A chemiluminescence immunoassay analyzer and its detection method

Abstract

An embodiment of the present application provides a chemiluminescent immunoassay analyzer and its detection method. The chemiluminescent immunoassay analyzer includes: a frame body; an incubation unit provided on the frame body for providing a constant temperature to the sample and reactants in the reaction tube; the incubation unit includes a plurality of holes for carrying the reaction tubes, and the first tube placement position, sample position, tube taking position, and reagent position are sequentially arranged counterclockwise on the incubation unit; a tube library corresponding to the first tube placement position, a sample library corresponding to the sample position, a reagent bin corresponding to the reagent position, and a cleaning unit corresponding to the tube taking position are sequentially surrounded outside the incubation unit; a detection unit for detecting the luminescence value of the reactants; and a plurality of grippers for transferring the reaction tubes. Based on the detection process steps of the instrument, the relative positions of each unit are rearranged in the present application, making the structure more compact. On the basis of reducing the volume of the chemiluminescent immunoassay analyzer, it is more convenient for detection operations.

Description

Technical Field

[0001] This application relates to the field of medical testing equipment, and particularly to a chemiluminescence immunoassay analyzer and its detection method. Background Art

[0002] A chemiluminescence immunoassay analyzer is a medical testing instrument that performs immunoanalysis on the human body by detecting the patient's serum, mainly including a sample library, a tube library unit, a cleaning unit, a detection unit, a incubation unit, etc. The chemiluminescence immunoassay analyzer can automatically detect samples and has the advantages of automation and high efficiency.

[0003] However, in the current chemiluminescence immunoassay analyzer, the structures of the sample library, the tube library unit, the cleaning unit, the detection unit, and the incubation unit are not reasonably designed, resulting in a relatively large occupied space. Moreover, the layout between multiple units is unreasonable, increasing the moving stroke of the reaction tubes and unable to correspond to each detection process step of the instrument, resulting in problems such as low detection efficiency and complex circuit pipelines and infusion pipelines between each unit. Summary of the Invention

[0004] In view of the technical problems existing in the prior art, the present application provides a chemiluminescence immunoassay analyzer, comprising: a frame body; an incubation unit disposed on the frame body for providing a constant temperature to the sample and reactants in the reaction tube; the incubation unit includes a plurality of holes for carrying the reaction tubes, and the holes at least include a first tube placement position, a sample position, a tube picking position, and a reagent position, and the first tube placement position, the sample position, the tube picking position, and the reagent position are arranged counterclockwise in sequence on the incubation unit; a tube library corresponding to the first tube placement position, a sample library corresponding to the sample position, a reagent bin corresponding to the reagent position, and a cleaning unit corresponding to the tube picking position are sequentially disposed outside the incubation unit; wherein, the tube library is used for loading the reaction tubes; the sample library is used for loading the test tubes containing the samples; the reagent bin is used for loading the reagent kits containing the reagents; the cleaning unit is used for cleaning the reactants in the reaction tube; the chemiluminescence immunoassay analyzer further includes: a detection unit disposed outside the cleaning unit with the cleaning unit in the middle, and the detection unit and the incubation unit are disposed opposite to the cleaning unit left and right, and the detection unit is used for detecting the luminescence value of the reactants; a plurality of grippers disposed on the frame body for sequentially transferring the reaction tubes from the tube library to the incubation unit, the cleaning unit, and the detection unit; and a control unit electrically connected to the incubation unit, the tube library, the sample library, the reagent bin, the cleaning unit, the detection unit, and the grippers respectively to control the working sequence of the incubation unit, the tube library, the sample library, the reagent bin, the cleaning unit, and the grippers, and complete the detection work of the sample. The present application redesigns the relative positions of the tube library, the sample rack, the incubation unit, the cleaning unit, the reagent bin, and the detection unit, making the structure more compact and reducing the volume of the chemiluminescence immunoassay analyzer.

[0005] For the chemiluminescence immunoassay analyzer as described above, the incubation unit further includes a second tube placement position corresponding to the cleaning unit, and it is used for carrying the reaction tubes transferred from the cleaning unit.

[0006] For the chemiluminescence immunoassay analyzer as described above, it further includes a diluent bin disposed on one side of the sample library, and the diluent bin is used for carrying diluent to dilute the sample.

[0007] For the chemiluminescence immunoassay analyzer as described above, it further includes a sample arm disposed on the frame body and located between the sample library, the incubation unit, and the diluent bin, and the sample arm is used for transporting the sample in the sample library and / or the diluent in the diluent bin into the reaction tube.

[0008] The chemiluminescence immunoassay analyzer as described above further includes a dilution and mixing station, which is arranged on the main body of the rack and located between the sample library and the diluent bin, and is used to mix the sample and the diluent in the reaction tube.

[0009] The chemiluminescence immunoassay analyzer as described above, the multiple grippers include: a tube library gripper, which is arranged between the incubation unit, the tube library and the dilution and mixing station, and is used to transfer the reaction tube on the tube library to the incubation unit and / or the dilution and mixing station; an incubation gripper, which is used to transfer the reaction tube to the insulation space of the incubation unit; a cleaning gripper, which is arranged between the incubation unit and the cleaning unit, and is used to move the reaction tube between the incubation unit and the cleaning unit; and a detection gripper, which is arranged between the cleaning unit and the detection unit, and is used to transfer the reaction tube on the cleaning unit to the detection unit and / or transfer the reaction tube on the detection unit to the waste channel.

