Sample sampling tube

Abstract

The utility model provides a sample sampling tube. The sample sampling tube comprises a tube body and a sampling piece, a first pipe cavity and a second pipe cavity are arranged in the pipe body, a first reagent is preloaded in the first pipe cavity, a second reagent is preloaded in the second pipe cavity, a connecting channel is arranged between the first pipe cavity and the second pipe cavity, the first pipe cavity is communicated with the second pipe cavity through the connecting channel, and a blocking structure is arranged on the connecting channel. The blocking structure is used for switching the blocking or communicating state of the connecting channel; the sampling member is used for collecting samples. According to the utility model, preloaded liquefied liquid and extraction-free preservation liquid can be separated, so that the operation complexity and the liquid sprinkling risk caused by additionally adding reagents by sampling personnel are avoided, meanwhile, the functional failure caused by mixing the liquefied liquid and the extraction-free preservation liquid in advance is avoided, and detection personnel can conveniently and directly collect and carry out subsequent amplification reaction; the sampling and detection process is simplified, and the reliability and accuracy of the detection result are improved.

Description

Technical Field

[0001] This utility model relates to the field of sample detection technology, and in particular to a sample sampling tube. Background Technology

[0002] Cervical cancer is the fourth most common cancer among women worldwide. Studies have shown a close association between persistent infection with high-risk HPV (human papillomavirus) and cervical cancer. Therefore, HPV screening is crucial for improving the early detection and treatment rates of cervical cancer. With the development of HPV testing technology, especially PCR-based DNA testing methods, HPV nucleic acid testing has become the WHO-recommended method for initial cervical cancer screening.

[0003] HPV self-sampling, where women collect samples themselves, improves the convenience and acceptability of screening, helping to address issues of low screening coverage and efficiency, especially in resource-scarce areas. Furthermore, HPV self-sampling, combined with extraction-free sample preservation solutions, is compatible with convenient, low-cost, and time-saving point-of-care testing (POCT) systems. It eliminates the need for cumbersome nucleic acid extraction steps, simplifying operation while saving significant manpower and equipment costs. This allows it to meet the testing needs of different application scenarios in various countries and regions.

[0004] HPV self-sampling also presents some drawbacks and challenges. In particular, the quality of self-sampled samples can be affected by the sampler's skill level and experience. Compared to samples collected by doctors, self-sampled samples may differ in quality and quantity, thus affecting the accuracy of test results. In self-sampled samples, some may contain excessive mucus, other secretions, or small amounts of blood due to improper handling during collection. Adding these directly to the extraction-free preservation solution can prevent the effective release of nucleic acids, affecting the subsequent direct amplification and leading to false negatives, thus impacting the accuracy of the test results. Furthermore, the high viscosity of the sample may increase the difficulty of aspiration, resulting in a poor experience for testing personnel during subsequent sampling.

[0005] To address the impact of impurities such as mucus, other secretions, and small amounts of blood in HPV self-sampling samples on subsequent test results, a liquefaction solution is typically added to the collected sample to reduce its viscosity and improve sample quality. After liquefaction, the sample is then added to an extraction-free preservation solution for storage, ensuring the accuracy and reliability of HPV testing. Current sampling consumables typically do not pre-store liquefaction solution or require adding it during sampling, causing inconvenience and potential omissions for the sampler. Therefore, improvements are needed. Utility Model Content

[0006] The purpose of this invention is to address the shortcomings of the aforementioned background technology by providing a sampling consumable that is pre-filled with liquefied liquid and extract-free preservation liquid, and that the two are stored separately before sampling.

[0007] To achieve the above objectives, this utility model provides a sample collection tube, including a tube body and a sampling component;

[0008] The tube body is provided with a first cavity and a second cavity. The first cavity is pre-filled with a first reagent, and the second cavity is pre-filled with a second reagent. A connecting channel is provided between the first cavity and the second cavity, and the connecting channel connects the first cavity and the second cavity. A blocking structure is provided on the connecting channel, and the blocking structure is used to switch the blocking or connecting state of the connecting channel.

[0009] The tube body has a detachable first tube cap at its first end and a detachable second tube cap at its second end. The sampling element is connected to the first tube cap and is used to collect samples.

[0010] Furthermore, the first reagent is a liquefied solution, and the second reagent is an extraction-free preservation solution.

[0011] Furthermore, the sampling device includes a sampling swab, the first end of which is connected to the first tube cap, and the second end of which is used to contact the human body sampling site for sampling.

[0012] Furthermore, the second end of the sampling swab is eccentrically positioned relative to the first end, so that when the first tube cap rotates, the second end of the sampling swab agitates the inside of the first tube cavity.

[0013] Furthermore, the length of the sampling swab is matched with the depth of the first lumen, so that when the first tube cap is closed on the first end of the tube body, the second end of the sampling swab is inserted into a preset position in the first lumen.

