Multifunctional analyzer and detection analysis method

Abstract

The application provides a multifunctional analyzer and a detection and analysis method, which comprises the following steps: a pipetting module is supported and installed on the upper part of a rack, is located above a detection module and a reagent bin, and realizes multi-axis movement under the control of an electrical module; the electrical module is electrically connected with the pipetting module, the detection module, the reagent bin and a liquid path module, and provides power supply and motion control signals for each module; the liquid path module is communicated with a consumable module, the pipetting module and the detection module through pipelines, and realizes the transportation and discharge of cleaning liquid, substrate and waste liquid; a computer control end is in communication connection with the electrical module, and realizes the instruction issuing, process scheduling, data acquisition and result output of the whole machine. The application integrates biochemical analysis and immune analysis functions on the same platform, can realize multi-parameter joint detection, reduces the number of equipment configurations, optimizes the experimental process, occupies small space, is flexible in deployment, has compact equipment structure, significantly reduces the inspection cost, improves the detection efficiency and data management ability, and effectively reduces the human operation error rate.

Description

Technical Field

[0001] This invention relates to a multifunctional analyzer and a detection and analysis method. Background Technology

[0002] Biochemical analyzers and immunoassay analyzers are two widely used types of testing equipment in the field of in vitro diagnostics, playing a crucial role in clinical diagnosis, disease monitoring, and public health control. Current biochemical analyzers generally use photoelectric colorimetry to quantitatively analyze specific chemical components in body fluids. Common indicators include transaminases, hemoglobin, albumin, total protein, cholesterol, creatinine, glucose, inorganic phosphorus, amylase, and calcium. These indicators reflect important physiological information such as human metabolic function, organ damage, and nutritional status. Immunoassay analyzers, based on the principle of antigen-antibody specific binding, detect immune-related components in body fluids such as antibodies, antigens, hormones, and tumor markers. They often employ high-sensitivity detection methods such as chemiluminescence and radioimmunoassay, and are widely used in clinical fields such as infectious disease detection, autoimmune disease assessment, endocrine disease monitoring, and tumor screening.

[0003] However, most existing medium and large-sized hospitals rely on two separate sets of equipment for biochemical and immunological analysis, which results in low testing efficiency, significant sample waste, and high operating costs. The main reasons for this are as follows:

[0004] (1) Biochemical and immunoassay detection require system initialization, calibration, sample loading and data management, which increases the workload and operational complexity of the laboratory.

[0005] (2) The simultaneous operation of the two sets of equipment will not only occupy a large amount of laboratory space, but also increase the turnover and testing time of samples, which cannot meet the needs of emergency and large-scale testing.

[0006] (3) The current clinical testing process is: clinical ordering - sample collection (multiple tubes) - sample transportation and distribution - testing - report generation. This process often takes 2-8 hours to complete. However, due to the lack of clinical medical staff with experience in the laboratory, there is often a problem: indicators that can be tested using the same testing method can be tested with one sample (such as liver and kidney function and alkaline phosphatase), which requires the collection of multiple tubes of blood or urine. However, in practice, not so many samples can be used, resulting in a waste of samples, time, consumables and manpower costs. Summary of the Invention

[0007] The purpose of this invention is to provide a multifunctional analyzer and a detection and analysis method.

[0008] To address the above problems, the present invention provides a multifunctional analyzer, comprising:

[0009] The frame 1 serves as the base for the entire machine installation. The consumable module 3, pipetting module 4, detection module 5, reagent compartment 6, electrical module 7, and fluid circuit module 8 are all directly fixedly installed on the frame 1.

[0010] The pipetting module 4 is mounted on the upper part of the frame 1, above the detection module 5 and the reagent compartment 6, and can move in multiple axes under the control of the electrical module 7;

[0011] Electrical module 7 is electrically connected to pipetting module 4, detection module 5, reagent compartment 6 and liquid circuit module 8 respectively, providing power supply and motion control signals to each module;

[0012] The liquid circuit module 8 is connected to the consumable module 3, the liquid transfer module 4 and the detection module 5 through pipelines to realize the transportation and discharge of cleaning fluid, substrate and waste liquid;

[0013] The computer control terminal is connected to the electrical module 7 to enable the issuance of instructions, process scheduling, data acquisition and result output for the whole machine.

[0014] Furthermore, in the aforementioned multifunctional analyzer, the computer control unit coordinates the operation of each module through the electrical module 7. Specifically, the reagent compartment 6 provides temperature-controlled reagents, the consumable module 3 provides the liquids required for testing and the collection of waste liquids, the pipetting module 4, driven by the electrical module 7, draws reagents from the reagent compartment 6 and samples from the sample rack 59 of the detection module 5, and distributes them to the detection module 5, the liquid path module 8 independently completes the delivery of cleaning solution and substrate and the treatment of waste liquids, and the detection module 5, after completing the reaction, incubation, cleaning and optical detection, transmits the detection signal back to the electrical module 7, and finally the computer control unit completes the data processing and output of results.

[0015] Furthermore, in the aforementioned multifunctional analyzer, the frame 1 includes: a base plate 11, a left support plate 12, an upper support plate 13, and a right support plate 14, wherein,

[0016] The base plate 11 is used to fix the consumable module 3, the bio-detection module 5, and the reagent compartment 6;

[0017] A pipetting X-axis 4101 is provided between the left support plate 12 and the right support plate 14 to support the movement of the pipetting module 4 along the X-axis direction;

[0018] The upper support plate 13 is located between the left support plate 12 and the right support plate 14. The upper support plate 13 is equipped with a reagent transfer X-axis synchronous belt 4102 and a sample transfer X-axis synchronous belt 4201, which are used to drive the reagent transfer module 41 and the sample transfer module 42 to move along the X-axis direction, respectively.

[0019] The electrical module 7 and the hydraulic module 8 are fixed on the back side of the upper support plate 13;

[0020] The lower parts of the reagent pipetting module 41 and the sample pipetting module 42 of the pipetting module 4 are respectively fitted onto the pipetting X-axis 4101. The lower parts of the reagent pipetting module 41 and the sample pipetting module 42 are respectively connected to the reagent transfer X-axis synchronization belt 4102 and the sample transfer X-axis synchronization belt 4201. The reagent transfer X-axis synchronization belt 4102 and the sample transfer X-axis synchronization belt 4201 carry the reagent pipetting module 41 and the sample pipetting module 42 to move on the pipetting X-axis 4101.

[0021] Furthermore, in the aforementioned multifunctional analyzer, the consumable module 3 is located below the biochemical and immunoassay detection module 5 and is fixed to the frame 1 via the consumable connecting plate 38. The consumable module 3 includes a consumable drawer 31, which is a thin-walled box with an open top. The consumable drawer 31 has a consumable drawer plate 32 mounted on top. The drawer plate 32 has through holes that match the shape of the containers to be placed, for accommodating the containers of the acid-base bottle 33, the substrate bottle 34, and the medical waste bin 35. The consumable drawer slide rail 37 is connected to the consumable drawer 31 and the consumable connecting plate 38, respectively.

[0022] Furthermore, in the aforementioned multifunctional analyzer, the sample pipetting module 42 of the pipetting module 4 draws samples from the sample tube rack 59, and the reagent pipetting module 41 of the pipetting module 4 draws corresponding reagents from the reagent compartment 6. Under the control of the electrical module 7, the pipetting module 4 accurately adds the samples and reagents to the reaction cup of the detection module 5 through the liquid circuit module 8.

[0023] The cleaning agent is directly delivered from the liquid circuit module 8 to the biochemical cleaning module 52 and the immune cleaning module 55 of the detection module 5.

[0024] Furthermore, in the aforementioned multifunctional analyzer, the liquid path module 8 obtains cleaning solution from the acid-base bottle 33 of the consumable module 3, and the liquid path module 8 directly delivers it to the needle cleaning mechanism, biochemical cleaning module 52 and immune cleaning module 55 of the pipetting module 4, respectively.

[0025] The liquid circuit module 8 obtains the substrate from the immunosubstrate vial 34 of the consumable module 3 and sends it directly to the immunooptical detection module 56 of the detection module 5;

[0026] The liquid circuit module 8 directly pumps the waste liquid from the needle cleaning tank, the biochemical cleaning module 52 of the detection module 5, and the immune cleaning module 55 into the medical waste bin 35 of the consumables module 3.

[0027] Furthermore, in the aforementioned multifunctional analyzer, the reagent pipetting module 41 includes: a pipetting X-axis 4101, a pipetting X-axis slider 4106, a pipetting Y-axis 4108, a pipetting Y-axis motor 4107, a slider 4109, a reagent needle 4103, and a pipetting Z-axis guide rail 4104, wherein,

[0028] The two ends of the pipetting X-axis 4101 are connected to the left support plate 12 and the right support plate 14, respectively;

[0029] The pipetting X-axis slider 4106 is slidably mounted on the pipetting X-axis 4101, and the pipetting X-axis slider 4106 is driven by the pipetting X-axis motor and the pipetting X-axis synchronous belt 4102;

[0030] One end of the pipetting Y-axis 4108 is fixed on the pipetting X-axis slider 4106, the pipetting Y-axis 4108 is slidably connected to the pipetting Y-axis slider 4112, and the pipetting Y-axis 4108 is slidably connected to the slider 4109;

[0031] The Y-axis motor 4107 is fixed on the X-axis slide block 4106 or the Y-axis slide block 4108.

[0032] The Y-axis motor 4107 drives the Y-axis timing belt 4111, which connects to and drives the slider 4109 to move along the Y-axis.

[0033] Slider 4109 is slidably mounted on the Y-axis 4108 of the pipetting system. Slider 4109 is integrated into the mounting.

[0034] The device comprises a reagent needle 4103, a Z-axis pipetting guide rail 4104, a Z-axis pipetting timing belt 4105, and a Z-axis pipetting motor 4110; wherein, the Z-axis pipetting guide rail 4104 is fixed on the slider 4109, and the Z-axis pipetting guide rail 4104 is slidably connected to the mounting base of the reagent needle 4103; the Z-axis pipetting motor 4110 is fixed on the slider 4109.

[0035] The Z-axis synchronous belt 4105 drives the pipetting, and the Z-axis synchronous belt 4105 connects to and drives the reagent needle 4103 to move up and down along the Z-axis. The reagent needle 4103 is installed on the Z-axis mechanism inside the slider 4109. The reagent needle 4103 is driven by the Z-axis synchronous belt 4105 and moves up and down along the Z-axis guide rail 4104.

[0036] Furthermore, in the aforementioned multifunctional analyzer, the biochemical detection module 5 includes: an incubation module 51, a cleaning module 52, an optical detection module 53, and a stirring module 58, wherein...

[0037] The biochemical incubation module 51 includes: a biochemical reaction cup loading block drive motor 5101, a cup loading block moving synchronous belt 5102, a biochemical reaction cup loading block 5103, a biochemical incubation chamber 5104, and a biochemical heating plate 5105. The biochemical incubation chamber 5104 is a reaction cavity formed by assembling metal plates, with the outer surface covered by the biochemical heating plate 5105 to provide a constant temperature environment. The top and sides of the biochemical incubation chamber 5104 have channel-type openings for pipetting, stirring, optical detection, and cleaning operations. The reaction cup loading block 5103 is arranged inside the incubation chamber and is driven by the biochemical reaction cup loading block drive motor 5101 and the cup loading block moving synchronous belt 5102 to move along the Y-axis to different working positions, thereby completing rapid switching between incubation, detection, and cleaning stations.

[0038] The biochemical cleaning module 52 includes: a needle module assembly, a needle module motion synchronization belt 5205, and a cleaning needle module drive motor 5206 connected in sequence; the needle module assembly includes a drying needle 5201, a waste removal needle 5202, a cleaning needle 5203, and a needle fixing block 5204.

[0039] The biochemical optical detection module 53 includes a spectrometer 5301 and a light source 5302, used to measure the absorbance of the reaction solution in the cuvette; the incident light emitted by the light source 5302 is transmitted through the outer aperture of the biochemical incubation chamber 5104 and the cuvette, and is received and analyzed by the spectrometer 5301, and the concentration of the target analyte is calculated according to the Lambert-Beer law; the biochemical optical detection module 53 has the functions of automatic light intensity compensation, background noise calibration and multi-wavelength scanning;

[0040] The stirring module 58 includes: a stirring base plate 5801, an X-axis stirring motor 5802, an X-axis stirring synchronous belt 5803, an X-axis stirring linear guide rail 5804, a Z-axis stirring synchronous belt 5805, a Z-axis stirring linear guide rail 5806, a connecting plate 5807, a stirring motor 5808, a stirring rod 5809, and a Z-axis stirring motor 5810. The stirring rod 5809 moves in both the X and Z directions and extends downwards into the reaction liquid in the Z-axis direction.

[0041] The X-axis stirring linear guide rail 5804 and the X-axis stirring synchronous belt 5803 are both mounted on the stirring base plate 5801;

[0042] The X-axis stirring motor 5802 is fixed on the stirring base plate 5801 and drives the X-axis stirring synchronous belt 5803.

