A magnetic separation and washing device, a sample analysis apparatus, and a magnetic separation and washing method

Abstract

The application discloses a magnetic separation and cleaning device, a sample analysis equipment and a magnetic separation and cleaning method. The magnetic separation and cleaning device comprises a magnetic separation disc, which comprises a magnetic separation rotating disc and coaxially fixed inner and outer discs. Configuration grooves are arranged on the inner and outer discs in the circumferential direction and magnetic members are arranged in the grooves. Double-magnetic-pole stations, single-magnetic-pole stations and non-magnetic-pole stations are formed in the circumferential direction of the magnetic separation disc, and the magnetic members of the inner and outer discs have the same magnetic pole polarity at the double-magnetic-pole stations. The magnetic attraction station and the pipetting station are arranged as double-magnetic-pole stations with the same polarity and the same strength, same-polarity magnetic fields are generated on both sides of the reaction cup, the magnetic bead adsorption speed and strength are enhanced, the residence time is shortened, the magnetic field unstable area is formed in the center area of the reaction cup at the pipetting station, the liquid suction needle can be safely inserted into the liquid suction without mis-suction of the magnetic beads, the magnetic loss problem is fundamentally solved, and the cleaning efficiency and the detection flux are improved.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a magnetic separation and cleaning device, a sample analysis equipment, and a magnetic separation and cleaning method. Background Technology

[0002] In the field of clinical in vitro diagnostics, chemiluminescence immunoassay is widely used for the qualitative or quantitative analysis of target components in biological samples such as blood and urine due to its high sensitivity and specificity. Fully automated sample analysis equipment achieves a high degree of automation in the detection process by integrating a series of steps including sample dispensing, reagent dispensing, isothermal incubation, magnetic separation and cleaning, substrate reaction, and optical detection. Among these, the magnetic separation and cleaning module is the core module that determines the accuracy, repeatability, and overall throughput of the analysis. Its principle is as follows: magnetic microparticles with surface-modified specific binding molecules capture the target substance in the sample, and an external magnetic field adsorbs the magnetic beads. During the adsorption state, waste liquid is removed and cleaning solution is added. This process is repeated multiple times to purify the target substance, creating a clean environment for the subsequent substrate luminescence reaction.

[0003] The core of the magnetic separation and cleaning module lies in its magnetic field design. An ideal magnetic field should create a strong and stable gradient within the reaction vessel to ensure that magnetic beads are quickly and fully adsorbed onto the vessel wall and remain adsorbed during liquid aspiration, preventing bead loss and ensuring a low "magnetic loss rate." Simultaneously, to meet high-throughput detection requirements, the residence time of the reaction vessel at each station must be minimized to improve overall efficiency. Therefore, achieving rapid, sufficient, and stable adsorption of magnetic beads under high-speed, short-residence conditions remains a key technical challenge requiring continuous optimization in this field.

[0004] To address this challenge, those skilled in the art have made various design attempts. Chinese invention patent CN119643848B discloses an automatic blood sample testing device, specifically a magnetic separation module integrating dispensing, magnetic attraction, and suction transfer. To ensure sufficient mixing, a mixing component is designed to act on the bottom of the reaction cup, enabling the reaction cup to perform rapid mixing within the in-situ of the magnetic separation module. The magnetic components are distributed in the inner ring of the magnetic separation turntable. This design generates a relatively weak magnetic field, requiring sufficient residence time to ensure... The adsorption rate of magnetic beads on the wall surface is low, which leads to low overall efficiency. Chinese invention patent CN116944126B discloses a magnetic separation cleaning device and method. The disclosed solution sets magnets in the inner disk of the magnetic separation module and specifies that the magnets configured in different functional operation positions are all bipolar. However, the magnetic arrangement of the magnets varies depending on the function. This verifies the magnetic field distribution generated by the bipolar magnets in the reaction cup, but the verification results show that the magnetic field on the side far from the magnet is very weak, indicating insufficient adsorption. CN1197... Chinese invention patent 02559A discloses a magnetic separation cleaning method, a magnetic cleaning device, and an immunoassay analyzer. The specific design incorporates a miniaturized magnetic separation module with a rotating disk having 12 reaction cup receiving positions. The rotating disk is also equipped with a set of liquid injection, liquid aspiration, and substrate addition positions. This design allows for fewer cleaning cycles but requires a larger volume of cleaning solution. Furthermore, the single-sided magnet design allows for a greater number of magnetic attraction positions, mitigating the problem of insufficient strength to some extent. Chinese invention patent CN111562400B discloses a cleaning device and a chemiluminescent immunoassay analyzer. In one specific design of the analyzer, the magnet is moved from the inner disk to the outer disk. To enhance the strength of the magnetic field generated by the magnet within the reaction vessel, part of the magnet on the outer disk is modified into a movable magnet that can be driven to move closer to the reaction vessel, allowing the magnetic beads inside to be more fully adsorbed onto the wall, ensuring cleaning and purification efficiency. However, this design is complex to control and has low reliability. Chinese invention patent CN112119312B discloses a fully automated chemiluminescence immunoassay analyzer, in which magnetic components are alternately arranged on one side of the inner and outer disks, and adjacent magnetic components on the same side have different magnetic properties. This method aims to promote the transfer of magnetic beads between different vessel walls through alternating switching of magnetic field polarity, achieving dispersion and cleaning. However, under high-throughput operating conditions, due to the brief magnetic field instability zone during magnetic field switching, magnetic beads may not be adsorbed onto one side of the vessel wall in a timely and sufficient manner, resulting in "missed" magnetic beads in the central area. In the subsequent waste liquid aspiration step, these free magnetic beads located in the central region are easily carried away by the aspiration needle, resulting in "magnetic loss" and seriously affecting the accuracy and reliability of subsequent detection.

[0005] In summary, existing magnetic separation and cleaning devices, particularly in the polarity configuration and intensity matching of magnets on the inner and outer sides, have not yet resolved the technical contradiction of simultaneously pursuing high detection throughput while ensuring the rapid, sufficient, and stable adsorption of magnetic beads to the cup wall, thus avoiding "magnetic loss" during critical pipetting steps. Therefore, there is an urgent need in this field for a magnetic separation and cleaning device design whose magnetic field arrangement can fundamentally optimize the magnetic field distribution within the reaction cup, thereby ensuring extremely high magnetic bead adsorption reliability and cleaning effect even under high-speed operation. Summary of the Invention

[0006] To address the aforementioned problems, this invention provides a magnetic separation cleaning device, sample analysis equipment, and magnetic separation cleaning method. By arranging several configuration slots at intervals along the circumference on the inner and outer disks, and selectively placing magnetic components within these slots, the magnetic separation disk forms dual-pole, single-pole, and non-magnetic-pole positions along the circumference. At the dual-pole position, the magnetic components on both the inner and outer disks have the same polarity, thereby generating a magnetic field of the same polarity on both sides of the reaction cup. This creates an unstable magnetic field region in the central area of ​​the reaction cup, causing the magnetic beads to disperse and adhere to the cup walls on both sides. This provides a liquid aspiration path free from magnetic bead interference for the aspiration needle inserted near the central axis. Its compact structure allows for flexible configuration of different functional operating positions, achieving efficient adsorption of magnetic beads, safe removal of waste liquid, and uniform substrate addition. This fundamentally reduces the risk of magnetization loss, shortens the magnetic bead adsorption time, and improves the overall detection throughput and the accuracy of the detection results.

[0007] This invention provides a magnetic separation cleaning device, characterized in that it includes a device body, the device body comprising: A magnetic separation disk includes a magnetic separation turntable that can rotate around an axis, and an inner disk and an outer disk that are fixedly disposed on the inner and outer sides of the magnetic separation turntable and are coaxial with the magnetic separation turntable; the magnetic separation turntable is provided with a plurality of receiving positions in the circumferential direction for receiving and driving the reaction cup to rotate. A plurality of configuration slots are spaced apart along the circumferential direction on the inner disk and the outer disk; A magnetic component is disposed within the configuration slot; The magnetic separation disk has several stations along its circumference. Each station is one of a dual-pole station, a single-pole station, or a non-magnetic-pole station. The inner and outer disks corresponding to the dual-pole station are provided with configuration slots, and the magnetic components in the configuration slots are arranged with the same polarity face. The inner or outer disks corresponding to the single-pole station are provided with configuration slots. The inner and outer disks corresponding to the non-magnetic-pole station are not provided with configuration slots.

[0008] By employing the aforementioned technical solution, and through the flexible configuration of dual-pole, single-pole, and non-pole stations along the circumference of the magnetic separation disk, and by ensuring that the magnetic polarity of the magnetic components on the inner and outer disks at the dual-pole station is the same, the problem of unstable magnetic field in the central region of the reaction cup and insufficient magnetic bead adsorption caused by insufficient magnetic field strength on one side or bipolar magnetic field is solved. This design ensures that at the dual-pole station, both sides of the reaction cup are subjected to magnetic fields of the same polarity, creating a weaker or unstable magnetic field region in the central area of ​​the reaction cup. This promotes the dispersion and adsorption of magnetic beads towards the cup walls on both sides, preventing the beads from becoming detached in the central region. This provides a magnetic bead-free aspiration path for subsequent liquid aspiration via insertion of the aspiration needle near the central axis, fundamentally reducing the risk of "magnetic loss." Simultaneously, the enhanced bipolar magnetic field shortens the time required for the magnetic beads to adhere to the cup wall, which is beneficial for improving the overall detection throughput.

[0009] Furthermore, the magnetic separation turntable is provided with operating stations for performing different functions in the circumferential direction, including a liquid injection station, a magnetic suction station, a liquid transfer station, and a substrate addition station; The magnetic suction station and the liquid transfer station are dual magnetic pole stations, and the magnetic components of the inner and outer disks at the same station have the same magnetic polarity and the same magnetic field strength. The liquid injection station is any one of the following: a non-magnetic pole station, a single magnetic pole station, and a dual magnetic pole station; The substrate filling station is a single magnetic pole station.

[0010] By adopting the above technical solution, and explicitly setting the magnetic suction station and the liquid transfer station as dual-polarity stations with the same magnetic polarity and magnetic field strength, while using more flexible magnetic component configurations for the liquid injection station and the substrate addition station, differentiated optimization of the magnetic field distribution for different functional operation positions is achieved. At the magnetic suction station, the identical polarity of the dual-sided magnetic field generates a strong and uniform adsorption force, ensuring that the magnetic beads are quickly and firmly adsorbed onto both sides of the cup wall. At the liquid transfer station, the identical polarity of the dual-sided magnetic field creates an unstable magnetic field region in the center of the reaction cup, allowing the aspiration needle to completely remove waste liquid without accidentally aspirating magnetic beads. This refined magnetic field design for different processes balances efficient magnetic bead adsorption with high safety during liquid aspiration, significantly improving the overall performance and reliability of magnetic separation cleaning.

[0011] Furthermore, there are at least two magnetic suction stations, and the magnetic component at each magnetic suction station has a different magnetic field strength than the magnetic component at the other magnetic suction station.

