Molecular diagnosis analyzer
By designing the relative motion of the mixing magnet assembly and the first bearing assembly in the molecular diagnostic analyzer, a three-dimensional magnetic field is generated, and the aerosol problem during the mixing of magnetic beads is solved, and the full movement and combination of magnetic beads is achieved during the nucleic acid extraction process is improved, and the purity and accuracy of nucleic acid extraction are improved.
Patent Information
- Application Number
- PCT/CN2025/074252
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-02-06
- Filing Date
- 2025-01-23
- Publication Date
- 2025-08-14
AI Technical Summary
The existing magnetic bead mixing technology is prone to produce aerosols during the nucleic acid extraction process, resulting in inaccurate sample test results, and the existing magnetic field methods cannot achieve sufficient movement of the magnetic beads in the solution, especially in the cleavage step of the nucleic acid extraction step, the full combination of the magnetic beads and nucleic acid cannot be achieved.
A molecular diagnostic analyzer is designed, and by setting a mixing magnet assembly and the first bearing assembly in the nucleic acid extraction module, it moves relative to each other, and generates a changing magnetic field in the horizontal and vertical directions, so that the magnetic beads in the sample container move in three-dimensionally in the reaction liquid, achieving sufficient mixing of the magnetic beads.
It effectively avoids the generation of aerosols, ensures the full movement and binding of magnetic beads during the nucleic acid extraction process, and improves the purity and accuracy of nucleic acid extraction.
Smart Images

Figure CN2025074252_14082025_PF_FP_ABST
Abstract
Description
Molecular diagnostic analyzers Technical Field
[0001] The present application relates to the field of in vitro diagnosis, and in particular to a molecular diagnostic analyzer. Background Art
[0002] With the development of technology, molecular diagnostic analyzers based on polymerase chain reaction (PCR) are increasingly being used in medical testing. The testing process is as follows: nucleic acid extraction from biological samples, amplification of the nucleic acids, and testing of the amplified nucleic acids. The nucleic acid extraction steps primarily include lysis, washing, and elution.
[0003] Magnetic bead-based nucleic acid extraction technology is widely used in molecular diagnostic analyzers due to its advantages, including high nucleic acid purity, short extraction times, automation, and high-volume operation. The basic principle is that specific groups on the surface of magnetic beads bind specifically to nucleic acid molecules. After washing and purification, the nucleic acids are eluted from the beads to obtain the final purified nucleic acid. During these steps of nucleic acid extraction, the magnetic beads and nucleic acids must be mixed thoroughly.
[0004] Currently, commonly used magnetic bead mixing techniques include blowing mixing, shaking mixing, vortex mixing, ultrasonic mixing, etc., but these mixing methods are accompanied by violent liquid surface vibration and breakage, resulting in the generation of a large amount of aerosols and certain pollution problems, thereby reducing the accuracy of sample test results.
[0005] In addition, solutions for cleaning or mixing magnetic beads based on magnetic fields have also been proposed in the prior art. However, existing magnetic mixing methods can only disperse the magnetic beads to a relatively weak degree and cannot achieve sufficient movement of the magnetic beads in the solution.
[0006] Especially for the lysis step of the nucleic acid extraction step, the existing magnetic mixing method cannot achieve sufficient combination of magnetic beads and nucleic acids. Summary of the Invention
[0007] Based on this background, the task of this application is to provide a molecular diagnostic analyzer, which can not only effectively avoid the generation of aerosols, but also enable the magnetic beads to perform three-dimensional motion in the reaction liquid in space, especially to make the magnetic beads distributed as much as possible in the entire fluid domain (reaction liquid) in space or to make the temporal motion trajectory of the magnetic beads spread throughout the entire fluid domain (reaction liquid), so that the nucleic acid is completely captured (also called adsorbed) by the magnetic beads, washed and purified or completely released, and ultimately achieve an optimized nucleic acid extraction effect.
[0008] In order to achieve the above tasks, the first aspect of the present application provides a molecular diagnostic analyzer, including a nucleic acid extraction module, an amplification module and a detection module, wherein the nucleic acid extraction module is configured to extract nucleic acid from a sample, the amplification module is configured to amplify the nucleic acid extracted by the nucleic acid extraction module, and the detection module is configured to detect the amplified nucleic acid.
[0009] The nucleic acid extraction module includes a mixing magnet assembly and a first carrier assembly disposed above the mixing magnet assembly. The mixing magnet assembly includes at least a first magnet array and a second magnet array extending horizontally, each magnet array comprising a plurality of magnets spaced apart and mounted on a magnet support. The first carrier assembly includes a container receiving portion for accommodating a sample container containing a reaction solution, wherein the reaction solution includes a sample containing nucleic acid and magnetic beads for adsorbing the nucleic acid.