[0010] The chemiluminescence immunoassay analyzer as described above further includes a reagent arm, which is arranged on the main body of the rack and located between the reagent bin and the incubation unit, and the reagent arm is used to transfer the reagent in the reagent bin to the reaction tube on the reagent position.

[0011] The chemiluminescence immunoassay analyzer as described above, the cleaning unit includes a photoelectric sensor, which is used to detect whether the reaction tube is placed on the cleaning unit.

[0012] The chemiluminescence immunoassay analyzer as described above further includes a liquid path unit, which is arranged on one side below the main body of the rack. The liquid path unit includes: a system liquid barrel, which is used to provide liquid for the pipelines and needle washing on the sample arm and the reagent arm; a cleaning liquid barrel, which is used to provide cleaning liquid for the cleaning unit; a special cleaning liquid barrel, which is used to provide special cleaning liquid for the sample arm; an excitation liquid barrel, which is used to provide excitation liquid for the detection unit; and a waste liquid barrel, which is used to recycle the waste liquid generated by the chemiluminescence immunoassay instrument.

[0013] The chemiluminescence immunoassay analyzer as described above further includes an electronic control unit, which is arranged on the other side below the main body of the rack. The electronic control unit includes: a power supply, which is used to provide electrical energy for the chemiluminescence immunoassay analyzer; an integrated circuit board, on which the control unit is arranged, and the integrated circuit board integrates the control circuits of one or more of the tube library, the sample library, the reagent bin, the cleaning unit, the detection unit and the grippers; and a heat dissipation device, which is used to dissipate heat and cool down the integrated circuit board.

[0014] According to another aspect of the present application, a detection method for a chemiluminescence immunoassay analyzer is proposed. The chemiluminescence immunoassay analyzer described above is used to detect a sample, and the working steps include: controlling the tube library gripper to move the reaction tube to the first tube placement position; controlling the sample arm to aspirate and transfer the sample on the sample library into the reaction tube; controlling the incubation unit to move the reaction tube to the reagent position, and the reagent arm to aspirate and transfer the reagent in the reagent storage into the reaction tube; controlling the incubation gripper to transfer the reaction tube to the insulation space of the incubation unit; in response to the end of incubation, controlling the cleaning gripper to transfer the reaction tube to the cleaning unit; and in response to the end of cleaning, controlling the detection gripper to transfer the reaction tube from the cleaning unit to the detection unit.

[0015] The detection method for the chemiluminescence immunoassay analyzer described above further includes: after the detection unit finishes detection, the detection gripper transfers the reaction tube after detection to the waste channel.

[0016] The detection method for the chemiluminescence immunoassay analyzer described above, when the sample needs secondary incubation, further includes: controlling the cleaning gripper to transfer the reaction tube from the cleaning unit to the second tube placement position; and controlling the incubation unit to transfer the reaction tube from the second tube placement position to the reagent position.

[0017] The detection method for the chemiluminescence immunoassay analyzer described above, when the sample needs to be diluted, further includes: controlling the tube library gripper to transfer the reaction tube on the tube library to the dilution and mixing position; controlling the sample arm to aspirate and transfer the sample on the sample library into the reaction tube; controlling the sample arm to aspirate and transfer the diluent in the diluent storage into the reaction tube; controlling the reaction tube on the dilution and mixing position to rotate to mix the sample and the diluent; and controlling the sample arm to transfer the diluted sample into the reaction tube, and controlling the tube library gripper to transfer the reaction tube on the dilution and mixing position to the waste channel.

[0018] The detection method for the chemiluminescence immunoassay analyzer described above further includes: in response to the power-on self-check after abnormal shutdown, including: using the photoelectric sensor to detect whether there is a reaction tube placed on the cleaning unit; in response to there being a reaction tube placed on the cleaning unit, using the detection gripper to transfer the reaction tube to the waste channel; and controlling the detection gripper to move near the detection unit, and sequentially perform a grasping action at multiple reaction tube placement positions on the detection unit. In response to grasping the reaction tube at the reaction tube placement position, transfer the reaction tube to the waste channel; otherwise, continue to perform the grasping action at the next reaction tube placement position until all the reaction tube placement positions are completed, and then enter the working steps.

[0019] In this application, the relative positions of the tube library, sample rack, incubation unit, cleaning unit, reagent warehouse, and detection unit are redesigned to make the structure more compact and reduce the volume of the chemiluminescence immunoassay analyzer. By separately arranging the electrical device and the device using liquid, this application optimizes the relative positions of each unit and improves the electrical safety. Description of the Drawings

[0020] Next, the preferred embodiments of this application will be further described in detail with reference to the drawings, where:

[0021] Figure 1A is a schematic diagram of the overall structure of a chemiluminescence immunoassay analyzer according to an embodiment of this application;

[0022] Figure 1B is Figure 1A a schematic diagram of the structure of the incubation unit of the partial A in

[0023] Figure 2A and Figure 2B are respectively schematic diagrams of the lower part of the luminescence immunoassay analyzer from different perspectives according to an embodiment of this application; and

[0024] Figure 3 is a detection method of a chemiluminescence immunoassay analyzer according to an embodiment of this application. Detailed Embodiments

[0025] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions in the embodiments of this application will be clearly and completely described below with reference to the drawings in the embodiments of this application. Obviously, the described embodiments are some but not all of the embodiments of this application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in this application without creative efforts shall fall within the scope of protection of this application.

