Sample sampling detection device

Abstract

The application belongs to the technical field of instant diagnosis, and particularly relates to a sample sampling and detecting device. The sample sampling and detecting device comprises a sample dilution component and a sampling component. The sample dilution component comprises a sample dilution box, and the sample dilution box has a containing cavity for storing sample diluent. The sampling component comprises a sampling head, a detection test paper and a flow guide structure. The sampling head has a liquid inlet, and the sampling head can be inserted into the containing cavity so that the sample diluent enters the interior of the sampling head through the liquid inlet and mixes with the sample. The flow guide structure is arranged in the interior of the sampling head, and the flow guide structure is provided with a flow guide part. A lateral flow channel exists between the flow guide part and the inner wall of the sampling head. By using the sample sampling and detecting device, the sample diluent can be prevented from overflowing from the gap between the outer wall of the sampling head and the inner wall of the sample dilution box during the process of inserting the sampling head into the sample dilution box. Meanwhile, the waste of the sample diluent caused by splashing can be prevented, and the full contact between the sample diluent and the detection test paper can be ensured.

Description

Technical Field

[0001] This invention belongs to the field of point-of-care diagnostics technology, and specifically relates to a sample sampling and detection device. Background Technology

[0002] Blood immunomarker detection is a laboratory technique that analyzes specific molecules or cells in the blood related to the immune system to assess the body's immune function, aid in disease diagnosis, and monitor treatment effectiveness. Its core lies in utilizing the principle of specific antigen-antibody binding to detect changes in immune-related indicators, providing precise medical information for clinical use. This enables the identification of causes, diagnosis and differential diagnosis of diseases, prediction of patient condition, and evaluation of treatment efficacy. Traditional stencil-based blood sample collection involves pricking the fingertip with a lancet, collecting blood in a sample collection container, mixing it with a sample diluent, inserting the appropriate test strip into the sample as specified, or adding the sample to the sample well of a reagent card, and waiting for a certain time before reading the results.

[0003] Traditional sampling methods are complex and difficult to operate, making them unsuitable for personal self-testing. Therefore, sampling and testing devices have emerged. Existing sampling and testing devices typically include a sampling head and a sample dilution container. The sample dilution container has a cavity for storing sample diluent. After sampling, the sampling head is inserted into the cavity to mix the sample and the sample dilution for testing. Existing sampling and testing devices have a filter element in the cavity, with the outer side of the filter element and the inner wall of the cavity tightly fitted. When the sampling head is inserted into the cavity, the fluid resistance is relatively high, easily causing the sample dilution to overflow from the gap between the sampling head and the sample dilution container. This results in incomplete use of the diluted sample and potential contamination. Without a filter element, when the sampling head is inserted into the cavity, the sample dilution splashes, preventing the sample from mixing well with the sample dilution.

[0004] Therefore, there is an urgent need to develop a sample sampling and detection device that can prevent the sample diluent from overflowing and splashing to solve the above problems. Summary of the Invention

[0005] The objective of this invention is to at least solve the problem of preventing sample diluent overflow and splashing. This objective is achieved through the following technical solution: A first aspect of the present invention provides a sample sampling and detection device, comprising: A sample dilution assembly, including a sample dilution box having a accommodating cavity for storing sample dilution solution; A sampling assembly includes a sampling head, a test strip, and a flow guiding structure. The sampling head has a liquid inlet, and the sampling end of the test strip is located inside the sampling head. The sampling head can be inserted into the accommodating cavity so that the sample diluent enters the interior of the sampling head through the liquid inlet and mixes with the sample. The flow guiding structure is disposed inside the sampling head and has a flow guiding section. There is a lateral flow channel between the flow guiding section and the inner wall of the sampling head, and the flow guiding section is arranged in the flow direction of the sample diluent.

[0006] The sample sampling and detection device in this technical solution eliminates the filter element found in existing solutions and incorporates a lateral flow channel, thereby improving the flow resistance of the accommodating cavity and preventing sample diluent from overflowing from the gap between the outer wall of the sampling head and the inner wall of the accommodating cavity during the insertion of the sampling head into the accommodating cavity. Furthermore, at the moment the sampling head is inserted into the accommodating cavity, the sample diluent rushes into the interior of the sampling head from the inlet. The sample diluent splashes onto the guide section of the flow guiding structure, where it is deflected by the flow guiding section and falls back. As more sample diluent falls back, it flows upward until it contacts the test strip. The flow guiding section prevents waste of sample diluent due to splashing, ensuring sufficient contact between the sample diluent and the test strip.

[0007] In addition, the sample sampling and detection device of the present invention may also have the following additional technical features: In some embodiments of the present invention, the flow guiding structure further includes a base plate and two first side plates. The two sides of the flow guiding part in the first direction are connected to the base plate through the first side plates and are spaced apart from the base plate. The base plate is provided with a flow guiding hole. The flow guiding part is positioned directly opposite the flow guiding hole. The two sides of the flow guiding part in the second direction form the lateral flow channels. The sample diluent in the accommodating cavity can sequentially contact the sampling end through the inlet, the flow guiding hole and the lateral flow channels. The first direction and the second direction are perpendicular.

[0008] In some embodiments of the present invention, the flow guiding structure further includes two second side plates, which are respectively located on both sides of the flow guiding portion in a second direction and are spaced apart from the flow guiding portion to form the lateral flow channel. The two ends of the second side plates along the second direction are respectively connected to the adjacent first side plates.

[0009] In some embodiments of the present invention, the sampling assembly further includes a bracket having a mounting groove, the portion of the test strip away from the sampling end being disposed inside the mounting groove, one end of the bracket near the sampling end being inserted into the sampling head, and the flow guide being arranged circumferentially around the bracket and sealing the gap between the outer periphery of the bracket and the inner wall of the sampling head.

