Device for testing substance to be analyzed in sample

Abstract

The present invention provides a device for testing an analyte in a sample, the device comprising: a sample chamber for receiving a sample collector; the sample cavity is provided with a sealing film which is easy to puncture; the containing cavity is used for receiving the sample cavity, a puncturing element used for puncturing the sealing film to release liquid in the sample cavity is arranged in the containing cavity, and a blade structure used for transversely cutting the film is arranged in the containing cavity.

Description

[0001] The present application claims priority to the Chinese prior application with the application number: 2024103980611 and the filing date: April 02, 2024, the contents of which are hereby incorporated by reference in its entirety. TECHNICAL FIELD

[0002] The present application relates to a device for collecting a liquid sample and a detection device, in particular a device for detecting an analyte in a liquid sample in the field of rapid diagnosis, such as a fecal sample, a saliva sample, and a sample for testing an analyte. BACKGROUND

[0003] The following background description is merely background information and does not constitute any limitation on the present application.

[0004] In the field of in vitro diagnosis (IVD), chromatography technology is often used to diagnose and detect diseases and other items. For example, immunocolloidal gold test paper, dry chemical test paper, and immunofluorescence test paper all use chromatography principles to pretreat samples, react with reagents, and finally obtain diagnostic results reflecting whether a disease is present. The process of a fluorescent immunochromatographic test paper is as follows: after the sample (whole blood, plasma, etc.) is added to the sample pad, the liquid flows to the absorbent paper end; sample processing is performed in the sample pad, red blood cells are filtered, and interfering substances are removed; the sample flows through the conjugate pad, antigen-antibody immunological binding occurs, and a fluorescent group is carried, when it flows through the nitrocellulose membrane, it specifically binds with the pre-bound antigen-antibody on the test line and control line, the accumulated fluorescent group on the test line and control line reflects the test result, and other interfering substances that are not combined are absorbed by the absorbent paper. Due to the characteristics of simple operation, strong specificity, high sensitivity, and quantification, fluorescent immunochromatographic technology has been widely used in the field of POCT detection in recent years. However, in the past few decades, most immunochromatographic test cards can only be used for single project detection with a single test paper. However, with the development of medical technology, the diagnosis of diseases requires simultaneous detection of multiple targets for more accurate determination, such as myocardial 3-plex, myocardial 5-plex, etc. In some cases, the state of multiple organs needs to be detected simultaneously to determine the disease, such as heart-lung 5-plex, etc.

[0005] Currently, detection devices for detecting whether a sample contains an analyte are widely used in hospitals or homes. These detection devices for rapid diagnosis include one or more test strips, such as early pregnancy detection, etc. Such rapid diagnostic detection devices are very convenient and can obtain a detection result on the test strip within one minute or at most ten minutes.

[0006] Fecal testing, traditionally, is done by collecting fecal matter with a collector and then testing the sample for the analyte. Some are collected with special collection tools and then sent to a professional testing facility. This is not very convenient and the sample can deteriorate during transport, affecting the final test and results. Currently, some fecal collection and testing integrated structures have appeared, but these structures still have some shortcomings, such as the control of the amount of sample collected, and the failure to collect some special samples. In particular, for home self-testing operations, it is not very convenient. Sometimes, when testing the analyte in the fecal matter, it is hoped that the testing can be done after collection and the results can be obtained, or the tester can test at home. Therefore, the existing traditional sample collection and testing need to be improved. SUMMARY

[0007] To overcome the shortcomings of the prior art, the present application provides a device for detecting an analyte in a liquid sample, which includes a sample chamber for receiving a collector, a receiving chamber for receiving the sample chamber so that when the sample chamber enters the receiving chamber, the liquid in the sample chamber is released for testing.

[0008] In some embodiments, the sample chamber receives a collector, and the sample chamber contains a treatment liquid for treating the liquid sample; when the sample chamber is inserted into the receiving chamber, the sample chamber is punctured to release the liquid.

[0009] In some embodiments, the sample chamber contains a collector, and the collector is detachably combined with the sample chamber. In some embodiments, the collector is combined with the sample chamber. In some embodiments, the collector seals the opening of the sample chamber and retains the solution for treating the sample in the sample chamber. In some embodiments, after the collector collects the sample, it is inserted into the sample chamber and seals the sample chamber, so that the collector and the sample chamber are integrated.

[0010] In some embodiments, the collector and the sample chamber exist independently and are not detachably combined. In this case, if the sample chamber contains a treatment liquid, the opening of the sample chamber is sealed by a sealing plug. In some embodiments, the collector has a structure for sealing the opening, and the collector has a sampling area that can take a powder sample or a liquid sample. When taking a liquid sample, the sampling area includes a water-absorbing material for absorbing the liquid sample. In some embodiments, the water-absorbing material can be compressed to release the liquid sample. In some embodiments, after the collector collects the sample, the sealing plug is removed and the collector is inserted so that the sampling area of the collector is located in the sample chamber, and the collector seals the opening of the sample chamber. In some embodiments, the collector can be inserted into the sample chamber as a whole, so that the opening of the sample is sealed by the sealing plug.

[0011] In some embodiments, the sample chamber is open at one end and closed at the other. When the collector is inserted into the chamber through the open end, the collector seals the opening of the tube or a sealing plug seals the opening of the sample chamber. In some embodiments, the closed end is sealed by a puncturable membrane. When the sample chamber is inserted into the receiving chamber, the sealing membrane is punctured, releasing the liquid.

[0012] In some embodiments, the receiving chamber is used to receive the sample chamber, allowing the sample chamber to be punctured in the receiving chamber, thereby releasing the liquid in the sample chamber. In some embodiments, the receiving chamber contains a puncturing element or puncturing structure, and the puncturing element is used to puncture the sealing film. The receiving chamber includes a tube body, and the sample chamber can be inserted into the tube body. In some embodiments, the tube body of the receiving chamber includes a structure with an opening at one end and a bottom at the other end, and the bottom includes a puncturing element protruding upward. In some embodiments, the distance between the top of the puncturing element and the opening of the tube body is smaller than the distance from the bottom of the sample chamber to the opening. In this way, when the sample chamber is inserted into the tube body of the receiving chamber, the puncturing element can puncture the sealing film at the bottom of the sample chamber. In some embodiments, after the puncturing element punctures the sealing film, part of the puncturing element enters the sample chamber and forms a puncture hole in the sealing film. In some embodiments, when the sample chamber is inserted into the collector, the opening is hermetically sealed, thereby forming an hermetically sealed space in the sample chamber. The sealed space contains gas and processing liquid (if any). When the puncture element enters the sample chamber, a certain pressure is applied to the gas, and the increased pressure causes the liquid to flow out through the punctured sealing film.

[0013] In some embodiments, the outer diameter of the puncture element is slightly smaller than the inner diameter of the sample cavity, so that when the puncture element fully or partially enters the sample cavity, the liquid in the sample cavity can flow out along the puncture element. In some embodiments, the puncture element has a drainage channel, which is provided on the puncture element, and when the puncture element is inserted into the sample cavity, the liquid flows out through the drainage channel. In some embodiments, when the puncture element enters the sample cavity, a portion of the drainage channel also enters the sample cavity, thereby facilitating the liquid to flow out along the drainage channel.

[0014] In some embodiments, the piercing element includes a sharp structure for piercing the sealing film. In some embodiments, the housing cavity further includes a blade structure for transversely cutting, incising, or tearing the sealing film, such that the blade structure can cut, incise, or tear the sealing film transversely when the sealing film contacts the blade structure, thereby forming a larger opening, a cut, an incision, or a tear in the sealing film. In some embodiments, the sharp structure of the piercing element pierces the sealing film longitudinally along the sample cavity to form a piercing opening, and the blade structure cuts, incises, or tears the sealing film transversely from the piercing opening to form a larger opening, or even to cut out a piece of the sealing film from the bottom of the sample cavity. In some embodiments, the blade structure is disposed on the piercing element. In other embodiments, the blade structure is disposed adjacent to the piercing structure. In some embodiments, the sharp structure of the piercing element is disposed closer to the surface of the sealing film than the blade structure. In some embodiments, the sharp structure of the piercing element is disposed higher than the blade structure if both are disposed on the bottom of the housing cavity.

[0015] In some embodiments, the blade structure is connected to the piercing element when the blade structure is disposed adjacent to the piercing element. In some embodiments, the blade structure is connected to the projection of the sharp structure of the piercing element, such that the blade structure can cut, incise, or tear the sealing film transversely from the piercing opening when the sharp structure pierces the sealing film to form the piercing opening.

[0016] In some embodiments, the sample cavity is inserted into the housing cavity, or is rotated into the housing cavity. When the sample cavity is rotated into the housing cavity, the bottom of the sample cavity first contacts the piercing element in the housing cavity to pierce the sealing film, and simultaneously or subsequently, the piercing element cuts, incises, or tears the sealing film transversely from the piercing opening to form a larger opening, or to cut out a piece of the sealing film from the bottom of the sample cavity. In some embodiments, the piercing element can include only a sharp piercing structure. In other embodiments, the piercing element can include a blade structure disposed longitudinally along the piercing structure. In some embodiments, the housing cavity is stationary, and the sample cavity is rotated into the housing cavity.

[0017] In some embodiments, the device further comprises a test cavity, wherein the test cavity comprises a test element, and the test element is capable of testing the presence or quantity of the substance being analyzed in the sample. In some embodiments, the accommodating cavity is disposed in the test cavity. In some embodiments, the accommodating cavity has a cover body, which is used to seal the opening of the test cavity. Therefore, the test cavity is surrounded by a bottom, an opening and a side wall, and a carrier for carrying the test element is provided on the side wall. In some embodiments, the accommodating cavity is a tube body, the bottom of the tube body is close to the bottom of the test cavity, and the cover body seals the opening of the test cavity. In some embodiments, the sample cavity is inserted into the accommodating cavity of the tube body, and the sample cavity seals the opening of the tube body. In some embodiments, the sealing method includes liquid sealing and air sealing. In some preferred embodiments, the sealing method is air sealing.

[0018] In some embodiments, the test chamber and the receiving chamber are fixedly combined. Thus, the receiving chamber and the test chamber are fixed, while the sample chamber and the collector are detachably combined. Of course, when the collector needs to be kept dry before collecting the sample, it is inserted into the sample chamber after collecting the sample, so that the collection area of ​​the collector is exposed to the processing fluid in the sample chamber. At this time, the sampler and the sample chamber exist separately and are packaged separately. Only after the collector collects the sample is the collector and the sample chamber combined or combined. In this embodiment, the sample chamber is sealed with a sealing plug to prevent leakage of the processing fluid.

[0019] In some embodiments, after the collector collects the sample, it is inserted into the sample cavity and seals the opening of the sample cavity. When the sample cavity is inserted into the receiving cavity, the sample cavity seals the opening of the receiving cavity. In some embodiments, the sample cavity enters the receiving cavity by means of a threaded rotation. In some embodiments, the puncture element also punctures the sealing film in a rotating manner and enters the bottom of the sample cavity. Direct puncture and rotational entry can puncture the sealing film to the greatest extent and form an opening to the greatest extent, making it convenient for the liquid to flow down from the bottom of the sample cavity. This is because, if the direct puncture method is used, the punctured part of the sealing film will contact the puncture element, thereby hindering the natural downward flow of the liquid. However, if the rotation method is used, the puncture element not only punctures the film, but also has the function of cutting scissors, allowing a hole to be cut in the film.

