Biological substance collection kit

Abstract

To provide a biological substance collection kit allowing a subject to collect biological substances by himself / herself at any place such as at home.SOLUTION: A biological substance collection kit comprises a collection tool 10 for collecting biological substances, a container body for storing a preservation solution of the biological substances, and a cap for sealing the container body. The collection tool 10 includes a collection body 15 for collecting the biological substances, a collection support 13 for supporting the collection body 15, a rod 11 detachably fixed to the collection support 13, and an internal space formed in the collection support 13 for sucking the biological substances and the preservation solution from the outside of the container body. The container body houses the collection body 15 and the collection support 13.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present invention relates to a collection kit for biological substances, and more particularly to a collection kit for biological substances for collecting pathogens such as viruses contained in biological substances such as cervical cells or mucus.

Background Art

[0002] For the detection of pathogens such as viruses, the polymerase chain reaction (PCR) method using PCR, which has become widespread with the development of genetic engineering, is used. A biological substance containing a pathogen is collected with a cotton swab or the like, nucleic acid (DNA or RNA) is extracted from the biological substance, the nucleic acid is amplified by the PCR method, and the pathogen is detected based on the amplified nucleic acid.

[0003] Cervical cancer is often caused by infection with the human papillomavirus (HPV). Since cervical cancer caused by the HPV virus can be prevented by vaccination with the HPV vaccine, an HPV virus test is required. Usually, when examining for cervical cancer, a doctor widens the vagina of the subject with a vaginal speculum, scrapes the cervix with a cotton swab or a brush to collect cells, and performs a cervical cytology examination to confirm with a microscope. Furthermore, an HPV virus test using the PCR method is also performed on the cells collected by cytology.

[0004] On the other hand, collection kits (biological sample collection devices) for collecting saliva and the like have been proposed, for example, in Patent Documents 1 and 2. The biological sample collection device of Patent Document 1 collects saliva using a collection body fixed to the tip of the collection device main body. Patent Document 2 was filed by the applicant of the present application, and the collection kit collects saliva using an elongated collection absorber.

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0006] Conventionally, in order to examine the bottom of tubular organs such as the cervix, doctors themselves have to collect biological-related substances such as cells from the subject. Therefore, the subject cannot collect biological-related substances at any place such as at home by themselves.

[0007] In addition, the biological sample collection device of Patent Document 1 and the collection kit of Patent Document 2 are for collecting saliva and are relatively short. Therefore, it is not suitable for introducing a collection body to the bottom of tubular organs such as the cervix and collecting biological-related substances such as cells from the cervix and the like.

[0008] Therefore, an object of the present invention is to provide a collection kit for biological-related substances that allows a subject to collect biological-related substances from the bottom of a tubular organ at any place such as at home by themselves.

Means for Solving the Problems

[0009] Each embodiment example of the present invention is configured as follows. (Embodiment Example 1) A collection kit for biological-related substances, comprising a collection tool for collecting biological-related substances, a container body for accommodating a solution containing the biological-related substances, and a cap for sealing the container body, wherein the collection tool includes a collection body for collecting the biological-related substances, a collection support for supporting the collection body, an elongated rod detachably fixed to the collection support, and an internal space formed in the collection support for sucking the biological-related substances and the preservation solution from outside the container body. The container body is a collection kit for biological-related substances that accommodates the collection body and the collection support.

[0010] (Embodiment Example 2) The collection kit for biological-related substances according to Embodiment Example 1, The collection support body is a collection kit for biological-related substances, comprising a bottomed cylindrical core part for mounting the collection body. (Embodiment Example 3) A collection kit for biological-related substances according to Embodiment Example 2, wherein the core part has a plurality of slots or holes, is a collection kit for biological-related substances. (Embodiment Example 4) A collection kit for biological-related substances according to Embodiment Example 3, wherein the plurality of slots or holes are formed on the circumferential surface of the core part, is a collection kit for biological-related substances.

[0011] (Embodiment Example 5) A collection kit for biological-related substances according to Embodiment Example 1, wherein the collection support body comprises one of a male screw or a female screw, and the rod comprises the other of the male screw or the female screw, is a collection kit for biological-related substances. (Embodiment Example 6) A collection kit for biological-related substances according to Embodiment Example 1, wherein the collection body and the support body are accommodated in the container main body in a state where the rod is removed, is a collection kit for biological-related substances. (Embodiment Example 7) A collection kit for biological-related substances according to Embodiment Example 6, wherein the cap comprises an opening for accessing the internal space and a seal for sealing the opening, is a collection kit for biological-related substances.

