Device for detecting analyte in sample

Abstract

The present invention provides a device for detecting an analyte in a liquid sample, including: a sample chamber for accommodating a collector, where a through-hole is disposed between the sample chamber and a testing chamber, the through-hole is covered with an elastic element, and increased air pressure in an interior of the sample chamber causes the elastic element to open the through-hole, so that the testing chamber is in fluid communication with the sample chamber.

Description

DEVICE FOR DETECTING ANALYTE IN SAMPLECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to US prior provisional application No. 63 / 667,864 filed on July 5, 2024. The specification, drawings, claims and abstract of this application are incorporated by reference in their entirety as part of this application.BACKGROUND OF THE INVENTIONField of the Invention

[0002] The present invention relates to a device for collecting and detecting a liquid sample, and in particular, to a device for detecting an analyte in a liquid sample in the field of rapid diagnosis, such as a urine and saliva collection and detection device.Description of the Related Art

[0003] The following introduction to the related art is only an introduction to some background knowledge and shall not constitute any limitation to the present invention.

[0004] At present, detection devices for detecting whether a sample contains an analyte are widely used in hospitals or homes. These detection devices applied to rapid diagnosis include one or more detection reagent strips, for example, for early pregnancy detection, drug of abuse detection, etc. Such detection devices for rapid diagnosis are very convenient, and can obtain detection results from the detection reagent strips in one minute or at most ten minutes or so. Drug detection is widely applied in institutions such as drug control departments, public security bureaus, drug rehabilitation centers, physical examination centers, and physical examination offices of national conscription. The types of drug detection are diverse, and the frequency is high. Some require sample collection followed by testing in professional testing institutions or laboratories. Some need to be completed on-site in time, such as roadside testing. For example, persons who drive after drug use (referred to as "drug driving") need to undergo on-site testing to obtain timely detection results.

[0005] For example, the detection of saliva samples has been gradually accepted and welcomed by detection institutions or personnel due to the convenience in collection. Various specimen collection and testing devices for clinical or household use have been described in some literature. For instance: For example, US Patent No. 5,376,337 discloses a saliva sampling device in which apiece of filter paper is used for collecting saliva from the mouth of a subject and delivering the saliva to an indicator reagent. US patents US 5,576,009 and US 5,352,410 each disclose a syringe-type liquid sampling device. For another example, US patent application with the application number of 14 / 893,461 and the publication number of US2016 / 0121322A1 discloses a detection device for a sample; the patent only discloses some basic detection schemes and principles, and appears more difficult in the actual implementation of a specific product. For example, for how to compress the pipette tip for absorbing saliva and how to move it if the cover body combination is matched with the detection combination, as well as how to mix with liquids effectively, the practical effects are undesirable.

[0006] For example, US patent applications such as US2020 / 0141934A1, US7,879,623B1, US 10,564, 155B1, and US7,879,623B1 disclose that the collector is integrated with the testing chamber, but secondary confirmation cannot be performed. When secondary confirmation is required, two collectors are needed to collect samples, one for testing and the second for secondary confirmation, resulting in cumbersome operations. In addition, such operations are not easy to implement in some cases where a sample size is small, and are cumbersome especially for saliva samples.

[0007] For the technical problems of some of the above conventional products, there is therefore a need to improve them and provide another way to solve the deficiencies of the existing traditional technologies.BRIEF SUMMARY OF THE INVENTION

[0008] In view of the above situations, in order to overcome defects in the traditional technologies, an objective of the present invention is to provide a device for detecting an analyte in a liquid sample. The device can realize the initial detection of a liquid sample, and when detection needs to be performed and confirmed, the sample reserved in the secondary confirmation chamber of the sample chamber can be used for detection and confirmation. In this way, one sample collection can be used for two detections, one is the initial test, and the other is the secondary confirmation detection.

[0009] In an aspect, the present invention provides a device for detecting an analyte in a liquid sample, including: a sample chamber for accommodating a collector; a through-hole connecting an interior of the sample chamber with an outside atmospheric environment; and an elastic element having a first state and a second state, where when the elastic element is in the first state, the through-hole is sealed, and when the elastic element is in the second state, the through-hole is opened.

[0010] In some embodiments, a change in a state of the elastic element is caused by a pressure change between the interior of the sample chamber and the outside.

[0011] In some embodiments, when air pressure in the interior of the sample chamber is greater than outside air pressure, the pressure difference causes the elastic element to be in the second state; and when air pressure in the interior of the sample chamber is less than or equal to outside air pressure, the pressure difference causes the elastic element to be in the first state.

[0012] In some embodiments, when the through-hole is sealed, the sample chamber is not in fluid communication with the outside through the through-hole, and when the through-hole is opened, the interior of the sample chamber can be in fluid communication with the outside. The fluid here can be a gas or a liquid. In some embodiments, when the through-hole is opened, a liquid in the interior of the sample chamber can flow out of the sample chamber through the through-hole. In some embodiments, a liquid flowing out of the sample chamber can come into contact with a testing element to assay the analyte in the liquid. In some embodiments, the liquid is a liquid sample.

[0013] In some embodiments, pressure is generated by compressing gas in a sealed space of the sample chamber, so as to form a pressure difference between the sample chamber and the outside. The sealed space is formed by inserting the collector into the sample chamber. In some embodiments, after the collector forms the sealed space, a volume of the sealed space is reduced, and the gas is compressed to increase the pressure in the sealed space. In some embodiments, the sealed space is in communication with the external atmospheric environment through the through-hole. In some embodiments, the sealed space contains a liquid sample, and when the sealed space is compressed, the liquid sample can flow out of the sample chamber through an opened through-hole.

[0014] In some embodiments, the liquid sample is derived from a liquid sample released by compressing the collector. In some embodiments, when the collector is inserted into the sample chamber, an absorbent element of the collector is compressed to release a liquid into the sealed space either simultaneously with or after formation of the sealed space.

[0015] In some embodiments, the sealed space is provided with a secondary confirmation chamber, and the released liquid first enters the secondary confirmation chamber. When the sealed space is compressed, an excess liquid in the secondary confirmation chamber flows out through the through-hole.

[0016] In some embodiments, the through-hole is located downstream of the secondary confirmation chamber, or a distance between the secondary confirmation chamber and the absorbent element of the collector is greater than a distance between the through-hole and theabsorbent element. In this way, the liquid released by compressing the absorbent element first flows into the secondary confirmation chamber, and the excess liquid can flow out of the sample chamber through the through-hole.

[0017] In some embodiments, the through-hole is located on a wall of the sample chamber, a recess is provided on the wall, and the through-hole is located within the recess. In some embodiments, the elastic element covers a periphery of the recess to seal the through-hole. In some embodiments, the recess is surrounded by an outer wall surface of the sample chamber, and the elastic element covers the outer wall surface. In some embodiments, a drainage channel is provided downstream of the through-hole, with a portion of the outer wall surface disposed between the drainage channel and the recess, and the elastic element covers the outer wall surface. This forms a valve-like structure. In an initial state, the elastic element covers the recess and the outer wall surface around the recess, thereby sealing the through-hole. When the pressure in the interior of the sample chamber increases, an excess gas is discharged from the through-hole under increased pressure. Discharged gas causes the elastic element covering the recess to protrude outward. During protrusion, a portion of the elastic element covering the portion of the outer wall surface between the drainage channel and the recess moves away from the surface, allowing the gas to discharge. Certainly, as the air pressure in the interior of the sample chamber continues to increase, if there is an excess liquid remaining in the secondary confirmation chamber within the sample chamber, the excess liquid is discharged through the valve structure and flows out along the drainage channel. A flowed-out liquid sample can then be used for testing or assay.

[0018] In some embodiments, to enable the absorbent element of the collector to be compressed, an extrusion element is disposed at an upper end of the secondary sample retention chamber. The extrusion element comes into contact with the absorbent element of the collector, thereby compressing the absorbent element to release the liquid sample into the secondary sample retention chamber. In some embodiments, it is ensured that the secondary sample retention chamber reserves sufficient samples for secondary confirmation testing.

[0019] In some embodiments, the collector is inserted into the sample chamber, and the sealed space is formed after the collector enters the sample chamber but before the absorbent element comes into contact with the extrusion element. In some embodiments, the collector is provided with an elastic sealing ring, and the elastic sealing ring cooperates with an inner wall of the sample chamber to form the sealed space. After the collector and the sample chamber form the sealed space, when the collector is further inserted into the sample chamber, the sealed space is compressed, causing the air pressure to rise, and an excess gas is discharged to the outsidethrough the through-hole. During or after a process of the absorbent element coming into contact with and being compressed by the extrusion element to release the liquid, the sealed space is still compressed to discharge a gas or an excess liquid through the through-hole for participation in the initial test.

[0020] In some embodiments, the device includes a testing chamber, and the testing chamber includes a testing element configured to detect the analyte in the liquid sample. The sample chamber and the testing chamber are in communication with each other through one through- hole.

[0021] In some embodiments, the first state of the elastic element includes the elastic element covering the through-hole for sealing. In some embodiments, the second state of the elastic element includes the elastic element moving away from the through-hole to keep the through-hole in an open state. In some embodiments, an increase in air pressure in the interior of the sample chamber causes the elastic element to be in the second state of moving away from the through- hole. In some embodiments, the increase in the air pressure in the interior of the sample chamber is caused by the collector entering the sample chamber. In some embodiments, the collector includes a liquid-absorbing element, and the liquid-absorbing element is configured to collect and absorb the liquid sample. In some embodiments, the liquid-absorbing element is inserted into the sample chamber and can be compressed to release the liquid sample. In some embodiments, the sample chamber is provided with a contact element for the absorbent element, and the element causes the absorbent element to be compressed. In some embodiments, a chamber for collecting the liquid sample is provided below the contact element, and a liquid in the chamber is used for a chamber as secondary confirmation. In some embodiments, a liquid outlet of the secondary confirmation chamber is lower than a position of the through-hole. In some embodiments, after the secondary confirmation chamber is filled with a liquid, an excess liquid flows out through the through-hole and enters the testing chamber. In some embodiments, the secondary confirmation chamber and the through-hole are both located in or in fluid communication with a space where air pressure increases. In some embodiments, the space where the air pressure increases includes the secondary assay confirmation chamber.

[0022] In a second aspect of the present invention, a device for detecting an analyte in a liquid sample is provided, including: a sample chamber for accommodating a collector, where the collector is configured to collect the liquid sample; a testing chamber including a testing element, where the testing element is configured to detect the analyte in the liquid sample; and a secondary confirmation chamber for collecting the liquid sample from the collector, where when thesecondary confirmation chamber is filled with a liquid, an excess liquid is forced into the testing chamber for initial testing of the analyte.

[0023] In some embodiments, the sample chamber is in fluid communication with the testing chamber through a through-hole. In some embodiments, the through-hole is covered with an elastic element, when the elastic element is in an initial first state, the through-hole is sealed, and when the elastic element is in a second state, the through-hole is opened. In some embodiments, the second state of the elastic element includes the elastic element moving away from the through-hole to keep the through-hole in an open state. In some embodiments, an increase in air pressure in an interior of the sample chamber causes the elastic element to be in the second state of moving away from the through-hole. In some embodiments, the increase in the air pressure in the interior of the sample chamber is caused by the collector entering the sample chamber. In some embodiments, the collector includes a liquid-absorbing element, and the liquid-absorbing element is configured to collect and absorb the liquid sample. In some embodiments, the liquidabsorbing element is inserted into the sample chamber and can be compressed to release the liquid sample. In some embodiments, a released liquid first flows into the secondary confirmation chamber. In some embodiments, the sample chamber is provided with an element coming into contact with the absorbent element, and the element causes the absorbent element to be compressed to release the liquid sample. In some embodiments, the secondary confirmation chamber is disposed below the contact element.

[0024] In some embodiments, the secondary confirmation chamber is located within the sample chamber, and the excess liquid in the secondary confirmation chamber is forced by increased air pressure in the sample chamber to flow into the testing chamber. In some embodiments, the increase in the air pressure in the interior of the sample chamber is caused by the collector being inserted into the sample chamber, thereby increasing air pressure in a space within the sample chamber. In some embodiments, the space with increased air pressure includes the secondary confirmation chamber. In some embodiments, a through-hole is provided between the sample chamber and the testing chamber, and the liquid flowing out of the secondary confirmation chamber flows into the testing chamber through the through-hole. In some embodiments, the through-hole is in fluid communication with a space where air pressure increases. In some embodiments, the through-hole is covered with an elastic element, when the elastic element is in an initial first state, the through-hole is sealed, and when the elastic element is in a second state, the through-hole is opened. In some embodiments, the second state of the elastic element includes the elastic element moving away from the through-hole to keep the through-hole in an open state. In some embodiments, an increase in air pressure in the interior of the sample chamber causes theelastic element to be in the second state of moving away from the through-hole, thereby forcing the liquid in the secondary confirmation chamber to flow into the testing chamber through the through-hole.

[0025] In some embodiments, the liquid sample is saliva, urine or blood.

[0026] In some embodiments, after the collector is inserted into the sample chamber, the collector and the sample chamber are in a locked state. The device further includes a locking element for keeping the collector in the locked state.

[0027] The present invention provides a method for detecting an analyte in a liquid sample, including: providing a sample chamber configured to receive a collector for sample collection, a through-hole connecting the sample chamber with the outside, and an elastic element covering the through-hole;

[0028] The elastic element has a first state and a second state. When the elastic element is in the first state, the through-hole is sealed by the elastic element; and when the elastic element is in the second state, the elastic element does not seal the through-hole, allowing the sample chamber to be in communication with the outside through the through-hole.

