Device for detecting analyzed substance in liquid sample

Abstract

The present invention provides an apparatus for detecting a substance to be analyzed in a liquid sample and a test method, the apparatus comprising: a cover body including a sample chamber for accommodating a sample collector and a liquid chamber containing a sample treatment liquid; therefore, when the amount of the sample collected by the collector is insufficient, the liquid in the liquid cavity is released to increase the volume of the liquid sample, or when a secondary test is carried out, the reduced liquid sample and even the dried liquid sample are dissolved again, so that the secondary test can be facilitated.

Description

Technical Field

[0001] The present invention relates to a device for collecting liquid samples and a detection device, in particular to a device for detecting substances to be analyzed in liquid samples in the field of rapid diagnosis, such as urine and saliva collection. Background Art

[0002] The following background technology introduction is merely an introduction to some background common sense and does not constitute any limitation to the present invention.

[0003] In the field of in vitro diagnosis (IVD), chromatography technology is often used to diagnose and test diseases and other items. For example, immunocolloidal gold test paper, dry chemical test paper, immunofluorescence test paper, etc. all use the principle of chromatography to pre-treat the sample, then react with the reagent, and finally obtain the diagnosis result reflecting whether the disease is present. The working process of the fluorescent immunochromatographic test paper is as follows: after the sample (whole blood, plasma, etc.) is dripped into the sample pad, the liquid flows to the absorbent filter paper end; the sample is processed in the sample pad, red blood cells are filtered, interference substances are removed, etc.; the sample flows through the binding pad, antigen-antibody immunobinds, and carries fluorescent groups, and when it flows through the nitrocellulose membrane, it specifically binds to the antigen-antibody pre-bound on it. The fluorescent groups gathered on the test line and the control line can reflect the test results, and other unbound interference substances are absorbed by the absorbent filter paper. Due to the characteristics of simple operation, strong specificity, high sensitivity, and quantification, the fluorescent immunochromatographic technology has been widely used in the field of POCT detection in recent years. However, in recent decades, most immunochromatographic test cards can only be a single card with a single test paper for single item detection. However, with the development of medical technology, the diagnosis of diseases requires the simultaneous detection of multiple targets for more accurate judgment, such as myocardial 3-joint test, myocardial 5-joint test, etc. In some cases, it is necessary to detect the status of multiple organs at the same time to determine the disease, such as cardiopulmonary 5-joint test, etc.

[0004] At present, detection devices for detecting whether a sample contains the substance to be analyzed are widely used in hospitals or homes. These detection devices for rapid diagnosis contain one or more test strips, such as early pregnancy tests, drug abuse tests, etc. This rapid diagnosis detection device is very convenient and can get the test results on the test strip in one minute, or at most ten minutes. Drug tests are of various types and are performed frequently. Some require sample collection, and then require professional testing institutions or testing laboratories to conduct tests. Some require on-site testing and timely acquisition of test results.

[0005] Sometimes, when the amount of collected samples is insufficient, it is hoped that the samples can be diluted before testing. Generally, the samples are diluted separately for testing. However, it is always hoped that the samples can be diluted at the same time when they are collected for testing, such as described in WO2021 / 019415A2. In order to make the operation more convenient, another solution still needs to be provided to achieve this. Summary of the invention

[0006] In order to overcome the defects of the prior art, a device for detecting an analyte in a liquid sample is provided. The device comprises a cover body, wherein the cover body comprises a sample cavity for accommodating a sample collector and a liquid cavity containing a sample processing liquid.

[0007] In some embodiments, the liquid chamber is movably connected to the cover, or the liquid chamber can move on the cover, and the liquid in the liquid chamber can be released during the movement. In some embodiments, the liquid chamber has a locked state and an unlocked state on the cover, in which the liquid chamber cannot move. In the locked state, the liquid chamber is fixed to a fixed position on the cover, and in the unlocked state, the liquid chamber can move relative to the cover.

[0008] In some embodiments, the liquid chamber can be locked on the cover body by a locking element, and when the locking element moves (for example, leaves the cover body), the liquid chamber is in a locked or unlocked state. The so-called movement of the locking element can be a change in the position of the locking element on the cover body, or it can be moved away from the cover body. In some embodiments, the locking element includes a snap ring, and the liquid chamber has a slot for receiving the snap ring. When the slot and the snap ring are combined, the liquid chamber is in a locked state, and when the slot and the snap ring are separated, the liquid chamber is in an unlocked state. In some embodiments, one end of the liquid chamber has a slot with a groove, the locking element has a snap ring, and the locking element moves horizontally to allow the snap ring to combine with the slot. In some embodiments, when the liquid chamber is locked by the locking element, the liquid chamber is in a relatively high position, and when the locking element moves to unlock, the liquid chamber can move from the high position to the low position. The high position and low position mentioned here are relative to the longitudinal direction of the cover body, or when the puncture element is located in the detection cavity, the high position and low position here are relative to the fixed puncture structure in the test cavity, the high position is the principle puncture element, and the low position is close to the puncture element.

[0009] In some embodiments, the cover has a docking area, and a hole is provided on the area, and the hole allows the liquid cavity to pass through and expose part of the liquid cavity. In some embodiments, the docking area has a plane, and a hole is provided on the plane for the liquid cavity to pass through. One end of the liquid cavity is exposed and is a certain distance above the plane, and the hole is located on the plane. In some embodiments, the locking element cooperates with the exposed part of the cavity, and the locking element includes a snap ring, and the exposed liquid cavity includes a slot, and the snap ring cooperates with the slot, so that the liquid cavity is fixed on the cover body through the locking element and is in a high position. In some embodiments, the locking element includes a card, and the card has a snap ring formed by a notch, and the snap ring cooperates with the exposed part of the cavity of the cover body, so that the liquid cavity is in a fixed position on the cover body. In some embodiments, the cavity exposed in the slot is formed by the pressing part at the top of the liquid cavity and the main body of the liquid cavity. The slot is similar to the "neck" of the liquid cavity. The slot includes a skirt and a groove around the top of the pressing part. The snap ring of the locking element is clamped in the groove or the neck, so that one end of the cavity (the pressing end of the liquid cavity) is higher than the plane of the area by a certain distance and is in a fixed position with the cover body. In some embodiments, the liquid cavity is in a fixed position with the cover body through the locking element. At the same time, the locking element makes the liquid cavity higher than the plane by a certain distance and in a fixed position with the cover body.

[0010] In some embodiments, the locking element occupies the entire docking area, so that the locking element is located or parked on the docking area, and the liquid cavity is blocked or concealed by the locking element, so that the liquid cavity is exposed only when the locking element is removed or detached from the docking area. In some embodiments, the locking element is removed or detached from the docking area, and the liquid cavity is in an unlocked state. At this time, the liquid cavity can be moved, such as pushing the liquid cavity from a high position to a low position, or pushing the liquid cavity into a test cavity. In some embodiments, the snap ring on the locking element also includes a covering surface, and the snap ring is located under the covering surface. Under the projection of the covering surface, the snap ring is located in the projection area, that is, when the covering surface is arranged parallel to the snap ring on the card, the card cannot be seen when looking down at the covering surface, or the covering surface covers the top of the liquid cavity, which is combined with the docking area, so that the locking element covers or wraps the liquid cavity on the entire plane, so that the liquid cavity is hidden.

[0011] In some embodiments, the cover has two faces, one of which is the face facing the inside of the detection cavity, which may also be referred to as the back side, and the other face opposite to the detection cavity, which may also be referred to as the front side. In some embodiments, the entrance of the sample cavity is located on the front side of the cover, and in some embodiments, the surface where the entrance of the sample cavity is located is higher than the plane of the docking area. Therefore, the docking area is similar to a step structure, such as an "L"-shaped structure. On the one hand, the locking element allows the liquid cavity to be in a locked position combined with the cover, and on the other hand, it covers the entire exposed liquid cavity portion to hide the liquid cavity. In addition, the locking position, since the locking element needs to be unlocked or locked, is also in a fixed position on the docking area. In some embodiments, when the locking element is located in the docking area, the locking element and the cover are integrated into a structure, and at this time, only the entrance of the sample cavity is left. The so-called "hiding" is that the structure of the locking element cooperates with the structure of the docking area on the cover, so that the outer part of the liquid cavity (at least the part above the plane of the docking area) is wrapped and the liquid cavity can be seen from the outside. If the device includes a test cavity, the part of the liquid cavity below the plane is located in the test cavity and is not easy to be seen. In this way, the whole device, viewed from the outside, seems to contain no liquid cavity. The main purpose of hiding is to prevent people from deliberately operating, so as to conduct tests in advance. For example, the subjects who collect samples do the tests themselves, instead of by professionals, so that sample falsification may not be discovered.

