Automatic Analysis System and Control Method

Abstract

This application relates to the field of medical device technology, and in particular to an automated analysis system and its control method. The automated analysis system includes a pretreatment module, a detection module, and a control module. The pretreatment module includes a pipetting assembly and a washing assembly. The detection module includes a chemiluminescence detection assembly and a multiplexer assembly. The control module includes a detection type control unit. When the detection method is a one-step or two-step chemiluminescence method, the analyte is washed by the washing assembly and then transferred to the chemiluminescence detection assembly by the pipetting assembly for detection. When the detection method is a two-step multiplexer assembly, the analyte is washed by the washing assembly and then transferred to the multiplexer assembly by the pipetting assembly for detection. This automated analysis system and its control method enable simultaneous chemiluminescence detection and multiplexer analysis within a single automated analysis system, improving detection efficiency, reducing cost, and minimizing the space required for medical applications.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to an automatic analysis system and its control method. Background Technology

[0002] Currently, immunodiagnostics mainly includes two methods: chemiluminescence immunoassay and multiplex liquid chromatography-array analysis. The principle of chemiluminescence is to mix a signal-carrying labeling substance and a recognition substance that binds to the target substance in the sample with the sample. If the target substance is present in the sample, the target substance, recognition substance, and signal-carrying labeling substance combine to form the analyte. Adding the signal-carrying labeling substance causes it to emit photons through catalysis and oxidation. The photomultiplier tube in the instrument detects the photons and transmits them to an amplifier, ultimately converting them into a digital signal for computer calculation to obtain the clinical result. When using a single chemiluminescence reagent to detect multiple indicators in a sample, it is necessary to detect multiple signal wavelengths corresponding to multiple target substances, with a one-to-one correspondence between the target substance type and the detection signal wavelength.

[0003] The principle of multiplex liquid chromatography-array analysis is as follows: different groups of liquid chromatography chips are laser-encoded, and then a recognition substance that binds to the target substance in the sample is chemically cross-linked onto the liquid chromatography chip. After the target substance in the sample specifically binds to the corresponding recognition substance on the coded surface of the specific liquid chromatography chip, a labeling substance with a fluorescent signal is added. The location of different coded liquid chromatography chips is identified by taking a bright-field photograph, and the fluorescence signal corresponding to each liquid chromatography chip is determined by taking a dark-field photograph. By converting the fluorescence intensity of the liquid chromatography chip into the concentration of the corresponding target substance, qualitative or quantitative results are obtained. When using a multiplex liquid chromatography reagent to detect multiple target substances in a sample, because the signals of different target substances originate from the image readings of multiple liquid chromatography chips within the same multiplex liquid chromatography reagent, even with a large number of indicators, multiple target substances can be detected with one bright-field photograph and one dark-field photograph. The more target substances there are, the longer the chemiluminescence analysis of multiplex liquid chromatography will take. In existing technologies, for autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, myositis, and vasculitis, diagnostic reagents that require the combined analysis of multiple indicator test results are more time-efficient than chemiluminescence methods when using multiplex liquid-phase chip analysis.

[0004] In existing technologies, because chemiluminescence immunoassay and multiplex liquid chromatography-array analysis (LC-ISA) operate on different analytical principles, the structures of diagnostic instruments using chemiluminescence and LC-ISA differ significantly. When medical personnel need to perform both chemiluminescence and LC-ISA analyses on the same sample, they must first separate the sample into two parts and then transfer them to the automated analysis systems for chemiluminescence and LC-ISA, respectively; or they must collect two samples from the patient and transfer them to two separate automated analysis systems for diagnosis. For hospitals, this is costly due to the high cost of purchasing both chemiluminescence and LC-ISA instruments simultaneously, and these instruments also require a large footprint. Therefore, there is an urgent need for an automated analysis instrument that can simultaneously perform chemiluminescence and LC-ISA analyses at a lower cost and with a smaller footprint in medical settings. Summary of the Invention

[0005] The purpose of this application is to provide an automated analysis system for analyzing the presence of target substances in samples by labeling, in order to solve the technical problems of existing technologies that cannot simultaneously use chemiluminescence and multiplex liquid-phase chip analysis, and that are costly and require a large amount of medical space.

[0006] In a first aspect, this application provides an automated analysis system for analyzing the presence of a target substance in a sample using labeled substances, comprising:

[0007] The pretreatment module is used to pretreat samples to form analytes, and includes a pipetting assembly and a washing assembly;

[0008] The detection module, used to detect the analyte, includes a chemiluminescence detection component and a multiplex interpretation component;

[0009] The control module includes a detection type control unit, which is used to determine the required detection method based on the sample, and control the preprocessing module to preprocess the sample and the detection module to detect the analyte according to the corresponding detection method.

[0010] When the detection method is a one-step chemiluminescence method or a two-step chemiluminescence method, the analyte, after being washed by the washing assembly, is transferred to the chemiluminescence detection assembly by the pipetting assembly for detection.

[0011] When the detection method is a two-step multi-phase liquid chip method, the analyte, after being washed by the washing component, is transferred to the multi-reading component for detection by the pipetting component.

[0012] Furthermore, the pretreatment module also includes a sample injection component, a sample addition component, a reaction vessel replenishment mechanism, a reagent component, and an incubation component;

[0013] The sample delivery assembly is used to deliver the sample;

[0014] The sample dispensing assembly is used to remove the sample and / or place the reaction container. The sample dispensing assembly is a sample dispensing turntable, and the sample dispensing turntable is provided with a reaction container replenishment position, a sample dilution position, a first reagent addition position, a sample dispensing position, and a sample removal position along its circumferential edge.

[0015] The reaction vessel replenishment mechanism is used to replenish the reaction vessel to the reaction vessel replenishment position;

[0016] The reagent assembly is used to store a first reagent, a second reagent, and / or a sample diluent. The reagent assembly is a reagent turntable, and the reagent turntable has a first reagent loading position and a second reagent loading position sequentially arranged along its circumferential edge.

[0017] The incubation assembly is an incubation turntable with a ring structure. The incubation turntable includes an inner incubation position and an outer incubation position disposed outside the inner incubation position. The outer incubation position includes a first incubation insertion position and a first incubation removal position. The inner incubation position includes a second incubation insertion position and a second incubation removal position.

[0018] The reagent turntable is located within the inner ring of the incubation turntable. The rotation centers of the incubation turntable and the reagent turntable coincide. The area swept by the sample dispensing turntable when it rotates does not coincide with the area swept by the incubation turntable when it rotates.

[0019] Furthermore, the washing assembly includes a first washing mechanism and a second washing mechanism, wherein the first washing mechanism is located between the incubation turntable and the chemiluminescence detection assembly, and the second washing mechanism is located between the incubation turntable and the multiplex interpretation assembly;

[0020] The first washing mechanism is a turntable structure, with a first washing inlet / outlet position, a first washing position, a second reagent inlet position, a first substrate liquid inlet position, and a first washing outlet position arranged sequentially along its circumference. Above the first washing position is a first washing component, and above the first substrate liquid inlet position is a first substrate liquid conveying mechanism for conveying the substrate liquid.

[0021] The second washing mechanism is a turntable structure, with a second washing inlet, a second washing position, a second substrate liquid inlet, a booster liquid inlet, and a second washing outlet arranged sequentially along its circumference. A second washing component is located above the second washing position. A second substrate liquid conveying mechanism for conveying the substrate liquid is located above the second substrate liquid inlet. A booster liquid conveying mechanism for conveying the booster liquid is located above the booster liquid inlet.

[0022] The pipetting assembly includes a first pipetting mechanism, a second pipetting mechanism, a third pipetting mechanism, a fourth pipetting mechanism, and a fifth pipetting mechanism;

[0023] The first pipetting mechanism is located between the sample dispensing turntable and the incubation turntable;

[0024] The second pipetting mechanism is located between the first washing mechanism and the incubation turntable;

[0025] The third pipetting mechanism is located between the second washing mechanism and the chemiluminescence detection component, and also between the first washing mechanism and the chemiluminescence detection component;

[0026] The fourth pipetting mechanism is located between the incubation turntable and the second washing mechanism;

[0027] The fifth pipetting mechanism is located between the second washing mechanism and the multiple interpretation component.

[0028] Furthermore, the pipetting assembly also includes a first reagent transfer mechanism and a second reagent transfer mechanism;

[0029] The first reagent transfer mechanism includes a first moving track and a first pipetting component;

[0030] The first reagent loading position and the first reagent adding position are located on the movement trajectory of the first pipetting component on the first moving track;

[0031] The second reagent transfer mechanism includes a second moving track and a second pipetting component.

[0032] The second reagent loading position and the second reagent adding position are located on the movement trajectory of the second pipetting component on the second moving track.

[0033] Furthermore, the sample introduction assembly also includes a sample transfer mechanism for extracting and moving samples, a scanner for scanning sample information, a sample buffer mechanism for temporarily storing the samples, an inlet and an emergency replenishment end for sample entry, and a sample transfer mechanism connected to the inlet and the emergency replenishment end respectively.

[0034] The scanning element is located on the sample transmission mechanism, and the sample transmission mechanism is also connected to the sample buffer mechanism;

[0035] The sample buffering mechanism sequentially includes an entry section, a first buffer area, a second buffer area, a third buffer area, an emergency area, and an exit section. The first buffer area, the second buffer area, the third buffer area, and the emergency area are respectively connected to the entry section and the exit section. The entry section is equipped with a scanner for scanning sample information. The scanner determines whether dilution is required based on the scanned sample information. If dilution is required, the entry section moves the sample into the third buffer area. If dilution is not required, the entry section moves samples requiring the same incubation, washing, and signal acquisition time into the first buffer area. The entry section moves samples requiring different incubation, washing, and signal acquisition times into the second buffer area. The entry section moves samples requiring urgent testing into the emergency area. The sample transfer mechanism is used to prioritize detecting whether there are samples in the emergency area and then transfer them.

