Fully automatic chemiluminescence immunoassay analyzer

Abstract

A fully automatic chemiluminescence immunoassay analyzer includes: a machine; a reagent strip module; a pipette module, configured to suck a sample to the reagent strip module, and mix the reagent and magnetic beads in the reagent strip module with the sample; a puncture and liquid separation module, configured to puncture the sealing film of the reagent strip module to achieve the dispensing of the cleaning solution and the substrate solution; an incubation and cleaning module, configured to perform temperature control on the reagent strip module, and extract and clean the mixture coated with magnetic beads in the reagent strip module with a magnetic rod; a measurement module, configured to measure and read the reagent strip module; wherein the reagent strip module includes at least two groups of reagent strip units, the incubation and cleaning module includes an incubation unit and a cleaning and separation unit for extracting and cleaning the mixture of the reagent strip units, and the incubation unit includes an incubation base for placing each group of reagent strip units, and a heating element arranged on the incubation base. It realizes full automation, which is convenient and fast.

Description

[Technical field]

[0001] The invention relates to a fully automatic chemiluminescence immunoassay analyzer, belonging to the technical field of medical devices. [Background technology]

[0002] Enzyme-catalyzed luminescent immunoassay technology uses enzyme-labeled antibodies (or antigens). After the reaction, a solid-phase coated antibody-antigen to be tested-enzyme-labeled antibody complex is formed. Luminol, isoluminol or AMPPD and other luminescent agents are added. The enzymatic reaction breaks the substrate and produces chemiluminescence. Since the enzymatic reaction will stably last for 15-60 minutes, the process of emitting photons is stable and highly reliable.

[0003] Based on the long duration, stable and reliable characteristics of enzymatic luminescence, many single-dose POCT analyzers have emerged on the market in recent years. That is, the reagents, cleaning fluids and substrates required for a single test are all encapsulated in a reagent strip. The operator first manually adds the sample to the sample position specified in the reagent strip, inserts the reagent strip into the instrument, and then the instrument performs the subsequent test process. A single instrument can support 6-10 reagent strips for simultaneous testing. Compared with large-scale equipment in the laboratory, its main advantage is that it is small and portable. Compared with multi-dose test kits, single-dose reagent packaging can prevent cross-contamination and evaporation after opening the bottle, and there is no liquid path system inside the instrument, which reduces the environmental requirements for the use of the instrument. However, the instruments in the current market also have the following defects: cumbersome operation, manual intervention in the detection and analysis process, and easy to cause biological contamination.

[0004] Therefore, it is necessary to improve the prior art to overcome the above defects in the prior art. [Summary of the invention]

[0005] The purpose of the present invention is to provide a fully automatic chemiluminescence immunoassay analyzer, which can realize full automation without manual intervention during the operation process, is convenient and fast, and improves the accuracy of detection and analysis.

[0006] The object of the present invention is to achieve the following technical solution: a fully automatic chemiluminescence immunoassay analyzer, comprising:

[0007] Machine;

[0008] A reagent strip module is arranged on the machine platform;

[0009] A pipette tip module is disposed on the machine platform and is movable relative to the reagent strip module; the pipette tip module is configured to suck the sample to the reagent strip module and mix the reagent and magnetic beads in the reagent strip module with the sample;

[0010] A puncture and liquid dispensing module is arranged on the machine platform and can move relative to the reagent strip module; the puncture and liquid dispensing module is configured to puncture the sealing film of the reagent strip module to achieve the dispensing of the cleaning solution and the substrate solution;

[0011] an incubation and cleaning module, which is disposed on the machine platform and can move relative to the reagent strip module; the incubation and cleaning module is configured to perform temperature control on the reagent strip module, and to extract and clean the mixture coated with magnetic beads in the reagent strip module using a magnetic rod;

[0012] A measuring module is disposed on the machine platform and is movable relative to the reagent strip module; the measuring module is configured to measure and read the reagent strip module;

[0013] Among them, the reagent strip module includes at least two groups of reagent strip units, the incubation and cleaning module includes an incubation unit for temperature control of the reagent strip units and a cleaning and separation unit for extracting and cleaning the mixture of the reagent strip units, the incubation unit includes a hollow incubation base for placing each group of the reagent strip units, and a heating element arranged on the incubation base, and the heating element is used to heat the incubation base.

