WO2009018607A1

WO2009018607A1 - Device and method for biological sampling

Info

Publication number: WO2009018607A1
Application number: PCT/AU2008/001120
Authority: WO
Inventors: Kristine Leigh Riley
Original assignee: Polartechnics Limited
Priority date: 2007-08-03
Filing date: 2008-08-01
Publication date: 2009-02-12

Abstract

A biological sampling device (1) is disclosed for collecting a biological sample from a body orifice. The biological sampling device comprises an elongate body (2) and a cap (3) removably attachable to the body (2). The body comprises a first end having a handle, by which a user can hold the biological sampling device (1), and a second end arranged for insertion in the orifice. The second end comprises a biological sampling formation (4) for taking a biological sample from the orifice. The cap (3) protects the sampling formation (4) from contamination.

Description

Device and Method for Biological Sampling

Technical Field

The present invention relates to a device and a method for collecting samples of biological material for testing. In particular, the invention relates to a device and a method for collecting DNA genetic material from the vagina for testing.

Background of the Invention

Human Papillomavirus (HPV) infection is considered to be a necessary factor in developing cervical cancer. A significant proportion of the adult population is infected with HPV. Approximately 1% of women with genital HPV infections will eventually go on to develop cervical cancer. Several hundred thousand women die each year from cervical cancer worldwide.

One procedure that has helped reduce the incidence and lethality of cervical cancer is the Cervical Pap smear test. This is a screening test used to examine cells from the cervix. Samples are collected from the outer opening of the cervix using a spatula or broom and are studied for HPV-induced cellular abnormalities. The sampling device mechanically interacts with the sensitive area of the cervix and can also, occasionally, be pushed further into the birth canal. Thus, the sampling procedure may cause discomfort to the patients. In addition, since the test is necessarily administered by a trained professional, a potential patient needs to make an appointment and allocate an appreciable amount of time for the test. As a result many women avoid taking the Pap smear test.

There are further problems with the Pap smear test. Human error during the collection and analysis of the Pap smear often reduces the efficiency of the test. Also, some women do not shed abnormal cervical cells, making it difficult to detect lesions by Pap smear alone. For these reasons, recently there has been a trend in the medical profession towards complementing the Pap smear test with an HPV test. While the presence of HPV in the body is not a conclusive proof of the development of cervical cancer, it is considered to be an important warning sign. Thus, it is believed that the combination of HPV test and a PAP smear test substantially improves the overall probability of detecting the cancer. On the other hand, the absence of HPV infection can be taken as an indication that the contraction of cervical cancer is unlikely. Thus, the need for frequent checks for patients with confirmed negative results is greatly reduced.

Accordingly, it is desirable to develop a simple and convenient test for HPV. It is specifically desirable to develop a convenient way for collecting DNA samples from vaginal cavities, so as to reduce the overall inconvenience associated with HPV testing.

Summary of the Invention

According to one aspect of the invention, there is provided a biological sampling device for collecting a biological sample from a body orifice. The biological sampling device comprises an elongate body and a cap removably attachable to the body for protecting the sampling formation from contamination. The body includes a first end comprising a handle, by which a user can hold the biological sampling device, and a second end. The second end is arranged for insertion in the orifice and comprises a biological sampling formation for taking a biological sample from the orifice. Preferably, the biological sampling formation includes a fibre flocked swab.

According to a second aspect of the invention, there is provided a method for collecting a sample from a body orifice with a biological sampling device according to any one of the preceding claims, the method comprising the user performing the following steps; removing the removable cap, inserting the biological sampling formation into the body orifice, taking the sample, extracting the biological sampling formation from the body orifice and replacing the removable cap onto the body. The steps are performed by the user applying a single continuous grip to the handle.

According to a third aspect of the invention, there is provided a test kit comprising the biological sampling device of the first aspect. According to a fourth aspect of the invention, there is provided a biological testing system comprising a biological sampling device of the first aspect and a biological analysis apparatus for analysing the biological sample collected by the device.