[0010] In some embodiments of the present invention, the sampling head includes a sampling part and a plug-in part, the sampling part and the plug-in part are connected, the sampling part is provided with at least one capillary channel, the plug-in part is provided with a communicating cavity, the liquid inlet is provided at one end of the sampling part away from the plug-in part, the liquid inlet, the capillary channel and the communicating cavity are connected in sequence, and the flow guiding structure is provided inside the communicating cavity and connected to the inner wall of the communicating cavity.

[0011] In some embodiments of the present invention, the capillary channel has a preset volume for collecting a preset volume of sample dilution.

[0012] In some embodiments of the present invention, the flow areas of the capillary channels are consistent along the extension direction of the capillary channels.

[0013] In some embodiments of the present invention, the capillary channel is a cylindrical channel.

[0014] In some embodiments of the present invention, the inner wall of the capillary channel is provided with a hydrophilic coating.

[0015] In some embodiments of the present invention, the accommodating cavity includes a first accommodating cavity and a second accommodating cavity that are connected to each other. When the sampling head is inserted into the accommodating cavity, the sampling part is located in the first accommodating cavity. The outer wall of the insertion part and the inner wall of the second accommodating cavity are interference-fitted. The cross-sectional area of ​​the sampling part is smaller than the cross-sectional area of ​​the insertion part. The cross-sectional area of ​​the first accommodating cavity is smaller than the cross-sectional area of ​​the second accommodating cavity. Attached Figure Description

[0016] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings: Figure 1 A schematic diagram of the structure of a sample sampling and detection device according to an embodiment of the present invention is shown. Figure 2 A schematic diagram of the structure of a sampling component according to an embodiment of the present invention is shown. Figure 3 An exploded view schematically illustrates a sample sampling and detection apparatus according to an embodiment of the present invention; Figure 4 The schematic diagram illustrates the structure of the flow guiding structure according to an embodiment of the present invention from a certain perspective. Figure 1 ; Figure 5The schematic diagram illustrates the flow guiding structure according to an embodiment of the present invention from another perspective. Figure 1 ; Figure 6 A schematic cross-sectional view (X direction) of a sample sampling and detection device according to an embodiment of the present invention is shown. Figure 1 ; Figure 7 The schematic diagram illustrates the structure of the flow guiding structure according to an embodiment of the present invention from a certain perspective. Figure 2 ; Figure 8 The schematic diagram illustrates the flow guiding structure according to an embodiment of the present invention from another perspective. Figure 2 ; Figure 9 A schematic cross-sectional view (X direction) of a sample sampling and detection device according to an embodiment of the present invention is shown. Figure 2 ; Figure 10 A schematic diagram of the flow guiding structure according to an embodiment of the present invention is shown. Figure 3 ; Figure 11 An assembly diagram of the sampling head and flow guiding structure according to an embodiment of the present invention is shown schematically; Figure 12 A schematic cross-sectional view (X direction) of a sample sampling and detection device according to an embodiment of the present invention is shown. Figure 3 ; Figure 13 A schematic diagram of the structure of the support according to an embodiment of the present invention is shown. Figure 1 ; Figure 14 A schematic diagram of the structure of the support according to an embodiment of the present invention is shown. Figure 2 ; Figure 15 A schematic diagram of the structure of a sampling head (preset volume of 10 μl) according to an embodiment of the present invention is shown. Figure 16 A cross-sectional view of a sampling head (preset volume of 10 μl) according to an embodiment of the present invention is shown schematically. Figure 17 A schematic diagram of the structure of a sampling head (preset volume of 20 μl) according to an embodiment of the present invention is shown. Figure 18 A cross-sectional view of a sampling head (preset volume of 20 μl) according to an embodiment of the present invention is shown schematically. Figure 19 A schematic diagram of the structure of a sampling head (preset volume of 5 μl) according to an embodiment of the present invention is shown. Figure 20 A cross-sectional view of a sampling head (preset volume of 5 μl) according to an embodiment of the present invention is shown schematically. Figure 21 A schematic diagram of the structure of a sampling head (preset volume of 15 μl) according to an embodiment of the present invention is shown. Figure 22 A cross-sectional view of a sampling head (preset volume of 15 μl) according to an embodiment of the present invention is shown schematically. Figure 23 A partial structural cross-sectional view (Y direction) of a sample sampling and detection device according to an embodiment of the present invention is schematically shown; Figure 24 A schematic diagram of the structure of a test strip according to an embodiment of the present invention is shown. The labels in the attached diagram are as follows: 100. Sample dilution assembly; 110. Sample dilution box; 111. Receiving cavity; 111a. First receiving cavity; 111b. Second receiving cavity; 120. Base; 130. Cover; 200. Sampling assembly; 210. Sampling head; 210a. Liquid inlet; 211. Sampling section; 211a. Capillary channel; 212. Insertion section; 212a. Connecting cavity; 213. Positioning ring rib; 220. Test paper; 221. Absorbent paper; 222. Nitrocellulose membrane; 222a. T-line; 222b. C-line; 223. Coupling pad; 224. Sample pad; 230. Flow guiding structure; 231. Flow guiding section; 231a. Lateral flow channel; 232. Base plate; 232a. Flow guiding hole; 233. First side plate; 234. Second side plate; 240. Support; 241. Mounting groove; 250. Outer shell; 251. Viewing window; 260. Tube plug. Detailed Implementation

[0017] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0018] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0019] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0020] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations.

[0021] like Figures 1 to 6As shown, the present invention proposes a sample sampling and detection device, including a sample dilution component 100 and a sampling component 200; the sample dilution component 100 includes a sample dilution box 110, which has a accommodating cavity 111 for storing sample dilution; the sampling component 200 includes a sampling head 210, a test strip 220 and a flow guiding structure 230, the sampling head 210 has an inlet 210a, the sampling end of the test strip 220 is located inside the sampling head 210, the sampling head 210 can be inserted into the accommodating cavity 111 so that the sample dilution enters the interior of the sampling head 210 through the inlet 210a and mixes with the sample, the flow guiding structure 230 is disposed inside the sampling head 210, the flow guiding structure 230 is provided with a flow guiding part 231, there is a lateral flow channel 231a between the flow guiding part 231 and the inner wall of the sampling head 210, and the flow guiding part 231 is disposed in the flow direction of the sample dilution.