[0012] In some embodiments, when the locking element is unlocked or leaves the docking area, the liquid cavity can move toward the back of the cover. In some embodiments, the liquid cavity can leave the docking area along the back of the cover, or the liquid cavity moves from a high position to a low position on the docking area. In some embodiments, when the cover is closed in the detection cavity, the liquid cavity can move into the detection cavity. In some embodiments, the detection cavity has a test element for testing a liquid sample and an analyte, and a puncture element. When the liquid cavity is locked by the locking element on the cover, the liquid cavity is not punctured, and when the liquid cavity is unlocked and moves from a high position to a low position or leaves the docking area, or thereafter, the puncture element punctures the liquid cavity, thereby releasing the processing liquid into the detection cavity. In some embodiments, when the liquid cavity is in the locked position, it is away from the puncture element. When unlocked, when the liquid cavity moves from a high position to a low position, or, it is close to the puncture element, or is punctured by the puncture element. In some embodiments, the liquid cavity includes a reagent solution for processing the sample. In some embodiments, the liquid chamber includes an easily pierceable sealing film, which can be easily pierced by a sharp piercing structure.

[0013] In some embodiments, the liquid cavity has a locked first position and an unlocked second position relative to the cover body. In some embodiments, when the liquid cavity is in the locked first position, the liquid in the liquid cavity is not released, and when in the unlocked second position, the liquid in the cavity is released. In some embodiments, the liquid cavity is in a locked position and is locked to the cover body by a locking element. In some embodiments, the locking element includes a structure capable of limiting the movement of the liquid cavity, and when the limiting structure is disengaged from the liquid cavity, the liquid cavity changes from a locked state to an unlocked state. In some embodiments, when the liquid cavity is in an unlocked state, the liquid cavity can move relative to the cover body. In some embodiments, the movement includes downward movement relative to the cover body.

[0014] In some embodiments, the sample cavity includes a channel, and when the collector is inserted into the sample cavity, the absorption element on the collector is squeezed, thereby releasing the liquid sample into the sample cavity, and then the liquid flows out of the sample cavity along the channel. In some embodiments, the bottom of the sample cavity has a platform forming a bottom, and the absorption element of the collector contacts the bottom and is squeezed, thereby releasing the liquid sample on the absorption element. In some embodiments, a channel extends downward from the bottom of the sample cavity, and the squeezed or released liquid sample flows out through the channel. In some embodiments, when the cover body is used to cover a test cavity with a test element, when the cover body is closed, the liquid sample flowing out of the sample cavity enters the test cavity. Alternatively, the sample cavity and the liquid cavity extend outward from the cover body, and the extension direction is the same. In some embodiments, the liquid chamber can move relative to the cover body, while the sample chamber and the cover body are integrated into a fixed integral structure and cannot move relative to each other. In this way, when the liquid chamber is located in the test chamber, its position in the test chamber is fixed, while the liquid chamber in the test chamber is able to move, and this movement is controlled by a locking element.

[0015] In some embodiments, the device further comprises a test cavity with a test element, the cover body covers the opening of the test cavity, and the sample cavity and the liquid cavity are located in the test cavity. In some embodiments, the test cavity comprises a puncture element that can puncture the liquid cavity, and when the liquid cavity moves into the test cavity relative to the cover body, the puncture element punctures the liquid cavity and enters the liquid cavity, thereby forcing the liquid in the liquid cavity to flow into the test cavity. In some embodiments, the puncture element has a sharp puncture needle and a base connected to the needle, and the diameter of the base is equivalent to the diameter of the liquid cavity. In some embodiments, the detection cavity comprises a carrier that carries the test element, and the carrier has a groove for fixing the test element.

[0016] In some embodiments, the cover includes a hole connected to the atmosphere, and the hole has a channel extending in the same direction as the sample cavity, or the extended channel extends in the same direction as the liquid cavity and the sample cavity, or both extend from the cover body to the back of the cover body, or both extend into the detection cavity. The purpose of providing the hole connected to the outside atmosphere is to keep the test cavity connected to the outside, so that when the treatment liquid in the liquid cavity is punctured, the treatment liquid can easily flow into the detection cavity, and the liquid sample collected by the sample cavity can also easily flow into the detection cavity.

[0017] In some embodiments, the present invention provides a method for detecting an analyte in a liquid sample, the method comprising: providing a device, a cover device comprising a cover body, the cover body comprising a sample cavity for accommodating a sample collector, and a liquid cavity containing a sample processing liquid, the liquid cavity having a locked state and an unlocked state, and a detection cavity, the detection cavity having a test element capable of testing the analyte in the sample; collecting the liquid sample with a collector and inserting it into the sample cavity and releasing the liquid sample in the sample cavity; the liquid sample in the sample cavity flows into the detection cavity and contacts the test element; the liquid cavity is unlocked, and then the liquid sample cavity is pushed into the detection cavity to release the processing liquid into the detection cavity. In some embodiments, a puncture element is provided in the detection cavity, the liquid cavity is contacted with the puncture element, and the puncture element punctures the liquid cavity to release the liquid. In some embodiments, the puncture element is allowed to enter the liquid cavity, thereby forcing the liquid cavity to release the processing liquid into the detection cavity.

[0018] In some ways, the timing of unlocking is also a unique feature of the present invention. This is mainly because, when performing the initial test, it is found that some test results are in an interval that cannot be judged, such as in a negative or positive interval, but the final result cannot be determined. This is an inherent problem of immunoassays. At this time, the tested samples need to be sent to more advanced and more sophisticated experimental equipment for confirmation testing. At this time, if the sample is relatively small, the water in the original sample will evaporate or even dry out during transportation. At this time, when the confirmation test is performed, the locking element is activated, and after unlocking, the processing liquid in the liquid cavity is punctured and flows into the detection cavity, dissolving the dry analyte, and then sampling is performed for secondary testing. This solves the problem that the sample is reduced or dried during transportation and cannot be confirmed for a second time.

[0019] In some embodiments, in all of the aforementioned embodiments, the liquid sample can be blood, urine, saliva, sweat, etc.

[0020] A method for detecting an analyte in a liquid sample, the method comprising:

[0021] Provided is a device, wherein the cover device comprises a cover body, wherein the cover body comprises a sample cavity for accommodating a sample collector, and a liquid cavity containing a sample processing liquid, wherein the liquid cavity has a locked state and an unlocked state, and a detection cavity, wherein the detection cavity has a test element capable of testing an analyte in the sample;

[0022] Collect the liquid sample with a collector and insert the collector into the sample chamber and release the liquid sample into the sample chamber;

[0023] The liquid sample in the sample chamber flows into the detection chamber and contacts the test element;

[0024] Leave the liquid chamber unlocked, and then push the liquid sample chamber into the detection chamber to release the processing liquid into the detection chamber.

[0025] Beneficial Effects

[0026] The present invention combines a treatment liquid with a liquid sample. When the liquid sample is small, the treatment liquid can be mixed with the liquid sample. If the liquid sample is sufficient, the treatment liquid may not be used, so that multiple options are available. In addition, the treatment liquid of the present invention is not used to directly contact the collector, but is set separately. After the initial detection is completed, if there are doubts and questions about the test results, a secondary confirmation is required. At this time, it is often necessary to transport the test results over a long distance to a professional laboratory. At this time, the sample in the detection chamber may evaporate and become less or even disappear (the water is evaporated). At this time, liquid can be used to enter the detection chamber to dissolve the remaining sample or the substance to be analyzed to form a new liquid sample, which makes it easy to take samples for secondary confirmation testing. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 It is a schematic diagram of the structure of a test element in a specific embodiment of the present invention.

