Testing device for detecting whether fluid sample contains analyzed substance or not

Abstract

The present invention provides a test device for detecting whether a fluid sample contains an analyte, the device comprising: a carrier element, the carrier element comprising a test element and a cavity, the cavity comprising a fluid introduction channel, the cavity being in fluid communication with the test element, through which the fluid is introduced into the test element; and the test performance of the test element can be prevented from being influenced by flood.

Description

[0001] This application is a divisional application of a Chinese prior application, application number: 202080049340.7, filing date: July 27, 2020, which claims priority to a Chinese prior application, application number: 201910699245.0, filing date: July 31, 2019, and a U.S. prior provisional application, application number 62 / 880,777, filing date July 31, 2019. TECHNICAL FIELD

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

[0003] The following background description is merely intended to provide some background information and does 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 contain one or more test strips, such as early pregnancy detection, drug abuse detection, etc. Such detection devices for rapid diagnosis are very convenient and can obtain a detection result on the test strip within one minute or at most within ten minutes.

[0005] Drug detection is widely used in drug control departments, public security bureaus, drug rehabilitation centers, physical examination centers, and state recruitment physical examination departments. Drug detection is diverse and frequent. Some require sample collection and then professional detection by detection agencies or detection laboratories. Some require on-site detection, such as roadside detection, for example, personnel who drive after drug use (referred to as "drug driving") need to be detected on-site and then obtain the detection result in time.

[0006] For example, for saliva sample detection, based on the convenience of collection, it is gradually accepted and welcomed by detection agencies or detection personnel. Various sample collection and testing devices for clinical or home use can be obtained and described in some documents. For example, U.S. Patent No. 5,376,337 discloses a saliva sampling device, in which a piece of filter paper is used to collect saliva from the mouth of a subject and transfer the saliva to an indicator reagent. U.S. Patent Nos. 5,576,009 and 5,352,410 each disclose a syringe-type fluid sampling device.

[0007] A sample detection device is disclosed in, for example, U.S. Patent Application No. 14 / 893,461, Publication No. US2016 / 0121322A1, which only discloses some basic detection schemes and principles, but it is difficult to realize a specific product, such as the cooperation of the cover combination and the detection combination, how to compress the liquid head for absorbing saliva, how to move, and how to effectively mix with the liquid. The actual effect is not ideal.

[0008] In view of the above technical problems of some conventional products, it is necessary to improve them and provide another way to solve the deficiencies of the existing conventional technology. SUMMARY

[0009] In view of the above situation, in order to overcome the defects of the prior art, the purpose of the present application is to provide a device for receiving a detection fluid sample to be analyzed, and a receiving device for cooperating with the detection device. The receiving device comprises a cavity, which comprises a liquid chamber for containing liquid and a piercing element movable in the device. The "receiving" in the receiving device here does not limit the specific use of the device, which can be called a liquid handling and mixing device, or a liquid sample transfer and transport device, so it can be called a device.

[0010] In a first aspect of the present application, a device is provided, which comprises a cavity for containing a processing liquid and a piercing element movable in the device.

[0011] In some embodiments, the device comprises a cavity, which comprises a sealed cavity containing a processing liquid in the cavity of the device, and a piercing element movable in the cavity.

[0012] In some embodiments, the device comprises a first cavity for containing a processing liquid and a second cavity for containing all or part of the piercing element. In some embodiments, the first cavity is a sealed cavity, which comprises a processing liquid in the sealed cavity. In some embodiments, the first cavity comprises a sealed cavity, which comprises a processing liquid in the sealed cavity. This is to separately place the processing liquid in a separate sealed cavity, and then place the sealed cavity in the first cavity. It can be understood that there is no so-called first cavity, and a sealed cavity containing a processing liquid is arranged in the position of the first cavity of the device.

[0013] In some embodiments, the piercing element comprises a piercing structure arranged to pierce the first cavity of the device to release the processing liquid.

[0014] In some embodiments, the lancing element includes a cavity configured to transport, mix, carry, transfer, or process a fluid sample. In the cavity of the lancing element, a fluid sample can be mixed with a processing fluid, a processing fluid can be flowed into the cavity of the lancing element to contact a fluid sample, or a fluid (processing fluid, mixed fluid of processing fluid and fluid sample, or fluid sample) in the cavity of the lancing element can be transported through the cavity of the lancing element to a test element for detection or analysis.

[0015] In some embodiments, the cavity of the lancing element is configured to receive an absorbent element configured to absorb a fluid sample. In some embodiments, the cavity of the lancing element is configured to mix a fluid sample from the absorbent element with a processing fluid to form a mixed fluid. In some embodiments, the mixed fluid formed in the cavity of the lancing element flows through the absorbent element to a test element for detection or analysis.

[0016] In some embodiments, the lancing structure is disposed on or in the cavity of the lancing element.

[0017] In some embodiments, the cavity of the lancing element includes a first cavity configured to receive a processing fluid from a cavity containing a processing fluid and a second cavity configured to receive a fluid sample. In some embodiments, the first cavity of the lancing element is in fluid communication with the second cavity such that a fluid sample and a processing fluid are mixed in the first cavity or the second cavity to form a mixed fluid.

[0018] In some embodiments, the mixed fluid sample is transported through the second cavity to a test element for testing the presence of an analyte in the fluid sample.

[0019] In some embodiments, the second cavity of the lancing element is configured to receive an absorbent element configured to absorb, draw, or wick a fluid sample, such as a saliva, urine, sweat, or other fluid sample. When the absorbent element absorbs a fluid sample, the second cavity indirectly receives the fluid sample. In some embodiments, the absorbent element is compressed in the second cavity to release the fluid sample into the first cavity of the lancing element to mix with a processing fluid from the device.

[0020] In some embodiments, the mixed fluid formed in the first cavity of the lancing element flows through the absorbent element in the second cavity and to a test element for detection or analysis.

[0021] In some aspects, movement of the piercing member accomplishes mixing, transport, or flow of the liquid. In some aspects, the piercing member moves within the device, and during, before, or after the movement, the piercing member accomplishes the entry of the treatment liquid in the first sealed chamber of the device into the chamber of the piercing member, such as the first chamber. For example, the piercing member moves, and the piercing structure of the piercing member pierces the first sealed chamber containing the treatment liquid, and the treatment liquid flows into the chamber of the piercing member. In some aspects, the chamber of the piercing member is configured to receive an absorbent member and compress the absorbent member to release an absorbed fluid sample into the chamber of the piercing member to mix with the treatment liquid. This can occur before, during, and / or after the movement of the piercing member, or simultaneously with the movement of the piercing member.

[0022] In some aspects, the piercing member has a first position and a second position in the first chamber of the device, and when the piercing member is in the first position, the piercing structure of the piercing member does not pierce the chamber containing the treatment liquid, and when the piercing member is in the second position, the piercing structure pierces the chamber containing the treatment liquid.

[0023] In some aspects, when the piercing member moves from the first position to the second position, or during the movement, the first chamber of the piercing member enters the first sealed chamber containing the treatment liquid, such as the first chamber of the device. The entry of the first chamber of the piercing member into the chamber containing the treatment liquid forces the treatment liquid into the first chamber of the piercing member. In some aspects, the first chamber of the piercing member includes a hole or a through hole, and the treatment liquid enters the first chamber through the hole. In some aspects, the second chamber of the piercing member receives an absorbent member, and before, during, or after the movement of the piercing member from the first position to the second position, the absorbent member is compressed to release a fluid sample. The released fluid sample flows into the first chamber of the piercing member to mix with the treatment liquid.

[0024] In some aspects, during the movement of the piercing member from the first position to the second position, or after the piercing member reaches the second position, the mixed liquid (the treatment liquid, the mixed liquid of the treatment liquid and the fluid sample, or the fluid sample) in the first chamber of the piercing member returns to the second chamber of the piercing member, flows through the absorbent member, and onto a test member. In some aspects, the liquid that returns and flows through the absorbent member does not necessarily flow directly onto the test member, but instead flows into a container for subsequent testing or analysis.

[0025] In some embodiments, the absorbent element is disposed on a sampler comprising a connecting rod and an absorbent element. The sampler is inserted into the second cavity of the puncture element, and the sampler pushes the puncture element from a first position to a second position. In some embodiments, the sampler is combined with a container, and the container comprises a connecting element, and the connecting element pushes the second cavity of the puncture element, thereby moving the puncture element from the first position to the second position. The contact of the connecting element with the puncture element occurs when the sampler is inserted into the second cavity of the puncture element.

[0026] In some embodiments, a portion of the piercing element is located in the second lumen of the device, has the first position and the second position in the second lumen, or is capable of moving from the first position to the second position. In some embodiments, the first lumen of the piercing element is located in the second lumen of the device, has the first position and the second position in the second lumen of the device, or is capable of moving from the first position to the second position.

[0027] In some embodiments, 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 embodiments, the first chamber containing the treatment liquid is in a sealed state, and the treatment liquid is sealed in the first chamber. When the liquid is sealed, it is a liquid seal. In some embodiments, 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 embodiments, the puncture element or a portion of the puncture element seals the second chamber of the device. In some embodiments, the movement of the puncture element in the second chamber allows the gas inside the second chamber of the device to be compressed to cause the air pressure to increase. In some embodiments, the puncture element includes an elastic sealing ring, and the elastic sealing ring contacts the inner wall of the second chamber of the device, thereby sealing the second chamber of the device.

[0028] In some embodiments, the first lumen of the device is located downstream of the piercing element, which is located upstream of the first sealed lumen of the device, and the piercing element moves from upstream to downstream, thereby piercing the first lumen of the device. In some embodiments, the piercing structure is proximal to the first lumen of the device, and the second lumen of the piercing element is distal to the first lumen of the device, or the first lumen of the piercing element is located between the second lumen of the piercing element and the first lumen of the device.

[0029] In some embodiments, the puncture structure of the puncture element is located on the first cavity of the puncture element. In another optional embodiment, the puncture structure is located on the outer wall of one end of the first cavity of the puncture element.

[0030] In some embodiments, the second chamber and the first chamber of the device are in fluid communication.

[0031] In some embodiments, the device further comprises a third cavity, the inner wall of the third cavity having a threaded structure that cooperates with the threaded mechanism of the connecting element, either interlocking or intermeshing, so that the receiving element with the piercing element is combined to form an integrated structure.

[0032] In some embodiments, the piercing element comprises a first cavity and a second cavity, the first cavity and the second cavity being fluidly connected, thereby forming a fluid channel.

[0033] In some embodiments, the first cavity is configured to receive the absorbent element, and the second cavity is configured to receive a fluid sample on the absorbent element.

[0034] In some embodiments, the piercing element comprises a hole or a through hole that connects the first cavity and the second cavity of the piercing element.

[0035] In some embodiments, the first cavity of the piercing element has a smaller inner diameter than the second cavity. In some preferred embodiments, the first cavity has an inner diameter that is smaller than the diameter of the absorbent element. In other words, the first cavity is substantially incapable of receiving the absorbent element into the first cavity. In other words, the second cavity is configured to receive the absorbent element while minimizing the entry of the absorbent element into the first cavity. Here, minimizing the entry does not mean that the entry is completely prevented. In some embodiments, the absorbent element can be partially or completely inserted into the first cavity. In this way, the entry or insertion of the absorbent element into the second cavity of the piercing element facilitates the compression or squeezing of the absorbent element. In preferred embodiments, the compression or squeezing of the absorbent element facilitates the movement of the piercing element.

[0036] In some embodiments, the fluid absorbing element is in fluid communication with a test element of the testing device, as described in detail below. In this way, when the fluid absorbing element is compressed in the lumen of the piercing element, the fluid sample flows out, and at the same time, the piercing element pierces the fluid containing lumen containing the treatment fluid, and the treatment fluid mixes with the fluid sample to form a mixed sample, or the treatment fluid contacts the fluid absorbing element to elute the analyte on the fluid absorbing element, and the mixture flows into the lumen of the piercing element and contacts the test element, which is disposed in the lumen of the piercing element. Alternatively, when the fluid absorbing element is compressed in the second lumen of the piercing element, the fluid sample released from the fluid absorbing element flows into the first lumen of the piercing element, and at the same time, as the first lumen of the piercing element enters the fluid containing lumen containing the treatment fluid, the treatment fluid enters the first lumen of the piercing element and mixes with the fluid sample to form a mixed fluid; as the first lumen continues to enter the fluid containing lumen containing the treatment fluid, the mixed fluid in the first lumen flows back into the second lumen and contacts the fluid absorbing element or passes through the fluid absorbing element to elute the analyte on the fluid absorbing element, and the new mixed fluid flows out of the piercing element; optionally, the new mixed fluid flows into the test element in fluid communication with the fluid absorbing element for analysis of the analyte.

[0037] In some embodiments, after the fluid absorbing element is compressed, the mixed fluid passes through the fluid absorbing element into a channel connecting the fluid absorbing element and the test element, and then flows into the test element through the channel. The channel is located in the connecting rod of the sampler, and the mixed fluid passes through the fluid absorbing element to elute some adsorbed substances on the fluid absorbing element, and after mixing with the fluid sample, the detection performance of the test element is improved, such as increasing the sensitivity or specificity of the detection. This is because some samples contain interfering substances that affect the detection performance, and mixing with the fluid reduces the interference. It is also possible that some substances (analytes) are adsorbed on the fluid absorbing element and need to be eluted by the liquid (e.g., treatment solution) to improve the accuracy of the test.

[0038] In some embodiments, the lumen containing the treatment fluid includes a thin film, such as a plastic film, double-sided tape, or aluminum foil film, which is easily pierced by the piercing structure to seal the lumen containing the treatment fluid.

[0039] In some embodiments, the piercing element can move in the lumen containing the treatment lumen from a first initial position to a second position. In some embodiments, when the piercing element is in the first initial position, the piercing end of the piercing element is located near the easily pierced film and does not substantially pierce the film. Preferably, the piercing end is located at the upper end of the piercing film. Preferably, the piercing end is in contact with the piercing film.

[0040] In some preferred embodiments, a gap or space is provided between the piercing element and the cavity housing the piercing element for receiving a portion of the testing device, such as a connecting element of the testing device. In some embodiments, a gap or space is provided between the second cavity of the piercing element and the third cavity of the receiving device for facilitating the mating of the threads of the outer wall of the connecting unit with the threads of the inner wall of the third cavity.

