Detection device and receiving device

Abstract

The present invention provides a device for detecting an analyte in a fluid sample and a receiving device for processing the fluid sample. The receiving device includes a receiving cavity, which contains a movable piercing element. The piercing element has a first position and a second position within the receiving cavity. A processing liquid for processing the fluid sample is included within the receiving cavity. By using the detection device or the receiving device of the present invention, sample processing and rapid acquisition of detection results can be achieved, which is particularly suitable for rapid detection of roadside drugs.

Description

[0001] This application claims the priority of a prior Chinese application with application number 201910699245.0 and filing date July 31, 2019; and a prior US provisional application with application number 62 / 880,777 and filing date July 31, 2019. Technical Field

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

[0003] The following introduction of background art is only an introduction of some common sense of background and will not constitute any limitation to the present invention.

[0004] Currently, detection devices for detecting whether a sample contains an analyte are widely used in hospitals or at home. These detection devices for rapid diagnosis include one or more test strips, such as early pregnancy detection. Such rapid diagnosis detection devices are very convenient and can obtain test results on the test strip in one minute or at most about ten minutes.

[0005] For example, the detection of saliva samples has been gradually accepted and welcomed by testing institutions or testers due to convenient collection. Various sample collection and testing devices for clinical or household use have been available and described in some literatures. 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 a subject and transfer the saliva to an indicating reagent. US Patents Nos. 5,576,009 and 5,352,410 each disclose a syringe-type fluid sampling device.

[0006] For example, in a US patent application with application number 14 / 893,461 and publication number US2016 / 0121322A1, a sample detection device is disclosed. This patent only discloses some basic detection schemes and principles, but it is relatively difficult to actually implement a specific product. For example, how the cover assembly and the detection assembly cooperate, how the washing head for sucking saliva is compressed and moves, and how to effectively mix with the liquid, and the actual effect is not ideal.

[0007] In view of the technical problems of the above-mentioned traditional products, it is necessary to improve them and provide additional ways to solve the deficiencies of the existing traditional technologies. Summary of the Invention

[0008] In view of the above situation, to overcome the deficiencies of the prior art, the object of the present invention is to provide a device for receiving and detecting an analyte in a fluid sample, and a receiving device for cooperating with the detecting device. The receiving device includes a cavity, and the cavity includes a liquid chamber for accommodating liquid and a piercing element that can move within the device. The "receiving" in the receiving device here does not limit the specific use of the device, and it can be called a liquid processing and mixing device, or a liquid sample transmission and transfer device, so it can be called a device.

[0009] In a first aspect of the present invention, there is provided a device, which includes a cavity for accommodating a processing liquid and a piercing element, and the piercing element can move within the device.

[0010] In some embodiments, the device includes a cavity, and within the cavity of the device, there is a sealed cavity for accommodating the processing liquid, and within the cavity, there is a piercing element that can move.

[0011] In some embodiments, the device includes a first chamber and a second chamber. The first chamber is used to accommodate the processing liquid, and the second chamber is arranged to accommodate all or part of the piercing element. In some embodiments, the first chamber is a sealed cavity, and the processing liquid is included in the sealed cavity. In some embodiments, the first chamber includes a sealed cavity, and the processing liquid is included in the sealed cavity. This is to place the processing liquid alone in a separate sealed cavity and then set the sealed cavity in the first chamber of the device. It can be understood that there is no so-called first chamber, and at the position of the first chamber of the device, there is a sealed cavity that contains the processing liquid.

[0012] In some embodiments, the piercing element includes a piercing structure, and this structure is arranged to pierce the first chamber of the device to release the processing liquid.

[0013] In some embodiments, the piercing element includes a cavity, and the cavity is arranged to transport, mix, convey, transfer, or process a fluid sample. In the cavity of the piercing element, the fluid sample can be mixed with the processing liquid, the processing liquid can flow into the cavity of the piercing element to contact the fluid sample, or still, through the cavity of the piercing element, the liquid (processing liquid, the mixed liquid of the processing liquid and the fluid sample, or the fluid sample) located in the cavity of the piercing element can be transported to the test element for detection or assay.

[0014] In some embodiments, the cavity of the piercing element is used to receive an absorption element, and the absorption element is arranged to absorb the fluid sample. In some embodiments, the cavity of the piercing element is arranged to mix the liquid sample from the absorption element with the processing liquid to form a mixed liquid. In some embodiments, the mixed liquid formed in the piercing cavity flows through the absorption element and into the test element for detection or assay.

[0015] In some ways, the piercing structure is disposed on or in the cavity of the piercing element.

[0016] In some ways, the cavity of the piercing element includes a first cavity and a second cavity. The first cavity is used to receive the processing fluid from the cavity containing the processing fluid, and the second cavity is used to receive the fluid sample. In some ways, the first cavity and the second cavity of the piercing element are in fluid communication, so that the fluid sample and the processing fluid are mixed in the first cavity or the second cavity to form a mixed liquid.

[0017] In some ways, the mixed fluid sample passes through the second cavity and is transported to the test element to test for the presence of the analyte in the fluid sample.

[0018] In some ways, the second cavity of the piercing element is used to receive an absorbent element, which is used to absorb and draw the fluid sample, such as fluid samples like saliva, urine, sweat, etc. When the absorbent element absorbs the fluid sample, the second cavity indirectly receives the fluid sample. In some ways, the absorbent element is squeezed in the second cavity, and the released fluid sample flows into the first cavity of the piercing element and mixes with the processing fluid from the first cavity of the device.

[0019] In some ways, the mixed liquid formed in the first cavity of the piercing element passes through the absorbent element in the second cavity and then flows to the test element for detection or assay.

[0020] In some ways, the movement of the piercing element is used to complete the mixing, transportation or flow of the liquid. In some ways, the piercing element moves in the device. During the movement, before the movement or after the movement, the processing fluid in the first sealed cavity of the device is allowed to enter the cavity of the piercing element, such as the first cavity. For example, the piercing element moves to allow the piercing structure to pierce the first sealed cavity containing the processing fluid, so that the processing fluid flows into the cavity of the piercing element. In some ways, the cavity of the piercing element is used to receive the absorbent element and compress the absorbent element to release the absorbed fluid sample into the cavity of the piercing element to mix with the processing fluid. This process can be carried out before, during and after the movement of the piercing element, or can be carried out simultaneously with the movement.

[0021] In some ways, the piercing element has a first position and a second position in the first cavity of the device. When the piercing element is in the first position, the piercing structure of the piercing element does not pierce the cavity containing the processing fluid. When the piercing element is in the second position, the piercing structure pierces the cavity containing the processing fluid.

[0022] In some ways, when the piercing element moves from the first position to the second position, or during the movement, the first cavity of the piercing element enters the first sealed cavity containing the processing liquid, such as the first cavity of the device. The first cavity of the piercing element entering the cavity containing the processing liquid forces the processing liquid into the first cavity of the piercing element. In some ways, the first cavity of the piercing element includes a hole or a through-hole, and the processing liquid enters the first cavity through this hole. In some ways, the second cavity of the piercing element receives the absorbent element, and before, during, or after the piercing element moves from the first position to the second position, the absorbent element is squeezed to release the fluid sample. The released fluid sample flows into the first cavity of the piercing element and mixes with the processing liquid.

[0023] In some ways, during or after the piercing element moves from the first position to the second position, the mixture (processing liquid, the mixture of processing liquid and fluid sample, or fluid sample) located in the first cavity of the piercing element returns to the second cavity of the piercing element, flows through the absorbent element and onto the test element. In some ways, the liquid that returns and flows through the absorbent element does not necessarily flow directly onto the test element, but into a container for subsequent detection or assay.

[0024] In some ways, the absorbent element is arranged on the sampler, and the sampler includes a connecting rod and the absorbent element. The sampler is inserted into the second cavity of the piercing element, and at the same time, the sampler pushes the piercing element from the first position to the second position. In some ways, the sampler is combined with the receiving element, and the receiving container has a connecting element, and the connecting element pushes the second cavity of the piercing element, so that the piercing element moves from the first position to the second position. The connecting element contacts the piercing element when the sampler is inserted into the second cavity of the piercing element.

[0025] In some ways, part of the piercing element is located in the second cavity of the device, and the first position and the second position are provided in the second cavity, or it can move from the first position to the second position. In some ways, the first cavity of the piercing element is located in the second cavity of the device, and the first cavity of the piercing element has the first position and the second position in the second cavity of the device, or it can move from the first position to the second position.

[0026] In some ways, the first chamber and the second chamber of the device are in a sealed state or are sealed, or the gas inside the first chamber and the second chamber of the device can be compressed to increase the air pressure. In some ways, the first chamber containing the processing liquid is in a sealed state, and the processing liquid is sealed in the first chamber. When the liquid is sealed, it is liquid sealing. In some ways, the second chamber of the device is sealed or the gas inside the second chamber can be compressed to increase the air pressure. In some ways, the piercing element or a partial piercing element seals the second chamber of the device. In some ways, the movement of the piercing element in the second chamber enables the gas inside the second chamber of the device to be compressed to cause the air pressure to rise. In some ways, the piercing element includes an elastic sealing ring, and the elastic sealing ring contacts the inner wall of the second chamber of the device to seal the second chamber of the device.

[0027] In some ways, the first chamber in the device is located downstream of the piercing element, the piercing element is located upstream of the first sealed chamber of the device, and the movement of the piercing element is from upstream to downstream to pierce the first chamber in the device. In some ways, the piercing structure is close to the first chamber of the device, the second chamber of the piercing element is far from the first chamber of the device, or the first chamber of the piercing element is between the second chamber of the piercing element and the first chamber of the device.

[0028] In some ways, the piercing structure of the piercing element is located on the first chamber of the piercing element. In another alternative way, the piercing structure is located on the outer wall at one end of the first chamber of the piercing element.

[0029] In some ways, the second chamber and the first chamber of the device are in a fluid communication state.

[0030] In some ways, the device includes a third chamber, and the inner wall of the third chamber has a threaded structure, which cooperates, engages, or meshes with the threaded mechanism of the connecting element, so that the receiving element and the device with the piercing element are combined together to form an integral structure.

[0031] In some ways, the piercing element includes a first cavity and a second cavity, and the first cavity and the second cavity are in fluid communication to form a fluid channel.

[0032] In some embodiments, the first cavity is used to receive the absorption element, and the second cavity is used to receive the fluid sample on the absorption element.

[0033] In some embodiments, the piercing element includes a small hole or a through hole, and the through hole communicates the first cavity and the second cavity of the piercing element.

[0034] In some embodiments, the inner diameter of the first cavity of the puncture element is smaller than the inner diameter of the second cavity. In some preferred embodiments, the inner diameter of the first cavity is smaller than the diameter of the liquid-absorbing absorption element. In other words, the first cavity substantially does not allow the absorption element to enter the first cavity. In other words, the second cavity is used to receive the liquid-absorbing absorption element, and the liquid-absorbing absorption element is not allowed to enter the first cavity as much as possible. Here, "not allowing" does not mean that it cannot be allowed. In some embodiments, the liquid-absorbing absorption element can be allowed to enter the first cavity in whole or in part. In this way, the absorption element is allowed to enter or be inserted into the second cavity of the puncture element, which facilitates the extrusion or compression of the absorption element. At the same time, in a preferred embodiment, the position of the puncture element can be moved by extruding or compressing the absorption element.

[0035] In some embodiments, the liquid absorbing element is in fluid communication with the test element of the detection device, which will be described in detail later. Thus, when the liquid absorbing element is compressed in the cavity of the puncturing element, the fluid sample flows out, and at this time the puncturing element punctures the liquid cavity containing the processing liquid, and the released liquid mixes with the fluid sample to form a mixed sample, or the processing liquid contacts the absorbing element to elute the analyzed substance on the absorbing element, so that the mixture flows into the cavity of the puncturing element and contacts the test element, which is set in the cavity of this puncturing element in advance. Alternatively, when the absorption element is compressed in the second cavity of the puncturing element, the fluid sample released by the absorption element flows into the first cavity of the puncturing element. At the same time, as the first cavity of the puncturing element enters the cavity liquid cavity containing the treatment liquid, the treatment liquid will enter the first cavity of the puncturing element to form a mixed liquid with the fluid sample; as the first cavity continues to enter the cavity liquid cavity containing the treatment liquid, the mixed liquid in the first cavity flows back into the second cavity again, and contacts the absorption element or passes through the absorption element to elute the absorption element to form a new mixed liquid, and the mixed liquid flows out of the puncturing case; optionally, it flows into a test element that is fluidically connected to the absorption element to perform testing on the substance to be analyzed.

[0036] In some embodiments, after the liquid absorption element is compressed, the mixed liquid enters a channel through the absorption element, and the channel connects the absorption element and the test element, thereby flowing into the test element through the channel. The channel is located in the connecting rod of the sampler. The mixed liquid passes through the absorption element. On the one hand, it can elute some adsorbed substances on the absorption element. On the other hand, after mixing with the liquid sample, it can improve the detection performance on the test element, such as improving the sensitivity or specificity of the detection. This is because some samples contain interfering substances that affect the detection performance, which are mixed with liquid to form a mixed sample to reduce interference. It is also possible that some substances (analyzed substances) are adsorbed on the absorption element by the absorption element, and these substances need to be eluted by liquid (such as a treatment solution) to improve the accuracy of the test.

[0037] In some ways, the cavity for containing the processing liquid includes a film that is easily punctured, such as a plastic film, double-sided tape, or aluminum foil film. This film seals the cavity containing the processing liquid and is thus easily punctured by a puncturing structure.

[0038] In some ways, the puncturing element can move within the cavity that houses the processing cavity, moving from a first initial position to a second position. In some ways, when the puncturing element is in the initial first position, the puncturing end of the puncturing element is near the film that is easily punctured and does not substantially puncture the film. Preferably, it is located above the puncturing film. Preferably, the puncturing end is in contact with the puncturing film.

[0039] In some preferred ways, there is a gap or clearance between the puncturing element and the cavity that houses the puncturing element, and this gap or clearance is used to receive a part of the detection device, such as a connecting element of the detection device. In some ways, there is a gap or spaced-apart space between the second cavity of the puncturing element and the third cavity of the receiving device, and this spaced-apart space facilitates the threaded engagement between the outer wall thread of the connecting unit and the inner wall thread of the third cavity.

[0040] In some ways, the detection device includes a detection element for detecting whether an analyte is present in a fluid sample. In some ways, the detection device includes an absorption element for absorbing the fluid sample. In some ways, the absorption element is detachably combined or cooperated with the detection element. This is very convenient for production and processing because the absorption element needs to be sterilized before collecting and absorbing the fluid sample, such as by high temperature or radiation sterilization. However, these steps will affect the chemicals of the test element. Therefore, before processing the absorption element, it can be separated from the test element, and after the processing is completed, it can be combined with the test element again, which is convenient for production and assembly and also reduces the adverse effects on the test element.

[0041] In some ways, the test element is disposed on a carrier that bears the test element, and the absorption element is detachably combined or cooperated with the carrier.

