Detection cartridge, method for preparing the detection cartridge, and method for using the detection cartridge

By using the separator as the partition layer in the detection card box, the structure and assembly process are simplified, and the reagent transfer of magnetic beads under the action of external magnetic field is realized, and the problems of complex structure and cumbersome assembly of the detection card box are solved, which improves convenience and simplicity of operation.

CN120249039BActive Publication Date: 2025-08-22AEROSPACE INFORMATION RES INST CAS
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Patent Information

Application Number
CN202510732804.9
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2025-06-03
Publication Date
2025-08-22
Estimated Expiration
2045-06-03

AI Technical Summary

Technical Problem

The existing detection cartridge has complex structure and cumbersome assembly, making it difficult to be suitable for portable fully integrated molecular diagnosis.

Method used

The separator is used as the separator layer, and different reagents are stably stored using the surface tension of the oil-water interface. The separator is cancelled, and the magnetic beads are transferred between reagents under the action of external magnetic fields.

Benefits of technology

The detection box structure is simplified, the assembly process is simplified, the dependence on the control equipment is reduced, and the control convenience is improved.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present application discloses a test cartridge, a method for preparing a test cartridge, and a method for using the test cartridge, comprising: a cartridge body having a closed end at one end and an open end at the other end, the cartridge body including a reaction chamber, a cleaning chamber, and a detection chamber connected in sequence, the reaction chamber being used to load a sample to be tested and a reaction solution mixed with magnetic beads, the detection chamber being loaded with a detection solution, and the cleaning chamber being loaded with a cleaning solution and a separator liquid, the separator liquid being used to separate the cleaning solution from the reaction solution and the cleaning solution from the detection solution, the separator liquid having a depth of h, a contact angle between the separator liquid, an upper liquid phase, and the inner wall of the cleaning chamber being θ1, a contact angle between the separator liquid, a lower liquid phase, and the inner wall of the cleaning chamber being θ2, and a radius of the cleaning chamber being r; and a cartridge cover being sealed and connected to the open end of the cartridge body. The present application avoids the use of a separator, thereby simplifying cartridge assembly.
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Description

Technical Field

[0001] The present application relates to the field of molecular diagnostic technology, and more specifically, to a detection cartridge, a method for preparing the detection cartridge, and a method for using the detection cartridge. Background Art

[0002] Molecular diagnosis is a technology that uses nucleic acids or proteins as biomarkers for clinical testing, providing a basis for prediction, diagnosis, prevention, and treatment of diseases. However, traditional clinical molecular diagnostic laboratories often require multiple isolated rooms to carry out multiple steps such as reagent preparation, sample extraction, amplification, and testing to avoid contamination between reactions, making it difficult to apply to on-site instant diagnosis applications. Therefore, portable fully integrated molecular diagnostic technology based on microfluidics is one of the important development trends in the field of in vitro diagnostics. According to different control principles, portable fully integrated molecular diagnostic technology can be divided into: pump valve control, centrifugal control, film extrusion control, electrowetting control, magnetic fluid control, etc. Among them, molecular diagnostic technology based on magnetic fluid control mainly uses magnetic beads as a medium, and uses magnetic force to drive the magnetic beads to transfer between different reagents, thereby completing the entire process of molecular diagnosis. Because it does not require complex control instruments, it has the advantages of small size and low cost.

[0003] Magnetic fluid-controlled test cartridges separate the various reagents needed for molecular diagnostics by placing separators between the different chambers of the test cartridge. These separators are then filled with an oil-phase liquid to form a partitioning layer. A notch on one side of the separator typically serves as a channel for magnetic beads to pass through. Driven by an external magnetic field, the magnetic beads can pass through the channels of the separator and into the various reagents, completing the various molecular diagnostic processes. However, the presence of the separators complicates the design of the test cartridge and makes assembly more cumbersome.

[0004] Therefore, how to simplify the structure of the detection cartridge is an urgent problem to be solved by those skilled in the art. Summary of the Invention

[0005] In view of this, the object of the present application is to provide a detection cartridge to simplify the structure of the detection cartridge;

[0006] Another object of the present application is to provide a method for preparing a detection cartridge and a method for using the detection cartridge.

[0007] To achieve the above objectives, this application provides the following technical solutions:

[0008] The first aspect of the present application provides a detection cartridge, comprising:

[0009] A cartridge body, wherein one end of the cartridge body is a closed end and the other end is an open end, and along the direction from the open end to the closed end, the cartridge body comprises a reaction chamber, a cleaning chamber and a detection chamber connected in sequence, the reaction chamber is used to load a sample to be tested and a reaction liquid mixed with magnetic beads, the detection chamber is loaded with a detection liquid, the cleaning chamber is loaded with a cleaning liquid and a separation liquid, the separation liquid is used to separate the cleaning liquid and the reaction liquid, as well as the cleaning liquid and the detection liquid, and the separation liquid is a substance that is immiscible with the aqueous phase reagent and can allow magnetic beads to pass through, the depth of the separation liquid is h, the contact angle of the separation liquid, the upper liquid phase and the inner wall of the cleaning chamber is θ1, the contact angle of the separation liquid, the lower liquid phase and the inner wall of the cleaning chamber is θ2, the radius of the cleaning chamber is r, then ;

[0010] The card box cover is used for sealingly connecting to the open end of the card box body.

[0011] In one possible implementation, the inner walls of the reaction chamber and the detection chamber have hydrophilic modified surfaces, the inner wall of the cleaning chamber and the area corresponding to the cleaning liquid have a hydrophilic modified surface, and the inner wall of the cleaning chamber and the area corresponding to the separation liquid have a hydrophobic modified surface.

[0012] In a possible implementation, the method further includes a storage element disposed in the cleaning chamber, wherein the storage element has a storage chamber in which a freeze-dried reagent is sealed by paraffin, and a magnetic bead channel for magnetic beads to pass through is formed between the storage element and the inner wall of the cleaning chamber.

[0013] In a possible implementation, an outer wall of the storage element is provided with a notch, the magnetic bead channel is formed between the notch of the storage element and the inner wall of the cleaning chamber, and the outer wall of the storage element other than the notch is in contact with the inner wall of the cleaning chamber;

[0014] And / or, the storage element is disposed at one end of the cleaning chamber close to the detection chamber;

[0015] And / or, the storage cavity is provided with an opening at one end of the storage element, and the opening of the storage cavity is arranged facing the detection cavity;

[0016] And / or, the storage chamber contains steel balls and freeze-dried reagents sealed with paraffin;

[0017] And / or, the storage element is arranged on the target segment of the cleaning chamber, and the maximum outer diameter of the storage element in the axial direction is larger than the minimum inner diameter of the target segment of the cleaning chamber, so that the storage element is clamped on the target segment of the cleaning chamber.

[0018] In a possible implementation, the reaction chamber is loaded with a reaction solution mixed with magnetic beads;

[0019] And / or, a cartridge fixing platform is provided on the reaction chamber, and the cartridge fixing platform is used to assemble the detection cartridge with the detection instrument;

[0020] And / or, the reaction chamber, the cleaning chamber and the detection chamber are located on the same straight line;

[0021] And / or, the outer wall of the cleaning chamber is provided with scale lines, and the scale lines are used to observe and calibrate the amount of cleaning liquid and separator liquid added to the cleaning chamber;

[0022] And / or, the material of the card box body is a transparent material;

[0023] And / or, the material of the card box body is polymer plastic or glass;

[0024] And / or, the card box cover is independently provided with the card box body or is connected to the card box body as a whole via a connecting portion;

[0025] And / or, the card box cover is provided with a card box cover sealing structure, and the open end of the card box body is provided with a card box body sealing structure that cooperates with the card box cover sealing structure;

[0026] and / or, the cross-sectional area of ​​the reaction chamber is larger than the cross-sectional areas of the cleaning chamber and the detection chamber;

[0027] And / or, the wall thickness of the detection chamber is smaller than the wall thickness of the reaction chamber and the cleaning chamber;

[0028] And / or, the detection cavity is flat or cylindrical;

[0029] and / or, the separator fluid is silicone oil, mineral oil, kerosene, paraffin or organic gel;

[0030] And / or, in the case of nucleic acid detection, the reaction solution is a lysate, the detection solution is a nucleic acid amplification solution, and in the case of protein detection, the reaction solution is an enzyme-labeled primary antibody or a fluorescent-labeled primary antibody solution, the detection solution is a luminescent substrate, and the magnetic beads are magnetic beads modified with a primary antibody;

[0031] And / or, a detection chamber connecting structure is provided at one end of the cleaning chamber away from the reaction chamber, and the detection chamber is configured to be detachably connected to the detection chamber connecting structure;

[0032] And / or, the cleaning chamber is loaded with at least two cleaning liquids, and two adjacent cleaning liquids are separated by a separator liquid.

[0033] In a possible implementation, the detection chamber is detachably connected to one end of the cleaning chamber, and the open end of the cleaning chamber for connecting to the detection chamber is sealed by tin foil;

[0034] The open end of the detection cavity used for connecting with the cleaning cavity is provided with a striker, and the striker is used for piercing the tin foil of the cleaning cavity.

[0035] The detection cartridge provided in this application sets a separation liquid as a separation layer at the connection between the cleaning chamber, the reaction chamber and the detection chamber to separate the various reagents required for molecular diagnosis in the cartridge body. The depth h of the separation liquid is designed to be By utilizing the surface tension between the oil and water interface, different reagents can be stably stored without the use of separators. This application simplifies cartridge assembly by avoiding the use of separators. The magnetic beads can pass through the separator liquid and transfer between different cavities under the action of an external magnetic field, eliminating the need for numerous control devices and making operation easier.

[0036] And / or, paraffin is loaded on the uppermost layer of the separation liquid in the cleaning chamber.

[0037] A second aspect of the present application provides a detection system, comprising a detection instrument for detecting the detection cartridge as described in any one of the above items;

[0038] The detection instrument comprises:

[0039] a first step slide, wherein a cartridge fixing frame for supporting the detection cartridge is provided on a moving portion of the first step slide;

[0040] A heating device, used for heating the detection cartridge;

[0041] a detection device for controlling the temperature of the reaction in the detection chamber and detecting optical signals;

[0042] The magnet is located on one side of the detection cartridge to enable the transfer of magnetic beads between the reaction chamber, the cleaning chamber and the detection chamber.

[0043] In a possible implementation, the magnet is a permanent magnet or an electromagnet;

[0044] And / or, the detection instrument further includes a photoelectric sensor, the cartridge fixing frame includes a cartridge fixing portion and a cartridge positioning portion, the cartridge fixing portion is used to support the detection cartridge, and the cartridge positioning portion is used to cooperate with the photoelectric sensor to achieve positioning of the detection cartridge;

[0045] And / or, the detection instrument further comprises a second stepping slide for driving the magnet to move along the detection cartridge.