[0041] In some embodiments, the testing device includes a testing element for testing the fluid sample for the presence of the analyte. In some embodiments, the testing device includes an absorbent element for absorbing the fluid sample. In some embodiments, the absorbent element is removably coupled or engaged with the testing element. This is convenient for manufacturing because the absorbent element needs to be sterilized, such as by heat or radiation, before it can be used to collect and absorb the fluid sample. However, these sterilization steps can affect the chemicals of the testing element. Therefore, the absorbent element can be separated from the testing element before the sterilization of the absorbent element and coupled with the testing element after the sterilization of the absorbent element. This facilitates the manufacturing and assembly of the testing device and reduces the adverse effect on the testing element.

[0042] In some embodiments, the testing element is provided on a carrier that carries the testing element and the absorbent element is removably coupled or engaged with the carrier.

[0043] In some embodiments, the testing element is provided on a carrier that carries the testing element and the absorbent element is removably coupled or engaged with the carrier.

[0044] In some embodiments, a fluid path is provided between the absorbent element and the testing element for allowing fluid to flow from the absorbent element to the testing element. This allows the testing element to test the fluid sample absorbed by the absorbent element for the presence of the analyte. The absorbent element can be made of a material that is capable of absorbing fluid, such as a sponge, filter paper, polyester fiber, etc.

[0045] In some embodiments, the absorbent element is in fluid communication with the testing element via a connecting rod. The connecting rod has a fluid path therein for connecting the absorbent element and the testing element or a carrier that carries the testing element.

[0046] In some embodiments, the carrier that carries the testing element is housed in a housing cavity that includes a space for housing the carrier. The cavity includes a connecting unit that is capable of being connected with the receiving device to facilitate the transfer of the fluid sample.

[0047] In a second aspect, the present application provides a method of processing a fluid sample, the method comprising: providing a device comprising a chamber for containing a processing fluid and a piercing element movable within the device, moving the piercing element to pierce the chamber containing the processing fluid to release the processing fluid.

[0048] In some embodiments, the piercing element comprises a chamber for receiving the released processing fluid.

[0049] In some embodiments, the absorbing element is moved into the chamber of the piercing element to contact the processing fluid to form a mixture of the processing fluid and the fluid sample. The absorbing element is compressed within the chamber of the piercing element to release the fluid sample which mixes with the processing fluid to form a mixture (first mixture). In some embodiments, the mixture is moved back into the absorbing element to contact the absorbing element to form a new mixture (second mixture) which is moved out of the piercing element. The mixture moved out of the piercing element is moved onto a test element for detection or analysis of the analyte.

[0050] In some embodiments, the device comprises a first sealed chamber for containing a processing fluid, a second chamber for containing a portion of the piercing element, the piercing element having a first position and a second position within the second chamber. The piercing element is moved from the first position to the second position to cause a piercing structure on the piercing element to pierce the first chamber containing the processing fluid to cause the processing fluid in the first chamber to enter a chamber of the piercing element. In some embodiments, a portion of the chamber of the piercing element enters the first chamber containing the processing fluid. In some embodiments, the piercing element comprises a first chamber containing the piercing structure and a second chamber for receiving an absorbing element, the first chamber of the piercing element is moved into the first chamber containing the processing fluid to force the processing fluid into the first chamber of the piercing element. In some embodiments, the second chamber of the piercing element receives the absorbing element and compresses the absorbing element to release the fluid sample, the released fluid sample enters the first chamber of the piercing element to mix with the processing fluid to form a first mixture. In some embodiments, the mixture enters the second chamber of the piercing element to contact or pass through the absorbing element to form a second mixture, the second mixture is moved out of the piercing element and onto a test element.

[0051] In some embodiments, the absorbent element is inserted into the cavity of the piercing element, causing the absorbent element to compress and simultaneously propel the piercing element from a first position to a second position. In some embodiments, the absorbent element is inserted into the second cavity of the piercing element and caused to compress, releasing the fluid sample, which then flows into the first cavity of the piercing element. The absorbent element propels the piercing element from the first position to the second position, causing the piercing element to puncture the first cavity containing the treatment fluid and allowing the first cavity of the piercing element to enter the cavity containing the treatment fluid, thereby forcing the treatment fluid into the first cavity of the piercing element to mix with the fluid sample.

[0052] In some embodiments, the absorbent element is connected to a connecting rod, which has a channel for transmitting liquid and is in fluid communication with the absorbent element. In some embodiments, the puncture element seals the second chamber of the device, so that the second chamber and the first sealed chamber containing the treatment liquid are in a sealed state. The absorbent element with the connecting rod is inserted into the second chamber of the puncture element and seals the second chamber. The absorbent element is compressed in the second chamber, and the puncture element is pushed 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 chamber of the puncture element enters the chamber containing the treatment liquid, the increased gas pressure and / or the pressure exerted by the first chamber of the puncture element on the liquid in the sealed first chamber forces the treatment liquid to enter the first chamber of the puncture element and mix with the fluid sample. Then, the further increased pressure causes the mixed liquid to flow into the second chamber of the puncture element, pass through the absorbent element, enter the channel of the connecting rod, and finally flow onto the test element. Here, the increased gas pressure can allow the mixed liquid to flow back to the absorption element alone, thereby eluting the absorption element and flowing out of the puncture element. As long as the puncture element punctures the first sealed cavity and the puncture element is directly and indirectly connected to the first sealed cavity, the increased pressure can force the treatment liquid to enter the cavity of the puncture element. This is because there is a pressure difference between the cavity of the puncture element and the device that is compressed to increase the air pressure.

[0053] In a third aspect, the present invention provides a detection device, which includes a test element, wherein the test element is arranged in a carrier, wherein the carrier includes a cavity, and the cavity is in fluid communication with the absorption element.

[0054] In some embodiments, the carrier includes a slot for mounting a test element, one end of which communicates with an opening of a cavity on the carrier. In some embodiments, the cavity includes an inlet port, which is one end of a fluid inlet channel. In some embodiments, a drainage strip is provided in front of the fluid inlet port, with one end of the drainage strip positioned in front of the inlet port and the other end contacting the test strip to facilitate fluid drainage.

[0055] In some embodiments, the chamber is divided into a first and a second region by a partitioning structure located adjacent to the fluid inlet, one end of the wick is located in the first region between the inlet and the partitioning structure, and the other end of the wick is in contact with or overlaid on the test element, preferably the other end is in contact with or overlaid on the sample application region of the test element. In some embodiments, the second region is configured to receive excess fluid sample from the inlet. In some embodiments, the sample application region of the test element is located at the opening of the chamber and in contact with the wick. The fluid sample can be the fluid sample itself, a mixture of the fluid sample and a processing fluid, or a mixed sample as defined herein.

[0056] In some embodiments, the carrier includes a vent in communication with the atmosphere. The carrier is preferably assembled in a closed space, and the chamber of the carrier is configured to receive fluid from the inlet channel. In one embodiment, the inlet channel is connected to the connecting rod, and the connecting rod is connected to the absorbent element. When the absorbent element is inserted into the chamber of the piercing element, such as the first chamber, as the piercing element moves, the fluid sample and the processing fluid are transferred to the chamber of the carrier. To reduce the resistance of the closed chamber of the carrier, the vent is provided to allow the fluid to quickly enter the carrier. As described above, when the piercing element and the receiving device form a sealed space, a pressure difference can be formed between the sealed space and the chamber of the piercing element. The pressure difference allows the mixed fluid of the processing fluid and the fluid sample to quickly enter the chamber of the carrier and flow to the test element for analysis or detection of the analyte.

[0057] In some embodiments, the detection device further comprises a receiving element comprising a receiving cavity configured to receive the carrier comprising the test element. The receiving cavity is configured to facilitate the assembly of the carrier and the collector, and to facilitate the operation of the device. In some embodiments, the receiving cavity comprises a slide track, and the carrier comprises a slide rail configured to mate with the slide track to facilitate the insertion of the carrier into the receiving cavity. In some embodiments, the insertion of the carrier into the receiving cavity is unidirectional or unique. The unidirectional insertion of the carrier into the receiving cavity means that the carrier has a front side and a back side, and the front side is always in contact with one side of the receiving cavity while the back side is always in contact with the other side of the receiving cavity. In some embodiments, the carrier comprises a limiting structure configured to limit the insertion of the carrier into the receiving cavity to one direction. In some embodiments, the limiting structure is located on the back side of the carrier. In some embodiments, the slide track of the receiving cavity comprises two tracks, and the slide rail of the carrier comprises two rails located on the side of the carrier, and the limiting structure is located between the two rails. The slide track, the slide rail and the limiting structure are configured to facilitate the unidirectional insertion of the carrier into the receiving cavity. In some embodiments, the carrier and the receiving cavity are configured to be detachably assembled. In some embodiments, the receiving element comprises a connecting element, and the connecting element is configured to have a threaded structure configured to mate with the internal threads of the third cavity of the device to facilitate the assembly of the collector with the device to facilitate the transfer of the liquid sample from the collector to the receiving element.

[0058] In some embodiments, the connecting element and the receiving cavity are configured to have a hole configured to allow the insertion of one end of the connecting rod into the hole, and the other end of the connecting rod is configured to be in contact with the inlet channel of the carrier. The hole is configured to allow the liquid sample in the connecting rod to flow into the inlet channel of the carrier, and the liquid sample is configured to flow through the flow guide element to the test element. The assembly of the collector and the carrier is configured to be detachable.

[0059] In some embodiments, the connecting rod comprises a protrusion configured to mate with the inner wall of the connecting element to facilitate the insertion of the connecting rod into the hole. In some embodiments, the protrusion is a ring-shaped protrusion configured to align the longitudinal axis of the connecting rod with the longitudinal axis of the connecting element. In some embodiments, the connecting rod is configured to have a threaded structure at one end, and the inlet channel of the carrier is configured to have a threaded structure configured to mate with the threaded structure of the connecting rod to facilitate the detachable assembly of the collector and the carrier. The assembly of the collector and the carrier is configured to be detachable, and the assembly of the collector and the carrier is configured to allow the receiving element and the carrier to be treated separately before the assembly of the collector and the carrier.

[0060] In some embodiments, 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 puncture element. When the absorption element is inserted into the cavity of the puncture element, the sealing ring cooperates with the inner wall of the cavity of the puncture element to seal, so that when the absorption element is squeezed, the fluid sample on the absorption element will not leak to the outside of the puncture element, but will allow the fluid sample to flow into the cavity of the puncture element.

[0061] In a fourth aspect, the present invention provides a system for detecting an analyte in a fluid sample. The system comprises the aforementioned receiving device and a detection device, wherein the detection device is provided with a collector comprising an absorbent element. In some embodiments, the collector and detection device are detachably assembled. In some embodiments, the detection device comprises a test element disposed on a carrier comprising a cavity for receiving a solution from the absorbent element.

[0062] In a fifth aspect, the present invention provides a method for detecting an analyte in a sample, the method providing a detection device and a receiving device as described above, the detection device comprising an absorption element, the absorption element being fluidically connected to a test strip in the detection device, the receiving device comprising a first cavity for accommodating a processing liquid and a puncture element, wherein the puncture element comprises a puncture structure and a cavity; the absorption element is inserted into the cavity of the puncture element, thereby compressing the absorption element and releasing the fluid sample.

[0063] In some embodiments, a fluid sample is collected using an absorbent element on the detection device, which is then inserted into the cavity of the piercing element.

[0064] In some embodiments, the piercing element is moved within the receiving device and pierces a cavity containing a treatment fluid, thereby allowing the treatment fluid to enter the cavity of the piercing element. In some embodiments, the treatment fluid is mixed with a fluid sample to form a first mixed liquid. In some embodiments, the first mixed liquid is allowed to flow through an absorbent element onto a testing element of a detection device.

[0065] In some embodiments, the piercing element has a first position and a second position in the receiving device, such that when the piercing element is in the first position, the piercing structure does not pierce the first cavity containing the treatment fluid, and when the piercing element is in the second position, the piercing structure pierces the first cavity containing the treatment fluid.

[0066] In some embodiments, the absorbent element is inserted into the lumen of the piercing element and compressed when the piercing element is in the first position, releasing the fluid sample into the lumen of the piercing element. In some embodiments, the detection device pushes the piercing element from the first position to the second position, thereby breaking the sealed first lumen and allowing the processing fluid in the first sealed lumen to flow into the lumen of the piercing element and mix with the fluid sample to form a first mixed fluid.

[0067] In some embodiments, the piercing element forms a sealed space within the receiving device, which is compressed by the movement of the piercing element, thereby increasing the pressure of the sealed space. In some embodiments, the increased pressure forces the processing fluid in the first sealed lumen to flow into the lumen of the piercing element and mix with the fluid sample to form a first mixed fluid.

[0068] In some embodiments, the detection device pushes the piercing element from the first position to the second position, thereby breaking the sealed first lumen and allowing the processing fluid in the first sealed lumen to flow into the lumen of the piercing element and contact the absorbent element.

[0069] Advantages

[0070] With the above structure, higher sensitivity detection can be achieved, and the absorbent element and the test element carrier can be assembled and disassembled, reducing assembly costs and reducing damage to different processed test elements. BRIEF DESCRIPTION OF DRAWINGS

[0071] Figure 1 is a structural exploded view of the receiving device and the detection device in one embodiment of the present application.

[0072] Figure 2 is a structural view of the test element carrier in one embodiment of the present application.

[0073] Figure 3 is a structural view of the test element carrier in another embodiment of the present application.

[0074] Figure 4A is a perspective exploded view of the position and cooperation of the drainage element and the carrier lumen after assembly of the test element carrier in one embodiment of the present application.

[0075] Figure 4B is a perspective view of the test element carrier after assembly in one embodiment of the present application.

[0076] Figure 5 is a perspective view of the receiving element in one embodiment of the present application.

[0077] Figure 6is a perspective view of a longitudinal section of the housing element in one embodiment of the application.

[0078] Figure 7 is a schematic view of the back of the carrier in one embodiment of the application.

[0079] Figure 8 is a schematic view of the assembly of the carrier into the housing cavity of the housing element in one embodiment of the application.

[0080] Figure 9 is a schematic view of the assembly of the carrier into the housing cavity of the housing element in one embodiment of the application.

