HPV self-sampling bag

Abstract

The invention belongs to the technical field of medical detection equipment, and particularly discloses an HPV self-sampling bag which comprises a packaging box and a supporting structure, the supporting structure is located in the packaging box, a sampler and a storage tube are arranged on the supporting structure, the sampler comprises a handle and a sampling head, bristles are spirally arranged at the top of the sampling head, and the tail ends of the bristles are spherically arranged. The bottom of the sampling head is hinged to the handle through a ball, an annular boss is arranged in the storage pipe, and storage liquid and a color indicator are arranged in the storage pipe and physically isolated through the annular boss. By adopting the HPV self-sampling bag, the sampling convenience, comfort and detection accuracy can be improved, and meanwhile, the stability of the sample in the transportation process is guaranteed through a specifically optimized preservation solution formula and a unique sample validity verification mechanism.

Description

Technical Field

[0001] This invention relates to the field of medical testing equipment, and in particular to an HPV self-sampling kit. Background Technology

[0002] Human papillomavirus (HPV) is a DNA virus found in humans, and the vast majority of cervical cancers are caused by HPV infection. Early HPV screening, detection, and treatment of precancerous cervical lesions are crucial for reducing the incidence and mortality of cervical cancer. Screening allows for early detection and treatment of cervical cancer and precancerous lesions, with a cure rate of 80%-90% for early-detected cervical cancer. HPV nucleic acid testing requires collecting a viral sample from the woman's cervix, primarily by inserting a swab into the vagina to collect sufficient exfoliated cervical epithelial cells. Existing sampling equipment is designed for doctors, nurses, and other professionals to perform the sampling.

[0003] With the gradual opening up of national policies, third-party medical testing laboratories can directly provide testing services to individual clients. Therefore, many tests that previously had to be completed in hospitals can now be done by self-sampling and mailing the samples, reducing time wasted on queuing and registration, and consequently reducing the risk of cross-infection. In recent years, some HPV self-sampling kits have emerged, allowing users to collect samples at home. However, these products still have shortcomings: the preservation solution formula is simple and cannot effectively stabilize viral nucleic acid; and there is a lack of effective operational feedback mechanisms, making it impossible for users to confirm whether the sampling was successful. Therefore, an improved HPV self-sampling kit is needed to enhance the sampling experience, ensure sample quality, and simplify the operation process. Summary of the Invention

[0004] The purpose of this invention is to provide an HPV self-sampling kit that can improve the convenience, comfort and accuracy of sampling, while ensuring the stability of the sample during transportation through a specifically optimized preservation solution formula and a unique sample validity verification mechanism.

[0005] To achieve the above objectives, the present invention provides an HPV self-sampling kit, including a packaging box and a support structure. The support structure is located inside the packaging box and is equipped with a sampler and a storage tube. The sampler includes a handle and a sampling head. The top of the sampling head is provided with spirally arranged bristles, and the ends of the bristles are spherically shaped. The bottom of the sampling head is hinged to the handle by a ball. The storage tube is provided with an annular boss and contains a storage solution and a color indicator. The storage solution and the color indicator are physically isolated by the annular boss.

[0006] Preferably, the upper part of the handle is provided with a pre-made V-shaped break line, so that the sampling head can be easily broken off and placed in the storage tube after sampling.

[0007] Preferably, the handle surface is provided with depth markings to guide the user to the correct insertion depth, and the handle surface is provided with concave and convex anti-slip textures for easy gripping and control.

[0008] Preferably, the bristles are 5-8 mm long, 0.15-0.25 mm in diameter, and have a bristle density of 150-200 bristles / cm². 2 .

[0009] Preferably, the top of the handle is provided with a spherical groove, and the sphere is located in the spherical groove. The two sides of the sphere are rotatably connected to the side wall of the spherical groove through a rotating shaft. The sphere moves in the spherical groove, so that the sampling head can deflect during sampling to adapt to the cervical anatomy.

[0010] Preferably, the color indicator is located above the annular boss, the preservation liquid is located below the annular boss, the circumferential sidewall of the annular boss is connected to the inner wall of the preservation tube, and a sealing film is provided at the center of the annular boss to isolate the color indicator and the preservation liquid.

