Sample collection and testing device and operation method therefor

Abstract

Disclosed in the present invention is a sample collection and testing device, comprising a sample collection chamber and a sample collector. The sample collector comprises a handheld part, a main body part and a sample absorption part; the sample collection chamber comprises an outer barrel, an inner barrel, an isolation seat and test paper; the inner barrel is provided with a filtering window, and allows the sample collector to partially extend into; the isolation seat is located between the outer barrel and the inner barrel and is provided with a sample outlet arranged in a staggered mode with the filtering window; when the sample absorption part is in a second state relative to the filtering window, the sample absorption part squeezes from a high position of the filtering window to a low position thereof, a sample is squeezed and discharged through the filtering window, and then the sample is guided by means of the sample outlet to flow towards the test paper. Also disclosed in the present invention is an operation method for the sample collection and testing device. A sample discharged after being squeezed by the sample absorption part first passes through a liquid flow channel formed by the collector, the inner barrel and the isolation seat to avoid a large amount of foam generated by sample squeezing, and then flows towards the test paper by means of the sample outlet; the test result is accurate.

Description

A sample collection and detection device and its operation method Technical Field

[0001] The present invention belongs to the technical field of sample collection devices, and in particular relates to a sample collection and detection device and an operating method thereof. Background Art

[0002] Detection devices for collecting samples and determining the presence or absence and / or quantifying the amount of various analytes in the sample are known in the market. These detection devices are commonly used for drugs of abuse, pregnancy and fertility testing, and infectious diseases. Most of these existing detection devices are typically designed for analyzing bodily fluids such as urine and saliva. The fundamental principle of these detection technologies is the specific binding properties between immune molecules, such as antibodies and antigens, haptens and antibodies, and biotin and avidin.

[0003] In the field of medical diagnostics, the use of a testing device or test cup to collect and test a liquid sample and determine whether the liquid sample contains an analyte is a common method. Such a testing device or test cup generally requires that the sample be collected in a sample container. A technician inserts a test strip and partially immerses the strip in the sample. After a period of time, the strip is removed and the test result is read.

[0004] In the detection of body fluid samples, especially saliva samples, due to their inconvenience in storage, they are usually taken and used immediately to ensure that the samples are not contaminated or replaced. In order to facilitate sampling and testing, devices that integrate the collection and detection of saliva and other samples have appeared on the market. U.S. Patents US20040184954A1 and US7114403B2 disclose some detection devices for collecting saliva and detecting whether there is drug abuse. In both patents, devices and methods for collecting and detecting saliva are provided. In these devices, after the sample is sampled onto the collector, the sample in the absorption component on the collector is squeezed into the collection chamber by applying external force, and then the test is performed. In addition, Chinese patent CN205748983U discloses "A saliva collection device and saliva detection kit", which includes a test cup, a fixing seat, a transparent sleeve, a saliva collection part, and a saliva detection card plate. A chassis is set at the bottom of the transparent sleeve, the saliva collection part is fixed on the chassis, the test strip is in contact with the saliva collection part, and the transparent sleeve and the fixing seat are connected by threads. In actual use, it was found that this type of saliva sample collection and testing device reduces the sensitivity of the test strip because the saliva expelled from the saliva collection unit directly and instantly impacts the test strip in the saliva testing card. Furthermore, since the saliva is expelled with foam, false negative or false positive results may occur, reducing the accuracy of the test strip. The fixing base and the test cup are generally sealed with threads or sealing rings. The threaded seal will cause the saliva collection unit to rotate and twist during rotation, generating shear force, resulting in inaccurate saliva volume. The sealing ring seal will rebound a certain distance during the extrusion process, also resulting in inaccurate saliva volume. Summary of the Invention

[0005] In order to overcome the shortcomings of the existing technology, the present invention provides a sample collection and detection device and an operating method thereof, which can eliminate the sample foam generated by squeezing, and the sample flows upward from the bottom of the test paper, thereby ensuring the detection sensitivity of the test paper and high detection accuracy.

[0006] The technical solution adopted by the present invention to solve the technical problem is: a sample collection and detection device, including a sample collection chamber and a sample collector, the sample collector including a handheld portion, a main body and a sample absorbing portion, the sample collection chamber including an outer cylinder, an inner cylinder, an isolation seat and a detection test paper;

[0007] The inner cylinder has a filter window for the sample collector to at least partially extend therein; the isolation seat is located between the outer cylinder and the inner cylinder and has a sample outflow port, which is staggered with the filter window;

[0008] When the sample absorbing portion is in the first state relative to the filter window, the sample absorbing portion blocks the filter window and no sample is discharged from the filter window; when the sample absorbing portion is in the second state relative to the filter window, the sample absorbing portion squeezes the filter window from the upper side to the lower side, the sample is squeezed and discharged through the filter window, and then guided through the sample outflow port to flow toward the test paper.

[0009] Furthermore, the test paper is located on opposite sides of the outer cylinder, and the sample flow outlet is arranged opposite to the test paper; or, the test paper is located on the back side of the isolation seat, and the sample flow outlet is not arranged opposite to the test paper.

[0010] Furthermore, the filter window is arranged opposite to the isolation seat, and the isolation seat completely blocks the filter window in the height direction.

[0011] Furthermore, after the sample absorbing part is squeezed downward, its top surface is flush with the lower part of the filter window, or, after the sample absorbing part is squeezed downward, its top surface is located below the higher part of the filter window, so that the squeezed sample flows through the filter window; the horizontal height of the sample outflow port is smaller than the horizontal height of the filter window.

[0012] Furthermore, the sample discharged after the sample absorbing portion is squeezed flows upward through the filter window, then flows downward to the space between the isolation seat and the inner cylinder, and finally flows to the bottom of the test paper through the sample outflow port.

