A fully automatic flow type fluorescent light emitting immunoassay analyzer

Abstract

The application discloses a full-automatic flow fluorescence luminescence immunoassay analyzer, which comprises a sample feeding module for carrying and transporting samples, a reaction cup arranging module for storing and arranging reaction cups, a reaction disc assembly for incubation, a sample disc assembly for carrying and transporting reaction cups, a reagent disc assembly for carrying, transporting and incubating reagent cups, a mixing module for uniformly mixing samples and reagents, a magnetic separation module for cleaning and purifying reaction mixtures, a light detection module for detecting treated sample liquids, a sample needle assembly and a reagent needle assembly for sucking sample liquids and reagents respectively, a first gripper assembly and a second gripper assembly for taking, placing and transporting reaction cups, and a rack. The flow fluorescence detection system, the pretreatment system and the full-automatic sample feeding module are organically combined, and have a significant synergistic effect, so that the detection flux of the single machine is improved to 200 samples / hour, which is 1.3 to 2 times of that of the existing analyzer.

Description

Technical Field

[0001] This invention relates to the field of detection and analysis equipment technology, and more specifically to a fully automated flow cytometry fluorescence immunoassay analyzer. Background Technology

[0002] Chemiluminescence immunoassay has become one of the mainstream methods for clinical laboratory diagnostics due to its high sensitivity and specificity. Existing technologies, such as those disclosed in patents CN201811240938.5 and CN201310167162.X, typically include multiple functional modules such as sample loading, reaction vessel delivery, sample addition, incubation, washing and separation, and detection. These instruments have made significant progress in terms of automation and throughput.

[0003] Flow cytometry (also known as suspended array or liquid-phase array) is a novel high-throughput detection technology developed in recent years. This technology uses coded microspheres as reaction carriers, and laser excitation of the classifying and reporter fluorescence on the microspheres enables rapid quantitative analysis of multiple analytes simultaneously within a single reaction tube. Compared to traditional immunoassay methods, flow cytometry offers theoretical advantages such as multi-analysis, lower sample consumption, and faster detection speed, and has been widely applied in clinical testing for autoantibodies, cytokines, and tumor markers.

[0004] Currently, several fully automated flow cytometry analyzers are available on the market, such as the TESMI F4000 from TransGen Biotech (120 samples / hour), the Mplex-MA1600 from Orient Gene (100 samples / hour), and the iMulti from YHLO (150 samples / hour). However, the actual throughput of these instruments is generally limited to 100-150 samples / hour, failing to fully realize the inherent high-throughput potential of flow cytometry technology. The main reason for this bottleneck is the insufficient automation and parallel processing capabilities of the pretreatment systems (including modules for sample loading, reaction vessel transport, sample addition, incubation, and magnetic separation and cleaning) in existing flow cytometry analyzers, as well as poor sample compatibility. This makes the pretreatment process a key factor restricting the overall throughput of the instrument.

[0005] Therefore, how to organically combine the high-throughput advantage of flow cytometry detection technology with the mature and efficient fully automated pretreatment system of chemiluminescence analyzer, and design an analyzer that can realize fully automated sample introduction, pretreatment and detection integration, is a technical problem that urgently needs to be solved in this field. Summary of the Invention

[0006] To address the shortcomings of existing technologies, the present invention aims to provide a fully automated flow cytometry fluorescence immunoassay analyzer. By organically combining the flow cytometry detection system, the pretreatment system platform, and the fully automated sample introduction module, a significant synergistic effect is generated, increasing the detection throughput of a single unit to 200 samples / hour, which is 1.3 to 2 times that of existing flow cytometry analyzers.

[0007] The technical solution adopted by this invention to solve the technical problem is: a fully automated flow cytometry fluorescence immunoassay analyzer, comprising: The sample injection module includes a sample injection component, a transport component, and a push rod component, and is used to carry and transport the sample to be tested. It also includes: a cup arrangement module for storing and organizing reaction cups; a reaction tray assembly for incubating reaction cups; a sample loading tray assembly for carrying and transporting reaction cups; a reagent tray assembly for carrying, transporting, and keeping reagent cups warm; a mixing module for uniformly mixing samples and reagents; a magnetic separation module for cleaning and purifying the reaction mixture; a photodetector module for laser-excited fluorescence detection of the processed sample solution; a sample needle assembly and a reagent needle assembly for drawing sample solution and reaction reagents, respectively; a first gripper assembly and a second gripper assembly for picking up, placing, and transporting reaction cups during operation; and a frame for supporting the various components of the analyzer.

[0008] Furthermore, in the sample introduction module, the sample introduction component is used to carry the sample holder; the transport component is used to transfer the sample holder between the sample introduction component and the pusher component, the transport component has translational degrees of freedom in at least three directions and rotational degrees of freedom about the vertical axis; the pusher component is mounted on the sample introduction frame and is used to push the sample holder along the suction rail.

[0009] Furthermore, the transport assembly includes a transport translation mechanism, a transport rotation mechanism, and a transport hook mechanism; the transport translation mechanism is connected to the transport hook mechanism and is used to drive the sample rack to achieve translational movements in the X, Y, and Z directions; the transport rotation mechanism is connected to the transport hook mechanism and is used to drive the sample rack to achieve rotation in the Z-axis direction; the transport hook mechanism controls the hook through a hook motion mechanism, and the hook engages with a groove below the sample rack to grasp the sample rack.

[0010] Furthermore, the sample introduction assembly includes an emergency area for emergency sample introduction and a tray area for routine sample introduction; the sample racks in the emergency area are tested in a priority order over the sample racks in the tray area.

[0011] Furthermore, both the tray area and the sample rack in the emergency area are equipped with a baffle mechanism. The baffle mechanism includes an L-shaped baffle and a lifting mechanism. Under the action of the lifting mechanism, the L-shaped baffle can block or allow the sample rack to pass.

[0012] Furthermore, the cup handling module includes a hopper, a slide assembly, a reaction cup conveying assembly, and a return chamber; the lower end of the hopper is connected to the slide assembly, which includes an inclined slide and a slide sensor; the outlet of the inclined slide is connected to the reaction cup conveying assembly, and the rear end of the reaction cup conveying assembly is connected to the return chamber.

[0013] Furthermore, the reaction disk assembly is mounted on the reaction disk base plate and includes a reaction disk insulated body and a reaction disk turntable for supporting reaction cups. The reaction disk turntable rotates along an axis under the action of a drive mechanism. The sample loading disk assembly is sleeved around the reaction disk assembly and includes a cup-supporting plate. The cup-supporting plate rotates under the drive of a synchronous pulley. The cup-supporting plate and the reaction disk turntable operate independently of each other. The reagent disk assembly includes a reagent disk insulated body, a reagent disk turntable, and a reagent disk base disposed on the reagent disk turntable. The reagent disk turntable rotates along an axis under the action of a drive mechanism, and the reagent disk base is used to place reagent bottles.

