A chemiluminescent immunoassay kit

Abstract

The application discloses a chemiluminescence immunoassay kit, which comprises a box body and a diaphragm assembly covering the opening of the box body; a plurality of chambers are arranged in the box body, each chamber encapsulating a reagent; the diaphragm assembly is provided with a liquid taking hole corresponding to each chamber; one of the chambers is a first chamber for encapsulating a magnetic particle reagent, and the liquid taking hole corresponding to the first chamber is a first liquid taking hole; the diaphragm assembly has a flexible oscillation part at the periphery of the first liquid taking hole, the oscillation part is in contact with a main probe and can oscillate with the main probe when the main probe is inserted into the first liquid taking hole; the bottom of the first chamber is provided with an oscillation sheet, the oscillation sheet is connected with the oscillation part through a connecting piece, so that the oscillation sheet vibrates with the oscillation part to mix the magnetic particle reagent. The application can improve the mixing efficiency of the magnetic particle reagent and avoid detection errors caused by poor mixing effect.

Description

Technical Field

[0001] This application relates to the field of chemiluminescence immunoassay technology, specifically to a chemiluminescence immunoassay kit. Background Technology

[0002] Chemiluminescent immunoassay (CLIA) combines highly sensitive chemiluminescence assays with highly specific immunoreactions for the detection and analysis of various antigens, antibodies, hormones, enzymes, fatty acids, vitamins, and drugs. CLI comprises two parts: an immunoassay system and a chemiluminescence analysis system. It uses a chemical reaction to generate light, which is then used to label antibodies and determine the concentration of the analyte. CLI offers advantages such as high sensitivity, a wide linear range, no interference from scattered light, and no radioactive contaminants. Therefore, it is widely used in life sciences and clinical diagnostics. CLI includes sandwich and competitive methods. In the competitive method, the enzyme-labeled antigen competes with a standard antigen for antibody. A higher concentration of the standard antigen results in less enzyme-labeled antigen binding to the antibody, a lower RLU (Rapid Unbounded Scale), and a lower B / B ratio. Figure 1 The diagram shown illustrates the execution steps of the competition method.

[0003] In existing technologies, Beckman Coulter's DX800, DX600, and Access2 are widely used fully automated chemiluminescence immunoassay analyzers. In these chemiluminescence immunoassay steps, corresponding antibody-coated magnetic microparticles are added, allowing the immunoreaction products to bind to the magnetic microparticles. After separation and washing under a magnetic field, a luminescent substrate is added, and finally, a cold light analyzer is used to detect the luminescence intensity (RLU) to determine the content of a specific antigen in the sample. Therefore, chemiluminescence immunoassay kits integrate multiple solution chambers, one of which is used to encapsulate the antibody-coated magnetic microparticle reagent. Because the magnetic microparticles are relatively heavy, they will settle at the bottom when left to stand. Therefore, the analyzer needs to mix the magnetic microparticle solution before aspirating it. In Beckman Coulter's fully automated chemiluminescence immunoassay analyzers such as the DX800, DX600, and Access2, the mixing and aspiration of the magnetic microparticle solution are mainly achieved using probes with ultrasonic oscillation capabilities. However, the inventors discovered that during the mixing process described above, the probe could not penetrate to the bottom of the kit, resulting in poor mixing of the magnetic particles and requiring a long mixing time. Especially when the kit was left to stand for a long time, the concentration of magnetic particles in the solution drawn by the probe was low when testing the first one or two samples because the magnetic particles were not completely mixed, thus affecting the sample detection results. Summary of the Invention

[0004] In view of the above problems, this application provides a chemiluminescence immunoassay kit to solve the technical problem of low mixing efficiency of magnetic microparticle solution in the above-mentioned chemiluminescence immunoassay kit.

