A sample collection pretreatment step-by-step detection integrated device

Abstract

The application relates to the field of biological sample processing devices, in particular to a sample collection, pretreatment and step-by-step detection integrated device which comprises a cup body, a closure for plugging a first channel, a cup cover capable of being opened to cover a sample adding opening, and a limiting component for limiting the movement of the cup cover along a first direction; the cup body comprises a first space and a second space which are independent of each other; a first channel is arranged between the first space and the second space; the first space is provided with a sample adding opening; a detection unit is arranged in the second space; the cup cover can move along the first direction relative to the cup body in a covering state to drive a pushing component to open the closure; the second channel comprises an output opening connected with the first space and an input opening exposed outside and capable of being opened and closed; the device is an integrated device and is convenient to operate; through the arrangement of the limiting component, the risk that the closure is opened to cause the sample to react with the detection unit in advance when the device is accidentally pressed can be reduced.

Description

Technical Field

[0001] This application relates to the field of biological sample processing devices, and more particularly to an integrated device for sample collection, pretreatment, and step-by-step detection. Background Technology

[0002] Mental illness is a common condition, primarily including schizophrenia, depression, anxiety disorders, and bipolar disorder. Medication monitoring plays a crucial role in the safe use of psychiatric medications. Due to the significant individual variability, narrow therapeutic window, and numerous adverse reactions associated with psychiatric drugs, medication concentration monitoring helps ensure patients receive optimal treatment outcomes and reduces the risk of overdose or underdose. Medication concentration monitoring helps to rationally control medication dosage, reduce side effects caused by overdose, and avoid treatment delays due to underdose, thereby improving patient satisfaction and quality of life in psychiatric settings. It also helps to shorten treatment duration and reduce healthcare costs.

[0003] In the current field of in vitro diagnostics (IVD) (such as the detection of drugs and medications), especially some psychoactive substances, the traditional processing technology for samples usually involves separating the sample collection, pretreatment (such as lysis), and detection into separate devices. In this fragmented processing mode, the sample needs to be transferred multiple times, resulting in high operational complexity.

[0004] In related technologies, some devices require the device to be fully opened before adding reagents during sample processing, which poses a high risk of exposure to biological contaminants. Such devices can be referred to as those disclosed in patent document CN218157563U.

[0005] In addition, for some devices with built-in detection reagents, such as the device disclosed in the patent document with publication number CN218157563U, the device is prone to premature reaction between the sample and the detection reagent inside the device after accidental pressure, making it difficult to guarantee the controllability of the reaction start time within the detection period. Utility Model Content

[0006] In order to solve at least one of the technical problems mentioned in the background art, the purpose of this application is to provide an integrated device for sample collection, preprocessing and step-by-step detection.

[0007] To achieve the above objectives, this application provides the following technical solution.

[0008] A sample collection, preprocessing, and step-by-step detection integrated device includes: The cup body includes a first space and a second space that are independent of each other; a first channel is provided between the first space and the second space; the first space has a sample dispensing port; and a detection unit is provided in the second space. A closure element is disposed in the first channel to block the first channel, and the closure element can be driven to open in a first direction so that the first space and the second space can communicate through the first channel; The cup lid can be opened to close the sample filling port. The cup lid includes a pusher and a second channel. The cup lid can move relative to the cup body in a first direction when closed, so as to drive the pusher to open the closing part. The second channel includes an output port connected to a first space and an exposed input port that can be opened and closed. A limiting member is used to restrict the movement of the cup lid in a first direction to prevent the pushing member from opening the closure, and it is releasably disposed between the cup body and the cup lid.

[0009] Compared with the prior art, the advantages of using this application are: First, the device provided in this application is essentially an integrated device, which can be used for sample collection, pretreatment (lysis) and detection, making it easier to operate.

