WO2021186361A1

WO2021186361A1 - Sample collection device

Info

Publication number: WO2021186361A1
Application number: PCT/IB2021/052225
Authority: WO
Inventors: Helen Lee
Original assignee: Diagnostics For The Real World, Ltd
Priority date: 2020-03-17
Filing date: 2021-03-17
Publication date: 2021-09-23
Also published as: GB202003860D0

Abstract

A sample collection device is described. The device comprises a container for receiving a sample, and a lid flexibly attached to the container to engage with an open end of the container to seal an interior of the container from the external environment. The lid comprises a pierceable surface to allow access to the interior of the container through the lid when it is engaged with the open end of the container. A sealing element is flexibly attached to the container, and is configured to engage with the lid when it is engaged with the open end of the container to form a seal over the pierceable surface of the lid and thereby seal the interior of the container from the external environment once the lid has been pierced. Kits comprising the device, and methods for collection of a sample using the device, are also described.

Description

Sample Collection Device

This invention relates to a sample collection device, in particular for collecting a hazardous sample, for example a hazardous biological sample. The invention also relates to kits comprising the sample collection device, and to methods for collection of a sample using the sample collection device.

When a hazardous sample is collected and processed for testing, it is important that it does not contaminate the person collecting and processing the sample, or the environment. For example, some biological samples may include potentially hazardous biological agents, such as infectious pathogens that can cause severe human disease. Biological samples may be collected and processed for testing to determine whether a subject is infected with a particular pathogen. In some cases (for example, Hazard Group 3 biological agents, which are agents that can cause severe human disease), it is necessary for the person collecting the sample to wear gloves, a lab coat, and goggles, and to have on their person provision for disposal of the biological agent.

There is a need for safe containment of a hazardous sample when it is collected and processed so that it does not contaminate the person collecting and processing the sample, or the environment.

According to the invention there is provided a sample collection device, which comprises: a container for receiving a sample; a lid flexibly attached to the container and configured to engage with an open end of the container to seal an interior of the container from the external environment, wherein the lid comprises a piercable surface to allow access to the interior of the container through the lid when the lid is engaged with the open end of the container; and a sealing element flexibly attached to the container, wherein the sealing element is configured to engage with the lid when the lid is engaged with the open end of the container to form a seal over the piercable surface of the lid and thereby seal the interior of the container from the external environment once the lid has been pierced.

The term “seal” is used herein to mean that the contents of the interior of the container are prevented from exchanging with contents of the external environment and vice versa. In particular, the seal should be sufficiently tight to prevent exit or entry of an infectious agent, such as a bacterium, virus, or fungus, components of an infectious agent, or of biological molecules, such as nucleic acid, carbohydrate, polypeptide, or protein, from or into the container. Optionally the seal is an air-tight, or hermetic seal.

The pierceable surface comprises a surface which is impermeable to any hazardous agent present in the sample, including for example biological agents (such as infectious agents, including viruses, bacteria, or fungi, or components of such agents), and biological molecules (such as nucleic acids, carbohydrates, polypeptides, proteins).

Optionally the pierceable surface is composed of a suitable material to allow it to be punctured by application of pressure by a user (i.e. manual pressure) to the pierceable surface with an end of a manipulation device. The term ‘manipulation device’ is used herein to refer to a device for injecting or withdrawing a fluid (preferably a liquid) through the piercable surface of the lid. Examples of suitable manipulation devices include a pipette tip, a needle, or a syringe, or devices that comprise a pipette tip, a needle, or a syringe. For example, the end of the manipulation device may comprise a pipette tip, a needle, or a syringe with an outer end diameter of up to 2.5mm, 2mm, 1 5mm, or 1 mm.

Advantageously, the material of the pierceable surface allows an end of the manipulation device to puncture a hole in the pierceable surface of a size which is as close as possible (or up to as close as possible) in area to the cross-sectional area of the largest part of the manipulation device that will penetrate the pierceable surface. This will leave as much as possible of the piercable surface intact after the piercable surface has been pierced by the manipulation device, and thereby reduce the risk of any sample in the container contaminating the user or the environment. Optionally the hole has an area that is up to 100%, 110%, 120%, 130%, 140%, 150%, 160%, 170%, 180%, 190%, or 200% of the cross-sectional area of the largest part of the manipulation device that will penetrate the pierceable surface.

