Integrated liquid sample rapid detection device and method

Abstract

This invention relates to the field of medical device technology and discloses an integrated rapid liquid sample detection device and method, comprising: a housing for providing an assembly position and space and displaying the detection process and results; a test strip fixedly installed in the inner cavity of the housing along its length, used to react with the liquid sample through a reaction reagent in the reaction zone to generate a detection result, which is displayed through a display window on the housing; a sampling structure disposed at the sample inlet of the housing and stacked with the sample inlet of the test strip, used to automatically collect, guide, and transfer a quantitative amount of liquid sample to the test strip via capillary action; and a puncture structure disposed at the sample inlet of the housing and correspondingly arranged with the sampling structure and the test strip, used to release the limiting mechanism after the quantitative collection of the liquid sample is completed, and then release the reaction reagent into the sample inlet of the test strip by pressing. Automatic mixing and detection are achieved through the synergy of the puncture structure, the sampling structure, and the test strip.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular, to an integrated rapid detection device and method for liquid samples. Background Technology

[0002] Liquid sample testing, as a convenient method for detecting biomarkers, is increasingly widely used in health monitoring, disease screening, and other fields. Currently available portable testing products typically require users to perform several independent steps: first, puncture the fingertip with a separate sampling needle to obtain a liquid sample; then, collect a small amount of liquid using external pipetting tools such as pipettes or capillaries; next, manually add or transfer the liquid sample to the designated injection port on the test card; some products also require the addition of diluent; finally, wait for and interpret the test results.

[0003] However, the existing detection methods mentioned above have significant shortcomings, affecting the accuracy, convenience, and user experience of the detection, as detailed below:

[0004] The operation steps are cumbersome, requiring users to complete multiple actions such as puncture, sampling, transfer, and sample addition in sequence. For non-professional users, the process is complicated, has a low error tolerance, and is prone to failure due to improper operation, making it difficult to use.

[0005] Precise quantification is difficult to achieve during sample collection and transfer. Manual operation is prone to introducing significant sampling errors, whether in the volume of liquid samples or the mixing ratio with reaction reagents, which can directly affect the consistency and accuracy of the final test results.

[0006] In addition, the separate components also increase the inconvenience of operation and the risk of contamination.

[0007] Therefore, there is an urgent need in the field for an improved detection device that can highly integrate quantitative sampling, sample addition and detection processes to simplify the operation process, reduce the difficulty of operation for users, and ensure precise control of sample volume, thereby improving the reliability of detection and user experience. Summary of the Invention

[0008] This invention provides an integrated rapid detection device and method for liquid samples. By setting a press-type puncture structure to release the reaction reagent, and working in conjunction with a capillary quantitative sampling structure and test strip, it realizes the automatic mixing and detection of quantitative liquid samples and reagents. This solves the technical problems of cumbersome operation steps, difficulty in controlling sample addition accuracy leading to poor detection consistency, low accuracy and poor user experience in the prior art.

[0009] According to one aspect of the present invention, an integrated rapid liquid sample detection device is provided, comprising: a housing for providing an assembly position and assembly space and displaying the detection process and detection results; a test strip fixedly installed in the inner cavity of the housing along the length direction of the housing, for reacting with the liquid sample through the reaction reagent in the reaction zone to generate a detection result, which is displayed through a display window of the housing; a sampling structure disposed at the sample inlet of the housing and stacked with the sample inlet end of the test strip, for automatically collecting, guiding and transferring a quantitative amount of liquid sample to the test strip through capillary action; and a puncture structure disposed at the sample inlet of the housing and correspondingly arranged with the sampling structure and the test strip, for releasing the limiting after the quantitative collection of the liquid sample is completed, and then releasing the reaction reagent into the sample inlet of the test strip by pressing.

[0010] Furthermore, the sampling structure includes an upper membrane, a spacer, and a lower membrane. The spacer is supported between the upper and lower membranes so that the upper and lower membranes are spaced apart. The upper membrane, spacer, and lower membrane together form a siphon channel with a siphon inlet. The upper membrane has a reagent hole connected to the output end of the puncture structure for introducing the reaction reagent. The lower membrane is attached to the test strip and has an output hole for allowing fluid to be output to the test strip. The reagent hole and the output hole are arranged vertically in correspondence.

[0011] Furthermore, the lower diaphragm has flow control holes for controlling the fluid flow path. Multiple flow control holes are arranged sequentially at intervals along the preset fluid flow path, and the output hole is located on the arrangement path of the flow control holes and is arranged close to the siphon inlet.

[0012] Furthermore, the siphon inlet is provided with a liquid suction groove, and multiple liquid suction grooves are located on the upper and lower membranes respectively and on the edge of the siphon inlet. The liquid suction grooves on the upper membrane and the liquid suction grooves on the lower membrane are staggered.

[0013] Furthermore, the liquid suction groove opening is designed as a V-shaped groove, and the corners of the V-shaped groove are all arc-shaped transitions.

[0014] Furthermore, the puncture structure includes a button and an outer cylinder. The button is axially and sealed within the inner cavity of the outer cylinder. The button has a receiving cavity for loading reaction reagents. The outer cylinder contains a puncture tube. An actuation component is provided between the button and the outer cylinder. The actuation component is used to achieve two-stage actuation for unlocking and pressing.

[0015] Furthermore, the actuation component employs a detachable limiting ring positioned between the button and the outer cylinder to restrict the button from moving into the inner cavity of the outer cylinder. By removing the limiting ring and pressing the button axially into the inner cavity of the outer cylinder, the puncture tube pierces into the receiving cavity of the button, thereby allowing the reaction reagent in the receiving cavity of the button to be output to the test strip through the channel of the inner cavity of the puncture tube.

[0016] Furthermore, the actuation component employs a slider disposed on the outer peripheral wall of the button and a groove disposed on the outer cylinder; the groove includes a first groove section disposed along the circumference of the outer cylinder and a second groove section disposed along the axial direction of the outer cylinder.

[0017] Furthermore, the button's receiving cavity has an opening and a sealing film that seals the opening, with the sealing film corresponding to the puncture tube. The sealing end of the button is sealed and inserted into the inner cavity of the outer cylinder by the first end of the outer cylinder. The second end of the outer cylinder extends radially inward and then axially inward to form the puncture tube, forming an insertion groove between the puncture tube and the outer cylinder. The outer diameter of the puncture tube matches the inner diameter of the button's receiving cavity, and the button's annular sidewall matches the insertion groove. The first end of the puncture tube is the puncture end, which faces the sealing film. The second end of the puncture tube is the reagent output end, with the puncture end arranged as an axially inclined slope to form a puncture tip. The reagent output end of the puncture tube is arranged as a tapered opening, wider at the inside and narrower at the outside. The button has an outer edge extending radially outward, and a limiting ring is engaged with the outer wall of the button and positioned between the outer edge and the end face of the outer cylinder. The limiting ring includes a snap-fit ​​ring and a handle ring. The opening direction of the snap-fit ​​ring is opposite to that of the handle ring, forming an S-shaped structure. The snap-fit ​​ring uses a 3 / 5 to 4 / 5 circle snap-fit ​​clamp for a circumferential snap-fit ​​connection.

[0018] Furthermore, the outer shell is provided with an observation window for displaying the completion of quantitative collection of liquid samples and a detection window for displaying the test results; the observation window, the detection window and the puncture structure are located on the same side of the outer shell.

[0019] Furthermore, the outer casing is also equipped with markings for judging the test results on the side of the detection window.

[0020] Furthermore, the outer casing includes an upper cover and a lower cover; the observation window, the detection window, and the puncture structure are all located on the upper cover; the lower cover has a first mounting groove for fixing the test strip in its inner cavity, and a second mounting groove for fixing the sampling structure and stacking the sampling structure with the sample inlet of the test strip; or, the lower cover has a first mounting groove for fixing the test strip in its inner cavity, and the upper cover has a second mounting groove for fixing the sampling structure and stacking the sampling structure with the sample inlet of the test strip; the upper and lower covers are connected by a snap-fit ​​connection so that the display area of ​​the test strip is vertically aligned with the detection window, the display area of ​​the sampling structure is vertically aligned with the observation window, the puncture structure abuts against the sampling structure, the reaction reagent output end of the puncture structure is sealed to the reagent hole of the sampling structure, and the siphon inlet of the sampling structure is exposed outside the outer casing.

