An automatic flow-through immunoassay system and its detection method

Abstract

The present invention discloses a fully automatic immunodetection system with a flowing water and its detection method. The system includes a to-be-tested area, a barcode recognition area, a conveying area, a plurality of detection areas, a sorting area, a controller and a power supply. The detection area is composed of a sampling / recovery unit, a conveyor belt unit, a shaking unit, a strip stacking unit, a reaction cup transfer unit, a sample arm, a reagent arm, a reagent storage unit, an incubation unit, a liquid path unit, a waste recycling unit and a detection unit. By providing the fully automatic immunodetection system with a flowing water and its detection method, it can adapt to various sample types, multiple indicators and multi-threads, and perform detections in a flowing water asynchronous manner, greatly improving the detection speed and application flexibility, being able to meet the application requirements of more customers, reducing the detection waiting time at the same time, and further increasing the use convenience.

Description

Technical Field

[0001] The present invention relates to a fully automatic immunoassay system, and particularly to a flow-through fully automatic immunoassay system and a detection method thereof. Background Art

[0002] This device is a POCT fully automatic quantitative system relying on an instrument. It realizes the identification of various sample types and the possible pretreatment required for samples through a unique sampling unit. At the same time, through the sample addition unit and the consumable unit (reaction cup transfer unit and reaction plate stack unit), the addition of samples and the entire dry fluorescence reaction process are completed, and finally the detection is completed. It realizes the rapid detection of automation, informatization, integration, personalization and modularization of POCT. Multiple sample types can be directly loaded onto the machine for detection, meeting the development requirements of hospital informatization and the multi-purpose needs and quality assurance of clinical emergencies. It has the following characteristics:

[0003] It can support the direct loading of multiple samples onto the machine for detection, and the original tubes can be directly loaded onto the machine for detection without opening the caps, avoiding biosafety risks and eliminating the cumbersome manual pretreatment before sample loading onto the machine;

[0004] The temperature can be controlled throughout the reaction process;

[0005] This device can perform simultaneous detection of multiple indicators, and the items cover rapid detections in cardiovascular diseases, infectious diseases, women's health, infections, embolisms, etc. and have obtained demonstration applications.

[0006] This device is a modular equipment, which can be used alone or in combination. At the same time, it has scalability and can be interconnected with the same type of equipment (meeting the interconnection requirements). This device is a rare immunoassay pipeline in the industry. The detection speed of a single unit is above 120T / H, and the rate is higher than that of the same dry immunoassay analyzer in the industry. While ensuring the advantages of JS3000 in adapting to multiple sample types, multi-index loading onto the machine for detection, and temperature control throughout the reaction process, it greatly improves the detection speed and application flexibility, can meet the application needs of more customers, reduces the waiting time of customers, and further increases the convenience of use. Summary of the Invention

[0007] The object of the present invention is to provide a fully automatic flow-through immunoassay system and a detection method thereof in view of the defects of the prior art.

[0008] To achieve the above object, the present invention adopts the following technical solutions:

[0009] A fully automatic flow-through immunoassay system, comprising a test area, a barcode recognition area, a transfer area, multiple detection areas, a sorting area, a controller and a power supply. The detection area consists of a sampling / recovery unit, a conveyor belt unit, a shaking unit, a strip stacking unit, a reaction cup transfer unit, a sample arm, a reagent arm, a reagent storage unit, an incubation unit, a liquid path unit, a waste recycling unit, and a detection unit;

[0010] A number of test samples are placed in the test area. The test samples are placed in test tubes on a test tube rack. The test tubes are provided with identification barcodes corresponding to the current test sample information. The test area is connected to the detection area, the sorting area, and the sampling / recovery unit of the detection area through the transfer area. One side of the sampling / recovery unit is connected to the transfer area and is used for the transfer of test samples and measured samples between the transfer area and the detection area. The other side of the sampling / recovery unit is provided with a conveyor belt unit for sequentially transferring the test samples to the shaking unit. A barcode recognition area is provided on the channel of the transfer area. The conveyor belt unit is adjacent to the shaking unit. Above the shaking unit is provided a sample arm. On one side of the sample arm is provided a strip stacking unit. The strip stacking unit is provided with a strip transfer mechanism. Above the strip stacking unit is provided a reaction cup transfer unit. The reaction cup transfer unit is provided with a reaction cup transfer device. The reaction cup transfer device is adjacent to the reagent arm. Below the reaction cup transfer unit is provided a waste recycling unit. On one side of the reagent arm is provided a reagent storage unit. The reagent arm is connected to the liquid path unit. On the other side of the reagent arm is provided an incubation unit. On one side of the incubation unit is provided a detection unit. A pushing mechanism is provided between the strip stacking unit, the incubation unit, and the detection unit. The pushing mechanism is a push rod. By the movement of the push rod, the strip is pushed from the strip stacking unit to the incubation unit and the detection unit. The sample arm and the reagent arm are connected to the liquid path unit.

[0011] Furthermore, sensors and push rods are provided between the transfer area, the sorting area, and the sampling / recovery unit. The sensors are used to detect whether the current sample-carrying rack is in place. After it is in place, the push rod is activated to push the rack into the unit. Retractable movable tabs are provided on both sides of the channels in the test area, the sorting area, and the sampling / recovery unit. The tabs are provided with electronic switches. After being opened, during the stroke movement of the tabs to push and pull the sample rack, they are fully extended along the guide rails on both sides and retract to both sides of the channel after pushing and pulling the sample rack to the designated position.

[0012] Furthermore, the shaking unit includes a test tube clamp, an anti-detachment strip, a shaking motor, a Z-axis motor, and a Y-axis motor. An anti-detachment strip is provided above the test tube clamp to prevent the test tubes in the test tube clamp from falling off during the shaking process. The shaking motor is movably connected to the test tube clamp, and the test tube clamp performs a shaking movement as the shaking motor rotates. The Z-axis motor is movably connected to the shaking motor through a belt and a runner on the Z-axis motor bracket. The Y-axis motor is movably connected to the Z-axis motor through a belt and a runner on the Y-axis motor bracket, enabling the test tube clamp to move forward and backward, up and down, to achieve the actions of lifting and lowering the test tube from the bracket.