[0012] (Embodiment Example 8) A collection kit for biological-related substances according to Embodiment Example 7, wherein the seal is a seal that can be perforated by a perforating tool or a peelable seal, is a collection kit for biological-related substances. (Embodiment Example 9) A collection kit for biological-related substances according to Embodiment Example 1, wherein the biological-related substance is cells or mucus of the uterine cervix, is a collection kit for biological-related substances. (Embodiment Example 10) A collection kit for biological-related substances according to Embodiment Example 1, The collection kit for biological-related substances, wherein the collection body has a lubricating fluid for lubricating the collection surface of the biological-related substances.

[0013] (Aspect Example 11) A collection kit for biological-related substances according to Aspect Example 10, comprising a sheath that detachably covers the collection body, a collection kit for biological-related substances. (Aspect Example 12) A collection kit for biological-related substances according to Aspect Example 1, wherein the rod has both ends swollen, and includes a first end portion 11a for the subject to grip and a second end portion to which the collection support is connected, a collection kit for biological-related substances. (Aspect Example 13) A collection kit for biological-related substances according to claim 1, wherein the container body includes a plurality of ribs, and the collection support fits or engages with the plurality of ribs, a collection kit for biological-related substances.

[0014] (Aspect Example 14) An inspection device for inspecting biological-related substances collected using the collection kit for biological-related substances according to Aspect Example 8, the perforator for perforating the pierceable seal, and a dispenser that is inserted into the internal space through the opening and sucks the biological-related substances and the preservation solution from the internal space, an inspection device. (Aspect Example 15) An inspection device according to Aspect Example 14, wherein the inspection device extracts nucleic acids from the biological-related substances, amplifies the extracted nucleic acids, and inspects the amplified nucleic acids, an inspection device. [Advantages of the Invention]

[0015] The collection kit and collection method for biological-related substances of the present invention enable a subject to collect biological-related substances from the innermost part of a tubular organ at any place such as at home by himself / herself. [Brief Description of the Drawings]

[0016]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Embodiments for Carrying out the Invention

[0017] An embodiment of a sampling kit and a sampling method for a biological-related substance (for example, vaginal mucus or cells) of the present invention will be described with reference to the drawings. In each figure, the same parts are denoted by the same reference numerals and the description will be omitted as appropriate. In each figure, the relative sizes and / or arrangements of the parts are, in principle, accurately illustrated, but the present invention is not limited thereto. Further, in the present invention, the biological-related substance to be sampled is not limited to vaginal mucus or cells, and can include any biological-related substance such as body fluid sampled from a living body.

[0018] The configuration of the sampler 10 for a biological-related substance according to an embodiment of the present invention will be described with reference to FIGS. 1 to 3. As shown in FIG. 1, the sampler 10 is composed of an elongated rod 11, a cylindrical sampling support 13 attached to one end of the rod 11, and a sampling body (absorbent) 15 supported by the sampling support 13.

[0019] Both ends of the rod 11 are swollen, and it has a first end 11a for the subject (user) to grip and a second end 11b to which the sampling support 13 is connected. An anti-slip can preferably be formed on the outer peripheral surface of the first end 11a. As shown in FIG. 2, a male screw 11c is formed on the outer peripheral surface of the second end 11b.

[0020] As shown in FIG. 2, the sampling support 13 is composed of a receiving end portion 13a that forms an opening for receiving the male screw 11c of the rod 11, a flexible core portion 13b extending from the receiving end portion 13a, and a female screw 13c (FIG. 3) formed on the inner peripheral surface of the opening of the receiving end portion 13a. By screwing the male screw 11c of the rod 11 and the female screw 13c of the sampling support 13, the rod 11 and the sampling support 13 can be detachably connected. Note that male screws may be formed on the sampling support 13 and female screws may be formed on the rod 11.

[0021] The bottomed cylindrical sampling support 13 has an internal space S1 at the receiving end portion 13a and an internal space S2 at the core portion 13b. The internal space S1 of the receiving end portion 13a is connected to the internal space S2 of the core portion 13b. A dispensing chip 31 of a dispenser described later can be inserted into the internal spaces S1 and S2.

