Reaction device for poct homogeneous luminescence immunoassay

Abstract

The present application relates to a kind of reaction device for POCT homogeneous luminescence immunoassay, including prestorage cup is provided with the diluent chamber and the thin wall of puncture hole intercommunication, diluent chamber is used to hold the mixed solution of sample liquid and diluent;Reaction cup, reaction cup is provided with reaction chamber, and dry reagent is encapsulated in reaction chamber;And puncture cover, puncture cover is provided with first puncture piece, and first puncture piece is set with the thin wall of puncture hole alignment;Wherein, prestorage cup is clamped in reaction cup along assembly direction when using, puncture cover is clamped in prestorage cup along assembly direction, and first puncture piece breaks the thin wall of puncture hole.The reaction device for POCT homogeneous luminescence immunoassay of the present application is only assembled by prestorage cup, reaction cup and puncture cover three components, simple structure, effectively reduce manufacturing and use cost, only need to be clamped in sequence along assembly direction when using, i.e., mixed solution and dry reagent contact detection reaction can be completed, it is convenient and labor-saving to operate, and operation difficulty is low, and the skill requirement of user is low.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical detection, and particularly to a reaction device for POCT homogeneous luminescence immunoassay. BACKGROUND

[0002] POCT is the abbreviation of Point-Of-Care Test, which is a new kind of in vitro diagnostic technology in recent years. The definition of POCT given by the National Academy of Clinical Biochemistry (NACB) is: clinical laboratory tests performed close to the patient by clinical personnel who have not received training in clinical laboratory science or by the patient (self-testing, monitoring). Homogeneous light-induced chemiluminescence technology is the fourth generation of chemiluminescence technology, which is based on nanoscale polymer microparticles and is a homogeneous, no-washing chemiluminescence analysis technology induced by light. It is a new generation of technology with high sensitivity and simple operation, and is another new milestone of chemiluminescence immunoassay technology. The principle of LOCI (Luminescent oxygen channeling immunoassay) homogeneous luminescence diagnostic technology is that intermolecular interaction will bring the donor and acceptor microspheres within the diffusion range of singlet oxygen, i.e. within 200 nm, thereby exciting the cascade amplification of the chemiluminescence reaction. The light-emitting principle is light-induced chemiluminescence. The surface of the donor microspheres is coated with a photosensitizer, benzidine blue, and the surface of the acceptor microspheres is coated with a luminescent agent, dimethylthiophene derivative, and chelated with rare earth atom europium. Thus, when irradiated with 680 nm laser, the photosensitizer on the surface of the donor microspheres decomposes the oxygen in the environment to form singlet oxygen molecules (oxygen free radicals). The singlet oxygen molecules diffuse to the acceptor microspheres, and finally transfer the energy to the rare earth atom europium, exciting the excitation light with a wavelength of 615 nm and a half-life of 0.3 s, which can be detected by a chemiluminescence analyzer.

[0003] However, the homogeneous luminescence diagnostic equipment on the market is not large and fully automatic equipment, and is characterized by high throughput and full automation. These devices are not designed for the POCT market, and not only have large equipment size and high price, but also require professional personnel to effectively operate, which has great applicational limitations. SUMMARY

[0004] The purpose of the present application is to provide a reaction device for POCT homogeneous luminescence immunoassay, which aims to solve the problems of large equipment size, high price, inconvenient and difficult operation of the prior art devices, and inability to be applied to POCT homogeneous luminescence immunoassay.

[0005] According to an aspect of the present application, a reaction device for POCT homogeneous luminescence immunoassay is provided, which comprises:

[0006] a pre-storage cup, the pre-storage cup being provided with a diluent chamber and a thin-walled puncture hole in communication, the diluent chamber being used for containing a mixture of sample liquid and diluent;

[0007] a reaction cup, the reaction cup being provided with a reaction chamber, the reaction chamber being encapsulated with dry reagent;

[0008] a puncture cover, the puncture cover being provided with a first puncture piece, the first puncture piece being arranged in position with the thin-walled puncture hole; wherein, in use, the pre-storage cup is fastened to the reaction cup along an assembly direction, the puncture cover is fastened to the pre-storage cup along the assembly direction, the first puncture piece punctures the thin-walled puncture hole, and the mixture of sample liquid and diluent in the diluent chamber flows into the reaction chamber through the punctured thin-walled puncture hole to react with the dry reagent.

