Lateral flow device

Abstract

A lateral flow device including a body portion and a removable swab, and a method of performing a lateral flow test using the same are provided. The swab includes a shaft having a proximal end and a distal end, and an absorbent head at the distal end. The body portion includes an inlet region for holding the swab before use and receiving the swab during use when performing a lateral flow test, a liquid chamber for containing a quantity of extraction solution, an outlet conduit, and a lateral flow assay strip. The liquid chamber opens when the absorbent head is forcibly inserted into the body portion through the inlet region during use, allowing the extraction solution to enter the outlet conduit while treating the absorbent head with the extraction solution. The outlet conduit includes or is in fluid communication with the proximal end of the lateral flow assay strip so that the extraction solution that has entered the outlet conduit during use reaches the proximal end of the assay strip and flows along the lateral flow assay strip from there to perform a lateral flow test.

Description

Technical Field

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

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

Background Art

[0003] Using a lateral flow device, a body fluid sample from a person (subject) can be examined to quickly indicate the presence (or absence) of a target substance in the sample. Test results are usually obtained within about a few minutes from the lateral flow device itself without the need for additional equipment or laboratory-based processing. The sample can be obtained by the user himself / herself (in the case of a "self-test") with the user as the subject, or from another person (e.g., by an adult for a child, or by a medical professional for a patient).

[0004] In particular, when examining oral fluid or nasal fluid for the presence of, for example, the SARS-CoV-2 virus, the lateral flow device is usually provided as part of a "rapid antigen" lateral flow test kit for determining the presence of, for example, the Covid-19 antigen. Such test kits typically include the following individual items. Withdrawal tube (usually incorporating a cap with a drip function), Container for the withdrawn solution (e.g., sachet or bottle), Swab (having an absorbent head at the end of the shaft), and The lateral flow device itself (usually including a lateral flow assay strip mounted in a plastic housing).

[0005] The swab is usually provided within its own sealed packaging material. Similarly, the lateral flow device is usually provided within its own sealed package to ensure that neither is contaminated before use. The extraction test tube can also be provided within its own separate package.

[0006] In use, the lateral flow device is removed from the package and placed on a clean flat surface to be in a usable state. The extraction tube is also removed from the package and placed on a clean surface or support (e.g., using a tube holder provided as part of the kit). The extraction solution (which may also be known as a "buffer") is transferred from the container to the extraction tube, but the user needs to take care not to spill the solution or contaminate the solution or the tube.

[0007] The swab is then removed from the packaging material, but the user needs to take care not to touch the absorbent head or contaminate it by other means. The swab is then used to collect a liquid sample from the subject, e.g., from the subject's nasal cavity and / or the back of the throat, using the absorbent head.

[0008] The absorbent head is then inserted into the extraction solution in the extraction tube, but the user needs to press the absorbent head against the wall of the extraction tube or compress it strongly to transfer the collected liquid sample containing the target substance (e.g., Covid-19 antigen), if present, into the extraction solution. The resulting solution containing the liquid sample can be referred to herein as the test solution. Care also needs to be taken not to contaminate the extraction solution or the resulting test solution during this process.

[0009] Next, a specific amount of the test solution (e.g., 2 or 3 drops) is transferred from the extraction tube to the inlet of the lateral flow device (e.g., by means of a drip cap if the extraction tube is equipped with one), taking care not to contaminate the test solution or the lateral flow device or lose the test solution during this process.

[0010] The test solution then moves from the inlet of the lateral flow device, by capillary flow along the assay strip, from the proximal end of the assay strip (which coincides with the aforementioned inlet) towards the distal end of the assay strip. As a result, if the target substance (e.g., the Covid-19 antigen) is present, a positive test line is generated in a first indicator region along the assay strip and, typically, a control line is also generated in a second indicator region along the assay strip, confirming that the test solution has flowed correctly along the assay strip.

[0011] More generally, the assay strip has a proximal end (for receiving the solution to be tested), a distal end (towards which the solution flows), and one or more indicator regions between the proximal and distal ends for determining the presence (or absence) of the target substance.

[0012] In practice, it will be appreciated by those skilled in the art that the composition of the assay strip will vary depending on the target substance detected in the test solution. The appropriate composition of the assay strip is well known to those skilled in the art and need not be described in detail herein. However, generally speaking, such an assay strip is designed to convey the test solution along the surface of a pad having reaction molecules that indicate a visual positive or negative result. The pad is based on a series of capillary beds such as several pieces of porous paper or polymers (e.g., microstructured polymers or sintered polymers) and can naturally transport the test solution. Typically, the assay strip sequentially includes a sample pad, a conjugate pad, and a wicking pad. The sample pad at the proximal end of the assay strip that coincides with the aforementioned inlet functions to absorb the test solution and retain excess test solution. From here, the test solution flows to the conjugate pad having a conjugate of a salt-sugar matrix. The conjugate usually contains lyophilized bioactive particles. The conjugate pad has the reagents necessary to produce a chemical reaction between the target substance (e.g., antigen) and the chemical partner of the target substance (e.g., antigen) immobilized on the particle surface. This marks the target particles when the target particles reach the test line and the control line in each indicator region through the pad. The test line gives a colored indication when the target substance is present. The control line contains an affinity ligand that indicates whether the test solution has passed through and whether the particles in the conjugate are active. After passing through these reaction zones, the test solution enters the wicking pad, which basically acts as a waste container.

[0013] It will be appreciated that with the use of conventional lateral flow devices of the type outlined above, there are a number of potential drawbacks or disadvantages, including the following. - Since the kit is composed of a number of separate items, it may be bulky to store and inconvenient for a person to carry around. - Since it is necessary to unpack the various separate items that make up the kit, it is difficult to handle (for example, for those with unskilled hands), time-consuming, and may generate a significant amount of packaging waste. - A clean flat surface is required to place the lateral flow device and the extraction tube. - It is necessary to carefully transfer the extraction solution from the container to the extraction tube without spilling the extraction solution and without contaminating either the extraction solution or the extraction tube. - It is necessary to transfer the collected liquid sample from the swab to the extraction solution (for example, by strongly compressing) without contaminating either the extraction solution or the resulting test solution. - It is necessary to transfer a specific amount (for example, a specific number of drops) of the test solution to the lateral flow device without contaminating either the test solution or the lateral flow device and without losing the test solution.

