Chemiluminescence detection equipment and detection control method

Abstract

The invention discloses chemiluminescence detection equipment and a detection control method. The equipment comprises an automatic sample injection module, an incubation reaction disc, a reagent treatment module, a reaction cup automatic loading module, a reaction cup transfer module, a magnetic bead cleaning module and a detection module which are mounted on a bottom plate of a complete machine, wherein the incubation reaction disc, the magnetic bead cleaning module and the detection module are positioned on a rotary motion track of the reaction cup transfer module; the reaction cup automatic loading module is positioned above the incubation reaction disc, and a feed opening of the reaction cup automatic loading module is aligned with an incubation hole site of the incubation reaction disc; the reagent treatment module can suck a reagent from a kit on the reagent disc and add the reagent into a reaction cup of the incubation reaction disc; the magnetic bead cleaning module is provided with a lifting assembly capable of moving up and down, a magnet assembly capable of adsorbing magnetic beads and a uniform mixing assembly capable of performing non-contact centrifugal uniform mixing on the reaction cup, and the lifting assembly drives the liquid spitting needle assembly and the liquid sucking needle assembly to move up and down. The equipment is reasonable in layout and compact in structure.

Description

Technical Field

[0001] This invention relates to the field of chemiluminescence detection technology, specifically a chemiluminescence detection device and detection control method. Background Technology

[0002] Chemiluminescence immunoassay analyzers are medical testing instruments that perform immunoassays on patients' serum, playing a crucial role in clinical diagnosis and chemical testing. However, current chemiluminescence immunoassay analyzers suffer from drawbacks such as complex structure, low throughput, and inconvenient operation. Therefore, developing a fully automated chemiluminescence immunoassay analyzer with a rational layout, convenient operation, and high throughput is an urgent technical challenge. Summary of the Invention

[0003] The purpose of this application is to provide a chemiluminescence detection device and a detection control method to at least partially solve the aforementioned technical problems. This purpose is achieved through the following technical solution: This application proposes a chemiluminescence detection device, including an automatic sample injection module, an incubation reaction plate, a reagent processing module, an automatic reaction cup loading module, a reaction cup transport module, a magnetic bead cleaning module, and a detection module, all mounted on the base plate of the device. The incubation reaction plate, the magnetic bead cleaning module, and the detection module are located on the rotational trajectory of the reaction cup transfer module. The automatic loading module for the reaction cup is located above the incubation reaction plate, and its discharge port is aligned with the incubation hole of the incubation reaction plate. The reagent processing module can draw reagents from the reagent kit on the reagent tray and add them to the reaction cup of the incubation reaction tray; The magnetic bead cleaning module is equipped with a lifting component that can move up and down, a magnet component that can attract magnetic beads, and a mixing component that can perform non-contact centrifugal mixing of the reaction cup. The lifting component drives the liquid ejection needle component and the liquid suction needle component to move up and down. The detection module includes a substrate chamber module, a substrate needle module, and a detection disk module; the detection module has a constant temperature incubation control function and is equipped with a mixing component that can achieve non-contact mixing of the substrate and magnetic beads.

[0004] In some embodiments, the incubation reaction disk has an incubation ring with concentric multi-ring incubation holes, the incubation ring being equipped with a heating component for temperature control; The heating assembly includes an annular heating element, a heat insulation pad, and a temperature sensor. The annular heating element is fixed to the bottom outer circumference of the incubation ring. A heat insulation pad is provided between the annular heating element and the incubation ring. The temperature sensor is embedded in a pre-drilled hole in the side wall of the incubation ring, and the detection end of the temperature sensor is flush with the inner wall of the incubation ring. Both the annular heating element and the temperature sensor are electrically connected to the temperature control circuit board via wires.

[0005] In some embodiments, the reagent processing module includes a reagent tray module and a reagent needle assembly; The reagent tray module is a ring-shaped cavity structure. The cavity contains reagent compartments evenly distributed along the circumference. An ultrasonic mixing device is installed at the bottom of the reagent compartment. The outside of the cavity is wrapped with a cooling and heat preservation layer. A cooling pipeline is installed between the cooling and heat preservation layer and the inner wall of the cavity, forming a temperature control system for refrigerating the reagent compartments. The reagent needle assembly includes a reagent needle, a three-dimensional moving mechanism, and a cleaning tank. The reagent needle is fixed to the execution end of the three-dimensional moving mechanism, and the cleaning tank is located beside the reagent tray module and within the movement trajectory range of the three-dimensional moving mechanism. The reagent tray module and the reagent needle assembly are connected by a host computer control system. The host computer controls the three-dimensional moving mechanism to move the reagent needle above the target reagent compartment according to the position information of the reagent compartment, so as to realize reagent aspiration.