[0012] By employing the aforementioned technical solution, and by setting up at least two magnetic attraction stations with different magnetic field strengths, the magnetic force experienced by the reaction vessel changes periodically as it passes through these stations. This alternating change in magnetic field strength causes the magnetic beads adsorbed on the vessel wall to undergo minute displacements or vibrations, helping to break up impurities trapped within the beads. This allows the cleaning solution to penetrate and clean the surface of the beads more thoroughly, effectively improving cleaning and purification efficiency. Simultaneously, this alternating strong and weak magnetic field design avoids the problem of excessively dense agglomeration of magnetic beads due to a single strong magnetic field, making them difficult to wet with subsequent cleaning solutions. While ensuring that the magnetic beads are not lost, it achieves deeper cleaning, ultimately improving the accuracy and repeatability of the test results.

[0013] Furthermore, multiple consecutive magnetic attraction stations are spaced apart in the circumferential direction of the magnetic separation turntable. Several adjacent magnetic attraction stations form a magnetic attraction processing module. In each magnetic attraction processing module, the magnetic field strength of several magnetic attraction stations gradually increases from the magnetic attraction station in the middle to the magnetic attraction stations at both ends.

[0014] By employing the aforementioned technical solution, a magnetic adsorption processing module is constructed by integrating multiple continuous magnetic adsorption stations into a magnetic field strength distribution that is "weak in the middle and strong at both ends," providing a gradual adsorption and release mode for the magnetic beads within the reaction vessel. When the reaction vessel enters this module, adsorption is rapidly initiated first under the influence of the strong magnetic field at the ends. Subsequently, it enters the weak magnetic field region in the middle, where the weak magnetic field allows some magnetic beads to be slightly released from the vessel wall, enabling the bead clusters to be more fully dispersed and cleaned in the cleaning solution. Finally, it re-enters the strong magnetic field region at the other end, efficiently recovering the thoroughly cleaned magnetic beads back to the vessel wall. This "strong-weak-strong" magnetic adsorption mode simulates an optimized cleaning process of alternating adsorption and dispersion, significantly enhancing the cleaning effect of the magnetic beads without adding additional mixing structures. It effectively removes non-specific adsorption and is particularly suitable for processing highly viscous or complex samples.

[0015] Furthermore, the radial distance between the magnetic element and the reaction cup at the substrate filling station is greater than the radial distance between the magnetic element and the reaction cup at other stations.

[0016] By employing the aforementioned technical solution, the radial distance between the magnetic component at the substrate loading station and the reaction vessel is set larger than at other stations, resulting in a relatively weaker magnetic field strength at the substrate loading station. This design cleverly avoids the possibility of an excessively strong magnetic field non-specifically adsorbing the luminescent substrate in the substrate liquid onto the magnetic beads or the vessel wall during substrate liquid loading, thus ensuring a full and uniform reaction between the substrate and the marker on the magnetic beads. Simultaneously, the weaker magnetic field allows the reaction vessel to be more effectively mixed after substrate loading without interference from a strong magnetic field, ensuring instantaneous and sufficient contact between the substrate liquid and the magnetic beads. This lays a crucial foundation for the subsequent generation of a stable and reliable optical signal, directly improving the sensitivity and accuracy of the detection.

[0017] Furthermore, it also includes an operating unit, which is disposed above the device body and includes: A dispensing assembly for dispensing cleaning fluid into the reaction vessel; A pipetting mechanism, including a suction needle configured to aspirate waste liquid from the reaction vessel; A substrate dispensing mechanism includes a substrate needle for dispensing substrate liquid into the reaction vessel.

[0018] By adopting the above-mentioned technical solution, a compact and efficient operating unit is constructed by integrating the dispensing assembly, pipetting mechanism, and substrate dispensing mechanism above the magnetic separation turntable of the device body. This operating unit can directly perform liquid dispensing, aspiration, and substrate dispensing operations above each station of the magnetic separation turntable of the device body, completing the entire process without removing the reaction cups from the magnetic separation module, thus simplifying the equipment structure and the reaction cup transfer steps. This highly integrated design not only shortens the processing cycle and increases analytical throughput but also reduces contamination or positional errors that may be introduced by transferring reaction cups between different modules, ensuring that the magnetic separation cleaning process is carried out in a closed-loop, controlled environment, thereby improving the stability and automation level of the overall detection process.

[0019] Furthermore, the dispensing component includes: A cup-gripping rotator is used to grip the reaction cup and drive the reaction cup to rotate around its own axis. A liquid injection channel is provided at the axis of the cup-gripping rotator. The injection needle is coaxially arranged with the rotating gripper cup. The injection needle can extend into the injection channel and act on the reaction cup. The injection needle is used to inject cleaning fluid into the reaction cup.

[0020] By employing the aforementioned technical solution, and by coaxially positioning the injection needle inside the rotating cup gripper that can grasp and rotate the reaction cup, a "rotation-while-injection" operation is achieved for the reaction cup. Simultaneously, the reaction cup is driven to rotate at high speed, utilizing centrifugal force to rapidly create turbulence within the cup, resulting in vigorous and thorough mixing with the existing reaction system liquid or magnetic beads. Compared to static injection or reliance on external mixing mechanisms, this dynamic mixing method offers higher mixing efficiency and more uniform results. It can quickly break up magnetic bead agglomerates, ensuring full contact between the cleaning fluid and the bead surface, thereby significantly improving the efficiency and quality of a single cleaning cycle. Furthermore, the compact design avoids the need for separate mixing stations or complex mixing mechanisms, simplifying the layout of the magnetic separation module and reducing equipment costs and failure rates.

[0021] A sample analysis device includes the above-mentioned magnetic separation and cleaning device, and further includes: a reagent carrying device, a reaction incubation device, a signal detection device, and a first transfer mechanism; A reagent carrier device, used to hold and provide reagents; A reaction incubation apparatus used to receive samples and reagents and to carry out incubation reactions; A signal detection device is used to perform optical detection on the reaction cup from the magnetic separation and cleaning device to obtain analysis results; A first transfer mechanism has a rotating shaft located in the middle region of the reagent carrier, reaction incubation device, magnetic separation and cleaning device, and signal detection device. The first transfer mechanism is used to transfer the reaction cup between the reagent carrier, reaction incubation device, magnetic separation and cleaning device, and signal detection device.

[0022] By adopting the above technical solution, and arranging the rotation axis of the first transfer mechanism at the center of the quadrilateral area enclosed by the four core functional modules—the reagent carrying device, the reaction incubation device, the magnetic separation and cleaning device, and the signal detection device—the first transfer mechanism achieves equal arm length and short path coverage for all functional modules of the entire equipment. This layout allows the cup-grabbing mechanism to quickly and accurately grab and place reaction cups between modules with minimal rotation angle and travel distance. This not only significantly shortens the reaction cup transfer time and increases the overall analytical throughput, but also simplifies the motion control and mechanical design of the first transfer mechanism, reduces the positioning accuracy requirements, and makes the equipment more stable and reliable in operation. Simultaneously, this compact layout optimizes the overall space utilization of the equipment, contributing to its miniaturization.

[0023] A magnetic separation cleaning method, applied to the aforementioned magnetic separation cleaning apparatus, characterized in that the magnetic separation cleaning apparatus includes an apparatus body, the apparatus body comprising: A magnetic separation disk includes a magnetic separation turntable that can rotate around an axis, and an inner disk and an outer disk that are fixedly disposed on the inner and outer sides of the magnetic separation turntable and are coaxial with the magnetic separation turntable; the magnetic separation turntable is provided with a plurality of receiving positions in the circumferential direction for receiving and driving the reaction cup to rotate. A plurality of configuration slots are spaced apart along the circumferential direction on the inner disk and the outer disk; A magnetic component is disposed within the configuration slot; The magnetic separation disk has several stations along its circumference. Each station is one of a dual-pole station, a single-pole station, or a non-magnetic-pole station. At the dual-pole station, both the inner and outer disks have configuration slots, and the magnetic components within these slots have the same polarity. At the single-pole station, either the inner or outer disk has a configuration slot. At the non-magnetic-pole station, neither the inner nor outer disk has a configuration slot. The magnetic separation disk also has operating stations along its circumference for performing different functions, including a liquid injection station, a magnetic suction station, a liquid transfer station, and a substrate addition station. The magnetic suction station and the liquid transfer station are dual magnetic pole stations, and the magnetic components of the inner and outer disks at the same station have the same magnetic polarity and the same magnetic field strength. The liquid injection station is any one of the following: a non-magnetic pole station, a single magnetic pole station, and a dual magnetic pole station; The substrate filling station is a single magnetic pole station; The magnetic separation cleaning method includes the following steps: Reaction vessel transfer procedure: Transfer the reaction vessel to the receiving position of the magnetic separation turntable; Multi-stage cleaning process: The driven magnetic separation turntable rotates around its axis, causing the reaction vessel to pass through the cleaning stages sequentially; each cleaning stage includes: Cleaning fluid filling sub-step: At the filling station, the cleaning fluid is added into the reaction cup through the filling component; Magnetic bead adsorption step: Drive the reaction cup through the magnetic adsorption station in sequence. Utilize the magnetic field generated by the magnetic components with the same magnetic polarity and magnetic field strength on the inner and outer disks to adsorb the magnetic beads and bridging target material in the reaction cup to the reaction cup wall. Waste liquid aspiration and transfer step: Drive the reaction cup to rotate to the transfer station. The magnetic components with the same magnetic polarity and magnetic field strength on the inner and outer disks form an unstable magnetic field region in the center of the reaction cup. Control the aspiration needle to insert into the reaction cup and aspirate the waste liquid. Substrate addition step: Drive the magnetic separation turntable to continue rotating, moving the reaction cup to the substrate addition station, and add the substrate liquid into the reaction cup through the substrate needle; Reaction cup output steps: Drive the magnetic separation turntable to continue rotating, transfer the reaction cup with substrate added to the output port, and complete the magnetic separation cleaning process.

[0024] By employing the aforementioned technical solution, the magnetic separation cleaning method is constructed as a cyclical cleaning process comprising cleaning fluid addition, magnetic bead adsorption, and waste liquid removal. Specifically, the magnetic bead adsorption and waste liquid removal steps utilize dual-pole, same-polarity, and same-strength magnetic components, resulting in a highly efficient and reliable cleaning flow. In the magnetic bead adsorption sub-step, the enhanced bilateral magnetic field ensures that the magnetic beads are fully adsorbed onto the cup wall within a very short residence time, creating conditions for subsequent rapid liquid removal. In the waste liquid removal sub-step, the unstable magnetic field region formed near the central axis of the reaction cup by the same magnetic component allows the suction needle to be safely inserted and remove the waste liquid without accidentally aspirating magnetic beads. This method tightly integrates the advantages of the hardware structure with process control, enabling the entire magnetic separation cleaning process to achieve higher processing speed and better cleaning results while maintaining an extremely low loss of magnetism, thus solving the technical challenge of simultaneously achieving efficiency and reliability in existing methods.

[0025] Furthermore, the dispensing component includes: A cup-gripping rotator is used to grip the reaction cup and drive the reaction cup to rotate around its own axis. A liquid injection channel is provided at the axis of the cup-gripping rotator. The injection needle is coaxially arranged with the gripping cup rotating component. The injection needle can extend into the injection channel and act on the reaction cup. The injection needle is used to inject cleaning fluid into the reaction cup. In the step of adding cleaning fluid, the reaction cup is first gripped by a cup-gripping rotating component and driven to rotate around its own axis. Then, the cleaning fluid is added into the rotating reaction cup through an injection needle coaxially arranged with the cup-gripping rotating component.