[0029] In some embodiments, a pressure difference is formed between the interior of the sample chamber and the outside, such that a change in the pressure difference alters a state of the elastic element sealing the through-hole. In some embodiments, pressure in the interior of the sample chamber is made greater than outside pressure, causing the elastic sealing ring to elastically deform and open the through-hole. When the pressure in the interior of the sample chamber is equal to or less than the outside pressure, the elastic element returns to its initial state and seals the through-hole. In some embodiments, the air pressure in the interior of the sample chamber is first made greater than the outside air pressure, so that an excess gas in the sample chamber is discharged through the through-hole. At this time, the elastic sealing ring deforms to open the through-hole. In some embodiments, as the pressure gradually increases, if there is an excess liquid in the sample chamber, the liquid is also discharged out of the sample chamber through the through-hole along with pressure release. If the liquid is a liquid sample, the liquid sample discharged out of the sample chamber can be used to test for the analyte.

[0030] In some embodiments, the collector is inserted into the sample chamber. During insertion of the collector, the pressure (air pressure or hydraulic pressure) in the interior of the sample chamber is made greater than the outside pressure, causing the elastic sealing ring to move away from the through-hole. The pressure causes a gas or a liquid in the sample chamber to be discharged out of the sample chamber.

[0031] In some embodiments, after the gas or the liquid is discharged, the pressure between the sample chamber and the outside is kept consistent or equal, and the elastic sealing ring returns to its initial state to seal the through-hole.

[0032] Beneficial effects

[0033] With the above structure, the initial test and secondary confirmation test for the analyte in the liquid sample can be realized. In particular, the sample for the secondary test is retained in the sample chamber and remains sealed during transportation, which maximizes the preservation of the properties of the secondary test sample. In some embodiments, the secondary confirmation sample chamber of the present invention is detachably combined with the testing chamber in the sample chamber. When a secondary test is required, the sample chamber is directly disassembled and sent to a secondary confirmation institution for testing.BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Fig. 1 A is a schematic diagram showing a principle structure design of the present invention according to a specific embodiment of the present invention (with an elastic element in an initial state).

[0035] Fig. IB is a schematic diagram showing a principle structure design of the present invention according to a specific embodiment of the present invention (with an elastic element opened, allowing a gas to discharge).

[0036] Fig. 1C is a schematic diagram showing a principle structure design of the present invention according to a specific embodiment of the present invention (with an elastic element opened, allowing a liquid to discharge).

[0037] Fig. 2 is a schematic diagram showing a three-dimensional structure of a sample chamber according to a specific embodiment of the present invention.

[0038] Fig. 3 is a schematic diagram showing a three-dimensional structure of a sample chamber according to a specific embodiment of the present invention.

[0039] Fig. 4 is a schematic diagram showing a longitudinal cross-sectional structure of a sample chamber according to a specific embodiment of the present invention (without an elastic element).

[0040] Fig. 5 is a partially enlarged schematic diagram of a sample chamber according to a specific embodiment of the present invention.

[0041] Fig. 6 is a partially enlarged schematic diagram showing a three-dimensional structure of a sample chamber according to a specific embodiment of the present invention (with a collector inserted into the sample chamber, lacking an elastic element).

[0042] Fig. 7 is a schematic diagram showing a cross-sectional structure of a collector being inserted into a sample chamber according to a specific embodiment of the present invention (lacking an elastic element).

[0043] Fig. 8 is a schematic diagram showing a three-dimensional structure of a collector being inserted into a sample chamber according to a specific embodiment of the present invention (lacking an elastic element).

[0044] Fig. 9A is a schematic diagram showing an external three-dimensional structure of a sample chamber according to a specific embodiment of the present invention (showing a partially enlarged view and a schematic diagram showing a structure of an elastic element being separated from a through-hole).

[0045] Fig. 9B is a schematic diagram showing an external three-dimensional structure of a sample chamber according to a specific embodiment of the present invention (showing a partially enlarged view and a schematic diagram showing a combined structure of an elastic element 408 covering a through-hole 304).

[0046] Fig. 10 is a schematic diagram showing a three-dimensional structure of a collector being inserted into a sample chamber and fixed therein according to a specific embodiment of the present invention (a state after a secondary confirmation chamber contains a liquid and an excess liquid is discharged out of the sample chamber through a through-hole).

[0047] Fig. 11 is a schematic diagram showing a three-dimensional structure of an elastic element provided on a sample chamber according to a specific embodiment of the present invention.

[0048] Fig. 12 is a schematic diagram showing a longitudinal cross-sectional structure of a three- dimensional structure as shown in Fig. 11 according to another specific embodiment of the present invention.

[0049] Fig. 13 is a schematic diagram showing an exploded structure of a sample chamber being separated from an elastic element according to a specific embodiment of the present invention.

[0050] Fig. 14 is a schematic diagram showing a three-dimensional structure of a collector being inserted into a fixed position of a sample chamber according to a specific embodiment of the present invention.

[0051] Fig. 15 is a three-dimensional schematic diagram showing a locking structure of fixing a collector in a sample chamber according to a specific embodiment of the present invention.

[0052] Fig. 16 is a schematic diagram showing a cross-sectional structure of a locking structure as shown in Fig. 15.

[0053] Fig. 17 is a schematic diagram showing a three-dimensional structure of a locking structure according to an embodiment of the present invention.

[0054] Fig. 18 is a schematic diagram showing an exploded three-dimensional structure of a testing device of the present invention with a sample chamber according to a specific embodiment of the present invention.

[0055] Fig. 19 is a schematic diagram showing a three-dimensional structure of a testing chamber according to a specific embodiment of the present invention.

[0056] Fig. 20 is a schematic diagram showing a cross-sectional structure of a testing chamber according to a specific embodiment of the present invention.

[0057] Fig. 21 is a schematic diagram showing a bottom structure of a testing chamber according to a specific embodiment of the present invention (with a cover body 400 in a locked state).

[0058] Fig. 22 is a schematic diagram showing a three-dimensional structure of a cover body being opened and a collector being inserted into a sample chamber according to a specific embodiment of the present invention.

[0059] Fig. 23 is a schematic diagram showing a cross-sectional structure of a collector being inserted into a sample chamber according to a specific embodiment of the present invention (showing a state where the collector is inserted into the sample chamber and begins to form a sealed space).

[0060] Fig. 24 is a schematic diagram showing a cross-sectional structure of a collector being inserted into a sample chamber and a collection element being extruded to release a liquid according to a specific embodiment of the present invention. At this time, a cover body 400 is closed to lock the collector. In this state, a liquid sample flows through a valve structure formed by a through-hole 304 and an elastic sealing ring 400, allowing a portion of a liquid sample to flow into a bottom 603 of a testing chamber and come into contact with a testing element on a test carrier 700 to complete assay.

[0061] Fig. 25 is a schematic diagram showing a structure of a testing element according to a specific embodiment of the present invention.DETAILED DESCRIPTION OF THE INVENTION

[0062] The structures involved in the present invention or the technical terms used are further explained below. Unless otherwise specified, they shall be understood and explained according to the general terms commonly used in the art.

[0063] Detection

[0064] Detection means assaying or testing the presence or absence of a substance or a material, including but not limited to, a chemical substance, an organic compound, an inorganic compound, a metabolite, a drug or a drug metabolite, an organic tissue or a metabolite of an organic tissue, a nucleic acid, a protein, or a polymer. In addition, detection means testing the quantity of a substance or a material. Further, assay also means immunoassay, chemical assay, enzyme assay, and the like.

[0065] Sample

[0066] Specimens tested by the detection device of the present invention include biological fluids (for example, case fluid or clinical specimens). Liquid specimens or fluid samples may be derived from solid or semi-solid specimens, including excreta, biological tissues, and food specimens. The solid or semi-solid specimens may be converted to liquid specimens by any appropriate methods, such as mixing, mashing, macerating, incubating, dissolving, or digesting the solid specimens by enzymolysis in suitable solutions, such as water, phosphate solutions, or other buffer solutions. "Biological specimens" include animal, plant, and food-derived specimens, including, for example, human or animal-derived urine, saliva, blood and components thereof, spinal fluid, vaginal secretions, sperm, stool, sweat, secretions, tissues, organs, tumors, cultures of tissues and organs, cell cultures, and media. Preferably, the biological specimen is urine; and preferably, the biological specimen is saliva. The food specimens include food-processed materials, final products, meat, cheese, wine, milk, and drinking water. Plant specimens include specimens derived from any plants, plant tissues, plant cell cultures, and media. “Environmental specimens” include specimens derived from the environment (for example, liquid specimens from lakes or other bodies of water, sewage specimens, soil specimens, groundwater, seawater, and waste liquid specimens). The environmental specimens may further include sewage or other wastewater.

[0067] An appropriate detection device according to the present invention can be used for detecting any analyte. Preferably, the detection device of the present invention is used for detecting small drug molecules in saliva and urine. In some embodiments, the detection device of the present invention includes a testing element.

[0068] Of course, the samples detected by the detection device of the present invention may be any samples of the above forms, regardless of being solid or liquid at the beginning, provided that these liquids or liquid samples can be absorbed by the sample application area of the testing element. Generally, the sample application area is made of a water-absorbing material, and liquid samples or fluid samples can be absorbed by the capillary or other characteristics of the material of an absorbent element, so that the fluid sample can flow in the sample application area. Thematerial of the fluid sample application area may be any material capable of absorbing liquid, such as sponge, filter paper, polyester fiber, gel, non-woven fabric, cotton, polyester film, and yam. Of course, the fluid sample application area may be made of a water-absorbing material or a non-water-absorbing material. However, the absorbent element is provided with through-holes, screw threads, and caves on which the samples can be collected. Generally, the samples are solid or semi-solid samples, and filled between screw threads and in the through-holes or caves for collection. Of course, optionally, the fluid sample application area may be composed of some non-absorbent fibers and hairs, and these materials are used to scrape a solid, semi-solid or liquid sample, so that these samples can be retained on the fluid sample application area. If detection needs to be performed, a buffer solution is applied to the sample application area to dissolve the sample, so that the dissolved sample flows on the testing element or the detection element.

[0069] In some embodiments, the fluid sample is located in the testing chamber, instead of being manually applied to the sample application area of the testing element of the present invention, where the sample application area is proximal to the bottom of the testing chamber; when there is the fluid sample at the bottom of the testing chamber, an end portion of the sample application area comes into contact with the fluid sample, the liquid sample sequentially flows into the label area, the testing area, and the sample absorption area depending on the capillary force, thereby completing the whole detection or initial test or first test.

[0070] Downstream and upstream

[0071] Downstream or upstream is divided according to the flow direction of a liquid. Generally, a liquid or fluid flows to a downstream area from an upstream area. The downstream area receives a liquid from the upstream area, and a liquid also may flow to the downstream area along the upstream area. Here, downstream or upstream is generally divided according to a flow direction of a liquid, for example, on some materials where capillary force is utilized to facilitate the flow of a liquid, a liquid may overcome gravity to flow towards an opposite direction to the gravity; and in this case, downstream or upstream is divided according to a flow direction of the liquid. For example, in the detection device of the present invention, when there is the fluid sample at the bottom of the testing chamber, for example, the liquid sample from the sample chamber, such as a urine sample or a saliva sample of a test subject, can flow from the sample application area to the label area, and then to the detection area, for example, a test result area and a test result control area. The testing area may be a polyester fiber film, and the diversion element may be a glass fiber, a polyester chip, and a polyester film. In some embodiments, within the sample chamber, a secondary sample retention chamber 320 is located downstream of an extrusion element 500 (see, e.g., FIG. 4). A liquid flows from the extrusion element (upstream)into the downstream position of the secondary sample retention chamber 320. When the liquid needs to flow out from a through-hole 304, this outflow is driven by pressure, enabling flow from the downstream of the secondary sample retention chamber 320 to the through-hole 304 located upstream. This flow is also a passive flow, similar to flow driven by capillary force, which overcomes the force of gravity. The flow from the extrusion element 500 into the secondary sample retention chamber 320 proceeds in the direction of gravitational force.

[0072] Gas communication or liquid communication

[0073] Gas communication or liquid communication means that a liquid or a gas can flow from one place to another. In the flow process, the liquid or the gas may pass through some physical structures that play a guiding role. The “passing through some physical structures” here generally means that the liquid passes through the surface of these physical structures or their inner space and flows to another place passively or actively, where passivity is generally caused by outer forces, such as flow under the capillary action and the action of air pressure. The flow here may also be a flow due to the self-action (gravity or pressure) of a liquid or gas, or a passive flow. The fluid under the action of air pressure may be a forward flow or a reverse flow; or a fluid is caused to flow from one position to another under the action of air pressure. The communication here does not mean that a liquid or a gas is necessarily present, but indicates a connection relationship or state between two objects in some cases. If a liquid is present, it can flow from one object to another. Here, it means a state in which two objects are connected. On the contrary, if the state of liquid communication or gas communication is not present between two objects, and if a liquid exists in or on one object but cannot flow into or onto another object, such a state is a noncommunication, non-liquid communication, or non-gas communication state.

