A detection device

Abstract

The present invention provides a detection device, comprising: a test element, and a transparent area, wherein the test element comprises a test area, wherein the test area is configured to detect whether a liquid sample contains an analyte; and a transparent area, wherein the transparent area is configured to read a test result on the test area through the transparent area; wherein part of the transparent area is in contact with part of the test area, or the test area and the transparent area are in a closed space, so that the closed space does not exchange fluid with the atmosphere outside the closed space; through such a scheme, atomization can be reduced and the test result can be clearly displayed.

Description

[0001] This application claims priority to a prior application in China, application number: 2019107055046, filing date: August 1, 2019, and a prior application in the United States, application number: 62 / 881,546, filing date: August 1, 2019. Technical Field

[0002] The invention relates to a collecting and detecting device, in particular to a device for collecting and detecting analyzed substances in a liquid sample in the field of rapid diagnosis. Background Art

[0003] The following background technology introduction is merely an introduction to some background common sense and does not constitute any limitation to the present invention.

[0004] Medical or household rapid detection devices are usually used to detect whether a sample contains an analyte, such as for early pregnancy testing, drug testing, etc. The detection device generally has a collection chamber for collecting the sample to be tested (some do not have a liquid sample collection chamber), and a test element is installed in the collection chamber. After the sample to be tested enters the collection chamber through the opening of the collection chamber, it contacts the test element, and the test element detects the sample to be tested. The test element has a detection area for displaying the test result, and the test result can be read from the outside of the collection chamber through the side wall of the collection chamber. Generally, the collection chamber is partially transparent, and the result on the test area is read through the transparent area. In some cases, after the test element detects the sample collected in the collection chamber, the test result is not read immediately, but sent in batches to the detection mechanism for mechanical electronic equipment to scan and read. Therefore, the detection device also includes a cover body, which cooperates with the collection chamber to form a closed cavity, and seals the sample, the test element, etc. in the collection chamber, so as to prevent the sample from being contaminated by the outside during transportation and transfer, or the sample from spilling or leaking from the collection chamber.

[0005] In addition, the test element is generally located in a shell, and the detection area of ​​the test element and the area corresponding to the shell (the area corresponding to the shell is generally transparent plastic or film) are read through the transparent area of ​​the shell to read the detection area of ​​the test element, especially the color depth of the test line to determine whether the test result is positive or negative.

[0006] After the existing collection and detection device detects the sample, it may be unable to accurately read the test result on the test element from the outside of the collection cavity or the shell corresponding to the detection area due to certain factors. Therefore, it is necessary to design and improve the traditional detection device to increase the convenience of use of the detection device and the accuracy of reading the detection result. Summary of the invention

[0007] The present invention relates to a collection and detection device, which has a simple structure and is easy to manufacture, and can clearly, quickly and conveniently read the detection result of a test element from the outside of a collection cavity without being affected by the external environment or the internal environment of the device.

[0008] In one aspect of the present invention, a detection device is provided, which includes a test element, the test element includes a detection area for detecting whether there is an analyte in a liquid sample; and a transparent area, through which the test result on the detection area is read, the detection area covers the surface of the transparent area, or the detection area and the surface of the transparent area are attached together. In some embodiments, the shell for accommodating the test element has the transparent area, and the test result on the detection area can be read through the transparent area. In this way, when testing, no tiny droplets will be formed on the surface of the transparent area, so that no fog will be generated in the transparent area, so that the test result on the detection area can be clearly read. In some embodiments, the test area of ​​the test element includes a water-absorbing material, allowing the liquid sample to flow through the water-absorbing material. In some embodiments, the detection area includes a substance for detection, through which the substance can be directly or detected whether the analyte is in the test sample. In some embodiments, the presence or absence of the analyte is indicated by a marking substance, and the marking substance is a colored marking substance that can be read by the naked eye. In other embodiments, the so-called reading includes reading by an electronic device, such as reading by a scanning device or a fluorescent reading device.

[0009] The substantial contact here includes a very short distance, which allows the absorbent material part of the test area to contact the transparent part, so that it can contact the tiny droplets on the transparent part, so that the droplets disappear from the transparent part (the absorbent material absorbs the droplets on the transparent area), so that it can reduce the coverage of the droplets, so that the transparent part is substantially free of droplets, becomes more transparent, and can display the test area more clearly. This contact can be direct contact or indirect contact. The so-called indirect contact means that the transparent area may have a multi-layer structure. If the area where the tiny droplets are formed is in some areas of the multi-layer structure, it is only necessary to let the test area contact with the area to reduce the effect of "fog". Of course, it is also possible not to have the test area contact it, and another absorbent material that can absorb tiny droplets can also contact it. In some ways, these absorbent materials are transparent, and the test results on the test area can be read through the transparent absorbent material.

[0010] In addition, for the contact area, the entire detection area may be in substantial contact with the transparent area, or part of the detection area may be in substantial contact with part of the transparent area. In some embodiments, the area with the detection line on the detection area is in substantial contact with the part of the transparent area. In some embodiments, the upstream of the detection area includes a result control area, and the control area or part of the control area is in substantial contact with the part of the transparent area.

[0011] The detection area of ​​the test element is directly or indirectly in contact with the transparent area for reading the test results of the detection area through the transparent part of the shell, so as to reduce the condensed droplets on the transparent part, thereby making it easy to read the test results. This is an easy way to achieve. The reason for the generation of micro-droplets on the surface of the transparent area is generally due to the temperature difference between the ambient temperature and the temperature of the transparent area itself. The droplets condensed in the transparent area (generally made of plastic material) are due to the ambient temperature being higher than the temperature of the transparent area itself or its surface. The water vapor in the environment encounters the transparent area and condenses into tiny droplets. Alternatively, after the detection device receives the droplet sample or collects the liquid sample, the temperature of the liquid sample itself is higher than the temperature of the transparent area, or the liquid sample obtains a temperature higher than the ambient temperature, so that the liquid sample evaporates water vapor and encounters the transparent part (the temperature is lower than the temperature of the vapor) to condense into droplets covering the surface of the transparent area, thereby forming a surface similar to "atomization", covering the test area, thus causing the test results on the test area to be unable to be accurately read.

[0012] In some embodiments, the detection device includes a barrier that can reduce or block the fluid exchange between the area between the detection area and the transparent area and the surrounding area. In some embodiments, the fluid is gas and / or liquid, or a mixture of gas and liquid, or water vapor. The barrier reduces the exchange of water vapor or water vapor by allowing the test area to contact the transparent area or allowing the test area to cover the transparent area, or blocks the exchange of water vapor between the contacting areas and the outside world. The transparent area is used to read the test results on the test area through the transparent part. The reading method includes reading with the naked eye or reading with a machine. The machine reading method uses photography or scanning to read.

[0013] In some embodiments, the test area and the transparent area do not necessarily need to be in physical contact. In this case, the test area and the transparent area are located in a relatively closed space, and the closed space does not substantially exchange water vapor with the area outside the space. The fluid here is generally a gas containing water vapor. In some embodiments, the water vapor can condense into droplets in the transparent area. In this way, water vapor from the outside is not allowed to enter the enclosed space including the test area and the transparent area, which reduces the entry of water vapor into the space. In this way, the formation of tiny droplets of water vapor in the enclosed space on the surface of the transparent area can also be reduced. In some embodiments, this seal can be achieved by a barrier.

[0014] It can also be understood that the test area covers the transparent area, and there is no space between the test area and the transparent area. This situation is a special case in which the test area and the transparent area are considered to be in a sealed space.

[0015] In some embodiments, the transparent area is located on the side wall of the liquid collection device, the collection device includes a cavity for collecting fluid samples, and the transparent area is located on the wall of the collection cavity. Therefore, in some embodiments, when the test element is combined with the collection cavity, the area between the detection area and the side wall of the collection cavity is in a sealed state, or the detection area is in contact with the side wall of the collection cavity, or the test area covers the side wall of the collection device. Preferably, when the test element is combined with the collection cavity, the area between the detection area and the inner wall of the collection cavity is in a liquid-tight state. This reduces the entry of external vapor into the inner wall of the collection cavity facing the detection area.

[0016] In some preferred embodiments, further, the barrier can make the detection area fit with the side wall of the collection chamber; the detection area is in substantial indirect contact with the partially transparent area on the collection chamber. Alternatively, the barrier can fill the area between the detection area and the side wall of the collection chamber; the barrier here can be located between the collection chamber and the detection area, and the barrier can also be transparent, so that the barrier is in substantial contact with the detection area. The fit here is a state of connection, indicating that the detection area and the barrier are in contact connection.

[0017] In some embodiments, the test element is located in a groove of a carrier, and the carrier is disposed on the side wall of the cavity. At this time, the side of the carrier with the test element is substantially in contact with the side wall of the collection cavity; or, the detection area of ​​the test element in the carrier is substantially in contact with the side wall of the cavity. When the test element is in the groove of the carrier and the test element is sealed in the groove of the carrier, or the detection area of ​​the test element is located in the groove of the carrier, and the carrier is disposed on the side wall of the cavity, at this time, the groove has a transparent part to read the test result on the test area, and in order to read the test result, it is necessary to read the result of the detection area through the transparent part of the side wall of the cavity and the transparent part on the groove. In this case, it is desired to make one side (outside) of the transparent part on the groove of the carrier directly contact the side wall of the cavity, and it is also desired that the detection area directly contact the other side of the transparent part of the groove (directly facing the test area), or one of the two methods is selected. This reduces the formation of tiny droplets on the transparent part of the groove and the side wall of the cavity, thereby covering the transparent surface.

[0018] Similarly, a substantially closed space is formed between the transparent part of the groove and the test area, thereby reducing the exchange of water vapor with the outside. Optionally, a substantially closed space is formed between the transparent part of the groove and the side wall of the cavity, thereby reducing the formation of tiny droplets between the transparent part of the groove and the side wall of the cavity.

[0019] In some embodiments, the transparent area is a planar structure, or the side wall portion of the collection chamber is a planar structure, which makes it convenient for the planar structure to contact or cover the test area.

[0020] In some embodiments, the barrier may be a protruding structure, the protruding structure being located in the groove of the carrier, and the protruding structure contacts the back of the test area of ​​the test element. When the carrier contacts the side wall of the cavity, the protruding structure allows the test area to be closely attached to the side wall surface of the cavity. The side wall is transparent, and is used to read the test result on the test area through the transparent area.

[0021] In some other embodiments, further, when the test element is combined with the collection chamber, the detection area of ​​the test element is disposed between the barrier and the inner wall of the collection chamber.

[0022] Furthermore, the barrier comprises a clamping portion for cooperating with the inner wall of the collection chamber and clamping the detection zone, and when the test element is combined with the collection chamber, the detection zone is clamped between the clamping portion and the inner wall of the collection chamber. The clamping portion here may include a protruding structure.

[0023] Further, when the test element is combined with the collection chamber, the clamping part covers the back of the detection area and the clamping part fits with the back of the detection area, so that the clamping part can make the test area and the side wall of the collection chamber close together. Preferably, there is one clamping part, and the clamping part covers the back of the detection area of ​​multiple test elements together; or, there are two or more clamping parts, and each clamping part covers the back of one, two or more detection areas. Preferably, the barrier can also be a part of the structure of the carrier of the test element, and the test element carrier has a groove for accommodating the test element, and the clamping part can be the bottom surface of the groove; or, the clamping part is a convex block arranged in the groove. In this way, the convex block of the groove makes the detection area of ​​the test element and the surface of the carrier substantially in the same horizontal plane, so that when the carrier is close to the side wall of the collection chamber, the detection area of ​​the test element can be close to the side wall, thereby reducing the formation of fog on the side wall by external vapor. The test area is close to the transparent side wall, blocking the external water vapor from condensing into tiny droplets in the close area. Even if liquid flows over the test area, tiny droplets may be generated in the close contact area, which will be absorbed by the test area composed of absorbent material.

[0024] Furthermore, the inner wall of the collecting chamber has a fitting portion for fitting the detection area, the fitting portion covers the detection area, and when the test element is combined with the collecting chamber, the detection area is clamped between the clamping portion and the fitting portion. Preferably, when the test element is combined with the collecting chamber, the clamping portion is aligned with the fitting portion. Preferably, the fitting portion is a partial area of ​​the inner wall of the collecting chamber; or, the fitting portion is a protrusion provided on the inner wall of the collecting chamber. Preferably, there is one fitting portion, and the fitting portion covers all the detection areas; or, there are two or more fitting portions, and each fitting portion covers one, two or more detection areas. In some embodiments, the fitting portion of the inner wall of the collecting chamber is a planar or flat plate structure. The fitting portion may also be a protrusion structure of the side wall, and the protrusion structure is transparent.

[0025] Furthermore, the clamping portion has a clamping surface for contacting the back of the detection area, and the fitting portion has a fitting surface for contacting the detection area, and when the test element is combined with the collection chamber, the clamping surface is parallel to the fitting surface. Preferably, the fitting surface and the clamping surface are planes, curved surfaces, cylindrical surfaces or conical cylindrical surfaces.