[0014] In one embodiment, the incubation unit further includes a temperature control plate and a temperature control protection switch arranged on the incubation base, wherein the temperature control plate is used to control the temperature of the incubation base, and the temperature control protection switch is used to disconnect when the temperature of the incubation base is too high when the temperature control plate is electrically short-circuited.

[0015] In one embodiment, the cleaning and separation unit includes a frame, a magnetic rod motor arranged on the frame, a magnetic rod connected to the magnetic rod motor, a magnetic rod reset optical coupler for detecting whether the magnetic rod is reset, and a magnetic sleeve motor arranged on one side of the magnetic rod motor.

[0016] In one embodiment, a first slide rail is provided on one of the machine table and the incubation base, and a slide groove slidably matched with the first slide rail is provided on the other of the machine table and the incubation base; the incubation and cleaning module also includes a reagent strip driving component for driving the reagent strip unit to move, and the reagent strip driving component is arranged on one side of the first slide rail.

[0017] In one of the embodiments, the suction head module includes a suction head unit and a suction head driving unit connected to the suction head unit, and the suction head driving unit is used to drive the suction head unit to move along a first direction, a second direction and a third direction, and the first direction, the second direction and the third direction are arranged perpendicular to each other.

[0018] In one embodiment, the suction head unit includes a suction head body for suction, and an air pump connected to the suction head body and used to generate negative pressure.

[0019] In one of the embodiments, the suction head module also includes a support base mounted on the machine platform, and the suction head drive unit is arranged on the support base; the suction head drive unit includes a first suction head drive component, a second suction head drive component and a third suction head drive component, and the third suction head drive component is connected to the suction head unit.

[0020] In one embodiment, the puncture and liquid dispensing module includes a substrate connected to the machine, a puncture needle driving unit disposed on the substrate, and a puncture unit connected to the puncture needle driving unit.

[0021] In one embodiment, the puncture unit includes a puncture needle body and a barcode scanner connected to the puncture needle body; the puncture needle drive unit includes a first puncture drive component for driving the puncture unit to move along a first direction, and a second puncture drive component for moving along a third direction.

[0022] In one embodiment, the fully automatic chemiluminescence immunoassay analyzer further includes a tip loading module, and the tip loading module is disposed above the reagent strip module to dock with the tip module.

[0023] Compared with the prior art, the present invention has the following beneficial effects: by independently arranging the pipette tip module, the piercing and dispensing module and the incubation and cleaning module, the pipette tip module mixes the sample with the reagent and magnetic beads in the reagent strip module, while the piercing and dispensing module pierces the reagent strip module and adds cleaning liquid and substrate liquid, and the incubation and cleaning module extracts and cleans the mixture coated with magnetic beads in the reagent strip module with a magnetic rod, so that the sample and the substrate are not contaminated, which is convenient and fast; at the same time, the pipette tip module, the piercing and dispensing module, the incubation and cleaning module and the measuring module do not require manual intervention during operation, so that full automation is achieved, and the accuracy of detection is improved;

[0024] The incubation and cleaning module is provided with a heating element, which heats the incubation base so that the reagent strip body can fully react under the set temperature environment, which is convenient and quick.

Brief Description of the Drawings

[0025] Figure 1 It is a structural schematic diagram of the fully automatic chemiluminescence immunoassay analyzer of the present invention.

[0026] Figure 2 yes Figure 1 Schematic cross-section of the reagent strip unit.