Optionally the pierceable surface does not comprise an elastomeric material, such that the pierceable surface does not re-seal itself once it has been pierced.

In other embodiments, the pierceable surface may comprise an elastomeric material, such that the pierceable surface re-seals once it has been pierced by an end of a manipulation device (such as a pipette tip, a needle, or a syringe). Examples of elastomeric materials are well-known to the skilled person, and include unsaturated or saturated rubbers.

Optionally the pierceable surface comprises a pierceable membrane.

Optionally the pierceable surface or pierceable membrane comprises polytetrafiuoroethylene (PTFE), silicone, santoprene, or aluminium foil.

It will be appreciated that access to the interior of the container through the pierceable surface allows manipulation of the sample to be carried out after it has been collected and deposited in the container. The presence of the pierceable surface of the lid reduces the risk that any sample in the container will contaminate the user or the environment whilst any such manipulation is carried out. In particular, the pierceable surface allows a reagent to be added to the container, or for contents of the container to be withdrawn, once the lid has been engaged with the open end of the container. For example, a reagent may be added to a sample present in the container for processing of the sample, or the reagent may be provided in the container prior to introduction of the sample, and the processed sample (or a portion of the processed sample) may be withdrawn for further processing and/or testing.

Once the interior of the container has been accessed for any necessary manipulation of the sample to be carried out, the sealing element can then be engaged with the lid to provide a more secure closure of the container, for example, prior to storage or transport of the sample collection device.

It will be appreciated that the sealing element acts as a second lid to secure closure of the container once any necessary manipulation of a sample collected in the container has been carried out by accessing the interior of the container through the pierceable surface of the lid.

Thus, a sample collection device of the invention allows a sample to be collected, processed, and manipulated with reduced risk of a user or the environment being contaminated by the sample. This is particularly advantageous for collection and processing of hazardous samples, especially hazardous biological samples. Once any necessary manipulation of the sample has been carried out, the sample collection device can then be sealed securely for transport or storage.

Optionally the sealing element is composed of a material that is more resistant to puncture (in particular, to puncture by a manipulation device) than the pierceable surface of the lid. Optionally the sealing element is composed of the same material as the container.

Examples of suitable material from which the container and/or the sealing element may be made include plastic, for example polyethylene terephthalate (PET), polypropylene, PPCO (polypropylene copolymer), polycarbonate or polystyrene. Polypropylene and PPCO tubes are autoclavable and provide excellent chemical resistance combined with good mechanical strength. Polycarbonate, PET and polystyrene offer exceptional optical clarity and disposability. Plastic tubes may be provided in tinted versions to protect light-sensitive samples.

Optionally the lid is configured to engage by a push-fit with the open end of the container. This is advantageous as a push-fit engagement allows a user to feel that the lid has engaged with the open end of the container and that a seal has been formed.

Optionally the lid comprises an external side wall for engaging with an internal side wall of the open end of the container to seal the interior of the container from the external environment. Optionally the external side wall of the lid comprises a seal which contacts the internal side wall of the open end of the container to seal the interior of the container from the external environment when the lid is engaged with the open end of the container.

Optionally the external side wall of the lid comprises a first seal, and a second seal spaced from the first seal along the external side wall of the lid, wherein each seal contacts the internal side wall of the open end of the container to seal the interior of the container from the external environment when the lid is engaged with the open end of the container. Provision of first and second seals is advantageous as this minimises the risk that material in the interior of the container could become exposed to the external environment if one of the seals is damaged or fails.

Optionally the lid comprises a recess for receiving the sealing element, wherein the recess is defined by an internal side wall and an end wall of the lid, and wherein the end wall of the lid comprises the pierceable surface.

Optionally the sealing element is configured to engage with the lid by a push-fit. Again, this is advantageous as a push-fit engagement allows a user to feel that the sealing element has engaged with the lid and that a seal has been formed.

Optionally the sealing element comprises an external side wall for engaging with an internal side wall of the lid to form a seal over the pierceable surface of the lid.

Optionally the external side wall of the sealing element comprises a seal which contacts the internal side wall of the lid to form a seal over the pierceable surface of the lid when the sealing element is engaged with the lid.

Optionally the external side wall of the sealing element comprises a first seal, and a second seal spaced from the first seal along the external side wall of the sealing element, wherein each seal contacts the internal side wall of the lid to form a seal over the pierceable surface of the lid when the sealing element is engaged with the lid. Again, provision of first and second seals is advantageous as this minimises the risk that the interior of the container could become exposed to the external environment if one of the seals is damaged or fails.