[0013] Furthermore, the strip stack unit includes a card holder, a card picking arm, a push rod, a card holder barcode scanner, and a card holder barcode scanner bracket. Strips (cards) are placed in the card holder, and strips corresponding to different test items are placed in different card holders. A card holder barcode scanner is provided at the rear of the card holder to distinguish the test items and the number of strips in the card holder. The card holder barcode scanner is arranged on the card holder barcode scanner bracket. A card picking arm bracket is provided below the card holder barcode scanner bracket. A push rod and a card picking arm are provided on the card picking arm bracket. A motor is provided under the card picking arm to enable the card picking arm to rotate. A card seat is provided on the card picking arm. A card picking telescopic rod is provided below the card seat. One end of the card picking telescopic rod is provided with a card picking hook, which is a telescopic movable card hook. When picking a strip, the card picking telescopic rod extends forward along the bottom guide rail of the card holder, and the card picking hook presses against the bottom of the card holder and extends forward. There is a card picking slot at the bottom of the card holder. When the card picking hook reaches the card picking slot opening at the bottom of the card holder, the card hook smoothly slides into the slot to pick the strip (card) at the bottom of the card holder. The height of the card hook matches the thickness of the strip (card).

[0014] Furthermore, the reaction cup transfer unit includes a drawer, a reaction cup rack, a gripper, a reaction cup seat, a movable cup rack, a gripper moving unit, and a reaction cup seat guide rail. One and / or more reaction cup racks are arranged in the drawer, and empty reaction cups are stored in the reaction cup racks. The gripper is provided above the reaction cup racks. The gripper is connected to the gripper moving unit through a gripper bracket. The reaction cup seat is connected to the reaction cup seat guide rail through a movable cup rack. The gripper moving unit includes a gripper bracket and a movable bracket. The movable bracket is controlled by a motor to move forward and backward. The gripper bracket is arranged on the movable bracket and is movably connected to the X-axis motor through a belt and a transmission wheel to control the left and right movement of the gripper. A Z-axis motor is arranged on the gripper bracket, and the Z-axis motor is movably connected to the gripper through a belt and a transmission wheel to control the up and down movement of the gripper. The guide rail is movably connected to the movable cup rack, and the movable cup rack can move along the guide rail. A reaction cup seat is provided on the movable cup rack. A return spring is provided on the reaction cup seat. The gripper is provided with a solenoid valve and a gripper jaw. The reaction cup guide rail is arranged on a guide rail bracket. A reagent arm is movably connected to the guide rail bracket through a motor, a belt, and a transmission wheel. A double-needle bracket is provided on the reagent arm. A reagent needle and a waste liquid needle are provided on the double-needle bracket. The reagent needle and the waste liquid needle are connected to a liquid path unit.

[0015] Furthermore, the sample arm includes a sample needle, a stirring device, a movable rod, a motor bracket, an arm group rotation motor, and an arm group lifting motor. The sample needle is arranged on a sample needle seat, the sample needle seat is connected to a movable rod, a stirring device is arranged on the movable rod, the movable rod is connected to an arm group motor bracket, an arm group rotation motor and an arm group lifting motor are arranged on the arm group motor bracket, an anti-collision device is arranged on the sample needle seat, and the anti-collision device is arranged at the top of the sample needle to artificially set a buffer space to prevent hard damage caused by the needle tip touching when the sample needle moves up and down. A DC motor is arranged on the stirring device, the DC motor is connected to an eccentric piece, a sample needle through-hole is arranged on the eccentric piece, and a needle washing pool is arranged below the sample needle through-hole. The sample needle moves up and down through the sample needle through-hole, and the through-hole is arranged on the eccentric piece. When the DC motor drives the eccentric piece, the sample needle through-hole surrounding the sample needle rotates, and at the same time drives the sample needle to stir; the needle washing pool below the sample needle is connected with cleaning liquid, which can wash the outer wall of the sample needle. The arm group rotation motor and the arm group lifting motor on the arm group motor bracket are connected to the movable rod through a transmission wheel and a belt. The lifting and rotation of the movable rod are realized by the forward and reverse rotation of the motor, and at the same time, the lifting and rotation of the sample needle seat are driven. A code disk is arranged between the movable rod and the arm group rotation motor, and the rotation angle of the sample needle rocker arm is calibrated through the code disk.

[0016] Furthermore, the reagent warehouse unit includes a cooling fan, a heat sink, reagent bottles, a warehouse body, a heat preservation layer, a window, a bar code printer, a sensor, a refrigeration chip, and a wind guiding device. The reagent bottles are arranged in a fan-shaped distribution in a reagent tray. The bottom of the reagent tray is connected to a bearing, and the bearing is connected to a stepping motor and a stepping sensor. The motor connected to the bearing can drive the entire warehouse body to rotate. A notch corresponding to the bar code on the reagent bottle is arranged on the reagent tray, a window corresponding to the notch is arranged on the warehouse body, and a bar code printer is arranged on one side of the window. By rotating the warehouse body, the bar code printer can read the information of each reagent bottle through the rotation of the warehouse body. A heat sink is arranged at the center of the reagent tray, a cooling fan is arranged above the heat sink, a refrigeration chip is arranged below the warehouse body, the refrigeration chip is connected to a wind guiding device, the reagent tray is connected to a stepping motor and a stepping sensor below, and the motor connected to the bearing can drive the entire warehouse body to rotate. A heat preservation layer is arranged outside the warehouse body, and the heat preservation layer is heat preservation cotton. The bottom of the warehouse body is connected to the liquid path unit for discharging the condensed water generated during refrigeration.

[0017] Furthermore, the liquid path unit includes an internal and external cleaning liquid path for the reagent needle, an internal fresh water cleaning liquid path for the sample needle, an external washing liquid cleaning liquid path for the sample needle, and a waste liquid discharge liquid path;

[0018] The internal and external cleaning liquid paths of the reagent needle include a water bucket, a first pump, a first valve, and a first needle washing pool connected in sequence. The reagent needle is disposed in the first needle washing pool. One path of the first valve is connected to a first plunger pump through a reagent needle interface to clean the inner wall of the reagent needle, and the other path of the first valve is connected to the first needle washing pool to clean the outer wall of the reagent needle. The first plunger pump can extract and discharge reagent solutions through the reagent needle.