[0014] Furthermore, the mixing module includes a mixing seat and a driving mechanism for driving the mixing seat to rotate eccentrically; the magnetic separation module includes a magnetic separation component and a plurality of cleaning needle components, and the magnetic separation module further includes a mixing component; the optical detection module includes a sampling needle component and a flow cytometry fluorescence detection component.

[0015] Furthermore, the sample needle assembly includes a sample needle, a sample needle cantilever, and a sample needle driving mechanism. The sample needle achieves displacement in the Z-axis direction and rotation in the horizontal plane under the drive of the sample needle driving mechanism. The reagent needle assembly includes a reagent needle, a reagent needle cantilever, and a reagent needle driving mechanism. The reagent needle achieves displacement in the Z-axis direction and rotation in the horizontal plane under the drive of the reagent needle driving mechanism.

[0016] Furthermore, the first gripper assembly includes a first elastic gripper and a first gripper motion mechanism. Under the control of the first gripper motion mechanism, the first elastic gripper moves in the Y-axis and Z-axis directions and opens and closes. The second gripper assembly includes a second elastic gripper and a second gripper motion mechanism. Under the control of the second gripper motion mechanism, the second elastic gripper moves in the Y-axis and Z-axis directions and opens and closes.

[0017] The beneficial effects of this invention are as follows: Compared with the prior art, the fully automated flow cytometry fluorescence immunoassay analyzer provided by this invention has the following advantages: 1) Significantly Increased Detection Throughput: The core breakthrough of this invention lies in the organic combination of the flow cytometry fluorescence detection system and the pretreatment system platform, resulting in a significant synergistic effect. Flow cytometry fluorescence technology itself possesses high-speed detection capabilities, while the pretreatment platform of this invention, through modular design (such as nested sample loading and reaction trays, parallel operation of dual grippers, and multi-degree-of-freedom injection), achieves efficient and parallel processing of samples and reagents, eliminating bottlenecks in the pretreatment process. The combination of these two technologies allows the detection throughput of a single unit to be increased to 200 samples / hour, which is 1.3 to 2 times that of existing mainstream flow cytometry fluorescence analyzers, greatly satisfying the high-throughput detection needs of large laboratories.

[0018] 2) High degree of automation and wide sample adaptability: This invention achieves fully automated closed-loop operation from sample loading, identification, sample addition, incubation, magnetic separation and cleaning to final detection and cup discarding, without the need for manual intervention.

[0019] 3) Optimized spatial layout: For example, in the sample introduction module, the multi-degree-of-freedom design of the transport components enables them to complete complex movements in a compact space without the need for a large range of moving tracks; the layout of the sample loading plate component surrounding the reaction plate component; and the compact arrangement of each functional module around the central area significantly reduce the overall footprint of the machine, shorten the stroke of each moving component, and further improve operating efficiency and reliability.

[0020] 4) In the sample introduction module of this invention, the transport component integrates three degrees of freedom: translation in the X, Y, and Z directions, and rotation around the Z-axis. It can grasp the sample holder from any position on the sample introduction component and directly adjust its attitude during transport, precisely aligning it with the suction rail of the pusher component. This design optimizes the transport path and shortens non-detection time. Simultaneously, by setting up a separate emergency area and emergency button, hardware-level priority scheduling of emergency samples is achieved. Attached Figure Description

[0021] Figure 1 This is a schematic diagram of the overall structure of the analyzer provided by the present invention.

[0022] Figures 2-4 The diagram shows the structure of the analyzer (without the outer casing) provided by this invention from various angles.

[0023] Figures 5-7 This is a schematic diagram of the sample injection module in this invention.

[0024] Figure 8 This is a schematic diagram of the transport component in the sample injection module.

[0025] Figure 9 This is a schematic diagram of the transport hook mechanism in the sample injection module.

[0026] Figure 10This is a schematic diagram of the sample injection component in the sample injection module.

[0027] Figure 11 This is a structural diagram of the baffle mechanism in the blocking state (preparing for the hook to grab).

[0028] Figure 12 This is a schematic diagram of the baffle mechanism in the release state (hook gripping).

[0029] Figure 13 This is a schematic diagram of the pusher assembly in the sample injection module.

[0030] Figures 14-15 This is a schematic diagram of the structure of the cup module in this invention.

[0031] Figure 16 This is a schematic diagram of the reaction disk assembly in this invention.

[0032] Figure 17 This is a cross-sectional structural diagram of the reaction disk assembly in this invention.

[0033] Figure 18 This is a schematic diagram of the sample loading tray assembly in this invention.

[0034] Figures 19-21 This is a schematic diagram of the reagent tray assembly in this invention.

[0035] Figure 22 This is a schematic diagram of the sample needle assembly in this invention.

[0036] Figure 23 This is a schematic diagram of the reagent needle assembly in this invention.

[0037] Figure 24 This is a schematic diagram of the structure of the first gripper assembly in this invention.

[0038] Figure 25 This is a schematic diagram of the structure of the second gripper assembly in this invention.

[0039] Figure 26 This is a schematic diagram of the mixing module in this invention.

[0040] Figure 27 This is a schematic diagram of the magnetic separation module in this invention.

[0041] Figure 28 This is a cross-sectional structural diagram of the magnetic separation module in this invention. Figure 29 and 30 This is a schematic diagram of the optical detection module in this invention.

[0042] Among them, 1-sample injection module; 11-sample injection component; 111-emergency area; 1111-emergency button; 1112-emergency indicator light; 1113-passive lifting mechanism; 1114-rotating shaft; 112-tray area; 1121-tray indicator light; 1122-active lifting mechanism; 1124-L-shaped baffle; 1125-groove; 1126-top plate; 12-transfer assembly; 121-transfer translation mechanism; 1211-X-guide rail; 122-transfer... 1221-Rotating shaft; 123-Handling hook mechanism; 1231-Hook; 1232-Hook guide rail; 1233-Sample rack detection sensor; 1234-Hook motor; 1235-Top block; 13-Push rod assembly; 131-Push rod transmission mechanism; 132-Push rod guide rail; 133-Push rod zero-position sensor; 134-Push rod; 14-Sample suction rail; 141-Temporary storage position; 142-Sample suction position; 143-Recovery position; 15-Hanging plate.

[0043] 2-Cup handling module; 21-Hopper; 22-Slide assembly; 221-Slide body; 222-Slide cover; 223-Slide sensor; 23-Recovery bin; 24-Reaction cup conveying assembly; 241-Chain; 242-Sprocket; 243-Conveyor motor; 244-Cup holder; 25-Return chamber.

[0044] 3-First gripper assembly; 31-First elastic gripper; 32-First gripper motion mechanism.