[0074] In a specific embodiment of the present invention, the state where an interior of a sample chamber 300 maintains fluid communication with the outside through the through-hole 304 can be divided into three states: a first state, where the through-hole 304 does not establish fluid communication between the interior 3023 of the sample chamber and the outside, so the space 3023 inside the sample chamber 300 cannot exchange gas or liquid with the outside through the through-hole 304; a second state, where the through-hole 304 establishes fluid communication between the sample chamber and the outside, allowing a fluid to flow from the interior of the sample chamber through the through-hole 304 to the exterior of the sample chamber; and a third state, which occurs after completing the second state and then reverting to the first state (this may be referred to as the third state), where the through-hole 304 prevents fluid communication between the interior of the sample chamber and the outside. In the present invention, the communication or loss of communication between the internal space 3023 of the sample chamber300 and outside through the through-hole 304 is achieved by an elastic element covering the through-hole. This implementation enables the through-hole 304 to be sealed or unsealed. When the through-hole is sealed, the interior 3023 of the sample chamber cannot be in fluid communication with the external space of the sample chamber 300 through the through-hole 304. When the through-hole is unsealed, the interior 3023 of the sample chamber can be in fluid communication with the external space of the sample chamber 300 through the through-hole 304. This communication can be either gas communication or liquid communication. Detailed descriptions follow.

[0075] Testing element

[0076] The “testing element” used herein refers to an element that can be used to detect whether a fluid sample or a fluid specimen (a liquid sample or a liquid specimen) contains an analyte of interest. Such detection can be based on any technical principles, such as immunology, chemistry, electricity, optics, molecular science, nucleic acids, and physics. The testing element can be a lateral flow detection test strip that can detect a variety of analytes. Of course, other suitable testing elements can also be used in the present invention.

[0077] Various testing elements can be combined for use in the present invention. One form is a test strip. The test strips used for analyzing analytes (such as drugs or metabolites that show physical conditions) in samples can be of various forms such as immunoassay or chemical analysis. A non-competitive or competitive analysis mode may be used for the test strips. The test strip generally includes a water-absorbing material having a sample application area, a reagent area and a testing area. Fluid or liquid samples are added to the sample application area and flow to the reagent area under the capillary action. If analytes exist in the reagent area, samples will bind to the reagent. The samples then continue to flow to the detection area. Other reagents, such as molecules that specifically bind to the analyte, are fixed in the detection area. These reagents react with the analyte (if any) in the sample and bind to the analyte in this area, or bind to a reagent in the reagent area. The label used to display a detection signal is present in the reagent area or a detached labeling area.

[0078] In a typical non-competitive analysis mode, if a sample contains the analyte, a signal will be generated; and if not, no signal will be generated. In a competitive method, if no analyte exists in the sample, a signal will be generated; and if the analyte exists, no signal will be generated.

[0079] The testing element may be a test strip, which may be made of a water-absorbing material or a non-water-absorbing material. The test strip can include a variety of materials for liquid sample delivery. One material of the test strip can cover another material thereof. For example, filter paper covers a nitrocellulose membrane. One or more materials can be used in one area ofthe test strip, and one or more other different materials can be used in the other area. The test strip can be stuck to a certain support or on a hard surface for improving the strength of holding the test strip.

[0080] The analyte could be is detected through a signal-generating system. For example, one or more enzymes that specifically react with this analyte are used, and the above method of fixing a specific binding substance on the test strip is used for fixing a combination of one or more signal generating systems in the analyte detection area of the test strip. The substance that generates a signal can be in the sample application area, the reagent area or the detection area, or on the whole test strip, and one or more materials of the test strip can be filled with this substance. A signal -containing solution is added onto the surface of the test strip or one or more materials of the test strip are immersed in the signal -containing solution. The test strip containing a signifier solution added is allowed to be dried.

[0081] Various areas of the test strip can be arranged as follows: sample application area 905, reagent area 907, and detection area 903, where the detection area includes a test result area 911 and a test result control area 910(Fig. 25). The control area 910 is located behind the detection area. All areas can be arranged on one test strip that is only made of one material. Alternatively, different areas can be made of different materials. Materials used can be those with good water absorption such as filter paper, glass fibers or nitrocellulose membranes. The test strip can also be in other forms.

[0082] The nitrocellulose membrane test strip is commonly used, that is, the detection area includes a nitrocellulose membrane (NC) on which a specific binding molecule is immobilized to display the detection result; and other test strips such as cellulose acetate membrane or nylon membrane test strips can also be used. For example, test strips and similar devices with test strips disclosed in the following patents: US 4857453; US 5073484; US 5119831; US 5185127; US 5275785; US 5416000; US 5504013; US 5602040; US 5622871; US 5654162; US 5656503; US5686315; US 5766961; US 5770460; US 5916815; US 5976895; US 6248598; US 6140136; US6187269; US 6187598; US 6228660; US 6235241; US 6306642; US 6352862; US 6372515; US6379620, and US 6403383. The test strips and similar devices with test strips disclosed in the above patents may be applied to the testing element or detection device of the present invention for detection of an analyte, for example, detection of an analyte in a sample.

[0083] The detection reagent strips used in the present invention may be commonly referred to as lateral flow test strips, and the specific structures and detection principles of these detection reagent strips are known to those skilled in the art in the prior art. A common detection reagent strip 900 (Fig. 25) includes a sample collection area or a sample application area 905, a label area906, and a detection area 903. The sample collection area includes a sample receiving pad, the label area includes a label pad, and the water absorption area may include a water absorption pad, where the detection area includes necessary chemical substances that can detect presence or absence of the analyte, such as an immune reagent or an enzyme chemical reagent. As shown in Fig. 25, the test strip 900 has the sample application area 905. The commonly used detection reagent strips are nitrocellulose membrane reagent strips, that is, the detection area 903 includes a nitrocellulose membrane, and an area 911 (T-line) on which a specific binding molecule is immobilized to display the detection result; and other test strips such as cellulose acetate membrane or nylon membrane test strips can also be used. Of course, in the downstream of the detection area, there may also be a test result control area 910 (C-line); generally, test strips appear on the test result control area and the detection area in the form of a horizontal line, namely, a detection line or a control line. Such detection reagent strips are conventional. Of course, they can also be other types of reagent strips for detection under the capillary action. In addition, generally, the detection reagent strip has dry chemical reagent components, such as fixed antibodies or other reagents. When the reagent strip contacts with a liquid, the liquid flows along the reagent strip with capillary action. With the flow, the dry reagent components are dissolved in the liquid, and then go to the next area to treat the dry reagent in this area to react to perform necessary detection. The liquid flow mainly relies on the capillary action. Here, the reagent strip can be applied to the detection device of the present invention or can be disposed in contact with liquid samples in a detection chamber or used for detecting the presence or absence of analytes in liquid samples that enter a detection chamber, or the quantity thereof.

[0084] In addition to the foregoing test strip or lateral flow test strip which is used for contact with the liquid sample to test whether the liquid samples contain analytes. The testing element of the present invention may be used as a detection device by itself to detect an analyte in a sample. Therefore, the detection device itself here is equivalent to a testing element. For example, after being mixed with a treatment solution, the fluid sample is detected with the testing element directly. The following is a specific description: When describing a receiving device for processing fluid samples, the testing element can be used independently for detection. For example, the liquid sample flowing out of the sample chamber 300 through the through-hole 304 can directly flow to the sample application area 905 of the testing element 90 for testing and assay. Alternatively, the liquid sample flowing out of the sample chamber can be collected by a container, and the testing element is inserted into the container for testing and assay. In the present invention, as shown in Fig. 18, the testing element is disposed on a carrier 700, and the carrier is provided with a plurality of slots 701, and each of the slots is provided with a testingelement that can be used for testing one analyte, as shown in Fig. 18, and the carrier 700 is provided with a plurality of slots 701 that can be used for detecting or testing a plurality of analytes. Generally, the sample application area 905 is located at a lower end 702 of the slot close to the carrier, while the water-absorbing element is near an upper portion 703 of the slot. When the carrier is inserted into a testing chamber 600, the end of the application area generally contact with the bottom area of the testing chamber (as shown in Fig. 24). In this way, when the liquid sample flows into the testing chamber, it all flows to the bottom of the testing chamber, and the sample application area of the testing strip contacts with the liquid sample to complete the initial test.

[0085] Analyte

[0086] Examples that can use an analyte related to the present invention include some smallmolecule substances, including drugs (such as drugs of abuse). “Drug of Abuse” (DOA) refers to the use of a drug (typically functions to paralyze the nerves) not directed to a medical purpose. Abuse of these drugs will lead to physical and mental damage, dependency, addiction and / or death. Examples of drug abuse include cocaine; amphetamine (AMP) (e.g., Black Beauty, white amphetamine tablets, dexamphetamine, dexamphetamine tablets, and Beans); methamphetamine (MET) (crank, meth, crystal and speed); barbiturate (BAR) (such as Valium, Roche Pharmaceuticals, Nutley, and New Jersey); sedatives (i.e., a sleep aid medicine); lysergic acid diethylamine (LSD); inhibitors (downers, goofballs, barbs, blue devils, yellow jackets, and methaqualone); tricyclic antidepressants (TCAs, i.e. imipramine, amitriptyline, and doxepin); dimethylenedioxymethylaniline (MDMA); phencyclidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); opiates (i.e., morphine (MOP) or opium, cocaine (COC), heroin, and hydroxydihydrocodeinone); and anxiolytic drugs and sedative -hypnotic drugs. The anxiolytic drugs are mainly used for relieving anxiety, tension, and fear, and stabilizing emotions, and have hypnotic and sedative effects. The anxiolytic drugs include benzodiazepines (BZO), atypical benzodiazepines (BZ), fused dinitrogen NB23C, benzodiazepines, ligands of BZ receptors, openring BZ, diphenylmethane derivatives, piperazine carboxylates, piperidine carboxylates, quinazolinones, thiazine and thiazole derivatives, other heterocycles, imidazole -type sedative / analgesic drugs (e.g., oxycodone (OXY) and methadone (MTD)), propylene glycol derivatives-carbamates, aliphatic compounds, anthracene derivatives, and the like. The detection device of the present invention may also be used to detect drugs belonging to a medical use but easy to be taken excessively, such as tricyclic antidepressants (imipramine or analogues) and acetaminophen. These drugs are metabolized into micromolecular substances after beingabsorbed by the human body. These micromolecular substances exist in blood, urine, saliva, sweat and other body fluids or in some body fluids.

[0087] For example, the analyte detected by the present invention includes but is not limited to creatinine, bilirubin, nitrite, (nonspecific) proteins, hormones (for example, human chorionic gonadotropin, progesterone, follicle-stimulating hormone, etc.), blood, leucocytes, sugar, heavy metals or toxins, bacterial substances (such as proteins or carbohydrates against specific bacteria, for example, Escherichia coli 0157:H7, Staphylococcus, Salmonella, Fusiformis, Camyplobacter genus, L. monocytogenes, Vibrio, or Bacillus cereus) and substances related with physiological features in a urine sample, such as pH and specific gravity. Any other clinical chemistry analysis may be performed by lateral flow detection in combination with the device of the present invention. The sample of the present invention may be urine, and the analyte may be HCG, LH, and other substances, which are used for testing ovulation or early pregnancy.

[0088] Detachable combination

[0089] A detachable combination means that two components are connected in several different states or positional relationships. For example, with two components being physical components, they can be separated at the beginning and connected or combined in an appropriate first case, and can be separated in an appropriate second case. Physically, such separation is spatial separation without contact. Alternatively, the two components are combined at the beginning, and can be physically spatially separated from each other when appropriate. Alternatively, two objects are separated at the beginning, combined to achieve a specified function if necessary, then separated, or later combined again for a purpose. In short, combination or separation of two components or two objects can be easily made and repeated many times. Of course, the combination or separation may also be single-use. In addition, such a combination may be a detachable combination between two components, or a two-by-two detachable combination between three or more components. For example, a first component, a second component, and a third component are provided, where a detachable combination is made between the first component and the second component or between the second component and the third component; and a detachable combination or separation is made between the first component and the third component. In addition, for the combination, two objects themselves can be detached or can be indirectly combined by other objects.

[0090] For example, in the present invention, a collector 100 and the sample chamber 300 could be detachably combined. When a sample needs to be collected, after an absorbent element 104 of the collector 100 absorbs the sample, the collector can be inserted into the sample chamber 300 to retain the sample for secondary confirmation, while keeping the collector in a locked state. Whena secondary confirmation test is required, the collector 100 is unlocked to separate from the sample chamber 300, and then a pipette is used to insert into the secondary confirmation chamber 320 of the sample chamber for sampling to perform the secondary confirmation test. In some embodiments, the sample chamber and the testing chamber are also detachably combined. As shown in Fig. 24, the sample chamber is inserted into the testing chamber 600 to form a combined testing device for the initial test. When it is needed to send the liquid in the secondary confirmation chamber to a secondary confirmation testing laboratory for testing, the sample chamber 300 can be directly removed from the testing chamber 600 (either with or without the collector), and only the sample chamber 300 needs to be sent to the secondary confirmation testing center for testing. This saves space and reduces shipping costs, while the remaining testing chamber 600 used for the initial test, as well as the carrier 700 disposed inside and the testing elements on the carrier 700, can be directly discarded or retained. Therefore, the detachable combination of the sample chamber and the testing chamber, as well as the detachable combination of the collector and the sample chamber, are specific embodiments in the examples.