[0021] According to another aspect of the present invention, a rapid detection method for integrated liquid samples is also provided, which employs the aforementioned rapid detection device for integrated liquid samples and includes the following steps: performing siphon quantitative sampling through a sampling structure; when the observation window shows that the liquid sample has been quantitatively collected, releasing the restriction of the puncture structure and releasing the reaction reagent into the sample inlet of the test strip by pressing; obtaining the detection result, and the detection is completed.

[0022] The present invention has the following beneficial effects: 1. Achieves high integration and process automation from sampling to reading: The sampling structure integrated inside the device utilizes the principle of capillary action to automatically and quantitatively complete the collection and delivery of liquid samples when the user brings the liquid sample into contact with the inlet. This process replaces the error-prone steps of manual pipetting and dripping required in traditional operations, which not only greatly simplifies user operation but also effectively reduces the risk of detection failure due to improper operation, thereby improving the ease of use of the product and the user experience.

[0023] 2. Precise control and sequential execution of key reaction steps are achieved: The device integrates the puncture structure, sampling structure, and test strip in a spatially stacked manner, and the structural design ensures the logical sequence of operations. Users must first complete the quantitative collection of liquid samples before releasing the limit and pressing the puncture structure. This ensures that the subsequent reagent release step is triggered only after a sufficient amount of liquid sample reaches the predetermined position of the sampling structure. When the puncture structure is pressed, it punctures the reagent chamber encapsulated inside, releasing a precisely pre-stored amount of reaction reagents (such as labeled antibodies, buffer solutions, etc.) directly into the sample inlet of the test strip, where they are instantly and quantitatively mixed with the liquid sample already in place. This sequential control of "quantitative sampling first, then quantitative reagent release" ensures the accuracy and consistency of the sample-to-reagent ratio in the reaction system, thereby improving the accuracy and repeatability of the test results (i.e., reducing intra-batch and inter-batch differences).

[0024] 3. The components work closely together in terms of space and function to achieve the simple goal of "sample in, result out": the outer shell not only provides physical support and assembly benchmarks for all components, but its integrated display window also intuitively shows the detection process and results, completing the closed loop of user experience; the test strip, as the core of reaction and signal generation, has its position and direction fixed to ensure the determination of the capillary flow path and the stable reading of the detection results; in the entire technical solution, no volume measurement, liquid transfer or timing operation is required by the user, and all key biochemical reaction steps are automatically and sequentially completed by the mechanical and fluid design inside the device.

[0025] In addition to the objectives, features, and advantages described above, the present invention has other objectives, features, and advantages. The invention will now be described in further detail with reference to the figures. Attached Figure Description

[0026] The accompanying drawings, which form part of this invention, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an undue limitation of the invention. In the drawings: Figure 1 This is a schematic diagram of the structure of an integrated rapid liquid sample detection device according to a preferred embodiment of the present invention; Figure 2 This is an exploded view of an integrated rapid liquid sample detection device according to a preferred embodiment of the present invention; Figure 3 This is a schematic diagram of the sampling structure of a preferred embodiment of the present invention; Figure 4 This is a cross-sectional structural diagram of an integrated rapid liquid sample detection device according to a preferred embodiment of the present invention; Figure 5 This is a schematic diagram of the puncture structure according to a preferred embodiment of the present invention; Figure 6 This is a schematic diagram of the outer cylinder of a preferred embodiment of the present invention; Figure 7 This is a bottom view of the top cover of a preferred embodiment of the present invention; Figure 8 This is a bottom view of the top cover according to another embodiment of the present invention.

[0027] Legend: 100. Outer shell; 101. Observation window; 102. Detection window; 103. Marking; 104. Top cover; 105. Bottom cover; 1051. First mounting slot; 1052. Second mounting slot; 200. Test strip; 300. Sampling structure; 301. Upper membrane; 3011. Reagent well; 302. Spacer; 303. Lower membrane; 3031. Output port; 3032. Flow control port; 304. Liquid aspiration port; 400. Puncture structure; 401. Button; 4011, outer edge; 402, outer cylinder; 4021, puncture cylinder; 4022, insertion groove; 4023, puncture end; 4024, reaction reagent output end; 403, limiting ring; 4031, snap ring; 4032, hand ring; 404, slider; 405, groove; 4051, first groove section; 4052, second groove section; 4053, limiting protrusion; 4054, transition slope; 500, connecting structure; 600, sealing structure. Detailed Implementation

[0028] The embodiments of the present invention will be described in detail below with reference to the accompanying drawings. However, the present invention can be implemented in many different ways as defined and covered below.

[0029] like Figure 1 and Figure 2As shown, the integrated rapid liquid sample detection device of this embodiment includes: a housing 100, which provides an assembly position and assembly space and displays the detection process and detection results; a test strip 200, which is fixedly installed in the inner cavity of the housing 100 along the length of the housing 100, and is used to react with the liquid sample through the reaction reagent in the reaction zone to generate a detection result, which is displayed through the display window of the housing 100; a sampling structure 300, which is disposed at the inlet of the housing 100 and stacked with the inlet end of the test strip 200, and is used to automatically collect, guide and transfer a quantitative liquid sample to the test strip 200 through capillary action; and a puncture structure 400, which is disposed at the inlet of the housing 100 and is correspondingly arranged with the sampling structure 300 and the test strip 200, and is used to release the limit after the quantitative collection of the liquid sample is completed, and then release the reaction reagent into the inlet of the test strip 200 by pressing. Preferably, the puncture structure 400 is pressed onto the sampling structure 300 and the test strip 200, or the sampling structure 300 is adhered to the puncture structure 400. This invention, an integrated rapid liquid sample detection device, utilizes the capillary action principle of its integrated sampling structure 300. This allows for automatic and quantitative collection and delivery of the liquid sample when the user brings the liquid sample into contact with the inlet. This process replaces the error-prone steps of manual pipetting and adding liquid in traditional operations, greatly simplifying user operation and effectively reducing the risk of detection failure due to improper operation, thus improving product usability and user experience. The device integrates the puncture structure 400, sampling structure 300, and test strip 200 in a spatially stacked manner, and ensures the logical sequence of operation through structural design. Users must first complete the quantitative collection of the sample before releasing the limit and pressing the puncture structure 400. This ensures that the subsequent reagent release step is triggered only after a sufficient amount of liquid sample reaches the predetermined position of the sampling structure 300. When the puncture structure 400 is pressed, it punctures the reagent chamber encapsulated inside, releasing a precisely pre-stored amount of reaction reagent (such as labeled antibodies, buffer solutions, etc.) directly into the sample inlet of the test strip 200, where it is instantly and quantitatively mixed with the liquid sample that has already arrived. This sequential control of "quantitative sampling first, then quantitative reagent release" ensures the accuracy and consistency of the sample-to-reagent ratio in the reaction system, thereby improving the accuracy and repeatability of the test results (i.e., reducing intra-batch and inter-batch differences). The outer casing 100 not only provides physical support and assembly benchmarks for all components, but its integrated display window also intuitively shows the detection process and results, completing the closed loop of user experience; the test strip 200, as the core of reaction and signal generation, has its position and orientation fixed to ensure the determination of the capillary flow path and the stable reading of the detection results; in the entire technical solution, no volume measurement, liquid transfer or timing operation is required by the user, and all key biochemical reaction steps are automatically and sequentially completed by the mechanical and fluid design inside the device.This invention relates to an integrated rapid liquid sample detection device. By integrating functional modules such as sequential capillary quantitative sampling, reagent release triggering, and detection display into a compact structure, it not only simplifies the user operation process and lowers the barrier to entry, but also achieves quantitative and sequential control of key liquids (samples and reagents) in the reaction system through mechanical design, thereby improving the accuracy and consistency of detection and achieving a balance between convenience and reliability.

