Immunoassay analyzer

Abstract

The invention discloses an immunity analyzer, which relates to the field of in vitro diagnosis, and comprises a main body divided into an upper layer space and a lower layer space, the lower-layer space is provided with a management module for storing samples and reagents, a cleaning module for magnetic separation and substrate adding and uniform mixing, a uniform mixing module for uniformly mixing liquid in the reaction cup, an incubation module for heating the reaction cup and a photometric module for photon counting measurement; the upper-layer space is provided with a sample adding module for transferring liquid in the management module, a gripper module for transferring reaction cups and a reaction cup supply module for storing and arranging the reaction cups; all the modules are reasonable in layout, the movement track of the gripper module is limited in a square area, and the working areas of the sample adding module and the gripper module are spatially overlapped and run in parallel. The technical effects that the instrument size is reduced, the test flux is improved, the movement time and the number of parts are reduced, and emergency operation is facilitated are achieved.

Description

Technical Field

[0001] The present invention relates to the field of in vitro diagnostic technologies, and more specifically, to an immunoassay analyzer. Background Art

[0002] In the field of medical testing, as a key device, the core function of an immunoassay analyzer is to perform high-precision quantitative or qualitative analysis on biological samples through chemiluminescence technology. With the rapid development of medical technologies, immunoassay analyzers not only need to meet the high-throughput testing requirements in large laboratories but also need to adapt to the application scenarios of primary medical institutions and rapid clinical testing.

[0003] To achieve the immunoassay function, existing technologies usually adopt a modular design concept, specifically including multiple functional modules such as sample management, reagent management, reaction cup supply, sample addition, mixing, incubation, cleaning, mixing, gripper transfer, and photometry. For example, samples and reagents are classified and managed through independent storage mechanisms; the sample addition module is responsible for adding samples and reagents into reaction cups as needed; the incubation module provides a constant temperature environment to promote the immunoassay reaction; the cleaning module removes non-target substances in the reaction cups through magnetic separation technology; the mixing module ensures sufficient mixing of samples and reagents; the gripper module realizes precise transfer of reaction cups between modules; the photometry module completes photon counting to obtain the test results. These modules work together through the circuit control module and the liquid path module to complete the entire detection process.

[0004] However, due to the suboptimal module layout in existing immunoassay analyzers, the overall device is relatively large in size and occupies a large area, making it difficult to meet the requirements of miniaturization and portability.

[0005] In summary, how to design an immunoassay analyzer with a compact structure, simple operation, and high detection efficiency is an urgent problem to be solved by those skilled in the art currently. Summary of the Invention

[0006] In view of this, the purpose of the present invention is to provide an immunoassay analyzer with the performance of a compact structure, simple operation, and high detection efficiency.

[0007] To achieve the above purpose, the present invention provides the following technical solutions:

[0008] An immunoassay analyzer includes a main body, which is divided into an upper space and a lower space. The lower space is provided with a management module for storing samples and reagents, a cleaning module for magnetic separation, adding substrates, and mixing, a mixing module for mixing the liquid in the reaction cups, an incubation module for heating the reaction cups, and a photometry module for photon counting measurement. The upper space is provided with a sample addition module for transferring the liquid in the management module, a gripper module for transferring the reaction cups, and a reaction cup supply module for storing and arranging the reaction cups.

[0009] The cleaning module, the mixing module, and the photometric module are located on the side of the incubation module, so that the movement trajectory of the gripper module is limited within a square area. The working stations of the cleaning module and the mixing module are both located on the movement trajectory of the sample addition module;

[0010] There is a spatial overlap between the working areas of the sample addition module and the gripper module. The sample addition module realizes liquid transfer within the management module through two-axis movement, and the gripper module realizes reaction cup transfer through three-axis movement. The sample addition module and the gripper module operate in parallel.

[0011] Preferably, the management module includes a sample storage mechanism for loading samples, a reagent storage mechanism for loading reagents, an RFID radio frequency identification device for scanning reagents, and a barcode scanning device for scanning sample tube barcodes. The sample storage mechanism is located outside the reagent storage mechanism, and the sample storage mechanism and the reagent storage mechanism move independently of each other.

