Detection device for detecting analyte in fluid sample

Abstract

The invention provides a device for detecting an analyte in a fluid sample, the device comprises a sample cavity for accommodating a collector and a test cavity in fluid communication with the sample cavity, the test cavity comprises a test element, the test element is arranged to detect the analyte in the fluid sample for the first time, and the test element is arranged to detect the analyte in the fluid sample for the second time. The collecting cavity is detachably combined with the testing cavity, and the collector comprises a first absorbing element which is used for absorbing liquid and can be compressed.

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] 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 include 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 test results on the test strip in one minute, or at most ten minutes. Drug tests are of various types and are frequent. Some require sample collection and then require professional testing agencies or testing laboratories to conduct tests. Some require on-site, such as roadside, timely completion of the test. For example, people who drive after taking drugs (referred to as "drug driving") need to be tested on-site and then get the test results in a timely manner.

[0004] For example, the detection of saliva samples is gradually accepted and welcomed by detection institutions or detection personnel based on the convenience of collection. Various sample collection and testing devices for clinical or home use have been available and described in some documents. For example, US Patent No. 5,376,337 discloses a saliva sampling device, in which a filter paper is used to collect saliva from the mouth of the subject and transfer the saliva to the indicator reagent. US Patent Nos. 5,576,009 and 5,352,410 each disclose a syringe-type fluid sampling device. For example, in the patent application in the United States, application number: 14 / 893,461, application publication number US2016 / 0121322A1, a sample detection device is disclosed. The patent only discloses some basic detection schemes and principles, but it is difficult to actually realize a specific product. For example, if the cover body assembly and the detection assembly are matched, how the washing head for absorbing saliva is compressed, how it moves, and how to effectively mix with the liquid, the actual effect is not ideal.

[0005] For example, patents disclosed in U.S. patent applications US2020 / 0141934A1, US7,879,623B1, US10,564,155B1, US7,879,623B1, etc. disclose that the collector is connected to the test chamber, but secondary confirmation cannot be performed. When secondary confirmation is required, two collectors are required to collect samples, and then one is used for testing and the second is for secondary confirmation. This operation is still cumbersome. In addition, it is even more difficult to implement for some cases where the sample volume is small, especially for saliva samples, the operation is cumbersome.

[0006] In view of the technical problems of some of the above-mentioned traditional products, it is necessary to improve them and provide other ways to solve the shortcomings of existing traditional technologies. Summary of the invention

[0007] In view of the above situation, in order to overcome the defects of traditional technology, the purpose of the present invention is to provide a device for detecting the substance to be analyzed in a fluid sample, which can realize the initial detection of the liquid sample. When it is necessary to conduct and confirm the test, the sample cavity and the test cavity can be separated. In this way, one sampling can be carried out twice. In addition, the absorption element that can be compressed is used to store the secondary sample. The absorption element is used to store the sample of the secondary test, which can ensure that the liquid is not volatilized or evaporated due to the dry environment. In addition, the safety of preservation is increased, for example, it is not easy to leak from the container. The traditional sample used for storing the secondary confirmation is stored in an empty container, and the amount of liquid is very small. If it is a saliva sample, it is easy to evaporate and dry during transportation, thereby causing sampling difficulties for the secondary confirmation. The present invention uses a water-absorbing element to absorb and retain liquid samples, such as saliva samples, which can effectively preserve the existence of saliva. When it is necessary to test, only the sample cavity is transported to the secondary confirmation center for testing, and the absorption element is compressed to release the remaining liquid for secondary confirmation testing.

[0008] In order to solve this problem, the present invention provides a detection device, which includes a sample chamber and a test chamber, and the sample chamber is in fluid communication with the test chamber. In some ways, the sample chamber is configured to receive a collector, which is used to collect fluid samples, and the test chamber includes a test element, which is used to test whether the fluid sample contains an analyte. In some ways, the sample chamber and the test chamber are detachably combined, so that when detection is required, the sample chamber and the test chamber are combined and maintained in fluid communication, and when the test is completed, the sample chamber is separated from the test chamber, so that the liquid sample in the sample chamber can be subjected to a secondary test. In some ways, the test strip is a lateral flow test strip based on the immune principle, and the secondary test is a method with higher sensitivity than the immune lateral flow test, such as a liquid phase, mass spectrometry, gas phase, etc. A more sensitive test method or means. In some ways, this detachable combination is combined together from the beginning, and the sample chamber and the liquid chamber maintain fluid circulation. After the initial test is completed, the sample chamber and the test chamber are separated.

[0009] In some embodiments, the test cavity is a cavity surrounded by a side wall of the test cavity, and a carrier carrying a test element is contained in the cavity. Generally, the test cavity is a flat sheet structure, and one or two notches are contained on the side wall of the test cavity. For example, the upper end of the test cavity includes a second notch or a second depression, and the lower end or near the bottom of the test cavity includes a first depression or a first notch, and the notch is also similar to a tube shape. The first notch or the first depression is connected to the cavity fluid of the test cavity. In some embodiments, the side wall of the sample cavity has a first protrusion and a second protrusion outwardly, and the protrusion of the sample cavity can be inserted into the notch of the side wall of the test cavity, so as to realize the combination of the test cavity and the sample cavity. When the two need to be disassembled, the first protrusion and the second protrusion are allowed to leave the first notch and the second notch on the test cavity to realize the separation of the two. In some embodiments, the first protrusion includes a liquid channel, one end of which is connected to the inside of the sample cavity and the other end is connected to the first recess. The first recess also contains a channel, one end of which is connected to the inside of the test cavity and the other end is connected to the channel fluid in the first protrusion. In this way, the sample cavity and the test cavity are connected through the liquid channel fluid. In this way, the liquid in the sample cavity can flow into the test cavity through the liquid channel. If the channel is close to the bottom of the test cavity, the liquid flows to the bottom of the test cavity and contacts the sample application area of ​​the test element located at the bottom, so that the liquid flows on the test element by capillary action to complete the test or assay. This test or assay is the first test or the first time, or the first assay. In some embodiments, the channel is a channel with capillary force, of course, it can also be a non-capillary channel, and the preferred mode is a non-capillary channel. Here, the second protrusion and the second recess can be omitted. The cooperation of the second protrusion and the second recess is only to make the sample cavity and the test cavity more stably and firmly combined together. It is also feasible if they are omitted. In some embodiments, the test cavity includes a seal for sealing the opening of the test cavity. On the one hand, the seal isolates the test element in the test cavity from the outside world to prevent moisture from causing the test to fail. In addition, the seal has an exhaust duct, one end of which is connected to the air inside the test cavity and the other end is connected to the outside atmosphere. When the liquid in the sample cavity flows into the test cavity through the first protruding channel, it is generally under pressure and enters the test cavity. There is no air pressure barrier, so that the liquid can flow smoothly and quickly into the test cavity. The pressure in the sample cavity is generally that the absorbing element of the collector is inserted into the sample cavity. In the process of compressing the absorbing element, the air seal between the collector and the inner wall of the sample cavity compresses the air in the sample cavity and increases the pressure. The pressure forces the liquid released from the absorbing element to enter the test cavity through the liquid channel, and the exhaust channel on the test cavity can reduce the volume of the air in the test cavity, so that the liquid can smoothly enter the test cavity with the pressure in the sample cavity. The exhaust channel is usually of millimeter diameter, which can smoothly discharge air or gas but not liquid.

[0010] In some embodiments, the sample chamber may further include a third protrusion, and a detachable cover is provided on the third protrusion, and the cover is used to seal the channel on the first protrusion on the sample chamber. In this way, when the sample chamber is separated from the test chamber, the liquid channel in the first protrusion on the sample chamber is connected to the outside world, and the cover is used to seal the protrusion, thereby preventing the liquid in the sample chamber from leaking through the channel, or allowing the liquid in the sample chamber to evaporate through the channel. In some embodiments, the cover and the first protrusion are meshed together through a threaded structure. In this way, the cover is located at the partition between the sample chamber and the test chamber. When combined, the cover cannot be found by the operator. Once separated, the channel of the first protrusion in the sample chamber is no longer connected to the test chamber, but is exposed to the outside world. The cover is used to seal the channel, so that the remaining liquid in the sample chamber will not leak, and will not evaporate due to the dry environment of the outside world.

[0011] In some embodiments, the sample cavity includes a secondary confirmation cavity for confirmation testing, which is used to receive and store liquid samples for subsequent secondary confirmation testing. In some embodiments, the secondary confirmation cavity includes an absorption element, which can absorb liquid and can be compressed to release liquid. In some embodiments, the first absorption element of the liquid sample absorbed by the collector is compressed in the sample cavity to release part of the liquid, which is absorbed and stored by the second absorption element in the secondary confirmation cavity, and the excess liquid sample flows into the test cavity through the liquid channel. Therefore, in some embodiments, the liquid channel fluid connects the secondary confirmation cavity and the test cavity. Alternatively, the liquid released from the first absorption element on the collector first flows into the secondary confirmation cavity, a part of the liquid flows into the test cavity through the liquid channel for the initial test, and the other part of the liquid is absorbed and stored by the second absorption. When the sample cavity is separated from the test cavity, the second absorption is compressed to release the liquid sample for secondary testing or analysis. In some embodiments, the amount of liquid absorbed by the second absorption element is constant, that is, the amount of saturated liquid absorbed is constant, and the volume of saturated liquid absorbed by the compressible first absorption element on the collector is greater than the volume of saturated liquid absorbed by the second absorption element. In this way, the amount or volume of liquid released by the first absorption element when compressed is greater than or equal to the volume of saturated liquid absorbed by the second absorption element, so that excess liquid flows into the test chamber to perform the initial immune test.