Optionally the lid is attached to the container by a first flexible arm. The first flexible arm allows the lid to be engaged with, and disengaged from, the open end of the container whilst retaining its attachment to the container. Optionally the sealing element is attached to the container by a second flexible arm. The second flexible arm allows the sealing element to be engaged with, and disengaged from, the lid whilst retaining its attachment to the container.

Optionally the first and/or second flexible arms are attached to a retaining element mounted towards the open end of the container.

Optionally the retaining element, the flexible arms, the lid, and the sealing element are formed as a single piece, for example from moulded plastic material (such as polyethylene terephthalate (PET), polypropylene, PPCO (polypropylene copolymer), polycarbonate or polystyrene).

Optionally the retaining element may be shaped asymmetrically to provide a one-way fit for operation in an automated sample processing machine (such as an automated sample processing machine described in WO 2014/140640).

Optionally the container comprises a collar which extends outwards from a side wall at the open end of the container, and which prevents the retaining element from sliding off the container at its open end.

Optionally the lid comprises a lip which extends over an end wall at the open end of the container when the lid is engaged with the open end of the container. The lip is advantageous because it covers the end wall at the open end of the container when the lid is engaged with the open end of the container, thereby providing some protection against ingress of material between the internal side wall of the container and the external side wall of the lid.

Optionally the lid comprises a flange which extends from its outer surface, and which is accessible when the lid is engaged with the open end of the container to allow a user to disengage the lid from the open end of the container by application of force to the flange. For example, the lid may be disengaged from the open end of the container by application of upward pressure to the flange, in particular, by upward thumb pressure.

Optionally the sealing element comprises a flange which extends from its outer surface, and which is accessible when the sealing element is engaged with the lid to allow a user to disengage the sealing element from the lid by application of force to the flange. For example, the sealing element may be disengaged from the lid of the container by application of upward pressure to the flange, in particular, by upward thumb pressure.

Optionally the container is at least two, three, four, or five times longer than its width. An example is a container of width and length dimensions 10mm x 50mm. Optionally the container comprises a tube. Optionally the tube is of generally circular cross- section.

Optionally the lid and the sealing element are each of generally circular cross-section.

Optionally the lid and the sealing element are each of generally circular cross-section, and an external side wall of the lid and an external side wall of the sealing element each comprise a seal which extends around the circumference of the side wall. Optionally the external side wall of the lid comprises first and second circumferential seals. Optionally the external side wall of the sealing element comprises first and second circumferential seals.

A device of the invention may be provided with the lid engaged with the open end of the container, and the sealing element disengaged from the lid.

A device of the invention may be provided with the lid engaged with the open end of the container, and the sealing element engaged with the lid.

A device of the invention may be provided with the lid disengaged from the open end of the container, and the sealing element disengaged from the lid.

Optionally the container comprises a reagent, for example a reagent for processing the sample.

A reagent for processing the sample may be a liquid reagent, or a solid reagent (for example, a lyophilised reagent).

Optionally the reagent inactivates (or reduces the activity of) any hazardous agent (particularly, any hazardous infectious agent) present in the sample when contacted with the sample (optionally additionally when the sample and reagent are heated, for example when present together in the container). For example, the reagent may comprise a lysis buffer capable of lysing cells in a biological sample. Clearly, inactivation (or reduced activity) of any hazardous agent is advantageous as this will further help to contain the agent once the sample has been collected, and minimise risk to the user and the environment.

It will be appreciated that if the container comprises a reagent for processing the sample, the lid should preferably be engaged with the open end of the container to avoid loss of the reagent from the container.

Optionally the interior of the container is sterile. For example, the sample collection device may be provided with the lid engaged with the open end of the container (and optionally the sealing element engaged with the lid) following sterilisation of the container. There is also provided according to the invention a package comprising a sample collection device of the invention. Optionally the package is a sealed, sterile package.

Suitable methods of sterilisation are well-known to those of skill in the art, and include methods such as gamma irradiation, and electron beam sterilisation.

There is also provided according to the invention a kit for collecting a sample, which comprises a sample collection device of the invention, or a package of the invention, and a collector for collecting a sample.

Optionally the collector is for collecting a biological sample from a subject.