[0006] In some embodiments, the reaction cup automatic loading module includes a hopper and a reaction cup feeding mechanism; The hopper is a funnel-shaped structure with an open top and a narrowed bottom. The bottom outlet of the hopper is fixedly connected to the inlet of the feeding mechanism through a flange, and an elastic sealing gasket is provided at the connection. The feeding mechanism includes a vibrating feeding track, a photoelectric counter, and a guide sleeve. The input end of the vibrating feeding track is connected to the bottom outlet of the hopper, and the output end of the vibrating feeding track is fixedly connected to the upper end of the guide sleeve. The lower end of the guide sleeve is the feeding port and is aligned with the incubation hole of the incubation reaction plate. The photoelectric counter is set on the middle side wall of the guide sleeve and is used to detect the number of reaction cups passing through.

[0007] In some embodiments, the reaction cup transfer module includes a reaction cup gripper assembly, through which the reaction cup is transferred between modules; The reaction cup gripper assembly includes a rotary drive mechanism, a lifting cylinder, a clamping claw, and a pressure sensor. The rotary drive mechanism is fixed to the base plate of the machine. The lifting cylinder is vertically fixed to the output end of the rotary drive mechanism. The clamping claw is installed at the end of the piston rod of the lifting cylinder. The clamping claw is a symmetrically arranged arc-shaped clamping plate structure. The inner side of the arc-shaped clamping plate is provided with an anti-slip rubber pad. The pressure sensor is embedded inside the anti-slip rubber pad and is used to detect the clamping pressure between the clamping claw and the reaction cup. The rotary drive mechanism and the lifting cylinder are both connected to the host computer control system.

[0008] In some embodiments, the automatic sample loading module includes a sample rack transport assembly, a sample rack buffer compartment, a rack loading area, a rack unloading area, and a barcode recognition device; The sample rack conveying assembly includes a conveying track, a stepper motor, and a pusher block. The conveying track is arranged horizontally, with the rack entry area and rack exit area located at both ends of the conveying track. The sample rack buffer compartment is located on the side of the middle of the conveying track. The pusher block is slidably connected to the conveying track and is drivenly connected to the output end of the stepper motor. It is used to push the sample racks in the rack entry area to the sample rack buffer compartment, or to push the sample racks that have been tested in the sample rack buffer compartment to the rack exit area. The barcode recognition device includes a bracket and a laser scanning head. The bracket is fixed above the sample rack buffer compartment, and the laser scanning head is installed at an angle on the bracket with the scanning end facing the barcode area of ​​the sample tube inside the sample rack buffer compartment. The barcode recognition device is connected to the host computer for uploading the recognized barcode information to the host computer.

[0009] In some embodiments, the reagent processing module is equipped with a barcode scanning device for recognizing the reagent barcodes on the reagent tray. The barcode information recognized by the automatic sample injection module and the reagent processing module is uploaded to the host computer for processing.

[0010] The present invention also provides a detection and control method based on the chemiluminescence detection device described above, comprising the following steps: S1: Sample and reaction cup loading control: The automatic sample feeding module transfers the sample rack to the sample rack buffer chamber and identifies the sample tube barcode, uploading it to the host computer; the incubation reaction plate rotates to the cup feeding station, and the feeding mechanism of the automatic reaction cup loading module accurately feeds the reaction cup into the incubation hole of the incubation reaction plate; S2: Sample and reagent addition control: The incubation reaction tray rotates the reaction cup to the sample addition station, the sampling needle draws up the sample and injects it into the reaction cup, and then the sampling needle starts the self-cleaning program; the incubation reaction tray continues to rotate to the reagent addition station, after the reagent processing module recognizes the reagent barcode, the reagent needle draws up the corresponding reagent and injects it into the reaction cup; S3: Incubation reaction control: The incubation ring of the incubation reaction plate maintains a preset constant temperature through the heating component, and at the same time, the mixing function is activated to ensure that the sample, reagents and magnetic beads are fully mixed and incubated in the reaction cup. The incubation time is preset according to the detection items. S4: Magnetic bead cleaning control: After incubation, the reaction cup transfer module transfers the reaction cup to the magnetic bead cleaning module. The lifting component drives the suction needle to suck up the waste liquid, the discharge needle adds the cleaning liquid, and the magnet component attracts the magnetic beads. The cleaning process is repeated four times to complete the four-stage cleaning. S5: Substrate addition and mixing control: After cleaning, the reaction cup is transferred to the substrate mixing component. The substrate needle module draws the substrate from the substrate chamber module and injects it into the reaction cup. The substrate mixing component mixes the substrate at high speed with a preset rotation speed and time. S6: Detection and post-processing control: The reaction cup is transferred to the detection tray module, which maintains a constant temperature and light-proof environment. The optical detection component collects the chemiluminescence signal inside the reaction cup, and the detection data is uploaded to the host computer. After the detection is completed, the reaction cup transfer module picks up the reaction cup and discards it.

[0011] In some embodiments, the detection control method further includes: If it is a one-step detection method, repeat steps S1-S6 to achieve continuous sample detection; If it is a two-step detection method, after step S4 is completed, the reaction cup transfer module will send the reaction cup back to the incubation reaction plate, and the reagent needle will add the second reagent again, repeating steps S3-S6.