[0005] To achieve the above objectives, the inventors provide a chemiluminescence immunoassay kit for use in a chemiluminescence immunoassay analyzer. The chemiluminescence immunoassay analyzer is equipped with a main probe, and the main probe is equipped with an ultrasonic oscillation module. The ultrasonic oscillation module is used to drive the main probe to oscillate at high frequency when it absorbs magnetic microparticle reagents.

[0006] The chemiluminescent immunoassay kit includes a box and a membrane assembly covering the opening of the box; the box has multiple chambers, each chamber corresponding to a reagent; the membrane assembly has a dispensing port corresponding to each chamber; one of the chambers is a first chamber for encapsulating magnetic microparticle reagents, and the dispensing port corresponding to the first chamber is a first dispensing port;

[0007] The membrane assembly has a flexible oscillating part on the outer periphery of the first liquid intake hole. The oscillating part contacts the main probe when the main probe is inserted into the first liquid intake hole and can oscillate with the main probe.

[0008] An oscillating plate is provided at the bottom of the first chamber. The oscillating plate is connected to the oscillating part through a connector, so that the oscillating plate oscillates with the oscillating part to mix the magnetic microparticle reagent.

[0009] In some technical solutions, the oscillation part includes a sleeve hole coaxially disposed at the bottom of the first liquid extraction hole. When the main probe is inserted into the first liquid extraction hole, the sleeve hole is sleeved on the outer periphery of the main probe. The sleeve hole is elastic and its diameter is smaller than the outer diameter of the main probe.

[0010] In some technical solutions, the diaphragm assembly includes a flexible film layer; the oscillating part is a portion of the flexible film layer, and a thinning ring is provided around the outer periphery of the oscillating part, the thickness of the thinning ring being less than the thickness of the flexible film layer.

[0011] In some technical solutions, two connectors are included, which are symmetrically distributed on both sides of the first liquid extraction hole.

[0012] In some technical solutions, the connector and the flexible film layer are integrally formed from the same material; the two ends of the oscillating plate are provided with connection holes for connecting with the connector.

[0013] In some technical solutions, the oscillating plate is uniformly provided with multiple through holes, and when the oscillating plate oscillates, the magnetic microparticle reagent shuttles through the through holes to form a turbulent flow around the oscillating plate.

[0014] In some technical solutions, the oscillating plate is made of aluminum, aluminum alloy, or magnesium alloy.

[0015] In some technical solutions, the membrane assembly further includes a sealing membrane disposed on the side of each of the liquid extraction holes near the housing to seal each of the chambers; the connector extends through the sealing membrane into the first chamber, and the sealing membrane is sealed to the connector.

[0016] In some technical solutions, the liquid extraction hole is a self-sealing opening formed by multiple flexible membrane flaps.

[0017] In some technical solutions, the inner wall of the first chamber is provided with two or more limiting protrusions, which are located above the oscillating plate and are used to limit the upward movement space of the oscillating plate.

[0018] Unlike existing technologies, the chemiluminescence immunoassay kit described above has an oscillating section on the outer periphery of the first dispensing port that oscillates with the main probe, and an oscillating plate at the bottom of the first chamber. The oscillating plate is connected to the oscillating section via a connector. Therefore, when the main probe is inserted into the first chamber for high-frequency oscillation to mix the magnetic microparticle reagent, the main probe can drive the connector and the bottom oscillating plate to oscillate together through the oscillating section, thereby achieving comprehensive mixing within the first chamber. In particular, the oscillating plate at the bottom can effectively disturb the magnetic microparticles precipitated in the chamber, greatly improving the mixing efficiency of the magnetic microparticle reagent and avoiding detection errors caused by poor mixing.

[0019] The above description of the invention is merely an overview of the technical solution of this application. In order to enable those skilled in the art to better understand the technical solution of this application and to implement it based on the description and drawings, and to make the above-mentioned objectives and other objectives, features and advantages of this application easier to understand, the following description is provided in conjunction with the specific embodiments and drawings of this application. Attached Figure Description

[0020] The accompanying drawings are only used to illustrate the principles, implementation methods, applications, features, and effects of specific embodiments of the present invention and other related contents, and should not be considered as limitations on this application.

