Method for uniformly mixing magnetic bead reagents for immunoassay device and immunoassay device

Abstract

To disclose a magnetic bead reagent uniform mixing method for an immunoanalyzer, and an immunoanalyzer that can uniformly mix a magnetic bead reagent, avoid the occurrence of a situation of magnetic bead aggregation, and ensure the accuracy of a detection result.SOLUTION: The present invention discloses a magnetic bead reagent uniform mixing method for an immunoanalyzer, and an immunoanalyzer. In the magnetic bead reagent uniform mixing method, a magnetic bead reagent tube filled with a magnetic bead reagent is brought into a variable speed state in a self-rotation process, and / or an impact force is applied to the magnetic bead reagent tube in the self-rotation process of the magnetic bead reagent tube, to disperse aggregated magnetic beads, and thereby the magnetic bead reagent is uniformly mixed. The present invention can uniformly mix the magnetic bead reagent, avoid a situation of magnetic bead aggregation, and ensure the accuracy of a detection result.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present invention relates to a method for uniformly mixing reagents and a device using this method, and in particular to a method for uniformly mixing magnetic bead reagents for an immunoassay device and an immunoassay device, which belong to the field of medical testing technology. [Background technology]

[0002] More than half a century has passed since the first automated chemical analyzer was manufactured, and fully automated immunoassay analyzers have become quite technologically advanced. Current fully automated immunoassay analyzers have the following features: 1. They use a multi-degree-of-freedom robotic arm to coordinate the movement of each module. 2. These instruments are highly flexible and can meet a variety of analytical needs. 3. They have fast testing speeds and can operate continuously for long periods without human intervention. 4. In terms of detection technology, they combine multiple technologies and fully automate the process, resulting in more accurate and precise detection results. Fully automated immunoassay analyzers can perform steps in the experimental testing process, such as removing the reaction cup, adding the sample, adding the reaction solution, shaking, accelerating the reaction, measuring, computational analysis, and cleaning. This replaces manual operations, thereby not only saving labor costs but, more importantly, eliminating human error and ensuring data accuracy. With the advantages of speed, efficiency, high accuracy, and reproducibility, fully automated immunoassay analyzers are widely used in fields such as processing, production, testing, and life-saving support, and are inevitably becoming a trend in the field of medical testing.

[0003] The reagents required for the reaction are stored in reagent cartridges, which are attached to a reagent tray. Therefore, the reagent tray of a fully automated immunoassay analyzer serves as a storage and supply unit for the reagents required for the reaction. When aspirating a reagent, the reagent tray rotates, causing the reagent cartridge in the reagent tray to rotate to the position where the reagent needle should aspirate the reagent. The reagent needle then aspirates the reagent in the reagent cartridge into the incubation tray, where it reacts with the sample.

[0004] As shown in Figures 1 and 2, a reagent cartridge 1 is provided with a plurality of independent reagent chambers 2, each open at its top to facilitate reagent aspirate with a reagent needle, and each reagent chamber 2 contains a different type of reagent. A magnetic bead reagent tube 3 is rotatably connected to one end of the reagent cartridge 1, and a reagent tube gear 311 is provided at the bottom of the magnetic bead reagent tube 3. The plurality of reagent cartridges 1 are mounted on the reagent rotating disk 4 in sequence along the circumferential direction of the reagent rotating disk 4, which can simultaneously rotate the plurality of reagent cartridges 1. The magnetic bead reagent tube 3 is filled with magnetic bead reagent, and due to the characteristics of magnetic bead reagent, precipitation and sedimentation are highly likely to occur. Continuous rotation is required during testing and aspirating to prevent precipitation and sedimentation. Therefore, in the prior art, during the testing process, a toothed disk 5 is installed at the center of the reagent rotating disk 4, and the reagent tube gears 311 at the bottom of the magnetic bead reagent tubes 3 in each reagent cartridge all mesh with the toothed disk 5. The reagent rotating disk 4 is rotated by a power mechanism, while the toothed disk 5 in the center remains stationary. The reagent rotating disk 4 rotates multiple reagent cartridges 1 simultaneously, and the toothed disk 5 and the reagent tube gears 311 mesh to transmit power, so that the magnetic bead reagent tubes 3 in multiple reagent cartridges 1 on the reagent rotating disk 4 are continuously rotated, thereby preventing the magnetic bead reagent from settling or accumulating in the magnetic bead reagent tubes 3 and ensuring the accuracy of the detection results.

[0005] The prior art has the following problems: The magnetic bead reagent tube rotates most of the time, which does not achieve a good uniform mixing effect between the magnetic beads and the reagent solution in the magnetic bead reagent, resulting in magnetic bead aggregation, which affects the accuracy of the detection results.

[0006] As a result of the search, the following patent documents were obtained. 1. A Chinese invention patent application, with publication number CN110160957A and publication date August 23, 2019, discloses a reagent tray module, which includes an opening device and a rotating member disposed at the bottom of the opening device for rotating the opening device; a scanning unit disposed on a side wall of the opening device, which can identify attributes of a reagent in the opening device through the scanning unit.

[0007] 2. A Chinese utility model with utility model registration number CN217156535U and registration date of August 9, 2022 discloses a sample-reagent integrated device, which includes a base, on which a reagent chamber system and a sample system are rotatably mounted, the reagent chamber system having a circular structure, the sample system having an annular structure and incorporating the reagent chamber system in a circumferential direction, and a first drive assembly and a second drive assembly provided on the base, which are used to drive the rotation of the reagent chamber system and the sample system, respectively.

[0008] In both of the above two patent documents, the above problems exist in the magnetic bead reagent in the reagent tray.

[0009] In summary, how to design a method for uniformly mixing magnetic bead reagents for immunoassay devices and an immunoassay device so that the magnetic bead reagents can be uniformly mixed, the magnetic bead aggregation situation can be avoided, and the accuracy of the detection results can be ensured has become an urgent technical issue. Summary of the Invention [Problem to be solved by the invention]

[0010] The main technical problem that the present invention aims to solve is to provide a method for uniformly mixing magnetic bead reagents for an immunoassay device and an immunoassay device, which can address the deficiencies of the prior art by uniformly mixing magnetic bead reagents, avoiding the occurrence of magnetic bead aggregation, and ensuring the accuracy of detection results. [Means for solving the problem]

[0011] To solve the above technical problems, the technical solution adopted by the present invention is as follows: A method for uniformly mixing magnetic bead reagent for an immunoassay device, in which a magnetic bead reagent tube filled with magnetic bead reagent is rotated at a variable speed during self-rotation in a reagent tray of the immunoassay device, and / or an impact force is applied to the magnetic bead reagent tube during self-rotation, thereby dispersing the aggregated magnetic beads and bringing the magnetic bead reagent into a uniformly mixed state.

[0012] Preferably, the toothed disk of the reagent tray is designed so that the continuous teeth distributed along the circumferential direction are discontinuous, thereby forming a plurality of toothed portions and notches on the toothed disk; the reagent cartridge is attached to the reagent rotating disk, and the magnetic bead reagent tube is rotatably connected to the reagent cartridge; the reagent rotating disk and the toothed disk rotate relative to each other, driving the reagent tube gear at the bottom of the magnetic bead reagent tube to move along the circumferential direction of the toothed disk; During the operation, when the magnetic bead reagent tube is in the toothed portion of the toothed disk, the toothed portion engages with the reagent tube gear at the bottom of the magnetic bead reagent tube, causing the magnetic bead reagent tube to rotate; when the magnetic bead reagent tube is in the notched portion of the toothed disk, the magnetic bead reagent tube loses its power for self-rotation, so the self-rotation speed of the magnetic bead reagent tube changes once within the notched portion; when the magnetic bead reagent tube is again in the toothed portion of the toothed disk, the toothed portion again engages with the reagent tube gear at the bottom of the magnetic bead reagent tube, causing the magnetic bead reagent tube to change speed once more and return to the self-rotating state; and this is repeated, so that the self-rotation speed of the magnetic bead reagent tube during the operation process is repeatedly changed into a speed-changing state; When the magnetic bead reagent tube moves from the notch to the toothed disk, the tooth that has just engaged with the reagent tube gear exerts an impact force on the magnetic bead reagent tube, thus performing an impact action.

[0013] Preferably, when the tooth portion has an arc length of L, the notch portion has an arc length of L / 2.

[0014] Preferably, a tube protrusion is provided on the inner wall of the magnetic bead reagent tube, so that the magnetic bead reagent tube can rotate at variable speeds and, when subjected to an impact force, the tube protrusion can mix the magnetic bead reagent more uniformly.

[0015] Preferably, two of the protrusions are provided so as to be symmetrically distributed with respect to the central axis of the magnetic bead reagent tube.

[0016] Preferably, during operation, when reagent aspiration is not required, the toothed disk is rotated in a controlled manner and the reagent rotating disk is kept stationary, thereby causing the magnetic bead reagent tube to self-rotate; When it is necessary to aspirate various reagents in the aspirating reagent cartridge, the reagent cartridge is driven to rotate to reagent collection point A, and then the reagent rotating disk is controlled to maintain the reagent cartridge at point A without moving, and then the various reagents in the reagent cartridge are aspirated.

[0017] Preferably, the rotation direction of the toothed disk and the rotation direction of the reagent rotating disk are controlled to be opposite to each other.

[0018] The present invention also provides The present invention discloses an immunoassay device including a reagent tray and a washing tray located on one side of the reagent tray, in which the reagent tray uniformly mixes the magnetic bead reagent by the above-described method for uniformly mixing the magnetic bead reagent.