[0013] Furthermore, the sample collecting chamber has a top cover with a perforation, and the sample collector has a lug. Part of the sample collector is extended into the perforation and then rotated. The lug can cooperate with the top cover to limit the perforation to achieve sealing of the sample collector by the perforation, and the relative rotation angle between the sample collector and the sample collecting chamber is less than or equal to 45°.

[0014] Furthermore, the inner cylinder includes an upper cylinder portion and a lower cylinder portion, the upper cylinder portion has a closed bottom and has a limiting groove, and the lower cylinder portion has a support seat that can be positioned and snapped into the limiting groove.

[0015] Furthermore, the filter window is located in the upper cylinder portion, the outer wall of the bottom of the upper cylinder portion forms an upper guide surface, and the outer wall of the lower cylinder portion forms a lower guide surface.

[0016] Furthermore, the number of the filter windows is at most two, and they are evenly spaced along the circumference.

[0017] Furthermore, the main body has a transition section, in which an expansion indicator is provided. The expansion indicator contacts the sample absorbing portion and changes in volume after absorbing the sample. The side wall of the transition section has an indicator line for indicating the position of expansion.

[0018] Furthermore, the outer wall of the main body is provided with a sealing member, which is sealed with the inner cylinder.

[0019] The present invention also discloses an operating method of a sample collection and detection device, comprising the following steps:

[0020] S1, the sample collector rotates relative to the sample collection chamber and then separates from the sample collection chamber;

[0021] S2. The sample collector absorbs the sample and observes whether a sufficient amount of sample is absorbed;

[0022] S3, inserting the sample collector after absorbing the sample into the sample collection chamber, and pressing down the sample absorbing part;

[0023] S4, the sample discharged from the sample absorption part flows through the filter window and the sample outlet in sequence toward the test paper;

[0024] S5. The sample collector is rotated relative to the sample collection chamber to a locked state, and the rotation angle is less than or equal to 45°;

[0025] S6. The test paper displays the test results.

[0026] Furthermore, in step S2, the expansion indicator in the transition section of the sample collector expands to a set size after absorbing the sample, so as to determine that the sample absorbing portion has absorbed a sufficient amount of sample.

[0027] Furthermore, in step S4, part of the sample in the sample absorbing part is squeezed and discharged directly from the filter window; part of the sample in the sample absorbing part is squeezed and enters between the outer wall of the main body and the inner wall of the inner cylinder, and then discharged through the filter window.

[0028] Furthermore, in step S4, the sample discharged from the filter window flows downward directly from the filter window, or flows downward after being blocked by the isolation seat.

[0029] Furthermore, in S3, the lug on the outer wall of the sample collector passes over the perforation of the sample collecting chamber top cover and enters the rotation channel. After the sample collector is pressed down, it rotates relative to the sample collecting chamber until the positioning clip on the lug rotates over the anti-rotation protrusion in the rotation channel.

[0030] The beneficial effects of the present invention are: 1) the sample discharged after being squeezed by the sample absorption part does not flow directly to or be sprayed directly to the test paper with great force, but first passes through the liquid flow channel formed by the collector, the inner cylinder, and the isolation seat to avoid a large amount of foam generated by sample squeezing, effectively avoiding the interference of foam on the detection, and then flows to the test paper through the sample outflow port, so that the sensitivity of the test paper is higher and the detection result is more accurate; 2) the removal of foam improves the fluidity of the sample, the entire flow channel of the sample is unobstructed, the sample fluidity is high, and foam is avoided from entering the flow channel to hinder the sample liquid from running smoothly from the bottom of the test paper to the upper plate, thereby avoiding false negative or false positive results; 3) after the sample is discharged from the filter window, it flows steadily downward to the space between the inner cylinder and the isolation seat through drainage, ensuring the flow The sample flows smoothly and stably toward the test paper; 4) The relative rotation angle between the sample collector and the sample collecting chamber is small. Since there is no repeated spiral rotation, no shear force is generated, thereby reducing the amount of foam generated during the extrusion process; 5) When the sample collector and the sample collecting chamber are used in conjunction with each other, the sample collector is pressed down and then rotated relative to the sample collecting chamber. During the process of the sample collector being squeezed downward relative to the sample collecting chamber, the sample is completely squeezed out and quantitatively discharged. Even if the sample collecting chamber and the sample collector rotate relative to each other during the locking process, the amount of sample discharged will not increase, and the quantitative discharge is more accurate. Moreover, the sample is rotated after being quantitatively discharged to avoid the generation of a large number of bubbles due to shear force; 6) It is easy to visually judge whether the sample absorption part has absorbed enough sample, and it is easy to use. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] FIG1 is a perspective view of a sample collection and detection device provided by the present invention.

[0032] FIG2 is a schematic structural diagram of the sample collector and the upper cylinder provided by the present invention.

[0033] FIG3 is a schematic structural diagram of a sample collector provided by the present invention.

[0034] FIG4 is a schematic structural diagram of the outer cylinder provided by the present invention.

[0035] FIG5 is a schematic structural diagram of the sample collector and the isolation seat provided by the present invention, where the test paper is located on the back side of the isolation seat.

[0036] FIG6 is a side view of the sample collection and detection device provided by the present invention.

[0037] FIG7 is a DD cross-sectional view in FIG6 .

[0038] FIG8 is an enlarged view of the structure at point B in FIG7 .

[0039] FIG9 is a schematic diagram of four paths along which samples are discharged from the filter window in the present invention.

[0040] FIG10 is a front view of the sample collection and detection device provided by the present invention.