[0042] In another way, the test element can be located on a carrier, and the carrier is housed in a cavity that houses the carrier. In some ways, the absorption element is detachably combined with the test element through the cavity that houses the carrier, and this is an indirect detachable combination.

[0043] In some ways, there is a liquid flow between the absorption element and the test element, that is, the liquid can flow through the absorption element to the test element. This enables the test element to detect the analyte in the liquid sample absorbed by the absorption element. The absorption element is generally made of a material that can absorb liquid, such as sponge, filter paper, polyester fiber, etc.

[0044] In some ways, the absorption element forms a fluid communication with the test element through a connecting rod. Therefore, there is a fluid channel inside the connecting rod, connecting the absorption element and the test element or the carrier carrying the test element.

[0045] In other ways, the carrier carrying the test element is accommodated in a receiving cavity. The cavity for accommodating the carrier includes a space for receiving the carrier, and the cavity includes a connecting unit that can be connected to the aforementioned receiving device to complete the transfer of the liquid sample.

[0046] In a second aspect, the present invention provides a method for processing a fluid sample, the method comprising: providing a device that includes a cavity for accommodating a processing liquid and a piercing element that can move in the device, and moving the piercing element to pierce the cavity containing the processing liquid to release the processing liquid.

[0047] In some ways, the piercing element includes a cavity, and the released processing liquid enters the cavity of the piercing element.

[0048] In some ways, the absorption element is introduced into the cavity of the piercing element to contact the processing liquid, thereby forming a mixed liquid of the processing liquid and the fluid sample. The absorption element is squeezed in the cavity of the piercing element to release the fluid sample, and the fluid sample is mixed with the processing liquid in the cavity to form a mixed liquid (the first mixed liquid). In some ways, the formed mixed solution is allowed to flow back to contact the absorption element to form a new mixed solution (the second mixed liquid), and the new mixed solution is allowed to flow out of the piercing element. The solution flowing out of the piercing element is introduced onto the test element for detection or assay of the analyte.

[0049] In some ways, the device has a first sealed cavity for accommodating the processing liquid and a second cavity for accommodating part of the piercing element. The piercing element has a first position and a second position in the second cavity. The piercing element is moved from the first position to the second position, so that the piercing structure on the piercing element pierces the first cavity containing the processing liquid, and the processing liquid in the first cavity enters the cavity of the piercing element. In some ways, part of the cavity of the piercing element enters the first cavity containing the processing liquid. In some ways, the piercing element includes a first cavity containing a piercing structure and a second cavity for receiving the absorption element. The first cavity of the piercing element enters the first cavity including the processing liquid, forcing the processing liquid into the first cavity of the piercing element. In some ways, the second cavity of the piercing element receives the absorption element and compresses the absorption element to release the fluid sample, and the released fluid sample enters the first cavity of the piercing element to be mixed with the processing liquid to form a first mixed liquid. In some ways, the mixed solution enters the second cavity of the piercing element to contact or pass through the absorption element to form a second mixed liquid, and the second mixed liquid flows out of the piercing element and is introduced onto the test element.

[0050] In some ways, the absorbent element is inserted into the cavity of the piercing element, so that the absorbent element is compressed while pushing the piercing element to move from the first position to the second position. In some ways, the absorbent element is inserted into the second cavity of the piercing element and the absorbent element is compressed to release a fluid sample, and the released fluid sample flows into the first cavity of the piercing element. The absorbent element pushes the piercing element to move from the first position to the second position, so that the piercing element pierces the first cavity containing the processing liquid, and the first cavity of the piercing element enters the cavity containing the processing liquid, so as to force the processing liquid to enter the first cavity of the piercing element to mix with the fluid sample.

[0051] In some ways, the absorbent element is connected to a connecting rod, and the connecting rod has a channel for transporting liquid and is in fluid communication with the absorbent element. In some ways, the second cavity of the piercing element sealing device is sealed, and the second cavity and the first sealed cavity containing the processing liquid are in a sealed state. The absorbent element with the connecting rod is inserted into the second cavity of the piercing element and the second cavity is sealed, and the absorbent element is compressed in the second cavity while pushing the piercing element to move from the first position to the second position. During the movement, the sealed space of the device is compressed, increasing the internal gas pressure. As the first cavity of the piercing element enters the cavity containing the processing liquid, the increased gas pressure and / or the pressure of the first cavity of the piercing element entering the sealed first cavity on the liquid forces the processing liquid to enter the first cavity of the piercing element to mix with the fluid sample. Subsequently, the further increased pressure causes the mixed liquid to flow into the second cavity of the piercing element and pass through the absorbent element into the channel of the connecting rod, and finally flow to the test element. Here, the increased gas pressure can alone cause the mixed liquid to flow back to the absorbent element, so as to elute the absorbent element and flow out of the piercing element. As long as the piercing element pierces the first sealed cavity and the piercing element is directly and indirectly in communication with the first sealed cavity, the increased pressure can force the processing liquid to enter the cavity of the piercing element because there is a pressure difference between the cavity of the piercing element and the device whose pressure is increased due to compression.

[0052] In a third aspect, the present invention provides a detection device, which includes a test element, and the test element is arranged in a carrier, wherein the carrier includes a cavity, and the cavity is in fluid communication with an absorbent element.

[0053] In some ways, the carrier includes a card slot for arranging the test element, and one end of the card slot is connected to the opening of the cavity on the carrier. In some ways, the cavity includes an inflow inlet, and the fluid inlet is one end of a fluid introduction channel. In some ways, a drainage strip is arranged in front of the fluid inlet, one end of the drainage strip is arranged in front of the inflow inlet, and the other end is in contact with the test strip to achieve fluid drainage.

[0054] In some ways, the cavity is divided into a first region and a second region by a dividing structure, which is located near the fluid inlet. One end of the drainage strip is located in the first region between the inlet and the dividing structure, and the other end of the drainage strip contacts or overlaps with the test element. Preferably, the other end contacts or overlaps with the sample application region of the test element. In some ways, the second region is arranged to receive the excess fluid sample from the inlet. In some ways, a part of the sample application region of the test element is located on the opening of the cavity and contacts the drainage strip. The fluid sample here can be the fluid sample itself, or a mixture or mixed sample mixed with the treatment liquid, or the meaning of the sample defined in the present invention.

[0055] In some ways, the carrier includes a vent hole communicating with the outside atmosphere. Mainly, after the carrier is assembled, it is in a sealed space, and the cavity on the carrier is used to receive the liquid from the inlet channel. In one way, the inlet channel is connected to the connecting rod, and the connecting rod is connected to the absorbing element. When the absorbing element is inserted into the cavity of the aforementioned puncturing element, such as the first cavity, with the movement of the puncturing element, the fluid sample and the treatment liquid are transmitted into the cavity of the carrier. In order to reduce the resistance of the sealed cavity of the carrier, there is a vent hole communicating with the outside, which facilitates the rapid entry of the liquid into the carrier. As described above, when the puncturing element and the receiving device form a sealed space, a pressure difference can be formed between the sealed space and the cavity of the puncturing element. This pressure difference can allow the liquid after mixing the treatment liquid and the fluid sample to quickly enter the cavity of the carrier and flow onto the test element for the analysis or detection of the analyte.

[0056] In some ways, the detection device further includes a receiving element having a receiving cavity, which is configured to receive a carrier containing a test element. The main function of the receiving cavity is to facilitate the combination of the test carrier and the collector, facilitating assembly and operation. In some ways, the receiving cavity includes a slideway, and the carrier includes a slide rail matching the slideway, making it easy for the carrier to be inserted into the receiving cavity. In some ways, the directionality of the carrier inserted into the receiving cavity is determined or unique. Here, the directionality means that the carrier has a front (or front side) and a back side. Generally, the front side is a layer with a test strip, and the test strip is covered by a film. Generally, it is a transparent film, and the detection result of the test strip can be read by the naked eye or a machine. In this way, when the carrier is inserted into or assembled into the receiving cavity, the front side is always close to one side of the receiving cavity, and the back side is always close to the other side of the receiving cavity. Therefore, in some ways, the carrier includes a limiting structure, which allows the carrier to be inserted into the receiving cavity in only one direction. In some ways, the limiting structure is located on the back side of the carrier. In a more specific way, the slideway of the receiving cavity is composed of two tracks, and the two slide rails on the carrier are respectively constituted by the sides of the carrier, and the limiting structure is arranged between the slide rails. Through the cooperation of the slideway, the slide rails and the limiting block, the carrier can only enter the receiving cavity in one direction. Therefore, the carrier and the receiving cavity are combined in a detachable manner. In one way, the receiving element includes a connecting element, and the outer surface of the connecting element is provided with a threaded structure, which is in threaded cooperation with the internal thread of the third cavity of the device, facilitating the connection with the receiving device and realizing the transmission or transportation of liquid samples.

[0057] In some ways, there is a small hole between the connecting element and the receiving cavity for one end of the connecting rod to pass through, so that one end of the connecting rod is connected to the introduction channel on the carrier, and the other end is connected to the absorption element. In this way, the channel in the connecting rod is communicated with the introduction channel of the carrier, so that the solution from the absorption element can flow through the channel into the cavity of the carrier, and then flow to the test element through the diversion element. This connection is a detachable connection method.

[0058] In some ways, the connecting rod includes a protrusion, which cooperates with the inner wall of the connecting element to limit the position of the connecting rod inserted into the small hole more accurately. In some ways, the protrusion on the connecting rod is a ring-shaped protrusion, making the connecting rod coincide with the longitudinal axis of the connecting element. In some ways, one end of the connecting rod has a thread, and the introduction channel on the carrier has a thread, so that the thread of the connecting rod is in threaded cooperation with the thread of the introduction channel, so that the collector and the carrier are detachably combined. This combination method allows the absorption element with the collector and the test element to be treated separately before assembly.

[0059] In some ways, the collector is provided with an elastic sealing element, such as a sealing ring, the purpose of which is to cooperate with the cavity of the piercing element. When the absorption element is inserted into the cavity of the piercing element, the sealing ring cooperates with the inner wall of the cavity of the piercing element for sealing. Thus, when the absorption element is squeezed, the fluid sample on the absorption element will not leak outside the piercing element, but the fluid sample will flow into the cavity of the piercing element.

[0060] In a fourth aspect, the present invention provides a system for detecting an analyte in a fluid sample. The system includes the receiving device and the detecting device as described above. The detecting device is provided with a collector, and the collector includes an absorption element. In some ways, the collector is detachably combined with the detecting device. In some ways, the detecting device includes a test element, the test element is arranged on a carrier, and a cavity is included on the carrier for receiving the solution from the absorption element.

[0061] In a fifth aspect, the present invention provides a method for detecting an analyte in a sample. The method provides the detecting device and the receiving device as described above. The detecting device includes an absorption element, and the absorption element is in fluid communication with a test strip in the detecting device. The receiving device includes a first cavity for containing a processing liquid and a piercing element, and the piercing element includes a piercing structure and a cavity. Insert the absorption element into the cavity of the piercing element, thereby compressing the absorption element and releasing the fluid sample.

[0062] In some ways, collect the fluid sample with the absorption element on the detecting device, and then insert the absorption element into the cavity of the piercing element.

[0063] In some ways, move the piercing element in the receiving device and let the piercing element pierce the cavity containing the processing liquid, so that the processing liquid enters the cavity of the piercing element. In some ways, mix the processing liquid with the fluid sample to form a first mixed liquid. In some ways, let the first mixed liquid flow through the absorption element onto the test element of the detecting device.

[0064] In some ways, the piercing element has a first position and a second position in the receiving device. When the piercing element is in the first position, the piercing structure does not pierce the first cavity containing the processing liquid. When the piercing element is in the second position, the piercing structure pierces the first cavity containing the processing liquid.

[0065] In some ways, when the piercing element is in the first position, the absorbing element is inserted into the cavity of the piercing element and compressed, releasing a fluid sample into the cavity of the piercing element. In some ways, the detection device is used to push the piercing element from the first position to the second position, thereby piercing the sealed first cavity, allowing the processing liquid in the first sealed cavity to flow into the cavity of the piercing element and mix with the fluid sample to form a first mixed liquid.

[0066] In some ways, the piercing element forms a sealed space within the receiving device, and the sealed space can be compressed by the movement of the piercing element, thereby increasing the pressure within the sealed space. In some ways, the increased pressure forces the processing liquid in the first sealed cavity to flow into the cavity of the piercing element and mix with the fluid sample to form a first mixed liquid.

[0067] In some ways, the detection device is used to push the piercing element from the first position to the second position, thereby piercing the sealed first cavity, allowing the processing liquid in the first sealed cavity to flow into the cavity of the piercing element and contact the absorbing element.

[0068] Advantageous Effects

[0069] By adopting the above structure, detection with higher sensitivity can be achieved. At the same time, the absorbing element and the test element are detachably combined, reducing the assembly cost and also reducing the damage to different processed test elements. Brief Description of the Drawings

[0070] Figure 1 is a schematic exploded view of the structures of the receiving device and the detection device in a specific embodiment of the present invention.

[0071] Figure 2 is a schematic view of the structure with a test element carrier in a specific embodiment of the present invention.

[0072] Figure 3 is a schematic view of the structure with a test element carrier in another specific embodiment of the present invention.

[0073] Figure 4A is a three-dimensional exploded schematic view showing the positional cooperation of the drainage element and the carrier cavity after the test element carrier in a specific embodiment of the present invention is assembled.

[0074] Figure 4B is a three-dimensional structure schematic view of the test element carrier after being assembled in a specific embodiment of the present invention.

[0075] Figure 5 is a three-dimensional structure schematic view of the receiving element in a specific embodiment of the present invention.

[0076] Figure 6It is a three-dimensional structural diagram of the longitudinal section of the receiving element in a specific embodiment of the present invention.

[0077] Figure 7 It is a schematic diagram of the back structure of the carrier in a specific embodiment of the present invention.

[0078] Figure 8 It is a three-dimensional structural diagram of the carrier being assembled into the receiving cavity of the receiving element in a specific embodiment of the present invention.

[0079] Figure 9 It is a schematic diagram of the three-dimensional partial sectional structure after the carrier is inserted into the receiving structure in a specific embodiment of the present invention.

[0080] Figure 10 It is an exploded structural diagram of the detection device in a specific embodiment of the present invention.

[0081] Figure 11 It is a schematic diagram of the structure of the detection device with a collector in a specific embodiment of the present invention.

[0082] Figure 12 It is a schematic diagram of the cooperation structure of the collector, the test element and the drainage element in a specific embodiment of the present invention.

[0083] Figure 13 It is a three-dimensional structural diagram of the receiving device or the receiving cup in a specific embodiment of the present invention.

[0084] Figure 14 It is an exploded three-dimensional sectional view of the various components of the receiving device or the receiving cup in a specific embodiment of the present invention.

[0085] Figure 15 It is a three-dimensional sectional view of the receiving device or the receiving cup (the piercing element is in the initial first position) in a specific embodiment of the present invention.

