Sample introduction module and single-molecule immunoassay analyzer containing it

Abstract

This application relates to a sample introduction module and a single-molecule immunoassay analyzer including the same. The sample introduction module comprises 2 to 4 sample racks, each arranged parallel to each other in the vertical direction and having the same structure. Each sample rack includes a microplate, a stage, and a linear reciprocating motion mechanism. The linear reciprocating motion mechanism includes a linear guide rail, a drive mechanism, a drawer slide rail, a synchronous belt, a drive wheel, a driven wheel, and a zero-position sensor. The single-molecule immunoassay analyzer includes a sample introduction module, a detection module, an incubation module, and a reagent processing module. The sample introduction module of this application can effectively reduce the size of the module while ensuring sample storage capacity. The single-molecule immunoassay analyzer of this application has a high degree of automation, a compact structure, low operation difficulty, and improved detection efficiency, reaching over 90 tests / hour.

Description

Technical Field

[0001] This application relates to medical devices, and more particularly to sample introduction modules and single-molecule immunoassay analyzers containing the same. Background Technology

[0002] An immunoassay analyzer is an instrument used for the quantitative analysis of target analytes such as antibodies and antigens contained in test samples, such as blood. In recent years, to meet the demand for ultrasensitive detection, single-molecule immunoassay methods have been developed. The main single-molecule immunoassay analyzers currently on the market are the Simoa-HD-1 and HD-X from Quanterix (USA). However, due to limitations in their operating principles, the Simoa-HD-1 and HD-X are relatively large; the HD-X, for example, measures 135×60×160cm, which is quite bulky. There is a need for a single-molecule immunoassay analyzer that can reduce the size while still meeting the requirements for ultrasensitive single-molecule detection.

[0003] The sample introduction module is an essential module of an immunoassay analyzer. Currently, sample introduction modules are basically set up with a single sample rack or multiple sample racks arranged side by side or in series in a pipeline. Although the latter can increase the sample loading capacity, it also makes the sample introduction module larger, resulting in the device not being compact enough (see patent documents 1-3).

[0004] Existing technical documents

[0005] Patent Document 1: CN205786676U

[0006] Patent Document 2: CN211348257U

[0007] Patent Document 3: CN113267639A Summary of the Invention

[0008] To address the aforementioned issues, the purpose of this application is to provide an injection module suitable for single-molecule immunoassay, which can effectively reduce module size while ensuring a large sample loading capacity, and a single-molecule immunoassay analyzer containing the module.

[0009] This application includes the following technical solutions.

[0010] In a first aspect, this application relates to a sample introduction module comprising 2 to 4 sample racks, each sample rack being arranged parallel to each other in the vertical direction and having the same structure. Each sample rack comprises, from top to bottom, a microplate, a stage and a linear reciprocating motion mechanism, the aforementioned linear reciprocating motion mechanism being used to move the microplate back and forth in the sample introduction direction.

[0011] In one embodiment, the distance between adjacent sample rack layers is 30 to 100 mm, and the gap between the bottom of the upper sample rack and the top of the lower sample rack is 5 to 15 mm.

[0012] In one embodiment, the aforementioned microplate is a 48, 96, or 384-well plate.

[0013] In one embodiment, the aforementioned sample introduction module includes two layers of sample holders.

[0014] In one embodiment, the aforementioned linear reciprocating motion mechanism includes: a linear guide mounting plate located below the linear guide for supporting the linear guide; two linear guides disposed below the stage and slidably contacting the left and right ends of the stage for linear movement of the stage; a zero-position sensor located on the linear guide mounting plate and on the side of the linear guide for providing an initial position to the sample holder and preventing positional deviation of the sample holder; a drive mechanism located below the linear guide mounting plate and connected to the drive wheel to provide power; a drawer slide rail located on the side of the linear guide mounting plate for fixing a single-layer sample holder and removing the sample holder when changing samples; a timing belt located on the side of one linear guide for driving the stage and microplate to slide on the linear guide; a drive wheel located at the end of one linear guide and connected to the drive mechanism; and a driven wheel located at the other end of one linear guide.