According to a fifth aspect of the invention, there is provided a method for conducting a biological test. The method comprises the steps of providing a user with a biological sampling device to be self administered by a user and posted to a predetermined location, retrieving at least some of the biological sample from the biological sampling device at the predetermined location and processing the retrieved biological sample by way of a biological analysis apparatus, at the predetermined location.

Brief Description of the Drawings

In the drawings: Fig. 1 is an exploded perspective view of a biological sampling device according to a first embodiment of the invention, with the cap separated from the body.

Fig. 2 is a cross-sectional side view of the biological sampling device of Fig. 1 , the device being shown with the cap attached to the body.

Fig. 3 is a side view of the body of the biological sampling device of Fig. 2, without a cap.

Fig. 4 is an exploded side view of a biological sampling device according to a second embodiment of the invention, the device having a slidable cover.

Fig. 5 is a side view of the biological sampling device of Fig. 4, with the cap on and the slidable cover being moved into a closed configuration of the device. Fig. 6 is a side view of a biological sampling device of Fig. 5, with the cap off.

Fig. 7 is a side view of the body of the biological sampling device of Fig. 4, without the cap and the slidable cover.

Detailed Description

The disclosed biological sampling device is used for collecting a biological sample from a body orifice. The collected biological sample is then tested in order to detect viral infection. Any living tissue or cellular material contains DNA. A virus also contains DNA information and this is typically used for an indication that a particular type of virus is in the sample of biological material that has been collected.

One embodiment of the biological sampling device 1, arranged for collecting a DNA sample from the vaginal cavity of the user, is shown in Fig. 1. The sampling device 1 is used for collecting samples for the purpose of conducting an HPV test. The illustrated sampling device 1 includes an elongate body 2 and a cap 3, which is removably attachable to the body 2. The body 2 comprises a biological sampling formation, in the form of a flocked fibre swab 4, and a handle portion 5. In use, a user holds the device 1 by the handle 5, inserts the swab 4 into the vagina and brushingly moves the device 1 against the walls of the vaginal cavity to collect DNA material with the swab 4. In view of the particular application of the device, the swab 4 is located at one end, and the handle 5 is located at the other end of the body 1.

The swab 4 comprises a plurality of fibres 6, each fibre having at least one of its ends attached to the outer surface of the body 1. Embodiments in which the fibres are bent and both ends of each fibre are attached to the outer surface of the body 1, are also possible. Polyester or nylon fibres 6 are used for the swab 4. Even though natural fibres can also be used, synthetic fibres are preferred. This is associated with the fact that the fibres need to be sufficiently soft so as to facilitate a convenient use of the device 1. The fibres, however, have to be also strong enough to be able to collect sufficient DNA material when brushed against the wall of the vagina. In addition, to avoid contaminating the DNA, when collecting it from the swab 4 in the processing laboratory, it is preferred that the biological material collected with the swab 4 does not have to be wrung out or extracted from the swab material. Accordingly, synthetic fibres are preferred because of their absorption characteristics.

The density, the particular arrangement and the exact location of the flocked fibre portion (also referred to as swab) 4 of the body 2 can vary in order to optimise the functionality of the device 1. For example, instead of single fibres, periodically or randomly spaced bunches of fibres can be used to define the swab 4. In relation to the fibre density, conducted experiments indicate that dense fibre coverage, akin to matted fibre configuration, is particularly suitable for the HPV sampling.

The physical characteristics of the variousxomponents of the device 1 are also chosen in view of the DNA collecting application of the device 1. For example, the dimensions and the shape of the body 2 and the swab 4 are chosen to enable a comfortable insertion of the swab 4 into a vagina. The length of the swab 4 and the body 2 can be varied depending on whether it is desirable for the swab 4 to reach the cervix during sampling. It was found that a swab with a shape of a cylinder having length of between one and ten centimetres or preferably between one and six centimetres, and a base diameter of between one and two centimetres, fulfils the above requirements. The dimensions of the handle 5 are not critical and are chosen in view of a convenient handling by the user. For example, a configuration having a fibre swab 4 with a length of approximately five centimetres, a non- flocked stem section 5' with a length of approximately four centimetres and a handle 5 with a length of approximately three centimetres, has proved to be particularly convenient.