[0012] Preferably, the reagent storage mechanism includes a plurality of reagent bins distributed in a ring. Each reagent bin integrates a magnetic bead mixing device and a thermoelectric cooler. The sample storage mechanism includes a sample tray and an emergency tray arranged concentrically. The sample tray is provided with sample storage positions, and the emergency tray independently sets emergency sample positions and liquid storage positions.

[0013] Preferably, the emergency tray includes at least one emergency sample position, at least one system cleaning liquid level, and at least one dilution liquid level. The emergency tray and the sample tray are driven by independent drive mechanisms to operate asynchronously.

[0014] Preferably, the sample tray includes a plurality of sample positions distributed circumferentially. A first adapter or a second adapter is installed in each sample position. The first adapter is a 10 - 13 mm adapter, and the second adapter is a 16 mm adapter.

[0015] Preferably, the mixing module includes a plurality of mixing heads provided with reaction cups and a drive motor for driving the plurality of mixing heads to rotate.

[0016] Preferably, the incubation module includes an incubation block with an array of holes and a heating device. The inner wall of the array of holes is provided with a heat conduction structure. The bottom of the incubation block is electrically connected to a temperature control device to achieve temperature control.

[0017] Preferably, the photometric module includes a horizontal movement mechanism, a light shielding mechanism, and a photomultiplier tube. The horizontal movement mechanism drives the reaction cup to move to a preset measurement position, and the light shielding mechanism is linked with a range switching mechanism to adjust the photon detection range.

[0018] Preferably, the reaction cup supply module includes a hopper, a slideway, and a reaction cup lifting mechanism. The hopper is communicated with the slideway. After the reaction cups are introduced into the slideway through the lifting mechanism, they are arranged along the slideway to the accessible position of the gripper module by gravity.

[0019] Preferably, the cleaning module includes a magnetic separation component and a flushing mechanism. The magnetic separation component adsorbs magnetic beads to the wall of the reaction cup through a magnetic field, and the flushing mechanism performs multiple liquid injection and suction cleaning on the adsorbed magnetic beads.

[0020] The immunoassay analyzer provided by the present invention divides the main body into upper and lower layer spaces, and arranges each module in a layered manner, realizing three-dimensional stacking, reducing the floor area, the volume and weight of the instrument, and also facilitating installation and handling; the cleaning, mixing, and photometric modules are placed on the side of the incubation module, so that the movement trajectory of the gripper module is limited to a square area, and the working stations of the cleaning and mixing modules are on the movement trajectory of the sample addition module. Combining the two-axis movement of the sample addition module and the three-axis movement of the gripper module, their working areas overlap and operate in parallel, which can minimize the movement stroke, save movement time, improve the test throughput of the instrument, and thus improve the floor space utilization ratio; due to fewer movement modules, the overall structure of the whole machine can be simplified, the number of parts can be reduced, and the cost can be lowered.

[0021] In the further solution provided by this application, at least one of the following beneficial technical effects can also be achieved:

[0022] Using the RFID radio frequency identification device to scan the reagent kit fundamentally avoids the problem of barcode scanning failure caused by fog in the scanning window of the traditional barcode scanner, ensuring the accuracy and stability of barcode scanning. Using a single barcode scanning device to scan the sample information on the sample tray and the emergency tray can reduce the number of barcode scanners;

[0023] With the adapters of different specifications being set on the sample positions in the sample tray according to requirements, namely 10-13mm adapters and 16mm adapters, users can select and match according to actual needs, greatly enhancing the compatibility of the instrument with different specifications of reagents;

[0024] Using the array holes, the heat conduction structure, and the temperature control device, the reaction cups can be heated more evenly, and the reaction cups close to the wall of the incubation block transfer heat faster, ensuring the suitable temperature environment required for the reaction, being beneficial to improving the efficiency and accuracy of the reaction, and at the same time facilitating the grasping of the reaction cups, not being restricted by the mechanical position, and the incubation time can also be flexibly adjusted according to specific projects, further improving the throughput and performance of the instrument. Description of the Drawings

[0025] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only the embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on the provided drawings.

[0026] Figure 1 It is a schematic plan layout diagram of the immunoassay analyzer in this embodiment;

[0027] Figure 2 It is a schematic overall appearance diagram of the immunoassay analyzer in this embodiment;

[0028] Figure 3 It is a schematic diagram of the lower layer space in this embodiment;

[0029] Figure 4 It is a schematic diagram of the upper layer space in this embodiment.

