Sample collection and detection device and kit

Abstract

The utility model relates to a sample collection and detection device and a kit. The sample collection and detection device comprises a collection structure and a liquid storage structure. The collection structure is provided with a containing cavity, the containing cavity is used for containing a detection 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 containing cavity; the liquid storage structure is provided with a liquid storage cavity and a movable opening communicated with the liquid storage cavity, the liquid storage cavity is used for storing diluent, and the collecting structure is used for entering the liquid storage cavity through the movable opening, 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 collecting structure can extrude the diluent to scour the sample to form a mixed solution, and meanwhile extrude the mixed solution to enter the containing cavity through the liquid inlet to be in contact with the detection piece. According to the sample collection and detection device, the collection structure and the liquid storage structure are arranged, so that sample adding, sample mixing and detection of the detection piece can be integrated in one step, the operation is simple, and the detection efficiency is improved.

Description

Technical Field

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

[0002] Fecal testing can be used for auxiliary diagnosis of various diseases and can be used to determine whether the subject is infected with bacteria or viruses. Current fecal testing devices require additional steps such as mixing and adding samples, which is cumbersome and reduces detection efficiency. Utility Model Content

[0003] 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 the detection efficiency.

[0004] In a first aspect, a sample collection and detection device comprises:

[0005] A collection structure, wherein the collection structure has a receiving cavity, the receiving cavity is used to place the detection element, the bottom end of the collection structure is used to collect samples, and the collection structure is provided with a liquid inlet connected to the receiving cavity;

[0006] 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 a diluent, and the collecting 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 to move along the cavity wall.

[0007] 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 be movably abutted against the cavity wall, the booster is provided with a through hole communicating with the liquid storage cavity inside, and the collection structure is used to enter the liquid storage cavity and push the booster to move relative to the cavity wall.

[0008] In one embodiment, the booster includes a first part and a second part connected at an angle, the first part is located on the outer periphery of the second part, the first part extends along the axial direction of the liquid storage cavity and can be movably abutted against the cavity wall, the second part is arranged along the radial direction of the liquid storage cavity, and the second part is provided with the through hole along the thickness direction of the second part.

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

[0010] The base lower cover comprises a main body and an extension part, the extension part is connected to the outer periphery of the main body and extends in a direction away from the main body, the main body has a first placement cavity and a first opening communicating with the first placement cavity, the base upper cover has 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 are arranged oppositely along the axial direction of the base upper cover, the diluent tube has the liquid storage cavity and the movable port, the pressurizing member is arranged in the diluent tube and abuts 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 base lower cover 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, and the movable port is at least partially exposed to the first opening and the second opening.

[0012] In one embodiment, the collection structure comprises 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, and the containing body has a through hollow portion along its length direction;

[0013] The collecting body is detachably connected to one end of the hollow part, and the covering body is detachably connected to the other end of the hollow part, 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 of the groove 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 element abuts against the upper surface of the filter body.

[0017] In one of the embodiments, the cover body is provided with a slot, and when the cover body is connected to the containing body, the slot is communicated with the containing cavity, and the 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] The above-mentioned sample collection and detection device can integrate sample addition, sample mixing, and detection of the detection element in one step by setting a collection structure and a liquid storage structure, which is simple to operate and improves the detection efficiency. Specifically, after the collection structure collects the sample, the collection structure enters the liquid storage cavity through the movable port. 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. In the process of the collection structure instantly entering the liquid storage cavity, the pressure inside the liquid storage cavity increases sharply, forcing the diluent to form a torrent to flush the sample outside the collection structure, so that the sample and the diluent are mixed 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 is reduced, and the mixed liquid is squeezed from the liquid inlet on the collection structure into the containing cavity of the collection structure. After the detection element contacts the mixed liquid, it can automatically detect the mixed liquid. Therefore, as long as the collection structure is inserted 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 the detection efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 A three-dimensional diagram of a sample collection and detection device provided in an embodiment of the present application.

[0021] Figure 2 A cross-sectional view of a sample collection and detection device provided in an embodiment of the present application.

[0022] Figure 3 A partial cross-sectional view of a sample collection and detection device provided in an embodiment of the present application.