[0046] In a possible implementation, the magnet is an electromagnet, and there are two magnets, which are symmetrically arranged on both sides of the detection cartridge;

[0047] Alternatively, the magnet is an electromagnet, and the magnets are in two groups, and the two groups of magnets are symmetrically arranged on both sides of the detection cartridge, and each group of magnets has a plurality of magnets;

[0048] Alternatively, the detection instrument further comprises a second stepping slide for driving the magnet to move along the detection cartridge and a rotation drive device for driving the second stepping slide to rotate around the detection cartridge.

[0049] The detection system provided in this application utilizes the above-mentioned detection cartridge, and therefore has all the technical effects of the above-mentioned detection cartridge, which will not be described in detail herein.

[0050] A third aspect of the present application provides a method for preparing a detection cartridge, for preparing the detection cartridge as described above, comprising one of the first preparation method, the second preparation method, the third preparation method, the fourth preparation method, and the fifth preparation method;

[0051] The first preparation method comprises:

[0052] Adding a test liquid into the test cavity;

[0053] Adding separation liquid, cleaning liquid and separation liquid into the cleaning chamber in sequence;

[0054] The second preparation method comprises:

[0055] Adding a test liquid into the test cavity;

[0056] Adding separation liquid, cleaning liquid and separation liquid into the cleaning chamber in sequence;

[0057] Adding a reaction solution mixed with magnetic beads into the reaction chamber;

[0058] The third preparation method comprises:

[0059] Adding a test liquid into the test cavity;

[0060] Adding a separation liquid, a first cleaning liquid, a separation liquid, a second cleaning liquid, and a separation liquid into the cleaning chamber in sequence;

[0061] Adding a reaction solution mixed with magnetic beads into the reaction chamber;

[0062] The fourth preparation method comprises:

[0063] Adding a test liquid into the test cavity;

[0064] Adding separation liquid, cleaning liquid and separation liquid into the cleaning chamber in sequence;

[0065] Add melted paraffin into the cleaning chamber and allow the paraffin to cool and solidify;

[0066] Adding a reaction solution mixed with magnetic beads into the reaction chamber;

[0067] The fifth preparation method comprises:

[0068] Adding a test liquid into the test cavity;

[0069] The freeze-dried storage device, the separator, the cleaning fluid, and the separator are sequentially added into the cleaning chamber. The freeze-dried storage device is prepared by embedding the freeze-dried reagent and the steel balls in the storage chamber of the storage device with melted paraffin until the paraffin cools and solidifies.

[0070] Add the reaction solution mixed with magnetic beads into the reaction chamber.

[0071] The method for preparing the detection cartridge provided in the present application has all the technical effects of the above-mentioned detection cartridges because it prepares the above-mentioned detection cartridges, and will not be described in detail herein.

[0072] A fourth aspect of the present application provides a method for using a detection cartridge for performing detection using the detection system described above, comprising one of a first method of use, a second method of use, a third method of use, a fourth method of use, a fifth method of use, and a sixth method of use;

[0073] The first method of use includes:

[0074] When the reaction solution mixed with magnetic beads is not added into the reaction chamber, the reaction solution mixed with magnetic beads and the sample to be tested are added into the reaction chamber; when the reaction solution mixed with magnetic beads is added into the reaction chamber, the sample to be tested is added into the reaction chamber;

[0075] The magnetic beads are driven by a magnet from the reaction solution through the separation solution into the cleaning solution, so that the cleaning solution cleans the magnetic beads;

[0076] The magnetic beads are driven by a magnet from the cleaning solution through the separator into the detection solution, the nucleic acid adsorbed on the magnetic beads is eluted by the detection solution, and then the magnetic beads are driven by a magnet from the detection solution through the separator back into the cleaning solution;

[0077] The detection cavity is heated by a heating device, and the signal value in the detection liquid is detected by a detection device to obtain a detection result;

[0078] The second method of use includes:

[0079] When the reaction solution mixed with magnetic beads is not added into the reaction chamber, the reaction solution mixed with magnetic beads and the sample to be tested are added into the reaction chamber; when the reaction solution mixed with magnetic beads is added into the reaction chamber, the sample to be tested is added into the reaction chamber;

[0080] The magnetic beads are driven by a magnet from the reaction solution through the separation solution into the second cleaning solution, so that the second cleaning solution cleans the magnetic beads;

[0081] The magnetic beads are driven by a magnet from the reaction solution through the separation solution into the first cleaning solution, so that the first cleaning solution cleans the magnetic beads;

[0082] The magnetic beads are driven by a magnet from the first cleaning solution through the separator solution into the detection solution, the nucleic acids adsorbed on the magnetic beads are eluted by the detection solution, and then the magnetic beads are driven by a magnet from the detection solution through the separator solution back into the first cleaning solution;

[0083] The detection cavity is heated by a heating device, and the signal value in the detection liquid is detected by a detection device to obtain a detection result;

[0084] The third method of use includes:

[0085] When the reaction solution mixed with magnetic beads is not added into the reaction chamber, the reaction solution mixed with magnetic beads and the sample to be tested are added into the reaction chamber; when the reaction solution mixed with magnetic beads is added into the reaction chamber, the sample to be tested is added into the reaction chamber;

[0086] In the cleaning chamber, when paraffin is loaded on the uppermost layer of the separation liquid, the cleaning chamber is heated by a heating device to melt the paraffin in the cleaning chamber, and the magnetic beads in the reaction liquid are driven by a magnet to be enriched on the inner wall of the reaction chamber;

[0087] The magnetic beads are driven by a magnet from the reaction solution through the separation solution into the cleaning solution, so that the cleaning solution cleans the magnetic beads;

[0088] The magnetic beads are driven by a magnet from the cleaning solution through the separator into the detection solution, the nucleic acid adsorbed on the magnetic beads is eluted by the detection solution, and then the magnetic beads are driven by a magnet from the detection solution through the separator back into the cleaning solution;

[0089] The detection cavity is heated by a heating device, and the signal value in the detection liquid is detected by a detection device to obtain a detection result;

[0090] The fourth method of use includes:

[0091] When the reaction solution mixed with magnetic beads is not added into the reaction chamber, the reaction solution mixed with magnetic beads and the sample to be tested are added into the reaction chamber; when the reaction solution mixed with magnetic beads is added into the reaction chamber, the sample to be tested is added into the reaction chamber;

[0092] The magnetic beads are driven by a magnet from the reaction solution through the separation solution into the cleaning solution, so that the cleaning solution cleans the magnetic beads;

[0093] The magnetic beads are driven by a magnet from the cleaning solution through the separator into the detection solution, the nucleic acid adsorbed on the magnetic beads is eluted by the detection solution, and then the magnetic beads are driven by a magnet from the detection solution through the separator back into the cleaning solution;

[0094] The storage element in the cleaning chamber is heated by a heating device to melt the paraffin in the storage chamber of the storage element, and the steel balls in the storage chamber are driven to move by a magnet, so that the steel balls and freeze-dried reagent in the storage chamber are released and dissolved in the detection liquid;

[0095] The detection cavity is heated by a heating device, and the signal value in the detection liquid is detected by a detection device to obtain a detection result;

[0096] The fifth method of use includes:

[0097] When the reaction solution mixed with magnetic beads is not added into the reaction chamber, the reaction solution mixed with magnetic beads and the sample to be tested are added into the reaction chamber; when the reaction solution mixed with magnetic beads is added into the reaction chamber, the sample to be tested is added into the reaction chamber;

[0098] The magnetic beads are driven by a magnet from the reaction solution through the separation solution into the cleaning solution, so that the cleaning solution cleans the magnetic beads;

[0099] The magnetic beads are driven by a magnet from the cleaning solution through the separation solution into the detection solution, and the nucleic acid adsorbed on the magnetic beads is eluted by the detection solution;

[0100] The detection cavity is heated by a heating device, and the signal value in the detection liquid is detected by a detection device to obtain a detection result;

[0101] The sixth method of use includes:

[0102] When the reaction solution mixed with magnetic beads is not added into the reaction chamber, the reaction solution mixed with magnetic beads and the sample to be tested are added into the reaction chamber; when the reaction solution mixed with magnetic beads is added into the reaction chamber, the sample to be tested is added into the reaction chamber;

[0103] In the case where the separation liquid is paraffin or organic gel, the separation liquid in the cleaning chamber is heated by a heating device so that the separation liquid melts into a liquid state, and then the magnetic beads are driven by a magnet from the reaction liquid through the separation liquid into the cleaning liquid, so that the cleaning liquid cleans the magnetic beads;

[0104] The magnetic beads are driven by a magnet from the cleaning solution through the separation solution into the detection solution, and the nucleic acid adsorbed on the magnetic beads is eluted by the detection solution;

[0105] The detection cavity is heated by the heating device, and the signal value in the detection liquid is detected by the detection device to obtain the detection result.

[0106] The method for using the detection cartridge provided in this application utilizes the above-mentioned detection cartridge and therefore has all the technical effects of the above-mentioned detection cartridge, which will not be described in detail herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0107] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0108] Figure 1 This is a schematic structural diagram of the detection cartridge disclosed in the embodiment of the present application;

[0109] Figure 2 This is a front view of the detection cartridge disclosed in the embodiment of the present application;

[0110] Figure 3 This is a schematic structural diagram of a detection cartridge disclosed in another embodiment of the present application;

[0111] Figure 4 This is a schematic structural diagram of the detection cartridge disclosed in an embodiment of the present application when the cover is closed;

[0112] Figure 5 A schematic diagram of a partial structure of a detection cartridge with a storage element disclosed in an embodiment of the present application;

[0113] Figure 6 A schematic diagram of the structure of the storage element disclosed in an embodiment of the present application at one angle;

[0114] Figure 7 This is a schematic structural diagram of the storage element disclosed in an embodiment of the present application from another angle;

[0115] Figure 8 This is a schematic diagram of the structure of the detection cartridge disclosed in the embodiment of the present application after the detection cavity is removed;

[0116] Figure 9 This is a partial enlarged view of the first connection structure of the detection cartridge disclosed in the embodiment of the present application;

[0117] Figure 10 This is a schematic diagram of the structure of the detection chamber disclosed in the embodiment of this application;

[0118] Figure 11 This is a schematic diagram of the structure of the test cartridge preparation process disclosed in the embodiments of the present application;

[0119] Figure 12 This is a schematic diagram of the internal structure of the detection cartridge disclosed in the embodiment of the present application;

[0120] Figure 13 This is a schematic diagram of the internal structure of a detection cartridge disclosed in another embodiment of the present application;

[0121] Figure 14 This is a structural diagram of the use process of the detection cartridge disclosed in the embodiment of the present application;

[0122] Figure 15 A schematic diagram of the structure of the detection system disclosed in the embodiment of this application;

[0123] Figure 16 A schematic structural diagram of a detection system disclosed in another embodiment of the present application;

[0124] Figure 17 This is a schematic structural diagram of a detection system disclosed in yet another embodiment of the present application;

[0125] Figure 18 This is a schematic structural diagram of a detection system disclosed in yet another embodiment of the present application;

[0126] Figure 19 This is a schematic diagram of the structure of the detection system with multiple sets of magnets in this application;

[0127] Figure 20 A schematic diagram of the depth of the separation fluid disclosed in the embodiments of the present application;

[0128] Figure 21 Schematic diagram of the coordinate system of the separation fluid depth disclosed in the embodiments of this application.