[0036] The washing assembly further includes a first cleaning mechanism, a second cleaning mechanism, and a third cleaning mechanism. The first cleaning mechanism is located on the moving trajectory of the sample transfer mechanism, the second cleaning mechanism is located on the moving trajectory of the first reagent transfer mechanism, and the third cleaning mechanism is located on the moving trajectory of the second reagent transfer mechanism.

[0037] The sample introduction component also includes a sample recovery mechanism, which is connected to the sample transfer mechanism.

[0038] Furthermore, the automated analysis system also includes a luminescent tube discarding mechanism, wherein the pipetting assembly transfers the analyte after detection from the chemiluminescence detection assembly into the luminescent tube discarding mechanism;

[0039] Preferably, the automatic analysis system further includes a multiple discarding mechanism, wherein the pipetting assembly removes the analyte after detection from the multiple interpretation assembly and transfers it into the multiple discarding mechanism.

[0040] Secondly, this application provides a control method for the automatic analysis system described in any of the foregoing claims, comprising:

[0041] Detection type determination step: The detection type control unit of the control module determines the detection method to be performed based on the sample;

[0042] Preprocessing step: The preprocessing module preprocesses the sample according to the detection method to form the analyte;

[0043] Wherein, if the detection method is a one-step chemiluminescence method or a two-step chemiluminescence method, the analyte after being washed by the washing component of the pretreatment module is transferred to the chemiluminescence detection component of the detection module through the pipetting component of the pretreatment module;

[0044] If the detection method is a two-step multi-phase liquid chip method, the analyte washed by the washing assembly is transferred to the multi-reading assembly of the detection module through the pipetting assembly.

[0045] Test object detection steps: The detection module detects the test object.

[0046] Furthermore, the pretreatment module also includes a sample injection component, a sample addition component, a reagent component, and an incubation component. The reagent component is used to store the first reagent, the second reagent, and / or the sample diluent. The incubation component is used to accelerate the formation of the analyte in the reaction vessel.

[0047] The preprocessing step further includes:

[0048] Perform the first incubation step: The sample introduction component adds the sample into the reaction vessel inside the sample addition component, and the pipetting component moves the reaction vessel into the incubation component to complete the first incubation;

[0049] The second incubation step is determined based on the detection method. If the detection method is a one-step chemiluminescence method, after the first incubation is completed, the pipetting assembly transfers the analyte to the washing assembly for washing.

[0050] If the detection method is a two-step method using multiple liquid phase chips or a two-step method using chemiluminescence, then after the first incubation is completed, the pipetting assembly transfers the intermediate to the washing assembly for the first washing, the pipetting assembly transfers the second reagent to the reaction vessel and mixes it with the intermediate, and then the pipetting assembly moves the reaction vessel to the incubation assembly for the second incubation.

[0051] Perform the second washing step: After the second incubation is completed, the pipetting assembly transfers the analyte to the washing assembly for a second washing.

[0052] Furthermore, the sample dispensing component is a sample dispensing turntable, which is provided with a reaction vessel replenishment position, a sample dilution position, a first reagent addition position, a sample dispensing position, and a sample removal position along its circumferential edge.

[0053] The reagent assembly is a reagent turntable, and the reagent turntable has a first reagent loading position and a second reagent loading position sequentially arranged along its circumferential edge;

[0054] The incubation assembly is an incubation turntable, which includes an inner incubation position and an outer incubation position disposed outside the inner incubation position; the outer incubation position includes a first incubation insertion position and a first incubation removal position; the inner incubation position includes a second incubation insertion position and a second incubation removal position;

[0055] The washing assembly includes a first washing mechanism and a second washing mechanism;

[0056] The first washing mechanism is a turntable structure, with a first washing inlet / outlet position, a first washing position, a second reagent inlet position, a first substrate liquid inlet position, and a first washing outlet position arranged sequentially along its circumference. Above the first washing position is a first washing component, and above the first substrate liquid inlet position is a first substrate liquid conveying mechanism for conveying the substrate liquid.

[0057] The second washing mechanism is a turntable structure, with a second washing inlet, a second washing position, a second substrate liquid inlet, a booster liquid inlet, and a second washing outlet arranged sequentially along its circumference. A second washing component is located above the second washing position. A second substrate liquid conveying mechanism for conveying substrate liquid is located above the second substrate liquid inlet. A booster liquid conveying mechanism for conveying booster liquid is located above the booster liquid inlet.

[0058] The pipetting assembly includes a first pipetting mechanism, a second pipetting mechanism, a third pipetting mechanism, a fourth pipetting mechanism, a fifth pipetting mechanism, a first reagent transfer mechanism, and a second reagent transfer mechanism; the first reagent transfer mechanism includes a first moving track and a first pipetting component; the second reagent transfer mechanism includes a second moving track and a second pipetting component;

[0059] The first incubation step is performed as follows: the first pipetting component moves along the first moving track, and the first pipetting component picks up the first reagent from the first reagent loading position and places it into the reaction container located at the first reagent adding position. The reaction container moves from the first reagent adding position to the sample adding position, and the sample injection component adds the sample into the reaction container located at the sample adding position, so that the sample and the first reagent are mixed in the reaction container. Then, the first pipetting mechanism moves the reaction container into the first incubation insertion position to perform the first incubation.

[0060] Furthermore, in determining whether to perform a second incubation step based on the detection method, if the detection method is a one-step chemiluminescence method, after completing the first incubation, the reaction container moves from the first incubation inlet position to the first incubation outlet position, the second pipetting mechanism moves the analyte from the first incubation outlet position to the first washing inlet / outlet position in the first washing mechanism, the reaction container then moves from the first washing inlet / outlet position to the first washing position, the first washing component washes the analyte, the reaction container moves from the first washing position to the first substrate liquid inlet position, the first substrate liquid delivery mechanism inputs the substrate liquid into the reaction container to mix with the analyte inside, the reaction container then moves from the first substrate liquid inlet position to the first washing outlet position, and the third pipetting mechanism moves the reaction container into the chemiluminescence detection component;

[0061] If the detection method is a two-step multiphase liquid chip method or a two-step chemiluminescence method, then after the first incubation is completed, the reaction container moves from the first incubation in position to the first incubation out position, the second pipetting mechanism moves the intermediate from the first incubation out position to the first washing in-out position, the reaction container then moves from the first washing in-out position to the first washing position, the first washing component performs the first washing of the intermediate, the reaction container moves from the first washing position to the second reagent addition position, the second pipetting component moves along the second moving track to pick up the second reagent from the second reagent loading position and place it into the reaction container at the second reagent addition position, so that the second reagent and the intermediate are mixed in the reaction container, the reaction container then moves from the second reagent addition position to the first washing in-out position, and the fourth pipetting mechanism moves the reaction container from the first washing in-out position to the second incubation in position for the second incubation.

[0062] Furthermore, during the second washing step, the reaction vessel is moved from the second incubation insertion position to the second incubation removal position, the fourth pipetting mechanism moves the reaction vessel from the second incubation removal position to the second washing insertion position, the reaction vessel is moved from the second washing insertion position to the second washing position, and the second washing component performs a second washing on the analyte.

[0063] After completing the second washing step, the step of determining the movement position of the object to be tested according to the detection method is as follows:

[0064] If the detection method is a two-step chemiluminescence method, the analyte after the second washing is moved from the second washing position to the second substrate liquid addition position. The second substrate liquid delivery mechanism inputs the substrate liquid into the reaction vessel and mixes it with the analyte inside. Then, the reaction vessel is moved from the second substrate liquid addition position to the second washing removal position. The third liquid transfer mechanism moves the reaction vessel from the second washing removal position into the chemiluminescence detection component.

[0065] If the detection method is a two-step multi-phase liquid chip method, the analyte after the second washing is moved from the second washing position to the enhancement liquid addition position. The enhancement liquid delivery mechanism inputs the substrate liquid into the reaction vessel and mixes it with the analyte inside. Then, the reaction vessel is moved from the enhancement liquid addition position to the second washing removal position, and the fifth liquid transfer mechanism moves the reaction vessel from the second washing removal position to the multi-reading component.

[0066] Furthermore, the control method of the automatic analysis system further includes: before performing the first incubation step, determining whether the sample needs to be diluted; if the sample needs to be diluted, the first pipetting component transfers the sample diluent into the reaction container at the sample dilution position, and the injection component adds the sample into the reaction container located at the sample dilution position, so that the sample is mixed with the sample diluent to dilute the sample;

[0067] If the sample does not require dilution, the injection component adds the sample to the reaction vessel at the injection site.

[0068] Furthermore, the pretreatment module also includes a reaction vessel replenishment mechanism for replenishing the reaction vessel to the sample loading assembly; the sample loading assembly is also equipped with a scanner for acquiring sample information;

[0069] The steps before determining whether the sample needs to be diluted include:

[0070] The reaction vessel replenishment mechanism replenishes the reaction vessel to the sample dispensing assembly;

[0071] The scanner acquires the sample information of the sample.

[0072] Furthermore, the automatic analysis system also includes a light-emitting waste disposal mechanism and a multiple waste disposal mechanism.

[0073] The steps following the detection module's detection of the test object also include:

[0074] The pipetting assembly moves the reaction vessel into the luminescent discarding mechanism, or the pipetting assembly moves the reaction vessel into the multiple discarding mechanism.