[0045] 4-Magnetic separation module; 41-Magnetic separation base plate; 42-Magnetic separation insulated pot body; 43-Magnetic separation turntable; 44-Liquid suction needle; 45-Needle washing pool; 46-Liquid injection needle; 47-Termination liquid injection needle.

[0046] 5-Second gripper assembly; 51-Second elastic gripper; 52-Second gripper motion mechanism.

[0047] 6-Reaction plate assembly; 61-Reaction plate base; 62-Reaction plate insulated pot; 621-Temperature sensor; 63-Reaction plate turntable; 631-Reaction cup placement hole; 64-Reagent needle washing pool; 65-Sample needle washing pool.

[0048] 7-Sample loading tray assembly; 71-Cup holder tray; 72-Thin-walled bearing; 73-Reaction cup placement position.

[0049] 8-Optical detection module; 81-Sampling needle assembly; 82-Flow cytometry fluorescence detection assembly; 83-Maintenance fluid bottle.

[0050] 9-Reagent tray assembly; 91-Reagent tray insulated pot body; 92-Reagent tray turntable; 93-Reagent tray base; 94-Drive mechanism; 95-Refrigeration module; 96-Reagent tray cover; 97-Lid door.

[0051] 10-Reagent needle assembly; 1001-Reagent needle; 1002-Reagent needle cantilever; 1003-Reagent needle drive mechanism.

[0052] 16-Sample needle assembly; 1601-Sample needle; 1602-Sample needle cantilever; 1603-Sample needle drive mechanism.

[0053] 17-Mixing module; 1701-Mixing seat; 1702-Eccentric rotary drive mechanism; 1703-Receiving cavity.

[0054] 18-Rack; 19-Cup disposal channel. Detailed Implementation

[0055] The present invention will be further illustrated below with specific embodiments. However, these examples are for illustrative purposes only and are not intended to limit the scope of the invention. Example

[0056] like Figures 1-4 As shown, a fully automated flow cytometry fluorescence immunoassay analyzer includes: a frame 18, on which are mounted a sample introduction module 1 for carrying and transporting samples to be tested; a cup handling module 2 for storing and organizing reaction cups; a reaction tray assembly 6 for incubating reaction cups; a sample dispensing tray assembly 7 for carrying and transporting reaction cups; a reagent tray assembly 9 for carrying, transporting, and keeping reagent cups warm; a mixing module 17 for uniformly mixing samples and reagents; a magnetic separation module 4 for cleaning and purifying the reaction mixture; a photodetector module 8 for laser-excited fluorescence detection of the processed sample solution; a sample needle assembly 16 and a reagent needle assembly 10 for drawing sample solution and reaction reagents, respectively; and a first gripper assembly 3 and a second gripper assembly 5 for handling the picking up, placing, and transporting reaction cups during operation.

[0057] Among them, such as Figures 5-7 As shown, the sample introduction module 1 includes a sample introduction assembly 11, a transport assembly 12, and a pusher assembly 13. Figure 10As shown, the sample introduction component 11 is used to carry sample racks, including an emergency area 111 for emergency sample introduction and a tray area 112 for regular sample introduction. The sample racks in the emergency area 111 are tested before those in the tray area 112. The emergency area 111 has at least one (e.g., six in this embodiment) emergency station for placing sample racks, and each emergency station has several emergency sample slots (e.g., six in this embodiment). The emergency area 111 has an emergency button 1111, and each emergency station has a sensor for detecting the sample racks and an emergency indicator light 1112 for displaying the operating status. By independently setting up an emergency area 111 with dedicated sensors and indicator lights, after the emergency sample rack is in place, pressing the emergency button 1111 will immediately trigger the sample introducer to prioritize the handling component 12 for processing the emergency samples. This design allows for the rapid insertion of emergency tasks without significantly interfering with the continuous injection of regular samples, greatly shortening the waiting and testing time for emergency samples and meeting the urgent need for rapid reporting of emergency samples in clinical testing.

[0058] In addition, the tray area 112 has at least two tray positions (five in this embodiment), and each tray position can hold several sample racks (five columns in this embodiment, with five samples per column). Each tray position is equipped with a sensor for detecting the sample racks and a tray indicator light 1121 for displaying the operating status. During normal sample testing, the samples can be placed together on the tray, and then the tray itself can be placed into the tray position in the tray area 112.

[0059] like Figures 11-12 As shown, a baffle mechanism is provided below the sample rack in the tray area 112. The baffle mechanism includes an L-shaped baffle 1124 and an active lifting mechanism 1122. Under the action of the active lifting mechanism 1122, the L-shaped baffle 1124 blocks or allows the sample rack to pass. A groove 1125 matching the hook 1231 is provided below the sample rack. The head of the L-shaped baffle 1124 has a limiting function, and the tail of the L-shaped baffle 1124 is connected to the active lifting mechanism 1122, and a rotating shaft 1114 is provided near the tail. When it is necessary to grab the sample rack, the hook 1231 in the transport hook mechanism 123 extends to the bottom of the sample rack, the active lifting mechanism 1122 is activated, and the tail of the L-shaped baffle 1124 is lifted upward. As the L-shaped baffle 1124 rotates along the rotating shaft 1114, the head of the L-shaped baffle 1124 moves downward, releasing the front end of the sample rack. At the same time, the transport translation mechanism 121 drives the transport hook mechanism 123 to move upward along the Z-axis, so that the hook 1231 is inserted into the groove 1125 under the sample rack. Then the transport hook mechanism 123 can drive the sample rack away from the tray position to perform the next X-axis displacement and Z-axis rotation.

[0060] The sample rack in the emergency area 111 is also equipped with a baffle mechanism, but it differs from the baffle mechanism in the tray area 112. The baffle mechanism includes an L-shaped baffle 1124 and a passive lifting mechanism 1113, which includes a rotating shaft 1114 and a top plate 1126. When samples from the emergency area 111 need to be tested, the transport assembly 12 moves to the area below the sample holder in the emergency area 111, aligning the hook 1231 with the groove 1125 below the sample holder. The top block 1235 presses against the top plate 1126 in the passive lifting mechanism 1113. As the transport translation mechanism 121 moves the transport hook mechanism 123 upward along the Z-axis, the top block 1235 pushes the top plate 1126 upward. The L-shaped baffle 1124 rotates along the pivot 1114, and the head of the L-shaped baffle 1124 moves downward, releasing the front end of the sample holder. At the same time, the transport translation mechanism 121 moves the transport hook mechanism 123 upward along the Z-axis, causing the hook 1231 to insert into the groove 1125 below the sample holder. Then, the transport hook mechanism 123 can move the sample holder away from the emergency area 111 to perform the next X-axis displacement and Z-axis rotation.

