A multi-layer self-sealing chemiluminescent immunoassay kit

Abstract

The present invention discloses a multi-layer self-sealing chemiluminescent immunoassay kit, which includes a box body and a diaphragm assembly covering the opening of the box body; the diaphragm assembly is formed by laminating two or more flexible diaphragm layers; each of the flexible diaphragm layers is provided with three or more flexible diaphragm flaps at the liquid extraction hole, and the flexible diaphragm flaps can elastically swing along the thickness direction, and the adjacent flexible diaphragm flaps on the same flexible diaphragm are spliced with each other to form a sealing structure capable of closing the liquid extraction hole; and the flexible diaphragm flaps on the adjacent two flexible diaphragm layers in the lamination direction are rotationally misaligned along the axis of the liquid extraction hole, so that the splicing seam between two adjacent flexible diaphragm flaps on the same layer is covered by one flexible diaphragm flap on the adjacent layer. The present invention can improve the sealing performance of the liquid extraction hole and avoid the contamination caused by poor sealing performance of the kit.

Description

Technical Field

[0001] This application relates to the technical field of chemiluminescence immunoassay, and particularly relates to a multi-layer self-sealing chemiluminescence immunoassay kit. Background Art

[0002] Chemiluminescence immunoassay (CLIA) is a detection and analysis technique that combines highly sensitive chemiluminescence determination technology with highly specific immune reactions for various antigens, antibodies, hormones, enzymes, fatty acids, vitamins, drugs, etc. Chemiluminescence immunoassay consists of two parts, namely an immune reaction system and a chemiluminescence analysis system. It is an analytical method that generates light through a chemical reaction and determines the concentration of the analyte using a labeled antibody. Chemiluminescence immunoassay has the advantages of high analytical sensitivity, wide linear range, no interference from scattered light, and no radioactive pollutants. Therefore, it is widely used in the fields of life science, clinical diagnosis, etc. Chemiluminescence immunoassay includes the sandwich method or the competitive method. Among them, in the competitive method, enzyme-labeled antigen competes with standard antigen for antibodies. The greater the concentration of the standard antigen, the less enzyme-labeled antigen binds to the antibodies, the smaller the RLU, and the smaller the B / B₀ value.

[0003] In the prior art, Dxi800, Dxi600, Access2, etc. of Beckman Coulter are all widely used fully automated chemiluminescence immunoassay analyzers. In these chemiluminescence immunoassay steps, magnetic microparticles coated with corresponding antibodies need to be added to make the immune reaction products bind to the magnetic microparticles. Then, after separation and washing in a magnetic field, a luminescent substrate is added, and finally, the luminescence intensity (RLU) is detected using a luminometer to determine the content of a certain antigen in the specimen. Therefore, multiple solution chambers are integrated in the chemiluminescence immunoassay kit, and one of them is used to encapsulate the magnetic microparticle reagent coated with antibodies. Since the mass of the magnetic microparticles is relatively heavy, the magnetic microparticles will precipitate to the bottom in a static state. Therefore, when the analyzer aspirates the magnetic microparticle solution, the magnetic microparticle solution needs to be mixed evenly. In fully automated chemiluminescence immunoassay analyzers such as Dxi800, Dxi600, and Access2 of Beckman, it is mainly through a probe with an ultrasonic oscillation function to mix and aspirate the magnetic microparticle solution. However, the inventor found that during the above mixing process, the probe cannot reach the bottom of the kit, so the mixing effect of the probe on the magnetic microparticles is not good, and a relatively long mixing time is required. Especially when the kit has been static for a long time, during the detection of the first one or two specimens, since the magnetic microparticles are not fully mixed, the concentration of magnetic microparticles in the magnetic microparticle solution aspirated by the probe is relatively low, thus affecting the specimen detection results.

[0004] And in the prior art, the chemiluminescence kit has high requirements for storage temperature and sealing. The refrigeration temperature control accuracy of many chemiluminescence detection devices is limited, and the sealing performance of the chemiluminescence kit after it is opened for use is low. Therefore, in order to avoid the deterioration or contamination of the chemiluminescence reagent, after the specimen is detected, the chemiluminescence kit needs to be removed from the detection device, then the sealing cover is put on, and then it is refrigerated in the refrigerator. When it is used next time, the chemiluminescence kit is taken out of the refrigerator and loaded on the detection device. Summary of the Invention

[0005] In view of the above problems, the present application provides a multi-layer self-sealing chemiluminescence immunoassay kit, which is used to solve the technical problems of poor sealing performance and easy contamination of the chemiluminescence immunoassay kit in the above technology.