[0030] like Figure 2 and Figure 3As shown, in this embodiment, the sampling structure 300 includes an upper membrane 301, a spacer 302, and a lower membrane 303. The spacer 302 is supported between the upper membrane 301 and the lower membrane 303, so that the upper membrane 301 and the lower membrane 303 are arranged at intervals. The upper membrane 301, the spacer 302, and the lower membrane 303 enclose and form a siphon channel with a siphon inlet. The upper membrane 301 has a reagent hole 3011 for introducing reaction reagents, which is connected to the output end of the puncture structure 400. The lower membrane 303 is attached to the test strip 200 and has an output hole 3031 for outputting fluid to the test strip 200. The reagent hole 3011 and the output hole 3031 are arranged vertically in correspondence. The siphon channel formed by the stacking of the upper membrane 301, spacer 302, and lower membrane 303 constitutes a capillary-driven flow path with a defined structure. One end of the capillary-driven flow path (siphon inlet) is used to receive and automatically draw liquid sample liquid, while the output hole 3031 in the middle is directly connected to the test strip 200, thereby reliably delivering a quantitative liquid sample to the reaction area (displayed through the display window). The support of the spacer 302 not only shapes the cross-sectional shape and volume of the channel but also ensures the stability and smooth flow of the flow path. The reagent orifice 3011 of the upper membrane 301 and the output orifice 3031 of the lower membrane 303 are arranged vertically in correspondence. During operation, the liquid sample is first drawn into the siphon channel by capillary action and propelled forward. After the liquid sample flows through or fills the sampling structure 300 and moves away from the inlet, the user presses to puncture the structure 400, allowing the stored reaction reagent to enter the test strip 200 from top to bottom through the reagent orifice 3011, the siphon channel, and the output orifice 3031. Because the reagent orifice 3011 is located above the output orifice 3031, the injected reaction reagent can flow vertically downwards, while simultaneously generating a certain degree of negative pressure within the siphon channel. The negative pressure system forces the residual liquid sample in the siphon channel into the test strip 200. The vertically flowing reaction reagent encounters the liquid sample located in the inner cavity and lower part of the siphon channel (especially near the output orifice 3031), achieving flushing and mixing as it flows towards the output orifice 3031. This sequence, direction, and flushing / mixing design of "first drawing in the sample, then vertically injecting the reagent" effectively promotes the uniformity of mixing between the two liquids. Fluid dynamics then propels the mixed reaction solution to the display area of ​​the test strip 200, avoiding liquid sample residue and improving the utilization rate of the reaction reagent and reaction efficiency. The multi-layer membrane stacking design enables complex flow path functions with extremely thin thickness, facilitating the miniaturization of the entire device. The entire sampling structure 300 is a prefabricated module, facilitating production and assembly and ensuring consistent product performance.

[0031] like Figure 2 and Figure 3As shown, in this embodiment, the lower diaphragm 303 has flow control holes 3032 for controlling the fluid flow path. Multiple flow control holes 3032 are arranged sequentially at intervals along a preset fluid flow path. The output hole 3031 is located on the arrangement path of the flow control holes 3032 and is positioned near the siphon inlet. In the siphon channel, the natural flow path of the fluid under capillary action may be uncertain. By sequentially opening a series of flow control holes 3032 on the lower diaphragm 303 along the preset flow path, a series of guiding capillary anchor points or path markers are essentially formed. These hole structures enhance local capillary action and effectively constrain the expansion direction of the fluid front, thereby firmly limiting the flow of the fluid (whether it is the liquid sample introduced first or the mixture of the reaction reagent and the liquid sample injected later) to a preset, defined path. This avoids undesirable diffusion, stagnation, or flow deviation of the fluid within the siphon channel, ensuring that the fluid can reliably flow to the target location according to the predetermined design. Multiple flow control orifices 3032 are arranged at intervals to form a non-smooth, periodic flow channel bottom, which generates micro-resistance to the fluid flow and may play a role in micro-mixing within the fluid through repeated "convergence-diffusion" effects, particularly promoting the mixing process between the subsequently injected reaction reagent and the pre-existing liquid sample. The output orifice 3031 is located near the siphon inlet, meaning that after completing the critical mixing and reaction path, the fluid can be output to the test strip 200 relatively quickly, helping to control the overall reaction time and potentially reducing unnecessary sample dwell time within the flow channel. The defined flow path reduces fluid behavior fluctuations that may be caused by assembly tolerances, user operation differences (such as pressing angle), or batch material differences, improving the performance consistency between different detection devices. This structured flow channel design, combined with the reagent orifice 3011 injection point of the upper diaphragm 301, together constructs a controlled and predictable microfluidic process from "liquid sample intake" to "reaction reagent injection and mixing" and then to "mixture output".

[0032] like Figure 2 and Figure 3As shown, in this embodiment, a liquid suction groove 304 is provided on the siphon inlet. Multiple liquid suction grooves 304 are respectively located on the upper membrane 301 and the lower membrane 303 and are located on the edge of the siphon inlet. The liquid suction grooves 304 on the upper membrane 301 and the liquid suction grooves 304 on the lower membrane 303 are staggered. Liquid suction grooves 304 are respectively set at the edges of the siphon inlet of the upper membrane 301 and the lower membrane 303, which is equivalent to setting open capillary initiation points on both the upper and lower surfaces of the flow channel inlet. When the user brings the liquid sample close to the inlet, the liquid sample can contact the liquid suction groove 304 simultaneously or selectively from multiple directions (above and below) and be quickly captured, increasing the area and probability of effective contact between the liquid sample and the capillary structure. Compared with flat edges or single-sided grooves, this design with liquid suction grooves 304 on both sides can start the siphon process more quickly and reliably, especially when the sample volume is small or the user's operating position is slightly deviated, it can still effectively collect samples. The suction grooves 304 on the upper membrane 301 and the lower membrane 303 are staggered rather than directly facing each other, avoiding a direct vertical connection between the upper and lower grooves after assembly. If the suction grooves 304 were directly facing each other, the softer membrane material might deform locally during assembly pressure or use, or tiny fibers or tissue fluid clots might more easily clog this relatively concentrated channel. Furthermore, this concentrated channel would reduce the contact area with the liquid sample, thus weakening capillary action. The staggered arrangement of the suction grooves 304 on the upper membrane 301 and the lower membrane 303 creates an interlaced structure in the inlet in three-dimensional space, ensuring sufficient capillary force for sample introduction while avoiding the formation of straight and easily deformable weak points. This enhances the mechanical stability and anti-clogging ability of the inlet structure, ensuring the long-term reliability and consistency of the siphon channel inlet. Fast and reliable initial sampling means that users do not need to maintain precise alignment between their fingertips and the device for a long time, reducing user anxiety and repetitive operations caused by poor startup, making the "one-click" testing experience smoother; the reliability of the inlet is the first step in the entire automated testing process, and its performance optimization ensures the smooth progress of all subsequent steps and improves the testing results.