[0010] Secondly, by setting a limiting component in this device, the cup lid can be limited, thereby reducing the risk that the closure will be opened when the device is accidentally compressed, causing the sample to react with the detection unit prematurely, thus ensuring the controllability of the reaction start time within the detection period.

[0011] Furthermore, in this application, a second channel is provided on the cup lid, so that relevant reagents can be added into the cup through the second channel without opening the cup lid, without having to fully open the entire cup lid, which helps to reduce the risk of exposure to biological contaminants.

[0012] Finally, in this application, whether the closure is opened or not is controlled by the action of the cup lid, so that the cup lid can operate in the closed state to control the opening of the closure. This also helps to reduce the risk of exposure to biological contaminants and the risk of sample contamination.

[0013] As an optional embodiment of this application, the closure includes a sliding member that is slidably and sealingly fitted in the first channel along a first direction; or the closure includes a sealing membrane that can be punctured by a pushing member.

[0014] As an optional embodiment of this application, the limiting member has a ring-shaped structure that surrounds between the cup body and the cup lid, and the limiting member can be broken by force; and / or the device further includes a plug that is detachably sealed at the input end of the second channel.

[0015] As an optional embodiment of this application, one end of the pushing member extends along a first direction toward the side closer to the closure member to form a driving end for pushing the closure member to open; the second channel is provided inside the pushing member, and the end of the second channel away from the driving end forms the input port; a through hole is provided on the side wall of the pushing member to form the output port, wherein the through hole is located away from the driving end.

[0016] As an optional embodiment of this application, at least a portion of the cup wall is a visible transparent area serving as an observation area; the detection unit includes a test strip or a detection reagent.

[0017] As an optional embodiment of this application, the first direction is parallel to the axial direction of the cup body; the first space and the second space are arranged sequentially in the first direction and are separated from each other by a partition, and the first channel is provided on the partition.

[0018] As an optional embodiment of this application, the cup body includes an outer cup body and an inner cup body, the inner cup body and the outer cup body being detachably nested together; the partition portion is disposed in the inner cup body; the mouth of the inner cup body constitutes the sample dispensing port, and the cup lid is disposed at the mouth of the inner cup body; the first space is formed between the cup lid and the partition portion, and the second space is formed between the partition portion and the bottom of the outer cup body.

[0019] As an optional embodiment of this application, the inner cup body and the outer cup body are connected by a threaded engagement or a snap-fit ​​connection; and / or the cup lid is connected to the inner cup body by a threaded engagement or a snap-fit ​​connection.

[0020] As an optional embodiment of this application, a sealing portion is formed on the inner side of the cup lid. When the cup lid is closed, the sealing portion abuts against the inner peripheral wall of the inner cup body to form a seal.

[0021] As an optional embodiment of this application, a stepped surface that protrudes radially from the inner cup body is formed on the outer peripheral wall of the inner cup body, and the limiting member is sleeved around the outer periphery of the inner cup body. In the closed state, the limiting member is positioned between the cup lid and the stepped surface.

[0022] Other advantages and effects of this application are explained in detail in the Detailed Description and Drawings sections.

[0023] It should be understood that the description in this section is not intended to identify key or essential features of the embodiments of this application, nor is it intended to limit the scope of this application. Other features of this application will become readily apparent from the following description. Attached Figure Description

[0024] The above and other objects, features, and advantages of exemplary embodiments of this application will become readily apparent from the following detailed description taken in conjunction with the accompanying drawings. Several embodiments of this application are illustrated in the drawings by way of example and not limitation, in which: In the accompanying drawings, the same or corresponding reference numerals indicate the same or corresponding parts.

[0025] Figure 1 An exploded view of this application is shown; Figure 2 A schematic diagram of the structure in the assembled state of this application is shown; Figure 3 An axial cross-sectional view of the present application in its assembled state is shown; Figure 4 A schematic diagram of the internal structure of the cup in this application is shown; Figure 5 A schematic diagram of the structure of the cup lid of this application is shown; Figure 6 A schematic diagram of the limiting ring of this application is shown.