[0026] Further, when the test element is combined with the collection chamber, the distance between the fitting surface and the clamping surface is less than or equal to the thickness of the detection zone. The thickness of the detection zone refers to the thickness of the area where the detection zone of the test element is located. Preferably, when the test element is combined with the collection chamber, the distance between the fitting surface and the clamping surface is greater than zero, so that the surface of the test area displaying the test result can be closely attached to the fitting surface.

[0027] In some other embodiments, when the test element is combined with the collection chamber, the barrier is located between the detection zone and the inner wall of the collection chamber, and the detection zone is closer to the barrier relative to the back of the detection zone. Preferably, the barrier is made of a transparent or translucent material. Preferably, the barrier is fixedly connected or detachably connected to the detection zone. Preferably, the barrier is detachably connected to the inner wall of the collection chamber. In this way, the test result displayed on the detection zone can be read through the barrier from the outside of the collection chamber.

[0028] Preferably, when the test element is mounted on the test element carrier, the barrier covers and fits the test area. Preferably, when the test element is combined with the collection chamber, the barrier fits the inner wall of the collection chamber. In this way, the barrier can occupy the area between the test area and the inner wall of the collection chamber. Preferably, the barrier has a first surface for covering and fitting the test area and a second surface for fitting the inner wall of the collection chamber, and the size of the barrier is a constant between the first surface and the second surface.

[0029] Furthermore, the barrier is a partial structure of the test element carrier. Further preferably, the test element carrier has a mounting surface, the mounting surface is provided with a groove for accommodating the test element, the first connection surface is the bottom surface of the groove, and the second connection surface is the back surface of the mounting surface; the distance between the bottom surface of the groove and the back surface of the mounting surface is a fixed value, so that the ground of the carrier is transparent in the portion corresponding to the test area.

[0030] A second aspect of the present invention provides a collecting and detecting device with a detecting cavity, which has a simple structure, low processing and assembly costs, is easy to use, and is convenient for installing and removing test elements.

[0031] A collection and detection device with a detection cavity, comprising a collection cavity, the collection cavity having an opening, the detection cavity being located below the opening, characterized in that the detection cavity is a cavity formed by the side wall of the collection cavity protruding outward, the side wall of the collection cavity having two connections with the detection cavity, and the lateral dimension of the detection cavity is greater than or equal to the lateral distance between the two connections. In this way, the test element can be inserted into the detection cavity through the connection between the collection cavity and the detection cavity, and installed in the detection cavity.

[0032] Further, the transverse dimension of the detection cavity is a fixed value; or, the transverse dimension of the detection cavity gradually expands outward from the connection. When the transverse dimension of the detection cavity gradually expands outward from the connection, the transverse dimension of the detection cavity is the smallest at the connection with the collection cavity.

[0033] Further, the detection cavity has a first side wall and a second side wall respectively connected to the two connection points, and the first side wall and the second side wall are parallel; or, the first side wall and the second side wall intersect. Preferably, the first side wall and the second side wall are both planes. Preferably, the first side wall and the second side wall are parallel to the axis of the collection cavity.

[0034] Further, the detection cavity has a third side wall for connecting the first side wall and the second side wall, and the edge of the third side wall relative to the collection cavity opening is close to the middle of the collection cavity. Preferably, the third side wall is a plane. Preferably, the third side wall is parallel to the axis of the collection cavity.

[0035] Further, the detection cavity has a top surface, the top surface is connected to the side wall of the collection cavity, and the top surface is located at the outer edge of the opening of the collection cavity. Preferably, the top surface is a plane. Preferably, the top surface is perpendicular to the axis of the collection cavity.

[0036] Furthermore, the detection cavity has a bottom surface, and the bottom surface and the bottom surface of the collection cavity are located in the same plane. Preferably, the bottom surface is parallel to the top surface.

[0037] Furthermore, the detection cavity has a locking structure, which includes a limiter, one end of which is a connecting end connected to the bottom surface of the detection cavity, and the other end of which is a free end, and the free end of the limiter is closer to the middle of the collection cavity relative to the connecting end of the limiter. Preferably, the limiter is a sheet structure. Preferably, the limiter is close to the third side wall.

[0038] Furthermore, the locking structure also includes a snap-in piece, which is a protrusion provided on the third side wall. The test element carrier is provided with a groove or a through groove for aligning and matching with the snap-in piece. When the test element is installed in the detection cavity, the snap-in piece is inserted into the groove to achieve the installation and fixation of the test element. Preferably, the snap-in piece is close to the top of the third side wall. In this way, the limiter can fix the lower side of the test element; the snap-in piece cooperates with the groove of the test element to achieve the fixation of the upper side of the test element.

[0039] Beneficial effects of the present invention:

[0040] 1. Design the structure of the collection and detection device itself to prevent the fluid in the collection chamber from entering the area between the detection area and the inner wall of the collection chamber, reduce or eliminate the influence of external factors on the reading results of the detection area, and improve the convenience of using the collection and detection device.

[0041] 2. The test element can be inserted through the opening of the collection cavity and installed in the detection cavity, thereby reducing the processing cost and assembly cost of the collection and detection device. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 It is a three-dimensional diagram of a collection chamber in one embodiment of the present invention.

[0043] Figure 2 It is a stereoscopic diagram of a collecting chamber in another embodiment of the present invention.

[0044] Figure 3 is a schematic diagram of a test element in one embodiment of the present invention.

[0045] Figure 4is a three-dimensional diagram of a test element carrier in one embodiment of the present invention.

[0046] Figure 5 is a three-dimensional diagram of a test element carrier in another embodiment of the present invention.

[0047] FIG. 6 is a schematic diagram showing the cooperation between the protrusion and the inner wall of the collection chamber in one embodiment of the present invention.

[0048] Figure 7 It is a schematic diagram of the coordination of the bump, the test element detection area and the inner wall of the collection chamber in one embodiment of the present invention.

[0049] Figure 8 It is a schematic diagram of the cooperation between the test element carrier and the protrusion in one embodiment of the present invention.

[0050] Fig. 9 It is a schematic diagram of the coordination of the test element carrier, the test element detection area and the protrusion in one embodiment of the present invention.

[0051] Fig.10 Schematic diagram of the matching of the protrusion and the bump in one embodiment of the present invention.

[0052] Fig.11 It is a schematic diagram of the coordination of the protrusion, the test element detection area and the bump in one embodiment of the present invention.

[0053] Fig.12 It is a three-dimensional diagram of the cooperation between the protrusion and the back side of the test element carrier in one embodiment of the present invention.

[0054] Fig.13 It is a schematic diagram of the coordination of the test element detection area, the test element carrier and the protrusion in one embodiment of the present invention.

[0055] Fig.14 yes Figure 2 Cross-section of the collection chamber.

[0056] Fig.15 yes Figure 2 Schematic diagram of the assembly of the collection chamber and the test element carrier.

[0057] Fig.16 yes Figure 2 Top view of the collection chamber.

[0058] Fig.17 It is a three-dimensional diagram of another collection chamber.

[0059] Fig.18 yes Fig.17 Cross-sectional view of the collecting chamber.

[0060] Fig.19 yes Fig.17 Schematic diagram of the assembly of the collection chamber and the test element carrier.

[0061] Fig. 20 yes Fig.17 Top view of the collecting chamber.

[0062] Fig.21 This is a comparison chart of the actual product test results.

[0063] Detailed description

[0064] The structures or technical terms involved in the present invention are further explained below. If not otherwise specified, they are understood and interpreted according to the general terms commonly used in the art.

[0065] Detection

[0066] Detection means to test or examine a substance or material for its presence or absence. The substance or material may be, for example, but not limited to, a chemical substance, an organic compound, an inorganic compound, a metabolite, a drug or a drug metabolite, an organic tissue or a metabolite of an organic tissue, a nucleic acid, a protein or a polymer. In addition, detection may also mean the amount of the substance or material tested. Assays may also refer to immunoassays, chemical assays, enzyme assays, etc.

[0067] sample

[0068] In the present invention, the sample collected by the detection device includes biological fluid. The initial state of the sample can be liquid, solid or semi-solid. The solid or semi-solid sample can be converted into a liquid sample by any appropriate method, such as mixing, crushing, macerating, incubating, dissolving, enzymolysis, etc., and then poured into the collection chamber, and the sample is detected by the test element to determine whether it contains the analyte. The sample can be taken from the human body, animals, plants, nature, etc. Samples taken from the human body can be, for example, liquid samples such as blood, serum, urine, cerebrospinal fluid, sweat, lymph, saliva, gastric juice, etc.; solid or semi-solid samples such as feces, hair, keratin, tartar, finger / toe nails, etc. Samples taken from plants can be, for example, solid samples such as roots, stems, leaves, etc.; liquid or semi-solid samples such as tissue fluid and cell fluid prepared from roots, stems, and leaves. Samples taken from nature can be, for example, liquid samples such as rainwater, river water, seawater, groundwater, etc.; solid or semi-solid samples such as soil, rocks, ores, and petroleum.

[0069] Fluid Exchange

[0070] In the present invention, fluid refers to one or a mixture of gas, air, water vapor or liquid. Fluid exchange means that the fluid can flow from one area to another. Fluid exchange can be a passive exchange of fluid under the action of external force, or it can be an active exchange due to the characteristics of the fluid itself. After the fluid exchange is blocked, the fluid in one area cannot flow to another area. The blocking of fluid exchange does not necessarily mean that liquid or gas must exist, but only indicates the connection relationship or state between the two areas in some cases; if there is liquid or gas in the area, the fluid in one area is not connected to the fluid in another area.

[0071] Test components

[0072] The test element refers to a component that can detect the analyte in the sample to be tested. The detection of the analyte by the test element can be based on any technical principle, such as immunology, chemistry, electricity, optics, molecular science, physics, etc. The test element of the present invention can be one or a combination of two or more test elements. The test element has a detection area for displaying the test result, and after the test is performed, the test area displays the test result.

[0073] A common form of test element is test paper or lateral flow strip (latteral flowstrip). The detection of the test paper to the sample to be tested can be based on the principle of immunoassay or chemical analysis, and the analysis mode of non-competitive method or competitive method can be adopted. The test paper includes a sample addition area, a reagent area and a test area in sequence. After the sample to be tested is added to the sample addition area, it flows to the reagent area by capillary action, reacts with the reagent in the reagent area, and then continues to flow to the test area by capillary action, and the test area generates a signal or does not generate a signal, thereby indicating that there is or does not exist an analyte in the sample to be tested. For example, if a T line (Test Line, Test Line) appears in the test area, it indicates that there is no analyte in the sample to be tested; if the T line does not appear in the test area, it indicates that there is an analyte in the sample to be tested. Some test papers are also provided with a control area, which is located after the test area, and the sample flowing through the test area continues to flow to the control area, and the control area is used to determine whether the test result of the test area is valid. For example, in some test strips, only when the C line (Control Line) appears in the control area, can the test result of the test area be shown to be valid, otherwise it indicates that the test result of the test area is invalid. In the present invention, when the test result of the test element can be read only through the test area, the test area of ​​the test element is the above-mentioned test area; when the test result of the test element needs to be judged in combination with the signals generated by the test area and the control area, the test area of ​​the test element includes the test area and the control area. Of course, in some cases, the test result of the test element needs to be judged in combination with the signals of other areas, so the detection area also includes the other areas. That is to say, in the present invention, the complete test result can be read through the detection area of ​​the test element. Generally, the test element includes at least a detection area, through which it can be obtained whether the analyzed substance exists in the sample. For example, through the appearance of color, color change, generally the color change can be seen through the naked eye, and can also be scanned and read by a scanning device, or the test result can be read by taking a photo. Or there is fluorescence, or rays appear, etc. The test result of the detection area is read by equipment and instruments.

[0074] The test element is generally composed of porous water-absorbing materials, such as filter paper, glass fiber, polyester film, nylon film, paper, non-woven fabric, etc. Any material that can absorb water is acceptable. Generally, the material that constitutes the test area is a water-absorbing material, such as a water-absorbing film, such as nitrocellulose membrane, nylon film, etc.