[0019] The internal clean water cleaning liquid path of the sample needle includes a water bucket, a second pump, a second valve, a second plunger pump, and a fourth valve connected in sequence. The second plunger pump is connected to the inside of the sample needle through a sample needle interface. When the fourth valve is selected, the internal clean water cleaning liquid path of the sample needle cleans the inner wall of the reagent needle. The second plunger pump can extract and discharge sample solutions through the sample needle.

[0020] The external cleaning liquid path of the sample needle includes a cleaning liquid bucket, a third pump, and a third valve connected in sequence. The sample needle is disposed in a second needle washing pool. The third valve is connected to the outer wall of the second needle washing pool. When the third valve is selected, the external cleaning liquid path of the sample needle cleans the outer wall of the sample needle.

[0021] The liquid path system further includes a condensate and waste liquid discharge liquid path, which includes a waste liquid needle, a fifth pump, and a fifth valve connected in sequence. One path of the fifth valve is connected to a reagent tray through a reagent tray interface, and the other path is connected to the waste liquid needle through a waste liquid needle interface. The fifth pump is used to discharge the condensate in the reagent tray and the waste liquid sucked by the waste liquid needle into a waste liquid bucket.

[0022] The bottom of the first needle washing pool is connected to a fourth pump, which is used to discharge the waste liquid in the first needle washing pool into a waste liquid bucket.

[0023] The bottom of the second needle washing pool is connected to a sixth pump, which is used to discharge the waste liquid in the second needle washing pool into a waste liquid bucket.

[0024] A filter and a connection joint are further provided between the water bucket and the first pump and the second pump.

[0025] A filter and a connection joint are further provided between the cleaning liquid bucket and the third pump.

[0026] A filter is provided between the reagent tray and the fifth valve.

[0027] Further, the incubation unit includes an incubation rack, a thermostat, and an incubation sensor. The incubation rack is provided with spaces for placing multiple placement slats (cards). The thermostat is used to heat the items in the incubation rack. The incubation sensor constantly detects the environmental temperature in the incubation rack. The incubation unit controls the movement of the incubation rack through an incubation rack motor and an incubation rack guide rail to correspond to the horizontal position of the slats (cards) pushed by the push rod.

[0028] Further, the detection unit includes a detection card holder, a detection card holder bracket, and a detector disposed above the detection card holder. The detection card holder bracket moves along a guide rail through a motor, a belt, and a transmission wheel. A push rod pushes the strip (card) that has met the incubation time in the incubation unit into the detection card holder. The detection card holder bracket drives the detection card holder to move under the detector for detection. After the detection is completed, the push rod pushes the strip (card) into the waste hole, and the waste hole is connected to the waste recycling unit.

[0029] A full-automatic flow-through immunoassay method includes a sample area to be tested, a barcode recognition area, a transfer area, a plurality of detection areas, a sorting area, a controller, and a power supply. The detection area is implemented in a system composed of a sample injection / recovery unit, a conveyor belt unit, a shaking unit, a strip stack unit, a reaction cup transfer unit, a sample arm, a reagent arm, a reagent storage unit, an incubation unit, a liquid path unit, a waste recycling unit, and a detection unit through the following steps:

[0030] Step 1. Transfer the sample in the sample area to be tested through the transfer area. When transferring, obtain the current sample information to be tested by scanning the code. The test tube containing the sample is placed on the sample holder, and a corresponding barcode label is pasted on the test tube arm.

[0031] Step 2. Obtain an empty reaction cup from the reaction cup transfer unit.

[0032] Step 3. Transfer the current sample to be tested to the sample injection / recovery unit in the corresponding detection area according to the obtained sample information to be tested. The strip stack unit prepares the corresponding strip, and the reagent storage unit prepares the corresponding reagent.

[0033] Step 4. The sample to be tested enters the detection area. The shaking unit sequentially grabs the samples to be tested on the holder and shakes them, and then puts them back on the holder in sequence.

[0034] Step 5. The reagent arm extracts the prepared reagent from the reagent storage unit through the reagent needle and injects it into the reaction cup. After completion, the reagent needle on the reagent arm is cleaned inside and on the needle body through the liquid path unit.

[0035] ]Step 6. The sample arm extracts the shaken sample to be tested through the sample needle and injects it into the reaction cup and stirs it. After all the samples to be tested on the holder are completed, the tested samples are sent to the sorting area through the sample injection / recovery unit.

[0036] Step 7. The sample arm extracts the stirred mixed solution through the sample needle and adds it to the prepared strip. After completion, the sample needle is cleaned inside and on the needle body through the liquid path unit. The reagent arm extracts the residual solution in the reaction cup through the waste liquid needle, and then pushes the empty reaction cup to the waste recycling unit through the waste liquid needle itself. After completion, the waste liquid needle is cleaned by itself through the liquid path unit.

[0037] Step 8. Send the strip added with the mixed solution to the incubation unit and set the incubation time.

[0038] In step 9, the strip that meets the incubation time is sent into the detection unit for detection, and after completion, the strip is discarded through the waste hole on the detection unit;

[0039] In step 10, the final detection information is obtained.

[0040] Adopting the technical solution of the present invention, the beneficial effects of the present invention are as follows: It is adaptable to various sample types, multiple indicators and multi-threads, performs detection in a flowing water asynchronous manner, greatly improves the detection speed and application flexibility, can meet the application needs of more customers, reduces the detection waiting time, and further increases the convenience of use. Description of the Drawings

[0041] Figure 1 It is a schematic structural diagram of the detection area in a flowing water full-automatic immunoassay system provided by the present invention;

[0042] Figure 2 It is a schematic structural diagram of the shaking unit provided by the present invention;

[0043] Figure 3 It is a schematic structural diagram of the reaction cup transfer unit provided by the present invention;

[0044] Figure 4 It is a schematic structural diagram of the sample arm provided by the present invention;

[0045] Figure 5 It is a schematic structural diagram of the reagent arm and part of the reaction cup transfer unit provided by the present invention;

[0046] Figure 6 It is a schematic structural diagram of the reagent storage unit provided by the present invention;

[0047] Figure 7 It is a schematic structural diagram of the liquid path of the detection area provided by the present invention;

[0048] Figure 8 It is a schematic structural diagram of the strip stack unit provided by the present invention;

[0049] Figure 9 It is a schematic structural diagram of the incubation unit provided by the present invention;

[0050] Figure 10 It is a schematic structural diagram of the detection unit provided by the present invention;

[0051] Figure 11 It is a schematic structural diagram of a flowing water full-automatic immunoassay system provided by the present invention.

