WO2018091906A1

WO2018091906A1 - Device for self-collection of a biological sample from a vaginal or anal orifice

Info

Publication number: WO2018091906A1
Application number: PCT/GB2017/053459
Authority: WO
Inventors: Lisa Smith; Jon WETTON; Mark Jobling
Original assignee: University Of Leicester
Priority date: 2016-11-17
Filing date: 2017-11-17
Publication date: 2018-05-24
Also published as: GB201619472D0

Abstract

A device (10) for self-collection of a biological sample from a vaginal or anal orifice (58) comprises an elongate swab (12) and an applicator (22). The elongate swab (12) has opposing first and second ends (14a, 14b) and it includes a handle portion (16) at the first end (14a) and an absorbent portion (18) at the second end (14b). The applicator (22) includes first and second applicator members (24, 26). The first applicator member (24) is secured to the handle portion (16). The second applicator member (26) is slidably moveable relative to the first applicator member (24) between a first extended position (E1) in which the second applicator member (26) is positioned towards the second end (14b) of the swab (12) so as to surround the absorbent portion (18), and a retracted position (R) in which the second applicator member (26) is positioned towards the first end (14a) of the swab (12) so as to expose the absorbent portion (18). The applicator (22) further includes a locking mechanism (28) which is configured to lock the second applicator member (26) in a second extended position (E2) upon slidable movement of the second applicator (26) member from the retracted position (R) past the first extended position (E1) to the second extended position (E2). The second applicator member (26) surrounds the absorbent portion (18) when in the second extended position (E2).

Description

DEVICE FOR SELF-COLLECTION OF A BIOLOGICAL SAMPLE FROM A VAGINAL OR ANAL ORIFICE

This invention relates to a device for self-collection of a biological sample from a vaginal or anal orifice, and to a kit for the collection of a biological sample.

The use of swab-type devices is well-known for the collection of biological samples. Not only are they useful in methods for screening cervical cancer in women, but they can also be used for screening of sexually transmitted diseases such as Gonorrhoea and Chlamydia.

Another important use of swab devices is to collect DNA in the investigation of sexual assault cases. These swab devices are used as part of a sexual assault evidence collection kit, which are usually collected by medical professionals, most commonly physicians and nurses. The process of collecting the biological samples by said professionals is highly invasive and extremely time-consuming. It is also difficult to preserve the evidence collected and prevent contamination, whilst at the same time collect the evidence early enough to prevent the DNA from degrading.

The invasive nature of the collection of the biological sample often deters sexual assault victims from reporting sexual assault cases. Furthermore victims' access to sexual assault evidence kits is often limited. In many locations across the world, the non-availability of sexual assault evidence kits prevents victims from obtaining such evidence that would otherwise aid in the criminal investigation and prosecution of their assailant. In locations where sexual assault evidence collection kits are available, a lack of trained examiners often prevents the victims from undergoing timely sexual assault examinations. Often, the examination does not take place within the desirable 72 hour timeframe, or the kits are incorrectly used. There is a need for a device in which DNA evidence can be recovered by self-collection so that trained professionals are not required, and which allows the sample to be protected from contamination so as to maintain the integrity of the sample. In particular, there is a need for an improved kit which allows self-collection of a biological sample which could be used by women in conflict zones, displaced communities and in remote areas where access is limited. According to a first aspect of the invention there is provided a device for self-collection of a biological sample from a vaginal or anal orifice comprising:

an elongate swab having opposing first and second ends, the swab including a handle portion at the first end and an absorbent portion at the second end; and

an applicator including first and second applicator members, the first applicator member being secured to the handle portion and the second applicator member being slidably moveable relative to the first applicator member between a first extended position in which the second applicator member is positioned towards the second end of the swab so as to surround the absorbent portion, and a retracted position in which the second applicator member is positioned towards the first end of the swab so as to expose the absorbent portion, the applicator further including a locking mechanism configured to lock the second applicator member in a second extended position upon slidable movement of the second applicator member from the retracted position past the first extended position to the second extended position, the second applicator member surrounding the absorbent portion when in the second extended position.

The elongate swab having a handle portion at one end and an absorbent portion at the other end allows a user to readily hold the device at one end when inserting the absorbent portion into a vaginal or anal orifice.

The second applicator member being slidably moveable relative to the first applicator member between a first extended position and a retracted position allows the second applicator member to surround, and thus protect, the absorbent portion from contamination in the first instance and allows the absorbent portion to be exposed for collection of a biological sample in the second instance. In this way, the absorbent portion is protected before and during the swab entering the vaginal or anal orifice.

Moreover, the applicator assists in the insertion of the swab and may be shaped and/or have a low friction surface to allow for easy and comfortable insertion into the vaginal or anal orifice.

Meanwhile, the locking mechanism arrangement permits the second applicator to be slid up towards the first extended position, past the first extended position and then lock in a second extended position as the absorbent portion is withdrawn from the vaginal or anal orifice. As such, the second applicator surrounds, and thus protects, the absorbent portion after the biological sample has been collected. Accordingly, the arrangement of the applicator according to the invention not only helps with insertion of the swab but also protects the absorbent portion from contamination before, during and after insertion of the swab into the vaginal or anal orifice. Optionally the locking mechanism includes first and second locking members, each of the first and second locking members being located on a respective facing surface of the first and second applicator members.