[0129] The meanings of the reference numerals in the figures are as follows:

[0130] 100 - test cartridge; 101 - cartridge cover; 102 - cartridge cover sealing structure; 103 - cartridge body sealing structure; 104 - cartridge fixing platform; 105 - support beam; 106 - reaction chamber; 107 - cleaning chamber; 108 - test chamber; 109 - scale line; 110 - first connecting structure; 111 - second connecting structure; 112 - striker; 113 - test fluid; 114 - separator fluid; 115 - cleaning fluid; 115a - second cleaning fluid; 115b - first cleaning fluid; 116 - reaction fluid;

[0131] 200-storage element; 201-magnetic bead channel; 202-storage chamber; 300-steel balls; 400-lyophilized reagent; 500-paraffin; 600-magnetic beads; 700-magnet; 800-cartridge fixing frame; 801-cartridge fixing part; 802-cartridge positioning part; 900-heating device; 1000-detection device; 1100-first stepping slide; 1200-photoelectric sensor; 1300-connecting frame; 1400-rotation drive device; 1500-second stepping slide. DETAILED DESCRIPTION

[0132] The core of this application is to provide a detection cartridge to simplify the structure of the detection cartridge;

[0133] Another core of the present application is to provide a method for preparing a detection cartridge and a method for using the detection cartridge.

[0134] The following describes the embodiments with reference to the accompanying drawings. Furthermore, the embodiments shown below do not limit the content of the application described in the claims. Furthermore, the entire contents of the configurations represented by the following embodiments are not limited to those necessary for the solution of the application described in the claims. It should be noted that, for ease of description, only the portions related to the relevant application are shown in the accompanying drawings. The embodiments and features in the embodiments of this application may be combined with each other unless there is a conflict.

[0135] like Figure 1 and Figure 2 As shown, the detection cartridge 100 disclosed in the embodiment of the present application includes a cartridge body and a cartridge cover 101. The cartridge body has a closed end at one end and an open end at the other. Along the direction from the open end to the closed end, the cartridge body includes a reaction chamber 106, a cleaning chamber 107, and a detection chamber 108, which are sequentially connected. The cartridge body can be a tubular structure with one end open and the other closed, with the reaction chamber 106, the cleaning chamber 107, and the detection chamber 108 being located at different locations within the tubular body.

[0136] The reaction chamber 106 is located at one end close to the open end of the cartridge body, the detection chamber 108 is located at one end close to the closed end of the cartridge body, and the cleaning chamber 107 is located between the reaction chamber 106 and the detection chamber 108 .

[0137] like Figure 13 As shown, the reaction chamber 106 is used to load the sample to be tested and the reaction solution 116 mixed with magnetic beads 600 (as shown in FIG. Figure 14As shown in FIG. 1 , when the test cartridge 100 leaves the factory, the reaction chamber 106 may or may not contain a reaction solution 116 mixed with magnetic beads 600. Prior to testing, the user loads the sample to be tested and the reaction solution 116 mixed with magnetic beads 600 into the reaction chamber 106. The detection chamber 108 is loaded with a detection solution 113, and the cleaning chamber 107 is loaded with a cleaning solution 115 and a separator 114. The separator 114 in the upper layer is used to separate the cleaning solution 115 from the reaction solution 116, while the separator 114 in the lower layer is used to separate the cleaning solution 115 from the detection solution 113. Specifically, separator liquid 114 is placed above and below the cleaning liquid 115 to seal and isolate the cleaning liquid 115 from other reagents (cleaning liquid 115 and detection liquid 113). For example, separator liquid 114 above cleaning liquid 115 is used to seal and isolate cleaning liquid 115 from reaction liquid 116; separator liquid 114 below cleaning liquid 115 is used to seal and isolate cleaning liquid 115 from detection liquid 113. It should be noted that paraffin wax 500 can be loaded at the top of cleaning chamber 107. That is, paraffin wax 500 is loaded above the topmost separator liquid 114 in cleaning chamber 107. Paraffin wax 500 can seal the cleaning liquid 115 and separator liquid 114 in cleaning chamber 107, as well as the detection liquid 113 in detection chamber 108, thereby ensuring the stability of the detection cartridge 100 during transportation and long-term storage.

[0138] The cleaning chamber 107 may be loaded with only one cleaning liquid 115 or may be loaded with at least two cleaning liquids, with the two adjacent cleaning liquids being separated by a separator 114. Figure 12 As shown, two cleaning fluids are used as an example. For ease of understanding, they are defined as a first cleaning fluid 115b and a second cleaning fluid 115a. A separator 114 is provided between the first cleaning fluid 115b and the second cleaning fluid 115a. This separates the different cleaning fluids and seals them. Using multiple cleaning fluids can achieve better cleaning results and increase detection sensitivity.

[0139] Since the cleaning solution 115 , the detection solution 113 and the reaction solution 116 are all aqueous reagents, the separation liquid 114 is a substance that is immiscible with the aqueous reagents and can allow the magnetic beads 600 to pass through. For example, the separation liquid 114 can be silicone oil, mineral oil, kerosene, paraffin or organic gel.

[0140] Depending on the purpose of detection, different reagents can be selected for the reaction solution 116 and the detection solution 113. For example, in the case of nucleic acid detection, the reaction solution 116 is a lysis solution and the detection solution 113 is a nucleic acid amplification solution; in the case of protein detection, the reaction solution 116 is an enzyme-labeled primary antibody or a fluorescent-labeled primary antibody solution, the detection solution 113 is a luminescent substrate, and the magnetic beads 600 are magnetic beads modified with a primary antibody.

[0141] like Figure 20 As shown, the radius of the cleaning chamber 107 is r, and the depth of the separator 114 is h (i.e., the distance between the highest and lowest points of the separator 114, which can also be understood as the thickness of the separator 114). The contact angle between the separator 114, the upper liquid phase, and the inner wall of the cleaning chamber 107 is θ1, and the contact angle between the separator 114, the lower liquid phase, and the inner wall of the cleaning chamber 107 is θ2. Given a fixed material for the cleaning chamber 107, θ1 and θ2 are inherent parameters between the reagent and the separator 114, and are dependent on the type of separator 114 and reagent selected. h1 is the distance between the highest and lowest points of the interface between the separator 114 and the upper liquid phase; h2 is the distance between the highest and lowest points of the interface between the separator 114 and the lower liquid phase.

[0142] It should be noted that the separator liquid 114 at different locations within the cleaning chamber 107 corresponds to different upper and lower liquid phases. For example, the separator liquid 114 at the upper side of the cleaning chamber 107 corresponds to the reaction liquid 116 as the upper liquid phase and the cleaning liquid 115 as the lower liquid phase; whereas the separator liquid 114 at the lower side of the cleaning chamber 107 corresponds to the cleaning liquid 115 as the upper liquid phase and the detection liquid 113 as the lower liquid phase.

[0143] like Figure 21 As shown, a plane rectangular coordinate system is constructed with the lowest point of the contact interface between the upper liquid phase and the separator 114 as the origin, and the contact interface is fitted with a quadratic function. The shape of the contact interface can be approximated as . The derivative of this function is:

[0144]

[0145] and

[0146] Therefore

[0147] therefore

[0148] The same logic applies

[0149] The depth h of the separation fluid must satisfy: h>h1+h2, then The above-obtained static boundary conditions for the stability of the multilayer interface are as follows. To ensure that the interface is sufficiently stable and not easily damaged by external vibrations, those skilled in the art can select the value of h according to their needs.

[0150] When the separator 114 is added, the contact angle θ1 and the contact angle θ2 can be obtained according to the materials of the separator 114, the upper liquid phase, and the lower liquid phase, and according to the formula , we can get the range of the depth of the separation liquid 114. Through experiments, it has been verified that those skilled in the art can ensure that the separation liquid 114 effectively and stably isolates the corresponding liquid phase reagents when selecting a specific depth of the separation liquid 114 according to the above formula.

[0151] The cartridge cover 101 is used to be sealed and connected to the open end of the cartridge body to isolate the reaction solution 116 in the reaction chamber 106 from the outside.

[0152] The detection cartridge 100 disclosed in the embodiment of the present application sets a separation liquid 114 as a separation layer at the connection between the cleaning chamber 107, the reaction chamber 106 and the detection chamber 108 to separate the various reagents required for molecular diagnosis in the cartridge body. The depth h of the separation liquid 114 is designed to be By utilizing the surface tension at the oil-water interface, the present invention enables stable storage of different reagents without the use of separators. By eliminating the use of separators, the present invention simplifies cartridge assembly. Under the influence of an external magnetic field, magnetic beads 600 can be transferred between different chambers through the separator 114, eliminating the need for complex control equipment and simplifying operation.

[0153] In order to reduce the depth h of the separation liquid 114 so that the separation liquid 114 without a larger depth h can still achieve isolation between reagents, in other words, when the same depth of the separation liquid 114 is selected, a more stable and reliable isolation can be obtained. In a specific embodiment of the present application, the inner walls of the reaction chamber 106 and the detection chamber 108 have a hydrophilic modified surface, that is, the hydrophilic modified surface is obtained by hydrophilically modifying the inner walls of the reaction chamber 106 and the detection chamber 108, so that the reaction liquid in the reaction chamber 106 contacts the hydrophilic modified surface, and the detection liquid 113 in the detection chamber 108 contacts the hydrophilic modified surface. It should be noted that it is not necessary to make the entire inner wall of the reaction chamber 106 and the detection chamber 108 a hydrophilic modified surface. It is sufficient to make the area close to the separation liquid 114 hydrophilic. Of course, the entire inner wall of the reaction chamber 106 and the detection chamber 108 can also be hydrophilically modified.

[0154] After the inner wall of reaction chamber 106 has been hydrophilically modified, the contact angle between reaction chamber 106 and reaction solution 116 is reduced, making it easier for reaction solution 116 to spread on its surface. Similarly, after the inner wall of detection chamber 108 has been hydrophilically modified, the contact angle between detection chamber 108 and detection solution 113 is reduced, making it easier for detection solution 113 to spread on its surface.

[0155] The inner wall of the cleaning chamber 107 corresponding to the cleaning liquid 115 has a hydrophilic surface, while the inner wall corresponding to the separator liquid 114 has a hydrophobic surface. The hydrophilic surface is obtained by hydrophilically modifying the inner wall region corresponding to the cleaning liquid 115, and the hydrophobic surface is obtained by hydrophobically modifying the inner wall region corresponding to the separator liquid 114. This allows the cleaning liquid 115 in the cleaning chamber 107 to contact the hydrophilic surface, while the separator liquid 114 in the cleaning chamber 107 contacts the hydrophobic surface. The position and area of ​​the hydrophilic and hydrophobic surfaces in the cleaning chamber 107 can be similar to those of the reaction chamber 106 and the detection chamber 108. This means that both hydrophilic and hydrophobic modifications can be applied throughout, or only near the interface.