[0015] In one embodiment, the aforementioned linear reciprocating motion mechanism further includes: a timing belt pressure plate that holds a timing belt; a timing belt adapter plate that is fixed to the platform and connected to the timing belt pressure plate, and together with the timing belt pressure plate assists the timing belt in driving the platform and the microporous plate to slide on the linear guide rail; and a zero-position sensor baffle that is connected to the platform and is used to assist the zero-position sensor in providing an initial position to the sample holder.

[0016] On the other hand, this application relates to a single-molecule immunoassay analyzer, comprising: the aforementioned sample injection module; a sample needle module for extracting samples from the sample injection module to the incubation module, and moving it to the sample needle cleaning station for cleaning after sampling; a cup gripping robot module for transferring reaction cups between the consumables module and the incubation module; a consumables module for storing consumables; a detection needle module for extracting reactants after mixing and reaction to the detection module, and moving it to the detection needle cleaning station after detection; a detection module for detecting the extracted reactants and outputting a single-molecule signal; an incubation module for placing the reaction cups and mixing and incubating the liquid in the reaction cups; a reagent processing module for providing a constant temperature range to the reagents, mixing the reagents, and recording reagent information; and a reagent needle module for extracting reagents from the reagent processing module to the incubation module, and moving it to the reagent needle cleaning station after extraction.

[0017] In one embodiment, the aforementioned incubation module and reagent processing module each include at least one turntable and a drive unit that drives the aforementioned turntable to rotate, and the aforementioned turntable is provided with multiple placement slots.

[0018] In one embodiment, the aforementioned sample needle module includes a sample needle, an X-axis module, and a Z-axis module. The aforementioned Z-axis module is disposed on the X-axis module and includes a Z-axis motor, a Z-axis zero-position sensor, a sample needle anti-collision device, and a Z-axis motion mechanism.

[0019] In one embodiment, the aforementioned detection needle module includes a detection needle, a Y-axis module, and a Z-axis module. The aforementioned Y-axis module includes a Y-axis motor, a Y-axis zero-position sensor, and a Y-axis motion mechanism. The aforementioned Z-axis module is disposed on the Y-axis module and includes a Z-axis motor, a Z-axis zero-position sensor, a detection needle anti-collision device, and a Z-axis motion mechanism.

[0020] In one embodiment, the aforementioned reagent needle module includes a reagent needle with liquid level detection function, an X-axis module, and a Z-axis module. The aforementioned X-axis module includes an X-axis motor, an X-axis zero-position sensor, and an X-axis motion mechanism. The aforementioned Z-axis module is disposed on the X-axis module and includes a Z-axis motor, a Z-axis zero-position sensor, a reagent needle anti-collision device, and a liquid level detection plate.

[0021] In one embodiment, the aforementioned detection module includes an optical detection module (such as a CCD detection module), a measurement chamber assembly, and a control assembly, wherein the control assembly includes a focusing assembly and a vibration damping assembly.

[0022] Compared with the prior art, this application achieves the following superior effects:

[0023] (1) By making each sample rack include a microplate, a stage and a linear reciprocating motion mechanism, a large sample storage capacity can be achieved with a simple structure;

[0024] (2) By setting up multi-layer sample racks, the sample storage capacity is further increased, and other idle sample racks can be replaced during the operation of one layer of sample racks, enabling continuous sample injection without stopping the machine and speeding up the detection rate;

[0025] (3) The multi-layer stacked structure effectively reduces the volume occupied by the sample injection module, making the device more compact. The size of the single-molecule immunoassay analyzer of this application can be within the range of 700-900mm in length × 600-800mm in width × 600-800mm in height, which is much smaller than the existing single-molecule immunoassay analyzers.

[0026] (4) The single-molecule immunoassay analyzer of this application has a high degree of automation, low operation difficulty, and improved detection efficiency, which can reach more than 90 tests / hour. Attached Figure Description

[0027] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of this application and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0028] Figure 1(a) is a schematic diagram of the structure of the sample introduction module (double-layer sample holder) shown in an embodiment of this application, and Figure 1(b) is a schematic diagram of the structure of the single-layer sample holder shown in an embodiment of this application.