[0026] By adopting the above-mentioned technical solution and introducing a dynamic addition method of "rotation first, then addition" in the cleaning solution addition step, the mixing effect between the cleaning solution and the mixture in the reaction vessel is greatly improved. When the rotating gripper drives the reaction vessel to rotate at high speed, the cleaning solution injected from its central axis is rapidly thrown against the vessel wall under the action of centrifugal force. In this process, it generates strong shear and turbulence effects with the original liquid, which can effectively break up the adsorbed magnetic bead clusters and make the surface of the magnetic beads more thoroughly cleaned. Compared with the traditional static addition, this dynamic addition and mixing method has significantly improved mixing efficiency and cleanliness. Especially for viscous samples or magnetic beads that have been tightly clustered after multiple adsorptions, it can achieve better cleaning results, thereby effectively reducing non-specific adsorption and further improving the purity and signal-to-noise ratio of the final detection signal.

[0027] In summary, due to the adoption of the above technical solution, the beneficial effects of the present invention are: 1. This application sets configuration slots on both the inner and outer disks of the magnetic separation disk and arranges magnetic components with the same magnetic polarity at the dual magnetic pole station, so that both sides of the reaction cup are subjected to the same polarity magnetic field. This creates a region with weaker or unstable magnetic field strength in the central area of ​​the reaction cup, thereby causing the magnetic beads to disperse and be attracted to the cup walls on both sides. This avoids the magnetic beads from becoming free in the central area and provides a liquid aspiration path without magnetic bead interference for the liquid aspiration needle to be inserted from near the central axis. This fundamentally reduces the risk of losing magnetism. At the same time, the enhanced dual magnetic field also shortens the time required for the magnetic beads to be attracted to the cup wall, which is beneficial to improving the overall processing and detection throughput of the machine.

[0028] 2. This application optimizes the magnetic field distribution for different functional operating positions by setting both the magnetic suction station and the liquid transfer station as dual-pole stations, with the inner and outer magnetic components at the same station having the same magnetic polarity and magnetic field strength. Simultaneously, it employs more flexible magnetic component configurations for the liquid injection station and the substrate addition station. At the magnetic suction station, the identical polarity of the two magnetic fields generates a strong and uniform adsorption force, ensuring that the magnetic beads are quickly and firmly adsorbed onto both sides of the cup wall. At the liquid transfer station, the identical polarity of the two magnetic fields creates an unstable magnetic field region in the center of the reaction cup, allowing the suction needle to completely remove waste liquid without accidentally aspirating the magnetic beads, thus balancing efficient magnetic bead adsorption with high safety during the liquid transfer process.

[0029] 3. This application sets at least two magnetic suction stations, with the magnetic components at each station having a different magnetic field strength than those at the other station. Alternatively, multiple consecutive magnetic suction stations can be constructed into a magnetic suction processing module where the magnetic field strength gradually increases from the middle to both ends. This causes the magnetic field force experienced by the reaction cup to change periodically as it passes through these stations, resulting in slight displacement or vibration of the magnetic beads adsorbed on the cup wall. This disperses the impurities encased within the magnetic beads, allowing the cleaning fluid to penetrate and clean the surface of the beads more thoroughly. This achieves deeper cleaning without adding an additional mixing structure and effectively removes non-specific adsorption.

[0030] 4. This application sets the radial distance between the magnetic component at the substrate loading station and the reaction cup to be greater than the radial distance between the magnetic component and the reaction cup at other stations. This results in a relatively weak magnetic field strength at the substrate loading station, thus avoiding the excessively strong magnetic field from adsorbing the luminescent substrate in the substrate liquid onto the magnetic beads or the cup wall. This ensures a full and uniform reaction between the substrate and the marker on the magnetic beads. At the same time, the weaker magnetic field allows the reaction cup to be more effectively mixed after substrate loading without being disturbed by the strong magnetic field. This lays a key foundation for the subsequent generation of stable and reliable optical signals, directly improving the sensitivity and accuracy of the detection.

[0031] 5. This application achieves a dynamic filling operation of the reaction cup by coaxially positioning the injection needle in the filling assembly inside the cup-gripping and rotating component, which can grasp and rotate the reaction cup. While adding the cleaning fluid, the reaction cup is driven to rotate at high speed, utilizing centrifugal force and turbulence to vigorously mix the cleaning fluid with the magnetic beads, quickly breaking up any agglomerates. This significantly improves the efficiency and uniformity of a single cleaning cycle. Furthermore, this compact design avoids the need for a separate mixing station, reducing equipment costs and failure rates.

[0032] 6. This application arranges the rotation axis of the first transfer mechanism in the sample analysis device at the center of the quadrilateral area formed by the four core functional modules: reagent carrying device, reaction incubation device, magnetic separation and cleaning device, and signal detection device. This achieves equal arm length and short path coverage of all modules by the first transfer mechanism, enabling the reaction cups to be transferred quickly and accurately within the minimum rotation angle and travel distance. This greatly shortens the reaction cup turnover time, increases the overall analytical throughput, simplifies motion control and mechanical design, reduces positioning accuracy requirements, improves the stability and reliability of equipment operation, and helps to achieve equipment miniaturization.

[0033] 7. This application constructs a magnetic separation cleaning method comprising a cyclic cleaning stage including cleaning fluid addition, magnetic bead adsorption, and waste liquid removal. In the magnetic bead adsorption and waste liquid removal steps, magnetic components with the same polarity and strength of dual magnetic poles are utilized, forming a highly efficient and reliable cleaning process. In the magnetic bead adsorption step, the enhanced dual-sided magnetic field ensures that the magnetic beads are fully adsorbed within a very short residence time; in the waste liquid removal step, the unstable region of the magnetic field is used to achieve safe liquid removal, avoiding magnetization loss. This method tightly integrates hardware advantages with process control, achieving higher processing speed and better cleaning effect while ensuring an extremely low magnetization loss rate, solving the technical challenge of balancing efficiency and reliability in existing methods. Attached Figure Description

[0034] Figure 1 This is a liquid circuit connection diagram of the injection needle and suction needle corresponding to a magnetic separation cleaning device provided in an embodiment of the present invention; Figure 2 This is a liquid circuit connection diagram of the substrate needle corresponding to a magnetic separation cleaning device provided in an embodiment of the present invention; Figure 3 This is a schematic diagram of the magnetic body arrangement structure of the functional operating station of a magnetic separation and cleaning device provided in an embodiment of the present invention; Figure 4 This is a top view of the magnetic structure of the magnetic body of a magnetic separation and cleaning device provided in an embodiment of the present invention, in which all magnetic poles are arranged in an N-pole configuration. Figure 5This is a top view of the magnetic body of a magnetic separation and cleaning device provided in an embodiment of the present invention, showing that all the magnetic elements of the device are arranged with S poles. Figure 6 This is a schematic diagram of the overall structure of a magnetic separation cleaning device provided in an embodiment of the present invention; Figure 7 This is a schematic diagram of the layout of the liquid injection station of the magnetic separation turntable in a magnetic separation cleaning device provided in an embodiment of the present invention; Figure 8 This is a schematic diagram of the magnetic separation turntable magnetic suction station layout of a magnetic separation cleaning device provided in an embodiment of the present invention; Figure 9 This is a schematic diagram of the magnetic separation turntable liquid transfer station layout of a magnetic separation cleaning device provided in an embodiment of the present invention; Figure 10 (a) is a schematic diagram of the filling component of a magnetic separation cleaning device provided in an embodiment of the present invention for preparing the cleaning fluid; Figure 10 (b) is a schematic diagram of the filling component holding the reaction cup in a magnetic separation cleaning device provided in an embodiment of the present invention; Figure 10 (c) is a diagram illustrating the process of adding cleaning fluid to the filling component of a magnetic separation cleaning device provided in an embodiment of the present invention; Figure 11 This is a flowchart illustrating the purification and substrate addition process performed in the reaction vessel of a magnetic separation and cleaning apparatus provided in this embodiment of the invention. Figure 12 This is a three-dimensional structural diagram of a sample analysis device provided in an embodiment of the present invention; Figure 13 This is a top view schematic diagram of a sample analysis device provided in an embodiment of the present invention; Figure 14 This is a schematic diagram of the structure of a rotating mixing mechanism of a sample analysis device provided in an embodiment of the present invention; Figure 15 This is an execution detection state diagram of a signal detection device for a sample analysis equipment provided in an embodiment of the present invention.

[0035] Explanation of reference numerals in the attached figures: 10-Reagent carrier; 11-Reaction incubation device; 12-Magnetic separation and cleaning device; 13-Signal detection device; 16-Rotating mixing mechanism; 17-Tube rack transfer mechanism; 100-Reaction cup; 1011-Reagent rack receiving slot; 1200-Cup gripping rotating component; 1201-First-order aspiration needle; 1202-Second-order aspiration needle; 1203-Third-order aspiration needle; 1204-Fourth-order aspiration needle; 121-Aspiration needle connecting base plate; 1211-First-order injection needle; 1212-Second-order injection needle; 1213-Third-order injection needle; 1214-Fourth-order injection needle; 12111-Aspiration lifting drive motor; 12112-Aspiration lifting transmission screw; 1215-Substrate needle; 122-Addition connecting base plate ; 123-Push rod connecting base plate; 1230-Magnetic separation turntable; 1231-First-stage liquid injection station; 1232-Second-stage liquid injection station; 1233-Third-stage liquid injection station; 1234-Fourth-stage liquid injection station; 1235-Substrate dispensing station; 124-Operating part mounting base plate; 1241-First-stage pipetting station; 1242-Second-stage pipetting station; 1243-Third-stage pipetting station; 1244-Fourth-stage pipetting station; 1251-First magnetic suction position; 1252-Second magnetic suction position; 1253-Third magnetic suction position; 1254-Fourth magnetic suction position; 1255-Fifth magnetic suction position; 1256-Sixth magnetic suction position; 1260-Gripper push rod; 1261-Push rod lifting transmission screw; 1262-Push rod lifting... 12601-Drive motor for lowering; 12701-Push head; 12701-Washing head rotation drive motor; 12702-Transmission drive wheel; 12703-Washing head rotation transmission belt; 12704-Washing head rotation drive wheel; 12705-Tension wheel; 130-Optical signal acquisition unit; 1301-Reading position; 131-Reading hole; 1321-Reading rotation drive motor; 1322-Reading rotation drive wheel; 1323-Reading rotation transmission belt; 141-Reaction cup storage unit; 142-Reaction cup lifting mechanism; 143-Reaction cup transfer unit; 144-Cup handling turntable; 151-Sample tube rack buffer unit; 152-Sample tube rack transfer unit; 160-Cup rotation position; 1601-Rotation motor; 1602-Rotation drive wheel; 1603- Rotary drive belt; 1604-Rotary driven wheel; 1605-Rotary shaft; 1606-Sensing block; 1607-Rotary sensor; 201-Reagent dispensing probe; 202-Sample dispensing probe; 203-Waste liquid suction and transfer mechanism; 2031-Waste suction lifting drive motor; 2032-Waste suction drive wheel; 2033-Waste suction drive belt; 2034-Waste suction drive wheel; 211-First transfer mechanism; 212-Second transfer mechanism; C10-Cleaning section; M11-Inner magnetic component; M12-Outer magnetic component; P10-Peristaltic pump assembly; P20-Plug rod driven pump assembly; P211-Substrate plunger pump; S101-First substrate storage tank; S102-Second substrate storage tank; V10-Three-way valve assembly; W10-Waste liquid recovery section. Detailed Implementation

[0036] The present invention will now be described in detail with reference to the accompanying drawings.