[0061] The transport assembly 12 is used to transfer the sample holder between the sample injection assembly 11 and the push rod assembly 13. The transport assembly 12 has translational degrees of freedom in at least three directions and rotational degrees of freedom about the vertical axis. The push rod assembly 13 is mounted on the sample injection frame and is used to push the sample holder along the suction rail 14.

[0062] Specifically, such as Figure 8 As shown, the transport assembly 12 includes a transport translation mechanism 121, a transport rotation mechanism 122, and a transport hook mechanism 123. The transport translation mechanism 121 is connected to the transport hook mechanism 123 via a mounting plate and includes an X-axis translation mechanism and a Z-axis translation mechanism, used to drive the sample rack to achieve X-axis and Z-axis translational movements. The X-axis translation mechanism includes an X-axis guide rail 1211, an X-axis motion motor, a cable chain, and an X-axis zero-position sensor; the Z-axis translation mechanism includes a Z-axis guide rail, a Z-axis motion motor, and a Z-axis zero-position sensor.

[0063] The transport and rotation mechanism 122 is connected to the transport hook mechanism 123 via a rotating shaft 1221, and is used to drive the sample rack to rotate in the Z-axis direction. The transport and rotation mechanism 122 includes a geared motor, a rotating shaft 1221, and a synchronous belt mechanism. The rotating shaft 1221 is connected to the transport hook mechanism 123. Driven by the geared motor, the synchronous belt mechanism drives the rotating shaft 1221 to rotate, thereby realizing the rotation of the transport hook mechanism 123 in the Z-axis direction. Since the transport hook mechanism 123 can grasp the sample rack, it can realize the rotation of the sample rack in the Z-axis direction. The transport and rotation mechanism 122 is also equipped with a barcode scanner, which can scan and analyze the sample during the process of moving the sample rack away from the tray position or emergency position.

[0064] like Figure 9 As shown, the handling hook mechanism 123 includes a hook motion mechanism and a hook 1231. The hook motion mechanism controls the hook 1231 to grasp the sample rack. The hook motion mechanism includes a hook motor 1234, a hook guide rail 1232, a timing belt, and a sample rack detection sensor 1233. Under the action of the hook motor 1234 and the timing belt, the hook 1231 moves along the hook guide rail 1232. When grasping the sample rack, the hook 1231 moves to below the sample rack, and after being fixed in place with the sample rack, the hook motion mechanism drives the hook 1231 and the sample rack to move in a direction away from the sample inlet assembly 11. After the sample rack detection sensor 1233 detects that the sample rack has been transported to the transport assembly 12, the transport assembly 12 translates in the Z and X directions, moves to the sample inlet rotation position, and rotates the sample rack along the Z-axis so that the sample inlet direction of the sample rack is parallel to the travel direction of the suction rail 14 of the pusher assembly 13. Then, the transport assembly 12 transports the sample rack onto the suction rail 14 of the pusher assembly 13. After the sample is suctioned, the transport assembly 12 moves to the sample outlet rotation position in the X direction, transports the sample rack back to the transport assembly 12, and then returns the sample rack to the sample inlet assembly 11.

[0065] like Figure 13 As shown, the push rod assembly 13 includes a push rod 134, a push rod transmission mechanism 131, a push rod guide rail 132, and a push rod zero-position sensor 133. Under the action of the push rod transmission mechanism 131, the push rod 134 moves along the push rod guide rail 132, which in turn pushes the sample holder to move on the temporary storage position 141, the suction position 142, and the return position 143 of the suction rail 14, realizing the switching between the various functional positions. Sensors, such as a temporary storage position sensor and a return position sensor, are provided at each functional position of the suction rail 14.

[0066] The sample injection module 1 is detachably connected to the frame 18 via a hanging plate 15. When sample injection is required, the sample injection module 1 is inserted into the corresponding insert (not shown) on the frame 18 via the hanging plate 15.

[0067] The operation of the above-mentioned sample injection module 1 is as follows: After the software submits a general sample testing application, the sample to be tested and the sample holder are placed in the tray, and then the tray is placed together with the sample inlet component 11 into the tray area 112. At this time, the sensor detects the placement of the tray, and the transport component 12 moves to the tray and detects the sample holder in the tray. After the detection is completed, the active lifting mechanism 1122 at the bottom of the sample inlet component 11 rises, causing the head of the L-shaped baffle 1124 of the sample holder in the tray to fall. Then, the transport component 12 moves the sample holders onto the transport component 12 according to the order of the sample holders in the tray using the hook 1231, and scans and parses the samples using a barcode scanner during the movement. Subsequently, after the sample holder detection sensor 1233 detects that the sample holder has been transported onto the transport component 12, the transport component 12 moves in the Z and X directions and moves to the sample inlet rotation position, rotating the sample holder so that the sample inlet direction of the sample holder is parallel to the travel direction of the sample suction rail 14 of the push rod component 13. Then, the transport assembly 12 moves in the Z-axis, raising the sample holder to a position consistent with the height of the suction rail 14 of the pusher assembly 13. Immediately afterwards, the hook 1231 in the transport assembly 12 and the X-axis translation mechanism operate simultaneously, transporting the sample holder to the sample holder temporary storage position 141 of the suction rail 14 of the pusher assembly 13. The transport assembly 12 then resets in the Z-axis direction, followed by a rotational reset. Simultaneously, after the temporary storage position sensor on the pusher assembly 13 detects a sample holder at the temporary storage position 141, the pusher 134 pushes the sample holder from the temporary storage position 141 to the suction position 142 to await suction by the host sample needle. After suction is completed, the pusher 134 pushes the sample holder back to the return position 143 of the suction rail 14. During the sample aspiration and push to the retrieval position 143, the transport component 12 moves to the sample dispensing rotation position in the X direction. After the retrieval position sensor of the aspiration rail 14 detects that there is a sample rack, the transport component 12 transports the sample rack to the transport component 12, and then sends the sample rack back to the sample injection component 11, and the process ends.

[0068] If the emergency position is used for sample delivery, after the sample rack is placed in the emergency position, manually press the emergency button 1111. At this time, the sample rack detection sensor 1233 will detect the sample rack and the transport component 12 will move to the emergency position to transport the sample rack to the transport component 12. The subsequent process is the same as that of ordinary tray sample delivery. Finally, the sample rack will be transported back to the emergency position and the process will end.

[0069] like Figures 14-15As shown, in the analyzer, the cup handling module 2 includes a hopper 21, a slide assembly 22, a recovery chamber 23, a reaction cup conveying assembly 24, and a return chamber 25. The hopper 21 is used to hold a large number of bulk reaction cups, and its outlet is connected to the slide assembly 22. A hopper sensor is installed on the outer wall of the hopper 21 to monitor the remaining amount of reaction cups in the hopper in real time. When the hopper sensor detects that the amount of reaction cups is below a set threshold, the system issues an alarm or prompts the user to replenish the reaction cups, ensuring the continuous operation of the analyzer over long periods.