[0014] As a result of the above-mentioned drawbacks, conventional lateral flow tests cannot be easily performed away from a home (or similar) environment. In particular, conventional lateral flow tests cannot be easily performed when a user who is away from home is standing, for example, in a queue at an airport, a railway station, a theater, a cinema, a concert hall, a conference venue, a retail store, a place of worship, a sports venue, a bar, a nightclub, a dance hall, or any of many other venues where many other people may be present. In such venues, if the user is infected with a virus (such as SARS-CoV-2), there is a risk of spreading the virus to other people in the venue (who may be many others). In such venues, it will be recognized that it is desirable to be able to confirm whether a person is infected with such a virus by a on-site lateral flow test and, if infected, not to enter the venue. Conversely, if the people in the venue are confirmed not to be associated with such a virus, the risk of spreading or contracting the virus is low, thus enabling free and safe communication within the venue.

[0015] Furthermore, from the above, it will be recognized that conventional lateral flow tests are prone to contamination or other problems (such as loss of liquid) when the test is performed, which can affect the accuracy of the results. Also, since it is necessary to unpack various items that make up the test kit, it is difficult to handle and there is a risk of generating a large amount of waste.

[0016] Accordingly, there is a need for a lateral flow device that people can use to self-test for the presence (or absence) of a target substance such as the SARS-CoV-2 virus, overcomes one or more of the above demerits, and allows users, including those away from home, to more easily perform the test. SUMMARY OF THE INVENTION

[0017] According to a first aspect of the present invention, there is provided a lateral flow device as defined in claim 1 of the appended patent claims. Also provided is a method of performing a lateral flow test using such a lateral flow device. Optional features and details of specific embodiments are described in the appended dependent claims.

[0018] Accordingly, according to a first aspect of the present invention, there is provided a lateral flow device comprising a body portion and a detachable swab. The swab includes a shaft having a proximal end and a distal end, and an absorbent head at the distal end. The body portion has an inlet region for holding the swab before use and for receiving the swab during use when performing a lateral flow test, a liquid chamber containing an amount of extraction solution (also referred to herein as "buffer"), an outlet conduit, and a lateral flow assay strip, The liquid chamber is configured to open when the absorbent head is forced into the body through the inlet region during use, allowing the absorbent head to be treated with the extraction solution (thereby mixing the extraction solution with the liquid sample collected on the absorbent head), and to allow the extraction solution (with the liquid sample mixed therein) to enter the outlet conduit. The outlet conduit includes or is in fluid communication with the proximal end of the lateral flow assay strip, so that the extraction solution (containing the liquid sample) that enters the outlet conduit during use reaches the proximal end of the lateral flow assay strip and can flow along the lateral flow assay strip from there to perform a lateral flow test.

[0019] Accordingly, the body and the swab can be conveniently provided as a single portable item before use. Further, by including the liquid chamber and the lateral flow assay strip, the body integrally incorporates all the components necessary to perform a lateral flow test on the liquid sample collected by the absorbent head of the swab. As a result, the device can be used quickly and easily, and a clean flat surface for placing the device is not required. Also, this enables the device to be used in locations away from the user's home. This includes, for example, when the user is standing in a queue at an airport, a railway station, a theater, a cinema, a concert hall, a conference venue, a retail store, a place of worship, a sports venue, a bar, a nightclub, a dance hall, or other such venues. Further, as a result of the liquid being automatically transported within the device, the user does not need to perform complex processing steps himself / herself, and the risk of contamination (of the liquid sample, extraction solution, swab, or other components) is significantly reduced.

[0020] The liquid chamber may have a first frangible seal at the proximal end of the liquid chamber and a second frangible seal at the distal end of the liquid chamber. In use, the first seal of the liquid chamber is configured to be penetrated and broken by the absorbent head of the swab when the swab is partially inserted into the body portion, and the second seal of the liquid chamber is configured to be penetrated and broken by the absorbent head of the swab when the swab is further inserted into the body portion. Since the second seal of the liquid chamber is adjacent to the outlet conduit, when the second seal is broken during use, the extraction solution can flow from the liquid chamber into the outlet conduit. Thus, such a liquid chamber can be easily opened during use simply by the user inserting the swab (preferably by simply pushing the swab completely into the targeted location within the body portion), thereby breaking the first and second seals.

[0021] Preferably, the inlet region, the liquid chamber, and the outlet conduit are arranged in-line within the body portion to enable the absorbent head of the swab to be linearly inserted from the inlet region, through the liquid chamber, and into the outlet conduit along the inlet region.

[0022] Advantageously, the inlet region and the outlet conduit are integrally formed within the body portion, and the liquid chamber is initially formed as a separate pre-filled component (basically a cartridge) that can be inserted into the body portion during manufacture. This facilitates the manufacture of the lateral flow device, particularly with regard to introducing the extraction solution into the device. Also, this allows the liquid chamber to be pre-filled and sealed under carefully controlled aseptic conditions, thus ensuring the sterility of the extraction solution.

[0023] Advantageously, the shaft includes a radially protruding portion (e.g., a flange) to define the extent to which the swab enters the body portion when the swab is fully inserted into the body portion (i.e., pushed into the targeted location), and the inlet region or the liquid chamber may include a stopper (or other stop). When the swab is fully inserted into the body portion during use, the radially protruding portion of the swab abuts (or engages) the stopper.

[0024] Advantageously, the length of the swab from the protruding portion to the tip of the absorbent head can correspond to the distance along the body portion from the stopper to a point midway along the outlet conduit. As a result, when the swab is fully inserted into the body portion, the tip of the absorbent head appears within the outlet conduit through the liquid chamber.

[0025] Preferably, the inlet region and the liquid chamber are cylindrical, allowing the swab (having a circular cross-section) to be inserted in any orientation about the axis.

[0026] Optionally, the inner diameter of the liquid chamber is smaller than the diameter of the absorbent head, and the absorbent head compresses radially as it enters the liquid chamber, which can assist in the release of the liquid sample collected by the absorbent head during use.

[0027] Preferably, the proximal end of the axis includes a handle head by which the user can push the swab into the body portion during use. The handle head has a diameter larger than the inlet region, and the handle head can have a lower side shaped such that it abuts the opening of the inlet region when the swab is fully inserted into the body portion during use. Further, the lower side of the handle head can be shaped to plug the opening of the inlet region when the swab is fully inserted into the body portion during use.