[0075] Compared with existing technologies, the automated analysis system and its control method provided in this application can perform one-step chemiluminescence, two-step chemiluminescence, and two-step multiplex liquid chromatography-chip detection in one automated analysis system. It integrates multiple detection methods into one automated analysis system, reducing purchase costs, reducing the medical space required, and optimizing and improving sample detection efficiency. It can use the same automated analysis system to perform multiple different tests on the same sample, or perform multiple different tests on multiple samples simultaneously. The work is orderly and does not interfere with each other, which greatly improves detection efficiency. Attached Figure Description

[0076] To more clearly illustrate the technical solutions in the specific embodiments of this application or the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0077] Figure 1 This is a schematic diagram of the overall structure of the automatic analysis system provided in the embodiments of this application;

[0078] Figure 2 This is a schematic diagram of the core structure and principle of the automatic analysis system provided in the embodiments of this application;

[0079] Figure 3 This is a schematic diagram of the auxiliary structure of the automatic analysis system provided in the embodiments of this application;

[0080] Figure 4 This is a flowchart of the automatic analysis system control method provided in the embodiments of this application.

[0081] Figure label:

[0082] 10-Sample introduction assembly; 11-Sample introduction channel; 111-Inlet end; 112-Emergency replenishment inlet end; 12-Sample transfer mechanism; 13-Reaction vessel replenishment mechanism; 20-Sample buffer mechanism; 21-Sample dispensing arm; 30-Sample dispensing turntable; 31-First reagent addition position; 32-Sample dispensing position; 33-Sample dispensing removal position; 40-Reagent turntable; 41-First reagent loading position; 42-Second reagent loading position; 50-Incubation turntable; 51-First incubation transfer position; 52-First incubation removal position; 53-Second incubation transfer position; 54-Second incubation removal position; 61-First washing turntable; 611-First washing transfer in / out position; 612-First washing removal position; 613-Second reagent addition position; 62 - Second washing turntable; 621- Second washing transfer position; 622- Second washing transfer position; 71- Sample transfer mechanism; 72- First reagent transfer mechanism; 721- First moving track; 722- First pipetting component; 73- Second reagent transfer mechanism; 731- Second moving track; 732- Second pipetting component; 74- First pipetting mechanism; 75- Second pipetting mechanism; 76- Third pipetting mechanism; 77- Fourth pipetting mechanism; 78- Fifth pipetting mechanism; 81- First cleaning mechanism; 82- Second cleaning mechanism; 83- Third cleaning mechanism; 91- Chemiluminescence detection component; 92- Multiplex interpretation component; 93- Sample recovery mechanism; 94- Chemiluminescence discarding mechanism; 95- Multiplex discarding mechanism. Detailed Implementation

[0083] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. The components of the embodiments of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0084] Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to illustrate selected embodiments of the application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0085] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0086] In the description of this application, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this application is in use. They are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on this application. In addition, the terms "first," "second," and "third," etc., are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0087] Furthermore, terms such as "horizontal," "vertical," and "sag" do not imply that components must be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal relative to "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0088] In the description of this application, it should also be noted that, unless otherwise expressly specified and limited, the terms "set up," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0089] The following detailed description of some embodiments of this application is provided in conjunction with the accompanying drawings. Unless otherwise specified, the following embodiments and features can be combined with each other.

[0090] It should be noted that, in the description of the embodiments in this application, the term "chemiluminescence method" refers to a trace analysis method that determines the content of an analyte by detecting the chemiluminescence intensity of the system under certain conditions, based on the principle that the concentration of the analyte in a chemical detection system and the chemiluminescence intensity of the system exhibit a linear quantitative relationship under certain conditions. The essential difference between chemiluminescence and other luminescence analyses lies in the different energy sources absorbed by the system to produce luminescence (light radiation). For a system to produce chemiluminescence, it must have a light radiation reaction that generates a detectable signal and a separate chemical reaction that provides sufficient energy to cause the luminescence phenomenon. Based on the characteristics of the energy-supplying reaction, chemiluminescence methods can be classified into ordinary chemiluminescence methods (where the energy-supplying reaction is a general chemical reaction), biochemiluminescence methods (where the energy-supplying reaction is a biochemical reaction), and electrochemiluminescence methods (where the energy-supplying reaction is an electrochemical reaction), etc.

[0091] The "one-step chemiluminescence method" refers to the simultaneous addition of a recognition substance that binds to the target substance in the sample and a labeling substance that carries a signal to the reaction system. Taking the "double antibody sandwich method" as an example, the target substance is the antigen to be tested, the recognition substance is the primary antibody, and the labeling substance is a secondary antibody with a luminescent substance. The one-step chemiluminescence method involves adding the primary antibody that binds to the antigen to be tested in the sample and the secondary antibody with a luminescent substance that binds to the complex formed by the antigen and the primary antibody to a single reaction system. The secondary antibody is labeled with a luminescent substance, and a primary antibody-antigen-secondary antibody-luminescent substance complex is formed in the system. If a substrate or enzyme needs to be added to the reaction system, after washing the system to remove unreacted substances, the substrate or enzyme reacts with the luminescent substance on the primary antibody-antigen-secondary antibody-luminescent substance complex, generating a light signal under certain excitation (e.g., excitation light).

[0092] The aforementioned "chemiluminescence two-step method" refers to the process of adding a recognition substance that binds to the target substance in the sample and a labeling substance that provides a signal to the reaction system in two separate steps. Taking the "double antibody sandwich method" as an example, the target substance is the antigen to be tested, the recognition substance is the primary antibody, and the labeling substance is the secondary antibody with a luminescent substance. The chemiluminescence two-step method involves adding the primary antibody, which binds to the target antigen in the sample, to the system containing the target antigen, forming an antigen-primary antibody complex. After removing unreacted substances from the system, the secondary antibody with the luminescent substance is added. The secondary antibody binds to the antigen-primary antibody complex, forming a primary antibody-antigen-secondary antibody-luminescent substance complex. Simultaneously, if a substrate or enzyme needs to be added to the reaction system, after washing the system and removing unreacted substances, the substrate or enzyme reacts with the luminescent substance on the primary antibody-antigen-secondary antibody-luminescent substance complex, generating a light signal under certain excitation (e.g., excitation light).

[0093] The aforementioned "two-step method for multiplex liquid-phase chips" refers to the following: During the establishment of the reaction system, a recognition substance immobilized on a multiplex liquid-phase chip that binds to the target substance in the sample, and a labeling substance with a signal, are added to the system in two separate steps. Taking the "double-antibody sandwich method" as an example, the target substance is the antigen to be tested, the recognition substance is the primary antibody, and the labeling substance with a signal is the secondary antibody with a luminescent substance. The "two-step method for multiplex liquid-phase chips" will be explained below. In the embodiments of this application, the antigen immobilized on the multiplex liquid-phase chip that binds to the antibody to be tested in the sample is added to the system containing the sample's antibody to be tested, forming a multiplex liquid-phase chip-antigen-antibody complex. After removing unreacted substances from the system, a luminescent secondary antibody is added to the system. The secondary antibody binds to the multiplex liquid-phase chip-antigen-antibody to be tested, forming a multiplex liquid-phase chip-antigen-antibody-secondary antibody-luminescent substance complex. Simultaneously, if it is necessary to add liquid to the reaction system to suspend the multiplex liquid-phase chip, an enhancement solution can be added.

[0094] In the description of the embodiments in this application, the term "analyte" refers to a complex formed by the combination of a target substance, a recognition substance, and a signal-bearing labeling substance, which can be used to detect the target substance. Taking the "double antibody sandwich method" as an example, the target substance is the antigen to be tested, the recognition substance is the primary antibody, the signal-bearing labeling substance is the secondary antibody with a luminescent substance, and the analyte refers to the formed primary antibody-antigen-secondary antibody-luminescent substance complex. In this application, the incubation component can be used to accelerate the formation of the analyte, but the analyte can still be formed even without the incubation component.

[0095] In the description of the embodiments in this application, the term "intermediate" refers to a complex formed after the target substance and the recognition substance bind together. Taking the "double antibody sandwich method" as an example, the target substance is the antigen to be tested, the recognition substance is the primary antibody, the labeling substance with a signal is the secondary antibody with a luminescent substance, and the intermediate refers to the formed primary antibody-antigen complex. In this application, the incubation component can be used to accelerate the formation of the intermediate, but the intermediate can still be formed even without the incubation component.

[0096] In the description of the embodiments of this application, the term "first reagent" refers to: a recognition substance that binds to the target substance in the sample in a one-step chemiluminescence method, or a marker substance having a signal; or a recognition substance that binds to the target substance in the sample in a two-step chemiluminescence method; or a recognition substance that binds to the target substance in the sample and is fixed on a multi-phase liquid chip in a two-step multi-phase liquid chip method.

[0097] The "second reagent" mentioned refers to: a signal-carrying labeled substance in a chemiluminescence two-step method; or, a signal-carrying labeled substance in a multiplex liquid-phase chip two-step method.

[0098] The “substrate liquid” mentioned refers to the labeled substance that reacts with the enzyme and generates a light signal when the substance is identified as an enzyme.

[0099] The "enhancing liquid" mentioned refers to the liquid that suspends the multiphase liquid chip.

[0100] The terms "washing assembly washes the reaction vessel", "washing assembly performs a first wash on the reaction vessel that has been moved into it", or "washing assembly performs a second wash on the reaction vessel that has been moved into it" refer to: the reaction vessel being moved into the washing assembly, where the washing assembly cleans the analyte inside the reaction vessel; or, the washing assembly cleaning the inner wall of the reaction vessel; or, after the analyte has been adsorbed, the washing assembly cleans the analyte.