[0030] Figures 1-4 Among them, the reference numerals include:

[0031] 1. Cleaning module; 2. Mixing module; 3. Cleaning cover; 4. Sampling module; 5. Management module; 6. Gripper module; 7. Outer shell; 8. Photometric module; 9. Incubation module; 10. Reaction cup supply module. Specific embodiments

[0032] The following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts belong to the scope of protection of the present invention.

[0033] Unless otherwise defined, the technical terms or scientific terms used in this application disclosure should have the ordinary meaning understood by those of ordinary skill in the field to which the present invention belongs. The "first", "second" and similar terms used in the present invention do not indicate any order, quantity or importance. "Connection" or "connected" and similar terms are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "Upper", "lower", "left", "right", etc. are only used to represent relative position relationships. When the absolute position of the object being described changes, the relative position relationship can also change accordingly. This application embodiment discloses an immunoassay analyzer.

[0034] The core of the present invention is to provide an immunoassay analyzer.

[0035] Please refer toFigure 1 。

[0036] The immunoassay analyzer provided by the present invention includes a main body, which is divided into an upper space and a lower space. The lower space is provided with a management module 5 for storing samples and reagents, a cleaning module 1 for magnetic separation and adding substrate for mixing, a mixing module 2 for mixing the liquid in the reaction cup, an incubation module 9 for heating the reaction cup, and a photometric module 8 for photon counting measurement. The upper space is provided with a sampling module 4 for transferring the liquid in the management module 5, a gripper module 6 for transferring the reaction cup, and a reaction cup supply module 10 for storing and arranging the reaction cups. The cleaning module 1, the mixing module 2, and the photometric module 8 are located on the side of the incubation module 9, so that the movement trajectory of the gripper module 6 is limited within a square area. The working stations of the cleaning module 1 and the mixing module 2 are both on the movement trajectory of the sampling module 4. There is a spatial overlap between the working areas of the sampling module 4 and the gripper module 6. The sampling module 4 realizes the transfer of the liquid in the management module 5 through two-axis movement, the gripper module 6 realizes the transfer of the reaction cup through three-axis movement, and the sampling module 4 and the gripper module 6 operate in parallel.

[0037] Specifically, the immunoassay analyzer includes an upper space (specifically as shown in Figure 4 ), and a lower space (specifically as shown in Figure 3 ). Among them, the upper space and the lower space adopt an up-and-down three-dimensional layout method. This layout method can effectively utilize the space, make the overall structure of the instrument more compact, reduce the floor area of the instrument, and is conducive to the collaborative work between modules, improving the overall performance of the instrument.

[0038] The lower space includes a management module 5, a cleaning module 1, a mixing module 2, an incubation module 9, and a photometric module 8. The upper space includes a sampling module 4, a gripper module 6, and a reaction cup supply module 10. The cleaning module 1, the mixing module 2, and the photometric module 8 are located on the side of the incubation module 9, so that the movement trajectory of the gripper module 6 is limited within a square area. The overall movement paths of the sampling module 4 and the gripper module 6 are close to a flag shape, minimizing the movement path. The working stations of the cleaning module 1 and the mixing module 2 are on the movement trajectory of the sampling module 4, facilitating work connection. There is a spatial overlap between the working areas of the sampling module 4 and the gripper module 6. The sampling module 4 realizes the transfer of the liquid in the management module 5 through two-axis movement, the gripper module 6 realizes the transfer of the reaction cup through three-axis movement, and the two can operate in parallel. This layout and working mode effectively and reasonably optimize the overall layout of the instrument, making the operation of each module more smooth and reducing the waste of movement time. It not only makes the whole machine smaller in volume, but also improves the throughput of the instrument.

[0039] The above immunoassay analyzer adopts a three-dimensional layout method, effectively optimizing the space utilization of the instrument and reducing the overall volume of the instrument.

[0040] The immune analyzer provided by the present invention will be introduced in more detail below with reference to the accompanying drawings and specific embodiments.