[0023] Figure 4 It is an exploded schematic diagram of the collection structure in the embodiment of the present application.

[0024] Figure 5 It is a three-dimensional diagram of the collecting body of the collecting structure in the embodiment of the present application.

[0025] Figure 6 This is a schematic diagram of an explosion of the liquid storage structure in an embodiment of the present application.

[0026] Description 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 absorption 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 portion; 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 part; 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 part; 2323. bending part; 233. diluent tube; 2331. overlapping part; 24. booster; 241. through hole. DETAILED DESCRIPTION

[0027] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0028] In the description of the present 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 the present 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 the present application.

[0029] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0030] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0031] Fecal testing can be used for auxiliary diagnosis of various diseases. It can be used to determine whether the subject is infected with bacteria or viruses by testing feces, so as to achieve the purpose of diagnosing diseases. At present, there are mainly two types of fecal testing devices. One type of fecal testing device uses a sampling rod to first collect a certain amount of fecal samples, and then extends the sampling rod into a collection tube filled with a diluent. The fecal sample on the collection rod is mixed with the diluent by scraping, shaking, and standing. Then, the sample mixture is added drop by drop to the sampling hole on the test plate or the test piece. This method requires additional mixing and adding steps, which are cumbersome and time-consuming. In addition, when the mixed liquid is shaken and the mixed liquid is added, it is easy to cause liquid leakage and secondary pollution. Another type of fecal testing device is to set a plug or a baffle between the diluent and the test piece, collect a certain amount of fecal samples using a sampling rod, and then extend the sampling rod into the structure filled with a diluent, shake to fully mix the fecal sample with the diluent, and then further use external force to destroy the plug or baffle structure of the sampling rod, so that the mixed liquid flows to the test piece. Although this type of detection device does not need to add samples drop by drop like the previous type of device, it still needs to be shaken and mixed before adding samples, and an additional sample addition trigger action is required. Therefore, the current feces detection device requires additional mixing and adding samples separately, the detection steps are cumbersome, and the detection efficiency needs to be improved.

[0032] Based on the above issues, first of all, please refer to Figure 1 An embodiment of the present application provides a sample collection and detection device 100, including a collection structure 1 and a liquid storage structure 2.

[0033] See also Figure 1 and Figure 2 The collection structure 1 has a accommodating chamber 101, and the accommodating chamber 101 is used to place the detection element 102. The bottom 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, and at the same time squeeze the mixed liquid 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 realize mixed 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.

[0034] 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 to flush the sample on the collection structure 1, so that the sample and the diluent are mixed 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 to contact the detection element 102. Therefore, by inserting the collection structure 1 into the liquid storage chamber 21, the effects of mixing, adding samples and detecting can be achieved at the same time, so that there is no need to perform additional steps such as shaking and adding samples, which greatly simplifies the detection steps and improves the detection efficiency.

[0035] 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, thereby improving the safety and hygiene of the sample collection and detection device 100 of the present application.

[0036] Furthermore, in the second type of feces detection device, a baffle or plug is used to isolate the diluent and the detection element. When the baffle or plug becomes loose or peeled off or is accidentally damaged, the diluent will directly soak the detection element, causing the detection element to fail, reducing the reliability of the detection device and affecting the detection result. In the sample collection device of the present application, the detection element 102 is arranged in the collection structure 1, the diluent is arranged in the liquid storage structure 2, and the detection element 102 and the diluent are arranged separately, thereby avoiding the possibility of accidental contact between the detection element 102 and the diluent, reducing the possibility of failure of the detection element 102, and improving the reliability and stability of the detection device.

[0037] Furthermore, in the two stool detection devices described above, the differences in operating habits of different subjects may cause inaccurate test results. For example, different mixing methods may cause uneven mixing of stool samples and diluents, resulting in poor dilution, and inaccurate control of the amount of dripping affects the detection accuracy. The sample collection 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 movement of the collection structure 1 from entering the liquid storage chamber 21 to abutting against the bottom of the liquid storage chamber 21 is consistent, and the compressed space is consistent, so that the amount of mixed liquid entering the containing 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.