[0021] In the accompanying drawings of the instruction manual:

[0022] Figure 1 This is a schematic diagram of the competitive immunoassay procedure in the prior art;

[0023] Figure 2 This is a schematic diagram of the three-dimensional structure of the chemiluminescent immunoassay kit described in the specific embodiment;

[0024] Figure 3 This is a schematic diagram of the internal structure of the chemiluminescent immunoassay kit described in a specific embodiment;

[0025] Figure 4 The chemiluminescent immunoassay kit described in the specific implementation method is as follows: Figure 1 Cross-sectional view along the AA direction;

[0026] Figure 5 for Figure 4 A magnified view of part B in the middle section;

[0027] The reference numerals used in the above figures are explained as follows:

[0028] 1. Chemiluminescent immunoassay kit; 2. Main probe; 21. Card slot;

[0029] 11. Diaphragm assembly; 12. Box body; 13. Connector; 14. Vibrating plate; 111. Liquid inlet; 112. Vibrating part; 113. First liquid inlet; 114. Sleeve hole; 121. Chamber; 122. First chamber; 141. Limiting protrusion; Detailed Implementation

[0030] To illustrate the possible application scenarios, technical principles, implementable specific solutions, and achievable objectives and effects of this application in detail, the following description, in conjunction with the listed specific embodiments and accompanying drawings, provides a detailed explanation. The embodiments described herein are merely illustrative of the technical solutions of this application and are therefore intended to limit the scope of protection of this application.

[0031] In this document, the term "embodiment" means that a specific feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The term "embodiment" appearing in various places throughout the specification does not necessarily refer to the same embodiment, nor does it specifically limit its independence or connection with other embodiments. In principle, in this application, as long as there are no technical contradictions or conflicts, the technical features mentioned in each embodiment can be combined in any way to form corresponding implementable technical solutions.

[0032] Unless otherwise defined, the technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains; the use of related terms herein is merely for the purpose of describing particular embodiments and is not intended to limit this application.

[0033] In the description of this application, the term "and / or" is used to describe the logical relationship between objects, indicating that three relationships can exist. For example, A and / or B means: A exists, B exists, and A and B exist simultaneously. Additionally, the character " / " in this document generally indicates that the preceding and following objects have an "or" logical relationship.

[0034] In this application, terms such as “first” and “second” are used only to distinguish one entity or operation from another, and do not necessarily require or imply any actual quantity, hierarchy or order relationship between these entities or operations.

[0035] Without further limitations, the use of terms such as “comprising,” “including,” “having,” or other similar open-ended expressions in this application is intended to cover non-exclusive inclusion, which does not exclude the presence of additional elements in a process, method, or product that includes the stated elements, such that a process, method, or product that includes a list of elements may include not only those defined elements but also other elements not expressly listed, or elements inherent to such a process, method, or product.

[0036] Similar to the understanding in the Examination Guidelines, in this application, expressions such as "greater than," "less than," and "exceeding" are understood to exclude the stated number; expressions such as "above," "below," and "within" are understood to include the stated number. Furthermore, in the description of the embodiments in this application, "multiple" means two or more (including two), and similar expressions related to "multiple" are also understood in this way, such as "multiple groups" and "multiple times," unless otherwise explicitly specified.

[0037] In the description of the embodiments of this application, the space-related expressions used, such as "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "vertical," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential," indicate the orientation or positional relationship based on the orientation or positional relationship shown in the specific embodiments or drawings. They are only for the purpose of describing the specific embodiments of this application or for the reader's understanding, and do not indicate or imply that the device or component referred to must have a specific position, a specific orientation, or be constructed or operated in a specific orientation. Therefore, they should not be construed as limitations on the embodiments of this application.