[0028] Preferably, the shaft and / or the inlet region include sealing means for forming a seal between the shaft and the inlet region when the absorbent head is inserted into the body portion (particularly into or beyond the liquid chamber) during use. For example, the sealing means can include one or more fins formed on the shaft.

[0029] In a presently preferred embodiment, the body portion further includes a housing in which at least a substantial portion of the lateral flow assay strip is received. The housing has one or more openings through which one or more indicator regions of the lateral flow assay strip can be viewed.

[0030] Preferably, the housing is arranged relative to the remainder of the body portion generally in the same manner as a pen clip is arranged relative to the remainder of the pen. That is, the housing (and the assist strip therein) is folded back relative to the remainder of the body portion to make the overall device more compact and to enable the entire device to be clip-attached to a pocket before or after use. In fact, the dimensions of the device can also be generally similar to those of a typical pen.

[0031] Preferably, the device further comprises a removable outer wrapper that at least surrounds the absorbent head of the swab before use, thereby keeping the absorbent head clean and sterile before use. The outer wrapper can include a barrier film packaging material, but in alternative embodiments, the outer wrapper can be substantially rigid. The shaft of the swab includes one or more ridges or fins (preferably plural), and the proximal end of the outer wrapper can be engaged around the one or more ridges or fins before use. The proximal end of the outer wrapper can be formed as an annular portion around the one or more protrusions, ridges, or fins.

[0032] Advantageously, the proximal end of the outer wrapper is provided with a tab and / or a punched hole, by which the outer wrapper can be peeled off and easily removed from the swab before use. The one or more protrusions, ridges, or fins around which the annular portion is formed can also function as a sealing means for forming a seal between the shaft and the inlet region when the absorbent head is inserted into the body portion during use.

[0033] Preferably, the diameter of the annular portion is larger than the diameter of the inlet region, thereby holding the outer wrapper relative to the inlet region before use. The length of the outer wrapper from the lower side of the annular portion to the distal end of the outer wrapper is smaller than the length of the body portion from the opening of the inlet region to the liquid chamber, thereby holding the swab away from the liquid chamber before use.

[0034] Preferably, the swab and / or the inlet region includes gripping means for releasably gripping the swab within the inlet region prior to use. For example, the gripping means may include one or more (preferably plural) ridges or fins formed on the shaft.

[0035] According to a second aspect of the present invention, there is provided a method of performing a lateral flow test using a lateral flow device according to the first aspect of the present invention. The method comprises removing the swab from the inlet region of the body portion, collecting a liquid sample using the absorbent head, inserting the absorbent head forcefully into the body portion, thereby opening the liquid chamber, treating the absorbent head with the extraction solution, allowing the extraction solution containing the liquid sample to enter the outlet conduit and reach the proximal end of the lateral flow test assay strip, and from there flowing along the lateral flow assay strip to perform the lateral flow test, and

[0036] As described above, when using a liquid chamber having a first frangible seal at the proximal end of the liquid chamber and a second frangible seal at the distal end of the liquid chamber, the first seal of the liquid chamber is penetrated and broken by the absorbent head of the swab when the swab is partially inserted into the body portion, and the second seal of the liquid chamber is penetrated and broken by the absorbent head of the swab when the swab is further inserted into the body portion.

[0037] If the swab initially has an outer wrapper, the method may further include removing the outer wrapper from the swab after removing the swab from the inlet region of the body portion and before collecting the liquid sample using the absorbent head.

Brief Description of the Drawings

[0038] Embodiments of the present invention will now be described by way of example only with reference to the drawings.

[0039]

Figure 1

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[0040] Throughout the drawings, like elements are denoted by like reference numerals.

Best Mode for Carrying Out the Invention

[0041] This embodiment shows the best method known to the applicant for carrying out the present invention. However, such a method is not the only method capable of achieving this.

[0042] Initial Overview Referring first to FIG. 1, the present disclosure provides a lateral flow device 10 comprising a main body 30 and a detachable swab 20. Briefly referring to FIGS. 9 and 10 (since in FIG. 1 the swab 20 is partially covered by the outer casing 50 and some of the features of the swab 20 are difficult to see), the swab 20 includes shafts 21, 25 having a proximal end and a distal end. At the distal end of the swab 20, an absorbent head 26 suitable for collecting a liquid sample during use is provided (for example, the liquid sample is nasal fluid and / or oral fluid from the user's nasal cavity and / or back of the throat and may contain a target substance such as a specific antigen if present).

[0043] In the embodiment shown in FIG. 1, the lateral flow device 10 is preferably supplied to the user with the swab 20 partially inserted into the inlet region 34 of the main body 30 and with the swab 20 partially covered by the detachable outer casing 50.

[0044] Alternatively, in principle, the swab 20 may be supplied separately from the main body 30, but supplying the swab 20 partially inserted into the main body 30 provides the advantage that the entire single device 10 including the main body 30 and the swab 20 is conveniently provided to the user in a state where it can be used as needed.

[0045] As shown in FIG. 1, the lateral flow device 10 is preferably supplied to the user with at least the absorbent head 26 covered by the detachable outer casing 50 in order to keep the absorbent head 26 of the swab 20 sterile and clean before use. The outer casing 50 is removed by the user immediately before the user collects a liquid sample with the swab 20 using the absorbent head 26.

[0046] On the one hand, the main body 30 integrally incorporates all the components necessary to perform a lateral flow test on the liquid sample collected by the absorbent head 26 of the swab 20. The components include a certain amount of extraction solution 39 and a lateral flow assay strip 40.

[0047] More specifically, the main body 30 sequentially includes four main parts. That is, An inlet region 34 (having an opening 32) for holding the swab 20 before use and receiving the swab 20 during use for performing the lateral flow test, A liquid chamber 36 pre-filled with a certain amount of extraction solution (also known as "buffer") 39 during manufacture, An outlet conduit 38, A lateral flow assay strip 40.

[0048] The entire device 10 preferably has an overall configuration that is generally slender and compact, similar to a pen, enabling the user to conveniently carry the device 10 (e.g., in a pocket of a coat or jacket, or in a handbag, etc.). Thus, the entire device 10 is well-suited for in-situ testing by a user who is away from home, for example, in a queue at an airport, a railway station, a theater, a cinema, a concert hall, a conference venue, a retail store, a place of worship, a sports venue, a bar, a nightclub, a dance hall, or other venues where many other people may be present. In such places, if the user is infected with a virus (e.g., SARS-CoV-2), there is a risk of transmitting the virus to other people (who may be many others) within the venue.