[0070] The chute assembly 22 includes a chute body 221, a chute cover 222, and a chute sensor 223. The chute body 221 is an inclined, narrow groove, its width allowing only a single reaction cup to pass through in a specific orientation (e.g., opening upwards, bottom downwards). The chute cover 222 covers the chute body 221 to prevent the reaction cup from jumping out during vibration or descent. The upper inlet of the chute body 221 is connected to the outlet of the hopper 21, and the lower outlet of the chute body 221 is connected to the recovery bin 23. The chute sensor (at least one) is installed at an appropriate location on the chute body (e.g., in the middle or lower section) to detect whether a reaction cup is passing through or accumulating in the chute. If the chute sensor detects no cup passing through for an extended period, the system can activate hopper vibration or trigger an alarm; if accumulation is detected, the conveying process is paused.

[0071] The recovery chamber 23 is located at the end of the slide assembly 22 and is used to temporarily store the reaction cups in the correct posture after they fall from the slide. The internal space of the recovery chamber 23 is matched to the size of a single reaction cup, ensuring that the reaction cups remain vertically aligned and in the same direction within the recovery chamber 23. The recovery chamber 23 has an opening at its bottom or side for docking with the reaction cup conveying assembly.

[0072] The reaction cup conveying assembly 24 includes a chain 241, a sprocket 242, a conveying motor 243, and several cup holders 244. The chain 241 wraps around the driving sprocket and the driven sprocket, and the conveying motor 243 drives the driving sprocket to rotate. During operation, the conveying motor 243 drives the chain 241 in a cyclical motion. When a cup holder 244 passes through the bottom opening of the recovery chamber, a reaction cup falls into the cup holder and moves upward or forward with the chain. The chain path design ensures that the reaction cup remains open and stable during conveying, without tipping over. The return chamber 25 is located at the end of the reaction cup conveying assembly 24 and is used to receive the reaction cups transported by the conveying assembly and arrange them in the grabbing position.

[0073] like Figure 16 and 17As shown, in the analyzer, the reaction plate assembly 6 provides a constant temperature environment for the immune reaction and carries the reaction cups to rotate intermittently during the incubation process to ensure uniform heating of each reaction cup. The reaction plate assembly is mounted on the reaction plate base plate 61 and mainly includes a reaction plate insulated pot body 62, a reaction plate turntable 63, a drive mechanism, a temperature control system, and a sensing system.

[0074] The reaction pan insulated pot 62 uses insulation cotton to reduce heat loss and heating elements to provide heat. A temperature sensor 621 is also installed on the pot body for real-time monitoring of the internal temperature. Both the heating elements and the temperature sensor are electrically connected to the control system, forming a closed-loop temperature control circuit. Multiple reaction cup placement holes 631 are evenly distributed along the circumference of the reaction pan turntable 63, each hole accommodating one reaction cup. The reaction pan turntable 63 is rotatably mounted inside the reaction pan insulated pot 62, and its bottom is connected to the reaction pan base plate 61 via bearings. A encoder is located at the bottom of the reaction pan turntable 63, and a encoder sensor, which works in conjunction with the encoder, is installed at a fixed position on the reaction pan base plate to detect the rotation angle and speed of the turntable in real time. Furthermore, a zero-position sensor is also provided on the reaction pan base plate 61 to detect the absolute zero position of the reaction pan turntable 63. The reaction pan turntable 63 is driven to rotate by a motor. A reagent needle washing pool 64 and a sample needle washing pool 65 are respectively located at corresponding positions on the reaction pan base plate 61. After the reagent needle or sample needle has completed the liquid addition operation, it will be moved to the corresponding needle washing tank for cleaning. The needle washing tank is designed to be located in an unused area of ​​the reaction disk assembly, so as not to interfere with the rotation of the reaction disk turntable.

[0075] like Figure 18 As shown, in the analyzer, the sample loading tray assembly 7 is used to support the reaction cup and, in conjunction with the sample needle assembly 11, reagent needle assembly 10, and various gripper assemblies, completes operations such as sample loading, reagent loading, mixing and transport, and detection transport. The sample loading tray assembly 7 is fitted around the reaction tray assembly 6, and the two operate independently, achieving efficient space utilization and parallel processing. Specifically, the sample loading tray assembly 7 includes a cup support tray 71, a thin-walled bearing 72, a thin-walled bearing seat, a synchronous pulley, a drive motor, and a sensing system.

[0076] The cup-supporting plate 71 is an annular disc structure with multiple reaction cup placement positions 73 evenly distributed along its circumference, each position accommodating one reaction cup. The cup-supporting plate 71 is fitted around the outer periphery of the reaction plate insulation pot body 62, with a gap between it and the reaction plate assembly 6 to ensure no interference during independent rotation. The cup-supporting plate 71 is mounted on a thin-walled bearing seat via a thin-walled bearing 72. The thin-walled bearing 72 features a small radial dimension and high load-bearing capacity, making it suitable for installation in space-constrained annular structures. Driven by a synchronous pulley, the thin-walled bearing 72 rotates the cup-supporting plate 71. A encoder is located at the bottom or edge of the cup-supporting plate 71, and a encoder sensor, in conjunction with the encoder, is used to detect the rotation angle and speed of the cup-supporting plate 71 in real time. Furthermore, a zero-position sensor is provided to detect the absolute zero position of the cup-supporting plate 71, ensuring the positional accuracy of each station after each rotation.

[0077] Because the sample loading tray assembly 7 is mounted around the reaction tray assembly 6 and the two operate independently, the sample loading tray assembly 7 is responsible for short-term turnover operations of the reaction cups (sample loading, reagent loading, and transfer), while the reaction tray assembly 6 is responsible for long-term incubation. The two can operate simultaneously and independently. For example, while the sample loading tray assembly 7 is loading samples and dispensing reagents, the reaction cups in the reaction tray assembly 6 are incubating. The second gripper assembly 5 can retrieve cups from the sample loading tray assembly 7 and transfer them to the reaction tray assembly 6, or retrieve cups from the reaction tray assembly 6 and return them to the sample loading tray assembly 7, achieving parallel processing in a streamlined manner and greatly improving the overall detection throughput of the instrument.

[0078] like Figures 19-22 As shown, in the analyzer, the reagent tray assembly 9 is used to hold, refrigerate, and automatically supply reagent bottles, working in conjunction with the reagent needle assembly to complete reagent aspiration. The reagent tray assembly 9 is mounted on the frame and mainly includes a reagent tray insulated body 91, a reagent tray turntable 92, a reagent tray base 93, a drive mechanism 94, and a refrigeration module 95. The reagent tray turntable 92 rotates along an axis under the action of the drive mechanism, and the reagent tray base 93 is used to hold reagent bottles.