[0020] In some embodiments, the receiving tube has an opening at the piercing element, the height of the opening is higher than the height of the piercing element. In some embodiments, the piercing element is located on a piston, the diameter of the piston is equivalent to the inner edge of the bottom of the sample chamber, and the piercing element and the blade structure are located on the end of the piston, when the piston is inserted into the sample chamber in a relative rotating manner, the sealing film is cut by the rotating piercing element. In some embodiments, the film is covered on the bottom of the sample chamber, the film can be cut along the inner edge of the bottom of the sample chamber, so that the film is completely separated from the bottom by the force of the piston entering the sample chamber, and the liquid can flow out of the sample chamber freely. In some embodiments, a drainage channel is provided on the side wall of the piston. The processing liquid in the sample chamber flows out along the drainage channel. In some embodiments, the liquid flowing out flows into the bottom of the test chamber and contacts the sample application part of the test element.

[0021] In some embodiments, the sampler is inserted into the sample chamber in a threaded rotating manner, and then the sampler is fixed together with the sample chamber. In some embodiments, the sample chamber is inserted into the containing chamber in a threaded rotating manner, and is fixed together with the containing chamber. When fixed together, the sample chamber cannot be separated from the containing chamber. In some embodiments, the sample chamber also has threads, and the containing chamber also has threads, and the threads directly engage with each other to allow the sample chamber to enter the containing chamber in a relative rotating manner by engaging the threads. When the threads are engaged with each other, it is not easy to reverse to separate the sample chamber from the containing chamber, so that the sample chamber and the containing chamber are integrated into a structure.

[0022] In some embodiments, the present application provides a device for detecting an analyte in a liquid sample, the device comprising: a sample chamber for receiving a sample collector, wherein the sample chamber and the collector are combined in a detachable manner; a detection chamber having a test element therein for testing the analyte in the liquid chamber; a containing chamber for receiving the sample chamber, wherein the containing chamber is in fluid communication with the detection chamber.

[0023] In some embodiments, the bottom of the sample chamber has a sealing film for piercing the container, and the bottom of the containing chamber has a piercing element, when the sample chamber is inserted into the containing chamber, the piercing element pierces the sealing film, thereby releasing the liquid in the sample chamber.

[0024] In some embodiments, the sample chamber further comprises a solution for processing the sample.

[0025] In some embodiments, the sample chamber further comprises a collector for collecting the sample, the collector comprises a cover and a collection head, the cover seals the opening of the sample chamber, and the collection head is located in the sample chamber. In some embodiments, the sample is feces, saliva, gastric juice sample. In some embodiments, the analyte is hemoglobin, Helicobacter pylori.

[0026] In some embodiments, the bottom of the test chamber is in fluid communication with the bottom of the holding chamber.

[0027] In some embodiments, the piercing element of the holding chamber is located on a piston, and when the sample chamber is pierced, the piston enters the sample chamber, forcing liquid to flow through the piston and into the bottom of the holding chamber. In some embodiments, the holding chamber has an opening at the piston through which liquid flows into the bottom of the test chamber. In some embodiments, the piston has a channel for drawing liquid from the sample chamber to the test chamber, into contact with the test element, to complete the test for the analyte in the sample.

[0028] In a third aspect, the present application provides a method for detecting an analyte in a sample, the method comprising providing a device comprising: a sample chamber containing a treatment fluid within the sample chamber, and a collector for insertion into the sample; a test chamber comprising a test element within the test chamber and a tube for receiving the sample chamber, the bottom of the tube being proximate to the test chamber, the tube comprising a cap having an opening for insertion of the sample chamber, the cap sealing the opening of the test chamber;

[0029] The collector is removed from the sample chamber, and the sampling end of the collector is used to take a sample from the sample. The sampling end is then inserted into the sample chamber.

[0030] In some embodiments, the sample chamber has a partition dividing the sample chamber into two chambers, one of which contains the treatment fluid and the other of which contains the sampling rod. In some embodiments, the sampling rod has a sealing element which seals the partition when the sampling rod is passed through the partition, thereby sealing the chamber containing the liquid, preferably hermetically.

[0031] In some embodiments, the sample chamber is inserted into the holding chamber in a rotational manner. In some embodiments, the sample chamber cannot be removed from the holding chamber or separated from the holding chamber when the sample chamber is secured to the holding chamber.

[0032] In some embodiments, the holding chamber has a piercing element at the bottom of the holding chamber which pierces the sealing membrane of the sealed chamber. In some embodiments, the piercing element is located on the surface of a piston. The sample chamber is inserted into the holding chamber in a rotational manner, and the piercing element on the surface of the piston pierces the sealing membrane while the piston enters the sample chamber. In some embodiments, when the piston enters the sample chamber, some of the treatment fluid flows into the bottom of the test chamber.

[0033] In some embodiments, the sample chamber and the collector are initially combined. The test chamber and the holding chamber are combined and inseparable.

[0034] In some methods, when testing is required, the sampler is removed from the sample chamber to collect a sample. In some methods, a liquid, solid, or semi-solid sample is adsorbed onto a collection head. After collection is complete, the sampler is reinserted into the sample chamber, and the sample head, with the sample collected, is immersed in the processing fluid within the sample chamber.

[0035] Beneficial effects

[0036] The present invention adopts the combination of the sample chamber and the receiving chamber to realize the separation of collection and testing, and also realizes the self-testing at home. The collection and testing are carried out in steps, which is particularly suitable for the testing of the elderly. Generally, the elderly can collect the samples by themselves, but they are not proficient in the operation. After the collection, they can let their family members operate or send the samples to the medical office for testing, thus reducing the operation errors. In addition, the collected samples can be collected separately, and when testing, professional structures can be used to test, thus ensuring the objectivity of the test. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] Figure 1 It is a schematic diagram of the test element structure in a specific embodiment of the present invention.

[0038] Figure 2 It is a schematic diagram of the three-dimensional structure of a test element in a specific embodiment of the present invention.

[0039] Figure 3 It is a structural decomposition explosion diagram of a detection device in a specific embodiment of the present invention.

[0040] Figure 4 It is a schematic diagram of the three-dimensional structure of a detection device in a specific embodiment of the present invention (the accommodating chamber and the testing chamber are combined together).

[0041] Figure 5A It is a schematic diagram of the three-dimensional structure of the combination of the collector and the sample chamber in a specific embodiment of the present invention (the collector and the sample chamber are detachable).

[0042] Figure 5B It is a schematic diagram of the three-dimensional structure of the combination of the collector and the sample chamber in a specific embodiment of the present invention.

[0043] Figure 6 It is a schematic diagram of the longitudinal cross-sectional structure of the sample chamber and collector combination in a specific embodiment of the present invention.

[0044] Figure 7 It is a schematic diagram of the three-dimensional structure of a sample chamber in a specific embodiment of the present invention.

[0045] Figure 8is a perspective view of the receiving chamber of the sample chamber in one embodiment of the application.

[0046] Figure 9 is a perspective view of the receiving chamber of the sample chamber in one embodiment of the application.

[0047] Figure 10 is a cross-sectional view of the receiving chamber of the sample chamber in one embodiment of the application.

[0048] Figure 11 is a cross-sectional view of the receiving chamber of the sample chamber in one embodiment of the application.

[0049] Figure 12 is an enlarged view of a detail of the receiving chamber in one embodiment of the application.

[0050] Figure 13 is a detail view of the piston element in one embodiment of the application.

[0051] Figure 14A is a detail view of the piston element with the piercing element in one embodiment of the application. Figure 14B is an enlarged view of the piercing structure.

[0052] Figure 15 is a detail view of the piston element with the piercing element in one embodiment of the application.

[0053] Figure 16A is a view of the structure of the sealing film sealing the bottom of the sample chamber; Figure 16B is a view of the structure of the sealing film being cut by the piercing element cooperating with the blade structure; Figure 16C is a view of the structure of the sealing film after being cut from the bottom of the sample chamber; 16D is a view of the cut sealing film.

[0054] Figure 17A is a view of the initial position of the sample chamber with the collector inserted into the receiving chamber in one embodiment of the application.

[0055] Figure 17B is a view of the initial position of the sample chamber with the collector inserted into the receiving chamber in one embodiment of the application (the film of the receiving chamber does not contact the piercing element).

[0056] Figure 18A is a view of the state of the sample chamber with the collector inserted into the receiving chamber and pierced by the piercing element in one embodiment of the application.

[0057] Figure 18BSchematic diagram of the longitudinal cross-sectional structure of a sample chamber with a collector in a specific embodiment of the present invention being inserted into a receiving chamber and punctured by a puncturing element (the film of the receiving chamber contacts the puncturing element).

[0058] Figure 19A Schematic diagram of the structure in which a sample chamber with a collector is inserted into a receiving chamber and punctured by a puncturing element in a specific embodiment of the present invention (the film of the receiving chamber contacts the puncturing element and allows the piston to enter the receiving chamber).

[0059] Figure 19B Schematic diagram of the structure in which a sample chamber with a collector is inserted into a receiving chamber and punctured by a puncturing element in a specific embodiment of the present invention.

[0060] Figure 20 A schematic diagram of the three-dimensional structure of a testing device in a specific embodiment of the present invention.

[0061] Figure 21 It is a schematic diagram of the three-dimensional structure of a testing device in a specific embodiment of the present invention.

[0062] Figure 22 It is a schematic cross-sectional structural diagram of a testing device in a specific embodiment of the present invention.

[0063] Figure 23 It is a schematic diagram of the structure of the detection device after testing (the sample chamber enters and exits the containing chamber).

[0064] Figure 24 It is a schematic diagram of the cross-sectional structure of the detection device test (the sample cavity is inserted into the receiving cavity to start the test).

[0065] Detailed description

[0066] The following is a further explanation of the structures involved in the present invention or the technical terms used. If not otherwise specified, they will be understood and interpreted according to the general terms commonly used in the art.

[0067] Detecting

[0068] "Assay" means to test or examine a substance or material for the presence or absence of a substance or material, such as, but not limited to, a chemical substance, an organic compound, an inorganic compound, a metabolite, a drug or drug metabolite, an organic tissue or its metabolite, a nucleic acid, a protein, or a polymer. Additionally, "assay" means to test for the amount of a substance or material. Furthermore, "assay" also includes immunoassays, chemical assays, and enzyme assays.

[0069] Sample

[0070] The sample of the detection device of the present invention includes a biological liquid sample (such as a case fluid or a clinical sample). Liquid sample or liquid sample can be derived from a solid or semi-solid sample, including excreta, biological tissue and food sample. Solid or semi-solid sample can be converted into a liquid sample by any appropriate method, such as mixing, crushing, macerating, incubating, dissolving or utilizing enzymatic digestion of solid sample in a suitable solution (such as water, phosphate solution or other buffer solution). "Biological sample" includes samples derived from animals, plants and food, such as urine, saliva, blood and its components, spinal fluid, vaginal secretions, sperm, feces, sweat, secretions, tissues, organs, tumors, cultures of tissues and organs, cell cultures and media derived from humans or animals. Preferably, the biological sample is urine, and preferably, the biological sample is saliva. Food sample includes food processed materials, final products, meat, cheese, wine, milk and drinking water. Plant sample includes any plant, plant tissue, plant cell culture and media derived from. An "environmental sample" is derived from the environment (eg, a liquid sample from a lake or other body of water, a sewage sample, a soil sample, groundwater, seawater, and a wastewater sample). An environmental sample may also include sewage or other wastewater.