[0086] Figure 16 It is a three-dimensional structural diagram of the piercing element with a cavity in a specific embodiment of the present invention.

[0087] Figure 17 It is a sectional structural diagram of the piercing element in a specific embodiment of the present invention.

[0088] Figure 18 It is a sectional structural diagram before the test device is inserted into the receiving device in a specific embodiment of the present invention.

[0089] Figure 19In a specific embodiment of the present invention, it is a schematic cross-sectional view (containing a processing solution) of a test device (an absorption element absorbs a fluid sample) before being inserted into a receiving device.

[0090] Figure 20 In a specific embodiment of the present invention, it is a schematic cross-sectional view of the test device inserted into the cavity of the piercing element in the receiving device with the absorption element being squeezed, and the piercing element is in the first initial position.

[0091] Figure 21 In a specific embodiment of the present invention, it is a schematic cross-sectional view of the piercing absorption element being moved from the first position to the second position by a connecting element when the test device is inserted into the cavity of the piercing element in the receiving device (the piercing structure pierces the cavity containing the processing solution and partially enters the cavity).

[0092] Figure 22 In a specific embodiment of the present invention, it is a schematic cross-sectional view of the piercing absorption element being moved from the first position to the second position by a connecting element (the first cavity of the piercing structure is inserted into the cavity, the processing solution enters the first cavity, mixes with the fluid sample, and then flows through the absorption element into the test element).

[0093] Figure 23 It is a schematic structural principle view (initial position of the moving element) in a specific embodiment of the present invention.

[0094] Figure 24 It is a schematic structural principle view (the moving element moves and the air pressure in the closed space increases) in a specific embodiment of the present invention.

[0095] Figure 25 It is a schematic structural principle view (liquid flows out) in a specific embodiment of the present invention.

[0096] Detailed description

[0097] The following further describes the structures involved in the present invention or the technical terms used herein. If not specifically specified, they are understood and interpreted according to the general terms commonly used in the art.

[0098] Detection

[0099] Detection means assaying or testing whether a substance or material is present, such as, but not limited to, chemical substances, organic compounds, inorganic compounds, metabolites, drugs or drug metabolites, organic tissues or metabolites of organic tissues, nucleic acids, proteins or polymers. Additionally, detection means testing the quantity of a substance or material. Further, assay also means immunoassay, chemical assay, enzyme assay, etc.

[0100] Sample

[0101] The detection device of the present invention or the collected sample includes biological liquids (such as case liquids or clinical samples). Liquid samples or fluid samples can be derived from solid or semi-solid samples, including excreta, biological tissues, and food samples. Any suitable method can be used to convert solid or semi-solid samples into liquid samples, such as mixing, mashing, macerating, incubating, dissolving, or digesting solid samples by enzymatic action in a suitable solution (such as water, phosphate solution, or other buffer solutions). "Biological samples" include those derived from animals, plants, and food samples, such as urine, saliva, blood and its components, cerebrospinal fluid, vaginal secretions, sperm, feces, sweat, secretions, tissues, organs, tumors, cultures of tissues and organs, cell cultures, and media derived from humans or animals. Preferably, the biological sample is urine, and preferably, the biological sample is saliva. Food samples include food processing substances, end products, meat, cheese, wine, milk, and drinking water. Plant samples include those derived from any plant, plant tissue, plant cell culture, and media. "Environmental samples" are derived from the environment (for example, liquid samples from lakes or other water bodies, sewage samples, soil samples, groundwater, seawater, and waste liquid samples). Environmental samples can also include sewage or other wastewater.

[0102] Using a suitable detection element or test element of the present invention, any analyte can be detected. Preferably, the present invention is used to detect small drug molecules in saliva and urine. Of course, the collector of the present invention can collect any of the above forms of samples, whether initially solid or liquid, as long as these liquids or liquid samples can be absorbed by the absorption element. Here, the absorption element 107 is generally made of a water-absorbing material and is initially dry. Through the capillary or other properties of the absorption element material, it can absorb liquid samples or fluid samples and keep the fluid samples in the absorption element. The absorption material can be any material that can absorb liquids, such as sponges, filter papers, polyester fibers, gels, non-woven fabrics, cotton, polyester film, yarns, and so on. Of course, the absorption element does not necessarily have to be made of a water-absorbing material. It can be made of a non-water-absorbing material, but there are pores, threads, or cavities on the absorption 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 pores to collect the samples. Of course, optionally, the absorption element can be composed of some non-water-absorbing fibers or hairs, and these materials are used to scrape a solid, semi-solid, or liquid sample so that these samples are retained on the absorption element.

[0103] Downstream and upstream

[0104] Downstream or upstream is divided according to the direction of liquid flow. Generally, liquid or fluid flows from upstream to downstream areas. The downstream area receives liquid from the upstream area, and the liquid can also flow along the upstream area to the downstream area. Here, it is generally divided according to the direction of liquid flow. For example, on some materials that use capillary force to promote liquid flow, the liquid can overcome gravity and flow in the direction opposite to gravity. At this time, the upstream and downstream are still divided according to the direction of liquid flow. For example, in the detection device 102 of the present invention, when the absorption element absorbs a fluid sample or a liquid sample, the fluid can flow from the absorption element 107 to the sample application area 1121 of the test element 112. At this time, the flow of the liquid from the sample application area 1121 to the absorption area is from upstream to downstream. During the flow process, it passes through the test area 1122, and there are a detection area 1126 and a detection result control area 1125 on the test area. The test area can be a polyester fiber film, and the sample application area can be a glass fiber. At this time, the absorption element 107 is upstream of the sample application area of the test element.

[0105] Of course, the upstream and downstream here can also be the trajectory or direction of the movement of an object, rather than the direction of liquid flow. For example, Figures 19 - 22 the piercing element is moved from upstream to downstream as shown in. At this time, the cavity containing the processing liquid is basically stationary, and the movement of the piercing element is a top-down movement and gradually approaches the cavity containing the processing liquid. For example, it pierces the sealed cavity containing the processing liquid and continues to enter the sealed cavity. The direction of the piercing movement and the processing liquid or fluid sample can be in the opposite direction, which can be the opposite of the whole process or only part of the process. For example, the piercing element moves from top to bottom, while the processing liquid or fluid flows in the direction opposite to the movement direction of the piercing element. Another example is that the piercing element moves from top to bottom, and the fluid sample initially flows from top to bottom (in the piercing element). As the piercing element continues to move, after the fluid sample is mixed with the processing liquid, it can flow in the direction opposite to the movement of the piercing element.

[0106] Gas connection or liquid connection

[0107] Gas connection or liquid connection means that liquid or gas can flow from one place to another, and some physical structures may play a guiding role during the flow process. The so-called passing through physical structures generally means that the liquid passes through the surface of these physical structures or the internal space of these structures and flows passively or actively to another place. Passive flow is generally caused by external forces, such as the flow under capillary action and air pressure. The flow here can also be due to the action of the liquid or gas itself (gravity or pressure), or it can be passive. The fluid under air pressure can flow in the forward direction, in the reverse direction, or the air pressure can cause the fluid to flow from one position to another. The connection here does not necessarily mean that there must be liquid or gas present. It only indicates the connection relationship or state between two objects in some cases. If there is liquid present, it can flow from one object to another. This refers to the connected state of two objects. On the contrary, if there is no liquid connection or gas connection state between two objects, and if there is liquid in or on one object, the liquid cannot flow into or onto the other object. Such a state is non-connection, a state of non-liquid or non-gas connection.

[0108] Detachable combination

[0109] A detachable combination refers to the connection relationship between two components being in several different states or positional relationships. For example, when the two components are physical components, they can initially be separated. When in a suitable first situation, they are connected or combined together. When in a suitable second situation, the two components can be separated, and this separation is a physical spatial separation without contact. Or, the two components are initially combined together, and when in a suitable situation, the two components can form a physical spatial separation. Or, the two objects are initially separated, combined together when needed to complete a certain function, then separated again, or later combined together again for a certain purpose. In short, the combination of the two or the separation between them can be easily carried out, and this combination or separation can be repeated multiple times in a cycle. Of course, it can also be a one-time combination and separation. In addition, it can be a detachable combination between two components, or a pairwise detachable combination between three or more components. For example, there are a first, a second, and a third component. The first component and the second component can be detachably combined, the second component and the third component can also be detachably combined, and the first component and the third component can also be detachably combined or separated. In addition, the combination method can be that the two objects themselves are detachable, or they can be indirectly combined through other objects. Here, the absorption element 107 can be detachably combined with the test element 112, and this detachable combination can be direct or indirect, which will be described in detail below. The carrier 111 with the test element and the cavity of the receiving element are also a kind of detachable combination. In this way, their combination forms a detection device, but after being disassembled, they can each have their own uses. In the present invention, after the absorption element and the test element are separated, the absorption element can be sterilized alone, such as by high temperature, X-ray, radiation sterilization, etc. After the sterilization is completed, it is combined with the test element again. In this way, fluid communication can be formed between the absorption element and the test element, so that the liquid from the absorption element can flow from the absorption element to the test element.

[0110] Test element

[0111] Here, the so-called "test element" refers to any element that can detect whether a sample or specimen contains an analyte of interest, and such detection can be based on any technical principle, such as immunology, chemistry, electrochemistry, optics, molecular science, nucleic acids, 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.

[0112] Various test elements can be combined and used in the present invention. One form is a test strip. The test strip for analyzing an analyte (such as a drug or a metabolite indicating a physical condition) in a sample can be in various forms, such as in the form of immunoassay or chemical analysis. The test strip can adopt a non-competitive or competitive analysis mode. Generally, the test strip includes a water-absorbing material with a sample loading area, a reagent area, and a test area. A fluid or liquid sample is added to the sample loading area and flows to the reagent area by capillary action. In the reagent area, if the analyte is present, the sample binds to the reagent. Then the sample continues to flow to the detection area. Some other reagents, such as molecules specifically binding to the analyte, are immobilized in the detection area. These reagents react with the analyte (if present) in the sample and bind the analyte in this area, or bind to one of the reagents in the reagent area. A marker for displaying the detection signal is present in the reagent area or a separate marker area.

[0113] In a typical non-competitive analysis mode, if the analyte is present in the sample, a signal will be generated, and if it is not present, no signal will be generated. In the competitive method, if the analyte is not present in the sample, a signal is generated, and if the analyte is present, no signal is generated.

[0114] The test element can be a test strip, and a water-absorbing or non-water-absorbing material can be selected. The test strip can include various materials for liquid sample transfer. One material of the test strip can cover another material, such as filter paper covering a nitrocellulose membrane. One or more materials can be selected for one area of the test strip, while one or more other different materials can be selected for another area. The test strip can be adhered to a certain support or a hard surface to improve the strength of holding the test strip.

[0115] The analyte is detected through a signal generation system. For example, one or more enzymes that specifically react with this analyte are used. By using the method of immobilizing specific binding substances on the test strip as described above, a composition of one or more signal generation systems is immobilized in the analyte detection area of the test strip. The substance generating the signal can be in the loading area, the reagent area, or the detection area, or throughout the test strip, and this substance can fill one or more materials of the test strip. A solution containing the signal substance is added to the surface of the test strip or one or more materials of the test strip are immersed in the solution containing the signal substance. The test strip added with the solution containing the signal substance is dried.

[0116] The various zones of the test strip can be arranged in the following manner: sample application zone, reagent zone, detection zone, control zone, zone for determining whether the sample is adulterated, and liquid sample absorption zone. The control zone is located after the detection zone. All the zones can be arranged on a single test strip made of only one material, or different zones can use different materials. Each zone can be in direct contact with the liquid sample, or different zones can be arranged according to the flow direction of the liquid sample, with the end of one zone connected to and overlapping the front end of another zone. The materials used can be materials with good water absorption properties such as filter paper, glass fiber, or nitrocellulose membrane, etc. The test strip can also be in other forms.

[0117] The commonly used reagent strip is usually 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 result; it can also be an acetate cellulose membrane or a nylon membrane, etc. For example, some reagent strips or devices containing reagent strips described in the following patents: US 4857453; US 5073484; US5119831; 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 6306642; US6352862; US 6372515; US 6379620; and US 6403383. The test strips and similar devices with test strips disclosed in the above patent documents can all be applied to the test element or detection device of the present invention for detecting the analyte, such as detecting the analyte in the sample.

[0118] The detection reagent strip applied to the present invention can be the commonly referred to lateral flow test strip. The specific structures and detection principles of these detection reagent strips are well-known technologies to those of ordinary skill in the art in the prior art. Ordinary detection reagent strips ( Figure 2) which includes a sample collection area or a sample loading area 1121, a labeling area (not shown), a detection area, and an absorption area. The sample collection area includes a sample receiving pad, the labeling area includes a labeling pad, and the absorption area may include an absorption pad. The detection area includes necessary chemical substances for detecting whether the analyte is present, such as immunoassay reagents or enzyme chemical reagents. Commonly used test strips are nitrocellulose membrane test strips, that is, the detection area includes a nitrocellulose membrane, and specific binding molecules are immobilized on the nitrocellulose membrane to show the detection result area; it can also be a cellulose acetate membrane or a nylon membrane, etc.; of course, downstream of the detection area, a detection result control area 1125 may also be included. Usually, the control area and the detection area appear in the form of a horizontal line, as the detection line 1126 or the control line 1125. Such a test strip is a traditional test strip. Of course, it can also be other types of test strips that utilize capillary action for detection. In addition, generally, the test strip has dry chemical reagent components, such as immobilized antibodies or other reagents. When encountering a liquid, the liquid flows along the test strip by capillary action. As it flows, the dry reagent components dissolve in the liquid, and then react with the dry reagents in the next area to perform necessary detections. The liquid flow mainly occurs through capillary action. All of these can 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 whether the analyte exists or the quantity of the analyte present in the liquid sample entering the detection chamber.

[0119] In addition to the above test strip or lateral flow test strip itself being used to contact the liquid sample to test whether the analyte is present in the liquid sample.

[0120] The test element of the present invention itself can be used as a detection device to detect the analyte in the sample. Therefore, the detection device itself is equivalent to the test element here. For example, after the fluid sample is mixed with the treatment liquid, it is directly detected using the test element. There will be specific descriptions below. When describing the receiving device for treating the fluid sample, the test element can be used alone for detection.