[0029] Figure 2(a) is a perspective view of a single-molecule immunoassay analyzer according to an embodiment of this application, and Figure 2(b) is a top view of a single-molecule immunoassay analyzer according to an embodiment of this application.

[0030] Figure 3 This is a 3D view of the sample needle module of a single-molecule immunoassay analyzer.

[0031] Figure 4 This is a 3D view of the cup-grabbing robotic arm module of a single-molecule immunoassay analyzer.

[0032] Figure 5(a) is a top view of the consumable module of the single-molecule immunoassay analyzer, and Figure 5(b) is a perspective view of the consumable module of the single-molecule immunoassay analyzer.

[0033] Figure 6 This is a 3D view of the detection needle module of a single-molecule immunoassay analyzer.

[0034] Figure 7 This is a schematic diagram of the detection module of a single-molecule immunoassay analyzer.

[0035] Figure 8 This is a top view of the incubation module of a single-molecule immunoassay analyzer.

[0036] Figure 9 This is a three-dimensional view of the reagent processing module of a single-molecule immunoassay analyzer.

[0037] Figure 10 This is a three-dimensional view of the reagent needle module of a single-molecule immunoassay analyzer.

[0038] Reference numerals: 100-Sample injection module; 110-Sample rack; 120-Fixed bracket; 102-Microplate; 103-Stage; 104-Linear reciprocating motion mechanism; 105-Linear guide rail mounting plate; 106-Linear guide rail; 107-Zero-position sensor; 108-Drive mechanism; 109-Driving wheel; 111-Drawer slide rail; 112-Synchronous belt; 113-Driven wheel; 114-Synchronous belt pressure plate; 115-Synchronous belt adapter plate; 116-Zero-position sensor baffle; 200-Sample needle module; 300-Cup gripping robot module; 400-Consumables module; 500-Detection needle module; 600-Detection module; 700-Incubation module; 800-Reagent processing module; 900-Reagent needle module; 10-Sample needle cleaning position; 20-Reagent needle cleaning position; 30-Detection needle cleaning position;

[0039] 201 - Sample needle; 202 - X-axis module; 203 - Z-axis module; 204 - Sample needle anti-collision device;

[0040] 301-X-axis motion assembly of robotic arm; 302-Y-axis motion assembly of robotic arm; 303-Z-axis motion assembly of robotic arm; 304-grip assembly of cup-grabbing robotic arm;

[0041] 401 - Consumables rack; 402 - Dispensing cup opening; 403 - Reaction cup tray; 404 - Reaction cup;

[0042] 501 - Detection probe; 502 - Y-axis module; 503 - Z-axis module; 504 - Detection probe anti-collision device;

[0043] 601 - Optical inspection module; 602 - Measurement chamber assembly; 603 - Control assembly;

[0044] 701 - Mixing component; 702 - Incubation tray main module; 703 - Reaction cup storage tank;

[0045] 801 - Reagent compartment body; 802 - Cooling and heat dissipation assembly; 803 - Barcode scanning and defogging assembly; 804 - Rotary motion mechanism;

[0046] 901 - Reagent needle; 902 - Z-axis module; 903 - X-axis module Detailed Implementation

[0047] The terms “first,” “second,” “third,” etc., are used only for distinguishing descriptions and do not indicate a sequence number, nor should they be interpreted as indicating or implying relative importance.

[0048] 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.

[0049] In the description of this application, it should be noted that the terms "inner", "outer", "left", "right", "upper", "lower", 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. Therefore, they should not be construed as limitations on this application.

[0050] In the description of this application, unless otherwise expressly specified and limited, the terms “set up,” “install,” “connect,” and “link” shall be interpreted broadly, for example, as a fixed connection, a detachable connection, or an integral connection; as a mechanical connection or an electrical connection; as a direct connection or an indirect connection through an intermediate medium; or as a connection within two components.

[0051] The technical solution of this application will now be clearly and completely described with reference to the accompanying drawings.

