Detection consumables and detection apparatus
Patent Information
- Application Number
- CN202522116661.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2025-09-30
- Publication Date
- 2026-10-09
- Estimated Expiration
- 2035-09-30
AI Technical Summary
[0004]针对上述的缺陷或不足,本实用新型提供了一种检测耗材及检测设备,旨在解决现有的检测耗材管缺乏有效的过滤机制的技术问题
通过在样本管内设置过滤部件,可在第一试剂转移至反应管前,有效截留并去除第一试剂中存在的黏液、组织残渣、纤维蛋白等杂质,从根本上避免了此类杂质对后续核酸提取或PCR扩增等反应的抑制与干扰,显著降低了检测出现假阴性或假阳性的机率,提高了检测的灵敏度和可靠性。同时,该过滤功能被集成在一次性耗材内,在样本放入样本管内后,过滤部件能够自动过滤,避免了后续额外开管、手动过滤杂质等操作,简化了操作流程,提高了效率。
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Figure CN224832691U_ABST
Abstract
Description
Technical Field
[0001] This utility model belongs to the field of medical device technology, specifically relating to a testing consumable and testing equipment. Background Technology
[0002] In sample processing (such as sputum, urine, and blood), it is usually necessary to pre-treat the sample by adding a processing solution to a test tube, and then use a pipette to transfer the pre-treated mixture to another container for subsequent detection steps such as nucleic acid extraction or PCR amplification. To simplify the operation process and reduce the risk of contamination from opening tubes, some integrated consumable structures have emerged that integrate sample pre-treatment, liquid aspiration, and output steps into a single device. These consumables generally consist of a sample tube and a reaction tube, separated by a diaphragm. By puncturing the diaphragm under specific conditions, contact between the solution in the sample tube and the solution in the reaction tube is achieved.
[0003] However, existing sample tubes lack effective filtration mechanisms, allowing impurities in the sample (such as mucus fragments in sputum, tissue debris, or fibrin clots in blood) to easily enter the reaction tube along with the solution when the septum is punctured. These impurities may not only interfere with nucleic acid extraction efficiency but also inhibit enzyme activity during PCR amplification, leading to decreased detection sensitivity and affecting the accuracy and reliability of the test. Utility Model Content
[0004] In view of the above-mentioned defects or deficiencies, this utility model provides a testing consumable and testing equipment, aiming to solve the technical problem that existing testing consumable tubes lack an effective filtration mechanism.
[0005] To achieve the above objectives, this utility model provides a testing consumable, comprising a sample tube, a reaction tube, an isolation component, a piston assembly, and a filter component. The sample tube contains a first reagent, and the reaction tube is detachably connected to the outlet end of the sample tube and contains a second reagent. The isolation component separates the outlet of the sample tube from the inlet of the reaction tube. The piston assembly is disposed within the sample tube and includes a piston rod and a piercing head. A reagent flow channel is formed between the piston rod and the inner peripheral wall of the sample tube. The piercing head is disposed at the end of the piston rod and is used to pierce the isolation component. The filter component is disposed within the reagent flow channel and is used to filter impurities in the first reagent as it flows from the inlet end to the outlet end of the sample tube.
[0006] In this embodiment, the filter element fills the cross-section of at least one location of the reagent flow channel, and the filter element is the necessary passage path for the first reagent as it flows from the inlet end to the outlet end of the sample tube.
[0007] In this embodiment, the piston rod is a hollow rod, and an adsorption hole communicating with the inner cavity of the hollow rod is provided on the peripheral wall of the hollow rod; wherein, in the length direction of the sample tube, the distance from the filter component to the end face of the inlet end of the sample tube is not greater than the distance from any adsorption hole to the end face of the inlet end of the sample tube.
[0008] In this embodiment, the piston rod is a hollow rod, and an adsorption hole communicating with the inner cavity of the hollow rod is provided on the peripheral wall of the hollow rod; wherein, in the length direction of the sample tube, the distance from the filter component to the end face of the outlet end of the sample tube is not greater than the distance from any adsorption hole to the end face of the outlet end of the sample tube.
[0009] In this embodiment, the sample tube includes a first tube segment and a second tube segment connected in sequence, a filter component is installed at the junction of the first tube segment and the second tube segment, and all adsorption pores are located in the first tube segment.