Any suitable collector may be provided. For example, the collector may comprise a swab stick for collecting a biological sample from a subject.

Optionally a kit of the invention comprises a first swab stick for collecting a nasal sample, and a second swab stick for collecting a throat sample from the subject. Such samples may be collected from a subject, for example, to carry out a test on the collected samples to determine whether the subject has been infected with an infectious agent, such as a virus, bacterium, or fungi. In particular, such samples may be collected to determine whether a subject has been infected with an agent causing a respiratory disease, such as influenza, SARS, or COVID-19.

Optionally the, or each swab stick is breakable to allow an end of the swab stick carrying a sample to be deposited in the container once the sample has been introduced into the container. Breakable swab sticks are known to the skilled person, and can readily be obtained. Examples include Copan Diagnostics Nylon Flocked Dry Swabs in Peel Pouches (Copan Diagnostics 503CS01). These swab sticks include a moulded breakpoint.

Optionally a kit of the invention further comprises a reagent for processing the sample.

Optionally the reagent inactivates (or reduces the activity of) any hazardous agent (particularly, any hazardous infectious agent) present in the sample when contacted with the sample (optionally additionally when the sample and reagent are heated, for example when present together in the container). For example, the reagent may comprise a lysis buffer capable of lysing cells in a biological sample. It will be appreciated that if the container comprises a reagent for processing the sample, the lid should preferably be engaged with the open end of the container to avoid loss of the reagent from the container.

Optionally a kit of the invention further comprises disposable gloves for use when a biological sample is collected from a subject.

Optionally a kit of the invention further comprises a mask or goggles for use when a biological sample is collected from a subject.

Optionally a kit of the invention further comprises an alcohol wipe.

Optionally a kit of the invention further comprises a manipulation device for piercing the pierceable surface of the lid.

There is also provided according to the invention a method of collecting a sample for processing, which comprises: i) providing a sample collection device comprising: a container for receiving a sample; a lid flexibly attached to the container and configured to engage with an open end of the container thereby sealing an interior of the container from the external environment, wherein the lid comprises a pierceable surface to allow access to the interior of the container through the lid when the lid is engaged with the open end of the container; and a sealing element flexibly attached to the container, wherein the sealing element is configured to engage with the lid when the lid is engaged with the open end of the container to form a seal over the pierceable surface of the lid and thereby seal the interior of the container from the external environment once the lid has been pierced; ii) depositing the sample into the container; and iii) engaging the lid with the open end of the container to seal the interior of the container from the external environment.

Optionally the sample is a biological sample carried on a swab stick, or on a portion of a swab stick. Optionally the swab stick comprises a breakable shaft, and wherein the sample is deposited in the container by breaking the shaft of the swab stick to deposit an end of the swab stick carrying the sample in the container prior to engaging the lid with the open end of the container.

Optionally a method of the invention further comprises contacting the sample with a processing reagent in the container. For example, the processing reagent may comprise a lysis buffer for lysing cells present in a biological sample. Nucleic acid may then be extracted from the sample using methods well-known to those of skill in the art.

Optionally a method of the invention further comprises extracting nucleic acid from the sample, amplifying nucleic acid extracted from the sample, and detecting the amplified nucleic acid. Examples of suitable methods for cell lysis, and for extraction, amplification, and detection of nucleic acid are described in WO 2008/090340 and WO 2010/015835.

For example, it may be desired to extract nucleic acid from a biological sample collected in the sample collection device, and subsequently amplify and detect the nucleic acid, to determine whether the sample includes nucleic acid of an infectious agent. The extraction process may be initiated by contacting the collected biological sample with a lysis buffer in the container (and optionally heating the biological sample and lysis buffer).

Optionally, the sample collection device may be provided with lysis buffer already present in the container so that the sample is contacted with the lysis buffer as soon as it is deposited in the container. This is advantageous as the lysis buffer is expected to inactivate any infectious agent present in the sample which may otherwise have the potential to cause disease.

It may be desired to use all of the collected sample, or only part of the collected sample. The sample, or part of the sample may be removed (for example, an aliquot of the sample in contact with a processing reagent, such as a lysis buffer) by accessing the interior of the container through the lid to withdraw the sample (or part of the sample), for example, with a manipulation device. The sealing element may then be engaged with the lid to again seal the container. The withdrawn sample, or part of the sample, may then be processed (or further processed) and tested. For example, nucleic acid may be extracted from the withdrawn sample (or part of the sample), and the extracted nucleic acid then amplified and detected. The sealed container containing any remaining collected sample may then be transported and/or stored (for example in a freezer) for future use.