[0026] In the following detailed description, reference may be made to the various specification drawings that form a part of this application and illustrate specific embodiments of the application. In the drawings, like reference numerals generally describe substantially similar components in different figures. The various specific embodiments of this application are described in sufficient detail below to enable those of ordinary skill in the relevant art and technology to implement the technical solutions of this application. It should be understood that other embodiments may also be utilized or structural, logical, or electrical changes may be made to the embodiments of this application.

[0027] Figure 1A is a schematic top view of a chemiluminescence immunoassay analyzer according to an embodiment of this application. As Figure 1AAs shown, the chemiluminescence immunoassay analyzer 10 includes a frame body 1400 and a tube library 100, a sample library 200, a diluent bin 300, a sample arm 400, a tube library gripper 500, an incubation unit 600, a cleaning gripper 700, a reagent arm 800, an incubation gripper 900, a cleaning unit 1000, a reagent bin 1100, a detection unit 1200, a detection gripper 1300, a liquid path unit (not shown), and a control unit (not shown) disposed thereon.

[0028] Figure 1B is Figure 1A Schematic diagram of the structure of the incubation unit at part A in. As Figure 1B and in combination with Figure 1A As shown, the incubation unit 600 is used to provide a constant temperature for the samples and reactants in the reaction tubes, where the temperature can be 37 °C with an error within the range of ±0.3 - 0.5 °C; the incubation unit 600 includes a plurality of hole positions for carrying the reaction tubes, and the hole positions at least include a first tube placement position 6i, a sample position 6j, tube picking positions 6d, 6e, 6f, and a reagent position 6k. The first tube placement position 6i, the sample position 6j, the tube picking positions 6d, 6e, 6f, and the reagent position 6k are sequentially arranged on the incubation unit 600. The incubation unit 600 includes a processing ring assembly 601 and an incubation disk 602. The first tube placement position 6i, the sample position 6j, and the reagent position 6k are arranged on the processing ring assembly 601, and the tube picking positions 6d, 6e, 6f are arranged on the incubation disk 602. Both the processing ring assembly 601 and the incubation disk 602 can rotate clockwise and / or counterclockwise. In one embodiment, the first tube placement position 6i, the sample position 6j, the tube picking positions 6d, 6e, 6f, and the reagent position 6k are sequentially arranged on the incubation unit 600 in the counterclockwise direction.

[0029] The hole positions further include a mixing position 6m and an operation position 6g, which are arranged on the frame body 1400 and are located on one side of the reagent position 6k for mixing the samples and reagents. When the processing ring assembly 601 rotates counterclockwise, the mixing position 6m is arranged on the right side of the reagent position 6k. The position of the mixing position 6m can be set according to the actual situation.

[0030] The operation position 6g is arranged on the frame body 1400 and is located on one side of the reagent position 6m for carrying the reaction tubes after mixing the samples and reagents. The incubation gripper 900 is arranged on the frame body 1400 and is located on one side of the operation position 6g, and it is used to transfer the reaction tubes on the operation position 6g to the tube placement positions 6a, 6b, or 6c on the incubation disk.

[0031] The tube library 100 is arranged at a position corresponding to the first tube placement position 6i and is used to load reaction tubes. The tube library 100 includes a cup arranging tray 101, and the tube library 100 can automatically arrange the disordered reaction tubes 102 on the cup arranging tray 101. The reaction tubes on the tube library 100 can be transferred within the incubation unit 600, the cleaning unit 1000, and the detection unit 1200 in the chemiluminescence immunoassay analyzer for carrying samples and reagents. A tube library gripper 500 is arranged between the incubation unit 600 and the tube library 100, and it grabs the reaction tube 102 from the tube gripping position 1a on the cup arranging tray 101 and transports it to the first tube placement position 6i.

[0032] The sample library 200 is arranged at a position corresponding to the sample position 6j. It is arranged below the tube library 100 and is used to load test tubes containing samples. The sample library 200 includes a sample bin, and the user can put a sample rack with multiple test tubes into the sample bin. The sample cart 201 in the sample library transfers the sample rack to the sampling position 2a. When the samples in all the test tubes on the sample rack are aspirated by the sample arm 400, the sample cart 201 transfers the sample rack back into the sample bin. The sample arm 400 is arranged on the frame body 1400 and is located between the sample library 200 and the incubation unit 600. It is used to aspirate the sample at the sampling position 2a and transfer it into the reaction tube at the sample position 6j. The chemiluminescence immunoassay analyzer 10 also includes a cleaning position 1401 arranged on one side of the sample arm 400. When the sample arm 400 aspirates a sample and / or diluent, the liquid adding needle of the sample arm 400 is cleaned at the cleaning position 1401 to prevent cross-contamination and improve the detection accuracy.