[0011] Preferably, the top of the storage tube is provided with threads and a threaded locking cap adapted to the threads.

[0012] Preferably, the color indicator uses a pH-sensitive bromocresol purple dye, which is fixed in a porous polymer matrix.

[0013] Preferably, the preservation solution comprises guanidine salt, thiocyanate, Tris-HCl, ethylenediaminetetraacetic acid, sodium azide, Proclin 300, Tween-20, Triton X-100, citrate, and phosphate.

[0014] Preferably, the outer side of the packaging box is provided with a temperature-sensitive indicator label, the inside of the packaging box is provided with a silicone moisture-proof bag, and the support structure is provided with positioning grooves adapted to the sampler and the storage tube respectively.

[0015] The advantages and beneficial effects of using the above-mentioned HPV self-sampling package in this invention are as follows: 1. Addressing the unique characteristics of cervical exfoliated cell samples, the preservation solution of this invention has been optimized: Virus protection specificity: A combination of guanidine salt and thiocyanate is used to effectively lyse cells while maximizing the preservation of HPV virus integrity. Nucleic acid stability specificity: A Tris-EDTA concentration optimized for HPV DNA characteristics prevents degradation of long-chain DNA. Transport adaptability: The addition of a specific surfactant combination of Tween-20 and Triton X-100 ensures sample stability under ambient temperature transport conditions.

[0016] 2. This invention provides a unique sample validity verification system with an intelligent color indication mechanism: Utilizing a pH-sensitive color-changing material, it confirms sampling validity by detecting changes in sample buffering capacity. The contact-triggered design separates the preservation solution from the color indicator, ensuring that color change is only triggered after sample addition. Precise break-off positioning: A V-shaped break line ensures the sampling head and a handle segment of a specific length are inserted into the preservation tube, guaranteeing full immersion while avoiding space waste. Optimized immersion design: The handle segment length is precisely calculated after breakage, ensuring the sampling head is fully immersed in the preservation solution while the color indicator contacts the sample liquid surface.

[0017] 3. This invention objectively confirms successful sampling through color indicator changes, solving the problem of existing technologies relying on subjective judgment; operational reliability: layered design and liquid surface triggering mechanism ensure that validity verification is only performed after sample addition; user experience optimization: clear color changes provide intuitive feedback, reducing user anxiety; detection accuracy: optimized storage conditions reduce false negative results and improve screening accuracy.

[0018] The technical solution of the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. Attached Figure Description

[0019] Figure 1 This is an exploded view of the packaging box and supporting structure of the present invention; Figure 2 This is a schematic diagram of the sampler of the present invention; Figure 3 This is a schematic diagram of the sampling head of the present invention without the storage tube inserted; Figure 4 This is a schematic diagram of the sampling head being placed into the storage tube according to the present invention; Figure 5 This is a schematic diagram of the spherical groove of the present invention; Figure 6 This is a schematic diagram of the annular boss of the present invention.

[0020] Figure Labels 1. Support structure; 2. Positioning groove; 3. Silicone moisture-proof bag; 4. Packaging box; 5. Temperature-sensitive indicator label; 6. Handle; 7. Depth scale mark; 8. Break line; 9. Sphere; 10. Sampling head; 11. Brush bristles; 12. Threaded locking cap; 13. Thread; 14. Storage tube; 15. Color indicator; 16. Annular boss; 17. Preservative solution; 18. Spherical groove; 19. Sealing film. Detailed Implementation

[0021] The technical solution of the present invention will be further described below with reference to the accompanying drawings and embodiments.

[0022] Unless otherwise defined, the technical or scientific terms used in this invention shall have the ordinary meaning understood by one of ordinary skill in the art to which this invention pertains. The terms "first," "second," and similar terms used in this invention do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Terms such as "comprising" or "including" mean that the element or object preceding the word encompasses the elements or objects listed following the word and their equivalents, without excluding other elements or objects. Terms such as "connected" or "linked" are not limited to physical or mechanical connections, but can include electrical connections, whether direct or indirect. Terms such as "upper," "lower," "left," and "right" are used only to indicate relative positional relationships; when the absolute position of the described object changes, the relative positional relationship may also change accordingly.