Such locking members being located on a respective facing surface of the first and second applicator members means that the locking mechanism forms part of the applicator and thus no external locking means is required. Also, the locking members being on facing surfaces of the applicator members, i.e. an internal surface of one applicator member and an external surface of another applicator member, obviates any protruding parts on the applicator which may be uncomfortable or cause injury to a user when inserting the applicator into the vaginal or anal orifice.

The first locking member may be configured to permit the second locking member to pass in a first direction as the second applicator member is slid from the first extended position to the second extended position, and to prevent the second locking member from passing in a second direction opposite to the first direction once the second applicator member is in the second extended position.

Such an arrangement allows the second applicator member to be slid beyond the first extended position (i.e. in the first direction) after a biological sample has been collected and to prevent the second applicator member from sliding back towards the retracted position (i.e. in the second direction) to prevent exposure of the biological sample collected on the absorbent portion.

In one embodiment of the invention the first locking member includes a ramp portion starting at one end of the first locking member and a stop portion at the other end of the first locking member.

Having such a ramp and stop portion readily permits movement of the second applicator member from the first extended position to the second extended position and then locking of the second applicator in the second extended position. Preferably the locking mechanism further includes a stop member configured to prevent the second applicator member from being slidably moved beyond the second extended position. The locking mechanism including a stop member prevents the second applicator member from sliding past the second extended position and being separated from the applicator, especially when the applicator is being removed from the vaginal or anal orifice. Moreover, the stop provides a user with tactile feedback that the second applicator is in the second extended position. This is particularly advantageous because the device will not be easily visible to the user when it is being inserted into the vaginal or anal orifice.

Optionally the applicator further includes a release mechanism configured to overcome the locking mechanism to permit the second applicator member to be slidably moved from the second extended position to the retracted position.

Such a release mechanism allows a laboratory professional to slide the second applicator member down to the retracted position so as to expose the absorbent portion for testing. It also allows a user to expose the absorbent portion if, for example, the absorbent portion is to be put into a vessel by the user which has testing fluid or a drying agent therein. Moreover, it allows a user to unlock the second applicator member if it has been moved to the second extended position in error.

The applicator may further include a release mechanism configured to overcome the locking mechanism to permit the second applicator member to be slidably moved beyond the second extended position so as to remove the second applicator member from the first applicator member.

Such a release mechanism permits the second applicator member to be removed from the device so as to expose the absorbent portion for testing. This may be carried out by a laboratory professional of by a user, as set out above.

In a particular embodiment of the invention the applicator further includes an engagement member configured to engage the first applicator member with the second applicator member in the first extended position until the second applicator member is forcibly slid towards the retracted position. The inclusion of such an engagement member helps to prevent the second applicator member from being slid towards the retracted position by mistake, in particular during manufacture and/or transit of the device. It also helps to keep the second applicator member in the first extended position as the applicator is being inserted into the vaginal or anal orifice.

Moreover, the engagement mechanism is overcome upon force of the second applicator member being slid towards the retracted position such that a user can readily slide the second applicator member to the retracted position once the applicator has been inserted into the vaginal or anal orifice.

Optionally the swab includes a frangible portion to enable the absorbent portion to be detached from the swab. This allows a user or laboratory professional to break the absorbent portion off for testing.

The device may further include an elongate support member received by the swab and extending between the first and second ends of the swab, the support member being configured to be pushed from the first end of the swab and abut the absorbent portion so as to rupture the frangible portion of the swab.

The inclusion of such an elongate support member provides strength and support to the swab so as to prevent it bending and breaking during use. Moreover, the elongate support member prevents premature breaking of the frangible portion. The elongate support member also acts as a plunger when pushed to overcome the frangible portion

In an embodiment of the invention the second applicator member includes a tapered portion which tapers towards a distal end of the device. Such tapering allows for ease of insertion of the device into the vaginal or anal orifice. Optionally the second applicator member includes at least two slits extending from the distal end of the device, the slits being configured to open so as to expose the absorbent portion when the first applicator member contacts the tapered portion of the second applicator member as the second applicator member is slid to the retracted position. The handle portion may contain a drying agent to prevent sample degradation. The drying agent may be selected from the group consisting of silica, molecular sieves, calcium chloride, sodium sulfate, calcium sulphate and magnesium sulfate. Optionally the handle portion includes an abutment formation configured to abut the second applicator member in the retracted position. Such an abutment portion provides a stop for the second applicator member when it is being slid towards the retracted position so as to prevent the second applicator member from being slid past the retracted position and potentially being detached from the device. It also provides a user with tactile feedback that the second applicator member is in the retracted position.

According to a second aspect of the invention there is provided a device assembly as described hereinabove and a vessel configured to receive the device.

The device assembly having a vessel that is configured to receive the device means that the device can be safely stored for transit of the device (before and after the device has been used to collect a biological sample).