[0022] The sample sampling and detection device in this technical solution eliminates the filter element found in existing solutions and incorporates a lateral flow channel 231a, thereby improving the flow resistance of the accommodating cavity 111. This prevents the sample diluent from overflowing from the gap between the outer wall of the sampling head 210 and the inner wall of the sample diluent 110 during the insertion of the sampling head 210 into the sample diluent container 110. Furthermore, at the instant the sampling head 210 is inserted into the accommodating cavity 111, the sample diluent rushes into the interior of the sampling head 210 from the inlet 210a. The sample diluent splashes onto the guide section 231 of the flow guiding structure 230, where it is deflected by the guide section 231 and falls back. As more sample diluent falls back, it flows upward until it contacts the test strip 220. The guide section 231 prevents waste of sample diluent due to splashing, ensuring sufficient contact between the sample diluent and the test strip 220.

[0023] Further, see Figures 1 to 3 The sample sampling and detection device in this technical solution also includes a housing 250 and a tube plug 260, with the sampling head 210 and the tube plug 260 respectively connected to both ends of the housing 250. Optionally, the sampling head 210 and the housing 250 are plugged in. For example, one end of the sampling head 210 away from the liquid inlet 210a is inserted into the housing 250. A positioning ring rib 213 is provided along the circumference of the sampling head 210. When the sampling head 210 is inserted to the position where the positioning ring rib 213 and the housing 250 abut, it indicates that the sampling head 210 and the housing 250 are installed in place. Optionally, the tube plug 260 and the housing 250 are detachably connected. The tube plug 260 is provided with a vent hole, which allows gas to be discharged to the outside when there is gas inside the housing 250. Further, the housing 250 is provided with a transparent viewing window 251, through which the detection results can be read.

[0024] Furthermore, the sample dilution assembly 100 also includes a base 120 and a cover 130. The sample dilution box 110 is disposed inside the base 120, and the cover 130 is fastened to the sample dilution box 110 and connected to the base 120. By placing the sample dilution box 110 in the cavity formed by the base 120 and the cover 130, the sample dilution assembly 100 can be stably placed on the operating platform.

[0025] Optionally, the flow guiding structure 230 can be made of a polymer elastomer or a thermoplastic. The polymer elastomer can be one of the following: natural rubber, styrene-butadiene rubber, fluororubber, ethylene propylene rubber, neoprene rubber, silicone rubber, methyl silicone rubber, fluorosilicone rubber, polyurethane rubber, or acrylate rubber. The thermoplastic can be general-purpose plastics such as PE, PP, PS, PVC, PMMA, etc.; engineering plastics such as ABS, PA, POM, PC, PPS, PEEK, etc.; or specialty plastics such as PTFE, PLA, PET, PU, ​​etc. Understandably, using polymer injection molding to produce the flow guiding structure 230 results in lower costs. Furthermore, the standardized nature of injection molding ensures high consistency in structural dimensions between batches, completely resolving batch variation issues.

[0026] Further, see Figure 4 , Figure 5 and Figure 6 The flow guiding structure 230 also includes a base plate 232 and two first side plates 233. The two sides of the flow guiding part 231 in the first direction are connected to the base plate 232 through the first side plates 233 and are spaced apart from the base plate 232. The base plate 232 is provided with a flow guiding hole 232a. The flow guiding part 231 is positioned directly opposite the flow guiding hole 232a. Lateral flow channels 231a are formed on both sides of the flow guiding part 231 in the second direction. The sample diluent in the accommodating cavity 111 can sequentially contact the sampling end through the inlet 210a, the flow guiding hole 232a and the lateral flow channel 231a. The first direction and the second direction are perpendicular.

[0027] The guide section 231 is supported by the base plate 232 and the first side plate 233, providing space below the guide section 231 for the sample diluent to pass through. Understandably, the guide hole 232a on the base plate 232 and the inlet 210a on the sampling head 210 are directly opposite each other, ensuring that the sample diluent can smoothly enter the interior of the sampling head 210 and contact the guide section 231. With the guide structure 230 configured in this way, after the sample diluent enters the interior of the sampling head 210 from the inlet 210a, it flows into the guide section 231, is blocked by the guide section 231, and then flows back. Simultaneously, the sample diluent can also flow upwards towards the test strip 220 through the lateral channels 231a on both sides of the guide section 231. Therefore, during the insertion of the sampling head 210 into the sample dilution box 110, splashing will not occur due to a sudden increase in internal pressure. By guiding the flow of the sample dilution, full contact between the sample dilution and the test strip 220 can be ensured, avoiding waste. Understandably, the dimension of the guide section 231 in the first direction is smaller than the dimension of the first side plate 233 in the first direction, thus creating a certain gap between the guide section 231 and the side wall of the sampling head 210; this gap is the lateral flow channel 231a. Optionally, the guide section 231 can be a rectangular plate structure, an oblong plate structure, or an elliptical plate structure, etc., depending on actual needs. Optionally, the first side plate 233 can be a square plate, a U-shaped plate, or an L-shaped plate, etc., without specific limitations.

[0028] Further, see Figure 7 , Figure 8 and Figure 9 The flow guiding structure 230 also includes two second side plates 234. The two second side plates 234 are located on both sides of the flow guiding part 231 in the second direction and are spaced apart from the flow guiding part 231 to form a lateral flow channel 231a. The two ends of the second side plates 234 along the second direction are respectively connected to the adjacent first side plates 233.