[0038] Unless otherwise expressly specified or limited, the terms "installation," "connection," "linking," "fixing," and "setting," as used in the description of the embodiments of this application, should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral setting; it can be a mechanical connection, an electrical connection, or a communication connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be the internal connection of two components or the interaction between two components. For those skilled in the art to which this application pertains, the specific meaning of the above terms in the embodiments of this application can be understood according to the specific circumstances.

[0039] Please see Figures 2 to 5 This embodiment provides a chemiluminescent immunoassay kit. This chemiluminescent immunoassay kit 1 can be used with Beckman Coulter's Dxi800, Dxi600, Access2, and other chemiluminescent immunoassay analyzers. The kit 1 can encapsulate different immunoassay reagents and magnetic microparticle reagents required for the same immunoassay. One chemiluminescent immunoassay kit 1 corresponds to one immunoassay. The magnetic microparticle reagent is a magnetic microparticle solution coated with antibodies corresponding to the immunoassay test item, thus it can be used for HCG level detection, CA199 tumor marker, alpha-fetoprotein concentration detection, and other immunoassays. Beckman Coulter's Dxi800, Dxi600, and Access2 are equipped with at least one main probe, which is connected to a precision valve, precision pump, flushing valve, and flushing pump. Through this main probe, the sample (serum), flushing solution, and test reagents can be automatically aspirated, enabling the chemiluminescent immunoassay analyzer to perform automated detection. The main probe is equipped with an ultrasonic oscillation module to drive it to oscillate at high frequency. After each liquid is aspirated, the main probe needs to move to the cleaning tower (where cleaning fluid flows) and be cleaned by high-frequency oscillation driven by the ultrasonic oscillation module. Similarly, when the main probe is inserted into the magnetic microparticle reagent of the chemiluminescent immunoassay kit to aspirate the magnetic microparticle reagent, the ultrasonic oscillation module is activated first to drive the main probe to oscillate at high frequency to mix the magnetic microparticle reagent. Since the magnetic microparticles in the reagent settle at the bottom of the kit, and the contact area of ​​the main probe is limited, thorough mixing is difficult. In this embodiment, an oscillating plate is placed at the bottom of the first chamber containing the magnetic microparticle reagent. The oscillating plate is physically connected to the main probe, allowing it to oscillate by the main probe. This effectively mixes the magnetic microparticles settled at the bottom, improving the oscillation efficiency of the magnetic microparticle reagent.

[0040] like Figure 2 and Figure 3 As shown, the chemiluminescence immunoassay kit 1 is used on a chemiluminescence immunoassay analyzer. The chemiluminescence immunoassay analyzer is equipped with a main probe 2, and the main probe is equipped with an ultrasonic oscillation module. The ultrasonic oscillation module is used to drive the main probe to oscillate at high frequency when it absorbs magnetic microparticle reagents.

[0041] The chemiluminescence immunoassay kit 1 includes a housing 12 and a membrane assembly 11 covering the opening of the housing; the housing 12 has a plurality of chambers 121, each chamber corresponding to a reagent; the membrane assembly 11 has a liquid dispensing port 111 corresponding to each of the chambers; one of the chambers is a first chamber 122 for dispensing magnetic microparticle reagents, and the liquid dispensing port corresponding to the first chamber is a first liquid dispensing port 113.

[0042] The membrane assembly 11 has a flexible oscillating part 112 on the outer periphery of the first liquid extraction hole. The oscillating part 112 contacts the main probe 2 when the main probe 2 is inserted into the first liquid extraction hole 113 and can oscillate with the main probe. An oscillating plate 14 is provided at the bottom of the first chamber 122. The oscillating plate 14 is connected to the oscillating part 112 through a connector 13, so that the oscillating plate 14 vibrates with the oscillating part 112 to mix the magnetic microparticle reagent.

