Fully automatic chemiluminescence immunoassay analyzer

Abstract

The present invention provides a fully automatic chemiluminescence immunoassay analyzer, which is used in conjunction with single-person packaged immunoassay reagent cards. The analyzer comprises a body, an operating room, a transfer table, a protective cover, a detection module, a sample loading module, a cleaning module, and an incubation module, a reagent card module, and a sample module distributed in parallel on the transfer table. The analyzer meets the comprehensive requirements of safety, stability, and accuracy in medical testing, and has a reasonable overall layout, a compact structure, and strong aesthetics. The analyzer is equipped with a dedicated immunoassay reagent card, which can streamline the testing process, improve testing efficiency, reduce the number of analyzer configuration devices, and achieve full automation of testing. The analyzer can also realize continuous sample loading, full automation of the testing process, moderate reagent positions, and avoid reagent waste. Therefore, the analyzer is very suitable for promotion in Class II hospitals, Class III hospitals, and small medical institutions.

Description

Technical Field

[0001] The invention belongs to the technical field of chemiluminescence detection of medical materials, in particular to a fully automatic chemiluminescence immunoassay analyzer. Background Art

[0002] Chemiluminescent immunoassays involve a chemiluminescent reaction between the analyte and the added reagents, collecting the light emitted by the analyte and determining its concentration based on its luminescent intensity. With the development of chemiluminescent immunoassay technology, the reaction cup and turntable mechanism have gradually replaced the laboratory strip method, which can improve the efficiency of detection.

[0003] Existing chemiluminescence analyzers usually pursue high detection throughput, so that opened reagent bottles can be completely consumed in a short period of time. However, for Class II hospitals, Class III hospitals or other small medical institutions, or for detection projects that require a small amount of single samples, it is impossible to consume large-volume reagent bottles in a short period of time. Once the reagents are opened, the shelf life will be significantly affected, which will cause the reagents to become invalid or wasted. In particular, for reagents that are more expensive and require very little, the defects are more significant. Based on this, single-person reagent cards are the development trend of small chemiluminescence analyzers. By adopting reagent cards in the form of single-person independent packaging, the reagent cards are pre-filled with various reagent quantities required for a single person's single detection, and directly using the reagent cards as detection reaction cups, not only can the detection process be simplified and the reliability and effectiveness of the detection process be improved, but also the situation where large-packaged reagents are wasted after being opened can be effectively avoided, thereby meeting the requirements of continuous testing. However, the existing chemiluminescence immunoassay does not yet have a corresponding reagent card or a fully automatic chemiluminescence immunoassay that is compatible with the reagent card for detection and analysis. Summary of the Invention

[0004] The object of the present invention is to provide a fully automatic chemiluminescence immunoassay analyzer to solve the problems in the above-mentioned background technology.

[0005] The technical solution of the present invention is achieved as follows:

[0006] The fully automatic chemiluminescence immunoassay analyzer is used for incubation and detection of single-dose immunoassay reagent cards. It includes a body, an operating room on the upper part of the body, and an opening cover on the side of the operating room with an openable and closable protective cover. The reagent card is integrally formed with a reaction cup and multiple reagent cups. The reagent cups are pre-filled with single-dose reagents. The body is divided into upper, middle and lower layers. The upper layer is the operating room, and the middle layer is parallel to the reagent card module, incubation module and sample module. The middle layer is also equipped with a cleaning module placed next to the incubation module and a detection module located directly below the reagent card module. The operating room is equipped with a sample loading module.

[0007] The incubation module is provided with several reagent card positions for placing reagent cards evenly distributed in a ring shape. The reagent card positions are divided into at least an incubation station, a card loading station, a sample adding station and a cleaning station. The card loading station and the sample adding station are arranged relatively to each other. There is one card loading station, adjacent to the reagent card module, for loading new reagent cards and grabbing reagent cards to be tested. There is one sample adding station, adjacent to the sample module, for dripping samples and reagents. There is at least one cleaning station and the rest are incubation stations. The incubation module can rotate to change the position of the reagent card position to switch the reagent cards on the card loading station, the sample adding station and the cleaning station.

[0008] The loading module includes an operating arm that can slide horizontally along the operating line. The operating arm slides and switches between the card loading station, the reagent card module, the sample module and the loading station to at least realize the card loading process and the loading process. The operating arm is provided with a pipetting device and a card loading device that can be raised and lowered to perform the operation respectively;

[0009] Reagent card module, used to store reagent cards and transport them vertically to just below the operating line;

[0010] The sample module is used to store the sample cup and transport the sample cup to the bottom of the operation line;

[0011] The cleaning module is used to clean the reaction solution in the reagent card and is placed outside the cleaning station.

[0012] Preferably, the middle layer is also provided with a Tip head module parallel to the sample module, which is used to store the Tip head and longitudinally transport the Tip head to the bottom of the operation line. The pipetting device adopts a disposable Tip head pipette. The operating arm can also realize the Tip head installation process and the Tip head unloading process. Before each sample addition process, it slides to the top of the Tip head module, and the pipetting device moves downward to insert the Tip head. A Tip head unloading plate is also provided directly below the operation line, and an unloading hole for removing the Tip head is provided on the Tip head unloading plate.