[0027] Figure 3 yes Figure 1 Schematic diagram of the structure of the suction head module.

[0028] Figure 4 yes Figure 1 Schematic diagram of the structure of the puncture and dispensing module.

[0029] Figure 5 yes Figure 1 Schematic diagram of the structure of the measurement module.

[0030] Figure 6 yes Figure 1 Schematic diagram of the structure of the tip loading module in FIG.

[0031] Figure 7 yes Figure 1 Schematic diagram of the structure of the incubation and cleaning module. [Specific implementation method]

[0032] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific implementation methods of the present invention are described in detail below in conjunction with the accompanying drawings. It is understood that the specific embodiments described herein are only used to explain the present invention, rather than to limit the present invention. It should also be noted that, for ease of description, only the parts related to the present invention rather than all structures are shown in the accompanying drawings. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0033] The terms "including" and "having" and any variations thereof in the present invention are intended to cover non-exclusive inclusions. For example, a process, method, system, product or device comprising a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products or devices.

[0034] Reference to "embodiments" herein means that a particular feature, structure, or characteristic described in conjunction with the embodiments may be included in at least one embodiment of the present invention. The appearance of the phrase in various places in the specification does not necessarily refer to the same embodiment, nor is it an independent or alternative embodiment that is mutually exclusive with other embodiments. It is explicitly and implicitly understood by those skilled in the art that the embodiments described herein may be combined with other embodiments.

[0035] See also Figures 1 to 7As shown, a fully automatic chemiluminescence immunoassay analyzer in a preferred embodiment of the present invention includes: a machine 1, a reagent strip module 2, a pipette tip module 3, a puncture and liquid dispensing module 4, an incubation and cleaning module 9 and a measurement module 5 arranged on the machine 1, wherein the pipette tip module 3, the puncture and liquid dispensing module 4, the incubation and cleaning module 9 and the measurement module 5 can all be moved relative to the reagent strip module 2 to perform corresponding operations on the reagent strip module 2.

[0036] Specifically, the reagent strip module 2 includes at least two groups of reagent strip units. When one group of reagent strip units completes the dispensing and mixing reaction and moves to the incubation and cleaning module 9 and the measurement module 5, the pipette tip module 3 and the puncture and liquid separation module 4 can perform dispensing and mixing reaction operations on the next group of reagent strip units to improve the detection and analysis efficiency.

[0037] Each group of reagent strip units includes a reagent strip body 21 and a handle 22 connected to the reagent strip body 21, and the handle 22 is used to facilitate the user to hold and place the reagent strip unit in the incubation and cleaning module 9. The reagent strip body 21 is provided with a cleaning position 211, a reaction position 212, a measurement position 213, a packaging position 214 and a cleaning hole 215 of the puncture needle body of the puncture needle module. Along the horizontal direction of the reagent strip body 21, the cleaning position 211, the reaction position 212, the measurement position 213, the packaging position 214 and the cleaning hole 215 are arranged in sequence. In the present embodiment, the number of the cleaning positions 211 is set to three, so that the mixture coated with magnetic beads is extracted and cleaned fully. Of course, in other embodiments, the number of the cleaning positions 211 can also be other, which is not specifically limited here and is determined according to actual conditions.

[0038] The packaging position 214 includes a first hole for placing a substrate, a second hole for placing a magnetic bead, and a third hole for placing an enzyme-labeled reagent. The first hole, the second hole, and the third hole are arranged in sequence, and a packaging film is arranged above the first hole, the second hole, and the third hole to prevent the items in the hole from leaking out. In the present embodiment, the packaging film is an aluminum foil composite film, which can be sealed while also being pierced by the piercing needle body or the suction head body 322. Similarly, because a cleaning solution is placed in the cleaning hole 215, a packaging film is also arranged on the cleaning hole 215, and the packaging film is the same as above. On the contrary, because the cleaning position 211, the reaction position 212, and the measurement position 213 are not encapsulated with any reagent when the reagent strip body 21 is in the initial state, no packaging film is provided.