[0028] Figure 2 It is a schematic diagram of the three-dimensional structure of a test element in a specific embodiment of the present invention.

[0029] Figure 3 It is a three-dimensional schematic diagram of the detection device of the present invention (completely assembled).

[0030] Figure 4 It is a schematic diagram of the exploded structure of the detection device of the present invention.

[0031] Figure 5 Schematic diagram of the three-dimensional structure of the cover (without locking elements).

[0032] Figure 6 Schematic diagram of the cross-sectional structure of the cover (with locking elements).

[0033] Fig. 7AIt is along Figure 7B Schematic diagram of the cross-sectional structure of the cover body of AA (the locking element is separated from the cover body).

[0034] Figure 7B It is a top view of the cover.

[0035] Figure 8 It is a schematic diagram of the three-dimensional structure of the cover body (excluding the liquid cavity).

[0036] Fig.9A It is a schematic diagram of the three-dimensional structure of the locking element.

[0037] Fig. 9B It is a three-dimensional structural schematic diagram of the AA' section of the top view of the locking element and a top view.

[0038] Fig. 10A Schematic diagram of the three-dimensional structure of the test chamber.

[0039] Fig. 10B is a top view of the test chamber.

[0040] Fig.11 It is a schematic diagram of the cross-sectional structure of the test chamber.

[0041] Fig.12 It is a cross-sectional structural diagram of a combination of a cover body and a test cavity, a collector located in the sample cavity, and a liquid cavity at a high position and in an unlocked state.

[0042] Figures 13A-13B It is a cross-sectional structural diagram of a combination of a cover body and a test cavity, a collector located in the sample cavity, and a liquid cavity at a low position and in an unlocked state. Detailed description

[0044] The structures involved in the present invention or the technical terms used are further explained below. If not specifically specified, they are understood and interpreted according to the general terms commonly used in the art.

[0045] Detection

[0046] Detection means to test or examine a substance or material for the presence or absence of a substance or material, such as, but not limited to, a chemical substance, an organic compound, an inorganic compound, a metabolite, a drug or a drug metabolite, an organic tissue or a metabolite of an organic tissue, a nucleic acid, a protein, or a polymer. In addition, detection means to test the amount of a substance or material. Furthermore, assay also means immunoassay, chemical assay, enzyme assay, etc.

[0047] sample

[0048] The sample of the detection device of the present invention includes biological fluid (such as case fluid or clinical sample). Liquid sample or liquid specimen can be derived from solid or semi-solid sample, including excrement, biological tissue and food sample. Solid or semi-solid sample can be converted into liquid sample by any appropriate method, such as mixing, crushing, macerating, incubating, dissolving or digesting solid sample by enzymolysis in a suitable solution (such as water, phosphate solution or other buffer solution). "Biological sample" includes samples derived from animals, plants and food, such as urine, saliva, blood and its components, cerebrospinal fluid, vaginal secretions, sperm, feces, sweat, secretions, tissues, organs, tumors, tissue and organ cultures, cell cultures and media derived from humans or animals. Preferably, the biological sample is urine, and preferably, the biological sample is saliva. Food samples include food processed substances, final products, meat, cheese, wine, milk and drinking water. Plant samples include any plant, plant tissue, plant cell culture and media. An "environmental sample" is derived from the environment (eg, a liquid sample from a lake or other body of water, a sewage sample, a soil sample, groundwater, seawater, and a wastewater sample). An environmental sample may also include sewage or other wastewater.

[0049] By using a suitable detection device of the present invention, any analyte can be detected. The present invention is preferably used to detect drug molecules in saliva and urine. Of course, the sample detected by the detection device of the present invention can be any form of sample above, whether it is solid or liquid at the beginning, as long as these liquids or liquid samples can be absorbed by the sample application area of ​​the test element. The sample application area here is generally prepared by water-absorbing materials, and through the capillary or other characteristics of the absorbing element material, the liquid sample or liquid sample can be absorbed, allowing the liquid sample sample application area to flow. The material of the liquid sample sample application area can be any material that can absorb liquid, such as sponge, filter paper, polyester fiber, gel, non-woven fabric, cotton, polyester film thin, yarn, etc. Of course, the liquid sample sample application area is not necessarily prepared by a material with water-absorbing properties, and can be prepared by a non-water-absorbing material, but there are holes, threads, and caves on the absorbing element, and samples can be collected on these structures. These samples are generally solid or semi-solid samples, and these samples are filled between the threads, holes, or holes to collect samples. Of course, the liquid sample application area can be optionally composed of some non-absorbent fibers and hairs, and these materials are used to scrape a solid, semi-solid or liquid sample, so that these samples are retained on the liquid sample application area. When detection is required, a buffer solution is applied to the sample application area to dissolve the sample, so that the dissolved sample flows on the test element or detection element.

[0050] Downstream and Upstream

[0051] Downstream or upstream is divided according to the direction of liquid flow. Generally, liquid or fluid flows from the upstream to the downstream area. The downstream area receives liquid from the upstream area, and the liquid can also flow along the upstream area to the downstream area. Here, it is generally divided according to the direction of liquid flow. For example, on some materials that use capillary force to promote the flow of liquid, the liquid can overcome gravity and flow in the opposite direction of gravity. At this time, the upstream and downstream are still divided according to the flow direction of the liquid. For example, in the detection device of the present invention, after the guide element receives the liquid sample, the fluid can flow from the guide element to the sample application area or sample application pad of the two test elements, and then the liquid flowing to the sample application pad flows to the downstream marking pad, and then mixes with the marked marking substance, and then flows to the downstream detection pad through the transition pad. On the detection pad, the test area is located upstream of the test result control area, and finally flows to the absorption pad on the downstream absorption area. The test area can be a polyester fiber film, and the guide element can be glass fiber, polyester sheet, or polyester film. At this time, the guide element is upstream of the marking area of ​​the test element. The specific structure of the test element is as follows. Figure 1-2 The structure shown in Figure 20. When part of the sample is applied to the pad, the liquid on the sample pad flows mainly by capillary force.

[0052] Gas connection or liquid connection

[0053] Gas connectivity or liquid connectivity means that liquid or gas can flow from one place to another, and some physical structures may be used to guide the flow process. The so-called passing through physical structures generally refers to the liquid passing through the surface of these physical structures, or the internal space of these structures and passively or actively flowing to another place. Passive flow is generally caused by external forces, such as flow under capillary action, air pressure, etc. The flow here can also be the liquid or gas due to its own action (gravity or pressure), or it can be passive flow. The fluid under the action of air pressure can be a flow in the same direction, or it can be a flow in the opposite direction, or it can be caused by the action of air pressure to cause the fluid to flow from one position to another. The connectivity here does not mean that liquid or gas must exist. It only indicates the connection relationship or state between two objects in some cases. If there is liquid, it can flow from one object to another. This refers to the state of connection between two objects. On the contrary, if there is no liquid connection or gas connection between the two objects, if there is liquid in or on one object, the liquid cannot flow into or on another object. Such a state is non-connected, non-liquid or gas connected.

[0054] Test components

[0055] The so-called "test element" here refers to an element that can detect whether a liquid sample or a fluid sample (liquid sample or liquid sample) contains an analyte of interest. This detection can be based on any technical principle, whether immunology, chemistry, electricity, optics, molecular science, nucleic acid, physics, etc. The test element can be a lateral flow test strip, which can detect a variety of analytes. Of course, other suitable test elements can also be used in the present invention. In the present invention, the test element and "lateral flow test element, or test strip" can be used interchangeably to express the same meaning.