[0014] Furthermore, the first pipe cap is threaded to the first end of the pipe body, and the second pipe cap is threaded to the second end of the pipe body. A sealing ring is provided at the gap between the first pipe cap and the first end of the pipe body, and a sealing ring is also provided at the gap between the second pipe cap and the second end of the pipe body.

[0015] Furthermore, the barrier structure includes a barrier valve disposed on the connection channel, the barrier valve having a closed state and an open state.

[0016] Furthermore, the barrier valve includes a valve seat, a valve cavity, a valve stem, and a valve disc. The valve cavity is a cavity within the valve seat, and its two ends are respectively connected to the two ends of the connecting channel. The valve disc is disposed within the valve cavity and is connected to a first end of the valve stem. The second end of the valve stem is threadedly connected to the valve seat and extends to the outside of the pipe body. Furthermore, a control wheel is also provided at the second end of the valve stem for hand-held rotation control.

[0017] Furthermore, a filter structure is also provided inside the tube, which is used to filter the mixed solution in the first tube cavity when it enters the second tube cavity.

[0018] The above-mentioned solution of this utility model has the following beneficial effects:

[0019] The sample collection tube provided by this utility model can separate the liquefied liquid and the extraction-free preservation liquid by pre-filling the first and second lumens of the tube body, respectively, and by setting a barrier structure between them. This avoids the cumbersome operation and spillage risk caused by the sampling personnel having to add additional reagents. At the same time, it avoids the functional failure caused by the liquefied liquid and the extraction-free preservation liquid being mixed in advance. During sampling, the sample is first added to the upper liquefied liquid to liquefy mucus samples and other secretions. When entering the second lumen, the liquefied sample is added to the extraction-free preservation liquid by opening the barrier structure. This makes it convenient for the testing personnel to directly collect and carry out subsequent amplification reactions, simplifying the sampling and testing process and improving the reliability and accuracy of the test results.

[0020] Other beneficial effects of this invention will be described in detail in the following detailed description section. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the overall structure of this utility model;

[0022] Figure 2 This is a cross-sectional view of the overall structure of this utility model;

[0023] Figure 3 This is a schematic diagram of the barrier valve of this utility model;

[0024] Figure 4 This is a schematic diagram of the sampling swab and the first tube cap of this utility model.

[0025] [Explanation of Labels in the Attached Image]

[0026] 1-Tube body; 2-First tube cavity; 3-Second tube cavity; 4-Liquefied liquid; 5-Extraction-free preservation liquid; 6-Connecting channel; 7-First tube cap; 8-Sampling swab; 9-Second tube cap; 10-Barrier valve; 11-Control wheel. Detailed Implementation

[0027] To make the technical problems, solutions, and advantages of this utility model clearer, a detailed description will be provided below with reference to the accompanying drawings and specific embodiments. Obviously, the described embodiments are only some, not all, of the embodiments of this utility model. All other embodiments obtained by those skilled in the art based on the embodiments of this utility model without creative effort are within the scope of protection of this utility model. Furthermore, the technical features involved in the different embodiments of this utility model described below can be combined with each other as long as they do not conflict with each other.

[0028] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0029] In the description of this utility model, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a locking connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this utility model based on the specific circumstances.

[0030] like Figure 1 , Figure 2 As shown, an embodiment of this utility model provides a sample collection tube, taking HPV sampling as an example, including a tube body 1 and a sampling component. The tube body 1 has a first cavity 2 and a second cavity 3. The first cavity 2 serves as a sample liquefaction chamber, used to store liquefied liquid 4, so that the collected sample is fully liquefied in the liquefied liquid 4. The second cavity 3 serves as a sample preservation chamber, used to store extraction-free preservation solution 5. A connecting channel 6 is provided between the first cavity 2 and the second cavity 3, also located within the tube body 1, for connecting the first cavity 2 and the second cavity 3. Simultaneously, a barrier structure is provided on the connecting channel 6 to isolate it, preventing the liquefied liquid 4 in the first cavity 2 and the extraction-free preservation solution 5 in the second cavity 3 from mixing before sampling.

[0031] It should be noted that liquefaction solution 4 is a reagent used to liquefy viscous samples such as sputum. Through the action of liquefaction solution 4, the collected sample is fully liquefied, resulting in better mixing with the extraction-free preservation solution 5, ensuring effective release of nucleic acid and avoiding any impact on subsequent test results. When preserving virus-containing samples, the extraction-free preservation solution 5 eliminates the need for subsequent nucleic acid extraction in PCR testing, combining preservation and extraction into one process, simplifying the subsequent PCR testing steps. Considering that liquefaction solution 4 needs to be separated from extraction-free preservation solution 5 before being fully mixed with the sample to avoid affecting their respective functions, in this embodiment, these two reagents are pre-filled in the first lumen 2 and the second lumen 3, respectively. Simultaneously, when not sampling, the barrier structure isolates the connecting channel 6, keeping the first lumen 2 and the second lumen 3 disconnected, thus preventing premature mixing of the two reagents. After the sample is fully liquefied in the first lumen 2, the connecting channel 6 is opened by a change in the barrier structure, allowing the mixed solution in the first lumen 2 to enter the second lumen 3 and fully mix with the extraction-free preservation solution 5.