[0081] Figure 10 is a schematic view of the exploded structure of the detection device in one embodiment of the application.

[0082] Figure 11 is a schematic view of the detection device with the collector in one embodiment of the application.

[0083] Figure 12 is a schematic view of the cooperation of the collector with the test element and the flow guide element in one embodiment of the application.

[0084] Figure 13 is a schematic view of the receiving device or the receiving cup in one embodiment of the application.

[0085] Figure 14 is a schematic view of the receiving device or the receiving cup in one embodiment of the application.

[0086] Figure 15 is a schematic view of the receiving device or the receiving cup in one embodiment of the application.

[0087] Figure 16 is a schematic view of the piercing element with the cavity in one embodiment of the application.

[0088] Figure 17 is a schematic view of the piercing element in one embodiment of the application.

[0089] Figure 18 is a schematic view of the insertion of the test device into the receiving device in one embodiment of the application.

[0090] Figure 19is a cross-sectional view of the insertion of a test device (absorbent element absorbs fluid sample) into a receiving device (contains treatment solution) in one embodiment of the present invention.

[0091] Figure 20 is a cross-sectional view of the insertion of a test device into the lumen of a piercing element of a receiving device, with the absorbent element being compressed, the piercing element in a first, initial position, in one embodiment of the present invention.

[0092] Figure 21 is a cross-sectional view of the movement of a piercing absorbent element by a connecting element from a first position to a second position, with the piercing structure piercing the lumen containing the treatment solution and partially entering the lumen, in one embodiment of the present invention.

[0093] Figure 22 is a cross-sectional view of the movement of a piercing absorbent element by a connecting element from a first position to a second position, with the first lumen of the piercing structure being inserted into the lumen, the treatment solution entering the first lumen and mixing with the fluid sample and passing through the absorbent element into the test element, in one embodiment of the present invention.

[0094] Figure 23 is a schematic view of the principle of the structure (initial position of the moving element) in one embodiment of the present invention.

[0095] Figure 24 is a schematic view of the principle of the structure (movement of the moving element, increase in pressure in the closed space) in one embodiment of the present invention.

[0096] Figure 25 is a schematic view of the principle of the structure (liquid flow) in one embodiment of the present invention. DETAILED DESCRIPTION

[0097] The following further describes the structure of the present invention or the technical terms used in the present invention, and if not otherwise specified, the general terms in the field are used and interpreted.

[0098] detecting

[0099] Detection means testing for the presence or absence of a substance or material, such as, but not limited to, a chemical substance, an organic compound, an inorganic compound, a metabolite, a drug or a drug metabolite, an organic tissue or a metabolite of an organic tissue, a nucleic acid, a protein or a polymer. In addition, detection means testing for the amount of a substance or material. Further, testing means immunoassay, chemical assay, enzyme assay, etc.

[0100] sample

[0101] The detection device or collected sample of the present application comprises a biological fluid (e.g., a bodily fluid or a clinical sample). The fluid sample or specimen can be derived from a solid or semi-solid sample, including excreta, biological tissue and food samples. The solid or semi-solid sample can be converted to a fluid sample by any suitable method, such as mixing, mashing, macerating, incubating, dissolving or digesting the solid sample with enzymes in a suitable solution (e.g., water, phosphate buffer or other buffer solution). A "biological sample" includes samples derived from animals, plants and food samples, such as urine, saliva, blood and its components, spinal fluid, vaginal secretions, semen, fecal matter, sweat, secretions, tissues, organs, tumors, cultures of tissues and organs, cell cultures and media, including samples derived from humans or animals. Preferably, the biological sample is urine, and more preferably, the biological sample is saliva. Food samples include food processing materials, end products, meat, cheese, wine, milk and drinking water. Plant samples include samples derived from any plant, plant tissue, plant cell cultures and media. An "environmental sample" is derived from the environment (e.g., a fluid sample from a lake or other body of water, a sewage sample, a soil sample, ground water, sea water and waste fluid sample). Environmental samples can also include sewage or other waste water.

[0102] Any analyte can be detected using the appropriate detection element or test element of the present application. Preferably, small drug molecules in saliva, urine are detected using the present application. Of course, any of the above samples can be collected using the collector of the present application, whether initially in a solid or liquid state, provided that the liquid or fluid sample can be absorbed by the absorbent element. The absorbent element 107 is typically made of a water-absorbing material that is initially dry and is capable of absorbing a liquid or fluid sample and retaining the fluid sample within the absorbent element by capillary or other properties of the absorbent material. The absorbent material can be any material that is capable of absorbing a liquid, such as a sponge, filter paper, polyester fiber, gel, non-woven fabric, cotton, polyester film, yarn, etc. Of course, the absorbent element need not be made of a water-absorbing material, but can be made of a non-water-absorbing material having holes, threads, cavities, etc. in which the sample, typically a solid or semi-solid sample, can be collected and retained within the threads, holes or cavities. Alternatively, the absorbent element can be made of non-water-absorbing fibers or hair that can be used to scrape a solid, semi-solid or liquid sample and retain the sample on the absorbent element.

[0103] downstream and upstream

[0104] The terms "downstream" and "upstream" are used to define the direction of liquid flow. Generally, liquid or fluid flows from the upstream to the downstream area. The downstream area receives liquid from the upstream area, and liquid can also flow along the upstream area to the downstream area. This is generally divided based on the direction of liquid flow. For example, in some materials that utilize capillary forces to promote liquid flow, liquid can overcome gravity and flow in the direction opposite to gravity. In this case, the upstream and downstream areas are still defined based on the direction of liquid flow. For example, in the detection device 102 of the present invention, after the absorbing element absorbs a fluid sample or liquid sample, the fluid can flow from the absorbing element 107 to the sample application area 1121 of the testing element 112. At this time, the liquid flows from the sample application area 1121 to the absorbing area 1123 from upstream to downstream. During this flow, the liquid passes through the testing area 1122, resulting in the detection area 1126 and the test result control area 1125. The testing area can be made of polyester film, and the sample application area can be made of glass fiber. In this case, the absorbing element 107 is located upstream of the testing element's sample application area.

[0105] Of course, the upstream and downstream here can also be the trajectory or direction of the object's movement, not the direction of liquid flow. Figures 19-22 The puncture element is moved from upstream to downstream, at which time the cavity containing the treatment liquid is basically in a stationary state, and the movement of the puncture element is to move from top to bottom and gradually approach the cavity containing the treatment liquid, such as puncturing the sealed cavity containing the treatment liquid and continuing to enter the sealed cavity. The direction of the puncture movement and the treatment liquid or fluid sample can be opposite directions, and can be opposite to the entire process or to part of the process. For example, the puncture element moves from top to bottom, and the treatment liquid flows in the direction opposite to the direction of movement of the puncture element. For example, the puncture element moves from top to bottom, and the fluid sample initially flows from top to bottom (in the puncture element). As the puncture element continues to move, the fluid sample and the treatment liquid are mixed and can flow in the direction opposite to the movement of the puncture element.

[0106] gas communication or liquid communication

[0107] Gas communication or liquid communication means that a liquid or a gas can flow from one place to another, possibly through some physical structure that can act as a guide. By passing through the physical structure, it generally means that the liquid passes through the surface of the structure or the space inside the structure to flow to another place passively or actively. Here, the flow can also be the flow of liquid or gas due to its own action (gravity or pressure), or passive flow. The gas pressure flow can be a flow in the same direction, or a flow in the opposite direction, or a flow from one position to another position under the action of gas pressure. Here, the communication does not mean that the liquid or gas must exist, but only in some cases indicates the connection relationship or state between two objects. If there is liquid, it can flow from one object to another. Here, it refers to the state of connection between two objects. On the contrary, if there is no liquid communication or gas communication between two objects, if there is liquid in or on one object, the liquid cannot flow into or onto another object. Such a state is non-communication, non-liquid or gas communication state.

[0108] detachable combination

[0109] The term "detachable combination" means that the connection between two components is in several different states or positions, for example, when the two components are physically separate, they can be combined or assembled together in a suitable first condition, and they can be separated in a suitable second condition, which is a physical separation without contact. Alternatively, the two components are initially combined together, and they can be separated in a suitable condition to form a physical separation. Alternatively, the two components are initially separated, combined together to perform a certain function, and then separated again, or combined again for another purpose. In summary, the combination of the two or the separation between the two can be easily performed, and the combination or separation can be repeated multiple times, of course, it can also be a one-time combination and separation. In addition, the detachable combination between two components can also be between three or more components. For example, there are first, second and third components, 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 can be directly detachable between the two objects, or indirectly detachable through another object. Here, the absorbent element 107 can be detachably combined with the test element 112, and the detachable combination can be direct or indirect, which will be described in detail below. The carrier 111 with the test element and the cavity 110 containing the element are also a detachable combination, so that they are combined together to form a detection device, but after being separated, they can have their own purposes. In the present application, after the absorbent element and the test element are separated, the absorbent element can be sterilized separately, for example, high temperature, X-ray, radiation sterilization, etc., and after sterilization is completed, the absorbent element and the test element are combined together. In this way, fluid communication is formed from the absorbent element to the test element, so that the liquid from the absorbent element can flow from the absorbent element to the test element.

[0110] test element

[0111] The term "test element" as used herein means an 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, electricity, optics, molecular biology, nucleic acid, physics, etc. The test element can be a lateral flow test strip, which can detect a variety of analytes. Of course, other suitable test elements can also be used in the present application.

[0112] Various test elements can be combined together for use in the present application. One form is a test strip. Test strips for analyzing an analyte in a sample, such as a drug or a metabolite indicative of a physical condition, can be in various forms, such as immunoassay or chemical analysis. Test strips can employ a non-competitive or competitive assay format. Test strips generally comprise a wicking material having a sample application zone, a reagent zone and a test zone. Fluid or liquid sample is applied to the sample application zone and flows by capillary action to the reagent zone. In the reagent zone, the sample binds to reagents if the analyte is present. The sample then flows to the test zone. Additional reagents, such as molecules that specifically bind to the analyte, are immobilized in the test zone. These reagents react with the analyte in the sample, if present, and bind the analyte in the zone, or bind to a reagent in the reagent zone. A label for indicating a test signal is present in the reagent zone or in a separate label zone.

[0113] A typical non-competitive assay format is one in which a signal is generated if the sample contains the analyte, and no signal is generated if the analyte is not present. In a competitive format, a signal is generated if the analyte is not present in the sample, and no signal is generated if the analyte is present.

[0114] The test element can be a test strip, which can be made of a wicking or non-wicking material. Test strips can include a variety of materials for liquid sample transport. One material of a test strip can be coated on another material, such as filter paper coated on a nitrocellulose membrane. One zone of a test strip can be made of one or more materials, while another zone is made of a different one or more materials. The test strip can be adhered to a support or rigid surface for improved handling strength of the test strip.

[0115] The analyte is detected by a signal generating system, such as one or more enzymes that specifically react with the analyte, using methods such as described above for immobilizing specific binding substances on a test strip, to immobilize one or more signal generating system compositions in the analyte detection zone of the test strip. The signal generating substance can be in the sample application zone, the reagent zone, or the test zone, or throughout the test strip, and the substance can be impregnated in one or more materials of the test strip. A solution containing the signal substance can be applied to the surface of the test strip or one or more materials of the test strip can be immersed in a solution containing the signal substance. The test strip with the signal substance solution applied is allowed to dry.

[0116] The various zones of the test strip can be arranged in the following order: sample application zone, reagent zone, detection zone, control zone, zone for determining whether the sample is adulterated, liquid sample absorption zone. The control zone is located after the detection zone. All of the zones can be arranged on a single test strip using only one material. It is also possible to use different materials for the different zones. The various zones can be directly contacted by the liquid sample, or the zones can be arranged in accordance with the direction of flow of the liquid sample, with the end of one zone being connected to and overlapping the beginning of another zone. The materials used can be materials having good water absorption, such as filter paper, glass fiber, or nitrocellulose membrane, etc. The test strip can also take other forms.

[0117] The reagent strip generally used is a nitrocellulose membrane reagent strip, i.e., the detection zone includes a nitrocellulose membrane (NC) on which specific binding molecules are immobilized to show the results of the detection. It can also be an acetate cellulose membrane or a nylon membrane, etc. Examples of reagent strips or devices containing reagent strips are described in the following patents: US 4857453; US 5073484; US 5119831; US 5185127; US 5275785; US 5416000; US 5504013; US 5602040; US 5622871; US 5654162; US 5656503; US 5686315; US 5766961; US 5770460; US 5916815; US 5976895; US 6248598; US 6140136; US 6187269; US 6187598; US 6228660; US 6235241; US 6306642; US 6352862; US 6372515; US 6379620; and US 6403383. The test strips and similar devices containing test strips disclosed in the above patent documents can be used in the test element or detection device of the present application for the detection of the analyte, e.g., the detection of the analyte in the sample.

[0118] The test reagent strip used in the present application can be a generally known lateral flow test strip. The specific structure and detection principle of the test reagent strip are known to those skilled in the art. The general test reagent strip Figure 2), including a sample collection area or sample application area 1121, a label area (not shown), a detection area 1122, and an absorbent area 1123. The sample collection area includes a sample receiving pad, the label area includes a label pad, and the absorbent area can include an absorbent pad. The detection area includes necessary chemicals, such as immunochemicals or enzymatic chemicals, for detecting the presence of the analyte. The detection area 1122 can include a nitrocellulose membrane, on which specific binding molecules are immobilized to show the result of the detection. Alternatively, the detection area can include an acetate cellulose membrane or a nylon membrane, etc. Of course, the detection device can further include a result control area 1125 downstream of the detection area. Typically, the control area and the detection area are in the form of horizontal lines 1126, which are detection lines 1126 or control lines 1125. Such a test strip is a conventional test strip, and of course, it can be other types of test strips that use capillary action for detection. In addition, the test strip usually has dry chemical components, such as immobilized antibodies or other reagents. When the liquid is encountered, the liquid flows along the test strip by capillary action, and as it flows, the dry reagent components dissolve in the liquid, and the reaction occurs in the next area where the dry reagent is processed, thereby performing the necessary detection. The flow of the liquid is mainly by capillary action. All of these can be used in the detection device of the present application, or can be placed in the detection chamber to contact the liquid sample, or can be used to detect whether the analyte exists in the liquid sample or the amount of the analyte in the liquid sample.