[0091] Secondary confirmation test

[0092] Second confirmation here means that after an initial test on a sample is performed, it is desired that secondary test on the sample is performed for confirmation. The samples for the initial test are the same as those for the secondary confirmation test. Here, the same samples refer to a same batch of samples, for example, a portion of obtained samples is used for the initial test and the other portion thereof is used for the secondary confirmation test. In some embodiments, the accuracy or sensitivity of the initial test is lower than that of the secondary confirmation test. For example, the initial test is performed using an immune-based method for a lateral flow testing element according to the present invention, and a label is a colored particle. If the secondary confirmation test needs to be performed, a method with better accuracy than immunoassay is used; for example, chromatography, fluorescence immunoassay, radioimmunoassay, chemiluminescence, gas phase or liquid phase, or gas / liquid phase-mass spectrometry is used for detection, ft can be understood that the initial test and the secondary test share methods, for example, the initial test is an immune test, and the secondary test can also be the same as the immune test of the initial test. In some embodiments, the initial test and the secondary confirmation test can be made by a same method and fall within a specific embodiment of the present invention. In some embodiments, when conducting an initial test, if the result of the initial test cannot be well determined, it is desired that the sample will be subjected to a more precise secondary test for confirmation, to finally give the test result of the analyte. For example, when an initial test is adopted, a certain analyte in the sample is near the threshold of the initial test, andit is impossible to accurately determine whether the analyte level is positive or negative. It is necessary to use a more precise test on the same sample to test whether the analyte really exists in the sample and the specific concentration, as to give the correct test result.

[0093] Sample chamber

[0094] In some embodiments, as shown in Figs. 1A-1C, which are schematic diagrams of the principle of the present invention. A sample chamber 7 is provided, which is used for collecting samples or performing sample distribution. A portion of the samples remains in the sample chamber 7 for a subsequent secondary confirmation test, and the other portion is subjected to an initial test. In some embodiments, the collector collects the sample and then is inserted into the sample chamber 7. An absorbent element 1 on the collector is absorbed with a liquid sample. When the collector is inserted into the sample chamber, the liquid is released into a downstream chamber 3 (secondary confirmation chamber) through the extrusion of an extrusion element 8. In this embodiment, a through-hole 4 is provided between the chamber 3 and the extrusion element, and the through-hole 4 is sealed by an elastic element 5, which is in an initial state (Fig. 1A). When the collector is inserted into the sample chamber 7, the collector forms a sealed space 9 in the sample chamber, that is, the space between the absorbent element 1 and the downstream secondary confirmation chamber 3 in the sample chamber 7 is sealed to form the sealed space 9. When the absorbent element 1 is compressed, for example, by an external force (as shown by the arrow direction in Fig. IB) applied to the absorbent element 1, the absorbent element is compressed to release the liquid into the secondary confirmation chamber 3. During the compression process, the sealed space 9 is still sealed by the collector. Since the absorbent element is compressed, the volume of the sealed space 9 is reduced, and the pressure in the sealed space 9 increases. To balance the internal and external pressures, the excess gas in the sample chamber 7 needs to be discharged. At this time, the elastic sealing material sealing the through- hole 4 itself has elasticity and can undergo elastic deformation. At this point, the excess gas acts on the elastic element 5 for the through-hole 4, so that the elastic element 5 protrudes outward at the through-hole 4, so that the elastic material around the sealed through-hole 4 moves away, and the through-hole 4 is kept in communication with the outside. In this way, the excess gas in the sealed space is discharged through the through-hole. Certainly, in some embodiments, the absorbent element 1 is compressed, and the compressed liquid first flows into the secondary confirmation chamber 3, as shown in Fig. IB. In this way, the secondary confirmation chamber is filled with the liquid sample. Although the liquid sample is filled, the volume of the sealed space 9 continues to decrease. Although the gas is discharged, if the pressure continues to increase and the volume continues to decrease, the increased pressure will force the secondary confirmationchamber to be filled with the liquid, and the excess liquid also needs to be discharged to the outside to achieve internal and external pressure balance. At this time, the excess liquid under pressure will also act on the elastic element 5 covering the through-hole 4, so that the elastic element moves away from the through-hole 4 and keeps the through-hole in communication with the outside. In this way, the liquid can be discharged out of the sample chamber 7 through the through-hole 4. If the test liquid is the liquid sample, the discharged liquid sample can be used for the initial test, for example, by contacting with a testing element to analyze the analyte in the liquid sample. Generally, after the discharge balances the pressure between the sample chamber 7 and the outside of the sample chamber, the elastic element 5 returns to its initial state (as shown in Fig. 1A), and the elastic element 4 reseals the through-hole 4, preventing fluid flow between the sealed space and the outside. At this point, the sample for secondary confirmation is retained within the sealed space 9. Since this sealed space cannot be in fluid communication with the outside, the liquid inside will not exchange with the outside. Therefore, even if the sample chamber with the collector is transported to the laboratory center for a secondary confirmation test, the liquid retained in the sealed space will not leak during transportation. In general, if the sample for secondary confirmation has fluid exchange with the outside during transportation, the liquid may vaporize and volatilize. By the time the liquid reaches the laboratory, it may have disappeared or no longer be in a liquid state, which affects the results of the secondary test. The sample for secondary confirmation needs to maintain the same state as the sample for the initial test, specifically in a liquid state. Although there may be volume differences, it is desired that the concentrations of the analytes remain objectively unchanged. In this way, the results of the secondary test can be more accurate and reliable. For example, if the test sample is in contact with the outside during transportation, water may evaporate or vaporize, leading to a reduction in water and its volume and an increase in the concentration of the analyte. As a result, the concentration of the analyte in the secondary test differs from that in the liquid sample for the initial test, making the secondary test results unreliable.

[0095] In some embodiments, the implementation of sample diversion and preservation, as well as the initial test and secondary confirmation test, in the present invention is illustrated according to specific products. As shown in Figs. 2-7 (elastic elements are omitted for descriptive convenience), in some embodiments, the sample chamber 300 includes an opening 303 and a bottom 3024. The sample chamber is enclosed by the bottom 3024, the opening 303, and a sidewall 302 to form a cavity structure, which is used to receive a sample collector with an absorbent element. On the one hand, the sample chamber is used to collect the liquid sample on an absorbent element 104 (Fig.7) of a sample collector 100. On the other hand, when theabsorbent elementl04 is inserted into the sample chamber, the collector and the sample chamber form an air-tight seal, forming an air-tight sealed space within the sample chamber 300. The gas in this sealed space can be compressed to increase the pressure, or the liquid in the sealed space can exert pressure. Alternatively, there is a segment of gas on the surface of the liquid within the sealed space that can be compressed, thereby increasing the pressure in the sealed space.

[0096] In some embodiments, the collector 100 includes a rod 103. One end of the rod is provided with an absorbent element 104, and the other end thereof is a hand-held portion- 102. The hand-held portion is in a disc-shaped structure, while the absorbent element 104 is an absorbent material that can absorb liquid and be compressed, such as polyester, sponge, filter paper, foam, cotton and other materials. These materials have water absorption properties to absorb a liquid. Additionally, when compressed after absorbing liquid, the volume decreases, allowing the liquid to be released. The absorbent material 104 is adhered to an absorbent disc 105. The absorbent disc 105 is a non-water-absorbing material. A sealing ring 106 is provided on the absorbent disc, which contacts with an inner wall 3025 of the sample chamber to form an airtight seal. The sealing ring can be an elastic sealing ring made of materials such as latex or silicone materials. Certainly, the collector is provided with a sealing groove 107 for mounting the sealing ring 106. This is one implementation of the collector. In the present invention, any collector suffices provided it is provided with an absorbent element and can form a seal with the inner wall 3025 of the sample chamber, thereby forming a sealed space within the sample chamber 300. For instance, the sealed space can be formed by the cooperation of the above elastic sealing ring 106 with the inner wall 3025 of the sample chamber, or it can take the form of a piston that fits with the inner wall 3025 of the sample chamber to form a sealed chamber. Of course, another approach is that any type of collector capable of collecting a sample and forming a sealed space when inserted into the sample chamber 300 can serve as an embodiment of the present invention.

[0097] For example, as shown in Fig. 7, when the collector 100 is inserted into the sample chamber 300, the absorbent element 104 also enters the sample chamber and forms a sealed chamber with the inner wall 3025 of the sample chamber via the sealing ring 106. This sealed chamber is the internal space starting from the contact point between the sealing ring and the inner wall 3025 to the bottom 3024 of the sample chamber, thus positioning the absorbent element 104 within an air-tight sealed chamber 3026 of the sample chamber. In fact, since the bottom of the sample chamber has a sealed structure, the sealing ring 106 forms a sealed space 3026 within the sample chamber (as shown in Fig. 7). The gas within this sealed space is compressed, thereby increasing the air pressure in the sealed space 3026.

[0098] In some embodiments, when the collector is inserted into the sample chamber, the sealed space can be formed before the absorbent element 104 is compressed. Alternatively, the collector can form an air-tight sealed space within the sample chamber 300 either before or during the compression of the absorbent element 104. As the collector is inserted or moves relative to the sample chamber, the sealed space is compressed, or its volume is reduced. Consequently, the volume of the air within the sealed space decreases, leading to an increase in the air pressure in the sealed space.

[0099] In some embodiments, a through-hole 304 is additionally provided in the sample chamber, and the through-hole 304 connects the sample chamber 300 to the outside. Preferably, the through-hole can exist in two distinct states relative to the sealed space 3026 and the outside: the through-hole 304 is opened, where the sealed space maintains fluid communication with the outside, and the through-hole is sealed, where the sealed space is not in fluid communication with the outside. When the sealed space maintains fluid communication with the outside, the exchange of a liquid or a gas between the sealed space and the outside can be achieved. When the sealed space is not in fluid communication with the outside, the outside and the sealed space cannot achieve liquid or gas exchange.

[0100] When the air in the sealed space 3026 is compressed, the internal air pressure increases. Excess air can be discharged to the outside through the through-hole 304 (if the through-hole is in an open state). If there is liquid present, the excess liquid can be discharged out of the sample chamber through the through-hole 304. For example, a treatment liquid is pre-stored in the sample chamber. This treatment liquid mixes with the sample from the absorbent element or the absorbent element 104 to elute the liquid sample from the absorbent element 104. All these liquids are stored in the space 3026 of the sample chamber. As the collector 100 is further inserted, the volume of this sealed space 3026 decreases, compressing the air and raising the air pressure. If there is excess air, it is discharged from the through-hole 304 into the external environment of the sample chamber 300. After the air is discharged, if there is still excess liquid or liquid remaining in the sample chamber, the liquid will also be subjected to pressure from the collector (e.g., pressure from the air pressure on the liquid surface or direct pressure on the liquid), causing the liquid to be discharged out of the sample chamber through the through-hole 304. The discharged liquid can then be tested, for example, in an initial test to determine the presence of the analyte in the liquid sample. Therefore, the sample chamber may initially contain a liquid sample or a liquid sample formed by mixing a buffer solution with the liquid sample. When the air or liquid is discharged from the sample chamber 300, an air pressure balance isessentially established between the sealed space 3026 and the outside, at which point the through- hole 304 can be sealed.

[0101] Therefore, in some embodiments, when the air pressure in the sealed space 3026 of the sample chamber rises and excess air needs to be discharged, the through-hole 304 is opened to release the air, excess liquid, or liquid sample. When the pressure inside the sealed space equals the outside pressure, the through-hole 304 is automatically closed. Here, if air is discharged, the internal and external pressures are equalized. If liquid is discharged, the liquid is forced by pressure to flow out of the sample chamber through the through-hole 304, which also achieves internal and external pressure equilibrium. At this point, the through-hole is automatically closed. It can be understood that the opening and closing of the through-hole are regulated by the pressure difference between the sealed space and the outside. If the pressure in the sealed space inside the sample chamber exceeds the outside pressure, the pressure difference keeps the through-hole 304 open, allowing air or liquid to be discharged. When the pressure inside and outside the sealed space is equalized, the through-hole 304 is automatically closed. In some embodiments, the opening and closing of the through-hole 304 can be repeated multiple times. For example, the process from opening to closing is one cycle, and 2 or more cycles can be achieved, allowing the pressure difference between the sealed space and the outside to repeatedly shift from pressure difference to pressure equilibrium multiple times.

[0102] In some embodiments, a fixed extrusion plat form 500 is provided within the space 3026. The extrusion platform comes into contact with the absorbent element 104. When the collector is inserted into the sample chamber 300, the extrusion platform 500 comes into contact with the absorbent element, and the force from inserting the collector (e.g., manual force applied to insert the collector) compresses the absorbent element 104, releasing liquid into the sample chamber, for example, releasing the sample into the sealed space.

[0103] In some embodiments, when it is desired to retain a portion of the liquid sample within the sealed space of the sample chamber 300 while discharging another portion through the through-hole 304, for instance, the portion of the liquid sample retained in the sealed space can be used for secondary verification, whereas the portion of the liquid sample discharged via the through-hole 304 is used for the initial test. To achieve this, although the through-hole 304 is in communication with the sealed space, its position is carefully considered. Thus, in some embodiments, the through-hole 304 on the sidewall of the sample chamber is not disposed at the lowest point of the sample chamber bottom but at a suitable height, allowing a space at the bottom to retain a portion of the liquid sample. When the absorbent element 104 of the collector is compressed, the liquid first flows into this space. If there is excess liquid, it flows out throughthe through-hole 304. The driving force for this outflow originates from the pressure difference formed between the sealed space (compressed by the collector) and the exterior of the sample chamber, which causes the liquid to flow out or be discharged.