[0043] The master probe can be, but is not limited to, the master probes on the Kermancourt Dxi800, Dxi600, and Access2 chemiluminescence immunoassay analyzers mentioned above. The master probe can also be a probe from other immunoassay analyzers similar to the Dxi800, equipped with an ultrasonic oscillation module for oscillation and mixing. The housing can be made of medical-grade plastics such as PVC or PP. The membrane assembly 11 includes a flexible film layer made of an elastic non-metallic material on the top layer, and a sealing membrane stacked on top of the flexible film layer. The flexible film layer can be made of flexible silicone, rubber, etc. The sealing membrane is disposed on the lower surface of the flexible film layer, and the liquid extraction hole is disposed on the flexible film layer and penetrates both the upper and lower surfaces of the flexible film layer. The sealing membrane is sealed to the opening of the housing and to the openings of each chamber.

[0044] The oscillating plate 14 can be made of materials such as iron, aluminum, or aluminum alloy. The oscillating plate 14 has a thin sheet structure and can be rectangular, circular, triangular, or other shapes. The size of the oscillating plate 14 can be comparable to (slightly smaller than) the bottom size of the first chamber. Under its own gravity, the oscillating plate can adhere to the bottom surface of the first chamber, so magnetic particles can be directly deposited on the upper surface of the oscillating plate.

[0045] During the production process, the oscillating plate 14 can be connected to the connector 13 first, and then the oscillating plate 14 can be placed at the bottom of the first chamber. Next, the corresponding reagents are injected into each chamber of the box. Then, a sealing film is covered at the opening of the box by a sealing device. The connector passes through the sealing film, and finally the flexible film layer is covered. The oscillating part of the flexible film layer is connected to the top of the connector.

[0046] During the process of the main probe drawing up the magnetic microparticle reagent, the main probe 2 is first inserted into the first liquid intake hole 113. The middle part of the oscillation section 112 is tightly fitted with the main probe 2. When the main probe 2 activates the ultrasonic oscillation module for oscillation and mixing, the main probe 2 drives the oscillation section 112 to oscillate (or vibrate), and the oscillation section 112 drives the connector 13 and the oscillating plate to vibrate. Therefore, the main probe can drive the connector and the bottom oscillating plate to oscillate together through the oscillation section, thereby achieving comprehensive oscillation and mixing in the first chamber 122. In particular, the oscillating plate located at the bottom can effectively disturb the magnetic microparticles precipitated in the chamber, greatly improving the mixing efficiency of the magnetic microparticle reagent and avoiding detection errors caused by poor mixing.

[0047] In some embodiments, to prevent contamination after the chemiluminescence immunoassay kit is opened and used, the sampling port is a self-sealing opening formed by multiple flexible membrane flaps. A sampling port can be formed by three, four, or more flexible membrane flaps. When the main probe is inserted into the sampling port, the flexible membrane flaps can elastically expand outwards. When the main probe is withdrawn from the sampling port, the flexible membrane flaps can spring back and close inwards, thereby isolating the chamber from the outside environment.

[0048] like Figure 4 and Figure 5 As shown, in one embodiment, to ensure that the oscillating part 112 can make close contact with the main probe 2, so that the oscillating part can oscillate better with the main probe 2, the oscillating part 112 includes a sleeve hole 114 coaxially disposed at the bottom of the first liquid extraction hole 113. When the main probe 2 is inserted into the first liquid extraction hole 113, the sleeve hole 114 is sleeved on the outer periphery of the main probe. The sleeve hole 114 is elastic and its diameter is smaller than the outer diameter of the main probe 2.

[0049] Because the socket 114 is elastic and its diameter is smaller than the outer diameter of the main probe 2, when the main probe 2 is inserted into the first liquid sampling hole 113, the socket 114 can be tightly fitted onto the outer circumference of the main probe 2. Therefore, through the static friction between the socket 114 and the main probe 2, the high-frequency oscillation of the main probe 2 can be transmitted to the oscillation section in a limited manner. Figure 5 As shown, in some embodiments, a slot 21 adapted to the socket 114 is also provided on the outer periphery of the main probe 2. The slot 21 can be formed by the inward recess of the outer surface of the main probe 2, and the thickness of the socket is approximately equal to the width of the slot 21, so that the outer ring of the socket can be well inserted into the slot.

