Sample collection and testing device, kit and testing method

Abstract

The present application relates to the field of prompt diagnosis, and in particular, to a sample collection and testing device, a kit and a testing method. The sample collection and testing device comprises a collection structure and a liquid storage structure. The collection structure is provided with an accommodating cavity used for accommodating a test piece. One end of the collection structure is used for collecting samples, and the collection structure is provided with a liquid inlet communicated with the accommodating cavity. The liquid storage structure is provided with a liquid storage cavity and a movable port communicated with the liquid storage cavity. The liquid storage cavity is used for storing a diluent. The collection structure enters the liquid storage cavity through the movable port, and is in interference fit with the cavity wall of the liquid storage cavity and moves along the cavity wall. After entering the liquid storage cavity, the collection structure can squeeze the diluent to flush the sample and form a mixed solution, which is simultaneously pressed through the liquid inlet into the accommodating cavity to come into contact with the test piece. According to the sample collection and testing device, by providing the collection structure and the liquid storage structure, sample addition, sample mixing and test piece testing can be integrated in one step, thereby achieving simple operation, and improving the testing efficiency.

Description

Sample collection and detection device, kit, and detection method Technical Field

[0001] The present application relates to the field of instant diagnosis, and in particular to a sample collection and detection device, a kit, and a detection method. Background Art

[0002] Stool testing can be used as an auxiliary diagnosis for a variety of diseases and can be used to determine whether the subject has a bacterial or viral infection. Current stool testing devices require additional steps such as mixing and adding samples, which is cumbersome and reduces detection efficiency.

[0003] Summary of the Invention

[0004] Based on this, it is necessary to provide a sample collection and detection device, a kit and a detection method to address the problem that the current feces detection device requires additional steps such as mixing and adding samples, which is cumbersome to operate and reduces detection efficiency.

[0005] In a first aspect, a sample collection and detection device comprises:

[0006] A collection structure, wherein the collection structure has a receiving cavity for placing the detection element, one end of the collection structure is used to collect the sample, and the collection structure is provided with a liquid inlet communicated with the receiving cavity;

[0007] The liquid storage structure comprises a liquid storage cavity and a movable port connected to the liquid storage cavity, wherein the liquid storage cavity is used to store the diluent, and the collection structure is used to enter the liquid storage cavity through the movable port, and to have an interference fit with the cavity wall of the liquid storage cavity and move along the cavity wall.

[0008] In one embodiment, the liquid storage structure includes a base and a booster, the base has the liquid storage cavity and the movable port, the booster is arranged in the liquid storage cavity and can movably abut against the cavity wall, the interior of the booster is penetrated by a through hole communicating with the liquid storage cavity, and the collection structure is used to enter the liquid storage cavity and push the booster to move relative to the cavity wall.

[0009] In one embodiment, the base includes a base upper cover, a base lower cover, and a diluent tube;

[0010] The base lower cover includes a main body and an extension portion, the extension portion being connected to the outer periphery of the main body and extending in a direction away from the main body, the main body having a first placement cavity and a first opening communicating with the first placement cavity, the base upper cover having a second placement cavity and a second opening and a third opening communicating with the second placement cavity, the second opening and the third opening being arranged opposite to each other in the axial direction of the base upper cover, the diluent tube having the liquid storage cavity and the movable port, the pressurizing member being disposed in the diluent tube and abutting against the inner wall of the diluent tube;

[0011] The diluent tube passes through the first opening and is located in the first placement cavity. The outer wall of the diluent tube abuts against the cavity wall of the first placement cavity. The lower cover of the base passes through the third opening and is located in the second placement cavity. The outer periphery of the extension part abuts against the cavity wall of the second placement cavity. The movable port is at least partially exposed to the first opening and the second opening.

[0012] In one embodiment, the collection structure includes a collection body, a sealing body, and a containing body. One end of the collection body is used to collect the sample. The collection body is provided with the liquid inlet. The containing body has a hollow portion extending along its length.

[0013] The collecting body is detachably connected to one end of the hollow portion, and the covering body is detachably connected to the other end of the hollow portion, so that the collecting body, the covering body and the containing body together constitute the containing cavity.

[0014] In one embodiment, the collection structure further includes a filter body, the filter body abuts against the cavity wall of the containing body, and the filter body at least partially contacts the liquid inlet and the detection element.

[0015] In one embodiment, the collecting body is concave toward its bottom end to form a groove, and the groove is connected to the accommodating cavity and the liquid inlet at the same time. The filter body is located in the groove, and the filter body abuts against the groove wall of the groove.

[0016] In one embodiment, the groove body includes a step portion and an abutment portion, the abutment portion is arranged at the top of the step portion, the filter body abuts against the upper surface of the step portion and the inner circumferential surface of the abutment portion at the same time, the filter body is located above the liquid inlet, and the detection member abuts against the upper surface of the filter body.

[0017] In one embodiment, the cover body is provided with a card slot. When the cover body is connected to the accommodating body, the card slot is communicated with the accommodating cavity, and the card slot is used to fix the detection member.

[0018] In a second aspect, the kit includes a sample collection and detection device, and the sample collection and detection device is the sample collection and detection device as described in the first aspect.

[0019] In a third aspect, the detection method is to detect a sample by using a sample collection and detection device, using the sample collection and detection device described in the first aspect, and the detection method includes the following steps:

[0020] Adhere the sample to the collection structure;

[0021] Inserting the collection structure with the sample attached into the liquid storage cavity through the movable port, squeezing the diluent in the liquid storage cavity to flush the sample to form a mixed liquid, and then forcing the mixed liquid into the receiving cavity to contact the detection element;

[0022] Observe the detection member in the collection structure accommodating cavity and read the detection result.