[0052] Among them, 1. Equipment support, 2. Shaking unit, 3. Reaction cup transfer unit, 4. Sample arm, 5. Reagent arm, 6. Reagent storage unit, 7. Liquid path unit, 8. Strip stack unit, 9. Incubation unit, 10. Detection unit, 11. Sampling / recovery unit, 12. Conveyor unit, 13. Detection area, 14. Sorting area, 15. Area to be tested, 16. Barcode recognition area, 17. Transfer area

[0053] 201. Test tube clamp, 202. Anti - detachment strip, 203. Shaking motor, 204. Z - axis motor, 205. Y - axis motor

[0054] 301. Reaction cup holder, 302. Gripper, 303. Reaction cup seat, 304. Spring, 305. X - direction motor, 306. Z - direction motor, 307. Movable cup holder, 308. Reaction cup seat guide rail, 309. Drawer, 310. Gripper support, 311. Movable support

[0055] 401. Sample needle, 402. Anti - collision device, 403. Stirring device, 404. DC motor, 405. Needle washing pool, 406. Encoder disk, 407. Arm group rotation motor, 408. Arm group lifting motor, 409. Arm group motor support, 410. Movable rod, 411. Sample needle seat

[0056] 501. Reagent needle, 502. Waste liquid needle, 503. Double - needle motor, 504. Double - needle motor support, 505. Guide rail motor, 506. Reagent needle pump, 507. Waste liquid needle pump, 508. Double - needle support, 509. Guide rail support

[0057] 601. Cooling fan, 602. Heat sink, 603. Reagent bottle, 604. Reagent tray, 605. Bearing, 606. Chamber body, 607. Thermal insulation cotton, 608. Window, 609. Barcode printer, 610. Sensor, 611. Thermoelectric cooler, 612. Air guiding device

[0058] 701. First pump, 702. First valve, 703. First plunger pump, 704. Second pump, 705. Second valve, 706. Second plunger pump, 707. Third pump, 708. Third valve, 709. Reagent needle interface, 710. Fourth pump, 711. Fourth valve, 712. Fifth pump, 713. Fifth valve, 714. Sixth pump, 715. Sample needle interface, 716. Reagent tray interface, 717. Waste liquid needle interface, 718. Connector, 719. Filter, 720. Clean water bucket, 721. Cleaning solution bucket, 722. Waste liquid bucket

[0059] 801. Card rack, 802. Card - picking arm, 803. Card - picking hook, 804. Card - picking telescopic rod, 805. Card seat, 806. Card - picking arm support, 807. Push rod, 808. Card rack barcode scanner, 809. Card rack barcode scanner support

[0060] 901, Incubation Rack, 902, Thermostat, 903, Incubation Sensor, 904, Incubation Rack Motor, 905 Incubation Rack Guide Rail,

[0061] 1001, Detection Card Holder, 1002, Detection Card Holder Bracket, 1003, Detector, 1004, Waste Hole. Detailed Embodiment

[0062] The present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments.

[0063] A fully automatic immunological detection method for a production line includes a sample area to be tested 15, a barcode identification area 16, a transfer area 17, a plurality of detection areas 13, a sorting area 14, a controller, and a power supply. The detection area 13 is composed of a sampling / recovery unit 11, a conveyor belt unit 12, a shaking unit 2, a strip stack unit 8, a reaction cup transfer unit 3, a sample arm 4, a reagent arm 5, a reagent storage unit 6, an incubation unit 9, a liquid path unit 7, a waste recovery unit, and a detection unit 10. The method is implemented through the following steps:

[0064] Step 1. The sample in the sample area to be tested is transferred through the transfer area 17. When transferring, the current sample information to be tested is obtained through the barcode identification area 16. The test tube containing the sample is placed on the sample support, and a corresponding barcode label is pasted on the test tube arm;

[0065] Step 2. An empty reaction cup is obtained from the reaction cup transfer unit 3;

[0066] Step 3. According to the obtained sample information to be tested, the current sample to be tested is transferred to the sampling / recovery unit 11 of the corresponding detection area 13. Since there are many types of detection items, blank strips corresponding to different detections are stored in different detection areas. At the same time, for each detection area, when the remaining number of detection strips is insufficient for the remaining items to be detected, the system automatically allocates the current sample to be tested to the detection area 13 with corresponding blank strips. The strip stack unit 8 prepares the corresponding strips, and the reagent storage unit 6 prepares the corresponding reagents;

[0067] Step 4. The sample to be tested enters the designated detection area 13, and the shaking unit 2 sequentially grabs the samples to be tested on the support and shakes them, and then returns them to the support in sequence;

[0068] Step 5. The reagent arm 5 extracts the prepared reagent from the reagent storage unit 6 through the reagent needle and injects it into the reaction cup. After completion, the reagent needle on the reagent arm 5 is cleaned through the liquid path unit 7 for the inside and the body of the needle;

[0069] Step 6. The sample arm 4 extracts the shaken sample to be tested through the sample needle and injects it into the reaction cup and stirs it. After all the samples to be tested on the support are completed, the tested samples are sent to the sorting area 14 through the sampling / recovery unit 11;

[0070] In step 7, the sample arm 4 extracts the stirred mixed solution through the sample needle and adds it to the prepared strip. After completion, the sample needle cleans the inside and the body of the needle through the liquid path unit 7. The reagent arm 5 extracts the residual solution in the reaction cup through the waste liquid needle, and then pushes the empty reaction cup to the waste recycling unit through the waste liquid needle itself. After completion, the waste liquid needle cleans itself through the liquid path unit 7;

[0071] In step 8, the strip added with the mixed solution is sent into the incubation unit 9 while setting the incubation time;

[0072] In step 9, the strip that meets the incubation time is sent into the detection unit 10 for detection. After completion, the strip is discarded through the waste hole 1004 on the detection unit;

[0073] In step 10, the final detection information is obtained.