[0050] like Figure 4As shown, in one embodiment, the diaphragm assembly 11 includes a flexible film layer; the oscillating portion is part of the flexible film layer, and a thinning ring 1121 is provided around the outer periphery of the oscillating portion, the thickness of the thinning ring 1121 being less than the thickness of the flexible film layer. The liquid extraction holes are all located on the flexible film layer, and the thinning ring 1121 refers to an annular groove formed by thinning treatment with the first liquid extraction hole 113 as its center. The thinning treatment includes removing material from the outer periphery of the oscillating portion after the flexible film layer is formed, or setting a retaining ring within the injection molding of the flexible film layer to reduce the thickness at the corresponding location.

[0051] In this embodiment, a thinning ring 1121 is provided on the outer periphery of the oscillation section, thereby reducing the oscillation resistance of the oscillation section 112, improving the oscillation response of the oscillation section 112, and confining the oscillation energy inside the thinning ring 1121 to prevent it from being transmitted outside the oscillation section and wasting energy.

[0052] like Figure 3 and Figure 4 As shown, in some embodiments, two connectors 13 are included, symmetrically distributed on both sides of the first liquid intake hole 113. That is, the oscillating part 112 is connected to two connectors 13, symmetrically distributed on both sides of the first liquid intake hole 113, and the bottoms of the two connectors 13 are respectively connected to both sides of the oscillating plate 14. Therefore, the entire oscillating plate can be driven to oscillate more effectively.

[0053] In some embodiments, the sealing membrane in the membrane assembly 11 is disposed on the side of each of the liquid inlet near the housing to seal each of the chambers; and the connector 13 extends through the sealing membrane into the first chamber, and the sealing membrane is sealed to the connector.

[0054] In other embodiments, the connector 13 and the flexible film layer are integrally formed from the same material; the two ends of the oscillating plate are provided with connection holes for connection with the connector. In this embodiment, the flexible film layer can be directly and sealingly connected to the housing 12, and each chamber is sealed by the flexible film layer. The liquid extraction hole is provided on the flexible film layer, and the sealing film is provided on the upper surface of the flexible film layer to seal each liquid extraction hole. In this embodiment, the connector 13 and the flexible film layer are integrally formed from the same material, thus reducing the production process of the chemiluminescent immunoassay kit. During production, the corresponding reagents can be injected into each chamber of the housing, the oscillating plate is connected to the connector and placed in the first chamber, then the flexible film layer with the oscillating plate connected is sealed at the opening of the housing, and finally the sealing film is sealed on the upper surface of the flexible film layer. In use, the sealing film can be removed, or the sealing film can be directly pierced by the main probe.

[0055] In some embodiments, the oscillating plate 14 is uniformly provided with a plurality of through holes, and when the oscillating plate oscillates, the magnetic microparticle reagent shuttles through the through holes to form a turbulent flow around the oscillating plate.

[0056] In this embodiment, the through-holes on the oscillating plate 14 serve two purposes: firstly, to reduce the weight of the oscillating plate 14, and secondly, to reduce its resistance to oscillation in the reagent. Both of these aspects contribute to a better oscillation response. Furthermore, during oscillation, the magnetic microparticles of reagent flow through the through-holes, forming a turbulent flow around the oscillating plate. Multiple turbulent flows agitate the reagent at the bottom of the first chamber, thereby ensuring more thorough mixing of the magnetic microparticles precipitated at the bottom.

[0057] In some embodiments, the oscillating plate is made of aluminum, aluminum alloy, or magnesium alloy. In this embodiment, aluminum, aluminum alloy, or magnesium alloy has good cold-keeping effect. When the chemiluminescence immunoassay kit is removed from the analyzer, the oscillating plate of aluminum, aluminum alloy, or magnesium alloy can slow down the temperature rise of the reagents inside the chemiluminescence immunoassay kit, thereby reducing the probability of the chemiluminescence immunoassay kit deteriorating due to prolonged exposure to the outside of the analyzer.