[0023] The above-mentioned sample collection and detection device, by providing a collection structure and a liquid storage structure, can integrate sample addition, sample mixing, and detection of the detection element into a single step, simplifying operation and improving detection efficiency. Specifically, after the collection structure collects the sample, it is allowed to enter the liquid storage cavity through the movable opening. Due to the interference fit between the collection structure and the cavity wall of the liquid storage cavity, a closed space is formed between the collection structure and the liquid storage cavity. During the instantaneous entry of the collection structure into the liquid storage cavity, the pressure inside the liquid storage cavity increases sharply, forcing the diluent to form a torrent that flushes the sample outside the collection structure, causing the sample and diluent to mix to form a mixed liquid. When the collection structure continues to move relative to the liquid storage cavity, the internal space of the liquid storage cavity decreases, squeezing the mixed liquid from the liquid inlet on the collection structure into the storage cavity of the collection structure. After contacting the mixed liquid, the detection element can automatically detect the mixed liquid. Therefore, by simply inserting the collection structure into the liquid storage cavity of the liquid storage structure, sample addition, sample mixing, and detection can be achieved in one step, without the need for additional sample mixing and sample addition steps, thereby improving detection efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] FIG1 is a perspective view of a sample collection and detection device provided in an embodiment of the present application.

[0025] FIG2 is a cross-sectional view of a sample collection and detection device provided in an embodiment of the present application.

[0026] FIG3 is a partial cross-sectional view of a sample collection and detection device provided in an embodiment of the present application.

[0027] FIG4 is an exploded schematic diagram of the collection structure in an embodiment of the present application.

[0028] FIG5 is a three-dimensional diagram of the collecting body of the collecting structure in the embodiment of the present application.

[0029] FIG6 is an exploded schematic diagram of the liquid storage structure in an embodiment of the present application.

[0030] Explanation of reference numerals: 100, sample collection and detection device; 1, collection structure; 101, accommodating chamber; 102, detection member; 1021, sample pad; 1022, protein coupling pad; 1023, nitrocellulose membrane; 1024, detection line; 1025, quality control line; 1026, water absorbent pad; 103, liquid inlet; 11, collection body; 111, groove; 111a, step portion; 111b, abutment portion; 112, second clamping portion; 112a, second neck portion; 112b, second shoulder; 113, first groove; 12, cover body; 121, slot; 122, first clamping portion; 122a, first neck portion; 122 b. first shoulder; 13. containing body; 131. hollow portion; 132. first protrusion; 133. window; 14. filter body; 15. tooth-shaped structure; 16. annular groove; 2. liquid storage structure; 21. liquid storage cavity; 22. movable opening; 23. base; 231. base upper cover; 2311. second placement cavity; 2312. second opening; 2313. third opening; 232. base lower cover; 2321. main body; 2321a. first placement cavity; 2321b. first opening; 2322. extension portion; 2323. bending portion; 233. diluent tube; 2331. overlapping portion; 24. booster; 241. through hole. DETAILED DESCRIPTION

[0031] To make the above-mentioned objects, features, and advantages of the present application more clearly understood, the specific embodiments of the present application are described in detail below with reference to the accompanying drawings. The following description sets forth many specific details to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways than those described herein, and those skilled in the art can make similar improvements without violating the scope of the present application. Therefore, the present application is not limited to the specific embodiments disclosed below.

[0032] In the description of this application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application.

[0033] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the number of technical features indicated. Therefore, a feature specified as "first" or "second" may explicitly or implicitly include at least one of such features. In the description of this application, if the term "plurality" appears, "plurality" means at least two, for example, two, three, etc., unless otherwise specifically defined.

[0034] In this application, unless otherwise specified or limited, the terms "mounted," "connected," "connected," "fixed," etc., should be interpreted broadly. For example, these terms may refer to fixed connections, removable connections, or integration; mechanical connections or electrical connections; direct connections or indirect connections through an intermediary; and internal communication between two components or interaction between two components, unless otherwise specified. Those skilled in the art will understand the specific meanings of these terms in this application based on the specific circumstances.

[0035] Stool testing can be used as an auxiliary diagnosis for a variety of diseases. By testing stool, it can be determined whether the subject has an infection such as bacteria or viruses, thereby achieving the purpose of diagnosing the disease. Currently, there are two main types of stool testing devices. One type of stool testing device uses a sampling stick to first collect a certain amount of stool sample, then inserts the sampling stick into a collection tube filled with a diluent, and then mixes the stool sample on the collection stick with the diluent through steps such as scraping, shaking, and letting it stand. The sample mixture is then added drop by drop to the sampling hole on the test plate or test piece. This method requires additional mixing and adding steps, which are cumbersome and time-consuming. In addition, when shaking and adding the mixed liquid, it is easy for the liquid to leak and cause secondary contamination. The other type of stool testing device is to set a plug or baffle between the diluent and the test piece. A certain amount of stool sample is collected using a sampling stick, then the sampling stick is inserted into the structure filled with diluent, shaken to fully mix the stool sample and diluent, and then further external force is used to break the plug or baffle structure on the sampling stick, so that the mixed liquid flows to the test piece. While this type of detection device doesn't require dropwise addition of samples like previous devices, it still requires shaking and mixing the sample before adding it, and an additional triggering action for adding the sample. Therefore, current fecal testing devices require additional mixing and adding samples, making the testing process cumbersome and requiring improved efficiency.

[0036] Based on the above problems, in the first aspect, referring to FIG1 , an embodiment of the present application provides a sample collection and detection device 100 , comprising a collection structure 1 and a liquid storage structure 2 .