[0074] A full-automatic flow-through immunoassay system, comprising a to-be-tested area 15, a barcode recognition area 16, a transmission area 17, a plurality of detection areas 13, a sorting area 14, a controller and a power supply. The detection area 13 is composed of a sampling / recovery unit 11, a conveyor belt unit 12, a shaking unit 2, a strip stack unit 8, a reaction cup transfer unit 3, a sample arm 4, a reagent arm 5, a reagent storage unit 6, an incubation unit 9, a liquid path unit 7, a waste recycling unit, and a detection unit 10;

[0075] A number of samples to be tested are placed in the area 15 to be tested. The samples to be tested are placed in test tubes on a test tube holder. An identification barcode corresponding to the current sample information to be tested is provided on the test tube. The area 15 to be tested is connected to the sampling / recovery unit 11 of the detection area 13, the sorting area 15, and the detection area 13 through the transfer area 17. One side of the sampling / recovery unit 11 is connected to the transfer area 17 and is used for the transfer of samples to be tested and tested samples between the transfer area 17 and the detection area 13. On the other side of the sampling / recovery unit 11, there is a conveyor belt unit 12 for sequentially transferring samples to be tested to the shaking unit 2. A barcode identification area 16 is provided on the channel of the transfer area 17. The conveyor belt unit 12 is adjacent to the shaking unit 2. Above the shaking unit 2, there is a sample arm 4. On one side of the sample arm 4, there is a strip stack unit 8. The strip stack unit 8 is provided with a strip transfer mechanism. Above the strip stack unit 8, there is a reaction cup transfer unit 3. The reaction cup transfer unit 3 is provided with a reaction cup transfer device. The reaction cup transfer device is adjacent to the reagent arm 5. Below the reaction cup transfer unit 3, there is a waste recovery unit. On one side of the reagent arm 5, there is a reagent storage unit 6. The reagent arm 5 is connected to the liquid path unit 7. On the other side of the reagent arm 5, there is an incubation unit 9. On one side of the incubation unit 9, there is a detection unit 10. A pushing mechanism is provided between the strip stack unit 8, the incubation unit 9, and the detection unit 10. The pushing mechanism is a push rod. By moving the push rod, the strip is pushed from the strip stack unit 8 to the incubation unit 9 and the detection unit 10. The sample arm 4 and the reagent arm 5 are connected to the liquid path unit 7.

[0076] Sensors and push rods are provided between the transfer area 17, the sorting area 14, and the sampling / recovery unit 11. The sensors are used to detect whether the holder carrying the sample is in place. After it is in place, the push rod is activated to push the holder into the sampling unit. Pull tabs are provided on both sides of the channels in the area 15 to be tested, the sorting area 14, and the sampling / recovery unit 11. The pull tabs are retractable movable pull tabs. The pull tabs are provided with electronic switches. After being turned on, during the stroke movement of the pull tabs to push and pull the sample holder, they are fully unfolded along the guide rails on both sides. After pushing and pulling the sample holder to the designated position, the pull tabs retract to both sides of the channel.

[0077] The shaking unit 2 includes a test tube clamp 201, an anti - detachment strip 202, a shaking motor 203, a Z - axis motor 204, and a Y - axis motor 205. An anti - detachment strip 202 is provided above the test tube clamp 201 to prevent the test tube in the test tube clamp 201 from falling off during the shaking process. The shaking motor 203 is movably connected to the test tube clamp 201, and the test tube clamp 201 performs a shaking motion as the shaking motor 203 rotates. The Z - axis motor 204 is movably connected to the shaking motor 203 through a belt and a runner on the Z - axis motor bracket. The Y - axis motor 205 is movably connected to the Z - axis motor 204 through a belt and a runner on the Y - axis motor bracket, enabling the test tube clamp 201 to move back - and - forth and up - and - down, realizing the actions of lifting and lowering the test tube from the bracket.

[0078] The strip stack unit 8 includes a card holder 801, a card - taking arm 802, a push rod 807, a card - holder barcode scanner 808, and a card - holder barcode scanner bracket 809. Strips (cards) are placed in the card holder 801, and strips corresponding to different detection items are placed in different card holders 801. A card - holder barcode scanner 808 is provided at the rear of the card holder 801 to distinguish the items and the number of strips tested in the card holder. The card - holder barcode scanner 808 is arranged on the card - holder barcode scanner bracket 809. A card - taking arm bracket 806 is provided below the card - holder barcode scanner bracket 809. A push rod 807 and a card - taking arm 802 are provided on the card - taking arm bracket 806. A motor is provided under the card - taking arm 802 to enable the card - taking arm 802 to rotate. A card seat 805 is provided on the card - taking arm 802. A card - taking telescopic rod 804 is provided below the card seat 805. A card - taking hook 803 is provided at one end of the card - taking telescopic rod 804. The card - taking hook 803 is a telescopic movable hook. When taking a strip (card), the card - taking telescopic rod 804 extends forward along the bottom guide rail of the card holder, and the card - taking hook 803 presses against the bottom of the card holder and extends forward. A card - taking slot is provided at the bottom of the card holder 801. When the card - taking hook 803 reaches the card - taking slot opening at the bottom of the card holder 801, the card hook smoothly slides into the slot to hook the strip (card) at the bottom of the card holder 801. The height of the card hook matches the thickness of the strip (card).