[0075] Analyte

[0076] Examples of analytes that can be used in the present invention include some haptens, including drugs (such as drugs of abuse). "Drugs of abuse" (DOA) refer to the use of drugs (usually for narcotic effects) for non-medical purposes. Abuse of these drugs can lead to physical and mental damage, dependence, addiction and / or death. Examples of drugs of abuse include cocaine; amphetamines AMP (e.g., Black Beauty, White Amphetamine Pills, Dextroamphetamine, Dextroamphetamine Pills, Beans); methamphetamines MET (crank, methamphetamine, crystal, speed); barbiturates BAR (e.g., Valium, Roche Pharmaceuticals, Nutley, New Jersey); sedatives (i.e., sleep aids); lysergic acid diethylamide (LSD); depressants (downers, goofballs, barbs, blue devils, yellowjackets, methaqualone); tricyclic antidepressants (TCAs, i.e., imipramine, amitriptyline, and doxepin); MDMA; PCP; tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); opiates (i.e., morphine MOP or, Opium, cocaine COC; heroin, hydroxydihydrocodeinone); antianxiety drugs and sedative hypnotic drugs, antianxiety drugs are a class of drugs mainly used to relieve anxiety, tension, fear, stabilize emotions, and have hypnotic and sedative effects, including benzodiazepines BZO (benzodiazepines), atypical BZ, fused diazepam NB23C, benzodiazepines, BZ receptor ligands, open-ring BZ, diphenylmethane derivatives, piperazine carboxylates, piperidine carboxylates, quinazolinones, thiazine and thiazole derivatives, other heterocyclics, imidazole sedatives / analgesics (such as hydroxydihydrocodeinone OXY, methadone MTD), propylene glycol derivatives-carbamates, aliphatic compounds, anthracene derivatives, etc. The detection device of the present invention can also be used to detect drugs that are for medical use but are easy to overdose, such as tricyclic antidepressants (imipramine or analogs) and acetaminophen. After being absorbed by the human body, these drugs will break down into different small molecules. These small molecules exist in body fluids such as blood, urine, saliva, sweat, or some body fluids.

[0077] For example, the analytes detected by the present invention include, but are not limited to, creatinine, bilirubin, nitrite, protein (non-specific), hormones (e.g., human chorionic stimulating hormone, progesterone hormone, follicle stimulating hormone, etc.), blood, white blood cells, sugars, heavy metals or toxins, bacterial substances (e.g., protein or sugar substances for specific bacteria, such as Escherichia coli 0157:H7, Staphylococcus, Salmonella, Clostridium, Campylobacter, L.monocytogenes, Vibrio, or Bacillus cereus) and substances related to physiological characteristics in urine samples, such as pH and specific gravity. Any other clinical urine chemistry analysis can be detected using the lateral flow detection format in conjunction with the device of the present invention.

[0078] Barrier

[0079] Transparent Area With test area

[0080] In the present invention, Transparent area and test area The positional matching relationship between the transparent area and the test area reduces the space or distance between them, thereby avoiding the exchange with the surrounding fluid, such as air, liquid, water vapor or steam. It can also be considered that the detection area on the test element is blocked, prevented, or reduced from exchanging liquid or gas with the outside world. Again, or, the detection area is in a relatively closed space, and the closed space is to let the test area be located in a closed space. The closed space also includes letting the test area as a part and the transparent area together to form a closed space (the detection area and the transparent area are close together, although there is no air between them, but it can be called closed. Another situation is that the detection area and the transparent area are in a closed space. One method in this case is that the detection area and the transparent area are part of the closed space. The closed space here is mainly for the outside, and there is no exchange of gas or water vapor with the outside). The closed space does not actually exchange liquid or gas with the outside world, or a mixture of water vapor and gas is exchanged with the outside world. For example, if the test area is attached to or covered on the surface of the transparent area, it can be avoided that the air with water vapor in the outside world contacts the surface of the transparent area, thereby avoiding the generation of fog. In the test area and transparentThe regions form a closed space, or are in a closed space, and the external gas, air, water vapor, and liquid cannot actually enter the closed space, so that there will be no exchange of gas, air, water vapor, and liquid between the closed space and the outside of the closed space, so that the humidity in the closed space will not be substantially affected. Even if there is a temperature difference between the density space and the outside, due to the low humidity in the closed space, there will be no condensation in the closed space or the probability of condensation will be reduced, thereby avoiding the occurrence of atomization, that is, the water vapor in the closed space condenses on the surface of the transparent area. At this time, the test area can or can absorb the liquid sample through capillary action, and the sample can flow through the test area through capillary action. The so-called closed space here does not allow the liquid sample to enter, which excludes the liquid, air, and water vapor in other atmospheric environments other than the liquid that the test area itself absorbs through capillary action and flows through the test area from entering the closed space without passing through the test area. This can reduce the formation of atomization, liquefaction, or the formation of small liquids on the transparent area.

[0081] In addition, the test area is in contact with the transparent area. This contact is partial contact, or the entire test area is in contact with the transparent area, or part of the test area is in contact with part of the transparent area. Or the distance between the test area and the transparent area is very close, such as 0-6 mm. For example, 0 mm is contact. When it is greater than 0 mm, there will be a small gap, such as 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.9, 1.0, 1.2, 1.3, 1.5, 2 mm, or 3-5 mm. When the test element or the test area is composed of a water-absorbing material, the liquid flows on the test area or passes through the test area through capillary action. At this time, the sample itself still has a certain temperature, such as 25-37 degrees Celsius. Due to the vapor pressure, the temperature of the ambient air may be lower than the sample temperature. At this time, the liquid on the test area will evaporate, and the evaporated water vapor will contact the transparent area. The temperature of the transparent area is lower than the ambient temperature or the temperature of the sample, and the water vapor will condense into small water droplets and adhere to the transparent area. Even if the ambient temperature is lower than the temperature of the liquid flowing through the test area, the steam generated in the test area will condense in the transparent area with a lower temperature (the vapor pressure of water is different at different temperatures) to form small water droplets. Since the water-absorbing material in the test area is in contact with the transparent area or close to it or very close to it (the distance between them is very short), the porous material can absorb the small water droplets on the transparent area, thereby reducing the phenomenon of atomization.

[0082] The material of the transparent area here is generally different from the material that constitutes the test area. Of course, the transparent area can also have the same material as the test area, such as nylon film or nitrocellulose film. When the materials are different, the test area is a porous film, or a porous water-absorbing material, and the transparent area is a non-porous material, such as a non-water-absorbing material, such as plastic, metal, PCV, and ceramic. The liquid here is generally a flowing sample or a sample containing water. The gas here generally refers to the air in the atmospheric environment, which may also include water vapor and air with a certain humidity. When a liquid sample containing water comes into contact with air, in the microenvironment, a state of equilibrium is reached between the liquid sample and the air, generating a corresponding vapor pressure.

[0083] Alternatively, the test area and the transparent area are not a closed space, but the distance between them is very close, such as 1 mm, 0.5 mm, 0.1 mm, 0.01 mm, 0.05 mm, 1.2 mm, 0 mm (the test area and the transparent area are attached together or substantially attached together, or close together). At this time, although there is a tiny gap between them, it is not considered a closed space. However, when there is a temperature difference between the transparent area and the outside world, for example, the temperature of the outside environment is higher than the temperature of the transparent area, tiny water droplets may be formed on the transparent area due to condensation, which can also be called atomization. However, since the transparent area has a side (front) that directly faces the test area, and a side (back) that does not face the test area. As long as the atomization phenomenon is reduced in front of the transparent area, the test results on the test area can be more clearly displayed without any unclear situation.

[0084] The material of the transparent area here is generally transparent, and the detection area on the test area is read through the transparent material, and the transparent material is generally plastic, PVC, transparent film, etc. Of course, these transparent areas can be located on the shell of the detection device, such as a test panel, a test cup, a test card, or a part of these shells.

[0085] Of course, the transparent area can be a multi-layer structure, for example, a combination of multiple transparent layers. As long as the multi-layer transparent areas corresponding to the test area are in close contact or have small gaps, or sealed spaces, liquid, air or water vapor will not enter between the multi-layer transparent areas, thereby reducing the occurrence of atomization.

[0086] Of course, what is being discussed here is a phenomenon in which sample droplets flowing over the test area generate atomization on the transparent area. Another situation is that when the test area is at a distance from the transparent area, the test area cannot rely on contacting the transparent area to absorb the tiny droplets on the transparent area. At this time, there are two ways to reduce the atomization phenomenon. One is to place the test area and the transparent area in a closed space to reduce the exchange of gas between the space and the outside world. The other way is to treat some chemical substances on the surface of the transparent area to reduce the atomization phenomenon. For example, some surfactants can make the surface of the transparent area more water-resistant and allow tiny droplets to spread on the surface of the transparent area, thereby increasing the clarity of the test area.

[0087] Here, "atomization" generally refers to when there is a temperature difference between two media, such as a temperature difference between the transparent area and the air, for example, the temperature of the transparent area is low, while the temperature of the air is high. Generally, there is water vapor in the air. When encountering low temperature, the water vapor will condense into tiny droplets. The number and speed of the droplets generated are directly related to the temperature difference and the humidity of the air. When in a micro environment, if the air humidity is high and the temperature difference is large, the speed of the tiny droplets generated is fast and the density on the transparent area is large. On the contrary, as long as one of the conditions in the air humidity or temperature difference changes, it will affect the amount and speed of the tiny droplets. In order to reduce the occurrence of atomization between the test area and the transparent area, on the one hand, it is necessary to reduce the humidity of the air, or reduce the temperature difference between the transparent area and the environment. When the test device is used, it is generally difficult to quickly change the temperature difference between the transparent area of ​​the test device and the environment, but it is easy to change the humidity of the air in contact with the transparent area, such as reducing the entry of humid air into the space between the test area and the transparent area. The way to reduce the humidity of the air between the two is to increase the humidity of the air between the two slowly, for example, within 1 minute, 2 minutes, 10 minutes, 20 minutes, 30 minutes, 50 minutes, 1 hour, 2 hours, the humidity between the two can increase to the condition that can produce atomization (when the temperature difference between the transparent area and the environment must be constant), and when there is a small gap between the test area and the transparent area. Or, do not allow moisture and air to enter or actually enter the space between the test area and the transparent area, such as the test area and the transparent area form a relatively closed space. Another way is to make the test area contact with the transparent area or have a very small gap, so that the small droplets produced can contact the test area, and when the liquid is formed, it will be absorbed by the test area composed of porous water-absorbing materials, which will reduce the atomization phenomenon in the transparent area and make the test results clearer and more discernible.

[0088] This is because, in the existing traditional products, although the test area is set in an environment wrapped by an external shell (plastic, or PCV material), such as an early pregnancy test device, or on some carriers, or in a test board, such as the device described in U.S. Patent No. US9,414,813, the test area of ​​the test element will have gas or liquid exchange with the outside world. Generally, the area corresponding to the test area is transparent, and the test results on the test area can be read through the transparent area (naked eyes, scanners, cameras or other equipment). Generally, the device is stored at a low temperature in advance. When testing is required, it needs to be taken out and placed at room temperature for incubation for a period of time. At this time, due to the low temperature of the entire detection device and the high temperature outdoors, at this time, the water vapor in the outdoor air will condense on the surface of the test device in the form of small water droplets or mist. If these small water droplets or mist are on the outer surface of the shell, they can still be wiped, but if they enter the area between the detection area and the transparent area or enter the internal space around the detection area, they will form small water droplets or mist on the transparent inner surface, thereby blocking the display of the test results of the test area.

[0089] In another case, when the ambient temperature is relatively low (e.g., in winter), and the temperature of the liquid sample is sometimes higher than the ambient temperature, such as the temperature of urine is 35-37 degrees Celsius, at this time, at low temperature, the temperature of the test device or the temperature of the external shell is generally lower than the temperature of the sample, and there is a temperature difference. At this time, since there is gas or liquid exchange with the outside world around the test area, the liquid and the atmospheric microenvironment have water vapor exchange, and the humidity in the microenvironment increases, it may also flow into the space around the test area, and may also form small water droplets around the test area or the detection area, so that a layer of tiny water droplets is formed on the transparent shell. Sometimes, it may be a combination of the above two factors. In short, there is a temperature difference between the detection device and the outside world or / and the detection device and the liquid sample. Generally, the temperature of the detection device is lower than the outside temperature or / and lower than the temperature of the liquid sample, and tiny water droplets will be formed on the wall around the detection area, which is called "fogging" and forms a pattern similar to frosted glass. In this way, after the test, there is a layer of tiny water droplets condensed or in the form of fog in the transparent area, which will affect the accuracy of reading the test results on the test area. Especially when the test area is between positive and negative, the atomization almost covers the results of the test area, resulting in the inability to read the results or inaccurate results. Sometimes, even if there are results in the test area, due to the effect of atomization, the scanning instrument cannot scan the results consistent with the actual results, or the test results are wrong.

[0090] In some embodiments, the test element is generally combined with a device or cavity for collecting samples. For example, the detection device includes a collection cavity, in which the test element is installed, and the test element has a detection area. The detection area is close to the side wall of the collection cavity relative to the back of the detection area, and the detection result displayed in the detection area of ​​the test element can be read from the outside of the collection cavity through the side wall of the collection cavity. However, in the existing detection device, after the test element is installed in the collection cavity, there is a gap between the test element and the inner wall of the collection cavity, especially there is a gap between the detection area of ​​the test element and the inner wall of the collection cavity, and the gap is in a state of fluid communication with the surrounding (such as other areas or spaces in the collection cavity), or the gap is in a state of fluid exchange with the surrounding. After the surrounding fluid (such as liquid or air) enters the gap, it may form atomization in the detection area of ​​the test element, thereby blocking the detection area of ​​the test element, resulting in the inability to accurately read the detection result displayed in the detection area from the outside of the collection cavity, affecting the use of the detection device.