[0037] Please refer to Figures 1 and 2. The collection structure 1 has a accommodating chamber 101, and the accommodating chamber 101 is used to place the detection element 102. One end of the collection structure 1 is used to collect samples, and the collection structure 1 is provided with a liquid inlet 103 connected to the accommodating chamber 101. The liquid storage structure 2 has a liquid storage chamber 21 and a movable port 22 connected to the liquid storage chamber 21. The liquid storage chamber 21 is used to store a diluent. The collection structure 1 is used to enter the liquid storage chamber 21 through the movable port 22, and has an interference fit with the cavity wall of the liquid storage chamber 21 and moves along the cavity wall to squeeze the diluent to flush the sample to form a mixed liquid. At the same time, the mixed liquid is squeezed into the accommodating chamber 101 through the liquid inlet 103 to contact the detection element 102. The sample collection and detection device 100 of the present application can automatically achieve sample mixing and sample addition by setting the collection structure 1 and the liquid storage structure 2, without the need for additional sample mixing and sample addition steps, thereby simplifying the detection steps and improving the detection efficiency.

[0038] Specifically, after the collection structure 1 collects the sample, it enters the liquid storage chamber 21 through the movable port 22. Due to the interference fit between the collection structure 1 and the wall of the liquid storage chamber 21, a sealed space is formed between the collection structure 1 and the liquid storage chamber 21. The moment the collection structure 1 enters the liquid storage chamber 21, the air pressure inside the sealed space increases, and the pressure forces the diluent to form a torrent that flushes the sample on the collection structure 1, thereby mixing the sample with the diluent to form a mixed liquid. The collection structure 1 further moves relative to the cavity wall, the sealed space shrinks, and the mixed liquid is squeezed and flows from the liquid inlet 103 into the accommodating chamber 101 of the collection structure 1 and contacts the detection element 102. Therefore, by inserting the collection structure 1 into the liquid storage chamber 21, the effects of sample mixing, sample addition and detection can be achieved simultaneously, thereby eliminating the need for additional steps such as shaking and sample addition, greatly simplifying the detection steps and improving detection efficiency.

[0039] Furthermore, due to the interference fit between the collection structure 1 and the liquid storage structure 2, the mixed liquid is completely stored in the sealed space formed by the collection structure 1 and the liquid storage structure 2 after the detection is completed, thereby avoiding secondary contamination caused by leakage of the mixed liquid, and improving the safety and hygiene of the sample collection and detection device 100 of the present application.

[0040] Furthermore, in the second type of feces detection device, a structure such as a baffle or plug is used to isolate the diluent and the detection member. When the baffle or plug becomes loose or peeled off or is accidentally damaged, the diluent will directly soak the detection member, causing the detection member to fail, reducing the reliability of the detection device and affecting the detection results. In the sample collection device of the present application, the detection member 102 is arranged in the collection structure 1, and the diluent is arranged in the liquid storage structure 2. The detection member 102 and the diluent are arranged separately, thereby avoiding the possibility of accidental contact between the detection member 102 and the diluent, reducing the possibility of failure of the detection member 102, and improving the reliability and stability of the detection device.

[0041] Furthermore, in the two feces detection devices described above, differences in the operating habits of different subjects can cause inaccurate test results. For example, different mixing methods may cause the feces sample and the diluent to mix unevenly, resulting in poor dilution, and inaccurate control of the dripping amount affects the detection accuracy. The sample collection and detection device 100 provided in the embodiment of the present application avoids the above problems. When the subject inserts the collection structure 1 into the liquid storage chamber 21, the collection structure 1 moves along a consistent path from entering the liquid storage chamber 21 to abutting against the bottom of the liquid storage chamber 21, and the compressed space is consistent, so that the amount of mixed liquid entering the holding chamber 101 is also close to the same, thereby avoiding the interference introduced by the manual mixing and adding steps and improving the accuracy of the test results.

[0042] The sample collected by the collection structure 1 can be excrement or secretion, etc. The collection structure 1 can be an integrally formed structure or a split-formed structure. In order to facilitate disassembly and assembly, the collection structure 1 is designed as a split structure.

[0043] Referring to Figures 2 and 4 , in some embodiments, the collection structure 1 includes a collection body 11, a cover 12, and a container 13. The exterior of the collection body 11 is used to collect samples. The collection body 11 is provided with a liquid inlet 103. The container 13 has a hollow portion 131 extending through its length. The collection body 11 is detachably connected to one end of the hollow portion 131, and the cover 12 is detachably connected to the other end of the hollow portion 131. Thus, the collection body 11, cover 12, and container 13 collectively form a container chamber 101.

[0044] Referring to FIG4 , the container 13 can be shaped like a column, box, sphere, ellipsoid, or flat. Referring to FIG1 , the container 13 can be made entirely of a transparent material, or partially of a transparent material, so long as it serves as a window 133 for observing the detection element 102 and does not interfere with the reading of the detection result of the detection element 102.

[0045] Please refer to Figure 2. The cover body 12 and the container body 13 can be rotatably connected by a threaded structure, or can be clamped by a clamping structure. For example, please refer to Figure 4. The cover body 12 includes a first clamping portion 122, and the first clamping portion 122 includes a first neck portion 122a and a first shoulder portion 122b that are connected. Along the radial direction of the cover body 12, the first shoulder portion 122b is located on the outside of the first neck portion 122a. The first neck portion 122a extends toward the inside of the hollow portion 131, and the first shoulder portion 122b extends toward the outside of the cover body 12 to increase the connection area between the two and the container body 13, thereby improving the connection stability. When the cover body 12 is connected to the container body 13, the outer peripheral surface of the first neck portion 122a of the cover body 12 abuts against the cavity wall of the container body 13, and the bottom surface of the first shoulder portion 122b abuts against the top surface of the container body 13.