[0023] The following examples are not intended to limit the invention, but are only for illustration. Unless otherwise specified, the experimental methods used in the following examples are generally performed under conventional conditions. Unless otherwise specified, the materials and reagents used in the following examples are commercially available.

[0024] Example 1 like Figure 1 As shown, an HPV self-sampling kit includes a packaging box 4 and a support structure 1. The packaging box 4 serves as a base assembly and also has a double-layer heat insulation structure. The support structure 1 is located inside the packaging box 4, and a sampler and a storage tube 14 are mounted on the support structure 1. Figure 2 As shown, the sampler includes a handle 6 and a sampling head 10, with the bottom of the sampling head 10 hinged to the handle 6 via a ball 9. Figure 3 As shown, the storage tube 14 is provided with an annular boss 16, and the storage tube 14 is provided with a storage liquid 17 and a color indicator 15. The storage liquid 17 and the color indicator 15 are physically isolated by the annular boss 16.

[0025] The sampling head 10 is connected to the handle 6 via a breakable connector. The upper part of the handle 6 is provided with a pre-made V-shaped break line 8, which makes it easy to break off the sampling head 10 after sampling and place it in the storage tube 14.

[0026] The top of the sampling head 10 is provided with spirally arranged bristles 11, with spherical ends. The bristles 11 are 5-8 mm long, 0.15-0.25 mm in diameter, and have a density of 150-200 bristles / cm. 2 The ends of the bristles 11 are designed as spheres 9 to avoid damaging the tissue.

[0027] The sampler features an ergonomic design, ensuring a stable and comfortable sampling process without the risk of injury due to improper operation. Specifically, the sampling head 10 is connected to the handle 6 via a spherical hinge. The sphere 9 can move within the spherical groove 18, causing the sampling head 10 to deflect left and right, adapting to individual anatomical differences and improving the sampling success rate.

[0028] The preservation tube 14 and the packaging box 4 ensure sample integrity and safe transportation.

[0029] The handle 6 has depth markings 7 on its surface to guide the user to the correct insertion depth. The handle 6 also has textured anti-slip grooves on its surface for easy grip and control. The user can accurately control the insertion depth through the depth markings, improving the accuracy of the sampling position. In addition, after sampling, the user can easily break off the sampling head 10 and place it in the storage tube 14 using the break line 8, avoiding direct contact with the sample.

[0030] like Figure 5 As shown, the top of the handle 6 is provided with a spherical groove 18, and the sphere 9 is located in the spherical groove 18. The two sides of the sphere 9 are rotatably connected to the side wall of the spherical groove 18 through a rotating shaft. The sphere 9 moves in the spherical groove 18, so that the sampling head 10 can deflect left and right during sampling to adapt to the anatomical structure of the cervix.

[0031] The color indicator 15 is located above the annular protrusion 16, and the preservation solution 17 is located below the annular protrusion 16. The circumferential sidewall of the annular protrusion 16 is connected to the inner wall of the preservation tube 14, and a sealing film 19 is provided at the center of the annular protrusion 16 (e.g., Figure 6 As shown), the color indicator 15 and the preservation liquid 17 are isolated. The preservation tube 14 adopts a special structural design. In the initial state, the preservation liquid 17 is located at the bottom of the tube and does not contact the color indicator in the tube. Liquid level triggering mechanism: After the sampling head 10 is inserted into the preservation tube 14, it punctures the sealing film 19 and enters below the annular protrusion 16. The sampling head 10 occupies the tube space, causing the liquid level of the preservation liquid 17 to rise through the punctured sealing film 19 to contact the color indicator 15 (as shown). Figure 4 (As shown).

[0032] The preservation tube 14 has a thread 13 at its top and a threaded locking cap 12 that matches the thread 13. An annular sealing ring is provided at the tube opening to ensure no leakage during transportation. The preservation tube 14 has a reliable sealing system and a sample validity indicator function. This ensures that the sample does not leak or degrade during transportation; furthermore, the color change of the color indicator 15 allows users to intuitively understand whether the sampling is valid, improving the reliability of the test.