[0006] To achieve the above object, the inventor provides a multi-layer self-sealing chemiluminescence immunoassay kit for use on a chemiluminescence immunoanalyzer. The chemiluminescence immunoassay kit includes a box body and a diaphragm assembly covering the opening of the box body;

[0007] A plurality of chambers are arranged in the box body, and the diaphragm assembly is provided with liquid taking holes corresponding to each chamber;

[0008] The diaphragm assembly is formed by laminating two or more layers of flexible diaphragm layers, and the liquid taking holes penetrate through each layer of the flexible diaphragm;

[0009] Each layer of the flexible diaphragm is provided with three or more flexible diaphragm flaps at the liquid taking hole. The flexible diaphragm flaps can elastically swing along the thickness direction, and the adjacent flexible diaphragm flaps on the same flexible diaphragm are spliced with each other to form a sealing structure that can close the liquid taking hole; and the flexible diaphragm flaps on the adjacent two flexible diaphragms in the lamination direction are rotationally misaligned along the axis of the liquid taking hole, so that the splicing seam between the adjacent two flexible diaphragm flaps in the same layer is covered by one flexible diaphragm flap on the adjacent layer.

[0010] In some technical solutions, the flexible diaphragm flap is fan-shaped, the vertices of the flexible diaphragm flaps in the same layer converge at the same position, and the position is covered by one flexible diaphragm flap on the adjacent layer.

[0011] In some technical solutions, smooth mirror layers formed by polishing and coating are respectively arranged on the upper and lower surfaces of the flexible diaphragm flap, and the surfaces of the adjacent two flexible diaphragm flaps in the lamination direction are closely attached without gaps through the mirror layers.

[0012] In some technical solutions, one of the chambers is a first chamber for encapsulating magnetic particle reagents, and the liquid taking hole corresponding to the first chamber is a first liquid taking hole;

[0013] The diaphragm assembly has a flexible oscillating portion on the outer periphery of the first liquid extraction hole. The oscillating portion contacts the main probe when the main probe is inserted into the first liquid extraction hole and can oscillate with the main probe;

[0014] An oscillating sheet is provided at the bottom of the first chamber. The oscillating sheet is connected to the oscillating portion through a connecting member, so that the oscillating sheet vibrates with the oscillating portion to mix the magnetic particle reagent.

[0015] In some technical solutions, the oscillating portion includes a socket hole coaxially provided at the bottom of the first liquid extraction hole. When the main probe is inserted into the first liquid extraction hole, the socket hole is sleeved on the outer periphery of the main probe. The socket hole is elastic and the aperture is smaller than the outer diameter of the main probe.

[0016] In some technical solutions, the diaphragm assembly is provided with a thinning ring on the outer periphery surrounding the oscillating portion. The thickness of the thinning ring is smaller than the thickness of the diaphragm assembly.

[0017] In some technical solutions, there are two connecting members, and the two connecting members are symmetrically distributed on both sides of the first liquid extraction hole.

[0018] In some technical solutions, a plurality of through holes are uniformly provided on the oscillating sheet. When the oscillating sheet oscillates, the magnetic particle reagent shuttles through the through holes to form a flocculent flow around the oscillating sheet.

[0019] In some technical solutions, the inner wall of the first chamber is provided with more than two limiting bumps. The limiting bumps are located above the oscillating sheet and are used to limit the upward movement space of the oscillating sheet.

[0020] Different from the prior art, in the above technical solutions, the diaphragm assembly of the multi-layer self-sealing chemiluminescent immunoassay kit is formed by laminating and compounding more than two flexible diaphragm layers. Each flexible diaphragm layer is provided with more than three flexible diaphragm flaps. The flexible diaphragm flaps of the same layer are spliced and surrounded to form a sealing structure that can close the liquid extraction hole. And the flexible diaphragm flaps on the adjacent two flexible diaphragm layers are rotationally misaligned along the axis of the liquid extraction hole, so that the splicing seam between two adjacent flexible diaphragm flaps in the same layer is covered by one flexible diaphragm flap on the adjacent layer. Therefore, the sealing performance between two adjacent flexible diaphragm flaps in the same layer can be improved, and further the self-sealing effect of the entire liquid extraction hole can be improved. Therefore, this chemiluminescent immunoassay kit will not be contaminated by the outside even without covering the sealing cap after being opened and used.