[0104] In some embodiments, the extrusion platform 500 is provided with a hole 501. When the absorbent element 104 contacts with the extrusion element or platform 500, the compressed liquid flows through hole 501 into the downstream space for storage. In some embodiments, the through-hole 304 is located between the extrusion platform 500 and the lowest point of the space below the extrusion platform. Alternatively stated, the through-hole 304 is located above the lowest point of the space below the extrusion platform 500. For example, as shown in Fig. 7, the lowest point below the extrusion platform is a bottom 3027 of the sample chamber, and the through-hole 304 is located higher than the lowest point, for example, 1 millimeter, 2 millimeters, 3 millimeters, 4 millimeters, 5 millimeters, 6 millimeters, 7 millimeters, 8 millimeters, 9 millimeters, 1 cm, or 2 cm above the lowest point. In this way, when the absorbent element 104 contacts with and is compressed by the extrusion platform 500, the liquid first flows into the lower space (e.g., to the lowest point 3027), forming a liquid level with a height (e.g., a height of 3 millimeters). If the compression of the absorbent element 104 can cause the liquid level in the lower space to rise to a height of 6 millimeters, the excess 3 millimeters of liquid can be discharged through the through-hole 304. The discharge occurs as the pressure difference between the sealed space 3026 and the outside causes the through-hole 304 to transition from its initial closed state to an automatically opened state, thereby enabling the discharge of liquid. In this way, a portion of the liquid is retained between the lowest point 3027 at the bottom and the 3 millimeter-high liquid level, while the excess liquid above the 3 millimeter level causes the through-hole 304 to open due to the pressure difference between the inside and outside, allowing it to be discharged outside the sample chamber 300 through the through-hole 304. The liquid retained in the sample chamber can be used for secondary confirmation or testing, while the first discharged liquid is used for the initial test. When further testing is required, additional pressure can be applied to the sealed space within the sample chamber, or the lower 3- millimeter-high space can be filled with a solid. This causes any excess liquid to be discharged through the through-hole 304 outside the sample chamber, enabling a secondary test. In some embodiments, the discharged liquid sample is used for the initial test, while the liquid sample retained within the sample chamber is reserved for subsequent secondary confirmation testing. When secondary confirmation testing is required, the sample chamber and collector are directly couriered to the laboratory. The collector is then removed, and a pipette is used to absorb the 3 -millimeter-high liquid sample retained at the bottom for secondary confirmation testing. In some embodiments,before couriering, the collector 100 can be removed from the sample chamber, and the opening 303 of the sample chamber is sealed with a cap or plug, which is then sent to the laboratory for secondary confirmation testing.

[0105] In some embodiments, the space below the extrusion platform 500 can be configured in a funnel-like shape to ensure the retained liquid meets the volume requirement for secondary confirmation testing, such as 1 microliter to 50 microliters, which can be freely set as needed. Thus, the partial chamber below the extrusion platform 500 can be named the secondary confirmation chamber 320, and the secondary confirmation chamber 320 is a space for collecting and preserving the liquid sample for secondary confirmation testing. The secondary testing chamber 320 is enclosed by the wall 313 forming the bottom of the sample chamber and the bottom 3024. The through-hole 304 is disposed on the sidewall of the chamber 320 to maintain fluid communication between the through-hole 304 and the secondary confirmation chamber 320 (as shown in Fig. 5 or Fig. 7), and the position of the through-hole is higher than the bottom 3027 of the secondary confirmation chamber 320.

[0106] In some embodiments, to ensure the liquid first fills the secondary confirmation chamber 320 and excess sample is discharged outside the sample chamber 300 due to the pressure difference between the inside and outside, a baffle 502 extends downward from the lower portion of the extrusion platform near the through-hole 304 (as shown in Fig. 5). With the baffle, the liquid left by the hole 501 of the extrusion platform does not directly flow to the through-hole 304 but first flows to the bottom of the secondary confirmation chamber 302, causing the liquid level to gradually rise. When the liquid level rises to the position of the through-hole 304, the excess liquid causes the through-hole 304 to open due to the pressure difference between the inside and outside, allowing the liquid to be discharged outside the sample chamber 300.

[0107] In some embodiments, the collector 100 forms a sealed space within the sample chamber when the elastic element 106 contacts with the inner surface 3025 of the sample chamber. At this point, the absorbent element 104 on the collector has not yet contact with the lower extrusion platform 500. Therefore, in some embodiments, the sample chamber includes an upper sample chamber 3021 and a lower sample chamber 3022(as shown in Fig. 2, or Fig. 4, Fig. 7). When the collector 100 is inserted into the upper sample chamber 3021, the elastic element 106 of the collector 100 does not contact with the inner wall. However, once it moves into the lower sample chamber 3022, the elastic element 106 contacts with the inner wall to form a sealed space, making the entire lower sample chamber 3022 be a sealed (e.g., air-tight) space 3026. As the collector continues to be inserted, the space 3026 is compressed, causing the pressure to rise. The increased pressure opens the through-hole 304, allowing excess air to be discharged outside thesample chamber 300 through the through-hole 304. During the insertion of the collector, when the absorbent element 104 contacts with the extrusion platform 500 and is compressed to release the liquid sample, the sealed space continues to be gradually compressed. This alternation between pressure difference between the inside and outside and pressure equilibrium occurs in a cyclic manner. One purpose of this process is to test whether the opening and closing of the through- hole 304 can function properly under the influence of pressure. This primarily ensures that subsequent liquid samples can be discharged normally and proactively detects whether the opening and closing functions of the through-hole 304 are normal. Then, when the absorbent element 104 contacts with the extrusion platform, the absorbent element 104 is compressed to release the liquid into the lower secondary confirmation chamber. In fact, the compression of the absorbent element 104 is also a process of compressing the sealed space, which further increases the internal pressure. When the secondary confirmation chamber 320 is filled with liquid, any excess liquid sample will cause the through-hole 304 to open due to the increased pressure and be discharged outside the sample chamber 300. For example, if the absorbent element 104 is compressed to 1 / 3 of its length, releasing e.g. 0.5 milliliters of liquid that fills the secondary testing chamber 320, continued compression to 1 / 2 of its length (releasing 1 milliliters) will result in the excess liquid sample (0.5 milliliters) being forced out through the through-hole 304 opened by the increased internal pressure and into contact with the testing element outside the sample chamber for analyte testing and assay.

[0108] To enable the through-hole 304 to be automatically opened and closed in response to pressure differences between the interior and exterior of the sample chamber, the following approaches can be adopted. In some embodiments, an elastic plug can be used to block the through-hole 304, keeping the through-hole sealed in the initial state. This allows a sealed space to form when the collector is inserted into the sample chamber 300, with possible fluid flow between the space and the through-hole 304. As air pressure increases, the plug can be forced out of the through-hole 304, opening the through-hole to discharge excess air or subsequent excess liquid. However, once the plug is opened, it is difficult to be automatically closed, requiring manual insertion of the elastic plug back into the through-hole 304 to retain the sample for subsequent secondary confirmation testing. This operation is inconvenient, especially if the sample chamber is located within a testing chamber (e.g., in the embodiments shown in Figs. 18- 27), where manually inserting the elastic plug detached from the through-hole 304 is unfeasible.

[0109] In a more preferred embodiment, through-hole 304 is covered with an elastic element on the outside. In the initial state, this elastic element seals the through-hole 304, maintaining the sealed state of the sample chamber, particularly the sealed space 3026. This seal can be air-tightor liquid-tight: air-tight when discharging air, and liquid-tight when discharging excess liquid later. In the preferred embodiment, an air-tight seal can be consistently employed. The "covering" here differs from "blocking" the through-hole. It refers to placing an elastic element over the outside of the through-hole, which can keep the through-hole in a sealed or open state by virtue of its own elastic deformation. Due to the pressure difference between the inside and outside of the sample chamber, for example, when the internal pressure exceeds the external pressure, the internal pressure (e.g., excess air or liquid) acts on the inner surface of the elastic element via the through-hole 304. This pressure causes the elastic element to undergo elastic deformation, bulging away from the through-hole 304 and partially detaching from the surface around the through-hole. This allows the through-hole 304 to be in communication with the outside, enabling the discharge of air or liquid from the sample chamber through the through-hole. Once the pressure inside and outside the sample chamber is balanced or equal, the elastic element has the ability to restore its initial state, covering the outer surface around the through-hole again to achieve sealing of the through-hole 304. By covering the through-hole with an elastic element, repeated cycles of closing and opening of the through-hole can be realized. The elastic element can be in a state of repeated cycles of sealing and opening. There is a pressure difference between the sample chamber and the outside of the sample chamber , and the pressure difference is sufficient to make the elastic element move away from the through-hole and partially move away from the position covering the surrounding outer surface, communication between the through-hole and the outside can be achieved. In this way, multiple discharges of fluid from the sample chamber to the outside world are achieved, such as multiple discharges of air or liquid. For example, the first liquid discharge is used for the initial test, and the second liquid discharge can be used for the secondary test or secondary confirmation test. The "multiple " here can be more than 2 times or more than three times.

[0110] The through-hole 304 connects the interior of the sample chamber 300 to the outside. Alternatively, it can be understood that the through-hole isolates the fluid flow between the sample chamber and the outside when sealed by an elastic film. Due to the elastic film, the elasticity can cover the through-hole 304 to seal the through-hole. The sealing method is to cover the periphery of the through-hole, so that the liquid or gas from the sample chamber inside the through-hole 304 cannot flow to the outside of the sample chamber. When the collector is inserted into the sample chamber 300, a sealed chamber is formed inside the sample chamber. As the collector is inserted, the volume of the sealed space is compressed, so that the air pressure in the sealed space increases. The increased air pressure causes the air to be discharged from the through-hole 304. Due to the sealing of the elastic sealing film, the gas or air acts on the elasticfilm, causing the elastic film to move away from the sealed through-hole. In some embodiments, a portion of the elastic film is allowed to move away from the periphery covering the channel, thus forming a channel, so that the gas coming out of the through-hole flows to the outside through the channel. Similarly, if there is liquid, it will flow out through the through-hole and pass through the channel to the outside of the sample chamber. If liquid flows out of the sample chamber, this liquid (if it is a liquid sample) can be used as a test sample for analysis by the testing element. Once the air pressure between the sealed chamber and the outside is balanced, or the pressure inside the sealed chamber is insufficient to deform the elastic film and form a flow channel, the elastic film covers the periphery of the through -hole again, so that the channel is in a closed state. This prevents air or liquid inside the sample chamber from flowing out of the chamber. The remaining liquid in the sample chamber can be directly transported to a testing laboratory for secondary confirmation or used for other subsequent tests. At this time, since the liquid is stored in a sealed space, it will not evaporate and be reduced during transportation.

[0111] Sealing film-formed valve

[0112] In a specific embodiment, as referenced in Fig. 11-14, in some embodiments, a layer of elastic sealing film 400 covers the sidewall surface of the sample chamber around the outer surface of the through-hole, so that the through-hole is sealed in the initial state. The covering method is, for example, as shown in Fig. 13. The through-hole 304 is provided on the sidewall, and around the through-hole is a sidewall surface 302 of the sample chamber. The area around the through-hole 304 is also a portion of the sidewall surface, and a layer of elastic film 400 can be covered around the through-hole 304 on the sidewall surface, so that the through-hole 304 is separated or not connected to the outside through the elastic film. The sealing and opening of the through-hole depend on the state change of the elastic film.

[0113] In some embodiments, the through-hole 304 is arranged on the sidewall of the sample chamber, and the through-hole connects the interior of the sample chamber 300 with the outside. An elastic film covers the outer wall 317 of the sample chamber where the through-hole is arranged. The film is covered around the outer surface of the sidewall around the through-hole, so that the through-hole 304 is sealed. For example, as can be seen from Figs. 9A-9B, the through- hole 304 is disposed on the sidewall, and the surface of the said well around the through-hole. The elastic sealing film 408 or the elastic element 400 covers the outer surface of the area around the through-hole 304, and at least the elastic element covers the surfaces 317 and 306 of the outer wall 302. A part of outer surface 317 that around the through-hole 304 is away from the bottom of the sample chamber, and the outer surface 306 that around the through- hole 304 is close to the bottom of the sample chamber (Fig.9 A -9B). In some preferred embodiments, the area where theelastic film covers the surface 317 of the outer wall 302 is larger than that covering the surface 306. In this way, when the elastic element is subjected to the impact force of gas and liquid coming out of the through-hole 304, the elastic element first moves away from the surface at the place with a smaller coverage area to form a valve channel for discharging gas and liquid.Alternatively, the elastic element has a boundary, and the place where the boundary is the shortest distance from the through-hole is the easiest to form an open channel. On the contrary, the farther the boundary is from the through-hole 304, the less likely it is to move away from the surface to form a valve channel under the same impact force.