[0041] In a specific embodiment, referring to Figure 1 , the management module 5 includes a sample storage mechanism for loading samples, a reagent storage mechanism for loading reagents, an RFID radio frequency identification device for scanning reagent information, and a barcode scanning device for scanning the barcodes of sample tubes. The sample storage mechanism is located outside the reagent storage mechanism, and the sample storage mechanism and the reagent storage mechanism move independently of each other.

[0042] Specifically, the management module 5 is used to store samples and reagents. It includes a sample storage mechanism (including the storage of ordinary samples and emergency samples, system cleaning fluid storage, diluent storage, and position transfer), a reagent storage mechanism (including reagent storage, refrigeration, heat preservation, magnetic bead mixing, information reading, and position switching), an RFID radio frequency identification device, and a barcode scanning device. The sample storage mechanism and the reagent storage mechanism are independent of each other. This design can avoid mutual interference between samples and reagents. The RFID radio frequency identification device is used to scan the information of reagent kits, and the barcode scanning device is used to scan the barcode information of sample tubes. Compared with traditional barcode scanners, the RFID radio frequency identification device is not affected by the fog in the scanning window and can read information more accurately. The independently movable sample storage mechanism and reagent storage mechanism can be flexibly adjusted according to actual needs, facilitating the accurate and efficient transfer of liquids by the sample addition module 4. By adopting the above technical solutions, not only the independence and safety of sample and reagent storage are improved, mutual contamination is avoided, but also the accuracy and reliability of barcode scanning are enhanced, ensuring the smooth reading of data during the operation of the instrument, thereby improving the overall working efficiency and stability of the immune analyzer.

[0043] Furthermore, the reagent storage mechanism includes a plurality of reagent bins distributed in a ring shape, and each reagent bin integrates a magnetic bead mixing device and a refrigerating sheet. The sample storage mechanism includes a sample tray and an emergency tray arranged concentrically. The sample tray is provided with sample storage positions, and the emergency tray is independently provided with emergency sample positions and liquid storage positions.

[0044] Specifically, the independently movable sample tray, emergency tray, and multiple reagent compartments distributed in a ring can be flexibly adjusted in position according to actual needs, facilitating the accurate and efficient transfer of liquid by the sample addition module 4. This not only improves the independence and safety of sample and reagent storage, avoiding cross-contamination, but also enhances the accuracy and reliability of barcode scanning, ensuring smooth data reading during the operation of the instrument, thereby improving the overall working efficiency and stability of the immunoassay analyzer. At the same time, each reagent compartment integrates a magnetic bead mixing device and a Peltier cooler, which can better meet the requirements of reagent storage, refrigeration, heat preservation, and magnetic bead mixing. The emergency tray has independent emergency sample positions and liquid storage positions, which facilitates users to perform emergency operations without affecting the detection of normal samples.

[0045] Based on any one of the above embodiments, referring to Figure 1 , the emergency tray includes at least one emergency sample position, at least one system cleaning liquid level, and at least one dilution liquid level. The emergency tray and the sample tray are driven by independent drive mechanisms to achieve asynchronous operation.

[0046] Specifically, the sample storage mechanism includes a sample tray and an emergency tray arranged concentrically. The emergency tray is located at a specific position and is relatively independent of the sample tray. In this embodiment, the emergency tray includes three emergency sample positions, one system cleaning liquid level, and two dilution liquid levels. It is driven by an independent drive mechanism to achieve asynchronous operation with the sample tray. This means that when the sample tray operates at its own pace, the emergency tray can be flexibly operated according to actual needs. When there is an emergency sample to be detected, the emergency tray can operate independently, quickly access the sample in the emergency sample position for detection, without interfering with the detection process being carried out by the sample tray. At the same time, the emergency tray can switch between the diluent and the system cleaning liquid, reducing the movement actions, lowering the speed, and preventing the crystallization of the diluent and the formation of a liquid film between the diluent and the system cleaning liquid, thereby avoiding the problem of false triggering of the liquid level detection caused by the liquid film. The independent sample tray can also slow down, use the time when reagents are not added during the test cycle to switch samples, reduce the switching speed of the sample circle position, prevent the liquid from shaking when switching positions, and avoid hemolysis of centrifuged samples. Through this setting, not only can the instrument flexibly respond to emergency detection needs and perform emergency operations without shutting down, but also the stability and accuracy of the detection process can be improved.