[0052] Figure 1 is a schematic diagram of the sample introduction module 100 according to an embodiment of this application, wherein (a) is a schematic diagram of the double-layer sample rack. Each layer of sample rack 110 has the same structure and is arranged parallel to each other in the vertical direction, with each layer moving independently. The distance between adjacent sample rack layers and the gap between the bottom of the upper sample rack and the top of the lower sample rack can be determined according to the total height of the analyzer to be designed and the ease of sample retrieval. The inventors of this application have found that when the distance between adjacent sample rack layers is set to 30-100 mm and the gap between the bottom of the upper sample rack and the top of the lower sample rack is set to 5-15 mm, both the size of the equipment and the accuracy of sampling can be simultaneously considered. Each layer of sample rack is slidably connected to a fixed bracket 120 located on the outside. The slidable connection can be achieved in various ways, such as screw connection. The number of fixed brackets is even, such as 2, 4, 6, etc. The sample rack shown in Figure 1(a) is double-layered, but it can also be 3 or 4 layers. Each layer of the sample holder moves between the microplate insertion position and the sample needle sampling position.

[0053] Figure 1(b) is a schematic diagram of a single-layer sample holder according to an embodiment of this application. As shown in Figure 1(b), each layer of the sample holder includes, from top to bottom, a microplate 102, a stage 103, and a linear reciprocating motion mechanism 104. The linear reciprocating motion mechanism is used to move the microplate back and forth in the sample injection direction and includes: a linear guide mounting plate 105, which is located below the linear guide 106 and is used to support the linear guide 106; two linear guides 106, which are disposed below the stage 103 and slidably contact the left and right ends of the stage 103 for linear movement of the stage 103; a zero-position sensor 107, which is located on the linear guide mounting plate 105 and on the side of the linear guide 106, for providing an initial position to the sample holder 110 to prevent positional deviation of the sample holder; and a drive mechanism 1. 08, located below the linear guide mounting plate 105, is connected to the drive wheel 109 to provide power; drawer slide 111, located on the side of the linear guide mounting plate 105, is used to fix the single-layer sample rack 110 and to remove the sample rack when changing samples; and synchronous belt 112, located on the side of a linear guide, is used to drive the stage 103 and microplate 102 to slide on the linear guide 106; drive wheel 109, located at the end of a linear guide and connected to the drive mechanism; and driven wheel 113, located at the other end of a linear guide.

[0054] The linear guide rail mounting plate 105 is connected to the fixed bracket 120 via drawer slides 111, thus realizing a drawer-type push-pull function. This allows for convenient and quick replacement of samples from each layer without affecting sampling of each layer, and eliminates the need for a sample rack lifting mechanism, making the equipment structure simpler. There are two drawer slides 111, located on the left and right sides of the linear guide rail mounting plate, respectively. For each sample rack, only one synchronous belt 112 is required, located on the side of one linear guide rail. In addition, only one drive wheel 109 and one driven wheel 113 are required, located at the two ends of the linear guide rail 106, respectively.

[0055] The linear reciprocating motion mechanism may further include a synchronous belt pressure plate 114, a synchronous belt adapter plate 115, and a zero-position sensor baffle 116. The synchronous belt pressure plate 114 clamps the synchronous belt 112, and the synchronous belt adapter plate 115 is fixed to the stage 103 and connected to the synchronous belt pressure plate 114, working together with the synchronous belt pressure plate 114 to assist the synchronous belt 112 in driving the stage 103 and the microporous plate 102 to slide on the linear guide rail 106. The zero-position sensor baffle 116 is connected to the stage 103 and is used to assist the zero-position sensor 107 in providing an initial position to the sample holder.

[0056] This invention, by employing a multi-layered sample rack, further increases sample storage capacity. Furthermore, it allows for the replacement of idle sample racks while one layer is in operation, enabling continuous sample injection without downtime and accelerating the detection rate. The multi-layered stacked structure effectively reduces the volume occupied by the sample injection module, making the device more compact.