[0012] In some embodiments, after the first absorption element on the collector absorbs the liquid, the sample cavity is compressed and the released liquid is completely absorbed by the second absorption element. Then, the first pressure is applied to the second absorption element, so that the second absorption element is compressed and part of the liquid is released. The released liquid flows into the test device through the liquid channel in the first protrusion. At this time, some chemical reagents can be processed in advance on the second absorption element. The chemical reagents can improve the flowability of the liquid sample, such as destroying the protein in the fluid sample or eliminating interfering substances, thereby facilitating the flowability of the liquid sample on the test element. For example, all chemical reagents in the European patent EP2823309B1 can be used in the present invention. After the first test is completed, the sample cavity is separated from the test cavity, and then the cover body on the sample cavity is allowed to seal the liquid channel in the first protrusion. When a second confirmation is required, the cover body is removed, and the second absorption element is subjected to the second pressure again, so that the second absorption element is compressed again, thereby releasing the liquid. The released liquid also flows out from the protrusion channel and is used for the second test. In fact, the liquid sample absorbed by the second absorption element is compressed and released by the first application of pressure for the initial test, and the other part of the liquid is compressed again after the second pressure is applied and the released liquid is used for the secondary confirmation test. At this time, the liquid set released by the first absorption element on the collector is all absorbed by the second absorption element. At this time, the amount of liquid saturated by the second absorption element can be greater than or equal to the amount or volume of liquid saturated by the first absorption element. In some ways, applying pressure twice to the second absorption element is to change the position of the collector in the sample cavity and continuously apply pressure in batches, or to allow the collector to move as a whole to apply the first pressure to the second absorption element. When performing the secondary test, some accessories in the collector move relative to the collector and apply the second pressure to the second absorption element. For example, after the collector is inserted into the sample cavity, first, the liquid sample collected by the collector is completely released to the second absorption element in the secondary confirmation cavity for absorption, and at the same time, the collector applies the first pressure to the secondary absorption element, so that the second absorption element is compressed and releases the liquid, and the released liquid flows into the test cavity through the liquid channel to complete the initial test. After the sample cavity is separated from the test cavity, the collector is allowed to continue to move downward, applying a second pressure to the second absorption element, thereby releasing part of the liquid for secondary confirmation testing. A limit block can be applied in the sample cavity to allow the collector to have a first position and a second position in the sample cavity. In the first position, the liquid is released and the first pressure is applied to the second absorption element. In the second position, the second pressure is applied to the second absorption element. Usually, in the first position, the collector is at the bottom of the sample cavity, and in the second position, the collector is close to the bottom of the sample cavity. At this time, the secondary confirmation cavity is located near the bottom of the sample cavity, which is formed by part of the sample cavity being sealed by the collector, and the second absorption element is contained in the secondary confirmation cavity.

[0013] In some embodiments, the height of the second absorption element in the secondary confirmation cavity is higher than the position of the entrance of the liquid channel in the first protrusion, so that when the second absorption element is compressed after being subjected to the first pressure, the released liquid can flow into the liquid channel and thus flow into the test cavity. In some embodiments, the second absorption element on the secondary confirmation cavity has a movable cover plate, which has a hole and can be compressed by applying pressure. In some embodiments, one side of the cover plate is used to receive the first absorption element and compress the first absorption element to release liquid to the second absorption element, and on the other hand, the cover plate is subjected to the pressure of the first absorption element, thereby compressing the second absorption element. In some embodiments, the cover plate covers the surface of the second absorption element. When the collector is inserted into the sample cavity and the first absorption element on the collector is compressed, the released liquid flows into the second absorption element through the hole on the cover plate. At this time, the collector seals the sample cavity, so that the secondary confirmed cavity and the absorption element in the cavity are in an airtight state. In this way, the absorption element of the collector is compressed, allowing the liquid to enter the second absorption element, allowing the second absorption element to absorb the liquid saturatedly. When the second absorption element is saturated with liquid, the excess liquid on the first collector enters the second absorption element and flows into the liquid channel of the first protrusion, and flows into the bottom of the test cavity through the channel, contacts the test element in the test cavity, and completes the initial test of the immune principle.

[0014] In some embodiments, the sample chamber further includes a movable chamber, which is used to receive a collector with a first absorption element, and the first absorption element on the collector can be compressed in the movable chamber to release liquid. In some embodiments, the secondary test chamber is located in the sample chamber, and the movable chamber makes the sample chamber of the secondary test in a sealed state. At the same time, the sample chamber of the secondary test includes an absorption element, and the second absorption element absorbs the liquid sample. In some embodiments, the secondary confirmation chamber is located at the bottom of the sample chamber, and the seal is sealed by the movable chamber, so that when the movable chamber moves downward, the air in the secondary confirmation chamber can be compressed, thereby causing the excess liquid in the secondary confirmation chamber to enter the test chamber from the liquid channel of the first protrusion. When the first absorption element on the collector is inserted into the movable chamber, the bottom of the chamber has a through hole, and the absorption element contacts the bottom of the movable chamber and is compressed, releasing the liquid into the secondary confirmation sealed chamber below, and the sealed chamber is provided with a second absorption element, which is used to absorb part of the liquid and store it for use in the secondary test. It will be appreciated that the collector is inserted into the movable cavity and is also hermetically sealed with the wall of the movable cavity, so that the secondary confirmed cavity is sealed.

[0015] It can be understood that the "seal" in the sealing of the secondary confirmation cavity here does not mean that the secondary confirmation cavity is completely closed and cannot exchange any gas or liquid with the outside world. The seal here means that the entire secondary confirmation cavity is sealed, and only the liquid channel connects the secondary confirmation cavity with the test cavity. It can also be considered that only the liquid channel is used to connect the fluid with the outside world. Generally, the liquid channel is used to transport liquid. When the volume of the sealed secondary confirmation cavity is reduced, the pressure increases. The increased pressure forces the internal liquid to flow out through the liquid channel. In this way, the ultimate goal is to eliminate the liquid. At the same time, the pressure of the sealed secondary confirmation cavity is also balanced with the outside world, so that the liquid flows more smoothly. This is a necessary condition for the implementation of the present invention.

[0016] In some embodiments, there is a space between the second absorption element and the bottom of the movable cavity, and the space is the same as the liquid channel connecting the sample cavity and the test cavity. When the movable cavity is in the first position, the liquid compressed by the first absorption element on the collector flows into the space, and part of the liquid is absorbed or saturated by the second absorption element in the secondary confirmation cavity, and part of the liquid is in the space. At this time, the movable cavity drives the collector to move downward, which actually compresses the secondary confirmation space, forcing the liquid in the space to flow into the test cavity through the liquid channel for initial testing or detection. When the initial test is completed, the sample cavity is separated from the test cavity, and the cover seals the outlet of the liquid channel on the first protrusion. When a second test is needed, the movable cavity is again allowed to compress the second absorption element at the bottom to release part of the liquid. In order to allow the cavity to directly compress the second absorption element, a pressure-applying structure is extended at the bottom of the cavity. The structure is located in the space. In this way, when the cavity moves downward again, the extended structure directly applies pressure to the second absorption element, causing the second absorption element to be compressed and release liquid into the space, and the space continues to be subjected to the pressure of the downward movement of the movable cavity, thereby allowing liquid to flow in from the channel for a second test sample.

[0017] In some other embodiments, the sample cavity and the test cavity are an integral structure and cannot be disassembled or separated, and the cavity for the secondary confirmation sample is not located in the sample cavity, but is located next to the test cavity. The cavity for the secondary confirmation is in fluid communication with the sample cavity and the test cavity. The liquid collected by the collector is released under pressure in the sample cavity, and the released liquid flows into the bottom of the test cavity through the liquid channel connected to the test cavity to participate in the initial detection of the test element. If there is excess sample, it flows into the cavity for the secondary confirmation, and the cavity for the secondary confirmation includes a second absorption element, which absorbs excess liquid sample for storage or preservation. When a secondary confirmation is required, the second absorption element can be directly removed for secondary testing. In some ways, in order to facilitate removal, the second absorption element is fixed by a carrier, and the second absorption element is fixed on the carrier. The carrier has a seal, which is sealed with the second cavity, so that the second absorption element is sealed in the secondary confirmation cavity. When a secondary confirmation is required, the carrier is directly removed from the confirmation cavity, and the second absorption element is squeezed to release the liquid. Alternatively, after the initial test is completed, the carrier is directly taken out from the confirmation cavity, the carrier is loaded into a vial, the vial is express or transported to the secondary confirmation test center, and when testing, the carrier containing the second absorption element is taken out from the vial, and the second absorption element is squeezed to release the liquid. The second absorption element containing the carrier can be called a second collector. Of course, the collection cavity here does not directly collect the liquid sample (such as absorbing saliva from the tester's mouth), but absorbs part of the liquid released by the first absorption. In some methods, the first absorption element and the second absorption element here can be compressed and absorbent, so the materials can be the same, of course, they can also be different, for example, filter paper, sponge, polyester fiber, and any other material that can absorb water and release liquid when compressed.