[0058] like Figure 4 As shown, in some embodiments, the inner wall of the first chamber is provided with two or more limiting protrusions 141, which are located above the oscillating plate 14 and are used to limit the upward movement space of the oscillating plate 14.

[0059] Finally, it should be noted that although the above embodiments have been described in the text and drawings of this application, this should not limit the scope of patent protection of this application. Any technical solutions that are based on the essential concept of this application and utilize the content described in the text and drawings of this application, resulting in equivalent structural or procedural substitutions or modifications, as well as the direct or indirect application of the technical solutions of the above embodiments to other related technical fields, are all included within the scope of patent protection of this application.

Claims

1. A chemiluminescent immunoassay kit for use in a chemiluminescent immunoassay analyzer, wherein the chemiluminescent immunoassay analyzer is provided with a main probe, the main probe is provided with an ultrasonic oscillation module, the ultrasonic oscillation module being used to drive the main probe to oscillate at high frequency when aspirating magnetic microparticle reagent; characterized in that The chemiluminescent immunoassay kit includes a box and a membrane assembly covering the opening of the box; the box has multiple chambers, each chamber corresponding to a reagent; the membrane assembly has a dispensing port corresponding to each chamber; one of the chambers is a first chamber for encapsulating magnetic microparticle reagents, and the dispensing port corresponding to the first chamber is a first dispensing port; The membrane assembly has a flexible oscillating part on the outer periphery of the first liquid intake hole. The oscillating part contacts the main probe when the main probe is inserted into the first liquid intake hole and can oscillate with the main probe. An oscillating plate is provided at the bottom of the first chamber. The oscillating plate is connected to the oscillating part through a connector, so that the oscillating plate vibrates with the oscillating part to mix the magnetic microparticle reagent. The oscillation section includes a sleeve hole coaxially disposed at the bottom of the first liquid extraction hole. When the main probe is inserted into the first liquid extraction hole, the sleeve hole is sleeved on the outer periphery of the main probe. The sleeve hole is elastic and its diameter is smaller than the outer diameter of the main probe.

2. The chemiluminescent immunoassay kit according to claim 1, characterized by, The diaphragm assembly includes a flexible film layer; the oscillating part is a portion of the flexible film layer, and a thinning ring is provided around the outer periphery of the oscillating part, the thickness of the thinning ring being less than the thickness of the flexible film layer.

3. The chemiluminescent immunoassay kit according to claim 1, characterized by, It includes two connectors, which are symmetrically distributed on both sides of the first liquid intake hole.

4. The chemiluminescent immunoassay kit according to claim 2, characterized by, The connector and the flexible film layer are integrally formed from the same material; the two ends of the oscillating plate are provided with connection holes for connecting with the connector.

5. The chemiluminescent immunoassay kit according to claim 1, characterized by, The oscillating plate has multiple through holes evenly arranged on it. When the oscillating plate oscillates, the magnetic microparticle reagent shuttles through the through holes and forms a turbulent flow around the oscillating plate.

6. The chemiluminescent immunoassay kit according to claim 1, characterized by, The oscillating plate is made of aluminum, aluminum alloy, or magnesium alloy.

7. The chemiluminescent immunoassay kit according to claim 1, characterized by, The membrane assembly further includes a sealing membrane disposed on the side of each of the liquid inlets near the housing to seal each of the chambers; the connector extends through the sealing membrane into the first chamber, and the sealing membrane is sealed to the connector.

8. The chemiluminescent immunoassay kit according to claim 1, characterized by, The liquid intake hole is a self-sealing opening formed by multiple flexible membrane flaps.

9. The chemiluminescent immunoassay kit according to claim 1, characterized by, The inner wall of the first chamber is provided with two or more limiting protrusions, which are located above the oscillating plate and are used to limit the upward movement space of the oscillating plate.

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