[0038] The sample collected by the collection structure 1 may be excrement or secretion, etc. The collection structure 1 may 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.

[0039] See also Figure 2 and Figure 4 In some embodiments, the collection structure 1 includes a collection body 11, a cover body 12 and a container body 13. The outside of the collection body 11 is used to collect samples. The collection body 11 is provided with a liquid inlet 103. The container body 13 has a hollow portion 131 that penetrates along its length. The collection body 11 is detachably connected to one end of the hollow portion 131, and the cover body 12 is detachably connected to the other end of the hollow portion 131, so that the collection body 11, the cover body 12 and the container body 13 together constitute a container cavity 101.

[0040] See also Figure 4 The container 13 can be in the shape of a column, a box, a sphere, an ellipsoid, a flat, etc. Figure 1 The container 13 may be made entirely of transparent material, or partially of transparent material, and may be used as a window 133 to observe the detection member 102 , without interfering with the reading of the detection result of the detection member 102 .

[0041] See also 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. Figure 4The 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 connected to each other. 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, so as to increase the connection area between the two and the containing body 13 and improve the connection stability. When the cover body 12 is connected to the containing body 13, the outer peripheral surface of the first neck portion 122a of the cover body 12 abuts against the cavity wall of the containing body 13, and the bottom surface of the first shoulder portion 122b abuts against the top surface of the containing body 13.

[0042] Furthermore, the cover body 12 is provided with air holes through it, so as to allow the detection member 102 to be subjected to chromatography. The air holes can also be provided on the containing body 13 of the collection structure 1.

[0043] See also 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 connected to 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 inside 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. There can be one or more slots 121, which are used to fix one or more detection members 102.

[0044] The collecting body 11 has multiple functions. On the one hand, it collects samples, on the other hand, it improves the mixing effect of the sample and the diluent, and on the other hand, it serves as an entrance for the mixed liquid to enter the containing chamber 101 for detection. The outer surface of the collecting body 11 can be inserted into the sample to be detected and then pulled out to collect the sample on the outer surface of the collecting body 11. The above operation can be repeated many times to make the collecting body 11 adhere to a sufficient amount of sample for dilution.

[0045] See also Figure 4 The collecting body 11 and the containing body 13 can also be connected by a spiral structure, or connected by a snap-fit ​​structure. Figure 5 , for example, see Figure 5The collecting body 11 includes a second clamping portion 112, and the second clamping portion 112 includes a second neck portion 112a and a second shoulder portion 112b. Along the radial direction of the collecting body 11, the second shoulder portion 112b is located outside the second neck portion 112a. The second shoulder portion 112b extends toward the inside of the hollow portion 131, and the second shoulder portion 112b extends toward the outside of the collecting body 11 to increase the clamping area between the collecting body 11 and the containing body 13. When the collecting body 11 is clamped with the containing body 13, the outer peripheral surface of the second neck portion 112a abuts against the cavity wall of the containing body 13, and the top surface of the second shoulder portion 112b abuts against the bottom surface of the containing body 13.

[0046] In order to further increase the stability of the connection between the collecting body 11 and the containing body 13, please refer to Figure 3 , along the radial direction of the containing body 13, the cavity wall of the containing body 13 is provided with a first protrusion 132, see Figure 5 The outer peripheral surface of the second neck 112a of the collecting body 11 is provided with a first groove 113. Figure 3 When the second neck 112a extends into the hollow portion 131 of the containing body 13, the first protrusion 132 and the first groove 113 are engaged, which can fix the collecting body 11 in the axial direction and prevent the collecting body 11 from slipping out of the containing body 13 axially.

[0047] See also Figure 5 The collecting body 11 gradually decreases in size from the middle to the bottom to form a cone, which reduces the resistance of the collecting body 11 inserted into the liquid storage cavity 21 and facilitates the insertion of the collecting body 11 into the liquid storage structure 2. In addition, the end of the conical collecting body 11 is narrow and is not easily blocked by solid particles or viscous substances, which can ensure that the mixed liquid can smoothly enter the containing cavity 101 from the liquid inlet 103.