[0022] The sampling support 13 is preferably formed from a resin having flexibility. Since the core portion 13b of the sampling support 13 has a plurality of slots (holes) 13d or meshes, it has greater flexibility than the receiving end portion 13a. Due to the slots 13d or meshes in the core portion 13b, a specimen solution containing collected cells or mucus can move from the sampler 15 into the internal space S2 of the core portion 13b. The internal space S2 of the core portion 13b accommodates the specimen solution, and as described later, the dispenser can suck the specimen solution from the internal space S2. The plurality of slots 13d or meshes can be formed on the peripheral surface of the core portion 13b.

[0023] The sampler 15 is bottomed cylindrical and has an opening, and is composed of fibers such as a sponge or cotton having elasticity. Since the diameter of the internal space of the sampler 15 is preferably formed to be slightly smaller than the diameter of the core portion 13b of the sampling support 13, when the sampler 15 is attached to the flexible core portion 13b as shown in FIG. 3, it is possible to prevent the sampler 15 from falling off the core portion 13b. The sampler 15 can preferably have glycerol (lubricating fluid) for lubricating the cervix. Since glycerol does not affect the PCR reaction, it is preferable as a lubricant.

[0024] The sampling body 15 can be provided with a detachable sheath 17 (Fig. 1) that covers the sampling body 15 in order to seal the glycerol of the sampling body 15. The sheath 17 is preferably low-cylindrical and is shaped along the outer surface of the sampling body 15. The opening of the sheath 17 is narrowed and has a plurality of slots around the opening.

[0025] As shown in Fig. 4, the rod 11 can be removed from the sampling support 13 and the sampling body 15 and accommodated in the sample container main body 21 and the cap (lid) 21. The sample container 20 is composed of a container main body 21 and a cap 23. The container main body 21 is bottomed cylindrical and is provided with a plurality of ribs 21a extending in the longitudinal direction on its inner peripheral surface. The cap 23 has an O-ring for sealing and an opening 23a for specimen suction on its upper surface. The opening 23a of the cap 23 is sealed by a seal (not shown). The seal can preferably be a pierceable aluminum seal or a peelable seal.

[0026] The sampling support 13 has a tapered outer peripheral surface 13d whose diameter decreases from the opening side toward the core portion 13b. The largest diameter of the sampling support 13 is formed slightly larger than the diameter of the circumference surrounded by the plurality of ribs 21a. When the sampling support 13 and the sampling body 15 are accommodated in the container main body 21, the plurality of ribs 21a of the container main body 21 fit or engage with the tapered surface 13d of the sampling support 13, and the sampling support 13 and the sampling body 15 are fixed to the container main body 21.

[0027] The sampling kit according to this embodiment is composed of a sampler 10, a cap 23, and a container main body 21. A preservation solution such as a buffer is pre-poured into the container main body 21 to dilute and preserve the specimen, and the container main body 21 is provided in a sealed state with the cap portion 21. The preservation solution can be, for example, about 1 to 2 ml.

[0028] A label is preferably attached to the peripheral surface of the container main body 21. The label preferably has an ID barcode or a QR code (registered trademark), and more preferably has a name portion for describing subject information such as the name and attributes of the subject.

[0029] A method for collecting cervical cells using the collection kit of this embodiment will be described. Before cell collection, the collection kit 1 preferably has a sampler 10 in FIG. 1 and a container body 20 (containing a preservation solution) sealed with a cap portion 21 respectively sealed in a package (not shown). The subject takes out the sampler 10 and the container body 22 from the package, removes the sheath 17 from the sampler 10, inserts the collection body 15 of the elongated sampler 10 to his / her own cervix, and wipes the cervix with the collection body 15 to collect mucus containing cells.

[0030] After the collection body 15 absorbs mucus containing cells, the subject inserts the collection body 15 side of the sampler 10 into the container body 21. A plurality of ribs 21a of the container body 21 engage with the tapered outer peripheral surface 13d of the collection support 13, and the collection support 13 is fixed to the container body 21. In this state, when the rod 11 is rotated, the rod 11 can be removed from the collection support 13 fixed to the container body 21. FIG. 4 is an exploded view of the state where the rod 11 is removed from the collection support 13. With the collection support 13 and the collection body 15 accommodated in the container body 21, the collection container body 21 is sealed with a sealed cap 23.