[0019] Preferably, the washing tray includes a washing tray cylinder, a rotating disk mechanism provided inside the washing tray cylinder, and a needle lifting mechanism provided above the washing tray cylinder, wherein both the liquid injection needles and the liquid suction needles are provided on the needle lifting mechanism, the reaction cups are placed on the rotating disk of the rotating disk mechanism, and the reaction cups can be rotated by the rotating disk, and a washing tank is provided inside the washing tray cylinder and below the rotating disk, and by moving the needle lifting mechanism downward, the liquid injection needles and the liquid suction needles can be moved downward and inserted into the reaction cups to wash the reaction cups, or after removing the reaction cups, they can be moved downward and inserted into the washing tank to wash the liquid injection needles and the liquid suction needles.

[0020] Preferably, the cleaning tank comprises a fully sealed annular tank body and a liquid injection needle cleaning tube and a liquid suction needle cleaning tube provided in the annular tank body, the internal spaces of both the liquid injection needle cleaning tube and the liquid suction needle cleaning tube being connected to the internal space of the annular tank body, a drainage pipe for drainage being further provided on the bottom surface of the annular tank body, holes for inserting the liquid injection needles and the liquid suction needles being provided on the top surfaces of the liquid injection needle cleaning tube and the liquid suction needle cleaning tube, respectively, and the liquid injection needle cleaning tube and the liquid suction needle cleaning tube are distributed according to the positions of the liquid injection needles and the liquid suction needles so that one liquid injection needle cleaning tube cleans one corresponding liquid injection needle, and one liquid suction needle cleaning tube cleans one corresponding liquid suction needle.

[0021] Preferably, the liquid suction needle cleaning tube penetrates the annular tank body vertically, and includes an outer cylinder and an inner cylinder arranged inside the outer cylinder, an annular space is formed between the outer cylinder and the inner cylinder, the annular space is connected to the internal space of the annular tank body, the top surface of the inner cylinder is lower than the top surface of the outer cylinder, the hole of the liquid suction needle cleaning tube is located on the top surface of the outer cylinder, and a water supply port is further provided in the liquid suction needle cleaning tube located below the annular tank body, the water supply port is connected to the bottom of the cavity of the inner cylinder, and the top of the cavity of the inner cylinder is connected to the internal space of the outer cylinder.

[0022] Preferably, the liquid injection needle cleaning tube comprises a cylinder, the bottom end of the cylinder is located at the top of the annular tank body, the cavity of the cylinder is connected to the internal space of the annular tank body, and the hole of the liquid injection needle cleaning tube is located at the top end of the cylinder.

[0023] Preferably, a reaction cup vibration mechanism is further provided inside the washing tray cylinder, and the reaction cup vibration mechanism includes first and second guide rails provided in the washing tray cylinder and a collision block slidably connected to the first and second guide rails, and a collision block driving mechanism is further provided inside the washing tray cylinder, and the collision block driving mechanism drives the push block to move back and forth along the first and second guide rails, thereby causing the collision block to collide back and forth with the reaction cups on the rotating disk in the liquid injection station, and dispersing the magnetic beads in the reaction cups through the collision.

[0024] Preferably, the collision block drive mechanism includes a collision block drive motor provided in the cleaning tray cylinder and a first collision block rotation shaft rotatably connected in the cleaning tray cylinder, wherein the output shaft of the collision block drive motor is fitted onto one end of the first collision block rotation shaft for rotatable connection, a second collision block rotation shaft is further provided on the other end face of the first collision block rotation shaft, the central axis of the first collision block rotation shaft and the central axis of the second collision block rotation shaft do not overlap, an oval hole is formed in the collision block, and the second collision block rotation shaft is inserted into the oval hole so as to be slidably connected, thereby controlling the collision block drive motor to rotate the first collision block rotation shaft and the second collision block rotation shaft, and the second collision block rotation shaft contacts the inner circumferential surface of the oval hole, thereby driving the collision block to move back and forth along the first guide rail and the second guide rail, and repeatedly collide with the reaction cups.

[0025] Preferably, the needle lifting mechanism has three basic cleaning units arranged in sequence around the circumference of the rotating disk, the basic cleaning units including two first basic cleaning units and one second basic cleaning unit, each of the first basic cleaning units having one first liquid injection needle and one liquid suction needle, the second basic cleaning unit having one integrated dual liquid injection needle and one liquid suction needle, the integrated dual liquid injection needle including one first liquid injection needle and one second liquid injection needle, and the first liquid injection needle, the liquid suction needle, the first liquid injection needle, the liquid suction needle, the integrated dual liquid injection needle, and the liquid suction needle are arranged in this order in the needle lifting mechanism along the circumference of the rotating disk.

[0026] Preferably, the integrated liquid injection twin needle is connected to the lifting plate of the needle lifting mechanism by a limiting block, the limiting block includes a base provided on the lifting plate and a screw cap screwed to the base, the base includes a bottom plate and a pillar provided on the bottom plate, the pillar and the bottom plate are penetrated through an attachment through-hole, and a groove is provided on the inner circumferential surface of the pillar through which the attachment through-hole penetrates, the groove is recessed in the radial direction of the pillar, one side is open and the remaining three sides are closed, a screw cap through-hole is drilled at the bottom of the screw cap, and the integrated liquid injection twin needle is further provided with a guide block, the guide block has a cylindrical shape with a diameter that matches the diameter of the mounting through-hole, and one side of the guide block is provided with a radially protruding bump; When installing, the first and second liquid injection needles are passed through the screw cap through-holes of the screw cap, the guide block, and the mounting through-holes of the base in that order, the bumps on the guide block are engaged with the grooves, and the first and second liquid injection needles are restricted in the circumferential direction by the engagement between the grooves and the bumps.The screw cap is then tightened onto the column, and the screw cap is used to push the bumps into the grooves, thereby restricting the first and second liquid injection needles in the axial direction. [Effects of the Invention]

[0027] The beneficial effects of the present invention are as follows: The present invention can uniformly mix magnetic bead reagents, avoiding the occurrence of magnetic bead agglomeration and ensuring the accuracy of detection results. The toothed disk is designed with intermittent teeth, and the relative rotation of the reagent rotating disk and the toothed disk allows the reagent tube gear at the bottom of the magnetic bead reagent tube to move along the circumferential direction of the toothed disk, thereby achieving a technical solution of "changing the uniform rotation state of the magnetic bead reagent tube during its self-rotation process and applying an impact force to the magnetic bead reagent tube during its self-rotation process, thereby dispersing the agglomerated magnetic beads." By controlling the rotation of the toothed disk and keeping the reagent rotating disk stationary, the magnetic bead reagent tubes are actively and uniformly mixed. This significantly shortens the overall detection time compared to traditional uniform mixing methods, thereby improving detection efficiency. The washing tray of the immunoassay device is designed to integrate the washing tank inside the washing tray and below the rotating disk, making full use of the internal space of the washing tray and the movement stroke of the needle lifting mechanism. When the washing tray is operating normally, the needle lifting mechanism moves downward, moving the liquid injection needles and liquid suction needles down to their operating position to wash the reaction cup. If the liquid injection needles or liquid suction needles need to be cleaned, the reaction cup is removed and the needle lifting mechanism moves further downward, moving them beyond their operating position until they are inserted into the washing tank for needle cleaning. This not only ensures that the liquid injection needles and liquid suction needles properly clean the magnetic beads in the reaction cup, but also allows for the liquid injection needles and liquid suction needles themselves to be cleaned, simplifying the cleaning process, improving the convenience of cleaning the liquid injection needles and liquid suction needles, and improving the cleaning effect of the liquid injection needles and liquid suction needles. The specific design of the washing tank and the cleaning process allows for the inner and outer walls of the liquid suction needles and the inner wall of the liquid injection needle to be cleaned simultaneously, improving the cleaning effect. A reaction cup vibration mechanism is provided inside the cleaning tray, and the liquid injection needle injects liquid into the reaction cup while repeatedly colliding with the reaction cup using the reaction cup vibration mechanism, dispersing the magnetic beads in the reaction cup through repeated collisions. The magnetic beads are also washed in combination with the cleaning liquid injected into the liquid injection needle, ensuring a cleaning effect.A reaction cup vibration mechanism is provided inside the washing tray, and while the liquid injection needle injects liquid into the reaction cup, the reaction cup vibration mechanism repeatedly collides with the reaction cup, dispersing the magnetic beads in the reaction cup and combining them with the washing liquid injected into the liquid injection needle to wash the magnetic beads, thereby ensuring the washing effect. The present invention uses a dual liquid injection needle mechanism to combine two different washing liquids, which can wash the magnetic beads in the reaction cup and remove any air bubbles remaining in the reaction cup, thereby ensuring the accuracy of the final detection results. [Brief explanation of the drawings]