[0121] Carrier element

[0122] In some specific ways, the test element can also be arranged on some carrier elements. In this way, the carrier element contains the test element to complete the abbreviation and assay of the analyte in the fluid sample. Therefore, in some ways, the detection device includes a carrier, and the test element is arranged on the carrier. Such as Figure 2As shown, for example, on some carriers 111, generally one or more grooves are provided on the carrier, and the test elements are located in the grooves. The carrier generally has a front side and a back side, and the test elements are located on the front side of the carrier. The number of grooves is not limited. Generally, one test element is located in one groove. Usually, one test element can detect one analyte in the sample. Of course, one test element can simultaneously detect one or more, one or more analytes. In some ways, the carrier 111 includes a cavity 1116 with an opening. There is a recessed area near the groove area to form the cavity 1116. The horizontal position of the opening 1114 of the cavity is substantially in the same plane as the bottom of the groove area where the test element is provided. In some ways, the length of the groove is less than the length of the test element. So when the test element is set in the groove, a part of the test element hangs over the opening 1114 of the cavity 1116 (as Figure 4A shown). The cavity 1116 includes a dividing element that divides the cavity 1116 into a first region and a second region. The dividing structure is similar to a baffle 1119. The baffle is located in front of the liquid inlet channel entrance 1117 on the carrier. However, the baffle does not cross the entire cavity, but leaves gaps (not shown) on both sides of the cavity, that is, the width of the baffle is less than the width of the cavity. So when the liquid flowing in through the liquid inlet channel entrance 1117 can flow through the gaps into the second region of the cavity. Of course, it can also be that the width of the baffle 1119 is the same as the width of the cavity, and the height of the baffle is less than the depth of the cavity. In this way, the excess liquid can overflow the baffle and flow into the second region for storage. In some ways, the baffle 1119 divides the cavity 1116 into a first region between the baffle 1119 and the entrance of the diversion channel, and the rest is the second region 1120 of the cavity. The second region is mainly used as a fluid sample buffer region. When the excess liquid flows into the cavity 1116, in addition to a part flowing into the test element, the other excess part can flow into the second region 1120. The cavity is generally in the shape of a cuboid. Of course, it can be other shapes, such as a cube or a cylinder. In some ways, a diversion element 113 is also provided on the carrier 111. The diversion element 113 connects the inlet channel entrance 1117 and the test element, or the sample addition area 1121 of the test element. For example, one end 1131 of the diversion element is set in the first region between the baffle 1119 and the channel entrance 1117, and the other part overlaps or covers part of the sample addition area 1121. In this way, once the liquid from the entrance of the diversion channel (or the liquid inlet) enters the carrier, it directly contacts the diversion element, and thus the liquid is diverted to the test element through the diversion element.

[0123] A baffle, a dividing element or a dividing structure is provided in front of the channel inlet. This is mainly to prevent the impact on the drainage element when the volume of the liquid sample flowing in through the liquid inlet is large or the inflow speed is fast. It can prevent the drainage element from being washed away or deformed by the impact, so as to achieve a stable diversion effect. The drainage element is generally a water-absorbing material, such as in the form of a glass fiber sheet. If there is excess sample, it can flow into the second region of the cavity 1116, and the second region plays a role in diverting. Because too much liquid sample flowing through the drainage element 113 to the sampling area will cause a "flood" of the test strip, so this reduces the flood phenomenon. In addition, the drainage element 113 also plays a role in alleviating the fluid impact. Because once liquid enters the channel inlet 1117, the first thing it contacts is the drainage element 113, and the drainage element can also play a role in blocking the liquid, thus delaying the liquid from entering the second region of the cavity. If the operation methods are different or the force inserted into the puncturing element is different, sometimes the speed of the liquid flowing into the carrier is fast and the impact force is large. The drainage plays a role in weakening the impact force, so that the liquid does not flow into the cavity in a "spray" form. If the liquid volume is relatively large, it will flow to the second region. The inflow method can be through the gap between the baffle and the cavity, or directly overflow the baffle and flow into the second region. In addition, the drainage element can guide the fluid flow to the area of the drainage element covering the test strip, so that the amount of liquid samples obtained by multiple test strips is basically the same. There is a slit between the baffle 1119 and the channel inlet 1117, which allows a part of the drainage element to be located between the baffle and the liquid inlet. One is the diversion effect, and in addition, the baffle is to prevent the position change of the drainage element 113. The drainage element is generally made of flexible filter paper, glass fiber and other materials. Under the impact of the liquid at the liquid inlet, if the position changes, it will affect that the guided liquid may not be evenly distributed to multiple test elements. In such as Figure 2 and Figure 3 and Figure 4A The method of the drainage element in further enhances the stability of the drainage element 113. If there is excess sample, it will flow to the concave area below the sampling area 1121 to gather, so as to avoid too much sample flowing onto the test strip 112. Of course, other forms of drainage elements, such as "T", "L" or any form, are also possible. The above are some preferred solutions of the present invention. Of course, without the concave area or cavity, without the baffle, without the drainage element, as long as the channel inlet 1117 is in fluid communication with the test element, it is also possible to realize the test of the analyte in the sample( Figure 2)。In order to better reduce the impact of the liquid, the first region can be made narrow so that only the diversion element can be inserted into this narrow region, with one end 1131 of the diversion element almost covering the fluid inlet, and the partition plate serves to fix the position of the diversion element, reducing the impact deformation on the diversion element; in other words, the width of the first region can be made equivalent to the thickness of the fluid element 131, which can also serve to fix the fluid element.

[0124] In some ways, after the test element is set in the groove of the carrier, a transparent or partially transparent film 114 is covered on the carrier. One is to seal the groove area of the carrier and the opening of the cavity. In addition, the transparent film is easy to observe the test results on the final detection area. The transparent film can also be a transparent plastic sheet, as long as it is transparent only in the test area 1122. Covering the entire carrier in the form of a film basically places the test element 112 and the cavity 1116 in a sealed space, preventing the test element from getting wet during packaging and transportation and affecting the test performance. In this way, when the liquid introduced through the inlet channel enters the carrier, for example, into the cavity 1116 on the carrier, the liquid occupies a certain space in the cavity or the carrier, compressing the originally existing air, which is not conducive to the smooth entry of the liquid. Therefore, in some ways, there are some notches 1118, 11181, etc. at the edge of the cavity 1116. When the film is covered, through holes are formed, so that the excess gas or air is discharged outside the carrier, keeping the air pressure inside the carrier the same as the external air pressure, facilitating the easy entry of the liquid into the carrier. This will be described in detail later. In some preferred ways, for example, when the absorption element 107 of the collector is inserted into the cavity of the piercing element 106, the cavity of the piercing element can be in fluid communication with the cavity 1116 on the carrier. In this way, the cavity of the piercing element communicates with the outside, keeping the air pressure inside the cavity of the piercing element the same as or not much different from the external air pressure, even the same or almost substantially the same.

[0125] Receiving element

[0126] In some ways, if the carrier and the absorption element are directly connected, during operation, it is still not very convenient and safe because it is not operated by people with specialized training in a professional laboratory. The users are all people with little testing experience. During sample collection or operation, it is not very user-friendly and may damage the test strip. For example, the places where the hands hold the test strip are different. Fingers may press or touch the test strip, which may have a negative impact on the test strip and affect the final test result. In addition, the absorption element needs to be inserted into the receiving device to squeeze the absorption element, and at the same time, force is required to push the puncturing element to move. In addition, a series of actions such as releasing the liquid in the solution chamber to mix with the sample, if only relying on the carrier itself to complete, although it can be completed, it is still not safe enough and the operator needs to be particularly careful. Therefore, on the one hand, in some ways, the detection device further includes a receiving element, which includes a receiving cavity 1104 for receiving the carrier 18 with the test element. The shape of the receiving cavity is similar to the overall shape of the carrier. In a specific embodiment, the carrier of the present invention is in the form of a cuboid, and the receiving cavity 1104 is also generally rectangular and has an upper surface 1102 or a back surface 1107. In some ways, the upper surface 1102 of the receiving cavity is transparent, and the test result of the test element on the carrier can be read through the transparent part, for example, by the naked eye or an electronic instrument such as a scanning device.

[0127] In some ways, to facilitate the smooth assembly or insertion of the carrier into the receiving cavity 1104, a slideway is provided in the receiving part. The slideway is composed of two groups of slideways. One of the groups of slideways 45, 1110 is provided on the side wall of the receiving cavity, and corresponding slideways (not shown) are also provided on the other side wall. In this way, the side surfaces 182, 181 on both sides of the carrier serve as slide rails. In this way, the carrier can be stably or relatively fixedly installed at a fixed position in the receiving cavity. During assembly, in order to make the upper surface (the side with the test element) of the carrier face the upper surface 1102 of the receiving cavity, a limiting structure is provided on the carrier to prevent the upper surface of the carrier from facing the lower surface 1107 of the receiving cavity during assembly. A limiting structure such as a limiting block 1112 is located on the back surface of the carrier and directly below the cavity 1116 of the carrier or below the liquid introduction channel 115. The limiting block 1112 is located between the slide rails, and the slide rails still pass through both ends 1822, 1811 of the limiting block. Generally, it is inserted into the receiving cavity from one end of the liquid introduction channel. The width between the slideway 45 and the slideway 1110 of the receiving cavity is equal to or slightly greater than the thickness of the carrier. Among them, one of the slideways is arranged in the form of "「", for example, as Figure 8 and 9As shown, a slideway on the side wall of the receiving cavity is designed in such a way that one side 1109 is parallel to the side, and the other side 1108 is perpendicular to the side wall of the receiving cavity. The other side wall of the corresponding receiving cavity also has the same structure. In fact, the upper slideways 45 (actually a pair) of the slideway structure and the slideways 1110 (also a pair, the side walls of the other receiving cavities are not shown) define different widths in the receiving cavity. When the carrier is inserted into the receiving cavity, if the front side of the carrier (the side covered by the film 114) faces the upper surface 1102 of the receiving cavity, the side surfaces 1811 and 1822 of the carrier, which are in the structure of the slide rails, contact the slideways 1110 and enter the receiving cavity. If the direction is opposite, the side surfaces 1811 and 1822 of the carrier, which are in the structure of the slide rails, contact the structure of the slideways 45. Since the distance between the structures of the slideways 45 is less than the width of the carrier, it cannot be inserted into the receiving cavity, so the carrier can only be inserted with its upper surface facing the upper surface of the receiving cavity, otherwise it cannot enter the receiving cavity. The existence of the limiting block can also more conveniently identify the front and back of the carrier.

[0128] Therefore, in some preferred ways, the carrier 18 with the test element is arranged in the cavity 11004 for accommodating the carrier, and the collector with the absorption element 107 can be directly connected to the carrier. For example, the absorption element is a cylindrical sponge, and the absorption element is connected to the carrier 111 through the connecting rod 109, for example, detachably connected together. In some ways, the connecting rod 109 includes a channel or pipe 12 ( Figure 11 ), and the pipe 12 is in fluid communication with the channel inlet 1117 on the carrier 111. When the absorption element 107 is compressed, the liquid sample can flow into the cavity 1106 of the carrier 111 through the pipe of the connecting rod, so as to analyze the analyte in the manner described above. The sample collector can be connected to the pipe 1115 with the liquid inlet on the carrier 18 through the end 1093 without the absorption element to form a liquid connection. Of course, the collector can also be in fluid communication with the receiving cavity 1104, and is also detachably connected. Then the receiving cavity 1104 is in fluid communication with the connecting pipe, which is also possible. In short, after the absorption element collects the liquid sample, the fluid sample, or the treatment liquid mixed with the fluid sample, can flow to the test element through the channel or flow path. Of course, making the absorption element be detachably combined with the carrier or the cavity is also convenient for separately sterilizing the absorption element. For example, in the US Patent of the applicant, Patent No. US10,05,146, the absorption element is bound to the test element and cannot be separated, so it is not easy to be separately processed, increasing the difficulty.

[0129] In some embodiments, the limiting block 1112 contains a cavity 1116 with a carrier disposed therein for receiving a fluid sample and a diversion element 113. Thus, since the grooves 1114, 11123, 11124 on the carrier for accommodating the test elements are relatively shallow, and the volume of the cavity 1116 on the carrier is relatively large enough to accommodate the liquid flowing in from the inlet channel. Therefore, in some embodiments, the cavity 1116 on the carrier is located inside the limiting block 1112.

[0130] In some embodiments, the opening 1103 of the receiving cavity 1104 matches the end tail structure 183 of the carrier, which can also serve to limit the front and back sides. For example, if the opening of the receiving cavity is designed as "D", then the end tail structure 183 of the carrier is also designed as "D". Of course, any other structure can achieve the function of the front and back sides.

[0131] In some embodiments, the receiving cavity includes a connecting element 1101, which is an extension of one end segment of the receiving cavity. There is a hole 11011 between the receiving cavity and the connecting element. When the carrier is inserted into the receiving cavity, the inlet pipe 1115 is located near the hole 11011. When the connecting element 1101 is a tubular structure, one end (such as the threaded end) of the connecting rod of the collector is inserted into the connecting element, and at the same time passes through the hole 11011 and is connected to the inlet pipe 1115 (as Figure 10 , shown in FIGS. 18 - 19). The collector includes an absorption element 107 for collecting a sample, such as a fluid sample. A connecting rod 109 is connected to the collector, and a channel 12 is provided in the connecting rod (as Figure 18 ). Thus, one end of the channel in the connecting rod is in fluid communication with the absorption element, and the other end is connected to the inlet pipe 1115. Thus, the liquid passing through the absorption element can flow through the transfer channel 12 in the connecting rod to the inlet channel, and then enter the cavity 1116 of the carrier, and is guided by the diversion element to the test element.

[0132] In some embodiments, the connecting rod 109 includes protruding structures 1091, 1092, which contact the inner wall of the connecting element 1101, mainly to limit the connecting rod to accurately align with the opening of the inlet pipe 1115 and make a connection. The connection manner between one end of the connecting rod and the inlet pipe 1115 here can be any suitable manner, such as snap connection, threaded connection, or piston - type connection.

[0133] In some ways, the absorption element 107 is detachably connected to the test element, which means that initially, they can be manufactured separately and assembled together when needed for use. The main advantage here is that when the absorption element needs to be inserted into the mouth to collect a saliva sample, the absorption element needs to be pre-sterilized, such as by high-temperature sterilization or radiation sterilization. Thus, if the test element is initially connected to the absorber, the test element will also be sterilized together with the absorption element. However, there are some chemical or biological species on the test element, and these sterilization methods may damage the activity of the substances on the test element, ultimately resulting in an inability to complete a correct test. For example, if the test element is treated with antibodies or antigens, high-temperature sterilization can cause the antibodies to denature and lose their binding ability. If some substances on the test element volatilize and decrease due to high temperature, it will also have an adverse impact on the monitoring performance of the test element. Additionally, the detachable method also facilitates transportation. The carrier and the sampler can be individually packaged and then assembled together when needed. This also increases the convenience of use. During manufacturing, they can be manufactured separately and then assembled individually, or the individual components can be manufactured separately and then transported to another location for assembly into a complete product (as Figures 10 - 11 shown). Figure 11 The figure shown is only a preferred embodiment of the present invention, and it may lack the cavity for accommodating the carrier, or the diversion element, or the connecting rod, etc.

[0134] Of course, in one way, after the carrier 111 with the test element 112 is assembled by the receiving element, and after the connecting rod 109 of the collector is assembled with the carrier 111, a final detection device is formed, as Figure 11 shown. In some ways, by the cooperation of the convex structures 1091, 1092 of the connecting rod with the inner wall 11012 of the connecting element 1101, the strength or rigidity of the connecting rod can be increased, so that when the absorption element is used to collect a sample, the connecting rod 109 will not break. Additionally, these convex ring structures can also keep the connecting rod at the central axis position of the connecting element, so that it is convenient to accurately align one end of the connecting rod with the inlet pipe 1115 on the carrier, thereby forming a fluid connection during assembly and installation.