[0043] The connecting plate 5807 is slidably mounted on the X-direction stirring linear guide rail 5804; the connecting plate 5807 is connected to the X-direction stirring synchronous belt 5803, and the connecting plate 5807 is driven by the X-direction stirring synchronous belt 5803 to move along the X direction;

[0044] Both the Z-axis stirring linear guide rail 5806 and the Z-axis stirring synchronous belt 5805 are mounted on the connecting plate 5807;

[0045] The Z-axis stirring motor 5810 is fixed on the connecting plate 5807 and drives the Z-axis stirring synchronous belt 5805.

[0046] The stirring motor 5808 is slidably mounted on the Z-direction stirring linear guide rail 5806; the stirring motor 5808 is connected to the Z-direction stirring synchronous belt 5805, and the stirring motor 5808 is driven by the Z-direction stirring synchronous belt 5805 to move along the Z direction;

[0047] The stirring rod 5809 is connected to the output end of the stirring motor 5808 and is driven to rotate by the stirring motor.

[0048] Furthermore, in the aforementioned multifunctional analyzer, the immunoassay cleaning module 55 includes: a fixing plate 5501, a cleaning cup holder drive motor 5502, a cleaning bracket 5503, a cleaning bracket timing belt 5504, a cleaning bracket drive motor 5505, a needle holder 5506, a cleaning needle 5507, a waste needle 5508, a cleaning cup holder moving guide rail 5509, a cleaning cup holder 5510, and a magnet mounting plate 551, wherein...

[0049] The fixing plate 5501 is fixedly installed on the base plate 11 of the frame 1;

[0050] The upper surface of the fixing plate 5501 is fixedly installed with the cleaning cup holder moving guide rail 5509, the cleaning bracket 5503, and the cleaning cup holder drive motor 5502;

[0051] The cup holder drive motor 5502 is fixed on the fixing plate 5501, and the output end of the cup holder drive motor 5502 is connected to the cup holder transmission structure.

[0052] The cup holder moving guide rail 5509 is fixed on the fixed plate 5501 and slidably connected to the cup holder 5510, providing a moving guide for the cup holder 5510.

[0053] The cleaning cup holder 5510 is slidably mounted on the cleaning cup holder moving guide rail 5509 and is driven to move along the guide rail by the cleaning cup holder drive motor 5502; a magnet mounting plate 5511 is fixedly mounted on the upper surface of the cleaning cup holder 5510 for accommodating the reaction cup.

[0054] Magnet mounting plate 5511 is fixed on cleaning cup holder 5510, and magnets are fixedly installed on the inside, corresponding to the reaction cups inside the cleaning cup holder 5510.

[0055] The cleaning bracket 5503 is fixed on the fixing plate 5501, and the cleaning bracket timing belt 5504 and the cleaning bracket drive motor 5505 are installed on it.

[0056] The cleaning bracket drive motor 5505 is fixed on the cleaning bracket 5503 and drives the cleaning bracket synchronous belt 5504 to rotate.

[0057] The cleaning bracket timing belt 5504 is mounted on the transmission mechanism of the cleaning bracket 5503 and connected to the needle holder 5506, driving the needle holder to move in the Z direction;

[0058] The needle holder 5506 is fixedly connected to the cleaning bracket synchronous belt 5504. The needle holder 5506 is driven by the cleaning bracket synchronous belt 5504 to move up and down in the Z direction. The cleaning needle 5507 and the waste removal needle 5508 are fixedly installed on the needle holder 5506.

[0059] The cleaning needle 5507 and the waste removal needle 5508 are both fixed on the needle holder 5506 and move synchronously in the Z direction with the needle holder.

[0060] Furthermore, in the aforementioned multifunctional analyzer, the immunoassay optical detection module 56 includes: an immunoassay base plate 5601, an immunoassay left side plate 5602, a photodetector 5603, a left light shield 5604, a substrate addition connector 5605, a light block 5606, a detection cup holder 5607, a right light shield 5608, an immunoassay right side plate 5609, and a linear module 5610, wherein...

[0061] The immunodetection base plate 5601 serves as the mounting base for the bottom of the module, and is fixedly connected to the left immunodetection left plate 5602 and the right immunodetection right plate 5609 to form the module frame.

[0062] The left side plate 5602 of the immunodetector is vertically fixed on the immunodetector base plate 5601. The left light shield 5604 and the photodetector 5603 are fixedly installed on the inside, and the photodetector is set to correspond to the detection window of the left light shield.

[0063] The right side plate 5609 of the immunodetection is vertically fixed on the immunodetection base plate 5601 and is arranged opposite to the left side plate 5602 of the immunodetection. The linear module 5610 is fixedly installed on the outer or inner side.

[0064] The left light-shielding box 5604 is fixed on the left side plate 5602 of the immunodetector and corresponds to the right light-shielding box 5608. Together they form a light-shielding detection space, and a light-transmitting detection window is provided at the position corresponding to the photodetector 5603.

[0065] The linear module 5610 is fixed on the right side plate 5609 of the immunoassay or the immunoassay base plate 5601, and its output end is fixedly connected to the right light shield 5608, driving the right light shield to reciprocate in the horizontal direction.

[0066] The light-shielding box 5608 is connected to the execution end of the linear module 5610. Driven by the linear module, it moves closer to or further away from the left light-shielding box 5604. When closed, it and the left light-shielding box together wrap around the detection cup holder 5607 to form a light-shielding environment.

[0067] The test cup holder 5607 is placed on the immunoassay base plate 5601, located between the left light shield box 5604 and the right light shield box 5608. It can be pushed into the test area of ​​the left light shield box by the right light shield box and is used to hold a single reaction cup.

[0068] The substrate addition connector 5605 is installed on the left light shield box 5604 and connected to the pipeline of the liquid system 8. Its outlet is aligned with the reaction cup in the detection cup holder 5607 for injecting luminescent substrate.

[0069] The light-blocking block 5606 is fixed at the corresponding position of the left light-blocking box 5604 or the detection area to fill the gap of the light-blocking structure, enhance the light-blocking effect, and avoid external stray light from interfering with the detection.

[0070] The photodetector 5603 is fixed on the left side plate 5602 of the immunoassay, with the detection end facing the detection window of the left light shield 5604, and is used to capture the light signal generated by the reaction between the luminescent substrate and the immune complex in the reaction cup.

[0071] Furthermore, in the aforementioned multifunctional analyzer, the biochemical detection module 5 also includes a clamping module 57. The clamping module 57 includes: a clamping mechanism Y-axis motor 5701, a clamping structure fixing plate 5702, a clamping mechanism Y-axis synchronous belt 5703, a clamping mechanism Y-axis guide rail 5704, a clamping structure X-axis motor 5705, a clamping structure X-axis synchronous belt 5706, a Z-axis linear module 5707, and a robotic arm 5708; wherein...

[0072] The clamping frame fixing plate 5702 serves as the mounting base for the entire clamping module. The clamping mechanism Y-axis guide rail 5704 and the clamping mechanism Y-axis synchronous belt 5703 are mounted on the clamping frame fixing plate 5702.

[0073] The clamping mechanism Y-axis motor 5701 is fixed on the clamping frame fixing plate 5702, driving the clamping mechanism Y-axis synchronous belt 5703;

[0074] The clamping structure X-axis motor 5705 and the clamping structure X-axis synchronous belt 5706 are mounted on the sliding part of the clamping mechanism Y-axis guide rail 5704 and move with the Y-axis.

[0075] The Z-axis linear module 5707 is connected to the X-axis synchronous belt 5706 of the clamping architecture and is driven to move along the X-axis by the X-axis synchronous belt;

[0076] The robotic arm 5708 is installed at the lower end of the Z-axis linear module 5707 and is driven to move up and down by the Z-axis linear module 5707.

[0077] Furthermore, in the aforementioned multifunctional analyzer, the reagent compartment 6 includes: a reagent carrier plate 6303, an immunoassay kit 6601 and a biochemical reagent kit 6602 disposed on the reagent carrier plate 6303, and a cooling mechanism 65 located below the reagent carrier plate 6303.

[0078] The cooling mechanism 65 includes: an air duct 6501, a lower heat sink 6502, an upper heat sink 6503, an upper cooling fan 6504, and a lower cooling fan 6505; the upper heat sink 6503 is connected to the cold end of the thermoelectric temperature control element; the lower heat sink 6502 is connected to the hot end of the thermoelectric temperature control element.

[0079] According to another aspect of the present invention, a detection and analysis method is also provided, characterized in that it employs a multifunctional analyzer as described in any of the preceding claims, the method comprising a software detection process, including:

[0080] S11: After the multi-function analyzer is started, log in to the software; after all initial actions are completed, the main interface of the software will be displayed, and subsequent operation permissions will be unlocked.

[0081] S12, Reagent Information Collection:

[0082] (1) Reagent barcode scanning and information collection: The reagent rack in the reagent compartment is used by operators to place the reagents into the reagent compartment according to the specifications. After the reagent rack is detected, the software of the multi-function analyzer automatically starts reagent barcode scanning and collects the core information of the reagents.

[0083] (2) Information storage: The software temporarily stores the scanned information in a data table;

[0084] S13: Sample information collection;

[0085] (1) Sample scanning and information entry: Place the sample tubes into the sample tube rack 59 in sequence, and manually push the sample tube rack 59 into the sample cart. During the pushing process, the software of the multi-functional analyzer scans the barcode information and temporarily stores the scanned information in a temporary database.

[0086] (2) Pre-allocation of testing process and reagent verification: The software of the multi-functional analyzer pre-processes the sample and allocates the testing modules in advance according to the biochemical or immunological type, detection principle and reagent requirements of the imported test items;

[0087] S14: Inspection process allocation;

[0088] The software of the multi-functional analyzer, combined with the characteristics of the testing items, enables intelligent planning and dynamic scheduling of the testing process:

[0089] The software of the multi-functional analyzer automatically analyzes the execution process, sample addition order, load type and reagent stability factors of each test item, dynamically adjusts the process order, avoids module resource conflicts, realizes parallel processing of multiple actions, and obtains and executes biochemical test process or immunoassay process.

[0090] S15: Data storage and processing;

[0091] After the biochemical or immunoassay testing process is completed, the multi-functional analyzer's software initiates a closed-loop data management process to ensure the accuracy and traceability of the results, while also meeting the requirements for system interaction.

[0092] (1) Result classification and saving: The software classifies and archives the test data into the corresponding result window according to the type of test item:

[0093] Immunization Project: Save relevant data to the immunization results window;

[0094] Biochemical Project: Save relevant data to the biochemical results window;

[0095] (2) Result viewing and confirmation: Allows operators to view detailed data in the corresponding result window, including the original signal curve, abnormal cause annotation, etc.;

[0096] (3) System synchronous reporting: Select the confirmed result and click the send button. Information including patient information, sample information, test items, result values, reference range, etc. will be synchronized to the hospital system through the network interface.

[0097] (4) Data archiving and traceability: All test data are archived and stored to meet the needs of clinical traceability and quality control.

[0098] Furthermore, the biochemical detection process in the above-mentioned detection and analysis methods includes:

[0099] S21, Instrument Preparation: After startup, the multi-function analyzer first performs a power-on self-test; the incubation system of the multi-function analyzer is preheated to the set temperature; the pipetting module of the multi-function analyzer is reset to the initial position to ensure the accuracy of the sample addition process and the normal working condition of the equipment.

[0100] S22, Sample addition: The reagent pipetting module and sample pipetting module of the multi-functional analyzer respectively draw the corresponding reagents and samples from the reagent compartment and sample tube rack. The drawn liquids are then accurately added to the cuvettes in the biochemical incubation chamber.

[0101] S23, Mixing: After the sample is added, the loading block of the biochemical reaction cup moves to the stirring station; the stirring rod rotates continuously driven by the stirring motor to fully stir the reaction liquid;

[0102] S24, Incubation: The mixed reaction solution will enter the incubation stage. The biochemical heater heats the incubation chamber and maintains a constant temperature.

[0103] S25, Optical Detection: After the reaction is complete, the cuvette is transferred to the optical detection station; the incident light emitted by the light source passes through the reaction liquid in the cuvette and is transmitted to the spectrometer; the optical detection device automatically collects the light intensity data of the transmitted light and transmits it to the multi-functional analyzer, which calculates the absorbance of the solution based on this data; using Lambert-Beer's law, the multi-functional analyzer converts the absorbance data into concentration information;

[0104] S26, Cleaning and Reset: After the test is completed, the reaction cup will be transferred to the cleaning station; the cleaning module will process the colorimetric cup, including waste removal, washing and drying.

[0105] Furthermore, the immunoassay process in the above-mentioned detection and analysis methods includes:

[0106] S31, Instrument initialization preparation: After the multi-function analyzer is powered on, the control system performs self-tests on each actuator, as well as verifies the effectiveness of reagents and consumables; after the preparation is completed, the system enters standby mode, waiting for the detection task to start.

[0107] S32, Sample and Reagent Loading: When the detection task is started, the reagent pipetting module and sample pipetting module of the multi-function analyzer respectively draw the corresponding reagents and samples from the reagent compartment and sample tube rack, and quantitatively distribute them into the reaction cups located on the reaction cup rack;

[0108] S33, Immunological reaction incubation: The heating element at the bottom of the reaction cup holder of the multi-functional analyzer is activated and enters the constant temperature control mode to heat the reaction cup and maintain the preset temperature range.