The removable cap 3 is made of plastic material and includes an inner surface rib 7 that snaps onto rib 8 disposed on the outer surface of the non-flocked section 5' of the body 2, to lock the cap 3 to the body 2. The locking engagement between the ribs 7 and 8 is shown in Fig. 2. A secure and reliable snap-locking engagement between the cap 3 and the body 2 is important for protecting the fibre swab 4 from contamination. To avoid sample contamination, it is important that swab 4 is kept clean both before and after the use of the HPV sampling device 1. A complementary seal in the form of rubber lining, not shown, can also be included to substantially waterproof the device 1.

The sampling device 1 shown in Figs. 1 to 3 comprises a single cap 3 that covers the sampling swab 4 and protects it from contamination. An alternative embodiment is shown in Fig. 4. Device l(a) in this figure comprises a body 2(a) and a snap-on cap 3(a). Similar to the first embodiment, the body 2(a) of the second embodiment comprises a handle 5(a) and a DNA collecting swab 4(a). However, the device l(a) further comprises a slidable cover 9 that is sleavingly engaged with at least a portion of the body 2(a) and is arranged to slide along the length of the body 2(a). In Fig. 4, cover 9 is slid towards handle 5(a), defining a fully open configuration of the device l(a). The open configuration is arranged to expose the sampling swab 4(a).

Figs. 5 to 7 show only the body 2(a) of the sampling device l(a). The cap 3 (a) is disregarded in these figures to more clearly illustrate the structure of the body 2(a).

Fig. 5, in particular, illustrates the closed configuration of the device l(a), in which slidable cover 9 is moved away from the handle 5(a) to substantially cover the swab 4(a). To allow the sliding movement of the cover 9 along the body 2(a), the slidable cover 9 comprises an opening 10. When the device l(a) is in a closed configuration, the opening 10 defines a peripheral portion 11 of the swab 4(a), which is not covered by the slidable cover 9. Nonetheless, the slidable cover 9 provides substantial protection for the swab 4(a). This protection is complemented and enhanced by the snap on cap 3(a), which in this case snaps on to slidable cover 9, when the device l(a) is in fully closed configuration. In particular, an inner rib 7(a) on the cap 3 (a) snap-lockingly engages rib 8(a) on the outer surface of the slidable cover 9. Snap-on cap 3(a) ensures that the swab 4(a) is completely covered and protected from contamination. It is envisaged that, similarly to the first embodiment, the snap-on cap in this embodiment can also be arranged to snap onto the body 2(a), instead of the slidable cover 9. Again sealing rubber or plastic lining can be applied to make the device waterproof.

Groove 12, shown in Figs. 5 to 7, is slidingly engageable with a projection 15 disposed on the internal surface of slidable cover 9, as shown in Fig. 6. This engagement is arranged to guide the sliding of the slidable cover 9 along the body 2(a). Each of notches 13 and 14, best shown in Fig. 7, is arranged to receive and lock the above mentioned projection 15 when the slidable cover 9, in the fully open or the fully closed configuration, is rotated in a respective direction. Thus, upon rotation in a respective direction, the sliding cover 9 is lockable in the fully open or the fully closed configuration. In particular, to facilitate the locking, when the slidable cover 9 is placed in one of these configurations, the user rotates the slidable cover 9 in a direction predetermined by the location of the notch 13 or notch 14 with respect to the projection 15. The locking engagement facilitated by the notch 13 ensures that the swab 4(a) is reliably protected when the device l(a) is in a closed configuration. The locking arrangement facilitated by notch 14 ensures a convenient operation of the device l(a), when the device is in the open configuration.

When the device l(a) is in use, the snap-on cap 3(a) is removed; the slidable cover 9 is pushed towards the handle 5 (a) and rotated to lock slidable cover 9 in the fully open configuration. After a sample has been collected, the slidable cover is rotatingly unlocked and slid into the closed configuration. In this configuration, cover 9 is rotated in an opposite direction to lock into the closed configuration. Snap-on cap 3 (a) is then lockingly engaged with the slidable cover to completely seal the swab 4(a) and prevent contamination of the collected sample.