Optionally the vessel is configured to receive the device when the second applicator member is in the second extended position.

The vessel being configured to receive the device when the second applicator member is in the second extended position means that a user can put the device straight into the vessel after collecting a biological sample and maintain protection of the absorbent portion. In the embodiment of the invention wherein the applicator includes a release mechanism configured to overcome the locking mechanism to permit the second applicator member to be slidably moved from the second extended position to the retracted position, the release mechanism may be activated upon insertion of the device into the vessel so as to permit the second applicator member to slide towards the retracted position.

In this way, the locking mechanism is automatically overcome when a user puts the device into the vessel and the second applicator member can be moved (e.g. by a stop in the vessel) to the retracted position to expose the absorbent portion as the device is put into the vessel. This is particularly advantageous when the vessel has a testing fluid or drying agent that is to come directly into contact with the absorbent portion. Preferably the vessel and the handle portion are engageable with one another to secure the device to the vessel. Such an arrangement secures the device to the vessel to thus protect the absorbent portion while at the same time reducing the number of parts of the device assembly.

The vessel may include a pouch containing a drying agent or a testing fluid. The pouch is preferably positioned within the vessel so that the device ruptures the pouch when the vessel receives the device when the second applicator member is in the second extended position.

Accordingly, the agent/fluid is only released when the device is re-inserted into the vessel after the sample has been collected.

According to a third aspect of the invention there is provided a kit for the collection of a biological sample comprising:

(i) a device assembly as described hereinabove;

(ii) a container for storing the contents of the kit

(iii) instructions providing information for using the kit

(iv) a labelling means for identifying a user

The labelling means may be paperwork which identifies the user (i.e. the sample donor). It may identify the user by a code so as to ensure anonymity during transit and processing of the sample. The labelling means may also contain information of the time/date of collection and identify the person providing the kit and collecting the kit. Such information may be written directly onto a printed panel on the device assembly (e.g. on the vessel), and so a writing implement may also be provided in the kit together with a label area that is suitable to retain indelibly writing from a writing implement of any sort.

In addition to the foregoing, the kit may also comprise one or more of the following:

- a tamper-proof sealable evidence bag for evidence collection (e.g. for clothing or other items which may carry bodily fluids from the assailant);

a re-sealable pot of sterile mouthwash for use in cases of oral intercourse; - sterile wipes for collection of assailant body fluids (e.g. semen, blood, saliva from donors skin); and/or

- sterile nail clippers and swabs for collecting body fluids of skin cells under the donor's fingernails and suitable tamper-proof evidence packaging to receive the samples. There now follows a brief description of preferred embodiments of the invention, by way of non-limiting examples, with reference being made to the accompanying drawings in which: Figure 1 shows a schematic view of a device according to a first embodiment of the invention;

Figure 2a shows a schematic view of a locking mechanism of the device shown in Figure 1 in a first extended position;

Figure 2b shows a schematic view of a locking mechanism of the device shown in Figure 1 in a second extended position;

Figures 3 shows a schematic view of a device according to a second embodiment of the invention;

Figures 4a and 4b show schematic views of a device according to a third embodiment of the invention;

Figures 5a to 5e illustrate steps involved to collect a biological sample using the device shown in Figure 1 ;

Figure 6 shows a schematic view of a device assembly according to a fourth embodiment of the invention; and

Figures 7a and 7b show schematic views of a device assembly according to a fifth embodiment of the invention.

A device according to a first embodiment of the invention is shown in Figures 1 , 2a, 2b and 5a to 5e and is designated generally by reference numeral 10. The device 10 includes an elongate swab 12 which has opposing first and second ends 14a, 14b. The swab 12 has a handle portion 16 at the first end 14a and an absorbent portion 18 at the second end 14b.

More specifically, the swab 12 has a shaft 20 extending between the first and second ends 14a, 14b. The shaft 20 may be made from plastic, wood or metal, or any combination thereof. The absorbent portion 18 is made from cotton wool, regenerated cellulose or microfilaments, or any other suitable material for collecting a biological sample from a vaginal or anal orifice. The device 10 also includes an applicator 22 which includes first and second applicator members 24, 26. The first applicator member 24 is secured to the handle portion 16 and the second applicator member 26 is slidably moveable relative to the first applicator member 24. The second applicator member 26 is slidably moveable between a first extended position Ei (as shown in Figure 1 ) in which the second applicator member 26 is positioned towards the second end 14b of the swab 12 so as to surround the absorbent portion 18, and a retracted position R (as shown in Figure 5c) in which the second applicator member 26 is position towards the first end 14a of the swab 12 so as to expose the absorbent portion 18.

The applicator 22 further includes a locking mechanism 28 which is configured to lock the second applicator member 26 in a second extended position E2 (as shown in Figure 5e) upon slidable movement of the second applicator member 26 from the retracted position R past the first extended position Ei to the second extended position E2. When the second applicator member 26 is in the second extended position E2, the second applicator member 26 surrounds the absorbent portion 18. The second applicator member 26 is slidable in a first direction Di from the retracted position R to the first extended position E-i, and from the first extended position Ei to the second extended position E2. The second applicator member is slidable in a second direction D2, opposite to the first direction D-i, from the second extended position E₂ to the first extended position Ei, and from the first extended position Ei to the retracted position R.