[0071] Using a suitable detection device of the present invention, any analyte can be detected. The present invention is preferably used to detect small drug molecules in saliva and urine, and can also detect hemoglobin and Helicobacter pylori antigens. Of course, the sample detected by the detection device of the present invention can be any of the above forms of samples, whether initially solid or liquid, as long as the liquid or liquid sample can be absorbed by the sample application area 905 of the test element 900. Here, the sample application area 905 is generally made of a water-absorbing material. Through the capillary action or other properties of the absorbent element material, it can absorb the liquid sample or liquid sample and allow the liquid sample to flow within the sample application area. The material of the liquid sample application area 905 can be any material that can absorb liquids, such as sponge, filter paper, polyester fiber, gel, non-woven fabric, cotton, polyester film, yarn, etc. Of course, the liquid sample application area does not necessarily have to be made of a water-absorbing material and can be made of a non-water-absorbing material, but it can also be made of a capillary action to transfer the liquid sample.

[0072] Liquid to liquid sample, processing liquid

[0073] The "liquid" in the present application can have different meanings in different cases. The liquid can include a liquid sample in liquid form, or a treatment solution used to treat the sample, such as dissolving a solid sample in the treatment liquid, or dissolving a liquid sample in the treatment solution, so as to form a mixed solution of the treatment solution and the liquid sample or the treatment solution and the solid sample. The sample treated by the treatment liquid can also be referred to as a liquid sample, which can be a liquid sample, a solid sample, or a powder sample. When used as a treatment liquid, the liquid herein is generally water as a solvent, and the treatment solution can include other reagents for improving the test performance, such as a PH adjusting reagent, a reagent for removing impurities in the sample, or a reagent for dissolving the sample, but does not contain the target analyte. Therefore, when the sample chamber 400 contains a solution (when there is no sample), it is generally a treatment liquid, a solution for dissolving, eluting, and improving reaction performance, which can dissolve the sample collected by the sample collector 200. Of course, the sample can be a liquid sample, a semi-solid sample, a solid sample, or a semi-solid sample between solid and liquid (such as a gel-like sample containing liquid). When the collector 200 is inserted into the sample chamber 400, the sample on the collector is in contact with the treatment liquid in the sample chamber, so that the sample is dissolved in the treatment liquid. At this time, the sample can also be considered as a liquid sample, which is a sample treated by the treatment liquid, especially when the sample contains the target analyte, and the analyte is dissolved in the treatment liquid. Of course, if the liquid itself is in the form of a liquid sample, the sample chamber can or can not contain a treatment liquid in advance. When the liquid sample is urine, the urine can be directly flowed into the sample chamber. When the liquid sample is saliva, nasal discharge, sputum, or other liquid forms, the sample chamber can be pre-stored with a treatment liquid to treat these liquid samples. For example, if the collector collects a fecal sample, the fecal sample is dissolved in the treatment liquid in the sample chamber 400. For example, when the collector collects a powder sample, the sample chamber 400 contains a treatment liquid, so that the powder sample is dissolved in the treatment liquid to form a liquid sample. Therefore, if the sample needs to contain a treatment liquid, the treatment liquid can be pre-stored in the sample chamber, and the treatment liquid and the sample are mixed to form a mixed liquid, which can be referred to as a sample solution. Of course, as described above, if the sample chamber does not contain a treatment liquid, the liquid sample can be directly stored in the sample chamber.

[0074] Downstream and upstream

[0075] Downstream or upstream is defined in terms of the direction of liquid flow, generally liquid or fluid flows from upstream to downstream. A downstream region receives liquid from an upstream region, liquid can also flow from an upstream region to a downstream region. Here, generally, the direction of liquid flow is defined, for example, some materials that use capillary force to promote liquid flow, liquid can flow against gravity, in this case, upstream and downstream are still defined in terms of the direction of liquid flow. For example, in the detection device of the present application, when the flow guide element receives the liquid sample, the fluid can flow from the flow guide element to the sample application region or sample application pad of the two test elements, then the liquid on the sample application pad flows to the downstream labeled pad, then mixes with the labeled labeling material, and then flows through the transition pad to the downstream detection pad, on the detection pad, the test region is upstream of the test result control region, and finally flows to the downstream absorption region on the absorption pad. The test region can be a polyester fiber film, the flow guide element can be glass fiber, polyester sheet, polyester film. At this time, the flow guide element is upstream of the test element labeling region. The specific structure of the test element is shown in Figures 1-2 When part of the sample application pad, the liquid on the sample pad mainly relies on capillary force to flow.

[0076] Gas communication or liquid communication

[0077] Gas communication or liquid communication means that liquid or gas can flow from one place to another, and the flow process may pass through some physical structures to guide. By passing through physical structures, it generally means that liquid passes through the surface of these physical structures or the space inside these structures to flow passively or actively. Passive flow is generally caused by external force, such as capillary flow, gas pressure, etc. Here, the flow of liquid or gas can also be due to its own action (gravity or pressure), and can also be passive flow. Gas pressure flow can be a natural flow, or it can be a reverse flow, or it can be a gas pressure flow from one location to another. Here, communication does not necessarily mean that liquid or gas must exist, but only in some cases, it indicates the connection relationship or state between two objects. If there is liquid, it can flow from one object to another. Here, it refers to the state of connection between two objects. On the contrary, if there is no liquid communication or gas communication between two objects, if there is liquid in or on one object, the liquid cannot flow into or onto another object. Such a state is non-communication, non-liquid or gas communication state.

[0078] Test element

[0079] As used herein, the term "test element" refers to an element that can detect the presence or absence of an analyte of interest in a liquid sample or fluid sample. The detection can be based on any number of techniques, immunological, chemical, electrical, optical, molecular, nucleic acid, physical, etc. The test element can be a lateral flow test strip that can detect a plurality of analytes. Of course, other suitable test elements can be used in the present application. In the present application, the test element and "lateral flow test element or test strip" are used interchangeably to mean the same thing.

[0080] Various test elements can be combined and used in the present application. One form is a test strip. Test strips for analyzing an analyte in a sample, such as a drug or a metabolite indicative of a physical condition, can be in a variety of formats, such as immunoassay or chemical analysis formats. The test strip can use a non-competitive or competitive assay format. The test strip generally includes a wicking material having a sample application zone, a reagent zone, and a test zone. Fluid or liquid sample is applied to the sample application zone and flows by capillary action to the reagent zone. In the reagent zone, the sample binds to the reagent if the analyte is present. The sample then flows to the test zone. Other reagents, such as molecules that specifically bind to the analyte, are immobilized in the test zone. These reagents react with the analyte in the sample, if present, and bind the analyte in the zone or to a reagent in the reagent zone. A label to indicate the test signal is present in the reagent zone or in a separate label zone.

[0081] A typical non-competitive assay format is one in which a signal is generated if the sample contains the analyte and no signal is generated if the sample does not contain the analyte. In a competitive format, a signal is generated if the analyte is not present in the sample and no signal is generated if the analyte is present.

[0082] The test element can be a test strip that can be made of a wicking or non-wicking material. The test strip can include a plurality of materials for the transport of the liquid sample. One material of the test strip can be coated on another material, such as filter paper coated on a nitrocellulose membrane. One zone of the test strip can be made of one or more materials and another zone can be made of a different one or more materials. The test strip can be adhered to a support or rigid surface to improve the handling strength of the test strip.

[0083] The analyte is detected by a signal generating system, such as by using one or more enzymes that react specifically with the analyte, and by using the method for fixing the specific binding substance on the test paper as described above, to fix the combination of one or more signal generating systems to the analyte detection area of ​​the test paper. The substance that generates the signal can be in the sample addition area, the reagent area, or the detection area, or on the entire test paper. The substance can be filled with one or more materials of the test paper. A solution containing the signal substance is added to the surface of the test paper or one or more materials of the test paper are immersed in the solution containing the signal substance. The test paper to which the signal substance solution is added is dried.

[0084] The various zones of the test paper or the lateral flow test strip 900 of the present invention can be arranged in the following manner: a sample application area 905, a marking area 904, a detection area 902, and the detection area includes a test result area 906 and a test result control area 907. The control area 907 is located after or downstream of the detection area 906. All zones can be arranged on a test paper using only one material. Different materials can also be used in different zones. Each zone can be in direct contact with the liquid sample, or different zones can be arranged according to the direction of flow of the liquid sample, with the end of each zone connected to the front end of another zone and overlapping. The material used can be a material with good water absorption such as filter paper, glass fiber or nitrocellulose membrane. The test paper can also be in other forms.

[0085] The commonly used reagent strips are nitrocellulose membrane reagent strips, that is, the detection area includes a nitrocellulose membrane (NC), and specific binding molecules are fixed on the nitrocellulose membrane to display the detection results; it can also be a cellulose acetate membrane or a nylon membrane, etc. For example, the following patents describe reagent strips or devices containing reagent strips: US 4857453; US 5073484; US 5119831; US ​​5185127; US 5275785; US 5416000; US 5504013; US 5602040; US 5622871; US ​​5654162; US 5656503; US 5686315; US 5766961; US ​​5770460; US 5916815; US 5976895; US 6248598; US 6140136; US 6187269; US 6187598; US 6228660; US 6235241; US The test strips and similar devices with test strips disclosed in the above patent documents can be applied to the test element or detection device of the present invention to detect the analyte, such as the analyte in the sample.

[0086] The test strip used in the present application can be a lateral flow test strip as commonly known in the art. A general test strip 900 Figures 1-2 includes a sample application area or sample application pad 905, a label area 904, a detection area 902, and a sample collection area including a sample receiving pad or sample application pad, and a label area including a label pad. A wicking area 901 can also be included to wick the liquid sample from the nitrocellulose membrane, and the wicking area can include a wicking pad. In some embodiments, the label area includes color particles coupled to an antibody, and the color particles can be latex particles, gold particles, or dyes. The detection area 902 includes necessary chemicals to detect the presence or absence of the analyte, such as an immunoreagent or an enzyme reagent. A general test strip is a nitrocellulose membrane test strip, i.e., the detection area 902 includes a nitrocellulose membrane, and specific binding molecules are immobilized on the nitrocellulose membrane to show a test result area 906 (T-line). It can also be an acetate cellulose membrane or a nylon membrane, etc. Of course, a test result control area 907 (C-line) can also be included downstream of the detection area, and generally, the control area and the detection area appear as horizontal lines, i.e., test lines or control lines. Such a test strip is a conventional test strip, and of course, it can be other types of test strips that use capillary action for detection. In addition, a general test strip has dry chemical reagent components, such as immobilized antibodies or other reagents, and when the liquid is present, the liquid flows along the test strip by capillary action, and as it flows, the dry reagent components dissolve in the liquid, and the reaction occurs in the next area with the dry reagent in that area, and thus, the necessary detection is performed. The liquid flow is mainly by capillary action. All of these can be used in the detection device of the present application, or they can be placed in the detection chamber to contact the liquid sample, or they can be used to detect the presence or absence of the analyte in the liquid sample that enters the detection chamber.

[0087] In addition to the test strip or lateral flow test strip itself being used to contact the liquid sample to test for the presence of the analyte in the liquid sample, the test element itself can be used as the detection device to detect the analyte in the sample. For example, the liquid sample can be mixed with a processing liquid, and the test element can be used directly for detection. The test element can be used alone for detection when the receiving device is used to process the liquid sample, as will be described below.

[0088] Analyte

[0089] Examples of analytes that can be used in the present invention include small molecules, including drugs (eg, drugs of abuse). "Drugs of abuse" (DOA) refer to the use of drugs for non-medical purposes (usually for narcotic effects).