[0013] More preferably, it also includes a testing process, the machine body is provided with a first module mounting plate for installing and fixing the reagent card module, on which is provided a testing chamber opening located directly below the reagent card module, and directly below the testing chamber opening is the card loading station of the testing module, and the card loading station is located directly below the operating line, and the testing process includes the opening action of the reagent card module and the testing action of the pipetting device clamping the reagent card from the loading station and sending it to the testing chamber opening for lowering.

[0014] Further preferably, the reagent card module includes a reagent cartridge, a reagent card conveying mechanism and a compartment door mechanism. The reagent card conveying mechanism drives the reagent cartridge to slide longitudinally to one side thereof at a fixed distance to convey the reagent card. An opening paddle is provided on one side end of the reagent cartridge. The compartment door mechanism includes a compartment cover and a compartment cover slide for guiding and supporting the compartment cover. The compartment cover is provided on the detection chamber opening. When the compartment opening action is implemented, the reagent card conveying mechanism drives the reagent cartridge to slide longitudinally to the other side thereof, and the compartment opening paddle moves the compartment cover to slide away from the detection chamber opening.

[0015] Further preferably, the cleaning station includes a primary cleaning station and a secondary cleaning station, the cleaning module includes two adjacent cleaning devices, which are respectively used for the primary cleaning station and the secondary cleaning station, the cleaning device includes a cleaning needle, a cleaning power system, a needle rack for installing the cleaning needle, a cleaning needle lifting mechanism for driving the needle rack to lift and lower, and a cleaning pipeline connecting the cleaning needle and the cleaning power system, the cleaning pipeline includes a three-way joint, a cleaning liquid delivery pipe and a cleaning waste liquid recovery pipe, and the three-way joint connects the cleaning needle with the cleaning liquid delivery pipe and the cleaning waste liquid recovery pipe respectively.

[0016] Further preferably, the incubation module includes a sample loading drive motor and an incubation panel, a reagent card incubation tray and a heating tray coaxially arranged from top to bottom. The incubation panel is embedded in the transfer table and is provided with a sample loading station hole, a cleaning station hole and a card loading station hole. The reagent card incubation tray has several reagent card positioning holes distributed along a circular array near the tray to serve as reagent card positions for placing reagent cards. The sample loading drive motor is used to drive the reagent card incubation tray to rotate, and the lower end of the reaction cup of the reagent card extends into the heating area of the annular structure heating tray.

[0017] Further preferably, the sample module includes a sample conveying mechanism, N fixed plates driven by the sample conveying mechanism to rotate synchronously, and N test tube positioning cylinders. The N test tube positioning cylinders are evenly distributed along the rotary conveying line and are used to insert sample cups. The sample conveying mechanism drives the sample cups to rotate in a circle along the rotary conveying line, and the lower end of the test tube positioning cylinder is fixed on two adjacent fixed plates.

[0018] Further preferably, the sample module has an idle area located in the middle of the rotary conveyor line, the Tip head unloading plate is arranged on the idle area, and a waste Tip head blanking box is connected directly below the unloading hole.

[0019] Further preferably, the detection module includes a detection chamber, a reagent card detection disk arranged in the detection chamber, a detection chamber cover plate provided on the upper end cover of the detection chamber, a detection sample feeding mechanism for driving the reagent card detection disk to rotate, and a photomultiplier tube body fixed on one side of the detection chamber. Several reagent card jacks are distributed in a circular array on the reagent card detection disk, which serve as a card loading station, several stations to be inspected, a detection station and a card return station in sequence according to the direction of rotation of the reagent card detection disk. The photomultiplier tube body is used to detect the reagent card at the detection station. A card loading station hole is provided on the detection chamber cover plate, and a card return bin is provided directly below the card return station, and the card return bin is connected to the bottom of the detection chamber.

[0020] Further preferably, the incubation module also includes a magnet disk, a disk rotation mechanism and a reagent card protection ring. The reagent card protection ring has a ring-shaped structure, and a number of protection grooves are distributed in a ring array on its inner side, which correspond one-to-one to the reagent card positioning holes on the reagent card incubation disk. The reagent card protection ring is fixedly connected to the reagent card incubation disk, and the reaction cup of the reagent card is inserted into the protection groove. The magnet disk is coaxially arranged with the reagent card protection ring and is located within its ring. The disk rotation mechanism drives the magnet disk to rotate, and rotates the magnets arranged around the magnet disk to the cleaning station, and the magnets act on the reaction cup in the protection groove.