[0114] The covering method can be to coat glue on the surface around the through-hole and then cover the elastic sealing ring on the through-hole. However, if it is need to facilitate the discharge of air or liquid passing through the through-hole, the glue is only coated on 3 / 4 of the area around the through-hole 304. It can be understood that the area around the through-hole is in a circular form, and the glue is not applied to the entire circumference when coating. Instead, approximately 1 / 4, 1 / 5, 1 / 6, 1 / 7, or 1 / 8 of the circumference is left uncoated. When the elastic film is bonded to the surface around the through-hole with glue, a valve-like structure is formed in the uncoated area. During covering, the elastic film is kept in a tensioned state, allowing it to closely adhere to the uncoated area. When the pressure in the sealed space of the sample chamber 300 increases, excess air passes through the through-hole 304 and acts on the elastic film. At same time, the film deforms and bulges outward. During the outward bulging process, the uncoated area naturally is allowed to be in communication with the outside, completing air discharge and forming an outlet looks like "air leakage or liquid leakage." If there is excess liquid in the sample chamber, by the same principle, the liquid under high pressure passes through the through-hole 304 and acts on the elastic film, causing the film to bulge outward. This makes the area closely adhering to the through-hole 304 without glue coating move away from the surface to form an outlet, allowing the liquid to flow or leak out. The leaked liquid sample can then be tested. Once the pressure inside and outside of the sample chamber is balanced, the elastic element restores to its initial state and adheres again to the surface around the through-hole, thus sealing the through-hole 304.

[0115] In other embodiments, a first recess 3191 is provided on the sidewall of the sample chamber, with a through-hole 304 set at the bottom of the recess, as shown in Figs. 4-5 and 9. The recess is surrounded by recessed surfaces 319 and 318 around the through-hole. The elastic element covers the sidewall surfaces 317 and 306 around the recess, but not the recessed surfaces 319 and 318. A second recess 305 is arranged near the first recess, separated by a partial surface 306 between the two recesses. The elastic element covers the partition surface 306 and other surfaces of the first recess. The elastic sealing film contacts with the partition surface 306 of theouter sidewall surface, where a valve-like principle is applied, which can also be understood as the formation and closure states of a channel. As shown in Figs. 11-13, the sealing element 400 covers the area around the through-hole 304, with a portion of the outer wall 306 around the through-hole 304 covered by the sealing film. The valve structure is formed where the elastic sealing film 400 covers 306. This area is prone to making the elastic film tense under external force, thus easily opening, or allowing the elastic film to move away from the surface 306. The valve structure formed by the surface 306 and the portion covered by the elastic element 400 can be automatically opened wider and closed. The opening of the valve means that the elastic element covering the surface 306 moves away from the surface to open, while the closing means that the elastic element covering the surface 306 clings to the surface 306 to close. It can be understood that the area covering the surface 306 is smaller than the area where the elastic element covers other surrounding parts of the first recess 3191. When the air or liquid emerging from the through-hole 304 acts on an inner surface 401 of the elastic element(Fig. 13), the force causes the area of the inner surface 401 to bulge outward. During this bulging process, other parts of the elastic element may contract, and the area covering the surface 306 will also contract, uncovering the recess 3191. As a result, the air or liquid flows out from the recess 3191 and from the portion of 306 not covered by the elastic element. Alternatively, when the air or liquid emerging from the through-hole 304 acts on the inner surface 401 of the elastic element (as indicated by the arrows in Figs. 12 and 13), the force causes the area of the inner surface 401 to bulge outward. During this bulging process, the entire elastic element may tend to detach from the outer wall surface. However, due to the smaller coverage area on the surface 306, the elastic element covering this part is more likely to move away from the surface 306, forming an open valve. This allows the air or liquid to flow out from the loosened surface 306 under pressure, with the purpose of balancing the pressure between the sample chamber 300 and the outside. Once the internal and external pressures are balanced or equal, the elastic element restores its initial natural state, thus clinging again to the surface around the recess 3191 to close the through-hole 304, forming a closed valve state.

[0116] In some embodiments, when the sealed space 3026 inside the sample chamber 300 is compressed, the air pressure is increased and the volume of the space 3026 is compressed. The excess gas gains momentum to escape outward through the through-hole 304, acting on the elastic sealing film. This force can cause the elastic seal to detach from the through-hole, particularly from the outer surface of the sample chamber it covers, as indicated by the arrows in Figs. 12-13. Once the sealing film moves away from the outer surface, for example, the film on the area 306 in contact with the outer wall, a channel (valve channel) is formed, connecting thethrough-hole 304 with the outside through this valve channel. Thus, the excess gas is discharged from the sample chamber through the valve channel. Once the internal and external air pressures are balanced, or the pressure in the sample chamber is insufficient to push the elastic sealing film away from the covered surface (e.g., the area shown as 306), the sealing film cannot form a valve channel with the covered outer surface, keeping the sealed space inside the sample chamber in a sealed state. In fact, it can be understood that the change in the pressure difference between the interior of the sample chamber and the outside causes the area where the elastic sealing film covers the area 306 of the outer wall surface of the sample chamber to be in a state of contact or non-contact. When there is no contact, a valve channel is formed; when in contact, valve sealing is achieved. This is similar of the principle of a valve: the valve is closed when being in contact and opened when not being in contact. Thus, the through-hole 304 can maintain states of connection and disconnection with the external environment through the valve. Of course, the closing and opening of the valve can alternate. For example, it starts in a closed state. When a pressure difference occurs, the valve opens; and when the pressure difference changes (e.g., decreases), the valve closes again. When the valve is closed, the fluid (gas, air or liquid, liquid sample) in the sample chamber cannot be exchanged with the outside, for example, it cannot flow to the outside. When the valve is opened, the fluid in the sample chamber can flow to the outside.

[0117] In some embodiments, as shown in Figs. 11-14, the elastic element does not cover the second recess 305. Instead, the elastic element only covers the partition surface 306 between the first recess 3191 and the second recess 305, which is also a portion of the wall surface of the sample chamber. At least the area where the elastic element covers the partition surface 306 should be smaller than the area where it covers other parts around the recess. Here, 306 makes it easier for the elastic element to detach from the partition surface 306 under the high pressure inside the sample chamber, forming a valve-like structure. In some embodiments, the downstream of the first recess 3191 is the second recess 305, which can be located below, to the left, or to the right of the first recess. Preferably, the second concave surface 305 is located below the first concave surface 3191. In some embodiments, if the through-hole 304 is not located within the concave surface but directly on the sidewall of the sample chamber, a concave surface 305 is still set downstream of the through-hole 304. A partition surface 306 is arranged between the through- hole and the concave surface 305 to form the valve structure. In some embodiments, the elastic element is shaped like a cylinder with an inner diameter slightly smaller than the outer diameter of the sample chamber. By virtue of the elastic deformation of the elastic element itself, the elastic element is fitted onto the outer wall surface of the sample chamber. This allows the elastic element to adhere to the outer wall of the sample chamber through elastic deformation, thussealing the through-hole. Therefore, the sleeve has two ends, a first end 402 and a second end 403. The first end 403 is configured to cover the surface 306 without covering the second recess 305. Thus, the area covering the surface 306 can be easily switched between the open and closed states. In some embodiments, the sealed sleeve has a first boundary and a second boundary formed by the first end 402 and the second end 403. The distance from the first end 402 to the through-hole 304 is greater than the distance from the second end 403 to the through-hole 304. Therefore, when gas or liquid emerging from the through-hole 304 impacts the elastic element 400, the portion of the elastic element closer to the through-hole is more likely to detach from the covered surface, forming a valve channel for discharging gas or liquid and achieving the function of the present invention. In some embodiments, the second end 403 of the sealing element 400 is thicker than the first end 402 of the sealing element 400. Therefore, when gas or liquid emerging from the through-hole 304 impacts the elastic element 400, the portion of thicker of the elastic element (second end) is easier to detach from the covered surface, forming a valve channel for discharging gas or liquid and achieving the function of the present invention. For example, the thick of the first end of the wall of the eminent 400 is IX, 2X, 3X, 4X,5X,6X than the thick of the second end of the wall of the sealing element 400. For instance, the second end of the wall of the element 400 is 0.5mm or 1mm, and the first end of the wall of the element 400 is mm 1 or 2 mm, 3mm.

[0118] Secondary confirmation

[0119] If there is a liquid sample inside the sample chamber 300, based on the above explanation, the liquid can flow out of the sample chamber when the valve is open. When the liquid is affected by the pressure difference changes within the sealed space, it can also flow out of the sample chamber. When the valve is closed, the liquid cannot flow and is retained within the sealed space. When the liquid is a liquid sample, the liquid flowing out of the sample chamber can be tested, such as for an initial test. Of course, the valve can also be opened for the second time, allowing the liquid to flow out of the testing chamber multiple times through the valve. For example, the first outflow is used for the initial test, and the second outflow can be used for the confirmation test or secondary confirmation test.

[0120] In some embodiments, a first recess 3191 is provided on the sidewall of the sample chamber, and the through-hole 304 is in the recessed area and connects the interior of the sample chamber with the outside. The first recessed area 3191 is a circular recess. In some other embodiments, a diversion channel 322 is further disposed on the sample chamber. The diversion channel 322 is also arranged on the second recessed area 305. The area between the two recessed areas is the valve area, which includes a portion of the outer wall 306 of the sample chamber.This portion of the outer wall is covered by an elastic film. When the liquid flows out from the through-hole 304, if the valve is open, the liquid passes through the valve area and flows into the diversion channel 322. The liquid flowing out of the diversion channel 322 can directly flow to the bottom of the testing chamber 600 to contact with the test strip, or be collected in a container for subsequent secondary confirmation testing.

[0121] The elastic film sealing the through-hole 304 here can be fixed to the outer wall surface of the sample chamber around the through-hole 304 by any means, such as adhesive bonding or any other fixing method for covering and fixing. In some embodiments, the sealing film is like a a tube (as shown in Figs. 11, 12 and 13) 400, which is sleeved on the outer surface of the sample chamber and covers the area around the through-hole 304. Because the sealing film has elasticity, the sealing film is fixed outside the sample chamber by virtue of elasticity. In some embodiments, the sealing film does not completely wrap the lower portion of the sample chamber, but exposes a portion of the lower chamber, especially a portion of the second recess 305 or the secondary confirmation chamber 320. This is to observe the liquid collection status in the secondary confirmation chamber 320, including whether it is full and whether the volume is sufficient. The elastic sealing film undergoes elastic deformation when subjected to a specific force. The area of deformation can expand from the point of force application, causing the region covering the surface to detach and form a channel, like the opening and closing of an elastic valve. Different materials require different forces for elastic deformation. Suitable elastic films can be selected, such as rubber films, silicone films, latex films, etc. Generally, gas or liquid emerging from the through-hole 304 acts on the film opposite to the through-hole 304 (as shown by the arrow in Fig. 12), causing the elastic film to deform. This deformation makes a portion of the film covering the area 306 on the sample chamber surface detach from the surface, opening the valve and forming a valve channel that allows gases such as air and liquids such as liquid samples to flow out of the testing chamber through the valve channel.

[0122] In some embodiments, when the collector 100 is inserted into the sample chamber, a sealed space is formed, including the extrusion platform 500, and the extrusion platform 500 has a through-hole 501. When the absorbent element 104 contacts with the extrusion platform 500, it is compressed to release liquid into the lower chamber 320, which is set with a certain volume, generally ranging from 1 to 2 milliliters. The chamber has a bottom 3027, and an extrusion platform is located above the chamber 320. The through-hole 304 is disposed near the extrusion platform but at a position higher than the bottom of the chamber 3027. At this point, the liquid extruded from the absorbent element 104 first flows into the chamber 320. When the chamber 320 is filled with liquid, the excess liquid can be discharged from the sample chamber through thethrough-hole 304. Here, when the collector is generally inserted, it contacts with the inner wall 316 of the chamber to form a sealed space 3026. During the compression of the sealed space, the collector is inserted into the sample chamber 300, and the absorbent element contacts with the extrusion platform 500 for compression. As the pressure increases, excess gas is generally discharged firstly. The discharge approach is that the gas is discharged to the through-hole 304, acts on the elastic film, and opens the valve for discharge. When the chamber 320 contains liquid, the liquid collects in the chamber 320 and rises to the level of the through-hole 304. If there is excess liquid, the force from the gas pushes the liquid out of the through-hole 304. The liquid acts on the elastic film to open the valve, allowing the liquid to flow out of the sample chamber, for example, through the diversion channel into the testing chamber.

[0123] As the liquid flows out, the valve formed by the elastic film and the outer wall of the sample chamber is closed, keeping the liquid reserved in the chamber 320 in a sealed state for subsequent secondary confirmation. Since the collector forms a seal with the inner wall 3025 of the sample chamber and is under pressure, to keep the collector fixed in the sample chamber continuously, after the collector is inserted into a specific position, a structure can be used to lock and fix the collector to maintain it in the chamber. In one embodiment, a cover body 200 is provided. The cover body 200 is connected to an element sealing the testing chamber via a hinge 201(Fig. 21 and Fig. 22). The hinge includes a shaft 800 inserted into two through-holes 311 and 312(Fig. 3, Fig, 22) to connect the cover body. After the collector 100 is inserted into the sample chamber 300 and the step of discharging the liquid out of the sample chamber is completed, the cover body 200 is closed (as shown in Fig. 21). The cover body200 exerts a fixed pressure on the collector 100 to keep the collector in the sample chamber or lock it therein, thereby maintaining the formed sealed space and keeping the liquid sample within the sealed space.

[0124] After the initial test is completed, the entire device or only the sample chamber is transported to a secondary confirmation center for testing. At this time, the collector can be removed from the sample chamber, and then a pipette can be inserted into the chamber 320 to absorb the liquid sample for the secondary test.