[0090] For example, the analytes detected by the present invention include, but are not limited to, hemoglobin, creatinine, bilirubin, nitrite, protein (non-specific), hormones (for example, human chorionic gonadotropin, progesterone, follicle-stimulating hormone, etc.), blood, white blood cells, sugar, heavy metals or toxins, bacterial substances (such as proteins or sugar substances targeting specific bacteria, such as Escherichia coli 0157:H7, Staphylococcus, Salmonella, Clostridium, Campylobacter, L.monocytogenes, Vibrio, or Bacillus, Helicobacter pylori) and substances related to physiological characteristics in urine samples, such as pH and specific gravity. Any other clinical chemical analysis can be detected using the lateral flow detection format in combination with the device of the present invention. It is also possible to detect the presence of viral antigens, such as new coronavirus antigens and influenza antigens.

[0091] Removable combination

[0092] A removable combination refers to the connection between two components being able to exist in several different states or positions. For example, two physically separate components can be initially separated, then connected or combined under a suitable first condition, and then separated under a suitable second condition. This separation is physically spatially separated without contact. Alternatively, the two components can be combined initially and then, under suitable conditions, physically separated. Alternatively, the two objects can be initially separate, then combined together to perform a function when needed, and then separated, or later combined again for a specific purpose. In short, the combination or separation of the two components can be easily performed, and this combination or separation can be repeated multiple times. Of course, it can also be a one-time combination and separation. Furthermore, the combination can be a removable combination of two components or a removable combination of three or more components. For example, a combination with first, second, and third components, where the first and second components are removable, can also be a removable combination of the second and third components, or can be removably combined or separated. Furthermore, the combination can be removable between the two objects themselves or indirectly through another object.

[0093] Carrier containing test element

[0094] In some embodiments, the test elements 900 can also be provided on a carrier element 500, such that the carrier element contains the test elements and performs the detection and analysis of the analyte in the liquid sample. Thus, in some embodiments, the detection device comprises a carrier 500 on which the test elements 900 are provided. In some embodiments, the carrier of the present application is a carrier element that is used to carry or house the test elements, and the carrier element itself does not participate in the direct detection function, but rather serves as a carrier or housing for the test elements that it carries or houses. For example, as shown in Figure 3 FIG. 20, a carrier 500 is provided that has slots 501 provided to receive test elements 900. Multiple slots can be provided on a carrier, each of which receives a test element. Typically, the sample application region of the test element is located at or extends from one end of the slot opening 503. When the test elements 900 are provided in the slots, a transparent film (not shown) is provided over the surface of the carrier 500, and the carrier 500 is then inserted into the test chamber 100. The test chamber has two opposing planar surfaces, and the carrier 500 is inserted into the test chamber 100 so that the surface of the carrier 500 with the test elements rests on one of the planar surfaces 102, and the surface of the test chamber 100 with the test elements rests on the other planar surface, so that the test results on the test elements can be read through the transparent surface 102 of the test chamber when the test is performed. Of course, the transparent surface of the test chamber 100 can also be placed under a scanner to scan and record the test results. In some embodiments, each slot in the carrier 500 has a raised structure at one end that is used to secure the test element in the slot. Typically, the raised structure is used to engage the position of the absorbent pad on the test element.

[0095] Test chamber containing test element

[0096] In some embodiments, as shown in Figure 3 FIGS. 20-22, the present application provides a test chamber 100 that contains test elements 900, which can be one or more test elements. In some embodiments, the test elements 900 are provided on a carrier 500 that has multiple slots, each of which receives a test element, and the carrier is positioned in the test chamber. As shown in Figure 1As shown in FIGS. 22-24, the test chamber 100 includes an opening 101 and a side wall and a bottom 105. The side wall is irregularly shaped, such as generally triangular, and has a transparent flat surface 102 on the side wall. The test chamber has a fixed structure 107 inside the test chamber, symmetrically disposed behind the flat surface 102 and extending upward from the bottom 105 of the test chamber. The carrier 500 with test elements 900 is disposed between the fixed structure and the flat surface 102, with the grooves of the carrier facing the flat surface 102 so that the test regions and control regions of the test elements 900 are visible through the flat surface 102. The outlet 503 of the grooves of the carrier is preferably near the bottom 105 of the test chamber. Preferably, the end of the sample application region 905 of the test element 900 is in contact with the bottom of the groove 104 at the groove 104 so that when the liquid sample or sample-containing liquid collects at the groove 104, it contacts the sample application region of the test element 900 and completes the assay of the analyte. In some embodiments, the bottom 105 is sloped, with the portion of the slope 106 at the junction of the flat surface 102 and the opposite surface 108 being higher than the portion of the slope 106 at the groove 104. The bottom 105 connects the surface 108 and the groove 104 so that when the liquid sample flows from the bottom of the containment chamber 300, it first flows to the higher portion 106 of the slope and then flows sequentially down the slope to the groove 104. The reason for not having the bottom of the containment chamber 300 near the groove 104 is that if the bottom were near the groove 104, some of the test elements would contact the liquid first and some would contact the liquid later, resulting in different test results at different times. On one hand, there is a diffusion process of the liquid, and on the other hand, there is a time limit for reading the test results on the test elements. It is desirable that all of the test elements 900, such as when there are multiple test elements, contact the liquid at the same time so that all of the test elements can complete the test within the same time frame.

[0097] Test chamber and containment chamber

[0098] In some aspects, the receiving cavity is not a cavity in the sense of having a cavity, but rather a structure that is configured to receive a sample cavity and cooperate with the sample cavity to release or transfer a liquid sample from the sample cavity. Thus, the "receiving cavity" as defined herein can include embodiments of structures that are not cavities. In some aspects, the "receiving cavity" can be understood as a structure that is configured to receive a sample cavity and release a sample from the sample cavity when the sample cavity is received by the receiving cavity, and the sample flows into a test cavity to perform a test for an analyte in the sample. In other aspects, the receiving cavity can be understood as a structure that is fixedly associated with a test cavity and cannot be separated from the test cavity. In other aspects, the receiving cavity can be understood as a structure that is removably associated with a test cavity. That is, the receiving cavity 300 can be initially separate from the test cavity, and the receiving cavity can be placed in the test cavity to release a liquid from a sample cavity into the test cavity. In some aspects, the test cavity can further include a receiving cavity that is configured to receive a sample cavity. In other aspects, the receiving cavity can be separate from the test cavity and can be used to release a liquid from a sample cavity into a container that is configured to receive a test element and perform a test for an analyte. In such embodiments, the receiving cavity is not associated with a test cavity, but rather serves to transfer or relay a sample.

[0099] In some aspects, the test cavity 100 and the receiving cavity 300 are initially assembled together, as shown in FIG. 1, and the receiving cavity 300 is configured to release a liquid from a sample cavity into the test cavity 100. In other aspects, the receiving cavity 300 is separate from the test cavity 100, and the receiving cavity 300 is configured to release a liquid from a sample cavity into a container that is configured to receive a test element and perform a test for an analyte. Figure 4As shown, the receiving cavity 300 has a tubular structure with an opening 301 for inserting the sample cavity 400 into the receiving cavity, and the tubular structure is used to receive the sample cavity 400. The tubular receiving cavity has a bottom 306 and a sidewall 308, and when it is combined with the testing cavity, the receiving cavity is fixed with the testing cavity by a fixing structure. In some embodiments, the testing cavity has an opening 101, and the receiving cavity has a cover structure 303 which cooperates with the opening of the testing cavity to seal the opening 101 of the testing cavity 100, and only the opening 301 of the receiving cavity is in fluid communication with the inside of the testing cavity. Specifically, the cover of the receiving cavity has an outer cover edge 310 and an inner cover edge 311, and the inner cover edge 311 and the outer cover edge 310 have a cover groove 312 therebetween, and the width of the cover groove 312 is equivalent to the edge of the opening 101 of the testing cavity, so that the edge of the opening 101 of the testing cavity is arranged in the cover groove 312 between the outer cover edge 310 and the inner cover edge 311, so that the inner cover edge 312 is located in the testing cavity and the outer cover edge 310 is located outside the testing cavity, thereby wrapping the opening 101 of the testing cavity, and the fixing manner can be ultrasonic welding, so that the receiving cavity 300 is welded with the testing cavity 100 by the cover 303, so that the tubular structure 308 of the receiving cavity is located in the testing cavity 100 and is fixed. In some embodiments, the cover 303 of the receiving cavity is similar to an irregular trapezoid, and has four edges 380, 304, 305, 381, and the long edge 305 is arranged opposite to the short edge 381, and the side edge 304 is arranged opposite to the side edge 380, and the opening 101 of the testing cavity 100 corresponds to the shape of the cover 303 and is also an irregular trapezoid, and is arranged in the same manner as the edges of the cover, so that the side wall 108 on which the edge 381' corresponding to the short edge 381 of the opening 101 is located, and the opposite long edge 305 corresponds to the edge 305' of the opening 101 on the side wall 102, so that the receiving cavity 308 is arranged close to the side wall 108, and the other two side edges 304, 380 correspond to the edges 380', 304' of the opening 101 respectively. In this way, the bottom 306 of the receiving cavity is basically located above the end 106 of the inclined surface 105 of the testing cavity 100. In this way, the liquid flowing out of the receiving cavity directly flows above the inclined surface 106 of the bottom 105, and then the liquid flows along the inclined surface 106 to the groove 104 of the bottom, and diffuses during the flow process, so that the testing element can simultaneously contact the liquid sample or the solution containing the liquid sample to complete the testing of the analyzed substance.

[0100] Sample collector and sample chamber

[0101] The sample collector of the present invention is used to collect a sample, which can be a liquid sample, a solid sample, a semi-solid sample, or a mixture of solid and liquid, or a powder sample. The collector generally includes a sample collection site, which is also referred to as a sample collection area or a collection portion, which is directly contacted with the sample to allow the sample to be retained or held on the area or portion.

[0102] In some embodiments, when the sample is a semi-solid sample, such as a fecal sample, the collection portion can be provided with threads, holes, or pores, or a rough surface, so that the solid in the semi-solid sample is adsorbed by the threads, holes, or pores, and the liquid is also adsorbed by the structures.

[0103] When the sample is a solid or a powder, the collection portion can be in the form of a brush, or a flocked swab, a sponge swab, or other fibrous material. Such a collector can be used to collect a powder sample, such as a drug abuse powder, which can be a single drug powder or a mixture of different drug powders. The powder sample can be collected by wiping a surface with such a brush.

[0104] In some embodiments, the collector can be used to collect a liquid sample. When the collector is used to collect a liquid sample, the sample collection area or the collection portion is made of a water-absorbing material, such as filter paper, fiber, sponge, polyester sponge, or other water-absorbing material. The material is initially dry, and becomes wet or moist after absorbing the liquid sample. Such a liquid sample can be saliva, sputum, or nasal or pharyngeal secretions. The amount of the collected liquid sample is determined by the saturated absorption capacity of the water-absorbing material of the collection area of the collector, which can be 5 milliliters, or 1-10 microliters, depending on the absorption volume or the saturated absorption capacity of the absorbing material.