[0079] The reaction cup transfer unit 3 includes a drawer 309, a reaction cup rack 301, a gripper 302, a reaction cup seat 303, a movable cup rack 307, a gripper moving unit, and a reaction cup seat guide rail 308. The one and / or more reaction cup racks 301 are arranged in the drawer 309, and empty reaction cups are stored in the reaction cup rack 301. The gripper 302 is provided above the reaction cup rack 301. The gripper 302 is connected to the gripper moving unit through a gripper bracket 310. The reaction cup seat 303 is connected to the reaction cup seat guide rail 308 through the movable cup rack 307. The gripper moving unit includes a gripper bracket 310 and a movable bracket 311. The movable bracket 311 is controlled by a motor to move back and forth. The gripper bracket 310 is arranged on the movable bracket 311 and is movably connected to the X-direction motor 305 through a belt and a transmission wheel to control the left and right movement of the gripper 302. A Z-direction motor 306 is arranged on the gripper bracket 310. The Z-direction motor 306 is movably connected to the gripper 302 through a belt and a transmission wheel to control the up and down movement of the gripper 302. The guide rail is movably connected to the movable cup rack 307, and the movable cup rack 307 can move along the guide rail. A reaction cup seat 303 is arranged on the movable cup rack 307. A return spring 304 is arranged on the reaction cup seat 303. The gripper 302 is provided with a solenoid valve and a gripper. The reaction cup guide rail 308 is arranged on a guide rail bracket. A reagent arm 5 is movably connected to the guide rail bracket through a motor, a belt, and a transmission wheel. A double-needle bracket 508 is arranged on the reagent arm 5. A reagent needle 501 and a waste liquid needle 502 are arranged on the double-needle bracket 508. The reagent needle 501 and the waste liquid needle **********

[0080] It should be noted that there seems to be an incomplete part in the translation of the last sentence where "the reagent needle 501 and the waste liquid needle 502 are connected with a liquid path unit 7" is not fully translated. You can check and correct it according to the actual situation.The sample arm 4 includes a sample needle 401, a stirring device 403, a movable rod 410, an arm group motor bracket 409, an arm group rotation motor 407, and an arm group lifting motor 408. The sample needle 401 is arranged on a sample needle base 411. The sample needle base 411 is connected to a movable rod 410. A stirring device 403 is provided on the movable rod 410. The movable rod 410 is connected to the arm group motor bracket 409. An arm group rotation motor 407 and an arm group lifting motor 408 are provided on the arm group motor bracket 409. An anti-collision device 402 is provided on the sample needle base 411. The anti-collision device 402 is arranged at the top of the sample needle 401, and a buffer space is artificially set to prevent hard damage caused by the needle tip touching when the sample needle 401 moves up and down. A DC motor 404 is provided on the stirring device 403. The DC motor 404 is connected to an eccentric disc. A sample needle through-hole is provided on the eccentric disc. A needle washing pool is provided below the sample needle through-hole. The sample needle 401 moves up and down through the sample needle through-hole. The through-hole is arranged on the eccentric disc. When the DC motor 404 drives the eccentric disc, the sample needle through-hole surrounding the sample needle 401 rotates, and at the same time drives the sample needle 401 to stir. The needle washing pool below the sample needle 401 is connected with a cleaning liquid, which can wash the outer wall of the sample needle. The arm group rotation motor 407 and the arm group lifting motor 408 on the arm group motor bracket are connected to the movable rod through a transmission wheel and a belt. The lifting and rotation of the movable rod are realized by the forward and reverse rotation of the motor, and at the same time, the lifting and rotation of the sample needle base are driven. A code disc 406 is provided between the movable rod 410 and the arm group rotation motor 407, and the rotation angle of the sample needle swing arm is calibrated through the code disc 406.

[0081] The reagent storage unit 6 includes a cooling fan 601, a heat sink 602, reagent bottles 603, a chamber body 606, a thermal insulation layer, a viewing window 608, a bar code printer 609, a sensor 610, a Peltier cooler 611, and an air guiding device 612. The multiple reagent bottles 603 are arranged in a fan-shaped distribution in a reagent tray 604. The bottom of the reagent tray 604 is connected to a bearing, and the bearing is connected to a stepping motor and a stepping sensor. The motor is connected to the bearing and can drive the entire chamber body 606 to rotate. The reagent tray 604 is provided with a notch corresponding to the bar code on the reagent bottle 603, and the chamber body 606 is provided with a viewing window corresponding to the notch. A bar code printer 609 is provided on one side of the viewing window. By rotating the chamber body 606, the bar code printer 609 can read the information of each reagent bottle 603 through the rotation of the chamber body 606. A heat sink 602 is provided at the center of the reagent tray 604, and a cooling fan 601 is provided above the heat sink 602. A Peltier cooler 611 is provided below the chamber body 606, and the Peltier cooler 611 is connected to an air guiding device 612. The reagent tray 604 is connected to a stepping motor and a stepping sensor below, and the motor is connected to the bearing and can drive the entire chamber body 606 to rotate. A thermal insulation layer is provided outside the chamber body 606, and the thermal insulation layer is thermal insulation cotton 607. The bottom of the chamber body 606 is connected to a liquid path unit 7 for discharging the condensed water generated during refrigeration.

[0082] The liquid path unit 7 includes an internal and external cleaning liquid path for the reagent needle, an internal fresh water cleaning liquid path for the sample needle, an external cleaning liquid path for the sample needle, and a waste liquid discharge liquid path.

[0083] The internal and external cleaning liquid path for the reagent needle 501 includes a water bucket 720, a first pump 701, a first valve 702, and a first needle washing pool that are connected in sequence. The reagent needle 501 is disposed in the first needle washing pool. One path of the first valve 702 is connected to a first plunger pump 703 through a reagent needle interface 709 to connect to the inside of the reagent needle 502 for cleaning the inner wall of the reagent needle, and the other path of the first valve 702 is connected to the first needle washing pool for cleaning the outer wall of the reagent needle 501. The first plunger pump 703 can extract and discharge the reagent solution through the reagent needle 501.

[0084] The internal fresh water cleaning liquid path for the sample needle 401 includes a water bucket 720, a second pump 704, a second valve 705, a second plunger pump 706, and a fourth valve 711 that are connected in sequence. The second plunger pump 706 is connected to the inside of the sample needle 401 through a sample needle interface 715. When the fourth valve 711 is selected, the internal fresh water cleaning liquid path for the sample needle 401 cleans the inner wall of the sample needle 401. The second plunger pump 706 can extract and discharge the sample solution through the sample needle.