[0033] like Figure 2 and Figure 3As shown, in this embodiment, the liquid suction groove 304 is configured as a V-shaped groove, and the corners of the V-shaped groove are all arc-shaped transitions. Optionally, the shape of the liquid suction groove 304 in this embodiment can be V-shaped, W-shaped, U-shaped, semi-circular, wavy, irregular serrated, etc. The tip of the V-shaped groove forms a natural capillary force convergence point pointing into the channel; when the liquid sample contacts the groove area, the two sloping surfaces on both sides of the V-shape can guide the droplets to converge towards the tip from a wider range, thereby quickly forming a high meniscus curvature, generating a stronger capillary driving force, and effectively promoting the rapid start of the siphon process; compared with straight edges or other shaped openings, the V-shaped structure optimizes the dynamics of the liquid-solid-gas three-phase contact line at the microscale, making the initial action of sucking the liquid sample into the channel more rapid and reliable. All corners within the 304 stainless steel aspiration groove feature rounded transitions, eliminating sharp angles. In capillary-driven microfluidic environments, sharp inner corners can easily cause fluid frontal stagnation, eddies, or the entrainment of microbubbles, increasing flow resistance and potentially leading to poor or incomplete flow. The rounded corners provide a smooth, streamlined transition, allowing fluids (whether liquid samples or subsequent mixtures) to flow more smoothly into and through the groove structure. This results in less and more uniform resistance along the flow path, reducing fluid residue and improving channel emptying efficiency. This ensures that samples and reagents are delivered more completely to the reaction zone, reducing the risk of cross-contamination or quantitative errors due to liquid residue, and ensuring the reliability and accuracy of the detection process. The V-groove itself has a certain structural orientation, while the rounded corners avoid stress concentration. During the processing (e.g., punching, die-cutting) and use of membrane materials (such as polymer films), sharp corners can easily become the starting point for tearing. The rounded corner design enhances the local mechanical strength of the groove, improving the durability and production yield of the membrane components.

[0034] like Figure 1 , Figure 2 and Figure 4 As shown, in this embodiment, the puncture structure 400 includes a button 401 and an outer cylinder 402. The button 401 is axially and sealed within the inner cavity of the outer cylinder 402. The button 401 has a cavity for loading reaction reagents. The outer cylinder 402 contains a puncture tube 4021. An actuation component is provided between the button 401 and the outer cylinder 402. The actuation component is used to achieve two-stage actuation of unlocking and pressing.

[0035] like Figure 1 , Figure 2 and Figure 4As shown, in this embodiment, the actuation component uses a detachable limiting ring 403 disposed between the button 401 and the outer cylinder 402 to restrict the button 401 from moving into the inner cavity of the outer cylinder 402; by removing the limiting ring 403 and pressing the button 401 axially into the inner cavity of the outer cylinder 402, the puncture cylinder 4021 punctures into the receiving cavity of the button 401, thereby allowing the reaction reagent in the receiving cavity of the button 401 to be output to the test strip 200 through the inner cavity channel of the puncture cylinder 4021. The receiving cavity of button 401, as an independent and sealed container, can reliably isolate liquid or lyophilized reaction reagents from the external environment (air, moisture) and other parts of the device (such as test strip 200 and sampling structure 300) during device production, transportation and storage, ensuring the biological activity and stability of the reagents within their shelf life; the puncture tube 4021, as the puncture execution component, only punctures the sealed part of the receiving cavity when the user actively presses button 401 after the restriction is lifted, realizing "instant puncture", ensuring the freshness of the reagents and avoiding the risk of failure due to premature contact with the external environment. The detachable limiting ring 403 acts as a physical lock, preventing the button 401 from being accidentally pressed in the initial state. The user must remove the limiting ring 403 first (this occurs after completing fingertip sampling and confirming that the liquid sample has been drawn in) before performing the pressing operation. This forced two-step operation of "removing the limiting ring first and then triggering the release" constitutes a reliable sequential interlock, ensuring that the subsequent "releasing the reaction reagent" step can only be performed after the preceding "quantitative liquid sample collection" step is completed. This forcibly guarantees the correct reaction sequence of "liquid sample first, reaction reagent mixed later," which is a key mechanism to avoid misoperation, ensure the correct ratio of the reaction system, and thus improve the accuracy and consistency of detection. After puncturing the receiving cavity, the inner channel of the puncture tube 4021 becomes the only path for reagent outflow. The puncture action itself is driven by a linear motion of axial pressing, with controllable stroke. Combined with the specific shape of the puncture tube 4021 (such as the tip design), stable and repeatable punctures can be achieved. The volume of the receiving cavity is precisely set in advance, ensuring that the amount of reaction reagent released each time is fixed. The reaction reagent is directly guided to the predetermined outlet (reagent hole 3011 of the upper membrane 301 of the sampling structure 300) through the inner channel of the puncture tube 4021, realizing direct connection from sealed storage to quantitative delivery to the target point, reducing reagent waste, contamination, or transfer errors. The entire component is integrated near the sample inlet of the outer shell 100. The user only needs to perform two simple actions, "removing the limit ring and pressing the button," to complete the reagent release. The operation is intuitive and the feedback is clear (the instantaneous change in resistance during puncture can be felt). The sealing sleeve between the outer cylinder 402 and the button 401 also prevents reagent leakage before and after release.