[0109] S34, Cleaning: After incubation, the clamping module of the multi-function analyzer transfers the reaction cup to the cleaning cup holder of the immunoassay cleaning module; the cleaning cup holder moves to the cleaning station under the action of the drive mechanism, and then the cleaning needle on the needle holder descends into the reaction cup;

[0110] S35, Chemiluminescence Detection: After cleaning, the clamping module of the multi-functional analyzer transfers the reaction cup to the detection cup holder of the immunofluorescence detection module; the moving module drives the detection cup holder to move into the light-shielding detection area; after reaching the detection station, the liquid system draws the substrate solution from the immunosubstrate vial in the consumable module and injects it into the reaction cup through the tubing and substrate addition connector to generate a light signal; the photodetector captures the light signal intensity in real time, and the control system calculates the concentration of the target substance through the signal processing model, where the luminescence intensity is positively correlated with the content of the target substance;

[0111] S36, Waste liquid extraction: After the test is completed, the clamping module transfers the reaction cup back to the cleaning cup of the immunoassay module; the waste extraction needle on the cleaning needle holder descends into the reaction cup and extracts the reaction residue and substrate waste liquid by suction, and then discards the reaction cup.

[0112] Compared with the prior art, the present invention has the following advantages:

[0113] (1) Achieving high integration of multiple technologies: This invention integrates biochemical analysis and immunoassay functions on the same platform, enabling joint detection of multiple parameters, reducing the number of equipment configurations, and optimizing the experimental process.

[0114] (2) Small space occupation and flexible deployment: The equipment has a compact structure, which can greatly reduce the laboratory floor space and is suitable for small and medium-sized hospitals, community clinics and primary medical institutions.

[0115] (3) Significantly reduce testing costs: The integrated architecture can effectively reduce equipment procurement and maintenance costs, while reducing the cost of single sample testing by reducing manual operation and reagent consumption.

[0116] (4) Improve testing efficiency and data management capabilities: The integrated automated process reduces sample transfer and manual operation, shortens the report issuance time, and can effectively reduce the human error rate.

[0117] (5) Promote the downward flow of medical resources: This invention is applicable to primary healthcare and remote diagnosis and treatment scenarios, and helps to improve the problems of "insufficient equipment, difficulty in testing, and high cost of medical treatment" in primary healthcare institutions, improve the balance of medical services and reduce the burden of medical insurance. Attached Figure Description

[0118] Figure 1 This is a schematic diagram of the module composition of an inspection and analysis instrument according to an embodiment of the present invention;

[0119] Figure 2 This is a schematic diagram of the main structure of an inspection and analysis instrument according to an embodiment of the present invention;

[0120] Figure 3 This is a schematic diagram of the frame structure of an experimental testing analyzer according to an embodiment of the present invention;

[0121] Figure 4 This is a schematic diagram of the consumable module of an inspection and analysis instrument according to an embodiment of the present invention;

[0122] Figure 5 This is a schematic diagram of the pipetting module of a test analyzer according to an embodiment of the present invention;

[0123] Figure 6 This is a schematic diagram of a biochemical detection module according to an embodiment of the present invention;

[0124] Figure 7 This is a schematic diagram of a biochemical cleaning module according to an embodiment of the present invention;

[0125] Figure 8 This is a schematic diagram of an immune detection module according to an embodiment of the present invention;

[0126] Figure 9 This is a schematic diagram of a biochemical stirring module according to an embodiment of the present invention;

[0127] Figure 10 This is a schematic diagram of an immune cleaning module according to an embodiment of the present invention;

[0128] Figure 11 This is a schematic diagram of an immune optical detection module according to an embodiment of the present invention;

[0129] Figure 12 This is a schematic diagram of the clamping module structure of an inspection and analysis instrument according to an embodiment of the present invention;

[0130] Figure 13 This is a schematic diagram of the reagent compartment cooling mechanism of a testing and analysis instrument according to an embodiment of the present invention;

[0131] Among them, 1-frame; 11-base plate; 12-left support plate; 13-upper support plate; 14-right support plate;

[0132] 3-Consumables module; 31-Consumables drawer; 32-Consumables drawer panel; 33-Round bottle; 34-Acid / alkali bottle; 35-Medical waste bin; 36-Consumables compartment door; 37-Consumables drawer slide; 38-Consumables connecting plate

[0133] 4-Pipeline module; 41-Reagent pipetting module; 42-Sample pipetting module; 4101-Pipeline X-axis; 4102-Reagent X-axis synchronization belt; 4103-Reagent needle; 4104-Pipeline Z-axis guide rail; 4105-Pipeline Z-axis synchronization belt; 4106-Pipeline X-axis slider; 4107-Pipeline Y-axis motor; 4108-Pipeline Y-axis; 4109-Slider; 4110-Pipeline Z-axis motor; 4111-Pipeline Y-axis synchronization belt; 4112-Pipeline Y-axis slider; 4201-Sample X-axis synchronization belt;

[0134] 5-Biochemical and immunoassay detection module; 51-Biochemical incubation module; 52-Biochemical cleaning module; 53-Biochemical optical detection module; 54-Immune incubation module; 55-Immune cleaning module; 56-Immune optical detection module; 57-Clamping module; 58-Stirring module; 59-Sample tube rack; 510-Reaction cup loading area; 5101-Reaction cup loading block drive motor; 5102-Cup loading block moving synchronous belt; 5103-Reaction cup loading block; 5104-Biochemical incubation chamber; 5105-Biochemical heating plate; 5201-Drying needle; 5202 - Waste removal needle; 5203 - Cleaning needle; 5204 - Needle fixing block; 5205 - Needle module motion timing belt; 5206 - Cleaning needle module drive motor; 5301 - Optical box; 5302 - Detection light source; 5401 - Reaction cup; 5402 - Reaction cup holder; 5501 - Fixing plate; 5502 - Cleaning cup holder drive motor; 5503 - Cleaning bracket; 5504 - Cleaning bracket timing belt; 5505 - Cleaning bracket drive motor; 5506 - Needle holder; 5507 - Cleaning needle; 5508 - Waste removal needle; 55 09-Cleaning cup holder moving guide rail; 5510-Cleaning cup holder; 5511-Magnet mounting plate; 5601-Immunodetection base plate; 5602-Immunodetection left side plate; 5603-Photodetector; 5604-Left light shield box; 5605-Substrate addition connector; 5606-Light blocking block; 5607-Detection cup holder; 5608-Right light shield box; 5609-Immunodetection right side plate; 5610-Linear module; 5701-Clamping mechanism Y-axis motor; 5702-Clamping frame fixing plate; 5703-Clamping mechanism Y-axis synchronous belt; 5704 - Clamping mechanism Y-axis guide rail; 5705 - Clamping structure X-axis motor; 5706 - Clamping structure X-axis synchronous belt; 5707 - Z-axis linear module; 5708 - Robotic arm; 5801 - Stirring base plate; 5802 - X-axis stirring movement motor; 5803 - X-axis stirring synchronous belt; 5804 - X-axis stirring linear guide rail; 5805 - Z-axis stirring synchronous belt; 5806 - Z-axis stirring linear guide rail; 5807 - Connecting plate; 5808 - Stirring motor; 5809 - Stirring rod; 5810 - Z-axis stirring movement motor;

[0135] 6-Reagent compartment; 6501-Air duct; 6502-Lower heat sink; 6503-Upper heat sink; 6504-Upper cooling fan; 6505-Lower cooling fan; 6601-Immunoassay kit; 6602-Biochemical kit. Detailed Implementation

[0136] The present invention will now be described in further detail with reference to the accompanying drawings.

[0137] Biochemical analyzers and immunoassay analyzers are two widely used types of testing equipment in the field of in vitro diagnostics, playing a crucial role in clinical diagnosis, disease monitoring, and public health control. Current biochemical analyzers generally use photoelectric colorimetry to quantitatively analyze specific chemical components in body fluids. Common indicators include transaminases, hemoglobin, albumin, total protein, cholesterol, creatinine, glucose, inorganic phosphorus, amylase, and calcium. These indicators reflect important physiological information such as human metabolic function, organ damage, and nutritional status. Immunoassay analyzers, based on the principle of antigen-antibody specific binding, detect immune-related components in body fluids such as antibodies, antigens, hormones, and tumor markers. They often employ high-sensitivity detection methods such as chemiluminescence and radioimmunoassay, and are widely used in clinical fields such as infectious disease detection, autoimmune disease assessment, endocrine disease monitoring, and tumor screening.

[0138] However, most existing medium and large-sized hospitals rely on two separate sets of equipment for biochemical and immunological analysis, which results in low testing efficiency, significant sample waste, and high operating costs. The main reasons for this are as follows:

[0139] (1) Biochemical and immunoassay detection require system initialization, calibration, sample loading and data management, which increases the workload and operational complexity of the laboratory.

[0140] (2) The simultaneous operation of the two sets of equipment will not only occupy a large amount of laboratory space, but also increase the turnover and testing time of samples, which cannot meet the needs of emergency and large-scale testing.

[0141] (3) The current clinical testing process is: clinical ordering - sample collection (multiple tubes) - sample transportation and distribution - testing - report generation. This process often takes 2-8 hours to complete. However, due to the lack of clinical medical staff with experience in the laboratory, there is often a problem: indicators that can be tested using the same testing method can be tested with one sample (such as liver and kidney function and alkaline phosphatase), which requires the collection of multiple tubes of blood or urine. However, in practice, not so many samples can be used, resulting in a waste of samples, time, consumables and manpower costs.

[0142] To address the problem of low testing efficiency, integrated in vitro diagnostic (IVD) automated systems can be employed. IVD automated systems are highly automated testing systems in medical laboratories, significantly improving efficiency and accuracy, and are core equipment in the IVD field. They are mainly divided into Total Laboratory Automation (TLA) systems and Task Target Automation (TTA) systems: TLA: Comprehensive functions, suitable for large hospitals, enabling full automation of sample processing, analysis, and storage. TTA: More flexible and economical, suitable for hospitals with smaller sample volumes, but typically only includes core modules such as centrifugation and cap opening, lacking intelligent sample processing capabilities. Because neither of these systems considers integration with clinical sample collection scenarios, sample allocation requires prior sampling based on clinical needs, followed by sample processing and allocation. This fails to address the problem of excessive sample extraction and waste, further contributing to low testing efficiency and prolonged report generation time. Moreover, both systems suffer from drawbacks such as large size, high procurement costs, and high maintenance difficulty.

[0143] Therefore, this invention, through optimized design, overcomes the limitations of existing detection methods and constructs a detection device that, while ensuring detection accuracy and reliability, achieves a high degree of integration of biochemical and immunological detection, is compact and miniaturized, and operates at low cost. This device aims to meet the testing needs of primary healthcare institutions and improve the accessibility of medical services. Specifically:

[0144] First, this invention improves the testing model by achieving the above-mentioned goals through efficient sample management and testing. Traditional testing involves drawing multiple tubes of blood or urine, or other bodily fluid samples, based on indicators, and then allocating them to relevant equipment in the laboratory according to the testing method. However, with the development of testing technology, biochemical and chemiluminescence immunoassays only require small amounts of sample (a few microliters). Therefore, the product designed in this invention draws 1-2 tubes of blood (approximately 10ml) according to clinical needs; these blood or other bodily fluid samples become the sample pool for testing. Then, based on the testing requirements transmitted from the clinic, the core control software in our designed equipment pre-designs the optimal testing process (since the testing requirements for each wave are different, theoretically each wave has an optimal testing process; the software designed in this invention inputs the single-time testing process for various indicators into the background database in advance, and the software can then design the optimal testing process according to actual needs). It automatically draws samples from the sample pool, uses an intelligent software-designed process, and allocates samples to different subsystems based on the testing time difference of different indicators, then completes the testing and generates a report. With this optimized testing process, completing a patient's test takes only about half an hour, a significant improvement in efficiency. However, realizing this goal requires the coordinated design of various software and hardware components.

[0145] Specifically as follows:

[0146] First, the instrument is equipped with a high-performance intelligent software system and an adaptive task allocation and scheduling algorithm. The intelligent software scheduling system utilizes machine reinforcement learning and big data analysis to optimize task allocation and scheduling, automatically adjusting task priority and resource allocation in dynamic environments to improve overall operational efficiency. The deep learning-based scheduling algorithm is the core of task allocation, involving how to optimally allocate tasks under limited resources. The software of this invention dynamically adjusts the task allocation strategy based on the current resource status and task requirements, optimizing resource usage in real time when the workload changes to avoid overload or resource waste. In this system, the software can intelligently allocate blood sample resources according to the detection characteristics and task requirements of different samples, thereby improving processing efficiency and accuracy.

[0147] The software system communicates with various functional modules in real time through the main control board to achieve overall machine operation scheduling, process management, and data processing. The software system includes modules for instrument control and scheduling, data acquisition and analysis, quality control and calibration management, security and access control, and a user interface system.

[0148] The instrument control and scheduling module coordinates the operational logic of key components such as the reagent pipetting module, sample pipetting module, biochemical incubation module, biochemical optical detection module, cleaning module, and stirring mechanism. Its core functions include: task allocation (the software system automatically generates detection tasks and detection processes based on actual needs); and action sequence scheduling and time slice management (automatically optimizing the work queues of each module to parallelize pipetting, stirring, incubation, detection, and cleaning actions, improving detection efficiency). The instrument control and scheduling module optimizes the detection process and significantly shortens detection time.