[0018] The sample for secondary confirmation transported or stored in the present invention is an absorption element. The advantage is that the absorption element absorbs liquid, which is convenient for transmission and transport, and can avoid liquid evaporation and loss during transportation. The traditional secondary sampling container contains liquid samples, which may leak during transportation, and may evaporate if the sealing is not good. Especially for saliva samples, saliva samples are viscous and rich in protein. If the amount of liquid is very small, such as 10-100 microliters, if it is liquid, it is likely to leak or evaporate and dry up during transportation in the secondary container, and secondary test sampling cannot be performed. However, if such a small volume of sample is absorbed by the second absorption element and sealed and stored, due to the capillary force of the absorption element, the liquid is not easy to evaporate and dry, and there will be no leakage problem. Therefore, the material of the first absorption element and the second absorption element can be the same, of course, it can also be different. Our experiments have proved that when a container without an absorption element is used to store 50 microliters of liquid, and an absorption element is used to absorb 50 microliters of liquid, both are placed in dry air (humidity is 20%), and the temperature is 40 degrees Celsius, the container containing the liquid evaporates and becomes dry in 24 hours, while the liquid stored in the absorption element still exists. By squeezing and compressing, about 40 microliters of liquid can be released, and it can be maintained for 120 hours continuously. There is still liquid that can be released under pressure, which meets the amount of secondary confirmation. Of course, the volume of liquid absorbed by the second absorption element used for secondary confirmation and storage of samples is quantitative, for example, any volume of sample between 10-1000 microliters, which depends on the amount of liquid absorbed by the second absorption element. Of course, the volume of liquid absorbed and protected by the second absorption element is determined by the volume of the second absorption element (when the material is unchanged). The size of this volume can be freely selected. At the same time, the second absorption element is not stored in a sealed cavity. When performing a secondary confirmation, the second absorption element can be compressed, or the second absorption element can be taken out of the sealed cavity and squeezed to release the liquid. Of course, the absorption element can also be immersed in an eluent to dissolve the liquid sample or the analyzed substance on the absorption element, and then a secondary confirmation can be performed.

[0019] The present invention also includes the following specific technical solutions:

[0020] A device for detecting an analyte in a fluid sample, the device comprising: a sample chamber for accommodating a collector, and a test chamber in fluid communication with the sample chamber, the test chamber comprising a test element, the test element being configured to initially detect an analyte in the fluid sample, the collection chamber and the test chamber being a detachable combination.

[0021] In some embodiments, the collector includes a first absorbent element for absorbing liquid and capable of being compressed.

[0022] In some embodiments, the device further comprises a secondary confirmation chamber comprising an absorbent element capable of absorbing liquid and being compressible.

[0023] In some embodiments, the secondary confirmation cavity is located in the sample cavity, and when the collector is inserted into the sample cavity, the secondary confirmation cavity is airtight. In some embodiments, the first absorption element on the collector is used to absorb the liquid sample, and when the sample cavity contains the collector, the first absorption element of the collector can be compressed to release the liquid, wherein the released liquid portion can flow into the cavity of the secondary confirmation test. In some embodiments, part of the liquid can be absorbed and preserved by the second absorption element located in the secondary confirmation cavity. In some embodiments, all the liquid released by the first absorption element is absorbed by the second absorption element. In some embodiments, a first pressure is applied to the second absorption element to release the liquid sample for the initial detection of the test element in the test cavity, and a second pressure is applied to the second absorption element to release part of the liquid sample for the secondary confirmation test.

[0024] In some embodiments, the secondary confirmation cavity is in fluid communication with the detection cavity. In some embodiments, the volume of liquid saturated by the second absorption element in the secondary confirmation cavity is constant. In some embodiments, the volume of liquid absorbed by the first absorption element is greater than the volume absorbed by the second absorption element. In some embodiments, the cavity for secondary confirmation detection is located at the bottom of the sample cavity or is in fluid communication with the sample cavity.

[0025] In some embodiments, the secondary confirmation sample cavity is fluidly connected to the detection cavity through a liquid channel, or the secondary confirmation cavity is fluidly connected to the sample cavity through the test cavity and the liquid channel. In this way, the liquid flowing out of the secondary confirmation cavity flows into the test cavity through the liquid channel for primary detection, or for secondary confirmation detection. In some embodiments, the secondary confirmation cavity and the sample cavity are fluidly connected through the test cavity, and the liquid in the sample cavity can flow into the test cavity for primary detection, while the excess liquid flows into the confirmation cavity. In some embodiments, the secondary confirmation cavity includes a second collector, and the second collector includes the second absorption element. When a secondary confirmation detection is required, the second collector containing the second absorption element is taken out from the secondary confirmation cavity and the second absorption compression release liquid is subjected to secondary confirmation.

[0026] In some embodiments, the sample cavity includes a first protrusion containing the liquid channel, and the first protrusion is detachably connected to the first recessed interface of the detection cavity, so that the channel can detachably connect the sample cavity and the test cavity. In some embodiments, the sample cavity also includes a cover, and the cover is configured to seal the liquid channel when the sample cavity is separated from the detection cavity.

[0027] In some embodiments, the sample cavity includes a second protrusion, and the second protrusion is detachably connected to the second recessed interface of the detection cavity. In some embodiments, the sample cavity also includes a third protrusion, and the cover is located on the third protrusion.

[0028] In some embodiments, the sample chamber further includes a movable chamber, which is configured to receive the collector and allow the first absorption element to be compressed to release the liquid, and the movable chamber has a first position and a second position in the sample. In some embodiments, the collector has a bottom, and the bottom and the side wall of the sample chamber surround the secondary confirmation chamber, and the chamber includes a second absorption element for absorbing the liquid sample. In some embodiments, when the collector or the first absorption element on the first collector is compressed and the liquid is released, the liquid flows to the secondary confirmation chamber, allowing the second absorption element to absorb the liquid, and the excess liquid flows to the detection chamber through the liquid channel to contact the test element, completing the test, and the movable chamber is located at the first position. In some embodiments, the collector is inserted into the movable chamber, so that the pressure in the secondary confirmation chamber increases, and the increased pressure prompts the remaining liquid to flow into the test chamber through the liquid channel. In some embodiments, the secondary confirmation chamber maintains fluid communication with the test chamber through the liquid channel. In some embodiments, when the collection chamber is separated from the test chamber and a secondary confirmation test is required, the movable chamber is moved to a second position, and the movable chamber compresses the second absorption element, thereby releasing liquid through the liquid channel, and the released liquid is used as a secondary confirmation test. In some embodiments, the test chamber includes a carrier for the test element, and the test element is located on the carrier, wherein the test chamber is connected to the outside atmosphere. In some embodiments, the test chamber includes a sealing body that seals the opening of the test chamber, and the sealing body includes a channel, and the channel connects the test chamber with the outside atmosphere. In some embodiments, the device also includes a base, and the test chamber and the sample chamber are located on the base and are combined with the base in a disassembled manner. In some embodiments, the analyzed substance is a small drug molecule. In some embodiments, the fluid sample is saliva, urine or blood.

[0029] On the other hand, the present invention provides a method for detecting an analyte in a liquid sample, the method comprising performing a primary test on the liquid sample and then performing a secondary confirmation test on the same liquid sample, wherein the secondary confirmation sample is stored in an absorption element.

[0030] In some embodiments, a detection device is provided, which includes a sample cavity for inserting a collector, and the collector includes a first absorption element for absorbing a liquid sample, and is inserted into the sample cavity so that the first absorption element is compressed and releases the liquid sample into the sample cavity. In some embodiments, when the collector is inserted into the sample cavity, a sealed space is formed at the bottom of the sample cavity, and the sealed space includes a second absorption element. The liquid released by the first absorption element is partially absorbed by the second absorption element in the sealed space, and the excess liquid remains in the sealed space. In some embodiments, there is a liquid channel between the sealed space and the test cavity. As the collector moves, pressure is applied to the sealed space, forcing the liquid remaining in the sealed space to flow through the liquid channel into the test cavity for an initial test. When the initial test is completed, the sample cavity is separated from the test cavity.

[0031] Beneficial Effects

[0032] By adopting the above structure, the initial test and secondary confirmation test of the analyzed substance of the liquid sample can be realized. In particular, the sample of the secondary test is retained in the absorption element, which can maximize the existence of the liquid sample without reduction. At the same time, the cavity of the secondary confirmation sample of the present invention is located in the sample cavity and can be detachably combined with the test cavity. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 It is a schematic diagram of the assembled three-dimensional structure of a detection device in a specific embodiment of the present invention.

[0034] Figure 2 It is a schematic diagram of an exploded view of a detection device in a specific embodiment of the present invention.

[0035] Figure 3 It is a detailed exploded schematic diagram of a detection device in a specific embodiment of the present invention.

[0036] Figure 4 It is a schematic diagram of the cross-sectional structure of a detection device in a specific embodiment of the present invention (the collector is inserted into the sample chamber).

[0037] Figure 5 It is a schematic diagram of the three-dimensional structure of the sample chamber in a specific embodiment of the present invention.

[0038] Figure 6 It is a schematic diagram of the three-dimensional structure of the sample chamber in a specific embodiment of the present invention.

[0039] Figure 7 It is a schematic diagram of the principle of movement of the sample chamber, the collector and the second absorption element in a specific embodiment of the present invention.

[0040] Figure 8It is a schematic cross-sectional structure diagram of a combination of a sample chamber and a collector in a specific embodiment of the present invention (it does not contain a cover body for sealing a liquid channel, nor does it contain a cover body for sealing the bottom of the sample chamber).

[0041] Fig. 9 It is a schematic diagram of the assembled three-dimensional structure of a detection device in another specific embodiment of the present invention.

[0042] Fig.10 It is a schematic diagram of the exploded structure of a detection device in a specific embodiment of the present invention.