[0026] Explanation of the labels in the diagram: L1, First Direction; 1. Outer cup body; 10. First space; 11. Protrusion; 2. Inner cup body; 20. Second space; 21. Protruding ring; 211. Stepped surface; 22. Partition; 221. First channel; 3. Sliding components; 4. Cup lid; 41. Sealing part; 42. Pushing component; 421. Second channel; 422. Through hole; 423. Inlet; 5. Limiting ring; 6. Plug; 61. Ring body; 7. Test strips. Detailed Implementation

[0027] To make the objectives, features, and advantages of this application more apparent and understandable, the technical solutions in the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0028] Example 1 Reference Figures 1-6 As shown, this embodiment provides a sample collection, preprocessing, and step-by-step detection integrated device (hereinafter referred to as "this device"), which can be used for sample processing in the field of pre-in vitro diagnostics (IVD), such as drug testing for psychotropic drugs and drug testing.

[0029] This device mainly includes a cup body, a sealing component, a cup lid 4, and a limiting component; the following is a detailed description of each component.

[0030] Combination Figure 3 As shown, the cup body includes a first space 10 and a second space 20 that are independent of each other; a first channel 221 is provided between the first space 10 and the second space 20, so that the first space 10 and the second space 20 can be connected to each other through the first channel 221; the first space 10 has a sample inlet, which is mainly used for adding samples; a detection unit is provided in the second space 20.

[0031] Preferably, the first space 10 and the second space 20 are arranged sequentially in the first direction L1. The first direction L1 claimed in this embodiment can be understood as the direction parallel to the axis of the cup body (i.e., the axial direction).

[0032] In some embodiments, a specific cup structure is provided, combined with Figure 1 As shown, the cup body includes an outer cup body 1 and an inner cup body 2 nested inside the outer cup body 1. Both the outer cup body 1 and the inner cup body 2 have top-opening structures. In some embodiments, the inner cup body 2 and the outer cup body 1 are basically round cup structures, and they are basically coaxial after being nested together.

[0033] The opening of the inner cup 2 constitutes the sample dispensing port.

[0034] Furthermore, the inner cup body 2 and the outer inner body are nested together in a detachable manner, for example: The inner cup 2 and the outer cup 1 are connected by a threaded connection, specifically, as shown below. Figure 3 As shown, the outer cup body 1 has an external thread section on its outer peripheral wall at the cup opening, and the inner cup body 2 has a convex ring 21 that surrounds the inner cup body 2 on its outer peripheral wall. The convex ring 21 protrudes radially from the inner peripheral wall, and the two form a space for the cup opening of the outer cup body 1 to be inserted. The inner peripheral wall of the convex ring 21 has an internal thread section that matches the external thread section of the outer cup body 1. The threaded connection between the inner cup body 2 and the outer cup body 1 is achieved through the threaded engagement of the internal thread section and the external thread section.

[0035] In order to improve the sealing performance of the threaded connection between the inner cup body 2 and the outer inner body, it is preferable that the threaded sections of the two are made of tough materials such as rubber to achieve a certain sealing effect.

[0036] Of course, in some other alternative implementations, the inner cup 2 and the outer inner body can also be connected together by interlocking.

[0037] The reason for assembling the inner cup 2 and the outer cup 1 in a detachable manner is that the inner cup 2 can be removed separately to collect samples and observe the sample status, avoiding interference from the detection unit in the outer cup 1; and the inner cup 2 can be directly heated in a water bath to pre-treat the sample and reach the temperature required for the detection reaction.

[0038] In order to make the first space 10 and the second space 20 relatively independent spaces, in some embodiments, such as Figure 3 As shown, the first space 10 and the second space 20 are separated by a partition 22, and the first channel 221 is located at the center of the partition 22.