[0036] like Figure 1 , Figure 2 and Figure 4As shown, in this embodiment, the receiving cavity of button 401 has an opening and a sealing film that seals the opening. The sealing film is correspondingly arranged with the puncture tube 4021. The sealed end of button 401 is sealed and inserted into the inner cavity of outer cylinder 402 by the first end of outer cylinder 402. The second end of outer cylinder 402 extends radially inward and then axially inward to form puncture tube 4021. An insertion groove 4022 is formed between puncture tube 4021 and outer cylinder 402. The outer diameter of puncture tube 4021 matches the inner diameter of receiving cavity of button 401, and the annular sidewall of button 401 matches the insertion groove 4022. The first end of the puncture tube 4021 is the puncture end 4023, which faces the sealing film. The second end of the puncture tube 4021 is the reagent output end 4024. The puncture end 4023 of the puncture tube 4021 is arranged with an axially inclined slope to form a puncture tip. The reagent output end 4024 of the puncture tube 4021 is arranged with a tapered opening that is larger inside and smaller outside. The button 401 has an outer edge 4011 extending radially outward. The limiting ring 403 is engaged with the outer wall of the button 401 and is located between the outer edge 4011 and the end face of the outer tube 402. The limiting ring 403 includes a retaining ring 4031 and a hand ring 4032. The opening direction of the retaining ring 4031 is opposite to the opening direction of the hand ring 4032, forming an S-shaped structure. The snap-fit ​​ring 4031 uses a 3 / 5 to 4 / 5 circle snap-fit ​​clamp for a circumferential snap-fit ​​connection. The sealing film seals the opening of the receiving cavity, which is crucial for ensuring the stability of the reaction reagent storage. The puncture end 4023 of the puncture tube 4021 is precisely aligned with the sealing film, so that during the pressing operation, the puncture force can be concentrated on the sealing point, ensuring reliable puncture with minimal stroke and resistance, and avoiding incomplete sealing or irregular tearing of the film material that could lead to reagent leakage or poor flow. The insertion groove 4022 provides a guide for the pressing and moving of the button 401, ensuring that the button 401 moves smoothly along the axial direction and avoids deflection; the depth of the insertion groove 4022 can limit the stroke of the button 401 and prevent excessive pressing from causing structural damage; since the button 401 and the outer cylinder 402 are sealed, that is, sliding in a sealed state, when the button 401 enters the insertion groove 4022, it can also squeeze out any accidentally falling into the insertion groove 4022 into the puncture cylinder 4021 for output, thereby improving the utilization rate of the reaction reagent.The fit between the side wall of button 401 and the insertion groove 4022, and the matching between the outer diameter of puncture tube 4021 and the inner diameter of the receiving cavity, together constitute a precise axial sliding guide and radial limiting system. This ensures that button 401 can only move smoothly along a predetermined axis when pressed, avoiding skewing, jamming, or shaking. This not only makes the puncture action reliable, but more importantly, before puncture, the sealing end of button 401 and the inner cavity of outer tube 402 form a sealed insertion fit, which, together with the sealing film, constitutes a double seal, further preventing the evaporation or contamination of reagents during storage. After puncture, the tight fit can still effectively constrain the reagent outflow path, guiding it all out through the inner cavity of puncture tube 4021, preventing reagent leakage into unexpected cavities and causing waste or contamination. The puncture tip 4023 is formed by an axially inclined bevel, which enables quick and clean puncture with lower pressure, reducing the required user force and improving the smoothness of operation. The reagent output tip 4024 is designed as a cone with a larger inner diameter and a smaller outer diameter, which helps the reagent droplets to gather at the tip at the moment of puncture. The guiding effect of the cone surface allows the reagent to flow more smoothly and centrally to the outlet (reagent orifice 3011 of the sampling structure 300), reducing the adhesion and residue of the reagent at the outlet and improving the output efficiency and quantitative accuracy of the reagent. The S-shaped structure with the hand ring 4032 and the locking ring 4031 arranged in opposite directions creates an asymmetrical removal method that requires force applied in a specific direction. This, along with its installation state where it is locked between the outer edge 4011 and the end face of the outer cylinder 402, constitutes a clear and tangible physical lock, clearly indicating the operating steps (it must be removed first) and effectively preventing accidental pressing, thus reinforcing the aforementioned sequential control logic. When disassembly is not required, the force applied to the hand ring 4032 is converted into a tangential force acting on the locking ring 4031. The retaining ring 4031 can only be pushed to rotate around the outer wall of the button 401 without dislodging it from the button 401, ensuring the relative stability between the limiting ring 403 and the button 401. Simultaneously, the handheld ring 4032 provides a convenient grip for the user, facilitating the application of disassembly force. By holding the handheld ring 4032 and applying a force in a specific direction (such as pressing the opening of the retaining ring 4031 after holding the handheld ring 4032), the limiting ring 403 can be easily removed from the button 401, making the operation simple and quick. The retaining ring 4031 adopts a large semi-circular (3 / 5 to 4 / 5 circle) clamp-type design, providing sufficient and uniform clamping force to stably restrict the position of the button 401, preventing accidental triggering due to vibration during storage and transportation. Optionally, the reaction reagent output end 4024 may also be located in the region where the radially inward extension of the second end of the outer cylinder 402 connects with the puncture cylinder 4021, so that the reagent falling into the insertion groove 4022 is output through the reaction reagent output end 4024, for example. Figure 6 As shown. Figure 5 and Figure 6As shown, in this embodiment, the actuation component includes a slider 404 disposed on the outer peripheral wall of the button 401 and a groove 405 disposed on the outer cylinder 402; the groove 405 includes a first groove segment 4051 disposed circumferentially along the outer cylinder 402 and a second groove segment 4052 disposed axially along the outer cylinder 402; the straight-line distance a from the slider 404 to the puncture end of the button 401 is less than the straight-line distance b from the first groove segment 4051 to the puncture cylinder 4021, and the sliding stroke c of the slider 404 in the second groove segment 4052 is greater than ba. The slide 405 includes a first groove segment 4051 arranged circumferentially and a second groove segment 4052 arranged axially. It decomposes the user's operation on the button 401 into two continuous and orthogonal motion stages, forcing the user to first drive the slider 404 to slide circumferentially in the first groove segment 4051 to complete a clear rotation unlock stroke. Only then can the slider 404 enter the second groove segment 4052, allowing the user to apply pressing pressure axially. This physical structural restriction forms a non-reversible operation logic that must be completed in sequence, effectively preventing accidental triggering caused by direct pressing by the user, and ensuring the intentionality and controllability of the operation. The straight-line distance 'a' from the slider 404 to the piercing end face of the button 401 is less than the straight-line distance 'b' from the first groove segment 4051 to the piercing cylinder 4021. This dimensional relationship establishes a safe physical gap between the piercing end face of the button 401 and the piercing tip of the piercing cylinder 4021 in the initial state. When the slider 404 is located at the starting end of the first groove segment 4051 (i.e., the initial locking position), no matter how much axial force is applied by the user, the piercing end face of the button 401 cannot contact the piercing cylinder 4021 because the slider 404 is blocked by the circumferential groove wall. This constitutes a reliable mechanical lock based on dimensional interference, eliminating the possibility of accidental piercing before the rotation unlocking action is completed, and greatly improving the safety of the device in the non-use state. The sliding stroke c of slider 404 within the second slot 4052 is designed to be greater than the distance difference (ba). This ensures that after the user rotates button 401 to transition slider 404 from the first slot 4051 to the second slot 4052, the available axial travel for pressing is sufficient and has a margin. This overtravel design ensures that after slider 404 enters the second slot 4052, the user has sufficient and smooth axial pressing travel to accumulate kinetic energy, ultimately driving button 401 to reliably impact the puncture cylinder 4021, ensuring successful execution of the puncture action. This overtravel provides the necessary operational tolerance, ensuring sufficient effective axial travel to complete the puncture even if the user does not precisely align the starting point of the second slot 4052 after rotating to unlock, or if the applied force is slightly off-center, thus enhancing operational robustness and user experience. Optionally, the slot wall of the first slot 4051 facing the puncture cylinder 4021 is set as an inclined slot wall that initially faces the puncture cylinder 4021 to achieve a locking effect on slider 404.Optionally, the groove wall of the first groove segment 4051 of the puncture cylinder 4021 facing the puncture cylinder 4021 is configured as a locking groove opened in the direction of the puncture cylinder 4021 in the initial position, so that the slider 404 falls into the locking groove to achieve a locking effect. Optionally, the slider 404 is arranged on the outer cylinder 402, and the slide groove 405 is arranged on the outer peripheral wall of the button 401.

[0037] like Figure 5 and Figure 6As shown, in this embodiment, the first groove segment 4051 is a through groove that runs radially through the outer cylinder 402. The groove wall of the first groove segment 4051 is provided with a limiting protrusion 4053. The first groove segment 4051 restricts the slider 404 of the button 401 in the first groove segment 4051 through the limiting protrusion 4053, so as to lock the button 401 in the outer cylinder 402. By applying force to the button 401, the slider 404 is made to pass over the limiting protrusion 4053, thereby unlocking. The first groove segment 4051 adopts a through groove structure that runs radially through the outer cylinder 402, providing a clear and open mechanical movement channel for the slider 404 on the button 401 in both the circumferential and radial dimensions of the outer cylinder 402. The radial through design allows the slider 404 to have a certain displacement space in the radial direction (inward or outward) under the action of external force, providing the mechanical feedback ("click" feeling) required for locking and unlocking through the limiting protrusion 4053 and the necessary clearance space for the slider 404 to pass over the limiting protrusion 4053. A limiting protrusion 4053 is provided on the wall of the through groove, and the slider 404 is restricted within the first groove section 4051 to achieve locking. The limiting protrusion 4053 constitutes a clear and perceptible stop. In the initial state, the cooperation between the slider 404 and the limiting protrusion 4053 prevents the slider 404 from sliding freely in the circumferential direction, thereby firmly locking the button 401 in the initial position. This is more reliable than the positioning method that relies solely on friction and can effectively resist unintentional interference such as transportation and vibration, ensuring the stability of the device in the non-use state. By applying force to button 401, slider 404 can pass over limit protrusion 4053 to achieve unlocking, defining an unlocking action with a clear operation threshold and tactile feedback. The user needs to apply a critical torque exceeding the resistance set by limit protrusion 4053 to cause slider 404 to undergo elastic deformation or force the protrusion / groove wall to undergo slight deformation, thereby allowing slider 404 to jump from the position restricted by the protrusion to the adjacent, slidable groove segment. This process will create a clear breakthrough point or "click" feeling for the user, not only providing positive feedback that the operation has taken effect, but also clearly distinguishing between the "locked" and "unlocked" states, preventing ambiguity due to insufficient operation force. After unlocking, slider 404 is released and can slide freely along the first groove segment 4051, thus smoothly transitioning to the subsequent pressing stage, namely the second groove segment 4052. Optionally, the limiting protrusion 4053 can be replaced with a spring sheet, which is integrally formed with the first groove segment 4051, or the spring sheet is snapped onto the groove wall of the first groove segment 4051. The corner parts of the limiting protrusion 4053 are all set as arc surfaces or slopes.