[0029] The addition of a second side plate 234 ensures the strength and stability of the flow guiding structure 230. Optionally, the height of the second side plate 234 can be the same as or different from the height of the first side plate 233, depending on the application requirements. The spacing between the flow guiding section 231 and the second side plate 234 is set according to the application requirements to ensure that the sample diluent can smoothly pass through the lateral flow channel 231a and contact the test paper 220, while also preventing splashing of the sample diluent during the insertion of the sampling head 210.

[0030] Further, see Figures 10 to 12The sampling assembly 200 also includes a bracket 240, which has a mounting groove 241. The portion of the test strip 220 away from the sampling end is disposed inside the mounting groove 241. The end of the bracket 240 near the sampling end is inserted into the sampling head 210. The guide portion 231 is arranged around the circumference of the bracket 240 and seals the gap between the outer periphery of the bracket 240 and the inner wall of the sampling head 210.

[0031] The support 240 provides support for the test strip 220, reducing the risk of bending or misalignment during use. For example, in this embodiment, the support 240 has two mounting slots 241, located on opposite sides of the support 240. Correspondingly, the outer casing 250 has two viewing windows 251, located on opposite sides of the casing 250 and corresponding to the two mounting slots 241. This structure allows for the mounting of two different test strips 220 onto the same support 240, depending on usage requirements.

[0032] Considering that different test items require different dilution ratios, i.e., different volumes of diluent, the volume of liquid entering the sampling head 210 when it is pressed into the sample dilution container 110 will vary, resulting in different liquid splash heights. On one hand, the guide section 213 should prevent liquid splashing. On the other hand, the height of the guide section 231 within the sampling head 210 is set according to the liquid level when the liquid fully enters the sampling head 210. This prevents the guide structure 230 from being submerged in the liquid, thus avoiding a rise in the liquid level (if the liquid level is too high, the liquid will submerge the sample pad 224 and the coupling pad 223, causing the test results to fail; generally, the liquid splash height is controlled below the coupling pad 223 to ensure stable testing). See also Figure 11 In one embodiment, the outer periphery of the flow guide 231 is fixedly connected to the inner wall of the sampling head 210. Exemplarily, the flow guide 231 and the sampling head 210 are integrally formed and detachably plugged into the bracket 240. See also Figure 13 In another embodiment, the inner ring of the flow guide 231 is fixedly connected to the bracket 240. Exemplarily, the flow guide 231 and the bracket 240 are integrally formed and detachably inserted into the sampling head 210. Of course, in other embodiments, the flow guide 231 can also be a separate component, which, during assembly, is first fitted onto the bracket 230 and then inserted into the sampling head 210. See also... Figure 14In other embodiments, the flow guide 231 may also be a protrusion structure disposed on both sides of the support 240, with the outer side of the protrusion structure contacting the inner wall of the sampling head 210. Of course, the flow guide 231 may also be a separate component. Understandably, the flow guide 231, located between the support 240 and the sampling head 210, can effectively prevent sample diluent from overflowing from the gap, contaminating the support 240, or causing waste of sample diluent.

[0033] Further, see Figures 15 to 22 The sampling head 210 includes a sampling section 211 and a plug-in section 212. The sampling section 211 and the plug-in section 212 are connected. The sampling section 211 is provided with at least one capillary channel 211a. The plug-in section 212 is provided with a connecting cavity 212a. The liquid inlet 210a is provided at one end of the sampling section 211 away from the plug-in section 212. The liquid inlet 210a, the capillary channel 211a and the connecting cavity 212a are connected in sequence. The flow guiding structure 230 is provided inside the connecting cavity 212a and is connected to the inner wall of the connecting cavity 212a.

[0034] The capillary channel 211a utilizes capillary action, the phenomenon of liquid rising through narrow channels or pores. This process is caused by the interaction between the surface tension of the liquid and the solid surface. Liquid surface tension arises from the cohesive forces between liquid molecules, causing the liquid surface to tend to contract. When liquid enters a narrow channel, the interaction between the liquid and the solid (such as adhesion) causes the liquid to form a curved surface within the channel, thus generating capillary action. The sample collected by the capillary channel 211a can be fingertip blood or blood from other parts of the body.

[0035] During sampling, the sampling component 200 is held in hand and the sampling part 211 is brought into contact with the blood flowing out after the skin is punctured. Capillary action is generated in the capillary channel 211a to draw the blood into the capillary channel 211a. After sampling is completed, the sampling head 210 is inserted into the sample dilution box 110, so that the sample release liquid enters the capillary channel 211a, thereby mixing the sample release liquid and the sample.

[0036] Furthermore, the capillary channel 211a has a preset volume for collecting a preset volume of sample dilution.

[0037] For example, the preset volume can be 2 μl, 5 μl, 10 μl, 15 μl, or 20 μl, etc. Because the capillary channel 211a has a preset volume, it can quantitatively collect samples and adapt the collected samples to the detection requirements. See also... Figures 15 to 18The capillary channel 211a can change the sample volume it fixes by adjusting its size in only one direction (e.g., keeping the Y-direction size constant while increasing the X-direction size). Since maintaining a smaller diameter in the capillary channel 211a increases the contact area between the sample and the channel wall, thereby enhancing capillary forces and ensuring the accuracy and repeatability of the collected sample volume, this embodiment keeps the Y-direction size constant and achieves quantitative sample collection by changing the X-direction size. In other embodiments, the sizes in both the X and Y directions can be adjusted simultaneously, making the inlet 210a square, rectangular, circular, or elliptical, etc.

[0038] Further, see Figures 19 to 22 In some embodiments, the capillary channel 211a is a cylindrical channel.