A sample collection device of the invention is particularly useful for use with apparatus and methods described in WO 2014/140640. This document describes an automated biological- sample-processing system comprising a pipette, a column of solid-phase material to which nucleic acid binds, a transport apparatus, an air-piston apparatus and an adaptor for coupling the pipette to the transport apparatus and to the air-piston apparatus. A sample collection device of the invention may be used in this system with a pipette of the system being used as a manipulation device to withdraw an aliquot of collected sample mixed with lysis buffer (i.e. a lysed sample as described in WO 2014/140640) from the container through the pierceable surface of the lid and dispensed into a column for nucleic acid extraction.

Embodiments of the invention are now described, by way of example only, with reference to the accompanying drawings in which:

Figure 1 shows a perspective view of a sample collection device according to an embodiment of the invention;

Figure 2 shows a side-view of the device shown in Figure 1 ; and Figure 3 shows a cross-sectional view of the device shown in Figure 1 .

A sample collection device according to an embodiment of the invention is shown in Figures 1-3. The sample collection device is for collection of a first swab stick carrying a nasal sample, and a second swab stick carrying a throat sample, collected from a subject.

The sample collection device 10 shown in Figures 1-3 comprises a container 12 for receiving a sample, a lid 14, and a sealing element 16. The container 12 is a tube of generally circular cross- section with a closed end 18, a side wall 20 with an interior surface 22, and an open end 24. Towards the closed end 18 of the container, the side wall converges. A collar 26 extends outwards from the side wall 20 at the open end 24 of the container 12. The lid 14 and the sealing element 16 are attached by respective flexible arms 28, 30 to a retaining element in the form of a ring 32 mounted at the upper end of the container, below the collar. The ring is prevented from sliding off the open end of the container by the collar, which has a diameter greater than the diameter of the ring. In this specific embodiment, the ring 32 is shaped asymmetrically so that the sample collection device has a one-way fit in an automated sample processing machine, such as a machine described in WO 2014/140640 (in other embodiments the ring 32 may have a symmetrical shape).

The lid 14 comprises an annular collar 34 attached to the flexible arm 28, a tubular side wall 36 extending away from the collar, and a circular base 38. The tubular side wall and the base together define a recess 40 for receiving the sealing element 16. Upper 42 and lower 44 ring seals protrude circumferentially around the side wall of the lid. The seals 42, 44 are sufficiently flexible to allow the lid to be engaged in the open end of the container by a push-fit. A flange 46 is attached to the collar at a position spaced from a point of attachment of the flexible arm 28 to the collar. The base 38 of the lid comprises a pierceable surface 48 which can be pierced by an end of a manipulation device (for example, a pipette tip) to access the interior of the container through the lid.

The sealing element 16 comprises an annular collar 50 attached to the flexible arm 30, a tubular side wall 52 extending away from the collar 50, and a circular base 54. Upper 56 and lower 58 ring seals protrude circumferentially around the side wall of the sealing element. The seals 56, 58 are sufficiently flexible to allow the sealing element 16 to be engaged in the recess 40 of the lid by a push-fit.

The container 12 is formed from a mouldable plastics material. The lid 14, sealing element 16, flexible arms 28, 30, and ring 32 form part of a single piece made from a mouldable plastics material. An example of a suitable mouldable plastics material is polypropylene.

The sample collection device 10 is provided with the lid 14 already engaged in the open end 22 of the container 12. The sealing element 16 is not engaged in the recess 40 of the lid. A lysis buffer (not shown) is provided in the container. The seals 42, 44 of the lid 14 are in contact with the interior surface of the side wall of the container around its circumference thereby sealing the interior of the container from the external environment.

When a user is ready to use the sample collection device, the lid is disengaged from the open end of the container by applying upward pressure to the flange (for example, using thumb pressure). The user inserts the end of a swab stick (not shown) carrying a biological sample (for example, a throat or a nasal swab sample obtained from a subject) to introduce the biological sample into the container. The swab stick comprises a breakable shaft so that the user, by applying pressure to the swab stick against the closed end of the container can break the shaft of the swab stick to release an end of the swab stick carrying the biological sample and deposit the end of the swab stick carrying the biological sample in the container. Alternatively, if the length of the swab stick is less than the length of the container, the entire swab stick carrying the biological sample can be deposited in the container without any need to break the swab stick.