[0048] See also 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 interval array in the direction from the top to the bottom, and each toothed structure 15 is arranged around the outer periphery of the collection body 11, and an annular groove 16 is formed between two adjacent toothed structures 15 above and below. 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, so as to better mix the sample and the 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 enable the diluent to flow back and forth in the annular groove 16, continuously flushing and exchanging, thereby improving the dilution effect of the sample.

[0049] See also Figure 5The liquid inlet 103 of the collection body 11 is arranged above the tooth-shaped structure 15 and keeps a certain distance from the tooth-shaped structure 15 to avoid being blocked by the sample. The liquid inlet 103 is opened on two opposite wide surfaces of the conical collection body 11, which can ensure that the diluent can fully cover and mix the sample on the outer surface of the collection body 11, effectively wash and mix the sample, reduce sample residue, improve the mixing effect, and facilitate the smooth injection of the mixed liquid into the receiving cavity 101.

[0050] See also Figure 2 In some embodiments, the collecting body 11 is concave toward its bottom end to form a groove 111, and the groove 111 is connected to the containing chamber 101 and the liquid inlet 103. The groove 111 can shorten the flow distance of the mixed liquid, so that the mixed liquid can enter the containing chamber 101 from the collecting body 11 faster, thereby improving the detection efficiency.

[0051] See also Figure 2 In some embodiments, the collection structure 1 further includes a filter 14, which abuts against the wall of the accommodating cavity 101, and at least partially contacts the liquid inlet 103 and the detection element 102. The filter 14 can buffer the mixed liquid, prevent the mixed liquid from splashing, and allow the mixed liquid to evenly infiltrate the detection element 102. On the other hand, it can filter insoluble solids or impurities in the sample, making the concentration and composition of the mixed liquid more reliable and avoiding interference with the detection of the detection element 102.

[0052] The filter 14 can be a hydrophobic material with micropores that does not absorb the mixed liquid, such as ultra-high molecular weight polyethylene, tetrafluoroethylene, polyolefin, etc. The pore size of the micropores in the filter 14 is 20 μm to 80 μm, for example, it can be any point value within the above range, such as 20 μm, 30 μm, 40 μm, 50 μm, 60 μm, 70 μm, 80 μm, etc.

[0053] See also Figure 2 In some embodiments, the filter 14 is located in the groove 111 of the collecting body 11, and the filter 14 abuts against the groove wall of the groove 111. The filter 14 is arranged in the collecting body 11, so that the mixed liquid flowing into the groove 111 from the liquid inlet 103 is filtered by the filter 14 in time, thereby improving the uniformity and consistency of the mixed liquid.

[0054] See also Figure 3In some embodiments, the groove body of the groove 111 includes a step portion 111a and an abutting portion 111b, the abutting portion 111b is arranged at the top of the step portion 111a, the filter body 14 abuts against the upper surface of the step portion 111a and the inner circumferential surface of the abutting portion 111b at the same time, the filter body 14 is located above the liquid inlet 103, and the detection member 102 abuts against the upper surface of the filter body 14. The step portion 111a is arranged to keep a certain distance between the filter body 14 and the liquid inlet 103, which can avoid interfering with the mixed liquid entering the groove 111, and make the mixed liquid enter the groove 111 more smoothly.

[0055] The detection element 102 in the embodiment of the present application can adopt a colloidal gold lateral chromatography structure, a fluorescent lateral chromatography structure, a quantum dot lateral chromatography mechanism, an enzymatic reaction longitudinal chromatography mechanism or a microfluidic siphon reaction structure. The above detection element 102 can apply antigen-antibody immunological reaction and chromatography reaction to achieve rapid and accurate color development to detect the object to be tested. The detection element 102 can detect a variety of analytes and can adopt a non-competitive method or a competitive method analysis method.