In the embodiment shown, the applicator members 24, 26 are cylindrical in shape and receive the swab 12 which extends through the applicator 22. The first and second applicator members 24, 26 are also telescopically arranged relative to one another. More specifically, the second applicator member 26 slidably receives the first applicator member 24. In other embodiments of the invention the first applicator member 24 may instead slidably receive the second applicator member 26.

The first applicator member 24 has a first applicator first end 30a which is positioned at the handle portion 16 of the swab 12, and a first applicator second end 30b which is positioned opposite to the first end 30a. The second applicator member 26 has a second applicator second end 32b which is positioned at a distal end of the device 10, and a second applicator first end 32a which is positioned opposite to the second end 32b. When the second applicator member 26 is in the first extended position E-i, the first applicator second end 30b and the second applicator first end 32a are adjacent to one another. When the second applicator member 26 is in the retracted position R, the first applicator first end 30a and the second applicator first end 32a are adjacent to one another. When the second applicator member 26 is in the second extended position E₂, the first applicator second end 30b and the second applicator first end 32a are again adjacent to one another, but this time the second applicator first end 32a is further along the first applicator second end 30b in the first direction D-i .

In the embodiment shown, the second applicator member 26 has a domed head 34 to permit easy insertion of the applicator 22 into a vaginal or anal orifice. The domed head 34 has a notch 36 extending from the tip of the domed head 34 to permit the second end 14b of the swab 12 to push through the domed head 34 and thus expose the absorbent portion 18. The domed head 34 may include a plurality of notches 36, or may instead include one or more slits. Alternatively, the domed head 34 may include any other type of opening to permit the second end 14b of the swab 12 to push through the domed head 34 whilst still providing a degree of protection to the absorbent portion 18 when the second applicator member 26 is in the first or second extended positions Ei, E₂.

The second applicator member 26 also has a first grip portion 38 located on the outer surface of the second applicator member 26 at the second applicator first end 32a. The handle portion 16 has a second grip portion 40. The first and second grip portions 38, 40 may be made from the same or from different materials to one another. For example, the grip portion(s) 38, 40 may be made from rubber or a high friction plastic. The grip portion(s) 38, 40 may also be formed from a plurality of ridges or dots so as to provide grip to a user's fingers. The first and second applicator members 24, 26 are made from a cardboard laminate which has low friction outer layers. The first and second applicator members 24, 26 may instead be made from plastic or any other suitable material.

In the embodiment shown, the locking mechanism 28 includes first and second locking members 42, 44. Each of the first and second locking members 42, 44 are located on a respective facing surface of the first and second applicator members 24, 26. More specifically, the first locking member 42 is located on the external surface of the first applicator member 24 and the second locking member 44 is located on the internal surface of the second applicator member 26. As such, the first and second locking members 42, 44 are located on the surfaces of the applicator members 24, 26 that face one another. Moreover, the first locking member 42 is located at the first applicator second end 30b while the second locking member 44 is located at the second applicator first end 32a.

The locking mechanism 28 is shown in more detail in Figures 2a and 2b. The first locking member 42 is configured to permit the second locking member 44 to pass in the first direction Di as the second applicator member 26 is slid from the first extended position Ei (as shown in Figure 2a) to the second extended position E2 (as shown in Figure 2b). Moreover, the first locking member 42 is configured to prevent the second locking member 44 from passing the first locking member 42 in the second direction D₂, i.e. it prevents the second applicator member 26 sliding back towards the first extended position Ei.

In the embodiment shown, the first locking member 42 has a ramp portion 46 that starts at one end of the first locking member 42, and a stop portion 48 at the other end of the first locking member 42. The cardboard material of the first and second applicator members 24, 26 provides a degree of flexibility in the applicator members 24, 26 such that the second locking member 44 is able to slide up and over the ramp portion 46. In particular, at least the second applicator member 26 bends slightly outwards to allow for the second locking member 44 to pass over the ramp portion 46, but springs back to its original shape to prevent the second locking member 44 from passing back over the stop portion 48 of the first locking member 42.

In other embodiments of the invention (not shown), one of the first and second locking members 42, 44 may instead (or additionally) be resiliently moveable relative to the respective applicator member 24, 26. For example, the first locking member 42 may be attached to the first applicator member 24 via a spring which is biased outwards away from a central axis A_c of the applicator 22 so that the first locking member 42 is pushed inwards towards the central axis A₀ of the applicator 22 as the second locking member 44 passes over the ramp portion 46, but springs back outwards from the central axis A_c once the second locking member 44 has passed the ramp portion 46. Alternatively, the second locking member 44 may be attached to the second applicator member 26 via a spring which is biased inwards towards a central axis A_c of the applicator 22 so that the second locking member 44 is pushed outwards away from the central axis A_c of the applicator 22 as the second locking member 44 passes over the ramp portion 46, but springs back inwards to the central axis A_c once the second locking member 44 has passed the ramp portion 46. It will be understood that other locking mechanisms which permit the movement of the second applicator member 26 in one direction but arrest movement of the second applicator member 26 in the opposite direction could be used. The locking mechanism 28 further includes a stop member 50 that is configured to prevent the second applicator member 26 from being slidably moved beyond the second extended position E2. In the embodiment shown, the stop member 50 protrudes from the outer surface of the first applicator member 24 and is positioned beyond the first locking member 42 in the first direction Di. The stop member 50 and the second locking member 44 include mutual abutment faces 52a, 52b which abut one another when the second applicator member 26 is slid to the second extended position E2. Once the second locking member 44 passes over the ramp portion 46, it is trapped between the stop portion 48 and the stop member 50, and so movement of the second applicator member 26 in either the first or second direction Di, D₂ is arrested.