[0056] Various test elements can be combined and applied to the present invention. One form is a test strip. The test strip used to analyze the analyte in the sample (such as drugs or metabolites indicating physical conditions) can be in various forms, such as immunoassays or chemical analysis. The test strip can adopt a non-competitive or competitive analysis mode. The test strip generally comprises a water-absorbing material with a sample application area, a reagent area and a test area. Add a fluid or liquid sample to the sample application area and flow to the reagent area through capillary action. In the reagent area, if the analyte is present, the sample combines with the reagent. Then the sample continues to flow to the detection area. Other reagents, such as molecules that specifically bind to the analyte, are fixed in the detection area. These reagents react with the analyte in the sample (if present) and bind the analyte to the area, or bind to a reagent in the reagent area. The marker used to display the detection signal is present in the reagent area or a separate labeling area.

[0057] The typical non-competitive assay format is that if the sample contains the analyte, a signal is generated, and if it does not contain the analyte, no signal is generated. In a competitive assay, if the analyte is not present in the sample, a signal is generated, and if the analyte is present, no signal is generated.

[0058] The test element can be a test paper, which can be made of absorbent or non-absorbent materials. The test paper can include multiple materials for liquid sample delivery. One material of the test paper can be covered on another material, such as filter paper covered on a nitrocellulose membrane. One area of ​​the test paper can be made of one or more materials, while another area can be made of one or more different materials. The test paper can be adhered to a certain support or hard surface to increase the strength of holding the test paper.

[0059] The analyte is detected through a signal generating system, such as by using one or more enzymes that react specifically with the analyte, and by using the method of fixing the specific binding substance on the test paper as described above, to fix the composition of one or more signal generating systems on the analyte detection area of ​​the test paper. The substance that generates the signal can be in the sample addition area, the reagent area, or the detection area, or on the entire test paper, and the substance can be filled with one or more materials of the test paper. A solution containing the signal substance is added to the surface of the test paper or one or more materials of the test paper are immersed in a solution containing the signal substance. The test paper to which the solution containing the signal substance is added is dried.

[0060] The various zones of the test paper or the lateral flow test strip of the present invention can be arranged in the following manner: a sample application area 905, a marking area 904, a detection area 902, and the detection area includes a test result area 906 and a test result control area 907. The control area is located after or downstream of the detection area. All zones can be arranged on a test paper using only one material. Different materials can also be used in different zones. Each zone can be directly in contact with the liquid sample, or different zones can be arranged according to the direction of flow of the liquid sample, and the end of each zone is connected to the front end of another zone and overlapped. The material used can be a material with good water absorption such as filter paper, glass fiber or nitrocellulose membrane. The test paper can also be in other forms.

[0061] The commonly used reagent strip is a nitrocellulose membrane reagent strip, that is, the detection area includes a nitrocellulose membrane (NC), and specific binding molecules are fixed on the nitrocellulose membrane to display the detection results; it can also be a cellulose acetate membrane or a nylon membrane, etc. For example, the following patents describe reagent strips or devices containing reagent strips: US 4857453; US 5073484; US 5119831; US ​​5185127; US 5275785; US 5416000; US 5504013; US 5602040; US 5622871; US5654162; US 5656503; US 5686315; US 5766961; US ​​5770460; US 5916815; US 5976895; US6248598; US 6140136; US 6187269; US 6187598; US 6228660; US 6235241; US The test strips and similar devices with test strips disclosed in the above patent documents can be applied to the test element or detection device of the present invention to detect the analyte, such as the analyte in the sample.

[0062] The test strip used in the present invention may be a so-called lateral flow test strip. The specific structure and detection principle of these test strips are well known to those skilled in the art. Figure 1-Figure 2 ), including a sample application area or a sample application area 905, a marking area 904, a detection area 902, a sample collection area including a sample receiving pad or a sample application pad, and a marking area including a marking pad. It can also include a water absorption area 901 to absorb the liquid sample from the nitrocellulose membrane, and the water absorption area can include a water absorption pad. In some ways, the marking area includes color particles coupled with antibodies, and the color particles can be latex particles, gold particles, or dyes. The detection area 902 includes necessary chemical substances that can detect whether the analyte is contained, such as immunoreagents or enzyme chemical reagents. The commonly used detection reagent strip is a nitrocellulose membrane reagent strip, that is, the detection area 902 includes a nitrocellulose membrane, and a specific binding molecule is fixed on the nitrocellulose membrane to display the detection result area 906 (T-line); it can also be a cellulose acetate membrane or a nylon membrane, etc.; of course, the downstream of the detection area can also include a detection result control area 907 (C-line), usually, the control area and the detection area appear in the form of horizontal lines, which are detection lines or control lines. Such a test strip is a traditional test strip, and of course, it can also be other types of test strips that utilize capillary action to detect. In addition, a general test strip has dry chemical reagent components, such as fixed antibodies or other reagents. When encountering a liquid, the liquid flows along the test strip along with the capillary action, and as it flows, the dry reagent components are dissolved in the liquid, so that the dry reagents in the next area are processed to react, thereby performing necessary detection. The liquid flows mainly through capillary action. It can be applied to the detection device of the present invention here, or be arranged in the detection chamber to contact with the liquid sample, or be used to detect the presence or quantity of the analyzed substance in the liquid sample entering the detection chamber.

[0063] In addition to the above-mentioned test strips or lateral flow test strips themselves being used to contact the liquid sample to test whether the liquid sample contains the substance to be analyzed. The test element of the present invention itself can be used as a detection device to detect the substance to be analyzed in the sample, so the detection device itself is equivalent to the test element. For example, after the liquid sample is mixed with the processing liquid, it is directly detected by the test element. There will be a detailed description below. When describing the receiving device to process the liquid sample, the test element can be used alone for detection. .

[0064] Analyte

[0065] Examples of analytes that can be used in the present invention include some small molecules, including drugs (such as drugs of abuse). "Drugs of abuse" (DOA) refer to the use of drugs for non-medical purposes (usually to paralyze nerves). Abuse of these drugs can cause physical and mental damage, dependence, addiction and / or death. Examples of drug abuse include cocaine; amphetamine AMP (for example, Black Beauty, White Amphetamine Pills, Dextroamphetamine, Dextroamphetamine Pills, Beans); methamphetamine MET (crank, methamphetamine, crystal, speed); barbiturates BAR (such as Valium, Roche Pharmaceuticals, Nutley, New Jersey); sedatives (i.e., sleeping aids); lysergic acid diethylamide (LSD); depressants (downers, goofballs, barbs, blue devils, yellow jackets, methaqualone); tricyclic antidepressants (TCA, i.e. imipramine, amitriptyline and doxepin); MDMA; PCP; THC, pot, dope, hash, weed, etc.); opiates (i.e. morphine MOP or opium, cocaine COC, heroin, hydroxydihydrocodeinone); antianxiety drugs and sedatives and hypnotics. Antianxiety drugs are a class of drugs mainly used to reduce anxiety, tension, fear, stabilize mood, and have Drugs with hypnotic and sedative effects include benzodiazepines BZO (benzodiazepines), atypical BZs, fused diazepine NB23Cs, benzodiazepines, ligands of BZ receptors, open-ring BZs, diphenylmethane derivatives, piperazine carboxylates, piperidine carboxylates, quinazolinones, thiazine and thiazole derivatives, other heterocyclics, imidazole-type sedatives / analgesics (such as oxycodone 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 purposes but are prone to overdose, such as tricyclic antidepressants (imipramine or analogs) and acetaminophen, etc. These drugs will be metabolized into small molecules after being absorbed by the human body. These small molecules exist in body fluids such as blood, urine, saliva, sweat, etc., or some body fluids contain the above-mentioned small molecules.

[0066] 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 villus stimulating hormone, progesterone hormone, follicle stimulating hormone, etc.), blood, white blood cells, sugars, heavy metals or toxins, bacterial substances (such as proteins or sugar substances for specific bacteria, such as Escherichia coli 0157: H7, Staphylococcus, Salmonella, Clostridium, Campylobacter, L.monocytogenes, Vibrio, or Bacillus cactus) and substances related to physiological characteristics in urine samples, such as pH and specific gravity. Any other clinical chemical analysis can be detected using the lateral flow detection format in conjunction with the device of the present invention. It is also possible to detect the presence of viral antigens, such as new crown antigens and influenza antigens.