[0057] Figure 2 is a perspective view and a top view of a single-molecule immunoassay analyzer according to an embodiment of this application. As shown in Figure 2(a), in addition to the sample injection module 100 described above, the single-molecule immunoassay analyzer also includes a sample needle module 200, a cup-gripping robotic arm module 300, a consumable module 400, a detection needle module 500, a detection module 600, an incubation module 700, a reagent processing module 800, and a reagent needle module 900. The sample needle module 200 is used to extract samples from the sample injection module 100 to the incubation module 700, and after sampling, it moves to the sample needle cleaning station 10 for cleaning. The reagent needle module 900 is used to extract reagents from the reagent processing module 800 to the incubation module 700, and after extraction, it moves to the reagent needle cleaning station 20. The detection needle module 50 is used to extract the mixed and reacted reactants to the detection module 600, and after detection, it moves to the detection needle cleaning station 30. The cup-gripping robotic arm module is used to transfer reaction cups between the consumable module 400 and the incubation module 700. The single-molecule immunoassay analyzer also includes a rack 40 for housing the various modules.

[0058] In Figure 2(a), the sample introduction module 100 is located on the far left of the analyzer, and the consumable module 400 is arranged adjacent to it along the length of the analyzer. The sample needle module 200, the detection needle module 500, and the reagent needle module 900 are all located at the rear of the analyzer, above the sample introduction module 100, the incubation module 700, and the reagent processing module 800, respectively, for easy sampling. In addition, sample needle cleaning positions 10, reagent needle cleaning positions 20, and detection needle cleaning positions 30 are arranged around the incubation module 700, each containing a solvent for cleaning the needles. By arranging the cleaning positions (10, 20, and 30) around the incubation module 700, the movement distance of each needle can be minimized, the detection rate can be accelerated, and the device can be made as compact as possible, reducing its size. A cup-grabbing robotic arm module 300 is arranged above the consumable module 400.

[0059] Figure 2(b) is a top view of a single-molecule immunoassay analyzer according to an embodiment of this application. As shown in Figure 2(b), the detection module 600 is arranged adjacent to the rear of the incubation module 700, and the detection needle cleaning position 30 is located between the incubation module 700 and the detection module 600, thereby shortening the movement distance of the detection needle and improving detection efficiency. The detection module 600 is used to detect the extracted reactants and output a single-molecule signal.

[0060] The following is a detailed description of each module of the single-molecule immunoassay analyzer, excluding the sample introduction module 100.

[0061] Figure 3 This is a perspective view of the sample needle module 200 of a single-molecule immunoassay analyzer. The sample needle module includes a sample needle 201, an X-axis module 202, and a Z-axis module 203. The Z-axis module 203 is mounted on the X-axis module 202 and includes a Z-axis motor, a Z-axis zero-position sensor, a sample needle anti-collision device 204, and a Z-axis motion mechanism. In the figure, the sample needle anti-collision device prevents the sample needle from colliding vertically along the Z-axis. When the needle encounters a hard object in the Z-axis direction due to unforeseen circumstances such as power failure or misoperation, the anti-collision device automatically resets the sample needle, thus avoiding adverse effects on the continued operation of the equipment. It also acts as a buffer, preventing the needle from being directly damaged and reducing the damage rate. Here, the sample needle anti-collision device is an anti-collision spring, but it is not limited to this. The X-axis module and Z-axis module are used to move the sample needle in the X-axis and Z-axis directions, respectively, and may include components such as motors, guide rails, sliders, and pulleys as motion mechanisms. The Z-axis module also includes a zero-position sensor.

[0062] Figure 4 This is a perspective view of the cup-grabbing robotic arm module 300 of a single-molecule immunoassay analyzer. It includes a robotic arm X-axis motion component 301, a robotic arm Y-axis motion component 302, a robotic arm Z-axis motion component 303, and a cup-grabbing robotic arm gripper component 304. The cup-grabbing robotic arm module 300 can move in the X, Y, and Z axes and simultaneously performs cup-grabbing, cup-placing, and cup-throwing functions. The cup-grabbing robotic arm gripper component 304 is mounted on the robotic arm Z-axis motion component 303. The robotic arm Z-axis motion component 303 can drive the gripper component 304 to move back and forth in the Z direction and is mounted on the robotic arm Y-axis motion component 302. The robotic arm Y-axis motion component 302 can drive the robotic arm Z-axis motion component 303 and the cup-grabbing robotic arm gripper component 304 to move back and forth in the Y direction and is mounted on the robotic arm X-axis motion component 301. The X-axis motion component 301 of the robotic arm can drive the Y-axis motion component 302, the Z-axis motion component 303, and the cup-gripping robotic arm gripper component 304 to move back and forth in the X direction. This achieves three-axis motion. The X-axis motion component 301, Y-axis motion component 302, and Z-axis motion component 303 may include components such as motors, guide rails, sliders, lead screws, pulleys, or sprockets. The cup-gripping robotic arm gripper component 304 can be electrically or pneumatically powered.

