Detection device

By designing a detection device that includes an amplification reaction unit and a test strip reaction unit, the problems of cumbersome operation and insufficient detection stability in the existing technology are solved, achieving efficient and stable amplification detection that is suitable for diverse scenarios.

CN121718418APending Publication Date: 2026-03-24CHANGZHOU FLUOSCIENCE MEDICAL TECHNOLOGY CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-12-10
Publication Date
2026-03-24

AI Technical Summary

Technical Problem

Existing amplification detection technologies suffer from cumbersome operation, limited sample storage, and insufficient detection stability, especially when transporting over long distances and storing for extended periods, making it difficult to guarantee the accuracy of test results.

Method used

Design a detection device comprising an amplification reaction unit and a test strip reaction unit. The reactants are stored in a sealed reaction chamber, reducing sample transfer steps, and the amplification products are directly fed into the test strip reaction unit to obtain detection results, avoiding the use of a pipette.

Benefits of technology

It improves the stability and accuracy of detection, simplifies the operation process, reduces costs, and is suitable for diverse detection scenarios.

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Abstract

The invention discloses a detection device. The detection device comprises at least one amplification reaction unit and a test paper reaction unit, the amplification reaction unit comprises a sample inlet, a flow guide cavity and a reaction cavity in which reactants are hermetically stored; the test paper reaction unit is in plug-in fit with the amplification reaction unit at a preset angle; the test paper reaction unit comprises a shell and a test strip arranged in the shell; a puncture needle is arranged at one end of the shell; when the bottom end of the amplification reaction unit is inserted into the puncture needle, the amplification product directly flows into the shell and is in contact with the test strip, so that a detection result of the amplification product is obtained. According to the invention, reactants are stored in the sealed reaction cavity, so that the reactants can be placed for a long time, the effectiveness and stability during detection are ensured, and the accuracy of a detection result is improved; the risk that collected samples and reactants are polluted in the whole process is reduced, operation is easy, detection efficiency is high, a pipette does not need to be additionally arranged, and cost is reduced.
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Description

Technical Field

[0001] This invention belongs to the field of biological detection technology, and in particular relates to a detection device. Background Technology

[0002] Amplification detection technology has significant application value in the field of biological detection, and the accuracy and ease of operation of its detection results directly affect the practical application effect. Traditional amplification detection methods usually use test strips to detect amplification products, but this method has obvious shortcomings: the detection process requires transferring the amplification products onto the test strip, which not only increases the number of steps, but may also lead to deviations in the detection results due to environmental factors (such as aerosol contamination, temperature changes, etc.) during the transfer process, affecting the reliability of the detection.

[0003] To overcome the above problems, existing technologies, such as patent CN118879482A "A Detection Device", propose an improved solution. This device reduces the transfer steps of amplification products by combining the amplification reaction unit with the test strip reaction unit. However, this technical solution still has the following limitations: (1) It requires a pipette to sequentially drop the collected sample and reagents into the amplification reaction unit and make them contact the test strip reaction unit. To ensure detection accuracy, at least the pipette used to collect the sample cannot be reused, so a large number of pipettes are required, which increases the complexity and cost of operation; (2) Due to the instability of the reagents, this detection method is only suitable for on-site sample collection or detection after short-term storage. For samples that need to be transported over long distances or reagents that need to be stored for a long time, it is difficult to ensure the effectiveness and stability of the collected samples and reagents, thus failing to guarantee the accuracy of the detection results.

[0004] Therefore, there is an urgent need to develop a more efficient, stable amplification detection technology that is applicable to diverse detection scenarios, in order to solve the problems of cumbersome operation, limited sample storage, and insufficient detection stability in existing technologies. Summary of the Invention

[0005] The purpose of this invention is to solve the above-mentioned problems existing in the prior art and to provide a detection device.

[0006] The objective of this invention is achieved through the following technical solution: A detection device includes at least one amplification reaction unit and a test strip reaction unit; The amplification reaction unit includes a sample inlet, a flow guiding cavity for sample flow, and a sealed reaction chamber containing reactants; the collected sample enters from the sample inlet and passes through the flow guiding cavity, and then enters the reaction chamber to react with the reactants to form amplification products; The test strip reaction unit is inserted into the amplification reaction unit at a preset angle; the test strip reaction unit includes a housing and a test strip disposed within the housing; a puncture needle is disposed at one end of the housing; when the bottom end of the amplification reaction unit is inserted into the puncture needle, the amplification product flows directly into the housing and comes into contact with the test strip, thereby obtaining the detection result of the amplification product.