[0009] In one of the embodiments, the reaction cup is further provided with a liquid containing groove, a receiving hole is arranged on the groove bottom of the liquid containing groove, and the receiving hole is arranged in position with the thin-walled puncture hole; the groove bottom of the liquid containing groove is further provided with a liquid flow channel, and the liquid flow channel communicates the liquid containing groove with the reaction chamber.

[0010] In one of the embodiments, the reaction device for POCT homogeneous phase luminescence immunoassay further comprises a red blood cell filter pad, the red blood cell filter pad is arranged in the liquid containing groove and covers the liquid inlet of the liquid flow channel.

[0011] In one of the embodiments, the pre-storage cup is further provided with a sealing protruding edge, the sealing protruding edge is matched with the shape and size of the liquid containing groove, and the sealing protruding edge sealingly abuts with the groove edge of the liquid containing groove.

[0012] In one of the embodiments, the pre-storage cup is further provided with a gas permeable hole, the reaction cup is further provided with a gas chamber arranged in position with the gas permeable hole and a gas chamber channel in communication with the gas chamber; the diluent chamber and the gas permeable hole are simultaneously sealed with a first sealing film, and the liquid containing groove and the gas chamber are simultaneously sealed with a second sealing film.

[0013] In one of the embodiments, the puncture cover is further provided with a second puncture piece, the second puncture piece is arranged in position with the gas permeable hole, and after the puncture cover, the pre-storage cup and the reaction cup are mutually fastened and assembled, the second puncture piece can puncture the first sealing film and the second sealing film to make the gas permeable hole, the gas chamber and the gas chamber channel sequentially communicate.

[0014] In one of the embodiments, the side surface of the reaction cup is further provided with a light transmission window, the light transmission window is in communication with the reaction chamber, and a light transmission film is sealingly arranged on the light transmission window.

[0015] In one of the embodiments, the puncture cover is further provided with a pressing plug column, which is arranged in position with the diluent chamber, and after the puncture cover is assembled with the pre-storage cup, the pressing plug column can extrude the mixed liquid of the sample liquid and the diluent to the thin wall of the puncture hole.

[0016] In one of the embodiments, the inner wall of the puncture cover is further provided with an anti-fool convex strip, the outer wall of the pre-storage cup is further provided with a first anti-fool sliding groove, the outer wall of the reaction cup is further provided with a second anti-fool sliding groove, the second anti-fool sliding groove is in position and communicates with the first anti-fool sliding groove in the assembling direction, and the anti-fool convex strip is slidingly inserted into the first anti-fool sliding groove and the second anti-fool sliding groove; or,

[0017] The outer wall of the puncture cover is provided with a first anti-fool bevel, the outer wall of the pre-storage cup is provided with a second anti-fool bevel in position with the first anti-fool bevel, and the outer wall of the reaction cup is provided with a third anti-fool bevel in position with the second anti-fool bevel.

[0018] In one of the embodiments, one of the pre-storage cup and the reaction cup is provided with a clamping body, and the other one of the pre-storage cup and the reaction cup is provided with a clamping site, and the clamping body is buckled with the clamping site; or

[0019] One of the pre-storage cup and the reaction cup is provided with a plug hole, and the other one of the pre-storage cup and the reaction cup is provided with a plug column, and the plug column is inserted and fixed with the plug hole;

[0020] The pre-storage cup and the reaction cup are in an integrated structure.

[0021] The embodiments of the present application have the following beneficial effects:

[0022] The reaction device for POCT homogeneous luminescence immunoassay of the scheme is used, first, the sample liquid to be detected is added into the diluent chamber preloaded with the diluent, so that the mixed liquid of the pre-mixed sample liquid and the diluent in the diluent chamber is filled; then the pre-storage cup is assembled and buckled with the reaction cup, and finally the puncture cover is assembled and buckled to the outside of the pre-storage cup, in the buckling process, the first puncture piece can directly puncture and pierce the thin wall of the puncture hole, so that the mixed liquid of the sample liquid and the diluent in the diluent chamber can flow into the reaction chamber of the reaction cup from the punctured thin wall of the puncture hole, so that the mixed liquid of the sample liquid and the diluent can react with the dry reagent, and finally the whole reaction device is transferred to the detection equipment, and the reaction signal can be read by the sensor. Compared with the prior art, the reaction device for POCT homogeneous luminescence immunoassay of the scheme is only composed of three components of the pre-storage cup, the reaction cup and the puncture cover, the structure is simple, the manufacturing and use cost can be effectively reduced, and when used, only the three are buckled in sequence along the assembly direction, the mixed liquid can be contacted with the dry reagent for detection reaction, the operation is convenient and labor-saving, the operation difficulty is low, the skill requirement of the user is low, not only professional medical staff can quickly and effectively complete the detection work, but also ordinary patients, ordinary nursing personnel and the like can efficiently and conveniently implement the detection operation, the usability is stronger, and the application scope and object are wider. BRIEF DESCRIPTION OF DRAWINGS