[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 exists in the liquid sample.

[0120] The test element of the present application itself can be used as a detection device to detect the analyte in the sample, so the detection device itself is equivalent to the test element. For example, after the fluid sample is mixed with the processing liquid, the test element is used directly for detection. The test element can be used alone for detection when the receiving device is described for processing the fluid sample.

[0121] carrier element

[0122] In some specific ways, the test element can also be placed on a carrier element, so that the carrier element contains the test element to complete the detection and analysis of the analyte in the fluid sample. Therefore, in some ways, the detection device includes a carrier on which the test element is placed. For example, Figure 2As shown, for example, some of the carriers 111 have one or more recesses 1115 in the front surface of the carrier, and a test element is disposed in the recess 1115. The carrier generally has a front surface and a back surface, and the test element is disposed on the front surface of the carrier. The number of recesses is not limited, and generally one test element is disposed in one recess. Typically, one test element can detect one analyte in a sample, although one test element can detect one or more, and one or more types of analyte. In some embodiments, the carrier 111 includes a cavity 1116 having an opening, and a recessed area near the recessed area forms the cavity 1116. The horizontal position of the opening 1114 of the cavity and the bottom of the recessed area where the test element is disposed are substantially in the same plane. In some embodiments, the length of the recess is less than the length of the test element, so that when the test element is disposed in the recess, a portion of the test element is suspended over the opening 1114 of the cavity 1116 (as shown). Figure 4A The cavity 1116 includes a partition element that divides the cavity 1116 into a first area and a second area. The partition element is similar to a baffle 1119 that is disposed in front of the inlet 1117 of the liquid flow channel on the carrier, but the baffle does not span the entire cavity, and instead has notches (not shown) on both sides of the cavity, and the width of the baffle is less than the width of the cavity. Thus, when liquid flows into the cavity through the liquid flow inlet 1117, the liquid can flow into the second area of the cavity through the notches. Of course, the width of the baffle 1119 can be the same as the width of the cavity, and the height of the baffle is less than the depth of the cavity. Thus, excess liquid can flow over the baffle into the second area for storage. In some embodiments, the baffle 1119 divides the cavity 1116 into a first area 1122 between the baffle 1119 and the inlet 1117 of the liquid flow channel, and the rest of the cavity is the second area 1120. The second area is mainly used as a buffer area for the fluid sample. When excess liquid flows into the cavity 1116, in addition to a portion of the liquid flowing into the test element, the excess portion can flow into the second area 1120. The cavity is generally cuboid in shape, but can be other shapes, such as square or cylindrical. In some embodiments, the carrier 111 further includes a flow guide element 113 that is connected to the liquid inlet 1117 and the test element, or the sample addition area 1121 of the test element. For example, one portion 1131 of the flow guide element is disposed in the first area between the baffle 1119 and the liquid inlet 1117, and another portion 1133 overlaps or covers part of the sample addition area 1121. Thus, once the liquid from the inlet or liquid inlet 1117 of the liquid flow channel enters the carrier, it directly contacts the flow guide element, and the liquid is guided by the flow guide element to the test element.

[0123] A baffle, partitioning element, or partitioning structure is provided in front of liquid inlet 1117 to prevent the drainage element from being impacted by a large amount of liquid sample flowing in through the inlet or flowing in at a high speed. This prevents the drainage element from being washed away or deformed by the impact, thereby achieving a stable diversion effect. The drainage element is generally made of a water-absorbing material, such as a fiberglass sheet. If there is excess sample, it can flow into the second area of ​​cavity 1116, which acts as a diversion. This second area reduces the flooding phenomenon, as excessive liquid sample flowing through drainage element 113 to the sample loading area would cause a "flood" on the test strip. Furthermore, drainage element 113 also serves to mitigate fluid impact. Once liquid enters liquid inlet 1117, it first contacts drainage element 113. The drainage element also acts as a barrier to the liquid, thereby delaying its entry into the second area of ​​the cavity. If the operation method is different or the force of inserting the puncture element is different, sometimes the liquid flowing into the carrier will be fast and the impact force will be large. The drainage plays the role of reducing the impact force so that the liquid does not flow into the cavity in the form of a "jet". If the amount of liquid is relatively large, it will flow to the second area. The way of flowing in can be through the gap between the baffle and the cavity, or directly overflowing the baffle and flowing into the second area. In addition, the guide element can guide the fluid to flow to the area of ​​the guide element covering the test strip, so that the amount of liquid sample obtained by multiple test strips is basically the same. There is a slit between the baffle 1119 and the liquid inlet 1117, that is, to allow part of the guide element to be located between the baffle and the liquid inlet. One is the diversion effect, and the other is to prevent the position of the guide element 113 from changing. The guide element is generally a flexible filter paper, glass fiber or other materials. Under the impact of the liquid at the liquid inlet, if the position changes, it will affect the guided liquid and may not be evenly distributed to multiple test elements. In such as Figure 2 and Figure 3 as well as Figure 4A The method of the flow guide element in the middle further enhances the stability of the flow guide element 113. If there is excess sample, it will flow to the recessed area below the sample addition area 1121 and collect therein, thereby preventing excess sample from flowing onto the test strip 112. Of course, other forms of flow guide elements, such as "T" or "L" in any form, are also possible. The above are some preferred solutions of the present invention. Of course, there is no recessed area or cavity, no baffle, and no flow guide element. As long as the liquid inlet 1117 maintains fluid communication with the test element, the test of the analyte in the sample can also be achieved ( Figure 2To better reduce the impact of the liquid, the first region can be made narrow so that the flow guide element can be inserted only into this narrow region, with one end 1131 of the element almost covering the fluid inlet 1117. The partition plate serves to fix the flow guide element in place, thereby reducing the impact and deformation of the flow guide element. In other words, the width of the first region can be made comparable to the thickness of the fluid element 131, thereby also serving to secure the fluid element.

[0124] In some embodiments, after the test element is set in the groove of the carrier, a transparent or partially transparent film 114 is covered on the carrier. Firstly, it seals the groove area of ​​the carrier and the opening of the cavity. In addition, the transparent film makes it easy to observe the test results on the final detection area. The transparent film can also be a transparent plastic sheet, which is transparent only in the test area 1122. The entire carrier is covered with a film, which basically puts the test element 112 and the cavity 1116 in a closed space, thus preventing the test element from getting wet during packaging and transportation and affecting the performance of the test. In this way, when the liquid introduced through the introduction channel 1115 enters the carrier, for example, enters the cavity 1116 on the carrier, a certain space is occupied in the cavity or the carrier due to the entry of the liquid, thereby compressing the air that originally existed, which is not conducive to the smooth entry of the liquid. Therefore, in some embodiments, the edges of cavity 1116 are provided with notches 1118, 11181. When the film is applied, these notches form through-holes, allowing excess gas or air to escape from the carrier, maintaining the pressure inside the carrier at the same level as the outside air pressure, and facilitating the easy entry of liquid into the carrier. This will be described in detail later. In some preferred embodiments, for example, when the collector's absorbent element 107 is inserted into the cavity of the piercing element 106, the piercing element cavity is fluidically connected to the cavity 1116 on the carrier. This allows the piercing element cavity to communicate with the outside world, maintaining the pressure inside the piercing element cavity consistent with that outside, or with minimal difference, or even the same or substantially the same pressure.

[0125] receiving element

[0126] In some embodiments, if the carrier is directly connected to the absorbent element, it is still not very convenient and safe to operate, because it is not professional laboratory with specially trained people to operate, the user is not much experience in testing people to operate, in the collection of samples or operation, it is not very friendly, and there is a possibility of damage to the test strip, such as the different places where the hand holds. The finger can press the test strip, or touch the test strip, which can have a negative impact on the test strip, affecting the final test results. In addition, the absorbent element needs to be inserted into the receiving device to squeeze the absorbent element, and at the same time, it also needs to push the piercing element to move, and other series of actions such as releasing the liquid in the solution chamber to mix with the sample. If it is only relied 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 embodiments, the detection device further comprises a receiving element 110, which comprises a receiving cavity 1104 for receiving the carrier 18 with the test element. The receiving cavity is similar in shape to the whole carrier. In a specific embodiment, the carrier of the present application is in the shape of a rectangular parallelepiped, and the receiving cavity 1104 is also generally rectangular, and has an upper surface 1102 or a back surface 1107. In some embodiments, the upper surface 1102 of the receiving cavity is transparent, and the test results of the test element on the carrier can be read through the transparent part, for example, by the naked eye, or by electronic instruments such as scanning equipment.

[0127] In some embodiments, it is convenient for the carrier to be smoothly assembled or inserted into the receiving cavity 1104, and a slide is provided in the receiving cavity, which is composed of two groups of slides, one of which is a slide 45, 1110 provided on the side wall of the receiving cavity, and the corresponding slide (not shown) is also provided on the other side wall. The side surfaces 182, 181 of the two sides of the carrier serve as slide rails. In this way, the carrier can be stably or relatively fixedly installed in a fixed position of the receiving cavity. In order to make the upper surface of the carrier (the surface with the test element) face the upper surface 1102 of the receiving cavity during assembly, 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 the two ends 1822, 1811 of the limiting block. Generally, the carrier is inserted into the receiving cavity from one end of the liquid introduction channel. The width between the slide 45 and the slide 1110 of the receiving cavity is equal to or slightly greater than the thickness or height of the carrier. Among them, one slide is arranged in the form of "「", for example, as shown in Figure 8 and 9As shown, one of the slides on the side wall of the housing chamber is designed in such a way that one edge 1109 is parallel to the side edge and the other edge 1108 is perpendicular to the side wall of the housing chamber. The other side wall of the housing chamber is also designed in the same way. Thus, in fact, the upper slide 45 (in fact, a pair) and the lower slide 1110 (also a pair, the other side wall of the housing chamber is not shown) of the slide structure define different widths in the housing chamber, so that when the carrier is inserted into the housing chamber, if the front surface (the surface covered by the film 114) of the carrier faces the upper surface 1102 of the housing chamber, the side surfaces 1811 and 1822 of the carrier will contact the slide 1110 as the slide structure and be inserted into the housing chamber. If the direction is reversed, the side surfaces 1811 and 1822 of the carrier will contact the slide 45 as the slide structure, and since the distance between the slide 45 structures is less than the width of the carrier, it cannot be inserted into the housing chamber, so that only the upper surface of the carrier can be inserted in the direction corresponding to the upper surface of the housing chamber, and vice versa. The presence of the limiting block can also more conveniently identify the front and back of the carrier.

[0128] Therefore, in some preferred embodiments, the carrier 18 with the test element is arranged in the carrier-receiving chamber 11004, and the collector with the absorbent element 107 can be directly connected with the carrier. For example, the absorbent element is a cylindrical sponge, and the absorbent element is connected with the carrier 111 through a connecting rod 109, such as detachable connection. In some embodiments, the connecting rod 109 includes a channel or pipe 12( Figure 11 ), which is in fluid communication with the liquid inlet 1117 on the carrier 111, so that when the absorbent element 107 is compressed, the liquid sample can flow into the chamber 1106 of the carrier 111 through the pipe of the connecting rod, so that the analysis of the analyte is carried out in the manner described above. The sample collector 109 can be connected with the pipe 1115 of the carrier 18 with the liquid inlet through the end 1093 without the absorbent element to form liquid communication. Of course, the collector can also be in fluid communication with the chamber 1104, and it is also detachably connected, and then the chamber 1104 is in fluid communication with the connecting pipe 1115, which is also possible. In summary, after the absorbent element collects the liquid sample, the fluid sample or the treatment liquid mixed with the fluid sample can flow through the channel or flow path to the test element. Of course, the detachable combination of the absorbent element with the carrier or with the chamber 110 makes it convenient to sterilize the absorbent element separately, such as the absorbent element described in the U.S. Patent No. US10,05,146 of the present applicant, which is bound together with the test element and cannot be separated, so that it is not easy to be treated separately, which increases the difficulty.

[0129] In some embodiments, the limiting block 1112 has a cavity 1116 inside which contains the carrier. The cavity 1116 is configured to receive the fluid sample and the wicking element 113. In some embodiments, the cavity 1116 is located inside the limiting block 1112 because the depth of the grooves 1110, 1114, 11123, 11124 on the carrier is relatively shallow, and the volume of the cavity 1116 on the carrier is relatively large, sufficient to receive the liquid from the introduction channel.

[0130] In some embodiments, the opening 1103 of the receiving cavity 1104 and the end tail structure 183 of the carrier are matched, which can also serve as a positive and negative function. For example, if the opening 1103 of the receiving cavity is designed as "D", the end tail structure 183 of the carrier is also designed as "D". Of course, any other structure can also achieve the function of positive and negative.

[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 introduction channel 1115 is located near the hole 11011, and when the connecting element 1101 is a tubular structure, it is used to allow one end of the connecting rod of the collector (for example, the end with threads) to be inserted into the connecting element and connected through the hole 11011 and the introduction channel 1115 (as shown in Figure 10 ,18-19). The collector includes an absorption element 107 for collecting a sample, such as a fluid sample. The connecting rod 109 in the collector is provided with a channel 12 (as shown in 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 introduction channel 1115, so that the liquid passing through the absorption element can flow through the transport channel 12 in the connecting rod to the introduction channel, and then into the cavity 1116 of the carrier, guided by the wicking element to the test element.

[0132] In some embodiments, the connecting rod 109 includes a protruding structure 1091, 1092, which is in contact with the inner wall of the connecting element 1101, mainly to limit the connecting rod to be accurately aligned with the opening of the introduction channel 1115 and connected. The way the one end 1093 of the connecting rod is connected to the introduction channel 1115 can be any suitable way, such as clamping, threaded connection, or piston connection.