[0028] [Figure 1] FIG. 2 is a schematic diagram of the three-dimensional structure of a reagent cartridge. [Figure 2] FIG. 10 is a schematic diagram of the three-dimensional structure of the fitting positional relationship between the reagent rotating disk and the toothed disk. [Figure 3] 1 is a schematic diagram of the principle structure of a method for uniformly mixing magnetic bead reagents in an embodiment of the present invention. [Figure 4] FIG. 2 is a partial schematic diagram of the internal three-dimensional structure of a magnetic bead reagent tube in an embodiment of the present invention. [Figure 5] FIG. 1 is a schematic diagram of the principle structure when a reagent is aspirated in the prior art. [Figure 6] FIG. 2 is a schematic diagram of the principle structure when a reagent is aspirated in an embodiment of the present invention. [Figure 7] FIG. 2 is a schematic diagram of the three-dimensional structure of a reagent tray in an embodiment of the present invention. [Figure 8] FIG. 2 is a schematic diagram of the cross-sectional structure of a reagent tray in the axial direction in an embodiment of the present invention. [Figure 9] 9 is a partially enlarged schematic structural view of part B in FIG. 8. FIG. [Figure 10] 1 is a schematic diagram of the top structure of an immunoassay device according to an embodiment of the present invention. [Figure 11] FIG. 2 is a schematic diagram of the three-dimensional structure of a cleaning tray according to an embodiment of the present invention. [Figure 12] FIG. 2 is a schematic cross-sectional view of the cleaning tray in the axial direction according to the embodiment of the present invention. [Figure 13] FIG. 2 is a schematic diagram of the top structure of a cleaning tray in an embodiment of the present invention. [Figure 14] FIG. 2 is a schematic diagram of the top structure of a cleaning tank in an embodiment of the present invention. [Figure 15] FIG. 2 is a schematic diagram showing the three-dimensional structure of a cleaning tank in an embodiment of the present invention. [Figure 16] FIG. 10 is a schematic diagram showing the state when a liquid injection needle is inserted into a reaction cup to inject a washing liquid. [Figure 17] FIG. 10 is a schematic diagram showing a state where a liquid suction needle is inserted into a reaction cup to suction liquid. [Figure 18] FIG. 15 is a schematic cross-sectional view taken along line CC in FIG. [Figure 19] FIG. 19 is a schematic diagram showing the state in which the liquid suction needle in FIG. 18 is washed. [Figure 20] FIG. 15 is a schematic cross-sectional view taken along line DD in FIG. [Figure 21] FIG. 21 is a schematic diagram showing the liquid injection needle being washed in FIG. 20. [Figure 22] 13 is a schematic cross-sectional view of a portion located on the rotary disk in FIG. 12. FIG. [Figure 23] 1 is a schematic diagram of a three-dimensional structure of a rotary disk mechanism according to an embodiment of the present invention. [Figure 24] 1 is a front structural schematic diagram of a rotary disk mechanism according to an embodiment of the present invention; [Figure 25] 3 is a schematic diagram showing the distribution of the liquid injection station, the liquid suction station, and the reaction cup vibration mechanism in an embodiment of the present invention; FIG. [Figure 26] FIG. 2 is a schematic diagram of a magnetic field position distribution in an embodiment of the present invention. [Figure 27] 1 is a partial three-dimensional structural schematic diagram of a cleaning tray according to an embodiment of the present invention, from which a needle lifting mechanism and a rotary disk mechanism are omitted. [Figure 28] FIG. 28 is a partial three-dimensional structural schematic diagram of the reaction cup vibration mechanism in FIG. 27. [Figure 29] FIG. 29 is a partial three-dimensional structural schematic diagram of the reaction cup vibration mechanism in FIG. 28, omitting the collision block of the reaction cup vibration mechanism. [Figure 30]30 is a schematic diagram of the three-dimensional structure of a portion located on the rotation axis of the first collision block and the rotation axis of the second collision block in FIG. 29. FIG. [Figure 31] 1 is a schematic axial cross-sectional view of a portion of a rotary disk positioned at a reaction cup after the reaction cup is placed in a cup hole of the rotary disk in an embodiment of the present invention; FIG. [Figure 32] FIG. 13 is a schematic cross-sectional view of the portion located in the needle lifting mechanism in FIG. 12. [Figure 33] FIG. 13 is a schematic diagram of the three-dimensional structure of a portion located in the needle lifting mechanism in FIG. 12. [Figure 34] FIG. 34 is a schematic diagram of the three-dimensional structure of the portion located at the integrated liquid injection twin needle in FIG. 33. [Figure 35] 1 is a schematic diagram of the three-dimensional structure of the base of the limiting block of the cleaning tray according to an embodiment of the present invention; [Figure 36] 1 is a schematic diagram of the three-dimensional structure of an integrated dual fluid injection needle according to an embodiment of the present invention after passing through a screw cap and a guide block. [Figure 37] FIG. 1 is a schematic diagram of the three-dimensional structure when an integrated dual liquid injection needle is attached to a lifting plate in an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0029] The technical solutions of the present invention will be described in more detail below with reference to the drawings and specific embodiments.

[0030] The magnetic bead reagent tube rotates most of the time, but the magnetic beads and reagent solution in the magnetic bead reagent are not mixed uniformly well, resulting in the problem of magnetic bead aggregation. After research, the applicant found that the magnetic bead reagent rotates most of the time, but at a constant low speed, so the magnetic beads are easily thrown against the inner wall of the magnetic bead reagent tube due to the action of centrifugal force, etc., which results in the magnetic beads agglomerating.

[0031] The present invention discloses a method for uniformly mixing magnetic bead reagents for immunoassay devices. This method involves varying the speed of a magnetic bead reagent tube during self-rotation and / or applying an impact force to the magnetic bead reagent tube during self-rotation to disperse clumped magnetic beads and thereby achieve a uniformly mixed state of the magnetic bead reagent. The applicant's research has revealed that the above problem can be solved by changing the uniform rotation speed of the magnetic bead reagent tube during self-rotation. This means that instead of maintaining the magnetic bead reagent tube at a uniform speed, the magnetic bead reagent tube's self-rotation speed is varied, thereby changing the magnitude of the centrifugal force received, thereby eliminating clumping of the magnetic beads. Alternatively, applying an external impact force during self-rotation of the magnetic bead reagent tube can disperse clumped magnetic beads. Most preferably, both of the above two technical solutions are used to eliminate clumping of the magnetic beads. The applicant's experiments have shown that the effects of these two technical solutions are optimal, and magnetic bead clumping is almost completely eliminated in magnetic bead reagents uniformly mixed using both of the above two technical solutions. [Example]

[0032] Regarding the technical solution of "dispersing the aggregated magnetic beads by changing the uniform rotation state during the self-rotation process of the magnetic bead reagent tube and applying an impact force during the self-rotation process of the magnetic bead reagent tube," the applicant has designed the toothed disk 5 so that the continuous teeth distributed along the circumferential direction are discontinuous, thereby forming notches between adjacent teeth, as shown in Figure 3. In this embodiment, the toothed disk 5 is provided with a total of 10 teeth 511 and 10 notches 512. During operation, when the magnetic bead reagent tube is in the toothed portion 511 of the toothed disk 5, the toothed portion 511 engages with the reagent tube gear 311 at the bottom of the magnetic bead reagent tube, providing the magnetic bead reagent tube with a force for self-rotation, causing the magnetic bead reagent tube to rotate. When the magnetic bead reagent tube is in the notch 512 of the toothed disk 5, there are no teeth in the notch 512 that engage with the reagent tube gear 311, so the magnetic bead reagent tube loses its self-rotation power and its rotation speed is not very fast. When the magnetic bead reagent tube loses its self-rotation power, its speed slows down and may even stop rotating. Therefore, the self-rotation speed of the magnetic bead reagent tube in the notch 512 changes once. When the magnetic bead reagent tube returns to the toothed portion 511 of the toothed disk 5, the toothed portion 511 again engages with the reagent tube gear 311 at the bottom of the magnetic bead reagent tube, providing the magnetic bead reagent tube with a self-rotating force. The magnetic bead reagent tube receives power and changes its speed once more, returning to a self-rotating state. This process is repeated, repeatedly changing the self-rotating speed of the magnetic bead reagent tube during its operation. Furthermore, when the magnetic bead reagent tube moves from the notch 512 of the toothed disk to the toothed portion 511, the toothed portion 511 that has just engaged with the reagent tube gear 311 applies an impact force to the magnetic bead reagent tube, thus creating an impact effect. The magnetic bead reagent tube is subjected to the combined effects of the self-rotating speed change and the impact force, dispersing any clumped magnetic beads in the magnetic bead reagent tube and resulting in a uniformly mixed magnetic bead reagent. This embodiment achieves uniform mixing of the magnetic bead reagent, avoiding clumping of the magnetic beads and ensuring accurate detection results.

[0033] As a result of repeated testing, the applicant discovered that the optimum effect of uniformly mixing the magnetic bead reagent in the magnetic bead reagent tube is achieved by setting the arc length of the notch portion 512 to L / 2, where L is the arc length of the tooth portion 511.

[0034] To further enhance the uniform mixing effect, a tube protrusion 312 is provided on the inner wall of the magnetic bead reagent tube 3, as shown in Figure 4. When the magnetic bead reagent tube 3 rotates at a variable speed and is subjected to an impact force, the tube protrusion 312 can mix the magnetic bead reagent more uniformly, further improving the uniform mixing effect. In this embodiment, two tube protrusions 312 are provided, symmetrically distributed about the central axis of the magnetic bead reagent tube 3.

[0035] The prior art has another problem. As shown in Figure 5, in the prior art, during operation, the toothed disk 5 is kept stationary in a central position, and the reagent rotating disk 4 is controlled to rotate the reagent cartridge 1, thereby causing the magnetic bead reagent tubes 3 in the reagent cartridge 1 to self-rotate through the meshing of the toothed disk 5 with the reagent tube gear 311. Usually, the reagents filled in the magnetic bead reagent tubes 3 and multiple reagent storage chambers 2 in the same reagent cartridge 1 are intended to test the same indicator. When detecting one indicator, let's say the reagent collection point is point A. To aspirate the magnetic bead reagent from the magnetic bead reagent tube 3 in the reagent cartridge 1, first control the reagent rotating disk 4 to rotate the reagent cartridge 1 to point A. Then, aspirate the magnetic bead reagent from the magnetic bead reagent tube 3. After aspirating, the reagent cartridge 1 must not remain in this position. Instead, control the reagent rotating disk 4 to rotate the reagent cartridge 1 one more time until it reaches point A again, aspirating the reagent from one of the reagent chambers 2 in this reagent cartridge 1 again. After aspirating, control the reagent rotating disk 4 to rotate the reagent cartridge 1 one more time until it reaches point A again, aspirating the reagent from the next reagent chamber 2 in this reagent cartridge 1. This process is repeated until testing for one indicator is complete. This uniform mixing method increases the overall detection time and reduces detection efficiency.