[0038] like Figure 5 and Figure 6As shown, in this embodiment, the second groove segment 4052 is formed in a blind groove (the bottom of the groove is closed) on the inner wall surface of the outer cylinder 402; a transition slope 4054 is provided between the first groove segment 4051 and the second groove segment 4052, which stops the slider 404 to lock the button 401 in the outer cylinder 402; by applying force to the button 401, the slider 404 slides into the second groove segment 4052 through the transition slope 4054, thereby unlocking. The second groove 4052 is designed as a blind groove with a closed bottom. The slider 404 provides radial clamping force to the button 401. At the same time, it provides a limiting structure with a clear path and endpoint for the axial sliding of the slider 404 after it enters the second groove 4052. This defines the limit position of the axial sliding of the slider 404, thereby precisely limiting the maximum stroke of the button 401 in the axial pressing. This ensures that in each operation, the contact position and relative stroke between the piercing end face of the button 401 and the piercing cylinder 4021 are fixed and repeatable. This prevents excessive or insufficient piercing due to stroke loss control, ensuring the consistency, reliability and safety of the piercing action, and avoiding impact damage to the internal structure. By using the transition ramp 4054 in conjunction with the second slot 4052 to circumferentially stop the slider 404, a locking mechanism is constructed at the critical position where the slider 404 transitions from the first slot 4051 to the second slot 4052. In the initial state, the slider 404 is restricted to the end of the first slot 4051, and its movement in the circumferential direction is blocked by the corner or boss formed by the transition ramp 4054 and the side wall at the beginning of the second slot 4052. This circumferential stop means that without the action of external rotational force, the slider 404 cannot move into the second slot 4052 by itself or only by axial force, thus forming an effective lock for pure axial movement. This prevents direct pressing unlocking caused by transportation or accidental contact, significantly improving the reliability of the lock. By applying force to button 401, slider 404 can slide into second slot 4052 via transition ramp 4054 to achieve unlocking, defining an unlocking action guided and controlled by the ramp structure; when the user applies sufficient rotational force, slider 404 begins to slide relative to transition ramp 4054 under the action of thrust, and then climbs or slides over the locking position blocked by circumferential stop, and finally smoothly transitions to the starting end of second slot 4052; this unlocking process guided by ramp not only requires a conscious rotational action to start, but also has clear mechanical feedback (such as resistance change), providing the user with a clear sense of unlocking operation and confirmation.

[0039] like Figure 1 , Figure 2 and Figure 4As shown, in this embodiment, the outer casing 100 is provided with an observation window 101 for displaying the completion of quantitative collection of liquid samples and a detection window 102 for displaying the test results; the observation window 101, the detection window 102, and the puncture structure 400 are located on the same side of the outer casing 100. Optionally, the portion of the outer casing 100 located to the side of the detection window 102 is also provided with an indicator 103 for judging the test results. The dedicated observation window 101 displays the completion of quantitative collection of liquid samples, allowing the user to directly and clearly confirm whether the preliminary sampling step has been successfully completed and met the quantitative requirements, replacing the ambiguous state where the user needs to judge or guess, and providing an objective and clear visual signal for proceeding to the next step; while the detection window 102 is specifically used to present the final biochemical reaction results; this functionally separated window design clearly distinguishes between process feedback and result output, making the logical stages of the entire testing process clear to the user at a glance, avoiding information confusion. The observation window 101, detection window 102, and button 401 (which requires user input) are arranged on the same side of the outer casing 100, forming an ergonomic "operation-observation surface." Users can complete the following sequentially from the same viewing angle: confirming quantitative aspiration of the liquid sample through the observation window 101; locating and operating the puncture structure 400 on the same side (pressing button 401 to release the reagent); and finally reading the results from the detection window 102 on the same side. Throughout the process, users do not need to flip or rotate the device, and their line of sight and operational focus do not need to frequently switch between different sides, simplifying operation and reducing operational errors or delays caused by searching for the operating location or observation point, making the testing process smoother and more intuitive. On the side of the test window 102 (next to the result line display area), there are markings 103 for judging the test results (such as the markings of the "C" control line and the "T" test line, or the colorimetric card reference area), which provide users with a direct interpretation benchmark. Users can quickly compare the color or position of the line displayed on the test strip 200 with these fixed markings 103, thereby reducing subjective misjudgment. This is especially beneficial for non-professional users or first-time users to read the results more confidently and accurately.

[0040] like Figure 1 , Figure 2 , Figure 4 , Figure 7 and Figure 8 As shown, in this embodiment, the outer casing 100 includes an upper cover 104 and a lower cover 105; the observation window 101, the detection window 102, and the puncture structure 400 are all located on the upper cover 104. Optionally, the lower cover 105 has a first mounting groove 1051 for fixing and installing the test strip 200, and a second mounting groove 1052 for fixing and installing the sampling structure 300 and stacking the sampling structure 300 and the sample inlet end of the test strip 200. Figure 2As shown. Optionally, the lower cover 105 has a first mounting groove 1051 for fixing and installing the test strip 200 in its inner cavity, and the upper cover 104 has a second mounting groove 1052 for fixing and installing the sampling structure 300 and stacking the sampling structure 300 and the sample inlet end of the test strip 200 in a layered arrangement, as shown. Figure 7 and Figure 8As shown. The upper cover 104 and the lower cover 105 are connected by a snap-fit ​​connection so that the display area of ​​the test strip 200 is arranged vertically and vertically with the detection window 102, the display area of ​​the sampling structure 300 is arranged vertically and vertically with the observation window 101, the puncture structure 400 is pressed against the sampling structure 300, the reaction reagent output end 4024 of the puncture structure 400 is sealed to the reagent hole 3011 of the sampling structure 300, and the siphon inlet of the sampling structure 300 is exposed to the outside of the outer shell 100. The first mounting groove 1051 and the second mounting groove 1052 provided in the inner cavity of the lower cover 105 provide unique and definite physical positioning references for the test strip 200 and the sampling structure 300, respectively. This allows these two key functional components to be quickly and accurately placed in their designed positions during assembly, especially ensuring the precise realization of the relative position of the stacked arrangement between the sampling structure 300 and the sample inlet end of the test strip 200. Alternatively, the upper cover 104 has a second mounting groove 1052 in its inner cavity for fixing and mounting the sampling structure 300 and stacking it with the sample inlet end of the test strip 200. This increases the sealing performance and prevents backflow or spillage of the reaction reagent that could puncture the structure 400. Preferably, in this embodiment, the sampling structure 300 is bonded or welded to the second mounting groove 1052. The upper cover 104 integrates the user interface (observation window 101, detection window 102) and the triggering mechanism (puncture structure 400). This layout physically separates the "user operation and observation surface" from the "core functional component bearing surface," which is beneficial for modularization and division of labor in production. When the upper cover 104 and the lower cover 105 are fastened together, this action is not a simple encapsulation, but rather a simultaneous completion of several precise assembly and functional integrations: the display area of ​​the test strip 200 is automatically and precisely aligned vertically with the observation window 101 and detection window 102 of the upper cover 104, ensuring that the user can observe the sampling status and test results without obstruction, ensuring clear human-computer interaction; the puncture structure 400 is pressed downward against the sampling structure 300 and the test strip 200, and the puncture structure 400, sampling structure 300, and test strip 200 are in surface contact. The design ensures smooth pressing action and guarantees the flow, impact mixing, and delivery of reaction reagents and liquid samples; it seals the reaction reagent output end 4024 of the puncture structure 400 onto the reagent hole 3011 of the sampling structure 300, forming a reliable point-to-point sealed connection channel from the reagent release point to the sample injection path of the test strip 200, ensuring that the released reagent can be completely and directionally delivered to the predetermined inlet without leakage or deviation; and it precisely exposes the siphon inlet of the sampling structure 300 to the outer shell 100 for easy user access.The modular mounting slots and snap-fit ​​structures ensure a high degree of consistency in the relative positions, alignment, and sealing pressure of the core components (test strip 200, sampling structure 300, and puncture structure 400) of each product during mass production. This repeatability is a crucial guarantee for achieving high repeatability of test results (i.e., minimal differences between different devices). The snap-fit ​​connection itself also constitutes the main outer shell 100 of the device, protecting the internal precision components from contamination and physical damage. The outer casing 100 adopts a split design with an upper cover 104 and a lower cover 105, and is equipped with a dedicated mounting groove. This provides a precise and stable positioning foundation for each core functional component. Through the final snap-fit ​​action, the alignment of the display window, the support of the mechanical trigger structure, and the establishment of the most critical point-to-point fluid sealing connection (the reagent output end 4024 sealingly docks with the reagent port 3011 of the sampling structure 300) are completed in one go with high precision. This precisely integrates and fixes the dispersed modules (detection, fluid, trigger) into a functionally coordinated whole in three-dimensional space, ensuring accurate observation, reliable triggering, and precise sealing of the reagent transmission path. This achieves integrated and automated detection functions and ensures consistency in mass production. Optionally, the upper cover 104 and the lower cover 105 are snapped together and connected and fixed using a connecting structure 500. Optionally, the connecting structure 500 can adopt a snap-fit, connecting buckle, tenon and mortise structure, etc.