[0149] The software system has the following advantages:

[0150] (1) Intelligent task allocation and scheduling significantly improve the efficiency of high-throughput operation;

[0151] Through multi-threaded scheduling and resource priority management, the processes of pipetting, stirring, incubation, detection and cleaning can be parallelized, which greatly reduces detection time and increases the detection throughput per hour.

[0152] (2) Highly modular and highly scalable;

[0153] The software architecture adopts a modular design, supporting upgrades and expansions.

[0154] (3) User-friendly human-computer interaction reduces the risk of misoperation;

[0155] The interface is intuitive and supports error prompts and intelligent operation path recommendations, effectively reducing human error.

[0156] The software system of this invention, as a crucial component of the entire instrument, achieves a comprehensive improvement in the automation, stability, and clinical reliability of in vitro diagnostic instruments through intelligent scheduling and precise data analysis algorithms. The introduction of the software system not only enhances the overall performance of the equipment but also significantly optimizes the user experience, providing a solid guarantee for the long-term stable operation of the instrument in scenarios such as clinical laboratories and biochemical and immunological laboratories.

[0157] Secondly, in order to facilitate the improvement of the testing mode and the operation of the software system, and in order to meet the requirements of primary healthcare institutions for miniaturization and low cost, this invention has made targeted designs for the hardware system.

[0158] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that the following embodiments are intended to help those skilled in the art better understand the structure and working principle of the present invention, and are not intended to limit the scope of protection of the present invention. Those skilled in the art can make equivalent substitutions or appropriate adjustments to the structural forms, material selections, and process details in the embodiments without departing from the spirit and substance of the present invention. In some cases, to avoid redundant obscuring of the core innovative points of the present invention, this specification does not describe some conventional operations or components in detail, but those skilled in the art can supplement and implement them based on common knowledge in the art.

[0159] like Figure 1 and Figure 2 As shown in the figure, this embodiment provides a test analyzer. The overall structure of the device includes: a frame 1, a consumable module 3, a pipetting module 4, a detection module 5, a reagent compartment 6, an electrical module 7, a liquid circuit module 8, a housing (not shown in the figure), and a computer control terminal.

[0160] The frame 1 serves as the base for the entire machine installation. The consumable module 3, pipetting module 4, detection module 5, reagent compartment 6, electrical module 7, and fluid circuit module 8 are all directly fixedly installed on the frame 1.

[0161] The pipetting module 4 is mounted on the upper part of the frame 1, above the detection module 5 and the reagent compartment 6, and can move in multiple axes under the control of the electrical module 7;

[0162] Electrical module 7 is electrically connected to pipetting module 4, detection module 5, reagent compartment 6, and liquid circuit module 8 respectively, providing power supply and motion control signals to each module;

[0163] The liquid circuit module 8 is connected to the consumable module 3, the liquid transfer module 4, and the detection module 5 through pipelines to realize the transportation and discharge of cleaning fluid, substrate, and waste liquid;

[0164] The outer casing is installed outside the frame 1, enclosing the consumable module 3, pipetting module 4, detection module 5, reagent compartment 6, electrical module 7, and liquid circuit module 8, serving as a protective and dustproof function;

[0165] The computer control terminal is connected to the electrical module 7 to enable the issuance of instructions, process scheduling, data acquisition and result output for the whole machine.

[0166] When the multi-functional analyzer is working, the computer control terminal coordinates the operation of each module through the electrical module 7. Specifically: the reagent compartment 6 provides temperature-controlled reagents, and the consumable module 3 provides the liquids required for testing and waste liquid collection; driven by the electrical module 7, the pipetting module 4 draws reagents from the reagent compartment 6 and samples from the sample rack 59 of the detection module 5, accurately distributing them to the detection module 5; the liquid path module 8 independently completes the delivery of cleaning solution and substrate and the treatment of waste liquid; after the detection module 5 completes the reaction, incubation, cleaning, and optical detection, it transmits the detection signal back to the electrical module 7, and finally the computer control terminal completes the data processing and result output, realizing fully automated detection.

[0167] The liquid circuit module 8 independently delivers the cleaning solution, which is located in the consumable module 3 (acid and alkali bottle 33). The liquid circuit module 8 uses its own pump, valve and tubing to deliver the cleaning solution directly to the needle cleaning mechanism of the pipetting module 4, the biochemical cleaning module 52 and the immunoassay cleaning module 55, without passing through the sample needle or reagent needle. This is called independent delivery.

[0168] Liquid path module 8 independently delivers the substrate (luminescent liquid). The substrate is present in consumable module 3 (immunosubstrate vial 34). Liquid path module 8 uses its own pump and tubing to deliver the substrate directly to the immunooptical detection module 56 of detection module 5, without passing through any needles in pipetting module 4. This is also an independent delivery.

[0169] The fluid path module 8 independently processes waste liquid from the needle cleaning tank, the biochemical cleaning module 52 and the immunoassay cleaning module 55 of the detection module 5. The fluid path module 8 uses its own suction pump and tubing to directly draw the waste liquid into the medical waste bin 35 of the consumables module 3, without passing through the pipetting module 4, and still processes it independently.

[0170] The frame 1 serves as the main load-bearing structure of this equipment, supporting and positioning the various functional modules while providing sufficient rigidity and mechanical stability to ensure long-term stable operation. In this embodiment, the frame 1 adopts a high-strength metal frame structure, possessing excellent seismic resistance and resistance to external interference. The metal frame design not only enhances the overall mechanical reliability of the system but also effectively extends the service life of the equipment in complex environments.

[0171] Consumables module 3 is mainly used to store various consumables and waste related to testing, including but not limited to reaction acid and alkali containers, cleaning solution containers, and medical waste bins 35. This module features a pull-out design, facilitating quick replacement and regular maintenance by operators. Furthermore, the module design considers safety and convenience, equipped with a dedicated waste container to ensure the safe disposal of waste liquids and used reagents, avoiding the risk of cross-contamination or leakage.

[0172] Module 5 is the core functional unit of this device, responsible for performing a series of operations including the aspiration, addition, mixing, incubation, detection, cleaning, and pipette cleaning of biochemical and immunological reagents. This module adopts an integrated automated design, allowing for adaptive configuration of different operating procedures according to different testing items, thus providing flexible testing solutions to meet diverse clinical needs. The modular design enables the device to quickly switch between different reagents and operating procedures, improving testing efficiency and flexibility, and ensuring rapid response to different testing requirements.

[0173] Reagent compartment 6 is used to store reagent kits and is equipped with a temperature control unit to ensure that reagents are stored under suitable temperature conditions. The compartment is designed with temperature control requirements in mind, employing efficient refrigeration technology to maintain reagents at low temperatures, ensuring their stability and accuracy during use. An intelligent monitoring system is also installed inside the compartment to monitor and automatically adjust the storage temperature in real time, ensuring that reagents used in each experiment are in optimal condition.

[0174] Electrical module 7 includes a motherboard, a drive unit, and communication components.

[0175] The pipetting module 4 and the liquid path module 8 together constitute the instrument's pipetting system, responsible for the precise aspiration, transport, mixing, and dispensing of samples, reagents, and cleaning solutions. This system employs multi-axis linkage technology and closed-loop control technology to ensure that the accuracy and repeatability of all operations throughout the liquid handling process meet industry standards. The liquid path module 8 is designed to prevent cross-contamination, achieving precise dispensing and effective control of each liquid through strict isolation and unidirectional fluid design, ensuring that each sample addition meets experimental requirements. The computer control unit is the instrument's "operational center," realizing full-process algorithm control, detection task management, data acquisition, and analysis functions. Through an intuitive graphical user interface, operators can quickly configure detection tasks, monitor equipment status, view test results, and perform data analysis. The system supports generating test reports and can upload results to hospital information systems or laboratory information management systems for archiving, depending on user needs.

[0176] The liquid circuit module 8 mainly consists of pumps, valves, connectors, and pipelines, which are fixed to the frame by a liquid circuit mounting plate. The main functions of the liquid circuit module include: transfer of reaction media, cleaning of components, and collection and discharge of waste liquid, including the extraction and discharge of waste liquid, ensuring that waste liquid does not contaminate the system during operation.

[0177] like Figure 3 As shown, the frame 1 mainly includes a base plate 11, a left support plate 12, an upper support plate 13, and a right support plate 14. The base plate 11 is used to fix functional modules such as the consumable module 3, the bioassay module 5, and the reagent compartment 6, and provides sufficient load-bearing capacity and vibration damping performance. A pipetting X-axis 4101 is set between the left support plate 12 and the right support plate 14 to support the movement of the pipetting module 4 along the X-axis direction. The upper support plate 13 is located between the left support plate 12 and the right support plate 14, and a reagent pipetting X-axis synchronous belt 4102 and a sample pipetting X-axis synchronous belt 4201 are installed on it to drive the reagent pipetting module 41 and the sample pipetting module 42 to move along the X-axis direction, respectively. Through the coordinated control of the above-mentioned optical axis, synchronous belt, and motor drive, high-speed positioning movement can be achieved, thereby shortening the operation time and improving the pipetting accuracy. In addition, the back of the upper support plate 13 is used to fix the electrical module 7 and the liquid circuit module 8, optimizing the internal structural layout and providing more efficient maintenance space. The lower parts of the reagent pipetting module 41 and the sample pipetting module 42 are respectively fitted onto the pipetting X-axis 4101. The lower parts of the reagent pipetting module 41 and the sample pipetting module 42 are respectively connected to the reagent pipetting X-axis synchronization belt 4102 and the sample pipetting X-axis synchronization belt 4201. The reagent pipetting X-axis synchronization belt 4102 and the sample pipetting X-axis synchronization belt 4201 carry the reagent pipetting module 41 and the sample pipetting module 42 to move on the pipetting X-axis 4101.

[0178] like Figure 1 and Figure 4As shown, the consumable module 3 is located below the biochemical and immunoassay detection module 5 and is fixed to the frame 1 via the consumable connection plate 38. This module adopts a drawer-type structure for easy and quick replacement and maintenance of consumables. The consumable drawer 31 is a thin-walled box with an open top, on which a consumable drawer plate 32 is installed. The drawer plate 32 has through holes that match the shape of the containers it holds, for accommodating containers such as acid / alkali bottles 33, substrate bottles 34, and medical waste bins 35. The consumable drawer slide rails 37 are connected to both the consumable drawer 31 and the consumable connection plate 38. Operators can pull the drawer using the handle of the consumable door 36 to achieve quick replacement and maintenance of consumables, thereby improving the convenience of system maintenance.

[0179] The sample pipetting module 42 (sample arm) of the pipetting module 4 draws samples from the sample rack 59, and the reagent pipetting module 41 (reagent arm) of the pipetting module 4 draws the corresponding reagents from the reagent compartment 6. Under the control of the electrical module 7, the pipetting module 4 accurately adds the samples and reagents to the reaction cup of the detection module 5 through the liquid path module 8. The cleaning agent is not delivered to the biochemical cleaning module 52 and the immunoassay cleaning module 55 by the pipetting module 4, but is directly delivered to the biochemical cleaning module 52 and the immunoassay cleaning module 55 of the detection module 5 by the liquid path module 8.

[0180] Here, as Figure 3 and Figure 5As shown, the main function of the pipetting module 4 is to draw a specified liquid from the reagent compartment 6 or the sample tube rack 59 and accurately add it to the preset reaction cup of the detection module 5 to complete the biochemical or immunoassay process. The pipetting module 4 includes a reagent pipetting module 41 and a sample pipetting module 42, which are basically the same in mechanical structure and driving method. Therefore, the reagent pipetting module 41 is used as an example for explanation. The reagent pipetting module 41 adopts a three-axis linkage structure design to achieve high-precision movement of the pipetting needle in the X, Y, and Z directions. The pipetting X-axis slider 4106 is mounted on the pipetting X-axis 4101 located between the left support plate 12 and the right support plate 14. It is driven by the pipetting X-axis motor (not shown in the figure) and the reagent X-axis synchronous belt 4102 to achieve linear movement of the reagent needle along the X-axis direction. A Y-axis pipetting mechanism 4108 is positioned between the X-axis slider 4106 and the Y-axis slider 4112. A slider 4109 is mounted on the Y-axis pipetting mechanism 4108 to fix and drive the reagent needle 4103. A Y-axis motor 4107 drives a Y-axis timing belt 4111, causing the reagent needle 4103 to move along the Y-axis, thus addressing different target positions. In the Z-axis direction, the reagent needle 4103 and its driving mechanism are integrated on the slider 4109. The Z-axis timing belt 4105, driven by the Z-axis motor 4110, drives the reagent needle 4103 to move up and down along the Z-axis guide rail 4104, thereby completing reagent aspiration and sample addition operations. This embodiment, through three-axis coordinated control, can achieve high-precision positioning, repeatable sample addition, and flexible path planning, meeting the requirements for sample addition speed, volume accuracy, and positional accuracy in biochemical and immunological detection. In addition, to ensure the reliability of the sample addition process, the pipetting module can be equipped with a liquid level detection device, a needle tip anti-collision function, and a mixing and oscillation function to reduce the risk of air intake, cross-contamination, and sample addition deviation.