[0037] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0038] Example 1 Figure 1 This is a liquid circuit connection diagram of the injection needle and suction needle corresponding to the magnetic separation cleaning device provided by the present invention. Figure 2 This is a liquid circuit connection diagram of the substrate needle corresponding to the magnetic separation and cleaning device provided by the present invention. The reaction system liquid formed by mixing biological samples and reagents is subjected to isothermal incubation reaction. In order to obtain accurate quantitative results of target substances, magnetic separation and cleaning and substrate addition are required. Finally, the final detection result can be obtained after detection.

[0039] like Figure 1 As shown, the present invention has multiple reaction cup receiving positions arranged in the circumferential direction of the magnetic separation turntable 1230, each of which can receive reaction cup 100. A fixed inner and outer disk are coaxially arranged on the inner and outer sides of the magnetic separation turntable 1230, respectively. Configuration grooves are provided in a portion of the circumferential direction of the inner and outer disks. Magnetic components are placed in at least a portion of the configuration grooves to form different operating positions that cooperate with the magnetic separation turntable 1230. Here, the magnetic separation cleaning device 12 has four injection stations, and correspondingly, four transfer stations. The first-order injection needle 1211 is fluidly connected to one of the piston rod drive pumps in the piston rod drive pump group P20, and finally connected to the cleaning section C10 through pipes and valves. The cleaning section C10 can have at least one cleaning tank arranged side-by-side, thus achieving… For a more continuous supply of cleaning fluid, the second-stage injection needle 1212 is fluidly connected to another piston rod driven pump within the piston rod driven pump assembly P20, and ultimately connected to the cleaning section C10 via pipes and valves. Similarly, the third-stage injection needle 1213 and the fourth-stage injection needle 1214 have the same connection structure. A three-way valve assembly V10 is also configured between the piston rod driven pump assembly P20 and the aforementioned first-stage injection needle 1211, second-stage injection needle 1212, third-stage injection needle 1213, and fourth-stage injection needle 1214. This allows the four different injection needles to converge and connect to the same cleaning section C10. The suction needles corresponding to the first-stage injection needle 1211, second-stage injection needle 1212, third-stage injection needle 1213, and fourth-stage injection needle 1214 are connected as follows: Figure 1As shown, the first-order suction needle 1201 is connected to one of the peristaltic pumps in the peristaltic pump group P10. Preferably, the peristaltic pump is used as the suction force driving the suction needle, which can avoid problems such as air blockage and achieve more complete transfer of liquid in the reaction cup 100. The peristaltic pump is also connected to the waste liquid recovery section W10, which is equipped with at least one waste liquid storage tank. Here, the first-order suction needle 1201 can be inserted into the reaction cup 100 from the central axis of the reaction cup 100 to suction liquid. At the first-order liquid transfer station, a first magnetic element is arranged in the configuration slots of the inner and outer disks. The first magnetic element located in the inner disk is denoted as the inner magnetic element M11, and the first magnetic element located in the outer disk is denoted as the outer magnetic element M12. The inner magnetic element M11 and the outer magnetic element M12 have the same magnetic and magnetic field strength, and here... The inner magnetic component M11 and the outer magnetic component M12 can be designed with their N poles facing each other. The N poles of both magnetic components are arranged close to the wall of the reaction cup 100. The influence of the same magnetism and the same magnetic field strength makes the central region of the reaction cup 100 a magnetically unstable region. The magnetic beads in this region cannot exist stably. Under the action of the magnetic components with the same magnetic field strength, the magnetic beads will be quickly dispersed and adsorbed near the inner or outer disk wall. In this way, when the first-order aspiration needle 1201 is used for liquid transfer, it can be ensured that the magnetic beads inside the reaction cup 100 are basically not lost. The second-order aspiration needle 1202 is connected to another peristaltic pump in the peristaltic pump group P10. This peristaltic pump is connected to the same waste liquid recovery section W10. Similarly, the third-order aspiration needle 1203 and the fourth-order aspiration needle 1204 also have the same connection structure.

[0040] Preferably, in one case, the peristaltic pump unit P10 can be a four-channel peristaltic pump driven by a single motor, making the overall structural design more compact and reasonable.

[0041] like Figure 2 As shown, the magnetic separation cleaning device 12 also includes a substrate filling station 1235. The substrate needle 1215 is fluidly connected to the substrate storage section. To ensure that the equipment is suitable for batch continuous operation, the substrate storage section includes two connection points for installing the first substrate storage tank S101 and the second substrate storage tank S102, respectively. The two substrate storage tanks are fluidly connected to the substrate needle 1215 through a two-position three-way valve. In order to accurately fill the substrate, a substrate plunger pump P211 is also configured between the substrate needle 1215 and the substrate storage tank three-way valve. The substrate plunger pump P211 can be driven independently to ensure accurate and efficient substrate filling. A drive three-way valve is also connected between the substrate plunger pump P211 and the substrate storage tank three-way valve, so that the substrate can be drawn from one of the substrate storage tanks and filled into the reaction cup 100.

[0042] like Figures 3-5 It can be seen that the magnetic separation turntable 1230 includes multiple reaction cup receiving positions, which can receive the transferred reaction cups 100 and drive the reaction cups 100 to rotate. Figures 3-5The diagram illustrates that the magnetic separation turntable 1230 can drive the reaction cup 100 to rotate clockwise. The reaction cup 100 is first rotated to a position that aligns with the first-stage injection station 1231 of the magnetic separation cleaning device 12. At this position, the first-stage injection needle 1211 can initially inject a preset amount of cleaning solution into the reaction cup 100. Since the reaction cup 100 still contains the incubated reaction system liquid, the amount of cleaning solution injected into the first-stage injection station 1231 is small, sufficient for initial dilution and cleaning. Neither the inner nor outer disk of the first-stage injection station 1231 is equipped with magnetic components; only simple cleaning solution injection is required here. Then, the magnetic separation turntable 1230 drives the reaction cup 100 to the first magnetic attraction position 1251. At position 1251, the inner and outer disks are provided with configuration slots, each containing a third magnetic element. The two separately arranged third magnetic elements have the same magnetic and magnetic field strength. Under their influence, the magnetic beads inside the reaction cup 100 cause the target material to adhere separately to the cup wall near the magnetic element, allowing the target material to be initially agglomerated and adsorbed. This separate adsorption allows for more thorough cleaning of the target material. The magnetic separation turntable 1230 continues to rotate, moving the reaction cup 100 to the second magnetic attraction position 1252. Here, the inner and outer disks of the second magnetic attraction position 1252 are provided with configuration slots, each containing a second magnetic element. The two separately arranged second magnetic elements have the same magnetic and magnetic field strength. Preferably, the magnetic field strength of the second magnetic element is less than that of the third magnetic element. The magnetic field strength of the two magnetic elements is preferably set to a ratio between 0.78 and 0.95. This allows the magnetic fields of the two magnetic attraction positions to change, resulting in a change in the adsorption position and area of ​​the magnetic beads within the reaction cup 100. This enables the magnetic beads to drive the target material with relatively large relative motion, improving cleaning efficiency, reducing the existence of magnetic dead zones, and preventing excessive aggregation of the magnetic beads during magnetic attraction. The magnetic beads in the second magnetic attraction position 1252 can both drive the target material to move sufficiently, ensuring cleaning efficiency, and maintain a moderate magnetic attraction. The magnetic separation turntable 1230 continues to rotate, moving the reaction cup 100 to the third magnetic attraction position 1253. At the third magnetic attraction position 1253, a third magnetic element is arranged in the configuration slots of the inner and outer disks. Within the suction position, the magnetic beads inside the reaction cup 100 undergo alternating magnetic attraction—strong magnetic attraction, weak magnetic attraction, and strong magnetic attraction. Preferably, the magnetic separation turntable 1230 drives the reaction cup 100 to move with intermittent rotational motion, interspersed with 6-11 seconds of stillness between rotational intervals. This ensures sufficient magnetic attraction through three magnetic attraction processes. Simultaneously, the arrangement of magnetic components on both sides strengthens the magnetic field. Compared to existing technologies requiring longer dwell times, the magnetic component arrangement of this invention enables faster magnetic adsorption. In schemes with magnetic components arranged on one side, a magnetic dwell time of 15-20 seconds is typically needed to ensure sufficient adsorption. This invention is more suitable for high-speed diagnostic scenarios.As the magnetic separation turntable 1230 continues to rotate, the reaction cup 100 is positioned within the first-order pipetting station 1241. Both the inner and outer disks of the first-order pipetting station 1241 contain mounting slots, each containing a first magnetic element. The first magnetic element located on the inner disk is designated as the inner magnetic element M11, and the first magnetic element located on the outer disk is designated as the outer magnetic element M12. The inner magnetic element M11 and the outer magnetic element M12 have the same magnetic and magnetic field strength. Preferably, the magnetic field strength of the first magnetic element is the same as that of the third magnetic element. The first-order suction needle 1201 included in the magnetic separation cleaning device 12 can be inserted into the reaction cup 100 near its central axis to apply the liquid. The reaction cup 100 is attracted and moved, and then, as the magnetic separation turntable 1230 continues to rotate, it is positioned at the second-stage injection station 1232. Here, the second-stage injection station 1232 only has a fourth magnetic component arranged in the configuration slot of the outer disk. The fourth magnetic component has the same magnetism as the first magnetic component, but its magnetic field strength is less than that of the first magnetic component. Preferably, to ensure the versatility of components within the module, the fourth magnetic component has the same magnetic field strength as the second magnetic component. Afterward, the reaction cup 100 is positioned at the same three-stage magnetic attraction position as before. Then, the cleaning liquid is transferred using the second-stage suction needle 1202 at the second-stage pipetting station 1242. The reaction cup 100 continues to rotate and is positioned at the third-stage injection station 1233. Subsequently... After three magnetic attraction cycles, the reaction cup 100 rotates to the third-stage pipetting station 1243, where the third-stage suction needle 1203 aspirates the cleaning solution. Preferably, the pipetting stations also include at least one magnetic attraction position. The magnetic separation disk rotates to align the reaction cup 100 with the fourth-stage injection station 1234. The magnetic component configuration of the fourth-stage injection station 1234 differs from that of the previous injection stations. Here, both the inner and outer disks are equipped with fourth magnetic components, making the final magnetic attraction stronger and achieving a better auxiliary mixing effect. The magnetic separation disk 1230 continues to rotate, aligning the reaction cup 100 with the fourth magnetic attraction position 1254, the fifth magnetic attraction position 1255, and the sixth magnetic attraction position 1256. Preferably, this is... To facilitate the adsorption of magnetic beads closer to the bottom of the cup, the heights of the magnetic components at the three magnetic adsorption positions are arranged in descending order. After completion, the reaction cup 100 is placed in the IV-stage pipetting station 1244, where the IV-stage suction needle 1204 is used to aspirate and transfer cleaning fluid to complete the cleaning operation within the reaction cup 100. Then, the reaction cup 100 is placed in the substrate filling station 1235, and the substrate liquid is added into the reaction cup 100 using the substrate needle 1215. The substrate filling station 1235 is equipped with magnetic components arranged radially spaced from the reaction cup 100 along the turntable. Preferably, the radial distance between the magnetic components in the substrate filling station 1235 and the reaction cup 100 is greater than the radial distance between the magnetic components and the reaction cup 100 at other stations.The spacing between the reaction cups is within a range of 2 to 10 times their original size. At the substrate filling station 1235, the gripper holds the reaction cup 100 and raises it by a preset distance so that the magnetic field influence area of ​​the magnetic component can cover at least a portion of the bottom area of ​​the reaction cup 100. After being raised, the reaction cup 100 can be rotated. Here, the magnetic field influence of the magnetic component is used to ensure that the added substrate is mixed more evenly and quickly. After the substrate filling is completed, the magnetic separation and cleaning device 12 can output the reaction cup 100.