[0021] The above description of the invention content is only an overview of the technical solution of this application. In order to enable those of ordinary skill in the art to more clearly understand the technical solution of this application, and then be able to implement it based on the content described in the specification and the drawings, and in order to make the above objects, other objects, features, and advantages of this application more easily understood, the following will be described in conjunction with the specific embodiments of this application and the drawings. Brief Description of the Drawings

[0022] The drawings are only used to illustrate the principles, implementation methods, applications, features, and effects of the specific embodiments of the present invention and other related contents, and should not be considered as a limitation to this application.

[0023] In the specification drawings:

[0024] Figure 1 It is a three-dimensional structure schematic diagram of the multi-layer self-sealing chemiluminescent immunoassay kit described in the specific embodiment;

[0025] Figure 2 It is a sectional view of the chemiluminescent immunoassay kit described in the specific embodiment along Figure 1 section A-A therein;

[0026] Figure 3 It is Figure 2 an enlarged view of the local position B therein;

[0027] Figure 4 It is a decomposition schematic diagram of the multi-layer flexible membrane flap described in the specific embodiment along the vertical direction;

[0028] Figure 5 It is an internal structure schematic diagram of the multi-layer self-sealing chemiluminescent immunoassay kit described in the specific embodiment;

[0029] The descriptions of the reference numerals involved in the above drawings are as follows:

[0030] 1. Chemiluminescent immunoassay kit; 2. Main probe; 21. Card slot;

[0031] 11. Membrane assembly; 12. Box body; 13. Connector; 14. Oscillating piece; 111. Liquid extraction hole; 112. Oscillating part; 113. First liquid extraction hole; 121. Chamber; 122. First chamber; 141. Limit projection;

[0032] 11-1. First flexible membrane; 11-2. Second flexible membrane; 11-3. Third flexible membrane;

[0033] 111-1. First flexible membrane flap; 111-2. Second flexible membrane flap; 111-3. Third flexible membrane flap. 111-4. Splicing seam; 111-5. Vertex convergence point. Specific Embodiments

[0034] To elaborate on the possible application scenarios, technical principles, specific implementable solutions, achievable objectives and effects of this application in detail, etc., the following will be described in detail with reference to the specific examples listed and in conjunction with the accompanying drawings. The examples recorded in this article are only used to more clearly illustrate the technical solutions of this application, so they are only examples and cannot be used to limit the protection scope of this application.

[0035] Referring to "embodiments" in this article means that the specific features, structures or characteristics described in connection with the embodiments may be included in at least one embodiment of this application. The term "embodiment" that appears in various positions in the specification does not necessarily refer to the same embodiment, nor does it specifically limit its independence or relevance to other embodiments. In principle, in this application, as long as there is no technical contradiction or conflict, the technical features mentioned in each embodiment can be combined in any way to form corresponding implementable technical solutions.

[0036] Unless otherwise defined, the meanings of the technical terms used in this article are the same as those generally understood by those skilled in the technical field to which this application belongs; the use of relevant terms in this article is only for describing specific embodiments and is not intended to limit this application.

[0037] In the description of this application, the phrase "and / or" is an expression used to describe the logical relationship between objects, indicating that there can be three relationships. For example, A and / or B means: there is A, there is B, and there is both A and B at the same time. In addition, the character " / " in this article generally represents an "or" logical relationship between the associated objects before and after.

[0038] In this application, terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual quantity, primary or secondary, or order relationship between these entities or operations.

[0039] Without more limitations, in this application, the open-ended expressions such as "including", "comprising", "having" or other similar expressions used in the statement are intended to cover non-exclusive inclusion. These expressions do not exclude that there may be other elements in the process, method or product including the said elements, so that the process, method or product including a series of elements may not only include those defined elements, but also include other elements not explicitly listed, or also include elements inherent to this process, method or product.

[0040] Similar to the understanding in the "Examination Guidelines", in this application, expressions such as "greater than", "less than", "exceeding", etc. are understood as not including the base number; expressions such as "above", "below", "within", etc. are understood as including the base number. In addition, in the description of the embodiments of this application, the meaning of "multiple" is two or more (including two). Similar expressions related to "many", such as "multiple groups", "multiple times", etc., are understood in this way unless otherwise clearly and specifically defined.

[0041] In the description of the embodiments of this application, the spatially related expressions used, such as "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "perpendicular", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc., the indicated orientation or positional relationship is based on the orientation or positional relationship shown in the specific embodiment or the drawing. It is only for the convenience of describing the specific embodiments of this application or for the reader to understand, rather than indicating or implying 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, it cannot be understood as a limitation to the embodiments of this application.