[0039] The cleaning hole 215 includes a cleaning liquid packaging hole 2151 and a puncture needle body cleaning hole 2152 disposed in the cleaning liquid packaging hole 2151. In the height direction of the reagent strip body 21, the height of the puncture needle body cleaning hole 2152 is less than the height of the cleaning liquid packaging hole 2151. The purpose of such a setting is that when the puncture needle body is transferred to the puncture needle body cleaning hole 2152, the cleaning liquid is spit out, and the cleaning liquid is used to clean the inner wall of the puncture needle body 421 under a certain pressure and flow rate, and the spitted cleaning liquid performs eddy current motion in the puncture needle body cleaning hole 2152 to clean the outer wall of the puncture needle body 421. It is worth noting that the height of the cleaning liquid in the puncture needle body cleaning hole 2152 should be lower than the height of the hole to prevent the eddy current motion from failing. This is achieved in this embodiment by quantitative packaging and filling of cleaning liquid.

[0040] The reagent strip unit further includes a magnetic sleeve 216 pre-installed on one side of the handle, that is, the magnetic sleeve 216 is pre-installed between the handle and the cleaning hole 215 .

[0041] The incubation and cleaning module 9 is configured to perform temperature control on the reagent strip module 2, and the mixture coated with magnetic beads in the reagent strip module 2 is extracted and cleaned with a magnetic sleeve 216. The incubation and cleaning module 9 includes an incubation unit 91 for temperature control of the reagent strip unit and a cleaning and separation unit 92 for extracting and cleaning the mixture of the reagent strip unit. The incubation unit 91 is used to place each group of reagent strip units and a hollow incubation base 911, a reagent strip body 21 arranged in the incubation base 911, and a heating element 913 arranged on the incubation base 911. The heating element 913 is used to heat the incubation base 911. Because the reagent strip body 21 is generally stored in cold air, the reaction temperature of the reagent strip body 21 is preferably 37°C. After the incubation base 911 is heated, the reagent strip body 21 is gradually heated to the reaction temperature in a certain temperature environment, which is convenient and quick. In the present embodiment, the heating element 913 is a heating film, and the heating film at least covers a portion of the incubation base 911. Of course, in other embodiments, the heating element 913 may be other, which is not specifically limited here and depends on the actual situation. In this embodiment, the heating film is fixedly arranged at the bottom of the incubation base 911 to ensure the uniformity of the temperature field of the incubation base 911.

[0042] The incubation unit 91 also includes a temperature control plate 912 and a temperature control protection switch 914 arranged on the incubation base 911. The temperature control plate 912 is used to control the temperature of the incubation base 911, and the temperature control protection switch 914 is used to disconnect when the temperature of the incubation base 911 is too high when the temperature control plate 912 is electrically short-circuited. Among them, the temperature control plate 912 is arranged on the side wall of the incubation base 911. As mentioned above, because the optimal reaction temperature of the reagent strip body 21 is 37°C, the temperature control plate 912 accurately controls the incubation temperature to be maintained at 37〒0.5°C. Correspondingly, the temperature control protection switch 914 is arranged on the side wall of the incubation base 911 and is arranged close to the temperature control plate 912.

[0043] Each group of reagent strip units can move along the Y-axis direction of the machine 1, so in this embodiment, a first slide rail is provided on one of the machine 1 and the incubation base 911, and a slide groove that slides with the first slide rail is provided on the other of the machine 1 and the incubation base 911. Correspondingly, the incubation and cleaning module 9 also includes a reagent strip drive component 915 for driving the reagent strip unit to move, and the reagent strip drive component 915 is arranged on one side of the first slide rail. In this embodiment, the reagent strip drive unit is a drive motor.

[0044] The incubation unit 91 further includes a reset optical coupler disposed on the other side of the first slide rail, and the reset optical coupler is used to detect whether the reagent strip unit is reset.