[0046] Furthermore, the cover body 12 is provided with air holes through it, so as to allow the detection element 102 to undergo chromatography. The air holes can also be provided on the container 13 of the collection structure 1.

[0047] Referring to Figure 4, in some embodiments, the cover body 12 is further provided with a slot 121. When the cover body 12 is connected to the containing body 13, the slot 121 is communicated with the containing cavity 101, that is, the slot 121 is located in the containing body 13, and the slot 121 is used to fix the detection member 102. The width of the slot 121 is consistent with the width of the detection member 102, which can more firmly fix the detection member 102 and prevent the detection member 102 from shifting. The slot 121 extends toward the interior of the hollow portion 131 to increase the fixed length of the detection member 102, thereby increasing the contact area with the detection member 102 and improving the fixing stability. The slot 121 can be one or more and is used to fix one or more detection members 102.

[0048] The collection body 11 has multiple functions: it collects the sample, improves the mixing of the sample and diluent, and serves as the entrance for the mixed liquid to enter the holding chamber 101 for testing. By inserting the outer portion of the collection body 11 into the sample to be tested and then removing it, the sample is collected on the outer surface of the collection body 11. This operation can be repeated multiple times until a sufficient amount of sample is adhered to the collection body 11 for dilution.

[0049] Referring to Figure 4 , the collection body 11 and the container 13 can also be rotationally connected via a spiral structure or snap-fitted via a snap-fit ​​structure. Referring to Figure 5 , for example, the collection body 11 includes a second snap-fitting portion 112, which includes a second neck portion 112a and a second shoulder portion 112b. Along the radial direction of the collection body 11, the second shoulder portion 112b is located outside the second neck portion 112a. The second shoulder portion 112b extends toward the interior of the hollow portion 131 and toward the exterior of the collection body 11 to increase the snap-fitting area with the container 13. When the collection body 11 is snap-fitted to the container 13, the outer circumferential surface of the second neck portion 112a abuts against the cavity wall of the container 13, and the top surface of the second shoulder portion 112b abuts against the bottom surface of the container 13.

[0050] To further enhance the stability of the connection between the collecting body 11 and the container 13, as shown in Figure 3 , a first protrusion 132 is provided on the wall of the container 13 in the radial direction. As shown in Figure 5 , a first groove 113 is provided on the outer circumference of the second neck portion 112a of the collecting body 11. Continuing with Figure 3 , when the second neck portion 112a extends into the hollow portion 131 of the container 13, the first protrusion 132 and the first groove 113 engage, securing the collecting body 11 in the axial direction and preventing it from slipping out of the container 13.

[0051] Referring to Figure 5 , the collecting body 11 gradually tapers from its midsection toward its bottom, forming a tapered shape. This reduces resistance to insertion of the collecting body 11 into the liquid storage chamber 21 and facilitates insertion of the collecting body 11 into the liquid storage structure 2. Furthermore, the tapered collecting body 11 has a narrower tip, making it less susceptible to clogging by solid particles or viscous substances, ensuring smooth passage of the mixed liquid from the liquid inlet 103 into the receiving chamber 101.

[0052] Please refer to Figure 5. The outer surface of the collection body 11 can be provided with a threaded structure or a toothed structure 15 to increase the contact area with the sample and improve the adhesion effect on the sample. Taking the toothed structure 15 as an example, the outside of the collection body 11 is provided with a plurality of toothed structures 15 in an array in a direction from the top to the bottom. Each toothed structure 15 is arranged around the outer periphery of the collection body 11, and an annular groove 16 is formed between the upper and lower adjacent toothed structures 15. On the one hand, it can increase the contact area between the liquid and the inner wall of the annular groove 16, increase the contact and friction between the liquid and the collection body 11, and better mix the sample and diluent. In addition, the annular groove 16 can change the direction and speed of the liquid flow, increase the turbulent motion of the liquid, thereby improving the mixing efficiency, and allowing the diluent to flow back and forth in the annular groove 16, constantly flushing and exchanging, thereby improving the dilution effect of the sample.

[0053] Referring to Figure 5 , the liquid inlet 103 of the collection body 11 is positioned above the toothed structure 15, maintaining a certain distance from the toothed structure 15 to prevent clogging by the sample. The liquid inlet 103 is located on two opposing wide sides of the conical collection body 11, ensuring that the diluent fully covers and mixes the sample on the outer surface of the collection body 11. This effectively rinses and mixes the sample, reduces sample residue, improves mixing efficiency, and facilitates smooth injection of the mixed solution into the holding chamber 101.

[0054] Referring to Figure 2 , in some embodiments, the collecting body 11 is concave toward its bottom end to form a groove 111, which is connected to both the receiving chamber 101 and the liquid inlet 103. The provision of the groove 111 can shorten the flow distance of the mixed liquid, allowing the mixed liquid to enter the receiving chamber 101 from the collecting body 11 more quickly, thereby improving detection efficiency.

[0055] Referring to Figure 2 , in some embodiments, the collection structure 1 further includes a filter 14, which abuts the wall of the accommodating chamber 101 and at least partially contacts the liquid inlet 103 and the detection element 102. Filter 14 not only buffers the mixed liquid, preventing splashing and allowing the mixed liquid to evenly infiltrate the detection element 102, but also filters insoluble solids or impurities in the sample, ensuring a more reliable concentration and composition of the mixed liquid and preventing interference with detection by the detection element 102.