[0021] Compared with the prior art, the immunoassay analyzer of the present invention has the following beneficial effects:

[0022] The analyzer is provided with an incubation module of a turntable structure, and a sample delivery module, a reagent card module and a Tip head module are arranged in parallel on both sides of the incubation module. The cleaning module can be arranged on the transfer table and placed next to the incubation module. Therefore, the incubation module not only has an incubation function, but also can realize sample loading and cleaning on it, making full use of the limited plane space of the transfer table. The operating arm is directly above the transfer table, and the operating arm slides horizontally between the incubation module, the sample delivery module, the reagent card module and the Tip head module to realize the card loading process, the sample loading process and the inspection process, etc., making full use of the operating arm to realize the automation of the incubation process. The detection module is located directly below the reagent card module and does not occupy the transfer table. Therefore, the analyzer meets the comprehensive requirements. In order to meet the needs of safety, stability and accuracy in medical testing, the analyzer has the characteristics of reasonable overall layout, compact structure and strong aesthetics. It is equipped with a dedicated immunoassay reagent card, which can streamline the detection process, improve detection efficiency, eliminate the need for some related configurations of the analyzer, streamline the overall structure of the analyzer, and the analyzer structure equipped with the corresponding reagent card is easier to achieve miniaturization and full automation of the detection process. More importantly, the analyzer integrates the advantages of the strip-type luminometer and the turntable-type luminometer while overcoming their shortcomings, so it can realize continuous sampling, full automation of the detection process, moderate reagent position, and avoid waste of reagents. The analyzer is very suitable for promotion in Class II hospitals, Class III hospitals and small medical institutions. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0024] Figure 1 This is a schematic diagram of the external structure of the immunoassay analyzer disclosed in the present invention (with the detection chamber cover open);

[0025] Figure 2 This is a three-dimensional diagram of the internal structure of the detection chamber of the immunoassay analyzer disclosed in the present invention;

[0026] Figure 3 This is a three-dimensional diagram of the internal structure of the detection chamber of the immunoassay analyzer disclosed in the present invention;

[0027] Figure 4 This is a schematic diagram of the three-dimensional structure of the immunoassay reagent card module disclosed in the present invention;

[0028] Figure 5 This is a schematic diagram of the three-dimensional structure of the sample module of the immunoassay analyzer disclosed in the present invention;

[0029] Figure 6 This is a schematic diagram of the three-dimensional structure of the cleaning module of the immunoassay analyzer disclosed in the present invention;

[0030] Figure 7 This is a schematic diagram of the three-dimensional structure of the detection module of the immunoassay analyzer disclosed in the present invention;

[0031] Figure 8 This is an exploded view of the incubation module assembly of the immunoassay analyzer disclosed in the present invention;

[0032] Figure 9 A reagent card structure for matching use.

[0033] In the figure: 100, body; 110, waste tip head compartment; 120, cleaning liquid compartment; 130, waste reagent card compartment; 140, transfer table; 150, first module mounting plate; 151, detection chamber opening; 160, second module mounting plate; 200, protective cover; 300, incubation module; 310, incubation panel; 311, sample loading station hole; 312, cleaning station hole; 313, card loading station hole; 320, reagent card incubation tray; 321, reagent card jack; 330, reagent card protection ring; 331, protective tank; 340, magnetic disk; 341, magnetic disk rotation mechanism; 350, heating plate; 351, sliding slot; 360, sample loading drive motor; 4, sample cup; 400, sample module; 401, test tube positioning cylinder; 402, fixing plate; 403, sample delivery detector; 404, sample delivery mechanism; 405, waste tip head drop box; 406, tip head unloading plate; 407, sample delivery calibration strip; 500, cleaning module; 511, cleaning needle; 512, cleaning pipeline; 520 , needle holder; 530, cleaning needle reset switch; 540, cleaning needle lifting mechanism; 550, cleaning power system; 6, reagent card; 61, reaction cup; 62, reagent cup; 63, diluent cup; 600, reagent card module; 611, reagent chuck; 612, opening paddle; 620, chuck reset switch; 631, compartment cover; 632, compartment cover slide; 640, reagent card transport mechanism; 700, sample loading module; 701, horizontal track plate; 702, horizontal sliding drive mechanism; 703, operation Arm; 704, manipulator; 705, manipulator lifting mechanism; 706, pipette lifting mechanism; 707, pipetting device; 800, Tip head module; 801, Tip head tray; 802, Tip head conveying mechanism; 803, Tip head disk reset switch; 900, detection module; 910, detection chamber cover; 920, detection chamber; 930, detection sample delivery mechanism; 940, sample disk reset switch; 950, card ejection bin; 960, photomultiplier tube body; 970, reagent card 6 detection disk. DETAILED DESCRIPTION