[0043] Fig.11 It is a schematic diagram of the three-dimensional structure of a base in a specific implementation manner.

[0044] Fig.12 This is a schematic diagram of an exploded three-dimensional structure of a detection device in another specific embodiment of the present invention.

[0045] Fig.13 It is a schematic diagram of the cross-sectional structure of an assembled detection device in a specific embodiment of the present invention (the collector is inserted into the sample cavity to start the test).

[0046] Fig.14 It is a schematic diagram of the exploded structure of a detection device in another specific embodiment of the present invention (the sample chamber and the test chamber contain a second absorption element).

[0047] Fig.15 It is a schematic diagram of the cross-sectional structure of an assembled detection device in a specific embodiment of the present invention (the sample chamber is fluidly connected to the test chamber, the chamber containing the second absorption element is fluidly connected to the test chamber, and the secondary confirmation chamber is not in the sample chamber).

[0048] Fig.16 It is a schematic diagram of the combined three-dimensional structure of a detection device according to another embodiment.

[0049] Fig.17 It is a schematic diagram of the exploded structure of a detection device in a specific implementation manner.

[0050] Fig.18 It is a schematic diagram of the exploded structure of the sample chamber, the collector and the movable chamber in a specific embodiment.

[0051] Fig.19 It is a schematic cross-sectional structure diagram of a specific implementation example of the present invention, in which the collector is located in a movable cavity, and the cavity is located in the sample cavity.

[0052] Fig. 20 is a top view of the test component.

[0053] Fig.21It is a schematic diagram of the three-dimensional structure of the test element.

[0054] Detailed description

[0055] 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.

[0056] Detection

[0057] 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.

[0058] sample

[0059] The sample of the detection device of the present invention includes biological fluid (such as case fluid or clinical sample). Liquid sample or fluid sample 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.

[0060] 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, it can absorb liquid samples or fluid samples and allow the fluid sample sample application area to flow. The material of the fluid 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 fluid 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, optionally, the fluid sample application area can be composed of some non-absorbent fibers and hairs, and these materials are used to scrape a solid, semi-solid or liquid sample, so that these samples are retained on the fluid 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.

[0061] In some embodiments, the sample application area of ​​the test element of the present invention does not require manual application of the fluid sample, but is located in the test cavity, and the sample application area is close to the bottom of the test cavity. When there is a fluid sample at the bottom, the end of the sample application area contacts the fluid sample, and the sample relies on capillary force to flow to the marking area, the test area, and then to the sample absorption area to complete the entire test. It can also be the initial or first test.

[0062] Downstream and Upstream

[0063] Downstream or upstream is divided according to the direction of liquid flow, and generally the liquid or fluid flows from the upstream to the downstream area. The downstream area receives the 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, when there is a liquid sample at the bottom of the test cavity, such as a liquid sample flowing into the sample cavity, such as a urine sample or a saliva sample of the tester, the fluid can flow from the sample application area to the marking area, and then flow to the detection area, such as the test result area and the test result control area. The test area can be a polyester fiber film, and the guide element can be glass fiber, polyester sheet, or polyester film.

[0064] Gas connection or liquid connection

[0065] 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.

[0066] Test components

[0067] Here, the so-called "test element" refers to an element that can detect whether a fluid sample or a fluid sample (liquid sample or liquid sample) contains an analyte of interest. Such detection can be based on any technical principle, such as 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.

[0068] 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] The various areas of the test paper can be arranged in the following manner: sample application area 405, reagent area 407, detection area 408, and the detection area includes a test result area 411 and a test result control area 410. The control area is located after the detection area. All areas can be arranged on a test paper using only one material. Different areas can also use different materials. Each area can be directly in contact with the liquid sample, or different areas can be arranged according to the direction of flow of the liquid sample, and the end of each area is connected to the front end of another area 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.

[0073] 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.

[0074] 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 20-21 ), including a sample collection area or a sample application area 405, a labeling area (406), and a detection area 408, wherein the sample collection area includes a sample receiving pad, the labeling area includes a labeling pad, and the water absorption area may include a water absorption pad, wherein the detection area includes necessary chemical substances that can detect whether the substance to be analyzed is contained, such as immune reagents or enzyme chemical reagents. Fig.21 As shown, the test strip has a sample application area 405. The commonly used test strip is a nitrocellulose membrane test strip, that is, the test area 408 includes a nitrocellulose membrane, and the specific binding molecules are fixed on the nitrocellulose membrane to display the result area 411 (T-line) of the test; it can also be a cellulose acetate membrane or a nylon membrane, etc.; of course, the downstream of the test area can also include a test result control area 410 (C-line), usually, the control area and the test area appear in the form of horizontal lines, which are test 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, the general test strip carries dry chemical reagent components, such as fixed antibodies or other reagents. When encountering liquid, the liquid flows along the test strip with capillary action, and as it flows, the dry reagent components are dissolved in the liquid, so that the dry reagent in the next area is processed to react, thereby performing necessary detection. The flow of liquid is mainly carried out by capillary action. Here, they can all be applied to the detection device of the present invention, or be arranged in the detection chamber to contact the liquid sample, or be used to detect the presence or amount of the analyzed substance in the liquid sample entering the detection chamber.

[0075] 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 fluid 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 fluid sample, the test element can be used alone for detection. In the present invention, the test element is arranged on a carrier 501, and a plurality of slots 504 are arranged on the carrier, and a test element is arranged on each slot, which can be used for one substance to be analyzed, such as Figure 3Therefore, a plurality of slots are provided on the carrier, and a plurality of analyte substances can be detected or tested. Generally, the sample application area 405 is located at the lower end of the slot body close to the carrier. When the carrier is inserted into the test cavity, the end of the application area is generally the area that contacts the bottom 304 of the test cavity. In this way, when the test liquid flows into the test cavity, it flows into the bottom of the test cavity, and the sample application area of ​​the test cavity contacts the liquid sample to complete the initial test.

[0076] Analyte

[0077] 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.

[0078] 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, sugar, heavy metals or toxins, bacterial substances (such as protein or sugar substances for specific bacteria, such as Escherichia coli 0157:H7, Staphylococcus, Salmonella, Clostridium, Campylobacter, L.monocytogenes, Vibrio, or Bacillus) 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. The sample of the present invention can be urine, and the analyte can be HCG, LH and other substances, which are used to test ovulation or early pregnancy.

[0079] Detachable combination

[0080] A detachable combination refers to a connection relationship between two parts that is in several different states or positional relationships. For example, when there are two parts in a physical sense, they can be separated at the beginning, connected or combined together in a suitable first situation, and can be separated in a suitable second situation. This separation is a physical spatial separation without contact. Alternatively, the two parts are combined together at the beginning, and when appropriate, the two parts can be separated in a physical spatial separation. Alternatively, the two objects are separated at the beginning, combined together to complete a certain function when needed, and then separated, or later combined again for a certain purpose. In short, the combination of the two or the separation of the two can be easily carried out, and this combination or separation can be repeated for many cycles. Of course, it can also be a one-time combination and separation. In addition, it can be a detachable combination between two parts, or a detachable combination between three or more parts. For example, there are first, second and third parts, the first part and the second part are detachable, the second part and the third part can also be a detachable combination, and the first part and the third part can also be a detachable combination or separation. In addition, the combination method can be that the two objects themselves are detachable, or it can be indirectly combined through another object.

[0081] Second confirmation of sample preservation

[0082] The secondary confirmation here means that after the sample is tested for the first time, it is hoped that the sample will be tested again for confirmation. The sample for the first test and the second confirmation test is the same liquid sample, and the same here refers to the sample of the same batch, such as the sample obtained, a part of which is used for the first test, and the remaining part is tested for the second confirmation test. In some ways, the accuracy or sensitivity of the first test is lower than that of the second confirmation test. For example, the first test is tested based on the immune method using the lateral flow test element of the present invention, but the marker is a colored particle. If a second confirmation test is required, a means with better accuracy than the immune test is adopted, such as chromatography, fluorescence immunoassay, radioimmunoassay, gas phase or liquid phase, or gas phase / liquid phase-mass spectrometry method. It can be understood that the means of the first primary test and the second test are the same, for example, the first test is an immune test, and the second test can also be the same as the immune test of the first test.