[0039] The capillary channel 211a is cylindrical, and correspondingly, the inlet 210a is circular. Compared to other structures, because its inner diameter is circular, the cylindrical capillary channel 211a experiences uniform stress throughout its inner wall, making it more suitable for drawing small volumes of samples. This sampling head 210 is well-suited for projects with high dilution ratios, i.e., small-volume sample quantification using the sampling head 210 in conjunction with a large-volume diluent container 110. See also... Figure 21 and Figure 22 The number of capillary channels 211a can also be multiple. The middle capillary channel 211a is set vertically, while the capillary channels 211a on both sides are designed in an inclined manner. The inclined cylindrical capillary channel 211a and the vertical cylindrical capillary channel 211a have little difference in force, and can also effectively measure the preset volume of sample. Compared with a single capillary channel 211a, the design of multiple capillary channels 211a can meet the needs of large volume sampling.

[0040] Further, see also Figures 15 to 22 Along the extension direction of capillary channel 211a, the flow area of ​​capillary channel 211a is consistent.

[0041] When the upper width of the inner wall of the capillary channel 211a is greater than that of the lower width (the position of the inlet 210a), the capillary force on the upper and lower ends of the sample is smaller at the top and larger at the bottom. Therefore, when the sampling part 211 leaves the sampling site (the blood surface of the fingertip laceration), some samples will be "pulled out" of the lower end of the sampling part 211 due to the uneven force on the capillary channel 211a. This is caused by the surface tension of the liquid formed during the process of the sample leaving the liquid phase and entering the gas phase (air) at the lower end of the sampling part 211. This results in a deviation in the volume fixed (quantitatively) by the capillary channel 211a. The magnitude of the deviation is related to the surface treatment state of the inner surface of the sampling part 211, the speed and angle at which the sampling part 211 leaves the liquid surface, and the viscosity of the blood at the fingertip. In this technical solution, the capillary channel 211a has uniform inner wall dimensions at both the upper and lower ends, and the capillary forces at the upper and lower ends are almost consistent. The measured volume results of the fingertip blood sample show that the structure in this technical solution can better retain the predetermined volume of sample, ensuring the accuracy of the liquid volume quantified by the capillary channel 211a, thereby ensuring the consistency and stability of the sampling volume and test results in each detection process.

[0042] Furthermore, the inner wall of the capillary channel 211a is provided with a hydrophilic coating.

[0043] To enhance the accuracy of the sampling volume of the sampling unit 211 and the surface tension of the capillary channel 211a, the sampling unit 211 undergoes hydrophilic modification treatment to varying degrees, resulting in stronger capillary forces within the capillary channel 211a. Depending on the product mass production process and fluid control requirements, the hydrophilic modification treatment can be applied to the entire sampling unit 211, the inner wall of the capillary channel 211a, or the entire inner wall of the sampling unit 211. Optionally, the hydrophilic coating can be a polymer material coating or a nanomaterial coating. Hydrophilic coatings typically consist of molecules with polar groups that can form bonds with water molecules through hydrogen bonds, thus exhibiting a strong affinity for water.

[0044] Common hydrophilic polymer materials include: 1) Natural polymer composite coatings, such as: ovalbumin (OVA) and tannic acid (TA) complex, chitosan (CS) and its derivatives.

[0045] 2) Synthetic polymer coatings: such as polyvinylpyrrolidone (PVP), polyacrylamide (PAM), polyethylene glycol (PEG), polyacrylic acid (PAA), polyvinyl alcohol (PVA), etc.

[0046] Common nanomaterials include: 1) Metal oxide nanoparticles, such as titanium dioxide (TiO2), graphene oxide (GO), and silver nanoparticles (AgNPs); 2) Composite nanosystems, such as silica nanoparticles, chitosan-polyethylene glycol complexes, etc.

[0047] Furthermore, the accommodating cavity 111 includes a first accommodating cavity 111a and a second accommodating cavity 111b that are connected to each other. When the sampling head 210 is inserted into the accommodating cavity 111, the sampling part 211 is located in the first accommodating cavity 111a. The outer wall of the insertion part 212 and the inner wall of the second accommodating cavity 111b are interference-fitted. The cross-sectional area of ​​the sampling part 211 is smaller than the cross-sectional area of ​​the insertion part 212, and the cross-sectional area of ​​the first accommodating cavity 111a is smaller than the cross-sectional area of ​​the second accommodating cavity 111b.

[0048] The structural design of the receiving cavity 111 reduces the dead volume of the first receiving cavity 111a, allowing as much sample diluent as possible to enter the interior of the sampling head 210. Furthermore, the first receiving cavity 111a can adopt a contour-following structural design, meaning its structure is designed according to the shape of the sampling section 211, thereby minimizing the liquid dead volume and ensuring that the sample diluent is almost completely transferred from the sample diluent container 110 to the interior of the sampling head 210 during the insertion of the sampling head 210 into the sample diluent container 110. This minimizes the dead volume caused by sample diluent accumulation due to excess space, solving the problem of sample diluent not fully entering the capillary channel 211a during the insertion of the sampling head 210 into the sample diluent container 110, significantly reducing the randomness of the detection results and improving the repeatability and stability of the detection results.

[0049] Further, see Figure 24The test strip 220 includes a laminated absorbent paper 221 for absorbing water, a nitrocellulose membrane 222, a coupling pad 223 for labeling proteins, a sample pad 224 for absorbing and pre-treating the sample, and a base pad for adhesion and support. The absorbent paper 221, nitrocellulose membrane 222, coupling pad 223, and sample pad 224 are all adhered to the base pad. Optionally, the base pad can be made of polyvinyl chloride. The labeling protein carried by the coupling pad 223 reacts with the corresponding detection substance in the sample. The reaction product acts on the nitrocellulose membrane 222, causing the nitrocellulose membrane 222 to develop color or emit light, thereby achieving the detection of the sample. The absorbent paper 221 enhances the chromatographic effect of the test strip 220, thereby increasing the accuracy of the detection. Each test strip 220 has one or more T-lines 222a (Test lines), enabling the test strip 220 to detect different items. For example, the nitrocellulose membrane 222 has two T-lines 222a and one C-line 222b (control line). The two T-lines 222a reflect the test results, while the C-line 222b is used for process control and result validity assessment. A viewing window 251 is located on the side of the test strip 220 closest to the nitrocellulose membrane 222. The transparent viewing window 251 allows for reading the test results, increasing the ease of reading them. Optionally, the sample pad 224 can be pretreated (e.g., surface modification or material composite) to directly capture and filter red blood cells and impurities in whole blood, eliminating the need for a filter cartridge in existing technologies and achieving optimization in both cost and technical redundancy.