[0085] The outer cleaning liquid path of the sample needle 401 includes a cleaning liquid bucket 721, a third pump 707, and a third valve 708 that are connected in sequence. The sample needle 401 is disposed in the second needle washing pool. The third valve 708 is connected to the outer wall of the second needle washing pool. When the third valve 708 is selected to be open, the outer cleaning liquid path of the sample needle 401 cleans the outer wall of the sample needle 401.

[0086] The liquid path system further includes a condensate and waste liquid discharge path. The condensate and waste liquid discharge path includes a waste liquid needle 502, a fifth pump 712, and a fifth valve 713 that are connected in sequence. One path of the fifth valve 713 is connected to a reagent tray through a reagent tray interface 716, and the other path is connected to the waste liquid needle 502 through a waste liquid needle interface 717. The fifth pump 712 is used to discharge the condensate in the reagent tray and the waste liquid sucked by the waste liquid needle 502 into a waste liquid bucket 722.

[0087] The bottom of the first needle washing pool is connected to a fourth pump 710, and the fourth pump 710 is used to discharge the waste liquid in the first needle washing pool into the waste liquid bucket 722.

[0088] The bottom of the second needle washing pool is connected to a sixth pump 715, and the sixth pump 715 is used to discharge the waste liquid in the second needle washing pool into the waste liquid bucket 722.

[0089] A filter 719 and a connection joint 718 are further provided between the clean water bucket 720 and the first pump 701 and the second pump 704.

[0090] A filter and a connection joint are further provided between the cleaning liquid bucket 721 and the third pump 707.

[0091] A filter is provided between the reagent tray and the fifth valve 713.

[0092] The incubation unit package 9 includes an incubation rack 901, a thermostat 902, and an incubation sensor 903. The incubation rack 901 is provided with spaces for placing a plurality of placement slats (cards). The thermostat 902 is used to heat the items in the incubation rack 901. The incubation sensor 903 constantly detects the ambient temperature in the incubation rack 901. The incubation unit 9 controls the movement of the incubation rack 901 through an incubation rack motor 904 and an incubation rack guide rail 905 to correspond to the horizontal position of the slat (card) pushed by the push rod 807.

[0093] The detection unit 10 includes a detection card holder 1001, a detection card holder bracket 1002, and a detector 1003 disposed above the detection card holder 1001. The detection card holder bracket 1002 moves along a guide rail through a motor, a belt, and a transmission wheel. A push rod 807 pushes the strip (card) that has met the incubation time in the incubation unit 9 into the detection card holder 1001. The detection card holder bracket 1002 drives the detection card holder 1001 to move under the detector 1003 for detection. After the detection is completed, the push rod 807 pushes the strip (card) into a waste hole 1004, and the waste hole 1004 is connected to a waste recycling unit.

[0094] Using the flow-through full-automatic immunoassay system and its detection method of the present invention, determinations of various detection items can be carried out, such as: determination of C-reactive protein, determination of neutrophil gelatinase-associated lipocalin, determination of β-human chorionic gonadotropin, determination of D-dimer, determination of procalcitonin, determination of heparin-binding protein, determination of intact C-reactive protein, determination of cardiac troponin I, determination of creatine kinase isoenzyme, determination of amino-terminal pro-brain natriuretic peptide, determination of progesterone, determination of serum amyloid A, determination of heart-type fatty acid-binding protein, determination of cardiac troponin I, determination of B-type natriuretic peptide, determination of myoglobin, determination of soluble growth-stimulating expressed gene 2 protein, determination of neutrophil gelatinase-associated lipocalin, determination of lipoprotein-associated phospholipase A2, determination of urinary microalbumin, determination of anti-Müllerian hormone, determination of β2-microglobulin, determination of interleukin 6, determination of pepsin 1 / 2, etc. According to specific items, parameters such as the shaking and oscillation speed and the incubation reaction time are adjusted accordingly, and all can be achieved through the technology described in the present invention.

[0095] Note that the above is only the preferred embodiment of the present invention and the technical principles applied. Those skilled in the art will understand that the present invention is not limited to the specific embodiments described herein. Various obvious changes, re-adjustments, and substitutions can be made by those skilled in the art without departing from the protection scope of the present invention. Therefore, although the present invention has been described in more detail through the above embodiments, the present invention is not limited to the above embodiments. Without departing from the concept of the present invention, it may include more other equivalent embodiments, and the scope of the present invention is determined by the scope of the appended claims.