[0156] After the inner wall of the cleaning chamber 107 has been hydrophilically modified, the contact angle between the cleaning chamber 107 and the cleaning solution 115 is reduced, making it easier for the cleaning solution 115 to spread on its surface. After the inner wall of the cleaning chamber 107 has been hydrophobically modified, the contact angle between the cleaning chamber 107 and the separator 114 is also reduced, making it easier for the separator 114 to spread on its surface. Furthermore, the area corresponding to the separator 114 is a hydrophobically modified surface. Therefore, the aqueous cleaning solution 115, the detection solution 113, and the reaction solution 116 are less likely to penetrate the separator 114 and enter the area where the hydrophobic surface is located, thus improving the storage stability.

[0157] Hydrophilic modification can be achieved through surface coating, chemical grafting, and plasma treatment. Surface coating involves applying a layer of hydrophilic material to the surface of a material. For example, a polymer coating containing hydroxyl groups can be applied to the inner surface of glass. Hydroxyl groups are highly hydrophilic, increasing the contact between the glass surface and water and improving its hydrophilicity.

[0158] Chemical grafting involves the use of chemical reactions to introduce hydrophilic groups onto a material's surface or molecular structure. For example, with some polymer materials, an initiator can trigger a free radical reaction, creating active sites on the material's surface. Monomers with hydrophilic groups (such as carboxyl or sulfonic acid groups) can then be grafted onto these sites, achieving hydrophilic modification.

[0159] Plasma treatment utilizes active particles in the plasma to react with the material surface, introducing hydrophilic groups there. For example, when a polymer material is placed in an oxygen-containing plasma environment, the oxygen atoms in the plasma react with carbon atoms on the material surface, forming hydrophilic groups such as hydroxyl and carbonyl groups, thereby increasing the material's hydrophilicity.

[0160] Hydrophobic modification can be achieved by surface coating with hydrophobic agents, chemical modification to introduce hydrophobic groups, and micro-nanostructure construction.

[0161] Surface hydrophobic coating involves applying a low-surface-energy hydrophobic agent to the surface of a material, forming a continuous hydrophobic layer. Common hydrophobic agents include silane compounds and fluorides. Chemical modification involves introducing hydrophobic groups into the material's molecular structure through chemical reactions. Micro- and nanostructure construction involves creating micro- and nanostructures on the surface of a material through physical or chemical methods, leveraging surface roughness and the presence of an air layer to achieve a hydrophobic effect.

[0162] In summary, the embodiment of the present application performs hydrophilic and hydrophobic modification on the corresponding areas of the inner wall of the detection cartridge 100. Specifically, the area where the aqueous phase reagent solution is placed is hydrophilic, and the area where the separator 114 is placed is hydrophobic. In this way, the aqueous phase reagent solution is more stable in the hydrophilic area and is not easy to enter the area where the hydrophobic separator 114 is located, and the oily separator 114 is more stable in the hydrophobic area and is not easy to enter the area where the aqueous phase reagent solution is placed. In this way, the contact angle between the separator 114 and the upper liquid phase is θ1, and the contact angle between the separator 114 and the lower liquid phase is θ2, both of which are closer to 90 degrees. The depth h of the separation fluid 114 required for stable stratification is infinitely close to 0, ensuring that the isolation and stratification are more stable.

[0163] like Figure 1 As shown, in one embodiment of the present application, a cartridge mounting platform 104 is provided on the reaction chamber 106. The cartridge mounting platform 104 is used to assemble the detection cartridge 100 with the detection instrument. The cartridge mounting platform 104 can be a plate-like structure and can be positioned at the top of the reaction chamber 106 to reduce space occupation. The cartridge mounting platforms 104 can be symmetrically arranged on both sides of the open end.

[0164] In order to improve the stability and reliability of the cartridge fixing platform 104, a support beam 105 can be added to fix and support the cartridge fixing platform 104. The support beam 105 is arranged on the lower side of the cartridge fixing platform 104 and connected to the cartridge fixing platform 104 and the outer wall of the reaction chamber 106 respectively.

[0165] The reaction chamber 106 , the cleaning chamber 107 and the detection chamber 108 are located on the same straight line, so that the linear displacement of a single magnet 700 can be used to drive the magnetic beads 600 to transfer between the various chambers in the cartridge.

[0166] For easy observation, scale lines 109 can be set on the outer wall of the cleaning chamber 107. The scale lines 109 are used to observe and calibrate the amount of cleaning liquid 115 and separation liquid 114 added to the cleaning chamber 107, thereby improving the accuracy of adding cleaning liquid 115 and separation liquid 114.

[0167] The material of the card box body can be a transparent material, specifically a polymer plastic such as polycarbonate, polypropylene, or glass, etc., which makes it convenient for the detection device to detect the reaction optical signal in the detection cavity 108; it should be noted that the detection card box 100 can have a certain draft angle to facilitate the use of plastic materials for injection molding.

[0168] The cartridge cover 101 is independently provided with the cartridge body, i.e., the cartridge cover 101 is another component independent of the cartridge body. If either the cartridge cover 101 or the cartridge body is damaged, only the damaged portion can be replaced without replacing the entire detection cartridge 100, thus reducing the cost of use.

[0169] Since the cartridge cover 101 is separate from the cartridge body, if not properly stored during use, the cartridge cover 101 can easily be lost, causing the test cartridge 100 to be unable to function properly or causing contamination of the reagents inside. Therefore, the cartridge cover 101 can also be connected to the cartridge body as a whole via a connecting portion to prevent loss due to its small size. The connecting portion can be a link or hinge, etc.

[0170] To ensure a tight seal at the connection between the cartridge cover 101 and the cartridge body, in this embodiment, a cartridge cover sealing structure 102 is provided on the cartridge cover 101, and a cartridge body sealing structure 103 is provided at the open end of the cartridge body to cooperate with the cartridge cover sealing structure 102. The cartridge cover sealing structure 102 and the cartridge body sealing structure 103 can be in the form of a slot, a thread, or the like. It should be noted that the cartridge cover sealing structure 102 and the cartridge body sealing structure 103 are structurally related to each other so that they can cooperate to complete the sealing of the detection cartridge 100. For example, if the cartridge cover sealing structure 102 is a slot structure, the cartridge body sealing structure 103 is a protrusion. Of course, if the cartridge cover sealing structure 102 includes both a slot and a protrusion, then the cartridge body sealing structure 103 accordingly includes both a protrusion that cooperates with the slot and a slot that cooperates with the protrusion. The cartridge cover sealing structure 102 can also be a sealing ring, and the cartridge body sealing structure 103 is a slot that engages the sealing ring. This application can adopt any sealing method, and the embodiments of this application do not limit the sealing method.

[0171] like Figure 1 As shown, the cross-sectional area of ​​the reaction chamber 106 can be designed to be larger than the cross-sectional area of ​​the cleaning chamber 107 and the detection chamber 108. The reaction chamber 106 has a larger cross-sectional area, which can be used to load more reaction liquid 116 for practical application needs, while avoiding the inconvenience caused by the high height of the chamber. Figure 3 As shown, the cross-sectional area of ​​the reaction chamber 106 may also be designed to be similar to or the same as the cross-sectional area of ​​the cleaning chamber 107 .

[0172] In a specific embodiment of the present application, the wall thickness of the detection chamber 108 can be designed to be thinner than the wall thicknesses of the reaction chamber 106 and the cleaning chamber 107. That is, compared to the reaction chamber 106 and the cleaning chamber 107, the detection chamber 108 has a thinner wall thickness, enabling faster heat transfer with the heating device, allowing the detection liquid 113 to quickly reach the set temperature. Those skilled in the art can select the actual wall thickness of the detection chamber 108 based on their needs.

[0173] like Figure 4 As shown, the detection cavity 108 can be flat. The flat detection cavity 108 has a smaller volume and a larger surface area, thereby increasing the heat exchange area of ​​the internal detection liquid 113 and ensuring that the detection liquid 113 is quickly heated to the set temperature. Of course, the detection cavity 108 can also have other shapes, such as a cylinder, an elliptical cylinder, etc.

[0174] like Figures 8-10 As shown, in one embodiment of the present application, a first connecting structure 110 is provided at one end of the cleaning chamber 107 away from the reaction chamber 106, and the detection chamber 108 is detachably connected to the first connecting structure 110. The detection chamber 108 can be stored separately from the rest of the cartridge body. If lyophilized reagents are not used, the rest of the cartridge body can be stored at room temperature while the detection chamber 108 is stored frozen, which can further save space and energy.

[0175] The detection chamber 108 is detachably connected to one end of the cleaning chamber 107 , and the open end of the cleaning chamber 107 for connecting to the detection chamber 108 is sealed by tin foil to prevent the reagent in the cleaning chamber 107 from being unable to remain in the cleaning chamber 107 .

[0176] The open end of the detection chamber 108, which is used to connect to the cleaning chamber 107, is provided with a striker 112, which is used to pierce the tin foil of the cleaning chamber 107. When the detection chamber 108 is installed at the end of the cleaning chamber 107, the striker 112 will pierce the tin foil sealing the cleaning chamber 107, maintaining the connection between the cleaning chamber 107 and the detection chamber 108.

[0177] The first connecting structure 110 is connected to the second connecting structure 111 of the detection chamber 108 to realize the connection between the detection chamber 108 and the cleaning chamber 107. The first connecting structure 110 and the second connecting structure 111 can be in the form of a slot, a thread, etc. It should be noted that the form of the first connecting structure 110 and the second connecting structure 111 match to complete the connection assembly of the detection chamber 108; further, the striker 112 can be set only at the edge of one side of the detection chamber 108 to ensure that the magnetic beads can pass smoothly at other positions of the detection chamber 108. It should be noted that the striker 112 pierces the tin foil and does not destroy the isolation function of the separation liquid 114.

[0178] like Figure 5-Figure 7As shown, in a specific embodiment of the present application, the detection cartridge 100 may further include a storage element 200 disposed within the cleaning chamber 107. The internal structure of the cleaning chamber 107 can be utilized to retain the storage element 200 within the cleaning chamber 107. For example, the storage element 200 is disposed on a target segment of the cleaning chamber 107, and the maximum axial outer diameter of the storage element 200 is greater than the minimum inner diameter of the target segment of the cleaning chamber 107, so that the storage element 200 is engaged with the target segment of the cleaning chamber 107. This allows the storage element 200 to be retained within the cleaning chamber 107 through a size relationship. The storage element 200 may have a draft angle to facilitate assembly with the cleaning chamber 107.

[0179] The storage element 200 has a storage cavity 202 , in which a freeze-dried reagent 400 is sealed by paraffin 500 . The storage cavity 202 also contains steel balls 300 sealed by paraffin 500 .