[0012] In some embodiments, the preset constant temperature in step S3 is 37℃±0.5℃, and the incubation time is 15-60 minutes; The preset rotation speed of the substrate mixing component in step S5 is 2000-3500 r / min, and the mixing time is 20-40 seconds; The temperature control accuracy of the detection plate module in step S6 is ±0.1℃, and the optical detection time is 1-5 seconds.

[0013] In one or more of the above specific embodiments, the method provided by the present invention has the following technical effects: 1. Reasonable layout and compact structure: The present invention integrates and installs each functional module on the base plate of the whole machine. The automatic loading module of the reaction cup is located above the incubation reaction plate. The incubation reaction plate, the magnetic bead cleaning module, and the detection module are located on the rotation trajectory of the reaction cup transfer module, which greatly shortens the transfer path of the reaction cup, reduces the space occupied by the whole machine, and makes the instrument structure more compact.

[0014] 2. Easy to operate: Reagent kits can be added from the side of the instrument without taking up space above the reagent tray, making it convenient for users to operate; at the same time, the automatic sample loading module realizes automatic loading and unloading of sample racks, and the automatic reaction cup loading module realizes automatic unloading of reaction cups, reducing manual operation steps and lowering the difficulty of operation.

[0015] 3. High test throughput: By optimizing the layout and workflow of each module, the reaction cup transfer time and waiting time of each step are reduced. At the same time, the incubation reaction plate adopts a concentric multi-ring incubation hole design, which increases the number of reaction cups incubated at the same time, significantly improving the overall test throughput of the machine, which can complete 180-240 tests per hour.

[0016] 4. High accuracy and stability of detection: The magnetic bead cleaning module adopts a four-stage cleaning design to effectively remove impurities and interference; the detection module has constant temperature incubation control function and light-proof detection environment. The non-contact mixing of substrate and magnetic beads ensures the fullness of reaction, which greatly improves the accuracy and stability of detection results. The coefficient of variation of detection results is ≤5%.

[0017] 5. High versatility: It supports both one-step and two-step detection processes, which can meet the needs of different reagents and detection items, and has a wider range of applications.

[0018] The above description is only an overview of the technical solution of this application. In order to better understand the technical means of this application and to implement it in accordance with the contents of the specification, and to make the above and other objects, features and advantages of this application more obvious and understandable, the following are specific embodiments of this application. Attached Figure Description

[0019] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the scope of this application. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings: Figure 1 This is one of the structural schematic diagrams of the chemiluminescence detection device provided by the present invention; Figure 2 This is a second schematic diagram of the chemiluminescence detection device provided by the present invention; Figure 3 This is the third schematic diagram of the chemiluminescence detection device provided by the present invention; Figure 4 This is the fourth schematic diagram of the chemiluminescence detection device provided by the present invention; Figure 5 This is the fifth schematic diagram of the chemiluminescence detection device provided by the present invention; Figure 6 This is the sixth schematic diagram of the chemiluminescence detection device provided by the present invention; Figure 7 This is the seventh schematic diagram of the chemiluminescence detection device provided by the present invention; Figure 8 This is a flowchart of the detection and control method provided by the present invention.

[0020] Explanation of reference numerals in the attached figures: 10—Automatic sample injection module; 20—Incubation reaction tray; 30—Reagent processing module; 40—Automatic reaction cup loading module; 50—Reaction cup transfer module; 60—Magnetic bead cleaning module; 70—Detection module; 701—Substrate compartment module; 702—Substrate needle module; 703—Detection tray module. Detailed Implementation

[0021] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0022] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also include the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0023] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0024] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented as "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions), and the spatial relative descriptors used in the text will be interpreted accordingly.

[0025] like Figures 1 to 7 As shown, according to the embodiments of this application, the proposed chemiluminescence detection device includes an automatic sample loading module 10, an incubation reaction plate 20, a reagent processing module 30, an automatic reaction cup loading module 40, a reaction cup transport module 50, a magnetic bead cleaning module 60, and a detection module 70, all mounted on the base plate of the device. The incubation reaction plate 20, the magnetic bead cleaning module 60, and the detection module 70 are located on the rotational trajectory of the reaction cup transport module 50. The automatic reaction cup loading module 40 is located above the incubation reaction plate 20, and its discharge port is aligned with the incubation hole of the incubation reaction plate 20. The reagent processing module 30... The reagent module 30 can draw reagents from the reagent kit on the reagent tray and add them to the reaction cup of the incubation reaction tray 20; the magnetic bead cleaning module 60 is equipped with a lifting component that can move up and down, a magnet component that can adsorb magnetic beads, and a mixing component that can perform non-contact centrifugal mixing of the reaction cup. The lifting component drives the dispensing needle component and the aspiration needle component to move up and down; the detection module 70 includes a substrate chamber module 701, a substrate needle module 702, and a detection tray module 703; the detection module 70 has a constant temperature incubation control function and is equipped with a mixing component that can realize non-contact mixing of substrate and magnetic beads.