[0181] Here, the two ends of the pipetting X-axis 4101 are connected to the left support plate 12 and the right support plate 14, respectively;

[0182] The pipetting X-axis slider 4106 is slidably mounted on the pipetting X-axis 4101, and the pipetting X-axis slider 4106 is driven by the pipetting X-axis motor and the pipetting X-axis synchronous belt 4102;

[0183] One end of the pipetting Y-axis 4108 is fixed on the pipetting X-axis slider 4106, the pipetting Y-axis 4108 is slidably connected to the pipetting Y-axis slider 4112, and the pipetting Y-axis 4108 is slidably connected to the slider 4109;

[0184] The Y-axis motor 4107 is fixed on the X-axis slide block 4106 or the Y-axis slide block 4108.

[0185] The Y-axis motor 4107 drives the Y-axis timing belt 4111, which connects to and drives the slider 4109 to move along the Y-axis.

[0186] Slider 4109 is slidably mounted on the Y-axis 4108 of the pipetting system. Slider 4109 is integrated into the mounting.

[0187] The device comprises a reagent needle 4103, a Z-axis pipetting guide rail 4104, a Z-axis pipetting timing belt 4105, and a Z-axis pipetting motor 4110; wherein, the Z-axis pipetting guide rail 4104 is fixed on the slider 4109, and the Z-axis pipetting guide rail 4104 is slidably connected to the mounting base of the reagent needle 4103; the Z-axis pipetting motor 4110 is fixed on the slider 4109.

[0188] The Z-axis synchronous belt 4105 drives the pipetting, and the Z-axis synchronous belt 4105 connects to and drives the reagent needle 4103 to move up and down along the Z-axis. The reagent needle 4103 is installed on the Z-axis mechanism inside the slider 4109. The reagent needle 4103 is driven by the Z-axis synchronous belt 4105 and moves up and down along the Z-axis guide rail 4104.

[0189] Specifically, the connection sequence here is: left / right support plate → pipetting X-axis 4101 → pipetting X-axis slider 4106 → pipetting Y-axis 4108 → slider 4109 → Z-axis guide rail / synchronous belt / Z-axis motor → reagent needle 4103.

[0190] The biochemical detection module 5 includes an incubation module 51, a cleaning module 52, an optical detection module 53, and a stirring module 58. These modules constitute the core unit of the biochemical detection function of this equipment.

[0191] like Figure 6 As shown, the biochemical incubation module 51 consists of a biochemical reaction cup loading block drive motor 5101, a cup-carrying block moving synchronous belt 5102, a biochemical reaction cup loading block 5103, a biochemical incubation chamber 5104, and a biochemical heating plate 5105. The biochemical incubation chamber 5104 is a reaction cavity formed by assembling metal plates, with the outer surface covered by the biochemical heating plate 5105 to provide a constant temperature environment. The top and sides of the biochemical incubation chamber 5104 have channel-type openings for pipetting, stirring, optical detection, and cleaning operations, avoiding heat loss caused by frequent opening and closing of the structure. The reaction cup loading block 5103 is arranged inside the incubation chamber and is driven by the biochemical reaction cup loading block drive motor 5101 and the cup-carrying block moving synchronous belt 5102, allowing it to move along the Y-axis to different working positions, thus enabling rapid switching between incubation, detection, and cleaning stations.

[0192] like Figure 7 As shown, the biochemical cleaning module 52 mainly includes a needle module (including a drying needle 5201, a waste extraction needle 5202, a cleaning needle 5203, and a needle fixing block 5204), a needle module motion synchronization belt 5205, and a cleaning needle module drive motor 5206. The biochemical cleaning module 52 adopts a multi-needle parallel cleaning structure, enabling efficient waste liquid extraction, reaction cup rinsing, and drying operations. By performing waste extraction, rinsing, and drying in steps, this module effectively avoids liquid residue and cross-contamination, enabling the recycling of cuvettes, reducing consumable costs, and improving detection efficiency.

[0193] The biochemical optical detection module 53 mainly includes a spectrometer 5301 and a light source 5302, used to measure the absorbance of the reaction solution in the cuvette. The incident light emitted by the light source 5302 is transmitted through the outer aperture of the biochemical incubation chamber 5104 and the cuvette, and is then received and analyzed by the spectrometer 5301. The concentration of the target analyte is calculated according to the Lambert-Beer law. This biochemical optical detection module 53 has functions such as automatic light intensity compensation, background noise calibration, and multi-wavelength scanning, and can adapt to the detection needs of various biochemical indicators.

[0194] like Figure 9 As shown, the stirring module 58 includes: a stirring base plate 5801, an X-axis stirring motor 5802, an X-axis stirring synchronous belt 5803, an X-axis stirring linear guide rail 5804, a Z-axis stirring synchronous belt 5805, a Z-axis stirring linear guide rail 5806, a connecting plate 5807, a stirring motor 5808, a stirring rod 5809, and a Z-axis stirring motor 5810. The stirring rod 5809 can move in both the X and Z directions and can extend downwards into the reaction liquid in the Z-axis direction. During operation, the stirring motor drives the stirring rod to rotate at high speed, achieving thorough mixing of the reaction liquid. The stirring method in this embodiment can effectively accelerate the reaction rate and improve detection sensitivity and repeatability.

[0195] The X-axis stirring linear guide rail 5804 and the X-axis stirring synchronous belt 5803 are both mounted on the stirring base plate 5801;

[0196] The X-axis stirring motor 5802 is fixed on the stirring base plate 5801 and drives the X-axis stirring synchronous belt 5803.

[0197] The connecting plate 5807 is slidably mounted on the X-direction stirring linear guide rail 5804; the connecting plate 5807 is connected to the X-direction stirring synchronous belt 5803, and the connecting plate 5807 is driven by the X-direction stirring synchronous belt 5803 to move along the X direction;

[0198] Both the Z-axis stirring linear guide rail 5806 and the Z-axis stirring synchronous belt 5805 are mounted on the connecting plate 5807;

[0199] The Z-axis stirring motor 5810 is fixed on the connecting plate 5807 and drives the Z-axis stirring synchronous belt 5805.

[0200] The stirring motor 5808 is slidably mounted on the Z-direction stirring linear guide rail 5806; the stirring motor 5808 is connected to the Z-direction stirring synchronous belt 5805, and the stirring motor 5808 is driven by the Z-direction stirring synchronous belt 5805 to move along the Z direction;

[0201] The stirring rod 5809 is connected to the output end of the stirring motor 5808 and is driven to rotate by the stirring motor.

[0202] The software testing process is as follows:

[0203] S11: Instrument preparation;

[0204] After the multi-functional analyzer is started, log in to the software; after all initial actions are completed, the main interface of the software will be displayed, and subsequent operation permissions will be unlocked.

[0205] S12: Reagent Information Collection;

[0206] (1) Reagent barcode scanning and information collection: The operator puts the reagent kit into the reagent rack in reagent compartment 6 according to the specifications. After the instrument detects the reagent rack, the multi-function analyzer software automatically starts the reagent barcode scanning and collects the core information of the reagent.

[0207] (2) Information storage: The software temporarily stores the scanned information in a data table;

[0208] S13: Sample information collection;

[0209] (1) Sample scanning and information entry: Place the sample tubes into the sample tube rack 59 in sequence, and manually push the sample tube rack 59 into the sample cart. During the pushing process, the software of the multi-functional analyzer scans the barcode information and temporarily stores the scanned information in a temporary database;

[0210] (2) Pre-allocation of testing process and reagent verification: The multi-functional analyzer software pre-processes samples and allocates testing modules in advance according to the imported test item type (biochemistry / immunology), test principle and reagent requirements;

[0211] S14: Inspection process allocation;

[0212] The software of the multi-functional analyzer combines the characteristics of the test items (item type, response time, module load) to intelligently plan and dynamically schedule the inspection process:

[0213] The core logic of the scheduling algorithm is as follows: The software automatically analyzes factors such as the execution flow, sample addition order, load type, and reagent stability of each test item, dynamically adjusts the flow order, avoids module resource conflicts (such as the reagent arm being the reagent pipetting module 41 and the sample arm being the sample pipetting module 42), and realizes parallel processing of multiple actions to obtain and execute biochemical or immunoassay test flows. For example, the biochemical test ALT (incubation for 10 minutes) and the immunoassay test TSH (incubation for 20 minutes) can be started simultaneously for sample addition. After the ALT test is completed, if the TSH test is still in the incubation stage, the software can continue to test other biochemical tests to improve efficiency.

[0214] S15: Data storage and processing;

[0215] After the biochemical or immunoassay testing process is completed, the software initiates a closed-loop data management process to ensure the accuracy and traceability of the results, while also meeting the requirements for system interaction.

[0216] (1) Result classification and saving: The software classifies and archives the test data into the corresponding result window according to the type of test item:

[0217] ① Immunization tests (such as TSH, CEA): Save the relevant data to the "Immunization Results" window;

[0218] ② Biochemical tests (such as ALT, GLU): Save the relevant data to the "Biochemical Results" window;

[0219] (2) Result viewing and confirmation: Operators can view detailed data in the corresponding result window, including the original signal curve, abnormal cause annotation, etc.;

[0220] (3) System synchronous reporting: Select the confirmed result and click the "send" button. The information, including patient information, sample information, test items, result values, reference range, etc., will be synchronized to the hospital system through the network interface.

[0221] (4) Data archiving and traceability: All test data (including result data, test reports, etc.) are archived and stored to meet the needs of clinical traceability and quality control.

[0222] The biochemical testing process is as follows:

[0223] S21: Instrument preparation;

[0224] After startup, the system first performs a self-test. Next, the incubation system preheats to the set temperature. The pipetting module then resets to its initial position to ensure the accuracy of the sample addition process and the normal operating status of the equipment.

[0225] S22: Sample addition;

[0226] The reagent pipetting module 41 and sample pipetting module 42 respectively draw the corresponding reagents and samples from the reagent compartment 6 and sample tube rack 59. The drawn liquids are then accurately added to cuvettes in the biochemical incubation chamber 5104. The precise operation of the reagent pipetting module and sample pipetting module ensures the efficiency and accuracy of the sample addition process and avoids cross-contamination of liquids.

[0227] S23: Mix well;

[0228] After the sample is added, the biochemical reaction vessel loading block 5103 will move to the stirring station. At this time, the stirring rod 5809 will continue to rotate under the drive of the stirring motor 5808, thoroughly stirring the reaction solution.

[0229] S24: Warming;

[0230] After mixing, the reaction solution will enter the incubation stage. The biochemical heater 5105 heats the incubation chamber 5104 and maintains a constant temperature. The incubation process is a key step in the biochemical reaction, and precise temperature control helps to avoid experimental errors caused by temperature fluctuations.

[0231] S25: Optical inspection;

[0232] After the reaction is complete, the cuvette is transferred to the optical detection station. At this point, the incident light emitted by the light source 5302 passes through the reaction solution in the cuvette and is transmitted to the spectrophotometer 5301. The optical detection device automatically collects the intensity data of the transmitted light and transmits it to the system. The system calculates the absorbance of the solution based on this data. Using Lambert-Beer's law, the system can convert the absorbance data into concentration information, achieving high-precision detection of the target substance.

[0233] S26: Cleaning and resetting;

[0234] After testing, the reaction cups are transferred to the cleaning station. The cleaning module 52 processes the cuvettes, including waste removal, washing, and drying. This cleaning process not only extends the equipment's lifespan but also improves testing efficiency and saves on consumable costs. At this point, the biochemical testing process is complete, and the equipment will automatically reset and be ready for the next test.

[0235] The main components of the immunoassay module 5 include: immunoincubation module 54, immunowashing module 55, immunooptical detection module 56, and clamping module 57. These modules work together to automate the entire immunoassay process, from reaction, washing, detection, and waste disposal.

[0236] The immune incubation module 54 is used to incubate the immune reaction system. It mainly consists of a reaction cup holder 5402 and a heater (not shown in the figure) located at its bottom. The reaction cup holder 5402 holds multiple reaction cups and has insulation cotton attached to its outside to improve heating efficiency and reduce heat loss. After incubation, the reaction cups are removed from the reaction cup holder by a clamping device and transferred to the immune washing module.

[0237] like Figure 10 As shown, the immunoassay cleaning module 55 is used to clean the reaction solution and extract waste liquid after luminescence detection. Its structure and function are as follows: The immunoassay cleaning module 55 includes: a fixing plate 5501; a cleaning cup holder drive motor 5502; a cleaning support 5503; a cleaning support timing belt 5504; a cleaning support drive motor 5505; a needle holder 5506; a cleaning needle 5507; a waste extraction needle 5508; a cleaning cup holder moving guide rail 5509; a cleaning cup holder 5510; and a magnet mounting plate 5511. The immunoassay cleaning module 55 is mounted on the base plate 11 of the frame 1 via the fixing plate 5501. The fixing plate 5501 is provided with the cleaning cup holder moving guide rail 5509. The cleaning cup holder 5510 is driven by the cleaning cup holder drive motor 5502 and can move linearly along the guide rail, thereby switching between multiple workstations. The cleaning cup holder 5510 is used to accommodate multiple reaction cups, and the cup holder is provided with a magnet mounting plate 5511. Magnets are installed on the inner side of the magnet mounting plate 5511. During the cleaning process, the magnets are in close contact with the reaction cup, thereby fixing the magnetic particles, preventing particle loss, and improving cleaning efficiency. A cleaning bracket 5503 is also installed on the mounting plate 5501. The cleaning bracket 5503 is equipped with a synchronous belt 5504 and a drive motor 5505, and is connected to a needle holder 5506. The needle holder 5506 completes Z-axis movement under the drive of the motor and synchronous belt. Through the above structure, the reaction cup can be efficiently processed at multiple stations such as cleaning and waste removal.