[0042] Unless otherwise clearly specified or limited, in the description of the embodiments of this application, the terms such as "installed", "connected", "joined", "fixed", "set", etc. should be understood in a broad sense. For example, the "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 directly connected, or indirectly connected through an intermediate medium; it can be the internal communication of two components or the interaction relationship between two components. For those skilled in the technical field to which this application belongs, the specific meanings of the above terms in the embodiments of this application can be understood according to specific circumstances.

[0043] Please refer to Figures 1 to 5, this embodiment provides a chemiluminescent immunoassay kit. The chemiluminescent immunoassay kit 1 can be applied to chemiluminescent immunoassay analyzers such as Dxi800, Dxi600, and Access2 of Beckman Coulter. Different immunoassay reagents and magnetic particle reagents required for the same immunoassay can be encapsulated in the chemiluminescent immunoassay kit 1. One chemiluminescent immunoassay kit 1 corresponds to one immunoassay. Among them, the magnetic particle reagent is a magnetic particle solution coated with an antibody corresponding to the immunoassay item. Therefore, it can be used for HCG value detection, CA199 tumor marker, alpha-fetoprotein concentration detection, and other immunoassays. At least one main probe is provided on the Dxi800, Dxi600, and Access2 of Beckman Coulter. The main probe is connected to a precision valve, a precision pump, a flushing valve, and a flushing pump. Through the main probe, the specimen (serum), flushing solution, and detection reagent for detection can be automatically aspirated, so that the chemiluminescent immunoassay analyzer can perform automatic detection. The main probe is provided with an ultrasonic oscillation module to drive the main probe to perform high-frequency oscillation. After each aspiration of a liquid, the main probe needs to move to the cleaning tower (where the cleaning solution flows in the cleaning tower) and be driven by the ultrasonic oscillation module to perform high-frequency oscillation cleaning; and when the main probe is inserted into the magnetic particle reagent in the chemiluminescent immunoassay kit to aspirate the magnetic particle reagent, the ultrasonic oscillation module is also first started to drive the main probe to perform high-frequency oscillation to mix the magnetic particle reagent evenly. Since the magnetic particles in the magnetic particle reagent precipitate at the bottom of the kit and the contact surface of the main probe is limited, it is not easy to mix evenly. And the sealing effect of the liquid extraction hole of the existing chemiluminescent immunoassay kit is not good. To avoid external contamination of the kit, it needs to be sealed with a sealing cap and refrigerated after use.

[0044] In this embodiment, a multi-layer sealing structure is provided at the liquid extraction hole of the chemiluminescent immunoassay kit to improve the sealing effect and avoid contamination of the kit after it is opened and used. And in this embodiment, an oscillating sheet is provided at the bottom of the first chamber for encapsulating the magnetic particle reagent. The oscillating sheet is physically connected to the main probe, so that it can be driven to oscillate by the main probe. Therefore, the magnetic particles precipitated at the bottom can be oscillated and mixed evenly, and the oscillation efficiency of the magnetic particle reagent can be improved.

[0045] As Figure 1 shown, the chemiluminescent immunoassay kit 1 is used on a chemiluminescent immunoassay analyzer. The chemiluminescent immunoassay analyzer is provided with a main probe 2. The main probe is provided with an ultrasonic oscillation module. The ultrasonic oscillation module is used to drive the main probe to perform high-frequency oscillation when aspirating the magnetic particle reagent.

[0046] The chemiluminescent immunoassay kit 1 includes a kit body 12 and a membrane assembly 11 covering the opening of the kit body. As Figure 2As shown, the box body 12 is provided with a plurality of chambers 121, each chamber corresponding to a reagent encapsulated; the diaphragm assembly 11 is provided with a liquid collection hole 111 corresponding to each chamber; one of the chambers is a first chamber 122 for encapsulating magnetic particle reagents, and the liquid collection hole corresponding to the first chamber is a first liquid collection hole 113.

[0047] Each layer of the flexible membrane is provided with more than three flexible membrane petals at the liquid collection hole, and the flexible membrane petals can swing elastically along the thickness direction. The adjacent flexible membrane petals on the same flexible membrane are spliced together to form a sealing structure that can close the liquid collection hole; and the flexible membrane petals on two adjacent layers of the flexible membrane in the stacking direction are rotated and misaligned along the axis of the liquid collection hole, so that the splicing seam of two adjacent flexible membrane petals on the same layer is covered by one flexible membrane petal on the adjacent layer.