In the device 1, the size of the handle 5, the removable cap 3 and the slidable cover 9 are chosen so that when the removable cap 3 is snapped onto the body, the handle 5 protrudes beyond the removable cap and is, thus, able to be gripped by the user. This configuration, best shown in Fig. 3, allows the entire sequence of steps involved in using the device 1 to be performed by solely the user by applying a single continuous grip to the handle. The particular steps involved in the use of the device are; gripping the handle 5 with a first hand, removing the removable cap 3 with the other hand, inserting the biological sampling formation 4 into the body orifice (eg. the vagina) and taking a biological sample. The very step of taking a biological sample may involve rotating and/or brushing the device against the inner walls of the body orifice by movement of the first hand. The obtaining of the sample is followed by extracting the biological sampling formation 4 from the body orifice with the first hand and replacing the removable cap 3 over the body 2 of the device with the second hand.

For a device with a slidable cover 9, the above steps would also include sliding the slidable cover 9 into open configuration with the other hand, before inserting the biological sampling formation 4 into the body orifice, and sliding the slidable cover 9 into closed configuration with the other hand, after extracting the biological sampling formation 4 from the body orifice. The ability to perform all these steps by a sole user applying a single continuous grip to the handle 5 is important for ensuring the purity of the sample taken by the device. While Figs. 1 to 7 and the above description disclose specific embodiments of the described HPV sampling device, alterations are also possible, which are still within the scope of this invention, hi particular, while the disclosed embodiments have been described in the context of a vaginal cavity sampling device, it is envisaged that such devices can be adapted for use for collecting DNA samples from any body orifice, i.e. for anal, throat, ear and nose sampling. Further, the swab can comprise fibres other than synthetic fibres or include a non-fibre material such as sponge or other soft material.

In addition, while the embodiments described in the above paragraphs are self administered and are directed towards a single use, nothing prevents the device from being used multiple times and being administered by a medical professional upon a patient. Regarding the term "user" used throughout this specification, in the context of someone manipulating the device for taking a sample of the body of another person, it will be assumed that the person handling the device is "the user".

Thee described device can be a part of a testing kit, which may also include for example rubber gloves, a brief description of the testing procedure and a pre- addressed envelope, or some other arrangement, for forwarding the collected sample for testing. A complete testing system, including the sampling device, can also be developed. For example, the device can be sold in retail outlets or online. The purchased device is then administered or self-administered to obtain a DNA sample. After use, the device is sealed to prevent any sample contamination and is posted, or otherwise forwarded, to a predetermined address for testing. A qualified technician or medical practitioner, located at this address, then retrieves some of the biological sample from the swab formation 4. A DNA test is then carried out on the retrieved sample by the qualified technician or medical practitioner, using specialised test equipment, in the form of a biological analysis apparatus. The user is then notified of the results of the test. In the case of positive results, a second HPV test or a PAP smear test may be carried out to confirm the result.

It is clear from the above description that a biological sampling device is disclosed that facilitates convenient collection of DNA samples from a vaginal cavity to facilitate an HPV test. An associated testing kit, system and method are also disclosed.

Apart from DNA sampling, the disclosed device can also be used for testing for other genetic material (e.g. RNA) or for collection of biological tissue for any other purposes. The sampled material is processed in a dedicated laboratory and used for diagnostic, forensic or other purposes. The device, the testing kit and the described method are also directly applicable in veterinary science. Of course, the size, the proportions and the materials used for making the sampling device will depend on the particular animals to which this is applied.

In the context of this specification, the word "comprising" means "including principally but not necessarily solely", or "having" or "including", and not "consisting only of. Variations of the word "comprising", such as "comprise" and "comprises" have correspondingly varied meanings.

Claims

Claims:

1. A biological sampling device for collecting a biological sample from a body orifice, the biological sampling device comprising; an elongate body including; a first end comprising a handle, by which a user can hold the biological sampling device, and a second end arranged for insertion in the orifice and comprising a biological sampling formation for taking the biological sample from the orifice; and a cap removably attachable to the body for protecting the sampling formation from contamination.