[0101] The phrases "washing the analyte using the washing assembly," "the washing assembly performing a first wash on the analyte placed inside," or "the washing assembly performing a second wash on the analyte placed inside" refer to: the reaction vessel being moved into the washing assembly, where the washing assembly cleans the analyte; or, after the analyte has been adsorbed, the washing assembly cleans the analyte. After cleaning, the analyte can be placed into a new reaction vessel or into the original reaction vessel.

[0102] like Figures 1 to 3 As shown, this application provides an automated analysis system for analyzing the presence of a target substance in a sample using labeled substances, and a control method applied to the automated analysis system. The automated analysis system may include a pretreatment module, a detection module, and a control module. The pretreatment module is used to pretreat the sample to form an analyte, and may include a pipetting assembly, a washing assembly, a sample injection assembly 10, a sample addition assembly, a reagent assembly, and an incubation assembly. The detection module is used to detect the analyte, and includes a chemiluminescence detection assembly 91 and a multiplexer assembly 92. The control module may include a detection type control unit, which determines the required detection method based on the incoming sample, and controls the pretreatment module to pretreat the sample and the detection module to detect the analyte according to the corresponding detection method. Specifically, when the detection method is a one-step or two-step chemiluminescence method, the analyte, after being washed by the washing component of the aforementioned pretreatment module, is transferred to the chemiluminescence detection component of the detection module by the pipetting component for detection; when the detection method is a two-step multiplex liquid phase chip method, the analyte, after being washed by the washing component, is transferred to the multiplex interpretation component by the pipetting component for detection.

[0103] The control method for using this automatic analysis system provided in this application may include the following steps:

[0104] Detection type determination steps: The detection type control unit of the control module determines the detection method to be performed based on the sample;

[0105] Pretreatment steps: The pretreatment module pretreatments the sample according to the detection method to form the analyte; wherein, if the detection method is a one-step or two-step chemiluminescence method, the analyte washed by the washing component of the pretreatment module is transferred to the chemiluminescence detection component of the detection module through the pipetting component of the pretreatment module; if the detection method is a two-step multiplex liquid phase chip method, the analyte washed by the washing component is transferred to the multiplex interpretation component of the detection module through the pipetting component;

[0106] Test object detection steps: The detection module detects the test object.

[0107] Compared with the prior art, the automatic analysis system and control method provided in this application embodiment can perform one-step chemiluminescence, two-step chemiluminescence, and two-step multiplex liquid phase chip detection in one automatic analysis system, and integrate multiple detection methods into one automatic analysis system, reducing purchase and production costs, reducing the floor space required, and optimizing and improving sample detection efficiency. It can use the same automatic analysis system to perform multiple different tests on the same sample, or perform multiple different tests on multiple samples simultaneously, with orderly operation and no interference between them, greatly improving detection efficiency.

[0108] like Figure 1 As shown, the aforementioned sample introduction component 10 is used to transport samples. It may include a sample introduction channel 11, an inlet end 111 connected to the sample introduction channel 11, and an emergency supplementary inlet end 112. It also includes a sample transfer mechanism 12 connected to the inlet end 111 and the emergency supplementary inlet end 112 respectively. The sample transfer mechanism 12 may also be a sample transfer channel. Staff can enter the sample transfer mechanism 12 through the inlet end 111 or the emergency supplementary inlet end 112 as needed.

[0109] The detection type control unit of the aforementioned control module needs to determine the corresponding detection method based on the incoming sample, such as one-step chemiluminescence detection, two-step chemiluminescence detection, or two-step multiplex liquid chromatography-chip detection. In this regard, one optional implementation is that the aforementioned sample transfer mechanism 12 may have a scanner for scanning the sample information of the incoming sample. This scanner can scan the sample information of the incoming sample, and the detection type control unit receives and determines the corresponding detection method—one-step chemiluminescence detection, two-step chemiluminescence detection, or two-step multiplex liquid chromatography-chip detection—based on this sample information. The subsequent preprocessing module and detection module then perform preprocessing and detection according to the determined detection method.

[0110] Furthermore, the automated analysis system provided in this application embodiment may also include a sample buffer mechanism 20 for temporarily storing samples. The aforementioned sample transfer mechanism 12 is connected to the sample buffer mechanism 20, allowing samples entering the sample transfer mechanism 12 to be temporarily stored in the sample buffer mechanism 20. The corresponding steps may include: moving samples into the sample buffer mechanism 20 via the sample transfer mechanism 12 within the sample introduction component. This allows the sample set to first enter the sample buffer mechanism 20, facilitating centralized processing and subsequent location-based retrieval by the transfer mechanism.

[0111] Furthermore, the aforementioned sample injection component 10 may also include a sample transfer mechanism 71 for extracting and moving samples. The sample transfer mechanism 71 can transfer samples from the aforementioned sample buffer mechanism 20 to the sample loading component. In order to facilitate centralized transfer, batch transfer and increase the transfer volume, the sample buffer mechanism 20 may also be provided with a loading arm 21 that works in conjunction with the sample transfer mechanism 71. The length of the loading arm 21 spans across the opposite ends of the sample buffer mechanism 20, covering the sample buffer area, speeding up the sample entry speed, speeding up the detection speed, increasing the number of samples detected per unit time, reducing the number of empty positions and improving detection efficiency.

[0112] Furthermore, the aforementioned pretreatment module may also include a reaction vessel replenishment mechanism 13, which transfers the reaction vessel to the sample loading assembly. The corresponding steps may include: a sample transfer mechanism 71 transferring at least a portion of the sample in the sample buffer mechanism 20 to the sample loading assembly, and the reaction vessel replenishment mechanism 13 transferring the reaction vessel to the sample loading assembly.

[0113] Based on the aforementioned embodiments, the aforementioned sample buffering mechanism 20 may further include an entry section, an exit section, and multiple buffer areas in sequence. This embodiment is illustrated by taking a first buffer area, a second buffer area, a third buffer area, and an emergency area in sequence as an example. The first buffer area, the second buffer area, the third buffer area, and the emergency area are respectively connected to the entry section and the exit section. The entry section is provided with a scanner for scanning sample information. The control unit determines whether dilution is required. If dilution is required, the entry section moves the sample entering it into the third buffer area. If dilution is not required, the entry section moves samples that require the same incubation, washing, and signal acquisition time into the first buffer area. The entry section moves samples that require different incubation, washing, and signal acquisition times into the second buffer area. The entry section moves samples that require urgent testing into the emergency area. When the aforementioned sample transfer mechanism transfers samples, it first checks whether there are samples in the aforementioned emergency area. If there are, it prioritizes transferring samples from the emergency area.

[0114] This setup allows for automatic separation and batching of samples fed into the sample introduction component 10 based on whether the incubation, washing, and signal acquisition times required during the testing process are the same, reducing the workload of medical staff. Furthermore, the separated samples can be analyzed without interrupting the automatic analysis system. When a sample requires urgent testing, medical staff can feed the sample into the aforementioned emergency supplementary inlet 112. The sample then enters the emergency area of ​​the sample buffer unit 20 via the aforementioned sample transfer mechanism 12. After the detection device of the sample transfer mechanism 71 detects that there is a sample in the emergency area, it first takes samples one by one from the emergency area for testing. When the detection device detects that there is no sample in the emergency area, it can perform testing in the order of the first buffer area, the second buffer area, and the third buffer area.

[0115] Furthermore, in a specific embodiment, the sample detection types of this automated analysis system may include chemiluminescence detection A, chemiluminescence detection B, chemiluminescence detection C, multiplex liquid chromatography-array detection D, and multiplex liquid chromatography-array detection E. Chemiluminescence detection A is the aforementioned one-step chemiluminescence detection method, and chemiluminescence detection B is the aforementioned two-step chemiluminescence detection method. The first incubation and first washing times are the same for both chemiluminescence detection A and chemiluminescence detection B, and the first incubation and first washing times are the same as the second incubation and second washing times for chemiluminescence detection B. Chemiluminescence detection C is a two-step chemiluminescence detection method that requires sample dilution but has the same incubation and washing times as chemiluminescence detection B. Multiplex liquid chromatography-array detection D is the aforementioned two-step multiplex liquid chromatography-array detection method with the same incubation and washing times as chemiluminescence detection B. Multiplex liquid chromatography-array detection E has different incubation and washing times than chemiluminescence detection B. Once samples are received, samples using chemiluminescence detection A, chemiluminescence detection B, or multiplex liquid chromatography-array detection D enter the first buffer; samples using multiplex liquid chromatography-array detection E enter the second buffer; and samples using chemical reagent C enter the third buffer. If reagents requiring different incubation and washing times are needed, the number of buffers can be increased according to the type of detection time.

[0116] like Figures 1 to 3 As shown, the aforementioned sample loading assembly is used for sample transfer and reaction container placement. Specifically, this assembly can be a sample loading turntable 30, with a reaction container replenishment position, a sample dilution position, a first reagent addition position 31, a sample loading position 32, and a sample removal position 33 along its circumferential edge. Multiple positions allow for simultaneous loading, uninterrupted sample transfer, and sample loading, improving detection efficiency. Multiple samples can be processed simultaneously. Furthermore, one or more of these positions can be configured, increasing the number of different samples that can be processed simultaneously during reagent loading, first reagent addition, and dilution. This improves the utilization rate of the sample loading turntable, allowing samples from different testing times to be placed simultaneously, facilitating use by medical personnel, increasing the number of simultaneous tests, and thus improving detection efficiency.