[0091] The most common example is that when the temperature of the sample to be tested in the collection chamber is higher than the temperature of the inner wall of the collection chamber or the environment (for example, in winter or when the room temperature is low, when testing the body fluid that has just been collected and has body temperature), the water in the sample evaporates and becomes gaseous (water vapor), enters the gap between the detection area of ​​the test element and the inner wall of the collection chamber, and condenses into water droplets or tiny water droplets on the inner wall of the collection chamber. The refraction of light by water droplets may cause a deviation between the read test result and the actual test result. For example, due to the small distance between the test area and the control area of ​​the test paper, it may be difficult to determine whether the displayed line is T line or C line under the refraction of water droplets. When the formed water droplets are very small, the small water droplets make the originally smooth and transparent inner wall of the collection chamber become similar to "frosted glass". In this case, the test result cannot be read from the outside of the collection chamber at all. Another example is that the sample collected in the collection chamber volatilizes colored gas, and the colored gas enters the gap between the detection area and the inner wall of the collection chamber, forming an obstruction to the test result. Another example is that when the liquid sample is splashed in the collection chamber, enters into the gap between the detection area of ​​the test element and the inner wall of the collection chamber in the form of small droplets and sticks to the inner wall of the collection chamber, it will also obstruct the test results. Especially when the liquid sample itself is turbid or opaque, such as blood, turbid urine, tissue fluid, etc., this obstruction effect is more obvious.

[0092] The present invention designs a collection detection device so that the detection device includes a transparent area and a test element with a test area. When the test element is combined with the transparent area, the transparent area can reduce or block the fluid exchange between the area between the detection area and the transparent area and the surrounding area. In the existing detection device, there is a large gap between the detection area and the inner wall of the collection chamber, and the detection device is not provided with any components to reduce the size and size of the gap. The gap is in a state of complete fluid communication with the surroundings, so the fluid around the gap can enter the gap, atomize, condense, or cause obstruction of the detection result due to the characteristics of the fluid itself.

[0093] The present invention reduces the fluid exchange between the area between the detection area and the transparent area and the surrounding area, and reduces the amount of surrounding fluid entering the area, thereby weakening the fluid shielding effect on the detection result. The degree of reduction of the fluid exchange between the area between the detection area and the transparent area and the surrounding area can be reduced by any value relative to the existing detection device, such as 5%, 25%, 50%, 80%, 90%... Blocking the fluid exchange between the area between the detection area and the inner wall of the transparent area and the surrounding area can be that there is no liquid exchange or gas exchange between the area between the detection area and the inner wall of the transparent area and the surrounding area, or there is neither liquid exchange nor gas exchange. When there is no liquid exchange between the area between the detection area and the inner wall of the transparent area and the surrounding area, after the collection chamber collects the sample, the liquid substance from the sample cannot enter the area between the detection area and the inner wall of the collection chamber. The above-mentioned liquid substance can be the sample itself, water formed by evaporation and condensation of water in the sample, an aqueous solution dissolved with some substances in the sample, or a substance generated by the sample in other forms. When there is no gas exchange between the detection area and the inner wall of the transparent area and the surrounding area, after the collection chamber collects the sample, the gaseous substance originating from the sample cannot enter the area between the detection area and the inner wall of the collection chamber. The above-mentioned gaseous substance can be a substance volatilized, evaporated, reacted or formed in other forms by the sample. When there is neither liquid exchange nor gas exchange between the detection area and the inner wall of the transparent area and the surrounding area, the above-mentioned liquid substance and gaseous substance originating from the sample cannot enter the area between the detection area and the inner wall of the collection chamber. In some preferred embodiments, the fluid is gas and / or liquid. In some preferred embodiments, when the test element is combined with the transparent area, the area between the detection area and the inner wall of the transparent area is in an airtight state. In some preferred embodiments, when the test element is combined with the transparent area, the area between the detection area and the inner wall of the collection chamber is in a liquid-tight state. Without the entry of liquid substances, when there is a temperature difference, the phenomenon of atomization is avoided, so that the results on the detection area can be correctly read.

[0094] There are two ways to reduce or block the fluid exchange between the area between the detection area and the inner wall of the transparent area and the surrounding area: the first way is that the inner wall of the transparent area fits the detection area. For example, the transparent area is a part of the cup collection cavity, such as a part of the wall of the cup body. Pressure is applied to the back of the test element, and the detection area of ​​the test element is pressed against the inner wall of the collection cavity, thereby reducing the size and size of the gap between the detection area and the inner wall of the collection cavity, or even eliminating the gap between the detection area and the inner wall of the collection cavity. The second way is to fill the area between the detection area and the inner wall of the inner wall of the transparent area. In other words, the size and size of the area between the detection area and the inner wall of the inner wall of the transparent area is reduced by filling. In some preferred ways, the area between the detection area and the inner wall of the transparent area can be filled. In some preferred ways, the inner wall of the transparent area is made of transparent or translucent material. In this way, from the outside of the collection cavity, the test results displayed on the detection area can be read through the transparent area. The following is a detailed description of the two types of barriers.

[0095] In the present invention, the barrier is a component used to reduce or block the fluid exchange between the area between the detection area and the inner wall of the collection chamber and the surrounding area. It can also be considered that the barrier blocks, prevents, or reduces the exchange of liquid or gas between the detection area on the test element and the outside world. Again, alternatively, the detection area is in a relatively closed space, and the closed space is to allow the test area to be located in a closed space. The closed space also includes allowing the test area as a part to form a closed space together with the barrier, and the closed space does not substantially exchange liquid or gas with the outside world, or a mixture of water vapor and gas is exchanged with the outside world.

[0096] The material of the barrier here is generally different from the material that constitutes the test area. Of course, the barrier can also be made of the same material as the test area, such as nylon film or nitrocellulose film. When the materials are different, the test area is a porous film, or a porous water-absorbing material, and the barrier is a non-porous material, such as a non-water-absorbing material, such as plastic, metal, PCV, and ceramic. The liquid here is generally a sample that can circulate or a sample containing water. The gas here generally refers to the air in the atmospheric environment, which may also include water vapor and air with a certain humidity. When a liquid sample containing water comes into contact with air, in the case of a microenvironment, a circulation system is formed between the liquid sample and the air, with water vapor exchange.

[0097] This is because, in the existing traditional products, although the test area is set in an environment wrapped by an external shell (plastic, or PCV material), such as an early pregnancy test device, or on some carriers, or in a test board, such as the device described in U.S. Patent No. US9,414,813, the test area of ​​the test element will have gas or liquid exchange with the outside world. Generally, the area corresponding to the test area is transparent, and the test results on the test area can be read through the transparent area (naked eyes, scanners, cameras or other equipment). Generally, the device is stored at a low temperature in advance. When it is needed to be tested, it needs to be taken out and placed at room temperature for incubation for a period of time. At this time, due to the low temperature of the entire detection device and the high temperature outside, at this time, the water vapor in the outdoor air will condense on the surface of the test device in the form of small water droplets or mist. If these small water droplets or mist are on the outer surface of the shell, they can still be wiped, but if they enter the area between the detection area and the transparent area or enter the internal space around the detection area, they will form small water droplets or mist on the transparent inner surface. In another case, when the external environment temperature is relatively low (such as winter), and the temperature of the liquid sample is sometimes higher than the external environment temperature, such as the temperature of urine is 35-37 degrees Celsius. At this time, at low temperature, the temperature of the test device or the temperature of the external shell is generally lower than the temperature of the sample, and there is a temperature difference. At this time, since there is gas or liquid exchange with the outside world around the test area, the liquid and the atmospheric microenvironment have water vapor exchange, and the humidity in the microenvironment increases, it may also flow into the space around the test area, and may also form small water droplets around the test area or the detection area, so that a layer of tiny water droplets is formed on the transparent shell. Sometimes, it may be a combination of the above two factors. In short, there is a temperature difference between the detection device and the outside world or / and the detection device and the liquid sample. Generally, the temperature of the detection device is lower than the outside temperature or / and lower than the temperature of the liquid sample, and tiny water droplets will be formed on the wall around the detection area, which is called "fogging" and forms a style similar to frosted glass. In this way, after the test, there is a layer of tiny water droplets condensed or in the form of fog in the transparent area, which will affect the accuracy of reading the test results on the test area. Especially when the test area is between positive and negative, the atomization almost covers the results of the test area, resulting in the inability to read the results or inaccurate results. Sometimes, even if there are results in the test area, due to the effect of atomization, the scanning instrument cannot scan the results consistent with the actual results, or the test results are wrong.

[0098] In some embodiments, the test element is generally combined with a device or cavity for collecting samples. For example, the detection device includes a collection cavity, in which the test element is installed, and the test element has a detection area. The detection area is close to the side wall of the collection cavity relative to the back of the detection area, and the detection result displayed in the detection area of ​​the test element can be read from the outside of the collection cavity through the side wall of the collection cavity. However, in the existing detection device, after the test element is installed in the collection cavity, there is a gap between the test element and the inner wall of the collection cavity, especially there is a gap between the detection area of ​​the test element and the inner wall of the collection cavity, and the gap is in a state of fluid communication with the surrounding (such as other areas or spaces in the collection cavity), or the gap is in a state of fluid exchange with the surrounding. After the surrounding fluid (such as liquid or air) enters the gap, it may form atomization in the detection area of ​​the test element, thereby blocking the detection area of ​​the test element, resulting in the inability to accurately read the detection result displayed in the detection area from the outside of the collection cavity, affecting the use of the detection device. The most common example is that when the temperature of the sample to be tested in the collection chamber is higher than the temperature of the inner wall of the collection chamber or the environment (for example, in winter or when the room temperature is low, when testing the body fluid that has just been collected and has body temperature), the water in the sample evaporates and becomes gaseous, enters the gap between the detection area of ​​the test element and the inner wall of the collection chamber, and condenses into water droplets or tiny water droplets on the inner wall of the collection chamber. The refraction of light by water droplets may cause a deviation between the read test result and the actual test result. For example, due to the small distance between the test area and the control area of ​​the test paper, it may be difficult to determine whether the displayed line is T line or C line under the refraction of water droplets. When the formed water droplets are very small, the small water droplets make the originally smooth and transparent inner wall of the collection chamber become similar to "frosted glass". In this case, the test result cannot be read from the outside of the collection chamber at all. Another example is that the sample collected in the collection chamber evaporates colored gas, and the colored gas enters the gap between the detection area and the inner wall of the collection chamber, forming an obstruction to the test result. Another example is that when the liquid sample is splashed in the collection chamber, enters into the gap between the detection area of ​​the test element and the inner wall of the collection chamber in the form of small droplets and sticks to the inner wall of the collection chamber, it will also obstruct the test results. Especially when the liquid sample itself is turbid or opaque, such as blood, turbid urine, tissue fluid, etc., this obstruction effect is more obvious.

[0099] The present invention designs a collection detection device so that the detection device includes a barrier. When the test element is combined with the collection chamber, the barrier can reduce or block the fluid exchange between the area between the detection area and the inner wall of the collection chamber and the surrounding area. In the existing detection device, there is a gap between the detection area and the inner wall of the collection chamber, and the detection device is not provided with any components to reduce the size and size of the gap. The gap is in a state of complete fluid communication with the surroundings, so the fluid around the gap can enter the gap and atomize or condense, or cause obstruction to the detection result due to the characteristics of the fluid itself. The present invention reduces the fluid exchange between the area between the detection area and the inner wall of the collection chamber and the surrounding area through a barrier, and the amount of surrounding fluid entering the area is reduced, which can weaken the fluid's obstruction to the detection result. The degree of reduction in fluid exchange between the area between the detection area and the inner wall of the collection chamber and the surrounding area can be any value compared to the existing detection device, such as 5%, 25%, 50%, 80%, 90%... Blocking the fluid exchange between the area between the detection area and the inner wall of the collection chamber and the surrounding area can be that there is no liquid exchange or gas exchange between the area between the detection area and the inner wall of the collection chamber and the surrounding area, or there is neither liquid exchange nor gas exchange. When there is no liquid exchange between the area between the detection area and the inner wall of the collection chamber and the surrounding area, after the collection chamber collects the sample, the liquid substance derived from the sample cannot enter the area between the detection area and the inner wall of the collection chamber. The above-mentioned liquid substance can be the sample itself, water formed by evaporation and condensation of water in the sample, an aqueous solution dissolved with some substances in the sample, or a substance generated by the sample in other forms. When there is no gas exchange between the area between the detection area and the inner wall of the collection chamber and the surrounding area, after the collection chamber collects the sample, the gaseous substance derived from the sample cannot enter the area between the detection area and the inner wall of the collection chamber. The above-mentioned gaseous substance can be a substance volatilized, evaporated, reacted, or formed in other forms by the sample. When there is neither liquid exchange nor gas exchange between the area between the detection zone and the inner wall of the collecting chamber and the surrounding area, the above-mentioned liquid and gaseous substances originating from the sample cannot enter the area between the detection zone and the inner wall of the collecting chamber. In some preferred embodiments, the fluid is gas and / or liquid. In some preferred embodiments, when the test element is combined with the collecting chamber, the area between the detection zone and the inner wall of the collecting chamber is in an airtight state. In some preferred embodiments, when the test element is combined with the collecting chamber, the area between the detection zone and the inner wall of the collecting chamber is in a liquid-tight state. Without the entry of liquid substances, when there is a temperature difference, the phenomenon of atomization is avoided, so that the results on the detection area can be correctly read.