[0033] The diluent bin 300 is arranged on one side of the sample library 200 and is used to hold the diluent for diluting the sample. A dilution and mixing position 1403 is provided on the frame body 1400 and is arranged between the sample library 200 and the diluent bin 300 for mixing the sample and the diluent in the reaction tube. Some test samples need to be diluted before detection. When the test sample needs to be diluted, the tube library gripper grabs the reaction tube 102 from the tube gripping position 1a on the cup arranging tray 101 and transports it to the dilution and mixing position 1403. The sample arm 400 aspirates the sample at the sampling position 2a and adds it to the reaction tube at the dilution and mixing position 1403. Then the sample arm 400 aspirates the diluent from the liquid taking port 3a or 3b or 3c on the diluent bin 300 and adds it to the reaction tube at the dilution and mixing position 1403. The dilution and mixing position 1403 mixes the sample and the diluent in the reaction tube. Finally, the sample arm 400 transfers the diluted sample to the reaction tube at the sample position 6j and controls the tube library gripper 500 to transfer the reaction tube at the dilution and mixing position 1403 into the waste channel 1402.

[0034] The reagent storage 1100 is arranged at a position corresponding to the reagent position 6k and is used to load the reagent kit containing reagents. The reagent storage 1100 includes a refrigeration device which can keep the reagent kit in a refrigerated environment of 2-8°C. The reagent arm 800 is arranged between the reagent storage 1100 and the incubation unit 600, and the reagent arm 800 is used to transfer the reagent in the reagent storage 1100 to the reaction tube on the reagent position 6k. The cleaning position 1401 is also arranged on one side of the reagent arm 800. After the reagent arm 800 aspirates the reagent, the liquid adding needle of the reagent arm 800 is cleaned at the cleaning position 1401 to prevent cross-contamination and improve the detection accuracy.

[0035] The cleaning unit 1000 is arranged at positions corresponding to the tube-taking positions 6d, 6e, 6f and is used to clean the conjugate of the sample and the reagent in the reaction tube, remove impurities and interfering substances, and can improve the detection accuracy. The cleaning gripper 700 is arranged between the incubation unit 600 and the cleaning unit 1000 and is used to move the reaction tube between the incubation unit 600 and the cleaning unit 1000. The incubation unit 600 transfers the incubated reaction tube to the tube-taking positions 6d, 6e, 6f, and the cleaning gripper 700 transfers the incubated reaction tube from the tube-taking positions 6d, 6e, 6f to the tube inlet position 10a of the cleaning unit 1000.

[0036] The detection unit 1200 is arranged outside the cleaning unit 1000 and centered on the cleaning unit 1000. The setting positions of the detection unit 1200 and the incubation unit 600 are opposite to the left and right of the cleaning unit 1000. The detection unit 1200 sequentially passes through the excitation liquid filling component and the photon counting detection component 1201 clockwise and can detect the luminescence value of the reactant to analyze and obtain the final detection result. The detection gripper 1300 is arranged between the cleaning unit 1000 and the detection unit 1200 and is used to transfer the reaction tube from the tube outlet position 10b on the cleaning unit 1000 to the tube inlet position 12a on the detection unit 1200; in addition, the detection gripper 1300 transfers the detected reaction tube from the tube inlet position 12a of the detection unit 1200 to the waste channel 1402.

[0037] The chemiluminescence immunoassay analyzer 10 further includes: a control unit (not shown), which is electrically connected to the incubation unit 600, the tube library 100, the sample library 200, the reagent warehouse 1100, the cleaning unit 1000, the detection unit 1200, and the grippers 500, 700, 900, 1300 respectively to control the working sequence of the incubation unit 600, the tube library 100, the sample library 200, the reagent warehouse 1100, the cleaning unit 1000, the detection unit 1200, and the grippers 500, 700, 900, 1300, and complete the detection work of the sample. The control unit can include one or more central processing units (CPUs), graphics processing units (GPUs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or combinations thereof. The control unit can execute software or computer-readable instructions stored in the memory to perform the methods or operations described herein. The control unit can be implemented in several different ways. For example, the control unit can include one or more embedded processors, processor cores, microprocessors, logic circuits, hardware finite state machines (FSMs), digital signal processors (DSPs), or combinations thereof.

[0038] In one embodiment, the incubation unit 600 further includes a second tube placement position 6h, which is correspondingly arranged with the cleaning unit 1000 and is used to carry the reaction tubes transferred from the cleaning unit 1000. Some samples require secondary incubation and secondary cleaning to obtain more accurate detection results. In this application, the second tube placement position 6h is set on the incubation unit 600. After the cleaning unit 1000 completes the first round of cleaning, the reaction tubes are transferred to the tube inlet position 10a, and the cleaning gripper 700 grabs the reaction tubes on the tube inlet position 10a to the second tube placement position 6h for the second round of reagent addition, incubation, and cleaning operations.

[0039] In one embodiment, when the sample requires secondary incubation and secondary cleaning, the reaction tubes on the processing ring assembly 601 of the incubation unit 600, the cleaning unit 1000, and the detection unit 1200 are stored at intervals. During the second round of incubation and cleaning, the reaction tubes are placed in the vacant positions at intervals to meet the requirements of secondary incubation and secondary cleaning.