[0117] The aforementioned pipetting assembly may specifically include a first reagent transfer mechanism 72, a second reagent transfer mechanism 73, a first pipetting mechanism 74, a second pipetting mechanism 75, a third pipetting mechanism 76, a fourth pipetting mechanism 77, and a fifth pipetting mechanism 78. The first pipetting mechanism 74, the second pipetting mechanism 75, the third pipetting mechanism 76, the fourth pipetting mechanism 77, and the fifth pipetting mechanism 78 may be a rocker structure. The rocker structure can transfer reagents by moving along a directional trajectory with a certain distance as the radius, centered on a certain point. On its movement trajectory, a certain reagent can be moved from a fixed point 1 to a fixed point 2.

[0118] The aforementioned reagent assembly is used to store the first reagent, the second reagent, and sample diluent, etc. Specifically, this reagent assembly can be a reagent turntable 40. The reagent turntable 40 can have a first reagent loading position 41, a second reagent loading position 42, and a reagent loading port sequentially arranged along its circumferential edge. The reagent turntable 40 simultaneously refrigerates chemiluminescent reagents and multiplex liquid phase chip reagents at low temperatures. Furthermore, the reagent turntable 40 can be divided into multiple rows of reagent wells from the outside in, significantly increasing the number of wells for placing the first reagent, the second reagent, and the sample diluent, thereby increasing the simultaneous reagent capacity, the number of simultaneous detections, and further improving detection efficiency. The aforementioned automated analysis system also includes a reagent loading and unloading mechanism, which allows for the replenishment and removal of reagents from the aforementioned reagent loading port without stopping the operation of other components within the automated analysis system besides the reagent turntable 40.

[0119] The corresponding steps may include: the aforementioned reaction container replenishment mechanism 13 can move the reaction container to the reaction container replenishment position of the aforementioned sample dispensing component; the sample dispensing component rotates to move the reaction container from its reaction container replenishment position to its first reagent addition position 31; the reagent component rotates to move the first reagent to the first reagent loading position 41; the aforementioned first reagent removal mechanism 72 removes the first reagent from the first reagent loading position 41 to the first reagent addition position 31 and injects it into the reaction container; the sample dispensing component rotates to move the reaction container from its first reagent loading position 41 to its sample dispensing position 32; the aforementioned sample removal mechanism 71 removes the sample to the sample dispensing position 32 and injects it into the reaction container; and the sample dispensing component rotates again to move the reaction container to its sample removal position 33.

[0120] Furthermore, the aforementioned incubation component can specifically be an incubation turntable 50. This incubation turntable 50 can be divided into an outer ring and an inner ring along its circumference from the outside in. The outer ring has outer incubation positions, which may include a first incubation insertion position 51 and a first incubation removal position 52. The inner ring has inner incubation positions, which may include a second incubation insertion position 53 and a second incubation removal position 54. Different incubation processes are carried out in separate areas within the outer and inner rings, which on the one hand improves the effectiveness of different incubation processes, and on the other hand facilitates the removal of samples by different transfer mechanisms at different positioning points. Multiple first incubation insertion positions 51, first incubation removal positions 52, second incubation insertion positions 53, and second incubation removal positions 54 can also be provided along the circumferential direction of both the outer and inner rings, facilitating the simultaneous incubation of multiple samples and improving detection efficiency. The incubation turntable 50 can also be equipped with a heating mechanism to provide reaction temperature for the liquid in the reaction vessel, and can also be equipped with an oscillation mechanism to evenly disperse the components in the reaction vessel, and a washing mechanism to remove components that need to be removed from the reaction vessel.

[0121] Further, in one optional embodiment, the aforementioned incubation turntable 50 can be a ring structure, and the aforementioned reagent turntable 40 can be located within the inner ring of the incubation turntable 50. The rotation centers of the incubation turntable 50 and the reagent turntable 40 coincide, the diameter of the incubation turntable 50 is larger than the diameter of the reagent turntable 40, and the area swept by the sample dispensing turntable 30 when rotating does not coincide with the area swept by the incubation turntable 50 when rotating. In another optional embodiment, the reagent turntable 40 can be located at the center of the inner ring of the incubation turntable 50, and the two are integrally formed with their rotation centers coinciding. The diameter of the incubation turntable 50 is larger than the diameter of the reagent turntable 40, and the area swept by the sample dispensing turntable 30 when rotating does not coincide with the area swept by the incubation turntable 50 when rotating. Both of these arrangements allow the incubation turntable 50 and the reagent turntable 40 to rotate independently without affecting each other, while also achieving a certain degree of structural integration and improving structural compactness, reducing the overall space occupied.

[0122] The corresponding steps may include that the first pipetting mechanism 74 of the aforementioned pipetting assembly can move the reaction container from the sample dispensing position 33 of the aforementioned sample dispensing assembly to the first incubation inlet position 51 located on the outer ring of the aforementioned incubation assembly for the first incubation. After the incubation assembly is completed, the rotation of the incubation assembly can move the reaction container from its first incubation inlet position 51 to its first incubation dispensing position 52.

[0123] In another preferred embodiment, the aforementioned washing assembly may include a first washing mechanism and a second washing mechanism. The first washing mechanism may specifically be a turntable structure, specifically a first washing turntable 61, with a first washing inlet / outlet position 611, a first washing position, a second reagent inlet position 613, a first substrate solution inlet position, and a first washing outlet position 612 respectively provided along its circumferential edge. A first washing element may be located above the first washing position, and a first substrate solution conveying mechanism for conveying the substrate solution is located above the first substrate solution inlet position. The second washing mechanism may also specifically be a turntable structure, specifically a second washing turntable 62, with a second washing inlet position 621, a second washing position, a second substrate solution inlet position, a reinforcing liquid inlet position, and a second washing outlet position 622 respectively provided along its circumferential edge. A second washing element is located above the second washing position, a second substrate solution conveying mechanism for conveying the substrate solution is located above the second substrate solution inlet position, and a reinforcing liquid conveying mechanism for conveying the reinforcing liquid is located above the reinforcing liquid inlet position. Setting up fixed points facilitates the positioning and relocation of the module's relocation mechanism or components, resulting in greater directional accuracy and higher efficiency.

[0124] The corresponding steps may include the second pipetting mechanism 75 causing the reaction container to be moved from the first incubation removal position 52 of the incubation component to the first washing inlet and removal position 611 of the first washing mechanism. The rotation of the first washing mechanism causes the reaction container to move from its first washing inlet position 611 to its first washing position and be washed by the first washing component above it.

[0125] In one specific embodiment, the aforementioned first reagent transfer mechanism 72 may include a first moving track 721 and a first pipetting component 722. The first reagent loading position 41 of the aforementioned reagent assembly and the first reagent adding position 31 of the sample dispensing assembly are located on the moving track 721. The first pipetting component 722 moves on the first moving track 721, causing the first reagent or sample diluent to be transferred from the first reagent loading position 41 to the first reagent adding position 31. This transfer mechanism is simple and direct to operate, and the transfer process is reliable. Similarly, the aforementioned second reagent transfer mechanism 73 may also include a second moving track 731 and a second pipetting component 732. The second reagent loading position 42 of the aforementioned reagent assembly and the second reagent adding position 613 of the aforementioned first washing mechanism are located on the moving track 731. The second pipetting component 732 moves on the second moving track, causing the second reagent to be transferred from the second reagent loading position 42 to the second reagent adding position 613. This transfer mechanism is simple and direct to operate, and the transfer process is reliable.

[0126] Based on the foregoing embodiments, a preferred embodiment is that the first moving track 721 can be a straight track, with the first reagent loading position 41 and the first reagent adding position 31 fixed on a straight line; the second moving track 731 can also be a straight track, with the second reagent loading position 42 and the second reagent adding position 613 fixed on a straight line; furthermore, the first moving track 721 and the second moving track 731 can be arranged parallel to each other. Another optional embodiment is that the first moving track 721 and the second moving track 731 are integrally formed into a single moving track, but two slide rails are respectively provided on both sides of this single moving track, corresponding to the positions of the first moving track 721 and the second moving track 731, and these two slide rails can be straight or parallel to each other.

[0127] In another preferred embodiment, the aforementioned washing assembly may further include a first washing mechanism 81, a second washing mechanism 82, and a third washing mechanism 83. The first washing mechanism 81 may be located on the movement trajectory of the aforementioned sample transfer mechanism 71. After the aforementioned sample transfer mechanism 71 has transferred a sample to the sample loading assembly, it may move to the first washing mechanism 81 for cleaning and then reset. The second washing mechanism 82 may be located on the movement trajectory of the aforementioned first reagent transfer mechanism 72. After the aforementioned first reagent transfer mechanism 72 has transferred a first reagent or sample diluent to the sample loading assembly, the first reagent transfer mechanism may move to the second washing mechanism 82 for cleaning and then reset. The third washing mechanism 83 may be located on the movement trajectory of the aforementioned second reagent transfer mechanism 73. After the second reagent transfer mechanism 73 has transferred a second reagent to the first washing mechanism, the second reagent transfer mechanism 73 may move to the third washing mechanism 83 for cleaning and then reset. This design allows for the removal of liquids that come into contact with the reagents during the transfer process. On the one hand, it effectively prevents reagents from being contaminated by other liquids when transferring different reagents, which could affect the test results or even lead to incorrect results. On the other hand, it ensures the cleanliness of the transfer mechanism, prevents it from being damaged due to contamination, and extends its service life.

[0128] The aforementioned chemiluminescence detection component 91 is used to perform chemiluminescence detection on the analyte delivered therein. By detecting the same reagent at different wavelengths, or different reagents at the same wavelength, the sample can be quantitatively or qualitatively detected.