[0007] Preferably, the amplification reaction unit includes an outer tube and an inner tube, both of which are open at least at one end; the inner tube is placed inside the outer tube; and the top of the inner tube is provided with a flange facing outward, the flange being tightly fitted with the inner wall of the outer tube, so that the outer wall of the inner tube and the inner wall of the outer tube are sealed to form the reaction chamber; the sample inlet is one of the open ends of the outer tube and the inner tube.

[0008] Preferably, a notch is provided on one side of the outer wall of the flange, and the notch is connected to the reaction chamber.

[0009] Preferably, the hollow interior of the inner tube is the flow guiding cavity, which is funnel-shaped.

[0010] Preferably, the amplification reaction unit further includes a sealing cap covering the flow channel cavity, the sealing cap being threadedly connected to the outer tube; a sealing device is provided between the opening of the outer tube and the sealing cap, and the sealing device is an inverted convex shape, with its small diameter portion located on the inner wall of the outer tube; the sealing device and the sealing cap are discrete components or an integral structure.

[0011] Preferably, the top of the inner tube is lower than the top of the outer tube, and the inner wall of the outer tube is provided with a limiting ring, which abuts against the top of the inner tube to lock the inner tube in place.

[0012] Preferably, the reactants are a set of reaction spheres.

[0013] Preferably, the housing of the test strip reaction unit has a liquid flow channel, the test strip is located in the liquid flow channel, and the housing is provided with a viewing window, which is configured to display the detection result status of the test strip.

[0014] Preferably, the housing includes a cover and a base that interlock; the viewing window is disposed on the cover; sealing strips are provided on both inner edges of the base to prevent leakage of amplification products in the test strip reaction unit; the cover is provided with one or more insertion interfaces for accommodating the amplification reaction unit, all of which are connected to the liquid flow channel, and the puncture needle is disposed on the liquid flow channel with its tip facing the insertion interface.

[0015] Preferably, the cover is provided with a set of insertion interfaces protruding from its surface, with adjacent insertion interfaces spaced apart, and each insertion interface respectively accommodating its corresponding amplification reaction unit.

[0016] Preferably, the base is provided with a set of puncture needles of the same number as the insertion interface; each puncture needle corresponds to one insertion interface; the base is also provided with a microchannel, the liquid inlet end of the microchannel is connected to the corresponding biased insertion interface, and its liquid outlet end is connected to the proximal end of the liquid channel, so that the amplification product in the biased amplification reaction unit comes into contact with the test strip through the microchannel.

[0017] Preferably, the base is provided with a set of liquid channels at intervals, and each liquid channel contains a test strip; the base is also provided with microchannels, the inlet end of the microchannels is connected to the insertion interface, and the outlet end of each microchannel is connected to the proximal end of the liquid channel; the cover is provided with a set of viewing windows, each viewing window corresponding to a test strip, to display the status of the test strip's detection result.

[0018] The advantages of the technical solution of this invention are mainly reflected in: By storing reactants in a sealed reaction chamber, the reactants can be stored for a longer period of time, ensuring the effectiveness and stability of the detection and improving the accuracy of the detection results. It reduces the risk of contamination of collected samples and reactants throughout the process, is simple to operate, has high detection efficiency, and does not require additional pipettes, thus reducing costs; The amplification reaction unit and the test strip reaction unit are designed with a one-to-many, many-to-one, or many-to-many distribution structure to improve the multi-target detection of amplification products and the detection efficiency. Attached Figure Description

[0019] Figure 1 Assembly diagram of a preferred embodiment of the detection device of the present invention; Figure 2 : Exploded view of a preferred embodiment of the detection device of the present invention; Figure 3 : An exploded view of the first embodiment of the amplification reaction unit in the detection device of the present invention; Figure 4a : A cross-sectional view of the amplification reaction unit in the detection device of the present invention in the first embodiment; Figure 4b : A cross-sectional view of the second embodiment of the amplification reaction unit in the detection device of the present invention; Figure 5 : Exploded view of the second embodiment of the detection device of the present invention; Figure 6 : Exploded view of the third embodiment of the detection device of the present invention. Detailed Implementation

[0020] The objectives, advantages, and features of this invention will be illustrated and explained through the following non-limiting description of preferred embodiments. These embodiments are merely typical examples of applying the technical solutions of this invention, and all technical solutions formed by equivalent substitutions or equivalent transformations fall within the scope of protection claimed by this invention.