[0067] Carrier containing test element

[0068] In some specific embodiments, the test element can also be arranged on some carrier elements, so that the carrier element contains the test element to complete the detection and analysis of the substance to be analyzed in the liquid sample. Therefore, in some embodiments, the detection device includes a carrier, and the test element is arranged on the carrier. In some embodiments, the carrier of the present invention is used to carry and accommodate the test element. The carrier element itself does not participate in the direct detection function, but serves as a carrier or shell for carrying or accommodating the test element. For example, Figure 4 As shown, two carriers 311, 301 are provided. Both carriers are provided with slots, which are used to accommodate test elements 20. Multiple slots 307, 308, 309, 310 can be provided on one carrier. Each of these slots is provided with a test element. Generally, the sample application area of ​​the test element is located at one end of the slot opening. After the test element is set in the slot, a transparent film is covered on the surface of the carrier 301, and then the carrier 301 is inserted into the test cavity. The test cavity has two relatively flat surfaces 312, 313. The carrier is inserted into the test cavity and rests on the flat surface, while the surface with the test element rests on the flat surface. In this way, when testing, the test results on the test element can be read through the transparent surface of the cavity.

[0069] In some embodiments, each groove on the carrier 301 has a raised structure at one end, which allows the test element to be fixed in the groove body. The raised structure is generally stuck in the position of the water absorbent pad on the water absorption area of ​​the test element. In some embodiments, the test cavity is open at one end 306, including a bottom and a side wall 312. The opening 306 can be sealed by the cover body, so as to form a sealed space in the test cavity, which contains the carrier, and one or more test elements are arranged on the carrier, and the test element can detect the analyzed substance in the sample. There is a raised structure in the middle position of the bottom of the test cavity, and the bottom of the raised structure forms a slit or groove with the bottom of the flat side wall 312, 313 of the test cavity. The carrier 301, 311 is arranged at the bottom of the groove, and the end of the sample application area of ​​the test element is close to the bottom of the groove. When the liquid sample enters the test cavity, the liquid sample can flow into the slit, where the liquid sample contacts the bottom of the test strip, especially the end of the sample application area of ​​the test strip, and the liquid flows on the test strip by capillary action, thereby detecting the substance to be analyzed in the liquid sample. The following will be further elaborated and explained in conjunction with specific implementation methods.

[0070] Test chamber containing test element

[0071] The present invention provides a test cavity 300, which contains a test element, which may be one or more test elements. In some embodiments, the test element is disposed on a carrier, which contains a plurality of slots, each of which is provided with a test strip, and the carrier is located in the test cavity. Figure 3 , as shown in 10-11, the test cavity shown includes an opening 306, including the bottom of the test cavity and the surrounding side walls to form the cavity, and a protruding structure 382 is provided at the bottom of the cavity, and grooves or channels 381, 3811 are formed between the protruding structure 382 and the two opposite planar side walls 312, 313, and the two channels are formed at the bottom of the walls of the respective planes. A groove or channel 387 is also provided in the protruding structure, and the channel is connected to the channels 381, 3881 under the side walls, so that fluid communication is formed between each channel, and fluid can flow between each channel. A circular table is provided on the protruding surface, and the channel 387 is provided between the protruding table surfaces, and the channel 387 divides the table surface into two parts 385, 386, and the protruding surface is used to receive the bottom 255 of the sample cavity. The bottom 255 of the sample chamber is in contact with the raised surfaces 385, 386, and a wall is formed around the raised table surface to surround the bottom of the sample chamber, so that the sample chamber is in a fixed position in the test chamber ( Fig.12). At the same time, the channel 224 located at the bottom of the sample cavity is located in the channel 387 between the two surfaces 385, 386. When the liquid sample in the sample cavity flows out through the channel 224 at the bottom 255 of the sample cavity, it flows directly into the channel 387, so that the liquid sample can flow into the grooves or channels 381, 3811 at the bottom of the test cavity, respectively. There is a sample application part of the test element at the bottom of the two grooves, or a carrier is arranged on the two grooves, and the end of the sample application area of ​​the test element on the carrier is located at the bottom of the groove, so that the liquid sample in the groove will contact the test element, thereby completing the detection of the analyzed substance in the liquid sample.

[0072] A puncture element 900 is disposed on one side of the bottom of the test cavity, for example, near the side wall 391. The element has a sharp puncture needle 901 and a base 909 for the needle to be disposed. The base is located on one side of the inside of the test cavity. There are four transverse partitions 903, 904, 905, and 906 on the base to divide the base into four parts. One function of the transverse partition is that when the puncture needle punctures the film at the bottom of the liquid cavity, the transverse partition plays a role in drainage to guide the treatment liquid to flow to the bottom of the test cavity. In addition, the transverse partitions intersect at a point at the top of the base 909, and the puncture needle is formed at this point. In some embodiments, the bottom of the base is located on an inclined surface 387, which is distributed on both sides of the base 909, and on the inclined surface 387 of the base close to the plane side wall 312, and the inclined surface 388 close to the plane side portion 313, and the inclined surface extends to the top of the channel. As shown in FIG. 10 , in order to allow the test carrier to be fixed in the grooves 381, 3811, fixed cards 392, 393 are set at both ends of the communication, and the fixed card and the piercing element base bracket are also where the inclined surface 387 extends. Correspondingly, the inclined surface 388 also extends between the fixed card 393 and the base of the piercing element. In this way, when the piercing element pierces the liquid cavity or the entire piercing base enters the liquid cavity, the liquid flows down along the piercing base. At this time, the processing liquid will flow along the inclined surface into the grooves or channels 381, 3811 respectively. If the amount of liquid on both sides is not necessarily the same, the groove 387 allows the liquid to reach a balance on both sides, so that the liquid is evenly distributed in the two channels 381, 3811. In some embodiments, a hole 391 is set on the side wall 305 of the test cavity, and a piston or sealing plug 304 is set on the hole. After the test is completed, the sample can be sampled for secondary confirmation through the hole 391.

[0073] Cover body with sample chamber and liquid chamber

[0074] In some embodiments, the present invention provides a cover body, which is a cover body configured to seal or cover a test cavity, and such a test cavity has an immunoassay element. In some embodiments, the cover body includes a sample cavity for receiving a collector and a liquid cavity including a treatment liquid, and the liquid cavity and the cover body are movably connected or the liquid cavity and the cover body can move relative to the liquid cavity, or the liquid cavity and the cover body are in a locked and fixed state and can move relative to the cover body after being unlocked. Figure 5-6 As shown, the cover body has two faces, a front face 222 and a back face 223, and a cover edge 221. The overall shape and size of the cover are comparable to the shape and size of the opening 306 of the test cavity to be covered. When the cover body is covered on the opening 306 of the test cavity, part of the liquid cavity and the sample cavity are located in the test cavity. In a specific embodiment of the present invention, the opening of the test cavity is similar to a U-shape, and the overall shape of the cover body is also a U-shape that matches the test cavity. In this way, when the cover body covers the test cavity, the direction is unique, avoiding errors during assembly. That is, when the cover body overlaps with the opening of the test cavity, it can be covered correctly. If the direction is wrong, the cover body cannot cover the test cavity.

