Abstract
A self-sampling apparatus for collection of a cellular sample, particularly a vaginal sample for detection of human papillomavirus and its use is disclosed. The apparatus has an evacuated sample container closed by a puncturable seal and a fluid sample chamber in fluid communication with the evacuated container via a needle assembly. A fluid sample is drawn into the evacuated sample container upon establishing fluid communication between the fluid sample chamber and the evacuated container.
Claims
1. (canceled)
2. (canceled)
3. A self-sampling apparatus for collection of a vaginal cellular sample comprising an evacuated sample container having an openable end which is closed by a puncturable seal and a fluid sample chamber adapted to receive a vaginal cellular sample which, in use, is in fluid communication with the evacuated container through the puncturable seal such that a vaginal cellular fluid sample is drawn into the evacuated sample container upon establishing fluid communication between the fluid sample chamber and the evacuated container.
4. A method of manually acquiring a cellular fluid sample, preferably a vaginal sample, comprising providing an evacuated sample container having a puncturable seal and a needle assembly and a fluid sample chamber for receiving a vaginal sample wherein the needle assembly provides a fluid communication conduit between the fluid sample chamber and the evacuated chamber wherein upon piercing the puncturable seal, whereby the vaginal cellular sample is urged from the fluid sample chamber to the evacuated container.
5. A self-sampling or home-testing kit for use by a subject to acquire a sample from themselves comprising a syringe comprising a body and a plunger, the plunger being removable to present an inlet for receiving a sanitary product having a vaginal cellular sample and an outlet at the opposite end of the syringe, especially a 5 ml-20 ml syringe, a needle assembly, preferably having a safety shroud, adapted to attach to the syringe outlet, and an evacuated container having a puncturable seal and containing a cell preservation solution the kit further comprising one or more sanitary products sized to fit in the syringe wherein the needle assembly provides a fluid communication path between the syringe and the evacuated chamber.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0034] The present invention is further described by way of example only with reference to the accompanying drawings, in which:
[0035] FIGS. 1A to 1C show a side elevation plan view of apparatus according to the invention at various stages in the sample acquisition process;
[0036] FIG. 2 shows a side elevation of an alternative embodiment of the invention to that shown in FIG. 1;
[0037] FIG. 3 shows a side elevation of an embodiment of the invention in FIG. 1;
[0038] FIG. 4 perspective view of another embodiment of the invention;
[0039] FIG. 5 shows a perspective view of a part of the apparatus of the invention configured for collecting a sample; and
[0040] FIGS. 6A to 6D show perspective views of other embodiments of the invention with an evacuated container connected to a sample collector.
DETAILED DESCRIPTION
[0041] FIGS. 1A to 1C show apparatus according to the invention showing a fluid sample collection chamber 1, in this case a syringe which has a body and a plunger 2. The chamber has an outlet connected to a needle assembly 3 which has a shroud 4 for protection. The shroud 4 is dimensioned such that it fits snugly over the end of the evacuated container 5 which contain a transport fluid or preservative 6. The puncturable seal which closes the open end of the evacuated container 5 is not shown.
[0042] The user places a used sanitary product 7a, such as a tampon, carrying vaginal cellular material into the syringe as shown in FIG. 1B. The plunger 2 is extended to accommodate the sanitary product 7a. FIG. 3 shows the apparatus being pushed onto the top of the evacuated container 5 such that the shroud 4 snugly engages or clips onto the top of the container and sheaths the top of the container and the puncturable seal and the needle 9. As the apparatus is pressed onto the evacuated container the needle 9 punctures the puncturable seal which, the plunger 2 being depressed such that it compresses the sanitary product and expels or otherwise removes or releases cellular material from the compressed sanitary product 7b. The expelled sample passes through the outlet 8 of the syringe, through the needle 9 and into the evacuated container 5 and the preservative 10.
[0043] The needle assembly 3 and the syringe may then be removed, the puncturable seal closes and the sample is retained in the container 5 which is closed by the puncturable, fluid tight sheath.
[0044] FIG. 2 shows an apparatus according to the invention having an evacuated container 5 which contains a preservative or other fluid material. A double ended needle having a first end 3a which passes through puncturable seal or septum 12 in the open end of the container 5 and a second end 3b which is engagable with a fluid sample chamber 13 such as a Moon Cup containing the cellular sample provides a conduit for fluid communication between the container 5 and the chamber 13. The double ended needle arrangement may be employed to obtain cytological samples directly from the human or animal body. The double ended needle 31, 3b is mounted in a manifold 11 and has shrouds 4a and 4b to shield the needles 3a and 3b.
[0045] FIG. 3 shows apparatus according to the invention as shown in FIG. 1 with a tampon 7b in a compressed state and the plunger 2 depressed into the syringe, thereby to extract or expel cellular material from the tampon for exit through outlet of the syringe into needle assembly 3 and into the evacuated container 5.
[0046] FIG. 4 shows another embodiment of the invention with evacuated container 5 with septum 12 which is engagable with shroud 4 which protects against needle 3, needle 3 is in fluid communication with a fluid sample chamber 14, which acts as a sample collector, via conduit 16. The sample collector is equipped with a probe 15a to 15f depending on the particular type of sample being taken. The fluid sample chamber has an outlet which is connectable to conduit 16.
[0047] FIG. 5 shows a fluid sample chamber/sample collector with an array of optional probes 15a to 15f as shown in FIG. 4. The outlet of sample collector 14 engages with a syringe 1 via syringe outlet 17. Upon withdrawal of the plunger 2, cellular material is drawn onto the probe 15a to 15f and into the syringe vias sample collector 14. The syringe may then be disconnected from the sample collector 14 and have a needle assembly attached to the end 17 of the syringe. The syringe, containing the cellular material is then suitably connected to an evacuated container and is, in effect a fluid sample chamber. Upon depression of the plunger 2, the cellular material is expelled through outlet 17 through the needle assembly into an evacuated container to provide a cellular sample for despatch for analysis.
[0048] FIG. 6 shows another embodiment of the invention with evacuated container 5 and needle shroud 4 ready to be connected. The needle (not shown) within the shroud punctures the septum in the top of container 5 and the shroud and container are suitably dimensioned so as to be engaged in a push-fit manner. Sample collector 14 is in fluid communication with the container 5 in use and the probe 15 is shaped and configured to obtain cellular samples from the human or animal body. The collector and container 5 may be connected by a fluid conduit 16 which may be flexible as shown in FIGS. 6B and 6C. The probe may be flexibly mounted on the sample connector as shown in FIGS. 15C and 15D.