[0083] Sample chamber, test chamber, secondary confirmation chamber

[0084] like Figure 1-8 What is shown is a specific embodiment of the present invention. The test device of the present invention includes a sample chamber 60, a test chamber 30, and a detachable combination of the test chamber 30 and the sample chamber 60. Generally, at the beginning, the sample chamber and the test chamber are combined together. After the initial test, the sample chamber and the test chamber can be separated. In some embodiments, the combined sample chamber and the test chamber are located together on a base 40, and the base and the combined sample chamber and the test chamber are also detachably combined. In other words, the sample chamber, the test chamber and the base are all detachable combinations. Figure 2-3As shown, the sample chamber 60 includes a chamber having an opening 606, which is used to insert a collector and collect liquid samples on the collector. The chamber has two insertion structures 601, 603, which extend outward from the wall of the chamber 60, similar to a protrusion, and there are two corresponding recesses 207, 208 next to the test chamber 30, which are mainly used to allow the protrusions 601, 603 of the sample chamber to be inserted, so that the sample chamber and the test chamber are connected together. In some embodiments, the recess 208 is located near the bottom of the test chamber, and the recess 208 is in fluid communication with the chamber of the test chamber. The protrusion 603 of the sample chamber includes a channel 607, one end of which is in fluid communication with the sample chamber, and the other end is in communication with the channel in the recess 208 or directly in three-dimensional communication with the test chamber. In this way, the liquid in the sample chamber can flow into the test chamber through the channel 607, contact with the test element located in the test chamber 30, and complete the initial detection. When the sample cavity is connected to the test cavity, the specific connection method is not expected to be seen from the outside, and a transitional protection area 20 is set between the sample cavity and the test cavity. The protection area can be directly connected to the test cavity 30 or directly connected to the sample cavity 60, so that the structure of the connection between the sample cavity and the test cavity is completely hidden. In addition, the sample cavity also includes a protrusion 602, which does not correspond to the depression on the test cavity, but is used to accommodate the cover body 203. When the sample cavity and the test cavity are connected together, the cover body is hung on the protrusion 602 and is also hidden by the transitional protection area 20. It can be understood that the protrusion 601 on the sample cavity 60 and the depression 207 on the test cavity 30 can be omitted, and the protrusion 603 with a channel on the sample cavity cooperates with the depression 208 on the test cavity, and the detachable combination of the sample cavity and the test cavity can also be completed. When the sample cavity and the test cavity are separated, the protrusion 603 on the sample cavity is separated from the depression 208 of the test cavity to achieve the separation of the two. After separation, since the channel 607 on the protrusion 603 is exposed, the cover body on the protrusion 602 can be removed, and the cover body is put on the protrusion 603, thereby sealing the channel 607 to prevent the liquid in the sample cavity from leaking or flowing to the outside to pollute the environment, which may cause pollution to the personnel operating the test. Of course, in order to allow the protrusion 603 to be inserted into the depression 208 on the test cavity to better play a connecting role, an elastic sealing ring 205 is provided on the protrusion. Contact with the elastic sealing ring can form a liquid seal between the protrusion 603 and the depression, and the liquid channel is connected to the test cavity, so that the liquid in the sample cavity can flow safely into the test cavity. In some embodiments, the test cavity has a cavity, which includes a carrier element 501, and a plurality of slots are provided on the carrier for accommodating the test element.The test cavity has a front 302 and a back 303, both of which are planar structures, surrounding a cavity. The carrier is inserted into the cavity through the opening 301 of the cavity, and then a sealing cover 502 is set on the test cavity. The cover is used to seal the opening 301 of the test cavity and limit the position of the carrier at the same time. Optionally, the carrier includes a channel 503, which extends from the sealing cover to the inside of the test cavity, so that the gas in the test cavity can maintain communication with the outside atmosphere through the channel 503, and it is convenient for the liquid in the sample cavity to enter the test cavity through the channel 607 without other pressure obstacles. The test cavity has a bottom 304, which is located in the groove 401 of the base 40, so as to maintain the stability of the test cavity. The base can be omitted here. The base is to make the entire test device stand during the test. The transition protection area 20 also has a top 201 and a bottom 202, the bottom is also located in the groove area 402 of the base 40, and the sample cavity is also located in the recessed area 403 of the base 40, so that the sample cavity, the test cavity and the transition area connecting the test cavity and the sample cavity are all located on the base. The base and the sample cavity 60 and the test cavity 30 are all combined in a detachable manner, and the base allows the sample cavity and the test cavity to be vertical. Figure 1-8 The covers 203 and 204 are actually the same cover, but are in different positions for distinction. Initially, the cover is located on the protrusion 602. When the sample cavity 60 is separated from the test cavity 30, the cover 203 is sealed on the protrusion 603 and the channel 607 is sealed.

[0085] like Figure 5-8As shown, the structure of the sample chamber and the structure of the collector are shown. In some embodiments, the sample chamber 60 is used to receive the collector and allow the collector to be inserted into the sample chamber and release liquid into the sample chamber. The sample chamber has two openings 606 and 611, wherein the opening 606 at one end is used to receive the insertion of the collector and is sealed by cooperating with the hand grip 101 of the collector, and the opening 611 at the other end is sealed by a cover 605. The cover 605 is threadedly engaged with the thread on the outer wall 610 of the opening 611 at one end of the sample chamber. In addition, a baffle 80 is also contained in the chamber, which is located in the sample chamber and close to the bottom of the sample chamber, so that a secondary confirmation chamber 608 is formed between the baffle 80 and the opening 611, and the chamber contains an absorption element 70, which is used to absorb the liquid sample in the sample chamber, and the secondary confirmation chamber 608 is in liquid communication with the test chamber through the liquid channel 607. The area of ​​the baffle 80 away from the opening 606 of the sample chamber is used to receive the insertion of the collector. The collector 10 includes a grip portion 101 and a connecting rod connected to the grip portion 101. An elastic sealing ring 104 is provided at the end of the connecting rod. A first absorption element 105 is provided at the lower part of the elastic sealing ring. The element is used to absorb the liquid sample, and the first absorption element can also be compressed. When the collector is inserted into the sample cavity, the baffle 80 contacts the first absorption element of the collector. As the collector is inserted into the sample cavity, the first absorption element is compressed to release the liquid. The baffle has an opening 801, and the liquid flows through 801 into the cavity 608 below the baffle. In some embodiments, the cavity 608 between the baffle and the opening 611 is completely occupied by the second absorption element (e.g., Figure 8), the baffle does not move, and the cavity 608 is also connected to the channel 607 on the protrusion 603, or the opening at one end of the liquid channel 607 is located between the baffle 80 and the opening 611 at one end of the sample cavity to form a secondary confirmation of liquid communication with the cavity 608. As the first absorption element 105 on the collector contacts the baffle and is compressed, the liquid released is firstly absorbed by the second absorption element 70. When the second absorption element is saturated, the excess liquid passes through the second absorption and flows into the bottom of the test cavity through the liquid channel 607. The excess liquid can only go out through one outlet, that is, the drainage capacity of the liquid channel 607 and flows out of the sample cavity. In order to allow the excess liquid to flow smoothly into the test cavity through the second absorption element via the liquid channel 607, the elastic sealing element 104 on the collector forms an airtight seal with the inner wall 609 of the sample cavity, so that the cavity for secondary confirmation is sealed. As the first absorption element is compressed, the elastic element 104 also moves together, so that a pressure is formed in the sealed space between the sealing element 104 and the sample cavity opening 611 (the opening is sealed by the cover body 605 at this time) (the volume of the sealed space 608 is constantly decreasing, while the pressure is increased, and the baffle is in the sealed space). The pressure causes the liquid squeezed from the first absorption element to flow into the second absorption element. When the second absorption element is saturated with absorption, the excess liquid is also subjected to the pressure and flows into the test cavity through the liquid channel 607. The test cavity has a channel 503 that maintains pressure communication with the outside world. In this way, there is a pressure difference between the sealed cavity 608 and the test cavity. The pressure difference allows the excess liquid to flow into the test cavity through the second absorption element and with the help of the liquid channel 607. Here, the secondary confirmation cavity 608 actually has two functions, one is to collect the liquid released by the compression of the absorption element on the collector, and the other is to act as an intermediary transmission. A part of the liquid is saturated and absorbed by the second absorption element in the secondary confirmation cavity 608, and the remaining liquid (which cannot be absorbed by the second absorption element) naturally flows to the test cavity through the liquid channel 607 and contacts the test element in the cavity to complete the initial test. Here, the volume of the saturated absorbed liquid of the second absorption element is smaller than the volume of the liquid released by the compression of the absorption element on the collector, so that there is excess liquid flowing to the test cavity.

[0086] When the test is completed, the sample chamber is separated from the test chamber, and the cover 203 on the protrusion 602 is engaged with the outside of the protrusion 603 to seal the liquid channel 607, and then the entire chamber 60 is separated from the base 40. Figure 6As shown, at this time, the collector 10 is located in the sample cavity 60, and the second absorption element is also located in the sample cavity. At this time, if a second confirmation test is required for the sample, the entire sample cavity can be sent to a professional laboratory for a second test. During the test, there are two ways. One way is to separate the cover 605 from the sample cavity, so that the second absorption element 70 is exposed. Since the second absorption element is absorbable and compressible, the second absorption element 70 can be compressed to release liquid for a second confirmation test. There are several ways to compress the second absorption element. One is to continue rotating the collector, and the collector continues to move downward in the sample chamber. At this time, the baffle 80 also moves. The movement of the baffle forces the second absorption element to be compressed, so that the second absorption element releases liquid due to compression. The released liquid can flow out from the liquid channel 607 (at this time, the cover 203 needs to be removed instead of the cover 605). The liquid that flows out can be used for secondary confirmation. The continued compression of the collector can be controlled, that is, the depth of the collector inserted into the sample chamber is controlled. The first insertion depth is to complete the initial detection, and the further insertion depth is longer, the compression of the second absorption element is completed and the liquid is released for secondary confirmation. This can be combined with Fig.13 To illustrate how the collector is controlled, the sample chamber also includes a control structure 13, which is located on the sample chamber entrance 121, similar to a small cavity 13 extending from the entrance of the sample chamber, so that the collector is inserted into the opening 132 of the control structure 13 and enters the sample chamber to complete the compression of the absorption element on the collector. When the controller 13 is removed from the sample chamber entrance for a second test, the collector can continue to move downward, move closer to the bottom of the sample chamber and may apply pressure to the second absorption element to release liquid for a second test. The controller can also be, for example Fig.16 The illustrated snap ring 700 can also achieve the above-mentioned objectives of the present invention.