[0047] Furthermore, the sample tray includes forty-eight sample positions, and a first adapter or a second adapter can be selectively installed in each sample position. The first adapter is a 10 - 13 mm adapter, and the second adapter is a 16 mm adapter.

[0048] Specifically, the sample disk contains forty-eight sample positions, and each sample position is provided with a replaceable first adapter with a size of 10-13 mm and a second adapter with a size of 16 mm. These two types of adapters coexist on the sample positions of the sample disk and can adapt to reagents of different specifications. Users can freely choose and use the appropriate adapter according to actual needs to flexibly handle the storage of various different specifications of samples. This design greatly improves the compatibility of the sample disk and provides convenience for users.

[0049] Based on any one of the above embodiments, referring to Figure 1 , the mixing module 2 includes a plurality of mixing heads provided with reaction cups and a driving motor for driving the plurality of mixing heads to rotate.

[0050] Specifically, the mixing module 2 is used for storing reaction cups, diluting and mixing samples, and mixing the liquid after adding samples and reagents. It includes a plurality of mixing heads provided with reaction cups and a driving motor for driving the plurality of mixing heads to rotate. The mixing head is generally a disk-shaped structure with grooves, and the reaction cup is placed in the groove. The driving motor drives the mixing head to rotate through belt drive or gear drive, etc., so that the liquid in the reaction cup is fully mixed. The double mixing heads can mix the sample and reagent mixture and dilute it, and the instrument has a high throughput. The mixing structure is driven by a single motor, and the double mixing heads work in parallel, with a simple structure and low cost.

[0051] In a specific embodiment provided by the present application, the incubation module 9 includes an incubation block with array holes and a heating device. The inner wall of the array holes is provided with a heat conduction structure, and the bottom of the incubation block is electrically connected to the temperature control device to achieve temperature control.

[0052] Specifically, the incubation module 9 is used for heating the reaction cup to provide a suitable temperature environment for the reaction. It includes an incubation block with array holes and a heating device. The inner wall of the array holes is provided with a heat conduction structure, such as copper or aluminum, etc., which can quickly transfer heat to the reaction cup. The bottom of the incubation block is electrically connected to the temperature control device. When the heating device is turned on, the heat will be transferred to the incubation block, and the heat conduction structure can quickly and evenly conduct the heat to the reaction cup placed in the array holes. The temperature control device can monitor and adjust the temperature of the incubation block in real time to ensure that the reaction in the reaction cup proceeds at a constant temperature, which can accelerate the reaction speed in the reaction cup, ensure that the reaction proceeds under stable temperature conditions, improve the accuracy and reliability of the reaction, and thus improve the overall performance and detection accuracy of the instrument.

[0053] Based on any one of the above embodiments, referring to Figure 1 , the light measurement module 8 includes a horizontal movement mechanism, a light shielding mechanism and a photomultiplier tube. The horizontal movement mechanism drives the reaction cup to move to a preset measurement position, and the light shielding mechanism is linked with the range switching mechanism to adjust the photon detection range.

[0054] Specifically, the photometric module 8 is used for photon counting measurement. It includes a horizontal movement mechanism, a light shielding mechanism, and a photomultiplier tube. The horizontal movement mechanism can drive the reaction cup to move to a preset measurement position. During this process, the reaction cup is accurately transported to a suitable detection site. It generally consists of a motor and a guide rail and can precisely control the movement of the reaction cup. The light shielding mechanism is linked with the range switching mechanism. When the reaction cup reaches the preset measurement position, the light shielding mechanism can create a relatively stable environment for photon detection to avoid interference from external light, while the range switching mechanism can flexibly adjust the photon detection range according to the actual light emission situation to avoid interference from external light and improve the measurement accuracy. The photomultiplier tube is used to measure the number of photons emitted by the luminescent substance, convert the optical signal into an electrical signal, and provide a basis for subsequent data analysis.

[0055] Based on any one of the above embodiments, referring to Figure 1 , the reaction cup supply module 10 includes a hopper, a chute, and a reaction cup lifting mechanism. The hopper is connected to the chute, and after the reaction cup is introduced into the chute by the lifting mechanism, it is arranged along the chute to the position accessible by the gripper module 6 under the action of gravity.