[0023] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings needed to be used in the embodiments or the prior art description. Obviously, the drawings in the following description only some embodiments of the present application, and for those skilled in the art, other drawings can be obtained without creative labor on the basis of these drawings.

[0024] Figure 1 The explosion schematic diagram of the reaction device for POCT homogeneous luminescence immunoassay of an embodiment of the present application;

[0025] Figure 2 The Figure 1 The structure schematic diagram of the pre-storage cup and the reaction cup assembled and buckled in the embodiment;

[0026] Figure 3 The Figure 1 The assembly structure schematic diagram of the reaction device for POCT homogeneous luminescence immunoassay in the embodiment;

[0027] Figure 4 The top view structure diagram of the pre-storage cup;

[0028] Figure 5 The axonometric structure diagram of the pre-storage cup;

[0029] Figure 6 The bottom view structure diagram of the pre-storage cup;

[0030] Figure 7 is a top view structural diagram of Figure 6

[0031] Figure 8 is an axonometric structural diagram of the reaction cup;

[0032] Figure 9 is a top view structural diagram of Figure 8

[0033] Figure 10 is a bottom view structural diagram of Figure 9

[0034] Figure 11 is an axonometric structural diagram of the piercing cap;

[0035] Figure 12 is a bottom view structural diagram of Figure 11

[0036] Figure 13 is a top view structural diagram of Figure 12

[0037] Figure 14 is an exploded schematic view of a reaction device for POCT homogeneous luminescence immunoassay of another embodiment;

[0038] Figure 15 is a structural schematic view of the pre-storage cup and the reaction cup assembled in Figure 14

[0039] Figure 16 is an assembly structural schematic view of a reaction device for POCT homogeneous luminescence immunoassay in Figure 14

[0040] Figure 17 is an exploded schematic view of a reaction device for POCT homogeneous luminescence immunoassay of a third embodiment;

[0041] Figure 18 is an assembly structural view of Figure 17

[0042] Figure 19 is a structural schematic view of the piercing cap;

[0043] Figure 20 is a bottom view structural diagram of the piercing cap in Figure 19

[0044] Figure 21 is a structural schematic view of the pre-storage cup and the reaction cup of an integral structure;

[0045] Figure 22 is a top view structural diagram of Figure 21 ​​​​​​​​​​

[0046] Figure 23 For Figure 21 the front view structural diagram.

[0047] Wherein:

[0048] 100, reaction device for POCT homogeneous luminescence immunoassay;

[0049] 10, pre-storage cup; 11, diluent chamber; 12, thin-walled puncture hole; 13, sealing protrusion; 14, air hole; 15, first foolproof chute; 16, second foolproof bevel; 17, clamping body; 18, insertion column;

[0050] 20, reaction cup; 21, reaction chamber; 22, liquid holding groove; 221, accommodating hole; 222, liquid flow channel; 23, red blood cell filter pad; 24, air chamber; 25, air chamber channel; 26, light transmission window; 27, light transmission film; 28, second foolproof chute; 29, third foolproof bevel; 29a, clamping position; 29b, insertion hole;

[0051] 30, puncture cover; 31, first puncture piece; 32, second puncture piece; 33, pressing plug column; 34, foolproof protrusion; 35, first foolproof bevel. DETAILED DESCRIPTION

[0052] In order to facilitate the understanding of the present application, the present application will be described in more detail below with reference to the relevant drawings. The preferred embodiments of the present application are shown in the drawings. However, the present application can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the disclosure of the present application more thorough and comprehensive.