[0079] The reagent tray insulated pot body 91 houses the reagent tray turntable 92 and reagent bottles. The outer wall of the pot body is insulated with multiple layers of insulation material to reduce heat loss. A cooling module 95 is installed at the bottom of the reagent tray insulated pot body 91 to provide a low-temperature environment (typically 2–8°C) inside the pot body to maintain reagent stability. The cooling module 95 uses conventional cooling elements, including cooling elements and heat sinks, which will not be described in detail here. The cooling module, temperature sensor, and control system form a closed-loop temperature control circuit to ensure a constant internal temperature for the reagent tray assembly 9.

[0080] The reagent tray turntable 92 is rotatably mounted inside the insulated pot body, and its bottom is connected to the pot body or frame via bearings. A reagent tray base 93 is fixed on the reagent tray turntable 92, and the base has multiple reagent bottle placement slots for accommodating reagent bottles. The shape of the placement slots matches the bottom of the reagent bottles. Under the action of the drive mechanism, the reagent tray turntable 92 rotates along a vertical axis, delivering the required reagent bottle to the liquid aspiration position of the reagent needle.

[0081] The reagent tray insulated pot body 91 is equipped with a reagent tray cover 96 on top, and the reagent tray cover 96 has an openable door 97 with a door handle for easy manual opening by the user. In addition, a barcode scanner is provided, with the scanning window of the barcode scanner facing the reagent bottle position on the reagent tray turntable 92; when the reagent tray turntable 92 rotates, each reagent bottle passes in front of the barcode scanner, and the barcode scanner automatically reads the information on the reagent bottle and uploads it to the control system.

[0082] like Figure 22 As shown, in the analyzer, the sample needle assembly 16 is used to draw the sample liquid to be tested from the sample holder of the sample injection module 1 and accurately inject it into the reaction cup on the sample application tray assembly 7. The sample needle assembly 16 is mounted on the frame 18 and mainly includes a sample needle 1601, a sample needle cantilever 1602, and a sample needle drive mechanism 1603. The sample needle drive mechanism includes a lifting component and a rotating component, which are used to drive the sample needle to achieve lifting displacement in the Z-axis direction and rotation in the horizontal plane. The lifting component mainly adopts a conventional lifting guide rail with sliding form, and the rotating component mainly adopts a rotary motor driving a rotating shaft; in order to improve accuracy, a zero-point sensor and a limit sensor are also provided; these are all conventional settings and will not be elaborated on here.

[0083] like Figure 23 As shown, in the analyzer, the reagent needle assembly 10 is used to draw reagents from the reagent tray assembly 9 and accurately inject them into the reaction cup on the sample tray. The reagent needle assembly 10 is mounted on the frame 18 and mainly includes a reagent needle 1001, a reagent needle cantilever 1002, and a reagent needle drive mechanism 1003. The reagent needle drive mechanism includes a lifting assembly and a rotating assembly, used to drive the reagent needle to achieve lifting displacement in the Z-axis direction and rotation in the horizontal plane. The lifting assembly mainly adopts a conventional lifting guide rail with sliding mechanism, and the rotating assembly mainly adopts a rotary motor driving a rotating shaft. To improve accuracy, a zero-point sensor and a limit sensor are also provided. The structure of the reagent needle assembly 10 is similar to that of the sample needle assembly 16; both are conventional configurations and will not be elaborated further here.

[0084] like Figure 24As shown, in the analyzer, the first gripper assembly 3 is mainly used to perform the initial loading and final discarding of reaction cups: that is, to grab unused reaction cups from the return chamber of the cup handling module 2 and place them on the cup receiving tray of the sample loading tray assembly 7; and to grab the reaction cups after testing from the discarding position of the reaction tray assembly 6 and drop them into the discarding channel 19. The first gripper assembly 3 is mounted on the frame 18 and mainly includes a first elastic gripper 31 and a first gripper movement mechanism 32. The first elastic gripper 31 is a pair of openable gripper arms used to grip the outer wall of the reaction cup. The inner side of the gripper arm is provided with a gripping groove that matches the outer edge of the reaction cup. An elastic element (such as a compression spring or torsion spring) is provided between the gripper arms so that the gripper remains normally closed or normally open when there is no external force driving it. The elastic force is overcome by the driving mechanism (such as a gripper motor or pneumatic component) to realize the opening and closing of the gripper. The first elastic gripper 31 is displaced in the Y-axis and Z-axis directions and opens and closes under the control of the first gripper motion mechanism 32. The first gripper motion mechanism 32 mainly controls the movement of the first elastic gripper through conventional driving methods such as guide rails, sliders and rotary motors, which will not be elaborated here.

[0085] like Figure 25 As shown, in the analyzer, the second gripper assembly 5 is mainly used to perform complex transfer operations of reaction cups between multiple functional modules, including: grabbing reaction cups with added samples / reagents from the sample loading tray, transferring them to the mixing module 17 for mixing, transferring them to the reaction tray assembly 6 for incubation, transferring them to the magnetic separation module 4 for cleaning and purification, transferring them back to the sample loading tray for secondary sample loading after magnetic separation, and finally transferring the fully processed reaction cups to the sample loading tray for sample aspiration by the detection module. The second gripper assembly 5 is mounted on the frame 18 and mainly includes a second elastic gripper 51 and a second gripper motion mechanism 52. Under the control of the second gripper motion mechanism 52, the second elastic gripper 51 realizes displacement in the Y-axis and Z-axis directions and the opening and closing of the gripper. The structure and operation of the second gripper assembly 5 are basically the same as those of the first gripper assembly, and will not be elaborated here.

[0086] like Figure 26 As shown, in the analyzer, the mixing module 17 is used to thoroughly and uniformly mix the sample solution and reagents in the reaction cup to promote the rapid and effective immune response. The mixing module 17 is mounted on the frame 18, located below the second gripper assembly 5, and mainly includes a mixing seat 1701 and an eccentric rotation drive mechanism 1702 for driving the mixing seat.

[0087] The mixing seat 1701 is a sleeve-shaped structure with an opening at the top and a receiving cavity 1703 that matches the shape of the reaction cup. In the eccentric rotation drive mechanism 1702 of the mixing seat, a motor drives an eccentric shaft to rotate, causing the center of the mixing seat 1701 to perform a circular motion around the motor axis with a radius equal to the eccentric distance. This causes the reaction cup inserted into the mixing seat 1701 to also perform the same high-frequency circular motion. Under the action of inertial force and the container wall, the liquid inside the reaction cup generates strong vortices and surface fluctuations, achieving rapid mixing of the sample and reagent. To facilitate the gripper assembly in accurately placing or removing the reaction cup from the mixing seat, the mixing module is equipped with a zero-position detection sensor to detect whether a reaction cup is present in the mixing seat and the initial position of the mixing seat.