[0036] For this reason, as shown in FIG. 6 , the applicant provides a first drive mechanism and a second drive mechanism for the toothed disk 5 and the reagent rotating disk 4, respectively. During operation, the first drive mechanism rotates the toothed disk 5 and keeps the reagent rotating disk 4 stationary, thereby keeping the reagent cartridge 1 fixed on the reagent rotating disk 4. The toothed disk 5 meshes with the reagent tube gear 311, allowing the magnetic bead reagent tube 3 in the reagent cartridge 1 to rotate automatically. When various reagents need to be aspirated from the reagent cartridge 1, the second drive mechanism drives the reagent rotating disk 4 to rotate the reagent cartridge 1 to reagent collection point A, and then keeps the reagent cartridge 1 stationary at point A. At this time, because the toothed disk 5 is still rotating, the magnetic bead reagent tube 3 in the reagent cartridge 1 is still rotating automatically. Therefore, even after the magnetic bead reagent in the magnetic bead reagent tube 3 in the reagent cartridge 1 has been aspirated, the reagent cartridge 1 can remain fixed at point A, allowing the reagent in the other reagent chambers 2 in the reagent cartridge 1 to continue to be aspirated. This significantly reduces the overall detection time compared to the conventional uniform mixing method, thereby improving detection efficiency.

[0037] In this embodiment, by controlling the rotation direction of the toothed disk 5 so that it is opposite to the rotation direction of the reagent rotating disk 4, the toothed disk 5 can be kept constantly rotating, and whether the reagent rotating disk 4 is rotating or not, the magnetic bead reagent tube 3 of the reagent cartridge 1 on the reagent rotating disk 4 can continuously rotate by itself, thereby preventing precipitation or deposition of the magnetic bead reagent in the magnetic bead reagent tube 3.

[0038] As shown in FIGS. 7 and 8 , the reagent rotating disk 4 is attached to the reagent tray 6 of the immunoassay analyzer. The reagent tray 6 includes a reagent tray cylinder 611 and a first driving mechanism provided at the bottom of the reagent tray cylinder 611. The reagent rotating disk 4 is located inside the reagent tray cylinder 611. The first driving mechanism is a first driving motor 7, the output shaft of which is connected to the reagent rotating disk 4. The reagent rotating disk 4 can be rotated by the operation of the first driving motor 7. Casters 8 are further provided at the bottom of the reagent rotating disk 4, and the casters 8 contact the inner bottom of the reagent tray cylinder 611, thereby ensuring more stable rotation of the reagent rotating disk 4. A toothed disk 5 is rotatably connected inside the reagent tray cylinder 611 and below the reagent rotating disk 4. The toothed disk 5 and the reagent rotating disk 4 are coaxially positioned. A second driving mechanism is further provided at the bottom of the reagent tray cylinder 611. The second drive mechanism is a second drive motor 9, and the output shaft of the second drive motor 9 is fitted into and rotatably connected to the toothed disk 5, so that the toothed disk 5 can be rotated by the operation of the second drive motor 9. A plurality of reagent through-holes 612 for sucking reagent are formed at the top of the reagent tray cylinder 611, and the position where the reagent through-holes 612 are present is the reagent collection point A.

[0039] 9 , a boss 10 is provided on the inner bottom of the reagent tray cylinder 611, the inner ring of a toothed disk bearing 11 is fitted onto the outer peripheral surface of the boss 10, the toothed disk 5 is connected to the outer ring of the toothed disk bearing 11, a first transmission toothed disk 12 is also fitted onto the outer ring of the toothed disk bearing 11, and a second transmission toothed disk 13 is further provided on the output shaft of the second drive motor 9, and the first transmission toothed disk 12 and the second transmission toothed disk 13 are meshed with each other to be rotatably connected, so that the toothed disk 5 can be rotated by the operation of the second drive motor 9. The reagent tube gear 311 of the magnetic bead reagent tube in the reagent cartridge 1 attached to the reagent rotary disk 4 is meshed with the toothed disk 5 to be rotatably connected.

[0040] 10 , the present invention also discloses an immunoassay device including a sample transport channel 14 and the above-described reagent tray 6, incubation tray 15, washing tray 16, optical detection mechanism 17, and consumables bin 18 provided on one side of the sample transport channel 14. A cup gripping arm 19 is provided between the incubation tray 15 and washing tray 16 for gripping reaction cups between the incubation tray 15 and washing tray 16. A reagent needle arm 20 is further provided between the incubation tray 15 and reagent tray 6 for aspirating a reagent in the reagent tray 6 and adding it to the reaction cup in the incubation tray 15. A reagent needle washing tank 21 is further provided beside the reagent needle arm 20 for washing the reagent needle arm 20 after aspirating one type of reagent so that the reagent needle arm 20 can aspirate another reagent. The consumable bin 18 is provided with a detection chip module 181, a tip head module 182, and a reaction cup module 183, each of which contains multiple components, i.e., multiple detection chips are arranged in the detection chip module 181, multiple tip heads are arranged in the tip head module 182, and multiple reaction cups are arranged in the reaction cup module 183, thereby enabling multiple detections by the immunoassay device. A three-dimensional mobile robot arm 60 is further provided between the incubating tray 15, the optical detection mechanism 17, and the consumable bin 18, and the three-dimensional mobile robot arm 60 is used to replace consumables and to suck the target sample in the reaction cup of the incubating tray 15 into the optical detection mechanism 17 for detection.

[0041] 11 and 12, the washing tray includes a washing tray cylinder 22, a rotary disk mechanism 23 provided inside the washing tray cylinder 22, and a needle lifting mechanism 24 provided above the washing tray cylinder 22. Reaction cups 25 are placed on a rotary disk 231 of the rotary disk mechanism 23, and the reaction cups 25 can be rotated by the rotary disk 231. A washing tank 26 is provided inside the washing tray cylinder 22 and below the rotary disk 231, and a liquid injection needle 27 and a liquid suction needle 28 are provided in the needle lifting mechanism 24. In normal operation, the needle lifting mechanism 24 moves downward, and both the liquid injection needle and the liquid suction needle are lowered and inserted into the reaction cup, thereby performing the reaction cup washing operation. When the liquid injection needles or liquid suction needles need to be cleaned, the reaction cup 25 is first removed from the rotating disk 231. Then, the needle lifting mechanism 24 is controlled to move downward, and the liquid injection needles and liquid suction needles are inserted through the rotating disk and into the washing tank 26 for cleaning. In this embodiment, the washing tank is integrated inside the washing tray and below the rotating disk, making full use of the internal space of the washing tray and the movement stroke of the needle lifting mechanism. When the washing tray is operating normally, the needle lifting mechanism moves downward to move the liquid injection needles and liquid suction needles down to their operating positions to clean the reaction cups. When the liquid injection needles or liquid suction needles need to be cleaned, the reaction cup is removed, and the needle lifting mechanism moves further downward. The liquid injection needles and liquid suction needles are then moved down further, beyond their operating positions, and inserted into the washing tank for cleaning. As a result, in this embodiment, it is possible to ensure that the liquid injection needles and liquid suction needles can properly wash the magnetic beads in the reaction cup, and it is also possible to wash the liquid injection needles and liquid suction needles themselves, simplifying the washing steps, improving the convenience of washing the liquid injection needles and liquid suction needles, and increasing the washing effect of the liquid injection needles and liquid suction needles.

[0042] 13 , the needle lifting mechanism 24 has two first basic cleaning units and one second basic cleaning unit arranged in sequence around the circumference of the rotating disk 231, each basic cleaning unit having a liquid injection station and a liquid suction station, each of the first basic cleaning units having one first liquid injection needle 271 and one liquid suction needle 28 at the liquid injection station and the liquid suction station of the second basic cleaning unit, each of the second basic cleaning unit having one integrated dual liquid injection needle S and one liquid suction needle 28 at the liquid injection station and the liquid suction needle 28, the integrated dual liquid injection needle S including one first liquid injection needle 271 and one second liquid injection needle 272. The first liquid injection needle 271, the liquid suction needle 28, the first liquid injection needle 271, the liquid suction needle 28, the integrated dual liquid injection needle S, and the liquid suction needle 28 are arranged in this order on the needle lifting mechanism 24 along the circumference of the rotating disk 231.

[0043] Since the liquid injection needles and liquid suction needles are distributed circumferentially around the rotating disk, the cleaning tank 26 is also configured in a ring shape, as shown in Figures 14 and 15. The cleaning tank 26 includes a completely sealed ring-shaped tank body 261 and a liquid injection needle cleaning tube 262 and a liquid suction needle cleaning tube 263 provided in the ring-shaped tank body 261. The internal spaces of both the liquid needle cleaning tube 912 and the liquid suction needle cleaning tube 263 are connected to the internal space of the ring-shaped tank body 261. A drain pipe 264 for drainage is further provided on the bottom surface of the ring-shaped tank body 261. Holes 29 for inserting the liquid injection needles and the liquid suction needles are provided on the top surfaces of the liquid needle cleaning tube 912 and the liquid suction needle cleaning tube 263, respectively. The liquid injection needle cleaning barrels 262 and liquid suction needle cleaning barrels 263 are arranged in accordance with the needle distribution on the needle lifting mechanism 24, with each liquid injection needle cleaning barrel 262 cleaning one corresponding liquid injection needle and each liquid suction needle cleaning barrel 263 cleaning one corresponding liquid suction needle. Therefore, in this embodiment, the liquid injection needle cleaning barrel 262, the liquid suction needle cleaning barrel 263, the liquid injection needle cleaning barrel 262, the liquid suction needle cleaning barrel 263, the liquid injection needle cleaning barrel 262, and the liquid suction needle cleaning barrel 263 are arranged in this order on the annular tank body. The design of the annular tank body and the annularly arranged cleaning barrels allows multiple liquid injection needles and liquid suction needles to be cleaned simultaneously, further improving cleaning efficiency.