[0053] It should be noted that when an element is referred to as being "fixed" to another element, it can be directly on the other element or there can be an intervening element. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or there can be an intervening element. The terms "vertical", "horizontal", "left", "right" and similar expressions used herein are for illustrative purposes only.

[0054] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0055] Reference should be made to Figure 1The reaction device 100 for POCT homogeneous luminescence immunoassay of an embodiment of the present application, the principle of POCT homogeneous luminescence immunoassay can be summarized as follows: under homogeneous conditions, the sample to be measured is mixed with reagents such as luminescent microspheres (nanoscale) containing luminescent materials and photosensitive microspheres (nanoscale) containing photosensitive materials. Since the luminescent microspheres and the photosensitive microspheres have biologically active molecules (antibodies or antigens, etc.) connected to their surfaces, the target molecules in the sample to be measured can be directly or indirectly captured, thereby forming an immune sandwich complex of the luminescent microspheres, the target molecules and the photosensitive microspheres. After excitation light irradiation, the photosensitive microspheres are induced to activate and release high-energy state active oxygen molecules. The high-energy state active oxygen molecules are captured by the luminescent microspheres at close range, thereby transferring energy to activate the luminescent compounds in the luminescent microspheres. After several microseconds, the luminescent compounds in the luminescent microspheres will release high-energy level red light. The high-energy level photons are measured by a single photon counter, and the number of photons is converted into the concentration of target molecules by a computer. When the sample does not contain target molecules, the immune sandwich complex cannot be formed. Although active oxygen ions are released from the photosensitive microspheres under excitation light irradiation, they cannot reach the luminescent microspheres, i.e. they are rapidly quenched in the liquid phase, and no high-energy level red light is generated during detection.

[0056] Please refer to Figures 1 to 16 For example, the reaction device 100 for POCT homogeneous luminescence immunoassay includes a pre-storage cup 10, a reaction cup 20 and a puncture cover 30. The pre-storage cup 10 is provided with a diluent chamber 11 and a puncture hole thin wall 12 in communication. The diluent chamber 11 is used to hold the mixed solution of the sample liquid and the diluent. The sample liquid can be any one of serum, plasma, whole blood, urine or saliva.

[0057] The reaction cup 20 is provided with a reaction chamber 21, and the dry reagent is packaged in the reaction chamber 21. The dry reagent can be photosensitive microsphere freeze-dried beads and luminescent microsphere freeze-dried beads.

[0058] The puncture cover 30 is provided with a first puncture piece 31, and the first puncture piece 31 is arranged in position with the puncture hole thin wall 12. When in use, the pre-storage cup 10 is clamped on the reaction cup 20 along the assembly direction, the puncture cover 30 is clamped on the pre-storage cup 10 along the assembly direction, the first puncture piece 31 punctures the puncture hole thin wall 12, and the mixed solution of the sample liquid and the diluent in the diluent chamber 11 flows into the reaction chamber 21 through the punctured puncture hole thin wall 12 to react with the dry reagent.

[0059] It can be understood that the above assembly direction specifically refers to the arrow direction in the drawing.

[0060] The embodiment of the present application is implemented, and the following beneficial effects will be obtained:

[0061] When the reaction device 100 for POCT homogeneous luminescence immunoassay of the scheme is used, first, the sample liquid to be detected is added to the diluent chamber 11 preloaded with the diluent, so that the mixed liquid of the pre-mixed sample liquid and the diluent in the diluent chamber 11 is filled; then the pre-storage cup 10 is assembled and buckled with the reaction cup 20, and finally the puncture cover 30 is assembled and buckled to the outside of the pre-storage cup 10. In the buckling process, the first puncture piece 31 can directly puncture and pierce the thin-walled hole 12, so that the mixed liquid of the sample liquid and the diluent in the diluent chamber 11 can flow into the reaction chamber 21 of the reaction cup 20 from the punctured thin-walled hole 12, so that the mixed liquid of the sample liquid and the diluent can react with the dry reagent. Finally, the entire reaction device is transferred to the detection equipment, and the reaction signal can be read by the sensor.