[0056] See also Figure 4 , the detection element 102 can detect a variety of analytes, and can adopt a non-competitive method or a competitive method analysis mode. The detection element 102 includes a sample pad 1021 made of a water-absorbing material for absorbing and receiving samples, a protein coupling pad 1022 coated with a label, a nitrocellulose membrane 1023 coated with an antibody detection line 1024 and an antibody quality control line 1025, and a water-absorbing pad 1026 with a water-absorbing effect. When the detection element 102 is set 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 line 1024 and the quality control line 1025 of the detection element 102 correspond to the window 133 of the containing body 13 to read the test results.

[0057] The detection principle of the detection element 102 is to use the immunochromatography technology and the specific binding between immune molecules to detect whether the analyte exists in the sample. The mixed solution is chromatographed under the capillary force. When the mixed solution passes through the protein coupling pad 1022, the analyte in the mixed solution reacts specifically with the immune complex in the protein coupling pad 1022 to produce an antigen-antibody complex. Under the action of continuous chromatography, the antigen-antibody complex is captured by the detection line 1024 and the quality control line 1025 coated with the nitrocellulose membrane 1023 to form a detection strip. The display of the detection line 1024 indicates that the analyte exists in the sample to be tested.

[0058] The analyte in the mixed solution may be hemoglobin or transferrin, which can be used to determine whether the subject has gastrointestinal bleeding. Alternatively, the analyte in the mixed solution may be Helicobacter pylori, which can be used to determine whether the subject has Helicobacter pylori infection. Alternatively, the analyte in the mixed solution may be rotavirus or adenovirus, which can be used to determine whether the subject has rotavirus or adenovirus infection.

[0059] The detection member 102 may include a variety of materials for the transfer of liquid samples. Exemplarily, the materials in the detection member 102 should be partially stacked and covered on adjacent materials, for example, the protein coupling pad 1022 should be covered on the nitrocellulose membrane 1023. The various components of the detection member 102 can be made of one or more materials, and each material can be adhered to a hard surface or a certain support to improve the overall strength of the detection member 102.

[0060] The detection member 102 can exist in various forms in the accommodating cavity 101. For example, the detection member 102 can be suspended in the middle of the accommodating cavity 101, or can be closely attached to one side of the cavity wall of the accommodating cavity 101, or a hard support can be set in the middle of the accommodating cavity 101 to fix the detection member 102. The detection items of the detection member 102 can be single items or multiple items, and the number of detection members 102 in the accommodating cavity 101 can be one or more.

[0061] See also Figure 1 and Figure 2 The liquid storage structure 2 is used as a storage place for the diluent, and its movable opening 22 is sealed by a sealing sheet. The sealing sheet can be aluminum foil, plastic, etc. The collection body 11 of the collection structure 1 pierces the sealing sheet and is inserted into the liquid storage cavity 21.

[0062] See also Figure 2 After the collection structure 1 enters the liquid storage chamber 21, the container 13 of the collection structure 1 needs to fit closely with the wall of the liquid storage chamber 21 to prevent liquid from leaking out, and at the same time generate an impact force to mix the sample with the diluent, and squeeze the mixed liquid to flow into the liquid inlet 103. In order to achieve an interference fit between the container 13 and the wall of the container 101, the following but not limited methods can be used: the hard materials of the two can be squeezed against each other to form a seal, or a sealing ring can be fixed on the wall of the liquid storage chamber 21 to seal the container 13 with the wall.

[0063] See also Figure 3 and Figure 6In some embodiments, the liquid storage structure 2 includes a base 23 and a booster 24. The base 23 has a liquid storage cavity 21 and a movable port 22. The booster 24 is disposed in the liquid storage cavity 21 and can be movably abutted against the cavity wall of the liquid storage cavity 21. The inside of the booster 24 is penetrated by a through hole 241 that is connected to the liquid storage cavity 21. The collection structure 1 is used to enter the liquid storage cavity 21 and push the booster 24 to move relative to the cavity wall, so that the booster 24 squeezes the diluent to flush the sample to form a mixed liquid, and then the mixed liquid rushes out through the through hole 241 and enters the accommodating cavity 101 from the liquid inlet 103. By arranging the booster 24 in the liquid storage cavity 21, the contact area with the diluent is further increased on the basis of the collection structure 1, and the pressurization effect on the diluent is improved, so that the diluent can be sprayed to better mix with the sample.