[0135] In some ways, one end of the connecting rod connecting the absorption element has an enlarged portion, and the absorption element is disposed on the enlarged portion. Generally, the cross-section of the absorption element is larger than that of the connecting rod. The enlarged portion can be a disc structure 805, and the absorption element is adhesively bonded to the surface of the disc. At this time, the channel 12 provided in the connecting rod connects the absorption element and the input channel, thereby fluidly connecting the cavity 1116 on the carrier, and thus also fluidly connecting the test element on the carrier. In some ways, an elastic sealing ring 108 is provided on the disc shape to keep the absorption element 107 in a sealed cavity and prevent the extruded fluid sample from flowing out.

[0136] Analyte

[0137] Examples of analytes involved in the present invention include some small molecule substances, and these small molecules include drugs (such as abused drugs). "Drug of abuse" (DOA) refers to the non-medical use of drugs (usually acting as nerve paralytics). The abuse of these drugs can cause physical and mental damage, dependence, addiction and / or death. Examples of drug abuse include cocaine; amphetamine AMP (e.g., black beauties, white amphetamine tablets, dextroamphetamine, dextroamphetamine tablets, Beans); methamphetamine MET (crank, meth, crystal, speed); barbiturate BAR (such as Valium, Roche Pharmaceuticals, Nutley, New Jersey); sedatives (i.e., sleep aids); lysergic acid diethylamide (LSD); depressants (downers, goofballs, barbs, blue devils, yellow jackets, methaqualone); tricyclic antidepressants (TCA, i.e., imipramine, amitriptyline, and doxepin); 3,4-methylenedioxymethamphetamine (MDMA); phencyclidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); opiates (i.e., morphine MOP or, opium, cocaine COC;, heroin, hydrocodone); anxiolytics and sedative-hypnotics. Anxiolytics are a class of drugs mainly used to relieve anxiety, tension, fear, stabilize emotions, and have hypnotic and sedative effects, including benzodiazepines BZO (benzodiazepines), atypical BZ classes, fused diazepines NB23C classes, benzazepines, ligands of BZ receptors, open-ring BZ classes, diphenylmethane derivatives, piperazine carboxylates, piperidine carboxylates, quinazolinones, thiazine and thiazole derivatives, other heterocyclic classes, imidazole-type sedative / painkillers (such as hydrocodone OXY, methadone MTD); propylene glycol derivatives - carbamates, aliphatic compounds, anthracene derivatives, etc. The detection device of the present invention can also be used for the detection of drugs that are for medical use but are prone to overdose, such as tricyclic antidepressants (imipramine or analogs) and acetaminophen. These drugs are metabolized into small molecule substances after being absorbed by the human body, and these small molecule substances are present in body fluids such as blood, urine, saliva, sweat, etc. or some of these small molecule substances are present in the above body fluids.

[0138] For example, analytes detected using the present invention include, but are not limited to, creatinine, bilirubin, nitrite, protein (non-specific), hormones (e.g., human chorionic gonadotropin, progesterone hormone, follicle-stimulating hormone, etc.), blood, white blood cells, sugar, heavy metals or toxins, bacterial substances (such as proteins or carbohydrate substances specific to specific bacteria, such as Escherichia coli O157:H7, Staphylococcus, Salmonella, Clostridium, Campylobacter, L. monocytogenes, Vibrio, or Bacillus cereus) and substances related to physiological characteristics in urine samples, such as pH and specific gravity. Any other clinical urine chemical analysis can be performed using the lateral flow detection format in combination with the device of the present invention.

[0139] In some embodiments, the processing fluid contained in the receiving device does not contain the analyte.

[0140] Liquid flow

[0141] The flow of a liquid generally refers to the movement from one place to another. Generally, the flow of natural liquids mostly relies on the action of gravity to flow from a higher place to a lower place. Here, the flow also relies on an external force, that is, the flow under the external gravity, which can be called the flow of natural gravity. In addition to gravity, the flow of a liquid can also overcome gravity and move from a lower place to a higher place. For example, the pumping of a liquid, or the pressing of a liquid, or the liquid being under pressure and flowing from a lower place to a higher place, or the flow due to pressure relationships and overcoming the self-gravity of the liquid. For example, Figure 9 , in 19, 22, 27, the first chamber is located above the second chamber, and the second chamber is located below the first chamber. When a liquid enters the second chamber, the liquid can flow from the first chamber to the second chamber naturally by gravity due to its own gravity, or can flow naturally from the upstream to the downstream position.

[0142] Detection device

[0143] A detection device refers to a device used to detect whether an analyte is contained in a sample. A receiving device refers to a part of the receiving detection device or allowing part of the detection device to be inserted into the receiving device to perform mixing or processing of the sample, elution of the absorption element, and processing of liquids or liquid samples. The receiving device does not exist specifically for receiving the detection device and can exist independently and have the function of processing fluid samples alone. The detection device may include a test element with a test function, or a carrier with a test element, and may also include a receiving element for the carrier. The detection device may include an absorption element for collecting the sample, or an absorption element with a connecting rod. The absorption element for collecting the sample may also be called a collection device or a collector. Therefore, the collection device may also include the detection device, or the collection device and the detection device are separated, and during detection, the collection device and the detection device are combined to complete the detection. The detection device may also include the collection device. It may also be that the collection device and the detection device are an integrated structure device. Once a liquid sample is collected, detection can be immediately performed to obtain a test result. Here, the meanings of the detection device or the test element can be interchanged.

[0144] The "receiving device" here is only for convenience of description. In a specific embodiment, the receiving device receives part of the collector, such as receiving the absorption element, or receiving part of the detection device with an absorption element. When the receiving device is not for the receiving function, it can also be called a sample processing or sample mixing device. When performing sample processing, it may not be necessary to receive the detection device and may be able to complete independently by only receiving the absorption element (there will be a more detailed introduction below). In short, the "receiving" here does not limit the scope of the device and does not play any role in limiting in the sense of patent law claims, but is only a term for convenience of description.

[0145] Combination, union or cooperation of collection device and detection device

[0146] The detection device and the collection device or collector of the present invention can form a detachable pair combination. Before liquid collection is required, the detection device is already combined with the collection device. After the liquid sample collection is completed, the absorption element on the collection device is compressed, and the liquid sample enters the test element to complete the assay. Of course, the collection device and the detection device can be separated at the beginning. When liquid sample collection is required, they are combined together. After collection is completed, the absorption element is compressed, and the liquid sample enters the test element to complete the assay. In some specific embodiments of the present invention, such as Figure 12In a specific embodiment shown, the present invention provides a detection device for detecting whether an analyte is contained in a liquid sample, or a collection device (the absorption element 107 and the connecting rod 109 form the collection device or collector) for collecting a liquid sample, which includes a detection component and a collection component, wherein the detection component is provided with a test element 112, the collection component is provided with an absorption element 107, and the detection component and the absorption component are combined, connected or assembled in a detachable manner.

[0147] Here, "combination, connection or assembly" actually means the same thing, only different words are used, and they can all mean being combined together, and this combination is corresponding to "separation". Both combination and separation can be under any conditions and can be freely selected. In some embodiments, when the detection component and the collection component are combined together, the detection component and the collection component are in a state of liquid flow. In other embodiments, before, during or after the detection component and the collection component are separated, the detection component and the collection component may not be in a state of liquid flow.

[0148] In some embodiments, the absorption element 107 is disposed on a connecting rod 109 to form a collection device or collector. The absorption element 107 can absorb a fluid sample, such as any sample like saliva, urine or blood. One end of the connecting rod 109 is connected to the absorption element 107, and the other end is connected to the connection pipe or input pipe 1115 of the carrier 111. The connection method can be a threaded method, a snap-fit method, a locking method, or a pin-and-socket connection method. These methods can achieve connection and also disassembly. Thus, when it is necessary to sterilize the absorption element or the absorber alone, sterilization treatment can be carried out separately, such as high temperature, X-ray, radiation sterilization, nuclear radiation sterilization, etc. After the sterilization is completed, it is then assembled with the carrier, such as Figures 10 - 11 the embodiment shown.

[0149] Receiving device

[0150] In some preferred embodiments, the present invention further provides a receiving device for receiving a part of the detection device, so as to perform a processing step or a processing process on the sample on the absorption element before the formal detection. Or, in another aspect of the present invention, a device for pre-processing a sample is provided. This device is not only for receiving the detection device, but also for processing the sample before the detection device performs sample detection. It can exist independently of the detection device and can also independently perform functions independently of the sample collector. Only in some specific embodiments, it is used in cooperation with the detection device or the sample collector. As explained above and with reference to the following description, the receiving device is only a term for convenience of description and does not have a substantial definition. It can be called a device, a processor, a system, etc.

[0151] As Figures 13 - 17 shown, in one embodiment, the device includes a cavity structure, similar to the shape of a lid or a tube structure. In some embodiments, the receiving device includes a cavity for receiving a processing liquid and a cavity 94 for accommodating a part of the piercing element. The receiving device can be open at one end and closed at the other end, forming a space or cavity 102. Different functional small cavities are distributed in this large cavity. For example, a first cavity for receiving a processing liquid and a second cavity for receiving or accommodating a part of the piercing element. For example, a space or cavity is provided at the bottom of the cavity 102 in the receiving device to accommodate a sealed container containing a processing liquid. The processing liquid may contain some chemical, biological reagents, enzyme preparations, substances for adjusting the pH value, buffer reagents, proteins, inorganic or organic reagents. This liquid solution is used to process fluid samples or absorption elements or samples, such as removing impurities in the sample, removing interfering substances that interfere with the test, or dissolving or diluting the sample, or eluting and dissolving the absorption element, or adjusting the pH value of the sample. Generally, the processing liquid described in the present invention does not contain the analyte, but is used to improve the detection sensitivity of the analyte, so as to process the sample, remove or eliminate, or reduce interfering substances or other impurities for the test of the analyte. The sealed container has a sealed cavity 1031 for storing the processing liquid. To facilitate the release of the processing liquid, the container is easily pierced by the piercing element. Therefore, in some embodiments, the sealed cavity is sealed by a material 104 that is easily pierced, such as aluminum foil, film, tape, or plastic sheet, etc. In this way, the entire sealed container can be disposed in the first cavity (as Figure 14 shown). The purpose of providing a separate sealed cavity in the first cavity is for convenience of processing. The container can be pre-filled with the processing liquid, and then the container mouth is sealed ( Figure 14As shown. Of course, a sealed space can be provided at the bottom of the cavity, and the solution to be processed is injected into this space, and then the space is sealed. For example, there is a first cavity 91 at the bottom of the device, and the processing liquid is accommodated in the cavity, and then the opening of the cavity is sealed. The sealing material can be the material that the solution is punctured. In any case, this sealed space is generally located within the cavity 102, and the solution for processing the sample is pre-filled in the sealed space. When needed, the solution for processing the sample can be released from the sealed space.

[0152] In some other solutions, the cavity 102 of the receiving device further includes a movable puncturing element 106 which can move in the receiving device and puncture the cavity containing the processing liquid through movement to release the processing liquid. In some ways, the puncturing element includes a puncturing structure 1066 and a cavity for receiving the processing liquid, the processing liquid from the first cavity of the receiving device. Therefore, after the puncturing element moves to puncture the cavity containing the processing liquid, the released processing liquid enters the cavity of the puncturing element. The cavity of the puncturing element can also be used to receive a sample, such as a liquid sample, or an absorbent element with a sample. In this way, the sample is processed in the cavity of the puncturing element to form a first mixed solution, and the processed mixed solution is used to test the analyte and is detected using a test element. In some ways, a collector 18 with an absorbent element is inserted into the cavity of the puncturing element. At this time, the puncturing element is in the first position (as shown in 15), and the puncturing structure 1066 is located above the cavity containing the processing liquid. When the collector is inserted into the cavity, in order to compress the absorbent element, pressure needs to be applied to the absorbent element, such as applying pressure to the absorbent element through a connecting rod. The applied pressure can also simultaneously push the puncturing element to move from the first position to the second position, so that the puncturing structure punctures the sealing film on the cavity containing the processing liquid. At this time, if the puncturing element is further moved, part of the cavity can enter the cavity containing the processing liquid, forcing part of the processing liquid into the cavity of the puncturing element. For example, there are small holes at the puncturing structure, and the processing liquid enters the cavity through the small holes and contacts the absorbent element in the cavity to process and mix with the absorbent element to form a first mixed liquid. Since the connecting rod has a channel connected to the absorbent element, during the process of part of the cavity entering the cavity containing the processing liquid, part of the cavity of the puncturing element has pressure on the processing liquid, and this pressure can make the processing liquid or the first mixed solution formed with the sample pass through the absorbent element and enter the channel of the connecting rod, and then flow out of the receiving device through the channel 12. In order to allow more liquid to flow into the connecting rod channel, the absorbent element can seal one end opening 1028 of the cavity in the puncturing element. At this time, the absorbent element fills the entire cavity or seals one end of the cavity, and the pressure of part of the cavity of the puncturing element entering the cavity containing the processing liquid can make more liquid or mixed liquid enter the channel of the connecting rod and be discharged outside the puncturing element.

[0153] In some ways, the mixed solution flowing out of the channel 12 can be directly used for the detection of the test element, or can be collected in another container, such as a dropper, and then the mixed solution is dropped onto the sample application area of the test element to complete the assay of the analyte.

[0154] The piercing element has a piercing end with one or more piercing structures 1066. The piercing element can be one or more, used to pierce the film containing the processing liquid so that the processing liquid can be released. In some ways, there is a through-hole 1065 near the piercing structure. It is desired that after the piercing structure pierces the sealed cavity containing the processing liquid, the through-hole comes into liquid contact or the through-hole is immersed in the processing liquid, facilitating the entry of the processing liquid into the cavity of the piercing element through the through-hole 1065.

[0155] In one way, the piercing element is also a tubular structure with a first tube body and a second tube body. The piercing part is arranged at the end of the first tube body. For example, Figure 16 , the piercing structures 1066 are evenly distributed on the outer surface of the first tube body. Here, the first tube body and the second tube body respectively define a first cavity 1062 and a second cavity 1061. The end of the first cavity with the piercing structure has a small hole. The end of the first cavity is brought close to the sealed cavity containing the processing liquid to pierce the sealing structure, and then the first cavity enters the sealed cavity. Relying on the drainage capacity of the first cavity, the processing liquid enters the first cavity 1062 through the small hole. This is because after being pierced by the piercing structure, if the first cavity enters the sealed cavity, some liquid will inevitably be discharged, and these liquids are likely to enter the first cavity 1062 of the piercing element through the through-hole 1065. In some ways, the downward movement of the piercing element to pierce the sealed cavity containing the processing liquid can be promoted by applying pressure to the collector. Of course, in other ways, it can also be that the connecting element on the receiving carrier contacts the piercing element to push the movement of the piercing element.

