solution and significantly reducing the risk of contamination;

[0149] - very quick and easy transfer of the collected fluid sample from the swab 20 to the extraction fluid 39 by the user (simply by inserting the swab 20 into the body portion 30), thereby eliminating any need to manually squeeze the absorbent tip 26 of the swab 20 and again significantly reducing the risk of contamination; and

[0150] - The user does not need to manually transfer a specific amount (ie a specific number of droplets) of solution to the lateral flow test strip, further facilitating the process and again significantly reducing the risk of contamination.

[0151] Modifications and Alternatives

[0152] Detailed embodiments and some possible alternatives have been described above. As will be appreciated by those skilled in the art, various modifications and further alternatives may be made to the above embodiments while still benefiting from the inventions embodied therein. Therefore, it should be understood that the present invention is not limited to the described embodiments and includes modifications apparent to those skilled in the art within the scope of the appended claims.

[0153] For example, in the illustrated embodiment, the removable sheath 50 comprises a barrier film packaging material. However, in alternative embodiments, the removable sheath may be a substantially rigid covering (e.g., made of any suitable plastic material) that surrounds at least the absorbent head 26 of the swab 20 prior to use. A rigid sheath of this nature may include a collar (similar to the collar 52 described above) to removably secure the sheath to the swab 20 and retain the sheath relative to the inlet region 34 of the body portion 30. Similar to the above-described embodiments, the length of such a sheath will be such as to retain the swab 20 away from the fluid chamber 36 prior to use.

Claims

1. A lateral flow device comprising a main body portion and a removable swab, wherein the swab comprises a stem having a proximal end and a distal end, having an absorbent head at the distal end, and the main body portion comprises: an inlet region for receiving a swab prior to use and for receiving the swab during use during performance of a lateral flow test; a fluid chamber containing a volume of extraction fluid; outlet conduit; and lateral flow test strips; wherein the fluid chamber is arranged to open, in use, when the absorbent head is forcibly inserted into the main body portion through the inlet region, so that the extraction liquid processes the absorbent head and enters the outlet conduit; and The outlet conduit includes the proximal end of the lateral flow test strip or is connected to the proximal fluid of the lateral flow test strip, so that when in use, the extraction liquid entering the outlet conduit can reach the proximal end of the lateral flow test strip and then flow along the lateral flow test strip to perform a lateral flow test.

2. The lateral flow device of claim 1 , wherein the fluid chamber has a first rupturable seal at a proximal end of the fluid chamber and a second rupturable seal at a distal end of the fluid chamber; in, In use, the first seal of the fluid chamber is arranged to be penetrated and broken by the absorbent head of the swab when the swab portion is inserted into the body portion; The second seal of the fluid chamber is arranged to be penetrated and ruptured by the absorbent head of the swab as the swab is further inserted into the body site; and The second seal of the fluid chamber is adjacent to the outlet conduit such that when the second seal is ruptured in use, extraction fluid can flow from the fluid chamber into the outlet conduit.

3. The lateral flow device according to claim 2, wherein The inlet region, the fluid chamber and the outlet conduit are arranged collinearly within the body portion.

4. A lateral flow device according to claim 2 or claim 3, wherein the inlet region and outlet conduit are integrally formed within the body portion and the fluid chamber is formed as an initially separate pre-filled component inserted into the body portion during manufacture.

5. A lateral flow device according to any one of claims 2 to 4, wherein the stem comprises a radial projection and the inlet region or fluid chamber comprises a stop against which the adjacent radial projection of the swab abuts when the swab is fully inserted into the body portion in use.

6. A lateral flow device according to claim 5, wherein the length of the swab from the protruding portion to the tip of the absorbent head corresponds to the distance along the body portion from the stopper to a point along the outlet conduit.

7. A lateral flow device according to any preceding claim, wherein the inlet region is cylindrical.

8. A lateral flow device according to any preceding claim, wherein the fluid chamber is cylindrical.

9. The lateral flow device according to claim 8, wherein the inner diameter of the fluid chamber is smaller than the diameter of the absorbent head.