[0125] Combination of sample chamber and testing chamber

[0126] When the sample chamber and detection chamber are combined, the liquid sample flowing out from the sample chamber can be subjected to an initial test simultaneously. Thus, in some embodiments, a detection chamber 600 is provided, featuring a bottom 602 and an opening 601. A carrier 700 is inserted into the detection chamber, with a testing element 900 mounted on the carrier. The sample application area of the testing element is located close to the bottom of the testing chamber or the sample collection area 603, allowing the liquid to contact with the testingelement in the collection area 603 for testing. The collection area 603 is located near the transparent sidewall 604 of the wall, enabling observation of the test results on the testing area of the internal testing element. In specific embodiments, the sample receiving chamber 300 is shaped like a test tube, equipped with closure element 301 for closing the opening 601 of the testing chamber. The closure element 301 includes a closed upper surface and a protruding edge in contact with the upper surface, and the closure element 301 matches the opening 601 of the testing chamber to close the opening 601 of the testing chamber. The closure element is provided with hinge structures 312 and 311 (Fig. 3, Fig. 22)to hingedly connect the cover body 200 to the closure element 601. In this way, the sample chamber 300 is located within the testing chamber, and the opening 303 of the sample chamber is disposed to receive the collector and allow it to be inserted into the sample chamber. The closure element 301 can be detachably combined with the testing chamber. After the initial test is completed, the closure element 301 can be separated from the testing chamber 600 together with the sample chamber 300, and then the sample chamber 300 is transported to the laboratory center alone for secondary confirmation. The specific process involves removing the collector 100, inserting a pipette through the through -hole 501 of the extrusion platform 500 into the chamber 320, and absorbing the liquid sample.

[0127] In some embodiments, the sample chamber is disposed within the testing chamber, which contains a testing element. When the liquid flows out of the sample chamber through the through- hole, it directly contact with the testing element in the testing chamber for laboratory testing.

[0128] In some embodiments, the through-hole 304 is in fluid communication with the sealed space 3026. In the initial state, the sealed space 3026 is not connected to the external space of the through-hole 304 (i.e., the space formed by the testing chamber 600), and the air pressure in the sample chamber is equal to that in the testing chamber. When the collector is inserted into the sample chamber, a segment of air 3026 is sealed inside the sample chamber, or a sealed chamber is formed. As the collector continues to be inserted, the absorbent element 104 is compressed by the extrusion platform 500, releasing the liquid sample. At same time, a portion of the released liquid sample remains in the secondary confirmation chamber 320 of the sample chamber. If the liquid level is higher than the position of the through-hole 304, the air pressure in the sealed chamber increases, forming a pressure difference between the testing chamber and the sample chamber. This pressure difference causes the liquid in the sample chamber to flow into the testing chamber through the through-hole 304. The specific process is as follows: if there is gas present, the increased air pressure causes the gas to exit from the through -hole 304, making the sealing film detach from the through-hole. Thus, the gas enters the testing chamber through the through- hole. If there is excess liquid, it will also flow into the testing chamber through the through-hole304 to contact with the testing element in the testing chamber, and undergo the test or assay for the analyte in the liquid sample. In some embodiments, the elastic element is configured to seal the through-hole. Meanwhile, when the air pressure inside the sample chamber increases, it facilitates the discharge of gas and allows liquid to flow into the testing chamber through the through-hole 304. The elastic sealing material can seal the through-hole, facilitating the inflow into the testing chamber. The through-hole is a recessed through-hole 3191, as shown in Fig. 12, with the through-hole 304 disposed at the center of the recess. The elastic material is shaped like a cylindrical material 400 wrapped around the outer wall of the sample chamber. When the sealed space 3026 is compressed to increase air pressure, the pressure is sufficient to make the elastic material detach from the through-hole, and the gas pressure can flow out from the bottom of the elastic material. The "detachment" refers to the elastic material below the through-hole separating from the outer wall surface (306) of the sample chamber. This detachment occurs when a pressure difference exists between the testing chamber and the sample chamber, forcing the gas or liquid inside the sample chamber to flow out of the through-hole 304 and through the space between the elastic element and the outer wall of the sample chamber to the bottom of the testing chamber.

[0129] It can be understood that the gas or liquid from within the sample chamber flows out through the through-hole 304 under pressure. As the liquid or gas flows downward, also driven by pressure, this flow naturally causes the elastic material covering the outer wall of the sample chamber to detach from the outer wall surface, allowing the liquid or gas to pass through the valve. Therefore, for the elastic sealing ring, the elastic material above the through-hole can be tightly adhered to the outer wall of the sample chamber, while the elastic material at and below the through-hole relies on its own elasticity to stick to the sealing surface of the sample chamber. This makes it easier for liquid or gas to flow into the testing chamber. In some embodiments, a sealing plug is arranged on the through-hole. Initially, the plug seals the through-hole. When the pressure inside the sample chamber increases due to the pressure difference between the sample chamber and the testing chamber, the plug is forced to disengage from the through-hole, allowing excess gas or liquid in the sample chamber to flow into the testing chamber through the through- hole. In some embodiments, to ensure the smooth inflow of liquid into the testing chamber, channels are provided in the testing chamber. These channels maintain gas communication with the outside while preventing liquid communication. This means the testing chamber can exchange gas with the outside but cannot exchange liquids, or it allows gas exchange with the outside while blocking liquid exchange. For example, a gas-permeable but water-impermeable material can be used to cover the outlets of the micro-channels between the testing chamber and the outside. In this way, when the liquid in the sample chamber enters the testing chamber, since the testingchamber maintains gas communication with the outside, the pressure in the sample chamber causes the liquid to flow into the testing chamber more easily.

[0130] In some embodiments, the bottom of the sample chamber also includes one chamber to reserve liquid for secondary confirmation testing. In some embodiments, the chamber for secondary confirmation testing is located below the extrusion plate 500, as shown in Fig. 7. One chamber 320 is provided beneath the extrusion plate 500, with its bottom 3027 located lower than the through-hole 304. When the collector is inserted into the sample chamber, the sealed space 3026 formed includes this secondary confirmation chamber 320. When the absorbent element 104 of the collector comes into contact with the extrusion plate, the extrusion plate is provided with a downward extending tube that extends all the way to the bottom of the secondary confirmation chamber. In this way, the liquid released from the absorbent element 104 first enters the secondary confirmation chamber 320. When the liquid level in the secondary confirmation chamber reaches the position of the through-hole 304, if the absorbent element continues to be compressed, the gas pressure within the sealed space will continue to rise. This causes the remaining liquid to be discharged from the through-hole 304. The discharged liquid then causes the elastic film to move away from the through-hole, allowing the liquid to flow into the testing chamber. In fact, when the liquid enters the secondary confirmation chamber 320 but has not reached the height of the through-hole 304, as the liquid flows into the secondary confirmation chamber, a portion of the gas must be discharged. The excess gas is then discharged into the testing chamber through the through-hole 304, and the gas entering the testing chamber is discharged to the atmosphere through the micro-channel that maintains gas communication between the testing chamber and the outside. In this way, the liquid can smoothly enter the secondary confirmation chamber 320. The volume of the secondary confirmation chamber can be flexibly set, for example, to hold 1-5 milliliters of liquid sample. Specifically, the volume can be adjusted by modifying the height difference between the through-hole 304 and the bottom of the secondary confirmation chamber. It can also be understood that the liquid sample first flows to the bottom of the secondary confirmation chamber and gradually fills it. Excess liquid then flows out through the through-hole 304 into the testing chamber, completing the initial test by the testing element.

[0131] Locking of collector

[0132] In some embodiments, after the collector is inserted into the sample chamber, it is locked in the sample chamber. There are two locking modes. One mode is that the device is further provided with a cover body 200, and the cover body can be fastened to the testing chamber, such that the cover body presses the hand-held portion of the collector, and the collector is located atthe fixed position of the sample chamber. The locking mode is mainly used to prevent the liquid in the secondary confirmation chamber from leakage, such that the liquid can be easily transported to professional departments for secondary validation. When secondary confirmation is required, the cover body 200 is opened, the collector is removed from the sample chamber, and then a washing liquid tube is inserted into the inlet of the sample chamber to aspirate the liquid from the secondary confirmation chamber for secondary confirmation testing. After the sample is aspirated, a sealing plug can be provided to seal the inlet 101 of the sample chamber to prevent liquid leakage.

[0133] Another locking structure is shown in Figs. 15-17. The end of the collector 100 has a structure with an external thread, and a locking cover 1000 is disposed outside the testing chamber. The locking cover 1000 is closed outside the testing chamber or fixed on the seal 301. The locking cover is provided with a through-hole, and several locking buckles 1002 (one or more) are disposed around the through-hole. The locking buckle 1002 has a lock head 10 and a lock body 11. The lock body is like a sheet, extending upward from the edge of the through-hole 1001. The lock body is parallel to the edge of the through -hole or in a plane, and the lock head 10 is inclined outward with a slope. The hand-held portion of the collector is a gradually expanding section with a cover, and the cover has a flange. Below the cover, the section gradually narrows. When the locking cover 1000 is placed over the surface of the testing chamber and the collector is inserted into the sample chamber, the hand-held portion of the collector is located on the locking cover. The locking buckles 1002 of the through-hole 1001 on the locking cover will expand outward. After insertion, the lock head of the locking buckle contact with the flange of the cover, which not only limits the insertion depth of the collector but also fixes the collector in the sample chamber to prevent it from falling off easily. The fixing force ensures that the collector remains sealed with the sample chamber, preventing the liquid in the secondary confirmation chamber from leaking. When secondary confirmation is required, the collector is removed from the sample chamber, and sampling for secondary confirmation is performed.

[0134] Operation method or registration test method

[0135] The operation method in a specific embodiment of the present invention is described in conjunction with Figs. 22-24. As shown in Fig. 23, the absorbent element 104 of the collector 100 is used to absorb the liquid sample. Then, the cover body 200 is opened, and the collector is inserted into the sample chamber 300 through the opening 303 of the sample chamber. During the insertion process, when reaching the second-section sample chamber 3021, the elastic ring 106 on the collector comes into contact with the inner wall 3025 of the sample chamber, forming a sealed space within the sample chamber. This sealed space includes the area from below the absorbentelement or below the sealing ring 106 to the bottom 3027 of the sample chamber, all of which are sealed. As the collector continues to be inserted, the volume of the sealed space decreases. The reduction in volume naturally increases the internal pressure, which prompts the valve structure formed by the elastic element 400 and the through-hole 304 to open, allowing air to be discharged into the testing chamber. At this time, the testing chamber remains connected to the outside, so the air discharged into the testing chamber is released into the atmosphere. As the collector continues to be inserted, the absorbent element 104 contact with the extrusion element 500 and is extruded, releasing the liquid sample into the secondary confirmation chamber 320 for storage. If there is excess liquid sample, the increasing pressure in the sealed space of the sample chamber forces the excess liquid through the valve structure formed by the through-hole 304 and the elastic element 400. The excess liquid is then discharged into the testing chamber, where it contact with the sample application area of the testing element 900 for the initial assay. The liquid flowing out from the sample chamber 300 is guided by the diversion channel 322 in the second recess 305 to the bottom of the testing chamber, where it collects and contact with the testing element. At this point, the cover body 200 is placed over the seal 301, thereby securing the collector in the sample chamber.

[0136] After the test is completed, if secondary confirmation of the sample is considered necessary, the entire detection device can be sent to a testing laboratory for secondary confirmation testing. Of course, at this point, the cover body 200 can be opened to remove the sample chamber 300 from the testing chamber 600. With the collector kept in the locked position, only the sample chamber and the collector are sent to the secondary testing center for testing. Alternatively, the collector 100 is removed from the sample chamber 300, then the opening 303 of the sample chamber is sealed with a plug, and then the sample chamber 300 is sent to the secondary testing center for testing and assay.

[0137] All patents and publications mentioned in the specification of the present invention indicate that these are disclosed techniques in the art and can be used by the present invention. All patents and publications cited herein are likewise listed in the references as if each publication is specifically and separately referenced. The present invention described herein may be implemented in the absence of any one or more elements, and one or more limitations, which are not specifically stated herein. For example, in each instance herein, the terms "comprising / including," "consisting essentially of," and "consisting of' may be replaced by either of the other 2 terms. The term “a / an” here merely means “one,” but does not exclude including 2 or more in addition to including only one. The terms and expressions employed herein are descriptive and are not limited thereto, and there is no intention herein to indicate that the termsand interpretations described herein exclude any equivalent features, but it can be noted that any appropriate changes or modifications can be made within the scope of the present invention and claims. It can be understood that the embodiments described in the present invention are preferred embodiments and features, and any person skilled in the art can make some modifications and changes based on the essence of the description of the present invention. These modifications and changes are also considered to be within the scope of the present invention and the scope limited by the independent claims and the dependent claims.

Claims

Claims1. A device for detecting an analyte in a liquid sample, comprising: a sample chamber that is configured to receiving a collector, wherein the sample chamber is provided with a through-hole, and the through-hole connecting an interior of the sample chamber to an exterior of the sample chamber; and an elastic element, wherein when the elastic element is in an initial first state, the through-hole is closed state; and when the elastic element is in a second state, the through-hole is opened state.