[0040] In one embodiment, the incubation unit 600 further includes a first sensor and a second sensor (not shown). The first sensor is disposed inside the incubation disk 602 and is used to detect whether there is a reaction tube placed on the incubation disk 602; the second sensor is disposed outside the processing ring assembly 601 and is used to detect whether there is a reaction tube placed on the processing ring assembly 601. In practical applications, the photoelectric sensor can also use a fiber optic sensor, etc., and the corresponding detection effect can also be achieved.

[0041] In one embodiment, the cleaning unit 1000 includes a photoelectric sensor for detecting whether a reaction tube is placed on the cleaning unit 1000. When the chemiluminescence immunoassay analyzer 10 abnormally shuts down, after restarting, the cleaning unit can automatically detect and clean the reaction tubes remaining on it. Specifically, the holes in the cleaning unit 1000 rotate, and at the tube outlet position 10b, the photoelectric sensor detects whether there is a remaining reaction tube. When a reaction tube is detected, the detection gripper 1300 is used to discard the remaining reaction tube into the waste channel 1402. Finally, every time the detection unit 1200 rotates one hole position, the detection gripper 1300 makes a grasping action. If there is a remaining reaction tube, it is discarded into the waste channel 1402. In practical applications, the photoelectric sensor can also be a fiber optic sensor, etc., which can also achieve the corresponding detection effect.

[0042] Figure 2A and Figure 2B are schematic structural diagrams of different perspectives of the lower part of the chemiluminescence immunoassay analyzer according to an embodiment of the present application. Figure 2B is Figure 2A the rear view of, and the present application describes the orientation of the structure with Figure 2A as the main perspective. As Figure 2A and Figure 2B shown, the liquid path unit 1500 is arranged on one side below the main body of the frame. The liquid path unit includes pumps, valves, liquid pipes, liquid barrels, connectors, floats, etc., and is used for the storage, transportation, and remaining amount detection of the liquids required for the whole machine.

[0043] The liquid path unit 1500 includes a waste liquid bucket 1501, a trash can 1502, a system liquid bucket 1503, a cleaning liquid bucket 1504, a special cleaning liquid bucket 1505, a quick connector unit 1506, a storage cabinet 1507, an excitation liquid bucket 1508, and a backup excitation liquid bucket 1509. The waste liquid bucket 1501 is arranged on one side below the main body of the frame and is used to recycle the waste liquid generated by the chemiluminescence immunoassay analyzer. The trash cans 1502 are symmetrically arranged below the main body of the frame and are used to store the reaction tubes discarded through the waste channel 1402. The system liquid bucket 1503 is arranged in the middle position between the two trash cans and is used to supply liquid to the pipelines and needle washers on the sample arm 400 and the reagent arm 800. The cleaning liquid bucket 1504 is arranged in front of the system liquid bucket 1503 and is used to supply cleaning liquid to the cleaning unit 1000. The special cleaning liquid bucket 1505 is arranged in front of the cleaning liquid bucket 1504 and is used to supply special cleaning liquid to the sample arm 400. The quick connector unit 1506 is arranged on the left side of the special cleaning liquid bucket 1505 and integrates quick connectors for liquid pipes and cables. When replacing the liquid bucket, the liquid pipes and cables connected to the liquid bucket can be conveniently separated, and after the replacement is completed, they can be directly plugged in to connect, which can shorten the replacement time. The two storage cabinets 1507 are respectively arranged in front of the two trash cans 1502 and are used to store things. The excitation liquid bucket 1508 is arranged above the quick connector unit 1506 and is used to supply excitation liquid to the detection unit 1200. In addition, the backup excitation liquid bucket 1509 is arranged adjacent to the excitation liquid bucket 1508. When the excitation liquid in the excitation liquid bucket 1509 is used up, the excitation liquid in the backup excitation liquid bucket 1509 can be directly switched to use, realizing the function of replacing the excitation liquid bucket without stopping the machine and ensuring continuous liquid supply of the instrument without interruption.

[0044] The chemiluminescence immunoassay analyzer further includes an electric control unit 1600, which is arranged at another position on the lower side of the main body of the frame. The electric control unit 1600 includes a power supply 1601, a power switch 1602, an integrated circuit board 1603, and a heat dissipation device 1604. The power supply 1601 is used to supply electrical energy to the chemiluminescence immunoassay analyzer. The power switch 1602 is electrically connected to the power supply 1601, and the power switch 1602 is used to control the on and off states of the chemiluminescence immunoassay analyzer. The control unit is arranged on the integrated circuit board 1603, and the integrated circuit board 1603 integrates the control circuits of one or more of the tube library 100, the sample library 200, the reagent warehouse 1100, the cleaning unit 1000, the detection unit 1200, and the grippers 500, 700, 900, 1300. The heat dissipation device 1604 is arranged opposite to the integrated circuit board 1603, and the heat dissipation device 1604 is used to dissipate heat from the integrated circuit board 1603 to ensure that the integrated circuit board 1603 is at the optimal working temperature. By arranging the liquid path unit 1500 and the electric control unit 1600 separately on the left and right in this application, it is beneficial to the maintenance of the device. Further, it can prevent problems such as electric leakage and improve the electrical safety of the instrument.