[0180] A magnetic bead channel 201 is formed between the storage unit 200 and the inner wall of the cleaning chamber 107, through which the magnetic beads 600 pass. The lyophilized reagent 400 can be stored for long periods at room temperature. The storage unit 200 primarily stores the lyophilized reagent 400 required for the testing solution 113. The testing solution 113 contains substances such as proteases required for biological reactions. These substances are prepared into the lyophilized reagent 400 through a freeze-drying process and then reconstituted in the testing solution 113 upon use. This extends the shelf life of the reagent and improves its stability under long-term storage conditions.

[0181] The outer wall of the storage element 200 is provided with a notch. A magnetic bead channel 201 is formed between the notch of the storage element 200 and the inner wall of the cleaning chamber 107. This channel is used to load the separation fluid 114 and ensure the passage of magnetic beads. The outer wall of the storage element 200, excluding the notch, is aligned with the inner wall of the cleaning chamber 107, and a small gap may be provided. If a gap exists, the separation fluid 114 can be filled in.

[0182] The storage element 200 is disposed at one end of the cleaning chamber 107 near the detection chamber 108, that is, at the bottom of the cleaning chamber 107. When the storage element 200 is disposed at the bottom of the cleaning chamber 107, the separation liquid 114 fills the gap between the magnetic bead channel 201 and the inner wall of the cleaning chamber 107. Furthermore, the separation liquid 114 can also be disposed above and below the storage element 200, enveloping the storage element 200 and effectively isolating the cleaning liquid 115 and the detection liquid 113, thereby enhancing the stability of the reagent separation.

[0183] The storage chamber 202 is provided with an opening at one end of the storage element 200, and the opening of the storage chamber 202 is provided facing the detection chamber 108. The storage element 200 is provided with an opening at only one end, mainly to ensure the accurate release and re-dissolution of the freeze-dried reagent 400. Specifically, by moving the external magnet 700 up and down, the steel ball 300 can be controlled to collide with the paraffin 500, thereby pushing the freeze-dried reagent 400 into the detection liquid 113 for re-dissolution; if an axially through structure is adopted, the steel ball 300 may bring the freeze-dried reagent 400 into the cleaning liquid 115 during movement, resulting in the freeze-dried reagent 400 not being dissolved in the detection liquid 113 as expected, causing the reaction to fail to proceed normally.

[0184] like Figure 15 As shown, the embodiment of the present application further discloses a detection system, which includes a detection instrument, and the detection instrument is used to detect the detection cartridge 100 disclosed in the above embodiment.

[0185] In the present embodiment, the detection instrument includes a first step slide 1100, a heating device 900, a detection device 1000 and a magnet 700. The magnet 700 can be a permanent magnet or an electromagnet, as long as it can absorb the magnetic beads 600. Wherein, a cartridge fixing frame 800 for supporting the detection cartridge 100 is provided on the movable portion of the first step slide 1100. During detection, the detection cartridge 100 can be fixed on the cartridge fixing frame 800. The cartridge fixing frame 800 can have a corresponding slot, and the cartridge fixing platform 104 can be inserted in the slot to achieve the fixation of the detection cartridge 100 on the cartridge fixing frame 800. Of course, other fixing methods can also be adopted, which are not limited to the method of cooperation between the cartridge fixing platform 104 and the slot. The position corresponding to the cartridge fixing frame 800 and the cartridge cover 101 has a notch to facilitate the operation of the cartridge cover 101 and achieve the opening and closing cover action.

[0186] The heating device 900 is used to heat the detection cartridge 100. When the first step slide 1100 drives the detection cartridge 100 to move up and down, the relative position of the heating device 900 and the detection cartridge 100 can be changed, thereby changing the heating position of the detection cartridge 100.

[0187] The detection device 1000 is used to control the temperature and detect optical signals of the reaction in the detection chamber 108. The magnet 700 is located on one side of the detection cartridge 100 to facilitate the transfer of magnetic beads 600 between the reaction chamber 106, the cleaning chamber 107 and the detection chamber 108.

[0188] It should be noted that the magnet 700, the heating device 900, and the detection device 1000 can be fixed by an external connection structure (not shown in the figure), and the detection card box 100 can be raised and lowered under the drive of the first step slide 1100, so that a relative displacement is generated between the detection card box 100 and the magnet 700, the heating device 900, and the detection device 1000, thereby realizing the functions of the magnet 700 manipulating the magnetic beads 600, the heating device 900 heating a specific position of the detection card box 100, and the detection device 1000 performing temperature control detection on the reaction in the detection cavity 108.

[0189] Furthermore, the detection instrument may also include a photoelectric sensor 1200, and the cartridge fixing frame 800 includes a cartridge fixing portion 801 and a cartridge positioning portion 802, the cartridge fixing portion 801 is used to support the detection cartridge 100, and the cartridge positioning portion 802 is used to sense and cooperate with the photoelectric sensor 1200 to achieve positioning of the detection cartridge 100.

[0190] In this embodiment, by providing the cartridge positioning portion 802 and the photoelectric sensor 1200, the detection cartridge 100 can be positioned. When the photoelectric sensor 1200 senses the cartridge positioning portion 802, it indicates that the detection cartridge 100 has moved to the positioning position. The positioning position can be any position requiring positioning, such as the initial position, the detection position, etc. Those skilled in the art can determine the position requiring positioning and set the arrangement position of the photoelectric sensor 1200 so that the detection cartridge 100 can stop at the corresponding positioning position when it moves to the corresponding positioning position.

[0191] like Figure 16 As shown, in a specific embodiment of the present application, the detection instrument may further include a second stepping slide 1500 that drives the magnet 700 to move along the detection cartridge 100. That is, in this embodiment, the detection instrument may use two stepping slides (the first stepping slide 1100 and the second stepping slide 1500) to control the movement of the detection cartridge 100 and the movement of the magnet 700, respectively.

[0192] It should be noted that the difference from the above-mentioned configuration of only the first stepper slide 1100 is that the use of the second stepper slide 1500 to control the movement of the magnet 700 can shorten the stroke of the first stepper slide 1100 that controls the movement of the detection cartridge 100, thereby reducing the overall height of the detection system and improving portability.

[0193] like Figure 18As shown, in a specific embodiment of the present application, the magnet 700 is an electromagnet, and there are two magnets 700 symmetrically arranged on both sides of the detection cartridge 100. When the magnetic beads 600 are located in the reaction solution 116, the cleaning solution 115, or the detection solution 113, the two magnets 700 are energized in sequence, and the alternating magnetic fields drive the magnetic beads 600 to move left and right on both sides of the inner wall of the corresponding cavity, thereby allowing the magnetic beads 600 to be fully mixed with the reagents during movement.

[0194] By controlling the power on and off of magnet 700, magnetic beads 600 are stirred, making automation easy. Parameters such as stirring time and intensity can be precisely controlled according to pre-set programs, automating and standardizing the molecular detection process. This improves detection efficiency, adapts to large-scale testing needs, and reduces manual operation errors.

[0195] The relatively gentle movement of the magnetic beads 600 under the influence of the magnetic field does not disrupt the molecular structure like vigorous mechanical stirring. Molecular structural integrity is crucial for subsequent testing. Gentle stirring ensures the stability of the physical and chemical properties of nucleic acids, ensuring that test results accurately reflect the nucleic acid content of the sample. For example, when testing for viral nucleic acid, excessive stirring prevents viral nucleic acid fragments from breaking and affecting test accuracy.

[0196] like Figure 19 As shown, in one embodiment of the present application, the magnets 700 are electromagnets, and there are two sets of magnets 700. The two sets of magnets 700 are symmetrically arranged on either side of the detection cartridge 100, with each set of magnets 700 containing multiple magnets. The two sets of magnets 700 are arranged in pairs, one for each other. This arrangement shortens the travel of the first step slide 1100 that controls the movement of the detection cartridge 100, thereby reducing the overall height of the accompanying detection instrument and improving portability.

[0197] like Figure 17 As shown, in a specific embodiment of the present application, the detection instrument further includes a second stepping slide 1500 that drives the magnet 700 to move along the detection cartridge 100, and a rotation drive device 1400 that drives the second stepping slide 1500 to rotate around the detection cartridge 100. In this embodiment, the second stepping slide 1500 that controls the movement of the magnet 700 can be fixed to the rotation drive device 1400 via a connecting frame 1300. The rotation drive device 1400 can be a hollow brushless motor.

[0198] It should be noted that when the magnetic beads 600 are located in the detection liquid 113, the cleaning liquid 115 or the reaction liquid 116, the magnet 700 can rotate around the detection card box 100 under the drive of the second stepping slide 1500 and the rotation drive device 1400, so that the magnetic beads 600 are driven by the magnet 700 to move in a spiral trajectory and can be fully mixed with the reagent.

[0199] Example 1

[0200] Example 1 of the present application discloses a detection method, which utilizes the detection cartridge disclosed in the above embodiment, including a method for preparing the detection cartridge and a method for using the detection cartridge. It should be noted that the method for preparing the detection cartridge and the method for using the detection cartridge can be implemented by different execution entities, for example, the method for preparing the detection cartridge is implemented by the manufacturer of the detection cartridge, while the method for using the detection cartridge is implemented by the user of the detection cartridge. Of course, they can also be implemented by a single execution entity, for example, both are implemented by the user of the detection cartridge.

[0201] like Figure 11 As shown, the method for preparing the detection cartridge disclosed in the first embodiment includes:

[0202] a) Adding a detection liquid 113 into the detection chamber 108;

[0203] b) adding a separation liquid 114 into the cleaning chamber 107 in sequence to cover and seal the detection liquid 113 in the detection chamber 108;

[0204] c) adding cleaning fluid 115 into the cleaning chamber 107;

[0205] d) adding a separator liquid 114 into the cleaning chamber 107 to cover and seal the cleaning liquid 115;

[0206] It should be noted that the reaction chamber 106 does not need to be filled with reaction solution. The user can then add the reaction solution 116 mixed with magnetic beads 600 and the sample to be tested to the reaction chamber 106 at the time of use. In this case, after step d) is completed, the cartridge cover 101 can be directly assembled and sealed. Of course, the reaction chamber 106 can also be filled with reaction solution. In this case, the test cartridge preparation method should also include step e).

[0207] e) Add the reaction solution 116 mixed with the magnetic beads 600 into the reaction chamber 106 , and install the cartridge cover 101 on the top of the reaction chamber 106 .

[0208] At this point, the preparation process of the detection cartridge is completed. At this time, the reagents stored in the detection cartridge are, from top to bottom, the reaction solution 116 , the separation solution 114 , the cleaning solution 115 , the separation solution 114 , and the detection solution 113 .

[0209] In this embodiment, a pipette or other device can be used to add the detection liquid 113, the separation liquid 114, the cleaning liquid 115 and the reaction liquid 116 into the detection cartridge. For other structural features of the detection cartridge, please refer to the detection cartridge disclosed in the previous embodiment and will not be repeated here.