[0021] In the description of the solution, it should be noted that the terms "center," "upper," "lower," "left," "right," "front," "rear," "vertical," "horizontal," "inner," and "outer," etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings and are only for the convenience and simplification of description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance. Also, in the description of the solution, with the operator as a reference, the direction closer to the operator is the proximal end, and the direction farther from the operator is the distal end.

[0022] This invention discloses a detection device, such as... Figure 1 As shown, it includes at least one amplification reaction unit 1 and a test strip reaction unit 2, wherein the test strip reaction unit 2 and the amplification reaction unit 1 are set at a preset angle. In this invention, the preset angle is any angle between 60° and 1060°.

[0023] Specific combination Figure 2 , Figure 3 and Figure 4a , 4b As shown, the amplification reaction unit 1 includes an outer tube 105 and an inner tube 106 with roughly similar shapes, each including an opening at the top. The inner tube 106 is placed inside the outer tube 105. The outer tube 105 and the inner tube 106 form a sample inlet 101, a flow channel 102, and a reaction chamber 103 that is sealed and stores the reactants 104.

[0024] The inner tube 106 has an outwardly extending flange 107 at its top, which fits tightly against the inner wall of the outer tube 105, sealing the reaction chamber 103 between the outer wall of the inner tube 106 and the inner wall of the outer tube 105. The sample inlet 101 is the opening end of both the outer tube 105 and the inner tube 106. The hollow interior of the inner tube 106 is the flow guide cavity 102, which is funnel-shaped. As is well known to those skilled in the art, a sealing membrane can be selectively provided at the opening end of the inner tube 106 to seal the flow guide cavity 102.

[0025] The flow guiding cavity 102 and the reaction cavity 103 can be selectively connected, specifically, as shown in the example below. Figure 3 and 4a As shown, the bottom of the inner tube 106 is provided with micropores, and the flow guiding cavity 102 is connected to the reaction cavity 103. Figure 4b As shown, the bottom of the inner tube 106 has an integrally formed structure, preferably a thin film. The flow guiding cavity 102 is not connected to the reaction cavity 103. The collected sample needs to be punctured to enter the reaction cavity 103. This design improves the sealing of the reaction cavity 103.

[0026] The collected sample enters the guide cavity 102 through the sample inlet 101, and then enters the reaction cavity 103 through the guide cavity 102, where it reacts with the reactant 104 to form an amplification product. In this invention, the reactant 104 is a set of reaction beads.

[0027] In this invention, an inner tube 106 is provided inside the outer tube 105, which reduces the space of the reaction chamber 103, restricting the freedom of movement of the reaction balls within the reaction chamber 103. This reduces the likelihood of the reaction balls being suspended in corners due to static electricity caused by shaking during transportation and handling, ensuring that the reaction balls are all located at the bottom of the reaction tube and can fully react with the sample, thus guaranteeing detection accuracy. Furthermore, the distance between the outer wall of the main body of the inner tube 106 and the inner wall of the outer tube 105 is less than the diameter of the reaction balls, ensuring that the reaction balls are all located at the bottom of the outer tube 105 and are not suspended in corners due to shaking and friction.

[0028] In addition, the top of the inner tube 106 is lower than the top of the outer tube 105, and the inner wall of the outer tube 105 is provided with a limiting ring 109. The limiting ring 109 abuts against the top of the inner tube 106 to lock the inner tube 106, effectively preventing the inner tube 106 from falling out of the outer tube 105.

[0029] In this preferred embodiment, a notch 110 is provided on one side of the outer wall of the flange 107. The notch 110 is connected to the reaction chamber 103, and the width of the notch 110 is greater than the width of the limiting ring 109. The notch 110 provides a certain deformation space for the inner tube 106 during assembly, enabling rapid assembly of the inner tube 106. Furthermore, when injecting the sample into the reaction chamber 103, the pressure inside the outer tube 105 can be released outward through the notch 110, thereby ensuring normal injection of the sample. Of course, the notch 110 is not large, and the airflow is still relatively small. Even if the reaction tube is placed in the air for a long time, the incoming air is unlikely to cause a significant reaction in the reaction beads inside the reaction tube, so it will not affect the detection results.

[0030] To enhance sealing performance, the amplification reaction unit 1 further includes a sealing cap 108 covering the flow guiding cavity 102. The sealing cap 108 is threadedly connected to the outer tube 105. A sealing device 111, preferably a sealing ring, is provided between the opening of the outer tube 105 and the sealing cap 108. The sealing device 111 is an inverted convex shape, with its smaller diameter portion located on the inner wall of the outer tube 105. The sealing device 111 and the sealing cap 108 are either discrete components or an integral structure.