[0045] Figure 3 It is a detection method of a chemiluminescence immunoassay analyzer according to an embodiment of the present application. In step S302, the tube library gripper 500 moves the reaction tube to the first tube placement position 6i. The tube library gripper 500 grabs the reaction tube 102 from the tube grabbing position 1a on the cup arranging tray 101 and transports it to the first tube placement position 6i.

[0046] In step S304, it is judged whether the sample needs to be diluted; when it is determined that the sample does not need to be diluted, step S306 is executed, and the sample arm 400 aspirates and transports the sample into the reaction tube. The processing ring assembly 601 rotates counterclockwise to transfer the reaction tube to the sample position 6j, and the sample arm 400 aspirates and transports the sample into the reaction tube at the sample position 6j.

[0047] In step S308, the incubation unit 600 moves the reaction tube to the reagent position 6k, and the reagent arm 800 aspirates and transports the reagent in the reagent warehouse 1100 into the reaction tube. The processing ring assembly 601 continues to rotate counterclockwise to move the reaction tube to the reagent position 6k, and the reagent arm 800 aspirates the reagent in the reagent kit 1101 in the reagent warehouse 1100 and adds it to the reaction tube on the processing ring assembly 601.

[0048] In step S310, the incubation gripper 900 transfers the reaction tube to the insulation space of the incubation unit 600. Before the reaction tube is transferred to the insulation space, the processing ring assembly 601 continues to rotate counterclockwise to transfer the reaction tube to the mixing position 6m, and the mixing position 6m mixes the sample and the reagent in the test tube. Then, the processing ring assembly 601 rotates counterclockwise to transfer the reaction tube to the operation position 6g, and the incubation gripper 900 transfers the reaction tube to the tube placement positions 6a or 6b or 6c on the incubation tray 602 for incubation operation.

[0049] In step S312, after incubation is completed, the cleaning gripper 700 transfers the reaction tube to the cleaning unit 1000. The cleaning gripper 700 transfers the reaction tube from the tube picking positions 6d or 6e or 6f to the tube inlet position 10a of the cleaning unit 1000, and the cleaning unit 1000 rotates counterclockwise to wash away the impurities or interfering substances in the reaction tube, leaving the clean conjugate.

[0050] In step S314, it is judged whether the sample needs one-step detection or two-step detection;

[0051] When it is determined that the sample needs one-step detection, step S316 is executed, and the detection gripper 1300 transfers the reaction tube from the cleaning unit 1000 to the detection unit 1200. The detection gripper 1300 transfers the reaction tube from the tube outlet position 10b of the cleaning unit 1000 to the tube inlet position 12a of the detection unit 1200, and the detection unit 1200 rotates clockwise, and the reaction tube sequentially passes through the injection of the excitation solution injection assembly and the photon counting detection assembly 1201, which is used to detect the luminescence value of the reactant.

[0052] In step S318, the detection gripper 1300 transfers the reaction tube after the detection is completed to the waste channel 1402. When the detection is completed, the detection gripper 1300 transfers the reaction tube from the tube inlet position 12a of the detection unit to the waste channel 1402.

[0053] When the sample needs to be diluted, the method is as follows:

[0054] In response to the sample needing to be diluted, step S320 is executed, and the tube library gripper 500 transfers the reaction tube on the tube library to the dilution and mixing position 1403. The tube library gripper 500 grabs the reaction tube from the tube taking position 1a on the cup arranging tray 101 and transfers it to the dilution and mixing position 1403.

[0055] In step S322, the sample arm 400 aspirates and transports the sample on the sample library 200 into the reaction tube. The sample arm 400 adds the aspirated sample into the reaction tube on the dilution and mixing position 1403.

[0056] In step S324, the sample arm 400 aspirates and transports the diluent in the diluent bin 300 into the reaction tube, and rotates the reaction tube to mix the sample and the diluent; then step S306 is executed, and the sample arm 400 aspirates and transports the sample into the reaction tube. The tube library gripper 500 transfers the reaction tube on the dilution and mixing position 1403 to the waste channel 1402.

[0057] The detection method of the sample includes the one-step method and the two-step method. The one-step method is that the sample only needs to be incubated and washed once to be detected. The two-step method is that the sample needs to be incubated and washed twice. In this application, a second tube placing position 6h is added to the incubation unit, and a control program related to the two-step method is added. On the same chemiluminescence immunoassay analyzer, it can perform both the one-step method detection and the two-step method detection. The detection steps are as follows:

[0058] In response to the sample needing to be detected by the two-step method, step S326 is executed, and the cleaning gripper 700 transfers the reaction tube from the cleaning unit 1000 to the second tube placing position 6h; then steps S308 - S312 are executed. When the sample is washed for the second time, it is directly transferred to the detection unit 1000 for detection.

[0059] The chemiluminescence immunoassay analyzer of this application can perform both the one-step method detection and the two-step method detection, can meet the detection requirements of different types of samples, increase the usage scenarios of the chemiluminescence immunoassay analyzer, and improve the user satisfaction.