[0105] In the detailed description of the present invention, a collector is provided, such as Figure 1As shown in Figure 6, the collector 200 includes an area 205 for collecting samples. The area is a threaded structure that absorbs solid or semi-solid samples through the gaps between the threads. The absorption area is connected by a rod 206. The rod 206 can also be connected to a threaded rod head 204. The rod head has an external thread 208 that engages with the internal thread 402 of the sample chamber 400. In some embodiments, the collector also has a cap structure 203. The cap structure is mainly used as a place to hold by hand to facilitate the collection area 205 to contact the sample. In some embodiments, there is a sealing portion between the collection rod 206 and the rod head 204. The seal 207 forms a seal with the structure in the sample chamber. In some embodiments, the sealing portion 207 has sealing rings 201, 202, such as latex, rubber or silicone sealing rings. These sealing portions 207 cooperate with a certain structure of the sample chamber to divide the sample chamber into two parts, one of which is a sealed space for storing the processing liquid, and the other part is also sealed and can be called a sample retention portion. For example, as Figure 6As shown, when the collector is inserted into the chamber 400, the sealing portion 207 divides the sample chamber 400 into a lower chamber 405 and an upper chamber 418. A partition is provided in the chamber of the sample chamber 400, which is similar to a short channel 406, the diameter of which is comparable to the diameter of the rod 206. When there is excess sample (solid or solid-liquid mixture) in the collection area 205, the excess sample (solid or solid-liquid mixture) is left in the chamber 418 when passing through the channel 406, and the sample adhered to the threads of the collection area 205 enters the lower chamber 405. This is to avoid too much sample entering the lower chamber 405, achieving the purpose of sample quantification. At the same time, the lower chamber 405 is in a sealed state through the cooperation of the sealing portion 207 and the dividing structure. This sealed state is provided to isolate the sealed chamber 405 from the outside world, which is to prevent the sample or liquid left in the upper chamber 418 from flowing into the lower chamber 405, and also to prevent the sample in the lower chamber 405 from leaking to the outside world and polluting the environment. Therefore, generally, there is space between the rod head 204 and the upper chamber 418 of the sample chamber 400 to store excess sample. At the same time, the rod head 204 has an external thread 208 that cooperates with the internal thread 402 of the sample chamber to be fixed. The cooperation of the threads fixes the collector in the sample chamber and also plays a sealing role to prevent the sample in the upper chamber 418 from leaking to the outside world and polluting the environment. In some ways, the lower chamber 405 of the sample chamber 400 is generally pre-filled with a treatment liquid, which is used to dissolve the sample on the sampling area 205, and also improves the performance of detection, such as dissolving impurities, removing a protein interference substance, etc. When the lower chamber 405 has a treatment liquid, the sampling area 205 needs to be immersed in the treatment liquid to dissolve the sample, mainly to dissolve the analyte in the sample into the treatment liquid to form a liquid sample containing the analyte or a diluted liquid sample. In the ways of the present application, the collector and the sample are detachably combined together, such as initially, when the collector does not collect the sample, the collector is inserted into the sample chamber (as shown in Figures 5A-5B , Figure 6 shown), and the sampling area 205 is immersed in the treatment liquid in the lower chamber 405. When sampling is needed, the cap structure 203 is rotated by hand to make the collector leave the sample chamber, and the collection area 205 collects the sample, such as a fecal sample. After collection, the collection area 205 is inserted into the sample chamber again to be immersed in the treatment liquid, thereby completing the process of collecting the sample.

[0106] In some embodiments, if the collection region 205 is not a threaded structure, but a brush structure, for collecting a powdered substance, such as a drug abuse powder, it is also possible that when the brush structure or a cotton swab, a sponge is used to dab, swipe, rub, etc. on a surface suspected of having a drug abuse powder, the powder is adsorbed on the surface of the fibers, either by electrostatic means or by surface energy, and the powder is adsorbed on the surface, and then the collector 200 is inserted into the sample chamber, so that the collection region 205 enters the lower chamber, and the sample with the powder is retained in the lower chamber. In such an embodiment, the collector 200 is initially separate from the sample chamber 400, and the collector 200 is not inserted into the sample chamber 400. Also, the lower chamber contains a treatment liquid, which elutes, dissolves the powder sample, thereby forming a liquid sample. In the present invention, the brush-like sampling region, or the sampling region formed by adsorptive material, such as a cotton swab, flocking, etc. is used as a sampling material. Such a sampler can be packaged separately, and does not need to be inserted into the sample chamber initially, and the opening 420 of the sample chamber 400 is sealed, that is, the sample chamber is not sealed by the stem head 204 of the collector, but is sealed by another technical means, such as a plug (not shown) sealing the opening 420 of the sample chamber, so that the entire sample chamber contains a treatment liquid, and the sample chamber exists separately in a sealed state. Of course, the plug can be a plug of any material, such as rubber, silicone, cork, etc. A film seal can also be used, such as a thermoplastic seal. Any means that can seal the opening 420 of the sample chamber 400 can be used. When the sampler is used to take dry powder, solid sample, after the sampling is completed, the plug is removed, and the collector is inserted into the sample chamber, and at this time the sampling region 205 with adsorptive material (adsorptive material, dry powder sample) enters the sample chamber and is immersed in the liquid in the lower chamber 405, so that the powder is dissolved in the treatment liquid to form a liquid sample containing the powder sample. At this time, the sealing portion 207 is sealed with the partition portion 419 of the sample chamber, and the lower chamber 405 containing the treatment liquid forms a sealed chamber. Of course, it can be understood that at this time the sample chamber can not contain the partition structure 419, such as the pipe 406 structure, but the sampling region with adsorbed dry powder is directly inserted into the sample chamber 400, and the stem head 204 of the sampler is sealed with the opening 420 of the sample chamber. Alternatively, the opening of the sample chamber is sealed by means of a screw, or by means of a separate sealing plug.In some embodiments, when the sampler is a sampler with an adsorbent material, such as a cotton swab or a flocked cotton swab, once the sample is taken, the entire sampler is directly inserted into the sample chamber 400, allowing the sampling area (the material that adsorbs the dry powder) to be immersed in the processing liquid in the lower chamber 405. Then, a plug (not shown) is used to seal the opening 420 of the sample chamber 400, or the sampling area 205 is separated from the collector, such as by breaking it, so that the sampling area is stored in the processing liquid in the sample chamber 400, and then the opening 420 of the sample chamber is sealed with a sealing plug. At this time, the sample containing the solution in the sample chamber forms a liquid sample, which can be used for the next step of testing or directly sent to a testing agency for testing and analysis.

[0107] In some ways, it is still provided as Figure 6 The sample chamber shown in FIG. 4 has an upper chamber 408 and a lower chamber 405, and a partition 419 is provided between the two chambers. A pipe 406 is provided on the partition, or a channel or an opening is provided. The sampling area of ​​the sampler is not as Figure 6 The threaded structure shown is not an absorbent material capable of absorbing liquid samples, such as cotton, polyester, sponge, filter paper, polyester foam, etc. A collector made of these materials is used to absorb liquid samples, such as a 50-100 microliter saliva sample, deep into the mouth. The absorbent material may or may not be compressible. Before absorbing the liquid, the collector is packaged separately. The collector comprises a collection area for absorbing the liquid sample, a collection rod or rod 206, a rod head 204, and a cap structure 203 connected to the rod head. After the absorbent material at the front absorbs the liquid sample, it is inserted into the sample chamber 400 through the opening 420 of the sample chamber. At this time, the collecting head also passes through the partition structure. In this case, the size of the partition structure is smaller than the size of the liquid to be absorbed. Alternatively, the absorbing head is squeezed or compressed at the partition (if the absorbent material is compressible). The purpose of the squeezing is to compress the absorbing head or area, thereby releasing the liquid sample into the lower chamber 405. The released liquid sample mixes with the treatment solution in the lower chamber 405. The absorbent head is then immersed in the treatment liquid, where it is dissolved or eluted by the treatment liquid, thereby dissolving or eluting the analytes in the liquid sample into the treatment liquid. Of course, if the absorption area of ​​the liquid cannot be compressed, the absorbent head or the absorption area can be directly detached from the collector and immersed in the treatment liquid in the lower cavity 405, such as a cotton swab head, sponge head, polyester head, or other material that absorbs the liquid sample.

[0108] In some embodiments, the processing fluid stored in the lower chamber in advance can be 5 milliliters to 50 microliters, when the sample chamber has a smaller volume, the volume of the stored processing fluid is smaller, and when the sample chamber has a larger volume, more processing fluid can be stored. When the collector collects a small amount of sample, the processing fluid is also reduced accordingly, such as when the collector collects a trace amount of sample, such as 50-100 microliters, or 50-10 milligrams or 50-10 micrograms of sample, at this time, the processing fluid in the sample chamber is 10-50 microliters to dissolve the trace amount of sample, and the test assay of the trace amount of sample can also be realized. Such a trace amount of sample is particularly suitable for a situation where the amount of sample is very small, such as a saliva sample, in a drug or drug abuse test, the saliva secretion of the person being tested is very small, and 5-10 microliters or 50 microliters can be collected for testing, but there will be a loss from the collector to the test strip for testing, so it may not be enough for the sample requirements of the test strip, especially when testing multiple drug abuses at the same time, the sample amount is required, such as 10 microliters of liquid is required for each test strip, and 100 microliters is required for 10 test strips, but the actual amount of sample collected is only 10 microliters, at this time, the processing fluid is needed to make the entire amount of sample reach 100 microliters or more to meet multiple tests, at this time, the processing fluid is necessary. Although the processing fluid may dilute the sample or dilute the concentration of the analyte, the chemical reagents of the test strip can be improved to improve the sensitivity, such as the method of improving the sensitivity described in European Patent EP2823309B1 can be implemented as part of the present application. In this way, for the collector, only a small amount of absorbent material can be absorbed, and a small amount of saliva can be collected by scraping the mouth, for example, for saliva testing.

[0109] The above are specific embodiments of the sample chamber storing processing fluid in advance, but in some embodiments, the sample chamber does not store processing fluid in advance, but is used to directly receive a liquid sample, such as a urine sample, similar to a urine cup form to receive a liquid sample, let the urine sample, then seal the opening 420 of the sample chamber 400 with a cover, and then send it to the laboratory for testing.

[0110] So, it can be appreciated that the sample chamber 400 can be assembled with the collector 200 at some time, and the collector 200 can be separated from the sample chamber 400. When the collector 200 collects the sample, the collector 200 can be assembled with the sample chamber 400 again, or the collector 200 can be inserted into the sample chamber 400, and at least the area of the sample can be absorbed or collected into the lower cavity and soaked in the liquid. At some time, the collector can be omitted, and only the sample chamber can be used to receive the liquid sample, such as urine, and the like, and 50-100 ml of urine can be absorbed, and the like. In such a manner, a sealing element can be provided to seal the opening 420 of the sample chamber.

[0111] In some embodiments, the bottom 425 of the sample chamber is sealed by a pierceable sealing film 404, and the sealing film can be pierced to release the liquid or the liquid sample in the sample chamber. The sample can be the liquid sample itself without mixing with the treatment liquid, or the liquid sample can be the liquid sample collected by the collector mixed with the treatment liquid in the sample chamber. The sealing film can be a plastic sheet, an aluminum foil, a plastic film, and the like, and the sealing manner can be to provide an opening at the bottom, and then to cover the metal film on the bottom by ultrasonic sealing, or to inject a plastic sheet, such as a 1 mm thick sheet, in the plastic injection process at the bottom. When the treatment liquid is added from the opening 420 of the sample chamber, the treatment liquid is stored in the lower cavity 405 without leakage. When needed, the film at the bottom of the sample chamber is pierced by a piercing element. For example, as shown in Figure 16A the sample chamber has a bottom, and a sealing film 404 is covered on the bottom, and the sealing film seals the bottom of the sample chamber by being bonded to the edge 490 of the side wall 402 of the sample chamber. The bonding manner can be to bond the film to the edge 490 of the bottom of the sample chamber by glue, ultrasonic heating, or welding.