2. The biological sampling device of claim 1 wherein the biological sampling formation includes a fibre flocked swab.

3. The biological sampling device of claim 2 wherein the swab comprises synthetic fibres.

4. The biological sampling device of any one of the preceding claims, wherein the biological sampling device is sized and shaped for collecting a DNA sample from a vaginal cavity to facilitate an HPV test.

5. The biological sampling device of any one of the preceding claims wherein the removable cap is arranged for a snap-on engagement with the body.

6. The biological sampling device of any one of the preceding claims wherein, when the removable cap is snapped onto the body, the handle protrudes beyond the removable cap, thus facilitating continuous gripping of the handle during use of the device.

7. The biological sampling device of any one of the preceding claims, the device further comprising a slidable cover sleavingly engaged with at least a portion of the body so as to slide between; an open configuration of the device, in which the slidable cover is slid towards the first end of the handle to expose the biological sampling formation; and a closed configuration of the device, in which the slidable cover substantially covers the biological sampling formation.

8. The biological sampling device of claim 7 wherein the snap-on cap is arranged to snap onto the sliding cover, when the device is in the closed configuration.

9. The biological sampling device of claim 7 or claim 8 wherein the slidable cover is lockable into the open and the closed configuration.

10. The biological sampling device of any one of claims 7 to 9, wherein the body comprises a groove and the slidable cover comprises a projection slidingly engageable with the groove to guide the sliding of the slidable cover along the body.

11. The biological sampling device of claim 10, wherein each end of the groove comprises a locking notch arranged to receive the projection, such that when the slidable cover is in the open configuration or in the closed configuration, a rotation of the slidable cover in a respective direction lockingly engages the projection with a corresponding locking notch to lock the slidable cover in the respective configuration.

12. The biological sampling device of any one of the preceding claims, wherein the biological sampling formation is of a cylindrical shape with a length of between one and six centimetres, and a base diameter of between one and two centimetres.

13. The biological sampling device of any one of the preceding claims, wherein the biological sampling formation is substantially waterproofed, when the removable cap is in its closed configuration.

14. A method for collecting a sample from a body orifice with a biological sampling device according to any one of the preceding claims, the method comprising the user performing the following steps; removing the removable cap; inserting the biological sampling formation into the body orifice; taking the sample; extracting the biological sampling formation from the body orifice; and replacing the removable cap onto the body, wherein all of the above steps are performed by the user applying a single continuous grip to the handle. s

15. The method of claim 14, the sampling device further comprising a slidable cover, wherein the method comprises the following additional steps; sliding the slidable cover into an open configuration, the step being performed before inserting the biological sampling formation into the body orifice, and o sliding the slidable cover into closed configuration, the step being performed after extracting the biological sampling formation from the body orifice.

16. The method of claim 14 or claim 15, wherein the user self-administers the biological sampling device. 5

17. A test kit comprising the biological sampling device of any one of claims 1 to 13.

18. A biological testing system comprising; a biological sampling device for collecting a biological sample, the sampling0 device being according to any one of claims 1 to 13; and a biological analysis apparatus for analysing the biological sample collected by the device.

19. The biological testing system of claim 18, wherein; 5 the biological sampling device is administered at a different location from that of the biological analysis apparatus; and the system further comprises a communication arrangement for sending the biological sample collected with the biological sampling device to the biological analysis apparatus site for analysis. 0

20. The biological testing system of claim 18 or claim 19, wherein the system is arranged for collecting a DNA sample from a vaginal cavity to facilitate an HPV test.

21. A method for conducting a biological test, the method comprising the steps of; providing a user with a biological sampling device to be self administered by a user and posted to a predetermined location; retrieving at least some of the biological sample from the biological sampling device at the predetermined location; and processing the retrieved biological sample by way of a biological analysis apparatus, at the predetermined location.

22. The method of claim 21 , wherein the biological sampling device is provided to the user through a retail outlet.

23. The method of claim 21 or claim 22, wherein the biological sampling device is mailed by the user to the predetermined location.

24. The method of any one of claims 21 to 23 , wherein the method is directed to collecting a DNA sample from a vaginal cavity to facilitate an HPV test.