[0039] In some embodiments, the partition portion 22 is specifically configured to be combined with Figure 3 and Figure 4 As shown, the partition 22 is disposed in the inner cup body 2. Preferably, the partition 22 and the inner cup body 2 are integrally constructed. In this case, the partition 22 is equivalent to the bottom of the inner cup body 2. The space between the cup lid 4 and the partition portion constitutes the aforementioned first space 10, and the space between the partition 22 and the bottom of the outer cup body 1 constitutes the second space 20. It can also be understood that the first space 10 is located on the upper side of the partition 22, and the second space 20 is located on the lower side of the partition 22. The two are connected by the first channel 221 on the partition 22, so that the sample in the first space 10 can flow into the second space 20 through the first channel 221.

[0040] In this embodiment, the second space 20 is equivalent to a detection space, and the specific detection work is carried out in the second space 20. Therefore, in this embodiment, the detection unit is set in the second space 20.

[0041] The detection unit here refers to the substance that can detect the sample to be tested. The specific material can be set according to the type of sample to be tested. The detection unit can be a test strip 7 or a detection reagent, such as a solution reagent that can detect color reaction. The specific design can be selected according to actual needs.

[0042] The test strips used include, but are not limited to, colloidal gold test strips, fluorescent colloidal gold test strips, and chemical colorimetric test strips.

[0043] In this embodiment, the test strip 7 is used as the detection unit. During installation, it is laid out along the bottom inner peripheral wall of the outer cup 1 so that the test strip 7 is placed between the bottom inner peripheral wall of the outer cup 1 and the bottom outer peripheral wall of the inner cup 2.

[0044] Of course, the test strip 7 can also be fixed in the outer cup 1 by means of a blister pack, injection molded sheet, reagent card, etc., without specific limitations.

[0045] The number of test strips 7 can be selected according to actual needs. For example, three, five, eight, or eleven test strips can be used.

[0046] like Figure 3 As shown, the sealing element is disposed in the first channel 221 and is mainly used to block the first channel 221 to cut off the connection between the first channel 221 and the first space 10 and the second space 20.

[0047] Furthermore, the closure can be driven open along the first direction L1 to allow the first space 10 and the second space 20 to communicate via the first channel 221.

[0048] In some embodiments, a specific closure is provided, such as Figure 3 As shown, the closure includes a sliding member 3, which is slidably and sealingly fitted in the first channel 221 along the first direction L1. The slidable sealing claimed in this embodiment can be understood as the two parts that can slide relative to each other being able to slide relative to each other while ensuring the sealing of the sliding contact point.

[0049] Taking the sliding member 3 as an example, the outer peripheral wall of the sliding member 3 can slide against the peripheral wall of the first channel 221 and ensure the sealing of the contact point. In short, the sliding member 3 is equivalent to a piston. In its natural state, or in its initial state, the sliding member 3 remains in the first channel 221 to block the first channel 221, so that the first space 10 and the second space 20 become two independent spaces that are isolated from each other.

[0050] When the piston is driven by an external force to push downward along the first direction L1 and disengage from the first channel 221, the blocking of the sliding member 3 is removed, and the first space 10 and the second space 20 can be connected through the first channel 221, so that the sample and / or reagent in the first space 10 can flow into the second space 20 through the first channel 221.

[0051] The sliding member 3 is preferably made of a tough material, such as plastic or rubber. Of course, in order to further improve the sealing between the sliding member 3 and the first channel 221, a sealing ring can also be nested on the outer peripheral wall of the sliding member 3.

[0052] Of course, in some other alternative embodiments, in addition to the sliding member 3 described above, the sealing member can also be a sealing membrane (not shown in the figure) that can be punctured by force as the sealing member. In the initial state, the sealing membrane blocks and isolates the first channel 221; when the sealing membrane is punctured, it is equivalent to opening the first channel 221, so that the first space 10 and the second space 20 are connected through the first channel 221.

[0053] In this embodiment, as Figure 2As shown, the cup lid 4 is mainly used to seal the sample inlet, and it closes the sample inlet in an openable manner.