[0210] like Figure 14 As shown, the method for using the detection cartridge includes:

[0211] a) If the reaction solution 116 mixed with the magnetic beads 600 is not added to the reaction chamber 106, the reaction solution 116 mixed with the magnetic beads 600 and the sample to be tested are added to the reaction chamber 106. If the reaction solution 116 mixed with the magnetic beads 600 is already added to the reaction chamber 106, the sample to be tested is added to the reaction chamber 106. The sample to be tested in the reaction chamber 106 is fully lysed in the reaction solution 116 to release nucleic acids. The released nucleic acids are fully combined with the magnetic beads 600, and the magnetic beads 600 in the reaction solution 116 are driven by the magnet 700 to be enriched on the inner wall of the reaction chamber 106.

[0212] b) The magnetic beads 600 are driven by the magnet 700 from the reaction solution 116 through the separation solution 114 into the cleaning solution 115;

[0213] Specifically, the magnet 700 drives the magnetic beads 600 to enter the cleaning solution 115 from the reaction solution 116. The detection cartridge can be moved upward while the magnet 700 is stationary, or the detection cartridge can be stationary while the magnet is moved downward, or the detection cartridge can be moved upward while the magnet is moved downward. It will be appreciated by those skilled in the art that as long as there is relative displacement between the magnet 700 and the detection cartridge, the magnetic beads 600 can be driven to move in the corresponding cavity of the detection cartridge. In the present embodiment, the movement of the magnetic beads 600 is not limited, and can be a linear movement or a curve such as a spiral movement. Since a separator is not provided in the detection cartridge of the present application, any position in the cavity can ensure the passage of the magnetic beads 600. Therefore, the movement and route of the magnetic beads 600 are not limited.

[0214] c) The magnetic beads 600 are driven by the magnet 700 to move back and forth in the cleaning solution 115 so that the cleaning solution 115 can fully clean the magnetic beads 600;

[0215] There is no limitation on the path, frequency and speed of the up and down reciprocating movement of the magnetic beads 600 in the cleaning solution 115, and those skilled in the art can select them according to their needs.

[0216] d) The magnetic beads 600 are driven by the magnet 700 from the cleaning solution 115 through the separation solution 114 into the detection solution 113;

[0217] Specifically, the magnet 700 drives the magnetic beads 600 from the cleaning solution 115 into the detection solution 113. The detection cartridge can be moved upward while the magnet 700 is stationary, or the detection cartridge can be stationary while the magnet is moved downward, or the detection cartridge can be moved upward while the magnet is moved downward. It will be appreciated by those skilled in the art that as long as there is relative displacement between the magnet 700 and the detection cartridge, the magnetic beads 600 can be driven to move within the corresponding cavity of the detection cartridge. In this embodiment, the movement of the magnetic beads 600 is not limited. It can be linear movement or curve movement such as spiral movement. Since no separator is provided in the detection cartridge of the present application, any position in the cavity can ensure the passage of the magnetic beads 600. Therefore, the movement and route of the magnetic beads 600 are not limited.

[0218] e) The nucleic acids adsorbed on the magnetic beads 600 are eluted by the detection solution 113. The magnetic beads 600 are then driven by the magnet 700 from the detection solution 113 through the separator 114 into the cleaning solution 115 (it should be noted that the magnetic beads 600 do not need to be transferred to the cleaning solution 115 and can remain in the detection solution 113). The detection chamber 108 is heated by the heating device to control the temperature of the detection chamber 108 to achieve nucleic acid amplification in the detection solution 113. The detection device detects the signal value in the detection solution 113 to obtain the detection result.

[0219] Variable temperature PCR (Polymerase Chain Reaction) amplification can be used, or constant temperature amplification, such as LAMP (loop-mediated isothermal amplification), RPA (Recombinase Polymerase Amplification), RCA (Rolling Circle Amplification), etc. The detection device 1000 scans and detects the signal value of the nucleic acid amplification solution in real time to obtain the detection result.

[0220] A detection method disclosed in Example 1 of the present application is applicable to fully integrated nucleic acid detection based on the magnetic bead method, wherein the reaction solution 116 is a lysis solution and the detection solution 113 is a nucleic acid amplification solution.

[0221] Example 2

[0222] like Figure 12 As shown, the difference between the detection method disclosed in the second embodiment of the present application and the above-mentioned first embodiment is that in the second embodiment, the cleaning chamber 107 is equipped with multiple cleaning solutions 115 to clean the magnetic beads, so step c) in the detection cartridge preparation method needs to be changed.

[0223] Step c) in the method for preparing the detection cartridge disclosed in the second embodiment specifically includes:

[0224] c1) adding a first cleaning liquid 115b into the cleaning chamber 107;

[0225] c2) adding a separation liquid 114 into the cleaning chamber 107 to cover and seal the first cleaning liquid 115b;

[0226] c3) Adding the second cleaning liquid 115 a into the cleaning chamber 107 .

[0227] It should be noted that the first cleaning liquid 115b and the second cleaning liquid 115a should be different types of cleaning liquids. Those skilled in the art can select the corresponding type of cleaning liquid according to the cleaning requirements and intensity. For example, since the second cleaning liquid 115a is located above the first cleaning liquid 115b, the second cleaning liquid 115a can be selected as a cleaning liquid with stronger cleaning ability, while the first cleaning liquid 115b can be selected as a cleaning liquid with relatively weaker cleaning ability. After the magnetic beads 600 are first cleaned by the second cleaning liquid 115a, most of the impurities are washed away due to the second cleaning liquid 115a having a stronger cleaning ability, and then the remaining impurities are washed away by the first cleaning liquid 115b with a weaker cleaning ability. This arrangement allows the magnetic beads entering the first cleaning liquid 115b to carry fewer impurities, and when the magnetic beads enter the first cleaning liquid 115b, the first cleaning liquid 115b has not yet been contaminated, thereby ensuring a better cleaning effect.

[0228] It should be noted that the depths of the first cleaning liquid 115b and the second cleaning liquid 115a may also be different. Of course, the first cleaning liquid 115b and the second cleaning liquid 115a may also be selected to have the same depth. This embodiment does not limit the depths of the first cleaning liquid 115b and the second cleaning liquid 115a.

[0229] In addition, the above embodiment is described with only two cleaning liquids 115 (a first cleaning liquid 115 b and a second cleaning liquid 115 a ). Those skilled in the art will appreciate that there may be more than two types of cleaning liquids 115 as long as the different types of cleaning liquids 115 are separated by the separator 114 .

[0230] The method of using the detection cartridge disclosed in the second embodiment is substantially the same as that of the first embodiment and will not be described in detail herein.

[0231] The detection method disclosed in Example 2 of the present application is applicable to a nucleic acid detection method using multiple cleaning solutions for magnetic bead cleaning, wherein the reaction solution 116 is a lysis solution and the detection solution 113 is a nucleic acid amplification solution.

[0232] Example 3

[0233] The detection method disclosed in Example 3 of this application differs from Example 1 described above in that paraffin wax is sealed at the top of the cleaning chamber 107 to ensure the stability of the detection cartridge during transportation and long-term storage. Due to the need to seal the top of the cleaning chamber 107 with paraffin wax, step d) of the detection cartridge preparation method needs to be modified.

[0234] like Figure 13 As shown, step d) in the method for preparing the detection cartridge disclosed in this embodiment 3 specifically includes:

[0235] d1) adding a separator liquid 114 into the cleaning chamber 107 to cover and seal the cleaning liquid 115;

[0236] d2) Add melted paraffin 500 into the cleaning chamber 107, and after the paraffin 500 cools and solidifies, proceed to step e).

[0237] After the paraffin 500 on the top of the cleaning chamber 107 cools and solidifies, the cleaning liquid 115 and the separation liquid 114 in the cleaning chamber 107 and the detection liquid 113 in the detection chamber 108 can be sealed to ensure the stability of the detection cartridge during transportation and long-term storage.

[0238] The other steps of the method for preparing the detection cartridge disclosed in the third embodiment are the same as those in the first embodiment and will not be described in detail herein.

[0239] The method for preparing the test cartridge disclosed in the third embodiment is different from that in the first embodiment, because step d) is changed, that is, paraffin 500 is added to the top of the cleaning chamber 107. Therefore, the method for using the test cartridge of the third embodiment also needs to be adjusted, and step a) needs to be adjusted.

[0240] Step a) in the method for using the detection cartridge disclosed in the third embodiment specifically includes:

[0241] a1) If the reaction solution 116 mixed with the magnetic beads 600 is not added to the reaction chamber 106, the reaction solution 116 mixed with the magnetic beads 600 and the sample to be tested are added to the reaction chamber 106. If the reaction solution 116 mixed with the magnetic beads 600 is already added to the reaction chamber 106, the sample to be tested is added to the reaction chamber 106. The sample to be tested in the reaction chamber 106 is fully lysed in the reaction solution 116 and nucleic acids are released. The released nucleic acids are fully bound to the magnetic beads 600.

[0242] a2) The cleaning chamber 107 is heated by a heating device to melt the paraffin 500 , and the magnetic beads 600 in the reaction solution 116 are driven by the magnet 700 to be concentrated on the inner wall of the reaction chamber 106 .

[0243] That is, when paraffin 500 is sealed at the top of the cleaning chamber 107, before the magnet 700 drives the magnetic beads 600 in the reaction liquid 116 to be enriched on the inner wall of the reaction chamber 106, the cleaning chamber 107 needs to be heated by a heating device so that the paraffin 500 melts into a liquid state. Otherwise, the magnet 700 cannot drive the magnetic beads 600 to break through the paraffin 500 and enter the cleaning chamber 107.

[0244] The other steps of the method for using the detection cartridge disclosed in the third embodiment are the same as those in the first embodiment and will not be described in detail herein.

[0245] The detection method disclosed in Example 3 of the present application is applicable to a nucleic acid detection method using a paraffin-sealed cleaning chamber, wherein the reaction solution 116 is a lysis solution and the detection solution 113 is a nucleic acid amplification solution.

[0246] Example 4

[0247] The detection method disclosed in Example 4 of the present application also includes a freeze-dried storage device preparation process, which includes: embedding the freeze-dried reagent 400 and the steel ball 300 in the storage cavity 202 of the storage element 200 using melted paraffin 500 until the paraffin 500 cools and solidifies (such as Figure 5-Figure 7 As shown); the structure of the storage element 200 can refer to the detection card box disclosed in the above embodiment, and will not be repeated here.

[0248] In the fourth embodiment, a freeze-drying storage device is installed in the cleaning chamber 107 , so step c) in the test cartridge preparation method needs to be changed.

[0249] Step c) in the method for preparing the detection cartridge disclosed in the fourth embodiment is specifically to sequentially add the freeze-dried storage device, the separator 114 , the cleaning solution 115 and the separator 114 into the cleaning chamber 107 .

[0250] The other steps of the method for preparing the detection cartridge disclosed in the fourth embodiment are the same as those in the first embodiment and will not be described in detail herein.