[0048] The main probe can be, but is not limited to, the main probe on the Dxi800, Dxi600, and Access2 chemiluminescent immunoassay analyzers of the above-mentioned Kerman Coulter Company. The main probe can also be a probe on other immunoassay analyzers similar to the Dxi800, which is provided with an ultrasonic oscillation module for oscillation and mixing. The box body can be made of medical-grade plastics such as PVC and PP, the diaphragm assembly 11 can be made of flexible silicone, rubber, etc., the sealing film is arranged on the lower surface of the diaphragm assembly 11, and the liquid collection hole is arranged on the diaphragm assembly 11 and passes through the upper and lower surfaces of the flexible film layer. The sealing film is sealed and connected to the opening of the box body, and the sealing film is sealed and connected to the openings of each chamber.

[0049] like Figure 2 and Figure 3 As shown, the diaphragm assembly 11 is formed by stacking more than two layers of flexible diaphragms, and the liquid collection hole 111 runs through each layer of the flexible diaphragms. In this embodiment, the diaphragm assembly 11 includes a first flexible diaphragm 11-1, a second flexible diaphragm 11-2, and a third flexible diaphragm 11-3 which are stacked in sequence along the thickness direction. Among them, the first flexible diaphragm 11-1, the second flexible diaphragm 11-2, and the third flexible diaphragm 11-3 can be made of the same flexible material and have the same profile, and the edges and the middle of each layer of the flexible diaphragms (except the location of the liquid collection hole) can be combined together by hot pressing or glue. Three first flexible membrane petals 111-1 are arranged on the first flexible membrane 11-1 at the liquid collection hole 111. The three first flexible membrane petals 111-1 are evenly distributed along the center point, the vertices of the three first flexible membrane petals 111-1 are located at the same position, and the edges of two adjacent first flexible membrane petals 111-1 are spliced with each other, so that the three first flexible membrane petals 111-1 enclose and form a sealing structure that can close the liquid collection hole 111.

[0050] Similarly, a plurality of second flexible membrane flaps 111-2 are provided at the liquid extraction hole 111 on the second flexible membrane 11-2, and the plurality of second flexible membrane flaps 111-2 surround to form a sealing structure that can close the liquid extraction hole 111; a plurality of third flexible membrane flaps 111-3 are provided at the liquid extraction hole 111 on the third flexible membrane 11-3, and the plurality of third flexible membrane flaps 111-3 surround to form a sealing structure that can close the liquid extraction hole 111.

[0051] When the main probe 2 is inserted into the liquid extraction hole 111, the flexible membrane flaps along each side can swing downward and toward the outer periphery of the liquid extraction hole, so that the liquid extraction hole is expanded; when the main probe is withdrawn from the liquid extraction hole, the flexible membrane flaps can rebound and close toward the middle due to the elastic force, so that the chamber is isolated from the outside. In this embodiment, the membrane assembly 11 is provided with multiple layers of flexible membrane flaps in the thickness direction, and each layer of flexible membrane flaps surrounds to form a sealing structure, so as to improve the sealing effect of the liquid extraction hole.

[0052] And as Figure 4 described, in this embodiment, the flexible membrane flaps on the adjacent two layers of the flexible membranes in the stacking direction are rotationally misaligned along the axis of the liquid extraction hole, so that the splicing seam between two adjacent flexible membrane flaps in the same layer is covered by one flexible membrane flap on the adjacent layer. As Figure 4 shown, the splicing seam 111-4 between two adjacent third flexible membrane flaps 111-3 on the third flexible membrane 11-3 is covered by one of the flexible membrane flaps 111-2 on the second flexible membrane 11-2, that is, the splicing seam 111-4 between two adjacent third flexible membrane flaps 111-3 is misaligned with the splicing seam of the second flexible membrane flap 111-2 on the second flexible membrane. Therefore, the splicing seams of the flexible membrane flaps are all covered by another flexible membrane flap on the adjacent layer, thereby improving the sealing performance between two adjacent flexible membrane flaps in the same layer, and further improving the self-sealing effect of the entire liquid extraction hole. Therefore, this chemiluminescent immunoassay kit will not be contaminated by the outside even without covering with a sealing cap after being opened and used.