[0032] In this embodiment, the sample collected by the sampling device is first placed into the first cavity 2, and after being fully liquefied by the liquefying liquid 4, it enters the second cavity 3 along with the mixed solution. The sampling device includes a sampling swab 8. A detachable first cap 7 is provided at the first end of the tube body 1. The first end of the sampling swab 8 is fixedly connected to the first cap 7, and the second end of the sampling swab 8 is used to contact the human body sampling site for sampling (absorbent cotton, etc., can be provided). The sampling swab 8 has a certain depth. When the first cap 7 is closed at the first end of the tube body 1, i.e., the entrance of the first cavity 2, while sealing the first end of the tube body 1, the second end of the sampling swab 8 can be fully inserted into the first cavity 2, so that the sample collected by the second end of the sampling swab 8 can fully contact the liquefying liquid 4, achieving the purpose of liquefaction.

[0033] Understandably, this design of the sampling device facilitates self-sampling. When the sample tube packaging is unopened, the first cap 7 is closed at the first end of the tube body 1, and the sampling swab 8 is pre-inserted into the first lumen 2. After opening the packaging, the sampling personnel first remove the first cap 7, and the sampling swab 8 is simultaneously pulled out from the first lumen 2, then inserted into the corresponding sampling location such as the mouth or nose for sample collection. After sampling, the sampling swab 8 is inserted back into the first lumen 2, ensuring full contact between the sample and the liquefied liquid 4, and the first cap 7 re-seals the first end of the tube body 1, thus improving the convenience of the sampling personnel's operation.

[0034] In addition, a removable second cap 9 is provided at the second end of the tube body 1. When the second cap 9 is closed at the second end of the tube body 1, i.e., the outlet of the second lumen 3, the extraction-free preservation solution 5 in the second lumen 3 will not leak out. This ensures stability when subsequent samples are mixed and preserved in the second lumen 3 with the extraction-free preservation solution 5. When the testing personnel need to perform testing, the second cap 9 is opened to collect the mixed solution containing the sample.

[0035] In a preferred embodiment, the first cap 7 and the second cap 9 are threadedly connected to the first and second ends of the tube body 1. A sealing ring is also placed at the gap between the first cap 7 and the first end of the tube body 1, and a sealing ring is also placed at the gap between the second cap 9 and the second end of the tube body 1. This ensures a tight seal after the threaded connection, preventing leakage during storage and transportation. Of course, in other embodiments, a flexible insertion method can be used for connection and sealing; however, this may result in loosening or leakage. Therefore, a threaded connection is preferred.

[0036] At the same time, such as Figure 3 As shown, in this embodiment, the blocking structure includes a blocking valve 10 disposed on the connecting channel 6. The blocking valve 10 is similar to a gate valve in the prior art, and includes a valve seat, a valve cavity, a valve stem, and a valve disc. The valve cavity is the cavity inside the valve seat, and its two ends are respectively connected to the two ends of the connecting channel 6, namely the outlet of the first cavity 2 and the inlet of the second cavity. The valve disc is disposed in the valve cavity and is connected to the first end of the valve stem. The second end of the valve stem is threadedly connected to the valve seat (or the pipe body 1). By adjusting the position of the valve disc by the valve stem, the through hole of the valve cavity is blocked or opened, thereby switching the closed and open states of the blocking valve 10, and thus switching the blocking or connected states of the first cavity 2 and the second cavity 3.

[0037] It should be noted that the second end of the first valve stem extends to the outside of the tube body 1 and is equipped with a control wheel 11, so that the sampling personnel can switch the barrier valve 10 open by controlling the control wheel 11, so that the mixed solution including the sample in the first tube 2 can enter the second tube 3 (and then the barrier valve 10 can be switched closed again), and the operation is equally convenient.

[0038] In a preferred embodiment, a filter structure is also provided inside the tube 1. The filter structure can be located at the outlet of the first cavity 2 or the inlet of the second cavity 3. The filter structure can take the form of a filter screen or a filter membrane, depending on the pore size. The filter structure further filters the mixed solution entering the second cavity 3 from the first cavity 2, preventing small amounts of blood, other secretions, or solid impurities in the collected sample from affecting the detection process, thereby better ensuring the accuracy of the test results. The barrier valve 10 also prevents the sample, which is fully mixed with the preservation solution, from flowing back into the first cavity 2.