[0045] The cleaning and separation unit 92 includes a frame, a magnetic rod motor 921 disposed on the frame, a magnetic rod connected to the magnetic rod motor 921, a magnetic rod reset optical coupler for detecting whether the magnetic rod is reset, and a magnetic sleeve motor 922 disposed on one side of the magnetic rod motor 921. The magnetic sleeve motor 922 and the magnetic rod motor 921 can drive the magnetic rod to move up and down along the Z axis. The magnetic sleeve motor 922 and the magnetic rod motor 921 move downward to extend the magnetic rod, and move to the magnetic sleeve 216 so that the magnetic sleeve 216 and the magnetic rod are attracted, and move to the cleaning position 211 to attract the magnetic beads, obtain the mixture coated with the magnetic beads, and wash and extract the mixture coated with the magnetic beads, and finally transfer it to the measurement position 213 by the magnetic sleeve 216. After the magnetic bead mixture and the pre-added substrate are fully reacted, it stably emits sustainable light with a wavelength of 470nm, and finally is converted and measured by the measurement unit.

[0046] The suction head module 3 includes a suction head unit 32 and a suction head drive unit 31 connected to the suction head unit 32, and the suction head drive unit 31 is used to drive the suction head unit 32 to move along the first direction, the second direction and the third direction, and the first direction, the second direction and the third direction are arranged perpendicular to each other. In the present embodiment, the first direction is the X-axis direction, the second direction is the Y-axis direction, and the third direction is the Z-axis direction. Of course, in other embodiments, the first direction, the second direction and the third direction may also have other indications, which are not specifically limited here and are determined according to actual conditions. Specifically, the suction head drive unit 31 includes a first suction head drive assembly 311, a second suction head drive assembly 312 and a third suction head drive assembly 313, and the third suction head drive assembly 313 is connected to the suction head unit 32. In this embodiment, the first suction head driving assembly 311, the second suction head driving assembly 312 and the third suction head driving assembly 313 are the same as the reagent strip driving assembly. The first suction head driving assembly 311, the second suction head driving assembly 312 and the third suction head driving assembly 313 can drive the suction head unit 32 to move through a chain transmission. This is a conventional structure and will not be described in detail here.

[0047] The suction head unit 32 includes a suction head body 322 for suction, and an air pump 321 connected to the suction head body 322 and used to generate negative pressure, and the suction head body 322 is docked with the pump body of the air pump 321. The air pump 321 can automatically load and unload the suction head, determine whether the suction head is in place or unloaded, quantitatively discharge liquid, and detect the liquid level. The suction head drive unit 31 drives the suction head body 322 to move to the sample to suck the sample and place the sample in the reaction position 212. Among them, the air pump 321 is connected to the third suction head drive assembly 313. The suction head module 3 also includes a support seat mounted on the machine 1, and the suction head drive unit 31 is arranged on the support seat. In this embodiment, the suction head drive unit 31 is arranged above the reagent strip module 2 and operates the reagent strip module 2. The suction head body 322 is generally made of plastic material, which can easily pierce the packaging film. Of course, in other embodiments, the material of the suction head body 322 may be other materials as long as the above-mentioned effects are achieved. No specific limitation is made here and it depends on the actual situation.

[0048] The tip drive unit 31 drives the tip unit 32 to move to add the sample into the reaction position 212 , and at the same time the tip moves downward to pierce the packaging film, and at the same time enters the second hole and the third hole to absorb the magnetic beads and the enzyme-labeled reagent and add them into the reaction position 212 to form a magnetic bead-coated mixture in the reaction position 212 .