[0053] As Figure 1 and Figure 4 shown, the flexible membrane flap is fan-shaped, the vertices of the flexible membrane flaps in the same layer converge at the same position, and the position is covered by one flexible membrane flap on the adjacent layer. The inventor has found through long-term research that the sealing effect is not good at the vertices of the flexible membrane flaps due to elastic failure or wear and deformation. Therefore, as Figure 4 shown, in this embodiment, the converging points 111-5 of the vertices of each layer of flexible membrane flaps are misaligned in the thickness direction. Figure 4The dashed line represents the axis of the liquid extraction hole. Among them, the vertices of the first flexible membrane flap 111-1 and the third flexible membrane flap 111-3 are located on the axis, while the convergence point of the vertices of each second flexible membrane flap 111-2 is not on the axis. Therefore, one side of the convergence point of the vertices of the second flexible membrane flap 111-2 is covered by one of the first flexible membrane flaps 111-1, and the other side is covered by one of the third flexible membrane flaps 111-3. Similarly, the convergence point 111-5 of the vertices of the third flexible membrane flap 111-3 is also covered by one of the second flexible membrane flaps. Therefore, in this embodiment, not only the splicing seams of each flexible membrane flap are covered by another layer of flexible membrane flap, but also the convergence points of the vertices of each layer of flexible membrane flaps are covered by another layer of flexible membrane flap, thereby improving the sealing performance of the splicing seams and the vertex convergence points of each layer of flexible membrane flaps.

[0054] In one embodiment, smooth mirror layers formed by polishing and coating are respectively provided on the upper and lower surfaces of the flexible membrane flap, and the surfaces of two adjacent flexible membrane flaps in the stacking direction are closely attached through the mirror layers. Due to the smooth mirror layers respectively provided on the upper and lower surfaces of the flexible membrane flap, two adjacent flexible membrane flaps in the stacking direction will be adsorbed together due to the surface tension of the reagent (liquid), thereby avoiding gaps between two adjacent flexible membrane flaps.

[0055] As Figure 2 and Figure 5 shown, in this embodiment, the membrane assembly 11 has a flexible oscillation part 112 on the outer periphery of the first liquid extraction hole. The oscillation 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 oscillation piece 14 is provided at the bottom of the first chamber 122, and the oscillation piece 14 is connected to the oscillation part 112 through a connecting piece 13, so that the oscillation piece 14 vibrates with the oscillation part 112 to mix the magnetic particle reagent.

[0056] The oscillation piece 14 can be made of materials such as iron, aluminum, and aluminum alloy. The oscillation piece 14 is in a thin sheet structure, and the shape of the oscillation piece 14 can be different shapes such as rectangular, circular, and triangular. The size of the oscillation piece 14 can be comparable to the size of the bottom of the first chamber (slightly smaller than the bottom size). The oscillation piece can be attached to the bottom surface of the first chamber under the action of its own gravity, so that the magnetic particles can be directly precipitated on the upper surface of the oscillation piece.

[0057] During the production process, the oscillation piece 14 can be first connected to the connecting piece 13, then the oscillation piece 14 is arranged at the bottom of the first chamber, then the corresponding reagents are injected into each chamber of the box body, and then a sealing film is covered at the opening of the box body through a sealing device. The connecting piece passes through the sealing film, and finally the flexible film layer is covered, and the oscillation part of the flexible film layer is connected to the top of the connecting piece.

[0058] During the process of the main probe sucking the magnetic particle reagent, the main probe 2 first inserts into the first liquid extraction hole 113, and the middle part of the oscillation part 112 is closely matched with the main probe 2. When the main probe 2 turns on the ultrasonic oscillation module for oscillation and mixing, the main probe 2 drives the oscillation part 112 to oscillate (or vibrate), and the oscillation part 112 drives the connecting piece 13 and the oscillation piece to vibrate. Therefore, the main probe can drive the connecting piece and the oscillation piece at the bottom to oscillate together through the oscillation part, so as to perform all-round oscillation and mixing in the first chamber 122. In particular, the oscillation piece arranged at the bottom can effectively disturb the magnetic particles precipitated in the test solution, greatly improving the mixing efficiency of the magnetic particle reagent and avoiding detection errors caused by poor mixing effect.

[0059] In one embodiment, in order to enable the oscillation part 112 to be in close contact with the main probe 2, so that the oscillation part can better oscillate with the main probe 2. The oscillation part 112 includes a socket hole coaxially arranged at the bottom of the first liquid extraction hole 113. When the main probe 2 inserts into the first liquid extraction hole 113, the socket hole is sleeved on the outer periphery of the main probe, and the socket hole has elasticity and the hole diameter is smaller than the outer diameter of the main probe 2.