[0133] In some embodiments, the absorbent element 107 is detachably connected to the test element, meaning that the two can be manufactured separately and assembled for use when needed. The main advantage of this is that the absorbent element, which needs to be sterilized before use, for example by heat sterilization or radiation sterilization, when needed to be inserted into the mouth to collect a saliva sample. If the test element is connected to the absorbent element from the beginning, the test element will also be sterilized together with the absorbent element, and the test element can contain some chemical or biological species that can be damaged by the sterilization method, thus the test element can not be able to perform the test correctly. For example, if the test element contains antibodies or antigens, the heat sterilization can cause the antibodies to denature and lose their binding ability. If the test element contains some species that can be reduced by heat sterilization, the heat sterilization can also affect the performance of the test element. In addition, the detachable design also facilitates transportation, as the carrier and the collector can be packaged separately, and then assembled when needed. This also increases the convenience of use. In manufacturing, the two parts can be manufactured separately and then assembled, or the two parts can be manufactured separately and then transported to another place for assembly to form a complete product (as shown in Figures 10-11 Figure 11 The above-mentioned carrier containing cavity, flow guide element, and connecting rod are only preferred embodiments of the present application, and can be omitted.

[0134] Of course, in one embodiment, when the carrier 111 with the test element 112 is assembled by the collector 110, the connecting rod 109 of the collector is assembled with the carrier 111 to form a final detection device, as shown in Figure 11 In some embodiments, the connecting rod protrusion structure 1091, 1092 and the inner wall 11012 of the connecting element 1101 can increase the strength or rigidity of the connecting rod, so that the connecting rod 109 will not break when the absorbent element is used to collect the sample. In addition, these protruding ring structures can also allow the connecting rod to be located on the central axis of the connecting element, so that the end of the connecting rod can be accurately aligned with the inlet channel 1115 on the carrier, thereby forming a fluid communication during assembly and assembly.

[0135] ​In some embodiments, one end of the connecting rod connecting the absorbent element has an enlarged portion, and the absorbent element is disposed on the enlarged portion, typically with a cross-section of the absorbent element larger than that of the connecting rod. The enlarged portion can be a disc 805, and the absorbent element is glued on the surface of the disc. In this case, the channel 12 disposed in the connecting rod connects the absorbent element and the input channel 1115, so that the cavity 1116 on the carrier is in fluid communication, and thus the test element on the carrier is also in fluid communication. In some embodiments, a resilient sealing ring 108 is disposed on the disc, so that the absorbent element 107 is in a sealed cavity, preventing the extrusion of the fluid sample.

[0136] analyte

[0137] Examples of analytes that can be detected using the present application include small molecules including drugs of abuse. "Drug of abuse" (DOA) refers to the use of a drug (usually one that acts to numb the nerves) for non-medical purposes. The use of these drugs can result in physical and mental harm, dependency, addiction and / or death. Examples of drugs of abuse include cocaine; amphetamines AMP (e.g., black beauties, white cross amphetamine tablets, dexedrine, dexedrine tablets, Beans); methamphetamine MET (crank, meth, crystal, speed); barbiturates BAR (e.g., Valium, Roche Pharmaceuticals, Nutley, New Jersey); tranquilizers (i.e., sleep aids); lysergic acid diethylamide (LSD); downers (goofballs, barbs, blue devils, yellow jackets, Quaaludes); tricyclic antidepressants (TCAs, i.e., imipramine, amitriptyline, and chlordiazepoxide); dimethoxy-methylamphetamine (MDMA); phencyclidine (PCP); tetrahydrocannabinol (THC, pot, dope, hash, weed, etc.); opiates (i.e., morphine MOP or, heroin, cocaine COC;, methadone, hydrocodone); anxiolytics and sedative-hypnotics, which are a class of drugs primarily used to reduce anxiety, tension, fear, stabilize mood, and have a sedative-hypnotic effect, including benzodiazepines BZO, atypical BZs, fused diazepines NB23C, benzodiazepines, ligands for BZ receptors, open-chain BZs, diphenylmethane derivatives, piperazine carboxylates, piperidine carboxylates, quinazolinones, thiazine and thiazole derivatives, other heterocyclics, imidazole-type sedative / pain relievers (e.g., hydrocodone OXY, methadone MTD), propylene glycol derivatives-carbamates, aliphatic compounds, anthracene derivatives, etc. The detection device of the present application can also be used to detect drugs that are used for medical purposes but are prone to overdose, such as tricyclic antidepressants (imipramine or the like) and acetaminophen. These drugs are metabolized into small molecules that are present in bodily fluids such as blood, urine, saliva, sweat, etc. or in some cases, the small molecules are present in the body.

[0138] For example, analytes detected using the present application include, but are not limited to, creatinine, bilirubin, nitrite, protein (non-specific), hormones (e.g., human chorionic gonadotropin, progesterone, follicle stimulating hormone, etc.), blood, white blood cells, sugars, heavy metals or toxins, bacterial agents (e.g., proteins or sugar agents specific to a particular bacteria such as E. coli 0157:H7, staphylococcus, salmonella, clostridium, campylobacter, L. monocytogenes, vibrio, or cactus bacillus) and substances related to physiological characteristics in urine such as pH and specific gravity. Any other clinical urine chemistry analysis can be detected using the lateral flow assay format in conjunction with the present device.

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

[0140] flow of liquid

[0141] The flow of liquid generally refers to the movement from one place to another. In general, the flow of liquid in nature is mostly due to the action of gravity from high to low. Here, the flow is also due to external force, i.e. the flow under the condition of external gravity, which can be the flow of natural gravity. In addition to gravity, the flow of liquid can also overcome gravity and move from low to high. For example, the extraction of liquid, or the compression of liquid, or the flow of liquid under pressure from low to high, or the flow of liquid overcoming its own gravity due to pressure. For example, Figure 9 In 19, 22, and 27, the first cavity is located above the second cavity, and the second cavity is located below the first cavity. When liquid enters the second cavity, the liquid can flow naturally from the first cavity to the second cavity due to its own gravity, or it can flow naturally from upstream to downstream.

[0142] detection device

[0143] The detection device refers to a device for detecting whether the sample contains the analyte. The receiving device refers to a device that receives part of the detection device or allows part of the detection device to be inserted into the receiving device to mix or process the sample, elute the absorbent element, and process the liquid or liquid sample. The receiving device is not specifically designed to receive the detection device, and it can exist independently and have the function of processing the fluid sample. The detection device can include a test element with a test function or a carrier with a test element, and can also include a receiving element of the carrier. The detection device can include an absorbent element for collecting a sample or an absorbent element with a connecting rod. The absorbent element with the collected sample can also be referred to as a collection device or a collector, so the collection device can also include the detection device, or the collection device and the detection device are separated, and the collection device and the detection device are combined during detection to complete the detection, and the detection device can also include the collection device. It can also be that the collection device and the detection device are a one-piece device, and once the liquid sample is collected, the detection can be performed immediately to obtain the test result. The detection device or test element herein can be interchangeable.

[0144] The "receiving device" herein is only for convenience of description, and in a specific embodiment, the receiving device receives part of the collector, such as receiving the absorbent element or receiving part of the detection device with the absorbent element. When the receiving device is not for the function of receiving, it can also be referred to as a sample processing or sample mixing device, and when the sample processing is performed, the detection device can not be required, and the receiving of the absorbent element can be completed independently (which will be described in detail below). In summary, the "receiving" herein cannot limit the scope of the device, and cannot have any patent law claim meaning, but is only a term for convenience of description.

[0145] combination, conjunction or cooperation of the collection device and the detection device

[0146] The detection device and the collection device or collector of the present application can form a detachable pair combination, and when liquid collection is required, the detection device is combined with the collection device, and when the liquid sample is collected, the absorbent element on the collection device is compressed, and the liquid sample enters the test element to complete the test. Of course, the collection device and the detection device can be separated at the beginning, and when liquid sample collection is required, they are combined, and after collection is completed, the absorbent element is compressed, and the liquid sample enters the test element to complete the test. In some specific embodiments of the present application, such as Figure 12In one embodiment, the present application provides a detection device for detecting whether a liquid sample contains an analyte, or a collection device (the collection device or collector is composed of the absorbent element 107 and the connecting rod 109) for collecting a liquid sample, which comprises a detection part with a test element 112 and a collection part with an absorbent element 107, wherein the detection part and the absorbent part are combined, connected or assembled in a detachable manner.

[0147] Here, "combined, connected or assembled" actually means the same thing, only the words used are different, and all can mean combined together, and this combination is opposite to "separated". The combination and separation can be under any condition, and can be freely selected. In some embodiments, when the detection part and the collection part are combined, the detection part and the collection part are in a liquid flow state. In other embodiments, before or when the detection part and the collection part are separated, or after the detection part and the collection part are separated, the detection part and the collection part can not be in a liquid flow state.

[0148] In some embodiments, the absorbent element 107 is provided on a connecting rod 109 to form a collection collector or collection device, and the absorbent element 107 can absorb a fluid sample, such as saliva, urine or blood, or any sample. One end of the connecting rod 109 is connected to the absorbent element 107, and the other end is connected to the connecting pipe or input channel 1115 of the carrier 111. The connection can be in the form of a screw, a buckle, a lock, or a plug and a socket, which can achieve connection and disconnection. In this way, when it is necessary to sterilize the absorbent element or the absorbent element alone, it can be sterilized separately, such as high temperature, X-ray, radiation sterilization, nuclear radiation sterilization, etc. After sterilization is completed, it is 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 portion of the detection device, thereby allowing the sample on the absorption element to undergo a processing step or a processing process before formal detection. Alternatively, another aspect of the present invention provides a device for pre-processing samples. This device is not merely for receiving the detection device, but rather processes the sample before the detection device performs sample detection. It can exist independently of the detection device and can also function independently of the sample collector. It is only used in conjunction with the detection device or the sample collector in some specific embodiments. As explained above, and with reference to the description below, the receiving device is merely a term for convenience of description and does not have a substantive definition. It can be referred to as a device, a processor, a system, etc.

[0151] like Figures 13-17 As shown, in one embodiment, the device includes a cavity structure, similar to a lid or tube structure. In some embodiments, the receiving device includes a cavity 91 for receiving a treatment fluid and a cavity 94 for accommodating a portion of the puncturing element. The receiving device can be open at one end and closed at the other, forming a space or cavity 102. This large cavity may contain smaller cavities with different functions, such as a first cavity 91 for receiving a treatment fluid and a second cavity for accommodating or housing a portion of the puncturing element. For example, a space or cavity 91 is provided at the bottom of cavity 102 of the receiving device to accommodate a sealed container 103. The container contains a treatment fluid, which may contain a chemical or biological reagent, an enzyme, a pH-adjusting agent, a buffer, a protein, an inorganic or organic reagent. The liquid solution is used to treat a fluid sample, an absorbent element, or a sample, such as removing impurities from the sample, removing interfering substances that may interfere with the test, dissolving or diluting the sample, eluting or dissolving the absorbent element, or adjusting the pH of the sample. Generally, the treatment liquid mentioned in the present invention does not contain the substance to be analyzed, but is used to improve the detection sensitivity of the substance to be analyzed, thereby processing the sample, removing or eliminating, or reducing the interfering substances or other impurities in the test of the substance to be analyzed. The sealed container 103 has a sealed cavity 1031, which is used to store the treatment liquid. In order to facilitate the easy release of the treatment liquid, the container is easily punctured by the puncture element. Therefore, in some methods, the sealed cavity is sealed by a material 104 that is easily punctured, such as aluminum foil, film, tape, or plastic sheet. In this way, the entire sealed container can be set in the first cavity 91 (such as Figure 14 The purpose of setting a sealed cavity 103 in the first cavity 91 is to facilitate processing. The container can be filled with a treatment liquid in advance, and then the container mouth is sealed ( Figure 14As shown). Of course, a sealed space can be provided at the bottom of the cavity, into which the treatment solution is injected, and then the space can be sealed. For example, a cavity 91 can be provided at the bottom of the device to hold the treatment solution, and the opening of the cavity can be sealed. The sealing material can be a material that can be punctured by the solution. In any case, the sealed space is generally located within cavity 102, and the sample treatment solution is pre-filled in the sealed space. When needed, the sample treatment solution can be released from the sealed space.

[0152] In other embodiments, the receiving device further includes a movable piercing member 106 in the cavity 102 of the receiving device. The piercing member 106 is movable within the receiving device to pierce the cavity containing the treatment fluid to release the treatment fluid. In some embodiments, the piercing member includes a piercing structure 1066 and a cavity for receiving the treatment fluid from the first cavity of the receiving device. Thus, movement of the piercing member to pierce the cavity containing the treatment fluid releases the treatment fluid into the cavity of the piercing member. The cavity of the piercing member can also receive a sample, such as a liquid sample, or an absorbent member containing a sample. Thus, the sample is treated in the cavity of the piercing member to form a first mixed solution which is used to test for the analyte using a test member. In some embodiments, the collector 18 containing the absorbent member is inserted into the cavity of the piercing member when the piercing member is in the first position (shown in Fig. 15) and the piercing structure 1066 is in the upper position in the cavity containing the treatment fluid. When the collector is inserted into the cavity, pressure is applied to the absorbent member to compress the absorbent member, such as by the connecting rod applying pressure to the absorbent member. The pressure applied to the absorbent member also simultaneously moves the piercing member from the first position to the second position so that the piercing structure pierces the seal in the cavity containing the treatment fluid. If the piercing member is further moved, a portion of the cavity of the piercing member enters the cavity containing the treatment fluid to force a portion of the treatment fluid into the cavity of the piercing member, such as through the aperture 1065 in the piercing structure 1066. The treatment fluid contacts the absorbent member in the cavity of the piercing member to treat and mix the absorbent member to form a first mixed solution. Because the connecting rod has a passageway in communication with the absorbent member, the pressure of the portion of the cavity of the piercing member that enters the cavity containing the treatment fluid forces the treatment fluid or the first mixed solution formed with the sample through the absorbent member and into the passageway of the connecting rod to flow out of the receiving device through the flow passage 12. To allow more of the liquid to flow into the passageway of the connecting rod, the absorbent member can seal the opening 1028 in the cavity of the piercing member. At this point, the absorbent member fills the entire cavity or seals one end of the cavity and the pressure of the portion of the cavity of the piercing member that enters the cavity containing the treatment fluid forces more of the liquid or mixed solution into the passageway of the connecting rod to flow out of the piercing member.

[0153] In some embodiments, the mixed solution that flows out of the flow passage 12 can be used directly for testing by the test member or can be collected in another container, such as a dropper, and then applied to the sample application area of the test member to perform the assay for the analyte.