[0062] Compared with the prior art, the reaction device 100 for POCT homogeneous luminescence immunoassay of the scheme is only composed of three components of the pre-storage cup 10, the reaction cup 20 and the puncture cover 30, which has a simple structure, a small overall volume, and can effectively reduce the manufacturing and use costs. When used, only the three components need to be buckled in sequence along the assembly direction, so that the mixed liquid can be in contact with the dry reagent for detection reaction, which is convenient and labor-saving, has low operation difficulty, and has low skill requirement for the user. Not only professional medical staff can quickly and effectively complete the detection work, but also ordinary patients, ordinary caregivers and the like can efficiently and conveniently perform the detection operation by themselves, so that the usability is stronger, and the application scope and object are wider.

[0063] In the present application, the puncture cover 30, the pre-storage cup 10 and the reaction cup 20 all adopt a rectangular cuboid shape structure, which has regular multiple sides, so that the user can effectively grasp and assemble them.

[0064] It can be understood that the assembly direction is specifically along the height direction of the puncture cover 30, the pre-storage cup 10 and the reaction cup 20, and the three components are sequentially stacked or nested and assembled. For example, in the present embodiment, the pre-storage cup 10 and the reaction cup 20 are only stacked and assembled in the assembly direction, and the puncture cover 30 is completely nested to the outside of the pre-storage cup 10 and part of the reaction cup 20 to form an inner-outer double-layer structure.

[0065] In order to reduce the manufacturing and use costs, the puncture cover 30, the pre-storage cup 10 and the reaction cup 20 preferably adopt a medical-grade plastic material. Of course, in other embodiments, the puncture cover 30, the pre-storage cup 10 and the reaction cup 20 can also adopt metal, composite material and the like.

[0066] Please refer to Figures 4 to 7In one embodiment, the reaction cup 20 is further provided with a liquid containing groove 22, which is formed on the top surface of the reaction cup 20 facing the pre-storage cup 10. The bottom of the liquid containing groove 22 is provided with a receiving hole 221 at one of the top corners of the reaction cup 20, which is arranged in alignment with the thin-walled puncture hole 12. When the puncture cover 30 is assembled with the pre-storage cup 10 and the reaction cup 20, the first puncture member 31 can extend into the receiving hole 221 after puncturing the thin-walled puncture hole 12, so that the receiving hole 221 can accommodate the first puncture member 31 and avoid interference between the reaction cup 20 and the first puncture member 31.

[0067] The bottom of the liquid containing groove 22 is further provided with a liquid flow channel 222, which communicates the liquid containing groove 22 with the reaction chamber 21. After the thin-walled puncture hole 12 is punctured, the mixed liquid of the sample liquid and the diluent will first flow into the liquid containing groove 22 through the punctured thin-walled puncture hole 12, and then slowly flow to the liquid flow channel 222, and finally flow into the reaction chamber 21 below from the liquid flow channel 222, so that the mixed liquid of the sample liquid and the diluent can gradually and slowly flow into the reaction chamber 21 to ensure more sufficient and complete contact reaction with the dry reagent.

[0068] Further, the reaction device 100 for POCT homogeneous phase luminescence immunoassay further comprises a red blood cell filter pad 23, which is arranged in the liquid containing groove 22 and covers the liquid inlet of the liquid flow channel 222.

[0069] Whether it is chemiluminescence immunoassay or photoluminescence immunoassay, the final detection is the light signal generated by the reaction. At the same time, the biggest scene of immunoassay application is to detect various substances to be tested in blood. Because there are a large number of red blood cells in the blood, the red blood cells and the hemoglobin in the cells have strong light absorption characteristics, which greatly interfere with the light signal generated by the reaction. If there are red blood cells in the detection reaction system, it will greatly affect the accuracy of the detection result. Compared with the related art which needs to additionally equip a red blood cell separation device or device (such as a centrifuge) and perform additional red blood cell separation operation, causing longer detection time and higher cost, the present scheme pre-installs a red blood cell filter pad 23 in the liquid containing groove 22, so that the mixed liquid of the sample liquid and the diluent flowing into the liquid containing groove 22 will first flow through the red blood cell filter pad 23, so that the red blood cells can be automatically separated out, avoiding the red blood cells flowing into the reaction chamber 21 to interfere with the accuracy of the detection result, and at the same time, without the need for additional equipment of a red blood cell separation device or device, the reaction device has the advantages of lower cost, simpler structure and shorter detection time.

[0070] In particular, the red blood cell filter pad 23 can be arranged in two or more layers at the same time, and the mixed liquid can be filtered at least twice in sequence through each layer of the red blood cell filter pad 23, so as to more completely filter out the red blood cells.