Claims

1. A fully automatic flow-through immunoassay system, characterized in that, It includes a sample area to be tested, a barcode recognition area, a transfer area, multiple detection areas, a sorting area, a controller and a power supply. The detection area is composed of a sampling / recovery unit, a conveyor belt unit, a shaking unit, a strip stack unit, a reaction cup transfer unit, a sample arm, a reagent arm, a reagent storage unit, an incubation unit, a liquid path unit, a waste recycling unit, and a detection unit; The sample area to be tested is connected to the detection area and the sorting area through the transfer area. The barcode recognition area is provided on the transfer area. The sampling / recovery unit is provided in the detection area. One side of the sampling / recovery unit is connected to the transfer area, and the conveyor belt unit is provided on the other side. The conveyor belt unit is adjacent to the shaking unit. The sample arm is provided above the shaking unit. The strip stack unit is provided on one side of the sample arm. The reaction cup transfer unit is provided above the strip stack unit. The reaction cup transfer unit is adjacent to the reagent arm. The waste recycling unit is provided below the reaction cup transfer unit. The reagent storage unit is provided on one side of the reagent arm, and the incubation unit is provided on the other side of the reagent arm. The detection unit is provided on one side of the incubation unit. A pushing mechanism is provided between the strip stack unit, the incubation unit and the detection unit. The sample arm and the reagent arm are connected to the liquid path unit; The reaction cup transfer unit includes a drawer, a reaction cup rack, a gripper, a reaction cup holder, a movable cup rack, a gripper moving unit, and a reaction cup holder guide rail. One and / or more reaction cup racks are arranged in the drawer. The gripper is provided above the reaction cup rack. The gripper is connected to the gripper moving unit through a gripper bracket. The reaction cup holder is connected to the reaction cup holder guide rail through a movable cup rack. The gripper moving unit includes a gripper bracket and a movable bracket. The gripper bracket is arranged on the movable bracket and is movably connected to an X-axis motor. A Z-axis motor is arranged on the gripper bracket. The Z-axis motor is connected to the gripper. The guide rail is movably connected to the movable cup rack. The movable cup rack is provided with a reaction cup holder. The reaction cup holder is provided with a return spring. The gripper is provided with a solenoid valve and a jaw. The reaction cup guide rail is arranged on a guide rail bracket. The reagent arm is movably connected to the guide rail bracket. The reagent arm is provided with a double-needle bracket. The double-needle bracket is provided with a reagent needle and a waste liquid needle. The reagent needle and the waste liquid needle are connected to the liquid path unit. The waste liquid needle itself pushes the empty reaction cup to the waste recycling unit; The automatic flow-through immunoassay system realizes the detection method through the following steps: It is characterized in that it includes a sample area to be tested, a barcode recognition area, a transfer area, multiple detection areas, a sorting area, a controller and a power supply. The detection area is composed of a sampling / recovery unit, a conveyor belt unit, a shaking unit, a strip stack unit, a reaction cup transfer unit, a sample arm, a reagent arm, a reagent storage unit, an incubation unit, a liquid path unit, a waste recycling unit, and a detection unit. The system realizes through the following steps: Step 1. Transfer the sample in the sample area to be tested through the transfer area, and obtain the current sample information to be tested by scanning the code during the transfer; Step 2. Obtain an empty reaction cup from the reaction cup transfer unit; Step 3 Transmit the current sample to be tested to the corresponding detection area according to the obtained sample information to be tested, and the strip stack unit prepares the corresponding strip, and the reagent bin unit prepares the corresponding reagent; Step 4 The sample to be tested enters the detection area, and the shaking unit shakes the sample to be tested; Step 5 The reagent arm extracts the prepared reagent from the reagent bin unit and injects it into the reaction cup, and after completion, cleans the reagent arm itself; Step 6 The sample arm extracts the shaken sample to be tested and injects it into the reaction cup and stirs it. After completion, the tested sample is sent to the placement area; Step 7 The sample arm extracts the stirred mixed solution and adds it to the prepared strip. After completion, the sample arm cleans itself, the reagent arm extracts the residual solution in the reaction cup, pushes the empty reaction cup to the waste recycling unit, and cleans itself; Step 8 Send the strip added with the mixed solution to the incubation unit and set the incubation time at the same time; Step 9 Send the strip that meets the incubation time to the detection unit for detection, and discard the strip after completion; Step 10 Obtain the detection information.

2. The fully automatic flow-through immunoassay system according to claim 1, characterized in that Sensors and push rods are provided between the transfer area and the placement area and the sampling / recovery unit. Pull tabs are provided on both sides of the channels in the area to be tested, the placement area and the sampling / recovery unit. The pull tabs are retractable movable pull tabs.

3. The fully automatic flow-through immunoassay system according to claim 1, characterized in that, The shaking unit includes a test tube clamp, an anti-detachment strip, a shaking motor, a Z-axis motor, and a Y-axis motor. An anti-detachment strip is provided above the test tube clamp. The shaking motor is movably connected to the test tube clamp. The Z-axis motor is movably connected to the shaking motor through a Z-axis motor bracket. The Y-axis motor is movably connected to the Z-axis motor through a Y-axis motor bracket.

4. The fully automatic flow-through immunoassay system according to claim 1, characterized in that, The strip stack unit includes a card rack, a card-taking arm, a push rod, a card rack barcode scanner, and a card rack barcode scanner bracket. Strips are placed in the card rack. A card rack barcode scanner is provided at the rear of the card rack. The card rack barcode scanner is arranged on the card rack barcode scanner bracket. A card-taking arm bracket is provided below the card rack barcode scanner bracket. A push rod and a card-taking arm are provided on the card-taking arm bracket. A card seat is provided on the card-taking arm. A card-taking telescopic rod is provided below the card seat. A card-taking hook is provided at one end of the card-taking telescopic rod.

5. The fully automatic flow-through immunoassay system according to claim 1, characterized in that, The sample arm includes a sample needle, a stirring device, a movable rod, a motor bracket, an arm group rotation motor, and an arm group lifting motor. The sample needle is arranged on a sample needle seat. The sample needle seat is connected to a movable rod. A stirring device is provided on the movable rod. The movable rod is connected to the motor bracket. An arm group rotation motor and an arm group lifting motor are provided on the motor bracket. An anti-collision device is provided on the sample needle seat. A DC motor is provided on the stirring device. The DC motor is connected to an eccentric plate. A sample needle through hole is provided on the eccentric plate. A needle washing pool is provided below the sample needle through hole. The arm group rotation motor and the arm group lifting motor on the motor bracket are connected to the movable rod through a transmission wheel and a belt. A code disk is provided between the movable rod and the arm group rotation motor. The sample arm is connected to a liquid path unit.

6. The fully automatic flow-through immunoassay system according to claim 1, wherein The reagent storage unit includes a cooling fan, a heat sink, reagent bottles, a storage body, a thermal insulation layer, a viewing window, a bar code printer, a sensor, a Peltier cooler, and an air guiding device. The reagent bottles are arranged in a fan-shaped distribution on a reagent tray. The bottom of the reagent tray is connected with a bearing. The reagent tray is provided with a notch corresponding to the bar code on the reagent bottle. The storage body is provided with a viewing window corresponding to the notch. A bar code printer is arranged on one side of the viewing window. A heat sink is arranged at the center of the reagent tray. A cooling fan is arranged above the heat sink. A Peltier cooler is arranged below the storage body. The Peltier cooler is connected with an air guiding device. A stepping motor and a stepping sensor are connected below the reagent tray. A thermal insulation layer is arranged outside the storage body.

7. The fully automatic flow-through immunoassay system according to claim 1, wherein, The liquid path unit includes an internal and external cleaning liquid path for the reagent needle, an internal pure water cleaning liquid path for the sample needle, an external cleaning liquid path for the sample needle, and a waste liquid discharge liquid path.

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