[0075] In some embodiments, the cover includes a sample cavity, which has an opening 211 and a tube 225 extending along the opening, and the tube has a cavity 266, which is used to receive the sample collector 400. The sample cavity and the cover are integrated into a structure, the opening is provided at the front 222 of the cover, and the tube extends toward the back 223 of the cover; when the cover is closed on the test cavity, the sample cavity is located in the test cavity, and in particular, the bottom of the sample cavity is located on the raised terraces 385, 386 of the test cavity, and the channel extending from the bottom is located in the channel 387 between the raised surfaces 385, 386. In some embodiments, the sample cavity has a bottom 255, which is mainly for contacting the absorption element 403 of the collector 400. The absorption element can absorb liquid samples and can also be compressed. In this way, when the bottom 255 of the sample cavity contacts the absorption element, the absorption element can be compressed by relying on the force of the bottom and the position of the collector inside the cavity, thereby releasing the sample from the absorption element into the sample cavity. In some embodiments, the bottom of the sample cavity has a channel 224. The purpose of the channel is that when the absorption element 403 is squeezed to release the liquid sample, the liquid sample flows out along the channel 224, or directly flows into the test cavity (if there is a test cavity). The collector is inserted from the opening 211 of the sample cavity, which is set on the cover body. There is a rotating arrow symbol near the opening of the sample cavity, indicating the direction of rotation of the collector after being inserted into the sample cavity, such as clockwise or counterclockwise rotation. The collector 400 has a hand grip 408, which has a similar protruding strip around it. This is to increase the roughness, and the hand grip increases the friction. The collector has an external thread at the lower end of the hand-held portion, and the external thread cooperates with the thread inside the sample cavity of the opening 211, so that the collector is inserted into the liquid cavity and fixed on the liquid cavity through the thread cooperation. At the same time, while the collector and the cavity are rotated and fixed to each other, the collector gradually enters the sample cavity. At this time, the absorption element 403 can be compressed to release the liquid sample. In some embodiments, the collector has an annular groove 405 at the upper end of the absorption element, and an elastic sealing ring 406 is arranged in the groove. When the collector is inserted into the sample cavity 266, the annular sealing ring 406 is sealed with the inner wall 229 of the cavity. In this way, when the absorption element 403 is squeezed or compressed, the liquid sample is allowed to flow out through the channel 224 of the bottom 255 as much as possible, and the liquid sample is prevented from flowing into the sample cavity defined by the sealing ring 406 and the thread.

[0076] Of course, if the cover body is assembled with the test cavity, the cover body generally seals the opening of the test cavity, thus forming a sealed space inside the test cavity. If the collector is also sealed with the sample cavity, the air pressure in the test cavity will increase, which is not conducive to the liquid sample flowing into the test cavity. Therefore, in some ways, the test cavity is connected to the outside atmosphere through other structural designs, so that in the absence of gas pressure, the liquid can flow naturally in the direction of natural gravity. Therefore, the cover body also includes a through hole 212, which has a channel 213 extending downward, which extends into the test cavity. The channel is mainly used to keep the test cavity connected to the outside atmosphere, so that the pressure inside the test cavity is equal to that of the outside atmosphere. At this time, the liquid can easily flow from the sample cavity to the test cavity.

[0077] In some embodiments, the cover also includes a liquid cavity, which includes a treatment liquid. The liquid outlet here generally does not contain the analyzed substance, but may include the following functional components. For example, when these treatment liquids are mixed with the liquid sample from the absorption element, the detection performance of the liquid sample on the test element can be improved, such as adjusting the pH reagent, removing the reagent of impurities such as protein and sugar, or some elution, stabilizing the analyzed substance, etc. In addition, another function of the treatment liquid is to mix with the liquid sample in time to increase the total volume of the liquid. This is mainly when the amount of sample absorbed by the absorption element 403 is relatively small, and it is hoped that multiple indicators or multiple analyzed substances can be detected at one time, so as to increase the total amount of liquid, when the actual collector collects insufficient liquid. For example, the present invention includes two carrier elements, each of which includes 8 test strips, a total of 16 test strips, which can basically detect 16 analyzed substances. Each test strip needs sufficient liquid to complete the entire flow to obtain effective test results. The liquid flows from the sample application area to the water absorption area. For example, each test strip requires 20 microliters of liquid, and 16 test strips require a minimum of 320 microliters of liquid. However, if the liquid compressed from the absorption element is only 300 microliters, plus the flow loss, the amount that reaches the test strip is at most 300 microliters, which is insufficient to complete the amount required for the entire liquid flow process of each test strip, which may cause failure to detect. At this time, the processing liquid in the liquid chamber is released and mixed with the liquid sample to increase the volume of the liquid, ensuring that the entire test can be completed, or at least ensuring that the amount of liquid is sufficient. The third function of the treatment liquid is to dissolve the analyte. For example, when the test element is tested for immunoassay, the squeezed liquid cavity on the absorption element 403 is sufficient to complete the test. However, when a secondary test is required, the entire test device needs to be transported to a more advanced laboratory and confirmed by more sophisticated equipment, such as liquid phase, meteorological or mass spectrometry equipment. However, the most common thing is that during transportation, the ambient temperature rises during transportation, causing the water in the liquid sample in the test cavity to evaporate or evaporate. Sometimes, there is no liquid at all, and the analyte is precipitated at the bottom of the test cavity and exists in the form of dry matter. At this time, secondary sampling cannot be performed for confirmation testing. If a secondary test is required at this time, the liquid sample in the test cavity needs to be sucked for testing. At this time, the treatment liquid is released into the test cavity. The treatment liquid dissolves the dried sample, so that the analyte in the dried sample is dissolved again, so that liquid can be sucked from the test cavity for secondary confirmation testing. The initial tests here are all completed with immunoassay strips, but they are not very accurate, especially for some ambiguous results that require further confirmation. At this time, they need to be sent to a professional laboratory for more precise testing to conduct and confirm the test, such as mass spectrometry, liquid chromatography or liquid chromatography-mass spectrometry connection testing.

[0078] Therefore, the treatment liquid in the liquid chamber of the present invention can be released at different times. In this way, the liquid sample cannot be released automatically, and it is carried out according to the conventional operation. However, it is necessary to release it for the first time and mix it with the liquid sample according to the amount of the sample, or when a second confirmation is needed after the initial immunoassay, the solution analyte needs to be released again. This requires the operator to release the treatment liquid under different circumstances, so it is necessary to have a control action on the liquid chamber of the treatment liquid. Moreover, the liquid in the liquid treatment chamber of the present invention does not directly contact the absorption element, nor is it for eluting the adsorbed substance on the absorption element, but acts as a liquid supplement. If the amount of liquid is insufficient, it is used as a supplementary liquid. If the second confirmation is that the liquid sample is evaporated, it is supplemented to the test chamber to dissolve the dry analyte. Therefore, in some embodiments, the cover body also includes a liquid cavity, and the liquid cavity and the cover body maintain two different states, a fixed locked state and a non-fixed locked state. In the fixed locked state, the liquid cavity remains fixed and cannot be operated (for example, it cannot be pushed or is not exposed), and the liquid sample is stored in the liquid cavity and cannot be released. When in the unlocked state, the liquid cavity can be moved, and the ability to be moved can allow the processing liquid to be released from the liquid cavity. In some embodiments, the cover body includes a docking area, similar to a ship berthing area, and the docking area includes a liquid sample cavity. At the same time, a locking element is also in the docking area, and the liquid cavity is fixed in the docking area by the locking element. When unlocked, the liquid cavity can leave or move or move in the docking area. For example, Figure 5-6 As shown, on the carrier, the docking area is located next to the sample cavity opening 211. The docking area is similar to a step or a gap. When the locking element enters the docking area, the gap is covered, and the cover looks like a complete cover without a gap from the outside. The docking area allows the locking element to fix the liquid cavity in a fixed position, which plays a role in covering the liquid cavity, thereby preventing misoperation. When the treatment liquid needs to be released, the locking element is removed to expose the liquid sample cavity, so that the liquid cavity can be operated, such as releasing the liquid into the test cavity, mixing with the liquid sample in the test cavity, etc.