[0063] Figure 5 shows a top view and a perspective view of the consumable module 400 of the single-molecule immunoassay analyzer. The consumable module includes two consumable racks 401 and a cup disposal port 402. Each of the two consumable racks 401 has a reaction cup tray 403 for storing reaction cups 404. The cup disposal port 402 is located on one side of the consumable rack for removing used reaction cups.

[0064] Figure 6 This is a perspective view of the detection needle module 500 of a single-molecule immunoassay analyzer. The detection needle module 500 includes a detection needle 501, a Y-axis module 502, and a Z-axis module 503. The Z-axis module 503 is mounted on the Y-axis module 502 and includes a detection needle anti-collision device 504. The detection needle anti-collision device 504 is used to prevent the detection needle 501 from colliding vertically along the Z-axis; in this case, it is an anti-collision spring, but not limited to this.

[0065] Figure 7 This is a side view and a perspective view of the detection module 600 of a single-molecule immunoassay analyzer. The detection module 600 includes an optical detection module (such as a CCD detection module) 601, a measurement chamber assembly 602, and a control assembly 603. The control assembly may include a focusing assembly and a vibration damping assembly. The optical detection module 601 is used to detect the measurement area, the measurement chamber assembly 602 has XY axis position calibration and magnetic adsorption functions, and the control assembly 603 has functions for reducing vibration of the measurement assembly and adjusting the focus.

[0066] Figure 8 This is a top view of the incubation module 700 of a single-molecule immunoassay analyzer. The incubation module 700 includes a mixing assembly 701 and an incubation tray main module 702. The mixing assembly 701 has the function of mixing samples and reagents, and includes mixing wheels and a drive mechanism (such as a motor). Figure 8 As shown, a mixing wheel is directly driven by a drive mechanism (such as a motor) to perform mixing, and the mixing wheel contacts the incubation tray at the mixing position. The main module 702 of the incubation tray is provided with multiple reaction cup storage slots 703, and a heating element (which can be a heating film) is installed at the bottom of the incubation tray to maintain the temperature of the incubation tray within a constant range (e.g., 40±0.5℃). The incubation module 700 is provided with a mixing position, a detection position, and a reaction cup placement position.

[0067] Figure 9This is a perspective view of the reagent processing module 800 of a single-molecule immunoassay analyzer. The reagent processing module 800 includes a reagent compartment body 801, a cooling and heat dissipation assembly 802, a barcode scanning and demisting assembly 803, and a rotary motion mechanism 804. It is used to provide a constant temperature storage range (e.g., 2–8℃ ± 0.5℃) for the reagents, to mix the reagents, and to record reagent information. The reagent compartment body 801 includes a mixing tray, a heat dissipation assembly (e.g., a cooling fan, a cooling block), a zero-position sensor, a mixing and stirring assembly, a mixing gear, a fixed spur gear, bearings, and a driven wheel. It is mainly used to store and mix the reagents. The barcode scanning and demisting assembly 803 includes a demisting heating assembly and a barcode scanner. It is mainly used for reagent information acquisition. The demisting heating assembly may include a heating film or plexiglass. The cooling and heat dissipation assembly 802 is used to cool the reagent compartment body 801. It may be located at the lower part of the reagent compartment body 801 and may include a cooling fan, a cooling plate, and a heat dissipation duct inlet. The rotary motion mechanism 804 may include a rotary motor, a zero-position sensor, a synchronous belt, a driving wheel, and a driven wheel, and is located at the lower part of the cooling and heat dissipation assembly 802.