[0044] In order to further improve the cleaning effect, the applicant conducted research and found that, as shown in Figures 16 and 17, during normal operation, when the cleaning tray is washing the magnetic beads in the reaction cups 25, when the liquid injection needles 27 are used to inject liquid into the reaction cups 25, the liquid injection needles 27 are inserted into the liquid 30 in the reaction cups 25, so when washing the liquid injection needles 27, only the inner walls of the liquid injection needles 27 need to be washed; and when the liquid suction needles 28 are used to aspirate liquid from the reaction cups 25, the liquid suction needles 28 need to be inserted into the liquid 30 in the reaction cups 25, so when washing the liquid suction needles 28, both the inner and outer walls of the liquid suction needles 28 need to be washed.

[0045] 18 and 19, the liquid suction needle cleaning tube 263 penetrates the annular tank body 261 in the vertical direction, and includes an outer cylinder 2631 and an inner cylinder 2632 provided inside the outer cylinder 2631, and an annular space 2633 is formed between the outer cylinder 2631 and the inner cylinder 2632, and the annular space 2633 communicates with the internal space 2611 of the annular tank body 261, and the inner The top surface of the inner cylinder 2632 is lower than the top surface of the outer cylinder 2631, and the hole 29 of the liquid suction needle cleaning tube 263 is provided on the top surface of the outer cylinder 2631. A water supply port 31 is further provided in the liquid suction needle cleaning tube 263 located below the annular tank body 261, and the water supply port 31 is connected to the bottom of the cavity 26321 of the inner cylinder 2632, and the top of the cavity 26321 of the inner cylinder 2632 is connected to the internal space of the outer cylinder 2631.

[0046] When cleaning the liquid suction needle 28, the liquid suction needle 28 is controlled to be inserted from the top hole 29 of the liquid suction needle cleaning tube 263 into the cavity 26321 of the inner cylinder 2632, cleaning water is sent from the water supply port 31 to the cavity 26321 of the inner cylinder 2632 by the external water pump, and the liquid suction needle 28 is controlled to start suctioning the liquid, so that some of the cleaning water is sucked into the liquid suction needle 28, thereby cleaning the inner wall of the liquid suction needle 28 with the cleaning water. Furthermore, because the water supply rate of the water pump is greater than the water absorption rate of the liquid suction needle 28, most of the remaining cleaning water flows sequentially through the cavity 26321 of the inner cylinder 2632, the annular space 2633, and the internal space 2611 of the annular tank body 261, and finally is discharged via the drain pipe 264, whereby the cleaning water that has flowed through the cavity 26321 of the inner cylinder 2632 cleans the outer wall of the liquid suction needle 28. By the above method, both the inner and outer walls of the liquid suction needle 28 are cleaned, and the cleaning effect is enhanced.

[0047] The water supply port 31 is provided on the side of the liquid suction needle cleaning tube 263, so that when cleaning the liquid suction needle, the cleaning water enters the cavity 26321 of the inner cylinder 2632 from the side of the liquid suction needle 28. In this way, the cleaning water does not flow directly from the bottom of the liquid suction needle into the liquid suction needle, but is sucked into the liquid suction needle by the liquid suction needle, ensuring the cleaning effect.

[0048] As shown in Figures 20 and 21, the liquid injection needle cleaning tube 262 includes a cylinder 2621, the bottom end of which is located at the top of the annular tank body 261, the cavity of the cylinder 2621 is connected to the internal space 2611 of the annular tank body 261, and the hole 29 of the liquid injection needle cleaning tube 262 is located at the top end of the cylinder 2621.

[0049] When cleaning the liquid injection needle 27, the liquid injection needle 27 is controlled to be inserted into the cavity of the cylinder 2621 through the top hole 29 of the cylinder 2621, and cleaning water begins to be injected through the liquid injection needle 27. The cleaning water is injected into the internal space 2611 of the annular tank body 261 and finally discharged through the drain pipe 264. In this way, the cleaning water flowing through the liquid injection needle 27 cleans the inner wall of the liquid injection needle 27, thereby improving the cleaning effect.

[0050] As shown in FIG. 12 , a washing tray separator 221 is installed inside the washing tray cylinder 22, dividing the interior of the washing tray cylinder 22 into an upper cylinder space 222 and a lower cylinder space 223. The rotating disk 231 of the rotating disk mechanism 23 is located within the upper cylinder space 222, and a heat-insulating material and a heating device (not shown) are installed within the upper cylinder space 222, with the heating device being an electric heating film. To ensure a constant operating temperature after the reaction cups are placed on the rotating disk, the interior of the upper cylinder space 222 is heated and maintained at a constant temperature by the heat-insulating material and heating device. In this embodiment, the rotating disk is installed within the heat-insulating space of the upper cylinder space, ensuring that the reaction cups on the rotating disk are always in a constant operating temperature environment.

[0051] 13, 22, and 23, the rotating disk mechanism 23 further includes a rotating disk motor and reducer 232, which is installed in the cleaning tray separator 221. A rotating shaft 2321 of the rotating disk motor and reducer 232 extends into the upper cylinder space 222 and is connected to the rotating disk 231. In the prior art, all rotating disks are driven by belt transmission, which makes the transmission structure complicated and occupies a large space. In this embodiment, however, the rotating disk motor integrated with the reducer is directly connected to the rotating disk, eliminating the belt transmission structure, thereby simplifying the structure of the rotation mechanism and reducing the space occupied.

[0052] The rotating disk 231 is provided with a plurality of cup holes 32 circumferentially for placing reaction cups. The top of the cleaning tray cylinder 22 is provided with reaction cup through-holes 33 for inserting and removing reaction cups 25. The reaction cup through-holes 33 are located at the zero station. When the rotating disk 231 rotates until one of the cup holes 32 coincides with the central axis of the reaction cup through-hole 33, one reaction cup 25 is inserted into the cup hole 32 through the reaction cup through-hole 33, or the reaction cup 25 is removed from the cup hole 32 through the reaction cup through-hole 33. Each cup hole 32 corresponds to one cleaning tube. When cleaning the liquid injection needle and the liquid suction needle, after removing the reaction cup 25 from the cup hole 32, the liquid injection needle and the liquid suction needle are moved downward to pass through the cup hole 32 of the rotating disk and inserted into the cleaning tank 26 for cleaning.

[0053] As shown in Fig. 11, a first sensor 34 is further provided on the side of the cleaning tray cylinder 22, and the number of reaction cups on the rotating disk and the presence or absence of reaction cups on the rotating disk are detected by the first sensor 34. As shown in Fig. 24, a detection ring 35 is provided on the bottom of the rotating disk 231, and a plurality of detection grooves 351 are formed in the detection ring 35. A second sensor 36 is further provided in the detection ring 35 in the cleaning tray separator 221. When the rotating disk rotates, the second sensor 36 detects the detection grooves 351 in the detection ring 35, thereby controlling the rotation angle and position of the rotating disk.

[0054] 25, one basic cleaning unit is provided for the steps of injecting liquid into the reaction cup and aspirating liquid into the reaction cup. In this case, the basic cleaning unit includes the above-mentioned first basic cleaning unit 37 and second basic cleaning unit 38, where the second basic cleaning unit 38 is a basic cleaning unit before detection and the first basic cleaning unit 37 is another basic cleaning unit. The first basic cleaning unit 37 and the second basic cleaning unit 38 are sequentially arranged above the rotating disk 231 along the circumferential direction of the rotating disk 231.

[0055] 22 and 26, a magnet stop ring 39 is further provided on the inner circumferential surface of the washing tray cylinder 22 and on the rotating disk 231. By providing a magnet on the magnet stop ring 39, a magnetic field 40 is formed within the washing tray cylinder 22 and between the liquid injection station and the liquid suction station in each basic washing unit. The interior of the washing tray cylinder 22 at the liquid injection station is outside the magnetic field 40, and the interior of the washing tray cylinder 22 at the liquid suction station is inside the magnetic field 40. After the reaction cup has been injected with washing liquid at the liquid injection station, the reaction cup enters the magnetic field 40 as the rotating disk rotates, and magnetic field 40 attracts the magnetic beads in the reaction cup before it rotates to the liquid suction station. When liquid is suctioned at the liquid suction station, the magnetic field 40 attracts the magnetic beads in the reaction cup, thereby preventing the magnetic beads from being sucked by the liquid suction needle. After the liquid suction is completed, the reaction cup leaves the magnetic field 40 and rotates to the liquid injection station, where there is no magnetic field and the liquid is injected into the reaction cup using the liquid injection needle, thereby shocking the magnetic beads and achieving the purpose of washing. In this embodiment, a total of three magnetic fields 40 are provided, and the magnets can be either permanent magnets or electromagnets.

[0056] As shown in Figures 27 and 28, in this embodiment, the washing tray includes one reaction cup vibration mechanism 41. The reaction cup vibration mechanism 41 is mounted on the washing tray separator 221 and located within the upper cylinder space 222. The reaction cup vibration mechanism 41 includes first and second guide rails 411 and 412 mounted on the washing tray separator 221 and a collision block 413 slidably connected to the first and second guide rails 411 and 412 by engaging with a slide. The washing tray separator 221 is further provided with a collision block drive mechanism, which drives a push block to reciprocate along the first and second guide rails 411 and 412. This causes the collision block 413 to repeatedly collide with the side of the reaction cup in the rotating disk cup hole 32 at the liquid injection station, dispersing the magnetic beads in the reaction cup. Even when all the washing solution in the reaction cup has been aspirated by the liquid suction needle and delivered to the liquid injection needle, the magnetic beads are still adsorbed to each other. In this embodiment, as the liquid injection needle injects liquid into the reaction cup, it repeatedly collides with the reaction cup due to the reaction cup vibration mechanism, and the magnetic beads in the reaction cup are dispersed by the repeated collisions.In addition, by combining this with washing the magnetic beads with the washing liquid injected into the liquid injection needle, the washing effect is ensured.