[0049] In a general sense, as shown by way of example in FIGS. 9, 10, and 12, the liquid chamber 36 is configured to open when the absorbent head 26 of the swab 20 is forcibly inserted into the main body 30 through the inlet region 34 during testing, allowing the absorbent head 26 to be treated with the extraction solution 39. This has the effect of transferring the liquid sample collected by the absorbent head 26 (including this if a target substance such as an antigen is present) into the extraction solution 39.

[0050] As shown in FIGS. 10 and 12, the extraction solution 39 (including this if a target substance is present) enters the outlet conduit 38. Since the outlet conduit 38 includes or is in fluid communication with the proximal end of the lateral flow assay strip 40, the extraction solution 39 that enters the outlet conduit 38 during use reaches the proximal end of the assay strip 40 and can flow along the assay strip 40 from there to perform a lateral flow test.

[0051] In the illustrated embodiment, the liquid chamber 36 is initially manufactured as a separate component, basically in the form of a cartridge pre-filled with the extraction solution 39. Thereafter, the pre-filled liquid chamber 36 is inserted into the main body 30 during manufacture. The liquid chamber 36 having a rectangular cross-section has a tubular sidewall, a first breakable seal 37a at one end (the proximal end if installed in the main body), and a second breakable seal 37b at the other end (the distal end if installed in the main body). The sidewall of the liquid chamber 36 can be made of any suitable plastic material such as, for example, polypropylene. The first and second seals 37a, 37b can be made of, for example, a metallized polymer film (such as metallized polypropylene or metallized polyethylene terephthalate). As an example, these films can be metallized using aluminum. The extraction solution 39 is contained between the first and second seals 37a, 37b. Preferably, the liquid chamber 36 is substantially filled with the extraction solution 39. The amount of the extraction solution may be about 1 ml (1 cm 3 )).

[0052] As shown in FIGS. 9, 10, and 12, in this cartridge-shaped liquid chamber 36, during use, by quickly and forcefully inserting the swab 20 deep into the main body 30 to the maximum extent allowed by the device's structure, in other words, by pushing the swab 20 to the targeted location within the main body 30, the absorbent head 26 breaks the first and second seals 37a, 37b, thereby opening the above-mentioned liquid chamber. The forced insertion of the swab 20 is preferably carried out as a one-way insertion operation without interruption, typically within 1 or 2 seconds, to push or insert the swab 20 to the targeted location within the main body 30.

[0053] More specifically, as the swab 20 is gradually inserted into the main body 30, the absorbent head 26 is first forced into the liquid chamber 36 and penetrates the first seal 37a (therefore, in FIG. 9, the number 37a is shown using a strike-through line). Next, the tip of the absorbent head 26 is forced out from the opposite end of the liquid chamber 36 and penetrates the second seal 37b (therefore, in FIG. 10, the number 37b is shown using a strike-through line).

[0054] In other words, the first seal 37a of the liquid chamber 36 is broken or ruptured by the absorbent head 26 when the swab 20 is partially inserted into the main body 30, and then the second seal 37b of the liquid chamber 36 is broken or ruptured by the absorbent head 26 when the swab 20 is further inserted into the main body 30 (i.e., when the swab 20 is fully pushed to the targeted location).

[0055] In this embodiment, the breaking of the first and second seals 37a, 37b of the liquid chamber 36 by gradually advancing the swab 20 is due to the absorbent head 26 contacting and applying pressure to each of the seals 37a, 37b in sequence. However, in an alternative embodiment, the breaking of the second seal 37b can occur as a result of the pressure increasing in the extraction solution 39 before the absorbent head 26 actually reaches the second seal 37b.

[0056] Since the second seal 37b of the liquid chamber 36 is adjacent to the outlet conduit 38, when the second seal 37b breaks during use, the extraction solution 39 (which contains the collected liquid sample) can flow from the liquid chamber 36 into the outlet conduit 38 and from there reach the integral lateral flow asset strip 40.

[0057] As shown, preferably the inlet region 34, the liquid chamber 36, and the outlet conduit 38 are arranged collinearly within the body portion 30 to enable the absorbent head 26 of the swab 20 to be linearly inserted from the inlet region 34 through the liquid chamber 36 into the outlet conduit 38 along the inlet region 34.

[0058] However, it should be noted that the above-described use of the cartridge-shaped liquid chamber 36 including breakable first and second seals 37a, 37b at each end is merely one technique for configuring the liquid chamber to open when the swab 20 is inserted into the body portion 30. Alternative mechanisms are also possible where inserting the swab 20 into the body portion 30 opens the liquid chamber, thereby treating the absorbent head 26 with the extraction solution from within the liquid chamber. For example, it is also possible to provide a mechanical configuration where inserting the swab 20 into the body portion 30 opens a flap on the liquid chamber, thereby releasing the internal extraction solution. Such a flap can be opened either directly by the inserted swab 20 or, for example, by a lever configuration actuated by the swab 20 inserted into the body portion 30. In another example, the liquid chamber takes the form of a breakable bag filled with the extraction solution and can rupture, for example, when the swab 20 is inserted.

[0059] Also, while the illustrated embodiment uses a liquid chamber 36 configured to have both ends open (by gradually inserting the swab 20 into the main body 30 and breaking the first seal 37a and then the second seal 37b as the absorbent head 26 passes through the liquid chamber 36), in an alternative configuration, a single opening is provided and when the swab 20 is inserted into the main body 30, the extraction solution in the liquid chamber is released through this opening, the extraction solution treats the absorbent head 26 of the swab 20, and it should be noted that the extraction solution (containing the collected liquid sample) can enter the outlet conduit 38 and reach the integrated lateral flow assay strip 40.

[0060] Details regarding the swab 20 As described above and as shown for example in FIGS. 9 and 10, the swab 20 includes shafts 21, 25 having a proximal end and a distal end. The shafts 21, 25 are preferably in a cylindrical / rod-like form, i.e., having a circular cross-section and can be used (and inserted into the main body 30) in any orientation about the axis. The absorbent head 26 is provided at the distal end of the swab 20 (i.e., attached to the region 25 of the shaft) and is suitable for collecting a liquid sample (e.g., nasal fluid and / or oral fluid from the user's nasal cavity and / or back of the throat) during use. Further, in the illustrated embodiment, a handle head 24 is provided at the proximal end of the swab 20 (i.e., attached to the region 21 of the shaft), whereby the user can forcefully push the swab 20 into the main body 30 to perform a lateral flow test.