[0031] In this invention, the outer tube 105 is integrally formed, and the thickness of the bottom of the outer tube 105 can be designed to be less than the thickness of the sidewall, making it suitable for puncture. Thus, the bottom of the outer tube 105 is easily punctured, allowing the amplification product after the reaction to flow into the test strip reaction unit 2. Of course, adding a sealing film to the bottom opening of the outer tube 105 is also an equivalent variation of the preferred embodiment.

[0032] like Figure 2 As shown, the test strip reaction unit 2 includes a housing 201 and a test strip 202 disposed within the housing 201; a puncture needle 203 is disposed at one end of the housing 201; when the bottom end of the amplification reaction unit 1 is inserted into the puncture needle 203, the amplification product flows directly into the housing 201 and comes into contact with the test strip 202, thereby obtaining the detection result of the amplification product.

[0033] In this preferred embodiment, the housing 201 of the test strip reaction unit 2 has a liquid flow channel 204, the test strip 202 is located in the liquid flow channel 204, and the housing 201 is provided with a viewing window 205, which is configured to display the detection result status of the test strip 202.

[0034] The housing 201 includes a cover 2011 and a base 2012 that are interlocked; the viewing window 205 is disposed on the cover 2011; and sealing strips 206 are provided on both inner edges of the base 2012 to prevent leakage of amplification products in the test strip reaction unit 2.

[0035] The cover 2011 is provided with an insertion interface 2013, which is used to accommodate the amplification reaction unit 1. The insertion interface 2013 is connected to the liquid flow channel 204. The puncture needle 203 is disposed on the liquid flow channel 204, preferably in a flat shape, with its tip facing the insertion interface 2013.

[0036] In use, the pipette tip passes through the sample inlet 101 of the outer tube 105, collects the sample, and then passes through the guide cavity 102 to fully contact the reaction ball in the reaction chamber 103, where it reacts to form amplification products. Next, the amplification reaction unit 1 is inserted into the insertion interface 2013, and the puncture needle 203 punctures the bottom of the outer tube 105 of the amplification reaction unit 1, allowing the amplification products to quickly flow into the liquid channel 204 and react with the test strip 202. The reaction results are displayed through the viewing window 205.

[0037] like Figure 5 The illustration shows a second embodiment of the present invention. This embodiment differs from the preferred embodiment in that the cover 2011 has a set of protruding insertion interfaces 2013 and 2013'. Adjacent insertion interfaces 2013 and 2013' are spaced apart, and each insertion interface 2013 and 2013' accommodates its corresponding amplification reaction unit 1. This embodiment includes one insertion interface 2013 disposed on the liquid flow channel 204, and two insertion interfaces 2013' offset from the liquid flow channel 204. Of course, more than one number or multiple arrangements of insertion interfaces 2013 are all within the scope of protection of this invention.

[0038] Preferably, the base 2012 is provided with a set of puncture needles 203, the same number as the insertion interfaces 2013 and 2013'; each puncture needle 203 corresponds to one insertion interface 2013 or 2013'; the base 2012 is also provided with a microfluidic channel 2014, the inlet end of the microfluidic channel 2014 is connected to the corresponding biased insertion interface 2013', and its outlet end is connected to the proximal end of the liquid channel 204, so that the amplification products in the biased amplification reaction unit 1 come into contact with the test strip 202 through the microfluidic channel 2014. Thus, this embodiment is very suitable for use when mixed detection is required.

[0039] like Figure 6 The diagram shows a third embodiment of the present invention. This embodiment differs from the preferred embodiment in that a set of liquid channels 204 and 204' are spaced apart on the base 2012, each containing a test strip 202. This embodiment includes a liquid channel 204 directly connected to the insertion interface 2013, and liquid channels 204' parallel to and offset on both sides of it. Of course, multiple liquid channels 204 arranged in various positions are also within the scope of this invention. The base 2012 also has microchannels 2014, whose inlet end is connected to the insertion interface 2013, and whose outlet end is connected to the proximal end of the offset liquid channels 204'.

[0040] Preferably, the cover 2011 is provided with a set of viewing windows 205, each viewing window 205 corresponding to one test strip 202 to display the status of the test result of the test strip 202. This embodiment is very suitable for test results that need to be displayed differently, for example, when the chemical properties of each test strip 202 are different, thus enabling the same sample to be tested for different purposes at the same time, which is convenient and fast.

[0041] This invention has many other embodiments. For example, as those skilled in the art will know, using multiple connectors to match multiple test strips for a more complex testing process is also within the scope of this invention. All technical solutions formed by equivalent transformations or equivalent modifications fall within the scope of this invention.