[0026] Thus, the device provided by this invention achieves efficient and precise scheduling of reaction cup transport through the integrated layout and trajectory adaptation design of each module, reducing redundancy in the transport path; the non-contact mixing design of the magnetic bead cleaning module avoids cross-contamination, and the linkage control of the lifting components ensures the accuracy of aspiration and expulsion liquids; the constant temperature control and non-contact mixing function of the detection module work together to improve the stability and uniformity of the chemiluminescence reaction, thereby ensuring the accuracy and repeatability of the detection results. The overall device achieves fully automated detection, significantly improving detection efficiency and reducing human operation errors.

[0027] The incubation reaction plate 20 has an incubation ring with concentric multi-ring incubation holes. The incubation ring is equipped with a heating assembly for temperature control. The heating assembly includes an annular heating element, a heat insulation pad, and a temperature sensor. The annular heating element is fixed to the bottom outer circumference of the incubation ring. A heat insulation pad is provided between the annular heating element and the incubation ring. The temperature sensor is embedded in a pre-drilled hole in the side wall of the incubation ring, and the sensing end of the temperature sensor is flush with the inner wall of the incubation ring. Both the annular heating element and the temperature sensor are electrically connected to the temperature control circuit board via wires. In this way, the incubation reaction plate 20 significantly increases the sample capacity for a single test through its concentric multi-ring incubation well design, enhancing the device's parallel testing capability. The design of the annular heating pad fitting against the outer circumference of the incubation ring ensures uniform heating, while the heat insulation pad effectively reduces heat loss and avoids temperature fluctuations. The design of the temperature sensor embedded in the side wall with the detection end flush with the inner wall enables real-time and accurate acquisition of the actual temperature of the incubation wells. Combined with the temperature control circuit board, this forms a closed-loop temperature control, ensuring the stability of the incubation environment. This provides precise temperature conditions for the antigen-antibody specific binding reaction, improving the sufficiency and consistency of the reaction, and thus ensuring the reliability of the test results.

[0028] The reagent processing module 30 includes a reagent tray module and a reagent needle assembly. The reagent tray module has a ring-shaped cavity structure with reagent compartments evenly distributed along the circumference inside. An ultrasonic mixing device is located at the bottom of each reagent compartment. A cooling and insulation layer surrounds the cavity, and cooling pipes are installed between the insulation layer and the inner wall of the cavity, forming a temperature control system for refrigerating the reagent compartments. The reagent needle assembly includes a reagent needle, a three-dimensional moving mechanism, and a cleaning tank. The reagent needle is fixed to the execution end of the three-dimensional moving mechanism, and the cleaning tank is located beside the reagent tray module and within the movement trajectory range of the three-dimensional moving mechanism. The reagent tray module and the reagent needle assembly are connected via a host computer control system signal. The host computer controls the three-dimensional moving mechanism to move the reagent needle above the target reagent compartment based on the position information of the reagent compartment, thereby achieving reagent aspiration.

[0029] Thus, the reagent processing module 30 provided by this invention adopts a ring-shaped cavity structure and a reagent compartment design with uniformly distributed circumference, which increases the reagent storage capacity while facilitating the movement and positioning of the reagent needle assembly and improving reagent aspiration efficiency. The ultrasonic mixing device ensures that the reagent is in a uniform state before detection, avoiding detection errors caused by reagent precipitation. The refrigeration temperature control system composed of the refrigeration insulation layer and refrigeration pipeline can maintain a low-temperature environment for reagent storage, effectively extending the reagent shelf life and preventing reagent deterioration. The three-dimensional moving mechanism realizes the precise displacement of the reagent needle, and together with the self-cleaning function of the cleaning tank, avoids cross-contamination between different reagents, improving the accuracy of reagent addition and the accuracy of detection results.

[0030] The automatic loading module 40 for reaction cups includes a hopper and a reaction cup feeding mechanism. The hopper is a funnel-shaped structure with an open top and a narrowed bottom. The bottom outlet of the hopper is fixedly connected to the inlet of the feeding mechanism via a flange, and an elastic sealing gasket is provided at the connection. The feeding mechanism includes a vibrating feeding track, a photoelectric counter, and a guide sleeve. The input end of the vibrating feeding track is connected to the bottom outlet of the hopper, and the output end of the vibrating feeding track is fixedly connected to the upper end of the guide sleeve. The lower end of the guide sleeve is the feeding port and is aligned with the incubation hole of the incubation reaction plate 20. The photoelectric counter is set on the middle side wall of the guide sleeve and is used to detect the number of reaction cups passing through. Thus, in the automatic reaction cup loading module 40 provided by this invention, the constricted design of the funnel-shaped hopper facilitates centralized feeding of reaction cups and avoids congestion; the flange connection and the cooperation of the elastic sealing gasket ensure the sealing and stability of the connection, reducing noise and displacement caused by vibration; the vibrating feeding track realizes the orderly transport of reaction cups through vibration, improving feeding efficiency; the guide sleeve ensures that the reaction cups fall accurately into the incubation holes of the incubation reaction plate, avoiding deviation; the photoelectric counter detects the number of reaction cups passing through in real time, which facilitates the upper computer to accurately control the loading quantity, realizes the automated and precise loading of reaction cups, reduces manual intervention, and improves the continuity of the detection process.