[0061] The absorbent head 26 can be made of any suitable material such as foam or cotton. As shown in FIGS. 11 and 12, in the illustrated embodiment, the shafts 21, 25 are hollow, and the absorbent head 26 is mounted around a core 25' which is an extension of smaller diameter than the region 25 of the shaft. Such a core 25' reinforces the absorbent head 26 and gives it a certain degree of rigidity, thereby facilitating the penetration of the first and second seals 37a, 37b during test execution. However, in an alternative embodiment, the absorbent head 26 can be formed without a reinforcing core 25'.

[0062] The shafts 21, 25 (and the core 25') are preferably made of a plastic material (e.g., by injection molding) and can incorporate depressions 22 (in the region 21 of the shaft) that act as grips to facilitate the operation of the swab 20 when collecting a liquid sample. The handle head 24 can be formed integrally with the remainder of the shafts 21, 25.

[0063] As shown in FIGS. 1 and 11, to keep the absorbent head 26 clean and sterile prior to use, the swab 20 has a detachable outer wrapper 50 that is fitted during manufacture and surrounds at least the absorbent head 26 of the swab 20. In the illustrated embodiment, the outer wrapper 50 includes a barrier film packaging material. To secure the film packaging material outer wrapper 50, the shaft 21 of the swab 20 includes one or more ridges or annular fins 27, or other protrusions, around which the proximal end of the outer wrapper 50 is engaged prior to use. In the illustrated embodiment, a plurality of (a first set of) such fins 27 are provided. In practice, the proximal end of the film packaging material outer wrapper 50 is formed as an annular portion 52 around the fin 27 (or ridge or other protrusion).

[0064] Since the diameter of the annular portion 52 of the outer package 50 is larger than the diameter of the opening 32 of the inlet region 34, the outer package 50 is held against the inlet region 34 before use (by maintaining the annular portion 52 outside the opening 32 of the inlet region 34). Further, the length of the outer package 50 from the lower side of the annular portion 52 to the distal end of the outer package 50 is shorter than the length of the main body 30 from the opening 32 of the inlet region 34 to the first seal 37a of the liquid chamber 36. For this reason, when the outer package 50 is in place, the swab 20 is held away from the first seal 37a and there is no risk of breaking it.

[0065] Referring to FIGS. 9, 10, 11, and 12, one or more ridges or fins 27 (or other protrusions) around which the annular portion 52 is formed can also function as a sealing means for forming a seal between the shafts 21, 25 and the inlet region 34 when inserting the absorbent head 26 into the liquid chamber 36 during testing. In use, the seal created by the ridges or fins 27 (etc.) ensures that the extraction solution 39 does not leak after the first seal 37a is broken. Further, the ridges or fins 27 (etc.) can also advantageously function as a pressure relief valve when the first seal 37a is broken and the swab 20 is pushed further into the main body 30.

[0066] Referring particularly to FIG. 11, the swab 20 and / or the inlet region 34 may also include gripping means for releasably gripping (i.e., temporarily holding) the swab 20 with an outer covering in the inlet region 34, for example at the opening 32 of the inlet region 34, prior to use. By such gripping means, the swab 20 and the body portion 30 are held together as a single unit 10 until the user is ready to remove the swab 20 to initiate the lateral flow test. As shown, the gripping means may include one or more ridges or annular fins 28 formed on the shafts 21, 25. Preferably, the one or more ridges or fins 28 are formed as an integral part of the shafts 21, 25. In the illustrated embodiment, a plurality of ridges or fins 28 are provided and can be regarded as a second set (in addition to the first set 27 described above). As shown in FIG. 11, these ridges or fins 28 provide a small frictional fit between themselves and the opening 32 of the inlet region 34, for example as a result of a small elastic deformation of the ridges or fins 28. As shown in FIG. 11, this gripping effect occurs regardless of the presence of the membrane outer covering 50 around the ridges or fins 28. In fact, the presence of the outer covering 50 may contribute to the gripping effect. Conversely, if the outer covering 50 is then removed during use, the gripping effect produced by the ridges or fins 28 alone is reduced, so that the swab 20 can be more easily inserted into the body portion 30 when performing the lateral flow test. In use, the ridges or fins 28 may also function as additional sealing means for forming a seal between the shafts 21, 25 and the inlet region 34 when inserting the absorbent head 26 into the liquid chamber 36 during the test.

[0067] For preparation of the device 10 for use, the user first removes the swab 20 with the outer covering from the body portion 30 (overcoming the above-described gripping effect provided by the ridges or fins 28), and then removes the outer covering 50 from the swab 20 to expose the absorbent head 26.

[0068] In the illustrated embodiment, as shown in, for example, FIG. 1, removal of the outer packaging 50 from the swab 20 is facilitated by providing a tab 54 and a series of punched holes 56 at the proximal end (annular portion 52) of the outer packaging 50. By pulling on the tab 54 and breaking the film between the punched holes 56, the outer packaging 50 can be easily peeled off the swab 20 and then disposed of.

[0069] Once the outer packaging has been removed, a liquid sample can be collected onto the absorbent head 26 using the swab 20. The user holds the swab 20 by the shaft 21 (assisted by the indentation / grip 22) and takes care not to contaminate the absorbent head 26 during the collection process naturally.

[0070] In the illustrated embodiment, as shown in, for example, FIG. 9, the swab 20 also incorporates a flange 29 (or other radially protruding portion) on the shaft 25. Preferably, the flange 29 is mounted as an integral part of the shaft 25. As shown in FIGS. 10 and 12, when the swab 20 is fully inserted (i.e., pushed into the targeted location), the position of the flange 29 is defined by abutting against a stopper 33 provided within the body portion 30, thereby defining the range within which the swab 20 can enter the body portion 30. Also, when the swab 20 is fully pushed into the targeted location within the body portion 30, a detent mechanism that can emit a clicking sound can be provided.

[0071] From FIGS. 10 and 12, it will be appreciated that the length of the swab 20 from the flange 29 (or other radially protruding portion) to the tip of the absorbent head 26 corresponds to the distance along the body portion 30 from the stopper 33 to a point midway along the outlet conduit 38, i.e., beyond the second seal 37b.