[0088] like Figure 27 and 28 As shown, in the analyzer, the magnetic separation module 4 is used to clean and purify the reaction mixture after the immune reaction, removing unbound free substances, reducing background interference, and improving detection sensitivity and accuracy. The magnetic separation module 4 is mounted on the frame 18 and mainly includes a magnetic separation assembly and several cleaning needle assemblies. The magnetic separation assembly is set on the magnetic separation base plate 41 and includes a magnetic separation insulated pot 42, a magnetic separation turntable 43, and a permanent magnet assembly. The magnetic separation base plate 41 has multiple reaction cup placement slots (stations), each station corresponding to a set of permanent magnets. The number of stations matches the number of needles in the cleaning needle assembly.

[0089] The magnetic separation insulated pot 42 is equipped with insulation material (such as insulation cotton or polyurethane foam) to maintain a constant temperature environment (typically 37℃±0.5℃) during the magnetic separation process. Heating elements and temperature sensors can be installed on the pot, and a closed-loop temperature control system ensures the cleaning process is carried out at a suitable temperature, preventing temperature fluctuations from affecting the reaction system. The magnetic separation turntable 43 is rotatably mounted inside the magnetic separation insulated pot 42 and is driven by a motor via a synchronous belt or direct drive. Multiple reaction cup placement holes (stations) are evenly distributed along the circumference of the magnetic separation turntable, each station accommodating one reaction cup. In this embodiment, four magnetic separation stations are provided. Permanent magnet groups (such as neodymium iron boron magnets) are embedded on the bottom or side of the magnetic separation turntable 43 corresponding to each station, used to attract magnetic beads from the reaction cup to one side of the cup wall when the magnetic separation turntable 43 rotates to a specific angle.

[0090] The cleaning needle assembly is used to perform liquid aspiration and injection operations during the magnetic separation process. The cleaning needle assembly is mounted vertically on the magnetic separation base plate via a guide rail and slider structure, and its Z-axis lifting is driven by a lifting motor. In this embodiment, the cleaning needle assembly includes four aspiration needles 44 arranged in a ring. These needles are used to aspirate waste liquid from the bottom of the reaction cup after the magnetic beads are attracted. Each aspiration needle is equipped with an independent needle washing pool 45 to clean the inner and outer walls of the aspiration needle after each aspiration, preventing cross-contamination. The cleaning needle assembly also includes four injection needles 46, which are used to inject cleaning liquid into the reaction cup, resuspending the magnetic beads. The injection needles can be integrated with the aspiration needles on the same needle holder and arranged at a certain interval. The cleaning needle assembly also includes a stop liquid injection needle 47, used to add stop liquid to the reaction cup in the final step of the magnetic separation cleaning process, resuspending the analyte in the stop liquid. The magnetic separation module also has a mixing function, mainly achieved by rotation to mix the liquid in the reaction cup.

[0091] like Figure 29 and 30 As shown, in the analyzer, the optical detection module 8 is used for quantitative detection of the sample solution after all immunoassays and magnetic separation purification have been completed. The optical detection module 8 employs the principle of flow cytometry fluorescence detection. It uses a laser to excite the fluorescence signal on the coded microspheres in the sample, and a photomultiplier tube (PMT) collects the signal and converts it into an electrical signal, thereby achieving accurate quantitative analysis of the analyte concentration. The optical detection module 8 is mounted on the rack 18 and mainly includes a sampling needle assembly 81, a flow cytometry fluorescence detection assembly 82, a liquid path auxiliary system, and a signal processing system.

[0092] The sampling needle assembly 81 is used to draw the final reaction solution from the reaction cup on the sample tray assembly 7 and deliver it to the flow chamber of the flow cytometry fluorescence detection assembly 82. The sampling needle assembly includes a sampling needle, guide rail, slider, synchronous belt, motor, etc. The sampling needle is equipped with an independent needle washing tank for cleaning the inner and outer walls after each sampling to prevent cross-contamination. The motor drives the slider to move up and down along the guide rail via the synchronous belt, and the sampling needle is fixed on the slider, realizing Z-axis lifting motion. The flow cytometry fluorescence detection assembly 82 is the core part of the optical detection module, used to detect the coded microspheres in the sample solution one by one. The flow cytometry fluorescence detection assembly 82 mainly includes a laser, collimator, focusing lens, cylindrical lens, flow chamber, dichroic mirror, photomultiplier tube (PMT), heating element, fan, etc.

[0093] During operation, the sample solution aspirated through a sampling needle is injected into the sample solution inlet of the flow cytometry fluorescence detection module. Simultaneously, sheath fluid (running fluid) is pumped from the sheath fluid tank of the rack assembly into the flow chamber, forming a sheath flow that envelops the sample solution flow, causing the coded microspheres in the sample to align in a single row and pass through the detection zone one by one. A waste pump continuously pumps the waste liquid (sample solution + sheath fluid) discharged from the flow chamber to the waste liquid tank. The laser emitted by the laser is collimated into parallel light and then focused into a tiny spot by a focusing lens, illuminating the detection zone of the flow chamber. A cylindrical lens elongates the spot into an ellipse along the flow direction, ensuring that the microspheres are effectively excited as they pass through. When the coded microspheres pass through the detection zone, the laser excites the fluorescent dye carried by the microspheres, generating two or more fluorescence signals. Classification fluorescence is used to identify the microsphere number, thereby determining the detection item; report fluorescence is used for quantitative analysis of the analyte concentration, with fluorescence intensity proportional to the analyte concentration. The fluorescence signal is collected by the optical system behind the flow chamber, separated by wavelength by a dichroic mirror, and then enters the corresponding photomultiplier tube (PMT). The PMT converts the optical signal into an electrical signal, which is then amplified, filtered, and converted from analog to digital by a signal board before being transmitted to the main control system.

[0094] The overall operation process of the above analyzer is as follows: 1) Preparation and Sample Addition: The cup preparation module 2 is activated, arranging the reaction cups. The first gripper assembly 3 picks up a single reaction cup and places it on the cup receiving tray of the sample addition tray assembly 7. At the same time, the sample injection module 1 transports the sample rack to the aspiration position, and the sample needle assembly 16 aspirates the sample liquid.

[0095] 2) Sample and reagent addition: The sample dispensing tray assembly 7 rotates to move the reaction cup to the sample dispensing position. The sample needle assembly 16 draws the sample solution at the aspiration position and injects it into the reaction cup. Subsequently, the sample dispensing tray assembly 7 continues to rotate to the reagent position. The reagent needle assembly 10 draws the first and second reagents from the reagent tray and injects them into the reaction cup.

[0096] 3) Mixing and Incubation: The sample loading tray assembly 7 rotates the reaction cup to the gripping position of the second gripper assembly 5. The second gripper assembly 5 grips the reaction cup and transfers it to the mixing module 17 for the first mixing. After mixing, the second gripper assembly 5 transfers the reaction cup to the reaction tray assembly 6 for incubation to ensure the immune reaction proceeds fully.