[0031] The reaction cup transfer module 50 includes a reaction cup gripper assembly, which enables the transfer of reaction cups between modules. The reaction cup gripper assembly includes a rotary drive mechanism, a lifting cylinder, a clamping claw, and a pressure sensor. The rotary drive mechanism is fixed to the base plate of the machine. The lifting cylinder is vertically fixed to the output end of the rotary drive mechanism. The clamping claw is installed at the end of the piston rod of the lifting cylinder. The clamping claw has a symmetrically arranged arc-shaped clamping plate structure, with an anti-slip rubber pad on the inner side. The pressure sensor is embedded inside the anti-slip rubber pad to detect the clamping pressure between the clamping claw and the reaction cup. The rotary drive mechanism and the lifting cylinder are both connected to the host computer control system. Thus, the reaction cup transfer module 50 provided by this invention achieves three-dimensional spatial transfer of the reaction cup between modules through the coordinated control of the rotary drive mechanism and the lifting cylinder. Combined with the trajectory layout of each module, the transfer efficiency is greatly improved. The arc-shaped clamping plate structure and the design of the anti-slip rubber pad increase the clamping contact area, improve clamping stability, and prevent the reaction cup from slipping. The pressure sensor detects the clamping pressure in real time, forming a closed-loop control to prevent excessive clamping force from damaging the reaction cup or insufficient clamping force from causing transfer failure. This ensures the safety and reliability of the transfer process and guarantees the smooth progress of the testing process.

[0032] The automatic sample feeding module 10 includes a sample rack conveying assembly, a sample rack buffer chamber, a rack loading area, a rack unloading area, and a barcode recognition device. The sample rack conveying assembly includes a conveying track, a stepper motor, and a pusher block. The conveying track is horizontally oriented, with the rack loading area and unloading area located at opposite ends of the track. The sample rack buffer chamber is positioned beside the middle of the conveying track. The pusher block is slidably connected to the conveying track and is driven by the output of the stepper motor, used to push sample racks from the loading area to the sample rack buffer chamber, or to push sample racks that have completed testing from the buffer chamber to the unloading area. The barcode recognition device includes a bracket and a laser scanning head. The bracket is fixed above the sample rack buffer chamber, and the laser scanning head is mounted at an angle on the bracket with its scanning end facing the barcode area of ​​the sample tube within the buffer chamber. The barcode recognition device is signal-connected to a host computer for uploading the recognized barcode information to the host computer.

[0033] Thus, the automatic sample feeding module 10 provided by this invention, through the stepper motor-driven push block and the conveying track, achieves precise and stable transport of sample racks. The layout design of the rack loading area, rack unloading area and buffer chamber enables orderly turnover of sample racks and improves the continuity of sample processing. The inclined installation design of the laser scanning head ensures the accuracy and stability of barcode recognition, enabling rapid identification of sample tube barcode information and uploading to the host computer, realizing automated entry and traceability of sample information, avoiding manual entry errors, and improving the standardization of sample management and the efficiency of the testing process.

[0034] The reagent processing module 30 is equipped with a barcode scanning device for recognizing the reagent barcodes on the reagent tray. The barcode information recognized by both the automatic sample injection module 10 and the reagent processing module 30 is uploaded to the host computer for processing. The barcode scanning device in the reagent processing module enables automated recognition of reagent information. Combined with the sample barcode recognition in the automatic sample injection module, sample and reagent information are simultaneously uploaded to the host computer. This facilitates accurate matching of samples with corresponding reagents, preventing reagent misuse. Simultaneously, it enables full traceability of sample and reagent information, improving the standardization and traceability of the testing process, reducing the risk of human error, and ensuring the reliability and accuracy of test results.