[0071] In another embodiment, the pre-storage cup 10 is further provided with a sealing protrusion 13, which is matched with the shape and size of the liquid containing groove 22, and sealingly abuts against the groove edge of the liquid containing groove 22. By sealingly abutting the sealing protrusion 13 against the groove edge of the liquid containing groove 22, the liquid containing groove 22 can be encapsulated after the pre-storage cup 10 is assembled with the reaction cup 20, so as to prevent the mixed liquid of the sample liquid and the dilution liquid from leaking.

[0072] Further, a sealing ring (such as a rubber ring) can be installed between the sealing protrusion 13 and the groove edge of the liquid containing groove 22 to enhance the sealing performance.

[0073] In addition, in yet another embodiment, the pre-storage cup 10 is further provided with a gas permeable hole 14, the reaction cup 20 is further provided with a gas chamber 24 which is arranged in position with the gas permeable hole 14, and a gas chamber channel 25 which is in communication with the gas chamber 24; the dilution liquid chamber 11 and the gas permeable hole 14 are simultaneously sealed with a first sealing film, and the liquid containing groove 22 and the gas chamber 24 are simultaneously sealed with a second sealing film. That is, the reaction device (for short, the reaction device 100 for POCT homogeneous phase luminescence immunoassay, the same below) of the present scheme can temporarily encapsulate the sample liquid and the dilution liquid in the dilution liquid chamber 11 when not in use, so as to avoid spilling and being affected by the temperature and humidity of the external environment; at the same time, the dry reagent can be encapsulated in the reaction chamber 21 to prevent the dry reagent from being affected by the external air and being damp.

[0074] Optionally, the first sealing film and the second sealing film can be made of aluminum film or plastic film. The encapsulation can be processed by heat sealing process.

[0075] Please refer to Figures 4 to 13 Further, the puncture cover 30 is further provided with a second puncture piece 32, which is arranged in position with the gas permeable hole 14, and the second puncture piece 32 can puncture the first sealing film and the second sealing film after the puncture cover 30, the pre-storage cup 10 and the reaction cup 20 are assembled with each other.

[0076] That is, when the puncture cover 30, the pre-storage cup 10 and the reaction cup 20 are assembled with each other, the first puncture piece 31 punctures the puncture hole thin wall 12, and the second puncture piece 32 also synchronously punctures the corresponding parts of the first sealing film and the second sealing film encapsulated on the gas permeable hole 14 and the gas chamber 24 when the mixed liquid of the sample liquid and the dilution liquid flows to the reaction chamber 21, so as to connect the gas permeable hole 14, the gas chamber 24 and the gas chamber channel 25, so as to balance the air pressure between the inside and the outside of the reaction device, and ensure that the mixed liquid can smoothly flow to the reaction chamber 21.

[0077] Optionally, in the present scheme, the first piercing member 31 and the second piercing member 32 are both rod members protruding on the inside of the puncture cover 30, and the end of the rod member is formed into a sharp conical structure. When the user fastens and presses the puncture cover 30, the pre-storage cup 10 and the reaction cup 20, the sharp conical structure can quickly and reliably pierce the thin-walled puncture hole 12, the first sealing film and the second sealing film, so that the operation of the reaction device is low in difficulty, convenient and labor-saving, and patients and patient families without medical equipment operation skills and experience can also easily use it.

[0078] In one of the embodiments, the side of the reaction cup 20 is also provided with a light-transmitting window 26, which communicates with the reaction chamber 21, and a light-transmitting film 27 is sealed and arranged on the light-transmitting window 26.

[0079] After the dry reagent is loaded into the reaction chamber 21, the light-transmitting film 27 is heat-sealed and arranged at the light-transmitting window 26, so that the dry reagent is completely sealed outside the closed reaction chamber 21. Since the light-transmitting film 27 is not blocked by the puncture cover 30, it also has good permeability to light of wavelengths of about 680 nm and about 615 nm, and can transmit excitation light and emission light during homogeneous luminescence immunoassay, so that the detection process can be carried out smoothly.

[0080] For example, the light-transmitting film 27 can be a transparent plastic film.