[0072] Accordingly, the second seal 37b (and the first seal 37a) breaks when the swab 20 is fully inserted into the body 30. When the second seal 37b breaks, the pressure increase in the liquid chamber 36 (due to the gradual advancement of the swab 20) is released, and the extraction solution 39 (containing the collected liquid sample) is forced into the outlet conduit 38 and then reaches the proximal end of the lateral flow assay strip 40 and then proceeds along the assay strip 40.

[0073] In view of the above, it can be considered that the device uses the "positive pressure displacement" principle when the absorbent head 26 of the swab 20 advances through the two-end cartridge-shaped liquid chamber 36.

[0074] For example, as shown in FIG. 1, the handle head 24 has a dome-shaped end 23 and can be made somewhat larger than the rest of the swab 20. This facilitates the user's operation of pushing the swab 20 forcefully (and comfortably) into the body 10 during use.

[0075] Also, in the illustrated embodiment, it should be noted that the handle head 24 has a diameter larger than the opening 32 of the inlet region 34. Further, as most clearly shown in FIGS. 10 and 12, the handle head 24 has a lower side 24a shaped to abut against the opening 32 of the inlet region 34 when the swab 20 is fully inserted into the body 30 during use, and a portion 24b shaped to plug the opening 32 of the inlet region 34. For this reason, in the illustrated embodiment, the lower side 24a of the handle head 24 is basically stepped and can abut against the opening 32 of the inlet region 34 from the front. The portion 24b is tapered and guides the handle head 24 to be centered (coaxial) with the opening 32 of the inlet region 34 to plug the opening 32.

[0076] Accordingly, in the illustrated embodiment, when the swab 20 is fully inserted into the body portion 30 (i.e., pushed to the targeted location), two abutment cases occur simultaneously. That is, the abutment of the flange 29 against the stopper 33 and the abutment of the lower side 24a of the handle head 24 against the opening 32 of the inlet region 34. As shown in FIGS. 10 and 12, as a result, when the swab 20 is fully inserted into the body portion 30, the entire device 10 uses a clearly defined configuration in a properly managed manner. The range of the longitudinal movement of the swab 20 with respect to the body portion 30 is precisely limited, and the swab 20 is concentrically (coaxially) aligned within the body portion 30.

[0077] Furthermore, from FIGS. 10 and 12, when the swab 20 is fully inserted into the body portion 30, the absorbent head 26 has passed through the first and second seals 37a, 37b of the liquid chamber 36, a part of the absorbent head 26 remains in the liquid chamber 36, and the distal tip of the absorbent head 26 has entered the outlet region 38. In this configuration, the extraction solution 39 from the liquid chamber 36 is mixed with the liquid sample collected by the absorbent head 26 and enters the outlet region 38, and thus reaches the proximal end of the lateral flow assay strip 40 that is in the outlet region 38 (or in fluid communication with the outlet region 38). Then, a lateral flow test is performed by the capillary flow of the extraction solution 39 (containing the collected liquid sample) along the assay strip 40.

[0078] Details regarding the body portion 30 As outlined above, the body portion 30 sequentially includes four main parts. That is, An inlet region 34 (having an opening 32) for holding the swab 20 before use and receiving the swab 20 during use for performing a lateral flow test, A liquid chamber 36 pre-filled with a certain amount of extraction solution (also known as "buffer") 39 during manufacturing, An outlet conduit 38, A lateral flow assay strip 40.

[0079] In the illustrated embodiment, both the inlet region 34 and the liquid chamber 36 are cylindrical (i.e., have a cylindrical internal 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 orientation about the axis. Also, the outlet conduit 38 can also generally be cylindrical. In use, when the first and second seals 37a, 37b of the liquid chamber 36 are broken, the inlet region 34, the liquid chamber 36, and the outlet conduit 38 co-axially form a continuous tubular channel through which the swab 20 passes. It will be appreciated that this continuous tubular channel need not have a constant inner diameter throughout the channel. In particular, as shown, the liquid chamber 36 can have a smaller inner diameter than the inlet region 34 and the outlet conduit 38. The main reason for this is that the liquid chamber 36 is initially formed as a separate pre-filled component.

[0080] In an alternative embodiment, at least a portion of the swab 20 and the internal cross-section of the inlet region 34 and / or the liquid chamber 36 can have a non-circular shape such as square or rectangular.

[0081] As noted, sealing means such as ridges or fins 27, 28 etc. can be provided on the swab 20. Alternatively or additionally, one or more sealing means such as O-rings can be provided along the inlet region 34 and / or the liquid chamber 36 (particularly along the inlet region 34) to provide further sealing between the shaft 21 and the inner wall of the inlet region 34 or, in some cases, between the shaft 25 and the inner wall of the liquid chamber 36.

[0082] Furthermore, in the illustrated embodiment, the inlet region 34 (with the stopper 33) and the outlet conduit 38 are integrally formed within the body portion 30 and share a common outer wall 31, whereas, as described above, the liquid chamber 36 is formed as a separate pre-filled component initially inserted into the body portion 30 during manufacture, such as a cartridge. As shown, for example, in FIG. 11, to fix the liquid chamber 36 in place, for example, to hold it in by press-fitting, an appropriate molded article can be provided within the wall 31 of the body portion 30. Also, the walls of the liquid chamber 36 incorporate annular fins 36a, 36b, by which the liquid chamber 36 can be coaxially gripped within the wall 31 of the body portion 30. Thus, as shown, the inner diameter of the liquid chamber 36 can be made smaller than the inner diameter of the inlet region 34 and the outlet conduit 38, or of the common outer wall 41.

[0083] As shown in FIG. 9, since the inner diameter of the liquid chamber 36 is smaller than the diameter of the absorbent head 26, the absorbent head 26 can be radially compressed as it enters the liquid chamber 36. Such radial compression of the absorbent head 26 facilitates releasing the liquid sample collected from the absorbent head 26 and mixing the liquid sample with the extraction solution 39 (released from the liquid chamber 36) within the liquid chamber 36.

[0084] Since the outlet conduit 38 includes or is in fluid communication with the proximal end of the lateral flow assay strip 40, the extraction solution 39 (containing the collected liquid sample) that enters the outlet conduit 38 during use reaches the proximal end of the assay strip 40 and can flow along the assay strip 40 from there to perform a lateral flow test.