[0043] Depend on Figures 6-9It is understood that the magnetic separation cleaning device 12 includes a device body at the bottom and an operating part at the top. The device body includes a magnetic separation turntable 1230 that can be driven to rotate. The magnetic separation turntable 1230 is arranged in an annular space between the stationary inner and outer discs in the magnetic separation disk. The magnetic separation turntable 1230 has multiple spaced receiving positions arranged in the circumferential direction, with each pair of receiving positions having a substantially equal spacing distance. Preferably, the outer disc can be wrapped with a heat insulation layer to ensure that the magnetic separation turntable 1230 can maintain a relatively constant reaction temperature. At least part of the circumferential direction of the inner and outer discs... Configuration slots are provided, with at least some of them located at corresponding intervals on the inner and outer disks. Magnetic components with the same magnetic properties are configured in the corresponding configuration slots. Preferably, the N poles of all magnetic components are arranged close to the reaction cup 100. Alternatively, the S poles of all magnetic components can be arranged close to the reaction cup 100 to apply a magnetic field to the reaction cup 100 within the magnetic separation turntable 1230 from both inside and outside directions. This allows the magnetic beads within the reaction cup 100 to drive the bridged target detection material to adhere to the wall of the reaction cup 100, facilitating subsequent aspiration of the cleaning liquid by the aspiration needle. The operating unit includes a suction needle connecting base plate 121, a push rod connecting base plate 123, and a dispensing connecting base plate 122 arranged sequentially along the height direction. An operating unit configuration base plate 124 is also arranged at the lower part of the magnetic separation disk. The suction needle connecting base plate 121 is located at the top layer and is used to install the suction needle and drive the suction needle to rise and fall independently. The push rod connecting base plate 123 is located between the suction needle connecting base plate 121 and the dispensing connecting base plate 122. A gripper push rod 1260 is installed on the push rod connecting base plate 123. The gripper push rod 1260 is arranged coaxially with the dispensing assembly and can be inserted into the dispensing assembly and act on the gripper of the cup rotating part 1200. The dispensing connecting base plate 122 is located below the push rod connecting base plate 123 and is used to install the dispensing assembly and drive the dispensing assembly to rise and fall as a whole. To ensure the stability of the top-layer suction needle connecting base plate 121 during movement and to prevent interference with other layer operation units, the suction needle connecting base plate 121 is configured to be driven to rise and fall independently relative to the device body. An upwardly extending support structure is provided on one side of the operation unit configuration base plate 124. The suction lifting drive motor 12111 is fixedly mounted on the support structure of the operation unit configuration base plate 124. One end of the suction lifting transmission screw 12112 is connected to the suction lifting drive motor 12111, and the other end is connected to a horizontal extension block at the top of the support structure. The suction needle connecting base plate 121 is threadedly connected to the suction lifting transmission screw 12112, so that the suction needle connecting base plate 121 can independently rise or fall through the forward or reverse rotation of the suction lifting drive motor 12111.A plurality of suction needles for aspirating cleaning liquid are fixedly connected to the suction needle connecting base plate 121. Here, there are four suction needles, namely the first-order suction needle 1201, the second-order suction needle 1202, the third-order suction needle 1203, and the fourth-order suction needle 1204 mentioned above. The spacing between each pair of suction needles is the same, which makes the operation and control of the device body simpler. In order to reduce reliability problems such as bending, blockage and breakage of suction needles due to obstruction, each suction needle and the suction needle connecting base plate 121 also includes an elastic element, which can compress the elastic element when the suction needle is obstructed, thereby protecting the suction needle and avoiding the aforementioned problems. The push rod connecting base plate 123 is movably connected to the dispensing connecting base plate 122, so that the push rod connecting base plate 123 can rise and fall synchronously with the dispensing connecting base plate 122 relative to the device body. The push rod connecting base plate 123 can also be driven to rise and fall independently relative to the dispensing connecting base plate 122, thereby driving the gripper push rod 1260 to rise and fall independently within the injection channel. The push rod connecting base plate 123 and the dispensing connecting base plate 122 are guided by several first guide rods; preferably, two first guide rods are arranged here. The push rod connecting base plate 123 can also be raised and lowered by push rods. The drive mechanism enables independent lifting and lowering relative to the filling connection base plate 122. The push rod lifting drive mechanism includes a push rod lifting drive motor 1262 connected to the push rod connection base plate 123, and a push rod lifting transmission screw 1261 that passes through the push rod connection base plate 123 and is rotatably limited to the filling connection base plate 122 via a rotating shaft at its bottom end. The push rod lifting drive motor 1262 generates relative rotational motion with the push rod lifting transmission screw 1261 by means of a drive current, thereby driving the push rod connection base plate 123 to lift and lower relative to the filling connection base plate 122 through threaded engagement. The push rod connection base plate 123 is connected to at least two gripper push rods 1260; here, there are four gripper push rods 1260, which, in conjunction with four cup-gripping rotating parts 1200, can perform clamping and gripping operations on the reaction cup 100.The filling connection base plate 122 is configured to be driven to independently raise and lower the filling assembly relative to the lower device body. The filling connection base plate 122 and the operation unit mounting base plate 124 are guided by several second guide rods. Preferably, three second guide rods are spaced apart between them. The filling lifting drive motor is mounted on the filling connection base plate 122. The filling lifting transmission screw passes through the filling connection base plate 122 and its lower end is connected to the magnetic separation disk. Preferably, the lower end of the filling lifting transmission screw is fixedly connected to a specific position on the inner disk and can be configured as a rotatable movable connection via a shaft or the like. The filling lifting drive motor generates relative rotational motion with the filling lifting transmission screw through a drive current, thereby driving the filling assembly through threaded engagement. The filling connection base plate 122 can be raised and lowered independently. When the filling connection base plate 122 is raised and lowered, the push rod connection base plate 123 is raised and lowered synchronously through the movable connection relationship. The filling connection base plate 122 is connected to no less than two filling components. The number of filling components can be set to four to cooperate with four gripping cup rotating parts 1200 to hold the reaction cup 100 and then add cleaning fluid. In order to add substrate more accurately and efficiently, a substrate filling component is also provided here in cooperation with the substrate needle 1215. In order to reduce the difficulty of system design and ensure better system maintainability, the structure and configuration of the substrate filling component and the filling component are basically the same. The reaction cup 100 in the receiving position can be driven to rotate to different positions so that it can cooperate with the filling component and the aspiration needle to perform cleaning fluid filling and aspiration operations respectively.

[0044] A lifting transmission block is fixedly connected to the suction needle connecting base plate 121. An internal thread is provided in the center hole of the lifting transmission block. The suction lifting transmission screw 12112 passes through the lifting transmission block, and the two are threadedly connected. The end of the suction lifting transmission screw 12112 is connected to the suction lifting drive motor 12111. Thus, the forward or reverse rotation of the suction lifting drive motor 12111 can drive the suction needle connecting base plate 121 to rise or fall. To precisely constrain the lifting movement, several third guide rods are connected between the push rod connecting base plate 123 and the filling connecting base plate 122; here, two third guide rods are used. The push rod lifting transmission screw 1261 passes through the push rod connecting base plate 123 and is constrained by the filling connecting base plate 122. Here, the bottom end of the push rod lifting transmission screw 1261 is rotatably connected to and constrained by the filling connecting base plate 122 via a bearing. The push rod lifting transmission screw 1261 passes through the push rod lifting drive motor 1262 fixedly connected to the push rod connecting base plate 123, thus enabling the push rod to rise and fall. The drive motor 1262 can generate relative rotational motion between the motor and the lead screw by relying on the drive current, and then drive the push rod connecting base plate 123 to move up and down through the threaded connection. Several first guide rods are also fixedly connected between the push rod connecting base plate 123 and the filling connecting base plate 122; here, two first guide rods are shown. Several second guide rods are arranged between the operating part mounting base plate 124 and the filling connecting base plate 122; here, three second guide rods are shown spaced apart between them. The filling lifting transmission lead screw passes through the filling connecting base plate 126. 22 is connected to the lower magnetic separation disk. The lower end of the filling lifting transmission screw is fixedly connected to a specific position of the inner disk, and can be configured as a rotatable movable connection through a rotating shaft, etc. The filling lifting transmission screw passes through the filling lifting drive motor fixedly connected to the filling connecting base plate 122. In this way, the filling lifting drive motor can generate relative rotational motion between the motor and the screw by relying on the drive current. Then, through the threaded connection, the filling connecting base plate 122 can be driven to move up and down. The filling lifting drive motor can generate relative rotational motion between the filling lifting drive motor and the filling lifting transmission screw by relying on the drive current. Then, through the threaded connection between the filling lifting transmission screw and the filling connecting base plate 122, the filling head connecting base plate is driven to move up and down. While the filling connecting base plate 122 is driven to move up and down, it can drive the push rod connecting base plate 123 to move up and down synchronously, making the motion drive of the entire operating part simpler. At the same time, the various functional units integrated on the upper part can be driven independently, making the operating part more flexible. The composite drive of multiple motors also gives the upper operating part a higher degree of freedom and functional integration.