[0049] The puncture and liquid dispensing module 4 is configured to puncture the sealing film of the reagent strip module 2 to achieve the dispensing of the cleaning liquid and the substrate liquid. The puncture and liquid dispensing module 4 includes a substrate connected to the machine 1, a puncture needle drive unit 41 arranged on the substrate, and a puncture unit 42 connected to the puncture needle drive unit 41. In the present embodiment, the height of the substrate is lower than the height of the support seat, that is, the puncture and liquid dispensing module 4 is located below the suction head module 3. Among them, the puncture unit 42 includes a puncture needle body 421 and a barcode scanner 422 connected to the puncture needle body 421, and the puncture needle body 421 is used to puncture the packaging film to add the quantitatively packaged cleaning liquid and substrate in the reagent strip to the cleaning position 211 and the measurement position 213 on the reagent strip body 21. The barcode scanner 422 reads the barcode on each reagent strip unit to record that the reagent strip unit has completed operations such as dispensing.

[0050] It is worth noting that in order to prevent contamination, in the present embodiment, the puncture needle body 421 needs to be cleaned before absorbing the substrate. The specific process is as follows: after the puncture needle body 421 is filled with cleaning fluid and before absorbing the substrate, it first absorbs a certain amount of cleaning fluid, then sucks a section of air column, and then absorbs a certain amount of substrate.

[0051] The puncture needle drive unit 41 includes a first puncture drive component 411 for driving the puncture unit 42 to move along a first direction, and a second puncture drive component 412 for moving along a third direction. As described above, in this embodiment, the first direction is the X-axis direction, and the third direction is the Z-axis direction. The first puncture drive component 411 and the second puncture drive unit 412 are consistent with the above, and are both drive motors. The connection between the two is achieved by chain rotation. It is a conventional structure and will not be described here.

[0052] The measuring module 5 is configured to measure and read the reagent strip module 2. The measuring module 5 includes a measuring base plate 51 disposed on the machine 1, a dark box 52, a photomultiplier tube 53 connected to the dark box 52, a first measuring driving component 54 for driving the photomultiplier tube 53 to move along the z-axis, and a second measuring driving component 55 disposed on the measuring base plate 51 and for driving the photomultiplier tube 53 to move along the x-axis. When the incubation base 911 drives the reagent strip body 21 to move along the first slide rail to the bottom of the dark box 52, the first measuring driving component 54 drives the dark box 52 to descend and press the reagent strip body 21, and the photomultiplier tube 53 is turned on to start measuring and reading.

[0053] The fully automatic chemiluminescence immunoassay analyzer also includes a tip loading module 7, which is arranged above the reagent strip module 2 to dock with the tip module 3. The tip loading module 7 is mainly used to store disposable tips, which can prevent cross contamination between different items. The tip loading module 7 includes a tip box bottom plate 61 arranged on the machine 1, a second slide rail 62 arranged on the tip box bottom plate 61, a tip box seat 64 that slides with the second slide rail 62 and is used to place the tip body 322, a positioning bearing 63 arranged on one side of the second slide rail 62, and a support plate 65 arranged on the tip box bottom plate 61 and opposite to the tip box seat 64, and a sensor 66 is arranged on the support plate 65 to detect whether the tip box seat 64 is in place to ensure that the tip body 322 is loaded smoothly. The support plate 65 is also provided with a magnet 67. Correspondingly, the tip box seat 64 is provided with a magnetic member matching with the magnet 67, or the tip box seat 64 is a metal that can be magnetically attracted. It is not specifically limited here and depends on the actual situation.

[0054] When the tip body 322 needs to be replaced, the tip box seat 64 is pulled out, and when the replacement is completed, the tip box seat 64 is pushed back, and it completes automatic positioning in the X-axis direction under the action of the four positioning bearings 63, and completes positioning and fixing in the Y-axis direction through the magnet 67 fixed on the support plate 65.