[0041] This embodiment of the integrated rapid liquid sample detection method uses the aforementioned integrated rapid liquid sample detection device and includes the following steps: siphon quantitative sampling is performed through the sampling structure 300; when the observation window 101 displays that the liquid sample has been quantitatively collected, the restriction of the puncture structure 400 is released, and the reaction reagent is released into the sample inlet of the test strip 200 by pressing; the detection result is obtained, and the detection is completed. This integrated rapid liquid sample detection method of the present invention sequentially performs siphon quantitative sampling, confirmation indication, release of restriction and release of reagent by pressing, and reading the result—a fixed sequence. This transforms all the complex and error-prone liquid operations in traditional detection (such as pipetting, timing, and sequential sample addition) into simple and intuitive physical actions (contact, observation, removal, and pressing). Essentially, the user only triggers several preset mechanical and chemical processes in sequence under the clear visual and physical guidance of the device, thereby greatly reducing the technical threshold and the possibility of misoperation, and realizing the de-skilling of detection. In this method, when the sample flows through or fills the side of the sampling structure 300 away from the inlet, indicating that the quantitative collection of the liquid sample is complete, the restriction of the puncture structure 400 is released. The mandatory requirement supported by the device structure (such as the physical indication of the observation window 101 and the locking of the limiting ring 403) ensures that the user can only proceed to the next step of removing the limiting ring 403 and pressing it after confirming (through the observation window 101) that the quantitative collection and delivery of the liquid sample has been completed in the internal fluid system of the device. This eliminates the erroneous operation sequence of adding reagents before sampling or adding reagents when the sampling is insufficient, and ensures that the ratio of liquid sample to reaction reagent in the reaction system meets the design requirements. This is the chemical reaction basis for obtaining consistent and accurate detection results. From the moment the user contacts the liquid sample solution with the siphon inlet to the final reading of the result in the detection window 102, all key biochemical reaction steps (quantitative sampling, reagent release, mixing, reaction, and result generation) are automatically and continuously completed within the device. The user does not need to handle any reagents or perform any manual quantitative operations, which not only improves safety (biosafety and chemical safety) but also minimizes human error, internalizing the quality control of the test results into the design of the device itself and the sequence of the method. This invention's integrated rapid liquid sample detection method, through a serial "trigger-confirmation-re-trigger" design, precisely coordinates with the device's visual cues and physical interlocking structure, transforming the complex in vitro diagnostic process into a simple, reliable, and closed user operation sequence. The mandatory sequential nature of the process ensures the correct timing and quantitative relationship of the biochemical reactions, thereby ensuring the accuracy and repeatability of the detection from the source. Simultaneously, by maximizing the simplification and guidance of user operation, it achieves the convenience and accessibility of professional-grade testing for the general public.

[0042] In practice, an integrated rapid liquid sample detection device is provided, comprising: Puncture Structure 400: The diluent is pre-placed in the button 401, which is sealed with an aluminum film (sealing film) at the bottom, integrating the diluent addition operation. The button 401 is fixed inside the puncture structure 400 by a waterproof ring (sealing structure 600) and limited by a limiting ring 403. When the limiting ring 403 is removed and the button 401 is pressed again, the aluminum film at the bottom of the button 401 is punctured by the puncture tube 4021, and the buffer solution inside the button 401 flows out, passing through the central hole of the puncture tube 4021 and guiding the test strip 200 through the membrane material. The puncture tube 4021 includes an end face slope design (puncture end 4023) and an internal rib design for drainage, ensuring that the buffer solution is smoothly and quantitatively introduced into the test strip 200 through the central hole. The inclined puncture tube 4021 is used to puncture the aluminum film inside the button 401. The buffer solution inside the button 401 flows into the guide hole due to gravity. The outer diameter of the inclined puncture tube 4021 matches the inner diameter of the button 401, which can accommodate the downward pressing of the button 401. At the same time, the puncture tube 4021 can completely cover the aluminum film and push the aluminum film upward. The buffer solution can flow into the detection port for dilution without waste.

[0043] Sampling structure 300: It is designed with two membranes to form a sampling channel, which can quantitatively and automatically siphon liquid samples to avoid deviations in test results caused by too much or too little sample, and ensure the accuracy and consistency of the test. The sampling port of the two membranes of the sampling structure 300 is provided with staggered liquid suction grooves 304, which, compared with the flat opening, can be repeated multiple times and smoothly for sampling.

[0044] Sampling structure 300: The upper and lower parts of the two membranes are designed with reagent wells 3011 and flow control wells 3032 with different inner diameters. The purpose is to control the flow of liquid samples and diluents and to introduce all liquid samples, diluents and mixtures into the test strip 200, so as to ensure the reliability of the detection process and the accuracy of the results.

[0045] The sampling structure 300 involves fundamental academic principles from two major fields: fluid mechanics and surface physics. It represents the engineering application of these principles in practical product design. 1. Fluid Mechanics: Bernoulli's Principle and Fluid Conduction.

[0046] The acute-angle structure of the V-shaped groove forms a contraction channel. According to Bernoulli's principle, the fluid (liquid) will accelerate when passing through a narrow channel. The inclined surface of the V-shape is equivalent to a guide wall, which reduces turbulence and energy loss during liquid flow, allowing the liquid to flow more concentratedly towards the core area of ​​liquid absorption. In contrast, the flat-mouth surface contact sample used in the existing design is prone to generating flow around and eddies, which reduces flow efficiency.

[0047] 2. Surface physics: Principles of surface tension and contact angle.

[0048] The sharp angle design of the V-shaped groove results in a smaller contact angle between the liquid and the opening (making it easier to wet and spread), which can overcome the constraints of liquid surface tension and allow for rapid convergence; the flat surface contact of the opening leads to a larger contact angle, making it easier for the liquid to form a liquid film at the opening and hindering adsorption. At the same time, the slit structure of the V-shaped opening utilizes capillary action to further promote liquid ascent and flow.

[0049] 3. Gas-liquid two-phase flow principle.

[0050] The liquid absorption process is essentially a gas-liquid two-phase flow, which requires a balance between "negative pressure adsorption and air pressure replenishment". The non-closed structure of the V-shaped opening conforms to the design logic of "separation of gas phase channel and liquid phase channel" in gas-liquid two-phase flow, avoiding flow interruption caused by "liquid sealing of gas phase channel" in flat opening. This is also one of the core design ideas of "gas-liquid contact equipment" in chemical and bioengineering.

[0051] This invention provides an integrated rapid detection method for liquid samples, comprising the following steps: sample aspiration through a sampling structure, color development through an observation window, release of buffer solution by puncturing an aluminum film, and detection. This integrated operation eliminates the need for manual steps such as using a pipette to transfer liquid samples from the fingertip and dripping diluent from the diluent tube onto the test card. The optimized operation process makes it more convenient for users, lowers the barrier to entry, and greatly improves the ease of use of the product.