[0100] The barrier of the present invention may only reduce or block the fluid exchange between the area between the detection zone and the inner wall of the collection chamber and the surrounding area during the detection process. For example, the detection process starts from the collection of samples in the collection chamber to the completion of the reading of the detection results. Of course, the barrier's role in reducing or blocking fluid exchange may also start before the collection chamber starts collecting samples and continue until the reading of the detection results is completed; or, from the combination of the test element and the collection chamber, the barrier continuously plays the role of reducing or blocking fluid exchange. As long as the barrier can reduce or avoid the interference of external factors on the reading of the detection results by reducing or blocking the fluid exchange between the area between the detection zone and the inner wall of the collection chamber and the surrounding area, it will be sufficient.

[0101] There are two ways in which the barrier reduces or blocks the fluid exchange between the area between the detection area and the inner wall of the collection chamber and the surrounding area: the first way is that the barrier makes the detection area fit with the inner wall of the collection chamber. That is, the barrier applies pressure to the back of the test element and presses the detection area of ​​the test element against the inner wall of the collection chamber, thereby reducing the size and size of the gap between the detection area and the inner wall of the collection chamber, or even eliminating the gap between the detection area and the inner wall of the collection chamber. The second way is that the barrier fills the area between the detection area and the inner wall of the collection chamber. That is, the size and size of the area between the detection area and the inner wall of the collection chamber is reduced by filling. In some preferred ways, the barrier can fill the area between the detection area and the inner wall of the collection chamber. In some preferred ways, the barrier is made of transparent or translucent material. In this way, from the outside of the collection chamber, the test results displayed on the detection area can be read through the second barrier. The two types of barriers are described in detail below.

[0102] The first method: the barrier makes the detection area fit with the inner wall of the collection chamber.

[0103] When the test element is combined with the collection chamber, the detection area is clamped between the barrier and the inner wall of the collection chamber. In some preferred embodiments, the barrier includes a clamping portion for cooperating with the inner wall of the collection chamber and clamping the detection area, and when the test element is combined with the collection chamber, the detection area is clamped between the clamping portion and the inner wall of the collection chamber. For example, the barrier can be a test element carrier, the test element carrier has a groove for accommodating the test element, and the clamping portion is the bottom surface of the groove; or, the clamping portion is a convex block provided in the groove.

[0104] In some preferred embodiments, when the test element is combined with the collection chamber, the clamping portion covers the back of the detection area and the clamping portion fits the back of the detection area. The test element has a certain thickness, and the back of the detection area refers to the side of the test element that is opposite to the detection area. The back of the detection area has the same shape, size and size as the detection area. In this way, the clamping portion can apply pressure to the entire detection area through the back of the detection area, press the entire detection area against the inner wall of the collection chamber, and achieve the fit between the inner wall of the collection chamber and the detection area.

[0105] The test element may have one, two or more test elements, and correspondingly, the test areas may also have one, two or more test areas. In some preferred embodiments, there is one clamping part, and the clamping part covers the back side of all the test areas; or, there are two or more clamping parts, and each clamping part covers the back side of one, two or more test areas. When there are two or more clamping parts, the number of test areas covered by the two or more clamping parts may be the same or different. For example, each clamping part covers the back side of one test area; or, each clamping part covers the back side of two test areas at the same time; or, each clamping part covers three test areas at the same time... or, the first clamping part covers the back side of one test area, the second clamping part covers the back side of two test areas, and the third clamping part covers the back side of three test areas.

[0106] In some preferred embodiments, the inner wall of the collection chamber has a fitting portion for fitting the detection area, the fitting portion covers the detection area, and when the test element is combined with the collection chamber, the detection area is clamped between the clamping portion and the fitting portion. The entire detection area is fitted with the fitting portion, so that the complete detection result of the detection area can be read from the outside of the collection chamber. In some embodiments, the fitting portion is a partial area of ​​the inner wall of the collection chamber; or, the fitting portion is a protrusion provided on the inner wall of the collection chamber.

[0107] The test element may have one, two or more test elements, and correspondingly, the test areas may also have one, two or more test areas. In some preferred embodiments, there is one fitting portion, which covers all the test areas; or, there are two or more fitting portions, each of which covers one, two or more test areas. When there are two or more fitting portions, the number of test areas covered by the two or more fitting portions may be the same or different. For example, each fitting portion covers one test area; or, each fitting portion covers two test areas at the same time; or, each fitting portion covers three test areas at the same time... or, the first fitting portion covers one test area, the second fitting portion covers two test areas, and the third fitting portion covers three test areas.

[0108] The thickness of the detection area of ​​the test element is usually a fixed value. After the detection area is clamped by the fitting portion and the clamping portion, it is also hoped that the thickness of the detection area is uniform, so that the sample to be tested can pass through the detection area at a constant speed, so that the detection has a higher accuracy. Therefore, when the test element is installed in the collection chamber, the clamping portion is required to apply equal pressure to each part of the detection area. In some preferred embodiments, the clamping portion has a clamping surface for contacting the back of the detection area, and the fitting portion has a fitting surface for contacting the detection area. When the test element is combined with the collection chamber, the clamping surface is parallel to the fitting surface. In this way, when the test element is installed in the collection chamber, the distance between the fitting surface and the clamping surface is a fixed value, so that the clamping portion can apply equal pressure to each part of the detection area. In some embodiments, the fitting surface and the clamping surface are planes, curved surfaces or arc surfaces.

[0109] In order to enable the detection zone to be firmly clamped between the fitting portion and the clamping portion, in some preferred embodiments, when the test element is combined with the collection chamber, the distance between the fitting surface and the clamping surface is less than or equal to the thickness of the detection zone. The thickness of the detection zone refers to the thickness of the area where the detection zone of the test element is located. When the distance between the fitting surface and the clamping surface is less than the thickness of the detection zone, the detection zone clamped between the fitting portion and the clamping portion is subjected to a certain pressure, and the detection zone is tightly fitted with the fitting surface of the fitting portion under pressure. When the distance between the fitting surface and the clamping surface is equal to the thickness of the detection zone, although the detection zone clamped between the fitting portion and the clamping portion is not subjected to the pressure of the fitting portion and the clamping portion, the detection zone can still fit with the fitting surface of the fitting portion. In addition, since the sample to be tested needs to flow through the detection zone, the detection zone can display the test result. After the test element is installed in the collection chamber, if the distance between the fitting portion and the clamping portion is less than zero, the fitting portion will hinder the installation of the test element; if the distance between the fitting portion and the clamping portion is equal to zero, the thickness of the detection area is close to zero under the clamping of the fitting portion and the clamping portion, thereby blocking the flow of the sample to be tested in the detection area and affecting the detection process. Therefore, in some preferred embodiments, when the test element is combined with the collection chamber, the distance between the fitting surface and the clamping surface is greater than zero.

[0110] The fitting portion cooperates with the clamping portion and the clamping detection area can have the following forms, which are explained by taking the test element carrier as a barrier. The test element carrier is a component used to fix the test element, and the test element can be installed in the collection cavity through the test element carrier. When the test element is installed in the collection cavity through the test element carrier, the combination of the test element and the collection cavity depends on the combination of the test element carrier and the collection cavity. The detection device includes a collection cavity, a test element and a test element carrier. The test element has a detection area. When the test element is combined with the collection cavity, the detection area is clamped between the test element carrier and the inner wall of the collection cavity, and the detection area is fitted with the inner wall of the collection cavity.

[0111] The first form: the test element carrier has a groove for accommodating the test element. When the test element is combined with the collection chamber, the distance between the bottom surface of the groove and the inner wall of the collection chamber is less than or equal to the thickness of the detection area. In this way, when the test element is combined with the collection chamber, the detection area is clamped between the bottom surface of the groove and the inner wall of the collection chamber, and the detection area is in contact with the inner wall of the collection chamber. In other words, the clamping part is the bottom surface of the groove, and the contact part is a partial area of ​​the inner wall of the collection chamber that is aligned with the clamping part. In some embodiments, the bottom surface of the groove is parallel to the inner wall of the collection chamber. The inner wall of the collection chamber can be a plane, a curved surface, a cylindrical surface, or a conical cylindrical surface.

[0112] The second form: the test element carrier has a groove for accommodating the test element, and a protrusion is provided in the groove. When the test element is combined with the collection chamber, the detection area is clamped between the protrusion and the inner wall of the collection chamber, and the detection area fits with the inner wall of the collection chamber. In other words, the clamping portion is a protrusion provided in the groove of the test element carrier; the area of ​​the inner wall of the collection chamber corresponding to the protrusion can be regarded as a fitting portion, or as a fitting surface of the fitting portion. When installing the test element, first install the test element in the groove of the test element carrier, and then install the test element carrier together with the test element into the collection chamber. When the test element carrier is installed in place, the protrusion in the groove of the test element carrier cooperates with the inner wall of the collection chamber to clamp the detection area of ​​the test element.

[0113] In some preferred embodiments, one end of the protrusion is connected to the groove, and the other end of the protrusion is a free end. When the test element is combined with the collection chamber, the free end face of the protrusion covers the back of the detection area, and the free end face of the protrusion fits the back of the detection area. The free end face of the protrusion is the end face of the free end of the protrusion, that is, the clamping face of the clamping part. In this way, when the test element is combined with the collection chamber, the protrusion applies pressure to the back of the detection area, pressing the entire detection area against the inner wall of the collection chamber, so as to achieve full coverage and fit of the inner wall of the collection chamber to the detection area.

[0114] The test element carrier has a mounting surface, and the groove is a groove concave from the mounting surface. The free end surface of the projection can be located outside the groove, flush with the groove, or inside the groove. That is, the height of the projection can be greater than, equal to, or less than the depth of the groove. The free end surface of the projection is flush with the groove, that is, the free end surface of the projection can be located in the same plane as the mounting surface. Since the projection is provided in the groove, the projection makes the detection area of ​​the test element protrude out of the groove relative to other areas of the test element. However, if the detection area is completely outside the groove, the two side walls of the groove cannot play a limiting role in the detection area, and the test element is easy to escape from the groove. In some preferred embodiments, the free end surface of the projection is located inside the groove. That is, the height of the projection is less than the depth of the groove, and the projection is located inside the groove as a whole. In this way, the detection area of ​​the test element can be fully or partially limited by the two side walls of the groove, increasing the stability of the test element installed in the groove, so that the test element is not easy to escape from the groove. The distance between the free end surface of the projection and the mounting surface can be less than or equal to the thickness of the detection area. When the distance between the free end face of the bump and the mounting surface is less than the thickness of the detection area, the detection area can be partially defined by the two side walls of the groove; when the distance between the free end face of the bump and the mounting surface is equal to the thickness of the detection area, the detection area can be completely defined by the two side walls of the groove. If the distance between the free end face of the bump and the mounting surface is greater than the thickness of the detection area, then when the test element is installed in the collection cavity, the inner wall of the collection cavity is interfered by the mounting surface and cannot contact the detection area, let alone cooperate with the bump to clamp the detection area.

[0115] There may be one, two or more test elements, and correspondingly, the test element carrier has one, two or more grooves for mounting the test elements. When the free end face of the projection is located within the groove, in some preferred embodiments, when there are two or more grooves, each groove has its own projection. When the test element is mounted in the collecting chamber, the distance between the free end faces of two or more projections and the inner wall of the collecting chamber may be equal or unequal. In order to facilitate the installation of the test element and the manufacture of the test element carrier, usually when there are more than two test elements, the detection areas of the two or more test elements or the two or more test elements have the same thickness. Therefore, in some preferred embodiments, the distance between the free end faces of two or more projections and the inner wall of the collecting chamber is equal. When the free end face of the projection is located outside the groove or flush with the groove, in other embodiments, when there are two or more grooves, there may be only one projection, which runs through all the grooves, and the projection covers the back of all the detection areas; or, there are two or more projections, the projection runs through two or more grooves, and the projection covers the back of two or more detection areas. When there are two or more protrusions, the number of back surfaces of the detection areas covered by each protrusion may be equal or unequal.