[0035] The present invention also provides a detection and control method for a chemiluminescence detection device, characterized in that, as Figure 8 As shown, the method includes the following steps: S1: Sample and reaction cup loading control: The automatic sample feeding module 10 transfers the sample rack to the sample rack buffer chamber and identifies the sample tube barcode, uploading it to the host computer; the incubation reaction plate 20 rotates to the cup feeding station, and the feeding mechanism of the automatic reaction cup loading module 40 accurately feeds the reaction cup into the incubation hole of the incubation reaction plate 20; S2: Sample and reagent addition control: The incubation reaction tray 20 rotates the reaction cup to the sample addition station, the sampling needle draws up the sample and injects it into the reaction cup, and then the sampling needle starts the self-cleaning program; the incubation reaction tray 20 continues to rotate to the reagent addition station, the reagent processing module 30 recognizes the reagent barcode, and the reagent needle draws up the corresponding reagent and injects it into the reaction cup; S3: Incubation reaction control: The incubation ring of the incubation reaction plate 20 maintains a preset constant temperature through the heating component, and at the same time, the mixing function is activated to ensure that the sample, reagents and magnetic beads are fully mixed and incubated in the reaction cup. The incubation time is preset according to the detection items. S4: Magnetic bead cleaning control: After incubation, the reaction cup transfer module 50 transfers the reaction cup to the magnetic bead cleaning module 60. The lifting component drives the suction needle to suck up the waste liquid, the discharge needle adds the cleaning liquid, and the magnet component attracts the magnetic beads. The cleaning process is repeated four times to complete the four-stage cleaning. S5: Substrate addition and mixing control: After cleaning, the reaction cup is transferred to the substrate mixing component. The substrate needle module 702 draws the substrate from the substrate chamber module 701 and injects it into the reaction cup. The substrate mixing component performs high-speed mixing at a preset speed and time. S6: Detection and post-processing control: The reaction cup is transferred to the detection tray module 703. The detection tray maintains a constant temperature and light-proof environment. The optical detection component collects the chemiluminescence signal inside the reaction cup and uploads the detection data to the host computer. After the detection is completed, the reaction cup transfer module 50 picks up the reaction cup and discards it. The method provided by this invention achieves fully automated closed-loop control of the entire process, from sample loading, reagent addition, incubation reaction, magnetic bead cleaning, substrate addition, detection, and post-processing, through step-by-step automated control. This significantly improves detection efficiency and reduces the intensity and error of manual operation. The sampling needle self-cleaning program and the four-stage magnetic bead cleaning process effectively avoid cross-contamination and improve the accuracy of detection results. Precise control of preset parameters ensures the stability of each reaction step, and the constant temperature and light-proof detection environment ensures the accuracy of chemiluminescence signal acquisition. The cup disposal process automates the treatment of detection waste, improving the standardization and safety of the detection process.

[0036] Furthermore, the detection and control method also includes: If it is a one-step detection method, repeat steps S1-S6 to achieve continuous sample detection; If it is a two-step detection method, after step S4 is completed, the reaction cup transfer module 50 sends the reaction cup back to the incubation reaction plate 20, and the reagent needle adds the second reagent again, repeating steps S3-S6.

[0037] By differentiating the process control of one-step and two-step detection methods, the detection methods can be adapted to the needs of different types of detection projects, improving the versatility and applicability of detection equipment. The continuous detection design of the one-step method improves the detection efficiency of batch samples, while the secondary reagent addition and incubation process of the two-step method ensures the sufficiency of the reaction for complex detection projects, guaranteeing the accuracy and reliability of the results of different detection projects.

[0038] In step S3, the preset constant temperature is 37℃±0.5℃, and the incubation time is 15-60 minutes; in step S5, the preset rotation speed of the substrate mixing component is 2000-3500 r / min, and the mixing time is 20-40 seconds; in step S6, the constant temperature control accuracy of the detection disk module 703 is ±0.1℃, and the optical detection time is 1-5 seconds.

[0039] The preset constant temperature of 37℃±0.5℃ precisely matches the physiological environment temperature of the human body, providing optimal temperature conditions for the specific binding reaction of antigen and antibody. The adjustable incubation time of 15-60 minutes adapts to the reaction requirements of different detection projects, ensuring the sufficiency of the reaction. The high-speed mixing speed of 2000-3500r / min and the mixing time of 20-40 seconds are combined to achieve rapid and thorough mixing of substrate and magnetic beads, improving the uniformity of chemiluminescence reaction. The high-precision constant temperature control of ±0.1℃ and the rapid optical detection of 1-5 seconds of the detection disk module ensure the stability of chemiluminescence signal and timely acquisition, further improving the accuracy and efficiency of detection results.

[0040] In summary, the chemiluminescence detection device provided by this invention has a reasonable overall layout, compact structure, and small footprint. Placing the reagent tray in the middle of the reaction tray saves space and makes the whole device more compact. The automatic feeding unit directly places the reaction cups onto the incubation plate, reducing intermediate steps and increasing efficiency. Through the reasonable design of the overall structural layout, the modular design of functional components, and the optimized design of the detection process, the chemiluminescence detection device provided by this invention features a high degree of automation, convenient operation, and high testing throughput.

[0041] During instrument operation, the actions of each component proceed according to the instrument's workflow. Figure 6 This is a flowchart of the chemiluminescence detection device provided by the present invention.

[0042] First, the automatic sample rack feeding system transports the sample rack to the sample rack buffer compartment. The incubation reaction tray rotates to the reaction cup feeding position, and the automatic feeding component loads the reaction cups from the hopper into the incubation holes of the incubation ring on the incubation reaction tray. The incubation ring rotates the reaction cups to the sample addition position, and the sampling needle draws the sample from the sample rack on the sample rack buffer compartment and adds it to the reaction cup on the incubation ring. Then, the cleaning system cleans the sampling needle. The incubation ring rotates the reaction cups to the reagent addition position, and the reagent needle draws the reagent and adds it to the reaction cup on the incubation ring. At this time, the reagents, samples, and magnetic beads in the reaction cups are mixed and incubated within the incubation ring.