[0087] Another way is to not remove the cover 203, but to remove the cover 605. The absorption element has a step 680 in the sealed cavity 608 in the sample cavity, with a large end 701 and a small end 702. The second absorption element fills the entire cavity 608. The large end 701 is compressed, and the surface of the compressed step cannot be compressed again, so the volume of the entire absorption element is reduced. The second absorption element 70 is saturated with liquid. When the large end 701 is compressed, the liquid released from the large end will naturally flow out through the small end 702 at the bottom and flow out from the opening 611 of the sample cavity, which can also be used for secondary confirmation testing. In the above method, the volume of the saturated liquid absorbed by the second absorption element is generally constant, that is, it can only absorb a certain volume of liquid to reach saturation and cannot absorb more liquid, and the volume of liquid absorbed by the first absorption element or the volume of liquid released by compression is greater than the volume of the saturated liquid absorbed by the second absorption element, so that there is excess liquid flowing into the test cavity for the initial test. In some embodiments, the space under the baffle is not completely occupied by the second absorbing element, and there is a space 781 between the second absorbing element and the baffle (with reference to Fig.19 ), the space is also connected to the fluid of the liquid channel 607. At this time, the baffle plate does not need to be moved. When the first absorption element of the collector is inserted into the sample chamber, the first absorption element contacts the baffle plate and is compressed to release the liquid sample. At this time, the liquid first flows into the space, and the second absorption element is first absorbed and saturated, and the excess liquid directly flows into the test chamber through the liquid channel 607. In this way, there is no obstruction from the second absorption element, and the liquid flows into the test chamber more smoothly. After the sample chamber leaves the test chamber 30 and the base 40, in order to complete the secondary confirmation test, the cover 605 can be removed, and a tool can be used to reversely apply pressure to the second absorption element, for example, a tool can be used to apply pressure to the position 611, thereby compressing the second absorption element, and the compressed and released liquid flows out from the liquid channel 607 for secondary testing. Of course, in order to better form a seal between the collector and the sample chamber, the collector may also include a second seal 103, which may also form an airtight seal with the inner wall of the sample chamber. In this way, when the collector is inserted into the sample chamber, the absorption element may be better compressed when the absorption element contacts the lever, and the liquid released by the absorption element may flow as much as possible into the secondary confirmation chamber below ( Figure 4 ).

[0088] Figure 9-13It is another specific embodiment. The device includes a sample chamber 12, a collector 90, a test chamber 70, and a base 11. The four parts are combined together to form an integral test device or system. Initially, the collector is packaged independently, and the sample chamber includes an opening 121, and the opening has a locking structure, such as a positioning and rotating locking, and the collector has a plug-in 910. When the plug-in is aligned with the opening of the locking hole 122, it is then rotated to fix the depth of the collector inserted into the sample chamber. The collector has two sealing elements, a sealing element 901 close to the cover body, and a sealing element 911 close to the first absorption element. The sealing element is snapped onto the groove 902, and the first absorption element 903 is located below the groove. In this embodiment, the carrier is composed of a whole panel, which has a certain thickness, and a groove 133 is opened in the panel, so as to divide the panel into two parts 131 and 132, and a plurality of grooves are opened in front of each panel, and these grooves are used to load the test element, and the sample application area of ​​the test element extends from the groove, and its end contacts the bottom 702 and 706 of the test cavity. The whole carrier is inserted into the test cavity 703, and the cover 80 is clamped on the panel 13, and the cover 80 also seals the opening of the test cavity. Generally, the cover is made of rubber material, so that it is convenient to assemble during production. There is a channel 81 on the cover 80 that is connected to the external atmospheric environment, which is to reduce the gas pressure generated by the compressed air when the collector enters the sample cavity or the discharge of the compressed air, so as to smoothly allow the liquid in the sample cavity to enter the bottom 706 of the test cavity. The test cavity 70 and the sample cavity can be formed in one piece, so that the collector can release liquid when inserted into the sample cavity, and the bottom of the sample cavity is connected to the bottom of the test cavity, and the liquid released by the collector can naturally flow to the bottom of the test cavity and contact the end of the sample application area located on the bottom, so as to perform the initial detection. During assembly, a sample cavity connected to the test cavity 703 is provided, one end of the test cavity is open 701, the other end is closed, and the sample cavity is connected to the bottom of the test cavity. Then a carrier 130 is provided, and a test element is loaded in the groove of the carrier. The end of the sample application area of ​​the carrier element is close to the bottom of the test cavity, so that the liquid entering the bottom of the test cavity contacts the sample application area, completing the initial test of the analyzed substance in the sample. A liquid channel 125 is also provided between the sample cavity and the test cavity. The liquid collected from the sample cavity is inserted into the collector, so that the liquid flows into the test cavity through the liquid channel 125 and contacts the test element to complete the initial test. If a secondary test is required, the plug 705 is removed (the plug seals the hole 704), and the liquid is directly sucked from the bottom of the test cavity through the hole 704 through the pipette to perform a secondary confirmation test. This is also achievable when a secondary test is desired immediately after the initial test, and sampling is convenient and quick.The sample sampler has a limiting structure 13, which has an opening 132 and an insert 131. The insert is inserted into the insertion port around the opening of the sample cavity. The insert can also be fixed with the thread of the collector. When testing is required, the entire collector and the limiting structure are used to collect liquid samples, and then inserted into the sample cavity. At this time, the absorption element can be squeezed to release the liquid. When the liquid is completely released, the limiting structure can be removed from the collector, and then the collector can be inserted into the sample cavity. The insertion depth is deeper, so that the absorption element can be completely compressed. Since the collector and the sample are in a sealed state, more liquid can be prompted to enter the test cavity. In this embodiment, the base 11 has a groove 111 for placing the test cavity, and the depression 112 is used to place the bottom of the sample cavity.

[0089] Figure 14-18 This is another specific embodiment of the present invention. In this specific embodiment, the sample chamber and the test chamber are an integrated structure, and the chamber for secondary confirmation and the sample chamber are respectively connected to the test sample fluid, and the secondary confirmation chamber is not located in the sample chamber, but is located on one side of the test chamber. Fig.14 As shown, this specific embodiment provides a test cavity 802, a sample cavity 102, and a cavity 803 for secondary confirmation. The sample cavity 102, the test cavity 802, and the cavity 803 for secondary confirmation are injection molded at one time, and cannot be separated, nor are they combined in a detachable manner. Specifically, the sample cavity is located on one side of the test cavity 802, and the cavity 803 for secondary confirmation is located on the other side of the test cavity 802. The test cavity contains a carrier 4, and the carrier has a plurality of grooves for accommodating test elements for initial testing, such as lateral flow elements. The test cavity has an opening 801 for inserting the carrier with the test element into the test cavity, and then the opening of the test cavity is sealed with a sealing cover 2. Similarly, the sealing cover 2 has a pipe 3 connected to the outside atmosphere to keep the inside of the test cavity connected to the outside atmospheric fluid. The cavity 803 for secondary confirmation is not used for secondary confirmation, but a second collector is inserted into the cavity 803, and the second collector has a second absorption element 809, two seals 808 and 807 connected to the collector, and a hand grip 806, and the left and right sides of the seals are sealed with the inner wall of the cavity 803. In this way, the second collector is inserted into the cavity 803 for secondary confirmation, so that the second absorption element 809 is located at the bottom of the cavity 803 for secondary confirmation, and the bottom of the cavity 803 is in fluid communication with the bottom of the test cavity 802 (such as Fig.15The collector is the same as the collector in the above-mentioned specific embodiment. The end of the rod 6 of the collector is provided with a sealing element 8. Under the sealing element is a first absorbing element 9 for absorbing the liquid sample. The collector for collecting the liquid sample in this embodiment can be referred to as the first collector. The first collector is the collector used for collecting the liquid sample for the first time and performing the initial test. Fig.14 And 15, the secondary confirmation cavity 803 has an opening 805 and a small notch 804, and the opening allows the second collector to be inserted into the cavity 803 and seal the opening. At the same time, the first sealing element 807 and the second sealing element 808 on the second collector cooperate with the inner wall of the secondary confirmation cavity 803 to form an airtight seal, mainly to prevent the liquid absorbed on the second absorption element 803 from volatilizing due to external temperature changes. The "volatilization" in this article mainly refers to the evaporation of the liquid in the absorption element due to changes in external environmental conditions, such as temperature changes (such as increases), and thus cannot be retained. In order to make the second collector more firmly fixed to the secondary confirmation cavity 803, there is a protrusion 815 on the collector, which cooperates with the notch 804 on the secondary confirmation cavity. Please refer to Fig.15As shown in the cross-sectional view, in the initial position, there is no first collector in the sample cavity 102, but there is a second collector in the secondary confirmation cavity. When testing, the first absorption element 9 of the first collector 5 is used to collect the liquid sample, and then inserted into the sample cavity 102, from the opening 101 of the sample cavity, and the first absorption element is compressed at the bottom of the sample cavity to release the liquid sample, and the liquid sample flows to the bottom 814 of the test cavity 802 through the liquid channel 805. A part of the liquid contacts the test element on the carrier in the test cavity 802 for the first detection, and another part of the liquid flows into the secondary confirmation cavity and is absorbed by the second absorption element 809 on the second collector and stored in the second absorption element 809. Of course, the so-called part is the liquid absorbed by the test element, and the liquid not absorbed by the test element can be absorbed by the second absorption element 809. It can be understood that the volume of the compressed liquid sample in the first collector is greater than the saturated absorption capacity of the second absorption element. For example, the first absorption element on the first collector is compressed and the volume of the released liquid is 2 ml, about 1 ml is used for the initial test, and the other 1 ml or 500 microliters is absorbed by the second absorption element of the second collector and stored in the second absorption element 809. When a secondary test is required, the second collector is directly taken out from the secondary confirmation cavity and the second collector is individually packaged in a container, similar to a small bottle, and delivered to the laboratory for secondary confirmation testing. During the test, the second absorption element 809 is compressed to release the liquid for secondary confirmation testing. As mentioned above, when an absorption element is used to store liquid, even if the amount of liquid is small, the secondary test can still be completed, especially when the test liquid is small, such as a saliva sample, the collection amount of the saliva sample is relatively small, and the saliva is relatively viscous. In this way, the absorption element is used to absorb the saliva sample to prevent the saliva sample from evaporating and drying. If a cavity without an absorption element is not used to collect saliva for secondary confirmation, the saliva may evaporate and dry up without an absorption carrier, making it difficult to conduct a secondary confirmation test. If a solution is added to dissolve the dried sample, the concentration of the sample will be diluted, and it may not be completely dissolved, making the secondary test result inaccurate.