[0112] Containment chamber and sample chamber

[0113] In some embodiments, the present application provides a receiving cavity or a conversion cavity, which is used to receive the sample chamber and to move the sample chamber relative to the receiving cavity to release the liquid in the sample chamber into the receiving cavity. The relative movement includes inserting the sample chamber 400 into the receiving cavity 300. In some embodiments, as shown in Figures 7-19B a receiving cavity 300 is provided, and the receiving cavity includes a piercing element, and when the sample chamber is inserted into the receiving cavity, the piercing element contacts the sealing film at the bottom of the sample chamber to pierce the sealing film and release the liquid sample.

[0114] In the traditional piercing structure, only a simple piercing element is used to pierce, and the liquid sample does not easily flow out naturally. For example, a sharp structure such as a needle is provided on the piercing element to pierce the sealing film. The ordinary sharp structure can pierce the sealing film, but when the piercing element pierces the film, part of the piercing element enters the sample cavity. The film is generally flexible, so although the piercing element has pierced the film, the flexible film still covers the surface of the piercing element or is in contact with the piercing element. Although there is a gap between the piercing element and the film, the liquid does not easily flow out. At this time, after the piercing element pierces the film, a piercing opening is formed, and although the piercing element leaves, the liquid does not easily flow out naturally at the piercing site (piercing opening). This is because, under natural conditions, the amount of liquid is sometimes very small, and although the film is pierced, the film has the ability to return to the state before being pierced. For example, some elastic films have a small piercing opening, and in addition to the small amount of liquid (light weight), the liquid does not easily flow out naturally by gravity. In the present application, in order to maintain the sealing of the bottom of the sample cavity before piercing, the opening 420 of the sample cavity 400 is sealed, or the seal between the elastic sealing ring 201, 202 on the rod 206 of the collector and the partition structure is used. In fact, the entire lower cavity containing the liquid is in a gas-tight or liquid-tight state. When the sample cavity 400 is vertically inserted into the containing cavity 300, the sealing film is pierced by the piercing element. We find that the liquid does not easily flow out. Since the sample cavity is in a sealed state, only the pierced area has an opening, and in addition to the piercing film having the ability to return to the original state, the opening is very small. Even if there is an opening, due to the effect of air pressure (the effect of external atmospheric pressure), the liquid does not easily flow out naturally or flows out very slowly. If the liquid does not flow out, it will cause the test to fail although the piercing has been performed. Otherwise, if the liquid sample in the sample cavity is originally very small, the liquid will flow out naturally very slowly, and sometimes it will not flow out at all. In addition, when a sample cavity is used to collect a small amount of sample, the treatment liquid in the sample cavity is originally very small, such as 50-100 microliters. The bottom of the sample cavity has a sealing film, and even if it is pierced, the small amount of sample does not easily flow downward by gravity. In addition, when the sample cavity of the present application is used to collect the sample, the collection head on the collector is often immersed in the treatment liquid, such as a water-absorbing element, filter paper, sponge, cotton, and plant fibers. After collecting the sample, the water-absorbing element is left alone in the sample cavity. In order to elute the analyzed substances on the water-absorbing element with the treatment liquid, the sample cavity 400 may be shaken. It is also possible that after collecting the sample, the test is not performed immediately, but needs to be transported to the test institution for testing. In this way, the water-absorbing material may be dispersed, or the water-absorbing fibers may be dissolved in the treatment liquid, for example, short fibers suspended in the liquid.Thus, when the piercing element pierces the sealing film, although there is a piercing hole, the scattered fibers will block the piercing hole or form a dense network covering the piercing hole, so that the liquid sometimes cannot flow out of the sample chamber naturally. In these cases, if only the conventional piercing element is used to achieve piercing and allow the sample to flow out of the sample chamber smoothly, it is actually difficult to achieve, and the problem is more serious when the piercing element pierces the sealing film and then leaves the film. The piercing structure is still in the sample chamber, the piercing hole is blocked by the piercing element, and the crack between the sealing film and the piercing element is small. The surface tension of the liquid also does not easily flow out. In order to facilitate operation, it is always desirable to release the liquid simply after the piercing element pierces the sealing film (the piercing element penetrates the sealing film and enters the sample chamber). If the piercing element pierces the sealing film and then leaves the pierced film, an additional step is added, such as controlling the piercing element to leave or controlling the bottom of the sample chamber to leave the piercing element, which is cumbersome in operation.

[0115] In order to solve the above problems of the conventional piercing element to allow the liquid to flow out smoothly or at a faster speed without increasing the operation steps and simplifying the operation process, the present application provides one way to improve the piercing element, that is, to set some "knife edge" structures that can tear, cut or shear the sealing film while piercing the sealing film (piercing along the longitudinal direction of the sample chamber). In this way, the sealing film can be torn or cut in other ways while piercing, so that the sealing film is opened to a larger hole, and sometimes even completely or partially detached. For example, the tearing or cutting is performed in a transverse direction. Figure 12-16, the puncturing element includes a sharp protrusion 317, 316, and the sharp protrusion includes a sharp structure 390 for puncturing the sealing film. The sharp structure is used to puncture the sealing film 404 along the longitudinal direction of the sample cavity. After puncturing, the sharp protrusions 317, 316 will pass through the film 404 and enter the bottom of the cavity. Then, blade-like blade structures are set on both sides of the sharp protrusions 316, 317 to tear, shear, and cut the film horizontally. In some embodiments, the blade structure includes a blade surface 318, similar to the blade of scissors, or a structure similar to a blade. When the bottom 425 of the sample chamber enters the receiving chamber, the sealing film 404 of the bottom 425 first hits the sharp structure 390 of the puncture element 317 or 316, thereby puncturing the sealing film to form a puncture hole 493. Then the sharp structure enters the chamber. At this time, the blade surfaces 318 distributed on both sides of the sharp structure contact the sealing film. At this time, the sample chamber is still allowed to continue to move downward, and the blade surface tears the sealing film horizontally at the puncture location (or the puncture hole location 493), so that the sealing film is completely torn off from the bottom 425 or partially torn off (such as Figure 16B As shown, with minimal pressure applied to the sample chamber, the sealing film 404 at the bottom of the sample chamber can be torn open, allowing the liquid sample to flow out more easily. Therefore, in the design of the piercing element, a sharp structure is first provided for piercing the seal, and a blade structure is also provided for cutting or tearing the film. The cutting or tearing can start from the puncture hole.

[0116] The so-called "blade" of the tear, cut, shear seal film can be understood as the part of the blade of a cutting knife. The blade can be in the form of a line, which is a thin face. The edge of the thin face forms the line. For example, the edge can be 1 mm or 0.5 mm thick and has a cutting ability. Therefore, the so-called blade face can be a face that includes a blade part and has a cutting ability, similar to the ability of a knife to cut paper or a pair of scissors to shear paper. The material of the blade structure can be any material, such as plastic, metal, or alloy. In some embodiments, the piercing element and the blade face are formed of the same material in different structures. The cutting, tearing, and shearing can be used interchangeably. It can also be understood as a way of making an opening on the seal film using a sharp blade. This opening method can be understood as a force applied to the film in the transverse direction, and the piercing element pierces in the direction of the longitudinal axis of the sample chamber. Of course, the rigidity of the blade is greater than that of the seal film, but this is not a necessary condition. When cutting or tearing starts from the piercing point or piercing opening, it is easy to crack or cut the seal film. This is because the opening formed by piercing the seal film itself is not regular and smooth, but has some small tear openings. If the blade cuts or tears from these small tear openings, it is much easier, and thus the seal film or part of the seal can be easily torn from the bottom 425 of the sample chamber 400 or a larger opening can be formed. Tearing or opening larger makes it easier for the liquid in the sample chamber 400 to flow out.

[0117] The piercing element can be any shape that can pierce the seal film. The main function of the blade face is to cut or tear the seal film. In some embodiments, the highest point (sharp structure) of the piercing element is higher than the position of the cutting or tearing blade structure. In this way, when the piercing element first pierces the seal film and has an opening, the cutting or tearing blade face can then cut or tear from the opening, thereby removing the seal film entirely or partially from the bottom of the sample chamber. For example, as shown in FIG. 6, the piercing element 600 has a sharp structure 602, and the cutting or tearing blade face 604 is located below the sharp structure 602. When the sharp structure 602 pierces the seal film 610, an opening 612 is formed. Then, the cutting or tearing blade face 604 cuts or tears from the opening 612, thereby removing the seal film 610 from the bottom of the sample chamber 400. Figure 14BAs shown, the piercing element 316 is shaped like a sharp triangular pyramid, including a base 393 and a tip 390, and a four-sided structure 392, 394, 395, 398, with the side 395 being angled to intersect the side 394 to form an intersection line that forms the sharp piercing structure 390. The piercing structure 390 is a thin, sharp edge, like the edge of a blade, that faces the surface of the sealing membrane and is used to pierce the sealing membrane to allow the piercing element to pass through the membrane 404 into the sample chamber 400. The sides of the piercing element 316, such as 392, can then be used to initiate tearing of the sealing membrane from the tear, and the area of the tip of the piercing element can be gradually increased from top to bottom to allow the entire piercing element to enter the sample chamber, for example, from the base 393 to the tip 390. The cutting edge is primarily used to tear and cut the sealing membrane from the piercing hole, and its primary function is to create a larger opening from the piercing hole that allows the sealing membrane to be removed from the sample chamber, either in whole or in part.

[0118] The piercing element can be one or more, and the cutting or tearing edge can be located anywhere as long as it is in contact with the sealing membrane after the piercing element. For example, Figures 16A-16D As shown, the sealing membrane 404 seals the bottom 425 of the sample chamber, and typically the entire perimeter of the sealing membrane is bonded to the bottom edge 490 of the sidewall 403 of the sample chamber, which forms a seal of the bottom 495 of the sample chamber. Figure 16A The piercing element can also be positioned to pierce the sealing membrane near the inner wall 499 of the sample chamber 400, for example, at the locations indicated by 493 or 492, which are near the inner wall 499 of the sidewall 403 of the sample chamber. The sharp structure 390 of the piercing element is used to pierce the sealing membrane to form a piercing hole 493 or 492, and the cutting or tearing edge is positioned near the inner wall 499 of the sidewall 403, for example, near the inner wall 403 of the sidewall 403, to cut or tear the sealing membrane along the piercing hole. Figure 16B As shown, the sealing membrane 404 is torn along the line 494 to remove a portion of the sealing membrane 404 from the sample chamber (as shown in Figure 16C This exposes the entire bottom 495 of the sample chamber to the liquid in the sample chamber 400, which is left in place. Of course, the sealing membrane can be pierced and cut at any location to remove a portion of the sealing membrane, for example, as shown in Figure 16BAs shown, the puncture is performed at position 466, and then the blade structure performs a transverse cut from the punctured opening, and then cuts the lower portion of the sealing film 4042, thereby forming an opening (blank area) without the sealing film. The arrangement of the positions of the puncturing element and the cutting blade can determine the shape of the sealing film to be cut, such as Figure 15 As shown, if the piercing element is disposed on a circular blade surface, the cut sealing film will be circular. If the blade surface 318 is formed into other shapes, such as a square, a circle, or an ellipse, and a raised piercing element is disposed on the blade surface 318, the cut sealing film will be square, circular, or elliptical. In this way, the sealing film can be cut into any opening. In a preferred embodiment, the sealing film is omitted at the opening, minimizing interference with the flow of liquid by the sealing film. In other words, the piercing element is responsible for piercing, while the specific arrangement of the blade structure determines the shape of the cut sealing film.