[0033] Color indicator 15 uses a pH-sensitive bromocresol purple dye, immobilized in a porous polymer matrix. A solid, stable detection element is fabricated by immobilizing a chemical indicator (such as a pH-sensitive dye) onto a porous polymer matrix (e.g., porous polyethylene, porous nylon, hydrogel, etc.). Based on pH-dependent color changes, it is initially yellow (pH < 6.0), turning purple upon contact with a sample (pH > 6.8), indicating valid sampling. Triggering mechanism: Initially, the preservation solution 17 is physically separated from the color indicator 15. Upon sample addition, the liquid level rises, contacting the indicator and triggering the color change.

[0034] Preservative solution 17 includes guanidine salt, thiocyanate, Tris-HCl, ethylenediaminetetraacetic acid (EDTA), sodium azide, Proclin 300, Tween-20, Triton X-100, citrate, and phosphate.

[0035] Virus preservative: Guanidine salts balance cell lysis and virus. Thiocyanate works synergistically with guanidine salts to enhance the integrity of HPV virus particles.

[0036] Nucleic acid stabilizers: Tris-HCl (tris(hydroxymethyl)aminomethane hydrochloride) buffer, one of the most commonly used buffer systems in molecular biology, is optimized for HPV DNA to prevent degradation of long DNA chains. EDTA (ethylenediaminetetraacetic acid) at specific chelating concentrations effectively inhibits nuclease activity.

[0037] Antibacterial agent: Sodium azide effectively inhibits bacteria and reduces interference with subsequent detection. Proclin 300 has broad-spectrum antibacterial properties; its main components are isothiazolinone compounds, and it is suitable for normal temperature transportation.

[0038] Surfactants: Tween-20 (polysorbate 20) provides gentle lysis, releasing intracellular viruses while protecting them. Triton X-100 works synergistically to enhance virus release efficiency.

[0039] pH buffering system: Citrate optimizes buffer capacity to adapt to the pH after sample addition. Phosphate enhances stability, ensuring effective storage at room temperature for 14 days. pH value of 6.8-7.4 optimizes the pH environment for HPV storage, distinguishing it from other viruses.

[0040] Mechanism of action of preservation solution 17: Guanidine salt and thiocyanate disrupt the viral protein structure and release viral DNA; the Tris-EDTA system stabilizes the nucleic acid structure and prevents degradation; surfactants promote cell lysis and release intracellular viruses; antibacterial agents prevent sample deterioration during transportation; and the buffer system maintains a suitable pH environment to ensure reagent stability.

[0041] The outer side of the packaging box 4 is equipped with a time-temperature indicator label, and the inside of the packaging box 4 is equipped with a silicone moisture-proof bag 3. The support structure 1 is equipped with positioning grooves 2 that are adapted to the sampler and the storage tube 14.

[0042] The packaging box 4 employs a double-layer vacuum insulation structure, with an inner layer of aluminum foil composite material and an outer layer of rigid cardboard. Positioning slot 2 design: The support structure 1 features precise positioning slots 2 for the sampler and storage tube 14, preventing movement and collisions during transportation. Temperature-sensitive indicator: The outer surface of the packaging box 4 has a temperature-sensitive indicator label 5 that changes color when exposed to high temperatures (>30℃) for more than 4 hours. Moisture-proof design: A silicone moisture-proof bag 3 is placed inside the box to keep it dry. The height and dimensions of the packaging box 4 are designed for easy handholding and operation. Furthermore, the double-layer insulation structure and temperature-sensitive indicator label 5 of the packaging box 4 protect the sampler and storage tube 14 from ambient temperature before and after sampling; during transportation, the temperature-sensitive indicator label 5 allows users to monitor whether the sampler has been exposed to adverse temperature conditions.

[0043] Workflow: 1. Sampling process: The user holds the non-slip handle 6 and collects the sample according to the instructions.

[0044] 2. Breaking operation: Break the handle 6 along the V-shaped break line 8, keeping the handle 6 segment connected to the sampling head 10.