[0045] After the mixture in reaction cup 100 has completed the incubation reaction, the reaction cups 100 can be transferred one by one to the magnetic separation and cleaning device 12 to complete cleaning and substrate addition operations, forming a mixed liquid system suitable for testing. The reaction cups 100 in the receiving position of the magnetic separation turntable 1230 in the magnetic separation and cleaning module are driven to rotate to the first-stage injection station 1231 to add a preset amount of cleaning liquid with the first-stage injection needle 1211. Here, the first-stage injection needle 1211 can be fixedly connected to the injection connection base plate 122 by a connecting block. In this way, the first-stage injection needle 1211 can move up and down with the injection connection base plate 122. In order to ensure the accuracy of the first-stage injection and reduce the possibility of splashing and other contamination during the injection process, the first-stage injection needle 1211... The portion of the liquid that passes through the filling connection substrate 122 and is exposed is longer than the length of the injection needle inside the filling assembly but shorter than the length of the suction needle. After filling, the magnetic separation turntable 1230 can be driven to rotate, causing the reaction cup 100 to rotate intermittently through several slots for configuring magnetic components. This magnetic attraction of magnetic beads and bridging target materials to the wall of the reaction cup 100 is repeated several times. As the rotation continues, the reaction cup 100 is driven to engage with the first-order suction needle 1201, i.e., the reaction cup 100 is driven to engage with the first-order pipetting station 1241. At this point, the first-order suction needle 1201 can be lowered by the suction lifting drive motor 12111 to insert into the reaction cup 100. It can be inserted from a position near the center line to a specific position below the liquid surface. Subsequently, as the liquid aspiration process proceeds, the height of the aspiration needle gradually decreases with the drop in liquid level until aspiration is complete. The first-stage aspiration needle 1201 is then driven upwards to detach from the reaction cup 100. The magnetic separation turntable 1230 is driven to continue rotating until it engages with the second-stage injection station 1232. At this point, the injection lifting drive motor drives the injection assembly to lower its height to at least a portion of the mouth of the reaction cup 100. The injection assembly then clamps and lifts the reaction cup 100, allowing the cleaning fluid to be injected into the reaction cup 100 while connected to the injection assembly. This lowers the outlet position of the cleaning fluid during injection, preventing splashing due to excessive injection height. To reduce the risk of splashing during cleaning fluid injection... Due to the magnetic influence during the injection process, the injection component can drive the reaction cup 100 to rise a preset distance before performing cleaning fluid injection and mixing. To achieve the combined functions of cleaning fluid injection and rotational mixing using the injection component, an injection needle fixing part is also connected to the injection connecting base plate 122. The injection needle connected to the injection needle fixing part can be at least partially inserted into the injection component, and the axis of the injection needle is aligned with the axis of the injection component. The injection component and the injection needle can move synchronously up and down driven by the injection connecting base plate 122. The injection connecting base plate 122 is then connected to the shampoo head rotation drive motor 12701. The output of the shampoo head rotation drive motor 12701 is connected to the transmission drive wheel 12702, and the transmission drive wheel 12702 is wound around the shampoo head rotation transmission belt 12703.The shampoo rotating drive belt 12703 is also wound around and connected to multiple shampoo rotating drive wheels 12704. This allows the same shampoo rotating drive motor 12701 to drive multiple shampoo rotating drive wheels 12704 to rotate. These shampoo rotating drive wheels 12704 can drive the cup-gripping rotating component 1200 within the dispensing assembly to rotate, causing the reaction cup 100 connected to the dispensing assembly to rotate. The multiple shampoo rotating drive wheels 12704 can drive multiple reaction cups 100 to rotate, efficiently mixing the magnetic beads and cleaning fluid within the reaction cup 100. To ensure that the shampoo rotating drive belt 12703 can be height-adjusted... To effectively tighten the belt, multiple tensioning pulleys 12705 are configured between the rotating drive wheels 12704. This configuration results in a lower cost and higher maintainability for the entire pulley drive mechanism. After the cleaning solution is added, the reaction cup 100 can be placed back into the magnetic separation turntable 1230. The adding component is driven back to the set position, and the magnetic separation turntable 1230 rotates so that the reaction cup 100 can cooperate with the second-stage aspiration needle 1202 to draw up the cleaning solution. This magnetic aspiration adding operation can be repeated. The cleaning operation can be repeated two, three, or more times to ensure that the target material after cleaning has higher purity and thus higher detection accuracy.

[0046] Depend on Figure 10 (a) Figure 10 (b) Figure 10(c) As can be seen, this explanation uses the second-order injection needle 1212 in conjunction with the second-order injection position as an example. The second-order injection needle 1212 can be at least partially inserted into the dispensing assembly, and the tip of the second-order injection needle 1212 is at least partially exposed outside the outer shell of the dispensing assembly. The center of the gripper push rod 1260, which is coaxially arranged with the second-order injection needle 1212, allows the second-order injection needle 1212 to pass through. The bottom of the gripper push rod 1260 is equipped with a push head 12601. Preferably, the push head 12601 has a conical structure. The bottom of the shampoo rotating drive wheel 12704 is connected to the connecting end of the cup gripping rotating component 1200 through an extension structure. The connecting end of the cup gripping rotating component 1200 is rotatably connected to the dispensing assembly through a rotating shaft. Thus, the shampoo rotating drive wheel 12704 outputs... The rotational motion of the component drives the connected cup-gripping rotating member 1200 to rotate. The other end of the cup-gripping rotating member 1200, opposite the connecting end, includes several separate grippers. The gripper push rod 1260 can be driven to move up and down, causing its push head 12601 to act at different positions inside the cup-gripping rotating member 1200. The push head 12601 can be driven to contact and act on the cup-gripping rotating member 1200, changing the opening of the grippers so that the grippers can hold the reaction cup 100 in the receiving position. The dispensing component is driven to lower its height to pick up the reaction cup 100 within the magnetic separation turntable 1230. When the dispensing component approaches the reaction cup 100, the gripper push rod 1260 can be driven to move and contact and act on the cup-gripping rotating member 1200. 0. The opening of the gripper changes, allowing it to hold the top opening of the reaction cup 100. After gripping the reaction cup 100, the gripper push rod 1260 rises, and the gripper retracts inward under its own elasticity, thus clamping the connected reaction cup 100 to complete the take-up operation. The gripper is made of metal or non-metallic material with specific strength, possessing elastic characteristics that deform under pressure. The top of the gripper is connected to the connecting end, and the inner walls of multiple grippers cooperate to form an action area. In its natural state, the area of ​​the action area gradually decreases from top to bottom. When the push head 12601 at the bottom of the gripper push rod 1260 extends into the action area, the inner wall of the gripper is close to the push head 12601. As the height of the push head 12601 gradually decreases, the gripper is pushed radially outward. When the jaws open, elastic deformation occurs, allowing the top of the reaction cup 100 to extend into the gripper. Then, as the pusher head 12601 rises, the jaws return to their original position under their own elastic force. At this point, the bottom of the jaws abuts against the outer top wall of the reaction cup 100, using their own elastic force to hold the reaction cup 100. The connected reaction cup 100 can then be driven to rotate and / or filled with cleaning fluid by the second-stage injection needle 1212. After the cleaning fluid filling is complete, the jaw pusher 1260 can be driven again to contact the cup-gripping rotating component 1200, increasing the jaw opening and releasing the reaction cup 100 into the magnetic separation turntable 1230. Preferably, to improve the maintainability of the module, the operating station adjacent to the last-stage suction needle is configured as the substrate filling station 1235.The substrate filling station 1235 here uses essentially the same unit assembly and fitting for its substrate filling mechanism and components, except that the central injection needle is replaced with a substrate needle 1215. After substrate filling is completed, the magnetic separation turntable 1230 drives the reaction cup 100 to rotate to the output port to complete the output.

[0047] To demonstrate the advantages of the magnetic component configuration within the magnetic separation cleaning device 12 of the present invention, the same drive control program was used to verify the detection results of the magnetic separation turntable 1230 with different configurations of the magnetic separation cleaning device 12. The following different detection schemes were verified: (1) Magnetic components were configured in one of the inner or outer disks of the magnetic separation cleaning device 12, forming a single-sided magnetic attraction scheme similar to that in the prior art on the inner side of the reaction cup 100, and the system containing this type of magnetic separation cleaning device 12 was marked as Comparative Example 1; (2) Magnetic components were arranged in a manner similar to that of the present invention, with magnetic components arranged in at least a portion of the inner and outer disks. Although the magnetic field strength is the same, the magnetic properties of the magnetic components in the same operating position are opposite. For example, at the liquid transfer position, the N pole of the inner disk magnetic component is close to the reaction cup 100 while the S pole of the outer disk is close to the reaction cup 100. The system containing this type of magnetic separation cleaning device 12 is marked as Comparative Example 2; (3) The scheme of the present invention arranges the magnetic components, and arranges the magnetic components at least in some positions of the inner disk and the outer disk, and the magnetic and magnetic field strengths are the same. Here, the N pole is close to the reaction cup 100 for verification. The system containing this type of magnetic separation cleaning device 12 is marked as Example 1. The detection CV results and loss rate statistics of various detection systems are shown in Table 1.

[0048] Table 1. CV results and loss rate statistics of different detection systems.

[0049] Note: In condition 1, the magnetic bead concentration is 0.2 mg / ml and the glycerol concentration is 0%; in condition 2, the magnetic bead concentration is 0.2 mg / ml and the glycerol concentration is 20%; in condition 3, the magnetic bead concentration is 0.8 mg / ml and the glycerol concentration is 0%; in condition 4, the magnetic bead concentration is 0.8 mg / ml and the glycerol concentration is 20%. The one-step method refers to the reaction vessel, after incubation in the reaction dish, being transferred to the magnetic separation module for purification and cleaning before detection. The two-step method refers to the reaction vessel being transferred to the magnetic separation module for purification and cleaning after incubation in the reaction dish, then transferred back to the magnetic separation module for secondary magnetic separation and cleaning, and finally transferred to the detection module for detection.

[0050] The test results above show that in Comparative Example 1, the single-sided magnetic attraction scheme combined with the magnetic separation turntable of the present invention results in the magnetic components not being able to perform reliable cleaning and purification within the same time frame. As the concentration of magnetic beads increases, the loss rate during the detection process is higher, and the overall CV value of the detection results is relatively high. This also indicates that in the timing sequence of the present invention, the single-sided magnetic attraction scheme cannot form sufficient and effective adsorption of magnetic beads in the reaction cup. When the cleaning liquid is transferred, there are still a lot of magnetic beads remaining in the center. The previous magnetic attraction station has not formed sufficient and effective pre-adsorption. In Comparative Example 2, the scheme was modified to be close to different wall positions of different polarities of the reaction cup. Relatively speaking, the loss rate in different detection scenarios has been improved to a certain extent. However, the loss rate test results are still relatively high. This indicates that, on the one hand, the magnetic beads in the magnetic attraction position have not been fully pre-adsorbed, and on the other hand, there are still a certain amount of magnetic beads remaining in the center of the reaction cup in the subsequent liquid transfer position, which results in a certain loss of magnetic beads during the transfer of the cleaning liquid. In Example 1, the solution of the present invention is adopted, and the reaction cup can be fully magnetically attracted within the magnetic attraction position. In the subsequent liquid transfer position, the magnetic beads are difficult to remain stably in the center, thus reducing the detected loss rate to the optimal result of the structure and timing of the present invention.

[0051] Preferably, the present invention also verifies that the magnetic attraction positions are arranged in a strong-weak interval, which can obtain more stable and accurate detection results. The strong-weak interval is specifically implemented in that the magnetic field strength ratio of the magnetic components at some magnetic attraction positions and liquid transfer positions is set to 0.78-0.95, and some magnetic attraction positions are set to have the same magnetic field strength.