[0057] As shown in Figures 28 and 29, the collision block drive mechanism includes a collision block drive motor (not shown) provided at the bottom of the cleaning tray separator 221 and a first collision block rotation shaft 42 rotatably connected to the top of the cleaning tray separator 221, and the output shaft of the collision block drive motor is fitted into one end of the first collision block rotation shaft 42 and rotatably connected thereto, and a second collision block rotation shaft 43 is further provided on the end surface of the other end of the first collision block rotation shaft 42, and the central axis of the first collision block rotation shaft 42 and the central axis of the second collision block rotation shaft 43 do not overlap, i.e., the central axis of the second collision block rotation shaft 43 is positioned offset from the central axis of the first collision block rotation shaft 42. An oblong hole 44 is opened in the collision block 413, and the second collision block rotating shaft 43 is inserted into the oblong hole 44 so as to fit into the oblong hole 44 and be slidably connected. Thereby, by controlling the collision block drive motor to rotate the first collision block rotating shaft 42 and the second collision block rotating shaft 43, the second collision block rotating shaft 43 comes into contact with the inner surface of the oblong hole 44, and the collision block 413 is driven to move back and forth along the first guide rail 411 and the second guide rail 412, so that it can repeatedly collide with the reaction cups.

[0058] As shown in FIG. 30 , the second collision block rotation shaft 43 includes a collision bearing 431 and a set screw 432. The set screw 432 passes through the inner ring of the collision bearing 431, locking the collision bearing 431 to the end face of the first collision block rotation shaft 42. When the second collision block rotation shaft 43 is inserted into the oval hole 44, the outer ring of the collision bearing 431 comes into contact with the inner circumferential surface of the oval hole 44, thereby fitting the second collision block rotation shaft 43 into the oval hole 44 and slidably connecting the second collision block rotation shaft 43. This configuration further ensures stability when the collision block is repeatedly moved. A detection tray 45 is provided on the outer circumferential surface of the first collision block rotation shaft 42, and a third sensor 46 is further provided on the detection tray 45 in the cleaning tray separator 221. The detection tray 45 and the third sensor 46 work together to detect the state of the first collision block rotation shaft 42.

[0059] As shown in Figures 25 and 28, the end of the collision block 413 is configured in an arc shape, and the arc-shaped end 4131 collides with the side of the reaction cup 25, and such collision does not damage the reaction cup.

[0060] The reaction cup vibration mechanism is installed between the second basic cleaning unit 38 and the first basic cleaning unit 37 closest to the second basic cleaning unit. The arc-shaped ends 4131 at both ends of the collision block 413 collide with the reaction cups located at the liquid injection position in the second basic cleaning unit 38 and the reaction cups located at the liquid injection position in the first basic cleaning unit 37, respectively. This allows the reaction cups to collide even during two liquid injections, ensuring more reliable collision and cleaning operations and improving the cleaning effect. In this embodiment, the first first basic cleaning unit 37 does not have a reaction cup vibration mechanism. This is because the reaction cups have just been placed on the rotating disk before moving to the liquid injection station of the first first basic cleaning unit 37, and are not affected by the magnetic field, or the magnetic field has only a small effect, resulting in a weak attraction force between the magnetic beads. Therefore, when the reaction cups move to the liquid injection station of the first first basic cleaning unit 37, the magnetic beads are dispersed by the cleaning solution, eliminating the need for vibration-induced collision.

[0061] 31, the reaction cup 25 includes a cup body 251 and a cup body flange 252 provided on the outer circumferential surface of the cup body 251. When the reaction cup 25 is placed in the cup hole 32 of the rotary disk 231, a collision gap 47 remains between the cup body 251 in the cup hole 32 and the inner circumferential surface of the cup hole 32. With this configuration, the collision block can easily collide with the reaction cup, further improving the cleaning effect.

[0062] 32 and 33, the needle lifting mechanism 24 includes a lifting plate 241 and a lifting motor 242. A guide bush 48 is provided on the lifting plate 241. A guide rod 49 is provided on the top surface of the cleaning tray cylinder 22. The guide rod 49 and the guide bush 48 are fitted together, thereby slidably connecting the lifting plate 241 to the guide rod 49. The lifting motor 242 is provided on the cleaning tray cylinder 22, and its output shaft is drivably connected to a lead screw 50. A cap screw 51 is provided on the lifting plate 241. The lead screw 50 and the cap screw 51 are fitted together to form a lead screw-nut mechanism, whereby the lifting plate 241 can be controlled to move up and down by operating the lifting motor 242. Both the liquid injection needle and the liquid suction needle are disposed on the lifting plate 241. In addition, the inclined bottom opening of the liquid injection needle prevents the cleaning solution sprayed from the bottom opening from impacting the reaction cup. This is because when a magnetic field is applied to the reaction cup in the liquid suction station, the magnetic beads are attracted to the inner wall of the reaction cup, and even after the magnetic field is removed, some of the magnetic beads remain attracted to the inner wall of the reaction cup. The inclined bottom opening of the liquid injection needle ensures that the cleaning solution disperses the magnetic beads attracted to the inner wall of the reaction cup, further ensuring the cleaning effect. A notch is provided on the bottom side wall of the liquid suction needle near its bottom opening to prevent the bottom opening of the liquid suction needle from being blocked when inserted into the bottom of the reaction cup and ensure normal liquid suction operation.

[0063] An upper position sensor 52 and a lower position sensor 53 are further provided on the top surface of the cleaning tray cylinder 22, and the upper position sensor 52 and the lower position sensor 53 are attached to the top surface of the cleaning tray cylinder 22 by support rods 54. A detection piece 55 is further provided on the lifting plate 241, and the detection piece 55, the upper position sensor 52, and the lower position sensor 53 cooperate to detect the upper and lower limit positions of the lifting plate 241. During operation, when the lifting plate 241 moves to the upper limit position, it indicates that the liquid injection needle and the liquid suction needle of the lifting plate 241 have moved to the desired positions and the reaction cup has been withdrawn, and at this time the rotary disk can rotate the reaction cup. When the lifting plate 241 moves down to the lower limit position, it indicates that the liquid suction needle of the lifting plate 241 is inserted below the liquid level in the reaction cup and the liquid suction operation can be performed.

[0064] As shown in Figures 34 and 35, the first liquid injection needle 271 and the second liquid injection needle 272 are connected to the lifting plate 241 by a restricting block, and the restricting block includes a base 56 locked to the lifting plate 241 by a screw, and a screw-type cap 57 screwed onto the base 56, and the base 56 includes a bottom plate 561 and a pillar 562 provided on the bottom plate 561, and the pillar 562 and the bottom plate 561 penetrate through a mounting through hole 563, and a groove 58 is provided on the inner surface of the pillar 562 through which the mounting through hole 563 penetrates, and the groove 58 is recessed radially of the pillar 562, with one side open and the remaining three sides closed.

[0065] As shown in Figures 36 and 37, a screw cap through-hole 571 is opened at the bottom of the screw cap 57, and a guide block 59 is further provided on the first liquid injection needle 271 and the second liquid injection needle 272. The guide block 59 has a cylindrical shape whose diameter matches the diameter of the mounting through-hole 563, and a bump 591 protruding radially is provided on one side of the guide block 59. When installing, the first liquid injection needle 271 and the second liquid injection needle 272 are passed through the screw cap through-hole 571 of the screw cap 57, the guide block 59, and the mounting through-hole 563 of the base 56 in that order, so that the bump 591 of the guide block 59 engages with the groove 58. The engagement between the groove 58 and the bump 591 restricts the first liquid injection needle 271 and the second liquid injection needle 272 in the circumferential direction. Next, the screw cap 57 is tightened onto the column 562, and the screw cap 57 is used to press the bump 591 against the groove 58, thereby restricting the first liquid injection needle 271 and the second liquid injection needle 272 in the axial direction. According to the above structural design, the first liquid injection needle 271 and the second liquid injection needle 272 are connected to the lifting plate 241, and the positions of the first liquid injection needle 271 and the second liquid injection needle 272 remain fixed, ensuring normal liquid injection operation.

[0066] 25, in this embodiment, during cleaning, the rotary disc 231 rotates the reaction cup, and the reaction cup passes through the first basic cleaning unit 37 and the second basic cleaning unit 38 in sequence, thus completing the cleaning operation. If the number of revolutions of the reaction cup by the rotary disc 231 is N2, then N2≧2.

[0067] When the number of revolutions N2=2, the cleaning step includes a first revolution cleaning step S1 and a second revolution cleaning step S2, and the first revolution cleaning step S1 includes the following:

[0068] 1) The rotating disk 231 rotates and drives the reaction cup (not shown) to the liquid injection station of the first basic washing unit 37, and then controls the rotation to stop.

[0069] 2) The first liquid injection needle 271 at the liquid injection station in the first first basic washing unit 37 is controlled to descend and extend into the reaction cup, washing liquid A is injected into the reaction cup, and the magnetic beads in the reaction cup are washed using the injected washing liquid A. After the injection is completed, the first liquid injection needle 271 at the liquid injection station in the first first basic washing unit 37 is controlled to ascend and return to its original position.