[0119] The above is that the sample chamber is directly inserted into the receiving chamber, and the puncture element cooperates with the cutting blade to cut the sealing film, so that part of the sealing film falls off, which makes it easier for the liquid to flow out of the sealed sample chamber. In some methods, the sample chamber 400 is rotated into the receiving chamber 300, so that it is more convenient to tear the sealing film. In this method, the puncture element itself can be slightly improved. For example, the sharp structure 390 is also allowed to contact the sealing film, so that the structure punctures the sealing film to form a puncture hole. When the sample chamber is in the process of rotation, the sharp puncture element is generally in a stationary position, and the sealing film is in the process of position rotation. After the sharp structure punctures the sealing film, the position of the sealing film is in the process of rotation, and the sharp structure is rotated relative to the sealing film. The sharp structure directly cuts or tears the sealing film from the punctured place (such as the puncture hole). After the sample chamber rotates one circle, the entire sealing film can be cut off basically by cutting or tearing with the sharp structure. Therefore, in such a case, Figure 14B As shown, the sealing film is punctured by the sharp structure 390 to form a puncture hole, and the so-called blade structure is a blade structure formed by the intersection of various surfaces to cut and tear. For example, the line 3921 where the surface 395 and the surface 392 intersect as the blade structure, or the line 3922 where the surface 394 and the surface 392 intersect as the blade structure to tear from the puncture hole. Figure 16BIf the piercing structure 390 pierces the seal 404 to form a piercing opening 493, the blade edge 3921 or 3922 on the piercing structure will cut or tear in the direction of rotation of the sample chamber (clockwise - shown by the dashed line 494). Thus, the blade structure can rely on a structure on the piercing element to act as a blade, provided that the structure is not curved but has a diamond shape. The piercing element can have two functions, one is to pierce the seal (generally perpendicular to the seal), and then as the sample chamber rotates, the piercing element can also act to cut laterally, thus allowing the seal to be opened more or to be removed from the sample chamber floor or partially removed. For example, Figure 16B As shown, for example, from the position 493, the piercing structure is through the seal and the seal is rotating, and the piercing element 316 is stationary, the piercing element can laterally cut or tear the seal from the piercing opening 493, as shown by the dashed line 494. Figure 16B Thus, the piercing element not only pierces the seal vertically, but also has the ability to laterally tear the seal from the piercing opening. Thus, in some embodiments, the piercing element can have a sharp piercing structure 390 and a blade edge or face that can laterally act on the seal. For example, the piercing element 316 can have a sharp piercing structure 390 that pierces the seal, and the blade edge 3921 can laterally shear the seal to allow the seal to be removed from the sample chamber. Figure 14B In some embodiments, the piercing element does not necessarily have a blade face. As discussed above, the piercing of the seal does not form a regular opening, but rather forms a plurality of small tears at the edge of the opening. If the seal is moved relative to the piercing element, such as by the piercing element being moved laterally relative to the seal, the piercing element can act on the small tears to tear the seal from the small tears to form a larger opening or to remove a portion of the seal from the sample chamber floor. When the seal is an aluminum or metal foil seal, the piercing element can easily form a larger opening in the seal or remove a portion of the seal from the sample chamber floor by piercing the seal and rotating the sample chamber, thus eliminating the effect of the seal on the flow of liquid.

[0120] In some embodiments, the cutting edge 318 can also be provided around the piercing element to make it easier to cut the seal film on the rotating sample chamber. In this way, the cutting edge 318 is essentially stationary while the sample chamber is rotating, so that the cutting edge 318 acts like a knife to slit the seal film to make it easier to remove the seal film. Preferably, the cutting edge 318 is provided to cut or tear the seal film from the opening created by the piercing element. In some embodiments, the cutting edge 318 is provided near the junction of the seal film and the side wall of the sample chamber to pierce and cut the seal film along the junction to make it easier to remove the entire seal film 404 from the bottom of the sample chamber. When the entire seal film 404 is removed from the bottom, the bottom is essentially free of seal film, so that it is easier for the liquid in the sample chamber to flow out of the sample chamber.

[0121] In some embodiments, the cutting edge 318 is provided in the form of a bevel rather than a flat surface. In one embodiment, the cutting edge is provided at a higher level near the piercing element 317 than the cutting edge away from the piercing element 317. As shown in Figure 10 , the sharp tip 390 of the piercing element 317 is provided at a higher level than the adjacent portion of the cutting edge 398, and the portion of the cutting edge 392 away from the piercing element 317 is provided at a lower level than the portion of the cutting edge 398. Although the portion of the cutting edge 398 and the portion of the cutting edge 392 are provided on the same cutting edge 318, the portion of the cutting edge 398 is provided at a higher level than the portion of the cutting edge 392. In this way, when the seal film 404 is moved downwardly against the piercing element 317, the piercing element 317 pierces the seal film 404 to form a hole, and the portion of the cutting edge 398 is the first portion of the cutting edge 318 to contact the seal film 404 to cut or tear the seal film 404, and the portion of the cutting edge 392 is the last portion of the cutting edge 318 to contact the seal film 404 to cut or tear the seal film 404. In this way, the seal film 404 is provided with a shearing force (e.g., the seal film 404 is provided at an angle to the cutting edge 318) to make it easier to cut or tear the seal film 404. Figure 10 The cutting edge 318 can be provided around the piercing element 317, 316, or in any other form, such as shown in Figure 14A , the piercing element 317 is provided with a sharp tip 391, and the piercing element 316 is provided with a sharp tip 390. The piercing element 317 is provided with a cutting edge 398 at the bottom of the piercing element 317, and the cutting edge 398 is provided in the form of an extended cutting edge 318. The cutting edge 318 is provided with a weakened surface 319 to make the cutting edge 318 thinner and sharper. The weakened surface 319 is provided in the form of a recess to make the cutting edge 318 thinner and sharper. The sharp piercing element 317 and the cutting edge 318 can be formed by injection molding in one step.

[0122] In some embodiments, the sharp tip or the cutting edge 318 is provided on a piston 307, and more preferably, the sharp tip or the cutting edge 318 is provided on the top surface 350 of the piston 307, as shown in Figure 12,13,14A, the piston is raised from the bottom of the containment cavity, and a raised piercing element 316, 317 is provided on the upper surface 350 of the piston on the periphery 320, while the middle of the piston is recessed and has a collapsed face 319, so that a very thin face is formed on the upper surface of the piston, which is the cutting edge face, cutting edge or cutting edge structure 318, which surrounds the periphery of the piston and is lower than the raised piercing element 317, 316. The piercing element has a sharp piercing element 391, 390, which is also a very thin sheet (e.g. Figure 14B ), and the piercing element is raised on the periphery of the upper surface of the piston in the shape of an acute triangle, with one edge (the intersection of the adjacent faces) 3921 as a transverse cutting face, which gives the sealing film a transverse cutting force when the sample cavity is rotated. Thus, when the sample cavity 400 is inserted into the containment cavity and is lowered in a rotating manner, the piercing element 316 first pierces the sealing film with the sharp structure 391, and then the piercing element gives the sealing film a transverse cut with its cutting edge 3921 (cutting face), in the process of cutting, the piston enters the inside of the sample cavity. On the one hand, the piston 307 pushes the cut film upwards, the pushing effect makes the sealing film tear quickly, and at the same time, the film leaves the sealed bottom, so that the opening of the bottom is larger, on the other hand, the entry of the piston gives the sealed sample cavity a pressure, so that the pressure promotes the liquid to flow out from the inside (if the cavity of the processing liquid is in a sealed state). In order to let the liquid flow out of the sample cavity 400 and in a relatively fixed direction, in some ways, a channel is provided on the piston 307, part of the channel also enters the sample cavity 400 when the piston enters the sample cavity, and the liquid first flows out along the channel when the liquid needs to flow out. The liquid flowing out of the channel is tested for the test. In some ways, two piercing elements 316, 317 are provided on the piston, and the channel 314 is provided between the two piercing elements. In some ways, the cross-sectional area of the piston is equivalent to the inner cutting surface of the bottom of the sample cavity, for example, as shown in Figure 16B , the cross-sectional area of the piston is equivalent to the area of the sealing film 404 and the shape is consistent, so that the piercing sharp structure 391, 390 of the piercing element and the cutting of the cutting edge 318 can be cut along the inner wall 499 of the sample cavity, and the entire sealing sheet 404 is pushed off or falls off from the bottom of the sample cavity as the piston enters the sample cavity (e.g. Figure 16C). In this way, the bottom 415 of the entire sample chamber is filled with the piston, and the liquid flows out of the channel. In this way, the liquid in the sample chamber can flow out smoothly and quickly under different conditions. Even if the fiber impurities are dissolved in the processing liquid, or the liquid sample is small, the combination of the structure of the piercing element and the operation mode can completely remove the sealing film and expose the entire bottom of the sample chamber. Under such operation, the liquid sample can flow out more quickly, reducing the obstruction to the liquid sample, and simplifying the operation steps. The piercing element does not need to be separated from the sealing film, and does not need to be given pressure in the sealed sample chamber (such as the lower cavity 405 of the sealed sample chamber 400). The liquid can flow out naturally by relying on the action of gravity.

[0123] In some ways, the sample chamber is rotated. One way is to provide a thread on the outer wall of the sample chamber 400 and a thread on the inner wall of the opening of the containing chamber 300. The sample chamber is rotated in the containing chamber by the thread cooperation. As shown in Figure 5A A threaded surface 406 is provided on the outer surface of the sample chamber, and a thread 402 is provided on the inner surface of the opening of the containing chamber 300. When the sample chamber 400 is inserted into the containing chamber 300, the bottom of the sample chamber is generally inserted into the containing chamber from the opening 301 of the containing chamber, and then the sample chamber 400 is rotated in the containing chamber 300 by the cooperation of the threads, so that the piercing element pierces the sealing film, thereby forming a piercing opening on the sealing film. With rotation, the piercing element (or the blade surface) tears the sealing film transversely, and the cutting blade is arranged to provide a transverse force to the sealing film, or is arranged separately near the piercing element, thereby tearing the sealing film from the piercing opening or cutting a piece of sealing film from the entire sealing film, as shown in Figure 16B The cut film can be a C piece, or an A or B piece.

[0124] In some ways, an opening 313 is provided on the opposite side of the channel 314 on the piston 304 of the containing chamber 300, and the opening faces the channel 314. The opening exposes the channel 314, and the opening is provided on the side wall 403 of the containing chamber. In this way, it can be seen whether the liquid flows out of the channel through the opening. Of course, the channel can be provided in the piston without being provided in the form of a groove on the surface of the piston.

[0125] In some embodiments, when the sample is collected by the collector, the collector is located in the lower cavity 405 of the sample chamber, and is rigid, and the recess 315 is provided on the piston, and the end of the collector 205 is inserted into the recess (when the sample chamber is pierced by the piston, as shown in Fig. 19), so that the sample chamber 400 is shorter and more miniaturized. Of course, when the sample is collected by the brush, the brush can be directly immersed in the treatment liquid in the sample chamber, and no matter how long the liquid is released, the liquid can be smoothly released. The combination of the piercing element or / and the cutting edge of the present application piercing the sealing film, cutting the sealing film, and the piston entering, and the direct insertion or rotation of the sample chamber into the sample chamber can achieve the above purposes and solve some defects of the conventional technology.