[0050] Example 1 AIDS is a highly dangerous infectious disease caused by the Human Immunovirus (HIV), a virus that attacks the human immune system. It primarily targets and destroys CD4 T lymphocytes, the most important cells in the immune system, leading to a loss of immune function. As a result, the body becomes susceptible to various diseases and malignant tumors, resulting in a high mortality rate. While AIDS is incurable, early intervention with medication can block the spread of HIV. Early detection and treatment can effectively suppress disease progression, improve the patient's quality of life, prolong lifespan, and significantly reduce the risk of HIV transmission.

[0051] Syphilis is a sexually transmitted infection caused by Treponema pallidum, transmitted through sexual contact and blood. Early detection and treatment of syphilis can effectively curb disease progression, prevent deterioration, and avoid serious complications. In the early stages of syphilis, treatment is highly effective, and most patients can be completely cured. However, as the disease progresses to later stages, treatment becomes significantly more difficult, and the cure rate decreases. Early detection and treatment of syphilis also reduce the spread of the virus in the population, protecting public health.

[0052] As two of the world's most serious infectious diseases, primarily transmitted through sexual contact and blood, HIV and syphilis testing is of paramount importance. Previously, testing for these two diseases was mostly conducted at specialized institutions such as hospitals, which was time-consuming and laborious. However, current home testing products often require large blood samples and involve prolonged wound exposure, posing significant risks to both the test subject and the operator. Therefore, finding a convenient testing method that effectively avoids the risk of infection is of utmost importance.

[0053] The following describes the usage of the sample collection and testing device provided in this technical solution, using HIV / TP (Treponema pallidum) antibody combined detection as an example: Step 1: Add sample diluent to the sample diluent container 110, and seal the opening of the sample diluent container 110 with an easily puncturable aluminum foil as a sealing sheet. Insert the sealed sample diluent container 110 into the locking cavity of the base 120 with the sealed end facing upwards. The sample diluent container 110 is fixed in the locking cavity by the locking structure within the locking cavity. Then, press the cover 130 into the base 120. The locking structure of the base 120 and the locking mechanism of the cover 130 cooperate with each other, tightly combining the sample diluent container 110, the base 120, and the cover 130 to form a complete sample diluent assembly 100.

[0054] Step 2: Place the flow guiding structure 230 into the connecting cavity 212a of the sampling head 210, with the flow guiding structure 230 and the cavity wall of the connecting cavity 212a interfering with each other. The outer wall of the sampling head 210 and the inner wall of the outer shell 250 are interfering with each other. Insert the prepared HIV antibody test strip 220 and TP antibody test strip 220 into the mounting slots 241 on both sides of the support 240 with the nitrocellulose membrane 222 facing outwards. Then insert the support 240 into the sampling head 210 and insert the sampling head 210 with the support 240 into the outer shell 250, so that the nitrocellulose membrane 222 of the HIV antibody test strip 220 and the nitrocellulose membrane 222 of the TP antibody test strip 220 correspond to the viewing windows 251 on both sides of the outer shell 250, respectively. Finally, connect the tube plug 260 and the outer shell 250. The HIV antibody test strip 220 contains a nitrocellulose membrane 222 with a control line coated with goat anti-mouse IgG and a test line coated with HIV-specific antigen. The coupling pad 223 contains another HIV-specific antigen labeled with colloidal gold. The TP antibody test strip 220 also contains a nitrocellulose membrane 222 with a control line coated with goat anti-mouse IgG and a test line coated with TP-specific antigen. The coupling pad 223 contains another TP-specific antigen labeled with colloidal gold.

[0055] Step 3: During the test, the sampling head 210 is brought into contact with the blood flowing out after the fingertip of the subject is pricked, so that the capillary channel 211a is filled with blood sample, and the sample collection is completed.

[0056] Step 4: After sampling, insert the sampling head 210 into the sample dilution container 110 through the opening of the cover 130. Since the sampling head 210 and the sample dilution container 110 form an interference fit, the sample dilution is forced from the sample dilution container 110 into the capillary channel 211a by squeezing air and creating space. It mixes with the sample collected in the capillary channel 211a and is guided by the flow guiding structure 230, forcing the liquid into contact with the sample pads 224 of the two test strips. After contact with the HIV antibody test strips 220 and the sample pads 224, the sample passes through the sample pads 224 and reaches the coupling pad 223. HIV antibodies bind to colloidal gold-labeled HIV-specific antigens to form a complex. This complex continues to pass through the nitrocellulose membrane 222 under chromatographic force, binding to the HIV-specific antigen detection lines coated on the membrane to form a colorimetric result. After the sample comes into contact with the sample pad 224 of the TP antibody test strip 220, it passes through the sample pad 224 and reaches the coupling pad 223. The TP antibodies in the sample bind to the colloidal gold-labeled TP-specific antigens to form a complex. This complex continues to pass through the nitrocellulose membrane 222 under chromatographic force, binding to the HIV-specific antigen detection lines coated on the membrane to form a colorimetric result.

[0057] Step 5: Let the testing device stand for 15 minutes. After the testing time is reached, the test result is read from the window 251 to complete the test. If the HIV antibody test strip 220 shows color on line 222b (C line) and no color on line 222a (T line), the result is HIV negative. If both line 222b and line 222a show color, the result is HIV positive. If the TP antibody test strip 220 shows color on line 222b (C line) and no color on line 222a (T line), the result is TP negative. If both line 222b and line 222a show color, the result is TP positive.