[0056] Specifically, the reaction cup supply module 10 is used for storing and arranging reaction cups. It includes a hopper, a chute, and a reaction cup lifting mechanism. The hopper is usually a relatively large container for storing a large number of reaction cups. The chute is generally an inclined channel made of smooth plastic or metal materials to ensure the smooth sliding of the reaction cups. The reaction cup lifting mechanism can be a chain drive or a belt drive device, which can lift the reaction cups in the hopper to the chute entrance. After the reaction cups are lifted to the chute entrance, they slide down along the chute under the action of gravity and finally are arranged at the position accessible by the gripper module 6. Such a design makes the supply of reaction cups more orderly and efficient, providing convenience for subsequent experimental operations.

[0057] It should be noted that the desktop instrument using the reaction cup supply module 10 can accommodate more than 1000 reaction cups, has a long off-machine time, and low water consumption.

[0058] Based on any one of the above embodiments, the cleaning module 1 includes a magnetic separation component and a flushing mechanism. The magnetic separation component adsorbs magnetic beads to the reaction cup wall through a magnetic field, and the flushing mechanism performs multiple liquid injection and suction cleaning on the adsorbed magnetic beads.

[0059] Specifically, the function of the cleaning module 1 is to clean the magnetic beads in the reaction cup. It includes a magnetic separation component and a rinsing mechanism. The magnetic separation component uses a magnetic field to adsorb the magnetic beads onto the wall of the reaction cup, and the rinsing mechanism performs multiple liquid injection and suction cleanings on the adsorbed magnetic beads to remove unwanted substances, reduce carryover, and improve the accuracy of detection. The magnetic separation component generally consists of a permanent magnet or an electromagnet, and by adjusting the intensity and direction of the magnetic field, effective adsorption of the magnetic beads is achieved. The rinsing mechanism usually includes an injection pump and a rinsing needle. The injection pump can precisely control the amount and speed of liquid injection and suction, and the rinsing needle accurately injects the cleaning liquid into the reaction cup. By adopting a five-stage magnetic separation method, the cleaning is more thorough and the BF carryover is reduced.

[0060] Based on any of the above embodiments, the sample addition module 4 is an important component that can achieve liquid transfer. It generally consists of a needle for sucking and releasing liquid, a driving device for moving the needle, and a controller for precisely controlling the amount of liquid sucked and released, etc. The needle is usually made of materials such as stainless steel, and its tip is designed to be relatively fine to ensure accurate sucking and dropping of trace amounts of liquid. The driving device can be a stepper motor or a servo motor, which can precisely control the movement of the needle in a two-dimensional plane according to a set program to achieve two-axis movement to complete the transfer of liquid in the management module 5. Of course, the driving device can also use pneumatic components such as air cylinders to achieve a similar function. The sample addition module 4, in cooperation with the management module 5 and the mixing module 2, accurately adds the sample and reagent to the reaction cup, providing a basis for subsequent reactions. Its working process is that the controller, according to a preset program, controls the driving device to drive the needle to move to the corresponding sample or reagent position in the management module 5, then sucks an appropriate amount of liquid through negative pressure, and then moves to the reaction cup on the mixing module 2 and drops the liquid into the reaction cup through positive pressure.

[0061] Based on any of the above embodiments, the gripper module 6 is the key part responsible for the transfer of the reaction cup. It mainly consists of a robotic arm, a grasping device, and a power system for driving the movement of the robotic arm. The robotic arm is usually made of lightweight and high-strength materials such as aluminum alloy to ensure flexibility and stability during movement. The grasping device can be in the form of a jaw or a suction cup, etc. The jaw is generally made of an elastic material and can be adaptively adjusted according to the shape and size of the reaction cup to firmly grasp the reaction cup; the suction cup uses the principle of negative pressure to adsorb the reaction cup. The power system generally consists of multiple motors and can achieve the movement of the robotic arm in three-dimensional space, that is, three-axis movement. In actual work, the power system drives the robotic arm to move to a specified position according to an instruction. After the grasping device grasps the reaction cup, it then transfers it to a target position, such as the incubation module 9, the cleaning module 1, or the photometric module 8, etc.