[0090] Figure 16-19 This is another specific embodiment of the present invention. In this embodiment, the sample cavity contains a movable cavity, and the collector is inserted into the movable cavity. When the movable cavity is in the first position, the collector is inserted into the movable cavity to complete the compression and release of the liquid sample on the first collector. A part of the released liquid flows to the test cavity to complete the initial test, and the other part flows to the second absorption element in the sample cavity to be absorbed and stored. When a secondary test is required, the movable cavity is moved downward to compress the second absorption element to release the stored liquid sample for a secondary confirmation test. Fig.16 This is a combined test device of a specific embodiment of this embodiment. Like the above test device, it includes a test chamber 30 and a sample chamber 600. The test chamber and the bottom of the sample chamber are fluidically connected through a liquid channel 780. The test chamber contains a carrier 13, which includes a plurality of grooves 1303, wherein a test element, such as a lateral flow test element ( Fig. 20 ), the carrier is inserted into the test cavity, so that the end of the sample application area 405 of the test element is close to the bottom 785 of the test cavity, and then the opening 301 of the test cavity is sealed with a sealing cover 502. Similarly, the sealing cover body has a pipe 503 that allows the test cavity to maintain gas communication with the outside world, so that the gas pressure in the test cavity is consistent with or equal to the atmospheric pressure outside. A socket 208 is set on the side wall of the test cavity 30, and the socket 208 is connected to the plug 6003 of the sample cavity. The plug has a liquid channel 780, and the sample cavity 600 is kept in fluid communication with the test cavity 30 through the liquid channel, for example Fig.17 As shown, the test cavity may also include a socket 207, which is in the form of a recess and is set on the wall of the test cavity 30, and a plug-in 6001 is set on the sample cavity 600, and the plug-in can be inserted into the socket 207. On the one hand, the sample cavity 600 and the test cavity 30 are detachably connected, and on the other hand, a liquid channel 780 is set to connect the sample cavity 600 and the test cavity 30 ( Fig.19 ). The socket 208 is close to the bottom of the test cavity, while the socket 207 is close to the opening of the test cavity. In addition to the matching method of the socket and the latch, any other detachable method can be applied by the present invention, such as locks, buttons, hinges, and plug-in methods can all be adopted by the present invention, and only a liquid channel is set in the specific disassembly structure to connect the fluid in the sample cavity with the fluid in the test cavity. The connection between the socket 208 and the latch 6003 of the present invention is a detachable connection method on the one hand, and on the other hand, a liquid channel is set to connect the sample cavity and the test cavity. When it is necessary to separate the sample cavity from the test cavity, the latch 6003 of the sample cavity is detached from the socket 208, or the plug-in 6001 is detached from the socket 207 to achieve separation of the two.

[0091] In some embodiments, a protrusion 6002 may be provided on the sample cavity 600. The protrusion is not connected to the test cavity, but a sealing cover 6008 is provided on the protrusion. The cover seals the liquid channel 780 on the sample cavity when the sample cavity 600 is separated from the test cavity. In some embodiments, the movable cavity 721 is located in the sample cavity 600, and the bottom 782 of the movable cavity is close to the bottom of the sample cavity. A space is provided between the bottom of the movable cavity and the bottom of the sample cavity. The space is the secondary confirmation cavity, which is used to receive the liquid sample from the collector, and a part of the sample is absorbed by the second absorption element 716 located in the space, while another part of the sample flows into the test cavity through the transmission of the liquid channel for the initial test.

[0092] In some embodiments, the movable cavity 721 includes an opening 426, which is used to receive the insertion of the collector 10. In addition, a first sealing element 722 and a second sealing member 723 are provided on the outer wall of the cavity, and the sealing member cooperates with the inner wall 6010 of the sample cavity to form an airtight seal. A second sealing member 723 is provided near the bottom of the movable cavity, so that the bottom of the movable cavity and the bottom of the sample cavity form an airtight structure. In some embodiments, the bottom of the movable cavity has a hole 784. When the collector is inserted, the first absorption element 105 contacts the bottom of the cavity and interacts with each other. The liquid compressed and released by the first absorption element flows into the secondary confirmation cavity below through the opening. In some embodiments, the movable cavity has a first position and a second position in the sample cavity. The first position and the second position are controlled by a limiting structure. When the limiting structure is provided, the movable cavity is in the first position. If the limiting structure is removed, the movable cavity can be moved from the first position to the second position. In some embodiments, the limiting structure is a snap ring 700, which has an annular structure. The annular structure includes a notch 7003, which is clamped outside the movable cavity from the horizontal direction, and with the help of the opening of the sample cavity, the first fixed position of the movable cavity is limited. In order to fix the position of the movable cavity, a ring structure 724 is set near the outer wall of the movable cavity near the opening, thereby forming a snap ring area 725, and the snap ring is clamped in this area, so that the movable area is better fixed in the first position. In order to make the position of the snap ring match the entrance of the sample cavity, an interface 6006 and an edge raised area 6007 are provided at the entrance of the sample cavity. The area and shape of the raised area are just the curvature and height of the snap ring notch 7003, and the interface 6006 is the area for the grip area 7005 of the snap ring to be clamped. In this way, the snap ring is fixedly clamped on the outer wall of the movable cavity, and the position in the sample cavity is a fixed position without axial rotation. The initial position of the movable cavity 721 is as shown in Fig.19 and 16As shown, the movable cavity is now in the initial position. At this time, the cavity formed by the bottom 782 of the movable cavity and the bottom of the sample cavity is a secondary confirmation cavity, and the secondary confirmation cavity includes a second absorption element 716. This cavity is the same as the aforementioned embodiment. The cavity actually also has two holes connected to the outside world, one is the liquid channel 780, and the other is the hole 6004 at the bottom of the sample cavity, but the hole is not sealed by the cover body 6009. In addition, the second absorption element does not completely fill the entire secondary confirmation cavity, but partially fills it, and a space 781 is reserved between the bottom of the movable cavity and the upper end of the second absorption element. As shown Fig.19 As shown, when conducting a test, the collector is used to collect liquid samples, for example, the first absorption element 105 of the collector is used to collect the liquid sample, and the liquid sample is allowed to absorb saturation or a sufficient amount, and then the collector is inserted into the movable cavity, so that the seals 103 and 104 on the collector 10 form an airtight seal with the inner wall of the movable cavity, and then the first absorption element is compressed to release the liquid sample, and almost all of the liquid sample flows into the secondary confirmation cavity below through the hole 784 at the bottom 782 of the movable cavity. This is because the collector needs to be inserted into the movable cavity and form a sealing structure with the inner wall of the movable cavity, and also needs to move in the movable cavity so that the first absorption element on the collector contacts and is compressed with the bottom 782 of the movable cavity. In fact, when the collector is inserted into the movable cavity, the collector needs to compress the air in the space in the movable cavity during movement, so as to reduce its volume and increase the pressure of the gas. The so-called space here refers to the space sealed by the collector in the movable cavity, which also includes the space for the secondary confirmation sample. On the other hand, the first absorption element is compressed to release the liquid. In order to allow the liquid to flow smoothly into the secondary confirmation cavity, a small hole 784 is opened at the bottom of the movable sample cavity. The compressed and released liquid quickly passes through the small hole 784 and flows into the secondary confirmation cavity with the pressure. In some embodiments, the second confirmation sample cavity 782 contains a second absorption element. After the liquid released from the first absorption element is first absorbed and saturated by the second absorption element, the excess liquid is located in the space 782 and as the pressure in the second confirmation cavity 782 increases, the excess liquid is prompted to flow into the bottom 785 of the test cavity 705 through the liquid channel 780, and contact the test element at the bottom of the test cavity, completing the initial test of the liquid.

[0093] After the initial test of the liquid sample is completed, the sample cavity plug-in structure plug-in 6001 6003 is separated from the jack 207, 208 of the test cavity, so that the sample cavity is separated from the test cavity, and the cover 6008 is removed from the protruding structure 6002 and sealed on the plug-in containing the liquid channel 780, thereby sealing the entire cavity for the second confirmation. In fact, inside the collector's air-sealed movable cavity, the movable cavity air-sealed the inside of the sample cavity, and in the formed air-sealed space, only the liquid channel is connected to the test cavity, and the test cavity is connected to the outside atmosphere through the pipe 707. Therefore, the formed air-sealed space shrinks in volume and increases in pressure as the collector moves. The increased pressure will cause the excess liquid (the remaining liquid sample after being absorbed by the second absorption element 716) to flow only from the liquid channel 780 to the bottom of the test cavity, completing the initial test of the liquid sample. It is understood that the process of inserting the collector into the movable cavity and sealing the interior of the cavity to complete the compression of the first absorption element and release of the liquid does not take a long time, and is basically completed within a few seconds or tens of seconds. In some embodiments, a certain distance is allowed between the surface of the second absorption element and the bottom of the movable cavity, and the distance is not occupied by the second absorption element, such as Fig.19 As shown, when the second absorption element is saturated with the liquid sample, excess liquid flows into the space, and the space is fluidly connected to the liquid channel 780. As the collector moves, the pressure increases, and the pressure causes the liquid in the space to flow into the test chamber through the liquid channel 780 for preliminary testing or the first test.