[0081] Please refer to Figures 12 to 13 In addition, in another embodiment, the puncture cover 30 is also provided with a plunger column 33, which is arranged in position with the diluent chamber 11. After the puncture cover 30 is assembled and fastened with the pre-storage cup 10, the plunger column 33 can extrude the mixture of the sample liquid and the diluent liquid towards the thin-walled puncture hole 12. Specifically, the plunger column 33 has an outer shape that is adapted to the shape of the diluent chamber 11. When the puncture cover 30 is assembled and fastened to the outside of the pre-storage cup 10, the plunger column 33 can perfectly fit the diluent chamber 11, thereby forming a piston effect in the diluent chamber 11. As the puncture cover 30 continuously fastens the pre-storage cup 10, the pressure of the plunger column 33 on the diluent chamber 11 gradually increases. Since the aperture formed after the first piercing member 31 pierces the thin-walled puncture hole 12 is usually small, the mixture of the sample liquid and the diluent liquid under increased pressure first flows towards the punctured thin-walled puncture hole 12, thereby more easily flowing through the aperture of the thin-walled puncture hole 12 into the liquid holding groove 22. Under the condition of continuously increasing pressure, the mixture in the liquid holding groove 22 can continuously flow through the red blood cell filter pad 23 and finally flow into the reaction chamber 21.

[0082] In order to avoid the piercing cap 30, the pre-storage cup 10 and the reaction cup 20 being assembled in the wrong direction and failing to be properly and smoothly buckled, in an embodiment, the inner wall of the piercing cap 30 is further provided with a foolproof protrusion 34, the outer wall of the pre-storage cup 10 is further provided with a first foolproof slot 15, the outer wall of the reaction cup 20 is further provided with a second foolproof slot 28, the second foolproof slot 28 is in alignment and communication with the first foolproof slot 15 in the assembly direction, and the foolproof protrusion 34 is slidingly assembled in the first foolproof slot 15 and the second foolproof slot 28; or, the outer wall of the piercing cap 30 is provided with a first foolproof bevel 35, the outer wall of the pre-storage cup 10 is provided with a second foolproof bevel 16 in alignment with the first foolproof bevel 35, and the outer wall of the reaction cup 20 is provided with a third foolproof bevel 29 in alignment with the second foolproof bevel 16.

[0083] That is, simply speaking, only when the foolproof protrusion 34 is in alignment with the first foolproof slot 15 and the second foolproof slot 28 at the same time or the first foolproof bevel 35, the second foolproof bevel 16 and the third foolproof bevel 29 are in alignment on the same straight line, the piercing cap 30, the pre-storage cup 10 and the reaction cup 20 can be properly assembled as a whole.

[0084] Further, one of the pre-storage cup 10 and the reaction cup 20 is provided with a clamping body 17, and the other one is provided with a clamping site 29a, and the clamping body 17 and the clamping site 29a are buckled and connected; or, one of the pre-storage cup 10 and the reaction cup 20 is provided with a plug hole 29b, and the other one is provided with a plug column 18, and the plug column 18 is inserted and fixed in the plug hole 29b. Thus, through the assembly mode of the buckled and connected clamping body 17 and the clamping site 29a or the inserted plug column 18 in the plug hole 29b, the pre-storage cup 10 and the reaction cup 20 can be connected and fixed, and a sealed liquid flow passage and a sealed air flow passage can be formed therebetween, so as to ensure that the mixed liquid flows into the reaction chamber 21 and effectively contacts with the dry reagent to complete the detection.

[0085] Please refer to Figures 17 to 23 , the reaction device of the third embodiment is provided, and the main difference from the above two embodiments is that the reaction cup 20 and the pre-storage cup 10 are integrated, that is, the reaction device only has two components, and the sealing film only needs two pieces, one piece seals the diluent pre-storage cup and the air permeable hole at the top, and the other piece covers the red blood cell separation area and the reaction chamber at the same time, so that the number of components can be further reduced, the production process can be reduced, and the production of the reagent box can be more effective and lower in cost. The working principle is basically the same as that of the above embodiments, and thus will not be described further.