[0156] In one way, the inner diameter of the first cavity 1062 is smaller than the inner diameter of the second cavity 1061. At the junction of the two cavities, there is a platform structure 1068. The first cavity and the second cavity form a liquid-connected cavity structure. When the piercing structure 1066 pierces the cavity containing the processing liquid, part of the processing liquid enters the cavity of the piercing element through the through-hole 1065, such as into the first cavity 1062 or the second cavity 1061. In some ways, the outer diameter of the second cavity 1061 is equivalent to the inner diameter of the tube containing the processing liquid. In this way, when the piercing part pierces the film, the first cavity 1062 is inserted into the interior of the tube containing the processing liquid. Since the inner diameter of the second tube body is equivalent to that of the tube containing the processing liquid, the processing liquid in the tube containing the processing liquid is forced to enter the first cavity 1062 through the through-hole 1065.

[0157] In some ways, since the inner diameter of the first cavity 1062 is smaller than that of the second cavity 1061, there is a platform structure 1068 at the interface of the two tube bodies. This platform can be used for the absorption element to contact, and used to compress the absorption element to extrude the liquid sample on the absorption element. The extruded liquid sample flows into the first cavity. In some ways, the inner diameter of the second cavity is comparable to the diameter of the absorption element. When the absorption element is inserted into the second cavity, during the process of the absorption element being squeezed, it almost blocks the opening of the second cavity. For example, through the extrusion of the platform, it is also equivalent to sealing or blocking the hole 20 between the first cavity and the second cavity. At the same time, the first cavity receives the fluid sample compressed from the absorption element. When the first cavity of the puncturing element pierces the cavity for processing the liquid and enters this cavity, the discharged processing liquid enters the first cavity 1062 of the puncturing element. One is that it can be mixed with the sample to achieve the purpose of processing the sample and form a first mixed solution. At the same time, the first cavity of the puncturing element is almost a sealed space. As the processing liquid enters, the pressure in the space increases, which will prompt the mixed solution to pass through the absorption element (the absorption element has voids), so that the absorption element can be eluted (for example, adsorbed with the analyte, such as THC). After elution, a second mixed solution is formed. This second mixed solution can enter the carrier through the channel of the connecting rod. Here, the extrusion of the absorption element releases the fluid sample into the first cavity of the puncturing element, and the puncturing structure pierces the sealed cavity to release the processing liquid. There is no need to distinguish the sequence in terms of operation time. It can be completed simultaneously, or the extrusion of the absorption element to release the fluid sample can be earlier than the puncturing action. Of course, it can also be that the puncturing action is earlier than the compression of the absorption element. In some other ways, the puncturing element lacks the second cavity and only includes the first cavity. The absorption element can be inserted into the first cavity 1062. The absorption element can be squeezed or not squeezed, and then let the processing liquid directly pass through or contact the absorption element, so as to form a mixed liquid. It is also feasible to use this mixed liquid for testing.

[0158] In some ways, the absorption element is adhered to the disc structure 805. The outer diameter of the disc structure is equivalent to the inner diameter of the second cavity 1061. In this way, when the absorption element is inserted into the second cavity, due to the matching of the inner diameter of the cavity and the outer diameter of the disc, when the absorption component is compressed, the liquid will not flow out through the gap between the disc structure and the inner wall 1067 of the second cavity 1061. If the liquid flows out, it can only flow out through the transmission channel 12 that is in liquid communication with the absorption element. Most preferably, the disc structure has an elastic sealing ring 108. Relying on the cooperation between the elastic sealing ring and the inner wall 1067 of the second cavity 1061 to form a sealing structure, this further ensures that when the absorption element contacts the platform structure 1068 and during the compression process, more fluid samples enter the first cavity 1062. When the mixed liquid in the first cavity flows back to the absorption element, more liquid flows out through the channel 12 communicating with the absorption element. The sealing of the disc also prevents the fluid sample or the mixed liquid formed with the treatment liquid from flowing outside the puncturing element, thus causing environmental pollution, and also will not cause pollution to the operator.

[0159] In some ways, the squeezing of the absorption element 107 and the puncturing of the cavity for containing the treatment liquid can be completed simultaneously. Here, "simultaneously" means having coherence in time. During the squeezing process, the puncturing of the sealed cavity, or during the puncturing of the sealed cavity, there is compression or squeezing of the absorption element. In some ways, the puncturing element 10 and the cavity for containing the treatment liquid are in a relative position. At this time, the puncturing structure 1066 is located above the sealing film 104 (as Figure 15 ). At this time, the puncturing structure 1066 can contact the sealing film, or be located above the sealing film (not contacting the film 104), or be in the directly above position (for example Figure 19The positional relationship shown). In some ways, the receiving device includes a first cavity for accommodating a sealed cavity, and a second cavity 94 and / or a third cavity 90 for accommodating a partial puncturing element. The second cavity 1061 of the puncturing element is located within the third cavity 90 of the receiving device, while the first cavity 1062 of the puncturing element is arranged within the second cavity 94 of the receiving device. There is an internal thread structure 1023 near the opening of the second cavity 1061 of the puncturing element, and an external thread 1105 on the outer surface of the connecting element 1101 of the detection device. During operation, first, the absorption element 107 is used to absorb a liquid sample, such as urine, saliva, or blood. At this time, the absorption element absorbs the liquid sample and then is inserted into the cavity of the receiving device 101. During the insertion process, the absorption element enters the second cavity 1061 of the puncturing element. When the absorption element 107 contacts the platform structure 1068 between the first cavity and the second cavity, due to the opposite acting force, the absorption element 107 is compressed, and thus the liquid sample is released from the absorption element and flows into the first cavity 1062. At this time, since the absorption element generally becomes soft when absorbing liquid, during compression, although it may cause a slight change in the position of the puncturing element, such as a slight movement, the downward force can also cause the puncturing element to pierce the sealing film 104. As the receiving cavity 110 of the detection device continues to move downward and enters the opening of the receiving device, the port 1108 of the connecting element contacts the opening 1070 of the second cavity of the puncturing element. At this time, the external thread 1105 of the connecting element engages with the internal thread structure 1023 at the opening of the cavity 90. At this time, the puncturing element 10 is basically in the initial position. As the receiving cavity continues to move downward, through relative rotation, for example, by continuing to engage the external thread 1105 of the connecting element with the internal thread structure 1023 on the inner wall of the third cavity of the receiving device, relying on the power transmitted by the contact between the port 1108 of the connecting element and the opening 1070 of the second cavity of the puncturing element, the entire puncturing element is driven to move downward. At this time, the position of the absorption element and the puncturing element remains relatively fixed. As the puncturing element moves downward, it pierces the sealing film, so that part of the processing liquid in the cavity for accommodating the processing liquid enters the first cavity through the through hole 1065 at the end of the first cavity 1062. If there is a liquid sample in the first cavity 1062, such as a saliva sample, the processing liquid will mix with the liquid sample to form a first mixture. As the puncturing element continues to move, the mixture passes through the absorption element, and some substances to be analyzed adsorbed on it, such as THC, can be eluted through the absorption element, and then flow into the channel 12 of the connecting rod 109, and then enter the carrier 111 and contact the test strip 112 to complete the analysis or assay of the substance to be analyzed (if the substance to be analyzed exists in the fluid sample).

[0160] The above description is about the absorption element being inserted into the cavity of the piercing element of the receiving device. It is easy to understand that the receiving device can also be moved closer to the collector containing the absorption element, so that the absorption element enters the cavity of the piercing element, or the collector containing the absorption element and the receiving device can move closer to each other simultaneously, so that the absorption element enters the cavity of the piercing element. These methods are all acceptable and are included within the scope of the present invention.

[0161] Of course, it can be understood that the amount of liquid sample absorbed by the absorption element 107 is small, or the connecting rod 109 is sufficiently rigid or long. During the process of the receiving and accommodating element carrier driving the absorption element 107 to be inserted into the second cavity 1061 of the first piercing element, as the liquid sample is squeezed out from the absorption element, it can drive the first cavity 1062 of the piercing element to approach and pierce the sealing film of the cavity containing the processing liquid. At this time, the accommodating element of the receiving carrier continues to drive the absorption element 107 to be inserted into the second cavity 1061 of the piercing element and continue to be compressed. At this time, the entire piercing element also continues to move downward, and part of the first cavity 1062 enters the cavity containing the processing liquid, forcing part of the processing liquid to flow into the first cavity through the through hole at the end of the first cavity, thereby forming a first mixed liquid in the first cavity. Then, the first mixed liquid passes through the absorption element to form a second mixed liquid and enters the channel 12 of the connecting rod 109, and then reaches inside the carrier, contacts the diversion element 113, and thus flows through the diversion element 113 onto the test strip to complete the detection.

[0162] In some ways, since this test device is mainly used for roadside detection, such as drug driving, or in public places, it is desired to have convenient operation and quickly obtain test results, and at the same time, it is desired that the liquid sample does not leak out. In order to quickly obtain the test results, it is desired that the liquid sample or the processing body fluid quickly passes through the absorption element and quickly enters the carrier to contact the test element. Let the processing liquid or the liquid sample, or the mixture of the liquid sample and the processing liquid; or, directly let the processing liquid pass through the absorption element quickly (if the absorption element is not compressed) or enter the carrier to contact the test element without passing through the absorption element; in addition, when the absorption element is vertically inserted into the cavity of the piercing element, it is necessary to make the liquid sample overcome the gravity and move or flow quickly in the direction opposite to the gravity direction. In addition, if the absorption element is compressed, it is also necessary to overcome the resistance of the compressed absorption element to allow the liquid to pass through the absorption element and enter the channel of the connecting rod. Or, in order to prevent the liquid in the second cavity and the first cavity of the receiving device from leaking to the outside and causing environmental pollution.

[0163] In some ways, to better achieve one or more of the above objectives, the piercing element 106 forms a sealed space within the cavity of the receiving device. The air or gas within this sealed space can be compressed. When compressed, the pressure within the sealed space increases. The increased pressure can overcome the gravitational force of the liquid mixture, or can prompt the liquid to quickly enter the cavity of the piercing element, or can overcome the resistance of the compressed absorption element to the liquid and pass through the absorption element. In some ways, the first cavity of the piercing element is located within the second cavity 94 of the receiving device. The elastic sealing ring 105 of the piercing element mates with the inner wall of the second cavity 94 of the receiving device, thereby forming a sealed space. This sealed space communicates with the outside only through the small holes in the first cavity of the piercing element. When the through-hole 1065 at the end of the first cavity of the piercing element enters the cavity containing the processing liquid, the small holes are sealed by the processing liquid. If the air in the second cavity 94 of the receiving device is compressed and the pressure increases, there is a pressure difference between the pressure in the second cavity and the first cavity within the piercing element (in the manner described above, the first cavity can maintain pressure balance with the outside). To achieve pressure balance between the pressure in the second cavity and the outside pressure of the first cavity within the piercing element, the increased pressure will force the processing liquid to enter the first cavity of the piercing element through the holes. As the piercing element continues to move, the volume of the second cavity 94 of the receiving device is further compressed, the pressure continues to increase, and the processing liquid entering the piercing element and the liquid sample released by the extrusion of the absorption element overcome the gravitational force and continue to pass through the compressed absorption element and enter the channel of the connecting rod.

[0164] In some ways, to prevent the absorption element from being inserted into the cavity of the piercing element and causing contamination of the liquid sample extruded to the outside, the absorption element also has an elastic sealing ring that forms a seal with the inner wall of the piercing element, so that the liquid extruded from the absorption element does not flow out to the outside.

[0165] From Figures 23 - 25Schematic diagram of the principle structure. In some ways, the piercing element 206 forms a sealed cavity 23 above the cavity 203 containing the processing liquid, and this cavity includes air or gas. The piercing element includes a first cavity 806, an end hole, and a piercing structure, and may also include a second cavity for receiving the absorption element. The second cavity is used to receive the absorption element 107. It can be understood that the piercing element does not necessarily require a second cavity to receive the absorption element. A sealed space 23 is formed and can be compressed. Once compressed, the pressure in the sealed space will increase, and the increased pressure will force the processing liquid in the cavity 203 containing the processing liquid to quickly flow into the first cavity of the piercing element. In this way, the piercing element generally enters the cavity 203 containing the processing liquid (of course, it can also not enter, just let the through-hole contact the processing liquid or seal the through-hole with the processing liquid). The piercing element also has a liquid drainage pressure on the liquid in the cavity 203, and this liquid drainage pressure will also cause the liquid to enter the piercing element. In this way, in some ways, under the dual pressures of the pressure in the sealed cavity and the piercing element entering the cavity 203 containing the processing liquid, the processing liquid can quickly enter the cavity of the piercing element, mix with the fluid sample, and quickly flow the mixed solution out of the piercing element. For example, it flows into the detection device through the channel of the connecting rod of the absorption element, such as into the cavity of the carrier.

[0166] Under such dual pressures, precisely because the flow rate of the liquid may be relatively fast, in some ways, a diversion element 113 is provided at the liquid inlet of the carrier. On the one hand, the diversion element plays a role in guiding the liquid to the test strip, and on the other hand, it plays a role in alleviating the impact of the liquid on the test strip. For example, without a reverse flow element, the liquid passing through the liquid inlet will quickly rush in, sometimes in a state similar to "spraying", and will splash onto the test strip, thereby prematurely wetting the test element or causing a "flood" phenomenon, resulting in inaccurate detection results. Since the flow rate of the liquid in the channel 12 is fast, a relatively large amount of liquid will flow in within a short period of time. If there is excess liquid, it can flow into the second area of the carrier to alleviate the "flood" phenomenon caused by too much liquid flowing onto the test element. It can be understood that there are various ways to slow down the flow rate of the fluid passing through the channel inlet 1117 or alleviate the situation of too much liquid flowing onto the test strip. For example, a mesh with small holes can be set at the liquid inlet, or the liquid inlet can be extended, or the diversion channel can be bent, folded, etc. In this way, the flow rate is slowed down, reducing the possible negative impact of the liquid on the test element.

[0167] In some ways, at this time, if the inner walls of the disc structure 805 with the absorption element and the moving element 206 are in a sealed state, the processing liquid or the processing liquid passing through the absorption element can easily and smoothly flow into the channel of the connecting rod 109. At this time, the absorption element can also be continuously compressed. Since the inner walls of the disc structure 805 and the moving element 206 are in a sealed state, the compression of the absorption element 107 will also increase the pressure in the space sealed by the solid structure, which is more conducive to the processing liquid passing through the absorption element flowing into the channel of the connecting rod. In this way, the liquid can flow onto the test strip to complete the detection.