It will be appreciated that other stop members which prevent the second applicator member 26 from being slidably moved beyond the second extended position E₂ may be used. Although not shown, the applicator 22 may further include a release mechanism which is configured to overcome the locking mechanism 28 to permit the second applicator member 26 to be slidably moved from the second extended position E2 to the retracted position R. The applicator 22 may further or alternatively include a release mechanism which is configured to overcome the locking mechanism 28 to permit the second applicator member 26 to be slidably moved beyond the second extended position E₂ so as to remove the second applicator member 26 from the first applicator member 24. The same release mechanism may achieve both releases.

The release mechanism may be a button located at the handle portion or at least at the first applicator first end 30a which, when pressed, pulls the first locking member 42 inwards (e.g. via a spring) towards the central axis A_c of the applicator 22 so that it lies flush with the outer surface of the first applicator member 24. Thus, the second locking member 44 is free to pass the first locking member 42 so that the second applicator member 26 can be slid down in the second direction D2 towards the retracted position R.

Alternatively (or in addition) the button may be pressed so as to pull the stop member 50 inwards (e.g. via a spring) towards the central axis A_c of the applicator 22 so that it lies flush with the outer surface of the first applicator member 24. Thus, the second locking member 44 is free to pass the stop member 50 so that the second applicator member 26 can be slid upwards in the first direction Di to separate the second applicator member 26 from the first applicator member 24.

The release mechanism may be formed from within the locking mechanism 28. For example, the first locking member 42 may include a passage to permit the second locking member 44 to pass therethrough, and a user rotates the second applicator member 26 to allow the second locking member 44 to locate the passage. The stop member 50 may instead or additionally include such a passage. Alternatively, the second locking member 44 may include a passage to permit the second locking member 44 and/or the stop member 50 to pass therethrough, and a user rotates the second applicator member 26 to allow the second locking member 44 and/or the stop member 50 to locate the passage. The release mechanism may take another form to overcome the locking mechanism 28.

Alternatively, the applicator 22 may not include a release mechanism and instead the first and second locking members 42, 44 and the stop member 50 may be shaped, sized and/or made from material which permits the locking mechanism 28 to be overcome upon the application of force. If the device 10 is made to be disposable, it does not matter if the locking mechanism 42 is broken when doing this.

The applicator 22 further includes an engagement member (not shown) which is configured to engage the first applicator member 24 with the second applicator member 26 when the second applicator member 26 is in the first extended position

until the second applicator member 26 is forcibly slid towards the retracted position R.

The engagement member may take the form of a shallow groove located on the outer surface of the first applicator member 24 at the second end 30b thereof into which a protrusion extending from the inner surface of the second applicator member 26 at the first end 32a thereof is located. The groove may instead be located on the second applicator member 26 and the protrusion on the first applicator member 24. The engagement member may be overcome by simply forcibly sliding (i.e. pushed by a user) the second applicator member 26 towards the retracted position R or instead by twisting the second applicator member 26 to separate the groove and the protrusion and then sliding the second applicator member 26 towards the retracted position R. It will be appreciated that the engagement member may take any other suitable form.

The handle portion 16 contains a drying agent 60 to help prevent sample degradation. The drying agent 60 may be any suitable desiccant, e.g. silica, molecular sieves, calcium chloride, sodium sulfate, calcium sulphate or magnesium sulfate. The drying agent 60 dries the closed atmosphere surrounding the swab 12.

The handle portion 16 also includes an abutment formation 56 which is configured to abut the second applicator member 26 when it is in the retracted position . More particularly, the handle portion 16 has a larger outer diameter than that of the first applicator member 24 so that the handle portion 16 extends beyond the first applicator member 24. The portion of the handle portion 16 which extends beyond the first applicator member 24 forms the abutment formation 56. A device 80 according to a second embodiment of the invention is shown in Figure 3. The device 80 shares the same features as the device 10 described hereinabove and like features have identical reference numerals.