[0154] The piercing element has a piercing end with one or more piercing structures 1066, which can be one or more, for piercing the membrane containing the treatment liquid, so that the treatment liquid can be released. In some embodiments, there is a through hole 1065 near the piercing structure, which is in contact with the liquid after the piercing structure pierces the sealed cavity containing the treatment liquid, or the through hole is deep into the treatment liquid, so that the treatment liquid can pass through the through hole 1065 into the cavity of the piercing element.

[0155] In one embodiment, the piercing element is also a tubular structure, which has a first tube and a second tube, and the piercing structures are arranged on the end of the first tube, for example Figure 16 The first tube and the second tube define a first cavity 1062 and a second cavity 1061, respectively, and the end of the first cavity with the piercing structures has a through hole 1065, so that when the end of the first cavity is close to the sealed cavity 91 or 103 containing the treatment liquid, the piercing structure pierces the sealed structure, and then the first cavity enters the sealed cavity 91 or 103, and the treatment liquid enters the first cavity 1062 through the through hole 1065 by the drainage capacity of the first cavity, because after the piercing structure is pierced, some liquid will be drained when the first cavity enters the sealed cavity, and these liquid will easily enter the first cavity 1062 of the piercing element through the through hole 1065. In some embodiments, the movement of the piercing element to pierce the sealed cavity containing the treatment liquid can be facilitated by applying pressure to the collector to move the piercing element, and in other embodiments, the connecting element on the receiving carrier can contact the piercing element to facilitate the movement of the piercing element.

[0156] In one embodiment, the inner diameter of the first cavity 1062 is smaller than the inner diameter of the second cavity 1061, and there is a platform structure 1068 at the junction of the two cavities. The first cavity and the second cavity form a liquid communication cavity structure. When the piercing structure 1066 pierces the cavity 103 containing the treatment liquid, part of the treatment liquid enters the cavity of the piercing element, such as the first cavity 1062 or the second cavity 1061, through the through hole 1065. In some embodiments, the outer diameter of the second cavity 1061 is equivalent to the inner diameter of the tube 103 containing the treatment liquid, so that when the piercing structure pierces the membrane, the first cavity 1062 is inserted into the interior of the tube 103 containing the treatment liquid, and because the second tube and the tube 103 containing the treatment liquid are equivalent in inner diameter, the treatment liquid in the tube containing the treatment liquid is forced to enter the first cavity 1062 through the through hole 1065.

[0157] In some embodiments, because the inner diameter of the first lumen 1062 is smaller than the inner diameter of the second lumen 1061, there is a platform 1068 at the interface of the two tubes, which can be used to contact the absorbent element, to compress the absorbent element to squeeze the fluid sample on the absorbent element, and the squeezed fluid sample flows into the first lumen 1061. In some embodiments, the inner diameter of the second lumen is comparable to the diameter of the absorbent element, and when the absorbent element is inserted into the second lumen, the absorbent element almost blocks the opening of the second lumen during the process of being squeezed, for example, by the platform, which is equivalent to sealing or blocking the hole 20 between the first lumen and the second lumen, while the first lumen receives the fluid sample squeezed out of the absorbent element. When the first lumen of the piercing element pierces the lumen 103 of the processing fluid and enters the lumen 103, the discharged processing fluid enters the first lumen 1062 of the piercing element, which can mix with the sample to achieve the purpose of processing the sample, forming a first mixed solution, and at the same time, for the first lumen of the piercing element, it is almost a sealed space, and as the processing fluid enters, the pressure of the space increases, which will promote the mixed solution to pass through the absorbent element (which has voids), so that the absorbent element can be eluted (for example, adsorbed with analyte substances, such as THC), and after elution, a second mixed solution is formed, which can enter the carrier through the channel of the connecting rod. Here, the squeezing of the absorbent element to release the fluid sample into the first lumen of the piercing element and the piercing structure to pierce the sealed lumen to release the processing fluid do not need to be distinguished in the order of operation time, and can be completed simultaneously, or the squeezing of the absorbent element to release the fluid sample can be earlier than the piercing action, of course, the piercing action can be earlier than the compression of the absorbent element. In some other embodiments, the piercing element lacks a second lumen and only includes a first lumen, and the absorbent element can be inserted into the first lumen 1062, and the absorbent element can be squeezed or not, and then the processing fluid directly passes through or contacts the absorbent element, thereby forming a mixed liquid, which is also feasible for testing.

[0158] In some embodiments, the absorbent element is attached to the disc structure 805, and the outer diameter of the disc structure is equivalent to the inner diameter of the second cavity 1061, so that when the absorbent 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, liquid will not flow out through the gap between the disc structure and the inner wall 1067 of the second cavity 1061 when the absorbent element is compressed, and if liquid flows out, it can only flow out through the transport channel 12 in liquid communication with the absorbent element. Most preferably, the disc structure has an elastic sealing ring 108, which forms a sealing structure with the inner wall 1067 of the second cavity 1061, so as to further ensure that when the absorbent element contacts the platform 1068 and is compressed, more fluid samples enter the first cavity 1062, and when the mixed liquid in the first cavity flows back to the absorbent element, more liquid flows out through the channel 12 in communication with the absorbent element. The sealing of the disc also prevents the fluid sample or the mixed liquid formed with the treatment liquid from flowing out of the piercing element, thereby causing environmental pollution, and also causing pollution to the operator.

[0159] In some embodiments, the compression of the absorbent element 107 and the piercing of the cavity 103 containing the treatment liquid can be completed simultaneously, where simultaneous means having continuity in time. During the compression, the sealing cavity 103 is pierced, or during the piercing of the sealing cavity, the compression or extrusion of the absorbent element containing the absorbent element. In some embodiments, the piercing element 10 and the cavity 103 containing the treatment liquid are in a relative position, and at this time the piercing structure 1066 is located above the sealing film 104 (for example Figure 15 ). At this time, the piercing structure 1066 can contact the sealing film, or be located above the sealing film (not contact the film 104), or be located directly above (for example Figure 19In some embodiments, the receiving device includes a first cavity 91 for receiving the sealed chamber 103, and a second cavity 94 and / or a third cavity 90 for receiving a portion of the piercing element. The second cavity 1061 of the piercing element is located within the third cavity 90 of the receiving device, and the first cavity 1062 of the piercing element is located within the second cavity 94 of the receiving device. The second cavity 1061 of the piercing element has a female threaded structure 1023 near the opening of the receiving device, and the connecting element 1101 of the detection device has a male threaded structure 1105 on the outer surface of the connecting element 1101. In operation, the absorbent element 107 is first used to absorb a fluid sample, such as urine, saliva, or blood. The absorbent element 107 is then inserted into the cavity of the receiving device 101. During the insertion, the absorbent element 107 enters the second cavity 1061 of the piercing element. When the absorbent element 107 contacts the platform 1068 between the first cavity and the second cavity, the absorbent element 107 is compressed by the opposing force, and the fluid sample is released from the absorbent element 107 into the first cavity 1062. At this point, the absorbent element 107 is generally soft due to the absorption of the fluid sample, and the compression of the absorbent element 107 can cause a slight movement of the piercing element, such as a slight movement of the piercing element. The downward force can also cause the piercing element to pierce the sealed membrane 104. As the receiving cavity 110 of the detection device continues to move downward into the opening of the receiving device, the port 1108 of the connecting element 1101 contacts the opening 1070 of the second cavity of the piercing element, and the male threaded structure 1105 of the connecting element 1101 engages the female threaded structure 1023 of the opening of the third cavity 90 of the receiving device. At this point, the piercing element 10 is substantially in the initial position. As the receiving cavity 110 of the detection device continues to move downward, the piercing element 10 is moved downward by the relative rotation of the male threaded structure 1105 of the connecting element 1101 and the female threaded structure 1023 of the opening of the third cavity 90 of the receiving device, and by the force transmitted through the contact between the port 1108 of the connecting element 1101 and the opening 1070 of the second cavity of the piercing element. At this point, the absorbent element 107 and the piercing element 10 are relatively fixed in position. As the piercing element 10 moves downward, the piercing element 10 pierces the sealed membrane 104, and a portion of the processing fluid in the chamber containing the processing fluid enters the first cavity 1062 through the hole 1065 at the end of the first cavity 1062. If there is a fluid sample, such as a saliva sample, in the first cavity 1062, the processing fluid mixes with the fluid sample to form a first mixture. As the piercing element 10 continues to move, the mixture passes through the absorbent element 107, elutes some of the analyte substances adsorbed on the absorbent element 107, such as THC, and then flows into the channel 12 of the connecting rod 109, and then contacts the test strip 112, and completes the analysis or test of the analyte substances (if the fluid sample contains the analyte substances).

[0160] It is to be understood that the above description of the absorbent element being inserted into the lumen of the piercing element of the receiving device, it is also possible for the receiving device to approach the collector containing the absorbent element, so that the absorbent element enters the lumen of the piercing element, or the collector containing the absorbent element and the receiving device approach each other at the same time, so that the absorbent element enters the lumen of the piercing element. These methods are all possible and are included within the scope of the present application.

[0161] Of course, it is understood that the liquid sample absorbed by the absorbent element 107 is not much, or the connecting rod 109 is rigid enough or longer, and in the process of inserting the absorbent element 107 into the second lumen 1061 of the first piercing element driven by the receiving and containing element carrier 110, the first lumen 1062 of the piercing element can be driven to approach the sealing film of the lumen containing the treatment liquid and pierce the sealing film during the process of extruding the liquid sample from the absorbent element. At this time, the receiving carrier 110 continues to drive the absorbent element 107 to insert into the second lumen 1061 of the piercing element and continue to compress, at this time, the whole piercing element also continues to move downward, and part of the first lumen 1062 enters the lumen containing the treatment liquid 103, forcing part of the treatment liquid to flow into the first lumen through the through hole at the end of the first lumen, thereby forming a first mixed liquid in the first lumen. Then, the first mixed liquid forms a second mixed liquid through the absorbent element and enters the channel 12 of the connecting rod 109, and then reaches the carrier and contacts the flow guide element 113, thereby flowing through the flow guide element 113 into the test strip to complete the detection.

[0162] In some ways, since the test device is mainly used for roadside detection, such as drunk driving, or in public places, it is desired to be convenient and fast to obtain test results, and at the same time it is desired that the liquid sample cannot leak out. In order to quickly obtain the detection result, it is desired that the liquid sample or the treatment liquid quickly passes through the absorbent element and quickly enters the carrier to contact the test element. Let the treatment liquid or the liquid sample, or the mixture of the liquid sample and the treatment liquid; or, let the treatment liquid directly pass through the absorbent element (if the absorbent element is not compressed) quickly through the absorbent element, or not through the absorbent element, enter the carrier to contact the test element; in addition, when the absorbent element is vertically inserted into the lumen of the piercing element, the liquid sample can quickly move or flow in the direction opposite to the direction of gravity. In addition, if the absorbent element is compressed, the liquid also needs to overcome the resistance of the compressed absorbent element to pass through the absorbent element into the channel of the connecting rod, or in order to prevent the liquid in the second lumen and the first lumen of the receiving device from leaking to the outside to pollute the environment.

[0163] To better achieve one or more of the above objects, in some embodiments, the piercing element 106 forms a closed space within the receiving device's cavity, and the air or gas within the closed space can be compressed, and the increased pressure within the closed space can overcome the gravitational force of the mixed liquid, or can cause the liquid to quickly enter the cavity of the piercing element, or can overcome the resistance of the compressed absorbent element and pass through the absorbent element. In some embodiments, the first cavity of the piercing element is located in the second cavity 94 of the receiving device, and the elastic sealing ring 105 of the piercing element cooperates with the inner wall of the second cavity 94 of the receiving device to form a closed space. The closed space is only in communication with the outside world through the small hole of the first cavity of the piercing element. When the hole 1065 at the end of the first cavity of the piercing element is inserted into the cavity containing the processing liquid, the small hole is sealed by the processing liquid, and if the air in the second cavity 94 of the receiving device is compressed and the pressure is increased, there is a pressure difference between the pressure in the second cavity and the first cavity in the piercing element (as in the above-mentioned embodiments, the first cavity can be in pressure balance with the outside world); in order to achieve pressure balance between the pressure in the second cavity and the outside pressure of the first cavity in the piercing element, the increased pressure will force the processing liquid to enter the first cavity of the piercing element through the hole 1065. As the piercing element continues to move, the volume of the second cavity 94 of the receiving device is continuously compressed, the pressure continues to increase, and the processing liquid entering the piercing element and the liquid sample squeezed out from the absorbent element overcome the gravitational force and continue to pass through the compressed absorbent element and enter the channel of the connecting rod.

[0164] In some embodiments, in order to avoid the squeezed-out liquid sample from the absorbent element flowing to the outside world and causing pollution, the absorbent element also has an elastic sealing ring that forms a seal with the inner wall of the piercing element, so that the liquid squeezed out from the absorbent element does not flow out to the outside world.

[0165] From Figures 23-25The principle structure of the piercing element 206 is shown in FIG. 8. In some embodiments, the piercing element 206 forms a sealed cavity 23 above the cavity 203 containing the treatment liquid, which contains air or gas. The piercing element includes a first cavity 806 and a hole at the end of the piercing structure, and can also include a second cavity for receiving the absorbent element 107. It is understood that the piercing element does not necessarily need a second cavity to receive the absorbent element. The sealed cavity 23 is formed and can be compressed, so that once compressed, the pressure in the sealed cavity increases, and the increased pressure forces the treatment liquid in the cavity 203 containing the treatment liquid to quickly flow into the first cavity of the piercing element. Thus, the piercing element generally enters the cavity 203 containing the treatment liquid (of course, it can not enter, but only let the through hole contact the treatment liquid or let the treatment liquid seal the through hole), and the piercing element also has a liquid discharge pressure in the cavity 203, which also allows the liquid to enter the piercing element. Thus, in some embodiments, under the double pressure of the pressure in the sealed cavity and the piercing element entering the cavity 203 containing the treatment liquid, the treatment liquid can quickly enter the cavity of the piercing element, mix with the fluid sample, and quickly flow out of the piercing element, such as through the channel of the connecting rod of the absorbent element into the detection device, such as into the cavity of the carrier.