[0070] 3) The rotating disk 231 drives the reaction cup to rotate to the liquid suction station in the first basic washing unit 37, and then controls the rotation to stop.

[0071] 4) The liquid suction needle 28 in the liquid suction station in the first basic washing unit 37 is controlled to descend and extend into the reaction cup, and the washing liquid in the reaction cup is sucked and discharged. After discharge is complete, the liquid suction needle 28 in the liquid suction station in the first basic washing unit 37 is controlled to ascend and return to its original position.

[0072] 5) The rotating disk 231 rotates the reaction cup to the liquid injection station in the second first basic washing unit 37, and then stops rotating.

[0073] 6) The first liquid injection needle 271 at the liquid injection station in the second first basic cleaning unit 37 is controlled to descend and extend into the reaction cup, and cleaning liquid A is injected into the reaction cup while the reaction cup vibration mechanism is controlled to collide with the reaction cup, washing the magnetic beads in the reaction cup through a combination of the collision with the injected cleaning liquid A. After the injection is complete, the first liquid injection needle 271 at the liquid injection station in the second first basic cleaning unit 37 is controlled to ascend and return to its original position.

[0074] 7) The rotating disk 231 rotates the reaction cup (not shown) to the liquid suction station in the second first basic washing unit 37, and then stops rotating.

[0075] 8) The liquid suction needle 28 in the liquid suction station in the second first basic washing unit 37 is controlled to descend and extend into the reaction cup, and the washing liquid in the reaction cup is sucked and discharged. After discharge is complete, the liquid suction needle 28 in the liquid suction station in the second first basic washing unit 37 is controlled to ascend and return to its original position.

[0076] 9) The rotating disk 231 drives the reaction cup (not shown) to rotate to the liquid injection station in the second basic washing unit 38, and then controls the rotation to stop.

[0077] 10) The first liquid injection needle 271 at the liquid injection station in the second basic cleaning unit 38 is controlled to descend and extend into the reaction cup, and cleaning liquid A is injected into the reaction cup, while the reaction cup vibration mechanism is controlled to collide with the reaction cup, washing the magnetic beads in the reaction cup through a combination of the collision with the injected cleaning liquid A. After the injection is complete, the first liquid injection needle 271 at the liquid injection station in the second basic cleaning unit 38 is controlled to ascend and return to its original position.

[0078] 11) The rotating disk 231 drives and rotates the reaction cup (not shown) to the liquid suction station in the second basic washing unit 38, and then controls the rotation to stop.

[0079] 12) The liquid suction needle 28 in the liquid suction station in the second basic washing unit 38 is controlled to descend and extend into the reaction cup, and the washing liquid in the reaction cup is sucked and discharged. After discharge is complete, the liquid suction needle 28 in the liquid suction station in the second first basic washing unit 37 is controlled to ascend and return to its original position.

[0080] The above steps complete the first cycle of cleaning step S1.

[0081] The second round cleaning step S2 is different from the first round cleaning step S1 in step 10), but all other steps are the same as the first round cleaning step S1. 10) The second liquid injection needle 272 at the liquid injection station in the second basic cleaning unit 38 is controlled to descend and extend into the reaction cup, and cleaning liquid B is injected into the reaction cup, while the reaction cup vibration mechanism is controlled to collide with the reaction cup, washing the magnetic beads in the reaction cup through a combination of the collision with the injected cleaning liquid B. After the injection is complete, the second liquid injection needle 272 at the liquid injection station in the second basic cleaning unit 38 is controlled to ascend and return to its original position. When the number of revolutions N2 is greater than 2, the cleaning steps include a cleaning step T1 of another revolution and a cleaning step T2 of the last revolution, where the cleaning step T1 of the other revolution is the same as the cleaning step S1 of the first revolution, and the cleaning step T2 of the last revolution is the same as the cleaning step S2 of the second revolution.

[0082] In this embodiment, two types of cleaning liquids are used in the cleaning process, namely, cleaning liquid A and cleaning liquid B. In the liquid injection step of the first basic cleaning unit 37, cleaning liquid A is injected into the reaction cup, and in the liquid injection step of the second basic cleaning unit 38, cleaning liquid B is injected into the reaction cup. Cleaning liquid A has high cleaning ability but leaves many air bubbles after cleaning, while cleaning liquid B is a cleaning liquid from which the remaining air bubbles have been removed. When the unit moves to the first basic cleaning unit 37, the magnetic beads in the reaction cup are washed with the injected cleaning liquid A. When the unit moves to the second basic cleaning unit 38, the injected cleaning liquid B removes the remaining air bubbles in the reaction cup.

[0083] Combining two different types of washing liquid not only has the effect of washing the magnetic beads in the reaction cup, but also makes it possible to remove air bubbles remaining in the reaction cup.

[0084] It should be noted that the term "plurality" in the present examples means "two or more than two." The above examples are merely for the purpose of illustrating the present invention and are not intended to limit the present invention. Those skilled in the art may make various modifications or variations without departing from the spirit and scope of the present invention. Therefore, all equivalent technical solutions should also fall within the scope of protection of the present invention, and the scope of protection of the present invention should be defined by the respective claims. [Explanation of symbols]

[0085] 1. Reagent cartridge, 2. Reagent storage chamber, 3. Magnetic bead reagent tube, 311. Reagent tube gear, 312. Tube protrusion, 4. Reagent rotating disk, 5. Toothed disk, 511. Toothed portion, 512. Notch portion, 6. Reagent tray, 611. Reagent tray cylinder, 612. Reagent through-hole, 7. First drive motor, 8. Caster, 9. Second drive motor, 10. Boss, 11. Toothed disk bearing, 12. First transmission toothed disk, 13. Second transmission toothed disk, 14. Sample transport channel, 15. Incubation tray, 16. Washing tray, 17. Optical detection mechanism, 18. Extinguishing mechanism Consumable bin, 181. detection chip module, 182. tip head module, 183. reaction cup module, 19. cup gripping arm, 20. reagent needle arm, 21. reagent needle washing tank, 22. washing tray cylinder, 221. washing tray separator, 222. upper cylinder space, 223. lower cylinder space, 23. rotating disk mechanism, 231. rotating disk, 232. rotating disk motor and reducer, 2321. rotating shaft, 24. needle lifting mechanism, 241. lifting plate, 242. lifting motor, 25. reaction cup, 251. cup body, 252. cup body flange, 26. Cleaning tank, 261. Annular tank body, 2611. Internal space, 262. Liquid injection needle cleaning tube, 2621. Cylinder, 263. Liquid suction needle cleaning tube, 2631. Outer cylinder, 2632. Inner cylinder, 26321. Cavity, 2633. Annular space, 264. Drain pipe, 27. Liquid injection needle, 271. First liquid injection needle, 272. Second liquid injection needle, 28. Liquid suction needle, 29. Hole, 30. Liquid, 31. Water inlet, 32. Cup hole, 33. Reaction cup through hole, 34. First sensor, 35. Detection ring, 351. Detection groove, 36. Second sensor, 37. First basic cleaning unit, 38. Second basic This cleaning unit, 39. magnet stop ring, 40. magnetic field, 41. reaction cup vibration mechanism, 411. first guide rail, 412. second guide rail, 413. collision block, 4131. arc-shaped end, 42. first collision block rotation axis, 43. second collision block rotation axis, 431. collision bearing, 432. set screw, 44. oval hole, 45. detection tray, 46. third sensor, 47. collision gap, 48. guide bush, 49. guide rod, 50. lead screw, 51. cap screw, 52. upper position sensor, 53. lower position sensor, 54. support rod, 55. detection piece, 56.Base, 561. Bottom plate, 562. Column body, 563. Mounting through-hole, 57. Screw cap, 571. Screw cap through-hole, 58. Groove, 59. Guide block, 591. Bump, 60. 3D mobile robot arm.

Claims

1. A method for uniformly mixing magnetic bead reagents for an immunoassay device, comprising: In a reagent tray of an immunoassay device, a magnetic bead reagent tube filled with a magnetic bead reagent is brought into a variable speed state during the self-rotation process around its central axis in the longitudinal direction, and an impact force is applied to the magnetic bead reagent tube during the self-rotation process around its central axis in the longitudinal direction, thereby dispersing the aggregated magnetic beads and bringing the magnetic bead reagent into a uniformly mixed state; The toothed disc (5) of the reagent tray is designed so that the continuous teeth distributed along the circumferential direction are replaced with intermittent teeth, thereby forming a plurality of toothed portions (511) and notches (512) on the toothed disc (5). The reagent cartridge (1) is attached to the reagent rotating disc (4), and the magnetic bead reagent tube is rotatably connected to the reagent cartridge (1). The reagent rotating disc (4) and the toothed disc (5) rotate relative to each other, driving the reagent tube gear (311) at the bottom of the magnetic bead reagent tube to move along the circumferential direction of the toothed disc (5). During the operation, when the magnetic bead reagent tube is in the toothed portion (511) of the toothed disk (5), the toothed portion (511) engages with the reagent tube gear (311) at the bottom of the magnetic bead reagent tube, causing the magnetic bead reagent tube to rotate; when the magnetic bead reagent tube is in the notch (512) of the toothed disk (5), the magnetic bead reagent tube loses its power for self-rotation, so the self-rotation speed of the magnetic bead reagent tube changes once within the notch (512); when the magnetic bead reagent tube is again in the toothed portion (511) of the toothed disk (5), the toothed portion (511) again engages with the reagent tube gear (311) at the bottom of the magnetic bead reagent tube, causing the magnetic bead reagent tube to change speed once more and return to the self-rotating state; and this is repeated, so that the self-rotation speed of the magnetic bead reagent tube during the operation process is repeatedly changed into a speed-changing state; A method for uniformly mixing magnetic bead reagents for an immunoassay device, characterized in that when a magnetic bead reagent tube moves from a notch (512) of a toothed disk to a toothed portion (511), the toothed portion (511) that has just engaged with a reagent tube gear (311) applies an impact force to the magnetic bead reagent tube, thereby performing an impact action.