[0129] The aforementioned multiplex interpretation component 92 is used to perform multiplex liquid-phase chip analysis and detection on the analyte delivered therein. It takes pictures under bright field to identify the position of different coded liquid-phase chips, takes pictures under dark field to determine the fluorescence signal corresponding to each liquid-phase chip, and converts the fluorescence intensity on the liquid-phase chip into the concentration of the corresponding target substance to obtain qualitative or quantitative detection results.

[0130] In another preferred embodiment, the automated analysis system provided in this application may further include a sample recovery mechanism 93, which can be connected to the aforementioned sample transmission mechanism 12. The corresponding steps may include sequentially sending samples to the sample recovery mechanism via the sample buffer mechanism 20 and the sample transmission mechanism 12. This configuration facilitates centralized processing of recovered samples after use.

[0131] The automated analysis system provided in this application may further include a reaction vessel disposal module, which specifically may include a chemiluminescence disposal mechanism 94 and a multiple disposal mechanism 95. The corresponding steps may include: the pipetting assembly transferring the reaction vessel, after detection, from the chemiluminescence detection assembly 91 into the chemiluminescence disposal mechanism for centralized processing; the pipetting assembly also transferring the reaction vessel from the aforementioned multiple interpretation assembly 92 into the multiple disposal mechanism 95 for centralized processing. This configuration facilitates the centralized processing and recovery of reaction vessels after detection.

[0132] The aforementioned preprocessing steps also include:

[0133] Perform the first incubation step: The sample introduction component adds the sample into the reaction vessel inside the sample addition component, and the pipetting component transfers the reaction vessel into the incubation component to complete the first incubation;

[0134] The decision on whether to perform a second incubation step depends on the detection method. If the detection method is a one-step chemiluminescence method, after the first incubation is completed, the pipetting assembly will transfer the analyte to the washing assembly for washing, and no second incubation will be performed.

[0135] If the detection method is a two-step method using multiplex liquid-phase chips or a two-step method using chemiluminescence, after the first incubation, the pipetting assembly transfers the intermediate to the washing assembly for the first wash. The pipetting assembly then transfers the second reagent from the reagent assembly to the reaction vessel and mixes it with the intermediate. After that, the pipetting assembly moves the reaction vessel to the incubation assembly for the second incubation. After the second incubation, the pipetting assembly transfers the analyte to the washing assembly for the second wash.

[0136] The aforementioned first incubation step includes: a first pipetting component moves along a first moving track, the first pipetting component displaces the first reagent from the first reagent loading position on the reagent assembly to the reaction container located at the first reagent addition position on the sample dispensing assembly, the reaction container moves from the first reagent addition position to the sample dispensing position, the sample injection assembly adds the sample to the reaction container located at the sample dispensing position, so that the sample and the first reagent are mixed in the reaction container, and then the first pipetting mechanism moves the reaction container into the first incubation dispensing position on the incubation assembly for the first incubation; wherein, when the detection method is a one-step chemiluminescence method, the analyte is generated when the first reagent, the second reagent and the sample are mixed, and the speed of analyte generation is accelerated during the first incubation.

[0137] The aforementioned determination of whether to perform a second incubation step is based on the detection method. If the detection method is a one-step chemiluminescence method, after the first incubation is completed, the reaction container moves from the first incubation inlet position to the first incubation outlet position. The second pipetting mechanism moves the analyte from the first incubation outlet position to the first washing inlet / outlet position in the first washing mechanism. The reaction container then moves from the first washing inlet / outlet position to the first washing position. The first washing element above the first washing position washes the analyte. The reaction container moves from the first washing position to the first substrate liquid inlet position. The first substrate liquid delivery mechanism above the first substrate liquid inlet position inputs the substrate liquid into the reaction container and mixes it with the analyte inside. After the reaction container moves from the first substrate liquid inlet position to the first washing outlet position, the third pipetting mechanism moves the reaction container into the chemiluminescence detection component.

[0138] If the detection method is a two-step multiphase liquid chip method or a two-step chemiluminescence method, after the first incubation, the reaction container moves from the first incubation inlet position to the first incubation outlet position. The second pipetting mechanism moves the analyte from the first incubation outlet position to the first washing inlet / outlet position in the first washing mechanism. The reaction container then moves from the first washing inlet / outlet position to the first washing position. The first washing component performs the first washing of the intermediate. The reaction container then moves from the first washing position to the second reagent addition position. The second pipetting component moves along the second moving track to pick up the second reagent from the second reagent loading displacement position and place it into the reaction container at the second reagent addition position, so that the second reagent and the intermediate are mixed in the reaction container. The reaction container then moves from the second reagent inlet position to the second reagent addition position. The reagent addition position moves to the first washing inlet / outlet position. The fourth pipetting mechanism moves the reaction container from the first washing inlet / outlet position to the second incubation inlet position on the incubation assembly for a second incubation. After the second incubation, the reaction container moves from the second incubation inlet position to the second incubation outlet position. The fourth pipetting mechanism moves the reaction container from the second incubation outlet position to the second washing inlet position on the second washing mechanism. The reaction container moves from the second washing inlet position to the second washing position, and the second washing component performs a second washing of the analyte. In the detection method of a two-step multi-phase liquid chip method or a two-step chemiluminescence method, the intermediate is generated when the first reagent is mixed with the sample, accelerating the generation rate of the intermediate during the first incubation. When the second reagent is added, the second reagent reacts with the intermediate to form the analyte, accelerating the generation rate of the analyte during the second incubation.

[0139] Determine the movement position of the test item after the second wash based on the detection method:

[0140] If the detection method is a two-step chemiluminescence method, the analyte after the second wash is moved from the second wash position to the second substrate liquid addition position. The second substrate liquid delivery mechanism above the second substrate liquid addition position inputs the substrate liquid into the reaction vessel and mixes it with the analyte inside. Then the reaction vessel is moved from the second substrate liquid addition position to the second wash removal position. The third liquid transfer mechanism moves the reaction vessel from the second wash removal position to the chemiluminescence detection component.

[0141] If the detection method is a two-step multi-phase liquid chip method, the analyte after the second wash is moved from the second wash position to the enhancement liquid addition position. The enhancement liquid delivery mechanism above the enhancement liquid addition position inputs the substrate liquid into the reaction vessel and mixes it with the analyte inside. Then the reaction vessel is moved from the enhancement liquid addition position to the second wash removal position. The fifth liquid transfer mechanism moves the reaction vessel from the second wash removal position to the multi-reading component.

[0142] Furthermore, before performing the aforementioned first incubation step, a step is also included to determine whether the sample needs to be diluted: if the sample transferred into the sample loading component needs to be diluted, the first pipetting component transfers the sample diluent into the reaction container located at the sample dilution position on the sample loading turntable, and the injection component adds the sample into the reaction container located at the sample dilution position to mix the sample with the sample diluent and dilute the sample. Afterward, the injection component removes the diluted sample and adds it into the reaction container at the sample loading position in the sample loading component.

[0143] If the sample transferred into the sample loading assembly does not require dilution, the injection assembly directly delivers the sample into the reaction vessel at the loading position within the sample loading assembly.

[0144] Furthermore, before determining whether the sample needs to be diluted, the process includes the following steps: the reaction vessel replenishment mechanism replenishes the reaction vessel to the sample loading assembly; and the scanner in the sample loading assembly acquires the sample information.

[0145] Furthermore, after the detection module detects the analyte, the process also includes the steps of: the pipetting assembly moving the reaction container into the luminescent discarding mechanism, or the pipetting assembly moving the reaction container into the multiple discarding mechanism.

[0146] Furthermore, reaction container replenishment refers to the replenishment of reaction containers by the reaction container replenishment mechanism to the reaction container replenishment position on the sample dispensing turntable. Reaction container replenishment can be completed before medical personnel deliver the sample, after medical personnel deliver the sample and before the sample information is read, or after the sample information is read and before the first reagent is added.

[0147] In summary, such as Figure 4 As shown, the specific steps of the automatic analysis system control method provided in this application embodiment can be as follows:

[0148] Step S1: The sample introduction component 10 allows the sample to enter. Staff can introduce the sample into the sample transfer mechanism 12 of the sample introduction component 10 through the inlet 111 or the emergency supplement inlet 112 as needed. The scanner inside scans the sample and records the sample information. The control unit inside receives the sample information and selects the corresponding one-step chemiluminescence detection, two-step chemiluminescence detection, or two-step multiplex liquid chromatography chip detection based on the sample information. After that, the sample transfer mechanism 12 moves the sample into the sample buffer mechanism 20 for temporary storage, and then proceeds to step S2.

[0149] Step S2: The reaction container replenishment mechanism 13 moves the reaction container to the reaction container replenishment position of the sample dispensing turntable 30. The sample dispensing turntable 30 rotates to move the reaction container from its reaction container replenishment position to its first reagent addition position 31. The reagent turntable 40 rotates to move the first reagent to its first reagent loading position 41. The first reagent transfer mechanism 72 transfers the first reagent from the first reagent loading position 41 to the first reagent addition position 31 and injects it into the reaction container located at the first reagent addition position 31, proceeding to S3.

[0150] Step S31: If the sample needs to be diluted, the reagent turntable 40 rotates to move the sample diluent to its first reagent loading position 41. The first reagent transfer mechanism 72 transfers the sample diluent from the first reagent loading position 41 to the first reagent addition position 31 of the aforementioned sample transfer turntable 30 and injects it into the reaction container for dilution, and then proceeds to S3.

[0151] Step S32: If the sample does not need to be diluted, proceed directly to step S3;

[0152] Step S3: The sample loading turntable 30 rotates to move the reaction container from its first reagent loading position 41 to its sample loading position 32. The sample transfer mechanism 71 transfers at least part of the sample in the sample buffer mechanism 20 to the sample loading position 32 and injects it into the reaction container located at the sample loading position 32, so that the sample in the reaction container is mixed with the first reagent. The sample loading turntable 30 then rotates to move the reaction container to its sample loading and unloading position 33, proceeding to step S4.