[0058] The sample collection and testing device provided by this technical solution can be used to conduct HIV / TP home self-testing conveniently and quickly, while reducing the risk of infection caused by non-professional operation in the home self-testing environment.

[0059] One hundred HIV-negative samples, one hundred HIV-positive samples, one hundred TP-negative samples, and one hundred TP-positive samples, all confirmed by standard testing, were selected. Tests were conducted using test strips 220 with the same conditions for each test, employing a traditional cartridge detection structure, existing sample sampling and detection devices, and the sample sampling and detection device described in this technical solution. The results showed that the sample sampling and detection device described in this technical solution has significant advantages in sampling accuracy, fading time, and positive detection rate. Specific results are as follows: Test results

[0060] The sample collection and testing device in this technical solution differs from existing HIV antibody and TP antibody tests in several ways: Currently, some traditional card-type home testing products on the market also collect blood samples from the fingertip, utilizing a tiny wound. This often requires repeated pressure on the wound to collect a sufficient sample volume for testing. The sample needs to be suspended during the test, posing a significant risk of sample contamination for inexperienced users. If the sample is placed in an inappropriate location, there is also a risk of infection to others due to sample exposure. Furthermore, the test strip is exposed, and users may come into contact with the bioactive substances on the strip during testing, potentially causing wound infection. Traditional card-type home testing products involve cumbersome sampling and testing procedures, complex operation, and a long testing time. All of these factors indicate that painless home testing products present problems such as inconvenience in operation and a high risk of infection.

[0061] Example 2 Vitamin D helps promote the absorption of minerals such as calcium and phosphorus, thus maintaining bone health and strength. It is crucial for the prevention and treatment of conditions such as fractures and osteomalacia. Vitamin D also plays an important role in the normal functioning of the immune system. Conventional vitamin D testing often requires a trip to a designated location (such as a hospital) and the use of large machines, a cumbersome and time-consuming process. Making vitamin D testing available at home would significantly save time. Home testing can greatly increase the detection rate of vitamin D in a more convenient and accessible way, helping people understand their vitamin D levels early and take timely measures to prevent potential health problems. For those already supplementing, home testing can help monitor the effectiveness of supplementation and ensure that adequate vitamin D levels are maintained.

[0062] The following section uses vitamin D detection as an example to illustrate the sample collection and detection device provided in this technical solution. The detailed steps are as follows: Step 1: Add sample diluent to the sample diluent container 110, and seal the opening of the sample diluent container 110 with an easily puncturable aluminum foil as a sealing sheet. Insert the sealed sample diluent container 110 into the locking cavity of the base 120 with the sealed end facing upwards. The sample diluent container 110 is fixed in the locking cavity by the locking structure within the locking cavity. Then, press the cover 130 into the base 120. The locking structure of the base 120 and the locking mechanism of the cover 130 cooperate with each other, tightly combining the sample diluent container 110, the base 120, and the cover 130 to form a complete sample diluent assembly 100.

[0063] Step 2: Place the flow guiding structure 230 into the connecting cavity 212a of the sampling head 210, with the flow guiding structure 230 and the cavity wall of the connecting cavity 212a interfering with each other. The outer wall of the sampling head 210 and the inner wall of the outer shell 250 are interfering with each other. Insert the prepared HIV antibody test strip 220 and TP antibody test strip 220 into the mounting slots 241 on both sides of the support 240 with the nitrocellulose membrane 222 facing outwards. Then insert the support 240 into the sampling head 210 and insert the sampling head 210 with the support 240 into the outer shell 250, so that the nitrocellulose membrane 222 of the HIV antibody test strip 220 and the nitrocellulose membrane 222 of the TP antibody test strip 220 correspond to the viewing windows 251 on both sides of the outer shell 250, respectively. Finally, connect the tube plug 260 and the outer shell 250. The 25-hydroxyvitamin D test strip 220 consists of a base pad that provides adhesion and support, a nitrocellulose membrane 222, absorbent paper 221, a coupling pad 223, and a sample pad 224. The nitrocellulose membrane 222 has a control line coated with goat anti-mouse IgG and a test line coated with a 25-hydroxyvitamin D-specific antibody. The coupling pad 223 has another 25-hydroxyvitamin D-specific antibody labeled with colloidal gold.

[0064] Step 3: During the test, the sampling head 210 is brought into contact with the blood flowing out after the fingertip of the subject is pricked, so that the capillary channel 211a is filled with blood sample, and the sample collection is completed.

[0065] Step 4: After sampling, insert the sampling head 210 into the sample dilution box 110 through the opening of the cover 130. Since the sampling head 210 and the sample dilution box 110 can form an interference fit, the sample dilution solution is forced from the sample dilution box 110 into the capillary channel 211a by squeezing air and space. It mixes with the sample collected in the capillary channel 211a and is guided by the flow guiding structure 230. The liquid is then forced into the sampling head 210 and into contact with the sample pads 224 of the two test strips. After the sample comes into contact with the sample pad 224 of the 25-hydroxyvitamin D test strip 220, it passes through the sample pad 224 and reaches the coupling pad 223. The 25-hydroxyvitamin D antigen in the sample binds to the colloidal gold-labeled 25-hydroxyvitamin D specific antibody to form a complex. Under the action of chromatographic force, the complex continues to pass through the nitrocellulose membrane 222 and binds to the detection line of the 25-hydroxyvitamin D specific antibody coated on the membrane to form a color development.

[0066] Step 5: Set the detection device to stand for 15 minutes. After the detection time is reached, read the detection result from the viewing window 251 to complete the detection. If line C 222b of the test strip shows color but line T 222a does not, it is determined to be vitamin D deficiency; if both line C 222b and line T 222a show color, the vitamin D content (deficient, insufficient, or sufficient) is determined based on the color intensity.