[0126] In some embodiments, the specific operation of the rotation is as follows: Figures 17A-17B is the initial state, first, the collector 200 is inserted into the sample chamber 400 by the rotation of the screw thread 208, and is rotated into the sample chamber by the needle, until it cannot be rotated, so that the sealing ring 201, 202 on the collector rod is sealed with the partition of the sample chamber. Then the sample chamber 400 with the collector is inserted into the containing cavity 300 by the rotation of the outer screw thread 402 and the inner screw thread 302 at the opening 301 of the containing cavity 300, that is, by the rotation of the clockwise direction. As shown in Figures 18A-18B , continue to rotate, the piston 307 located on the bottom 306 of the containing cavity and the piercing element 316, 317 provided on the upper surface of the piston first pierce the sealing film to form a piercing hole, and then rely on the cutting edge 318 provided on the piercing element to cut the piercing hole of the sealing film transversely, tear, so as to increase the opening of the sealing film or cut off part of the sealing film, and at the same time, the piston enters the sample chamber and pushes open the torn sealing film (as shown in Figures 19A-19B ), so that the liquid in the sample chamber flows out from the channel 314 on the piston.

[0127] As shown in Figure 23,24, if the containment cavity 300 is assembled in the test cavity 100 at the beginning, and the opening 313 at the bottom of the containment cavity is directed towards the side wall 108 of the test device, if the side wall is transparent, then the passage 314 on the piston 307 can be observed to see if liquid flows out. Similarly, the sample cavity 400 with the collector 200 (at this time the collector has collected a sample and is inserted into the sample cavity) is screwed into the containment cavity 300 in the test cavity 100, the piercing element 316 at the bottom of the containment cavity and the piercing element with the blade surface 392 or the separate blade surface 318 pierce and cut the sealing film transversely, releasing the liquid onto the inclined surface 108 at the bottom of the test cavity, and then into the groove 104, where it comes into contact with the sample application area 905 of the test strip arranged there, and thus the analysis of the analyte is carried out. If a fecal sample is collected, hemoglobin, Helicobacter pylori can be tested, if a powder sample is collected, the powder can be tested for the presence of one or more drug abuse substances. If a micro-amount of saliva sample is collected, the saliva can be tested for analytes such as drug abuse small molecules. DETAILED DESCRIPTION

[0128] Test device: when the sample cavity is combined with the collector in a detachable manner, the collected sample is a fecal sample, 3 milliliters of treatment liquid (phosphate buffer) is filled in the lower cavity of the sample cavity 400 in advance, and then the collector 200 is inserted into the sample cavity at the beginning, the sample collection area is the threaded structure 205, which is immersed in the treatment liquid in the manner shown in Figure 6 , the containment cavity is the containment cavity shown in Figure 7 , the piercing element arranged at the bottom of the containment cavity is shown in Figure 12 ,13,14, the piston 307 is arranged at the bottom of the containment cavity, two protruding piercing elements 316,317 are arranged on the periphery of the surface of the piston, each piercing element has a sharp structure 390,391, and at the same time, the blade structure 318 is arranged around the periphery of the piston 307, starting from the bottom surface of the piercing element (as shown in Figures 14A-14B ), both the piercing and the blade structure are arranged on the surface of the piston 307.

[0129] Collection of sample: the fecal sample is collected using a laboratory preserved sample, in which some short fibers (1-5 millimeter fibers), hair are artificially mixed in to simulate some complex fecal samples. Then the collector 200 is used to collect the fecal sample, which is then inserted into the sample cavity, so that the fecal sample on the threads is dissolved in the treatment liquid, and then inserted into the containment cavity 300 through the rotational fitting of the outer threads and the inner threads of the sample cavity, so that the piercing element at the bottom of the containment cavity pierces and cuts the sealing film, and the amount of liquid sample flowing out is observed. Method 1: Insertion method rather than rotation method (sample chamber and containment chamber lack threaded structure) (fecal sample) is to let the sample chamber directly inserted into the containment chamber and to the bottom without movement.Method 2: Rotation method (sample chamber and containment chamber have threaded cooperation) (fecal sample) is to let the sample chamber

[0130] The experiment was performed using 100 sample chambers, divided into two groups. In one group, the sample chambers of the present application were inserted into the receiving chambers and the volume of fluid that flowed out of the bottom of the sample chambers was collected. It was found that 50 of the sample chambers each flowed out more than 2.5 ml of solution and most of the sealing membranes were cut. Similarly, another group was used as a control and the piercing structure was simply a piercing element with a piston but without the cutting edge structure on the piercing element and without the cutting edge face 318 around the piercing element. The sample chambers were inserted into the receiving chambers rather than being rotated into the receiving chambers and the average volume that flowed out of the 50 sample chambers was 0.8 ml. It was later observed that the small volume of fluid that flowed out was due to a layer of fibers, hair, etc. that was on the surface of the sealing membrane of the sample chambers. The piercing structure pierced the sealing membrane but the fibers, etc. in the treatment fluid clogged the piercing hole and prevented the fluid from flowing out. The sealing membrane was not cut and remained on the bottom of the sample chamber. In both cases, the piercing element did not leave the sealing membrane after piercing the sealing membrane.

[0131] Threaded cooperation to enter the containment chamber in a rotational manner, and let the bottom of the sample move to the bottom of the piston without movement. Rotation method (sample chamber and containment chamber have threaded cooperation) (micro saliva) ​

[0132] Similarly, the experiment was performed using 100 sample chambers, divided into two groups. In one group, the sample chambers of the present application were inserted into the receiving chambers and the volume of fluid that flowed out of the bottom of the sample chambers was collected. It was found that 50 of the sample chambers each flowed out more than 2.8-2.9 ml of solution and it was found that all of the sealing membranes were cut and were not on the bottom of the sample chambers. Some of the sealing membranes were directly pushed up by the piston and were on the inside of the sample chamber. Similarly, another group was used as a control and the piercing structure was simply a piercing element with a piston but without the cutting edge structure on the piercing element (the piercing element had a sharp piercing point but the main body was round) and without the cutting edge face 318 around the piercing element. The average volume that flowed out of the 50 sample chambers was 1.2-1.5 ml. The reason for this was that most of the sealing membranes remained on the bottom of the sample chambers and reduced the flow of fluid.

[0133] ​

[0134] 1 ml of treatment liquid (containing 100 mg of short fibers to simulate a complex solution) is stored in the sample cavity in advance, and then a sponge cotton swab is used to collect saliva from the mouth. A sponge cotton swab absorbs about 50-100 microliters of saliva, and then the cotton swab head is directly inserted into the treatment liquid in the sample cavity and kept in the treatment liquid, and then the opening of the sample cavity is sealed with a stopper. There are 100 such sample cavities, and each group of 50 is divided into two groups. In one group, the sample cavity and the holding cavity of the present invention are operated, and then the volume of the liquid flowing out is collected from the bottom of the sample cavity. It was found that 50 samples each flowed out more than 0.8 ml of solution. Similarly, another group was used as a control, and the puncture structure used was just puncture, and also had a piston, but there was no blade structure on the puncture element, and there was also no blade structure 318 around the puncture element. The average volume flowing out of the 50 sample cavities was 0.1-0.2 ml. Since the processing liquid in the sample chamber itself is small in volume and light in weight, it needs to rely on its own gravity to flow out naturally, which is more difficult. However, the method of the present invention allows the sealing film at the bottom of the sample chamber to be removed by shearing, so that the liquid can flow out with almost no resistance. This can meet the needs of analyzing the analyte with the liquid and separating multiple different analytes.

[0135] All patents and publications cited in this specification are intended to indicate that they are state of the art and that the present invention may be used. All patents and publications cited herein are incorporated by reference in their entirety, as if each publication were specifically incorporated by reference. The invention described herein may be practiced in the absence of any element or elements, limitation or limitations, unless otherwise specified. For example, in each instance, the terms "comprising," "consisting essentially of," and "consisting of" may be replaced with either of the other two terms. The term "a" or "an" herein simply means "one" and does not exclude the inclusion of only one or more. The terms and expressions used herein are intended to be descriptive, not limiting, and are not intended to exclude any equivalent features. However, it is understood that any suitable changes or modifications may be made within the scope of the present invention and the appended claims. It is understood that the embodiments described herein are preferred embodiments and features, and that modifications and variations can be made by persons of ordinary skill in the art based on the spirit of the present invention. Such modifications and variations are considered to be within the scope of the present invention and the scope of the independent and appended claims.

Claims

1. A device for testing an analyte in a sample, the device comprising: a sample chamber for receiving a sample collector; The sample chamber is provided with a sealing film that is easily punctured; A holding chamber for receiving a sample chamber, wherein the holding chamber contains a puncturing element for puncturing a sealing film to release liquid in the sample chamber, wherein the holding chamber includes a blade structure for transversely cutting the film; wherein the holding chamber is located in a test chamber, wherein the test chamber contains an analyte for testing a liquid sample.

2. The device according to claim 1, wherein The blade structure is arranged on the puncture element or in the vicinity of the puncture element.

3. The device according to claim 2, wherein When the blade structure is disposed adjacent the piercing element, the resulting blade arrangement is coupled to the piercing structure.

4. The device according to claim 3, wherein When the position of the blade structure is lower than the puncture apex of the puncture element.

5. The device according to claim 2, wherein When the blade structure is provided on the puncturing structure, it is provided along the longitudinal direction of the puncturing structure.

6. The device according to claim 1, wherein The piercing element pierces the sealing film in a vertical direction.

7. The device according to claim 1, wherein When the sample chamber enters the accommodating chamber, or during the process of entering, the sample chamber enters the accommodating chamber in a rotating or turning manner relative to the accommodating chamber.

8. The device according to claim 7, wherein The accommodating chamber includes a thread, and the sample chamber includes a thread. The relative rotation is caused by the mutual engagement of the thread of the accommodating chamber and the thread of the sample chamber.

9. The device according to claim 8, wherein The accommodating cavity includes an internal thread, and the sample cavity includes an external thread.

10. The device according to claim 9, wherein The accommodating chamber is in a stable fixed state, and the sample chamber enters the accommodating chamber in a rotating or rotating manner.

11. The device according to claim 10, wherein The sealing film seals the bottom of the sample cavity, and part of the sealing film is adhered to the edge of the side wall of the sample cavity.

12. The device according to claim 11, wherein When the puncture point of the puncture element contacts the sealing film, it contacts the portion of the sealing film close to the inner wall of the sample chamber.

13. The device according to claim 1, wherein The sample cavity includes a collector detachably combined with the sample cavity. The sample cavity includes an opening, a side wall and a bottom with the sealing film. The partial collector seals the opening of the sample cavity.

14. The device according to claim 1, wherein The sample cavity includes a processing liquid, and the processing liquid is sealed in the sample cavity.

15. The device according to claim 1, wherein The accommodating chamber includes a bottom, and the bottom includes a piston. When the puncturing element punctures the sealing film, the piston can pass through the sealing film and enter the sample chamber.

16. The device according to claim 15, wherein The piston comprises a surface, and the puncturing element and the blade surface are both arranged on the surface of the piston.

17. The device according to claim 16, wherein The puncturing element is arranged on the circumference of the piston, and the blade surface is also arranged on the circumference.

18. The device according to claim 17, wherein The puncture element includes two puncture elements, and a channel is set between the two puncture elements for draining liquid from the sample cavity.

19. The device according to claim 18, wherein The piston is cylindrical, the sample cavity is also cylindrical, and the diameter of the piston is substantially equal to the inner diameter of the sample cavity.

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