[0085] The body portion 30 further includes a housing 42 that houses at least a substantial portion of the lateral flow assay strip 40. In other words, the entire assay strip 40 may be housed within the housing 42, or, apart from the proximal portion that is within (or exposed to) the outlet conduit 38, substantially all of the assay strip 40 may be housed within the housing 42. The housing 42 has one or more openings 44 through which one or more indicator regions of the lateral flow assay strip 40 can be viewed.

[0086] Structurally, as shown in FIGS. 11 and 12, the housing 42 is formed as opposing first and second portions 42a, 42b between which the assay strip 40 can be mounted. In the illustrated embodiment, the housing 42 is connected to the remainder of the body portion 30 by an end portion 41 and a bridging portion 42'. The end portion 41 also functions as an end wall of the outlet conduit 38.

[0087] In terms of design, the arrangement of the housing 42 relative to the remainder of the body portion 30 is generally similar to the arrangement of a pen clip (e.g., of a fountain pen) relative to the remainder of the fountain pen. That is, the housing 42 (and the assay strip 40 therein) is folded back relative to the remainder of the body portion 30 to make the entire device 10 more compact and to enable the entire device 10 to be clip-attached to the user's pocket (e.g., a jacket or coat pocket) before or after use.

[0088] Also, the dimensions of the device are generally similar to those of a typical pen. For example, in the configuration shown in FIG. 1, the overall length of the device can be about 100 mm to 150 mm, preferably about 120 mm. The outer diameter of the body portion can be about 10 mm to 15 mm, preferably about 12 mm.

[0089] The lateral flow assay strip 40 can have any suitable configuration considering the target substance being detected. For example, this can have the configuration outlined in the "Background Art" section above. The indicator region of the assay strip 40 that can be viewed through one or more apertures 44 includes a first indicator region where a positive test line occurs when the target substance (e.g., target antigen) is present in the extraction solution, and usually further along the assay strip, a second indicator region where a control line occurs to confirm that the extraction solution has flowed correctly along the assay strip 40.

[0090] Also, a QR code 46 or other test identification means, and / or text or an image for guidance or explanation (e.g., regarding the meaning of the test lines) may be provided on the housing 42 or at other locations on the main body 32.

[0091] Method of Use To perform the lateral flow test, the method performed by the user simply includes the following. Removing the swab 20 with the outer package from the main body 30, Removing the outer package 50 from the swab 20, for example by pulling the tab 54 and using the punched hole 56 to peel off the outer package 50, to expose the absorbent head 26, Collecting a liquid sample (e.g., oral fluid or nasal fluid) using the absorbent head 26, and then, Forcibly inserting the absorbent head 26 into the main body 30 (e.g., from the configuration shown in FIG. 9 to the configurations shown in FIGS. 10 and 12), thereby opening the liquid chamber 36, treating the absorbent head 26 with the extraction solution 39, causing the extraction solution 39 containing the collected liquid sample to enter the outlet conduit 38 and reach the proximal end of the lateral flow test assay strip 40, and from there flowing (by capillary action) along the assay strip 40 to perform the lateral flow test. Then, after a given time period, displaying the test result by one or more indicator regions within one or more apertures 44 on the housing 42.

[0092] More specifically, when using the above-described liquid chamber 36 having a first frangible seal 37a at the proximal end of the liquid chamber 36 and a second frangible seal 37b at the distal end of the liquid chamber, the first seal 37a is penetrated and broken by the absorbent head 26 when the swab 20 is partially inserted into the body portion 30, and the second seal 37b is penetrated and broken by the absorbent head 26 when the swab 20 is further (i.e., fully) inserted into the body portion 30.

[0093] After performing the lateral flow test, if the device is in a closed configuration as shown in FIGS. 10 and 12 (and FIGS. 13 and 14), the device is self-sealed by the above-described sealing means 27, 28 and the plug portion 24b of the handle head 24. This prevents the extraction solution 29 from leaking and also enables the device 10 to be returned to a pocket or the like after the test is performed. Further, thereby, the solution 29 is firmly accommodated within the device 10, preventing the device 10 from drying out over a long period of time.

[0094] After performing the lateral flow test, it will be appreciated that the test results remain visible in one or more indicator regions of the assay strip 40 within one or more apertures 44. Thus, if the test result is negative, the user can easily show the completed test device 10 to other people, providing evidence of the user's negative status.

[0095] Summary of Advantages Compared to conventional lateral flow devices outlined in the "Background Art" section above, the present lateral flow device 10 provides the following advantages. - The device 10 is provided to the user as a single item (such as shown in FIG. 1 for example), so it is compact for storage, convenient for people to carry, and can be used quickly and easily. - Since the user does not need to unpack a number of separate items before use, the device 10 is facilitated for quick and easy use by (for example, people with clumsy hands), and the package waste is significantly reduced (only the outer package 50 needs to be removed before use). - There is no need to prepare a clean flat surface to place the device 10 for use. The device can be used in virtually any location, including when the user is standing, for example, away from home. - Since the user does not need to transfer the extraction solution from a separate container to the device 10, the risk of spilling the solution is eliminated and the contamination risk is significantly reduced. - It is very quick and easy for the user to transfer the liquid sample collected on the swab 20 to the extraction solution 39 (simply by inserting the swab 20 into the main body 30), so there is no need to manually and strongly compress the absorbent head 26 of the swab 20, and the contamination risk is also significantly reduced in this regard. - Since the user does not need to manually transfer a specific amount (e.g., a specific number of drops) of the solution to the lateral flow assay strip, the process becomes even easier and the contamination risk is also significantly reduced in this regard.

[0096] Modifications and Alternatives Detailed embodiments and several possible alternatives have been described above. As will be appreciated by those skilled in the art, numerous modifications and other alternatives are possible to the above-described embodiments, and in such cases, the advantages of the invention embodied therein can still be obtained. Accordingly, the invention is not limited to the above-described embodiments and it will be understood that the invention includes modifications that are obvious to those skilled in the art falling within the scope of the appended claims.

[0097] For example, in the illustrated embodiment, the detachable outer cover 50 includes a barrier film packaging material. However, in an alternative embodiment, the detachable outer cover may be a substantially rigid cover (e.g., made of any suitable plastic material) that at least surrounds the absorbent head 26 of the swab 20 before use. Such a rigid outer cover can incorporate an annular portion (similar to the annular portion 52 described above) for removably fixing the outer cover to the swab 20 and for holding the outer cover against the inlet region 34 of the main body 30. Similar to the above-described embodiment, the length of such an outer cover is such that it holds the swab 20 away from the liquid chamber 36 before use.