[0068] Figure 10 This is a three-dimensional view of the reagent needle module 900 of a single-molecule immunoassay analyzer. The reagent needle module 900 includes a reagent needle 901 with liquid level detection function, a Z-axis module 902, and an X-axis module 903. The Z-axis module 902 is mounted on the X-axis module 903 and includes a reagent needle anti-collision device 904, providing anti-collision functionality. Using the reagent needle 901 with liquid level detection function allows for the detection of the reagent liquid level, improving accuracy during repeated extractions. The reagent needle module 900 is used to extract multiple reagents from the reagent processing module 800 to the incubation module 700. After each extraction, the reagent needle 901 moves to the reagent needle cleaning position 20 for cleaning.

[0069] This application, by setting up the above modules and adopting a streamlined structure, can realize integrated operation of sample addition, incubation, reagent addition, mixing, cleaning and detection. It has a high degree of automation, reduces the difficulty of operation and improves the detection efficiency.

[0070] The following describes the specific working process steps using a single reaction vessel as an example. It should be noted that this is only an example and should not be interpreted as a limitation of this technical solution.

[0071] A: The cup-gripping robotic arm module's cup-gripping gripper assembly places the reaction cup from the consumables module into the reaction cup placement position of the incubation module;

[0072] B: The multi-layer sample rack of the sample module loads a 96-well plate containing the sample; this 96-well plate moves from the sample changing position to the sample extraction position of the sample needle module, and at the same time the sample needle of the sample needle module moves to the same position to extract the sample;

[0073] C: The sample needle moves to the sample dispensing position of the incubation module. The incubation module moves the reaction cup (which has completed action A) to the sample dispensing position, and the sample needle adds the sample to the reaction cup. After the sample is added, the sample needle moves to the sample needle cleaning position for cleaning.

[0074] D: The barcode scanning component of the reagent processing module enters the reagent kit information. The reagent needle module moves to the reagent extraction position to extract reagent R1, and simultaneously moves the reaction cup that has completed action C to the mixing position of the incubation module. The reagent needle module moves to the mixing position and adds R1; at this time, the incubation module heats and incubates, and the reagent needle module moves to the reagent needle cleaning position for cleaning. The mixing component at the mixing position mixes the reaction cup containing reagent R1.

[0075] E: The barcode scanning component of the reagent processing module enters the reagent kit information. The reagent needle module moves to the reagent extraction position to extract reagent R2. At the same time, the reaction cup that has completed action D is moved to the mixing position of the incubation module. The reagent needle module moves to the mixing position to add R2. At this time, the incubation module heats and incubates. The reagent needle module moves to the reagent needle cleaning position for cleaning. The mixing component at the mixing position mixes the reaction cup containing reagent R2.

[0076] F: After incubation is complete, the incubation module moves the reaction cup that has completed the reaction to the detection position, and at the same time, the detection needle of the detection needle module moves to the detection position to extract the analyte.

[0077] G: The detection needle module moves the extracted object to be tested to the flow cell in the measurement chamber component of the detection module, where it is detected and photographed by the optical detection module. After the detection is completed, the detection needle module moves to the detection needle cleaning position for cleaning.

[0078] H: The cup-grabbing robotic arm module removes the reaction cup that has completed the reaction from the reaction cup placement position of the incubation module (step A), and moves it to the cup-discarding port of the consumables module to discard the waste cup.

[0079] This process is repeated, with multiple reaction vessels proceeding in an orderly manner without interference, enabling continuous and automated detection. During use, the sample needle, reagent needle, and detection needle can be cleaned separately at the sample needle cleaning station, reagent needle cleaning station, and detection needle cleaning station. Therefore, this application adopts a streamlined structure, which enables integrated operation of sample addition, incubation, reagent addition, mixing, cleaning, and detection, resulting in a high degree of automation, reduced operational difficulty, and improved detection efficiency.