[0153] Step S4: The first pipetting mechanism 74 moves the reaction container from the sample dispensing position 33 of the aforementioned sample dispensing turntable 30 to the first incubation position 51 located on the outer ring of the aforementioned incubation turntable 50 for the first incubation. After the first incubation is completed, the rotation of the incubation turntable 50 can move the reaction container from its first incubation position 51 to its first incubation position 52, and proceed to step S5.

[0154] Step S5, the second pipetting mechanism 75 can move the reaction container from the first incubation removal position 52 of the aforementioned incubation turntable 50 to the first washing inlet and removal position 611 of the first washing turntable 61. The first washing turntable 61 rotates to move the reaction container from its first washing inlet position 611 to its first washing position, and washes it through the first washing mechanism above it.

[0155] If a one-step chemiluminescence detection method is used, the analyte is fully formed after the first incubation. The first washing turntable 61 rotates to move the reaction container from its first washing position to its first substrate liquid addition position. After the substrate liquid is added to the reaction container through the first substrate liquid delivery mechanism above it, the first washing turntable 61 rotates to move the reaction container from its first substrate liquid addition position to its first washing removal position 612. The third liquid transfer mechanism 76 removes the reaction container from the first washing removal position 612 of the first washing turntable 61 into the chemiluminescence detection component 91, and proceeds to step S8.

[0156] If a two-step chemiluminescence method or a two-step multiplex liquid phase chip method is used for detection, the intermediate is fully formed after the first incubation. The first washing turntable 61 rotates to move the reaction vessel from its first washing position to its second reagent addition position 613. The aforementioned reagent turntable 40 rotates to move the second reagent on it to its second reagent loading position 42. The second reagent transfer mechanism 73 transfers the second reagent from the second reagent loading position 42 of the reagent turntable 40 to the second reagent addition position 613 of the first washing turntable 61 and adds it to the reaction vessel. After that, the first washing turntable 61 rotates to move the reaction vessel from its second reagent addition position 613 to its first washing transfer-in-transfer-out position 611, and proceeds to step S6.

[0157] Step S6: The second pipetting mechanism 75 moves the reaction container from the first washing inlet / outlet position 611 of the first washing turntable 61 to the second incubation inlet position 53 of the incubation turntable 50 for a second incubation. After the second incubation is completed, the analyte is fully formed. The incubation turntable 50 rotates to move the reaction container from its second incubation inlet position 53 to its second incubation outlet position 54, and proceeds to step S7.

[0158] In step S7, the fourth pipetting mechanism 77 moves the reaction container from the second incubation removal position 54 of the aforementioned incubation turntable 50 to the second washing removal position 621 of the aforementioned second washing turntable 62. The second washing turntable 62 rotates, causing the reaction container to move from its second washing removal position 621 to its second washing position, and is washed by the second washing mechanism above it. If a two-step chemiluminescence detection method is used, the second washing turntable 62 rotates, causing the reaction container to rotate from its second washing position to its second substrate liquid addition position, and the second substrate liquid delivery mechanism above it adds substrate liquid to the reaction container. Then, the second washing turntable 62 rotates, causing the reaction container to move from its second substrate liquid addition position to its second washing removal position 622. The third pipetting mechanism 76 moves the reaction container from the second washing removal position 622 to the chemiluminescence detection component 91, and proceeds to step S8.

[0159] If a two-step detection method using multiple liquid phase chips is adopted, the second washing turntable 62 rotates to move the reaction container from its second washing position to its enhancement liquid addition position, and the enhancement liquid is added to the reaction container through the enhancement liquid delivery mechanism above it. Then, the second washing turntable 62 rotates to move the reaction container from its enhancement liquid addition position to its second washing removal position 622, and the fifth liquid transfer mechanism 78 removes the reaction container from the second washing removal position 622 to the multiple interpretation component 92, and proceeds to step S9;

[0160] Step S8: The pipetting assembly moves the reaction vessel into the chemiluminescence detection assembly to complete the chemiluminescence detection;

[0161] Step S9: The pipetting assembly moves the reaction vessel into the multiplex interpretation assembly to complete the multiplex liquid phase chip detection.

[0162] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application.

Claims

1. An automated analysis system for analyzing the presence of a target substance in a sample by using labeled substances, characterized in that, include: The pretreatment module is used to pretreat samples to form analytes, and includes a pipetting assembly and a washing assembly; The detection module, used to detect the analyte, includes a chemiluminescence detection component and a multiplex interpretation component; The control module includes a detection type control unit, which is used to determine the required detection method based on the sample, and control the preprocessing module to preprocess the sample and the detection module to detect the analyte according to the corresponding detection method. When the detection method is a one-step chemiluminescence method or a two-step chemiluminescence method, the analyte, after being washed by the washing assembly, is transferred to the chemiluminescence detection assembly by the pipetting assembly for detection. When the detection method is a two-step multi-phase liquid chip method, the analyte, after being washed by the washing assembly, is transferred to the multi-reading assembly for detection by the pipetting assembly. The pretreatment module further includes a sample injection component, which includes a sample transfer mechanism, a scanner for scanning sample information, a sample buffer mechanism, an inlet and an emergency supplementary inlet for the sample to enter, and a sample transmission mechanism that is connected to the inlet and the emergency supplementary inlet respectively. The sample transmission mechanism is connected to the sample buffer mechanism. The sample buffering mechanism includes, in sequence, an entry section, a first buffer area, a second buffer area, a third buffer area, and an exit section. The first, second, and third buffer areas are respectively connected to the entry section and the exit section. The entry section is equipped with a scanner for scanning sample information. The scanner determines whether dilution is required based on the scanned sample information. If dilution is required, the entry section moves the sample into the third buffer area. If dilution is not required, the entry section moves samples requiring the same incubation, washing, and signal acquisition time into the first buffer area, and samples requiring different incubation, washing, and signal acquisition times into the second buffer area. The sample removal mechanism detects and removes samples in the order of the first buffer area, the second buffer area, and the third buffer area.

2. The automatic analysis system according to claim 1, characterized in that, The pretreatment module also includes a sample addition component, a reaction vessel replenishment mechanism, a reagent component, and an incubation component; The sample dispensing assembly is used to remove the sample and / or place the reaction container. The sample dispensing assembly is a sample dispensing turntable, and the sample dispensing turntable is provided with a reaction container replenishment position, a sample dilution position, a first reagent addition position, a sample dispensing position, and a sample removal position along its circumferential edge. The reaction vessel replenishment mechanism is used to replenish the reaction vessel to the reaction vessel replenishment position; The reagent assembly is used to store a first reagent, a second reagent, and / or a sample diluent. The reagent assembly is a reagent turntable, and the reagent turntable has a first reagent loading position and a second reagent loading position sequentially arranged along its circumferential edge. The incubation assembly is an incubation turntable with a ring structure. The incubation turntable includes an inner incubation position and an outer incubation position disposed outside the inner incubation position. The outer incubation position includes a first incubation insertion position and a first incubation removal position. The inner incubation position includes a second incubation insertion position and a second incubation removal position. The reagent turntable is located within the inner ring of the incubation turntable. The rotation centers of the incubation turntable and the reagent turntable coincide. The area swept by the sample dispensing turntable when it rotates does not coincide with the area swept by the incubation turntable when it rotates.

3. The automatic analysis system according to claim 2, characterized in that, The washing assembly includes a first washing mechanism and a second washing mechanism. The first washing mechanism is located between the incubation turntable and the chemiluminescence detection assembly, and the second washing mechanism is located between the incubation turntable and the multiplex interpretation assembly. The first washing mechanism is a turntable structure, with a first washing inlet / outlet position, a first washing position, a second reagent inlet position, a first substrate liquid inlet position, and a first washing outlet position arranged sequentially along its circumference. Above the first washing position is a first washing component, and above the first substrate liquid inlet position is a first substrate liquid conveying mechanism for conveying the substrate liquid. The second washing mechanism is a turntable structure, with a second washing inlet, a second washing position, a second substrate liquid inlet, a booster liquid inlet, and a second washing outlet arranged sequentially along its circumference. A second washing component is located above the second washing position. A second substrate liquid conveying mechanism for conveying the substrate liquid is located above the second substrate liquid inlet. A booster liquid conveying mechanism for conveying the booster liquid is located above the booster liquid inlet. The pipetting assembly includes a first pipetting mechanism, a second pipetting mechanism, a third pipetting mechanism, a fourth pipetting mechanism, and a fifth pipetting mechanism; The first pipetting mechanism is located between the sample dispensing turntable and the incubation turntable; The second pipetting mechanism is located between the first washing mechanism and the incubation turntable; The third pipetting mechanism is located between the second washing mechanism and the chemiluminescence detection component, and also between the first washing mechanism and the chemiluminescence detection component; The fourth pipetting mechanism is located between the incubation turntable and the second washing mechanism; The fifth pipetting mechanism is located between the second washing mechanism and the multiple interpretation component.

4. The automatic analysis system according to claim 3, characterized in that, The pipetting assembly further includes a first reagent transfer mechanism and a second reagent transfer mechanism; The first reagent transfer mechanism includes a first moving track and a first pipetting component; The first reagent loading position and the first reagent adding position are located on the movement trajectory of the first pipetting component on the first moving track; The second reagent transfer mechanism includes a second moving track and a second pipetting component. The second reagent loading position and the second reagent adding position are located on the movement trajectory of the second pipetting component on the second moving track.