The device 80 differs from the device 10 of the first embodiment of the invention in that the second applicator member 26 includes a tapered portion 82 which is tapered towards the second applicator second end 32b (i.e. the distal end of the device 80). The tapered portion 82 begins at around half the length of the second applicator member 26, but may be more or less this amount. Moreover, the notches 36 are omitted from the second applicator member 26 and instead the second applicator member 26 includes at least two (preferably four) elongate slits 84 extending from the second applicator second end 32b along the length of the tapered portion 82. The elongate slits 84 are positioned to open as the second applicator member 26 is slid towards the second direction D2 and the first applicator member 24 comes into contact with the tapered portion 82 of the second applicator member 26. As such, when the second applicator member 26 is slid to the retracted position, the first applicator member 24 forces open the elongate slits 84 to expose the absorbent portion 18.

In addition, the second applicator member 26 is made from a resiliently deformable material which returns to its original shape after the tapered portion 82 has been forced open. As such, when the second applicator member 26 is slid in the first direction Di and the first applicator member 24 no longer contacts the tapered portion 82, the second applicator member 26 returns to its original shape. Thus, the slits 84 return to their closed shape.

A device 90 according to a third embodiment of the invention is shown in Figures 4a and 4b. The device 90 shares the same features as the device 10 of the first embodiment of the invention described hereinabove and like features have identical reference numerals. The applicator members 24, 26 are not shown in Figures 4a and 4b for clarity purposes.

The device 90 differs from the device 10 described hereinabove in that it includes a frangible portion 92 which is configured to permit the absorbent portion 18 to break away from the device 10. In particular, the frangible portion 92 is formed in the shaft 94 of the swab 12. The shaft 94 differs from the shaft 20 described hereinabove in relation to the first embodiment of the invention in that it receives a rigid support member 96 that runs along the length of the shaft 94. The shaft 94 may be made from a hollow tube of plastic or cardboard while the rigid support member 96 may be a metal or plastic post.

The rigid support member 96 abuts the absorbent portion 18 and the rigid support member 96 is moveable in the first and second directions D-i, D2 upon activation and release of a plunger 98. When the plunger 98 is pushed in the first direction D-i, as shown in Figure 4b, the rigid support member 96 overcomes the frangible portion 92 and thus breaks the absorbent portion 18 from the remainder of the shaft 94. The absorbent portion 18 can then be removed from the rigid support member 96 and taken for testing. The rigid support member 96 provides support and strength to the shaft 94 and in particular the frangible portion 18 so that the frangible portion 18 is unaffected by twisting or flexing (and thus does not prematurely fracture).

As shown, the plunger 98 is recessed within the handle portion 16 so as to prevent accidental activation. A part of the handle portion 16 may be removed by a laboratory professional so as to activate the plunger 98 as necessary. In an alternative embodiment of the invention (not shown), the rigid support member 96 can instead be removed from the handle portion 16, or at least moved in the second direction D2, so that it no longer extends past the frangible portion 92. The frangible portion 92 can thereafter be easily fractured and the absorbent portion 18 removed from the remainder of the shaft 94.

The device 10 is used to collect a biological sample from a vaginal or anal orifice 58 according to the following steps. The following steps are described with regards to the device 10 of the first embodiment of the invention but it will be understood that the same steps apply to device 80 or device 90 as described above.

The device 10 is removed from any packaging and is presented with the second applicator member 26 in the first extended position E-i . A user grips the first grip portion 38 and the handle portion 16. The user preferably grips the device 10 with one hand. One option for gripping the device 10 with one hand is shown in Figure 5a in which the user grips the second applicator member 24 at the first grip portion 38 between the thumb and middle fingers, while at the same rests the index finger on the handle portion 16.

An alternative way to grip the device 10 with one hand would be to grip the second applicator member 26 at the first grip portion 38 between the index and middle fingers, while at the same time gripping the second grip portion 40 between the thumb and the little and/or ring finger.

Alternatively, the user may wish to grip the first grip portion 38 with one hand and the second grip portion 40 with another hand.

In any event, as shown in Figure 5b, the user then inserts the applicator 22 into a vaginal or anal orifice 58 via the domed head 34 of the second applicator member 26. The applicator 22 is inserted up to the second applicator first end 32a which is easily recognisable to the user because this is where the user is gripping the applicator 22.

Next, the user pushes the handle portion 16 in the first direction Di towards the vaginal or anal orifice 58. Such pushing force overcomes the engagement member and the second applicator member 26 slides in the second direction D2 until it abuts the abutment formation 56 of the handle portion 16. As the second applicator member 26 slides in the second direction D2, the absorbent portion 18 bursts through the notch 36 and out of the second applicator second end 32b so as to expose the absorbent portion 18. If necessary, the second applicator member 26 is twisted to overcome the engagement member before pushing the handle portion 16 in the first direction D-i . In any event, the second applicator member 26 is now in the retracted position R as shown in Figure 5c. As also shown in Figure 5c, the user then gently rotates and possibly agitates the device 10 so as to collect a biological sample.

Next, the user pulls the handle portion 16 back from the said orifice 58 while still gripping the second applicator member 26 via the first grip portion 38). The handle portion 16 is pulled back until the user either feels/hears the second locking member 44 passing the first locking member 42 or until the user feels/hears the second locking member 44 abut the stop member 50. More specifically, as the handle portion 16 is pulled back, the second locking member 44 travels up the ramp portion 46 of the first locking member 42. As the second locking member 44 travels up and over the ramp portion 46, the cardboard material of the second applicator member 26 permits the second applicator member 26 to flex outwards, thus allowing the second locking member 44 to pass the ramp portion 46. Once the second locking member 44 has passed the ramp portion 46, the cardboard material of the second applicator member 26 returns to its original shape, and thus the second locking member 44 cannot now easily pass back over the ramp portion 46.