[0079] In some embodiments, the docking area includes a platform area 217, and a docking area is arranged near the platform area, and the docking area includes limit areas 290, 219, 226, and 218 arranged on both sides. In a specific embodiment, the locking element can be fixed on the docking area in both the platform area and the docking area, and the locking element can also be allowed to leave the docking area. That is, by setting a mechanism simultaneously in any one or both of the platform area and the docking area, the locking element is fixed in the area, and the liquid cavity is also fixed in the area through the locking element. Optionally, it is also hidden in the area while being fixed. Specifically, a hole 216 is arranged on the platform area 217, and the hole allows the liquid cavity to extend out of the hole. When there is a hole 216, the platform area is divided into an area containing the hole and a plane area 217 surrounding the hole. The platform area includes an extension area 209 arranged in a stepped manner with a plane area 217. The extension area is also a part of the cover body and is a curved area as a whole. The area 209 is matched with the opening of the test cavity. The partial area 3911 of the opening of the test cavity is a curved surface, so the extension area is also a curved surface. A slot 220 is formed between the platform area 217 and the extension area 209. Figure 5It can be seen that the platform area 217 partially extends to the extension area 209, and a groove structure is formed in the distance between the two areas 217, 209. The card slot structure cooperates with the protruding ribs 282, 2991, 233 of the locking element to fix the locking element on the docking area. Specifically, the card slot 220 is in an arc position, and part of the card slot is distributed on both sides 293, 2931 of the cover body. The card operation on both sides cooperates with the protruding ribs 299, 233 on the locking element, so that the locking element enters the docking area through the card slot, and the entry method is similar to the way of sliding rails and sliding slots, and the card slot 220 cooperates with the protruding ribs 2991 to fix the locking element on the docking area 294 on the cover body. In a specific embodiment, for example, the locking element as described in Figure 9, the locking element includes a three-dimensional semicircular structure, including a main structure, the main structure includes a top surface area 231 and a bottom surface area 299, and a cross-section 201 connecting the top surface and the bottom surface, the top surface area 231 forms a semicircular notch 281, and a semicircular card 282 is arranged between the top surface and the bottom surface. The card has a notch 286 to form a structure similar to a snap ring. The size of the notch matches the size of the pressing portion 202 of the liquid cavity, which is also the top of the liquid cavity and the neck 208 formed between the cavity body 205. In this way, the notch of the card can enter the neck 208 of the liquid cavity, so that the neck is in a fixed position on the locking element, and cannot fall off naturally from the cover body, or the liquid cavity is in a high position. The neck portion here is actually a ring-shaped groove 208 formed between the pressing portion 202 and the liquid chamber body 205, and the notch 286 of the card can be clamped together around the groove 208. The card has a certain width, so that the pressing portion is located on the card, so that the liquid chamber is in a fixed high position. The ring-shaped card or snap ring has two ends 285, 232, from Figure 8 Combination Figure 6It can be seen that the docking area and the plane vertical surfaces 291, 292 of the docking area contact the two ends 285, 232 of the clamping ring, thereby limiting the distance of lateral movement of the locking element. For example, the locking element enters the docking area in the direction shown by the arrow in Figure 7. In some embodiments, the card 282 is disposed within the space formed between the top surface area 231 and the bottom surface 299 of the locking element. For example, the ends 285 and 232 of the card are both retracted inside the edge formed by the notch in the top surface 231, that is, the projection area of ​​the card on the top surface 231 is located within the top surface area 3231. Although the top surface area also has a notch, the top surface area 231 covers the pressing portion 202 of the entire liquid cavity, thereby hiding the liquid cavity in the docking area. In addition, the top surface area has a notch 281, which is similar to an arc-shaped notch. The notch cooperates with the area formed by the surfaces 266, 290 of the limiting area of ​​the docking area and the liquid cavity inlet 211, so as to cover the upper part of the entire liquid cavity. The locking body is semicircular, and the left and right areas of the docking area are also covered by the locking element, thereby wrapping and hiding the entire liquid cavity exposed in the docking area. The bottom surface 299 of the locking element is actually defective or missing, and one or more ribs or inwardly extending clips 233, 282, 2991 are provided inwardly at the bottom edge of the cross section 201. These inwardly extending ribs will enter into the card slots 220, 293, 2931 formed between the platform area 217 and the extension area 209 to cooperate, thereby limiting the longitudinal position of the locking element in the docking area. The distance between the ribs or clips 233, 282, 2991 and the notched clip 282 is equal to the distance between the liquid chamber neck 208 and the platform area 217. In this way, when the locking element enters the docking area, the liquid chamber is in the initial first position (such as Figure 5 ). When the locking element leaves the docking area, leaving the liquid chamber in a free state, pressure can be applied to the liquid chamber so that it moves from top to bottom along the longitudinal direction, allowing the neck 208 to move onto the plane 217, or allowing the neck with the pressing portion 202 to move through the hole 216 to separate from the cover body. In order to better fix the locking element on the docking area, two face-to-face surfaces 2882, 283 are formed on the cross section 201, and the two surfaces are in contact with the surfaces 219, 218 of the docking area, so that the locking element is fixed on the docking area, limiting the left and right positions of the locking element. Similarly, the notch 281 of the top surface 231 matches the area formed by the surfaces 290, 226 of the limiting area and the edge of the opening of the sample chamber, so that the top surface of the notch 281 is in contact with the surfaces 219, 226 of the limiting area. When the cross section 201 is solid and not hollowed out, the locking element can cover the entire docking area, so that the liquid cavity is hidden in the docking area. At the same time, the position of the liquid cavity cannot be known from the outside, thus preventing some misoperations (such as Figure 3Only when the locking structure leaves the docking area, the position of the liquid cavity is exposed (as shown in Figure 5 ,12,15). Some arrows are set on the top surface of the locking structure to indicate how to make the locking structure leave the docking area and put the liquid chamber in an unlocked state when the liquid chamber needs to be activated. That is, the initial state of the locking element entering the docking area makes the liquid chamber fixed and unable to move. At this time, the liquid chamber is also in a high position ( Fig.12 ), when the locking element leaves the docking area, the liquid sample is in a free or movable state, so that the liquid cavity can move, thereby possibly releasing the liquid. In some ways, on the liquid cavity, some raised ribs are set on the outer wall below the pressing portion 202, and the surface of the ribs contacts the hole 206 on the platform 217, so that there is a gap between the liquid cavity and the hole. The ribs mainly increase the friction between the liquid cavity and the inner surface of the hole. When the locking element leaves, the liquid cavity is basically kept at the initial high position and cannot fall off the plane area freely. Another function is that the gap keeps the test cavity connected to the outside world. Although there is a locking structure covering the docking area, some small holes can be opened on the top surface 231 of the locking structure to allow the inside of the test cavity to communicate with the outside world through the gap. Of course, it can also contact the mechanical gap between the locking structure and the docking area to maintain communication. In this way, when the liquid cavity enters the test cavity from the high position, the excess gas occupied by the liquid cavity can be discharged from the gap, and of course, it can also be discharged from the gas channel 213. Of course, it can also be that there is a lack of gaps, and if Figure 6 In the manner shown, the liquid cavity 205 is sealed with the inner wall of the extension pipe 2161 of the hole 216 in the docking area of ​​the cover body, and the outer wall of the liquid cavity has a sealing ring 2031 that seals with the inner wall of the pipe to form a sealing fit, and the balance between the test cavity and the external atmosphere is maintained by the vent hole 210 and the pipe 213 extending to the test cavity.

[0080] Figure 3 It is a three-dimensional structural schematic diagram of the entire detection device combined in the present invention, Fig.12 It is a schematic diagram of the cross-sectional structure without the locking element. It can be seen from the figure that the sample cavity and the liquid cavity are both located in the test cavity. Fig.12 It means that the collector is inserted into the sample chamber and releases the liquid sample into the test chamber. At this time, it is desired to release the treatment liquid in the liquid chamber, so the locking element is moved away from the docking area to expose the liquid chamber, which is in a high position. At this time, the liquid chamber can be moved. The liquid chamber contains the treatment liquid, and the bottom is sealed by a sealing film. In the test chamber, it is above the puncture element. When the liquid chamber is pushed down from the high position to the low position ( Fig.12), the liquid cavity is punctured by the puncturing element located in the test cavity, and then the treated liquid in the liquid cavity is released into the test cavity and mixed with the liquid sample released by the absorbing element on the collector, so that a normal test can be completed.