[0041] FIG11 is a CC cross-sectional view in FIG10 .

[0042] FIG12 is a perspective view of the sample collector provided by the present invention.

[0043] FIG13 is a cross-sectional view of the sample collector provided by the present invention.

[0044] FIG14 is an enlarged view of the structure at point A in FIG1 .

[0045] FIG15 is a three-dimensional view of the top cover provided by the present invention.

[0046] FIG16 is a schematic structural diagram of the sample collector, the top cover, and the sample collection chamber provided by the present invention.

[0047] FIG17 is a schematic diagram of the structure of the top cover and the sample collection chamber provided by the present invention.

[0048] FIG18 is a schematic structural diagram of the sample collection chamber provided by the present invention.

[0049] Among them, 1-sample collection chamber, 11-outer cylinder, 12-inner cylinder, 121-filter window, 122-upper cylinder, 123-lower cylinder, 124-limiting groove, 125-support seat, 126-upper guide surface, 127-lower guide surface, 13-isolation seat, 131-sample outflow port, 14-test paper, 15-top cover, 16-perforation, 161-hole body, 17-notch groove, 18-stop protrusion, 181-arc surface, 2-sample collector, 21-handle part, 211-anti-slip ridge, 22-main body, 221 -transition section, 222 -seal, 223 -sealing layer, 23 -sample absorbing portion, 231 -trough body, 24 -lug, 25 -positioning card portion, 251 -arc-shaped surface, 26 -rotating channel, 261 -air hole, 262 -recessed groove, 3 -expansion indicator, 31 -outer annular space, 4 -elastic sleeve, 41 -channel, 42 -communication window, 43 -inner cavity. DETAILED DESCRIPTION

[0050] In order to enable those skilled in the art to better understand the solutions of the present invention, the following will provide a clear and complete description of the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts should fall within the scope of protection of the present invention.

[0051] Based on the universality and representativeness of saliva testing, the present invention will be described in detail below using saliva testing as an example, but this does not mean that the present invention is limited to saliva testing devices.

[0052] As shown in Figure 1, a sample collection and detection device includes a sample collection chamber 1 and a sample collector 2. The sample collector 2 is used to obtain the sample to be tested, specifically to absorb saliva. A test paper 14 is placed in the sample collection chamber 1. After the sample collector 2 obtains the sample to be tested, it is inserted into the sample collection chamber 1. After the sample is squeezed and stressed, it is discharged toward the test paper 14 to complete the sample detection.

[0053] As shown in Figure 3, the sample collector 2 includes at least a handle 21, a main body 22, and a sample absorbing portion 23. As shown in Figures 2 and 4 to 10, the sample collecting chamber 1 includes an outer cylinder 11, an inner cylinder 12 into which at least a portion of the sample collector 2 extends, an isolation chamber 13 located between the outer cylinder 11 and the inner cylinder 12, and a test paper 14. The inner cylinder 12 has a filter window 121, and the isolation seat 13 has a sample outflow port 131, which is offset from the filter window 121. The test paper 14 is located downstream of the sample outflow port 131. Therefore, after the sample is squeezed out of the sample absorbing portion 23 and passes through the filter window 121, it flows from the sample outflow port 131 to the test paper 14 under the restriction of the isolation seat 13, thereby achieving the purpose of sample detection.

[0054] In the present invention, the sample discharged from the sample absorption portion 23 after being squeezed does not flow directly to or be forcefully sprayed toward the test paper 14. Instead, it first passes through the liquid flow channel formed by the collector 2, the inner cylinder 12, the filter window 121, and the isolation seat 13, effectively preventing the sample from being squeezed and generating a large amount of foam. The flow path of the sample after being generated includes four paths from the squeezed discharge filter window 121 and three paths from the filter window 121 to the sample outlet 131 after being discharged. Finally, it flows to the test paper 14 through the sample outlet 131, so that the sample can eventually slowly run upward from the bottom of the test paper 14. The test paper 14 has higher sensitivity and more accurate test results. In addition, less foam generation also improves the fluidity of the sample, preventing foam from entering the flow channel and hindering the sample liquid from running smoothly from the bottom of the test paper 14 to the top of the test paper, thereby avoiding false negative or false positive results.

[0055] Specifically, as shown in Figure 9, the four paths for the sample to be squeezed out include: the first path ① is to be discharged directly through the filter window 121, the second path ② is to flow upward from the lower point of the filter window 121 and then to be discharged outward through the filter window 121, the third path ③ is to flow to the filter window 121 through the channel formed by the transition section 221 and the inner wall of the inner cylinder 12 and then to be discharged outward through the filter window 121, and the fourth path ④ is to flow upward from the lower point far away from the filter window 121 (referring to another low point corresponding to the above-mentioned low point) and then flow to the filter window 121 through the channel formed by the transition section 221 and the inner wall of the inner cylinder 12 and then to be discharged outward through the filter window 121.

[0056] The three paths of the sample after being discharged from the filter window 121 include: the first path is to directly pass through the drainage of the upper guide surface 126 and the lower guide surface 127, and flow steadily downward to the space between the inner cylinder 12 and the isolation seat 13; the second path is to pass through the obstruction of the isolation seat 13, and flow downward along the inner wall of the isolation seat 13 to the space between the inner cylinder 12 and the isolation seat 13; the third path is to return to the outside of the inner cylinder 12 after being blocked by the isolation seat 13, and flow downward through the drainage of the upper guide surface 126 and the lower guide surface 127 to the space between the inner cylinder 12 and the isolation seat 13.