Claims

1. A detection device, characterized in that: It includes at least one amplification reaction unit (1) and a test strip reaction unit (2). The amplification reaction unit (1) includes a sample inlet (101), a flow channel (102) for sample flow, and a reaction chamber (103) sealed and storing reactants (104). The collected sample enters from the sample inlet (101) and passes through the flow channel (102), and then enters the reaction chamber (103) to react with the reactants (104) to form amplification products. The test strip reaction unit (2) is inserted into the amplification reaction unit (1) at a preset angle. The test strip reaction unit (2) includes a housing (201) and a test strip (202) disposed in the housing (201). A puncture needle (203) is provided at one end of the housing (201). When the bottom end of the amplification reaction unit (1) is inserted into the puncture needle (203), the amplification product flows directly into the housing (201) and comes into contact with the test strip (202), thereby obtaining the detection result of the amplification product.

2. The detection device according to claim 1, characterized in that: The amplification reaction unit (1) includes an outer tube (105) and an inner tube (106), both of which are open at least at one end. The inner tube (106) is placed inside the outer tube (105). The top of the inner tube (106) is provided with a flange (107) facing outward. The flange (107) and the inner wall of the outer tube (105) are tightly fitted together, so that the outer wall of the inner tube (106) and the inner wall of the outer tube (105) are sealed to form the reaction chamber (103). The sample inlet (101) is the open end of the outer tube (105) and the inner tube (106).

3. The detection device according to claim 2, characterized in that: The flange (107) has a notch (110) on one side of its outer wall, and the notch (110) is connected to the reaction chamber (103).

4. The detection device according to claim 2, characterized in that: The amplification reaction unit (1) also includes a sealing cap (108) covering the flow guide cavity (102), and the sealing cap (108) is connected to the outer tube (105) by a thread; a sealing device (111) is provided between the opening of the outer tube (105) and the sealing cap (108), and the sealing device (111) is an inverted convex shape, with its small diameter part located on the inner wall of the outer tube (105); the sealing device (111) and the sealing cap (108) are discrete components or an integral structure.

5. The detection device according to claim 4, characterized in that: The top of the inner tube (106) is lower than the top of the outer tube (105), and the inner wall of the outer tube (105) is provided with a limiting ring (109), which abuts against the top of the inner tube (106) to lock the inner tube (106).

6. The detection device according to any one of claims 1-5, characterized in that: The test strip reaction unit (2) has a liquid channel (204) inside its housing (201), and the test strip (202) is located inside the liquid channel (204). The housing (201) is provided with a viewing window (205), which is configured to display the detection result status of the test strip (202). The housing (201) includes a cover (2011) and a base (2012) that are interlocked. The viewing window (205) is located on the cover (2011). Sealing strips (206) are provided on both inner edges of the base (2012) to prevent leakage of amplification products in the test strip reaction unit (2).

7. The detection device according to claim 6, characterized in that: The cover (2011) is provided with an interface (2013) for accommodating the amplification reaction unit (1). The interface (2013) is connected to the liquid channel (204). The puncture needle (203) is disposed on the liquid channel (204) with its tip facing the interface (2013).

8. The detection device according to claim 7, characterized in that: The cover (2011) is provided with a set of protruding insertion interfaces (2013, 2013') on its surface, with adjacent insertion interfaces (2013, 2013') spaced apart, and each insertion interface (2013, 2013') accommodating its corresponding amplification reaction unit (1).

9. The detection device according to claim 8, characterized in that: The base (2012) is provided with a set of puncture needles (203) of the same number as the insertion interfaces (2013, 2013'); each puncture needle (203) corresponds to one insertion interface (2013, 2013'); the base (2012) is also provided with a microchannel (2014), the liquid inlet end of the microchannel (2014) is connected to the corresponding biased insertion interface (2013'), and its liquid outlet end is connected to the proximal end of the liquid channel (204) so ​​that the amplification product in the biased amplification reaction unit (1) can contact the test strip (202) through the microchannel (2014).

10. The detection device according to claim 7, characterized in that: The base (2012) is provided with a set of liquid channels (204, 204') spaced apart, and each liquid channel (204, 204') contains a test strip (202); the base (2012) is also provided with microchannels (2014), the inlet end of the microchannels (2014) is connected to the connector (2013), and the outlet end is connected to the proximal end of the liquid channels (204, 204'); the cover (2011) is provided with a set of viewing windows (205), each viewing window (205) corresponds to a test strip (202) to display the status of the test result of the test strip (202).