Moreover, the stop portion 48 of the first locking member 42 abuts the second locking member 44 if the second applicator member 26 is moved backwards in the second direction D2. Furthermore, the mutual abutment faces 52a, 52b of the second locking member 44 and the stop member 50 abut one another if the second applicator member 26 is moved further upwards in the first direction Di. Thus, further movement of the second applicator member 26 in both the first and second directions D1 , D₂ is prevented.

The second applicator member 26 is now locked in the second extended position E₂, as shown in Figure 5d.

The user then removes the applicator 22 fully from the said orifice 58. The second applicator member 26 is in the second extended position E2 and the absorbent portion 18, with the biological sample thereon, is surrounded by the second applicator member 26 (as shown in Figure 5e). A device assembly according to a fourth embodiment of the invention is shown in Figure 6 and is designated generally by reference numeral 100. The device assembly 100 includes the device 10 as described hereinabove and a vessel 102 which is configured to receive the device 0. The device assembly 100 may instead include device 80 or device 90 as described hereinabove.

In the embodiment shown, the vessel 102 is an elongate tube with a first closed end 104 and a second open end 106.

The vessel 102 is long enough to receive the device 10 when the second applicator member 26 is in the second extended position E₂. The open second end 106 of the vessel 102 and the handle portion 16 of the device 10 are engageable with one another so as to secure the device 10 to the vessel 102. In particular, the handle portion 16 and the open second end 106 are configured to push/friction fit together. The handle portion 16 and the open second end 106 may be configured to engage with one another by another means, such as a screw fit.

In embodiments of the invention where the applicator 22 includes a release mechanism, the release mechanism may be configured to be activated upon insertion of the device 10 into the vessel 102 so as to permit the second applicator member 26 to slide towards the retracted position R.

For example, a small ridge may extend from the inner surface of the vessel 102 which depresses the button of the release mechanism as the device 10 is inserted into the vessel 102. Such an arrangement means that when the device 10 is removed from the vessel 102, the second applicator member 26 can be readily removed from the device 10 so that the absorbent portion 18 can be tested.

The vessel 102 may be made from a plastic material and may typically be transparent. The vessel 102 may also include labels on the outer surface thereof which contain information regarding the intended user. Moreover, the vessel 102 may contain a drying agent at the first closed end 104 of the vessel 102. The vessel 102 may instead contain a testing fluid at the first closed end 104. One such vessel 102' (forming part of a device assembly 100') is shown as an example at Figures 7a and 7b. The vessel 102' shares the same features of the vessel 102 described hereinabove.

The vessel 102' includes a pouch 108 at the closed end 104' of the vessel 102' which contains either a drying agent or a testing fluid 110. The drying agent or testing fluid 110 is sealed by a membrane 112 facing towards the open end 106' of the vessel 102'. The fluid 110 may contain an anti-microbial and anti-fungal agent.

The pouch 108 is positioned within the vessel 102' such that when the device 10 is inserted into the vessel 102' in the first extended position Ei, the device 10 does not rupture the membrane 112 (as shown in Figure 7a), but the device 10 does rupture the membrane 112 when the device 10 is inserted in the second extended position E2 (as shown in Figure 7b).

As also shown in Figure 7b, the vessel 102' may additionally include a release mechanism 114 which overcomes the locking mechanism 28 as the device 10 is re-inserted into the vessel 102'. The release mechanism 114 shown in a flange 116 which catches the first grip portion 38 on the device 10 so as to break the locking mechanism 28 once the device 10 has been fully inserted back into the vessel 102'. In this way, the second applicator member 26 is free to move in the second direction D₂ to thus expose the absorbent portion 18 to the drying agent/testing fluid 110. The sides of the membrane 112 also abut the second applicator member 26 as the device 10 is inserted fully into the vessel 102' so as to push the second applicator member 26 back towards the second direction D2, thus exposing the absorbent portion 18 to be surrounded by the fluid 110.

The vessel 102' may include another ridge located towards the closed end 104' of the vessel 102' which abuts the end of the second applicator member 26 when the device 10 is being inserted back into the vessel 102', thus pushing the second applicator member 26 back towards the second direction D2.

In this embodiment, the seal between the handle portion 16 and the vessel 102' is fluid tight to prevent leakage. Use of the device assembly 100 is described below. It will be understood that the same steps can be followed for the device assembly 00' described immediately above.

A user receives the device 10 in the vessel 102. The user removes the device 10 from the vessel 102 by pulling (or twisting, as the case may be) the handle portion 16 to release the device 10 from the vessel 102.