[0060] In response to the abnormal shutdown of the chemiluminescence immunoassay analyzer, when it is powered on again, the self-check program will be started. The self-check method after power-on includes:

[0061] Use a second sensor to detect whether a reaction tube is placed on the processing ring assembly 601. The processing ring assembly 601 can be rotated, and the second sensor sequentially detects multiple hole positions on the processing ring assembly 601;

[0062] In response to a reaction tube being placed on the processing ring assembly 601, use the tube library gripper 500 to transfer the reaction tube to the waste channel 1402;

[0063] Use a first sensor to detect whether a reaction tube is placed on the incubation plate 602; The incubation plate 602 can be rotated, and the first sensor sequentially detects multiple hole positions on the incubation plate 602.

[0064] In response to a reaction tube being placed on the incubation plate 602, use the incubation gripper 900 to transfer the reaction tube to the processing ring assembly 601;

[0065] Use a second sensor to detect whether a reaction tube is placed on the processing ring assembly 601;

[0066] In response to a reaction tube being placed on the processing ring assembly 601, use the tube library gripper 500 to transfer the reaction tube to the waste channel 1402.

[0067] Meanwhile: Use a photoelectric sensor to detect whether a reaction tube is placed on the cleaning unit 1000;

[0068] In response to a reaction tube being placed on the cleaning unit, use the detection gripper 1300 to transfer the reaction tube to the waste channel 1402; and

[0069] Control the detection gripper 1300 to move near the detection unit 1200, and sequentially perform a grasping action at multiple reaction tube placement positions on the detection unit 1200. In response to a reaction tube being grasped at the reaction tube placement position, transfer the reaction tube to the waste channel 1402; In response to the detection gripper 1300 not grasping a reaction tube at the reaction tube placement position, continue to perform a grasping action at the next reaction tube placement position until all reaction tube placement positions have been completed.

[0070] In summary, this application redesigned the relative positions of the tube library, sample library, incubation unit, cleaning unit, reagent warehouse, and detection unit, making the structure more compact and reducing the volume of the chemiluminescence immunoassay analyzer. By separately arranging the electrical device and the device using liquid, this application optimized the relative positions of each unit and improved the electrical safety. Further, this application can not only detect samples suitable for the one-step method but also detect samples for the two-step method, expanding the usage scenarios of the chemiluminescence immunoassay analyzer.

[0071] The above embodiments are only for illustrating the present application and are not intended to limit the present application. Those of ordinary skill in the relevant technical field can also make various changes and modifications without departing from the scope of the present application. Therefore, all equivalent technical solutions should also fall within the scope of the disclosure of the present application.

Claims

1. A chemiluminescence immunoassay analyzer, characterized in that, Comprising: The frame body; An incubation unit, disposed on the frame body, for providing a constant temperature to the sample and reactants in the reaction tube; the incubation unit includes a plurality of hole positions for carrying the reaction tubes, and the hole positions at least include a first reaction tube placement position, a sample position, a reaction tube retrieval position, and a reagent position, and the first reaction tube placement position, the sample position, the reaction tube retrieval position, and the reagent position are sequentially arranged counterclockwise on the incubation unit; Outside the incubation unit, there is sequentially disposed a tube library corresponding to the first reaction tube placement position, a sample library corresponding to the sample position, a reagent bin corresponding to the reagent position, and a cleaning unit corresponding to the reaction tube retrieval position; wherein, The tube library is used for loading the reaction tubes; The sample library is used for loading the test tubes containing the samples; The reagent bin is used for loading the reagent kits containing the reagents; The cleaning unit is used for cleaning the reactants in the reaction tube; The chemiluminescent immunoassay analyzer further includes: A diluent bin, disposed on one side of the sample library; A dilution and mixing position, disposed on the frame body and between the sample library and the diluent bin, for mixing the sample and the diluent in the reaction tube; A sample arm, disposed on the frame body and between the sample library, the incubation unit, and the diluent bin, the sample arm includes a liquid adding needle, and the sample arm is used for transporting the sample in the sample library and / or the diluent in the diluent bin to the reaction tube, and the sample arm is further used for transporting the diluted sample to the reaction tube at the sample position. A cleaning position is disposed on one side of the sample arm, and the cleaning position is used for cleaning the liquid adding needle of the sample arm; A detection unit, disposed outside the cleaning unit, with the cleaning unit in the middle, and the setting positions of the detection unit and the incubation unit are opposite to each other left and right with respect to the cleaning unit, and the detection unit is used for detecting the luminescence value of the reactant; A plurality of grippers, disposed on the frame body, for sequentially transferring the reaction tubes from the tube library to the incubation unit, the cleaning unit, and the detection unit; and A control unit, electrically connected to the incubation unit, the tube library, the sample library, the reagent bin, the cleaning unit, the detection unit, and the grippers respectively to control the working sequence of the incubation unit, the tube library, the sample library, the reagent bin, the cleaning unit, and the grippers, and complete the detection work of the sample.

2. The chemiluminescence immunoassay analyzer according to claim 1, wherein The incubation unit further includes a second reaction tube placement position, which is correspondingly disposed with the cleaning unit and is used for carrying the reaction tube transferred from the cleaning unit.

3. The chemiluminescence immunoassay analyzer according to claim 1, wherein, The diluent bin is used for carrying the diluent to dilute the sample.