Claims

1. A lateral flow device comprising a body portion and a detachable swab, wherein the swab has a shaft including a proximal end and a distal end, and has an absorbent head at the distal end, the body portion comprising an inlet region for holding the swab before use and receiving the swab during use when performing a lateral flow test, a liquid chamber containing a quantity of extraction solution, an outlet conduit, and a lateral flow assay strip, wherein the liquid chamber is configured to open when the absorbent head is forcibly inserted into the body portion through the inlet region during use, to treat the absorbent head with the extraction solution, and to allow the extraction solution to enter the outlet conduit, the outlet conduit including or being in fluid communication with the proximal end of the lateral flow assay strip, such that the extraction solution entering the outlet conduit during use reaches the proximal end of the assay strip and can flow along the lateral flow assay strip therefrom to perform a lateral flow test. A lateral flow device.

2. The liquid chamber has a first frangible seal at the proximal end of the liquid chamber and a second frangible seal at the distal end of the liquid chamber, wherein during use, the first seal of the liquid chamber is configured to be penetrated and broken by the absorbent head of the swab when the swab is partially inserted into the body portion, the second seal of the liquid chamber is configured to be penetrated and broken by the absorbent head of the swab when the swab is further inserted into the body portion, the second seal of the liquid chamber being adjacent to the outlet conduit, such that when the second seal is broken during use, extraction solution can flow from the liquid chamber into the outlet conduit. The lateral flow device according to claim 1.

3. The inlet region, the liquid chamber, and the outlet conduit are arranged in a straight line within the body portion. The lateral flow device according to claim 2.

4. The inlet region and the outlet conduit are integrally formed within the body portion, the liquid chamber being formed as a first initially separate pre-filled component inserted into the body portion during manufacture. The lateral flow device according to claim 2 or 3.

5. The shaft includes a portion protruding in the radial direction, The inlet region or the liquid chamber includes a stopper, and when the swab is fully inserted into the main body during use, the portion of the swab protruding in the radial direction abuts against the stopper. The lateral flow device according to any one of claims 2 to 4.

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

7. The inlet region is cylindrical. The lateral flow device according to any one of claims 1 to 6.

8. The liquid chamber is cylindrical. The lateral flow device according to any one of claims 1 to 7.

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

10. The proximal end of the shaft includes a handle head, and the user can push the swab into the main body during use by means of the handle head. The lateral flow device according to any one of claims 1 to 9.

11. The handle head has a diameter larger than that of the inlet region, The handle head has a lower side shaped such that it abuts against the opening of the inlet region when the swab is fully inserted into the main body during use. The lateral flow device according to claim 10.

12. The lower side of the handle head is further shaped such that it plugs the opening of the inlet region when the swab is fully inserted into the main body during use. The lateral flow device according to claim 11.

13. The shaft and / or the inlet region includes a sealing means for forming a seal between the shaft and the inlet region when the absorbent head is inserted into the main body during use. The lateral flow device according to any one of claims 1 to 12.

14. The sealing means includes one or more fins formed on the shaft. The lateral flow device according to claim 13.

15. The lateral flow device according to any one of claims 1 to 14, wherein the main body portion further includes a housing in which at least a substantial portion of the lateral flow assay strip is accommodated.

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

17. The lateral flow device according to claim 15 or 16, wherein the arrangement of the housing with respect to the remaining portion of the main body portion is generally like the arrangement of a pen clip with respect to the remaining portion of the pen.

18. The lateral flow device according to any one of claims 1 to 17, further comprising a removable outer package that surrounds at least the absorbent head of the swab before use.

19. The lateral flow device according to claim 18, wherein the outer package includes a film packaging material.

20. The lateral flow device according to claim 18, wherein the outer package is substantially rigid.

21. The shaft according to any one of claims 18 to 20 includes one or more protrusions, ridges, or fins, and the proximal end of the outer package is engaged around the one or more protrusions, ridges, or fins before use.

22. The lateral flow device according to claim 21, wherein the proximal end of the outer package is formed as an annular portion around the one or more protrusions, ridges, or fins.

23. The proximal end of the outer package is provided with a tab and / or a punched hole, and the outer package can be peeled off by the tab and / or the punched hole and removed from the swab before use. The lateral flow device according to claim 21 or 22.

24. The one or more protrusions, ridges, or fins around which the annular portion is formed also function as a sealing means for forming a seal between the shaft and the inlet region when the absorbent head is inserted into the main body portion during use. The lateral flow device according to claim 22 or claim 23 when dependent on claim 22.

25. The diameter of the annular portion is larger than the diameter of the inlet region. The length of the outer package from below the annular portion to the distal end of the outer package is less than the length of the main body portion from the opening of the inlet region to the liquid chamber, the lateral flow device according to claim 22 or claim 24, or claim 23 when dependent on claim 22.

26. The swab and / or the inlet region includes gripping means for releasably gripping the swab within the inlet region prior to use, the lateral flow device according to any one of claims 1 to 25.

27. The gripping means includes one or more ridges or fins formed on the shaft, the lateral flow device according to claim 26.

28. A method of performing a lateral flow test using the lateral flow device according to any one of claims 1 to 27, comprising: removing the swab from the inlet region of the main body portion; collecting a liquid sample using the absorbent head; inserting the absorbent head forcefully into the main body portion, thereby opening the liquid chamber, treating the absorbent head with the extraction solution, allowing the extraction solution containing the liquid sample to enter the outlet conduit, reaching the proximal end of the lateral flow test assay strip, and flowing along the lateral flow assay strip from there to perform a lateral flow test. A method comprising the above steps.

29. The first seal of the liquid chamber is penetrated and broken by the absorbent head of the swab when the swab is partially inserted into the main body portion, The second seal of the liquid chamber is penetrated and broken by the absorbent head of the swab when the swab is further inserted into the main body portion, the method according to claim 28 when dependent on claim 2.

30. After removing the swab from the inlet region of the main body portion and before collecting a liquid sample using the absorbent head, further comprising removing the outer package from the swab, the method according to claim 28 or claim 29 when dependent on any one of claims 18 to 25.

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