[0056] Filter 14 can be made of a hydrophobic material containing micropores that does not absorb the mixed liquid, and can be made of, for example, ultra-high molecular weight polyethylene, tetrafluoroethylene, or polyolefin. The pores in filter 14 can have a pore size between 20 μm and 80 μm, and can be any value within this range, such as 20 μm, 30 μm, 40 μm, 50 μm, 60 μm, 70 μm, or 80 μm.

[0057] Referring to Figure 2, in some embodiments, the filter 14 is located within the groove 111 of the collecting body 11, and the filter 14 abuts against the wall of the groove 111. The filter 14 is disposed within the collecting body 11 so that the mixed liquid flowing from the liquid inlet 103 into the groove 111 is promptly filtered by the filter 14, thereby improving the uniformity and consistency of the mixed liquid.

[0058] Referring to FIG3 , in some embodiments, the body of the groove 111 includes a stepped portion 111a and an abutting portion 111b. The abutting portion 111b is disposed at the top of the stepped portion 111a. The filter 14 abuts both the upper surface of the stepped portion 111a and the inner circumferential surface of the abutting portion 111b. The filter 14 is located above the liquid inlet 103, and the detection element 102 abuts the upper surface of the filter 14. The stepped portion 111a maintains a certain distance between the filter 14 and the liquid inlet 103, thereby avoiding interference with the mixed liquid entering the groove 111 and allowing the mixed liquid to enter the groove 111 more smoothly.

[0059] The detection element 102 in the embodiments of the present application can employ a colloidal gold lateral flow structure, a fluorescent lateral flow structure, a quantum dot lateral flow mechanism, an enzymatic longitudinal flow mechanism, or a microfluidic siphon reaction mechanism. These detection elements 102 can utilize antigen-antibody immunological reactions and chromatographic reactions to achieve rapid and accurate color development for detecting analytes. The detection element 102 can detect a variety of analytes and employ both non-competitive and competitive analytical methods.

[0060] Referring to Figure 4 , the detection element 102 can detect a variety of analytes and can employ either non-competitive or competitive analysis modes. The detection element 102 comprises a sample pad 1021 made of a water-absorbing material to absorb and receive the sample, a protein coupling pad 1022 coated with a marker, a nitrocellulose membrane 1023 containing an antibody-coated detection line 1024 and an antibody-coated quality control line 1025, and a water-absorbing pad 1026. When the detection element 102 is placed in the collection structure 1, the absorbent paper is inserted into the card slot 121 of the cover body 12, the sample pad 1021 contacts the filter body 14 in the collection body 11, and the detection lines 1024 and quality control lines 1025 of the detection element 102 correspond to the window 133 of the container 13 to read the test results.

[0061] The detection principle of detection element 102 is based on immunochromatography, which exploits the specific binding between immune molecules to detect the presence of the analyte in the sample. As the mixed solution undergoes capillary chromatography, it passes through protein coupling pad 1022. The analyte in the mixed solution reacts with the immune complex within the protein coupling pad 1022 to produce an antigen-antibody complex. Under continuous chromatography, the antigen-antibody complex is captured by detection line 1024 and quality control line 1025 coated with nitrocellulose membrane 1023, forming a detection strip. The presence of the analyte in the sample is indicated by the detection line 1024.

[0062] The analyte in the mixed solution may be hemoglobin or transferrin, which can be used to determine if the subject has gastrointestinal bleeding. Alternatively, the analyte in the mixed solution may be Helicobacter pylori, which can be used to determine if the subject is infected with Helicobacter pylori. Alternatively, the analyte in the mixed solution may be rotavirus or adenovirus, which can be used to determine if the subject is infected with rotavirus or adenovirus.

[0063] The detection element 102 can be composed of a variety of materials for transferring liquid samples. For example, materials within the detection element 102 can be partially layered over adjacent materials, for example, the protein coupling pad 1022 can be overlaid on the nitrocellulose membrane 1023. The various components of the detection element 102 can be made of one or more materials, each of which can be adhered to a hard surface or a support to enhance the overall strength of the detection element 102.

[0064] The detection element 102 can be positioned in various ways and forms within the accommodating cavity 101. For example, the detection element 102 can be suspended in the center of the accommodating cavity 101, or can be closely attached to one side of the cavity wall of the accommodating cavity 101. A hard support can also be provided in the center of the accommodating cavity 101 to secure the detection element 102. The detection item of the detection element 102 can be a single item or multiple items, and the number of detection elements 102 in the accommodating cavity 101 can be one or more.

[0065] Referring to Figures 1 and 2, the liquid storage structure 2 serves as a storage location for the diluent, and its movable opening 22 is sealed by a sealing sheet. The sealing sheet can be made of aluminum foil, plastic, etc. The collecting body 11 of the collecting structure 1 pierces the sealing sheet and is inserted into the liquid storage cavity 21.

[0066] Referring to Figure 2 , after the collection structure 1 enters the liquid storage chamber 21, the container 13 of the collection structure 1 must fit tightly against the wall of the liquid storage chamber 21 to prevent liquid leakage, while also generating an impact force to mix the sample and diluent and squeeze the mixed liquid into the liquid inlet 103. To achieve an interference fit between the container 13 and the wall of the storage chamber 101, the following methods may be used, but are not limited to: rigid materials of the two may be pressed against each other to form a seal, or a sealing ring may be fixed to the wall of the liquid storage chamber 21 to seal the container 13 against the wall.