[0034] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0035] like Figure 1-8 The fully automatic chemiluminescence immunoassay analyzer shown is dedicated to the incubation detection of single-person packaged immunoassay reagent cards 6 to meet the needs of small-throughput detection projects and small-batch detection. The reagent card 6 is integrally formed with a reaction cup 61 and multiple reagent cups 62. Figure 9As shown, the reagent cup 62 is pre-filled with a single dose of diluent, enzyme-labeled secondary antibody solution and substrate solution, and the reaction cup 61 is used for sample incubation and detection. The analyzer for detection in conjunction with the reagent card 6 includes a body 100, the hollow area of the upper layer of the body 100 is an operating room, and the middle layer of the body 100 is provided with a first module mounting plate 150 and a second module mounting plate 160 for mounting each module. In order to increase the aesthetics, the middle layer is also provided with a transfer table 140 extending along the plane of the incubation panel 310, and the lower layer is a waste storage area. The operating room is opened by a retractable protective cover 20 0 covers the operating chamber hatch. The protective cover 200 is a visible cover. The analyzer is equipped with at least a detection module 900, an incubation module 300, a reagent card module 600, a sample module 400, and a sample loading module 700. In order to reduce the cross-sectional area of the analyzer and maximize the use of the planar space of the transfer table 140 to make the overall structure of the analyzer more compact, the incubation module 300 is located in the center of the transfer table 140. On one side of the incubation module is the reagent card module 600 mounted on the first module mounting plate 150, and on the other side is the sample module mounted on the second module mounting plate 160. 400, the cleaning module 500 is also arranged in the available area around the incubation module 300 to achieve primary cleaning and secondary cleaning during the incubation process. The cleaning module 500 is installed on the first module mounting plate 150. Operation holes are provided on the transfer table 140 at the corresponding positions of the reagent card module 600, the sample module 400 and the cleaning module 500. By adjusting the relative positions of the first module mounting plate 150 and the second module mounting plate 160 to adapt to the height of the reagent card 6 and the sample cup 4, it is convenient to unify the lifting stroke of multiple stations. The detection module 900 has a light-proof function. Therefore, it is arranged directly below the reagent card module 600, that is, between the first module mounting plate 150 and the second module mounting plate 160, so as to reduce the plane space occupied by the transfer table 140 and facilitate the construction of a closed darkroom. The sample loading module 700 located above the transfer table 140 is used to slide and automatically realize the card loading process and the sample loading process, etc. In addition, the lower layer of the body 100 is a waste product storage area, including a cleaning liquid tank 120 and a waste reagent card tank 130. A cleaning liquid storage tank and a cleaning waste liquid recovery tank are set in the cleaning liquid tank 120 to facilitate the provision of cleaning liquid and automatic storage of waste liquid.

[0036] Among them, the incubation module 300 is fixed on the first module mounting plate 150, and adopts the form of a turntable mechanism. Several reagent card positions for placing reagent cards 6 are evenly distributed in an annular shape, which are adapted to the shape of the reagent card 6 body, and the reagent card positions are at least divided into incubation stations, card loading stations, sample loading stations and cleaning stations corresponding to the above modules. By rotating the turntable mechanism, the reagent card positions are switched between the stations respectively, and the sample loading module 700 sliding laterally thereon cooperates to realize the automation of the card loading, sample loading and incubation processes. Among them, the card loading station corresponding to the reagent card module 600 and the sample loading station corresponding to the sample module 400 are arranged relative to each other. The reagent card module 600 is set next to the card loading station to facilitate the loading of new reagent cards 6 and the grabbing of reagent cards 6 to be tested. The sample module 400 is set next to the sample loading station to facilitate the dripping of samples. There are two cleaning stations. During implementation, other corresponding process stations can also be set according to the needs of the detection process, and the rest are incubation stations;

[0037] The loading module 700 includes a transverse track plate 701, an operating arm 703, and a transverse sliding drive mechanism 702 that drives the operating arm 703 to slide along the transverse track plate 701. The track line along which the operating arm 703 slides transversely is the operating line. The card loading station, the loading station, the reagent card module 600, and the sample module 400 are all located directly below the operating line. The operating arm 703 is provided with a manipulator lifting mechanism 705, a pipette lifting mechanism 706, a pipette device 707 driven by the pipette lifting mechanism 706, and a manipulator 704 driven by the manipulator lifting mechanism 705. The hand 704 is an electric finger gripper, which is located on the side of the operating arm 703 close to the reagent card module 600 and is used to clamp and move the reagent card 6. The pipetting device 707 is located on the other side of the operating arm 703. Therefore, the lateral sliding of the operating arm 703 at least realizes the card loading process and the sample loading process, making full use of the lateral sliding drive mechanism 702. The sample loading process includes the action of using the pipetting device 707 to suck the sample from the sample module 400 and send it to the reagent card 6 at the sample loading station, and the action of sucking the reagent in each reagent cup 62 of the reagent card 6 on the sample loading station and dripping it into the reaction cup 61 of the reagent card 6.

[0038] As a further technical solution, Figure 2-3As shown, the pipetting device 707 is a pipette with a disposable rubber Tip head. In order to prevent cross contamination and ensure the safety and accuracy of the test, a clamping structure for inserting and connecting the Tip head is set at the lower end of the pipette. According to the set trigger program, before each sample addition process, the operating arm 703 first implements the Tip head insertion process, that is, it carries the pipetting device 707 to slide to the top of the Tip head module 800, and automatically inserts the Tip head downward. The Tip head module 800 is installed on the second module mounting plate 160 and is arranged in parallel on one side of the sample module 400. The Tip head module 800 includes a Tip head tray 801 and a Tip head conveying mechanism 802 that drives the Tip head tray 801 to slide longitudinally. The Tip head tray 801 is provided with multiple rows and columns of Tip head holes. The tip head conveying mechanism 802 drives the tip head tray 801 to transport the tip heads in an arrangement to the bottom of the operating line. The pipetting device 707 slides under program control to the top of the tip heads to be loaded, and inserts the tip heads in sequence. After completing each sample loading process, the operating arm 703 automatically performs the tip head unloading process. A tip head unloading plate 406 is also provided directly below the operating line. The tip head unloading plate 406 is provided with an unloading hole. The pipetting device 707 moves downward to insert into the large hole area on one side of the unloading hole, slides to the small hole area on the other side, and moves upward to detach the tip head at the lower end of the pipette. A tip head tray reset switch 803 is also provided at the front end of the longitudinal sliding direction of the tip head tray 801. When all the tip heads are consumed, the system reminds and drives the tip head tray 801 to return to the initial position.