[0062] It should be noted that in this embodiment, an immunoassay analyzer disclosed in this embodiment further includes a circuit control module for instrument circuit control, signal processing, communication, etc., a liquid path module for liquid transfer driving and loading, and a built-in computer and a touch display. The circuit control module includes a power supply component, a communication component, and a control component. It mainly provides instrument power supply, electrical connection, signal acquisition and processing, motion control, etc., and transmits information to the computer. The liquid path module is used for liquid path connection, information acquisition and execution of the sampling module 4, substrate system, magnetic separation system, etc. The built-in computer mainly performs instrument control, information processing, result feedback, and human-computer interaction functions.

[0063] It should also be noted that as Figure 2 shown, the positions corresponding to the cleaning solution and the dilution solution are in the lower right corner, which are two different positions from the sample placement and retrieval. Thus, after lifting the cleaning cover 3 at the lower right corner position, the sample position is blocked by the machine housing 7, and the liquid splashed during the cleaning solution and dilution solution placement and retrieval will not contaminate the sample. In addition, the liquid can flow out through the bottom waste liquid hole. And the emergency sample is placed and retrieved from the position of the cleaning cover 3.

[0064] According to the immunoassay analyzer provided in the above embodiment, the detection process adopted by the one-step method is as follows: The gripper module 6 grabs the reaction cup to the mixing station of the mixing module 2 - the sampling needle of the sampling module 4 moves in a straight line to add the sample (for dilution items, dilution solution needs to be added, mixed, and dispensed), add the reagent, and the mixing module 2 performs mixing - the gripper module 6 grabs the reaction cup and moves it to the incubation module 9 for incubation - the gripper module 6 grabs the reaction cup and moves it to the cleaning module 1 for magnetic washing, add the substrate and mix - the gripper module 6 grabs the reaction cup to the incubation module 9 for incubation, and then grabs the reaction cup to the photometric module 8 for photometry - discard;

[0065] The detection process adopted by the two-step method is as follows: Grab the reaction cup to the mixing station of the mixing module 2 - the sampling needle of the sampling module 4 moves in a straight line to add the sample (for dilution items, dilution solution needs to be added, mixed, and dispensed), add the reagent, and the mixing module 2 performs mixing - the gripper module 6 grabs the reaction cup and moves it to the incubation module 9 for incubation - the gripper module 6 grabs the reaction cup and moves it to the cleaning module 1 for magnetic washing - the gripper module 6 grabs the reaction cup to the mixing station of the mixing module 2 to add the reagent and mix - the gripper module 6 grabs the reaction cup to the incubation module 9 for incubation - the gripper module 6 grabs the reaction cup and moves it to the cleaning module 1 for magnetic washing, add the substrate and mix - the gripper module 6 grabs the reaction cup to the incubation module 9 for incubation, and then grabs the reaction cup to the photometric module 8 for photometry - discard.

[0066] In the two-step method, for the second addition of the reagent, it is also possible not to go to the mixing position, and the sampling needle can move in a straight line directly to the sampling position in the magnetic washing position.

[0067] The implementation principle of an immunoassay analyzer according to an embodiment of the present application is as follows: By dividing the instrument main body into an upper space and a lower space and adopting a three-dimensional layout method, the space utilization of the instrument is effectively optimized, and the overall volume of the instrument is reduced. Each module has a clear division of labor and works collaboratively. The working areas of the sample addition module 4 and the gripper module 6 overlap and operate in parallel, reducing unnecessary movement strokes and time, and improving the test throughput of the instrument. At the same time, the independent design of the sample and reagent storage mechanisms in the management module 5 and various adaptation methods improve the compatibility and operation convenience of the instrument. The reasonable configuration and precise control of the cleaning module 1, the mixing module 2, the incubation module 9, and the photometric module 8 ensure the accuracy and reliability of immunoassay. This design not only reduces the production cost of the instrument, but also improves the stability and floor efficiency ratio of the instrument, solves the problems of existing immunoassay analyzers in terms of space utilization, test throughput, and operation convenience, and provides a better solution for the immunoassay field.

[0068] The various embodiments in this specification are described in a progressive manner. The key point of each embodiment is to illustrate the differences from other embodiments. The same or similar parts among the various embodiments can be referred to each other.

[0069] The above has introduced in detail an immunoassay analyzer provided by the present invention. Specific examples are used herein to elaborate on the principle and implementation manner of the present invention. The description of the above embodiments is only used to help understand the method and its core idea of the present invention. It should be noted that for those of ordinary skill in the art in this technical field, without departing from the principle of the present invention, several improvements and modifications can be made to the present invention, and these improvements and modifications also fall within the protection scope of the present invention.