[0251] Step e) in the method for using the detection cartridge disclosed in the fourth embodiment specifically includes:

[0252] e1) The nucleic acid adsorbed on the magnetic beads 600 is eluted by the detection solution 113 , and then the magnetic beads 600 are moved from the detection solution 113 through the separation solution 114 into the cleaning solution 115 by the magnet 700 ;

[0253] e2) The storage chamber 202 is heated by the heating device to melt the paraffin 500 in the storage chamber 202 . Simultaneously, the magnet 700 moves up and down, driving the steel balls 300 in the storage chamber 202 to impact the paraffin 500 and accelerate its melting. After the paraffin 500 is completely melted, the lyophilized reagent 400 is released and dissolved in the detection solution 113 .

[0254] e3) The detection chamber 108 is heated by a heating device to control the temperature of the detection chamber 108 to achieve nucleic acid amplification in the detection liquid 113 , and a detection device is used to detect a signal value in the detection liquid 113 to obtain a detection result.

[0255] The other steps of the method for using the detection cartridge disclosed in the fourth embodiment are the same as those in the first embodiment and will not be described in detail herein.

[0256] The detection method disclosed in Example 4 of the present application is applicable to a method for nucleic acid detection using paraffin-embedded freeze-dried reagents in a storage element, wherein the reaction solution 116 is a lysis solution and the detection solution 113 is a nucleic acid amplification solution.

[0257] Example 5

[0258] The detection method disclosed in Example 5 of the present application also includes a method for preparing a detection cartridge and a method for preparing a detection cartridge. The method for preparing a detection cartridge and a method for preparing a detection cartridge disclosed in Example 5 are substantially the same as those in Example 1. The only difference is that the temperature at which the heating device heats the detection chamber 108 is different, the detection liquid 113 is a luminescent substrate, the reaction liquid 116 is an enzyme-labeled primary antibody or a fluorescently labeled primary antibody solution, and the magnetic beads 600 are magnetic beads modified with a primary antibody.

[0259] The detection method disclosed in Example 5 of this application is applicable to fully integrated multi-sample protein detection. Those skilled in the art can refer to the detection process of protein detection in the prior art, which will not be described in detail here.

[0260] Example 6

[0261] The detection method disclosed in Example 6 of the present application is applicable to a separator liquid that is solid at room temperature and liquid after heating. For example, when the separator liquid is paraffin or gel, there are some differences in the method of using the detection cartridge from the method of using the detection cartridge disclosed in Example 1, while the method of preparing the detection cartridge is basically the same as that in Example 1, the only difference being that after adding the separator liquid 114 into the cleaning chamber 107, it is necessary to wait for the separator liquid 114 to cool and solidify before adding other reagents.

[0262] The method for using the detection cartridge disclosed in Example 6 of the present application includes:

[0263] a) If the reaction solution 116 mixed with the magnetic beads 600 is not added to the reaction chamber 106, the reaction solution 116 mixed with the magnetic beads 600 and the sample to be tested are added to the reaction chamber 106. If the reaction solution 116 mixed with the magnetic beads 600 is already added to the reaction chamber 106, the sample to be tested is added to the reaction chamber 106. The sample to be tested in the reaction chamber 106 is fully lysed in the reaction solution 116 to release nucleic acids. The released nucleic acids are fully combined with the magnetic beads 600, and the magnetic beads 600 in the reaction solution 116 are driven by the magnet 700 to be enriched on the inner wall of the reaction chamber 106.

[0264] b) heating the separation liquid 114 above the cleaning liquid 115 by a heating device, and driving the magnetic beads 600 from the reaction liquid 116 through the separation liquid 114 into the cleaning liquid 115 by a magnet 700;

[0265] c) The magnetic beads 600 are driven by the magnet 700 to move back and forth in the cleaning solution 115 so that the cleaning solution 115 can fully clean the magnetic beads 600;

[0266] d) heating the separator 114 below the cleaning solution 115 by a heating device, and driving the magnetic beads 600 from the cleaning solution 115 through the separator 114 into the detection solution 113 by the magnet 700;

[0267] e) The nucleic acids adsorbed on the magnetic beads 600 are eluted by the detection solution 113. The magnetic beads 600 are then moved from the detection solution 113 through the separation solution 114 into the cleaning solution 115 by the magnet 700. The detection chamber 108 is heated by the heating device to control the temperature of the detection chamber 108 to achieve nucleic acid amplification in the detection solution 113. The detection device detects the signal value in the detection solution 113 to obtain the detection result.

[0268] In the description of this application, unless otherwise clearly defined, terms such as setting, installing, and connecting should be understood in a broad sense, and technicians in the relevant technical field can reasonably determine the specific meanings of the above terms in this application based on the specific content of the technical solution.

[0269] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0270] This document uses specific examples to illustrate the principles and implementation methods of this application. The description of the above examples is only intended to help understand the method and core ideas of this application. It should be noted that for those skilled in the art, without departing from the principles of this application, various improvements and modifications can be made to this application, and such improvements and modifications also fall within the scope of protection of the claims of this application.

Claims

1. A detection cartridge, characterized in that: include: A cartridge body, wherein one end of the cartridge body is a closed end and the other end is an open end, and along the direction from the open end to the closed end, the cartridge body comprises a reaction chamber (106), a cleaning chamber (107) and a detection chamber (108) which are sequentially connected, the reaction chamber (106) being used to load a sample to be tested and a reaction liquid (116) mixed with magnetic beads (600), the detection chamber (108) being loaded with a detection liquid (113), the cleaning chamber (107) being loaded with a cleaning liquid (115) and a separation liquid (114), the separation liquid (114) being used to The cleaning liquid (115) and the reaction liquid (116) are separated, as well as the cleaning liquid (115) and the detection liquid (113), and the separating liquid (114) is a substance that is immiscible with the aqueous phase reagent and can allow the magnetic beads to pass through, the depth of the separating liquid (114) is h, the contact angle between the separating liquid (114), the upper liquid phase and the inner wall of the cleaning chamber (107) is θ1, the contact angle between the separating liquid (114), the lower liquid phase and the inner wall of the cleaning chamber (107) is θ2, and the radius of the cleaning chamber (107) is r, then The inner walls of the reaction chamber (106) and the detection chamber (108) have hydrophilic modified surfaces, the inner wall of the cleaning chamber (107) and the region corresponding to the cleaning liquid (115) have hydrophilic modified surfaces, and the inner wall of the cleaning chamber (107) and the region corresponding to the separation liquid (114) have hydrophobic modified surfaces; The card box cover (101) is used for sealingly connecting to the open end of the card box body.

2. The detection cartridge according to claim 1, wherein The invention also includes a storage element (200) disposed in the cleaning chamber (107), wherein the storage element (200) has a storage chamber (202), wherein a freeze-dried reagent (400) is sealed in the storage chamber (202) by paraffin (500), and a magnetic bead channel (201) for the magnetic beads (600) to pass through is formed between the storage element (200) and the inner wall of the cleaning chamber (107).

3. The detection cartridge according to claim 2, wherein: The outer wall of the storage element (200) is provided with a notch, the magnetic bead channel (201) is formed between the notch of the storage element (200) and the inner wall of the cleaning chamber (107), and the outer walls of the storage element (200) other than the notch are in contact with the inner wall of the cleaning chamber (107); and / or, The storage element (200) is arranged at one end of the cleaning chamber (107) close to the detection chamber (108); and / or, The storage cavity (202) is provided with an opening at one end of the storage element (200), and the opening of the storage cavity (202) is arranged facing the detection cavity (108); and / or, The storage cavity (202) contains steel balls (300) and a freeze-dried reagent (400) sealed by paraffin (500).

4. The detection cartridge according to claim 2, wherein: The storage element (200) is arranged on the target segment of the cleaning chamber (107), and the maximum outer diameter of the storage element (200) in the axial direction is greater than the minimum inner diameter of the target segment of the cleaning chamber (107), so that the storage element (200) is clamped on the target segment of the cleaning chamber (107).

5. The detection cartridge according to claim 1, wherein: The reaction chamber (106) is loaded with a reaction solution (116) mixed with magnetic beads (600); and / or, A cartridge fixing platform (104) is provided on the reaction chamber (106), and the cartridge fixing platform (104) is used to assemble the detection cartridge with the detection instrument; and / or, The reaction chamber (106), the cleaning chamber (107) and the detection chamber (108) are located on the same straight line; and / or, The outer wall of the cleaning chamber (107) is provided with scale lines (109), and the scale lines (109) are used to observe and calibrate the amount of cleaning liquid (115) and separation liquid (114) added to the cleaning chamber (107); and / or, The material of the card box body is transparent material; and / or, The material of the card box body is polymer plastic or glass; and / or, The card box cover (101) is independently provided with the card box body or is connected to the card box body as a whole via a connecting portion; and / or, The card box cover (101) is provided with a card box cover sealing structure (102), and the open end of the card box body is provided with a card box body sealing structure (103) that cooperates with the card box cover sealing structure (102); and / or, The cross-sectional area of ​​the reaction chamber (106) is larger than the cross-sectional areas of the cleaning chamber (107) and the detection chamber (108); and / or, The wall thickness of the detection chamber (108) is smaller than the wall thickness of the reaction chamber (106) and the cleaning chamber (107); and / or, The detection cavity (108) is flat or cylindrical; and / or, The separator (114) is silicone oil, mineral oil, kerosene, paraffin or organic gel; and / or, In the case of nucleic acid detection, the reaction solution (116) is a lysis solution, the detection solution (113) is a nucleic acid amplification solution, and in the case of protein detection, the reaction solution (116) is an enzyme-labeled primary antibody or a fluorescent-labeled primary antibody solution, the detection solution (113) is a luminescent substrate, and the magnetic beads (600) are magnetic beads modified with a primary antibody; and / or, The detection chamber (108) is detachably connected to one end of the cleaning chamber (107); the open end of the cleaning chamber (107) for connecting to the detection chamber (108) is sealed by tin foil; the open end of the detection chamber (108) for connecting to the cleaning chamber (107) is provided with a striker (112); the striker (112) is used to pierce the tin foil of the cleaning chamber (107); and / or, The cleaning chamber (107) is loaded with at least two cleaning liquids, and two adjacent cleaning liquids are separated by a separator (114); and / or, In the cleaning chamber (107), paraffin (500) is loaded on the uppermost layer of the separation liquid (114).

6. A detection system, characterized in that: A detection instrument for detecting the detection cartridge (100) according to claim 1 or 5; The detection instrument comprises: A first step slide (1100), wherein a cartridge fixing frame (800) for supporting the detection cartridge (100) is provided on a movable portion of the first step slide (1100); A heating device (900), used for heating the detection cartridge (100); A detection device (1000) for controlling the temperature of the reaction in the detection chamber (108) and detecting optical signals; The magnet (700) is located on one side of the detection cartridge (100) to enable the magnetic beads (600) to be transferred between the reaction chamber (106), the cleaning chamber (107) and the detection chamber (108).

7. The detection system according to claim 6, wherein: The magnet (700) is a permanent magnet or an electromagnet; and / or, The detection instrument further comprises a photoelectric sensor (1200), the cartridge fixing frame (800) comprises a cartridge fixing portion (801) and a cartridge positioning portion (802), the cartridge fixing portion (801) being used to support the detection cartridge (100), and the cartridge positioning portion (802) being used to cooperate with the photoelectric sensor (1200) in induction to achieve positioning of the detection cartridge (100); and / or, The detection instrument further comprises a second stepping slide (1500) for driving the magnet (700) to move along the detection cartridge (100).