[0116] In some preferred embodiments, when the test element is installed in the collection chamber, the free end face of the protrusion is parallel to the inner wall of the collection chamber. In some preferred embodiments, the inner wall of the collection chamber is a plane, a curved surface, a cylindrical surface or a conical cylindrical surface. In some preferred embodiments, when the test element is installed in the collection chamber, the distance between the free end face of the protrusion and the inner wall of the collection chamber is less than or equal to the thickness of the detection area. In some preferred embodiments, when the test element is installed in the collection chamber, the distance between the free end face of the protrusion and the inner wall of the collection chamber is greater than zero.

[0117] The third form: the test element carrier has a groove for accommodating the test element, and the inner wall of the collecting cavity is provided with a protrusion. When the test element is installed in the collecting cavity, the detection area is clamped between the protrusion and the groove, and the detection area fits with the protrusion. In other words, the fitting portion is the protrusion provided on the inner wall of the collecting cavity; the bottom surface of the groove corresponds to the protrusion, or the area aligned with the protrusion can be regarded as a clamping portion or a clamping surface. When installing the test element, first install the test element in the groove of the test element carrier, and then install the test element carrier together with the test element into the collecting cavity. When the test element carrier is installed in place, the protrusion on the inner wall of the collecting cavity presses the detection area of ​​the test element located in the groove, so that the protrusion cooperates with the bottom surface of the groove to clamp the detection area of ​​the test element.

[0118] In some preferred embodiments, one end of the protrusion is a connection end connected to the inner wall of the collection chamber, and the other end of the protrusion is a free end. When the test element is installed in the collection chamber, the free end surface of the protrusion covers the detection area, and the free end surface of the protrusion fits the detection area. The free end surface of the protrusion is also the fitting surface. In some preferred embodiments, the connection end of the protrusion covers the detection area. In some preferred embodiments, the size of the protrusion is a fixed value, for example, the protrusion is a cuboid, a cube or a cylinder; or, the size of the protrusion increases gradually from the free end of the protrusion to the connection end of the protrusion, for example, the protrusion is a triangular pyramid, a quadrangular pyramid, a conical cylinder, etc.

[0119] In some preferred embodiments, when the test element is installed in the collection chamber, the protrusion is inserted into the groove or the protrusion is located outside the groove. The test element has a certain thickness, and the thickness of the test element may be greater than, less than or equal to the depth of the groove of the test element carrier. If the thickness of the test element detection area is greater than the depth of the groove, when the test element is installed in the groove of the test element carrier, the test element detection area is partially exposed in the groove; if the thickness of the test element detection area is equal to or less than the depth of the groove, when the test element is installed in the groove of the test element carrier, the test element detection area is completely located in the groove. When the thickness of the test element detection area is greater than or equal to the depth of the groove, there are two types of positional relationships between the protrusion and the groove: the first type, the distance between the free end surface of the protrusion and the bottom surface of the groove is equal to the thickness of the detection area, and the protrusion is located outside the groove; the second type, the distance between the free end surface of the protrusion and the bottom surface of the groove is less than the thickness of the detection area, and the protrusion can be located outside the groove or partially inserted into the groove. When the thickness of the detection zone of the test element is smaller than the depth of the groove, in order to achieve the matching of the protrusion and the groove, clamping the detection zone, and making the free end surface of the protrusion cover and fit the detection zone, the protrusion must be inserted into the groove.

[0120] There may be one, two or more test elements, and correspondingly, the test element carrier may have one, two or more grooves for mounting the test elements. In some preferred embodiments, there is one protrusion, and the free end surface of the protrusion covers and fits all the detection areas; or, there are two or more protrusions, and the free end surface of each protrusion covers one, two or more detection areas. For example, when the protrusion is located outside the groove and can cooperate with the bottom surface of the groove, clamp the detection area, and achieve the fit of the free end surface of the protrusion with the detection area, there may be only one protrusion, and the free end surface of the protrusion can cover and fit all the detection areas; or, there are two or more protrusions, and the free end surface of each protrusion covers one, two or more detection areas. When the protrusion must be inserted into the groove to cooperate with the bottom surface of the groove, clamp the detection area, and achieve the fit of the free end surface of the protrusion with the detection area, the groove, the detection area and the protrusion correspond one to one. At this time, when there are two or more grooves, there are also two or more protrusions.

[0121] In some preferred embodiments, when the test element is installed in the collection chamber, the free end face of the protrusion is parallel to the bottom surface of the groove. In this way, the distance between the free end face of the protrusion and the bottom surface of the groove is a constant. In some preferred embodiments, the free end face of the protrusion is a plane, a curved surface, a cylindrical surface or a conical cylindrical surface. In some preferred embodiments, when the test element is installed in the collection chamber, the distance between the free end face of the protrusion and the bottom surface of the groove is less than or equal to the thickness of the detection area. In some preferred embodiments, when the test element is installed in the collection chamber, the distance between the free end face of the protrusion and the bottom surface of the groove is greater than zero.

[0122] The fourth method: the test element carrier has a groove for accommodating the test element, a convex block is arranged in the groove, and a protrusion is arranged on the inner wall of the collection chamber. When the test element is installed in the collection chamber, the protrusion is aligned with the protrusion, the detection area is clamped between the protrusion and the protrusion, and the detection area is attached to the protrusion. In this method, the clamping part is the protrusion arranged in the groove, and the attaching part is the protrusion arranged on the inner wall of the collection chamber.

[0123] In some preferred embodiments, one end of the protrusion is connected to the inner wall of the collection chamber, and the other end of the protrusion is a free end. When the test element is installed in the collection chamber, the free end surface of the protrusion covers the detection area, and the free end surface of the protrusion fits the detection area. The free end surface of the protrusion is a fitting surface.

[0124] In some preferred embodiments, one end of the protrusion is connected to the groove, and the other end of the protrusion is a free end. When the test element is installed in the collection cavity, the free end surface of the protrusion covers the back of the detection area, and the free end surface of the protrusion is in contact with the back of the detection area. The free end surface of the protrusion is a clamping surface.

[0125] In some preferred embodiments, when the test element is installed in the collection chamber, the free end surface of the protrusion is parallel to the free end surface of the protrusion. In this way, the distance between the free end surface of the protrusion and the free end surface of the protrusion is a constant value. The free end surface of the protrusion can be a plane, a curved surface, a cylindrical surface or a conical cylindrical surface.

[0126] In order to make the test element firmly installed in the groove of the test element carrier and not easy to fall out of the groove, in some preferred modes, the free end face of the protrusion is located in the groove; when the test element is combined with the collection chamber, the protrusion is inserted into the groove or the protrusion is located outside the groove. When the test element is installed in the groove of the test element carrier, the thickness of the detection area can be greater than, equal to or less than the distance between the free end face of the protrusion and the mounting surface. When the thickness of the detection area is greater than the distance between the free end face of the protrusion and the mounting surface, the detection area is partially exposed in the groove; when the thickness of the detection area is less than or equal to the distance between the free end face of the protrusion and the mounting surface. The detection area is completely contained in the groove. When the thickness of the detection area is greater than or equal to the distance between the free end face of the protrusion and the mounting surface, the positional relationship between the protrusion and the groove has the following two types: the first type, the distance between the free end face of the protrusion and the free end face of the protrusion is equal to the thickness of the test element, and the protrusion is located outside the groove; the second type, the distance between the free end face of the protrusion and the free end face of the protrusion is less than the thickness of the test element, and the protrusion can be located outside the groove or partially inserted into the groove. When the thickness of the detection area is smaller than the distance between the free end surface of the projection and the mounting surface, the projection must be inserted into the groove to cooperate with the projection to achieve clamping, covering and bonding of the detection area.

[0127] In some preferred embodiments, each groove has its own protrusion. In some preferred embodiments, there is one protrusion, and the free end surface of the protrusion covers and fits all the detection areas; or, there are two or more protrusions, and the free end surface of each protrusion covers one, two or more detection areas.

[0128] In some preferred embodiments, when the test element is installed in the collection chamber, the distance between the free end face of the protrusion and the free end face of the bump is less than or equal to the thickness of the detection zone. In some preferred embodiments, when the test element is installed in the collection chamber, the distance between the free end face of the protrusion and the free end face of the bump is greater than zero. In this way, it is possible to avoid the protrusion and the bump interfering with each other and hindering the installation of the test element when the test element is installed in the collection chamber (when the distance between the free end face of the protrusion and the free end face of the bump is less than zero), and it is possible to avoid the protrusion and the bump from forming too much clamping force on the detection zone and blocking the flow of the sample to be tested in the detection zone (when the distance between the free end face of the protrusion and the free end face of the bump is equal to zero).

[0129] The barrier can fill the area between the detection zone and the inner wall of the collection chamber.

[0130] The barrier reduces or eliminates the gap between the detection zone and the inner wall of the collection chamber by filling the area between the detection zone and the inner wall of the collection chamber, thereby reducing or blocking the fluid exchange between the area between the detection zone and the inner wall of the collection chamber and the surrounding area. In this way, when the test element is combined with the collection chamber, the barrier is located between the detection zone and the inner wall of the collection chamber, and the detection zone is close to the test element carrier relative to the back of the detection zone. In some preferred embodiments, the barrier is made of transparent or translucent material. The transparent or translucent material can be, for example, plastic, glass, gel, etc.

[0131] The barrier may be fixedly connected or detachably connected to the inner wall of the collecting chamber. For example, the barrier is a transparent adhesive sheet, which covers the entire detection area with the adhesive sheet, and then the entire detection area is bonded to the inner wall of the collecting chamber through the adhesive sheet, thereby achieving a fixed connection between the barrier and the detection area and the inner wall of the collecting chamber. However, the adhesive sheet contains volatile substances, which may affect the detection accuracy of the test element. Moreover, since the test element is usually disposable, after the detection area is fixedly connected to the inner wall of the collecting chamber, it is difficult to reuse the collecting chamber. Therefore, the preferred method is that the barrier is detachably connected to the inner wall of the collecting chamber. In some preferred methods, the barrier is detachably connected to the inner wall of the collecting chamber. In some methods, the barrier is fixedly connected or detachably connected to the detection area.

[0132] In order to enable the barrier to minimize the gap between the detection zone and the inner wall of the collection chamber, in some preferred embodiments, the barrier can fill the area between the detection zone and the inner wall of the collection chamber. In some preferred embodiments, when the test element is mounted on the test element carrier, the barrier covers and fits the detection zone. In some preferred embodiments, when the test element is combined with the collection chamber, the barrier fits the inner wall of the collection chamber. In some preferred embodiments, the barrier has a first connecting surface for covering and fitting the detection zone and a second connecting surface for fitting the inner wall of the collection chamber, and the size of the barrier is a constant between the first connecting surface and the second connecting surface; or, the size of the barrier increases gradually from the first connecting surface to the second connecting surface.

[0133] In some embodiments, the inner wall of the collecting chamber is provided with a connecting portion for fitting with the barrier element, and the connecting portion is a protrusion on the inner wall of the collecting chamber.

[0134] In some preferred embodiments, the barrier is a test element carrier. The test element carrier has a mounting surface, and a groove is provided on the mounting surface for accommodating the test element. After the test element carrier is mounted in the groove, the detection area is in contact with the bottom surface of the groove. When the test element is combined with the collection cavity, the back surface of the mounting surface of the test element carrier is in contact with the inner wall of the collection cavity, so that the test element carrier fills the area between the detection area and the inner wall of the collection cavity. At this time, the bottom surface of the groove is the first connection surface of the barrier, and the back surface of the mounting surface of the test element carrier is the second connection surface.

[0135] In some preferred embodiments, the barrier is fixedly connected or detachably connected to the detection area. For example, when the test element is installed in a groove of the test element carrier, the test element can be fixedly connected to the groove, or the test element can be detachably connected to the groove through a clamping structure in the groove.

[0136] Collection chamber

[0137] The collection chamber is a cavity for accommodating samples. In order to realize the detection function of the collection detection device, the test element needs to be installed in the collection chamber before the sample is collected. In order to facilitate the installation of the test element, the existing collection detection device designs the collection chamber into two or more parts, and realizes the disassembly and assembly of the test element by splitting and combining the two or more parts, which is inconvenient to operate and has high processing and assembly costs. Therefore, the present invention designs a collection detection device with a detection chamber, including a collection chamber, the collection chamber has an opening, the detection chamber is located below the opening, the detection chamber is a cavity formed by the side wall of the collection chamber protruding outward, the side wall of the collection chamber has two connections with the detection chamber, and the lateral size of the detection chamber is greater than or equal to the lateral distance between the two connections. Assuming that a transverse cross section cuts the collection chamber, the transverse cross section intersects with the two connections between the side wall of the collection chamber and the detection chamber respectively to form a first connection point and a second connection point, and the lateral distance between the two connections refers to the distance between the first connection point and the second connection point. Assume that a longitudinal section cuts the detection cavity, the longitudinal section is perpendicular to the above-mentioned transverse section, and the longitudinal section is parallel to the line between the two connection points. The longitudinal section, the transverse section and the side wall of the detection cavity intersect to form two intersections. The transverse dimension of the detection cavity refers to the distance between the two intersections. The transverse direction refers to the direction perpendicular to the axis of the collection cavity. The longitudinal direction refers to the direction parallel to the axis of the collection cavity. In this way, the test element can be inserted into the detection cavity through the connection between the collection cavity and the detection cavity, and installed in the detection cavity, which is easy to operate; and the collection cavity is integrally formed, and the processing cost is low.