[0060] Since the socket hole has elasticity and the hole diameter is smaller than the outer diameter of the main probe 2, when the main probe 2 inserts into the first liquid extraction hole 113, the socket hole can be tightly sleeved on the outer periphery of the main probe 2. Therefore, through the static friction force between the socket hole and the main probe 2, the high-frequency oscillation of the main probe 2 can be limitedly transmitted to the oscillation part. As Figure 5 shown, in some embodiments, a clamping groove 21 adapted to the socket hole is further arranged on the outer periphery of the main probe 2. The clamping groove 21 can be formed by inwards recessing the outer surface of the main probe 2, and the thickness of the socket hole is equivalent to the width of the clamping groove 21, so that the outer ring of the socket hole can be well clamped into the clamping groove.

[0061] As Figure 4 shown, in one embodiment, the oscillation part of the diaphragm assembly 11 is a part of the diaphragm assembly 11, and a thinning ring 1121 is arranged around the outer periphery of the oscillation part. The thickness of the thinning ring 1121 is smaller than the thickness of the flexible film layer. The thinning ring 1121 refers to an annular groove formed by thinning treatment with the first liquid extraction hole 113 as the center. The thinning treatment includes removing the material outside the oscillation part after the diaphragm assembly 11 is formed, or arranging a retaining ring in the injection mold of the diaphragm assembly 11 to reduce the thickness at the corresponding position.

[0062] In this embodiment, the thinning ring 1121 is arranged on the outer periphery of the oscillation part, so that the oscillation resistance of the oscillation part 112 is smaller, the oscillation response of the oscillation part 112 is better, and the oscillation energy is blocked inside the thinning ring 1121, avoiding being transmitted outside the oscillation part to do useless work.

[0063] like Figure 3 and Figure 4 As shown, in some embodiments, two connecting members 13 are included, and the two connecting members are symmetrically distributed on both sides of the first liquid collection hole 113. That is, the oscillating part 112 is connected to two connecting members 13, and the two connecting members 13 are symmetrically distributed on both sides of the first liquid collection hole 113, and the bottoms of the two connecting members 13 are respectively connected to the two sides of the oscillating plate 14. Therefore, the entire oscillating plate can be better driven to oscillate together.

[0064] In some embodiments, the sealing film in the diaphragm assembly 11 is arranged on one side of each liquid extraction hole close to the box body to seal each chamber; and the connecting member 13 extends through the sealing film into the first chamber, and the sealing film is sealed and connected to the connecting member.

[0065] In other embodiments, the connector 13 and the flexible film layer are integrally formed of the same material; both ends of the oscillating sheet are provided with connection holes for connecting with the connector. In this embodiment, the flexible film layer can be directly sealed and connected to the box body 12, and each chamber is sealed by the flexible film layer, the liquid collection 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 collection hole. In this embodiment, the connector 13 and the flexible film layer are integrally formed of the same material, so the production process of the chemiluminescent immunoassay kit can be reduced. During production, the corresponding reagent can be injected into each chamber of the box body, the oscillating sheet is connected to the connector and placed in the first chamber, and then the flexible film layer connected with the oscillating sheet is sealed at the opening of the box body, and finally the upper surface of the flexible film layer is covered with a sealing film. The sealing film can be peeled off when in use, or the sealing film can be directly pierced by the main probe.

[0066] In some embodiments, a plurality of through holes are evenly arranged on the oscillating plate 14 , and when the oscillating plate oscillates, the magnetic particle reagents shuttle through the through holes to form floccules around the oscillating plate.

[0067] In this embodiment, the through holes are provided on the oscillating plate 14 to reduce the weight of the oscillating plate 14 on the one hand, and to reduce the resistance of the oscillation in the reagent on the other hand, both of which can make the oscillating plate have a better oscillation response. When the oscillating plate 14 oscillates, the magnetic particle reagent shuttles through the through holes to form floccules around the oscillating plate, and the multiple floccules can stir the reagent at the bottom of the first chamber up and down, so that the magnetic particles precipitated at the bottom are mixed more fully.

[0068] In some embodiments, the oscillating sheet is made of aluminum, aluminum alloy or magnesium alloy. In this embodiment, aluminum, aluminum alloy or magnesium alloy has a good cold preservation effect. When the chemiluminescent immunoassay kit is removed from the analyzer, the oscillating sheet made of aluminum, aluminum alloy or magnesium alloy can slow down the rise of the temperature of the reagent in the chemiluminescent immunoassay kit, thereby reducing the probability of deterioration of the chemiluminescent immunoassay kit when it is placed outside the machine for a long time.