[0168] In some ways, when the piercing element moves downward ( Figures 10 - 15 ), the air or gas in the sealed space 23 is compressed and the pressure increases. When the piercing element pierces the sealed film, it forces the processing liquid to substantially enter the cavity of the piercing element and contact the absorption element located in the cavity. (At this time, the absorption element can be compressed, or it can be not compressed, or it can be compressed to a certain extent, or it can be not completely compressed), mix with the sample in the absorption element, or mix with the liquid sample extruded from the absorption element, or pass through the absorption element to elute the analyte on the absorption element, and then quickly flow into the flow channel (the channel in the connecting rod, the introduction channel of the carrier, the connecting rod is in fluid connection with the connecting channel), and then quickly enter the carrier and contact the test strip. The speed of movement of the piercing element and the degree of compression of the sealed space are used to increase the pressure in the sealed space, so that the pressure forces the processing liquid and the liquid sample located in the piercing element, or the mixed liquid of the processing liquid and the liquid sample to quickly flow onto the test element. The way of increasing the pressure and the speed of increase will affect the speed of the liquid flowing to the test element. The faster the pressure increases, the faster the flow speed. There are many ways to realize the sealed space. For example, a sealing ring 108 is arranged on the outer periphery of the piercing element, and the sealing ring is matched with the inner wall of the cavity of the receiving device to form a sealed space; or, the piercing element is closely matched with the inner wall of the cavity of the receiving device, and a sealed space can also be formed. In this way, the compression of the sealed space can not only accelerate the flow of the liquid, but also prevent the liquid located in the sealed space from leaking into the environment, causing pollution to the operator and the environment. Generally, the collector with the absorption element is vertically inserted into the receiving device to make the liquid overcome gravity and move upward. The compression of the sealed space to increase the pressure has a better effect.

[0169] In some ways, the absorbent element enters the cavity of the piercing element, and the disc structure 805 that fixes the absorbent element also forms a sealed structure with the inner wall of the cavity of the piercing element. Whether it is the liquid sample compressed from the absorbent element or the processing liquid entering the piercing element, it will not flow out of the piercing element to pollute the operator and the environment. At the same time, since the disc mechanism also forms a seal with the cavity of the piercing element, the absorbent element can be further compressed. Since the disc structure 805 is in a sealed state with the inner wall (such as the second cavity) of the piercing element 10, the compression of the absorbent element 107 will also increase the pressure in the space sealed by the fixing piece (the fixing piece also forms a sealed space in the cavity of the piercing element), which is more conducive to the processing liquid passing through the absorbent element and flowing into the channel of the connecting rod. In this way, the liquid can flow onto the test strip to complete the detection. At this time, the piercing element has entered the processing liquid. The compression of the double sealed spaces (the sealed space of the disc mechanism in the piercing element and the sealed space formed by the cavity of the piercing element and the receiving device) doubles the pressure, which makes the liquid sample, or the processing liquid mixed with the liquid sample, or the processing liquid alone pass through the absorbent element or not pass through the absorbent element and enter the fluid channel, quickly reaching the test strip and facilitating the rapid acquisition of the detection result. At the same time, the processing liquid will not flow outside the receiving device and will not cause pollution to the environment or the operator. In fact, in this way, the channel 12 in the connecting rod 109 is in pressure communication with the outside. In this way, the increase in pressure can only cause the liquid to be transmitted to the carrier through the channel 12, and there is almost no possibility of passing through other places. This is a most preferred way of the present invention.

[0170] In some ways, for example Figures 19 - 22 to illustrate the operation process of the present invention. The specific detection device and receiving device described in this operation process are only a specific embodiment and cannot impose any limitation on the present invention.

[0171] As Figure 10 described, a detection device is provided, including a carrier element 111, on which there are 4 grooves 1114, 11123, 11124. A lateral flow test strip 1128, 1129, 1130 is respectively arranged in each of the 4 grooves, and each test strip corresponds to a specific analyte. When setting the test strip, the water-absorbing element 1123 of the test strip is arranged at one end of the carrier element away from the introduction channel, and the sample application area 1121 of the test strip is close to the end of the introduction channel. At the same time, part of the sample application area is "suspended" on the opening of the cavity 1116 of the carrier element 111 (as Figure 4A)。There is a dividing element within the cavity 1116, which divides the cavity 1116 into two parts. The specific method adopted is to set a baffle 1119. The height of this baffle is less than the depth of the cavity 1116. The baffle is arranged in front of the channel entrance 1117 of the inlet channel, forming a narrow slit between the entrance and the baffle. One end 1131 of the flow guiding element is inserted into the slit, almost covering or covering the channel entrance 1117. Then, the other end 1133 of the inlet element is folded, and the folding line position 1132 contacts the end of the sample application area of the test strip, while the folded end covers the sample application area (such as Figure 18 )。Then, a transparent single-sided adhesive film is covered on the front surface of the carrier to seal the entire groove and the opening of the cavity, forming a relatively sealed space. A channel is arranged on both sides of the opening of the cavity 1116, thus forming a ventilation channel communicating with the outside together with the film 114. The carrier is inserted into the cavity of the receiving element, with the front surface of the carrier (the side covered with the film) facing the upper surface 1102 of the cavity of the receiving element. The receiving cavity is also made of transparent plastic.

[0172] A collector is provided, which includes an absorption element 107 and a connecting rod 109. One end of the connecting rod has a disc structure 805. The absorption element 107 is adhesively bonded to the disc structure 805 with glue. There is an elastic sealing ring 108 on the disc structure. There is a transmission channel 12 in the connecting rod. One end of this channel is in fluid communication with the absorption element 107, and the other end is connected to the inlet channel on the carrier to achieve fluid communication. The absorption element is made of sponge material, which is rigid when dry and becomes soft when wet and can be squeezed or compressed. The other end of the connecting rod 109 has a thread, and an internal thread is provided in the inlet channel. The receiving element 111 includes a connecting element 1101, and an external thread 1105 is provided on the outer wall of the connecting element. The connecting element has an opening, and the diameter of the opening is the same as that of the opening of the second cavity of the puncturing element, which is convenient for the opening of the connecting element to contact the opening of the second cavity of the puncturing element and convenient for pushing the puncturing element to move. Ring-shaped protrusions 1191, 1192 are provided on the connecting rod. These protrusions can basically contact and cooperate with the inner wall of the connecting element. In this way, the threaded end of the connecting rod 109 passes through the hole 11011 before the connecting element 1101 and the receiving cavity. Through the inner wall of the connecting element and the ring-shaped protrusions on the connecting rod 109, the thread 1193 of the connecting rod can be threadedly connected to the opening at one end of the inlet channel to form fluid conduction. In this way, a detection device in a specific embodiment of the present invention is formed, such as Figure 19 The schematic cross-sectional structure diagram of the above.

[0173] When assembling the detection device, first assemble the carrier with the test element, then insert the carrier into the cavity of the receiving element, provide a collector with an absorption element, sterilize the collector by irradiating it with rays, and then assemble it with the carrier through the receiving element.

[0174] In a specific embodiment of the present invention, a receiving device is provided. The device has a cavity structure that is divided into three parts: a first cavity 91, a second cavity 94, and a third cavity 90. A sealed cavity is provided in the first cavity 91. The sealed cavity contains a treatment solution 1038 and is sealed by a sealing film 104, which is actually an aluminum foil seal. The second and third cavities of the receiving device include a puncturing element. The puncturing element includes a first cavity 1062 and a second cavity 1061. The specific structure is shown in Figure 16 and Figure 17 . At the connection between the first and second cavities of the puncturing element, two grooves 95, 96 are provided at the end of the second cavity. Elastic sealing rings 105 ( Figure 17 ) are respectively provided in the grooves. The elastic seals contact the inner wall of the second cavity of the receiving device, thereby forming a sealed space 80 below the contact of the elastic seal in the second cavity. This space includes the second and first cavities of the receiving device. The inner wall of the third cavity of the receiving device has a recessed thread structure that mates with the protruding thread structure on the surface of the connecting element. The second cavity of the puncturing element is located in the third cavity of the receiving device, and there is a space distance between the outer wall of the second cavity of the puncturing element and the inner wall of the third cavity of the receiving device, which facilitates the mating of the protruding thread on the outer surface of the connecting element with the recessed thread on the inner surface of the second cavity, thereby driving the movement of the puncturing element. The initial position of the puncturing element in the receiving device is as shown in the lower part of Figure 19 .

[0175] When in actual use, first let the absorption element of the detection device, such as a sponge tip, extend into the mouth to absorb a saliva sample. When the sponge tip absorbs the saliva sample, it will become soft. After absorbing the saliva sample, insert the absorption element into the second cavity 1061 of the puncturing element. Since the collector is provided with a sealing ring 108, when inserted into the second cavity of the puncturing element, the softened absorption element that has absorbed saliva contacts the step of the puncturing element, thereby squeezing the saliva sample into the first cavity. At this time, the elastic sealing ring seals the second cavity of the puncturing element, and the opening edge 1108 of the connecting element 1101 of the receiving element contacts the edge 1070 of the second cavity opening of the puncturing element. At this time, the puncturing element is in the initial position (as shown in Figure 20) The absorbent element has been compressed to release the saliva sample into the first cavity 1062 of the piercing element. As the external wall thread 1105 of the connecting element and the threaded rotating teeth of the third cavity 90 of the receiving device engage, the connecting element 1101 pushes the piercing element to move downward from the initial position. At this time, the volume of the space 80 sealed by the elastic sealing rings 1051 and 1052 on the piercing element gradually decreases, and the space pressure increases. At this time, the absorbent element has been squeezed, and the relative positions of the piercing element and the absorbent element are fixed. Therefore, during the movement, the absorbent element and the piercing element move together. As the piercing element moves, the piercing structure 1066 on the outer surface of the end of the first body 1062 of the piercing element contacts the sealing film 104 of the sealed cavity. The piercing structure is generally a relatively sharp and pointed structure. After piercing the sealing film 104 of the sealed cavity, the first cavity of the piercing element continues to move downward and partially enters the cavity. Due to the compression of the sealed space, the pressure increases, and in addition, the pressure of the liquid caused by the entry of the first cavity into the sealed cavity. It can be understood here that, in fact, the connecting rod of the absorbent element is in fluid communication with the cavity 1116 on the carrier 110, and the gas is also in communication. The cavity 1116 is in communication with the outside atmosphere through the provided air holes 1103. Therefore, the two cavities (the first and second cavities) of the piercing element are actually indirectly in communication with the outside atmosphere through the absorbent element. Therefore, the combination of the compression of the sealed space and the pressure of the liquid droplets when the first cavity of the piercing element enters the sealed cavity creates a pressure difference between the pressure in the cavity of the piercing element and the sealed space 80 of the receiving element. In this way, it forces the processing liquid in the sealed cavity to enter the first cavity through the small holes in the first cavity and mix with the saliva sample to form the first mixed liquid. As the pressure in the sealed cavity 80 continues to increase, the first mixed liquid passes through the compressed absorbent element 107 to form the second mixed liquid, passing through the absorbent element to elute the absorbent element, such as eluting THC adsorbed by the absorbent element, entering the channel 12 of the connecting rod, flowing into the cavity 1116 on the carrier through the introduction channel on the carrier, and at the same time contacting the diversion element 113 to allow the second mixed liquid to flow onto the test element 112 for testing and analysis of the substance to be analyzed ( Figure 22 ) If there is excess second mixed liquid, it enters the second area in the cavity 1116 on the carrier for relief or storage. After the testing is completed, the results of the test area and the control area on the test element are read through the transparent film on the carrier. The latter takes pictures of the test results or records the test results in a scanned form.

[0176] In some ways, since the absorbent element becomes soft after absorbing liquid (the material is porous absorbent material such as sponge, filter paper, cotton, etc.), but after being compressed, its texture becomes tight, allowing the liquid to enter the channel 12 through the absorbent element. The increased pressure in the sealing cavity 80 makes it easier and faster for the mixed liquid to pass through the tight absorbent element. On the contrary, it may be difficult to pass through.

[0177] In some other ways, the absorbent element may not be compressed. For example, the absorbent element is a rod-shaped body for feces, and some concave threads or grooves are provided on the rod-shaped body to collect solid or semi-solid samples. The inside of the rod-shaped body is in fluid communication with the channel 12 in the connecting rod. After the above operations, the processing liquid entering the cavity inside the piercing element from the sealing cavity dissolves the fecal sample in the groove on the rod-shaped body and flows into the test element through the channel 12 in the connecting rod.

[0178] It can be understood that the second cavity of the receiving device may not be sealed, and it is also feasible to rely only on the first cavity 1062 of the piercing element to enter the sealing cavity 103, so that the processing liquid enters the first cavity of the piercing element.

[0179] The present invention also includes the following embodiments.

[0180] 1. A receiving device, comprising: a cavity, which includes a first sealed cavity for accommodating a processing solution and a piercing element inside the cavity, and the piercing element can move inside the cavity, wherein the piercing element is arranged to pierce the sealed cavity.

[0181] 2. The device according to clause 1, wherein the piercing element has a first position and a second position in the cavity.

[0182] 3. The device according to clause 2, wherein the piercing element includes a cavity and a piercing structure. During the process of the piercing element moving from the first position to the second position, the piercing structure pierces the first sealed cavity, so that the processing liquid enters the cavity of the piercing element.

[0183] 4. The device according to clause 2, wherein when the piercing element is in the first position, the piercing element is away from the sealed cavity.

[0184] 5. The device according to clause 4, wherein when the piercing element is in the second position, a part of the cavity of the piercing element enters the sealed cavity, so as to force the processing liquid to enter the cavity of the piercing element.

[0185] 6. The device according to Clause 5, wherein the piercing element includes a through-hole, and the processing liquid flows into the cavity through the through-hole.

[0186] 7. The device according to Clause 3 or 5, wherein the cavity of the piercing element is configured to receive a fluid sample, and when the processing liquid enters the cavity of the side-piercing element, the processing liquid forms a first mixed liquid with the pierced fluid sample.

[0187] 8. The device according to Clause 7, wherein the cavity of the side-piercing element is configured to receive an absorbent element, and the absorbent element is compressed or squeezed to release the fluid sample.

[0188] 9. The device according to Clause 2, wherein the piercing element includes a first cavity and a second cavity for receiving an absorbent element, and a piercing structure is provided on the first cavity.

[0189] 10. The device according to Clause 9, wherein when the piercing element is in the first position, the piercing structure does not pierce the first sealed cavity, and when the piercing element is in the second position, the piercing structure pierces the first sealed cavity.

[0190] 11. The device according to Clause 10, wherein when the piercing element is in the second position, a part of the first cavity of the piercing element enters the first sealed cavity, thereby forcing the processing liquid into the first cavity of the piercing element.

[0191] 12. The device according to Clause 10, wherein when the piercing element is in the first position, the water-absorbing element is compressed or squeezed to release the fluid sample into the first cavity of the piercing element, thereby forming a first mixed liquid with the processing liquid in the first cavity.

[0192] 13. The device according to Clause 12, wherein when the piercing element is in the second position, the first mixed liquid passes through the absorbent element to form a second mixed liquid.