[0057] In this embodiment, the two side walls of the outer cylinder 11 are relatively parallel, while the other two side walls are curved and convex outward. The test strip 14 is located on opposite sides of the outer cylinder 11, specifically on opposite sides of the parallel side walls of the outer cylinder 11. As shown in Figure 4, the isolation seat 13 comprises two opposing curved walls, with the sample outlet 131 formed between adjacent isolation seats 13. The sample outlet 131 is positioned opposite the test strip 14. In this embodiment, there are two isolation seats 13 and two sample outlets 131. However, in other embodiments, any number of isolation seats 13 and sample outlets 131 is possible, without limitation.

[0058] Of course, as shown in FIG5 , the test paper 14 can also be set on the back side of the isolation seat 13 away from the collector 2; or, the test paper 14 can also be set on the curved side wall of the outer cylinder 11; in this case, the test paper 14 is not directly opposite to the sample outflow port 131, or is completely misaligned.

[0059] As shown in Figures 7 and 8, the filter window 121 is arranged opposite to the isolation seat 13, and the isolation seat 13 completely blocks the filter window 121 in the height direction. In other words, the sample discharged from the filter window 121 will be blocked by the isolation seat 13 and will not be directly sprayed toward the test paper 14. In this embodiment, there are two filter windows 121 and two sample outlets 131, which are evenly spaced along the circumference. In other words, the central angle between the filter window 121 and the sample outlet 131 is 90°. In a more preferred embodiment, there is one filter window 121. In this way, the sample is discharged from only one filter window 121, and the sample obtains a greater initial force and higher fluidity. Correspondingly, there is also one isolation seat 13.

[0060] In order to ensure that the sample squeezed out by the sample absorbing part 23 can quantitatively pass through the filter window 121, the top surface of the sample absorbing part 23 is flush with the lower part of the filter window 121 after being squeezed downward, or the top surface of the sample absorbing part 23 is located below the higher part of the filter window 121 after being squeezed downward.

[0061] When the sample absorbing portion 23 is squeezed downward by force, the top surface is flush with the lower part of the filter window 121. Here, it means that the sample absorbing portion 23 has been compressed to the limit state. Then, part of the sample discharged after the sample absorbing portion 23 is squeezed downward is discharged directly through the filter window 121, part of it flows upward from the lower part of the filter window 121 and then is discharged outward through the filter window 121, part of it flows to the filter window 121 through the channel formed by the transition section 221 and the inner wall of the inner cylinder 12 and then is discharged outward through the filter window 121, and part of it flows from the lower part far away from the filter window 121 (referring to another lower part corresponding to the above-mentioned lower part). The sample is squeezed out of the sample collecting chamber 1 and discharged outwardly through the filter window 121. Finally, no sample is accumulated in the space formed by the transition section 221 and the inner wall of the inner cylinder 12, ensuring that the amount of sample extruded and discharged is the set amount, and the amount of sample flowing to the test paper 14 is relatively constant. In other words, the sample is completely squeezed out and quantitatively discharged as long as the sample collector 2 is squeezed downward relative to the sample collecting chamber 1. Even if the sample collecting chamber 1 and the sample collector 2 rotate relative to each other during the locking process, the discharge amount of the sample will not increase.

[0062] Similarly, when the sample absorbing portion 23 is squeezed downward by force, the top surface is located below the high point of the filter window 121. Here, it means that the sample absorbing portion 23 has been compressed to the limit state. Then, a part of the sample discharged after the sample absorbing portion 23 is squeezed downward is directly discharged outward through the filter window 121, a part flows upward from the low point of the filter window 121 and then is discharged outward through the filter window 121, a part flows to the filter window 121 through the channel formed by the transition section 221 and the inner wall of the inner cylinder 12 and then is discharged outward through the filter window 121, and a part flows upward from the low point of the filter window 12 (referring to another low point corresponding to the above-mentioned low point) and then flows to the filter window 121 through the channel formed by the transition section 221 and the inner wall of the inner cylinder 12 and then is discharged outward through the filter window 121. Finally, no sample will accumulate in the space formed by the transition section 221 and the inner wall of the inner cylinder 12, ensuring that the amount squeezed and discharged is the set amount, and the amount of sample flowing to the test paper 14 is relatively constant.

[0063] When the sample absorbing portion 23 is squeezed downward and its top surface is located below the filter window 121, sample will accumulate in the space below the filter window 121. During the rotation of the sample collector 2 relative to the sample collecting chamber 1, the sample below the filter window 121 will be stirred, causing the sample accumulated below the filter window 121 to be forced to be discharged toward the filter window 121, resulting in the inability to achieve quantitative discharge of the sample.

[0064] As shown in FIG3 , the outer wall of the main body 22 of the sample collector 2 is provided with a seal 222, which seals with the inner cylinder 12 to prevent the sample from being discharged from the upper portion. The seal 222 has a certain elasticity and can cause frictional interference with the inner wall of the inner cylinder 12 during the insertion of the sample collector 2 into the inner cylinder 12, thereby achieving a certain sealing effect. Furthermore, there is a space between the seal 222 and the sample absorbing portion 23, which facilitates the flow of the sample through this space to the filter window 121. Furthermore, the horizontal height of the sample outflow port 131 is lower than the horizontal height of the filter window 121. That is, after passing through the filter window 121, the sample does not flow directly through the sample outflow port 131 to the test paper 14. Instead, it first flows downward to the space between the inner cylinder 12 and the isolation seat 13, and then flows through the sample outflow port 131 to the bottom of the test paper 14. In other words, the sample extruded by squeezing is absorbed by the test paper 14 only after flowing through a longer path. Even if a small amount of foam is generated, the flow rate of the foam is slower than that of the liquid, which can effectively avoid the interference of the foam on the detection and ensure the high sensitivity and accuracy of the test paper 14.