[0238] Here, the fixing plate 5501 is fixedly installed on the base plate 11 of the frame 1, providing the installation foundation for the entire module;

[0239] The upper surface of the fixing plate 5501 is fixedly installed with the cleaning cup holder moving guide rail 5509, the cleaning bracket 5503, and the cleaning cup holder drive motor 5502;

[0240] The cup holder drive motor 5502 is fixed on the fixed plate 5501, and the output end of the cup holder drive motor 5502 is connected to the cup holder transmission structure (implied, driving the cup holder to move).

[0241] The cup holder moving guide rail 5509 is fixed on the fixed plate 5501 and slidably connected to the cup holder 5510, providing a moving guide for the cup holder 5510.

[0242] The cleaning cup holder 5510 is slidably mounted on the cleaning cup holder moving guide rail 5509 and is driven to move along the guide rail by the cleaning cup holder drive motor 5502; a magnet mounting plate 5511 is fixedly mounted on the upper surface of the cleaning cup holder 5510 for accommodating the reaction cup.

[0243] Magnet mounting plate 5511 is fixed on cleaning cup holder 5510, and magnets (hidden components) are fixedly installed on the inside, corresponding to the reaction cups inside the cleaning cup holder 5510;

[0244] The cleaning bracket 5503 is fixed on the fixing plate 5501, and the cleaning bracket timing belt 5504 and the cleaning bracket drive motor 5505 are installed on it.

[0245] The cleaning bracket drive motor 5505 is fixed on the cleaning bracket 5503 and drives the cleaning bracket synchronous belt 5504 to rotate.

[0246] The cleaning bracket timing belt 5504 is mounted on the transmission mechanism of the cleaning bracket 5503 and connected to the needle holder 5506, driving the needle holder to move in the Z direction;

[0247] The needle holder 5506 is fixedly connected to the cleaning bracket synchronous belt 5504. The needle holder 5506 is driven by the cleaning bracket synchronous belt 5504 to move up and down in the Z direction (implying a guide engagement with the bracket). The cleaning needle 5507 and the waste removal needle 5508 are fixedly installed on the needle holder 5506.

[0248] The cleaning needle 5507 and the waste removal needle 5508 are both fixed on the needle holder 5506 and move synchronously in the Z direction with the needle holder.

[0249] like Figure 8 and Figure 11 As shown, the immunoluminescence detection module 56, based on the chemiluminescence detection principle, is used to detect the light signal generated by the reaction of the immune complex with the luminescent substrate, thereby achieving quantitative analysis of the target substance concentration. The immunoluminescence detection module includes a detection cup holder 5607, a left light-shielding box 5604, a right light-shielding box 5608, and a linear module 5610. The detection cup holder 5607 can accommodate a single reaction cup, with its left and right parts placed in the left and right light-shielding boxes 5604 and 5608, respectively. The linear module 5610 drives the right light-shielding box 5608 to move, pushing the cup holder 5607 into the left light-shielding box 5604 during operation. After the reaction cup reaches the detection station, the liquid system 8 draws the luminescent substrate from the immunosubstrate vial 34 in the consumable module 3 and injects it into the reaction cup via 5605. The photodetector 5603 captures the light signal released during the reaction. The instrument calculates the concentration of the target substance based on the light intensity; the light intensity is positively correlated with the concentration of the target substance in the sample.

[0250] Here, the immunoassay optical detection module 56 includes: an immunoassay base plate 5601, an immunoassay left side plate 5602, a photodetector 5603, a left light shield 5604; a substrate addition connector 5605; a light block 5606; a detection cup holder 5607; a right light shield 5608; an immunoassay right side plate 5609; and a linear module 5610.

[0251] The immunodetection base plate 5601 serves as the mounting base for the bottom of the module, and is fixedly connected to the left immunodetection left plate 5602 and the right immunodetection right plate 5609 to form the module frame.

[0252] The left side plate 5602 of the immunodetector is vertically fixed on the immunodetector base plate 5601. The left light shield 5604 and the photodetector 5603 are fixedly installed on the inside, and the photodetector is set to correspond to the detection window of the left light shield.

[0253] The right immunoassay plate 5609 is vertically fixed on the immunoassay base plate 5601 and is arranged opposite to the left immunoassay plate 5602. The linear module 5610 is fixedly installed on the outer or inner side.

[0254] The left light-shielding box 5604 is fixed on the left side plate 5602 of the immunodetector and corresponds to the right light-shielding box 5608. Together they form a light-shielding detection space, and a light-transmitting detection window is provided at the position corresponding to the photodetector 5603.

[0255] The linear module 5610 is fixed on the right side plate 5609 of the immunoassay (or the immunoassay base plate 5601), and its output end is fixedly connected to the right light shield 5608, driving the right light shield to reciprocate in the horizontal direction.

[0256] The light-shielding box 5608 is connected to the actuator end of the linear module 5610. It can move closer to or further away from the left light-shielding box 5604 under the drive of the linear module. When closed, it together with the left light-shielding box wraps around the detection cup holder 5607 to form a light-shielding environment.

[0257] The test cup holder 5607 is placed on the immunoassay base plate 5601, located between the left light shield box 5604 and the right light shield box 5608. It can be pushed into the test area of ​​the left light shield box by the right light shield box and is used to hold a single reaction cup.

[0258] The substrate addition connector 5605 is installed on the left light shield box 5604 (or the fixed structure corresponding to the detection area) and connected to the pipeline of the liquid system 8. Its outlet is aligned with the reaction cup in the detection cup holder 5607 for injecting luminescent substrate.

[0259] The light-blocking block 5606 is fixed at the corresponding position of the left light-blocking box 5604 or the detection area to fill the gap of the light-blocking structure, enhance the light-blocking effect, and avoid external stray light from interfering with the detection.

[0260] The photodetector 5603 is fixed on the left side plate 5602 of the immunoassay, with the detection end facing the detection window of the left light shield 5604, and is used to capture the light signal generated by the reaction between the luminescent substrate and the immune complex in the reaction cup.

[0261] like Figure 12 As shown, the biochemical detection module 5 also includes a clamping module 57 for transferring and positioning reaction cups between different modules. The module is equipped with a robotic arm 5708 for clamping the reaction cups and performing high-precision spatial movement. The clamping module has X, Y, and Z-direction movement capabilities: the X and Y directions are driven by motors and synchronous belts; the Z direction is driven by a linear module. The clamping module 57 includes: a clamping mechanism Y-direction motor 5701, a clamping structure fixing plate 5702, a clamping mechanism Y-direction synchronous belt 5703, a clamping mechanism Y-direction guide rail 5704, a clamping structure X-direction motor 5705, a clamping structure X-direction synchronous belt 5706, a Z-direction linear module 5707, and a robotic arm 5708.

[0262] The clamping frame fixing plate 5702 serves as the mounting base for the entire clamping module. The clamping mechanism Y-axis guide rail 5704 and the clamping mechanism Y-axis synchronous belt 5703 are mounted on the clamping frame fixing plate 5702.

[0263] The clamping mechanism Y-axis motor 5701 is fixed on the clamping frame fixing plate 5702, driving the clamping mechanism Y-axis synchronous belt 5703;

[0264] The clamping structure X-axis motor 5705 and clamping structure X-axis synchronous belt 5706 are mounted on the sliding part of the clamping mechanism Y-axis guide rail 5704 and move with the Y-axis.

[0265] The Z-axis linear module 5707 is connected to the X-axis synchronous belt 5706 of the clamping architecture and is driven to move along the X-axis by the X-axis synchronous belt;

[0266] The robotic arm 5708 is installed at the lower end of the Z-axis linear module 5707 and is driven to move up and down by the Z-axis linear module 5707.

[0267] The immunoassay workflow of this invention is geared towards automated chemiluminescence immunoassay processes. It employs a modular, collaborative approach to complete sample processing, reaction, washing, detection, and waste disposal, enabling rapid, sensitive, and highly repeatable detection. The complete immunoassay workflow is as follows.

[0268] S31: Instrument initialization preparation;

[0269] After the instrument is powered on, the control system performs self-checks on each actuator and verifies the validity of reagents and consumables. Once preparation is complete, the system enters standby mode, awaiting the start of the testing task.

[0270] S32: Sample and reagent loading;

[0271] Once the detection task is initiated, the reagent pipetting module 41 and the sample pipetting module 42 respectively draw the corresponding reagents and samples from the reagent compartment 6 and the sample tube rack 59, and quantitatively distribute them into the reaction cups located on the reaction cup rack 5402. The sample addition process employs a precision volume control pump and liquid level detection technology to ensure the accuracy of the added volume and the repeatability of the addition process, and to avoid cross-contamination.

[0272] S33: Immune response incubation;

[0273] The heating element at the bottom of the reaction cup holder 5402 is activated and enters a constant temperature control mode to heat the reaction cups and maintain them within a preset temperature range. Precise temperature control and constant temperature maintenance accelerate the immunodynamic process, improving detection sensitivity and repeatability.

[0274] S34: Cleaning;

[0275] After incubation, the clamping module 57 transfers the reaction cup to the cleaning cup holder 5510 of the immunoassay cleaning module 55. The cleaning cup holder 5510 moves to the cleaning station under the action of the drive mechanism, and then the cleaning needle 5507 on the needle holder 5506 descends into the reaction cup. This process effectively removes impurities and improves the effectiveness of the detection.

[0276] S35: Chemiluminescence detection:

[0277] After cleaning, the clamping module 57 transfers the reaction cup to the detection cup holder 5607 of the immunooptical detection module 56. The moving module 5610 drives the detection cup holder 5607 into the light-shielding detection area. Upon reaching the detection station, the liquid system 8 draws substrate solution from the immunosubstrate vial 34 in the consumable module 3 and injects it into the reaction cup through tubing and substrate addition connector 5605 to generate a light signal. The photodetector 5603 captures the light signal intensity in real time, and the control system calculates the concentration of the target substance through a signal processing model, where the luminescence intensity is positively correlated with the content of the target substance.

[0278] S36: Waste liquid extraction;

[0279] After the test is completed, the clamping module 57 transfers the reaction cup back to the cleaning cup holder 5510 of the immunoassay cleaning module 55. The waste removal needle 5508 on the cleaning needle holder 5506 descends into the reaction cup and removes the reaction residue and substrate waste liquid by suction, and then discards the reaction cup.

[0280] In addition, this instrument is equipped with a needle cleaning mechanism (not shown in the figure) for efficient cleaning of reagent needles and sample needles, thereby avoiding cross-contamination and improving the reliability and repeatability of test results. The needle cleaning mechanism typically includes a cleaning fluid path, a needle cleaning tank, a waste liquid extraction assembly, and related sensors. During operation, after a sample addition operation, the reagent needle or sample needle automatically enters the cleaning tank for cleaning. The cleaning fluid rinses the inside and outside of the needle body through the fluid path system, ensuring that residual sample or reagent is thoroughly removed. Simultaneously, the waste liquid extraction assembly promptly extracts the contaminated liquid from the needle body and the cleaning tank into a waste liquid container. In some embodiments, the needle cleaning mechanism may employ a multi-stage cleaning strategy, including pre-washing, main washing, and drying steps, to further reduce interference from residues on subsequent detection.

[0281] Reagent compartment 6 is used to store biochemical and immunological reagents and is designed with a temperature control structure to keep the reagents stored at low temperatures and avoid loss of reagent activity.

[0282] like Figure 13 As shown, the reagent compartment 6 includes: a reagent carrier plate 6303, an immunoassay kit 6601 and a biochemical reagent kit 6602 disposed on the reagent carrier plate 6303, and a cooling mechanism 65 located below the reagent carrier plate 6303. The cooling mechanism 65 includes: an air duct 6501, a lower heat sink 6502, an upper heat sink 6503, an upper cooling fan 6504, and a lower cooling fan 6505. The cooling mechanism 65 of the reagent compartment 6 is located below the reagent carrier plate 6303, effectively controlling the storage temperature of the reagents. The cooling mechanism 65 includes components such as the upper and lower heat sinks 6502 and 6503. The upper heat sink 6503 is connected to the cold end of a thermoelectric temperature control element, greatly increasing the cooling area; the lower heat sink 6502 is connected to the hot end of a thermoelectric temperature control element. In addition, the cooling system is equipped with a fan to promote air circulation and ensure uniform temperature distribution within the reagent compartment. This design can precisely control the storage temperature of the reagents and prevent loss of reagent activity due to temperature fluctuations.

[0283] The electrical module of this instrument includes core components such as the electrical support, power supply, and control board. The power supply provides drive voltage to various functional modules of the instrument, including the motor drive module, optical detection module, liquid circuit system, and control circuit. The power supply module is equipped with an electromagnetic compatibility suppression unit to reduce system noise interference with the detection signal. The control board coordinates and controls the various actuators, typically integrating a microprocessor, communication interface, driver chip, and multiplexer analog-to-digital converter circuit, enabling high-speed real-time control of multiple internal actuators. During detection, the control board can dynamically adjust the operating rhythm of each module according to preset programs or external operating commands, such as pipetting speed, heating power, number of cleaning cycles, and optical detection time, to achieve comprehensive optimization of detection accuracy and efficiency.