[0031] The container body 21 sealing the collection support 13 and the collection body 15 is transferred to a PCR testing device to analyze the nucleic acid of pathogens (such as viruses) contained in the cervical cells or mucus. For this analysis, preferably, a PCR fully automatic testing system (geneLEAD series) provided by Precision System Science Co., Ltd. can be used. This PCR fully automatic testing system can perform a PCR test without touching the collection body 15 from which cells have been collected.

[0032] This fully automatic PCR testing system is equipped with a dispenser that aspirates the preservation solution containing cells in the sample container body 20. This fully automatic PCR testing system preferably includes a perforator (not shown) that perforates the seal of the cap 23. This fully automatic PCR testing system can preferably automatically perform an extraction process of extracting nucleic acids of pathogens by performing pretreatment on the specimen solution containing the aspirated cells or mucus, an amplification process of amplifying the extracted nucleic acids by the PCR method, and a detection process of detecting the amplified nucleic acids.

[0033] The fully automatic PCR testing system perforates the seal of the cap 23 with a perforator for the specimen container body 21 containing cells or the like. After perforating the seal, as shown in FIG. 5, the dispensing chip 31 attached to the dispensing nozzle 30 of the dispenser is inserted into the specimen container body 21 with the cap 23 through the opening 23a of the cap 23. The lower end opening 31a of the dispensing chip 31 is inserted into the internal space S2 for aspiration through the internal space S1 of the sampling support 13, and the specimen solution containing cells or mucus can be aspirated from the internal space S2.

Explanation of Signs

[0034] 10 Sampling tool 11 Rod 11c Male thread 13 Sampling support 13a Receiving end 13b Core part 13c Female thread 15 Sampling body 17 Sheath 20 Sample container 21 Container body 23 Cap S1 Internal space S2 Internal space

Claims

1. A collection kit for biological-related substances, comprising a collection tool for collecting biological-related substances, a container body for containing a solution containing the biological-related substances, and a cap for sealing the container body, wherein the collection tool includes a collection body for collecting the biological-related substances, a collection support for supporting the collection body, an elongated rod detachably fixed to the collection support, and an internal space formed in the collection support for sucking the biological-related substances and the preservation solution from outside the container body. The container body is a collection kit for biological-related substances that houses the collection body and the collection support.

2. The collection kit for biological-related substances according to Claim 1, wherein the collection support includes a bottomed cylindrical core portion for mounting the collection body.

3. The collection kit for biological-related substances according to Claim 2, wherein the core portion has a plurality of slots or holes.

4. The collection kit for biological-related substances according to Claim 3, wherein the plurality of slots or holes are formed on the circumferential surface of the core portion.

5. The collection kit for biological-related substances according to Claim 1, wherein the collection support has one of a male thread or a female thread, and the rod has the other of the male thread or the female thread.

6. The collection kit for biological-related substances according to Claim 1, wherein the collection body and the support are housed in the container body with the rod removed.

7. The collection kit for biological-related substances according to Claim 6, wherein the cap includes an opening for accessing the internal space and a seal for sealing the opening.

8. The collection kit for biological-related substances according to Claim 7, wherein the seal is a seal that can be perforated by a perforating tool or a peelable seal.

9. The collection kit for biological-related substances according to Claim 1, wherein the biological-related substance is cells or mucus from the cervix.

10. The collection kit for biological-related substances according to Claim 1, wherein the collection body has a lubricating fluid for lubricating the collection surface of the biological-related substances.

11. The collection kit for biological-related substances according to Claim 10, A collection kit for biological-related substances, comprising a sheath that removably covers the collection body.

12. The collection kit for biological-related substances according to claim 1, wherein the rod has both ends swollen, and includes a first end portion 11a for a subject to grip and a second end portion to which the collection support is connected, the collection kit for biological-related substances.

13. The collection kit for biological-related substances according to claim 1, wherein the container body includes a plurality of ribs, and the collection support fits or engages with the plurality of ribs, the collection kit for biological-related substances.

14. An inspection device for inspecting biological-related substances collected using the collection kit for biological-related substances according to claim 8, the perforator for perforating the pierceable seal, and a dispenser that is inserted into the internal space through the opening and sucks the biological-related substances and the preservation solution from the internal space, the inspection device.

15. The inspection device according to claim 14, wherein the inspection device extracts nucleic acids from the biological-related substances, amplifies the extracted nucleic acids, and inspects the amplified nucleic acids, the inspection device.

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