[0067] Referring to Figures 3 and 6 , in some embodiments, the liquid storage structure 2 includes a base 23 and a pressurizing member 24. The base 23 has a liquid storage chamber 21 and a movable port 22. The pressurizing member 24 is disposed in the liquid storage chamber 21 and is movably in contact with the wall of the liquid storage chamber 21. A through hole 241 is provided in the interior of the pressurizing member 24, communicating with the liquid storage chamber 21. The collection structure 1 is configured to enter the liquid storage chamber 21 and push the pressurizing member 24 relative to the wall, so that the pressurizing member 24 squeezes the diluent to flush the sample to form a mixed liquid. The mixed liquid then flows out through the through hole 241 and enters the receiving chamber 101 from the liquid inlet 103. By providing the pressurizing member 24 in the liquid storage chamber 21, the contact area with the diluent is further increased compared to the collection structure 1, thereby enhancing the pressurization effect on the diluent and enabling the diluent to be ejected for better mixing with the sample.

[0068] Referring to Figure 6 , specifically, the booster 24 is an annular structure with an L-shaped axial cross-section. The booster 24 comprises a first portion and a second portion connected at an angle. The first portion is arranged axially along the liquid storage chamber 21, and the second portion is arranged radially along the liquid storage chamber 21. The second portion is provided with through holes 241 extending through its thickness. The number of through holes 241 may be one or more. When the booster 24 abuts the wall of the liquid storage chamber 21, the outer peripheral surface of the first portion abuts the wall of the liquid storage chamber 21. Thus, compared to a flat structure, the booster 24 has a concave structure, which increases the strength and stability of the booster 24, enabling it to withstand greater pressure and reduce deformation and distortion. The addition of the first portion increases the contact area between the booster 24 and the wall of the liquid storage chamber 21, improving the abutment between the booster 24 and the liquid storage chamber 21, generating a stable extrusion force on the mixed liquid and improving the pressurization effect on the mixed liquid.

[0069] It should be noted that before the collection structure 1 is inserted into the liquid storage chamber 21, the pressurizing member 24 is positioned in the middle of the liquid storage chamber 21 along the axial direction, with the second portion suspended in the liquid storage chamber 21. After the collection structure 1 is inserted into the liquid storage chamber 21, the pressurizing member 24 gradually moves toward the bottom end of the liquid storage chamber 21 until the second portion abuts the bottom end of the liquid storage chamber 21.

[0070] The base 23 is used to store the diluent and provides stable support when the collection structure 1 is inserted into the liquid storage chamber 21. The base 23 can be integral or split. Referring to Figures 3 and 6 , in some embodiments, the base 23 includes an upper base cover 231 , a lower base cover 232 , and a diluent tube 233 .

[0071] 3 , the diluent tube 233 has a liquid storage cavity 21 and an active opening 22 . The diluent tube 233 directly stores the diluent and has a direct interference fit with the collection structure 1 . The pressurizing element 24 is disposed in the diluent tube 233 and abuts against the inner wall of the diluent tube 233 .

[0072] Please refer to Figure 3, the base lower cover 232 includes a main body 2321 and an extension portion 2322. The extension portion 2322 is connected to the outer periphery of the main body 2321 and extends away from the main body 2321. The main body 2321 has a first placement cavity 2321a and a first opening 2321b connected to the first placement cavity 2321a.

[0073] 3 , the base cover 231 has a second placement cavity 2311 and a second opening 2312 and a third opening 2313 communicating with the second placement cavity 2311 . The second opening 2312 and the third opening 2313 are disposed opposite to each other along the axial direction of the base 23 .

[0074] Referring to Figure 3 , the diluent tube 233 passes through the first opening 2321b and is located within the first placement cavity 2321a. The outer wall of the diluent tube 233 abuts the wall of the first placement cavity 2321a. The base lower cover 232 passes through the third opening 2313 and is located within the second placement cavity 2311. The outer periphery of the extension 2322 abuts the wall of the second placement cavity 2311. The movable port 22 is at least partially exposed to the first opening 2321b and the second opening 2312. In other words, during assembly of the base 23, the diluent tube 233 is inserted into the first placement cavity 2321a of the base lower cover 232, and then the base upper cover 231 and the base lower cover 232 are snap-fitted together.

[0075] Please refer to Figure 3. Furthermore, the movable opening 22 of the diluent tube 233 is protruded toward its outer periphery to form a lap joint 2331. When the diluent tube 233 is inserted into the first placement cavity 2321a of the base lower cover 232, the lap joint 2331 overlaps the top of the base lower cover 232.

[0076] Referring to Figure 3 , the extension portion 2322 of the base lower cover 232 radially expands the support area of ​​the base 23, thereby improving the support stability of the liquid storage structure 2. The extension portion 2322 is L-shaped. After extending radially along the base lower cover 232, the extension portion 2322 bends upward to form a bend portion 2323. The bend portion 2323 increases the connection area with the base upper cover 231, thereby improving the snap-fit ​​between the base upper cover 231 and the base lower cover 232.

[0077] When the base upper cover 231 and the base lower cover 232 are docked, the portion of the base upper cover 231 near the second opening 2312 abuts against the overlapping portion 2331 of the diluent tube 233, thereby axially pressing the diluent tube 233. The portion of the base upper cover 231 near the third opening 2313 abuts against the bent portion 2323 of the base lower cover 232, thereby radially securing the base lower cover 232 and the diluent tube 233. Thus, the base upper cover 231 can fully secure the diluent tube 233 in both the axial and radial directions, ensuring the overall stability of the liquid storage structure 2 and preventing the diluent tube 233 from becoming loose.

[0078] Referring to FIG3 , the upper cover 231 of the base is provided with a second placement cavity 2311. The second placement cavity 2311 cooperates with the extension portion 2322 and the bend portion 2323 of the lower cover 232 of the base, so that the upper cover 231 of the base has a hollow structure. On the one hand, it can accommodate the lower cover 232 and the diluent tube 233 of the base. On the other hand, it can reduce the weight of the upper cover 231 of the base, thereby reducing the weight of the base 23 as a whole, making it easier to carry. Furthermore, it can lower the center of gravity of the base 23 to ensure stability during placement during testing.