[0039] It is worth mentioning that when the sampling swab 8 is inserted into the first lumen 2 after collecting the sample, it is best to agitate it to ensure that the sample and the liquefied liquid 4 flow and mix thoroughly, so as to achieve a better liquefaction effect within a certain time. Therefore, a stirring structure can be further provided. One method is to set up a separate stirring structure, but this will increase the overall complexity and the cumbersomeness of operation. Therefore, as a preferred embodiment, and as... Figure 4 As shown, in this embodiment, the second end of the sampling swab 8 is eccentrically positioned relative to the first end. That is, after the first tube cap 7 is installed, the sampling swab 8 and the center line of the first tube cavity 2 are inclined at an angle. Therefore, when the first tube cap 7 is tightened and rotated, the second end of the sampling swab 8 can rotate relative to the first end, thereby generating a significant stirring effect on the liquefied liquid 4, allowing the sample at the second end of the sampling swab 8 to fully contact and mix with the liquefied liquid 4. Of course, if the sampling personnel feel that the mixing is still insufficient, they can hold the first tube cap 7 and rotate or stir it back and forth to improve the degree of mixing.

[0040] When performing self-sampling using the sample collection tube provided in this embodiment, the sampling personnel open the packaging, take out the sample collection tube, and first remove the first tube cap 7. Simultaneously, the sampling swab 8 is drawn from the first tube cavity 2 and inserted into the corresponding sampling location such as the mouth or nose to collect the sample. After sampling, the sampling swab 8 is inserted back into the first tube cavity 2, and then the first tube cap 7 is reinstalled, sealing the first end of the first tube cavity 2. This process is accompanied by an eccentric rotation of the second end of the sampling swab 8, allowing the sample and liquefied liquid 4 to fully contact and mix. Then, the barrier valve 10 is opened, allowing the mixed solution in the first tube cavity 2 to enter the second tube cavity 3. After filtration, it is fully mixed with the extraction-free preservation solution 5 in the second tube cavity 3, thus completing the sampling. Subsequently, after obtaining the sample collection tube containing the preserved sample, the testing personnel can open the second tube cap 9 to collect the sample.

[0041] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0042] The above embodiments are merely illustrative of several implementation methods of this application, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this application should be determined by the appended claims.

Claims

1. A sample sampling tube, characterized by, The tube body (1) and the sampling member are included. The first tube cavity (2) is preloaded with the first reagent, and the second tube cavity (3) is preloaded with the second reagent. The first end of the tube body (1) is provided with a detachable first tube cover (7), and the second end of the tube body (1) is provided with a detachable second tube cover (9).

2. The sample sampling tube of claim 1, wherein, The first reagent is liquefied liquid (4), and the second reagent is extraction-free storage liquid (5).

3. The sample sampling tube of claim 1, wherein, The sampling member includes a sampling swab (8), and the first end of the sampling swab (8) is connected with the first tube cover (7).

4. The sample sampling tube of claim 3, wherein, The second end of the sampling swab (8) is eccentrically arranged relative to the first end, so that when the first tube cover (7) rotates, the second end of the sampling swab (8) agitates the inside of the first tube cavity (2).

5. The sample sampling tube according to claim 3 or 4, characterized in that The length of the sampling swab (8) matches the depth of the first tube cavity (2), so that when the first tube cover (7) is covered on the first end of the tube body (1), the second end of the sampling swab (8) is inserted into the preset position in the first tube cavity (2).

6. The sample sampling tube of claim 1, wherein, The first tube cover (7) and the first end of the tube body (1) and the second tube cover (9) and the second end of the tube body (1) are threadedly connected, and the gap position between the first tube cover (7) and the first end of the tube body (1) is provided with a sealing ring, and the gap position between the second tube cover (9) and the second end of the tube body (1) is also provided with a sealing ring.

7. The sample sampling tube of claim 1, wherein, The blocking structure includes a blocking valve (10) arranged on the connecting channel (6), and the blocking valve (10) has a closed and opened state.

8. The sample sampling tube of claim 7, wherein, The blocking valve (10) includes a valve seat, a valve cavity, a valve stem and a valve flap, the valve cavity is a cavity in the valve seat, the two ends of the valve cavity are communicated with the two ends of the connecting channel (6), the valve flap is arranged in the valve cavity, the valve flap is connected with the first end of the valve stem, and the second end of the valve stem is threadedly connected with the valve seat and extends to the outside of the tube body (1).

9. The sample sampling tube of claim 8, wherein, The second end of the valve stem is also provided with a control wheel (11), and the control wheel (11) is used for hand control rotation.

10. The sample sampling tube of claim 1, wherein, The tube body (1) is also provided with a filtering structure, which is used for filtering the mixed solution in the first tube cavity (2) when entering the second tube cavity (3).

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