[0052] like Figure 11As shown, the first transfer mechanism 211 can transfer the incubated reaction cup 100 to the receiving position of the reaction cup 100 within the magnetic separation turntable 1230. When the magnetic separation turntable 1230 rotates and moves the reaction cup 100 to the first-stage injection station 1231, the first-stage injection needle 1211 adds cleaning fluid into the reaction cup 100. The magnetic separation turntable 1230 rotates and moves the reaction cup 100 to at least one magnetic attraction position to perform magnetic adsorption of the magnetic beads within the reaction cup 100. Here, to ensure sufficient magnetic adsorption, the rotation and dwell time interval can be... The short interval of 6-11 seconds significantly shortens the detection time compared to the 15-second or even 20-second intervals in existing technologies. Simultaneously, the double-sided magnetic adsorption facilitates stronger adsorption and more accurate detection. After magnetic adsorption, the magnetic separation turntable 1230 moves the reaction cup 100 to the first-stage pipetting station 1241, where the first-stage aspiration needle 1201 aspirates the waste liquid from the reaction cup 100. The magnetic separation turntable 1230 then moves the reaction cup 100 to the second-stage injection station 1232, where the second-stage injection... The liquid injection needle 1212 adds cleaning fluid into the reaction cup 100. The cup-gripping rotating component 1200, coaxially arranged with the second-stage injection needle 1212, rotates the held reaction cup 100. Then, the second-stage injection needle 1212 adds cleaning fluid into the rotating reaction cup 100. This process is repeated several times with magnetic attraction and transfer until the magnetic separation turntable 1230 rotates, moving the reaction cup 100 to the nth-stage pipetting position. The nth-stage suction needle then removes the waste liquid from the reaction cup 100. Finally, the magnetic separation turntable 1230 moves the reaction cup 100 to the substrate. At the filling station 1235, the substrate needle 1215 adds substrate into the reaction cup 100. The cup-gripping rotating component 1200, which is coaxially arranged with the substrate needle 1215, drives the held reaction cup 100 to rotate. Then, the substrate needle 1215 adds substrate into the rotating reaction cup 100. After the substrate is added, the magnetic separation turntable 1230 rotates and drives the reaction cup 100 to the removal position. The first transfer mechanism 211 removes the reaction cup 100 with added substrate from the magnetic separation cleaning device 12. Preferably, n can be 3, 4, 5, etc. in this process.

[0053] like Figure 12 , Figure 13As shown, this embodiment is laid out within a rectangular three-dimensional space. A cleaning fluid storage unit is located at the bottom of this space, and it is fluidly connected to the upper operating platform via a flow pipeline. This allows the equipment to automatically and continuously perform different functional operations. The space below the operating platform can be isolated into multiple independent storage spaces to receive various cleaning fluids. A vacuum pump and a connected waste liquid recovery tank can also be installed, enabling larger-scale waste liquid recovery and ensuring more continuous and longer-term operation of the equipment. The operating platform includes a reagent carrying device 10, which contains... The rotating disk structure is driven to rotate, and multiple reagent rack receiving slots 1011 arranged circumferentially are arranged on the rotating disk. A magnetic bead mixing gear is fixedly arranged at the center of the reagent carrying device 10. Each reagent rack receiving slot 1011 has a hollow part arranged near the center position. The reagent tube rack can be detachably installed in the reagent tube rack receiving slot, and the position closest to the center is arranged as a magnetic bead reagent bottle receiving position, which can movably receive a magnetic bead reagent bottle equipped with magnetic bead liquid. Here, the bottom of the magnetic bead reagent bottle is formed with a bottle bottom gear, and the rotation axis of the bottle bottom gear is aligned with the rotation axis of the magnetic bead reagent bottle. In the overlapping configuration, after the reagent tube rack is placed into the reagent tube rack receiving slot, the bottom gear of the bottle can pass through the hollow part and mesh with the magnetic bead mixing gear. This allows the rotating disc to drive the reagent tube rack to rotate around its center, ensuring that the various reagents within the reagent tube rack are thoroughly mixed. Furthermore, the magnetic bead reagent bottle, relying on the meshing of the bottom gear, also rotates around its own axis, using a greater mixing driving force to thoroughly mix and suspend the magnetic bead reagent. To ensure long-term reagent preservation, the reagent carrying device 10 is also equipped with a cooling source, and the controller enables the reagent carrying device 10 to... To maintain a suitable refrigeration temperature and ensure a constant low-temperature environment within the reagent carrier 10, a reaction incubation device 11 is arranged adjacent to the reagent carrier 10. Multiple reaction cups 100 are arranged circumferentially within the reaction incubation device 11. A reagent dispensing probe 201 is positioned between the reagent carrier 10 and the reaction incubation device 11. A reagent needle cleaning mechanism is also provided between the reagent carrier 10 and the reaction incubation device 11. After multiple reagent dispensing operations, the reagent dispensing probe 201 can be driven to engage with the reagent probe cleaning mechanism to perform a cleaning operation.At the rear end of the operating table, a magnetic separation and cleaning device 12 and a signal detection device 13 are also configured. The rotating shaft 1605 of the first transfer mechanism 211 is configured within the quadrilateral area formed by the reagent carrier 10, the reaction incubation device 11, the magnetic separation and cleaning device 12, and the signal detection device 13. This allows the rotating shaft 1605 to drive the first transfer mechanism 211 to rotate within a travel range covering at least a portion of the reaction incubation device 11, the magnetic separation and cleaning device 12, and the signal detection device 13, thereby transferring the reaction cup 100 to perform different functional operations. A rotating mixing mechanism 16 is also arranged on the operating table, positioned between the reaction incubation device 11 and the signal detection device 13, and causing the rotating... The mixing mechanism 16 is positioned closer to the signal detection device 13, allowing the rotational stroke of the first transfer mechanism 211 to more precisely cover the mixing mechanism 16. A sample tube rack transfer section 152 is also located near the innermost part of the operating table, capable of transferring sample tube racks containing the samples to be analyzed via at least one transfer rail. The layout of the parallel transfer rails is illustrated here. This innermost placement also minimizes the risk of contamination, allowing for the shortest possible input and output of sample tube racks within the device. The sample dispensing probe 202 is positioned in the innermost region of the device, its rotational trajectory covering at least a portion of the transfer rails and the reaction incubation device 11. A sample dispensing probe 202 cleaning mechanism is also arranged at one of these locations. This allows for a cleaning process after each sample pipetting, minimizing the risk of contamination during sample transfer. During operation, the reagent dispensing probe 201 is driven to rotate and transfer reagents and / or magnetic beads from the reagent tray to the reaction cup 100 within the reaction incubation device 11. Similarly, the sample dispensing probe 202 is driven to rotate and transfer samples from the sample tube on the transfer rail to the reaction cup 100 within the reaction incubation device 11. The reaction incubation device 11 continues to rotate, allowing the reaction cup 100, after sample and reagent dispensing, to be rotated to engage with the first transfer mechanism 211 for clamping and transfer. The rotating mixing mechanism 16 receives samples from the reaction incubation device 11 collected by the first transfer mechanism 211. The reaction cup 100 is taken and rotated to mix the sample and reagent mixture dispensed inside. The first transfer mechanism 211 transfers the mixed reaction cup 100 back into the reaction incubation device 11. A heat source can be configured in the reaction incubation device 11 to maintain a suitable incubation temperature to promote the rapid occurrence of the incubation reaction. After the incubation reaction is completed, the reaction cup 100 can be transferred to the magnetic separation and cleaning device 12 for cleaning and separation and substrate addition. The first transfer mechanism 211 can also transfer the reaction cup 100 from the magnetic separation and cleaning device 12 to the signal detection device 13. The signal detection device 13 includes a light signal acquisition unit 130 to detect whether there is a target substance in the reaction cup 100 or to quantify the target substance content.The operating table also includes a reaction cup storage section 141, which can batch load reaction cups 100. The reaction cups 100 can be loaded by tilting, making the loading operation simple and quick. A reaction cup lifting mechanism 142 and a reaction cup transfer section 143 are arranged in conjunction with the reaction cup storage section 141. The reaction cup lifting mechanism 142 can pick up the reaction cups 100 in the reaction cup storage section 141 and lift them. One end of the reaction cup transfer section 143 is connected to the reaction cup lifting mechanism 142 to receive the lifted reaction cups 100, and the other end is connected to a cup sorting turntable 144. The cup sorting turntable 144 includes multiple receiving positions arranged in a circumferential direction, which can receive reaction cups 100 one by one. The sorting and transfer principle of the reaction cups 100 is not described in detail here. A second transfer mechanism 212 is also configured between the cup sorting turntable 144 and the reaction incubation device 11. The second transfer mechanism 212 can rotatably transfer the reaction cups 100. The empty reaction cup 100 is transferred to the reaction incubation device 11. The second transfer mechanism 212 is also specifically configured to transfer the empty reaction cup 100, reducing contamination while ensuring the automated loading efficiency of the reaction cup 100. The operating table also includes a sample tube rack buffer section 151, which contains multiple sample tube rack buffer slots arranged side by side along the depth of the equipment. This allows a specific number of samples to be tested to be buffered on the side of the equipment, enabling the equipment to be configured as a batch processing pipeline system, achieving the goal of high-speed continuous sample processing. In conjunction with the sample tube rack buffer section 151, a tube rack transfer mechanism 17 that can slide along the depth of the equipment is also arranged. The tube rack transfer mechanism 17 can pick up a sample tube rack in one of the sample tube rack buffer slots and transfer it to the transfer rail of the sample tube rack transfer section 152, thus realizing fully automated sample tube rack buffering and short-stroke flow operation within the equipment.

[0054] like Figure 14As shown, after the sample is added to the reaction cup 100 in the reaction incubation device 11, it can rotate to a position that can cooperate with the first transfer mechanism 211. At this time, the first transfer mechanism 211 can pick up the reaction cup 100 in the reaction incubation device 11 and rotate it around its axis to cooperate with the rotary mixing mechanism 16. The rotary mixing mechanism 16 includes a rotating cup position 160 that can receive the transferred reaction cup 100. The rotating cup position 160 is connected to a rotating shaft 1605, which is fixedly connected to the bottom of the rotating cup position 160, so that the rotating shaft is driven to rotate. The rotating cup 160 is able to rotate, thus thoroughly mixing the reagent and sample mixture within it. A driven wheel 1604 is sleeved on the rotating shaft 1605. The driven wheel 1604 is fixedly sleeved on the opposite end of the rotating shaft 1605 connected to the rotating cup 160. A driven wheel 1602 is positioned at a predetermined distance from the driven wheel 1604. A rotating transmission belt 1603 is sleeved between the two wheels. The driven wheel 1602 is also connected to the output shaft of a rotating motor 1601. Thus, the rotation of the motor output shaft can be achieved through the belt drive mechanism and the rotating shaft 1605. The transmission mechanism drives the rotating cup 160 to rotate. The diameter of the rotating drive wheel 1602 is no less than twice the diameter of the rotating driven wheel 1604. This larger transmission ratio allows the rotating cup 160 to rotate at a higher speed, enhancing the mixing effect of the mixture within the reaction cup 100 and reducing the impact of vibration during mixing. This design achieves higher mixing speeds using a simple transmission mechanism. Preferably, to ensure precise adjustment of important parameters such as the drive current of the output motor, a sensing block 1606 is also fixedly connected to the rotating shaft 1605. A rotation sensor 1607 is fixedly connected at a set position of the rotation mixing mechanism 16. When the rotating shaft 1605 drives the connected sensing block 1606 to rotate, it can be intermittently engaged between the transmitting end and the receiving end of the rotation sensor 1607. Therefore, the rotation speed of the rotating shaft can be accurately detected by the cooperation of the two, thereby realizing precise control of the rotation speed of the rotating cup position 160. The reaction cup 100 that has completed the rotation mixing can be picked up by the first transfer mechanism 211 and rotated back into the reaction plate to perform an incubation reaction at a specific temperature, such as constant temperature incubation at 37°C.