Once the sample has been deposited in the container, the user engages the lid 14 in the open end of the container by push-fit. In this position, the seals 42, 44 of the lid contact the internal side wall of the open end of the container around its circumference thereby forming a hermetic seal, and sealing the interior of the container from the external environment. The container, with the biological sample and lysis buffer may then be heated to assist with lysis of cells in the biological sample and to inactivate any infectious agent present in the sample.

When it is desired to further process the collected biological sample, for example to determine whether it contains nucleic acid of an infectious agent, the interior of the container can be accessed through the lid by piercing the pierceable surface of the lid with the end of a pipette tip to withdraw an aliquot of the sample in the lysis buffer. Once an aliquot has been withdrawn, and the pipette tip removed, the sealing element is engaged with the lid to again seal the interior of the container from the external environment.

The sample collection device may then be stored (for example, in a freezer) to retain the remainder of the sample in lysis buffer for future testing. The collected sample in lysis buffer may be accessed by opening the lid of the container by applying upward pressure to the flange 46 of the lid 14 (for example by applying upward thumb pressure to the flange) to disengage the lid from the open end of the container and allow access to the interior of the container as before using a manipulation device which pierces the pierceable surface of the lid.

Claims

1 . A sample collection device which comprises: a container for receiving a sample; a lid flexibly attached to the container and configured to engage with an open end of the container to seal an interior of the container from the external environment, wherein the lid comprises a pierceable surface to allow access to the interior of the container through the lid when the lid is engaged with the open end of the container; and a sealing element flexibly attached to the container, wherein the sealing element is configured to engage with the lid when the lid is engaged with the open end of the container to form a seal over the pierceable surface of the lid and thereby seal the interior of the container from the external environment once the lid has been pierced.

2. A device according to claim 1 , wherein the pierceable surface of the lid is pierceable by an end of a manipulation device, preferably a pipette tip.

3. A device according to claim 1 or 2, wherein the lid is configured to engage by a push-fit with the open end of the container.

4. A device according to any preceding claim, wherein the lid comprises an external side wall for engaging with an internal side wall of the open end of the container to seal the interior of the container from the external environment.

5. A device according to claim 4, wherein the external side wall of the lid comprises a seal which contacts the internal side wall of the open end of the container to seal the interior of the container from the external environment when the lid is engaged with the open end of the container.

6. A device according to claim 5, wherein the external side wall of the lid comprises a first seal, and a second seal spaced from the first seal along the external side wall of the lid, wherein each seal contacts the internal side wall of the open end of the container to seal the interior of the container from the external environment when the lid is engaged with the open end of the container.

7. A device according to any preceding claim, wherein the lid comprises a recess for receiving the sealing element, wherein the recess is defined by an internal side wall and an end wall of the lid, and wherein the end wall of the lid comprises the piercable surface.

8. A device according to any preceding claim, wherein the sealing element is configured to engage with the lid by a push-fit.

9. A device according to any preceding claim, wherein the sealing element comprises an external side wall for engaging with an internal side wall of the lid to form a seal over the pierceable surface of the lid.

10. A device according to claim 9, wherein the external side wall of the sealing element comprises a seal which contacts the internal side wall of the lid to form a seal over the pierceable surface of the lid when the sealing element is engaged with the lid.

11. A device according to claim 10, wherein the external side wall of the sealing element comprises a first seal, and a second seal spaced from the first seal along the external side wall of the sealing element, wherein each seal contacts the internal side wall of the lid to form a seal over the pierceable surface of the lid when the sealing element is engaged with the lid.

12. A device according to any preceding claim, wherein the lid is attached to the container by a first flexible arm.

13. A device according to any preceding claim, wherein the sealing element is attached to the container by a second flexible arm.

14. A device according to claim 12 or 13, wherein the first and/or second flexible arms are attached to a retaining element mounted towards the open end of the container.

15. A device according to claim 14, wherein the container comprises a collar which extends outwards from a side wall at the open end of the container, and which prevents the retaining element from sliding off the container at its open end.

16. A device according to any preceding claim, wherein the lid comprises a lip which extends over an end wall at the open end of the container when the lid is engaged with the open end of the container.