2. The device according to claim 1, wherein the elastic element covers the through -hole in the initial first state.

3. The device according to claim 1, wherein the elastic element forms a valve structure on an outer surface of the sample chamber, and the valve structure is capable of being in an open or closed state; and when in the open state, the sample chamber is in fluid communication with the outside of the sample chamber , and when in the closed state, the sample chamber is not in fluid communication with the outside of the sample chamber.

4. The device according to any one of claims 1-3, wherein the first state of the elastic element comprises the elastic element covering the through-hole to closed the through-hole, thereby preventing the interior of the sample chamber from being in fluid communication with the outside of the sample chamber.

5. The device according to any one of claims 1, wherein the second state of the elastic element comprises the elastic element moving away from the through-hole to keep the through-hole in an open state, thereby allowing the interior of the sample chamber to be in communication with the outside of the sample chamber.

6. The device according to any one of claims lor 3, wherein a change in a state of the elastic element or a state of the valve structure is caused by an air pressure difference between the interior of the sample chamber and the outside of the sample chamber.

7. The device according to any one of claims 6, wherein when air pressure in the interior of the sample chamber is greater than outside air pressure, the air pressure difference causes the elastic element to move away from the through-hole, allowing the sample chamber to be in communication with the outside through the through-hole, or when air pressure in the interior of the sample chamber is greater than outside air pressure, the valve structure opens, causing the through-hole to be in communication with the outside through the valve structure.

8. The device according to any one of claims 6, wherein when the air pressure in the interior of the sample chamber is less than or substantially equal to the outside air pressure, the air pressuredifference causes the elastic element to seal the through-hole, causing the sample chamber to be incapable of being in communication with the exterior of the sample chamber through the through-hole; or the valve structure closes, causing the through-hole to be incapable of being in communication with the outside through the valve structure.

9. The device according to any one of claims 6-8, wherein a change in the air pressure in the interior of the sample chamber is caused by a collector entering into the sample chamber, causing formation of a change in relative air pressure between the interior of the sample chamber and the outside.

10. The device according to claim 9, wherein the air pressure in the interior of the sample chamber is greater than the outside air pressure.

11. The device according to claim 9, wherein the collector is configured to collect a liquid sample and comprises an absorbent element, and when the collector is inserted into the sample chamber, the absorbent element is capable of being compressed.

12. The device according to any one of claims 9-11, wherein when the collector is inserted into the sample chamber or during an insertion process, a sealed space is formed by sealing a section of space in the interior of the sample chamber, the through-hole is in communication with the sealed space, and an increase in the air pressure in the sample chamber is caused by compression of gas in the sealed space.

13. The device according to claim 7, wherein if the sample chamber contains a fluid, the fluid is capable of flowing out of the sample chamber through the through-hole.

14. The device according to claim 8, wherein if the sample chamber contains a fluid, the fluid is incapable of flowing out of the sample chamber through the through-hole.

15. The device according to claim 14 or 13, wherein the fluid comprises a gas or a liquid sample.

16. The device according to claim 15, wherein the liquid is a liquid sample that is collected by a absorbent element on the collector and released from the absorbent element into the sample chamber.

17. The device according to claim 12, wherein the sealed space comprises a sample retention chamber, and the sample retention chamber is configured for secondary confirmation testing.

18. The device according to claim 17, wherein when the collector is inserted into the sample chamber, and a liquid released by compression of the absorbent element is capable to flow into the sample retention chamber.

19. The device according to claim 1, further comprising a testing device, wherein the testing device is configured to initially test whether a portion of a liquid sample flowing from a sealed space to an exterior of the sample chamber contains the analyte.

20. The device according to claim 17, wherein the sample chamber is located in a testing chamber, and the testing chamber comprises a testing element.

21. The device according to claim 1, further comprising a secondary confirmation chamber, and the secondary confirmation chamber is in fluid communication with the through-hole.

22. The device according to claim 21, wherein the secondary confirmation chamber is configured to collect a liquid sample from the collector.

23. The device according to claim 21, wherein when the through-hole is sealed, a fluid in the secondary confirmation chamber is incapable of flowing out of the chamber through the through- hole, and when the through-hole is opened, a fluid in the secondary confirmation chamber is capable of flowing out of the sample chamber through the through-hole.

24. The device according to claim 23, wherein the elastic element forms a valve structure with the sample chamber, and the valve structure is capable of being in an open or closed state.

25. The device according to claim 24, wherein the valve structure is formed by the elastic element covering a portion of an outer wall surface of the sample chamber.

26. The device according to claim 24, wherein the valve structure is located near the through-hole.

1. The device according to any one of claims 24-26, wherein a change in a state of the elastic element, causing opening or closing of the through-hole, is caused by an air pressure difference between the interior of the sample chamber and the outside.

28. The device according to claim 1 wherein when air pressure in the interior of the sample chamber is greater than outside air pressure, the air pressure difference causes the elastic element to move away from the through-hole, keeping the through-hole in an open state, and when air pressure in the interior of the sample chamber is less than or equal to outside air pressure, the air pressure difference causes the elastic element to recover and cover the through-hole, keeping the through-hole in a closed state.

29. The device according to claim l, wherein the air pressure difference is generated when the collector is inserted into the sample chamber, allowing air pressure in the interior of the sample chamber to be greater than air pressure in the exterior of the sample chamber, thereby causing the elastic element to open a sealed through-hole, so that the pressure difference causes the sample in the secondary confirmation chamber to flow out of the sample chamber, or causing the valve structure to open, allowing the through-hole to be in fluid communication with the outside through the valve structure.

30. The device according to any one of claims 21-29, wherein the secondary confirmation chamber is located downstream of the through-hole .

31. The device according to any one of claims 21-30, wherein a liquid outlet of the secondary confirmation chamber is downstream of a position of the through-hole.

32. The device according to any one of claims 21-31, wherein after the secondary confirmation chamber is filled with a liquid, an excess liquid flows out of the sample chamber through the through-hole.

33. The device according to any one of claims 25-30, wherein the secondary confirmation chamber and the through-hole are both located in or in fluid communication with a space where the air pressure in the interior of the sample chamber.

34. The device according to claim 33, wherein the space where the air pressure increases comprise the secondary confirmation chamber.

35. The device according to claim 31, wherein the collector is inserted into the sample chamber to form a sealed space within the sample chamber, the sealed space comprises the secondary confirmation chamber, and the sealed space is in communication with the outside through the through-hole.

36. The device according to claim 32, wherein the liquid flowing out of the sample chamber to contact with a testing element to assay whether the liquid contains an analyte.

37. The device according to claim 36, wherein the elastic element covers a periphery of the through- hole.

38. The device according to claim 37, wherein the elastic element covers the outer wall surface of the sample chamber.

39. The device according to claim 1, wherein the sample chamber further comprises a drainage channel, and the drainage channel is configured to receive a liquid flowing out of the through- hole.

40. The device according to claim 39, wherein the through-hole and an inlet of the drainage channel are separated by the elastic element, and when air pressure in the interior of the sample chamber increases, the elastic element moves away from a separation, allowing the through-hole to be in communication with the inlet of the drainage channel.

41. The device according to claim 40, wherein the separation is located on an outer surface of the chamber, and the elastic element covers the outer surface.

42. The device according to claim 41, wherein the separation is defined on an outer wall surface of the sample chamber, and the elastic element covers the portion of the outer wall surface, and when the air pressure in the interior of the sample chamber increases, the elastic element moves away from the portion of the outer wall surface, allowing the liquid from the through-hole to flow into the inlet of the drainage channel.

43. The device according to claim 42, wherein the sample chamber is in a testing chamber, and the liquid from the drainage channel flows to a bottom of the testing chamber to contact with a testing element in the testing chamber, thereby testing the analyte in the liquid.

44. A device for detecting an analyte in a liquid sample, comprising: a sample chamber for accommodating a collector, wherein the collector is configured to collect a liquid sample; a testing chamber comprising a testing element, wherein the testing element is configured to detect the analyte in the liquid sample; and a secondary confirmation chamber for collecting the liquid sample from the collector, wherein when the secondary confirmation chamber is filled with a liquid, an excess liquid is forced into the testing chamber for initial testing of the analyte.

45. The device according to claim 42, wherein the sample chamber and the testing chamber are in fluid communication through a through-hole.

46. The device according to claim 45, wherein the through-hole is covered with an elastic element, when the elastic element is in an initial first state, the through-hole is sealed by the elastic element, and when the elastic element is in a second state, the through-hole is opened.

47. The device according to claim 46, wherein the second state of the elastic element comprises the elastic element moving away from the through-hole to keep the through-hole in an open state.

48. The device according to claim 46, wherein an increase in air pressure in an interior of the sample chamber causes the elastic element to be in the second state of moving away from the through- hole.

49. The device according to claim 48, wherein the increase in the increase in air pressure in the interior of the sample chamber causes the excess liquid located in the secondary confirmation chamber to flow out through the through-hole.

50. The device according to claim 48 or 49, wherein the increase in air pressure inside the sample chamber is caused by the collector entering the sample chamber.

51. The device according to claim 48, wherein the collector is inserted into the sample chamber, forming a sealed space, and the sealed space is compressed, thereby increasing an air pressure in the sealed space.

52. The device according to claim 51, wherein the sealed space is in fluid communication with the through-hole.

53. The device according to claim 51, wherein the collector comprises a liquid-absorbing element, and the liquid-absorbing element is configured to collect and absorb the liquid sample.

54. The device according to claim 53, wherein the liquid-absorbing element is inserted into the sample chamber and is capable of being compressed to release the liquid sample.

55. The device according to claim 54, wherein a released liquid from the liquid sample first flows into the secondary confirmation chamber.

56. The device according to claim 55, wherein the sample chamber is provided with an extrusion element for compressing an absorbent element, and the element causes the liquid-absorbing element to be compressed to release the liquid sample.

57. The device according to claim 56, wherein the secondary confirmation chamber is disposed below the extrusion element or located beneath the extrusion element.

58. The device according to claim 56, wherein the through-hole is located downstream? of the extrusion element.

59. The device according to any one of claims 49-55, wherein the sealed space comprises the secondary confirmation chamber.

60. The device according to any one of claims 45-59, wherein the through-hole is disposed between the sample chamber and the testing chamber, and a liquid flowing out of the secondary confirmation chamber flows into the testing chamber through the through-hole.

61. The device according to any one of claims 1-60, wherein the liquid sample is saliva, urine or blood.

62. The device according to any one of claims 1-61, wherein the analyte is a substance of drug abuse.

63. A method, comprising providing a sample chamber provided with a through-hole, the through- hole connecting an interior of the sample chamber to the outside of the sample chamber, wherein a periphery of the through-hole is covered with an elastic element, and the elastic element forms a valve structure with an outer surface of the sample chamber.

64. The method according to claim 63, wherein when the valve structure is in a first state, the valve structure is in a closed state, so that the sample chamber is incapable of being in fluid communication with the outside, and when the valve structure is in a second state, the valve structure is in an open state, enabling the sample chamber to be capable of being in fluid communication with the outside.

65. The method according to claim 64, wherein the valve structure comprises a portion of the elastic element and a portion of an outer wall surface of the sample chamber, and the elastic element covers the outer wall surface.

66. The method according to claim 63, wherein when the valve structure is in the open state, the elastic element moves away from the outer wall surface; and when the valve is in the closed state, the elastic element contact with the outer surface of the sample chamber.

67. The method according to any one of claims 63-66, wherein closing or opening of the valve structure is caused by a change in a pressure difference between the interior of the sample chamber and the outside.

68. The method according to claim 67, wherein the pressure difference comprises pressure in the interior of the sample chamber being greater than pressure outside the sample chamber; or pressure in the interior of the sample chamber is less than or substantially equal to pressure of outside the sample chamber.

69. The method according to claim 64, wherein a collector for collecting a liquid sample is inserted into the sample chamber, thereby causing a pressure difference between air pressure in the interior of the sample chamber and outside pressure.

70. The method according to claim 66, wherein a collector is inserted into the sample chamber to form a sealed space in the sample chamber, and a volume of the space is compressed, so that pressure in the interior of the sample chamber is greater than outside pressure.

71. The method according to claim 70, wherein when the pressure in the interior of the sample chamber is greater than the pressure outside the sample chamber, the valve is opened; or when the pressure in the interior of the sample chamber is less than or substantially equal to the pressure outside the sample chamber, the valve is closed.

72. A device for detecting an analyte in a liquid sample, comprising: a sample chamber for accommodating a collector, wherein the collector is configured to collect the liquid sample; a testing chamber comprising a testing element, wherein the testing element is configured to detect the analyte in the liquid sample; and a secondary confirmation chamber for collecting the liquid sample from the collector, wherein when the secondary confirmation chamber is filled with a an excess of the liquid sample, the excess is forced into the testing chamber for initial testing of the analyte, wherein the secondary confirmation chamber is in communication with an external space outside the sample chamber through a through-hole, and the through-hole is covered with an elastic element, wherein when the elastic element is in an initial first state, the through-hole is sealed, and when the elastic element is in a second state, the through-hole is opened.

73. The device according to claim 72, wherein the sample chamber comprises a sealed space, the sealed space comprises the secondary confirmation chamber, and the sealed space is in communication with the through-hole at the same time.

74. The device according to claim 73, wherein when the collector is inserted into the sample chamber, the collector and the sample chamber jointly form the sealed space.

75. The device according to claim 74, wherein gas in the sealed space is capable of being compressed to increase air pressure in the sealed space, and increased air pressure causes the elastic element to move away from the through-hole, thereby changing the through-hole from the first state to the second state.

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