[0055] The fully automatic chemiluminescence immunoassay analyzer further includes a waste collection module 8 for collecting discarded pipette tip bodies 322 and a sample loading module 7 for placing samples. The waste collection module 8 is a waste box 8, and the sample loading module 7 is disposed on the waste box 8. The sample loading module 7 includes a sample rack 72 and a test tube 71 placed in the sample rack 72, and the sample is stored in the test tube 71. The sample loading module 7 further includes a limit bar disposed on the waste box 8, a guide pin disposed on one side of the limit bar, a positioning plunger for positioning the sample rack 72, and an in-position sensor for detecting whether the sample rack 72 is in position. The sample rack 72 can slide along the guide pin and the limit bar, and a drop channel is disposed on the positioning plunger, and the drop channel is communicated with the waste box.

[0056] The overall action flow of the present invention is as follows: after the sample and the reagent strip body 21 are loaded, the tip module 3 is loaded with a disposable tip, and the sample, enzyme-labeled reagent and magnetic beads are quantitatively added to the reaction position 212 of the reagent strip body 21 to form a magnetic bead-coated mixture. The mixture in the reagent strip body 21 is fully reacted in the 37°C environment of the incubation unit 91. During the incubation process, the puncture needle body 421 on the liquid separation module 4 is punctured to pre-fill the quantitatively packaged cleaning liquid and substrate in the reagent strip body 21 into the cleaning position 211 and the measurement position 213 corresponding to the reagent strip body 21. After the incubation is completed, the incubation unit 91 moves to the cleaning position 211, and the magnetic sleeve motor 922 and the magnetic rod motor 921 extract and clean the magnetic bead-coated mixture, and finally transferred to the measurement position 213 by the magnetic sleeve 216. After the magnetic bead mixture fully reacts with the pre-added substrate, it stably emits sustainable light with a wavelength of 470nm, and finally converted and read by the measurement module 5. During the incubation and cleaning period, the pipette tip module 3 will continue to add samples for the next project. Therefore, except for the serial action of the pipette tip module 3, the other action processes are parallel actions and do not interfere with each other.

[0057] In summary, the pipette tip module 3, the piercing and dispensing module 4 and the incubation and cleaning module 9 are independently arranged, so that the pipette tip module 3 mixes the sample with the reagent and magnetic beads in the reagent strip module 2, and the piercing and dispensing module 4 pierces the reagent strip module 2 to add cleaning liquid and other operations, and the incubation and cleaning module 9 absorbs the magnetic sleeve 216 of the reagent strip module 2 to extract and clean the mixture coated with the magnetic beads, so that the sample and the substrate are not contaminated, which is convenient and fast; at the same time, the pipette tip module 3, the piercing and dispensing module 4, the incubation and cleaning module 9 and the measuring module 5 do not require manual intervention during the operation process, and realize full automation, thereby improving the accuracy of detection;

[0058] The incubation and cleaning module 9 is provided with a heating element 913, which heats the incubation base 911 so that the reagent strip body 21 can fully react under the set temperature environment, which is convenient and quick.

[0059] The above is only a specific implementation of the present invention, and any other improvements made based on the concept of the present invention are considered to be within the protection scope of the present invention.