[0039] As a further technical solution, Figure 3 、 Figure 6-7 As shown, after the incubation and cleaning of the sample are completed, the operating arm 703 can also automatically realize the inspection process of the reagent card 6. The first module mounting plate 150 is provided with a detection chamber opening 151 located directly below the reagent card module 600, which fully utilizes the spatial position of the reagent card module 600. The detection chamber opening 151 is directly below the detection module 900. After closing the detection chamber opening 151, the interior of the detection module 900 becomes a detection space with a closed darkroom. The card loading station is located directly below the operation line. Therefore, the inspection process of transferring the incubated and cleaned reagent card 6 to the detection module 900 includes: the opening action of the reagent card module 600, that is, pushing the reagent card module 600 away from directly below the operation line and exposing the detection chamber opening 151; the pipetting device 707 clamps the reagent card 6 to be tested at the card loading station and sends it to the card loading station for inspection. After completing the inspection action, the reagent card module 600 automatically returns to its original position.

[0040] As a further technical solution of the reagent card module 600, Figure 4As shown, it includes a reagent cartridge 611, a reagent card conveying mechanism 640 and a compartment door mechanism. The reagent cartridge 611 is provided with multiple rows and no less than two columns of card insertion positions. The reagent card conveying mechanism 640 drives the reagent cartridge 611 to slide longitudinally to one side thereof at a fixed distance, and conveys the reagent card 6 to the bottom of the operation line in order. The manipulator 704 sequentially clamps the reagent cards 6 in the card insertion position row for loading. A cartridge reset switch 620 is also provided on the first module mounting plate 150, which is located on one side of the reagent cartridge 611. When all the reagent cards 6 are consumed, the system reminds and drives the reagent cartridge 611 to return to its initial position. At one end of the reagent cartridge 611, It is provided with an opening paddle 612, and the door mechanism includes a bin cover 631 and a bin cover slide 632 that guides and supports the bin cover 631. The bin cover 631 seals the detection chamber opening 151 and is provided with a boss. When the bin opening action is implemented, the reagent card conveying mechanism 640 drives the reagent cartridge 611 to slide longitudinally to the other side thereof, and the lower end of the opening paddle 612 moves the bin cover 631 boss to slide it away from the detection chamber opening 151, thereby making full use of the power of the reagent card conveying mechanism 640 to realize automatic bin opening. After completing the inspection process, the reagent cartridge 611 returns to its original position, and the bin cover 631 automatically returns to the sealing position under the action of the elastic member provided on the bin cover slide 632.

[0041] As a further technical solution of the cleaning module 500, Figure 6 As shown, the cleaning station includes a primary cleaning station and a secondary cleaning station. The primary cleaning is performed after the completion of the initial incubation, and the secondary cleaning is performed after the completion of the primary cleaning and the addition of enzyme-labeled secondary antibody solution for re-incubation. Therefore, two adjacent cleaning devices are set to perform corresponding operations. The cleaning device includes a cleaning needle 511, a cleaning power system 550, a needle holder 520 for installing the cleaning needle 511, a cleaning needle lifting mechanism 540 for driving the needle holder 520 to rise and fall, and a cleaning pipeline 512 connecting the cleaning needle 511 and the cleaning power system 550. The cleaning device can simultaneously realize the transportation of cleaning liquid and the recovery of cleaning waste liquid, and the cleaning liquid is transferred to the cleaning needle 511 through a three-way connector. The liquid delivery pipe and the cleaning waste liquid recovery pipe are connected to the cleaning needle 511, the cleaning liquid delivery pipe connects the cleaning needle 511 and the cleaning liquid storage tank, and the cleaning liquid is delivered through the delivery pump of the cleaning power system 550. The cleaning waste liquid recovery pipe connects the cleaning needle 511 and the cleaning waste liquid recovery tank, and the cleaning waste liquid is recovered through the recovery pump of the cleaning power system 550. Therefore, the cleaning device can use the same cleaning needle 511 to simultaneously deliver cleaning liquid and recover waste liquid. A positioning plate is provided on the needle rack 520, which cooperates with the cleaning needle reset switch 530 located behind the needle rack 520 to realize the reset of the downward needle rack 520. The reset height is preset according to the bottom position of the reaction cup 61.