[0080] The above are merely preferred embodiments of this application and are not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A sample introduction module, characterized by, Includes 2-4 layers of sample racks, Each sample rack is arranged in parallel in the vertical direction and has the same structure. Each sample rack includes a microplate, a stage and a linear reciprocating motion mechanism from top to bottom. The linear reciprocating motion mechanism is used to move the microplate back and forth in the sample injection direction. The linear reciprocating motion mechanism includes: a linear guide mounting plate located below the linear guide for supporting the linear guide; two linear guides located below the stage and slidably contacting the left and right ends of the stage for linear movement of the stage; a drive mechanism located below the linear guide mounting plate and connected to the drive wheel to provide power; a drawer slide rail located on the side of the linear guide mounting plate for fixing a single-layer sample rack and removing the sample rack when changing samples; a synchronous belt located on the side of one linear guide for driving the stage and microplate to slide on the linear guide; a drive wheel located at the end of one linear guide and connected to the drive mechanism; a driven wheel located at the other end of one linear guide; a synchronous belt pressure plate clamping the synchronous belt; and a synchronous belt adapter plate fixed to the stage and connected to the synchronous belt pressure plate, which, together with the synchronous belt pressure plate, assists the synchronous belt in driving the stage and microplate to slide on the linear guide. The microplate has a sample replacement position and a sample needle module for extracting samples. The drawer slide rail moves out in the direction from the sample needle module's sample extraction position to the sample replacement position.

2. The sample introduction module as described in claim 1, characterized in that, The distance between adjacent sample rack layers is 30~100mm, and the gap between the bottom of the upper sample rack and the top of the lower sample rack is 5~15mm.

3. The sample introduction module as described in claim 1 or 2, characterized in that, The microplate is a 48, 96, or 384-well plate.

4. The sample introduction module as described in claim 1 or 2, characterized in that, It contains two layers of sample racks.

5. The sample introduction module as described in claim 1 or 2, characterized in that, The linear reciprocating motion mechanism includes a zero-position sensor located on the linear guide mounting plate and on the side of the linear guide, which provides an initial position to the sample holder to prevent positional deviation of the sample holder.

6. The sample introduction module as described in claim 1 or 2, characterized in that, The linear reciprocating motion mechanism also includes: a zero-position sensor baffle, which is connected to the stage and is used to assist the zero-position sensor in providing an initial position to the sample holder.

7. A single-molecule immunoassay analyzer, characterized in that, The device comprises: an injection module as described in any one of claims 1 to 6; a sample needle module for extracting a sample from the injection module to an incubation module; a cup-grabbing robot module for transferring a reaction cup between a consumable module and an incubation module; a consumable module for storing consumables; a detection needle module for extracting the reactants after mixing and reaction to a detection module; a detection module for detecting the extracted reactants and outputting a single-molecule signal; an incubation module for placing the reaction cup and mixing and incubating the liquid in the reaction cup; a reagent processing module for providing a constant temperature range to the reagents, mixing the reagents, and recording reagent information; and a reagent needle module for extracting the reagents from the reagent processing module to the incubation module.

8. The single-molecule immunoassay analyzer as described in claim 7, characterized in that, The incubation module and the reagent processing module each include at least one turntable and a drive unit that drives the turntable to rotate. The turntable is provided with multiple placement slots.

9. The single-molecule immunoassay analyzer as described in claim 7 or 8, characterized in that, The sample needle module includes a sample needle, an X-axis module, and a Z-axis module. The Z-axis module is mounted on the X-axis module and includes a Z-axis motor, a Z-axis zero-position sensor, a sample needle anti-collision device, and a Z-axis motion mechanism.

10. The single-molecule immunoassay analyzer as described in claim 7 or 8, characterized in that, The detection probe module includes a detection probe, a Y-axis module, and a Z-axis module. The Y-axis module includes a Y-axis motor, a Y-axis zero-position sensor, and a Y-axis motion mechanism. The Z-axis module is mounted on the Y-axis module and includes a Z-axis motor, a Z-axis zero-position sensor, a detection probe anti-collision device, and a Z-axis motion mechanism.

11. The single-molecule immunoassay analyzer as described in claim 7 or 8, characterized in that, The reagent needle module includes a reagent needle with liquid level detection function, an X-axis module, and a Z-axis module. The X-axis module includes an X-axis motor, an X-axis zero-position sensor, and an X-axis motion mechanism. The Z-axis module is mounted on the X-axis module and includes a Z-axis motor, a Z-axis zero-position sensor, a reagent needle anti-collision device, and a liquid level detection plate.

12. The single-molecule immunoassay analyzer as described in claim 7 or 8, characterized in that, The detection module includes an optical detection module, a measurement chamber assembly, and a control assembly. The control assembly includes a focusing assembly and a vibration damping assembly.

Images