[0079] Referring to Figures 2 and 3, the following describes in detail the assembly method of a sample collection and detection device 100 provided in an embodiment of the present application: Insert the sealed diluent tube 233 into the first placement cavity 2321a of the base lower cover 232 with the movable opening 22 facing upward. Then, press and engage the base upper cover 231 and the base lower cover 232, thereby completing the assembly of the liquid storage structure 2. Push the filter 14 into the groove 111 in the collection body 11, so that the filter 14 abuts and presses against the step 111a and the abutment 111b. Next, engage the collection body 11 at the bottom end of the hollow portion 131 of the container 13. Then, engage the detection member 102 in the engagement groove 121 of the cover 12. Engage the cover 12 at the top end of the hollow portion 131 of the container 13, so that the detection member 102 is in direct contact with the filter 14. This completes the assembly of the collection structure 1.

[0080] In summary, the sample collection and detection device 100 provided in the embodiment of the present application has at least the following technical effects: First, it achieves automatic mixing, eliminating the need for additional manual shaking, mixing, and adding samples. The detection steps are simple, reducing the number and time that the subject needs to contact the sample, improving detection efficiency and accuracy, and avoiding the impact of excessive detection steps on the test results. Second, the sample collection and detection device is reliable, allowing the diluent and the detection element to be separated into different spaces, preventing the detection element from being infiltrated by the diluent and becoming ineffective. Third, the sample collection and detection device has a compact and sophisticated structure, which improves space utilization. After use, the collection structure and the liquid storage structure are tightly connected to form a whole, so that the mixed liquid is enclosed in the device, reducing secondary contamination and facilitating centralized collection and processing. Fourth, as a home self-testing product, compared to testing in large medical institutions, it has lower time and space requirements, can be tested at any time, and problems can be discovered in a timely manner, prompting the subject to seek medical treatment in a timely manner. Fifth, the test results are not affected by the operating habits of the subject, the learning cost is low, and it is suitable for young children or the elderly, improving the user experience.

[0081] In a second aspect, embodiments of the present application further provide a kit comprising a sample collection and testing device 100. Sample collection and testing device 100 may be the sample collection and testing device 100 described in the first aspect. The kit may include one, two, or other sample collection and testing devices 100. This kit can be used to detect Helicobacter pylori infection or occult blood in stool in a subject.

[0082] In a third aspect, an embodiment of the present application further provides a detection method, which detects a sample by using a sample collection detection device 100. The sample collection detection device 100 is the sample collection detection device 100 of the first aspect. The detection method includes the following steps: adhering the collection structure 1 to the sample; inserting the collection structure 1 with the sample adhered into the liquid storage chamber 21 through the movable port 22, squeezing the diluent in the liquid storage chamber 21 to flush the sample to form a mixed liquid, and forcing the mixed liquid into the accommodating chamber 101 to contact the detection member 102.

[0083] Observe the detection member in the collection structure accommodating cavity and read the detection result.

[0084] The following is a detailed introduction to the solution of this application with specific examples and comparative examples:

[0085] Example 1

[0086] Embodiment 1 provides a kit for detecting Helicobacter pylori antigens. The kit includes a sample collection and detection device. The sample collection and detection device includes a collection structure and a liquid storage structure. A Helicobacter pylori detection test strip is disposed within a receiving cavity of the collection structure. The detection line on the nitrocellulose membrane of the Helicobacter pylori detection test strip is coated with Helicobacter pylori-specific antibodies, the quality control line is coated with goat anti-mouse antibodies, and the protein coupling pad is coated with colloidal gold-labeled Helicobacter pylori-specific antibodies.

[0087] Example 2

[0088] Example 2 provides a test kit for the combined detection of fecal occult blood / transferrin. The test kit includes a sample collection and detection device. The sample collection and detection device includes a collection structure and a liquid storage structure. Two test papers are provided in the accommodating cavity of the collection structure, one is a test paper for detecting fecal occult blood, and the other is a test paper for detecting transferrin. The detection line on the nitrocellulose membrane of the fecal occult blood test paper is coated with anti-hemoglobin-specific antibodies, the quality control line is coated with goat anti-mouse antibodies, and the protein coupling pad is coated with anti-hemoglobin-specific antibodies labeled with colloidal gold. The detection line on the nitrocellulose membrane of the transferrin detection test paper is coated with anti-transferrin-specific antibodies, the quality control line is coated with goat anti-mouse antibodies, and the protein coupling pad is coated with anti-transferrin-specific antibodies labeled with colloidal gold.

[0089] Comparative Example 1

[0090] Comparative Example 1 provides a kit for detecting Helicobacter pylori antigens. The kit includes a sampling stick, a sample dilution tube filled with diluent, and a Helicobacter pylori antigen detection plate with a sample addition hole.

[0091] Comparative Example 2

[0092] Comparative Example 2 provides a kit for the combined detection of fecal occult blood / transferrin. The kit comprises a sampling stick, a sample dilution tube filled with a diluent, and a fecal occult blood / transferrin detection plate provided with a sample addition hole.

[0093] Testing and result analysis

[0094] Insert the collection structures of the sample collection and detection devices in Example 1 and Example 2 into the feces sample to be tested respectively, insert the collection structure into the liquid storage cavity and press down until the booster contacts the bottom of the liquid storage cavity, and wait for the results to be read.