[0065] The inner cylinder 12 includes an upper cylinder portion 122 and a lower cylinder portion 123. The bottom of the upper cylinder portion 122 is closed and has a limiting groove 124. The lower cylinder portion 123 is fixedly connected to the outer cylinder 11 and has a support seat 125. The support seat 125 can be positioned and snapped into the limiting groove 124. In other words, when the upper cylinder portion 122 is downwardly assembled into the outer cylinder 11, when the support seat 125 falls into the limiting groove 124, the two can form a radial limit, ensuring the concentric and coaxial assembly of the upper and lower cylinder portions 122, 123.

[0066] An upper guide surface 126 is formed on the outer wall of the bottom of the upper cylinder 122, extending obliquely from top to bottom and from outside to inside. A lower guide surface 127 is formed on the outer wall of the lower cylinder 123, extending obliquely from top to bottom and from inside to outside. The filter window 121 is located above the upper guide surface 126 of the upper cylinder 122. As shown in Figure 8, after the sample is discharged from the filter window 121, a portion of it directly passes through the upper guide surface 126 and the lower guide surface 127, steadily flowing downward to the space between the inner cylinder 12 and the isolation seat 13; a portion of it passes through the isolation seat 13 and flows downward along the inner wall of the isolation seat 13 to the space between the inner cylinder 12 and the isolation seat 13; and a portion of it passes through the isolation seat 13 and returns to the outside of the inner cylinder 12, then passes through the upper guide surface 126 and the lower guide surface 127 and flows downward to the space between the inner cylinder 12 and the isolation seat 13. The outer wall of the lower cylinder 123 forms an inclined surface, which not only serves to drain the sample, but also reduces the transverse cross-section between the lower cylinder 123 and the isolation seat 13, thereby facilitating the rapid and concentrated flow of the sample to the sample outlet 131.

[0067] In order to intuitively determine whether the sample collector 2 absorbs a sufficient amount of sample, a transition section 221 is provided on the main body 22. The outer wall of the transition section 221 is made of transparent material, and an expansion indicator 3 is provided inside it. Part of the expansion indicator 3 is inserted into the sample absorbing part 23, that is, part of the expansion indicator 3 is in contact with the sample absorbing part 23, so that the sample in the sample absorbing part 23 can be transferred to the expansion indicator 3, so that the volume of the expansion indicator 3 changes, and the more sample the expansion indicator 3 absorbs, the larger its volume becomes. Through the outer wall of the transition section 221, it can be intuitively judged whether the sample absorbing part 23 has absorbed a sufficient amount of sample according to whether the volume of the expansion indicator 3 reaches the preset target.

[0068] Specifically, in this embodiment, the sample absorbing portion 23 is cylindrical, with a concentric and coaxial groove 231 formed at its top. The expansion indicator 3 is tightly inserted into the groove 231. In other embodiments, the expansion indicator 3 can be attached to any position on the top of the sample absorbing portion 23, or connected to the top of the sample absorbing portion 23 via other adapters. This is not a limitation.

[0069] As shown in Figures 12 and 13, the outer periphery of the main body 22 is provided with an elastic sleeve 4 made of an elastic material. The elastic sleeve 4 cooperates with the outer wall of the main body 22 to form an inner cavity 43 with a variable internal space. A communication window 42 is formed on the outer wall of the main body 22 at a position corresponding to the elastic sleeve 4. The elastic sleeve 4 is located above the level of the transition section 221, and a channel 41 is defined at the top of the transition section 221. The inner cavity 43 is connected to the interior of the transition section 221 through the communication window 42 and the channel 41. Of course, in other embodiments, the channel 41 can be located elsewhere than at the top of the transition section 221, and the specific location is not limited.

[0070] When sampling using the sample collector, the elastic sleeve 4 is first compressed so that the gas in its inner cavity 43 is discharged in sequence through the connecting window 42, the channel 41, the transition section 221, and the sample absorbing portion 23; the sample absorbing portion 23 is then placed in the oral cavity to absorb the saliva sample. As the saliva sample fills the sample absorbing portion 23, the airways inside the sample absorbing portion 23 are closed. That is, when the sample absorbing portion 23 does not absorb the saliva sample, it has criss-crossing airways inside. These airways exist due to the characteristics of the material of the sample absorbing portion 23, such as a sponge. After the sample absorbing portion 23 absorbs the saliva sample, the airways are closed due to the presence of the saliva sample; the external force compressing the elastic sleeve 4 is stopped. At this time, the inner cavity 43 is in a negative pressure state, that is, the elastic sleeve 4 enters a negative pressure state. Under its influence, the interior of the transition section 221 can also enter a negative pressure state. This negative pressure state can assist the sample absorbing portion 23 in absorbing the saliva sample and accelerate its absorption of a sufficient amount of saliva sample.

[0071] To ensure that the elastic sleeve 4 can enter a negative pressure state, a sealing layer 223 is provided within the main body 22, above the communication window 42. This sealing layer 223 isolates the spaces above and below it. Furthermore, the main body 22 is designed with a reduced diameter section at the location of the sealing layer 223. This design not only allows the elastic sleeve 4 to be installed without increasing the volume of the sample collector, but also reduces the space below the sealing layer 223, facilitating the elastic sleeve 4 to quickly enter a negative pressure state. The specific location of the sealing layer 223 is not limited. It can be located within the handle 21 of the sample collector 2 to form a top seal, within the main body 22 to form a seal, or in other structures that isolate the communication window 42 from below. Specifically, in this embodiment, the closer the sealing layer 223 is to the communication window 42, the better the performance. Positioning the elastic sleeve 4 close to the handle 21 also facilitates operation and provides a better user experience.