[0166] Under such double pressure, because the flow rate of the liquid can be relatively fast, in some embodiments, a flow guide element 113 is arranged at the liquid inlet of the carrier, which not only guides the liquid to the test strip, but also relieves the impact of the liquid on the test strip. For example, without the flow guide element, the liquid flowing through the liquid inlet will quickly rush in, sometimes in a "jet" state, and splash onto the test strip, causing the test element to be prematurely wetted or causing the "flood" phenomenon to cause inaccurate test results. Because the liquid flows quickly in the channel 12, a large amount of liquid will flow in a short period of time, and if there is excess liquid, it can flow into the second area of the carrier, relieving the "flood" phenomenon caused by too much liquid flowing onto the test element. It is understood that there are many ways to slow down the flow rate of the fluid through the liquid inlet 1117 or to relieve the excessive liquid flowing onto the test strip, such as arranging a small-pore mesh at the liquid inlet, or lengthening the liquid inlet or bending, folding, etc. the flow guide channel 1115, so that the flow rate is slowed down, reducing the possible negative impact of the liquid on the test element.

[0167] In some ways, if the disc structure 805 with the absorbing element and the inner wall of the moving element 206 are in a sealed state, the processing liquid or the processing liquid passing through the absorbing element can easily flow into the channel of the connecting rod 109. At this time, the absorbing element can also be compressed. Since the disc structure 805 and the inner wall of the moving element 206 are in a sealed state, the compression of the absorbing element 107 can also increase the pressure of the sealed space, which is more conducive to the processing liquid passing through the absorbing element flowing into the channel of the connecting rod, so that the liquid can flow into 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, the pressure increases, and when the piercing element pierces the sealed film, the processing liquid is forced to enter the cavity of the piercing element, contacts the absorbing element in the cavity, (at this time the absorbing element can be compressed, or can not be compressed, or have a certain degree of compression, or not be compressed completely), mixes with the sample in the absorbing element, or mixes with the liquid sample squeezed from the absorbing element, or elutes the analyte on the absorbing element through the absorbing element, thereby quickly flowing into the flow channel (the channel in the connecting rod, the introduction channel of the carrier, the connecting rod and the connecting channel are in fluid connection), and then quickly entering the carrier and contacting the test strip. The speed of the movement of the piercing element, the degree of compression of the sealed space, and the increase of the pressure of the sealed space, so that the pressure forces the processing liquid and the liquid sample in the piercing element, or the mixed liquid of the processing liquid and the liquid sample, to quickly flow to the test element. The way and speed of pressure increase will affect the speed of liquid flowing to the test element. The faster the pressure increases, the faster the liquid flows. 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 cooperates with the inner wall of the cavity of the receiving device to form a sealed space; or the piercing element tightly cooperates with the inner wall of the cavity of the receiving device, which can also form a sealed space. In this way, the compression of the sealed space not only accelerates the flow of the liquid, but also prevents the liquid in the sealed space from leaking into the environment, thereby preventing the operator and the environment from being contaminated. Generally, the collector with the absorbing element is vertically inserted into the receiving device, so that the liquid overcomes the gravity and moves upward, and the compression of the sealed space increases the pressure, which has a good effect.

[0169] In some ways, the absorption element enters the cavity of the piercing element, and the disc mechanism 805 that fixes the absorption element also forms a sealed structure with the inner wall of the cavity of the piercing element, no matter whether the liquid sample compressed out of the absorption element or the processing liquid that enters the piercing element, will not flow out of the outside to pollute the operator and the environment. At the same time, the disc mechanism also forms a sealed structure with the cavity of the piercing element, and the compression of the absorption element can continue, because the disc mechanism 805 is in a sealed state with the inner wall of the piercing element 10 (such as the second cavity), the compression of the absorption element 107 will also increase the pressure of 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 flow of the processing liquid through the absorption element into the channel of the connecting rod, so that the liquid can flow into the test strip to complete the detection, at this time the piercing element has entered the processing liquid, the compression of the double-sealed space (the sealed space of the disc mechanism in the piercing element and the sealed space formed by the piercing element and the cavity of the receiving device) and the double-increased pressure, make the liquid sample, or the processing liquid mixed with the liquid sample, or the processing liquid alone through the absorption element or not through the absorption element into the fluid channel, quickly reach the test strip, and obtain the detection result quickly. At the same time, the processing liquid will not flow out of the receiving device, and will not pollute the environment or the operator. In fact, in this way, the pressure flow with the outside world is the channel 12 in the connecting rod 109, so that the increase in pressure can only make the liquid pass through the channel 12 and be transmitted to the carrier, and there is almost no possibility of passing through elsewhere. This is one of the most preferred ways of the present application.

[0170] In some ways, for example Figures 19-22 The operation process of the present application is described, and the specific detection device and receiving device described in this operation process are only a specific embodiment and cannot limit the present application.

[0171] As Figure 10 Described, the detection device is provided, including a carrier element 111, which has four grooves 1110, 1114, 11123, and 11124 on the carrier element, and four grooves are respectively provided with a lateral flow test strip 1128, 1129, 1130, and 1131, each test strip corresponds to a specific analyte. When setting the test strip, the water absorption element 1123 of the test strip is arranged at the end of the carrier element away from the introduction channel 1115, and the sample application area 1121 of the test strip is arranged close to the introduction channel 1115. At the same time, part of the sample application area is "suspended" on the opening of the cavity 1116 of the carrier element 111 (such as Figure 4A). A dividing element is provided in the cavity 1116 to divide the cavity 1116 into two parts. The specific method is to set a baffle 1119. The height of the baffle is less than the depth of the cavity 1116. The baffle is set in front of the entrance 1117 of the introduction channel 1115, forming a narrow gap between the entrance and the baffle, allowing one end 1131 of the guide element to be inserted into the narrow gap, almost covering or obscuring the entrance 1117. Then, the other end 1133 of the introduction element is folded, and the fold line position 1132 contacts the end of the sample application area of ​​the test strip, while the folded end 1133 covers the sample application area (such as Figure 18 ). Then, a transparent single-sided adhesive film is applied to the front of the carrier, allowing the film to seal the entire groove and the opening of the cavity, forming a relatively sealed space. A channel 1118 is provided on both sides of the opening of the cavity 1116, thereby forming a ventilation channel connected to the outside world with the film 114. The carrier is inserted into the cavity of the receiving element 110, so that the front of the carrier (the side covered with the film) faces 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, comprising an absorbent element 107 and a connecting rod 109. One end of the connecting rod has a disc 805, to which the absorbent element 107 is glued. The disc has an elastic sealing ring 108. The connecting rod has a transmission channel 12, one end of which is in fluid communication with the absorbent element 107, and the other end of which is connected to an inlet channel 1115 on the carrier for fluid communication. The absorbent element is made of a sponge material that is rigid when dry and becomes soft when wet, allowing it to be squeezed or compressed. The other end of the connecting rod 109 has threads 1093, while the inlet channel 1115 has internal threads. The receiving element 111 includes a connecting element 1101, the outer wall of which is provided with external threads 1105. The connecting element has an opening whose diameter is the same as the opening of the second cavity of the puncture element, facilitating contact between the opening of the connecting element and the opening of the second cavity of the puncture element, thereby facilitating movement of the puncture element. The connecting rod is provided with annular protrusions 1191, 1192, which can basically contact and cooperate with the inner wall of the connecting element. In this way, the threaded end of the connecting rod 109 is passed through the hole 11011 between the connecting element 1101 and the receiving cavity. Through the inner wall of the connecting element and the annular protrusion on the connecting rod 109, the thread 1193 of the connecting rod can be threadedly connected to the opening of the introduction channel 1115 to form a fluid connection. This forms a detection device in a specific embodiment of the present invention, such as Figure 19 Schematic diagram of the cross-sectional structure above.

[0173] In the assembly of the detection device, first, the carrier with the test element is assembled, then the carrier is inserted into the cavity of the receiving element, the collector with the absorbing element is provided, the collector is irradiated for sterilization, and then the receiving element and the carrier are assembled together.

[0174] In the specific embodiment of the present application, a receiving device is provided, which is a cavity structure divided into three parts, a first cavity 91, a second cavity 94 and a third cavity 90, a sealed cavity 103 is arranged in the first cavity, and a treatment solution 1038 is contained in the sealed cavity, which is sealed by a sealing film 104, which is actually an aluminum foil sealing. The piercing element is contained in the second and third cavities of the receiving device, and the piercing element includes a first cavity 1062 and a second cavity 1061, and the specific structure is shown in Figure 16 and Figure 17 The connection between the first cavity and the second cavity of the piercing element has two grooves 95, 96 at the end of the second cavity, and an elastic sealing ring 105 is arranged in each groove Figure 17 , which contacts the inner wall of the second cavity of the receiving device, so that a sealed space 80 is formed below the elastic sealing ring contacting the second cavity, which includes the second cavity and the first cavity of the receiving device. The inner wall of the third cavity of the receiving device has a recessed thread structure, which cooperates with the protruding thread structure on the surface of the connecting element. The second cavity of the piercing element is located in the third cavity of the receiving device, and a space is left between the outer wall of the second cavity of the piercing element and the inner wall of the third cavity of the receiving device, so that the protruding thread on the outer surface of the connecting element cooperates with the recessed thread on the inner surface of the second cavity, thereby driving the movement of the piercing element. The initial position of the piercing element in the receiving device is shown in the lower part of Figure 19 .

[0175] In specific use, first, the absorbing element of the detection device, such as a sponge head, is inserted into the mouth to absorb the saliva sample. After the sponge head absorbs the saliva sample, it becomes soft. After absorbing the saliva sample, the absorbing element is inserted into the second cavity 1061 of the piercing element. Since the collector has a sealing ring 108, when it is inserted into the second cavity of the piercing element, the absorbing element with saliva absorbed and softened contacts the step 1068 of the piercing element, so as to squeeze the saliva sample into the first cavity. At this time, the elastic sealing ring seals the second cavity of the piercing element, and the opening along 1108 of the connecting element 1101 of the receiving element contacts the edge 1070 of the second cavity of the piercing element. At this time, the piercing element is in the initial position (as shown in Figure 20), the absorbent element has been compressed, releasing the saliva sample into the first cavity 1062 of the piercing element. As the outer threads 1105 of the connecting element rotate and engage with the threads of the third cavity 90 of the receiving device, the connecting element 1101 pushes the piercing element downward from its initial position. At this point, the volume of the space 80 enclosed by the elastic sealing rings 1051 and 1052 on the pierced element gradually decreases, and the pressure in the space increases. At this point, the absorbent element has been squeezed, and the relative positions of the piercing element and absorbent element are fixed. Therefore, during this movement, the absorbent and piercing elements move together. As the piercing element moves, the piercing mechanism 1066 on the outer surface of the distal end of the first cavity 1062 of the piercing element contacts the sealing film 104 of the sealed cavity 103. The piercing mechanism is generally a relatively sharp structure. After piercing the sealing film 104 of the sealed cavity 103, the first cavity of the piercing element continues to move downward, partially entering the cavity 103. Due to the compression of the sealed space, the pressure increases, and this is combined with the pressure exerted on the liquid by the first cavity entering the sealed cavity 103. It can be understood here that, in fact, the connecting rod of the absorption element is fluidically connected to the cavity 1116 on the carrier 110, and the gas is also connected, and the cavity 1116 is connected to the outside atmosphere through the set air hole 1103. Therefore, the two cavities (the first and second cavities) of the puncture element are actually indirectly connected to the outside atmosphere through the absorption element. Therefore, the compression of the sealed space and the pressure of the droplet entering the sealed cavity 103 from the first cavity of the puncture element are combined, so that the pressure in the cavity of the puncture element has a pressure difference with the sealed space 80 of the receiving element. In this way, the processing liquid in the sealed cavity 103 is forced to enter the first cavity through the small hole 1065 of the first cavity, mix with the saliva sample, and form a first mixed liquid. As the pressure of the sealed cavity 80 continues to increase, the first mixed liquid passes through the compressed absorption element 107 to form a second mixed liquid, passes through the absorption element to elute the absorption element, for example, elutes THC adsorbed by the absorption element, enters the channel 12 of the connecting rod, and flows into the cavity 1116 on the carrier through the introduction channel 1115 on the carrier. At the same time, it contacts the guide element 113, allowing the second mixed liquid to flow into the test element 112 for testing and analysis of the analyzed substance ( Figure 22 ) If there is excess second mixed liquid, it enters the second area of ​​cavity 1116 on the carrier to ease the process or be stored. After the test is completed, the results of the test area and control area on the test element are read through the transparent film on the carrier. The latter is recorded by photographing the test results or scanning the test results.

[0176] In some embodiments, the absorbent element becomes soft after absorbing the liquid (both materials are porous water-absorbing materials, such as sponge, filter paper, cotton, etc.), but becomes tight after being compressed, so that the liquid can pass through the absorbent element into the channel 12, and the increased pressure in the sealed cavity 80 makes it easier and faster for the mixed liquid to pass through the tight absorbent element, and vice versa.

[0177] In other embodiments, the absorbent element can not be compressed, for example, the absorbent element is a rod-shaped body for absorbing feces, and the rod-shaped body is provided with some concave threads or grooves for solid or semi-solid samples, and the rod-shaped body has a fluid communication with the channel 12 in the connecting rod. After the above operation, the treatment liquid in the sealed cavity 103 enters the cavity in the piercing element, dissolves the feces sample in the grooves of 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 can not be sealed, and only the first cavity 1062 of the piercing element enters the sealed cavity 103, so that the treatment liquid enters the first cavity of the piercing element is also feasible.

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

[0180] 1. A receiving device comprising: a cavity comprising a first sealed cavity for holding a treatment solution and a piercing element, the piercing element being movable within the cavity, wherein the piercing element is configured to pierce the first sealed cavity.

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

[0182] 3. The device of clause 2, wherein the piercing element comprises a cavity and a piercing structure, the piercing structure piercing the first sealed cavity during movement of the piercing element from the first position to the second position, thereby causing the treatment solution to enter the cavity of the piercing element.

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

[0184] 5. The device of clause 4, wherein a portion of the cavity of the piercing element enters the first sealed cavity when the piercing element is in the second position, thereby forcing the treatment solution to enter the cavity of the piercing element.

[0185] 6. The device of clause 5, wherein the piercing member includes a passageway through which the treatment fluid flows into the chamber.