[0052] The integrated liquid sample rapid detection device (integrated liquid sample test reagent card) of the present invention has the following detection method steps: A liquid sample is collected using the sampling structure 300. The liquid absorption slot 304 of the sampling structure 300 is aligned with the target position. Due to capillary action, the liquid sample flows into the liquid sample channel formed by the upper membrane 301, the lower membrane 303, and the spacer 302. The liquid sample flows from the first end of the sampling structure 300 to the last end. When the user observes that the liquid sample fills the entire observation window 101, it indicates that a quantitative amount of liquid sample has fully flowed into the channel. The liquid sample flows into the test strip 200 through the output hole 3031. At this time, the user removes the limiting ring 403 and presses the button 401. The beveled tip of the piercing structure 400 pierces the aluminum film at the bottom of the button 401. The buffer solution pre-stored in the button 401 flows into the central hole, the output hole 3031, and downwards into the test strip 200 through the guide channel due to gravity. The buffer solution contacts and dilutes the liquid sample. Under capillary action, the diluted liquid sample flows towards the detection end of the test strip. The test strip 200 of this invention uses commercially available in vitro test strips, which will not be described in detail here.

[0053] Compared with existing technologies, the beneficial effects of the integrated liquid sample rapid detection device and method of the present invention are: Compared with existing related testing devices, the testing device of this invention can quantitatively and automatically siphon liquid samples, avoiding deviations in test results caused by excessive or insufficient sample volume, and ensuring the accuracy and consistency of the test. Its integrated design streamlines the entire process from sample aspiration through the sampling structure, color development through the observation window, piercing the aluminum film, to detection. This eliminates the need for manual steps such as using a pipette to transfer liquid samples from the fingertip and dripping diluent from the diluent tube onto the test card, optimizing the operation process, making it more convenient for users, lowering the barrier to entry, and greatly improving the ease of use of the product. It also reduces invalid results caused by user errors. Furthermore, the integrated design and reduced accessories effectively reduce the product's cost. These combined features significantly enhance the user experience.

[0054] Matters not covered in this invention are common knowledge.

[0055] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0056] The embodiments described above are merely examples of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention.

[0057] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. An integrated liquid sample rapid detection device, characterized in that, include: The outer casing (100) is used to provide an assembly position and assembly space and to show the inspection process and inspection results; The test strip (200) is fixedly installed in the inner cavity of the outer shell (100) along the length direction of the outer shell (100). It is used to react with the liquid sample through the reaction reagent in the reaction zone to generate the test result, which is displayed through the display window of the outer shell (100). The sampling structure (300) is located at the inlet of the outer shell (100) and is stacked with the inlet of the test strip (200) to automatically collect, guide and transfer a quantitative liquid sample to the test strip (200) through capillary action. The puncture structure (400) is set at the inlet of the outer shell (100) and is arranged in correspondence with the sampling structure (300) and the test strip (200). It is used to release the limit after the liquid sample is quantitatively collected, and then release the reaction reagent into the inlet of the test strip (200) by pressing.

2. The integrated rapid liquid sample detection device according to claim 1, characterized in that, The sampling structure (300) includes an upper diaphragm (301), a spacer (302), and a lower diaphragm (303). The spacer (302) is supported between the upper diaphragm (301) and the lower diaphragm (303) so that the upper diaphragm (301) and the lower diaphragm (303) are spaced apart. The upper diaphragm (301), the spacer (302), and the lower diaphragm (303) enclose a siphon channel with a siphon inlet. The upper membrane (301) has a reagent hole (3011) for introducing the reaction reagent, which is connected to the output end of the puncture structure (400). The lower membrane (303) is attached to the test strip (200) and has an output hole (3031) for allowing the fluid to be output to the test strip (200). The reagent port (3011) and the output port (3031) are arranged vertically in correspondence.

3. The integrated rapid liquid sample detection device according to claim 2, characterized in that, The lower diaphragm (303) has flow control holes (3032) for controlling the flow path of the fluid. Multiple flow control holes (3032) are arranged sequentially at intervals along the preset flow path of the fluid. The output hole (3031) is located on the arrangement path of the flow control holes (3032) and is arranged close to the siphon inlet.

4. The integrated rapid liquid sample detection device according to claim 2, characterized in that, The siphon inlet is provided with a liquid suction groove (304). Multiple liquid suction grooves (304) are located on the upper membrane (301) and the lower membrane (303) respectively and are located on the edge of the siphon inlet. The liquid suction grooves (304) on the upper membrane (301) and the liquid suction grooves (304) on the lower membrane (303) are arranged in a staggered manner.

5. The integrated rapid liquid sample detection device according to claim 1, characterized in that, The puncture structure (400) includes a button (401) and an outer cylinder (402). The button (401) is axially and sealed in the inner cavity of the outer cylinder (402). The button (401) has a cavity for loading reaction reagents. The outer cylinder (402) is provided with a puncture tube (4021). An actuation component is provided between the button (401) and the outer cylinder (402), which is used to achieve two-stage actuation for unlocking and pressing.

6. The integrated rapid liquid sample detection device according to claim 5, characterized in that, The actuation assembly employs a detachable limiting ring (403) disposed between the button (401) and the outer cylinder (402) to restrict the movement of the button (401) into the inner cavity of the outer cylinder (402); By removing the limiting ring (403) and pressing the button (401) axially into the inner cavity of the outer cylinder (402), the puncture tube (4021) pierces into the receiving cavity of the button (401), thereby allowing the reaction reagent in the receiving cavity of the button (401) to be output to the test strip (200) through the inner cavity channel of the puncture tube (4021).

7. The integrated rapid liquid sample detection device according to claim 5, characterized in that, The actuation assembly uses a slider (404) arranged on the outer peripheral wall of the button (401) and a groove (405) arranged on the outer cylinder (402). The chute (405) includes a first chute section (4051) arranged circumferentially along the outer cylinder (402) and a second chute section (4052) arranged axially along the outer cylinder (402).

8. The integrated rapid liquid sample detection device according to any one of claims 1 to 7, characterized in that, The outer casing (100) is provided with an observation window (101) for displaying the completion of quantitative collection of liquid samples and a detection window (102) for displaying the detection results. The observation window (101), the detection window (102), and the puncture structure (400) are located on the same side of the outer shell (100).

9. The integrated rapid liquid sample detection device according to claim 8, characterized in that, The outer casing (100) includes an upper cover (104) and a lower cover (105); The observation window (101), the detection window (102), and the puncture structure (400) are all located on the top cover (104); The lower cover (105) has a first mounting groove (1051) for fixing the test strip (200) in its inner cavity, and a second mounting groove (1052) for fixing the sampling structure (300) and making the sampling structure (300) and the sample inlet end of the test strip (200) overlap; or, The lower cover (105) has a first mounting groove (1051) for fixing the test strip (200) in the inner cavity, and the upper cover (104) has a second mounting groove (1052) for fixing the sampling structure (300) and making the sampling structure (300) and the sample inlet end of the test strip (200) stacked in a layered arrangement. The upper cover (104) and the lower cover (105) are connected by snapping together so that the display area of ​​the test strip (200) and the detection window (102) are arranged vertically and vertically, the display area of ​​the sampling structure (300) and the observation window (101) are arranged vertically and vertically, the puncture structure (400) is pressed against the sampling structure (300), the reaction reagent output end (4024) of the puncture structure (400) is sealed in the reagent hole (3011) of the sampling structure (300), and the siphon inlet of the sampling structure (300) is exposed outside the outer shell (100).

10. A rapid detection method for integrated liquid samples, characterized in that, The integrated rapid liquid sample detection device according to any one of claims 1 to 9 includes the following steps: Quantitative siphon sampling is performed using the sampling structure (300); When the observation window (101) shows that the liquid sample has been quantitatively collected, the restriction of the puncture structure (400) is released and the reaction reagent is released into the injection port of the test strip (200) by pressing. The test results are in; the test is complete.

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