[0072] A channel 41 is defined at the top of the transition section 221. This channel 41 can be one, two, or more. A communication window 42 is positioned above and adjacent to the channel 41. In this embodiment, two channels 41 are radially symmetrically arranged, corresponding to the outer annular space 31 of the expansion indicator 3 when no sample is being absorbed. This ensures that during negative pressure adsorption of the sample, the circumferential pressure of the sample absorption portion 23 is relatively balanced, resulting in relatively uniform absorption of the sample.

[0073] To intuitively determine whether the expansion indicator 3 has expanded to its target volume, a graduated area can be provided on the sidewall of the transition section 221. Once the expansion height reaches the target scale, the expansion indicator 3 is deemed to have absorbed a sufficient amount of sample, and an indicator line in the graduated area indicates that the expansion indicator 3 has reached the predetermined expansion position. Alternatively, sufficient sample absorption can be determined by the expansion indicator 3 expanding to abut against the top surface. The transition section 221 can be entirely or partially transparent. Specifically, the transition section 221 can be transparent only at its highest point of expansion. This means that the expansion indicator 3 is visible only through the transparent portion when the expansion reaches the desired volume, and the transparent portion serves as the indicator line.

[0074] In this embodiment, the material of the expansion indicator 3 is plant fiber, or the material of the expansion indicator 3 is pure cotton, or can be sponge, water-absorbing rubber strips, water-absorbing resin, polyester fiber, terylene fiber, etc.

[0075] As shown in Figures 15 and 18 , sample collection chamber 1 has a top cover 15 with a perforation 16 extending through the thickness of top cover 15. As shown in Figures 14 and 16 , sample collector 2 has a lug 24. After partially extending into perforation 16 and rotating, lug 24 engages with top cover 15 to seal perforation 16. This allows sample collector 2 to maintain a tight seal against perforation 16, while maintaining a relative rotation angle of 45° or less between sample collector 2 and sample collection chamber 1.

[0076] Specifically, the lug 24 is located on the outer wall of the main body 22. As shown in Figure 15, the through-hole 16 includes a hole body 161 and a notched slot 17. The inner diameter of the hole body 161 is comparable to, but not identical to, the outer diameter of the main body 22. In other words, the hole body 161 should be able to accommodate the main body 22 but not be identical to the outer diameter of the main body 22. The notched slot 17 is adapted to the lug 24. In other words, the lug 24 extends into the through-hole 16 through the notched slot 17, and the size and shape of the lug 24 and the notched slot 17 are adapted. Of course, in other embodiments, the notched slot 17 can be larger than the lug 24.

[0077] To ensure that the sample collector 2 seals the perforation 16, the outer diameter of the handle 21 is greater than or equal to the outer diameter of the outer ring of the notch 17. Furthermore, the spacing between the lug 24 and the handle 21 is comparable to, and can be the same as, the thickness of the top cover 15. In other words, when the upper surface of the lug 24 abuts against the lower surface of the top cover 15 to form a retaining fit, this retaining fit prevents the sample collector 2 from axially separating from the sample collection chamber 1. At this point, the lower surface of the handle 21 also abuts against the upper surface of the top cover 15, preventing the gap between the handle 21 and the top cover 15 from causing the sample in the sample collection chamber 1 to leak out.

[0078] As shown in FIG14 , a lug 24 extends radially outward from the outer wall of the main body 22. A positioning latch 25 is provided radially outward of the lug 24. Accordingly, as shown in FIG16 and FIG17 , the sample collection chamber 1 includes a rotation-stopping protrusion 18. When the sample collector 2 rotates, the positioning latch 25 passes over the rotation-stopping protrusion 18, thereby preventing the sample collector 2 from rotating in the opposite direction and easily detaching from the sample collection chamber 1. To reduce the rotation angle of the sample collector 2 relative to the sample collection chamber 1, the rotation-stopping protrusion 18 can be positioned closer to the notch 17.

[0079] To facilitate the positioning clamp 25's passage over the anti-rotation protrusion 18, ensuring ease of operation and the stability of the reverse anti-rotation structure, the outer wall of the positioning clamp 25 has a curved surface 251, and the outer wall of the anti-rotation protrusion 18 also has a curved surface 181. The curved surface 251 and the curved surface 181 cooperate to ensure stable positioning. When the positioning clamp 25 passes over the anti-rotation protrusion 18, the angle formed by the curved surface 251 on one side that cooperates with the anti-rotation protrusion 18 is acute and smaller than the angle formed on the other side. This means that compared to the clamping seal, greater force is required to rotate and disengage.

[0080] In order to facilitate the rotation of the sample collector 2 relative to the sample collecting chamber 1 , an anti-slip ridge 211 is provided on the outer wall of the handle portion 21 .

[0081] The number of lugs 24 can be one or two or more. In order to ensure the structural stability of the sample collecting chamber 1 and the sample collector 2 after assembly, and also to ensure the sealing performance of both, in this embodiment, the number of lugs 24 is two, which are symmetrically arranged on both radial sides of the main body 22.

[0082] To limit the rotation angle of sample collector 2, sample collection chamber 1 includes a rotation channel 26 within which lug 24 can rotate. When lug 24 abuts against the end wall of rotation channel 26, lug 24 is unable to rotate further, thus achieving a position limit. The aforementioned anti-rotation protrusion 18 is located within rotation channel 26 and is specifically formed by protruding from the outer sidewall of rotation channel 26.

[0083] Specifically, as shown in Figures 17 and 18, the sample collecting chamber 1 includes an outer cylinder 11 and an inner cylinder 12. A recessed groove 262 is formed on the top of the inner cylinder 12. The recessed groove 262 cooperates with the top cover 15 to form a rotating channel 26 with an open inner side.