[0010] In this embodiment, the number of filter components is one or more.
[0011] In this embodiment, the filter element is at least one of a porous filter structure, a sponge filter structure, a brush filter structure, a mesh filter structure, or a fiber filter structure.
[0012] In this embodiment, the filter component can be detachably installed inside the sample tube, or the filter component can be fixedly connected to the sample tube, or the filter component can be one of the assembly parts of the sample tube.
[0013] In this embodiment, the outlet end of the sample tube is provided with a docking channel for docking with the reaction tube. The inlet of the docking channel is the outlet end of the sample tube. An isolation component is disposed in the docking channel. A piercing head is used to pierce the isolation component so that the reagent flow channel, the docking channel, and the inlet of the reaction tube are connected in sequence.
[0014] To achieve the above objectives, this utility model also provides a testing device, wherein the testing device includes the testing consumables described above.
[0015] Through the above technical solution, the testing consumables provided in this utility model embodiment have the following beneficial effects: By incorporating a filter element within the sample tube, impurities such as mucus, tissue residue, and fibrin present in the first reagent can be effectively intercepted and removed before the first reagent is transferred to the reaction tube. This fundamentally avoids the inhibition and interference of such impurities on subsequent nucleic acid extraction or PCR amplification reactions, significantly reducing the probability of false negatives or false positives and improving the sensitivity and reliability of the test. Furthermore, this filtering function is integrated into the disposable consumable; after the sample is placed in the sample tube, the filter element automatically filters, eliminating the need for subsequent additional tube opening and manual impurity filtration, simplifying the operation process and improving efficiency.
[0016] Other features and advantages of this invention will be described in detail in the following detailed description section. Attached Figure Description
[0017] The accompanying drawings are provided to illustrate the present invention and form part of the specification. They are used together with the following detailed description to explain the present invention, but do not constitute a limitation thereof. In the drawings: Figure 1 This is a schematic diagram of the overall structure of the testing consumables in this embodiment; Figure 2 This is a cross-sectional view of the testing consumables in this embodiment; Figure 3 This is a schematic diagram of the piston assembly in this embodiment; Figure 4 This is a schematic diagram of the structure of the piercing head and the guide post in this embodiment; Figure 5 This is a schematic diagram of the structure of the filter component located near the outlet end of the sample tube in this embodiment; Figure 6 This is a schematic diagram of the structure of the filter component located near the inlet end of the sample tube in this embodiment; Figure 7 This is a schematic diagram of the structure of the porous filter component in this embodiment; Figure 8 This is a schematic diagram of the structure of the sponge-type filter component in this embodiment; Figure 9 This is a schematic diagram of the structure of the brush-type filter component in this embodiment; Figure 10 This is a schematic diagram of the structure of the filter component of the filter type in this embodiment; Figure 11 This is a schematic diagram of the structure of the fiber-type filter component in this embodiment.
[0018] Explanation of reference numerals in the attached figures 1. Sample tube; 1a. Inlet end; 1b. Outlet end; 11. First tube section; 11a. Reagent flow channel; 12. Second tube section; 12a. Docking channel; 121. Guide column; 122. Conical structure; 2. Reaction tube; 3. Isolation component; 4. Piston assembly; 41. Piston rod; 411. Adsorption hole; 412. Baffle; 42. Puncture head; 5. Filter component; 6. Sealing component; 7. Tube base; 8. Cap. Detailed Implementation
[0019] The specific embodiments of this utility model will be described in detail below with reference to the accompanying drawings. It should be understood that the specific embodiments described herein are for illustration and explanation only and are not intended to limit the scope of this utility model.
[0020] The testing consumables of this utility model are described below with reference to the accompanying drawings.
[0021] This utility model discloses a testing consumable, such as Figure 1 and Figure 2 As shown, the testing consumables include a sample tube 1, a reaction tube 2, an isolation component 3, a piston assembly 4, and a filter component 5.
[0022] One end of the sample tube 1 is the inlet end 1a, and the other end is the outlet end 1b. The sample tube 1 is used to contain the first reagent, which can be the sample solution or a mixed reagent of the sample and the pretreatment solution.
[0023] The reaction tube 2 is detachably connected to the outlet end 1b of the sample tube 1, and the reaction tube 2 is used to contain the second reagent.