[0284] This invention relates to the field of in vitro diagnostic (IVD) equipment technology, and more particularly to an integrated detection device for performing biochemical and immunological analyses on clinical laboratory samples. Specifically, this invention is a laboratory analysis instrument capable of performing multi-item combined detection. Compared with existing technologies, this invention has the following advantages:

[0285] (1) Achieving high integration of multiple technologies: This invention integrates biochemical analysis and immunoassay functions on the same platform, enabling joint detection of multiple parameters, reducing the number of equipment configurations, and optimizing the experimental process.

[0286] (2) Small space occupation and flexible deployment: The equipment has a compact structure, which can greatly reduce the laboratory floor space and is suitable for small and medium-sized hospitals, community clinics and primary medical institutions.

[0287] (3) Significantly reduce testing costs: The integrated architecture can effectively reduce equipment procurement and maintenance costs, while reducing the cost of single sample testing by reducing manual operation and reagent consumption.

[0288] (4) Improve testing efficiency and data management capabilities: The integrated automated process reduces sample transfer and manual operation, shortens the report issuance time, and can effectively reduce the human error rate.

[0289] (5) Promote the downward flow of medical resources: This invention is applicable to primary healthcare and remote diagnosis and treatment scenarios, and helps to improve the problems of "insufficient equipment, difficulty in testing, and high cost of medical treatment" in primary healthcare institutions, improve the balance of medical services and reduce the burden of medical insurance.

[0290] Obviously, those skilled in the art can make various modifications and variations to this application without departing from the spirit and scope of this application. Therefore, if such modifications and variations fall within the scope of the claims of this application and their equivalents, this application also intends to include such modifications and variations.

[0291] It should be noted that the present invention can be implemented in software and / or a combination of software and hardware, for example, using an application-specific integrated circuit (ASIC), a general-purpose computer, or any other similar hardware device. In one embodiment, the software program of the present invention can be executed by a processor to implement the steps or functions described above. Similarly, the software program of the present invention (including associated data structures) can be stored in a computer-readable recording medium, such as RAM memory, a magnetic or optical drive, a floppy disk, or similar devices. Furthermore, some steps or functions of the present invention can be implemented in hardware, for example, as circuitry that works with a processor to perform the various steps or functions.

[0292] Furthermore, a portion of this invention can be applied as a computer program product, such as computer program instructions, which, when executed by a computer, can invoke or provide the methods and / or technical solutions according to the invention through the operation of the computer. The program instructions invoking the methods of the invention may be stored in a fixed or removable recording medium, and / or transmitted via a data stream in a broadcast or other signal-carrying medium, and / or stored in the working memory of a computer device operating according to the program instructions. Here, an embodiment of the invention includes an apparatus comprising a memory for storing computer program instructions and a processor for executing the program instructions, wherein, when the computer program instructions are executed by the processor, the apparatus is triggered to operate the methods and / or technical solutions based on the foregoing embodiments of the invention.

[0293] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from the spirit or essential characteristics of the invention. Therefore, the embodiments should be considered illustrative and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be embraced within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims. Furthermore, it is clear that the word "comprising" does not exclude other units or steps, and the singular does not exclude the plural. Multiple units or devices recited in the apparatus claims may also be implemented by a single unit or device in software or hardware. The terms "first," "second," etc., are used to indicate names and do not indicate any particular order.

Claims

1. A multifunctional analyzer, characterized in that, include: The rack (1), consumable module (3), pipetting module (4), detection module (5), reagent compartment (6), electrical module (7) and liquid circuit module (8) are all installed on the rack (1); The pipetting module (4) is supported and installed on the upper part of the frame (1), located above the detection module (5) and the reagent compartment (6), and realizes multi-axis movement under the control of the electrical module (7); The electrical module (7) is electrically connected to the pipetting module (4), the detection module (5), the reagent compartment (6) and the liquid circuit module (8) respectively, providing power supply and motion control signals to each module; The liquid circuit module (8) is connected to the consumable module (3), the liquid transfer module (4) and the detection module (5) through pipelines to realize the transportation and discharge of cleaning fluid, substrate and waste liquid; The computer control terminal is connected to the electrical module (7) to realize the issuance of instructions, process scheduling, data acquisition and result output of the whole machine.

2. The multifunctional analyzer as described in claim 1, characterized in that, The computer control terminal coordinates the operation of each module through the electrical module (7). The reagent compartment (6) provides temperature-controlled reagents, and the consumable module (3) provides the liquid and waste liquid collection required for the test. The pipetting module (4), driven by the electrical module (7), draws reagents from the reagent compartment (6) and samples from the sample tube rack (59) of the detection module (5) and distributes them to the detection module (5). The liquid circuit module (8) independently completes the delivery of cleaning solution and substrate and the treatment of waste liquid. After the detection module (5) completes the reaction, incubation, cleaning and optical detection, it sends the detection signal back to the electrical module (7). Finally, the computer control terminal completes the data processing and result output.

3. The multifunctional analyzer as described in claim 1, characterized in that, The frame (1) includes: a base plate (11), a left support plate (12), an upper support cross plate (13), and a right support plate (14), wherein, The base plate (11) is used to fix the consumable module (3), the detection module (5), and the reagent compartment (6); A pipetting X-axis (4101) is provided between the left support plate (12) and the right support plate (14) to support the movement of the pipetting module (4) along the X-axis direction; The upper support plate (13) is located between the left support plate (12) and the right support plate (14). The upper support plate (13) is equipped with a reagent transfer X-axis synchronous belt (4102) and a sample transfer X-axis synchronous belt (4201) for driving the reagent transfer module (41) and the sample transfer module (42) to move along the X-axis direction, respectively. The electrical module (7) and the hydraulic module (8) are fixed on the back side of the upper support plate (13); The lower parts of the reagent pipetting module (41) and sample pipetting module (42) of the pipetting module (4) are respectively fitted onto the pipetting X-axis (4101), and the upper parts of the reagent pipetting module (41) and sample pipetting module (42) are respectively connected to the reagent pipetting X-axis synchronization belt (4102) and the sample pipetting X-axis synchronization belt (4201). The reagent pipetting X-axis synchronization belt (4102) and the sample pipetting X-axis synchronization belt (4201) drive the reagent pipetting module (41) and sample pipetting module (42) to move on the pipetting X-axis (4101).

4. The multifunctional analyzer as described in claim 1, characterized in that, The consumable module (3) is located below the biochemical and immunoassay detection module (5) and is fixed to the frame (1) via the consumable connecting plate (38). The consumable module (3) includes a consumable drawer (31) which is a thin-walled box with an open top. A consumable drawer plate (32) is installed above the consumable drawer (31). The drawer plate (32) has through holes that match the shape of the containers to be placed, for matching the containers of acid and alkali bottles (33), substrate bottles (34) and medical waste bins (35). The consumable drawer slides (37) are connected to the consumable drawer (31) and the consumable connecting plate (38) respectively.

5. The multifunctional analyzer as described in claim 3, characterized in that, The sample pipetting module (42) of the pipetting module (4) picks up the sample from the sample tube rack (59), and the reagent pipetting module (41) of the pipetting module (4) picks up the corresponding reagent from the reagent compartment (6). Under the control of the electrical module (7), the pipetting module (4) accurately adds the sample and reagent to the reaction cup of the detection module (5) through the liquid circuit module (8). The cleaning agent is directly delivered from the liquid circuit module (8) to the biochemical cleaning module (52) and the immune cleaning module (55) of the detection module (5).

6. The multifunctional analyzer as described in claim 5, characterized in that, The liquid circuit module (8) obtains cleaning solution from the acid-base bottle (33) of the consumable module (3), and the liquid circuit module (8) directly delivers it to the needle cleaning mechanism, biochemical cleaning module (52) and immune cleaning module (55) of the pipetting module (4); The liquid circuit module (8) obtains the substrate from the immunosubstrate vial (34) of the consumable module (3) and sends it directly to the immunooptical detection module (56) of the detection module (5); The liquid circuit module (8) directly pumps the waste liquid from the needle cleaning tank, the biochemical cleaning module (52) of the detection module (5) and the immune cleaning module (55) into the medical waste bin (35) of the consumables module (3).

7. The multifunctional analyzer as described in claim 3, characterized in that, The reagent pipetting module (41) includes: a pipetting X-axis (4101), a pipetting X-axis slider (4106), a pipetting Y-axis (4108), a pipetting Y-axis motor (4107), a slider (4109), a reagent needle (4103), and a pipetting Z-axis guide rail (4104), wherein, The two ends of the pipetting X-axis (4101) are connected to the left support plate (12) and the right support plate (14) respectively; the pipetting X-axis slider (4106) is slidably mounted on the pipetting X-axis (4101), and the pipetting X-axis slider (4106) is driven by the pipetting X-axis motor and the reagent X-axis synchronous belt (4102); One end of the pipetting Y-axis (4108) is fixed on the pipetting X-axis slider (4106), the pipetting Y-axis (4108) is slidably connected to the pipetting Y-axis slider (4112), and the pipetting Y-axis (4108) is slidably connected to the slider (4109); A Y-axis pipetting motor (4107) is fixed on the X-axis pipetting slider (4106) or the Y-axis pipetting axis (4108). The Y-axis pipetting motor (4107) drives the Y-axis pipetting timing belt (4111), which connects to and drives the slider (4109) to move along the Y-axis. The slider (4109) is slidably mounted on the Y-axis (4108) of the pipetting system. The slider (4109) is integrated into the mounting. The reagent needle (4103), the pipetting Z-axis guide rail (4104), the pipetting Z-axis synchronous belt (4105), and the pipetting Z-axis motor (4110) are included; wherein, the pipetting Z-axis guide rail (4104) is fixed on the slider (4109), and the pipetting Z-axis guide rail (4104) is slidably connected to the mounting base of the reagent needle (4103); The Z-axis motor (4110) is fixed on the slider (4109) and drives the Z-axis synchronous belt (4105). The Z-axis synchronous belt (4105) is connected to and drives the reagent needle (4103) to move up and down along the Z-axis. The reagent needle (4103) is mounted on the Z-axis mechanism inside the slider (4109). The reagent needle (4103) is driven by the Z-axis timing belt (4105) and moves up and down along the Z-axis guide rail (4104).

8. The multifunctional analyzer as described in claim 1, characterized in that, The biochemical detection module (5) includes: an incubation module (51), a cleaning module (52), an optical detection module (53), and a stirring module (58), wherein, The biochemical incubation module (51) includes: a biochemical reaction cup loading block drive motor (5101), a cup loading block moving synchronous belt (5102), a biochemical reaction cup loading block (5103), a biochemical incubation chamber (5104), and a biochemical heating plate (5105); wherein, the biochemical incubation chamber (5104) is a reaction chamber formed by combining metal plates, and the outer surface is covered with a biochemical heating plate (5105) to provide a constant temperature environment; the top and sides of the biochemical incubation chamber (5104) have channel-type openings for realizing pipetting, stirring, optical detection and cleaning operations; the reaction cup loading block (5103) is arranged inside the incubation chamber and is driven by the biochemical reaction cup loading block motor (5101) and the cup loading block moving synchronous belt (5102) to move to different working positions along the Y-axis, thereby completing the rapid switching between incubation, detection and cleaning stations; The biochemical cleaning module (52) includes: a needle module assembly, a needle module motion timing belt (5205), and a cleaning needle module drive motor (5206) connected in sequence; the needle module assembly includes a drying needle (5201), a waste extraction needle (5202), a cleaning needle (5203), and a needle fixing block (5204); The biochemical optical detection module (53) includes a spectrometer (5301) and a light source (5302) for measuring the absorbance of the reaction solution in the cuvette. The incident light emitted by the light source (5302) is transmitted through the outer aperture of the biochemical incubation chamber (5104) and the cuvette, and is received and analyzed by the spectrometer (5301). The concentration of the target analyte is calculated according to the Lambert-Beer law. The biochemical optical detection module (53) has the functions of automatic light intensity compensation, background noise calibration and multi-wavelength scanning. The stirring module (58) includes: a stirring base plate (5801), an X-axis stirring motor (5802), an X-axis stirring synchronous belt (5803), an X-axis stirring linear guide (5804), a Z-axis stirring synchronous belt (5805), a Z-axis stirring linear guide (5806), a connecting plate (5807), a stirring motor (5808), a stirring rod (5809), and a Z-axis stirring motor (5810). The stirring rod (5809) moves in both the X and Z directions and extends downwards into the reaction liquid along the Z-axis. The X-axis stirring linear guide (5804) and the X-axis stirring synchronous belt (5803) are both mounted on the stirring base plate (5801); The X-axis stirring motor (5802) is fixed on the stirring base plate (5801) and drives the X-axis stirring synchronous belt (5803); The connecting plate (5807) is slidably mounted on the X-axis stirring linear guide (5804); The connecting plate (5807) is connected to the X-direction stirring synchronous belt (5803), and the connecting plate (5807) is driven by the X-direction stirring synchronous belt (5803) to move along the X direction; The Z-axis stirring linear guide (5806) and the Z-axis stirring synchronous belt (5805) are both mounted on the connecting plate (5807); The Z-axis stirring motor (5810) is fixed on the connecting plate (5807) and drives the Z-axis stirring synchronous belt (5805); The stirring motor (5808) is slidably mounted on the Z-axis stirring linear guide rail (5806); The stirring motor (5808) is connected to the Z-axis stirring synchronous belt (5805), and the stirring motor (5808) is driven by the Z-axis stirring synchronous belt (5805) to move along the Z-axis; The stirring rod (5809) is connected to the output end of the stirring motor (5808) and is driven to rotate by the stirring motor.