[0084] To allow the sample collector 2 to expel air from the inner and outer cylinders 12 and 11 when the inner cylinder 12 moves downward, an air hole 261 is defined within the recessed groove 262, i.e., within the rotating channel 26. When the lug 24 engages with the top cover 15, i.e., when the sample collector 2 seals the perforation 16, the lug 24 also blocks the air hole 261, assisting in achieving a seal.

[0085] The use and coordination process of the sample collection chamber 1 and the sample collector 2 is as follows: the sample collector 2 with the sample such as saliva is inserted into the through-hole 16, the lug 24 is opposite to the notch 17 of the through-hole 16, and the sample collector 2 moves downward so that the lug 24 enters the rotating channel 26. At this time, the gas in the inner cylinder 12 and the outer cylinder 11 is discharged outward through the air hole 261, the rotating channel 26, and the through-hole 16; when the sample collector 2 can no longer move downward, that is, the lower surface of the hand-held part 21 abuts against the upper surface of the top cover 15, an external force is applied to the hand-held part 21 to rotate the sample collector 2 clockwise, and the lug 24 moves in the rotating channel 26. The positioning card part 25 of the lug 24 passes over the anti-rotation protrusion 18. At this time, the operator will be given an obvious tactile prompt, prompting the operator to complete the assembly of the sample collector 2 and the sample collection chamber 1, and the rotation is less than or equal to 45°. At the same time, the lug 24 also blocks the air hole 261. When the sample collector 2 and the sample collecting chamber 1 need to be separated, a greater external force than the clockwise rotation needs to be applied to the handheld portion 21 to rotate it in the reverse direction.

[0086] As the sample collector 2 and the sample collecting chamber 1 move relative to each other, the sample is squeezed out from the sample absorbing portion 23 , and the sample undergoes chromatography reaction on the test paper in the sample collecting chamber 1 .

[0087] A method for operating a sample collection and detection device comprises the following steps:

[0088] S1. The sample collector is rotated relative to the sample collection chamber and then removed from the sample collection chamber. Specifically, the sample collector may be rotated 45° counterclockwise relative to the sample collection chamber, thereby breaking the seal between the sample collector and the sample collection chamber, allowing the sample collection chamber to communicate with the outside world, and allowing the sample collector to be easily removed from the sample collection chamber.

[0089] S2. Place the sample collector into the oral cavity to absorb the sample, and observe whether a sufficient amount of sample is absorbed. Furthermore, the expansion indicator in the transition section of the sample collector expands to a set size after absorbing the sample. Specifically, the sample absorption part can be judged to have absorbed a sufficient amount of sample based on the scale area or whether the expansion indicator fills the transition section in the height direction. Furthermore, first compress the elastic sleeve on the periphery of the main body so that the gas in its inner cavity is discharged through the connecting window, channel, transition section, and sample absorption part in sequence, and then place the sample collector into the oral cavity to absorb the sample. After a period of time, stop applying the external force of compressing the elastic sleeve and observe whether the expansion indicator in the transition section of the sample collector expands to a set size after absorbing the sample, so as to determine whether a sufficient amount of sample is absorbed.

[0090] S3. Insert the sample collector after aspirating the sample into the sample collection chamber and press down on the sample absorption portion. This transitions the sample absorption portion from a first state to a second state. In the first state, the sample absorption portion blocks the filter window, preventing sample from exiting the filter window. In the second state, the sample absorption portion presses from the upper portion of the filter window toward the lower portion, forcing the sample to exit through the filter window. Specifically, the lugs on the outer wall of the sample collector pass through the perforations in the sample collection chamber's top cover and enter the rotating channel.

[0091] S4. The sample discharged from the sample absorption section flows sequentially through the filter window and the sample outlet toward the test strip. Specifically, there are four transmission paths for sample extrusion: the first is direct discharge through the filter window; the second is upward flow from the lower point of the filter window and then out through the filter window; the third is flow through the channel formed by the transition section and the inner wall of the inner cylinder toward the filter window and then out through the filter window; the fourth is flow upward from the lower point of the filter window (referring to the other lower point corresponding to the lower point at the far end) and then through the channel formed by the transition section and the inner wall of the inner cylinder toward the filter window and then out through the filter window. Specifically, after the sample is discharged from the filter window, there are three transmission paths: the first is direct flow through the upper and lower guide surfaces, steadily flowing downward to the space between the inner cylinder and the isolation seat; the second is blocked by the isolation seat and flowing downward along the inner wall of the isolation seat to the space between the inner cylinder and the isolation seat; the third is blocked by the isolation seat and then returned to the outside of the inner cylinder, flowing downward through the upper and lower guide surfaces to the space between the inner cylinder and the isolation seat.

[0092] S5. The sample collector is rotated relative to the sample collection chamber until it is locked, with the rotation angle being less than or equal to 45°. After pressing down, the sample collector is rotated relative to the sample collection chamber until the positioning latch on the lug passes over the anti-rotation protrusion in the rotation channel. A rotation angle of less than or equal to 45° prevents shear forces from causing additional impact on the sample absorbing portion, which could lead to inaccurate quantitative measurements.

[0093] S5. Wait for a certain period of time, and the test paper will display the test results. During the waiting process, the sample contacts the end of the test paper and reacts with the components in the test paper through chromatography.

[0094] The above specific embodiments are used to illustrate the present invention rather than to limit the present invention. Any modifications and changes made to the present invention within the spirit of the present invention and the protection scope of the claims shall fall within the protection scope of the present invention.