[0067] The vitamin D testing method provided in this embodiment differs from conventional vitamin D testing methods in several ways: Conventional vitamin D testing requires a trip to a professional medical institution for quantitative vitamin D measurement, involves a sample volume of 3-5 ml, and often takes several hours to obtain results, resulting in a high time and effort cost. In contrast, the home self-testing method proposed in this embodiment significantly optimizes the patient's vitamin D testing experience. Firstly, this method requires minimal space, allowing testing to be completed at home; secondly, it requires a small sample volume, only 10 μl of fingertip blood, reducing patient discomfort; and thirdly, the testing time is short, with results available in just 15 minutes, and the results can be visually interpreted, greatly saving time and effort. Furthermore, the home self-testing product facilitates convenient vitamin D level monitoring, which is beneficial for individuals with vitamin D abnormalities to monitor their treatment progress.

[0068] Fifty VD samples that had been assigned values ​​using Roche chemiluminescence reagents were selected. Using the same test strip 220, tests were conducted using a traditional cartridge detection structure, a sample sampling and detection device in the prior art, and the sample sampling and detection device of this technical solution. The sample sampling and detection device of this technical solution showed higher sensitivity and better correlation in detecting the colorimetric gradient. Specific results are as follows (colorimetric intensity increases sequentially from G1 to G9): Statistical analysis of sample concentration and colorimetric intensity results of each device

[0069] Because the sampling head 210 in this technical solution can achieve accurate quantitative sampling, the results are more reliable; by setting the flow guiding structure 230, the sample reaches the test strip 220 through a designated path, preventing splashing and overflow, and reducing the loss of effective substances, the detection sensitivity is higher, and samples with lower concentrations can be detected.

[0070] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A sample sampling and detection device, characterized in that, include: The sample dilution assembly (100) includes a sample dilution box (110) having a accommodating cavity (111) for storing sample dilution solution. The sampling assembly (200) includes a sampling head (210), a test strip (220), and a flow guiding structure (230). The sampling head (210) has an inlet (210a). The sampling end of the test strip (220) is located inside the sampling head (210). The sampling head (210) can be inserted into the accommodating cavity (111) so that the sample diluent enters the interior of the sampling head (210) through the inlet (210a) and mixes with the sample. The flow guiding structure (230) is disposed inside the sampling head (210). The flow guiding structure (230) is provided with a flow guiding part (231). There is a lateral flow channel (231a) between the flow guiding part (231) and the inner wall of the sampling head (210). The flow guiding part (231) is disposed in the flow direction of the sample diluent to prevent the sample diluent from splashing. The flow guiding structure (230) further includes a base plate (232) and two first side plates (233). The two sides of the flow guiding part (231) in the first direction are connected to the base plate (232) through the first side plates (233) and spaced apart from the base plate (232). The base plate (232) is provided with a flow guiding hole (232a). The flow guiding part (231) is positioned directly opposite the flow guiding hole (232a). The two sides of the flow guiding part (231) in the second direction form the lateral flow channel (231a). The sample diluent in the accommodating cavity (111) can sequentially contact the sampling end through the inlet (210a), the flow guiding hole (232a) and the lateral flow channel (231a). The first direction and the second direction are perpendicular.

2. The sample sampling and detection device according to claim 1, characterized in that, The flow guiding structure (230) further includes two second side plates (234), which are located on both sides of the flow guiding part (231) in the second direction and are spaced apart from the flow guiding part (231) to form the lateral flow channel (231a). The two ends of the second side plates (234) along the second direction are respectively connected to the adjacent first side plates (233).

3. The sample sampling and detection device according to claim 1, characterized in that, The sampling assembly (200) also includes a bracket (240) having a mounting groove (241). The portion of the test strip (220) away from the sampling end is disposed inside the mounting groove (241). One end of the bracket (240) near the sampling end is inserted into the sampling head (210). The guide portion (231) is arranged around the circumference of the bracket (240) and blocks the gap between the outer periphery of the bracket (240) and the inner wall of the sampling head (210).

4. The sample sampling and detection device according to any one of claims 1-3, characterized in that, The sampling head (210) includes a sampling section (211) and a connector (212). The sampling section (211) and the connector (212) are connected. The sampling section (211) is provided with at least one capillary channel (211a). The connector (212) is provided with a connecting cavity (212a). The liquid inlet (210a) is located at one end of the sampling section (211) away from the connector (212). The liquid inlet (210a), the capillary channel (211a) and the connecting cavity (212a) are connected in sequence. The flow guiding structure (230) is located inside the connecting cavity (212a) and is connected to the inner wall of the connecting cavity (212a).

5. The sample sampling and detection device according to claim 4, characterized in that, The capillary channel (211a) has a preset volume for collecting samples of the preset volume.

6. The sample sampling and detection device according to claim 4, characterized in that, Along the extension direction of the capillary channel (211a), the flow area of ​​the capillary channel (211a) is consistent.

7. The sample sampling and detection device according to claim 4, characterized in that, The capillary channel (211a) is a cylindrical channel.

8. The sample sampling and detection device according to claim 4, characterized in that, The inner wall of the capillary channel (211a) is provided with a hydrophilic coating.

9. The sample sampling and detection device according to claim 4, characterized in that, The accommodating cavity (111) includes a first accommodating cavity (111a) and a second accommodating cavity (111b) that are connected to each other. When the sampling head (210) is inserted into the accommodating cavity (111), the sampling part (211) is located in the first accommodating cavity (111a). The outer wall of the insertion part (212) and the inner wall of the second accommodating cavity (111b) are press-fitted together. The cross-sectional area of ​​the sampling part (211) is smaller than the cross-sectional area of ​​the insertion part (212). The cross-sectional area of ​​the first accommodating cavity (111a) is smaller than the cross-sectional area of ​​the second accommodating cavity (111b).

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