[0055] like Figure 15The signal detection device 13 shown cooperates with the optical signal acquisition unit 130 to perform the detection state diagram. The reaction cup 100 taken from the magnetic separation cleaning device 12 by the first transfer mechanism 211 can be rotated and transferred to the signal detection device 13. Here, the signal detection device 13 has a plurality of reading positions 1301 arranged in the circumferential direction to receive the transferred reaction cup 100. The bottom of the signal detection device 13 includes a reading rotation drive motor 1321. The output shaft of the motor is connected to the reading rotation drive wheel 1322. The drive wheel is wound with a reading rotation transmission belt 1323. The transmission belt is also connected to a reading rotation driven wheel 1604 arranged coaxially with the signal detection device 13. In this way, the reading rotation drive motor 1321 can drive the reaction cup 100 to rotate. The signal detection device 13 rotates around an axis. A light signal acquisition unit 130 is fixedly connected to one side of the signal detection device 13. The side of the signal detection device 13 has multiple reading holes 131 corresponding to reading positions 1301, allowing the light signal acquisition unit 130 to acquire signals from the reaction vessel 100 through the reading holes 131. Preferably, the side of the signal detection device 13 may be equipped with a heat-insulating and light-blocking layer. As the inner layer rotates, the multiple reading positions 1301 pass through the light signal acquisition unit 130 one by one to acquire their internal optical signals. A signal detection device cover is also fitted to the top of the signal detection device 13. The signal detection device cover has a loading / unloading hole located away from the light signal acquisition unit 130. The distance between the pipette orifice, the loading / unloading orifice, and the light signal acquisition unit 130 is smaller than the distance between the loading / unloading orifice and the light signal acquisition unit 130. This ensures that the signal detection device 13 maintains a darkroom environment. Loading the reaction cup 100 and aspirating waste liquid will not interfere with the detection. There is no risk of inaccurate detection results due to light leakage caused by the small distance between the functional orifices and the detection unit. Furthermore, there are no influencing factors such as vibration caused by transfer during the detection process. The pipette orifice is equipped with a waste liquid aspiration mechanism 203 that can be driven to move up and down. This mechanism includes a waste aspiration needle driven by a pipette arm. The pipette arm can be driven to move up and down by the waste aspiration lifting and lowering mechanism, allowing the waste aspiration needle to insert into or move away from the reaction cup 100 at the reading position 1301. The drive motor 2031 output is connected to the waste suction drive wheel 2032, and a waste suction transmission wheel 2034 is fixedly set at a preset distance between them. The two are wound together with a waste suction transmission belt 2033. The waste suction transmission belt 2033 is connected to the lifting rod of the pipette arm through a fixing member and moves up and down. The waste suction lifting drive mechanism lowers the height of the waste suction needle so that the waste liquid in the reaction cup 100 can be more reliably concentrated and collected. The reaction cup 100 that has completed waste suction can be driven by the signal detection device 13 to rotate to the position of the first transfer mechanism 211. The first transfer mechanism 211 takes in the reaction cup 100 that has completed waste suction from the signal detection device 13 through the loading and unloading hole, and finally collects the used reaction cup 100 into the waste recycling drawer through the waste recycling port.

[0056] This document uses specific embodiments to illustrate the principles and implementation methods of the present invention. The descriptions of these embodiments are only intended to aid in understanding the method and core ideas of the present invention. It should be noted that those skilled in the art can make various improvements and modifications to the present invention without departing from its principles, and these improvements and modifications also fall within the scope of protection of the claims of the present invention.

[0057] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship in which the product of this invention is usually placed during use. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0058] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

Claims

1. A magnetic separation cleaning device, characterized in that, Includes a device body, the device body comprising: A magnetic separation disk includes a magnetic separation turntable that can rotate around an axis, and an inner disk and an outer disk that are fixedly disposed on the inner and outer sides of the magnetic separation turntable and are coaxial with the magnetic separation turntable; the magnetic separation turntable is provided with a plurality of receiving positions in the circumferential direction for receiving and driving the reaction cup to rotate. A plurality of configuration slots are spaced apart along the circumferential direction on the inner disk and the outer disk; A magnetic component is disposed within the configuration slot; The magnetic separation disk has several stations along its circumference. Each station is one of a dual-pole station, a single-pole station, or a non-magnetic-pole station. The inner and outer disks corresponding to the dual-pole station are provided with configuration slots, and the magnetic components in the configuration slots are arranged with the same polarity face. The inner or outer disks corresponding to the single-pole station are provided with configuration slots. The inner and outer disks corresponding to the non-magnetic-pole station are not provided with configuration slots.

2. The magnetic separation cleaning device according to claim 1, characterized in that, The magnetic separation turntable is provided with operating stations for performing different functions in the circumferential direction. The operating stations include liquid injection station, magnetic suction station, liquid transfer station and substrate addition station. The magnetic suction station and the liquid transfer station are dual magnetic pole stations, and the magnetic components of the inner and outer disks at the same station have the same magnetic polarity and the same magnetic field strength. The liquid injection station is any one of the following: a non-magnetic pole station, a single magnetic pole station, and a dual magnetic pole station; The substrate filling station is a single magnetic pole station.

3. The magnetic separation cleaning device according to claim 2, characterized in that, The magnetic suction station has at least two locations, and the magnetic component at each magnetic suction station has a different magnetic field strength than the magnetic component at the other magnetic suction station.

4. The magnetic separation cleaning device according to claim 2, characterized in that, Multiple consecutive magnetic attraction stations are spaced apart along the circumference of the magnetic separation turntable. Several adjacent magnetic attraction stations form a magnetic attraction processing module. In each magnetic attraction processing module, the magnetic field strength of several magnetic attraction stations gradually increases from the middle magnetic attraction station to the magnetic attraction stations at both ends.

5. The magnetic separation cleaning device according to claim 2, characterized in that, The radial distance between the magnetic component and the reaction cup at the substrate filling station is greater than the radial distance between the magnetic component and the reaction cup at other stations.

6. The magnetic separation cleaning device according to claim 1, characterized in that, It also includes an operating unit, which is disposed above the device body and includes: A dispensing assembly for dispensing cleaning fluid into the reaction vessel; A pipetting mechanism, including a suction needle configured to aspirate waste liquid from the reaction vessel; A substrate dispensing mechanism includes a substrate needle for dispensing substrate liquid into the reaction vessel.

7. The magnetic separation cleaning device according to claim 6, characterized in that, The dispensing component includes: A cup-gripping rotator is used to grip the reaction cup and drive the reaction cup to rotate around its own axis. A liquid injection channel is provided at the axis of the cup-gripping rotator. The injection needle is coaxially arranged with the rotating gripper cup. The injection needle can extend into the injection channel and act on the reaction cup. The injection needle is used to inject cleaning fluid into the reaction cup.

8. A sample analysis device, characterized in that, The magnetic separation and cleaning apparatus as described in any one of claims 1-7 further includes: a reagent carrying device, a reaction incubation device, a signal detection device, and a first transfer mechanism; A reagent carrier device, used to hold and provide reagents; A reaction incubation apparatus used to receive samples and reagents and to carry out incubation reactions; A signal detection device is used to perform optical detection on the reaction cup from the magnetic separation and cleaning device to obtain analysis results; A first transfer mechanism has a rotating shaft located in the middle region of the reagent carrier, reaction incubation device, magnetic separation and cleaning device, and signal detection device. The first transfer mechanism is used to transfer the reaction cup between the reagent carrier, reaction incubation device, magnetic separation and cleaning device, and signal detection device.

9. A magnetic separation cleaning method, applied to the magnetic separation cleaning apparatus as described in any one of claims 1-7, characterized in that, The magnetic separation cleaning device includes a device body, the device body comprising: A magnetic separation disk includes a magnetic separation turntable that can rotate around an axis, and an inner disk and an outer disk that are fixedly disposed on the inner and outer sides of the magnetic separation turntable and are coaxial with the magnetic separation turntable; the magnetic separation turntable is provided with a plurality of receiving positions in the circumferential direction for receiving and driving the reaction cup to rotate. A plurality of configuration slots are spaced apart along the circumferential direction on the inner disk and the outer disk; A magnetic component is disposed within the configuration slot; The magnetic separation disk has several stations along its circumference. Each station is one of a dual-pole station, a single-pole station, or a non-magnetic-pole station. At the dual-pole station, both the inner and outer disks have configuration slots, and the magnetic components within these slots have the same polarity. At the single-pole station, either the inner or outer disk has a configuration slot. At the non-magnetic-pole station, neither the inner nor outer disk has a configuration slot. The magnetic separation disk also has operating stations along its circumference for performing different functions, including a liquid injection station, a magnetic suction station, a liquid transfer station, and a substrate addition station. The magnetic suction station and the liquid transfer station are dual magnetic pole stations, and the magnetic components of the inner and outer disks at the same station have the same magnetic polarity and the same magnetic field strength. The liquid injection station is any one of the following: a non-magnetic pole station, a single magnetic pole station, and a dual magnetic pole station; The substrate filling station is a single magnetic pole station; The magnetic separation cleaning method includes the following steps: Reaction vessel transfer procedure: Transfer the reaction vessel to the receiving position of the magnetic separation turntable; Multi-stage cleaning process: The driven magnetic separation turntable rotates around its axis, causing the reaction vessel to pass through the cleaning stages sequentially; each cleaning stage includes: Cleaning fluid filling sub-step: At the filling station, the cleaning fluid is added into the reaction cup through the filling component; Magnetic bead adsorption step: Drive the reaction cup through the magnetic adsorption station in sequence. Utilize the magnetic field generated by the magnetic components with the same magnetic polarity and magnetic field strength on the inner and outer disks to adsorb the magnetic beads and bridging target material in the reaction cup to the reaction cup wall. Waste liquid aspiration and transfer step: Drive the reaction cup to rotate to the transfer station. The magnetic components with the same magnetic polarity and magnetic field strength on the inner and outer disks form an unstable magnetic field region in the center of the reaction cup. Control the aspiration needle to insert into the reaction cup and aspirate the waste liquid. Substrate addition step: Drive the magnetic separation turntable to continue rotating, moving the reaction cup to the substrate addition station, and add the substrate liquid into the reaction cup through the substrate needle; Reaction cup output steps: Drive the magnetic separation turntable to continue rotating, transfer the reaction cup with substrate added to the output port, and complete the magnetic separation cleaning process.

10. The magnetic separation cleaning method according to claim 9, characterized in that, The dispensing component includes: A cup-gripping rotator is used to grip the reaction cup and drive the reaction cup to rotate around its own axis. A liquid injection channel is provided at the axis of the cup-gripping rotator. The injection needle is coaxially arranged with the gripping cup rotating component. The injection needle can extend into the injection channel and act on the reaction cup. The injection needle is used to inject cleaning fluid into the reaction cup. In the step of adding cleaning fluid, the reaction cup is first gripped by a cup-gripping rotating component and driven to rotate around its own axis. Then, the cleaning fluid is added into the rotating reaction cup through an injection needle coaxially arranged with the cup-gripping rotating component.

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