5. The automatic analysis system according to claim 4, characterized in that, The sample buffer mechanism also includes an emergency area, which is connected to the entry section and the exit section. The entry section determines whether dilution is needed by scanning the sample information of the scanned document. If dilution is needed, the entry section causes the sample to enter the third buffer area. If dilution is not needed, the entry section causes the sample that needs to be tested urgently to enter the emergency area. The sample removal mechanism is used to prioritize detecting whether there is a sample in the emergency area and remove it. The washing assembly further includes a first cleaning mechanism, a second cleaning mechanism, and a third cleaning mechanism. The first cleaning mechanism is located on the moving trajectory of the sample transfer mechanism, the second cleaning mechanism is located on the moving trajectory of the first reagent transfer mechanism, and the third cleaning mechanism is located on the moving trajectory of the second reagent transfer mechanism. The sample introduction component also includes a sample recovery mechanism, which is connected to the sample transfer mechanism.

6. The automatic analysis system according to claim 1, characterized in that, The automated analysis system also includes a luminescent tube discarding mechanism, wherein the pipetting component transfers the detected analyte from the chemiluminescence detection component into the luminescent tube discarding mechanism; The automated analysis system also includes a multiple discard mechanism, in which the pipetting assembly transfers the tested analyte from the multiple interpretation assembly into the multiple discard mechanism.

7. A control method applied to the automatic analysis system according to any one of claims 1 to 6, characterized in that, include: Detection type determination step: The detection type control unit of the control module determines the detection method to be performed based on the sample; Preprocessing step: The preprocessing module preprocesses the sample according to the detection method to form the analyte; Wherein, if the detection method is a one-step chemiluminescence method or a two-step chemiluminescence method, the analyte after being washed by the washing component of the pretreatment module is transferred to the chemiluminescence detection component of the detection module through the pipetting component of the pretreatment module; If the detection method is a two-step multi-phase liquid chip method, the analyte washed by the washing assembly is transferred to the multi-reading assembly of the detection module through the pipetting assembly. Test object detection steps: The detection module detects the test object.

8. The control method for the automatic analysis system according to claim 7, characterized in that, The pretreatment module further includes a sample injection component, a sample addition component, a reagent component, and an incubation component. The reagent component is used to store the first reagent, the second reagent, and / or the sample diluent. The incubation component is used to accelerate the formation of the analyte in the reaction vessel. The preprocessing step further includes: Perform the first incubation step: The sample introduction component adds the sample into the reaction vessel inside the sample addition component, and the pipetting component moves the reaction vessel into the incubation component to complete the first incubation; The second incubation step is determined based on the detection method. If the detection method is a one-step chemiluminescence method, after the first incubation is completed, the pipetting assembly transfers the analyte to the washing assembly for washing. If the detection method is a two-step method using multiple liquid phase chips or a two-step method using chemiluminescence, then after the first incubation is completed, the pipetting assembly transfers the analyte to the washing assembly for the first washing, the pipetting assembly transfers the second reagent to the reaction vessel and mixes it with the intermediate, and then the pipetting assembly moves the reaction vessel to the incubation assembly for the second incubation. Perform the second washing step: After the second incubation is completed, the pipetting assembly transfers the analyte to the washing assembly for a second washing.

9. The control method for the automatic analysis system according to claim 8, characterized in that, The sample dispensing assembly is a sample dispensing turntable, which is provided with a reaction container replenishment position, a sample dilution position, a first reagent addition position, a sample dispensing position, and a sample removal position along its circumferential edge. The reagent assembly is a reagent turntable, and the reagent turntable has a first reagent loading position and a second reagent loading position sequentially arranged along its circumferential edge; The incubation assembly is an incubation turntable, which includes an inner incubation position and an outer incubation position disposed outside the inner incubation position; the outer incubation position includes a first incubation insertion position and a first incubation removal position; the inner incubation position includes a second incubation insertion position and a second incubation removal position; The washing assembly includes a first washing mechanism and a second washing mechanism; The first washing mechanism is a turntable structure, with a first washing inlet / outlet position, a first washing position, a second reagent inlet position, a first substrate liquid inlet position, and a first washing outlet position arranged sequentially along its circumference. Above the first washing position is a first washing component, and above the first substrate liquid inlet position is a first substrate liquid conveying mechanism for conveying the substrate liquid. The second washing mechanism is a turntable structure, with a second washing inlet, a second washing position, a second substrate liquid inlet, a booster liquid inlet, and a second washing outlet arranged sequentially along its circumference. A second washing component is located above the second washing position. A second substrate liquid conveying mechanism for conveying substrate liquid is located above the second substrate liquid inlet. A booster liquid conveying mechanism for conveying booster liquid is located above the booster liquid inlet. The pipetting assembly includes a first pipetting mechanism, a second pipetting mechanism, a third pipetting mechanism, a fourth pipetting mechanism, a fifth pipetting mechanism, a first reagent transfer mechanism, and a second reagent transfer mechanism; the first reagent transfer mechanism includes a first moving track and a first pipetting component; the second reagent transfer mechanism includes a second moving track and a second pipetting component; The first incubation step is performed as follows: the first pipetting component moves along the first moving track, and the first pipetting component picks up the first reagent from the first reagent loading position and places it into the reaction container located at the first reagent adding position. The reaction container moves from the first reagent adding position to the sample adding position, and the sample injection component adds the sample into the reaction container located at the sample adding position, so that the sample and the first reagent are mixed in the reaction container. Then, the first pipetting mechanism moves the reaction container into the first incubation insertion position to perform the first incubation.

10. The control method for the automatic analysis system according to claim 9, characterized in that, In determining whether to perform a second incubation step based on the detection method, if the detection method is a one-step chemiluminescence method, then after completing the first incubation, the reaction container moves from the first incubation inlet position to the first incubation outlet position, the second pipetting mechanism moves the analyte from the first incubation outlet position to the first washing inlet / outlet position in the first washing mechanism, the reaction container then moves from the first washing inlet / outlet position to the first washing position, the first washing unit washes the analyte, the reaction container moves from the first washing position to the first substrate liquid inlet position, the first substrate liquid delivery mechanism inputs the substrate liquid into the reaction container and mixes it with the analyte inside, the reaction container then moves from the first substrate liquid inlet position to the first washing outlet position, and the third pipetting mechanism moves the reaction container into the chemiluminescence detection component; If the detection method is a two-step multiphase liquid chip method or a two-step chemiluminescence method, then after the first incubation is completed, the reaction container moves from the first incubation in position to the first incubation out position, the second pipetting mechanism moves the intermediate from the first incubation out position to the first washing in-out position, the reaction container then moves from the first washing in-out position to the first washing position, the first washing component performs the first washing of the intermediate, the reaction container moves from the first washing position to the second reagent addition position, the second pipetting component moves along the second moving track to pick up the second reagent from the second reagent loading position and place it into the reaction container at the second reagent addition position, so that the second reagent and the intermediate are mixed in the reaction container, the reaction container then moves from the second reagent addition position to the first washing in-out position, and the fourth pipetting mechanism moves the reaction container from the first washing in-out position to the second incubation in position for the second incubation.

11. The control method for the automatic analysis system according to claim 9, characterized in that, During the second washing step, the reaction vessel is moved from the second incubation insertion position to the second incubation removal position, the fourth pipetting mechanism moves the reaction vessel from the second incubation removal position to the second washing insertion position, the reaction vessel is moved from the second washing insertion position to the second washing position, and the second washing component performs a second washing on the analyte. The step of determining the movement position of the test object according to the detection method after completing the second washing step: If the detection method is a two-step chemiluminescence method, the analyte after the second washing is moved from the second washing position to the second substrate liquid addition position. The second substrate liquid delivery mechanism inputs the substrate liquid into the reaction vessel and mixes it with the analyte inside. Then, the reaction vessel is moved from the second substrate liquid addition position to the second washing removal position. The third liquid transfer mechanism moves the reaction vessel from the second washing removal position into the chemiluminescence detection component. If the detection method is a two-step multi-phase liquid chip method, the analyte after the second washing is moved from the second washing position to the enhancement liquid addition position. The enhancement liquid delivery mechanism inputs the substrate liquid into the reaction vessel and mixes it with the analyte inside. Then, the reaction vessel is moved from the enhancement liquid addition position to the second washing removal position. The fifth liquid transfer mechanism moves the reaction vessel from the second washing removal position to the multi-reading component.

12. The control method for the automatic analysis system according to any one of claims 9 to 11, characterized in that, Also includes: Before performing the first incubation step, a step is taken to determine whether the sample needs to be diluted: if the sample needs to be diluted, the first pipetting component transfers the sample diluent into the reaction container at the sample dilution position, and the injection component adds the sample into the reaction container at the sample dilution position, so that the sample and the sample diluent are mixed to dilute the sample; If the sample does not require dilution, the injection component adds the sample to the reaction vessel at the injection site.

13. The control method for the automatic analysis system according to claim 12, characterized in that, The pretreatment module also includes a reaction container replenishment mechanism for replenishing the reaction container to the sample loading assembly; the sample loading assembly is also equipped with a scanner for acquiring sample information. The steps before determining whether the sample needs to be diluted include: The reaction vessel replenishment mechanism replenishes the reaction vessel to the sample dispensing assembly; The scanner acquires the sample information of the sample.

14. The control method for the automatic analysis system according to claim 13, characterized in that, The automated analysis system also includes a light-emitting waste disposal mechanism and a multiple waste disposal mechanism. The steps following the detection module's detection of the test object also include: The pipetting assembly moves the reaction vessel into the luminescent tube discarding mechanism, or The pipetting assembly moves the reaction vessel into the multiple discard tube mechanism.

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