[0095] Insert the sampling stick from the kits for Comparative Example 1 and Comparative Example 2 into the stool sample to be tested. Place the sampling stick into a sample dilution tube containing the diluent, tighten it, shake well, and let it sit for a while. After the rest period, remove the sampling stick, tighten the sample dilution tube, and vertically drip 2 to 3 drops of the mixed solution onto the liquid addition hole of each test plate. Let it sit for a while and wait for the results to be read.

[0096] Table 1

[0097] Result Analysis

[0098] The results in Table 1 clearly show that, compared to Comparative Examples 1 and 2, the detection steps in Examples 1 and 2 of the present application are significantly reduced, and the detection time is shortened from several minutes to a few seconds, greatly shortening the overall detection time. Compared to traditional home self-testing products, the sample collection and detection device provided by the present application has simple operation steps, high detection efficiency, and better safety.

[0099] In this application, unless otherwise expressly specified or limited, if a first feature is described as being "above" or "below" a second feature, or similar descriptions, this may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Furthermore, when a first feature is described as being "above," "above," or "above" a second feature, it may mean that the first feature is directly above or diagonally above the second feature, or simply means that the first feature is at a higher level than the second feature. When a first feature is described as being "below," "below," or "below" a second feature, it may mean that the first feature is directly below or diagonally below the second feature, or simply means that the first feature is at a lower level than the second feature.

[0100] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be an intermediate element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only embodiment.

[0101] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned 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.

[0102] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person of ordinary skill in the art may make various modifications and improvements without departing from the spirit of the present application, and these modifications and improvements fall within the scope of protection of the present application. Therefore, the scope of protection of the present patent application shall be determined by the appended claims.

Claims

1. A sample collection and detection device, characterized in that: include: A collection structure, wherein the collection structure has a accommodating cavity, the accommodating cavity is used to place the detection element, one end of the collection structure is used to collect samples, and the collection structure is provided with a liquid inlet connected to the accommodating cavity; a liquid storage structure, wherein the liquid storage structure has a liquid storage cavity and a movable port connected to the liquid storage cavity, the liquid storage cavity is used to store the diluent, and the collection structure is used to enter the liquid storage cavity through the movable port, and has an interference fit with the cavity wall of the liquid storage cavity and moves along the cavity wall.

2. The sample collection and detection device according to claim 1, characterized in that: The liquid storage structure includes a base and a booster, the base has the liquid storage cavity and the movable port, the booster is arranged in the liquid storage cavity and can movably abut against the cavity wall, the interior of the booster is penetrated by a through hole communicating with the liquid storage cavity, and the collection structure is used to enter the liquid storage cavity and push the booster to move relative to the cavity wall.

3. The sample collection and detection device according to claim 2, characterized in that: The base includes a base upper cover, a base lower cover and a diluent tube; The base lower cover includes a main body and an extension portion, the extension portion being connected to the outer periphery of the main body and extending in a direction away from the main body, the main body having a first placement cavity and a first opening communicating with the first placement cavity, the base upper cover having a second placement cavity and a second opening and a third opening communicating with the second placement cavity, the second opening and the third opening being arranged opposite to each other in the axial direction of the base upper cover, the diluent tube having the liquid storage cavity and the movable port, the pressurizing member being disposed in the diluent tube and abutting against the inner wall of the diluent tube; The diluent tube passes through the first opening and is located in the first placement cavity. The outer wall of the diluent tube abuts against the cavity wall of the first placement cavity. The lower cover of the base passes through the third opening and is located in the second placement cavity. The outer periphery of the extension part abuts against the cavity wall of the second placement cavity. The movable port is at least partially exposed to the first opening and the second opening.

4. The sample collection and detection device according to claim 1, characterized in that: The collection structure includes a collection body, a sealing body and a container body. One end of the collection body is used to collect the sample. The collection body is provided with the liquid inlet. The container body has a hollow portion running through it along its length. The collecting body is detachably connected to one end of the hollow portion, and the covering body is detachably connected to the other end of the hollow portion, so that the collecting body, the covering body and the containing body together constitute the containing cavity.

5. The sample collection and detection device according to claim 4, characterized in that: The collection structure further includes a filter body, which abuts against the cavity wall of the containing body, and at least partially contacts the liquid inlet and the detection element.

6. The sample collection and detection device according to claim 5, characterized in that: The collecting body is concave toward its bottom end to form a groove, and the groove is communicated with the accommodating cavity and the liquid inlet at the same time. The filter body is located in the groove, and the filter body abuts against the groove wall of the groove.

7. The sample collection and detection device according to claim 6, characterized in that: The groove body includes a step portion and an abutment portion, the abutment portion is arranged at the top of the step portion, the filter body abuts against the upper surface of the step portion and the inner circumferential surface of the abutment portion at the same time, the filter body is located above the liquid inlet, and the detection part abuts against the upper surface of the filter body.

8. The sample collection and detection device according to claim 4, characterized in that: The cover body is provided with a card slot. When the cover body is connected to the accommodating body, the card slot is communicated with the accommodating cavity. The card slot is used to fix the detection member.

9. A kit, characterized in that The kit includes a sample collection and detection device, and the sample collection and detection device is the sample collection and detection device according to any one of claims 1 to 8.

10. A detection method, characterized in that: Utilizing the sample collection and detection device according to any one of claims 1 to 8, the detection method comprises the following steps: Adhere the sample to the collection structure; Inserting the collection structure with the sample adhered thereto into the liquid storage chamber through the movable port, squeezing the diluent in the liquid storage chamber to flush the sample to form a mixed liquid, and forcing the mixed liquid into the receiving chamber to contact the detection element; Observe the detection member in the collection structure accommodating cavity and read the detection result.

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