[0054] In some embodiments, the cup lid 4 and the inner cup body 2 are connected by threads to achieve opening / closing. Specifically, the outer peripheral wall of the top of the inner cup body 2 is provided with an external thread section, and the inner peripheral wall of the lid is provided with an internal thread section that matches the external thread section. The internal and external thread sections engage to achieve the threaded connection between the cup lid 4 and the inner cup body 2. Thus, when the cup lid 4 needs to be removed, it is only necessary to screw the cup lid 4 on.

[0055] Of course, in some other alternative implementations, the lid 4 and the inner cup 2 can also be connected by interlocking.

[0056] In order to enable the cup lid 4 to cooperate with the opening and closing mechanism, in some embodiments, a specific cup lid 4 is provided: like Figure 3 As shown, the cup lid 4 includes a pusher member 42. The cup lid 4 can move relative to the cup body in the first direction L1 when it is closed, so as to drive the pusher member 42 to open the closure. For example, in this embodiment, the cup lid 4 is closed on the cup body by means of a threaded fit. By rotating the cup lid 4 in the direction of tightening the cup lid 4, the cup lid 4 can move downward in the first direction L1, thereby driving the pusher member 42 to move downward together, so as to open the closure.

[0057] In some embodiments, one end of the pushing member 42 extends along the first direction L1 toward the side near the closure member to form a driving end for pushing the closure member open, for example, as... Figure 3 As shown, the pushing member 42 is in the shape of a straight tube and is basically coaxial with the cup lid 4. Its lower end constitutes the aforementioned driving end, which is used to push the sliding member 3.

[0058] In addition, to improve the sealing performance of the cup lid 4 in the closed state, in some embodiments, such as Figure 5 As shown, a sealing part 41 (e.g., a sealing ring) is formed on the inner side of the cup lid 4. The sealing part 41 is basically coaxially arranged with the cup lid 4. When the cup lid 4 is closed, as shown... Figure 3 As shown, the sealing part 41 abuts against the inner peripheral wall of the inner cup body 2 to form a seal. In some embodiments, the sealing part 41 and the cup lid 4 are integrally constructed.

[0059] Furthermore, in order to allow for the continued addition of reagents to the device without opening the cup lid 4, in some embodiments, such as Figure 3 As shown, the cup lid 4 also includes a second channel 421, which includes an output port connected to the first space 10 and an exposed and closable input port 423. Here, "exposed" can be understood as the input port 423 being open, for example, in this embodiment... Figure 1As shown, the inlet 423 protrudes from the top wall of the cup lid 4.

[0060] The second channel 421 is preferably disposed in the driving component. For example, the driving component has a straight tube structure, and a portion of its interior area constitutes the aforementioned second channel 421. The end of the second channel 421 away from the driving end constitutes the input port. A through hole 422 is provided on the side wall of the pushing member 42 to constitute the output port. The through hole 422 is located on the side away from the driving end, and the through hole 422 is preferably located above the middle of the pushing member 42.

[0061] Thus, by setting up the second channel 421, when reagents need to be added midway, it is not necessary to open the entire cup lid 4. Instead, the reagents can be added into the cup through the second channel 421. Compared with directly opening the cup lid 4 to add reagents, the inlet 423 of the second channel 421 is smaller than the sample inlet, which can reduce the risk of sample contamination and sample leakage.

[0062] In short, this device allows reagents to be added to the cup without opening the lid 4, thereby reducing the risk of exposure to biological contaminants.

[0063] In addition, to prevent sample leakage through the second channel 421, in some embodiments, combined with Figure 1 and Figure 3 As shown, a plug 6 is provided in the input port 423 of the second channel 421. The plug 6 is used to block the input port 423 of the second channel 421 and to control the opening / closing of the input port 423 of the second channel 421.