[0045] 3. Insert the storage tube 14: Insert the sampling head 10 together with the connected handle 6 into the storage tube 14. The top of the sampling head 10 pierces the sealing film 19 of the annular protrusion 16 and enters the lower part of the annular protrusion 16 to contact the storage liquid 17. The sampling head 10 extends into the storage liquid 17 and occupies part of the volume. The liquid level of the storage liquid 17 rises through the pierced sealing film 19 to the annular protrusion 16 and contacts the color indicator 15. The color indicator 15 changes color.

[0046] 4. Color verification: The color indicator 15 changes from yellow to purple, confirming that the sampling is valid and the sample size is sufficient.

[0047] Therefore, this invention employs the aforementioned HPV self-sampling kit, which, through a specific preservation solution formulation, an intelligent color indicator system, and an optimized sampler structure, ensures sample quality and simplifies the operation process. The color indicator's change objectively confirms successful sampling, resolving the reliance on subjective judgment in existing technologies. Operational reliability is ensured. The layered design and liquid surface triggering mechanism ensure that validity verification is only performed after sample addition. User experience is optimized: clear color changes provide intuitive feedback, reducing user anxiety. Detection accuracy is improved: optimized preservation conditions reduce false negative results and enhance screening accuracy.

[0048] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit them. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can still be made to the technical solutions of the present invention, and these modifications or equivalent substitutions cannot cause the modified technical solutions to deviate from the spirit and scope of the technical solutions of the present invention.

Claims

1. An HPV self-sampling kit, comprising a packaging box and a supporting structure, characterized in that: The support structure is located inside the packaging box. The support structure is equipped with a sampler and a storage tube. The sampler includes a handle and a sampling head. The top of the sampling head has spirally arranged bristles with spherical ends. The bottom of the sampling head is hinged to the handle by a ball. The storage tube has an annular boss inside. The storage tube contains a storage liquid and a color indicator. The storage liquid and the color indicator are physically isolated by the annular boss.

2. The HPV self-sampling package according to claim 1, characterized in that: The upper part of the handle is provided with a pre-made V-shaped break line, which makes it easy to break off the sampling head and place it in the storage tube after sampling.

3. The HPV self-sampling package according to claim 1, characterized in that: The handle surface has depth markings to guide the user to the correct insertion depth, and the handle surface has a textured surface for easy gripping and control.

4. The HPV self-sampling package according to claim 1, characterized in that: The bristles are 5-8mm long, 0.15-0.25mm in diameter, and have a bristle density of 150-200 bristles / cm². 2 .

5. An HPV self-sampling package according to claim 1, characterized in that: The top of the handle is equipped with a spherical groove, and the ball is located in the spherical groove. The two sides of the ball are rotatably connected to the side wall of the spherical groove through a rotating shaft. The ball moves in the spherical groove, allowing the sampling head to deflect during sampling and adapt to the cervical anatomy.

6. The HPV self-sampling package according to claim 1, characterized in that: The color indicator is located above the annular boss, and the preservation liquid is located below the annular boss. The circumferential sidewall of the annular boss is connected to the inner wall of the preservation tube. A sealing film is provided at the center of the annular boss to isolate the color indicator and the preservation liquid.

7. The HPV self-sampling package according to claim 1, characterized in that: The top of the storage tube is provided with threads and a threaded locking cap adapted to the threads.

8. The HPV self-sampling package according to claim 1, characterized in that: The color indicator uses a pH-sensitive bromocresol purple dye, which is fixed in a porous polymer matrix.

9. An HPV self-sampling package according to claim 1, characterized in that: The preservation solution includes guanidine salt, thiocyanate, Tris-HCl, ethylenediaminetetraacetic acid, sodium azide, Proclin 300, Tween-20, Triton X-100, citrate, and phosphate.

10. An HPV self-sampling package according to claim 1, characterized in that: The outer side of the packaging box is equipped with a temperature-sensitive indicator label, the inside of the packaging box is equipped with a silicone moisture-proof bag, and the support structure is equipped with positioning grooves that are adapted to the sampler and the storage tube.

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