[0064] See also Figure 6 Specifically, the booster 24 is an annular structure with an L-shaped axial cross section. In some embodiments, the booster 24 includes a first part and a second part connected at an angle, the first part is located at the periphery of the second part, the first part is arranged along the axial direction of the liquid storage chamber 21 and can be movably abutted against the cavity wall, the second part is arranged along the radial direction of the liquid storage chamber 21, and the second part is penetrated with a through hole 241 along its thickness direction, and the number of the through holes 241 can be one or more. When the booster 24 abuts against the cavity wall of the liquid storage chamber 21, the outer peripheral surface of the first part abuts against the cavity wall of the liquid storage chamber 21. Therefore, compared with the flat structure, the booster 24 is a concave structure, which can increase the strength and stability of the booster 24, so that it can withstand greater pressure and reduce deformation and distortion. The addition of the first part increases the contact area between the booster 24 and the cavity wall of the liquid storage chamber 21, so that the abutment effect between the booster 24 and the liquid storage chamber 21 is better, and a stable extrusion force can be generated on the mixed liquid, and the boosting effect on the mixed liquid is better.

[0065] It should be noted that, before the collection structure 1 is inserted into the liquid storage chamber 21, the booster 24 is disposed in the middle position of the liquid storage chamber 21 along the axial direction, and the second portion is suspended in the liquid storage chamber 21. After the collection structure 1 is inserted into the liquid storage chamber 21, the booster 24 gradually moves toward the bottom end of the liquid storage chamber 21 until the second portion abuts against the bottom end of the liquid storage chamber 21.

[0066] The base 23 is used to store the diluent on one hand, and can provide a stable support when the collection structure 1 is inserted into the liquid storage chamber 21 on the other hand. The base 23 can be an integrated or split type. Figure 3 and Figure 6 In some embodiments, the base 23 includes a base upper cover 231 , a base lower cover 232 and a diluent tube 233 .

[0067] See also Figure 3The diluent tube 233 has a liquid storage cavity 21 and an active port 22. The diluent tube 233 is used as a place to directly store the diluent and is directly interference fit with the collection structure 1. The booster 24 is disposed in the diluent tube 233 and abuts against the inner wall of the diluent tube 233.

[0068] See also 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 in a direction away from the main body 2321, and the main body 2321 has a first placement cavity 2321a and a first opening 2321b connected to the first placement cavity 2321a.

[0069] See also Figure 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 arranged opposite to each other along the axial direction of the base 23 .

[0070] See also Figure 3 , the diluent tube 233 passes through the first opening 2321b and is located in the first placement cavity 2321a, the outer wall of the diluent tube 233 abuts against the cavity wall of the first placement cavity 2321a, the base lower cover 232 passes through the third opening 2313 and is located in the second placement cavity 2311, the outer periphery of the extension part 2322 abuts against the cavity wall of the second placement cavity 2311, and the movable port 22 is at least partially exposed to the first opening 2321b and the second opening 2312. In other words, during the assembly process 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 clamped.

[0071] See also 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 is lapped on the top of the base lower cover 232 .

[0072] See also Figure 3 The extension part 2322 of the base lower cover 232 can expand the support area of ​​the base 23 in the radial direction, thereby improving the support stability of the liquid storage structure 2. The extension part 2322 is an L-shaped structure. After the extension part 2322 extends in the radial direction of the base lower cover 232, it bends and extends upward to form a bending part 2323. The bending part 2323 can increase the connection area with the base upper cover 231 and improve the clamping effect of the base upper cover 231 and the base lower cover 232.

[0073] When the base upper cover 231 is docked with the base lower cover 232, the portion of the base upper cover 231 close to the second opening 2312 abuts against the overlap portion 2331 of the diluent tube 233, thereby pressing the diluent tube 233 in the axial direction. The portion of the base upper cover 231 close to the third opening 2313 abuts against the bent portion 2323 of the base lower cover 232, thereby fixing the base lower cover 232 and the diluent tube 233 in the radial direction, thereby the base upper cover 231 can fully fix the diluent tube 233 in the axial direction and the radial direction, ensuring the overall stability of the liquid storage structure 2 and preventing the diluent tube 233 from loosening.