[0094] When the initial test is completed, the sample cavity 600 can be separated from the test cavity. At this time, the sample cavity includes a movable cavity 721, a first collector 10, and a second absorption element located in the cavity 600. At this time, the insert 6003 containing the channel is sealed with a cover 6008. At this time, the entire secondary cavity is in a sealed state and can be transported to the laboratory for secondary confirmation testing. When a secondary test is required, it can be achieved in the following ways. The first way is to cover the cover 6008, so that the liquid channel 780 is connected to the external atmospheric environment, and then remove the limit ring 700, so that the movable cavity continues to move in the sample cavity, and apply pressure to the second absorption element 716, so that the second absorption element is compressed to release liquid. The released liquid increases the pressure of the compressed air during the downward movement of the movable cavity, and the pressure causes the liquid released from the second absorption element to flow from the liquid channel 780 to the outside, such as a test tube, for a secondary confirmation test. The second method is to not remove the cover 6008, but to remove the cover 6009 at the bottom of the sample chamber, and then compress the second absorption element, so that the released liquid flows out from the bottom of the sample chamber for secondary confirmation of the test. It can be understood that there is an opening 6004 at the bottom of the sample chamber 600, which is sealed by the cover 6009, and the second absorption element is in a T shape, and the second absorption element is fixed on the step of the T, so that when the movable chamber 721 moves downward, its bottom directly contacts the second absorption element and compresses the second absorption element, and the excess liquid passes through the lower part 788 of the second absorption element and flows out from the opening 786. In some embodiments, in order to make the first embodiment easier to implement, a protruding structure 789 is provided at the small hole 784 at the bottom of the movable cavity. The structure extends from the bottom to the surface close to the second absorption element. As the movable cavity 721 moves downward, the top of the extended structure first contacts the second absorption element. As the movable cavity 721 moves downward, the extended structure squeezes and compresses the second absorption element and releases liquid. The liquid is located in the space between the surface of the second absorption element and the bottom of the movable cavity. The space has a liquid channel 780 connected to the outside world. Therefore, the liquid flowing into the space will flow to the outside world through the liquid channel 780 for secondary confirmation testing. Of course, the extended structure can also be some protrusions extending from the bottom of the movable cavity toward the surface of the second absorption element. These protruding structures can also exert pressure on the second absorption element, thereby compressing the second absorption element to release the liquid sample for secondary confirmation.

[0095] Example 1 Effect of the storage of liquid samples with and without absorption elements of the present invention

[0096] See also Figure 4 and 5In the example shown, such a sample chamber 60 is provided, and a collector is used to absorb the saliva sample. The absorption element 70 of the collector is saturated with 2 ml of the saliva sample and then inserted into the sample chamber. Through the squeezing of the absorption element, a part of the liquid is absorbed by the second absorption element 70 (the saturated liquid absorbed is 0.8 ml), and the excess liquid sample flows out through the liquid channel 607. The volume of the saliva flowing out is 1.0 ml. After the excess liquid flows out, the liquid channel is sealed with the cover 204.

[0097] Correspondingly, the same structure is used, the only difference is that there is no second absorption element, and 0.8 ml of saliva sample is retained in the space 201 without the second absorption element. Equivalently, the same volume of saliva sample is absorbed and preserved by the second absorption element of the present invention in one way, and is not absorbed and preserved but remains in the cavity in another way, and the material of the second absorption element is polyester foam material.

[0098] The storage capacity of liquid samples under different conditions was investigated. The specific conditions are as follows: using the above-mentioned sample chamber, there are 5 for each treatment, and the average value is calculated. The sample chambers for each treatment are placed in different sealed containers, with 5 placed in each sealed container. The sealed container is connected to a negative pressure compression device, and the air is extracted to keep it under a constant negative pressure state for different periods of time, and the remaining amount of saliva sample under different conditions is measured. For direct measurements without a second absorption element, for those containing an absorption element, the absorption element is squeezed to see the volume of the released liquid. The specific results are shown in Table 1 below:

[0099] Table 1: Storage capacity of saliva samples in a sealed container under negative pressure and at room temperature.

[0100]

[0101]

[0102] From Table 1, it can be seen that under such negative pressure, the sample chamber containing the absorbent element can continue to hold the liquid sample, although it is reduced, mainly due to evaporation caused by negative pressure, while the liquid storage capacity without the absorbent element decreases rapidly. The reason for evaporation is that these seals cannot be very precise seals and evaporation can occur under negative pressure, causing the liquid volume to decrease. Negative pressure mainly simulates the transportation environment under air transportation.

[0103] Table 2: Capacity of storing liquids under negative pressure in sealed containers (45°C, 50% humidity)

[0104]

[0105]

[0106] From the results in Table 2, it can be seen that under the conditions of constant negative pressure, relatively high temperature and relatively dry environment, the ability of the absorbent element to retain liquid is more superior. Generally, the sample chambers of the liquid used for secondary confirmation are transported from the place of initial testing to the laboratory by air or freight. During the air transportation process, the liquid is in a negative pressure and dry environment, which can easily reduce the volatilization of the liquid, and sometimes even evaporates and dries up and cannot be used for secondary confirmation. The present invention uses an absorbent element to store samples, which can effectively avoid the evaporation of the liquid and can be used for secondary confirmation.

[0107] 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 fluid sample, the device comprising: A sample chamber for accommodating a collector, and a test chamber connected to the sample chamber fluid, wherein the test chamber includes a test element, and the test element is configured to detect an analyte in a fluid sample for the first time, the sample chamber and the test chamber are a detachable combination, and the collector includes a first absorption element for absorbing liquid and capable of being compressed.

2. The device according to claim 1, further comprising a cavity for secondary confirmation detection, wherein the cavity comprises a compressible second absorption element capable of absorbing the liquid sample.

3. The device according to claim 2, when the sample chamber contains a collector, the first absorption element of the collector can be compressed to release liquid, wherein the released liquid portion can flow into the cavity of the secondary confirmation test and be absorbed by the second absorption element.

4. The device according to claim 3, wherein the cavity for secondary confirmation detection is in fluid communication with the detection cavity, and the liquid sample absorbed by the second absorption element is used for secondary confirmation detection.

5. The device according to claim 4, wherein the volume of the saturated absorption liquid of the second absorption element in the secondary confirmation chamber is constant.

6. The device according to claim 5, wherein the volume of the liquid sample released by compression from the first absorption element is greater than or equal to the volume of the liquid saturatedly absorbed by the second absorption element.

7. The device according to claim 6, wherein the cavity for the secondary confirmation detection is located at the bottom of the sample cavity.

8. The device according to claim 7, wherein the cavity for secondary confirmation detection is fluidically connected to the detection cavity via a liquid channel.

9. The device according to claim 8, wherein the chamber for the secondary confirmation test is in fluid communication with the sample chamber through the test chamber and the liquid channel.

10. The device according to claim 9, wherein the second absorption element is arranged on an absorber with a handle, and the absorber can be moved away from the secondary confirmation cavity.

11. The device according to claim 7, wherein the sample chamber comprises a first protrusion containing the liquid channel, and the first protrusion is detachably connected to the first recessed interface of the detection chamber, so that the channel enables the sample chamber to be detachably connected to the test chamber.

12. The device according to claim 11, further comprising a cover on the sample chamber, wherein the cover is configured to seal the liquid channel when the sample chamber is separated from the detection chamber.

13. The device according to claim 3, wherein: When the sample chamber contains a collector, the collector seals the sample chamber, thereby making the secondary confirmation chamber airtight. In this way, if the movement of the collector can compress the secondary confirmation chamber, the gas in the secondary confirmation chamber is compressed and the pressure in the secondary confirmation chamber increases.

14. The device according to claim 13, wherein the sample chamber further comprises a movable cavity, the cavity being configured to receive the collector and allow the first absorption element to be compressed to release liquid, and the movable cavity has a first position and a second position in the sample chamber.

15. According to the device of claim 13, when the absorption element is compressed to release the liquid, the liquid flows into the secondary confirmation detection cavity, allowing the second absorption element to absorb the liquid, and the excess liquid flows into the detection cavity through the liquid channel to contact the test element to complete the test. At this time, the movable cavity is located in the first position.

16. According to the device of claim 15, when a secondary confirmation test is required after the collection chamber is separated from the test chamber, the movable chamber moves together with the collector to the second position, and the movable chamber compresses the second absorption element, thereby releasing liquid through the liquid channel, and the released liquid is used as a secondary confirmation test.

17. The device according to claim 16, wherein the test chamber comprises a carrier for carrying the test element, the test element is located on the carrier, wherein: The test cavity is communicated with the outside atmosphere.

18. The device according to claim 1, further comprising a base, wherein the test chamber and the sample chamber are located on the base and are assembled with the base in a detachable manner.

19. The device according to claim 1, wherein the substance to be analyzed is a small drug molecule.

20. The device according to claim 1, wherein the fluid sample is saliva, urine or blood.

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