[0042] As a further technical solution of the incubation module 300, Figure 8As shown, the incubation module 300 can include a sample loading drive motor 360 and an incubation panel 310, a reagent card incubation tray 320 and a heating tray 350 coaxially arranged from top to bottom, wherein the incubation panel 310 is flush with the transfer table 140, and is provided with a sample loading station hole 311, a cleaning station hole 312 and a card loading station hole 313, which correspond to the sample loading station, the cleaning station and the card loading station respectively. The reagent card incubation tray 320 is provided with several square reagent card 6 positioning holes distributed in a circular array near the tray as a reagent card position for placing the reagent card 6. The reagent card 6 positioning holes are radially arranged along the reagent card incubation tray 320 with the long side. The reaction cup 61 of the reagent card 6 is close to the edge of the reagent card incubation tray 320. The sample loading drive motor 360 is used to drive the reagent card incubation tray 320 to rotate. According to the preset cycle of the detection process, the reagent card position on it is transported to the sample loading station for sample or reagent dripping, to the cleaning station for primary or secondary cleaning, and to the card loading station for card loading or unloading. The heating tray 350 presets the temperature to heat and keep warm all the reagent card 6 reaction cups 61 on the reagent card incubation tray 320. The heating tray 350 is an annular structure with an L-shaped cross section. A heating zone is formed inside the ring to heat and keep warm the bottom and cup surface of the reaction cup 61.

[0043] To further protect and position the reaction cup 61 and increase the heat transfer surface, a reagent card protection ring 330 is fixed below the reagent card incubation tray 320 and rotates synchronously with it. A circle of sliding grooves 351 are provided along the inner wall surface of the bottom of the heating tray 350. The lower end of the reagent card protection ring 330 extends into the sliding groove 351. The inner ring surface of the reagent card protection ring 330 is vertically provided with a plurality of protection grooves 331, which correspond one-to-one to the positioning holes of the reagent card 6 on the reagent card incubation tray 320. The reagent card 6 is placed on the reagent card incubation tray 320, and the lower end of the reaction cup 61 is inserted into the protection groove 331.

[0044] In addition, the incubation module 300 is also provided with a magnet disk 340 and a disk rotation mechanism 341, which are used to adsorb the magnetic particles in the reaction tube onto the tube wall during the primary cleaning process and the secondary cleaning process. The magnet disk 340 is coaxially arranged with the reagent card protection ring 330 and is located inside the ring. The magnet disk 340 is installed on the sample loading drive motor 360 body 100 through a bearing. The magnets arranged around the magnet disk 340, when needed, the disk rotation mechanism 341 drives the magnet disk 340 to rotate, and rotates the magnet to the notch of the protection groove 331 of the primary cleaning station or the secondary cleaning station. The reaction cup 61 in the protection groove 331 is in the magnetic field of the magnet.

[0045] As a further technical solution of the sample module 400, Figure 5As shown, the sample module 400 includes a sample transport mechanism 404, N fixed plates 402 driven by the sample transport mechanism 404 to rotate synchronously, and N test tube positioning cylinders 401. The sample cup 4 is inserted into the test tube positioning cylinder 401. The sample module 400 can be loaded with N serum samples at a time. In order to utilize the limited horizontal space of the transfer table 140 to load as many sample cups 4 as possible and realize automatic sample transportation at the same time, the sample module 400 adopts a rotary table transportation method. The N test tube positioning cylinders 401 rotate along the transport table. The sample delivery mechanism 404 is chain-driven. The fixed plate 402 is fixed on the chain and rotates clockwise or counterclockwise along the longitudinal direction synchronously with the chain. The test tube positioning cylinder 401 is fixed by two adjacent fixed plates 402. The fixed plate 402 extends to form a protruding end for extending out of the test tube positioning cylinder 401 and cooperating with the sample delivery detector 403 placed at one end of the sample module 400 to detect and record the sample tube delivery sequence and assist in controlling the sample delivery mechanism 404 to stop, so as to accurately locate the test tube at the operating position. In order to compensate for the defect of insufficient positioning accuracy of the sample station on the sample module 400 due to insufficient chain rigidity, a sample delivery correction bar 407 is provided below the sample station. The chain is corrected, limited and supported by the horizontal straight slide groove of the sample delivery correction bar 407 to maintain the vertical position of the sample cup 4 on the sample station. The sample delivery correction bar 407 spans at least three test tube positioning cylinders 401 to achieve correction of the three adjacent sample cups 4 centered on the sample cup 4 at the sample station. Position; The sample module 400 using a rotary turntable conveying method has an idle area, which is located in the middle of the rotary conveying line. The tip head unloading plate 406 is set in the idle area. At the same time, a waste tip head blanking box 405 is provided directly below the tip head unloading plate 406. After unloading, the waste tip heads fall from the unloading hole and are collected by the tip head blanking box to the waste tip head bin 110 in the waste product storage area. The waste tip head bin 110, the cleaning liquid bin 120 and the waste reagent card bin 130 are arranged side by side below the body 100.