[0074] See also Figure 3 The base upper cover 231 is provided with a second placement cavity 2311, and the second placement cavity 2311 cooperates with the extension portion 2322 and the bending portion 2323 of the base lower cover 232, so that the base upper cover 231 is a hollow structure. On the one hand, it can accommodate the base lower cover 232 and the diluent tube 233, and on the other hand, it can reduce the weight of the base upper cover 231, thereby reducing the overall weight of the base 23 for easy carrying, and further, it can lower the center of gravity of the base 23 to ensure the stability of placement during detection.

[0075] See also Figure 2 and Figure 3 , the following will specifically introduce the assembly process of a sample collection and detection device 100 provided in an embodiment of the present application: insert the diluent tube 233 with the sealed diluent into the first placement cavity 2321a of the base lower cover 232 in a manner that the movable port 22 faces upward, and then press and snap the base upper cover 231 and the base lower cover 232 together, thereby completing the assembly of the liquid storage structure 2. Push the filter body 14 into the groove 111 in the collection body 11, so that the filter body 14 abuts and presses against the step portion 111a and the abutment portion 111b. Next, snap the collection body 11 at the bottom end of the hollow portion 131 of the containing body 13, and then snap the detection member 102 into the card slot 121 of the cover body 12, snap the cover body 12 at the top of the hollow portion 131 of the containing body 13, so that the detection member 102 is in direct contact with the filter body 14, thereby completing the assembly of the collection structure 1.

[0076] In summary, a sample collection and detection device 100 provided in the embodiment of the present application has at least the following technical effects: First: automatic mixing is achieved, and no additional manual shaking and sample addition actions are required. The detection steps are simple, the number and time of the test subject contacting the sample are reduced, the detection efficiency and detection accuracy are improved, and the test results are avoided from being affected by too many detection steps. Second: the sample collection and detection device is reliable, so that the diluent and the detection piece are independent of different spaces, and the detection piece is prevented from being infiltrated and ineffective by the diluent. Third: the sample collection and detection device has a compact and exquisite structure, which improves the space utilization rate. 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 pollution, and facilitating centralized collection and processing. Fourth: as a home self-testing product, compared with testing in large medical institutions, it has low requirements for time and space, can be tested at any time, problems can be found in time and prompt the test subject to seek medical treatment in time. Fifth: the test results are not affected by the operating habits of the test subject, the learning cost is low, it is suitable for young children or the elderly, and the user experience is improved.

[0077] In a second aspect, the present application also provides a kit, which includes a sample collection and detection device 100, which can be the sample collection and detection device 100 described in the first aspect. One, two, or the like sample collection and detection devices 100 can be provided in the kit. The kit can be used to detect whether a subject is infected with Helicobacter pylori, or whether there is occult blood in stool, etc.

[0078] The scheme of the present application will be specifically introduced below with specific embodiments and comparative examples:

[0079] Embodiment 1

[0080] Embodiment 1 provides a kit for detecting Helicobacter pylori antigen. The kit includes a sample collection detection device. The sample collection detection device includes a collection structure and a liquid storage structure. A Helicobacter pylori detection test paper is arranged in the receiving cavity of the collection structure. The detection line on the nitrocellulose membrane of the Helicobacter pylori detection test paper is coated with Helicobacter pylori-specific antibodies, the quality control line is coated with sheep anti-mouse antibodies, and the protein coupling pad is coated with colloidal gold-labeled Helicobacter pylori-specific antibodies.

[0081] Embodiment 2

[0082] Embodiment 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 strips are provided in the accommodating chamber of the collection structure, one is a test strip for fecal occult blood detection, and the other is a test strip for transferrin detection. The detection line on the nitrocellulose membrane of the fecal occult blood test strip is coated with anti-hemoglobin-specific antibodies, the quality control line is coated with sheep 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 strip is coated with anti-transferrin-specific antibodies, the quality control line is coated with sheep anti-mouse antibodies, and the protein coupling pad is coated with anti-transferrin-specific antibodies labeled with colloidal gold.