17. A device according to any preceding claim, wherein the lid comprises a flange which extends from its outer surface, and which is accessible when the lid is engaged with the container to allow a user to disengage the lid from the open end of the container by application of force to the flange.

18. A device according to any preceding claim, wherein the sealing element comprises a flange which extends from its outer surface, and which is accessible when the sealing element is engaged with the lid to allow a user to disengage the sealing element from the lid by application of force to the flange.

19. A device according to any preceding claim wherein the container comprises a tube.

20. A device according to claim 19, wherein the tube is of generally circular cross-section.

21 . A device according to claim 20, wherein the lid and the sealing element are each of generally circular cross-section.

22. A device according to claim 21 , wherein an external side wall of the lid and an external side wall of the sealing element each comprise a seal which extends around the circumference of the side wall.

23. A device according to any preceding claim, in which the container comprises a reagent for processing the sample, preferably a lysis buffer for lysing cells present in a biological sample.

24. A device according to any preceding claim in which the lid is engaged with the open end of the container.

25. A device according to claim 24 in which the interior of the container is sterile.

26. A sample collection device substantially as described with reference to the accompanying drawings.

27. A package comprising a sample collection device according to any of claims 1 to 26.

28. A package according to claim 27 which is a sealed, sterile package.

29. A kit for collecting a sample, which comprises a sample collection device according to any of claims 1-26, or a package according to claim 27 or 28, and a collector for collecting a sample.

30. A kit according to claim 29, wherein the collector comprises a swab stick for collecting a biological sample from a subject.

31 . A kit according to claim 30, which comprises a first swab stick for collecting a nasal sample, and a second swab stick for collecting a throat sample from the subject.

32. A kit according to claim 30 or 31 , wherein the, or each swab stick is breakable to allow an end of the swab stick carrying a sample to be deposited in the container.

33. A kit according to any of claims 29 to 32, which further comprises a reagent for processing the sample, preferably a lysis buffer for lysing cells present in a biological sample.

34. A kit according to any of claims 29 to 33, which further comprises disposable gloves for use when a sample is collected.

35. A kit according to any of claims 29 to 34, which further comprises a mask for use when a sample is collected.

36. A kit according to any of claims 29 to 35, which further comprises an alcohol wipe.

37. A method of collecting a sample for processing, which comprises: i) providing a sample collection device comprising: a container for receiving a sample; a lid flexibly attached to the container and configured to engage with an open end of the container thereby sealing an interior of the container from the external environment, wherein the lid comprises a pierceable surface to allow access to the interior of the container through the lid when the lid is engaged with the open end of the container; and a sealing element flexibly attached to the container, wherein the sealing element is configured to engage with the lid when the lid is engaged with the open end of the container to form a seal over the pierceable surface of the lid and thereby seal the interior of the container from the external environment once the lid has been pierced; ii) depositing the sample into the container; and iii) engaging the lid with the open end of the container to seal the interior of the container from the external environment.

38. A method according to claim 37, wherein the sample is a biological sample carried on a swab stick or on a portion of swab stick.

39. A method according to claim 38, wherein the swab stick comprises a breakable shaft, and wherein the sample is deposited into the container by breaking the shaft of the swab stick to deposit an end of the swab stick carrying the sample into the container prior to engaging the lid with the open end of the container.

40. A method according to any of claims 37 to 39, which further comprises contacting the sample with a processing reagent in the container.

41 . A method according to claim 40, wherein the processing reagent is provided in the container before the sample is deposited into the container.

42. A method according to claim 40 or 41 , which further comprises heating the container once the sample is in contact with the processing reagent.

43. A method according to any of claims 40 to 42, wherein the processing reagent comprises a lysis buffer for lysing cells present in a biological sample.

44. A method according to any of claims 37 to 43, which further comprises: accessing the interior of the container through the pierceable surface of the lid to carry out a manipulation of the sample; and then engaging the sealing element with the lid to again seal the container.

45. A method according to claim 44, wherein the interior of the container is accessed through the pierceable surface of the lid using a manipulation device, preferably a pipette tip.

46. A method according to claim 44 or 45, wherein the interior of the container is accessed through the pierceable surface of the lid to withdraw an aliquot of the sample in contact with a processing reagent from the container.

47. A method according to any of claims 37 to 46, which further comprises extracting nucleic acid from the sample, or from a withdrawn aliquot comprising part of the sample, amplifying nucleic acid extracted from the sample, and detecting the amplified nucleic acid.