The device assembly 100 may have a seal that spans over the handle portion 16 and a portion of the vessel 102 at the open end 106 thereof which is broken when the device 10 is removed from the vessel 102. Such a seal could optionally incorporate an indicator dye that changes colour when exposed to DNA sterilization methods such as ethylene oxide treatment.

In any event, the device 10 is then used to collect a biological sample from a vaginal or anal orifice as already described hereinabove.

Once the biological sample is collected, the user re-inserts the device 10 into the vessel 102 and connects the handle portion 16 to the second open end 106 of the vessel 102. The vessel 102 can then be transported to a laboratory while keeping the collected biological sample safe and free from contamination.

A laboratory professional can then remove the device 10 from the vessel 102 and activate the release mechanism to expose the absorbent portion 18. If there is no release mechanism, the laboratory professional can instead force the second applicator member 26 either in the first or second direction Di, D₂ so as to overcome the locking mechanism 28.

Alternatively, the user may manually activate the release mechanism and either slide the second applicator member 26 back to the retracted position R or slide the second applicator member 26 up past the second extended position E₂ to separate the second applicator member 26 from the first applicator member 24. Thus the absorbent portion 18 is exposed and the device can be re-inserted into the vessel 102. If there is no release mechanism but the user is required to expose the absorbent portion 18 before re-inserting the device 10 into the vessel 102, the user can instead force the second applicator member 24 to overcome locking mechanism 28.

Claims

CLAIMS:

1. A device for self-collection of a biological sample from a vaginal or anal orifice comprising:

2. The device according to Claim 1 wherein the locking mechanism includes first and second locking members, each of the first and second locking members being located on a respective facing surface of the first and second applicator members.

3. The device according to Claim 2 wherein the first locking member is configured to permit the second locking member to pass in a first direction as the second applicator member is slid from the first extended position to the second extended position, and to prevent the second locking member from passing in a second direction opposite to the first direction once the second applicator member is in the second extended position.

4. The device according to Claim 3 wherein the first locking member includes a ramp portion starting at one end of the first locking member and a stop portion at the other end of the first locking member.

5. The device according to any preceding claim wherein the locking mechanism further includes a stop member configured to prevent the second applicator member from being slidably moved beyond the second extended position.

6. The device according to any preceding claim wherein the applicator further includes a release mechanism configured to overcome the locking mechanism to permit the second applicator member to be slidably moved from the second extended position to the retracted position.

7. The device according to any preceding claim wherein the applicator further includes a release mechanism configured to overcome the locking mechanism to permit the second applicator member to be slidably moved beyond the second extended position so as to remove the second applicator member from the first applicator member.

8. The device according to any preceding claim wherein the applicator further includes an engagement member configured to engage the first applicator member with the second applicator member in the first extended position until the second applicator member is forcibly slid towards the retracted position.

9. The device according to any preceding claim wherein the swab includes a frangible portion to enable the absorbent portion to be detached from the swab.

10. The device according to Claim 9 further including an elongate support member received by the swab and extending between the first and second ends of the swab, the support member being configured to be pushed from the first end of the swab and abut the absorbent portion so as to rupture the frangible portion of the swab.

11. The device according to any preceding claim wherein the second applicator member includes a tapered portion which tapers towards a distal end of the device.

12. The device according to Claim 1 1 wherein the second applicator member includes at least two slits extending from the distal end of the device, the slits being configured to open so as to expose the absorbent portion when the first applicator member contacts the tapered portion of the second applicator member as the second applicator member is slid to the retracted position.

13. The device according to any preceding claim wherein the handle portion contains a drying agent to prevent sample degradation.

14. The device according to Claim 13 wherein the drying agent is selected from the group consisting of silica, molecular sieves, calcium chloride, sodium sulfate, calcium sulphate and magnesium sulfate.

15. The device according to any preceding claim wherein the handle portion includes an abutment formation configured to abut the second applicator member in the retracted position.

16. A method of analysing a biological sample collected on a device as defined in any one of Claims 1 to 15.

17. A device assembly including a device according to any one of Claims 1 to 15 and a vessel configured to receive the device.

18. The device assembly according to Claim 17 wherein the vessel is configured to receive the device when the second applicator member is in the second extended position.

19. The device assembly according to either Claim 17 or Claim 18 when dependent on Claim 6 wherein the release mechanism is activated upon insertion of the device into the vessel so as to permit the second applicator member to slide towards the retracted position.

20. The device assembly according to any one of Claims 17 to 19 wherein the vessel and the handle portion are engageable with one another to secure the device to the vessel.

21. The device assembly according to any one of Claims 17 to 19 wherein the vessel includes a pouch containing a drying agent or a testing fluid.

22. The device assembly according to Claim 21 wherein the pouch is positioned within the vessel so that the device ruptures the pouch when the vessel receives the device when the second applicator member is in the second extended position.

23. A kit for the collection of a biological sample comprising:

(v) a device assembly according to any one of Claims 17 to 22;

(vi) a container for storing the contents of the kit;

(vii) instructions providing information for using the kit; and

(viii) a labelling means for identifying a user.

24. A device generally as herein described with reference to and/or as illustrated in the figures.

25. A device assembly generally as herein described with reference to and/or as illustrated in the figures.