[0064] The plug 6 is designed to detachably seal the inlet of the second channel 421. For example, the plug 6 is screwed into the inlet of the second channel 421 in a threaded manner. Specifically, the plug 6 is a plug with a threaded structure on its outer circumference, while the inlet is equivalent to a threaded hole structure, thus achieving a threaded fit between the two.

[0065] In addition, to further improve the sealing performance of plug 6, such as Figure 5 As shown, a ring 61 is formed around the outer periphery of the plug 6. In the blocked state, as... Figure 3 As shown, the lower end of the ring 61 is pressed against the top wall of the cup lid 4, wherein the plug 6 can be a plastic part or a tough material, such as rubber.

[0066] The limiting component is mainly used to restrict the movement of the cup lid 4 along the first direction L1 to prevent the pushing component 42 from opening the closure. In other words, the limiting component, as a limiting part, will limit the maximum screwing depth (i.e. the maximum downward movement distance) of the cup lid 4 in an unremovable state, so that even if the cup lid 4 is squeezed or accidentally screwed, it will not drive the pushing component 42 to move downward and open the closure.

[0067] The limiting member is disposed between the cup body and the cup lid 4 in a releasable manner. Here, "releasable" means that the limiting member can be released from its limiting state. After being released, its restriction on the cup lid 4 is invalid, so as to ensure that the cup lid 4 can continue to rotate downwards to push open the closure.

[0068] In some embodiments, a specific limiting member is provided, combined with Figure 6 As shown, the limiting member has a ring-shaped structure and is used as a limiting ring 5, which surrounds the cup body and the cup lid 4. Specifically, the limiting ring 5 is sleeved on the outer periphery of the inner cup body 2.

[0069] In addition, in this embodiment, the limiting ring 5 can be broken by force at least once to achieve release. For example, the limiting ring 5 is an open ring structure with a break, and the limiting ring 5 can be pulled open at the break to be removed from the cup body.

[0070] Alternatively, the limiting ring 5 may be a closed-loop structure, wherein a break line (or tear line) is formed on the limiting ring 5, and the limiting ring 5 may be broken by force at the break line.

[0071] The limiting ring 5 can be made of materials such as plastic.

[0072] In some embodiments, to cooperate with the limiting ring 5, a stepped surface 211 radially protruding from the inner cup 2 is formed on the outer peripheral wall of the inner cup 2, wherein the stepped surface 211 is located below the threaded section on the outer periphery of the inner cup 2, and the specific configuration of the stepped surface 211 can be as follows: Figure 3 As shown, the top surface of the protruding ring 21 on the inner cup body 2 constitutes the stepped surface 211.

[0073] During installation, the limiting ring 5 is looped around the outer periphery of the inner cup body 2. In the closed state, the limiting component is positioned between the cup lid 4 and the step surface 211. That is, the cup lid 4 presses the limiting ring 5 onto the step surface 211. Under the restriction of the step surface 211, the limiting ring 5 cannot move downward relative to the inner cup body 2. Thus, the limiting ring 5 restricts the cup lid 4 from moving downward relative to the inner cup body 2, thereby achieving the effect of lower limiting the cup lid 4. This ensures that the cup lid 4 will not drive the pushing component 42 to open the closing part when the limiting ring 5 is not released.

[0074] In addition, in order to control the embedding depth of the inner cup 2 relative to the outer cup 1, such as Figure 3 As shown, a protrusion 11 is provided on the outer periphery of the outer cup body 1. In the assembled state, the lower end of the protruding ring 21 on the inner cup body 2 abuts against the protrusion 11, and the protrusion 11 restricts the inner cup body 2 from being screwed down relative to the outer cup body 1.

[0075] In addition, in order to be able to observe the test results inside the cup through the cup body, in some embodiments, at least part of the cup body is a visible transparent area as an observation area; for example, both the inner cup body 2 and the outer cup body 1 are made of transparent material.