[0138] In some preferred embodiments, the transverse dimension of the detection cavity is a fixed value; or the transverse dimension of the detection cavity gradually expands outward from the connection. When the transverse dimension of the detection cavity gradually expands outward from the connection, the transverse dimension of the detection cavity is the smallest at the connection with the collection cavity.

[0139] In some preferred embodiments, the detection cavity has a first side wall and a second side wall connected to the two connection points respectively, and the first side wall and the second side wall are parallel; or, the first side wall and the second side wall intersect. In some preferred embodiments, the first side wall and the second side wall are both planes. In some preferred embodiments, the first side wall and the second side wall are parallel to the axis of the collection cavity.

[0140] In some preferred embodiments, the detection cavity has a third side wall for connecting the first side wall and the second side wall, and the edge of the third side wall relative to the collection cavity opening is close to the middle of the collection cavity. In some preferred embodiments, the third side wall is a plane. In some preferred embodiments, the third side wall is parallel to the axis of the collection cavity.

[0141] In some preferred embodiments, the detection cavity has a top surface, the top surface is connected to the side wall of the collection cavity, and the top surface is located at the outer edge of the collection cavity opening. In some preferred embodiments, the top surface is a plane. In some preferred embodiments, the top surface is perpendicular to the axis of the collection cavity.

[0142] In some preferred embodiments, the detection cavity has a bottom surface, and the bottom surface and the bottom surface of the collection cavity are located in the same plane. In some preferred embodiments, the bottom surface is parallel to the top surface.

[0143] In some preferred embodiments, the detection cavity has a locking structure, which includes a stopper, one end of which is a connection end connected to the bottom surface of the detection cavity, and the other end of which is a free end, and the free end of the stopper is closer to the middle of the collection cavity relative to the connection end of the stopper. In some preferred embodiments, the stopper is close to the third side wall.

[0144] In some preferred embodiments, the locking structure further includes a snap-in piece, which is a protrusion provided on the third side wall. The test element is provided with a groove or a through groove for aligning and matching with the snap-in piece. When the test element is installed in the detection cavity, the snap-in piece is inserted into the groove to achieve the installation and fixation of the test element. In some preferred embodiments, the snap-in piece is close to the top of the third side wall. In this way, the limiter can fix the lower side of the test element; the snap-in piece cooperates with the groove of the test element to achieve the fixation of the upper side of the test element. DETAILED DESCRIPTION

[0145] The present invention is further described in detail below with reference to specific embodiments.

[0146] A collection detection device, comprising a collection chamber and a test element, wherein the test element has a detection area, characterized in that the collection detection device comprises a barrier, and when the test element is combined with the collection chamber, the barrier can reduce or block the fluid exchange between the area between the detection area and the inner wall of the collection chamber and the surrounding area. In some embodiments, the fluid is a gas and / or a liquid. In some embodiments, when the test element is combined with the collection chamber, the area between the detection area and the inner wall of the collection chamber is in an airtight state. In some embodiments, when the test element is combined with the collection chamber, the area between the detection area and the inner wall of the collection chamber is in a liquid-tight state.

[0147] The barrier reduces or blocks the fluid exchange between the area between the detection area and the inner wall of the collection chamber and the surrounding area by making the detection area fit with the inner wall of the collection chamber, such as described in Examples 1 to 3; or, the barrier reduces or blocks the fluid exchange between the area between the detection area and the inner wall of the collection chamber and the surrounding area by filling the area between the detection area and the inner wall of the collection chamber, such as described in Example 4. Fitting is a state of close connection.

[0148] The following further describes the implementation of the present invention in conjunction with the accompanying drawings. These descriptions are only the most preferred way to explain how to implement the present invention and do not constitute any limitation to the present invention.

[0149] Example 1

[0150] A detection device includes a collection chamber 1, such as Figure 1 As shown, the test element 2, for example Figure 3 The test element carrier 3 shown, for example Figure 4 As shown. The test element 2 has a detection area 201, and the test element carrier 3 has a groove 301 for accommodating the test element, and a protrusion 4 is arranged in the groove 301. The test element carrier is arranged in the groove 301, and the detection area is located on the protrusion 4, and the side of the detection area with the test reagent (such as an antibody, or a chemical substance, or an antigen) faces upward, and these reagents contact the analyte in the sample, and can indirectly or directly detect whether the sample includes the analyte. The height 306 of the distance difference between the protrusion 4 and the depth of the groove 305 is almost the same as the thickness of the test area or slightly less than the thickness of the test area 201. The test area is generally composed of a water-absorbing material. In this way, the detection area 201 is located on the protrusion 4, and slightly protrudes from the surface of the carrier on the carrier. When the carrier is close to the side wall in the collection chamber, since the carrier is an integral substantially planar structure, and the side wall of the collection chamber is also a substantially planar structure, in this way, the test area contacts the inner wall of the collection chamber, or slightly clings to the surface of the inner wall 101 of the collection chamber.

[0151] In other words, when the test element 2 on the carrier is combined with the collection chamber 1, the detection area 201 is clamped between the protrusion 4 and the inner wall 101 of the collection chamber, and the detection area 201 is in contact with the inner wall 101 of the collection chamber, as shown in FIG. 6 and FIG. Figure 7 When the test element is installed in the collection chamber, the inner wall of the collection chamber covers the detection area, or covers part of the detection area.

[0152] In some embodiments, in order to allow the carrier to closely contact the side wall 101, some external pressure can be applied to the carrier, so that the detection area of ​​the test element on the carrier is closely attached to the side wall 101 inside the collection chamber. An elastic element 701 is set in the cavity. When the carrier is clamped between the elastic element and the inner wall 101 of the collection chamber, the elastic element can apply a certain force to the carrier. In this way, a Figure 7 As shown, one side 201 of the test area is attached to or covered on the inner wall 101 of the collection chamber. Alternatively, there is no space between the test area 201 and the interior of the collection chamber.

[0153] The inner wall 101 of the collection chamber is made of transparent plastic, and the results on the test area can be read with the naked eye through the transparent plastic, or the results of the test area can be scanned by a scanning device and the test results can be saved.

[0154] When the collection chamber collects the fluid sample, the collection chamber with the test element is generally packaged in a packaging bag containing a dry reagent and stored at room temperature (25°C) or a low temperature environment (25-30°C). In some cold places, the ambient temperature may be below zero, for example, minus 5-20°C. In the test device at these temperatures, the collection chamber is generally made of plastic material, and the temperature of the plastic part is equal to or close to the ambient temperature.

[0155] When the collection chamber device is taken out from these temperature environments for testing and analysis, for example, the test subject is generally asked to collect samples on the spot, such as urine, and the test subject is asked to urinate in the collection chamber. The temperature of the urine sample is generally 35-38 degrees Celsius, which is higher than the ambient temperature and higher than the temperature of the collection chamber itself. At this time, there will be water vapor or mist in the urine. When encountering a solid with a lower temperature than the urine, it will condense into droplets on the surface of the solid, such as multiple droplets covering the solid surface. In this test device, since the test area is closely attached to the transparent inner wall 101, there is no vapor condensation in the transparent area, so that the test results on the test area can be clearly read.

[0156] On the contrary, if the test area is not allowed to be close to, touch or cover the transparent area 1001 of the side wall, but a certain distance or space (such as Fig. 6A As shown, for example, if the protrusion 401 is missing, the test strip is located in the groove. Even if the groove is close to the groove, there is still a certain space 900 between the groove and the transparent area 1001. The water vapor generated by the urine sample 1004 will condense into tiny droplets 1003 on the surface of the transparent area 1001 and cover the transparent area. When the sample flows along the test element to the detection area by capillary action, a reaction will occur in the detection area, such as colored lines appearing in the detection area or no colored lines appearing, indicating that the sample is negative or positive. When liquid covers the transparent area 1001, the test result on the test area on the test element cannot be read through the transparent area 1001. When the test is scanned with a scanning device, it may be due to the reflection of the droplets. Even if it can be scanned, the test result will not be correctly and truly retained. In particular, when the colored lines of the test results in the test area are relatively light or the color is relatively light, the mist or water droplets on the transparent area 1001 will cover the results on the test area, resulting in incorrect interpretation. This method is the existing traditional carrier ( Figure 5) has a depth greater than the thickness of the test element, so that the test element is located in the groove, thereby protecting the test element from damage, but ignoring the problem raised by the present invention.

[0157] like Figure 7 As shown, one side of the protrusion 4 is connected to the groove or is located in the groove, and the other side 401 of the protrusion is a free surface. When the test element is combined with the collection cavity, the free surface 401 of the protrusion covers and fits the back side 202 of the detection area, for example Figure 6B and Figure 7 As shown. In this way, the protrusion applies pressure to the back of the detection area, pressing the entire detection area against the inner wall 101 of the collection chamber, so as to achieve full coverage and fit of the inner wall of the collection chamber to the detection area. In some embodiments, the free end face of the protrusion can be a curved surface, a cylindrical surface, or a conical cylindrical surface. Any structure that can allow the test area to cover, contact, or be close to the inner wall of the collection chamber is acceptable. The essence of being close is to reduce the contact between water vapor and the inner wall of the transparent area 1001, thereby reducing the chance of condensation into smiling droplets on the inner wall surface and reducing the chance of atomization.

[0158] When the test element is combined with the collection chamber, the distance between the free end surface 401 of the projection 4 and the inner wall 101 of the collection chamber is equal to the thickness of the detection area, for example Figure 7 As shown. In some embodiments, when the test element is combined with the collection chamber, the distance between the free end face 401 of the protrusion and the inner wall of the collection chamber is less than the thickness of the detection area, so that when the test element is installed in the collection chamber through the test element carrier, the free end face 401 of the protrusion 4 can press the detection area 201 against the inner wall of the collection chamber to achieve the fit between the detection area and the inner wall of the collection chamber. When the test element is combined with the collection chamber, the distance between the free end face 401 of the protrusion and the inner wall of the collection chamber is greater than zero. The protrusion can be implemented with a separate structure to allow the test area to be tightly attached to the inner wall 101 of the collection chamber, in particular, tightly attached to the transparent area 1001.

[0159] In some embodiments, the free end surface 401 of the protrusion may be located within the groove 301, for example Figure 3 As shown. In this way, the detection area of ​​the test element can be completely or partially defined by the two side walls of the groove, which increases the stability of the test element installed in the groove and makes it difficult for the test element to fall out of the groove. When blocked in the groove of the carrier, there are multiple protrusions, each groove has its own protrusion, and each protrusion covers the back of a detection area, for example Figure 4 In some embodiments, there is one protrusion, and the protrusion covers the back side of all the detection areas; or, there are two or more protrusions, and each protrusion covers the back side of one, two or more detection areas.

[0160] Example 2

[0161] A detection device includes a collection chamber 1, such as Figure 2 As shown, the test element 2, for example Figure 3 The test element carrier 3 shown, for example Figure 5 As shown, the test element 2 has a detection area 201, the test element carrier 3 has a groove 301 for accommodating the test element, and a protrusion 5 is provided on the inner wall 101 of the collection chamber. When the test element is installed in the collection chamber, the detection area 201 is clamped between the protrusion 5 and the groove 301, and the detection area is in contact with the protrusion, for example Figure 8 and Fig. 9 As shown. At this time, it can be understood that the test element is in the groove, and when the carrier is close to the inner wall 101 of the collection chamber, part of the protrusion 5 enters the groove and contacts the test area on the test element located in the groove, so that the test area 201 can be fitted with the protrusion 5. At this time, the protrusion 5 is transparent, so the test result on the test area can be read through the transparent side wall 101.

[0162] Similarly, one side of the protrusion 5 is a connection end connected to the inner wall of the collection chamber, and the other side 501 of the protrusion is a free end. When the test element is combined with the collection chamber, the free end surface 501 of the protrusion 5 covers and fits the detection area 201, for example Fig. 9 The protruding connection end covers the detection area. The size of the protrusion is a fixed value, such as Figure 8 and Fig. 9 As shown, the protrusion is a cuboid. In some embodiments, the protrusion may be a cube or a cylinder. In some embodiments, the size of the protrusion increases gradually from the free end of the protrusion to the connecting end of the protrusion. For example, the protrusion is a triangular pyramid, a quadrangular pyramid, a conical column, etc. Figure 8 As shown, when the test element is installed in the collection chamber, the free end surface 501 of the protrusion is parallel to the bottom surface 3011 of the groove. In this way, the distance between the free end surface of the protrusion and the bottom surface of the groove is a constant value. The free end surface 501 of the protrusion is a plane. In some embodiments, the free end surface of the protrusion can be a curved surface, a cylindrical surface, or a conical cylindrical surface.