Claims

1. A sample collection and detection device, comprising a sample collection chamber (1) and a sample collector (2), characterized in that: The sample collector (2) comprises a handheld portion (21), a main body (22) and a sample absorbing portion (23); the sample collecting chamber (1) comprises an outer cylinder (11), an inner cylinder (12), an isolation seat (13) and a test paper (14); The inner cylinder (12) is provided with a filter window (121) for the sample collector (2) to at least partially extend therein; the isolation seat (13) is located between the outer cylinder (11) and the inner cylinder (12) and has a sample outlet (131), and the sample outlet (131) is arranged in a staggered manner with respect to the filter window (121); When the sample absorbing portion (23) is in a first state relative to the filter window (121), the sample absorbing portion (23) blocks the filter window (121), and no sample is discharged from the filter window (121); when the sample absorbing portion (23) is in a second state relative to the filter window (121), the sample absorbing portion (23) presses from a high position to a low position of the filter window (121), the sample is pressed and discharged through the filter window (121), and then guided through the sample outflow port (131) to flow in the direction of the test paper (14).

2. The sample collection and detection device according to claim 1, characterized in that: The test paper (14) is located on two opposite sides of the outer cylinder (11), and the sample flow outlet (131) is arranged opposite to the test paper (14); or, the test paper (14) is located on the back side of the isolation seat (13), and the sample flow outlet (131) is not arranged opposite to the test paper (14).

3. The sample collection and detection device according to claim 1 or 2, characterized in that: The filter window (121) is arranged opposite to the isolation seat (13), and the isolation seat (13) completely blocks the filter window (121) in the height direction.

4. The sample collection and detection device according to claim 1, characterized in that: After the sample absorbing portion (23) is pressed downward, its top surface is flush with the lower part of the filter window (121), or, after the sample absorbing portion (23) is pressed downward, its top surface is located below the higher part of the filter window (121), so that the sample extruded and discharged flows through the filter window (121); the horizontal height of the sample outflow port (131) is less than the horizontal height of the filter window (121).

5. The sample collection and detection device according to claim 1, 2 or 4, characterized in that: The sample discharged after being squeezed by the sample absorbing portion (23) flows upward through the filter window (121), then flows downward to the space between the isolation seat (13) and the inner cylinder (12), and finally flows to the bottom of the test paper (14) through the sample outflow port (131).

6. The sample collection and detection device according to claim 1, 2 or 4, characterized in that: The sample collecting chamber (1) has a top cover with a perforation (16), and the sample collector (2) has a lug (24). A portion of the sample collector (2) extends into the perforation (16) and then rotates. The lug (24) can cooperate with the top cover (15) to achieve sealing of the perforation (16) by the sample collector (2), and a relative rotation angle between the sample collector (2) and the sample collecting chamber (1) is less than or equal to 45°.

7. The sample collection and detection device according to claim 1, 2 or 4, characterized in that: The inner cylinder (12) comprises an upper cylinder portion (122) and a lower cylinder portion (123); the upper cylinder portion (122) has a closed bottom and is provided with a limiting groove (124); and the lower cylinder portion (123) has a support seat (125) that can be positioned and snapped into the limiting groove (124).

8. The sample collection and detection device according to claim 7, characterized in that: The filter window (121) is located on the upper cylinder portion (122); the outer wall of the bottom of the upper cylinder portion (122) forms an upper guide surface (126); and the outer wall of the lower cylinder portion (123) forms a lower guide surface (127).

9. The sample collection and detection device according to claim 1, 2 or 4, characterized in that: The number of the filter windows (121) is at most two, and they are evenly spaced apart along the circumferential direction.

10. The sample collection and detection device according to claim 1, 2 or 4, characterized in that: The main body (22) has a transition section (221), and an expansion indicator (3) is arranged in the transition section (221). The expansion indicator (3) is in contact with the sample absorbing section (23), and the volume changes after absorbing the sample; the side wall of the transition section (221) has an indicator line.

11. The sample collection and detection device according to claim 1 or 4, characterized in that: The outer wall of the main body (22) is provided with a sealing member (222) which is in sealing cooperation with the inner cylinder (12).

12. A method for operating a sample collection and detection device, characterized in that: The following steps are involved: S1, the sample collector rotates relative to the sample collecting chamber and then leaves the sample collecting chamber; S2, the sample collector absorbs the sample and observes whether a sufficient amount of sample is absorbed; S3, inserting the sample collector after absorbing the sample into the sample collection chamber, and pressing down the sample absorbing part; S4, the sample discharged from the sample absorption part flows toward the test paper through the filter window and the sample outlet in sequence; S5. The sample collector is rotated relative to the sample collection chamber to a locked state, and the rotation angle is less than or equal to 45°; S6. The test paper displays the test result.

13. The operating method according to claim 12, characterized in that: In step S2, the expansion indicator in the transition section of the sample collector expands to a set size after absorbing the sample, so as to determine that the sample absorbing part has absorbed a sufficient amount of the sample.

14. The operating method according to claim 12, characterized in that: In step S4, part of the sample in the sample absorbing part is squeezed and discharged directly from the filter window; part of the sample in the sample absorbing part is squeezed and enters between the outer wall of the main body and the inner wall of the inner cylinder, and then discharged through the filter window.

15. The operating method according to claim 14, characterized in that: In the step S4, the sample discharged from the filter window flows downward directly from the filter window, or flows downward after being blocked by the isolation seat.

16. The operating method according to claim 12, characterized in that: In S3, the lug on the outer wall of the sample collector passes over the perforation of the top cover of the sample collecting chamber and enters the rotating channel. After the sample collector is pressed down, it rotates relative to the sample collecting chamber until the positioning clamp on the lug rotates over the anti-rotation protrusion in the rotating channel.

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