[0076] To better understand this device, the specific application of this device will be specifically illustrated through the following two embodiments: Example 2 This embodiment, based on Embodiment 1, specifically provides a method for detecting psychotropic substance abuse using the device provided in Embodiment 1: The detection unit uses an eight-piece test strip 7. For example, the drugs being tested include: olanzapine OZP, quetiapine QTP, clozapine CLP, risperidone RPD, aripiprazole ARP, lamotrigine LTG, chlorpromazine CPM, and sertraline STL. The corresponding test strips 7 include OZP, QTP, CLP, RPD, ARP, LTG, CPM, and STL test strips.

[0077] In addition, the detection threshold of test strip 7 can also be selected according to actual detection needs, such as 10ng / mL, 50ng / mL, 100ng / mL, 200ng / mL, 500ng / mL, 1000ng / mL, etc.

[0078] Among them, the detection indicators of the target analyte 7 can be selected, but are not limited to, the original, metabolites, and intermediate products in the metabolic process.

[0079] First, remove the cup lid 4 and add the urine sample to be tested into the inner cup 2.

[0080] Next, install the cup lid 4 onto the inner cup body 2 until the cup lid 4 can no longer move down relative to the inner cup body 2. At this point, the cup lid 4 is effectively restricted from moving down by the limiting ring 5.

[0081] To avoid interference from the chemical components of the test strip 7 inside the testing device on the sample for on-machine testing, to ensure the authenticity of the sample registration, and to prevent the need for retesting when there are doubts about the test results, the cup lid 4 can be opened in a biosafety cabinet or other facilities to take out a portion of the sample for record-keeping.

[0082] Release the limiting ring 5 and drive the cup lid 4 to move down, so that the pushing member 42 on the cup lid 4 moves down, so that the pushing member 42 pushes the sliding member 3 out of the first channel 221. At this time, the sample in the first space 10 will enter the outer cup body 1 (i.e. the second space 20) through the first channel 221 and come into contact with the detection unit (test strip 7) to start the detection of the sample.

[0083] For interpreting sample test results, one can choose to read the results visually or insert them into a matching machine for interpretation.

[0084] Example 3 This embodiment, based on Embodiment 1, provides a method for detecting psychotropic drug residues using the device provided in Embodiment 1: First, remove the lid 4, add the food sample to be tested into the inner cup 2, and add sample lysis buffer to lyse the sample and release the substance to be tested.

[0085] Food samples include, but are not limited to, fixed samples, liquid samples, and powder samples.

[0086] Next, install the lid 4 onto the inner cup body 2 until the lid 4 can no longer move downwards relative to the inner cup body 2. At this point, the limiting ring 5 effectively restricts the downward movement of the lid 4. To ensure that the lysis solution fully lyses the sample, the device can be vortexed or placed on a shaker.

[0087] To ensure that the enzyme components in the lysis buffer react efficiently at the optimal temperature, the inner cup 2 can be removed separately and heated in a water bath or placed in a constant temperature shaker.

[0088] After the pyrolysis is completed, remove the plug 6 and add the stop solution from the inlet of the second channel 421. The stop solution flows into the inner cup 2 (in the first space 10) through the second channel 421 to terminate the pyrolysis reaction and prevent the components of the pyrolysis solution from interfering with the subsequent detection reaction.

[0089] Of course, to avoid interference from strong acid and strong base components in the stop solution with subsequent detection reactions, pH indicator and pH adjuster can be added from the inlet of the second channel 421 to adjust the pH to the optimal range before subsequent detection.

[0090] Release the limiting ring 5 and drive the cup lid 4 to move down, so that the pushing member 42 on the cup lid 4 moves down, so that the pushing member 42 pushes the sliding member 3 out of the first channel 221. At this time, the sample in the first space 10 will enter the outer cup body 1 (i.e. the second space 20) through the first channel 221 and come into contact with the detection unit (test strip 7) to start the detection of the sample.