[0046] As a further technical solution of the detection module 900, Figure 7As shown, the detection principle of the detection module 900 is as follows: the luminescent substrate generates an unstable excited state product under the catalysis of the enzyme, and when the excited state product returns to the ground state from the excited state, chemiluminescence is generated, and the number of photons generated by the reaction is measured by a photomultiplier tube. The number of photons generated is proportional to the concentration of antiphospholipid antibody IgG in the sample, and a calibration curve is drawn to determine the amount of analyte in the sample; therefore, the detection module 900 for detecting the reagent card 6 to be tested after incubation, cleaning and addition of substrate includes a cylindrical detection chamber 920, a reagent card detection disk 970 provided in the detection chamber 920, and a detection chamber 920. 0 is provided with a detection chamber cover 910 on the upper end, a detection sample feeding mechanism 930 that drives the reagent card detection disk 970 to rotate, and a photomultiplier tube body 960 fixed on the circumference of the detection chamber 920. The reagent card detection disk 970 is similar to the reagent card incubation disk 320. There are several reagent card insertion holes 321 distributed in a circular array on it, and the number of the reagent card insertion holes 321 is adapted to the positioning holes of the reagent card 6 to meet the detection arrangement of the samples in batch processing. The difference is that the reagent card 6 is placed and positioned on the reagent card incubation disk 320, while the reagent card 6 to be tested is positioned at the upper part by the reagent card insertion hole 321, and its lower end surface is placed on the detection chamber 920. The test chamber 920 is fixed on a loading plate at the bottom, and the reaction cup 61 of the reagent card 6 to be tested is located outside the circular loading plate. The reagent card insertion hole 321 serves as a card loading station, several waiting stations, testing stations and card return stations in sequence according to the rotation direction of the reagent card test disk 970. The card loading station, testing station and card return station are arranged adjacent to each other. Among them, a card loading station hole 313 is provided on the test chamber cover 910, corresponding to the card loading station. The card loading station hole 313 is fixed in series with the test chamber port 151 and is also sealed by the bin cover 631. After the card loading is completed, the reagent card 6 to be tested is rotated from the waiting station to enter the test station in sequence. The photomultiplier tube body 960 is located on the side of the detection station, and the reagent card 6 reaction tube is measured and detected by the side plane. After the detection is completed, the reagent card 6 enters the card return station. A card return hole is provided at the bottom of the material loading plate and the detection chamber 920, which is located directly below the card return station. The reagent card 6 falls into the card return bin 950 from the card return hole and is collected in the waste reagent card bin 130. A sample tray reset switch 940 is provided at the bottom of the detection chamber 920. After completing the detection of all reagent cards 6 of this batch, a signal is sent to drive the reagent card detection tray 970 to return to the initial position so that the next batch of reagent cards 6 can be loaded in sequence.

[0047] In the present invention, the terms "upper", "lower", "side", "lateral", "longitudinal", "front", "back" and the like indicate directions or positional relationships based on the attached Figure 1-3 The orientation or position relationship shown; these terms are mainly used to better describe the present invention and its embodiments, and are not used to limit the indicated devices, elements or components to have a specific orientation, or to be constructed and operated in a specific orientation;

[0048] Furthermore, some of the above terms may be used to express other meanings besides indicating a position or location. For example, the term "on" may also be used to indicate a dependency or connection in certain circumstances. Those skilled in the art will understand the specific meanings of these terms in the present invention based on the specific circumstances.