4. The chemiluminescence immunoassay analyzer according to claim 1, wherein The plurality of grippers includes: A tube library gripper, disposed between the incubation unit, the tube library, and the dilution and mixing position, for transferring the reaction tube on the tube library to the incubation unit and / or the dilution and mixing position; An incubation gripper, for transferring the reaction tube to the heat preservation space of the incubation unit; A cleaning gripper, disposed between the incubation unit and the cleaning unit, for moving the reaction tube between the incubation unit and the cleaning unit; and The detection gripper is arranged between the cleaning unit and the detection unit, and is used to transfer the reaction tubes on the cleaning unit to the detection unit and / or transfer the reaction tubes on the detection unit to the waste channel.

5. The chemiluminescence immunoassay analyzer according to claim 4, wherein It further includes a reagent arm, which is arranged on the main body of the frame and located between the reagent storage and the incubation unit. The reagent arm is used to transfer the reagent in the reagent storage to the reaction tubes on the reagent positions.

6. The chemiluminescence immunoassay analyzer according to claim 4, wherein The cleaning unit includes a photoelectric sensor, which is used to detect whether there is a reaction tube placed on the cleaning unit.

7. The chemiluminescence immunoassay analyzer according to claim 5, characterized in that, It further includes a liquid path unit, which is arranged at a position on one side below the main body of the frame. The liquid path unit includes: A system liquid bucket, which is used to supply liquid to the pipelines and needle washers on the sample arm and the reagent arm; A cleaning liquid bucket, which is used to supply cleaning liquid to the cleaning unit; A special cleaning liquid bucket, which is used to supply special cleaning liquid to the sample arm; An excitation liquid bucket, which is used to supply excitation liquid to the detection unit; and A waste liquid bucket, which is used to collect the waste liquid generated by the chemiluminescence immunoassay instrument.

8. The chemiluminescence immunoassay analyzer according to claim 7, wherein It further includes an electric control unit, which is arranged at a position on the other side below the main body of the frame. The electric control unit includes: A power supply, which is used to supply electrical energy to the chemiluminescence immunoassay analyzer; An integrated circuit board, on which the control unit is arranged. The integrated circuit board integrates the control circuits of one or more of the tube library, the sample library, the reagent storage, the cleaning unit, the detection unit, and the gripper; and A heat dissipation device, which is used to dissipate heat and cool down the integrated circuit board.

9. A detection method for a chemiluminescence immunoassay analyzer, characterized in that, Using the chemiluminescence immunoassay analyzer according to any one of claims 5 and 7 to perform detection work on a sample, the working steps include: Controlling the tube library gripper to move the reaction tube to the first tube placement position; Controlling the sample arm to aspirate and transfer the sample on the sample library to the reaction tube; Controlling the incubation unit to move the reaction tube to the reagent position, and the reagent arm to aspirate and transfer the reagent in the reagent storage to the reaction tube; Controlling the incubation gripper to transfer the reaction tube to the insulation space of the incubation unit; In response to the end of incubation, controlling the cleaning gripper to transfer the reaction tube to the cleaning unit; and In response to the end of cleaning, controlling the detection gripper to transfer the reaction tube from the cleaning unit to the detection unit.

10. The detection method of the chemiluminescence immunoassay analyzer according to claim 9, characterized in that, It further includes: After the detection unit finishes detection, the detection gripper transfers the detected reaction tube to the waste channel.

11. A detection method for a chemiluminescent immunoassay analyzer, characterized in that, Using the chemiluminescence immunoassay analyzer according to claim 2 to perform detection work on a sample, the working steps include: When the sample needs secondary incubation, controlling the corresponding gripper of the cleaning unit to transfer the reaction tube from the cleaning unit to the second tube placement position; and Controlling the incubation unit to transfer the reaction tube from the second tube placement position to the reagent position.

12. A detection method for a chemiluminescent immunoassay analyzer, characterized in that, Using the chemiluminescence immunoassay analyzer according to claim 4 to perform detection work on a sample, the working steps include: Controlling the tube library gripper to transfer the reaction tube on the tube library to the dilution and mixing position; Controlling the sample arm to aspirate and transfer the sample on the sample library to the reaction tube; Controlling the sample arm to aspirate and transfer the diluent in the diluent storage to the reaction tube; Controlling the rotation of the reaction tube at the dilution and mixing position to mix the sample and the diluent; and Controlling the sample arm to transfer the diluted sample into the reaction tube, and controlling the tube library gripper to transfer the reaction tube at the dilution and mixing position to the waste channel.

13. A detection method for a chemiluminescence immunoassay analyzer, characterized in that, Using the chemiluminescence immunoassay analyzer according to claim 6 to perform detection work on the sample, and the working steps include: Responding to the power-on self-check after abnormal shutdown; The power-on self-check in response to abnormal shutdown includes: Using a photoelectric sensor to detect whether there is a reaction tube placed on the cleaning unit; Responding to the presence of the reaction tube on the cleaning unit, using the detection gripper to transfer the reaction tube to the waste channel; and Controlling the detection gripper to move near the detection unit, and sequentially performing a grasping action at a plurality of reaction tube placement positions on the detection unit. When the reaction tube is grasped at the reaction tube placement position, transferring the reaction tube to the waste channel; otherwise, continuing to perform the grasping action at the next reaction tube placement position until all the reaction tube placement positions are completed, and then entering the working step.

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