[0086] The above embodiments only express several implementation manners of the present application, and the description is more specific and detailed, but it should not be understood as a limitation on the scope of the application. It should be noted that for ordinary skilled persons in the art, without departing from the concept of the present application, several modifications and improvements can be made, which are within the scope of protection of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

Claims

1. A reaction device for homogeneous chemiluminescence immunoassay in point-of-care testing (POCT), characterized in that, include: A pre-storage cup, wherein the pre-storage cup is provided with a thin wall that connects to a diluent chamber and a puncture hole, wherein the diluent chamber is used to hold a mixture of sample liquid and diluent; A reaction vessel, wherein the reaction vessel is provided with a reaction chamber, and the reaction chamber is sealed with a drying reagent; and The puncture cap is provided with a first puncture element, which is aligned with the thin wall of the puncture hole. In use, the pre-storage cup is fastened to the reaction cup along the assembly direction, and the puncture cap is fastened to the pre-storage cup along the assembly direction. The first puncture element punctures the thin wall of the puncture hole, and the mixture of sample liquid and diluent in the diluent chamber flows into the reaction chamber through the punctured thin wall of the puncture hole to react with the drying reagent. The puncture cap is also provided with a stopper, which is aligned with the diluent chamber. After the puncture cap is fastened and assembled with the pre-storage cup, the stopper can squeeze the mixture of sample liquid and diluent against the thin wall of the puncture hole. The reaction cup is also provided with a liquid holding tank, the bottom of which is provided with a receiving hole, which is aligned with the thin wall of the piercing hole; the bottom of the liquid holding tank is also provided with a liquid flow channel, which connects the liquid holding tank to the reaction chamber. The pre-storage cup is also provided with a vent hole, and the reaction cup is also provided with a gas chamber that is aligned with the vent hole and a gas chamber channel that communicates with the gas chamber; the diluent chamber and the vent hole are simultaneously sealed with a first sealing film, and the liquid tank and the gas chamber are simultaneously sealed with a second sealing film.

2. The reaction apparatus for homogeneous chemiluminescence immunoassay in POCT according to claim 1, characterized in that, The reaction device for POCT homogeneous luminescent immunoassay also includes a red blood cell filter pad, which is installed in the liquid tank and seals the inlet of the liquid flow channel.

3. The reaction apparatus for homogeneous chemiluminescence immunoassay in POCT according to claim 1, characterized in that, The pre-storage cup is also provided with a sealing flange, which is adapted to the shape and size of the liquid holding tank, and the sealing flange is in sealing contact with the edge of the opening of the liquid holding tank.

4. The reaction apparatus for homogeneous chemiluminescence immunoassay in POCT according to claim 1, characterized in that, The puncture cap is also provided with a second puncture member, which is aligned with the vent hole. After the puncture cap, the pre-storage cup and the reaction cup are fastened together, the second puncture member can puncture the first sealing film and the second sealing film, so that the vent hole, the air chamber and the air chamber channel are connected in sequence.

5. The reaction apparatus for homogeneous chemiluminescence immunoassay in POCT according to claim 1, characterized in that, The side of the reaction cup is also provided with a light-transmitting window, which is connected to the reaction chamber, and the light-transmitting window is sealed with a light-transmitting film.

6. The reaction apparatus for homogeneous chemiluminescence immunoassay in point-of-care testing (POCT) according to any one of claims 1 to 5, characterized in that, The inner wall of the puncture cap is also provided with a foolproof protrusion, the outer wall of the pre-storage cup is also provided with a first foolproof groove, and the outer wall of the reaction cup is also provided with a second foolproof groove. The second foolproof groove and the first foolproof groove are aligned and connected in the assembly direction, and the foolproof protrusion is slidably inserted into the first foolproof groove and the second foolproof groove.

7. The reaction apparatus for homogeneous chemiluminescence immunoassay in point-of-care testing (POCT) according to any one of claims 1 to 5, characterized in that, The outer wall of the puncture cap is provided with a first anti-foolproof angle, the outer wall of the pre-storage cup is provided with a second anti-foolproof angle that is aligned with the first anti-foolproof angle, and the outer wall of the reaction cup is provided with a third anti-foolproof angle that is aligned with the second anti-foolproof angle.

8. The reaction apparatus for homogeneous chemiluminescence immunoassay in point-of-care testing (POCT) according to any one of claims 1 to 5, characterized in that, One of the pre-storage cup and the reaction cup is provided with a locking body, and the other of the pre-storage cup and the reaction cup is provided with a locking position, wherein the locking body and the locking position are snapped together; or One of the pre-storage cup and the reaction cup is provided with a socket, and the other of the pre-storage cup and the reaction cup is provided with a post, and the post is inserted and fixed to the socket; The pre-storage cup and the reaction cup are an integral structure.

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