[0049] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A fully automatic chemiluminescence immunoassay analyzer for incubation and testing of single-dose immunoassay reagent cards, comprising a body, an operating chamber at the top, and a retractable protective cover covering the side opening of the operating chamber. The reagent card is integrally formed with a reaction cup and multiple reagent cups, each pre-filled with a single-dose reagent. The instrument is characterized by: The body is divided into an upper layer, a middle layer and a lower layer, the upper layer is the operating room, the middle layer is parallel and sequentially distributed with a reagent card module, an incubation module and a sample module, the middle layer is also provided with a cleaning module placed next to the incubation module and a detection module located directly below the reagent card module, and a sample loading module is provided in the operating room; the body is provided with a first module mounting plate for mounting and fixing the reagent card module, on which a detection chamber port is provided directly below the reagent card module, and directly below the detection chamber port is a card loading station for the detection module, and the card loading station is located directly below the operating line, wherein, The incubation module is provided with several reagent card positions for placing the reagent cards in a ring-shaped uniform distribution, and the reagent card positions are divided into at least an incubation station, a card loading station, a sample loading station and a cleaning station. The card loading station and the sample loading station are arranged relatively to each other, one card loading station is adjacent to the reagent card module, one sample loading station is adjacent to the sample module, at least one cleaning station is, and the rest are incubation stations, and the incubation module can rotate to change the position of the reagent card positions to switch the reagent cards on the card loading station, the sample loading station and the cleaning station; the incubation module includes a sample loading drive motor and an incubation panel, a reagent card incubation tray and a heating tray coaxially arranged from top to bottom, the incubation panel is provided with a sample loading station hole, a cleaning station hole and a card loading station hole, and the reagent card incubation tray is distributed along a ring array near the tray. a reagent card positioning hole as the reagent card position, the sample loading drive motor drives the reagent card incubation disk to rotate, and the lower end of the reaction cup of the reagent card extends into the heating area of the heating disk of the ring structure; the incubation module also includes a magnet disk, a magnetic disk rotation mechanism and a reagent card protection ring, the reagent card protection ring is annular, and a plurality of protection grooves are distributed in an annular array on its inner side surface, which correspond one to one with the reagent card positioning holes on the reagent card incubation disk, the reagent card protection ring is fixedly connected to the reagent card incubation disk, the reaction cup is inserted into the protection groove, the magnet disk is coaxially arranged with the reagent card protection ring, and is located inside the reagent card protection ring, the magnetic disk rotation mechanism drives the magnet disk to rotate, and rotates the magnet arranged on the circumference of the magnet disk to the cleaning station, and the magnet magnetically acts on the reaction cup in the protection groove; The sample loading module includes an operating arm that can slide horizontally along the operating line. The operating arm slides and switches between the card loading station, the reagent card module, the sample module and the sample loading station to implement at least the card loading process, the sample loading process and the inspection process. The operating arm is provided with a pipetting device and a card loading device that can be raised and lowered to perform operations respectively; the inspection process includes the opening action of the reagent card module and the action of the pipetting device clamping the reagent card to be tested from the card loading station and delivering it to the detection chamber port for lowering. The reagent card module is used to store the reagent card and longitudinally transport the reagent card to just below the operation line. It includes a reagent cartridge, a reagent card transport mechanism and a compartment door mechanism. The reagent card transport mechanism drives the reagent cartridge to slide longitudinally to one side thereof at a fixed distance to transport the reagent card. An opening paddle is provided at one end of the reagent cartridge. The compartment door mechanism includes a compartment cover and a compartment cover slide frame that guides and supports the compartment cover. The compartment cover is provided on the detection chamber opening. When the compartment opening action is implemented, the reagent card transport mechanism drives the reagent cartridge to slide longitudinally to the other side thereof, and the compartment opening paddle paddles the compartment cover to slide away from the detection chamber opening. The sample module is used to store the sample cup and transport the sample cup to the bottom of the operation line; The cleaning module is used for cleaning the reaction solution in the reagent card and is placed outside the cleaning station.

2. The immunoassay analyzer according to claim 1, wherein: The middle layer is also provided with a Tip head module parallel to the sample module, which is used to store the Tip head and longitudinally transport the Tip head to the bottom of the operation line. The pipetting device adopts a disposable Tip head pipette. The operating arm can also realize the Tip head installation process and the Tip head unloading process. Before each sample addition process, it slides to the top of the Tip head module, and the pipetting device moves downward to insert the Tip head. A Tip head unloading plate is also provided directly below the operation line, and an unloading hole for disassembling the Tip head is provided on the Tip head unloading plate.

3. The immunoassay analyzer according to claim 1, wherein: The cleaning station includes a primary cleaning station and a secondary cleaning station. The cleaning module includes two adjacent cleaning devices, corresponding to the primary cleaning station and the secondary cleaning station respectively. The cleaning device includes a cleaning needle, a cleaning power system, a needle rack for installing the cleaning needle, a cleaning needle lifting mechanism for driving the needle rack to lift and lower, and a cleaning pipeline connecting the cleaning needle and the cleaning power system. The cleaning pipeline includes a three-way joint, a cleaning liquid delivery pipe and a cleaning waste liquid recovery pipe. The three-way joint connects the cleaning needle with the cleaning liquid delivery pipe and the cleaning waste liquid recovery pipe respectively.

4. The immunoassay analyzer according to claim 2, wherein: The sample module includes a sample conveying mechanism, N fixed plates driven by the sample conveying mechanism to rotate synchronously, and N test tube positioning cylinders. The N test tube positioning cylinders are evenly distributed along the rotary conveying line and are used to insert the sample cups. The sample conveying mechanism drives the sample cups to rotate along the rotary conveying line. The lower ends of the test tube positioning cylinders are fixed to two adjacent fixed plates.

5. The immunoassay analyzer according to claim 4, wherein: The sample module has an idle area located in the middle of the rotary conveyor line, the Tip head unloading plate is arranged on the idle area, and a waste Tip head blanking box is connected directly below the unloading hole.

6. The immunoassay analyzer according to claim 1, wherein: The detection module includes a detection chamber, a reagent card detection disk arranged in the detection chamber, a detection chamber cover plate provided on the upper end cover of the detection chamber, a detection sample feeding mechanism for driving the reagent card detection disk to rotate, and a photomultiplier tube body fixed on one side of the detection chamber. A plurality of reagent card insertion holes are distributed in a circular array on the reagent card detection disk, which serve as the card loading station, a plurality of stations to be inspected, a detection station and a card return station in sequence according to the direction of rotation of the reagent card detection disk. The photomultiplier tube body is used to detect the reagent card at the detection station. The card loading station hole is provided on the detection chamber cover plate, and a card return bin is provided directly below the card return station, and the card return bin is connected to the bottom of the detection chamber.

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