[0024] The isolation component 3 is used to isolate the outlet of sample tube 1 from the inlet of reaction tube 2.
[0025] The piston assembly 4 is disposed inside the sample tube 1 and includes a piston rod 41 and a piercing head 42. A reagent flow channel 11a is formed between the piston rod 41 and the inner peripheral wall of the sample tube 1. The piercing head 42 is disposed at the end of the piston rod 41. The piston rod 41 can move relative to the sample tube 1 to drive the piercing head 42 to pierce the isolation component. After the isolation component is pierced, the first reagent will flow out from the outlet end 1b of the sample tube 1 and flow into the reaction tube 2.
[0026] The filter element 5 is disposed in the reagent flow channel 11a and is used to filter impurities in the first reagent when the first reagent flows from the inlet end 1a of the sample tube 1 to the outlet end 1b of the sample tube 1.
[0027] By incorporating a filter element 5 within sample tube 1, impurities such as mucus, tissue residue, and fibrin present in the first reagent are effectively intercepted as it flows from the inlet end 1a to the outlet end 1b of sample tube 1. This fundamentally prevents such impurities from entering reaction tube 2 and inhibiting or interfering with subsequent nucleic acid extraction or PCR amplification, significantly reducing the probability of false negatives or false positives and improving the sensitivity and reliability of the test. Furthermore, this filtration function is integrated into disposable consumables. After the sample is placed in sample tube 1, the filter element 5 automatically filters, eliminating the need for additional tube opening and manual impurity filtration, simplifying the operation process and improving efficiency.
[0028] To ensure filtration effectiveness, such as Figure 2 , Figure 5and Figure 6 As shown, in this embodiment, the filter element 5 is configured to fill at least one cross-section of the reagent flow channel 11a. For example, if the cross-sectional shape of the reagent flow channel 11a is annular, the filter element 5 can be a matching annular filter. At the installation position of the filter element 5, the outer peripheral wall of the annular filter is in close contact with the inner wall of the sample tube 1, and the inner peripheral wall of the annular filter is in close contact with the outer wall of the piston rod 41, thereby achieving complete filling of the cross-section at that position. When the reagent flows from the inlet end 1a to the outlet end 1b of the sample tube 1, the reagent must penetrate the filter element 5 to reach the outlet end 1b of the sample tube 1.
[0029] In this embodiment, depending on the cross-sectional shape of the reagent flow channel 11a, the filter element 5 can also be other shapes.
[0030] Filter element 5 can generally only filter some larger particles, but it is effective for filtering smaller particles such as proteins and lipids. Figure 2 and Figure 3 As shown, in this embodiment, the piston rod 41 can be configured as a hollow rod, and an adsorption element can be disposed inside the hollow rod. Simultaneously, a plurality of adsorption holes 411 communicating with the inner cavity of the hollow rod are provided on the peripheral wall of the hollow rod. By providing the adsorption holes 411 and the adsorption element, small-particle-size impurities in the first reagent can be adsorbed, thereby increasing the purity of the first reagent.
[0031] After opening the adsorption hole 411, in order to prevent the first reagent from skipping the filter component 5 and flowing directly from the adsorption hole 411 and the inner cavity of the piston rod 41 to the outlet end 1b of the sample tube 1, the installation position of the filter component 5 can be optimized.
[0032] like Figure 6 As shown, in one embodiment, the installation position of the filter component 5 can be set such that, in the length direction of the sample tube 1, the distance from the filter component 5 to the end face of the inlet end 1a of the sample tube 1 is not greater than the distance from any adsorption hole 411 to the end face of the inlet end 1a of the sample tube 1.
[0033] Specifically, taking sample tube 1 placed vertically as an example. With sample tube 1 in this vertical position, the top of sample tube 1 is the inlet end 1a. The filter element 5 can be positioned close to the top of sample tube 1, and the height of the filter element 5 is not lower than the installation height of any adsorption hole 411. Thus, when the first reagent is poured in from the top of sample tube 1, it will first be filtered by the filter element 5. After filtration, the first reagent will flow out from the bottom of the filter element 5 before contacting the adsorption hole 411 and the adsorption element for adsorption pretreatment.