8. The detection system according to claim 6, wherein: The magnet (700) is an electromagnet, and there are two magnets (700) symmetrically arranged on both sides of the detection cartridge (100); or, The magnets (700) are electromagnets, and there are two groups of magnets (700). The two groups of magnets (700) are symmetrically arranged on both sides of the detection cartridge (100), and each group of magnets (700) has a plurality of magnets; or, The detection instrument further comprises a second stepping slide (1500) for driving the magnet (700) to move along the detection cartridge (100) and a rotation drive device (1400) for driving the second stepping slide (1500) to rotate around the detection cartridge (100).

9. A detection system, characterized in that: A detection instrument for detecting the detection cartridge (100) according to any one of claims 2 to 4; The detection instrument comprises: A first step slide (1100), wherein a cartridge fixing frame (800) for supporting the detection cartridge (100) is provided on a movable portion of the first step slide (1100); A heating device (900), used for heating the detection cartridge (100); A detection device (1000) for controlling the temperature of the reaction in the detection chamber (108) and detecting optical signals; The magnet (700) is located on one side of the detection cartridge (100) to enable the magnetic beads (600) to be transferred between the reaction chamber (106), the cleaning chamber (107) and the detection chamber (108).

10. A method for preparing a detection cartridge, characterized in that: For preparing the detection cartridge according to claim 1, comprising one of the first preparation method, the second preparation method, the third preparation method and the fourth preparation method; The first preparation method comprises: Adding a detection liquid (113) into the detection chamber (108); Adding a separation liquid (114), a cleaning liquid (115), and a separation liquid (114) into the cleaning chamber (107) in sequence; The second preparation method comprises: Adding a detection liquid (113) into the detection chamber (108); Adding a separation liquid (114), a cleaning liquid (115), and a separation liquid (114) into the cleaning chamber (107) in sequence; Adding a reaction solution (116) mixed with magnetic beads (600) into the reaction chamber (106); The third preparation method comprises: Adding a detection liquid (113) into the detection chamber (108); Adding a separation liquid (114), a first cleaning liquid (115b), a separation liquid (114), a second cleaning liquid (115a), and a separation liquid (114) into the cleaning chamber (107) in sequence; Adding a reaction solution (116) mixed with magnetic beads (600) into the reaction chamber (106); The fourth preparation method comprises: Adding a detection liquid (113) into the detection chamber (108); Adding a separation liquid (114), a cleaning liquid (115), and a separation liquid (114) into the cleaning chamber (107) in sequence; Adding melted paraffin wax into the cleaning chamber (107) to allow the paraffin wax to cool and solidify; A reaction solution (116) mixed with magnetic beads (600) is added into the reaction chamber (106).

11. A method for preparing a detection cartridge, characterized in that: For preparing the detection cartridge as claimed in claim 2, comprising the fifth preparation method; The fifth preparation method comprises: Adding a detection liquid (113) into the detection chamber (108); A freeze-dried storage device, a separator (114), a cleaning solution (115), and a separator (114) are sequentially added to the cleaning chamber (107), wherein the freeze-dried storage device is prepared by embedding the freeze-dried reagent and steel balls in the storage chamber of the storage device using melted paraffin until the paraffin is cooled and solidified; A reaction solution (116) mixed with magnetic beads (600) is added into the reaction chamber (106).

12. A method for using a detection cartridge, characterized in that: Used to perform detection using the detection system according to claim 6, comprising one of a first use method, a second use method, a third use method, a fourth use method and a fifth use method; The first method of use includes: When the reaction solution (116) mixed with the magnetic beads (600) is not added into the reaction chamber (106), the reaction solution (116) mixed with the magnetic beads (600) and the sample to be tested are added into the reaction chamber (106); when the reaction solution (116) mixed with the magnetic beads (600) is added into the reaction chamber (106), the sample to be tested is added into the reaction chamber (106); The magnetic beads (600) are driven by the magnet (700) from the reaction solution (116) through the separation solution (114) into the cleaning solution (115), so that the cleaning solution (115) cleans the magnetic beads (600); The magnetic beads (600) are driven by the magnet (700) from the cleaning solution (115) through the separation solution (114) into the detection solution (113), the nucleic acid adsorbed on the magnetic beads (600) is eluted by the detection solution (113), and then the magnetic beads (600) are driven by the magnet (700) from the detection solution (113) through the separation solution (114) back into the cleaning solution (115); heating the detection cavity (108) by a heating device, and detecting a signal value in the detection liquid (113) by a detection device to obtain a detection result; The second method of use includes: When the reaction solution (116) mixed with the magnetic beads (600) is not added into the reaction chamber (106), the reaction solution (116) mixed with the magnetic beads (600) and the sample to be tested are added into the reaction chamber (106); when the reaction solution (116) mixed with the magnetic beads (600) is added into the reaction chamber (106), the sample to be tested is added into the reaction chamber (106); The magnetic beads (600) are driven by the magnet (700) from the reaction solution (116) through the separation solution (114) into the second cleaning solution (115a), so that the second cleaning solution (115a) cleans the magnetic beads (600); The magnetic beads (600) are driven by the magnet (700) from the reaction solution (116) through the separation solution (114) into the first cleaning solution (115b), so that the first cleaning solution (115b) cleans the magnetic beads (600); The magnetic beads (600) are driven by the magnet (700) from the first cleaning solution (115b) through the separation solution (114) into the detection solution (113), the nucleic acid adsorbed on the magnetic beads (600) is eluted by the detection solution (113), and then the magnetic beads (600) are driven by the magnet (700) from the detection solution (113) through the separation solution (114) back into the first cleaning solution (115b); heating the detection cavity (108) by a heating device, and detecting a signal value in the detection liquid (113) by a detection device to obtain a detection result; The third method of use includes: When the reaction solution (116) mixed with the magnetic beads (600) is not added into the reaction chamber (106), the reaction solution (116) mixed with the magnetic beads (600) and the sample to be tested are added into the reaction chamber (106); when the reaction solution (116) mixed with the magnetic beads (600) is added into the reaction chamber (106), the sample to be tested is added into the reaction chamber (106); In the cleaning chamber (107), when paraffin is loaded on the uppermost layer of the separation liquid (114), the cleaning chamber (107) is heated by a heating device to melt the paraffin in the cleaning chamber (107), and the magnetic beads (600) in the reaction liquid (116) are driven by the magnet (700) to be enriched on the inner wall of the reaction chamber (106); The magnetic beads (600) are driven by the magnet (700) from the reaction solution (116) through the separation solution (114) into the cleaning solution (115), so that the cleaning solution (115) cleans the magnetic beads (600); The magnetic beads (600) are driven by the magnet (700) from the cleaning solution (115) through the separation solution (114) into the detection solution (113), the nucleic acid adsorbed on the magnetic beads (600) is eluted by the detection solution (113), and then the magnetic beads (600) are driven by the magnet (700) from the detection solution (113) through the separation solution (114) back into the cleaning solution (115); heating the detection cavity (108) by a heating device, and detecting a signal value in the detection liquid (113) by a detection device to obtain a detection result; The fourth method of use includes: When the reaction solution (116) mixed with the magnetic beads (600) is not added into the reaction chamber (106), the reaction solution (116) mixed with the magnetic beads (600) and the sample to be tested are added into the reaction chamber (106); when the reaction solution (116) mixed with the magnetic beads (600) is added into the reaction chamber (106), the sample to be tested is added into the reaction chamber (106); The magnetic beads (600) are driven by the magnet (700) from the reaction solution (116) through the separation solution (114) into the cleaning solution (115), so that the cleaning solution (115) cleans the magnetic beads (600); The magnetic beads (600) are driven by the magnet (700) from the cleaning solution (115) through the separation solution (114) into the detection solution (113), and the nucleic acid adsorbed on the magnetic beads (600) is eluted by the detection solution (113); heating the detection cavity (108) by a heating device, and detecting a signal value in the detection liquid (113) by a detection device to obtain a detection result; The fifth method of use includes: When the reaction solution (116) mixed with the magnetic beads (600) is not added into the reaction chamber (106), the reaction solution (116) mixed with the magnetic beads (600) and the sample to be tested are added into the reaction chamber (106); when the reaction solution (116) mixed with the magnetic beads (600) is added into the reaction chamber (106), the sample to be tested is added into the reaction chamber (106); In the case where the separation liquid (114) is paraffin or organic gel, the separation liquid (114) in the cleaning chamber (107) is heated by a heating device so that the separation liquid (114) melts into a liquid state, and then the magnetic beads (600) are driven by the magnet (700) from the reaction liquid (116) through the separation liquid (114) into the cleaning liquid (115), so that the cleaning liquid (115) cleans the magnetic beads (600); The magnetic beads (600) are driven by the magnet (700) from the cleaning solution (115) through the separation solution (114) into the detection solution (113), and the nucleic acid adsorbed on the magnetic beads (600) is eluted by the detection solution (113); The detection cavity (108) is heated by a heating device, and the signal value in the detection liquid (113) is detected by a detection device to obtain a detection result.

13. A method for using a detection cartridge, characterized in that: For use in performing detection using the detection system of claim 9, including a sixth method of use; The sixth method of use includes: When the reaction solution (116) mixed with the magnetic beads (600) is not added into the reaction chamber (106), the reaction solution (116) mixed with the magnetic beads (600) and the sample to be tested are added into the reaction chamber (106); when the reaction solution (116) mixed with the magnetic beads (600) is added into the reaction chamber (106), the sample to be tested is added into the reaction chamber (106); The magnetic beads (600) are driven by the magnet (700) from the reaction solution (116) through the separation solution (114) into the cleaning solution (115), so that the cleaning solution (115) cleans the magnetic beads (600); The magnetic beads (600) are driven by the magnet (700) from the cleaning solution (115) through the separation solution (114) into the detection solution (113), the nucleic acid adsorbed on the magnetic beads (600) is eluted by the detection solution (113), and then the magnetic beads (600) are driven by the magnet (700) from the detection solution (113) through the separation solution (114) back into the cleaning solution (115); The storage element (200) in the cleaning chamber (107) is heated by a heating device to melt the paraffin in the storage chamber (202) of the storage element (200), and the steel ball (300) in the storage chamber (202) is driven to move by a magnet (700), so that the steel ball (300) and the freeze-dried reagent (400) in the storage chamber (202) are released and dissolved in the detection liquid (113); The detection cavity (108) is heated by a heating device, and the signal value in the detection liquid (113) is detected by a detection device to obtain a detection result.

Citation Information

Patent Citations

  • Gene detection method based on liquid segment control and device thereof

    CN107384774A

  • Preparation method of test tube and use method of test tube

    CN117282482A

  • Integrated nucleic acid extraction and digital detection device and use method thereof

    CN117568160A