[0043] After the sample reagent mixture in the reaction vessel is mixed and incubated to complete the specific reaction, the reaction vessel gripper assembly moves the reaction vessel to the magnetic bead cleaning tray. The reaction vessel undergoes four cleanings in the magnetic bead cleaning tray. After cleaning, the reaction vessel is moved to the substrate mixing assembly. The substrate needle aspirates the substrate and adds it to the reaction vessel. At this time, the substrate mixing assembly mixes the mixture in the reaction vessel at high speed. After mixing, the reaction vessel is transferred to the detection tray, where it undergoes incubation and photometric measurement. After detection, the reaction vessel gripper assembly removes the reaction vessel from the detection tray and discards it.

[0044] The above steps are then repeated to test each reaction tube.

[0045] Figure 6 The two-step method described herein is set according to the reagent requirements. If it is a two-step method, after cleaning the reaction cup, the reaction tube is transported to the reaction tray through the gripper assembly. At this time, the reagent needle adds the second reagent to the reaction cup again, and then the mixture is mixed and incubated. The subsequent steps and processes are as described above.

[0046] The above description is merely a preferred embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A chemiluminescent detection apparatus, characterized by comprising: The automatic sample injection module (10), the incubation reaction disc (20), the reagent processing module (30), the reaction cup automatic loading module (40), the reaction cup transfer module (50), the magnetic bead cleaning module (60) and the detection module (70) are installed on the whole machine bottom plate; The incubation reaction disc (20), the magnetic bead cleaning module (60) and the detection module (70) are located on the rotating motion track of the reaction cup transfer module (50); The reaction cup automatic loading module (40) is located above the incubation reaction disc (20), and the discharge port thereof is aligned with the incubation hole position of the incubation reaction disc (20); The reagent processing module (30) can suck reagents from reagent boxes on a reagent disc and add the reagents into the reaction cups of the incubation reaction disc (20); The magnetic bead cleaning module (60) is provided with a lifting assembly capable of moving up and down, a magnet assembly capable of adsorbing magnetic beads and a mixing assembly capable of non-contact centrifugal mixing of the reaction cups, and the lifting assembly drives the liquid discharge needle assembly and the liquid suction needle assembly to move up and down; The detection module (70) comprises a substrate bin module (701), a substrate needle module (702) and a detection disc module (703); the detection module (70) has a constant temperature incubation control function and is provided with a mixing assembly capable of realizing non-contact mixing of the substrate and the magnetic beads.

2. The chemiluminescent detection apparatus according to claim 1, wherein The incubation reaction disc (20) has an incubation ring with concentric multiple incubation hole positions, and the incubation ring is provided with a heating assembly for temperature control; The heating assembly comprises a ring-shaped heating sheet, a heat insulation pad and a temperature sensor, the ring-shaped heating sheet is fixedly attached to the bottom outer peripheral surface of the incubation ring, the heat insulation pad is arranged between the ring-shaped heating sheet and the incubation ring, the temperature sensor is embedded in the reserved hole in the side wall of the incubation ring, and the detection end of the temperature sensor is flush with the inner wall of the incubation ring; the ring-shaped heating sheet and the temperature sensor are electrically connected to the temperature control circuit board through wires.

3. The chemiluminescent detection apparatus according to claim 1, wherein The reagent processing module (30) comprises a reagent disc module and a reagent needle assembly; The reagent disc module is a ring-shaped cavity structure, the cavity is internally provided with reagent bins uniformly distributed along the circumference, the bottom of the reagent bin is provided with an ultrasonic mixing device, the cavity is wrapped with a refrigeration insulation layer on the outside, a refrigeration pipeline is arranged between the refrigeration insulation layer and the inner wall of the cavity, and a temperature control system for refrigerating the reagent bin is formed; The reagent needle assembly comprises a reagent needle, a three-dimensional moving mechanism and a cleaning tank, the reagent needle is fixed to the execution end of the three-dimensional moving mechanism, and the cleaning tank is arranged beside the reagent disc module and within the motion track range of the three-dimensional moving mechanism; The reagent disc module and the reagent needle assembly are signal connected through the upper computer control system, and the upper computer controls the three-dimensional moving mechanism to move the reagent needle above the target reagent bin according to the position information of the reagent bin, so as to realize reagent suction.

4. The chemiluminescent detection apparatus according to claim 1, wherein The reaction cup automatic loading module (40) comprises a hopper and a reaction cup discharging mechanism; The hopper is a funnel-shaped structure with an open top and a narrowed bottom, the bottom discharge port of the hopper is fixedly connected with the feeding port of the discharging mechanism through a flange plate, and an elastic sealing gasket is arranged at the connection. The feeding mechanism comprises a vibrating feeding track, a photoelectric counter and a guide sleeve. The input end of the vibrating feeding track is connected with the bottom discharge port of the hopper. The output end of the vibrating feeding track is fixedly connected with the upper end of the guide sleeve. The lower end of the guide sleeve is the feeding port and is aligned with the incubation hole of the incubation reaction disc (20). The photoelectric counter is arranged on the side wall of the middle part of the guide sleeve and is used for detecting the passing number of the reaction cup.