[0193] 14. The device according to Clause 13, wherein the absorbent element is in fluid communication with a channel in the connecting rod, and the second mixed liquid formed by passing through the absorbent element flows into the channel of the connecting rod.

[0194] 15. The device according to Clause 1, wherein the piercing element defines a compressible sealed space within the cavity of the receiving device, and the first sealed cavity is included within the sealed space.

[0195] 16. The device according to clause 15, wherein the cavity of the receiving device includes a second cavity, the partial piercing element is located in the second cavity, and the compressible partial sealed space is located in the second cavity.

[0196] 17. The device according to clause 16, wherein the piercing element has a first position and a second position in the second cavity of the receiving device.

[0197] 18. The device according to clause 17, wherein the piercing element includes a first cavity and a second cavity for receiving an absorption element, and a piercing structure and a through hole are provided on the first cavity.

[0198] 19. The device according to clause 18, wherein when the piercing element is in the first position, the piercing structure does not pierce the first sealed cavity, and when the piercing element is in the second position, the piercing structure pierces the first sealed cavity.

[0199] 20. The device according to clause 19, wherein when the piercing element is in the second position, the sealed space is compressed so that the pressure in the sealed space increases, thereby forcing the processing liquid to enter the first cavity of the piercing element through the through hole.

[0200] 21. The device according to clause 20, wherein when the piercing element is in the first position, the water-absorbing element is compressed or squeezed to release a fluid sample into the first cavity of the piercing element, thereby forming a first mixed liquid with the processing liquid in the first cavity.

[0201] 22. The device according to clause 21, wherein when the piercing element is in the second position, the increased pressure in the sealed space forces the first mixed liquid to pass through the absorption element, forming a second mixed liquid.

[0202] 23. The device according to clause 22, wherein the absorption element is in fluid communication with a channel in the connecting rod, and the second mixed liquid formed by passing through the absorption element is forced by the increased pressure in the sealed space to flow into the channel of the connecting rod.

[0203] 24. The device according to clause 23, wherein the channel of the connecting rod is in fluid communication with the test element, and the second mixed liquid can flow onto the test element to detect whether there is an analyte or the quantity of the analyte in the second mixed liquid.

[0204] 25. The device according to clause 19, wherein when the piercing element is in the second position, a part of the first cavity of the piercing element enters the first sealed cavity.

[0205] 26. The device according to clause 15, wherein the piercing element has a cavity, and the movement of the piercing element compresses the sealed space, thereby increasing the pressure within the sealed space.

[0206] 27. The device according to clause 26, wherein the movement of the piercing element causes the piercing structure of the piercing element to pierce the sealed first cavity, so that the increased pressure in the sealed space forces the processing liquid in the first sealed cavity to flow into the cavity of the piercing element.

[0207] 28. The device according to clause 1, wherein the first sealed cavity includes a film that can be pierced.

[0208] 29. A device for detecting whether an analyte is contained in a fluid sample, the device comprising:

[0209] A carrier element, which includes a test element and a cavity. The cavity includes a fluid inlet channel, and the cavity is in fluid communication with the test element. The test element includes a sample application area and a test area.

[0210] 30. The device according to clause 29, wherein the device further includes a drainage element, and the drainage element is in fluid communication with the inlet channel and the test element.

[0211] 31. The device according to clause 30, wherein the inlet channel includes a fluid inlet, and the fluid inlet is in fluid communication with the cavity. The cavity includes a dividing element, and the dividing element divides the cavity into a first region and a second region. The first region is located between the dividing element and the fluid inlet.

[0212] 32. The device according to clause 31, wherein one end of the reference element is located in the first region, and the other end covers part of the sample application area.

[0213] 33. The device according to clause 32, wherein the second region is configured to receive the fluid sample.

[0214] 34. The device according to clause 32, wherein one end of the drainage element covers the fluid inlet.

[0215] 35. The device according to clause 29, wherein the device includes a collector, and the collector includes an absorption element and a connecting rod.

[0216] 36. The device according to clause 35, wherein the collector and the carrier are detachably connected.

[0217] 37. The device according to clause 36, wherein the device further comprises a receiving element including a receiving cavity, and the carrier element is located in the receiving cavity.

[0218] 38. The device according to clause 37, wherein the carrier element is arranged to be inserted into the receiving cavity in a unique direction.

[0219] 39. The device according to clause 37, wherein the receiving cavity further comprises a connecting element, and the connecting rod of the collector passes through the connecting element and is connected to the inlet channel of the carrier.

[0220] 40. The device according to clause 39, wherein the connecting element further comprises a threaded structure.

[0221] 41. The device according to clause 29, wherein the cavity on the carrier comprises a vent hole communicating with the outside atmosphere.

[0222] 1. A method for processing a liquid sample, the method comprising: providing a device including a first sealed cavity for containing a processing liquid and a piercing element movable in the device, moving the piercing element to pierce the sealed cavity containing the processing liquid to release the processing liquid.

[0223] 2. The method according to clause 1, wherein the piercing element comprises a cavity, and allowing the released processing liquid to enter the cavity of the piercing element.

[0224] 3. The method according to clause 1, allowing an absorption element to enter the cavity of the piercing element to contact the processing liquid, thereby forming a first mixed liquid of the processing liquid and the fluid sample.

[0225] 4. The method according to clause 3, squeezing the absorption element in the cavity of the piercing element to release the fluid sample, and the fluid sample is mixed with the processing liquid in the cavity to form the first mixed liquid.

[0226] 5. The method according to clause 4, allowing the formed first mixed solution to flow back to contact the absorption element to form a second mixed solution, and allowing the second mixed solution to flow out of the piercing element.

[0227] 6. The method according to clause 4, allowing the second mixed liquid flowing out of the piercing element to flow onto a test element for detection or assay of the analyte.

[0228] 7. The method according to clause 1, wherein the device further comprises a second cavity for accommodating a part of the piercing element, and the piercing element has a first position and a second position in the second cavity.

[0229] 8. The method according to clause 7, wherein the piercing element is moved from a first position to a second position, so that the piercing structure on the piercing element pierces the first chamber containing the treatment liquid, and the treatment liquid in the first chamber enters the chamber of the piercing element.

[0230] 9. The method according to clause 8, wherein a part of the chamber of the piercing element enters the first chamber containing the treatment liquid.

[0231] 10. The method according to clause 8, wherein the piercing element includes a first chamber containing a piercing structure and a second chamber for receiving an absorbent element. The first chamber of the piercing element enters the first chamber of the treatment liquid, and the treatment liquid is forced into the first chamber of the piercing element.

[0232] 11. The method according to clause 10, wherein the second chamber of the piercing element receives the absorbent element and compresses the absorbent element to release a fluid sample. The released fluid sample enters the first chamber of the piercing element and mixes with the treatment liquid to form a first mixed liquid.

[0233] 12. The method according to clause 10, wherein the first mixed solution enters the second chamber of the piercing element and contacts or passes through the absorbent element to form a second mixed liquid. The second mixed liquid flows out of the piercing element and into the test element.

[0234] 13. The method according to clause 7, wherein the absorbent element is inserted into the chamber of the piercing element, so that the absorbent element is compressed, and at the same time, the piercing element is pushed from the first position to the second position.

[0235] 14. The method according to clause 8, wherein the absorbent element is inserted into the second chamber of the piercing element and the absorbent element is compressed to release a fluid sample. The released fluid sample flows into the first chamber of the piercing element.

[0236] 15. The method according to clause 8, wherein the absorbent element pushes the piercing element from the first position to the second position, so that the piercing element pierces the first sealed chamber containing the treatment liquid, and the first chamber of the piercing element enters the chamber containing the treatment liquid, so that the treatment liquid is forced into the first chamber of the piercing element to mix with the fluid sample.

[0237] 16. The method according to clause 13, wherein the absorbent element is connected to a connecting rod, and the connecting rod has a channel for transporting liquid and is in fluid communication with the absorbent element.

[0238] 17. The method according to clause 13, wherein the piercing element forms a sealed space in the sealing device, and the space can be compressed to increase the pressure of the space, wherein the sealed space includes the first sealed chamber containing the treatment liquid.

[0239] 18. The method according to clause 17, wherein an absorption element with a connecting rod is inserted into the second cavity of the piercing element, and the second cavity is sealed. The absorption element is compressed in the second cavity while the piercing element is pushed from the first position to the second position.

[0240] 19. The method according to clause 17, wherein the sealed space of the device is compressed, increasing the pressure in the sealed space. As the first cavity of the piercing element enters the cavity containing the processing liquid, the increased pressure forces the processing liquid into the first cavity to mix with the fluid sample.

[0241] 20. The method according to clause 19, wherein the increased pressure causes the mixture to flow into the second cavity of the piercing element, pass through the absorption element and into the channel of the connecting rod, and finally flow onto the test element.

[0242] The present invention provides a detection system, comprising a detection device as described in clauses 29 - 41 and a receiving device as described in clauses 1 - 28.

[0243] All patents and publications mentioned in the specification of the present invention indicate that these are publicly known technologies in the art and can be used in the present invention. All patents and publications cited herein are equally listed in the references, just as each publication is specifically individually referenced. The present invention described herein can be implemented in the absence of any one or more elements, one or more limitations, where such limitations are not specifically described. For example, in each instance herein, the terms "comprising", "consisting essentially of", and "consisting of" can be replaced by the remaining two of the three terms. The so-called "a" herein merely means "one", and does not exclude including only one, nor does it exclude including more than two. The terms and expressions used herein are for descriptive purposes and are not limiting. There is no intention herein to indicate that the terms and interpretations described in this book exclude any equivalent features, but it can be understood that any suitable 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 all preferred embodiments and features, and any person of ordinary skill in the art can make some changes and variations based on the essence described in the present invention, and these changes and variations are also considered to be within the scope of the present invention and the scope limited by the independent claims and the dependent claims.

Claims

1. A receiving device, comprising: A cavity, which includes a first sealed cavity for accommodating a processing solution and a piercing element. The piercing element can move within the cavity. Among them, the piercing element is arranged to pierce the first sealed cavity; the piercing element forms a sealed space within the cavity of the receiving device, and the air or gas in this sealed space can be compressed. The air or gas within the sealed space can be compressed by the movement of the piercing element, so as to increase the air pressure within the sealed space. Among them, the first sealed cavity is included within the sealed space. Among them, the piercing element includes a cavity. When the piercing element moves and pierces the first sealed cavity, the air pressure within the sealed space increases due to the movement of the piercing element, and the increased air pressure forces the processing solution in the first sealed cavity to flow into the cavity of the piercing element to contact the liquid sample, and the liquid sample can be detected by the test element.

2. The device according to claim 1, wherein The piercing element has a first position and a second position within the cavity.

3. The apparatus according to claim 2, wherein, The piercing element includes a piercing structure. During the process of the piercing element moving from the first position to the second position, the piercing structure pierces the first sealed cavity, so that the processing liquid in the first sealed cavity enters the cavity of the piercing element.

4. The device according to claim 2, wherein When the piercing element is in the first position, the piercing element is away from the first sealed cavity, or the piercing element does not pierce the first sealed cavity.

5. The device according to claim 4, wherein When the piercing element is in the second position, a part of the cavity of the piercing element enters the first sealed cavity, so as to force the processing liquid to enter the cavity of the piercing element; or the piercing element pierces the first sealed cavity, so as to release the processing liquid from the first sealed cavity.

6. The device according to claim 5, wherein, The piercing element includes a through hole, and the processing liquid flows into the cavity of the piercing element through the through hole.

7. The device according to claim 3 or 5, wherein, The cavity of the piercing element can be arranged to receive a liquid sample. When the processing liquid enters the cavity of the piercing element, the processing liquid and the liquid sample form a first mixed liquid.

8. The apparatus according to claim 7, wherein, The cavity of the side piercing element can be arranged to receive an absorption element, and the absorption element is compressed or squeezed to release the liquid sample.

9. The device according to claim 2, wherein The cavity of the piercing element includes a first cavity and a second cavity for receiving the absorption element, and a piercing structure is included on the first cavity.

10. The device according to claim 9, wherein, When the piercing element is in the first position, the piercing structure does not pierce the first sealed cavity. When the piercing element is in the second position, the piercing structure pierces the first sealed cavity.

11. The apparatus according to claim 10, wherein When the piercing element is in the second position, a part of the first cavity of the piercing element enters the first sealed cavity, so as to force the processing liquid to enter the first cavity of the piercing element.

12. The apparatus according to claim 10, wherein, When the piercing element is in the first position, the absorption element is compressed or squeezed to release the liquid sample into the first cavity of the piercing element, and the liquid sample can form a first mixed liquid with the processing liquid entering the first cavity of the piercing element.

13. The apparatus according to claim 12, wherein, When the piercing element is in the second position, the first mixed liquid passes through the absorption element to form a second mixed liquid.

14. The apparatus according to claim 13, wherein, The absorption element is in fluid communication with a channel in the connecting rod, and the second mixed liquid formed by passing through the absorption element flows into the channel of the connecting rod.

15. The device according to claim 1, wherein, The cavity of the receiving device further includes a second cavity, a part of the piercing element is located in the second cavity, and a part of the sealed space is located in the second cavity.

16. The device according to claim 15, wherein, The piercing element has a first position and a second position in the second cavity of the receiving device.

17. The apparatus according to claim 16, wherein, The cavity of the piercing element includes a first cavity and a second cavity for receiving the absorption element. The first cavity is provided with a piercing structure and a through hole.

18. The device according to claim 17, wherein, When the piercing element is in the first position, the piercing structure does not pierce the first sealed cavity. When the piercing element is in the second position, the piercing structure pierces the first sealed cavity.

19. The apparatus according to claim 18, wherein, When the piercing element is in the second position, the sealed space is compressed so that the pressure in the sealed space increases. The increased pressure forces the processing liquid in the first sealed cavity to enter the first cavity of the piercing element through the through hole.

20. The apparatus according to claim 19, wherein, When the piercing element is in the first position, an absorption element is compressed or squeezed to release a liquid sample into the first cavity of the piercing element, so as to form a first mixed liquid with the processing liquid in the first cavity.

21. The apparatus according to claim 20, wherein, When the piercing element is in the second position, the increased pressure in the sealed space forces the first mixed liquid to pass through the absorption element to form a second mixed liquid.

22. The device according to claim 21, wherein, The absorption element is in fluid communication with a channel in the connecting rod, and the second mixed liquid formed by passing through the absorption element is forced by the increased pressure in the sealed space to flow into the channel of the connecting rod.

23. The device according to claim 22, wherein, The channel of the connecting rod is in fluid communication with the test element, and the second mixed liquid can flow onto the test element to detect whether there is an analyte or the quantity of the analyte in the second mixed liquid.

24. The apparatus according to claim 20, wherein, When the piercing element is in the second position, a part of the first cavity of the piercing element enters the first sealed cavity.

25. The device according to claim 1, wherein The piercing element includes an elastic sealing ring, and the sealed space is formed with the inner wall of the cavity of the device through the elastic sealing ring.

26. The device according to claim 1, wherein The first sealed cavity includes a film that can be pierced.

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