[0186] 7. The device of clause 3 or 5, wherein the chamber of the piercing member is configured to receive a fluid sample, and wherein the treatment fluid forms a first mixed fluid with the fluid sample when the treatment fluid enters the chamber of the piercing member.

[0187] 8. The device of clause 7, wherein the chamber of the piercing member is configured to receive an absorbent member, and wherein the absorbent member is compressed or squeezed to release the fluid sample.

[0188] 9. The device of clause 2, wherein the piercing member includes a first chamber including a piercing structure and a second chamber configured to receive an absorbent member.

[0189] 10. The device of clause 9, wherein the piercing structure does not pierce the first sealed chamber when the piercing member is in a first position, and wherein the piercing structure pierces the first sealed chamber when the piercing member is in a second position.

[0190] 11. The device of clause 10, wherein a portion of the first chamber of the piercing member enters the first sealed chamber when the piercing member is in the second position, thereby forcing the treatment fluid into the first chamber of the piercing member.

[0191] 12. The device of clause 10, wherein the absorbent member is compressed or squeezed to release the fluid sample into the first chamber of the piercing member to form a first mixed fluid with the treatment fluid in the first chamber when the piercing member is in the first position.

[0192] 13. The device of clause 12, wherein the first mixed fluid passes through the absorbent member to form a second mixed fluid when the piercing member is in the second position.

[0193] 14. The device of clause 13, wherein the absorbent member is in fluid communication with a passageway in the connecting rod, and wherein the second mixed fluid formed by passing through the absorbent member flows into the passageway of the connecting rod.

[0194] 15. The device of clause 1, wherein the piercing member defines a compressible sealed space within the chamber of the receiving device, and wherein the first sealed chamber is included in the sealed space.

[0195] 16. The device of clause 15, wherein the receiving device comprises a second chamber in the cavity of the receiving device, the partial piercing element is located in the second chamber, and the compressible partial seal is located in the second chamber.

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

[0197] 18. The device of clause 17, wherein the piercing element comprises a first chamber and a second chamber for receiving the absorbent element, the first chamber comprises a piercing structure and a through hole.

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

[0199] 20. The device of clause 19, wherein the seal is compressed when the piercing element is in the second position, thereby increasing the pressure of the seal, thereby forcing the treatment fluid through the through hole into the first chamber of the piercing element.

[0200] 21. The device of clause 20, wherein the absorbent element is compressed or squeezed when the piercing element is in the first position, thereby releasing the fluid sample into the first chamber of the piercing element, thereby forming a first mixed fluid with the treatment fluid in the first chamber.

[0201] 22. The device of clause 21, wherein the increased pressure of the seal forces the first mixed fluid through the absorbent element when the piercing element is in the second position, thereby forming a second mixed fluid.

[0202] 23. The device of clause 22, wherein the absorbent element is in fluid communication with a channel in the connecting rod, and the second mixed fluid formed by the absorbent element is forced by the increased pressure of the seal into the channel of the connecting rod.

[0203] 24. The device of clause 23, wherein the channel of the connecting rod is in fluid communication with a test element, and the second mixed fluid is able to flow to the test element, thereby detecting the presence or amount of the analyte in the second mixed fluid.

[0204] 25. The device of clause 19, wherein a portion of the first chamber of the piercing element enters the first seal when the piercing element is in the second position.

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

[0206] 27. The device of clause 26, wherein movement of the piercing member causes the piercing structure of the piercing member to pierce the sealed first cavity, and the increased pressure within the sealed space forces the treatment fluid of the first sealed cavity to flow into the cavity of the piercing member.

[0207] 28. The device of clause 1, wherein the first sealed cavity comprises a membrane that is pierceable.

[0208] 29. A device for detecting the presence of an analyte in a fluid sample, the device comprising:

[0209] a carrier member comprising a test member and a cavity, the cavity comprising a fluid introduction channel, the cavity being in fluid communication with the test member, the test member comprising a sample application region and a test region.

[0210] 30. The device of clause 29, further comprising a wicking member, the wicking member being in fluid communication with the introduction channel and the test member.

[0211] 31. The device of clause 30, wherein the introduction channel comprises a fluid inlet, the fluid inlet being in fluid communication with the cavity, and wherein the cavity comprises a partition member, the partition member dividing the cavity into a first region and a second region, the first region being located between the test member and the fluid inlet.

[0212] 32. The device of clause 31, wherein one end of the wicking member is located in the first region and the other end covers a portion of the sample application region.

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

[0214] 34. The device of clause 32, wherein one end of the wicking member covers the fluid inlet.

[0215] 35. The device of clause 29, wherein the device comprises a collector, the collector comprising an absorbent member and a connecting stem.

[0216] 36. The device of clause 35, wherein the collector and the carrier are removably connected.

[0217] 37. The device according to clause 36, wherein the device further comprises a receiving element, the receiving element comprises 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 configured to be insertable into the receiving cavity in a unique orientation.

[0219] 39. The device according to clause 37, wherein the receiving chamber further comprises a connecting element, and the connecting rod of the collector passes through the connecting element and is connected to the introduction 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 includes a vent connected to the outside atmosphere.

[0222] 1. A method for processing a liquid sample, the method comprising: providing a device comprising a first sealed cavity for containing a processing liquid and a puncture element capable of moving within the device, allowing the puncture element to move to puncture the sealed cavity containing the processing liquid and release the processing liquid.

[0223] 2. The method according to claim 1, wherein the puncturing element comprises a cavity, and the released treatment liquid enters the cavity of the puncturing element.

[0224] 3. According to the method described in Item 1, the absorption element is allowed to enter the cavity of the puncture element to contact the treatment liquid, thereby forming a first mixed liquid of the treatment liquid and the fluid sample.

[0225] 4. According to the method described in Item 3, the absorption element is squeezed in the cavity of the puncture element to release the fluid sample, and the fluid sample is mixed with the treatment liquid in the cavity to form the first mixed liquid.

[0226] 5. According to the method described in Item 4, the first mixed solution is allowed to flow back to the absorption element and contact the absorption element to form a second mixed solution, and the second mixed solution is allowed to flow out of the puncture element.

[0227] 6. According to the method described in Item 4, the second mixed liquid flowing out of the puncture element flows into the test element to detect or test the substance to be analyzed.

[0228] 7. The method according to clause 1, further comprising a second cavity for accommodating a portion of the puncture element, the puncture element having a first position and a second position in the second cavity.

[0229] 8. The method of claim 7, moving the lancing element from the first position to the second position to cause the lancing structure on the lancing element to puncture the first chamber containing the treatment fluid and to cause the treatment fluid from the first chamber to enter the cavity of the lancing element.

[0230] 9. The method of claim 8, causing a portion of the cavity of the lancing element to enter the first chamber containing the treatment fluid.

[0231] 10. The method of claim 8, the lancing element comprising a first chamber containing the lancing structure and a second chamber for receiving the absorbent element, causing the first chamber of the lancing element to enter the first chamber of the treatment fluid and forcing the treatment fluid into the first chamber of the lancing element.

[0232] 11. The method of claim 10, causing the second chamber of the lancing element to receive the absorbent element and compress the absorbent element to release the fluid sample, causing the released fluid sample to enter the first chamber of the lancing element and mix with the treatment fluid to form a first mixed fluid.

[0233] 12. The method of claim 10, causing the first mixed fluid to enter the second chamber of the lancing element and contact or pass through the absorbent element to form a second mixed fluid, causing the second mixed fluid to exit the lancing element and flow onto the test element.

[0234] 13. The method of claim 7, inserting the absorbent element into the cavity of the lancing element to cause the absorbent element to compress and simultaneously urge the lancing element to move from the first position to the second position.

[0235] 14. The method of claim 8, inserting the absorbent element into the second chamber of the lancing element and causing the absorbent element to compress and release the fluid sample, causing the released fluid sample to flow into the first chamber of the lancing element.

[0236] 15. The method of claim 8, the absorbent element urging the lancing element to move from the first position to the second position to cause the lancing element to puncture the first sealed chamber containing the treatment fluid and to cause the first chamber of the lancing element to enter the chamber containing the treatment fluid to force the treatment fluid into the first chamber of the lancing element and mix with the fluid sample.

[0237] 16. The method of claim 13, the absorbent element being connected to a connecting rod having a passageway therein for the transmission of fluid and being in fluid communication with the absorbent element.

[0238] 17. The method of claim 13, the lancing element forming a sealed space within the sealing device that can be compressed to increase the pressure within the space, wherein the sealed space comprises the first sealed chamber containing the treatment fluid.

[0239] 18. The method of clause 17, inserting the absorbent element with the connecting rod into the second cavity of the lancing element and sealing the second cavity, compressing the absorbent element in the second cavity while pushing the lancing element from the first position to the second position.

[0240] 19. The method of clause 17, compressing the sealed space of the device, increasing the pressure of the sealed space, the increased pressure forcing the treatment fluid into the first cavity of the lancing element and mixing with the fluid sample as the first cavity of the lancing element enters the cavity containing the treatment fluid.

[0241] 20. The method of clause 19, wherein the increased pressure flows the mixture into the second cavity of the lancing element and through the absorbent element into the channel of the connecting rod and ultimately onto the test element.

[0242] The present application 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 this specification are indicative of the levels of those skilled in the art to which the application pertains, and are hereby incorporated by reference to the same extent as if each individual publication was specifically and individually incorporated by reference. All patents and publications referenced in this specification are indicative of the levels of those skilled in the art to which the application pertains, and are hereby incorporated by reference to the same extent as if each individual publication was specifically and individually incorporated by reference. The application described herein can be carried out in the absence of any element or elements, or in the presence of one or more additional elements or steps, not specifically described herein. For example, the terms "comprising", "consisting essentially of and "consisting of as used herein are used in their broadest sense and encompass both the stated elements and additional elements. The term "a" or "an" as used herein means "one" or "only one" unless otherwise indicated. As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise. As used herein, the term "includes" and / or "including" means, without limitation, "including", but also including. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention that in the use of such terms and expressions of describing the application the same be construed to imply any such non- limiting characteristics with respect to this application except as specifically set forth herein. It is also understood that the examples and embodiments described herein are illustrative only and are not intended to be limiting in any way unless specifically indicated otherwise. Any change in the design or implementation of the application described herein can be made without departing from the spirit and scope of the application. It is understood that any of the features of the application can be used in any combination, and that the application includes any combination of the features described herein.

Claims

1. A testing device for detecting whether a fluid sample contains an analyte, the device comprising: The carrier element comprises a test element and a cavity, wherein the cavity comprises a fluid introduction channel, and the cavity is in fluid communication with the test element.

2. The testing device according to claim 1, wherein: The device further comprises a drainage element, wherein the drainage element fluidly connects the introduction channel and the test element.

3. The testing device according to any one of claims 1 to 2, wherein: The inlet channel includes a fluid inlet, which is in fluid communication with the cavity. The cavity includes a dividing element, which divides the cavity into a first area and a second area. The first area is located between the dividing element and the fluid inlet.

4. The testing device according to any one of claims 2 to 3, wherein: One end of the drainage element is located in the first area, and the other end covers a portion of the sample application area of ​​the test element.

5. The testing device according to any one of claims 3 to 4, wherein: The second area is configured to receive the fluid sample, or is configured to receive excess fluid sample flowing out of the drainage element.

6. The testing device according to any one of claims 3 to 5, wherein: One end of the guide element covers the fluid inlet, or a portion of the guide element located in the first area covers the fluid inlet.

7. The testing device according to any one of claims 1 to 6, wherein: The device further comprises a collector, and the collector comprises an absorbing element and a connecting rod.

8. The testing device according to claim 7, wherein: The collector and the carrier are connected in a detachable manner.

9. The testing device according to any one of claims 1 to 8, wherein: The device further comprises a receiving element, the receiving element comprises a receiving cavity, and the carrier element is located in the receiving cavity.

10. The testing device according to claim 9, wherein: The carrier element is configured to be inserted into the receiving cavity in a unique direction.

11. The testing device according to any one of claims 9 to 10, wherein: The receiving chamber further comprises a connecting element, and the connecting rod of the collector passes through the connecting element and is detachably connected to the introduction channel of the carrier.

12. The testing device according to claim 11, wherein: The connecting element also includes a thread structure.

13. The testing device according to any one of claims 1 to 12, wherein: The cavity on the carrier includes a vent hole connected to the outside atmosphere.

14. The testing device according to any one of claims 1 to 13, wherein the testing element and the cavity are covered by a transparent film.

15. The testing device according to any one of claims 1 to 13, wherein: The testing device further includes a receiving device, comprising: a first sealed cavity for accommodating a processing solution and a cavity of a puncture element, wherein the puncture element is capable of moving within the cavity, wherein the puncture element is configured to puncture the sealed cavity.

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

17. The device according to claim 16, wherein The puncture element includes a cavity and a puncture structure. When the puncture element moves from the first position to the second position, the puncture structure punctures the first sealed cavity, so that the treatment liquid in the first sealed cavity enters the cavity of the puncture element.

18. The device according to claim 17, wherein When the piercing element is located at the first position, the piercing element is away from the sealed cavity, or the piercing element does not pierce the first sealed cavity.

19. The device according to claim 18, wherein When the puncture element is in the second position, part of the cavity of the puncture element enters the sealed cavity, thereby forcing the treatment liquid to enter the cavity of the puncture element; or, the puncture element punctures the first sealed cavity, thereby releasing the treatment liquid from the first sealed cavity.

20. The device according to claim 19, wherein The puncture element includes a through hole, and the treatment liquid flows into the cavity of the puncture element through the through hole.

21. The device according to claim 20, wherein The cavity of the puncturing element may be configured to receive a fluid sample. When the treatment liquid enters the cavity of the side-breaking element, the treatment liquid and the fluid sample form a first mixed liquid.

22. The device according to claim 21, wherein The cavity of the puncturing element can be configured to receive the absorbent element of the collector, and the absorbent element is compressed or squeezed to release the fluid sample.

23. The device according to claim 22, wherein The piercing element includes a first cavity and a second cavity for receiving the absorbent element, and the first cavity includes a piercing structure.

24. The device according to claim 23, wherein The absorption element is compressed in the second cavity of the puncture element to release the liquid sample, and the liquid sample is mixed with the processing liquid sample to form the first mixed liquid.

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