[0097] 4) Magnetic Separation and Secondary Sample Addition: After incubation, the second gripper assembly 5 grasps the reaction cup and transfers it to the magnetic separation module 4 for cleaning and purification. Then, the second gripper assembly 5 returns it to the sample loading tray assembly 7. The sample loading tray assembly 7 rotates the reaction cup to the reagent position again, and adds a third reagent to the reaction cup via the reagent needle assembly 10.

[0098] 5) Cycling and Detection: After adding the third reagent, continue the mixing, incubation, and magnetic separation processes, and finally add the stop solution for resuspending. The second gripper assembly 5 transfers the final processed reaction cup to the reaction disk assembly 6. The reaction disk assembly 6 rotates the reaction cup to the detection position, and the sampling needle of the optical detection module 8 draws the final sample solution from the reaction cup and enters the flow cytometry fluorescence detection assembly for laser detection.

[0099] 6) Discarding the cup: After the test is completed, the reaction disk assembly 6 rotates and moves the reaction cup to the first gripper assembly 3. The first gripper assembly 3 grabs the used reaction cup and throws it into the discarding cup channel 19.

[0100] The above embodiments are only used to illustrate the present invention and are not intended to limit the present invention. Those skilled in the art can make various changes and modifications without departing from the spirit and scope of the present invention. Therefore, all equivalent technical solutions also fall within the scope of the present invention, and the patent protection scope of the present invention should be defined by the claims.

Claims

1. A fully automated flow cytometry fluorescence immunoassay analyzer, characterized in that, include: The sample injection module includes a sample injection component, a transport component, and a push rod component, and is used to carry and transport the sample to be tested. It also includes: a cup-sorting module for storing and organizing reaction cups; The reaction plate assembly for incubating reaction cups; the sample loading plate assembly for carrying and transporting reaction cups; the reagent plate assembly for carrying, transporting, and keeping reagent cups warm; the mixing module for uniformly mixing samples and reagents; the magnetic separation module for cleaning and purifying the reaction mixture; the photodetector module for laser-excited fluorescence detection of the processed sample solution; the sample needle assembly and reagent needle assembly for aspirating sample solution and reaction reagents, respectively; the first gripper assembly and the second gripper assembly for picking up, placing, and transporting reaction cups during operation; and the frame for supporting the various components of the analyzer.

2. The fully automated flow cytometry fluorescence immunoassay analyzer as described in claim 1, characterized in that: In the sample injection module, the sample injection component is used to carry the sample holder; the transport component is used to transfer the sample holder between the sample injection component and the pusher component, and the transport component has translational degrees of freedom in at least three directions and rotational degrees of freedom about the vertical axis; the pusher component is mounted on the sample injection frame and is used to push the sample holder along the suction rail.

3. The fully automated flow cytometry fluorescence immunoassay analyzer as described in claim 1, characterized in that: The transport assembly includes a transport translation mechanism, a transport rotation mechanism, and a transport hook mechanism; the transport translation mechanism is connected to the transport hook mechanism and is used to drive the sample rack to achieve translational movements in the X, Y, and Z directions; the transport rotation mechanism is connected to the transport hook mechanism and is used to drive the sample rack to achieve rotation in the Z-axis direction; the transport hook mechanism controls the hook through a hook motion mechanism, and the hook engages with a groove under the sample rack to grasp the sample rack.

4. The fully automated flow cytometry fluorescence immunoassay analyzer as described in claim 1, characterized in that: The sample introduction assembly includes an emergency area for emergency sample introduction and a tray area for routine sample introduction; the sample racks in the emergency area are tested in a priority order over the sample racks in the tray area.

5. The fully automated flow cytometry fluorescence immunoassay analyzer as described in claim 4, characterized in that: Both the tray area and the sample rack in the emergency area are equipped with a baffle mechanism. The baffle mechanism includes an L-shaped baffle and a lifting mechanism. The L-shaped baffle blocks or allows the sample rack to pass under the action of the lifting mechanism.

6. The fully automated flow cytometry fluorescence immunoassay analyzer as described in claim 1, characterized in that: The reaction cup handling module includes a hopper, a slide assembly, a reaction cup conveying assembly, and a return chamber; the lower end of the hopper is connected to the slide assembly, which includes an inclined slide and a slide sensor; the outlet of the inclined slide is connected to the reaction cup conveying assembly, and the rear end of the reaction cup conveying assembly is connected to the return chamber.

7. The fully automated flow cytometry fluorescence immunoassay analyzer as described in claim 1, characterized in that: The reaction disk assembly is mounted on the reaction disk base plate and includes a reaction disk insulated body and a reaction disk turntable for supporting reaction cups. The reaction disk turntable rotates along an axis under the action of a drive mechanism. The sample loading disk assembly is sleeved around the reaction disk assembly and includes a cup-supporting plate, which rotates under the drive of a synchronous pulley. The cup-supporting plate and the reaction disk turntable operate independently of each other. The reagent disk assembly includes a reagent disk insulated body, a reagent disk turntable, and a reagent disk base disposed on the reagent disk turntable. The reagent disk turntable rotates along an axis under the action of a drive mechanism, and the reagent disk base is used to place reagent bottles.

8. The fully automated flow cytometry fluorescence immunoassay analyzer as described in claim 1, characterized in that: The mixing module includes a mixing seat and a driving mechanism for driving the mixing seat to rotate eccentrically; the magnetic separation module includes a magnetic separation component and several cleaning needle components, and the magnetic separation module also includes a mixing component; the optical detection module includes a sampling needle component and a flow cytometry fluorescence detection component.

9. The fully automated flow cytometry fluorescence immunoassay analyzer as described in claim 1, characterized in that: The sample needle assembly includes a sample needle, a sample needle cantilever, and a sample needle drive mechanism. The sample needle, driven by the sample needle drive mechanism, achieves displacement in the Z-axis direction and rotation in the horizontal plane. The reagent needle assembly includes a reagent needle, a reagent needle cantilever, and a reagent needle drive mechanism. The reagent needle, driven by the reagent needle drive mechanism, achieves displacement in the Z-axis direction and rotation in the horizontal plane.

10. The fully automated flow cytometry fluorescence immunoassay analyzer as described in claim 1, characterized in that: The first gripper assembly includes a first elastic gripper and a first gripper motion mechanism. Under the control of the first gripper motion mechanism, the first elastic gripper moves in the Y-axis and Z-axis directions and opens and closes. The second gripper assembly includes a second elastic gripper and a second gripper motion mechanism. Under the control of the second gripper motion mechanism, the second elastic gripper moves in the Y-axis and Z-axis directions and opens and closes.

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