[0091] For interpreting sample test results, you can choose to read the results visually or insert them into the accompanying machine for interpretation.

[0092] It should be understood that the various forms of processes shown above can be used to rearrange, add, or delete steps. For example, the steps described in this application can be executed in parallel, sequentially, or in different orders, as long as the desired result of the technical solution disclosed in this application can be achieved, and this is not limited herein.

[0093] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, "a plurality of" means two or more, unless otherwise explicitly specified.

[0094] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A sample collection, pretreatment, and step-by-step detection integrated device, characterized in that, include: The cup body includes a first space and a second space that are independent of each other; A first passage is provided between the first space and the second space; The first space has a sample dispensing port; A detection unit is provided in the second space; A closure element is disposed in the first channel to block the first channel, and the closure element can be driven to open in a first direction so that the first space and the second space can communicate through the first channel; The cup lid can be opened to close the sample inlet. The cup lid includes a pusher and a second channel. The cup lid can move relative to the cup body in a first direction when closed, so as to drive the pusher to open the closure. The second channel includes an output port connected to a first space and an exposed input port that can be opened / closed. A limiting member is used to restrict the movement of the cup lid in a first direction to prevent the pushing member from opening the closure, and it is releasably disposed between the cup body and the cup lid.

2. The integrated device for sample collection, pretreatment, and step-by-step detection according to claim 1, characterized in that, The closure includes a sliding member that is slidably sealed in the first channel along a first direction; or the closure includes a sealing membrane that can be punctured by a pushing member.

3. The integrated device for sample collection, pretreatment, and step-by-step detection according to claim 1, characterized in that, The limiting member has a ring-shaped structure that surrounds the cup body and the cup lid, and the limiting member can be broken by force; and / or the device also includes a plug that is detachably sealed at the inlet of the second channel.

4. The integrated device for sample collection, pretreatment, and step-by-step detection according to any one of claims 1-3, characterized in that, One end of the pusher extends along a first direction toward the side of the closure to form a drive end for pushing the closure open; the second channel is provided inside the pusher, and the end of the second channel away from the drive end forms the input port; a through hole is provided on the side wall of the pusher to form the output port, wherein the through hole is located away from the drive end.

5. The integrated device for sample collection, pretreatment, and step-by-step detection according to claim 1, characterized in that, The cup body has at least a portion of its wall wall as a visible transparent area for observation; the detection unit includes a test strip or a test reagent.

6. The integrated device for sample collection, pretreatment, and step-by-step detection according to claim 1, characterized in that, The first direction is parallel to the axial direction of the cup body; the first space and the second space are arranged sequentially in the first direction and are separated from each other by a partition, and the first channel is provided on the partition.

7. The integrated device for sample collection, pretreatment, and step-by-step detection according to claim 6, characterized in that, The cup body includes an outer cup body and an inner cup body, which are detachably nested together; the partition is disposed in the inner cup body; the mouth of the inner cup body constitutes the sample dispensing port, and the cup lid is disposed at the mouth of the inner cup body; the first space is formed between the cup lid and the partition, and the second space is formed between the partition and the bottom of the outer cup body.

8. The integrated device for sample collection, pretreatment, and step-by-step detection according to claim 7, characterized in that, The inner cup body and the outer cup body are connected by a threaded connection or by interlocking; and / or the cup lid is connected to the inner cup body by a threaded connection or by interlocking.

9. The integrated device for sample collection, pretreatment, and step-by-step detection according to claim 7, characterized in that, A sealing part is formed on the inner side of the cup lid. When the cup lid is closed, the sealing part abuts against the inner peripheral wall of the inner cup body to form a seal.

10. The integrated device for sample collection, pretreatment, and step-by-step detection according to claim 7, characterized in that, The outer peripheral wall of the inner cup has a stepped surface that protrudes radially from the inner cup. The limiting member is looped around the outer periphery of the inner cup. In the closed state, the limiting member is positioned between the cup lid and the stepped surface.

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