9. The multifunctional analyzer as described in claim 5, characterized in that, The immune cleaning module (55) includes: a fixing plate (5501), a cleaning cup holder drive motor (5502), a cleaning support (5503), a cleaning support timing belt (5504), a cleaning support drive motor (5505), a needle holder (5506), a cleaning needle (5507), a waste removal needle (5508), a cleaning cup holder moving guide rail (5509), a cleaning cup holder (5510), and a magnet mounting plate (5511). The fixing plate (5501) is fixedly installed on the base plate (11) of the frame (1); The upper surface of the fixing plate (5501) is fixedly installed with the cleaning cup holder moving guide rail (5509), the cleaning bracket (5503), and the cleaning cup holder drive motor (5502); The cup holder drive motor (5502) is fixed on the fixed plate (5501), and the output end of the cup holder drive motor (5502) is connected to the cup holder transmission structure. The cup holder moving guide rail (5509) is fixed on the fixed plate (5501) and slidably connected to the cup holder (5510), providing movement guidance for the cup holder (5510); The cup holder (5510) is slidably mounted on the cup holder moving guide rail (5509) and is driven to move along the guide rail by the cup holder drive motor (5502); A magnet mounting plate (5511) is fixedly installed on the upper surface of the cleaning cup holder (5510) to accommodate the reaction cups; the magnet mounting plate (5511) is fixed on the cleaning cup holder (5510), and magnets are fixedly installed on the inner side, corresponding to the reaction cups inside the cleaning cup holder (5510); A cleaning bracket (5503) is fixed on a fixing plate (5501), on which a cleaning bracket timing belt (5504) and a cleaning bracket drive motor (5505) are installed; The cleaning bracket drive motor (5505) is fixed on the cleaning bracket (5503) and drives the cleaning bracket synchronous belt (5504) to rotate; The cleaning bracket timing belt (5504) is mounted on the transmission mechanism of the cleaning bracket (5503) and connected to the needle holder (5506), driving the needle holder to move in the Z direction; the needle holder (5506) is fixedly connected to the cleaning bracket timing belt (5504), and the needle holder (5506) is driven by the cleaning bracket timing belt (5504) to move up and down in the Z direction; A cleaning needle (5507) and a waste removal needle (5508) are fixedly installed on the needle holder (5506); both the cleaning needle (5507) and the waste removal needle (5508) are fixed on the needle holder (5506) and move synchronously in the Z direction with the needle holder.

10. The multifunctional analyzer as described in claim 6, characterized in that, The immunoassay optical detection module (56) includes: an immunoassay base plate (5601), an immunoassay left side plate (5602), a photodetector (5603), a left light shield (5604), a substrate addition connector (5605), a light block (5606), a detection cup holder (5607), a right light shield (5608), an immunoassay right side plate (5609), and a linear module (5610), wherein, The immunodetection base plate (5601) serves as the mounting base for the bottom of the module, and is fixedly connected to the left immunodetection plate (5602) and the right immunodetection plate (5609) to form the module frame; The left side plate (5602) of the immunodetector is vertically fixed on the immunodetector base plate (5601), and the left light shield (5604) and photodetector (5603) are fixedly installed on the inside, and the photodetector is set to correspond to the detection window of the left light shield. The right side plate of the immunoassay (5609) is vertically fixed on the immunoassay base plate (5601) and arranged opposite to the left side plate of the immunoassay (5602). A linear module (5610) is fixedly installed on the outer or inner side. The left light-shielding box (5604) is fixed on the left side plate (5602) of the immunodetector and corresponds to the right light-shielding box (5608) to form a light-shielding detection space. A light-transmitting detection window is provided at the position corresponding to the photodetector (5603). The linear module (5610) is fixed on the right side plate of the immunoassay (5609) or the immunoassay base plate (5601), and its output end is fixedly connected to the right light shield (5608), driving the right light shield to reciprocate in the horizontal direction; The right light shield (5608) is connected to the actuator of the linear module (5610). Driven by the linear module, it moves closer to or further away from the left light shield (5604). When closed, it and the left light shield together wrap around the detection cup holder (5607) to form a light-proof environment. The test cup holder (5607) is placed on the immunoassay base plate (5601), located between the left light shield box (5604) and the right light shield box (5608), and is pushed into the test area of ​​the left light shield box by the right light shield box to hold a single reaction cup; The substrate addition connector (5605) is installed on the left light shield box (5604) and connected to the pipeline of the liquid system (8). Its outlet is aligned with the reaction cup in the detection cup holder (5607) for injecting luminescent substrate. The light-blocking block (5606) is fixed in the corresponding position of the left light-blocking box (5604) or the detection area to fill the gap of the light-blocking structure, enhance the light-blocking effect, and avoid external stray light from interfering with the detection. A photodetector (5603) is fixed on the left side plate (5602) of the immunoassay, with the detection end facing the detection window of the left light shield (5604), and is used to capture the light signal generated by the reaction between the luminescent substrate and the immune complex in the reaction cup.

11. The multifunctional analyzer as described in claim 6, characterized in that, The biochemical detection module (5) also includes a clamping module (57), which includes: a clamping mechanism Y-axis motor (5701), a clamping structure fixing plate (5702), a clamping mechanism Y-axis synchronous belt (5703), a clamping mechanism Y-axis guide rail (5704), a clamping structure X-axis motor (5705), a clamping structure X-axis synchronous belt (5706), a Z-axis linear module (5707), and a robotic arm (5708); among which, The clamping frame fixing plate (5702) serves as the mounting base for the entire clamping module. The clamping mechanism Y-axis guide rail (5704) and the clamping mechanism Y-axis synchronous belt (5703) are mounted on the clamping frame fixing plate (5702). The clamping mechanism Y-axis motor (5701) is fixed on the clamping frame fixing plate (5702) and drives the clamping mechanism Y-axis synchronous belt (5703); The clamping frame X-axis motor (5705) and clamping frame X-axis synchronous belt (5706) are mounted on the sliding part of the clamping mechanism Y-axis guide rail (5704) and move with the Y-axis; the Z-axis linear module (5707) is connected to the clamping frame X-axis synchronous belt (5706) and is driven by the X-axis synchronous belt to move along the X-axis; The robotic arm (5708) is installed at the lower end of the Z-axis linear module (5707) and is driven to move up and down by the Z-axis linear module (5707).

12. The multifunctional analyzer as described in claim 6, characterized in that, The reagent compartment (6) includes: a reagent carrier plate (6303), an immunoassay kit (6601) and a biochemical reagent kit (6602) disposed on the reagent carrier plate (6303), and a cooling mechanism (65) located below the reagent carrier plate (6303), wherein, The cooling mechanism (65) includes: an air duct (6501), a lower heat sink (6502), an upper heat sink (6503), an upper cooling fan (6504), and a lower cooling fan (6505); the upper heat sink (6503) is connected to the cold end of the thermoelectric temperature control element; the lower heat sink (6502) is connected to the hot end of the thermoelectric temperature control element.

13. A detection and analysis method, characterized in that, Using the multifunctional analyzer as described in any one of claims 1 to 12, the method includes a software detection process, comprising: S11. After the multi-function analyzer is started, log in to the software; after all initial actions are completed, the main interface of the software is displayed, and subsequent operation permissions are unlocked. S12, Reagent Information Collection: (1) Reagent barcode scanning and information collection: The reagent rack in the reagent compartment is used by operators to place the reagents into the reagent compartment according to the specifications. After the reagent rack is detected, the software of the multi-function analyzer automatically starts reagent barcode scanning and collects the core information of the reagents. (2) Information storage: The software temporarily stores the scanned information in a data table; S13: Sample information collection; (1) Sample scanning and information entry: Place the sample tubes into the sample tube rack 59 in sequence, and manually push the sample tube rack 59 into the sample cart. During the pushing process, the software of the multi-functional analyzer scans the barcode information and temporarily stores the scanned information in a temporary database. (2) Pre-allocation of testing process and reagent verification: The software of the multi-functional analyzer pre-processes the sample and allocates the testing modules in advance according to the biochemical or immunological type, detection principle and reagent requirements of the imported test items; S14: Inspection process allocation; The software of the multi-functional analyzer, combined with the characteristics of the testing items, enables intelligent planning and dynamic scheduling of the testing process: The software of the multi-functional analyzer automatically analyzes the execution process, sample addition order, load type and reagent stability factors of each test item, dynamically adjusts the process order, avoids module resource conflicts, realizes parallel processing of multiple actions, and obtains and executes biochemical test process or immunoassay process. S15: Data storage and processing; After the biochemical or immunoassay testing process is completed, the multi-functional analyzer's software initiates a closed-loop data management process to ensure the accuracy and traceability of the results, while also meeting the requirements for system interaction. (1) Result classification and saving: The software classifies and archives the test data into the corresponding result window according to the type of test item: Immunization Project: Save relevant data to the immunization results window; Biochemical Project: Save relevant data to the biochemical results window; (2) Result viewing and confirmation: Allows operators to view detailed data in the corresponding result window, including the original signal curve, abnormal cause annotation, etc.; (3) System synchronous reporting: Select the confirmed result and click the send button. Information including patient information, sample information, test items, result values, reference range, etc. will be synchronized to the hospital system through the network interface. (4) Data archiving and traceability: All test data are archived and stored to meet the needs of clinical traceability and quality control.

14. The detection and analysis method as described in claim 13, characterized in that, The biochemical testing process includes: S21, Instrument Preparation: After startup, the multi-function analyzer first performs a power-on self-test; the incubation system of the multi-function analyzer is preheated to the set temperature; the pipetting module of the multi-function analyzer is reset to the initial position to ensure the accuracy of the sample addition process and the normal working condition of the equipment. S22, Sample addition: The reagent pipetting module and sample pipetting module of the multi-functional analyzer respectively draw the corresponding reagents and samples from the reagent compartment and sample tube rack. The drawn liquids are then accurately added to the cuvettes in the biochemical incubation chamber. S23, Mixing: After the sample is added, the loading block of the biochemical reaction cup moves to the stirring station; the stirring rod rotates continuously driven by the stirring motor to fully stir the reaction liquid; S24, Incubation: The mixed reaction solution will enter the incubation stage. The biochemical heater heats the incubation chamber and maintains a constant temperature. S25, Optical Detection: After the reaction is complete, the cuvette is transferred to the optical detection station; the incident light emitted by the light source passes through the reaction liquid in the cuvette and is transmitted to the spectrophotometer; the optical detection device automatically collects the light intensity data of the transmitted light and transmits it to the multi-functional analyzer, which calculates the absorbance of the solution based on this data; using Lambert-Beer's law, the multi-functional analyzer converts the absorbance data into concentration information; S26, Cleaning and Reset: After the test is completed, the reaction cup will be transferred to the cleaning station; the cleaning module will process the colorimetric cup, including waste removal, washing and drying.

15. The detection and analysis method as described in claim 13, characterized in that, The immune testing process includes: S31, Instrument Initialization Preparation: After the multi-function analyzer is powered on, the control system performs self-tests on each actuator and verifies the effectiveness of reagents and consumables; after preparation is complete, the system enters standby mode, waiting for the detection task to start; S32, Sample and Reagent Loading: When the detection task is started, the reagent pipetting module and sample pipetting module of the multi-function analyzer respectively draw the corresponding reagents and samples from the reagent compartment and sample tube rack, and quantitatively distribute them into the reaction cups located on the reaction cup rack; S33, Immunological reaction incubation: The heating element at the bottom of the reaction cup holder of the multi-functional analyzer is activated and enters the constant temperature control mode to heat the reaction cup and maintain the preset temperature range. S34, Cleaning: After incubation, the clamping module of the multi-function analyzer transfers the reaction cup to the cleaning cup holder of the immunoassay cleaning module; the cleaning cup holder moves to the cleaning station under the action of the drive mechanism, and then the cleaning needle on the needle holder descends into the reaction cup; S35, Chemiluminescence Detection: After cleaning, the clamping module of the multi-functional analyzer transfers the reaction cup to the detection cup holder of the immunofluorescence detection module; the moving module drives the detection cup holder to move into the light-shielding detection area; after reaching the detection station, the liquid system draws the substrate solution from the immunosubstrate vial in the consumable module and injects it into the reaction cup through the tubing and substrate addition connector to generate a light signal; the photodetector captures the light signal intensity in real time, and the control system calculates the concentration of the target substance through the signal processing model, where the luminescence intensity is positively correlated with the content of the target substance; S36, Waste liquid extraction: After the test is completed, the clamping module transfers the reaction cup back to the cleaning cup of the immunoassay module; the waste extraction needle on the cleaning needle holder descends into the reaction cup and extracts the reaction residue and substrate waste liquid by suction, and then discards the reaction cup.

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