Claims

1. An immunoassay analyzer, comprising a main body, characterized in that, The main body is divided into an upper space and a lower space. The lower space is provided with a management module (5) for storing samples and reagents, a cleaning module (1) for magnetic separation and adding substrate for mixing, a mixing module (2) for mixing the liquid in the reaction cup, an incubation module (9) for heating the reaction cup, and a photometric module (8) for photon counting measurement. The upper space is provided with a sampling module (4) for transferring the liquid in the management module (5), a gripper module (6) for transferring the reaction cup, and a reaction cup supply module (10) for storing and arranging the reaction cups; The cleaning module (1), the mixing module (2), and the photometric module (8) are located on the side of the incubation module (9) so that the movement trajectory of the gripper module (6) is limited within a square area. The working stations of the cleaning module (1) and the mixing module (2) are both located on the movement trajectory of the sampling module (4); There is a spatial overlap between the working areas of the sampling module (4) and the gripper module (6). The sampling module (4) realizes the transfer of the liquid in the management module (5) through two-axis movement, and the gripper module (6) realizes the transfer of the reaction cup through three-axis movement. The sampling module (4) and the gripper module (6) operate in parallel.

2. The immunoassay analyzer according to claim 1, wherein The management module (5) includes a sample storage mechanism for loading samples, a reagent storage mechanism for loading reagents, an RFID radio frequency identification device for scanning reagents, and a barcode scanning device for scanning the barcodes of sample tubes. The sample storage mechanism is located outside the reagent storage mechanism, and the sample storage mechanism and the reagent storage mechanism move independently of each other.

3. An immunoassay analyzer according to claim 2, characterized in that, The reagent storage mechanism includes a plurality of reagent bins distributed in a ring. Each reagent bin integrates a magnetic bead mixing device and a thermoelectric cooler. The sample storage mechanism includes a sample tray and an emergency tray arranged concentrically. The sample tray is provided with sample storage positions, and the emergency tray independently sets emergency sample positions and liquid storage positions.

4. The immunoassay analyzer according to claim 3, wherein, The emergency tray includes at least one emergency sample position, at least one system cleaning liquid level, and at least one dilution liquid level. The emergency tray and the sample tray are driven by independent drive mechanisms to operate asynchronously.

5. An immunoassay analyzer according to claim 3, characterized in that, The sample tray includes a plurality of sample positions distributed in a circumference. A first adapter or a second adapter is installed in each sample position. The first adapter is a 10-13 mm adapter, and the second adapter is a 16 mm adapter.

6. An immunoassay analyzer according to any one of claims 1-5, characterized in that, The mixing module (2) includes a plurality of mixing heads provided with reaction cups and a drive motor for driving the plurality of mixing heads to rotate.

7. An immunoassay analyzer according to any one of claims 1-5, characterized in that, The incubation module (9) includes an incubation block with an array of holes and a heating device. A heat conduction structure is provided on the inner wall of the array of holes. The bottom of the incubation block is electrically connected to a temperature control device to achieve temperature control.

8. An immunoassay analyzer according to any one of claims 1-5, characterized in that, The photometric module (8) includes a horizontal movement mechanism, a light shielding mechanism, and a photomultiplier tube. The horizontal movement mechanism drives the reaction cup to move to a preset measurement position, and the light shielding mechanism is linked with a range switching mechanism to adjust the photon detection range.

9. An immunoassay analyzer according to any one of claims 1-5, characterized in that, The reaction cup supply module (10) includes a hopper, a slideway, and a reaction cup lifting mechanism. The hopper is communicated with the slideway. After the reaction cups are introduced into the slideway by the lifting mechanism, they are arranged along the slideway to the position accessible by the gripper module by gravity.

10. An immunoassay analyzer according to any one of claims 1-5, characterized in that, The cleaning module (1) includes a magnetic separation component and a flushing mechanism. The magnetic separation component adsorbs magnetic beads to the wall of the reaction cup through a magnetic field, and the flushing mechanism performs multiple liquid injection and suction cleaning on the adsorbed magnetic beads.

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