[0081] Therefore, in terms of operation methods, Figure 3 In the three-dimensional assembly diagram shown, the collector is not located in the sample cavity, but is in an independent package. When testing is required, the absorption element of the collector 400 is inserted into the mouth to absorb the saliva sample. After the absorption element 403 absorbs the liquid sample, the collector is then inserted into the sample cavity 225. The threads on the collector are rotated with the threads in the sample cavity opening 211 to allow the absorption element of the collector to contact the bottom 255 of the sample cavity. As the collector as a whole rotates in the sample cavity, the collector as a whole moves downward in the sample cavity, so that the absorption element 403 is squeezed, thereby releasing the liquid sample from the squeezed absorption element 403. The absorption element here is made of any water-absorbing material, such as filter paper, fiber, sponge, degreasing sponge, degreasing resin, polyester material, etc. Among them, some materials are hard when dry and become soft after absorbing water. After softening, they can be compressed to release the liquid sample. The compressed and released liquid sample flows into the channel 387 through the channel 224 at the bottom of the Yangben cavity, and then flows to the channels 381 and 3881 on both sides of the channel 387 to contact the test element. At this time, when it is found that the amount of liquid on the collector is relatively small and may not be able to complete the required amount of liquid for all test strips, at this time, the locking element is allowed to leave the cover body to expose the liquid cavity (such as Fig.12 ), and then press the liquid chamber to move the liquid chamber downward in the test chamber, so that the piercing element 900 located at the bottom of the test chamber pierces the sealing film at the bottom of the liquid chamber, so that the treatment liquid in the liquid chamber flows into the test chamber. Because the test chamber is generally transparent, it is possible to observe whether the liquid sample is sufficient through the side wall of the test chamber. If it is insufficient, the locking element is activated to allow the locking element to leave the cover body, exposing the liquid chamber, and perform the subsequent operations.

[0082] When it is felt that the amount of the liquid sample is sufficient to complete the flow test of the immune test strip, the liquid cavity does not need to be started, and the liquid cavity continues to be hidden, and the locking element does not need to leave the docking area on the cover. After the initial test, when it is suspected that there is a problem with the test result or the result displayed by the T line on the test strip cannot be correctly judged, such as when it is not known whether it is positive or negative, it is hoped that the sample will be sent to a more professional laboratory for secondary confirmation. When the laboratory performing the secondary test receives the sample, it extends the aspirator through the hole 391 of the side wall to absorb the sample. If it is found that the sample amount is insufficient or there is no liquid sample, the liquid cavity is started at this time, the locking element is allowed to leave the cover, and then the liquid cavity is exposed, and the pressing part 202 of the liquid cavity is pushed hard to move the liquid cavity from a high position to a low position, so that the puncture structure in the test cavity punctures the liquid cavity, and releases the treatment liquid into the test cavity to dissolve the dry sample or increase the volume of the sample. Generally, the volume of the treatment liquid in the liquid cavity is fixed, such as 1 ml, 2 ml, 3 ml, 4 ml, 5 ml. In this way, the volume of the treatment liquid is known in advance. When the liquid sample is insufficient, the volume of the treatment liquid released is known, and the multiple rate of dilution of the liquid sample can be simply converted. In some embodiments, the docking area includes more than two liquid chambers, and the arrangement of the liquid chamber is the same as the structure of the above-mentioned specific embodiment. For example, two holes are arranged on the plane 217 of the docking area, and a liquid chamber is arranged in each hole, and two parallel puncture elements are arranged in the detection chamber, and each liquid chamber is locked together by a locking element. When unlocked, both liquid chambers can be pushed and punctured by the puncture element in the test chamber. Setting two liquid chambers is to give the operator more choices. For example, one liquid chamber contains a treatment liquid to adjust the pH value of the liquid sample, and the other treatment liquid is used to dilute the sample and remove large particles in the liquid sample. When targeted selection is made according to the characteristics of the sample. Of course, after the operation of the liquid chamber is completed, the liquid chamber is in a low position at this time, but the locking element can still enter the docking area again, thereby covering the entire docking area, and putting the liquid chamber in a hidden position again, so as to maintain the integrity of the test device or other misoperations.

[0083] All patents and publications mentioned in the present specification indicate that these are public technologies in the field and can be used in the present invention. All patents and publications cited here are also listed in the references, just as each publication is specifically cited separately. The present invention described here can be implemented in the absence of any one or more elements, one or more restrictions, and such restrictions are not specifically stated here. For example, in each example here, the terms "comprising", "substantially consisting of..." and "consisting of..." can be replaced by the other two terms of one of the two. The so-called "one" here only means "one", but does not exclude that it only includes one, and can also mean that it includes more than two. The terms and expressions used here are descriptive and not limited by them. There is no intention to indicate that these terms and explanations described in this book exclude any equivalent features, but it can be known that any appropriate changes or modifications can be made within the scope of the present invention and the claims. It can be understood that the embodiments described in the present invention are some preferred embodiments and features, and any person skilled in the art can make some changes and variations based on the essence of the present invention, and these changes and variations are also considered to belong to the scope of the present invention and the scope limited by the independent claims and the appended claims.

Claims

1. A device for detecting an analyte in a liquid sample, the device comprising: The cover body comprises a sample cavity for accommodating a sample collector and a liquid cavity containing a sample processing liquid.

2. The device according to claim 1, wherein: The liquid chamber containing the treatment liquid can be moved relative to the cover body.

3. The device according to claim 2, wherein: The liquid chamber has a first locked position and a second unlocked position relative to the cover body.

4. The device according to claim 3, wherein: When the liquid cavity is in the locked first position, the liquid in the liquid cavity is not released, and when it is in the unlocked second position, the liquid in the cavity can be released.

5. The device according to claim 3, wherein: The liquid chamber is in a locked position and is locked on the cover body by a locking element.

6. The device according to claim 5, wherein: The locking element comprises a limiting structure capable of limiting the movement of the liquid cavity. When the limiting structure is separated from the liquid cavity, the liquid cavity changes from a locked state to an unlocked and non-locked state.

7. The device according to claim 6, wherein: When the liquid chamber is in an unlocked state, the liquid chamber can move relative to the cover body.

8. The device according to claim 7, wherein: The movement includes longitudinal movement from a high position to a low position relative to the cover body.

9. The device according to claim 8, wherein: The liquid chamber comprises a sealing film which is easily punctured. When the liquid chamber moves downward relative to the cover body, the sealing film is punctured by the puncturing element, thereby releasing the liquid in the liquid chamber.

10. The device according to claim 5, wherein: The cover body comprises a docking area, the liquid chamber is located in the docking area, and the locking element keeps the liquid chamber in a fixed locking position on the docking area.

11. The device according to claim 10, wherein: The locking element allows the liquid cavity to be hidden in the docking area when in the docking area, and exposes the liquid cavity when the locking element leaves the docking area.

12. The device according to claim 10, wherein: The docking station includes a platform, a hole is included on the platform, the liquid chamber passes through the hole and is in a high position away from the platform, wherein the high position away from the platform is locked by the locking element.

13. The device according to claim 12, wherein: When the locking element is away from or out of the docking area, the liquid chamber can move from a high position away from the platform to a low position close to the platform.

14. The device according to claim 1, wherein: The sample cavity includes a channel. When the collector is inserted into the channel of the sample cavity, the absorption element on the collector is squeezed to release the liquid sample into the sample cavity, and then the liquid flows out of the sample cavity along the channel.

15. The device according to claim 7, wherein: The device also includes a test cavity with a test element. The cover body covers the opening of the test cavity. The sample cavity and the liquid cavity are located in the test cavity.

16. The device according to claim 1, wherein The sample cavity and the liquid cavity extend outward from the cover body in the same extending direction.

17. The device according to claim 15, wherein: The test cavity includes a puncturing element that can puncture the liquid cavity. When the liquid cavity moves toward the test cavity relative to the cover body, the puncturing element punctures the liquid cavity and enters the liquid cavity, thereby forcing the liquid in the liquid cavity to flow into the test cavity.

18. The device according to claim 17, wherein: The puncture element comprises a sharp puncture needle and a base connected to the needle, and the diameter of the base is equivalent to the diameter of the liquid cavity.

19. The device according to claim 15, wherein: The detection chamber comprises a carrier for carrying the test element, and the carrier has a groove for fixing the test element.

20. The device according to claim 19, wherein The cover body comprises a hole connected to the atmosphere, and the hole has a channel extending toward the test cavity.

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