5. The chemiluminescent detection apparatus according to claim 1, wherein The reaction cup transfer module (50) comprises a reaction cup gripper assembly, and the reaction cup gripper assembly is used for transferring the reaction cup between the modules. The reaction cup gripper assembly comprises a rotary driving mechanism, a lifting cylinder, a clamping jaw and a pressure sensor. The rotary driving mechanism is fixed on the bottom plate of the whole machine. The lifting cylinder is vertically fixed on the output end of the rotary driving mechanism. The clamping jaw is installed on the piston rod end of the lifting cylinder. The clamping jaw is a symmetrical arc-shaped clamping piece structure. The inner side of the arc-shaped clamping piece is provided with an anti-skid rubber pad. The pressure sensor is embedded in the anti-skid rubber pad and is used for detecting the clamping pressure between the clamping jaw and the reaction cup. The rotary driving mechanism and the lifting cylinder are signal-connected with the upper computer control system.

6. The chemiluminescent detection apparatus according to claim 1, wherein The automatic sampling module (10) comprises a sample rack conveying assembly, a sample rack buffer bin, a feeding area, a discharging area and a bar code recognition device. The sample rack conveying assembly comprises a conveying track, a stepping motor and a pushing block. The conveying track is arranged in the horizontal direction. The feeding area and the discharging area are respectively located at the two ends of the conveying track. The sample rack buffer bin is arranged beside the middle part of the conveying track. The pushing block is slidingly connected to the conveying track and is drivingly connected to the output end of the stepping motor, so as to push the sample rack in the feeding area to the sample rack buffer bin or push the sample rack in the sample rack buffer bin to the discharging area after detection. The bar code recognition device comprises a bracket and a laser scanning head. The bracket is fixed above the sample rack buffer bin. The laser scanning head is obliquely installed on the bracket and the scanning end faces the bar code area of the sample tube in the sample rack buffer bin. The bar code recognition device is signal-connected with the upper computer and is used for uploading the recognized bar code information to the upper computer.

7. The chemiluminescent detection apparatus according to claim 1, wherein The reagent processing module (30) is provided with a bar code scanning device for recognizing the reagent box bar code on the reagent disc. The bar code information recognized by the automatic sampling module (10) and the reagent processing module (30) is uploaded to the upper computer for processing.

8. A detection control method for the chemiluminescence detection apparatus according to any one of claims 1 to 7, characterized by, The method comprises the following steps: S1: sample and reaction cup loading control: the automatic sampling module (10) transfers the sample rack to the sample rack buffer bin and recognizes the sample tube bar code, and uploads the bar code information to the upper computer. The incubation reaction disc (20) is rotated to the cup feeding position. The feeding mechanism of the reaction cup automatic loading module (40) accurately feeds the reaction cup into the incubation hole of the incubation reaction disc (20). S2: sample and reagent addition control: the incubation reaction disc (20) drives the reaction cup to rotate to the sample adding position. The sampling needle sucks the sample and injects it into the reaction cup. Then the sampling needle starts the self-cleaning program. The incubation reaction disc (20) continues to rotate to the reagent adding position. After the reagent processing module (30) recognizes the reagent box bar code, the reagent needle sucks the corresponding reagent and injects it into the reaction cup. S3: Incubation reaction control: the incubation ring of the incubation reaction disc (20) is maintained at a preset constant temperature by the heating assembly, and the mixing function is started to fully mix and incubate the sample, reagent, and magnetic beads in the reaction cup. The incubation time is preset according to the detection item; S4: Magnetic bead cleaning control: after incubation, the reaction cup transfer module (50) transfers the reaction cup to the magnetic bead cleaning module (60). The lifting assembly drives the liquid suction needle to suck the waste liquid, the liquid injection needle to add cleaning liquid, and the magnet assembly to adsorb the magnetic beads. The four-stage cleaning process is repeated four times to complete the four-stage cleaning; S5: Substrate addition and mixing control: after cleaning, the reaction cup is transferred to the substrate mixing assembly. The substrate needle module (702) sucks the substrate from the substrate warehouse module (701) and injects it into the reaction cup. The substrate mixing assembly mixes at a preset speed and time; S6: Detection and post-processing control: the reaction cup is transferred to the detection disc module (703). The detection disc maintains a constant temperature and light-proof environment. The optical detection assembly collects the chemiluminescence signal in the reaction cup. The detection data is uploaded to the upper computer. After detection, the reaction cup is grabbed and thrown by the reaction cup transfer module (50).

9. The detection control method according to claim 8, characterized by, Also includes: If it is a one-step detection, repeat steps S1-S6 to realize continuous sample detection; If it is a two-step detection, after step S4 is completed, the reaction cup transfer module (50) sends the reaction cup back to the incubation reaction disc (20). The reagent needle adds the second reagent again, and steps S3-S6 are repeated.

10. The detection control method according to claim 8, characterized by, The preset constant temperature in step S3 is 37°C ± 0.5°C, and the incubation time is 15-60 minutes; In step S5, the preset speed of the substrate mixing assembly is 2000-3500 r / min, and the mixing time is 20-40 seconds; In step S6, the constant temperature control accuracy of the detection disc module (703) is ±0.1°C, and the optical detection time is 1-5 seconds.

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