[0083] Comparative Example 1

[0084] Comparative Example 1 provides a kit for detecting Helicobacter pylori antigens. The kit comprises a sampling rod, a sample dilution tube filled with diluent, and a Helicobacter pylori antigen detection plate with sample addition holes.

[0085] Comparative Example 2

[0086] Comparative Example 2 provides a kit for combined detection of fecal occult blood / transferrin. The kit includes a sampling rod, a sample dilution tube filled with a diluent, and a fecal occult blood / transferrin detection plate with a sample addition hole.

[0087] Testing and result analysis

[0088] Insert the collection structures of the sample collection and detection devices in Example 1 and Example 2 into the feces samples to be tested respectively, insert the collection structure into the liquid storage cavity and press it down until the pressure-boosting member contacts the bottom of the liquid storage cavity, and wait for the reading result.

[0089] The sampling sticks in the kits of comparative example 1 and comparative example 2 were respectively inserted into the stool samples to be tested, and then the sampling sticks were placed in the sample dilution tubes containing the diluent, tightened, shaken and left to stand for a period of time. After the standing was completed, the sampling sticks were taken out and the sample dilution tubes were tightened, and 2 to 3 drops of the mixed solution were vertically dripped onto the liquid addition holes of the respective test plates, and then left to stand and wait for the results to be read.

[0090] Table 1

[0091]

[0092] Results Analysis

[0093] From the results in Table 1, it can be seen intuitively that compared with Comparative Examples 1 and 2, the detection action steps of Examples 1 and 2 of the present application are significantly reduced, the action time is shortened from several minutes to several seconds, and the overall detection time is greatly shortened. Compared with traditional home self-testing products, the sample collection and detection device provided by the embodiment of the present application has simple operation steps, high detection efficiency, and better safety.

[0094] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it 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. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0095] 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 a central 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 a central element at the same time. If present, 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 implementation method.

[0096] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above-described 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.

[0097] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A sample collection and detection device, characterized in that: include: A collection structure, wherein the collection structure has a receiving cavity, the receiving cavity is used to place the detection element, the bottom end of the collection structure is used to collect samples, and the collection structure is provided with a liquid inlet connected to the receiving cavity; 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 a diluent, and the collecting 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 to move 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 be movably abutted against the cavity wall, the inside of the booster is penetrated by a through hole connected to 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 booster includes a first part and a second part connected at an angle, the first part is located at the outer periphery of the second part, the first part extends along the axial direction of the liquid storage cavity and can be movably abutted against the cavity wall, the second part is arranged along the radial direction of the liquid storage cavity, and the second part is penetrated by the through hole along the thickness direction of the second part.

4. The sample collection and detection device according to claim 2, characterized in that: The base comprises a base upper cover, a base lower cover and a diluent tube; The base lower cover comprises a main body and an extension part, the extension part is connected to the outer periphery of the main body and extends in a direction away from the main body, the main body has a first placement cavity and a first opening communicating with the first placement cavity, the base upper cover has 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 are arranged oppositely along the axial direction of the base upper cover, the diluent tube has the liquid storage cavity and the movable port, the pressurizing member is arranged in the diluent tube and abuts 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 base lower cover 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, and the movable port is at least partially exposed to the first opening and the second opening.

5. The sample collection and detection device according to claim 1, characterized in that: The collection structure comprises 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, and the containing body has a hollow portion penetrating along its length direction; The collecting body is detachably connected to one end of the hollow part, and the covering body is detachably connected to the other end of the hollow part, so that the collecting body, the covering body and the containing body together constitute the containing cavity.

6. The sample collection and detection device according to claim 5, characterized in that: 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.

7. The sample collection and detection device according to claim 6, characterized in that: The collecting body is concave inwardly 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.

8. The sample collection and detection device according to claim 7, characterized in that: The groove body of the groove 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.

9. The sample collection and detection device according to claim 5, characterized in that: The cover body is provided with a clamping groove. When the cover body is connected to the containing body, the clamping groove is communicated with the containing cavity. The clamping groove is used to fix the detection member.

10. A kit, characterized in that: The kit comprises 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 9.

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