[0163] When the test element is combined with the collection chamber, the distance between the free end surface 501 of the protrusion and the bottom surface 3011 of the groove is greater than zero. When the test element is combined with the collection chamber, the distance between the free end surface 501 of the protrusion and the bottom surface 3011 of the groove is less than the thickness of the detection area 201, for example Fig. 9 In some embodiments, when the test element is combined with the collection chamber, the distance between the free end surface of the protrusion and the bottom surface of the groove is equal to the thickness of the detection area. When the test element is combined with the collection chamber, the protrusion is inserted into the groove; or, the protrusion is located outside the groove. The protrusion has one, and the free end surface of the protrusion covers and fits all the detection areas, for example Figure 2As shown; or, there are two or more protrusions, and the free end surface of each protrusion covers and fits one, two or more detection areas.

[0164] In some methods, it is not necessary for the test area to cover the transparent area. When there is space between the test area and the transparent area, the test area and the transparent area can be placed in a relatively closed space to reduce the fluid flow between the space and the outside world. This can also reduce the probability of water vapor condensing on the surface of the transparent area. Figure 6B As shown. The test area 201 is located on the protrusion 4, but the thickness is relatively thin. There is a gap between the test area 201 and the collection cavity. If there is a liquid sample, mist or tiny droplets can still be formed on the inner surface of the transparent area 101, thereby covering the test results on the test area. In order to be in a closed space, a spacing structure 81, 80 can be set between the test strip and the side wall, so that the test area and the transparent area are in a closed area, so that the external water vapor, water vapor or water vapor in the air will not enter the closed space, thus reducing the chance of condensation of water droplets on the inner surface of the transparent area 1001 in the closed space, thereby preventing the generation of fog on the inner surface.

[0165] For example, for Fig.21 For example, the left side of the number 2083 is a carrier without a groove with protrusion 4. There is a distance and space between the detection area of ​​the test strip (with lines, the detection line is below and the detection result control line is above) and the inner wall of the transparent collection chamber, and it is not a sealed space; the right side is a groove structure with protrusion 4 (208, 209, 210, 211), the test area is in contact with or covers the transparent area, and after collecting urine samples and testing, there are micro-droplets or atomization on the left side of the test area, which blocks the test area, especially the test lines or control lines. In the area on the right, there is almost no atomization or droplets condensed on the transparent inner wall, and the result area is clearly visible, which clearly shows the different effects brought by different structures.

[0166] Example 3

[0167] This embodiment combines Embodiment 1 and Embodiment 2. An anti-atomization detection device includes a collection chamber 1, for example Figure 2 As shown, the test element 2, for example Figure 3 The test element carrier 3 shown, for example Figure 4As shown, the test element 2 has a detection area 201, the test element carrier 3 has a groove 301 for accommodating the test element, a protrusion 4 is provided in the groove 301, and a protrusion 5 is provided on the inner wall of the collection chamber. When the test element 2 is combined with the collection chamber 1, the protrusion 5 and the protrusion 4 are arranged face to face (so that the detection area is located between the two protrusions), and the detection area 201 is arranged between the protrusion 5 and the protrusion 4, and the detection area 201 is in contact with the protrusion 5, as shown in Figures 10 and 11. Fig.11 shown.

[0168] One side of the protrusion 4 is connected to the groove, and the other side of the protrusion 4 is a free end 401. When the test element 2 is combined with the collection chamber 1, the free end 401 of the protrusion covers and fits the back side of the detection area 201. Fig.10 and Fig.11 The free end surface of the projection is located in the groove, for example Figure 4 shown.

[0169] Example 4

[0170] In some embodiments, the present invention provides a detection device, including a collection chamber 1, for example Figure 2 As shown, the test element 2, for example Figure 3 The test element carrier 3 shown, for example Figure 5 As shown, the test element 2 has a detection area 201. When the test element 2 is combined with the collection chamber 1, the test element carrier 3 is located between the detection area 201 and the inner wall 101 of the collection chamber, that is, the detection area 201 showing the test result is in contact with the bottom of the groove of the carrier, and the back side 202 of the detection area is outside the groove, so that the detection area is closely attached to the bottom of the carrier groove, so that the back side 202 of the detection area is close to the test element carrier 3, for example Fig.13 That is, in this embodiment, the barrier is a test element carrier, and the test element is located between the carrier and the side wall of the collection chamber. The test element carrier is made of a transparent material. In some embodiments, the test element carrier is made of a translucent material, so that the carrier corresponding to the test area is transparent, and the side wall or protrusion 5 of the collection chamber is also transparent, so that the result of the test area 201 on the test element can be read through the transparent area. Fig.13 In the structure shown, the test area is in contact with the bottom of the groove of the carrier, and the carrier is in close contact with the region 5, so that external water vapor or water vapor will not condense into droplets on the surface where the protrusion 5 contacts the carrier, and no droplets will be generated on the surface where the test area contacts the carrier, thereby avoiding an atomized interface.

[0171] In some embodiments, the test element carrier is detachably connected to the test element and the inner wall of the collection chamber. In some embodiments, the test element carrier can be fixedly connected to the test element. When the test element 2 is mounted on the test element carrier 3, the test element carrier 3 covers and fits the detection area 201; when the test element 2 is combined with the collection chamber 1, the test element carrier 3 fits the inner wall 101 of the collection chamber, for example Fig.12 and 13 In this way, the test element carrier can fill the area between the detection area and the inner wall of the collection chamber as much as possible.

[0172] In some embodiments, the inner wall of the collection chamber is provided with a protrusion for fitting with the test element carrier, such as FIG. Fig.13 As shown, one side of the protrusion 5 is a connection end connected to the inner wall of the collection chamber, and the other side of the protrusion 5 is a free end. When the test element 2 is combined with the collection chamber 1, the free end surface 501 of the protrusion covers the detection area 201. In this embodiment, the test element carrier is located between the protrusion and the detection area. When the protrusion covers the detection area, it is in direct contact with the detection area. The size of the protrusion is a fixed value, for example Figure 2 and Fig.13 As shown, the protrusion is a cuboid, in some embodiments, the protrusion can be a cube or a cylinder. In some embodiments, the size of the protrusion increases from the free end of the protrusion to the connecting end of the protrusion, for example, the protrusion is a triangular pyramid, a quadrangular pyramid, a conical column, etc.

[0173] The test element carrier has a mounting surface, which is provided with a groove 301 for accommodating the test element. When the test element is mounted on the test element carrier, the bottom surface of the groove covers and fits the detection area; when the test element is combined with the collection cavity, the back surface of the mounting surface fits the inner wall of the collection cavity, and the distance between the bottom surface of the groove and the mounting surface is a fixed value.

[0174] Example 5

[0175] A collection detection device having a detection cavity, such as Figure 2 and Fig.14 , Fig.17 and Fig.18 As shown, it includes a collecting chamber 1, the collecting chamber has an opening 102, and the detection chamber 6 is located below the opening 102. The detection chamber 6 is a cavity formed by the side wall of the collecting chamber protruding outward. The side wall of the collecting chamber has two connections 103 with the detection chamber, and the lateral dimension of the detection chamber 6 is greater than or equal to the lateral distance between the two connections 103. In this way, the test element can be inserted into the detection chamber through the connection between the collecting chamber and the detection chamber and installed in the detection chamber. The two connections 103 are symmetrical about the axis of the collecting chamber 1; the detection chamber 6 is symmetrical about the axis of the collecting chamber 1, as shown in FIG. Fig.16 or Fig. 20 shown.

[0176] The transverse dimension of the detection cavity 6 is a fixed value, such as Fig.16 or Fig. 20 In some embodiments, the transverse dimension of the detection cavity gradually expands outward from the connection. When the transverse dimension of the detection cavity gradually expands outward from the connection, the transverse dimension of the detection cavity is the smallest at the connection with the collection cavity.

[0177] The detection chamber 6 has a first side wall 601 and a second side wall 602 connected to the two connection points respectively, and the first side wall 601 and the second side wall 602 are parallel. Fig.16 or Fig. 20 As shown. In some embodiments, the first side wall and the second side wall intersect, so that the lateral dimension of the detection cavity gradually expands outward from the connection. The first side wall and the second side wall are both planes. The first side wall and the second side wall are parallel to the axis of the collection cavity.

[0178] The detection chamber 6 has a third side wall 603 for connecting the first side wall 601 and the second side wall 602. The third side wall 603 is close to the middle of the collection chamber relative to the edge of the collection chamber opening 102. Figure 2 or Fig.17 As shown, the third side wall 603 is a plane and is parallel to the axis of the collection chamber.

[0179] The detection chamber 6 has a top surface 604, which is connected to the side wall of the collection chamber and is located at the outer edge of the opening of the collection chamber. Fig.16 or Fig. 20 As shown, the top surface 604 is a plane and is perpendicular to the axis of the collection chamber.

[0180] The detection chamber 6 has a bottom surface 605, and the bottom surface 605 and the bottom surface of the collection chamber are located in the same plane. Fig.14 or Fig.18 The bottom surface 605 is parallel to the top surface 604 .

[0181] like Fig.14 and Figure 5 ,or Fig.18 and Fig.19As shown, the detection cavity 6 has a locking structure, which includes a limiter 701, a connection end 7011 at one end of the limiter 701 connected to the bottom surface of the detection cavity, and a free end 7012 at the other end of the limiter. The free end 7012 of the limiter is close to the middle of the collection cavity relative to the connection end 7011 of the limiter. The limiter 701 is close to the third side wall 603. The locking structure also includes a snap-in 702, which is a protrusion provided on the third side wall 603. The test element carrier 3 is provided with a groove or a through groove for aligning and matching with the snap-in. When the test element is installed in the detection cavity, the snap-in is inserted into the groove to achieve the installation and fixation of the test element. The snap-in 702 is close to the top of the third side wall 603. In this way, the limiter can fix the lower side of the test element; the snap-in cooperates with the groove of the test element to achieve the fixation of the upper side of the test element.

[0182] The contents described in the embodiments of this specification are merely an enumeration of the implementation forms of the inventive concept. The protection scope of the present invention should not be regarded as limited to the specific forms described in the embodiments. The protection scope of the present invention also extends to equivalent technical means that can be conceived by those skilled in the art based on the inventive concept.

Claims

1. A detection device, comprising: A test element, wherein the test element comprises a test area, and the test area is configured to detect whether the liquid sample contains an analyte; and a transparent area, wherein the transparent area is configured to read the test result on the test area through the transparent area; the test area and the transparent area are within a closed space, so that the closed space does not exchange fluid with the atmosphere outside the closed space; the detection device also includes a barrier element, wherein the barrier element allows the test area of ​​the test element to be closely attached to the surface of the transparent area; at the same time, the barrier element allows the test area and the transparent area of ​​the test element to be within the closed space.

2. The detection device according to claim 1, wherein the test area includes a side for displaying the test results and a back side, the transparent area includes a side facing the test area, and the side for displaying the test results covers the side of the transparent area facing the test area.

3. The detection device according to claim 2, wherein the test area indicates the test result by color change. 4 . The detection device according to claim 2 , comprising a cavity for collecting a fluid sample, wherein the cavity comprises a side wall, and the transparent area is located on the side wall.

5. The detection device according to claim 4, wherein the detection device is a carrier for accommodating the test element, the carrier comprises a groove, and the test element is located in the groove.

6. The detection device according to claim 5, wherein the barrier element is located in the groove of the carrier, and the barrier element includes a side that contacts the back of the test area, and when the carrier and the cavity are combined together, the barrier element allows the test area to be tightly attached to the transparent area of ​​the side wall.

7. The detection device according to claim 6, wherein the barrier element is located on the transparent area of ​​the side wall, and when the carrier and the cavity are combined together, the barrier element allows the test area to be closely attached to one surface of the barrier element, and the barrier element is transparent.

8. According to the detection device of claim 7, the transparent area is a planar structure.

9. According to the detection device of claim 8, the blocking element is a protruding structure, which includes a side that contacts the back of the test area, and when the carrier and the cavity are combined together, the distance between the side of the protruding structure that contacts the back of the test area and the surface of the transparent area is less than or equal to the thickness of the test area.

10. The detection device according to claim 2, wherein the test area comprises a porous water-absorbing material.

11. The detection device according to claim 10, wherein the porous water-absorbing material comprises a nitrocellulose membrane or a nylon membrane.

12. The detection device according to claim 10, wherein the test area comprises a detection line and a control line, wherein: The color or color depth of the test line indicates the presence or amount of the analyzed substance.

13. The detection device according to claim 1, wherein the reading comprises reading the test result of the test area with the naked eye or an electronic device.

14. The detection device according to claim 13, wherein the electronic device is an electronic scanning device.

15. The detection device according to claim 1, wherein the fluid comprises a gas containing water vapor.

16. The detection device according to claim 1, wherein the liquid sample is a urine sample.

17. According to the detection device of claim 1, the analyzed substance includes small molecule drug substances.

18. The detection device according to claim 1, wherein the transparent area is formed of a transparent non-water-absorbing material.

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