[0069] As Figure 4 shown, in some embodiments, the inner wall of the first chamber is provided with more than two limiting bumps 141. The limiting bumps 141 are located above the oscillating sheet 14 and are used to limit the upward movement space of the oscillating sheet 14.

[0070] Finally, it should be noted that although the above embodiments have been described in the text and drawings of the specification of the present application, the patent protection scope of the present application cannot be limited thereby. Any technical solution obtained by equivalent structure or equivalent process substitution or modification based on the substantial concept of the present application and using the content recorded in the text and drawings of the specification of the present application, as well as any technical solution directly or indirectly implemented in other related technical fields of the above embodiments, is included in the patent protection scope of the present application.

Claims

1. A multi-layer self-sealing chemiluminescent immunoassay kit for use on a chemiluminescent immunoassay analyzer, characterized in that, The chemiluminescence immunoassay kit includes a box body and a diaphragm assembly covering the opening of the box body; A plurality of chambers are arranged in the box body, and liquid extraction holes corresponding to each chamber are arranged on the diaphragm assembly; The diaphragm assembly is formed by laminating and compounding two or more flexible diaphragm layers, and the liquid extraction holes penetrate through each flexible diaphragm layer; On each flexible diaphragm layer, three or more flexible diaphragm flaps are arranged at the liquid extraction holes. The flexible diaphragm flaps can elastically swing along the thickness direction, and adjacent flexible diaphragm flaps on the same flexible diaphragm layer are spliced with each other to form a sealing structure capable of closing the liquid extraction holes; and the flexible diaphragm flaps on two adjacent flexible diaphragm layers in the lamination direction are rotationally displaced along the axis of the liquid extraction holes, so that the splicing seam between two adjacent flexible diaphragm flaps on the same layer is covered by one flexible diaphragm flap on the adjacent layer; The flexible diaphragm flaps are fan-shaped, the vertices of the flexible diaphragm flaps on the same layer converge at the same position, and the position is covered by one flexible diaphragm flap on the adjacent layer.

2. The multi-layer self-sealing chemiluminescent immunoassay kit according to claim 1, wherein Smooth mirror layers formed by polishing and coating are respectively arranged on the upper and lower surfaces of the flexible diaphragm flaps, and the surfaces of two adjacent flexible diaphragm flaps in the lamination direction are in seamless contact through the mirror layers.

3. The multi-layer self-sealing chemiluminescent immunoassay kit according to claim 1, wherein One of the chambers is a first chamber for encapsulating magnetic particle reagents, and the liquid extraction hole corresponding to the first chamber is a first liquid extraction hole; The diaphragm assembly has a flexible oscillation part on the outer periphery of the first liquid extraction hole. When the main probe of the chemiluminescence immunoanalyzer is inserted into the first liquid extraction hole, the oscillation part contacts the main probe and can oscillate with the main probe; An oscillation sheet is arranged at the bottom of the first chamber, and the oscillation sheet is connected to the oscillation part through a connecting piece, so that the oscillation sheet vibrates with the oscillation part to mix the magnetic particle reagents.

4. The multi-layer self-sealing chemiluminescent immunoassay kit according to claim 3, wherein, The oscillation part includes a socket hole coaxially arranged at the bottom of the first liquid extraction hole. When the main probe is inserted into the first liquid extraction hole, the socket hole is sleeved on the outer periphery of the main probe. The socket hole has elasticity and an aperture smaller than the outer diameter of the main probe.

5. The multi-layer self-sealing chemiluminescent immunoassay kit according to claim 4, wherein The diaphragm assembly is provided with a thinning ring on the outer periphery surrounding the oscillation part, and the thickness of the thinning ring is smaller than the thickness of the diaphragm assembly.

6. The multi-layer self-sealing chemiluminescent immunoassay kit according to claim 5, wherein It includes two connecting pieces, and the two connecting pieces are symmetrically distributed on both sides of the first liquid extraction hole.

7. The multi-layer self-sealing chemiluminescent immunoassay kit according to claim 4, wherein A plurality of through holes are uniformly arranged on the oscillation sheet. When the oscillation sheet oscillates, the magnetic particle reagents shuttle through the through holes to form a flocculent flow around the oscillation sheet.

8. The multi-layer self-sealing chemiluminescent immunoassay kit according to claim 3, wherein Two or more limiting bumps are arranged on the inner wall of the first chamber, and the limiting bumps are located above the oscillation sheet and are used to limit the upward movement space of the oscillation sheet.

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