2. 2. The method for uniformly mixing magnetic bead reagents according to claim 1, wherein the arc length of the tooth portion (511) is L, and the arc length of the notch portion (512) is L / 2.

3. 2. The method for uniformly mixing magnetic bead reagents according to claim 1, characterized in that a tube protrusion (312) is provided on the inner wall of the magnetic bead reagent tube (3), and when the magnetic bead reagent tube (3) rotates at a variable speed and is subjected to an impact force, the tube protrusion (312) can mix the magnetic bead reagent more uniformly.

4. 4. The method for uniformly mixing magnetic bead reagents according to claim 3, wherein two of the tube protrusions (312) are provided so as to be symmetrically distributed with respect to the central longitudinal axis of the magnetic bead reagent tube (3).

5. During operation, when reagent aspiration is not required, the toothed disc (5) is rotated in a controlled manner and the reagent rotating disc (4) is kept stationary, thereby causing the magnetic bead reagent tube to self-rotate; 2. The method for uniformly mixing magnetic bead reagents according to claim 1, wherein when it is necessary to aspirate various reagents in the aspirating reagent cartridge (1), the reagent cartridge (1) is driven to rotate to a reagent collection point A, the rotation is stopped, and then the reagent rotating disk (4) is controlled to maintain the reagent cartridge (1) at point A without moving, and then the various reagents in the reagent cartridge (1) are aspirated.

6. 6. The method for uniformly mixing magnetic bead reagents according to claim 5, wherein the rotation direction of the toothed disk (5) and the rotation direction of the reagent rotating disk (4) are controlled to be opposite to each other.

7. An immunoassay device, comprising: An immunoassay device comprising: a reagent tray (6); and a washing tray (16) located on one side of the reagent tray (6), wherein the reagent tray (6) uniformly mixes magnetic bead reagents by the magnetic bead reagent uniform mixing method according to any one of claims 1 to 6.

8. The washing tray includes a washing tray cylinder (22), a rotary disk mechanism (23) provided inside the washing tray cylinder (22), and a needle lifting mechanism (24) provided above the washing tray cylinder (22), wherein both a liquid injection needle (27) and a liquid suction needle (28) are provided in the needle lifting mechanism (24), a reaction cup (25) is placed on a rotary disk (231) of the rotary disk mechanism (23), and the reaction cup (25) can be rotated by the rotary disk (231), The immunoassay apparatus according to claim 7, characterized in that a washing tank (26) is provided inside the washing tray cylinder (22) and below the rotating disk (231), and when the needle lifting mechanism (24) moves downward, the liquid injection needle (27) and the liquid suction needle (28) can be moved downward and inserted into the reaction cup (25) to perform a reaction cup washing operation, or after the reaction cup (25) is removed, they can be moved downward and inserted into the washing tank (26) to perform a washing operation of the liquid injection needle and the liquid suction needle.

9. The cleaning tank (26) includes a completely sealed annular tank body (261), a liquid injection needle cleaning tube (262) and a liquid suction needle cleaning tube (263) provided in the annular tank body (261), and the internal spaces of the liquid injection needle cleaning tube (262) and the liquid suction needle cleaning tube (263) are both connected to the internal space of the annular tank body (261). A drain pipe (264) for drainage is further provided on the bottom surface of the annular tank body (261), and the liquid injection needle cleaning tube (262) and the liquid suction needle cleaning tube (263) are connected to the internal space of the annular tank body (261). The immunoassay device according to claim 8, characterized in that the top surfaces of the respective needles are provided with holes (29) for inserting the liquid injection needles and the liquid suction needles, and the liquid injection needle washing tubes (262) and the liquid suction needle washing tubes (263) are distributed in accordance with the positions of the liquid injection needles (27) and the liquid suction needles (28) so that one liquid injection needle washing tube (262) washes one corresponding liquid injection needle (27), and one liquid suction needle washing tube (263) washes one corresponding liquid suction needle (28).

10. The liquid suction needle cleaning tube (263) penetrates the annular tank body (261) vertically, and includes an outer cylinder (2631) and an inner cylinder (2632) provided inside the outer cylinder (2631). An annular space (2633) is formed between the outer cylinder (2631) and the inner cylinder (2632). The annular space (2633) communicates with the internal space (2611) of the annular tank body (261). The top end surface of the inner cylinder (2632) is in communication with the outer cylinder (2631). The immunoassay apparatus of claim 9, characterized in that the hole (29) of the liquid suction needle cleaning tube (263) is provided on the top surface of the outer cylinder (2631) lower than the top surface of the outer cylinder (2631), and a water supply port (31) is further provided in the liquid suction needle cleaning tube (263) located below the annular tank body (261), the water supply port (31) is connected to the bottom of the cavity (26321) of the inner cylinder (2632), and the top of the cavity (26321) of the inner cylinder (2632) is connected to the internal space of the outer cylinder (2631).

11. The immunoassay device of claim 9, wherein the liquid injection needle cleaning tube (262) includes a cylinder (2621), the bottom end of the cylinder (2621) is located at the top of the annular tank body (261), the cavity of the cylinder (2621) is connected to the internal space (2611) of the annular tank body (261), and the hole (29) of the liquid injection needle cleaning tube (262) is located at the top end of the cylinder (2621).

12. 9. The immunoassay device according to claim 8, wherein a reaction cup vibration mechanism (41) is further provided inside the washing tray cylinder (22), the reaction cup vibration mechanism (41) including a first guide rail (411) and a second guide rail (412) provided inside the washing tray cylinder (22), and a collision block (413) slidably connected to the first guide rail (411) and the second guide rail (412). The washing tray cylinder (22) is further provided with a collision block drive mechanism, which drives a push block to move back and forth along the first guide rail (411) and the second guide rail (412), thereby causing the collision block (413) to collide back and forth with the reaction cup (25) on the rotating disk (231) in the liquid injection station, dispersing the magnetic beads in the reaction cup (25) through the collision.

13. The collision block drive mechanism includes a collision block drive motor provided in the cleaning tray cylinder (22) and a first collision block rotation shaft (42) rotatably connected in the cleaning tray cylinder (22), an output shaft of the collision block drive motor is fitted into one end of the first collision block rotation shaft (42) and is rotatably connected thereto, a second collision block rotation shaft (43) is further provided on an end face of the other end of the first collision block rotation shaft (42), a central axis of the first collision block rotation shaft (42) and a central axis of the second collision block rotation shaft (43) do not overlap, and the collision block (413) 13. The immunoassay device according to claim 12, wherein an elongated hole (44) is formed in the first guide rail (411) and the second guide rail (412), and the second collision block rotating shaft (43) is inserted into the elongated hole (44) so ​​as to be slidably connected thereto, whereby the collision block drive motor is controlled to rotate the first collision block rotating shaft (42) and the second collision block rotating shaft (43), and the second collision block rotating shaft (43) comes into contact with the inner surface of the elongated hole (44), thereby driving the collision block (413) to move back and forth along the first guide rail (411) and the second guide rail (412), and repeatedly collides with the reaction cups.

14. The immunoassay device of claim 8, wherein the needle lifting mechanism (24) has three basic cleaning units arranged in sequence around the circumference of the rotating disk (231), the basic cleaning units including two first basic cleaning units and one second basic cleaning unit, each of the first basic cleaning units having one first liquid injection needle (271) and one liquid suction needle (28), the second basic cleaning unit having one integrated two-pronged liquid injection needle (S) and one liquid suction needle (28), the integrated two-pronged liquid injection needle (S) including one first liquid injection needle (271) and one second liquid injection needle (272), and the first liquid injection needle (271), the liquid suction needle (28), the first liquid injection needle (271), the liquid suction needle (28), the integrated two-pronged liquid injection needle (S), and the liquid suction needle (28) are arranged in this order in the needle lifting mechanism (24) along the circumference of the rotating disk (231).

15. The integrated liquid injection twin needle (S) is connected to the lifting plate (241) of the needle lifting mechanism (24) by a limiting block, and the limiting block includes a base (56) provided on the lifting plate (241) and a screw cap (57) screwed onto the base (56). The base (56) includes a bottom plate (561) and a pillar (562) provided on the bottom plate (561). The pillar (562) and the bottom plate (561) penetrate through an attachment through-hole (563). A groove (58) is provided on the inner surface of the pillar (562) through which the attachment through-hole (563) penetrates. The groove (58) is recessed in the radial direction of the pillar (562), with one side open and the remaining three sides closed. A screw cap through-hole (571) is drilled at the bottom of the screw cap (57), and the integrated liquid injection twin needle (S) is further provided with a guide block (59), which is cylindrical in shape and has a diameter that matches the diameter of the mounting through-hole (563). One side of the guide block (59) is provided with a bump (591) that protrudes radially. When mounted, the first liquid injection needle (271) and the second liquid injection needle (272) are inserted through the screw cap through-hole (571) of the screw cap (57), the guide block (59), and the base (5 15. The immunoassay device according to claim 14, wherein the first and second liquid injection needles (271) and (272) are sequentially passed through the mounting through-holes (563) of the guide block (59) so that the bumps (591) of the guide block (59) engage with the grooves (58), and the first and second liquid injection needles (271) and (272) are restricted in the circumferential direction by the engagement of the grooves (58) and the bumps (591). Next, a screw-type cap (57) is fastened to the column (562), and the screw-type cap (57) is used to press the bumps (591) against the grooves (58), thereby restricting the first and second liquid injection needles (271) and (272) in the axial direction.

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