Claims

1. A fully automatic chemiluminescence immunoassay analyzer, characterized in that: include: Machine; A reagent strip module is arranged on the machine platform; A pipette tip module, which is disposed on the machine platform and is movable relative to the reagent strip module; The suction head module is configured to suck the sample to the reagent strip module and mix the reagent and magnetic beads in the reagent strip module with the sample; A puncture and liquid dispensing module is arranged on the machine platform and can move relative to the reagent strip module; the puncture and liquid dispensing module is configured to puncture the sealing film of the reagent strip module to achieve the dispensing of the cleaning solution and the substrate solution; an incubation and cleaning module, which is disposed on the machine platform and can move relative to the reagent strip module; the incubation and cleaning module is configured to perform temperature control on the reagent strip module, and to extract and clean the mixture coated with magnetic beads in the reagent strip module using a magnetic rod; A measuring module is disposed on the machine platform and is movable relative to the reagent strip module; the measuring module is configured to measure and read the reagent strip module; Wherein, the reagent strip module comprises at least two groups of reagent strip units, the incubation and cleaning module comprises an incubation unit for temperature control of the reagent strip units and a cleaning and separation unit for extracting and cleaning the mixture of the reagent strip units, the incubation unit comprises a hollow incubation base for placing each group of the reagent strip units, and a heating element arranged on the incubation base, the heating element being used to heat the incubation base; The incubation unit further comprises a temperature control plate and a temperature control protection switch arranged on the incubation base, wherein the temperature control plate is used to control the temperature of the incubation base, and the temperature control protection switch is used to disconnect when the temperature of the incubation base is too high when the temperature control plate is electrically short-circuited; The cleaning and separation unit comprises a frame, a magnetic bar motor arranged on the frame, a magnetic bar connected to the magnetic bar motor, a magnetic bar reset optical coupler for detecting whether the magnetic bar is reset, and a magnetic sleeve motor arranged on one side of the magnetic bar motor; Each set of reagent strip units includes a reagent strip body and a handle connected to the reagent strip body, the handle is used for the user to hold and place the reagent strip unit in the incubation and cleaning module, the reagent strip body is provided with a cleaning position, a reaction position, a measurement position, a packaging position and a cleaning hole of the puncture needle body of the puncture needle module, and the cleaning position, the reaction position, the measurement position, the packaging position and the cleaning hole are arranged in sequence along the horizontal direction of the reagent strip body; The encapsulation position includes a first hole for placing a substrate, a second hole for placing magnetic beads, and a third hole for placing an enzyme-labeled reagent. The first hole, the second hole, and the third hole are arranged in sequence, and a packaging film is arranged above the first hole, the second hole, and the third hole.

2. The fully automatic chemiluminescence immunoassay analyzer according to claim 1, characterized in that: A first slide rail is arranged on one of the machine table and the incubation base, and a slide groove slidably matched with the first slide rail is arranged on the other of the machine table and the incubation base; the incubation and cleaning module also includes a reagent strip driving component for driving the reagent strip unit to move, and the reagent strip driving component is arranged on one side of the first slide rail.

3. The fully automatic chemiluminescence immunoassay analyzer according to claim 1, characterized in that: The suction head module includes a suction head unit and a suction head driving unit connected to the suction head unit, wherein the suction head driving unit is used to drive the suction head unit to move along a first direction, a second direction and a third direction, wherein the first direction, the second direction and the third direction are arranged perpendicular to each other.

4. The fully automatic chemiluminescence immunoassay analyzer according to claim 3, characterized in that: The suction head unit comprises a suction head body for suction, and an air pump connected to the suction head body and used for generating negative pressure.

5. The fully automatic chemiluminescence immunoassay analyzer according to claim 3, characterized in that: The suction head module also includes a support base mounted on the machine platform, and the suction head drive unit is arranged on the support base; the suction head drive unit includes a first suction head drive component, a second suction head drive component and a third suction head drive component, and the third suction head drive component is connected to the suction head unit.

6. The fully automatic chemiluminescence immunoassay analyzer according to claim 1, characterized in that: The puncture and liquid-dispensing module includes a substrate connected to the machine, a puncture needle driving unit arranged on the substrate, and a puncture unit connected to the puncture needle driving unit.

7. The fully automatic chemiluminescence immunoassay analyzer according to claim 6, characterized in that: The puncture unit includes a puncture needle body and a barcode scanner connected to the puncture needle body; the puncture needle drive unit includes a first puncture drive component for driving the puncture unit to move along a first direction, and a second puncture drive component for moving along a third direction.

8. The fully automatic chemiluminescence immunoassay analyzer according to claim 1, characterized in that: The fully automatic chemiluminescence immunoassay analyzer further includes a pipette tip loading module, which is disposed above the reagent strip module to dock with the pipette tip module.

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