10. A lateral flow device according to any preceding claim, wherein the proximal end of the stem comprises a handle head, through which a user can push the swab into the body portion in use.

11. A lateral flow device according to claim 10, wherein the handle head has a wider diameter than the inlet region, the handle head having an underside shaped to abut the opening of the inlet region when the swab is fully inserted into the body portion in use.

12. A lateral flow device according to claim 11, wherein the underside of the handle head is further shaped to plug the opening of the access area when the swab is fully inserted into the body portion in use.

13. A lateral flow device according to any preceding claim, wherein the stem and / or the inlet region comprises sealing means for forming a seal between the stem and the inlet region when the absorbent head is inserted into the main body portion in use.

14. A lateral flow device according to claim 13, wherein the sealing means comprises one or more fins formed on the rod.

15. A lateral flow device according to any preceding claim, wherein the body portion further comprises a housing, at least a majority of the lateral flow test strip being contained within the housing.

16. The lateral flow device of claim 15, wherein the housing has one or more openings through which the one or more indicator regions of the lateral flow test strip can be viewed.

17. A lateral flow device according to claim 15 or claim 16, wherein the housing is arranged relative to the remainder of the body portion substantially in the manner of a pen clip relative to the remainder of a pen.

18. A lateral flow device according to any preceding claim, further comprising a removable sheath surrounding at least the absorbent head of the swab prior to use.

19. The lateral flow device of claim 18, wherein the sheath comprises a film packaging material.

20. The lateral flow device of claim 18, wherein the sheath is substantially rigid.

21. A lateral flow device according to any one of claims 18 to 20, wherein the stem comprises one or more protrusions, ridges or fins, the proximal end of the sheath being engaged around the protrusions, ridges or fins prior to use.

22. The lateral flow device of claim 21, wherein the proximal end of the sheath is formed as a collar around one or more protrusions, ridges or fins.

23. A lateral flow device according to claim 21 or 22, wherein the proximal end of the sheath is provided with tabs and / or perforations through which the sheath can be torn to enable it to be separated from the swab prior to use.

24. A lateral flow device according to claim 22 or claim 23 when dependent on claim 22, wherein the one or more protrusions, ridges or fins formed around the collar also serve as sealing means for forming a seal between the stem and the inlet region when the absorbent head is inserted into the main body portion in use.

25. A lateral flow device according to claim 22 or claim 24 or claim 23 when dependent on claim 22, wherein the diameter of the collar is greater than the diameter of the inlet region, and the length of the sheath from the underside of the collar to the distal end of the sheath is less than the length of the main body from the opening of the inlet region to the fluid chamber.

26. A lateral flow device according to any preceding claim, wherein the swab and / or the inlet region comprises a retaining member for releasably retaining the swab in the inlet region prior to use.

27. The lateral flow device of claim 26, wherein the gripping member comprises one or more ridges or fins formed on the rod.

28. A method of performing a lateral flow test using a lateral flow device according to any preceding claim, the method comprising: Remove the swab from the entry area of ​​the main body; Collecting a fluid sample using an absorbent head; and The absorbent tip is forcibly inserted into the main body portion, thereby opening the fluid chamber, and the extraction liquid processes the absorbent tip and the extraction liquid containing the fluid sample enters the outlet conduit, reaches the proximal end of the lateral flow test strip, and then flows along the lateral flow test strip to perform a lateral flow test.

29. A method according to claim 28, when dependent on claim 2, wherein: When the swab portion is inserted into the main body portion, the first seal of the fluid chamber is penetrated and broken by the absorbent head of the swab; and As the swab is further inserted into the body portion, the second seal of the fluid chamber is penetrated and ruptured by the absorbent tip of the swab.

30. A method according to claim 28 or claim 29, when dependent on any one of claims 18 to 25, wherein After removing the swab from the access area of ​​the body portion and before collecting the fluid sample using the absorbent tip, the method further includes removing the sheath from the swab.

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