[0034] like Figure 5As shown, in another embodiment, the installation position of the filter element 5 can be set such that, in the length direction of the sample tube 1, the distance from the filter element 5 to the end face of the outlet end 1b of the sample tube 1 is not greater than the distance from any adsorption hole 411 to the end face of the outlet end 1b of the sample tube 1.
[0035] Continuing with the example of sample tube 1 being placed vertically, the outlet end 1b of sample tube 1 is generally located near the lower end of sample tube 1. The filter component 5 can also be located near the lower end of sample tube 1, and the height of the filter component 5 is not higher than the installation height of any adsorption hole 411. In this way, the first reagent in sample tube 1 can undergo adsorption pretreatment above the filter component 5. When the isolation component 3 is punctured, the first reagent flows towards the outlet end 1b of sample tube 1, and the filter component 5 will filter the first reagent.
[0036] like Figure 2 and Figure 5 As shown, in this embodiment, the sample tube 1 may include a first tube segment 11 and a second tube segment 12 connected in sequence. A piston rod 41 is located inside the first tube segment 11, and a reagent flow channel 11a is formed between the inner wall of the first tube segment 11 and the piston rod 41. The second tube segment 12 forms a docking channel 12a, which communicates with the reagent flow channel 11a. To further ensure the filtration effect, such as... Figure 5 As shown, the filter element 5 can be disposed at the bottom of the first pipe section 11, that is, the filter element 5 is mounted against the junction of the first pipe section 11 and the second pipe section 12, and all adsorption holes 411 are located inside the first pipe section 11.
[0037] like Figure 2 As shown, in this embodiment, the isolation component 3 is located inside the second pipe section 12 and blocks the docking channel 12a. When the piston rod 41 moves down, the piercing end of the piercing head 42 can extend into the second pipe section 12 and pierce the isolation component 3. After piercing, the reagent flow channel 11a, the docking channel 12a, and the inlet of the reaction tube 2 are connected in sequence.
[0038] like Figure 2 and Figure 4 As shown, in this embodiment, the second tube segment 12 is also provided with a guide post 121. The guide post 121 is located at one end of the second tube segment 12 facing the first tube segment 11, and the guide post 121 can extend into the first tube segment 11. The guide post 121 forms a guide space, and the guide space is aligned with the central axis of the docking channel 12a in the length direction of the sample tube 1. The guide post 121 can guide the piercing head 42 to accurately extend into the docking channel 12a.
[0039] like Figure 2 and Figure 4As shown, in this embodiment, the docking channel 12a is tapered at one end near the first tube segment 11, and the tapered structure 122 is used to guide the first reagent to flow toward the outlet end 1b of the sample tube 1.
[0040] like Figure 2 and Figure 4 As shown, in this embodiment, a tube base 7 can also be provided on the outer periphery of the reaction tube 2, and the reaction tube 2 is placed inside the tube base 7, which can protect the reaction tube 2.
[0041] like Figure 2 As shown, in this embodiment, the inlet end 1a of the sample tube 1 may also be provided with a cap 8.
[0042] like Figure 2 and Figure 3 As shown, in this embodiment, the piston rod 41 is also provided with a baffle 412, which can guide the path when the piston rod 41 moves along the length direction of the sample tube 1.
[0043] like Figure 2 and Figure 3 As shown, in this embodiment, a clearance notch may be provided on the baffle 412 to facilitate the entry of the sample into the sample tube 1.
[0044] like Figure 2 As shown, in this embodiment, the piston rod 41 is provided with a sealing member 6 at the end away from the piercing head 42. The sealing member 6 is used to block the inlet of the sample tube 1.
[0045] In this embodiment, the isolation device may be an isolation membrane.
[0046] In this embodiment, the number of filter components 5 can be one or more. When there are multiple filter components 5, the multiple filter components 5 can be arranged at intervals or in contact with each other along the length of the sample tube 1.
[0047] In this embodiment, the filter structure of the filter component 5 can take many forms, such as... Figures 7-11 As shown, the filter element 5 can be a porous filter, a sponge filter, a brush filter, a mesh filter, a fiber filter, etc. Furthermore, when there are multiple filter elements 5, the filtration structures of the different filter elements 5 can be different.
[0048] In this embodiment, the filter component 5 can be a separate component placed in the sample tube 1, or the filter component 5 can be fixedly installed in the sample tube 1 by a connector, or the filter component 5 can be one of the components of the sample tube 1.
[0049] like Figure 2 As shown, in this embodiment, the reaction tube 2 can be installed at the outlet end 1b of the sample tube 1 by means of threaded connection, snap-fit connection, etc.
[0050] To achieve the above objectives, this utility model also provides a testing device, wherein the testing device includes the testing consumables described above. Since the testing device adopts all the technical solutions of the above embodiments, it at least possesses the beneficial effects brought by the above embodiments, and will not be repeated here.
[0051] In the description of this utility model, it should be understood that 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 indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this utility model, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.
[0052] In this utility model, unless otherwise explicitly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection, an electrical connection, or a connection that allows communication between them; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this utility model according to the specific circumstances.
[0053] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the present invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.
[0054] Although embodiments of the present invention have been described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention.
Claims
1. A testing consumable, characterized in that, The testing consumables include: Sample tube (1), used to contain the first reagent; The reaction tube (2) is detachably connected to the outlet end (1b) of the sample tube (1) and is used to contain the second reagent; An isolation component (3) is used to isolate the outlet of the sample tube (1) from the inlet of the reaction tube (2); A piston assembly (4) is disposed inside the sample tube (1) and includes a piston rod (41) and a piercing head (42). A reagent flow channel (11a) is formed between the piston rod (41) and the inner peripheral wall of the sample tube (1). The piercing head (42) is disposed at the end of the piston rod (41) and is used to pierce the isolation component (3). A filter element (5) is disposed within the reagent flow channel (11a) and is used to filter impurities in the first reagent as the first reagent flows from the inlet end (1a) of the sample tube (1) to the outlet end (1b).
2. The testing consumables according to claim 1, characterized in that, The filter element (5) fills the cross-section of at least one location of the reagent flow channel (11a), and the filter element (5) is the necessary passage path for the first reagent as it flows from the inlet end (1a) of the sample tube (1) to the outlet end (1b) of the sample tube (1).
3. The testing consumables according to claim 2, characterized in that, The piston rod (41) is a hollow rod, and an adsorption hole (411) is provided on the peripheral wall of the hollow rod, which communicates with the inner cavity of the hollow rod. In the length direction of the sample tube (1), the distance from the filter component (5) to the end face of the inlet end (1a) of the sample tube (1) is not greater than the distance from any of the adsorption holes (411) to the end face of the inlet end (1a) of the sample tube (1).
4. The testing consumables according to claim 2, characterized in that, The piston rod (41) is a hollow rod, and an adsorption hole (411) is provided on the peripheral wall of the hollow rod, which communicates with the inner cavity of the hollow rod. In the length direction of the sample tube (1), the distance from the filter component (5) to the end face of the outlet end (1b) of the sample tube (1) is not greater than the distance from any of the adsorption holes (411) to the end face of the outlet end (1b) of the sample tube (1).
5. The testing consumables according to claim 4, characterized in that, The sample tube (1) includes a first tube segment (11) and a second tube segment (12) connected in sequence. The filter component (5) is installed at the junction of the first tube segment (11) and the second tube segment (12). All the adsorption holes (411) are located in the first tube segment (11).
6. The testing consumables according to any one of claims 1 to 5, characterized in that, The number of the filter components (5) is one or more.
7. The testing consumables according to any one of claims 1 to 5, characterized in that, The filter element (5) is at least one of the following: porous filter, sponge filter, brush filter, mesh filter, and fiber filter.
8. The testing consumables according to any one of claims 1 to 5, characterized in that, The filter component (5) can be detachably installed inside the sample tube (1), or the filter component (5) can be fixedly connected to the sample tube (1), or the filter component (5) can be one of the assembly parts of the sample tube (1).
9. The testing consumables according to any one of claims 1 to 5, characterized in that, The sample tube (1) includes a first tube segment (11) and a second tube segment (12) connected in sequence. The inner wall of the first tube segment (11) and the piston rod (41) form the reagent flow channel (11a). The second tube segment (12) forms a docking channel (12a) which is connected to the reagent flow channel (11a). The isolation component (3) is disposed in the second tube section (12), and the piercing head (42) is used to pierce the isolation component (3) so that the reagent flow channel (11a), the docking channel (12a), and the inlet of the reaction tube (2) are connected in sequence.
10. A testing device, characterized in that, The testing consumables include any one of claims 1 to 9.