[0010] The first carrier assembly and the mixing magnet assembly are arranged relative to each other so that when a sample container is received in the container receiving portion, at least the bottom of the sample container is located between the first magnet array and the second magnet array. The first carrier assembly and the mixing magnet assembly can move horizontally relative to each other so that the mixing magnet assembly can mix the magnetic beads in the sample container received in the container receiving portion. Furthermore, the first carrier assembly and the mixing magnet assembly are arranged relative to each other so that when the first carrier assembly and the mixing magnet assembly move horizontally relative to each other, at least two magnets in the mixing magnet assembly have different heights relative to the bottom of the sample container received in the container receiving portion.
[0011] In the molecular diagnostic analyzer provided in the first aspect of the present application, by arranging the first carrier assembly and the mixing magnet assembly relative to each other, when the two move horizontally relative to each other, at least two magnets in the mixing magnet assembly have different heights relative to the bottom of the sample container received in the container receiving portion, so that the magnetic beads in the sample container can perform three-dimensional movement in the reaction liquid, especially traverse the entire reaction liquid, and achieve sufficient mixing of the magnetic beads in the lysis and capture stage, the washing stage, or the elution stage, thereby achieving sufficient nucleic acid capture, washing or elution, etc.
[0012] A second aspect of the present application provides another molecular diagnostic analyzer, comprising a nucleic acid extraction module, an amplification module and a detection module, wherein the nucleic acid extraction module is configured to extract nucleic acid from a sample, the amplification module is configured to amplify the nucleic acid extracted by the nucleic acid extraction module, and the detection module is configured to detect the amplified nucleic acid.
[0013] The nucleic acid extraction module includes a first carrying component, a mixing magnet component and a driving device, wherein the first carrying component is configured to place a sample container containing a reaction liquid, wherein the reaction liquid includes a sample containing nucleic acid and magnetic beads for adsorbing the nucleic acid, and the mixing magnet component includes a movable magnet bracket and a plurality of magnets fixed on the magnet bracket, wherein the driving device is configured to drive the magnet bracket to move, so as to drive the plurality of magnets fixed on the magnet bracket to move relative to the sample container on the first carrying component, so that the magnetic beads in the sample container placed on the first carrying component perform three-dimensional movement in the reaction liquid under the action of the moving magnets.
[0014] In the molecular diagnostic analyzer provided in the second aspect of the present application, the magnet is driven to move by the magnet bracket to generate a relatively changing magnetic field. The relatively changing magnetic field causes the magnetic beads in the sample container to move three-dimensionally in the reaction liquid under the action of the moving magnet, thereby achieving sufficient mixing of the magnetic beads in the lysis and capture stage, the washing stage, or the elution stage, thereby achieving sufficient nucleic acid capture, washing, or elution, etc.
[0015] The third aspect of the present application provides another molecular diagnostic analyzer, comprising a nucleic acid extraction module, an amplification module and a detection module, wherein the nucleic acid extraction module is configured to extract nucleic acid from a sample, the amplification module is configured to amplify the nucleic acid extracted by the nucleic acid extraction module, and the detection module is configured to detect the amplified nucleic acid.
[0016] The nucleic acid extraction module includes a first carrying component, a mixing magnet component and a driving device. The first carrying component is configured to place a sample container containing a reaction liquid. The reaction liquid includes a sample containing nucleic acid and magnetic beads for adsorbing the nucleic acid. The mixing magnet component is configured to generate a magnetic field. The driving device is configured to drive the first carrying component and the mixing magnet component to move relative to each other, so that the mixing magnet component generates an alternating magnetic field relative to the sample container on the first carrying component, so that the magnetic beads in the sample container can perform three-dimensional movement in the reaction liquid under the action of the alternating magnetic field.
[0017] In the molecular diagnostic analyzer provided in the third aspect of the present application, by generating a magnetic field that alternates relative to the sample container, the magnetic beads in the sample container perform three-dimensional movement in the reaction liquid under the action of the relatively alternating magnetic field, thereby achieving sufficient mixing of the magnetic beads in the lysis and capture stage, the washing stage, or the elution stage, thereby achieving sufficient nucleic acid capture, washing, or elution, etc.
[0018] The fourth aspect of the present application provides another molecular diagnostic analyzer, comprising a nucleic acid extraction module, an amplification module and a detection module, wherein the nucleic acid extraction module is configured to extract nucleic acid from a sample, the amplification module is configured to amplify the nucleic acid extracted by the nucleic acid extraction module, and the detection module is configured to detect the amplified nucleic acid.
[0019] The nucleic acid extraction module includes: a first carrier component, which is configured to place a sample container containing a reaction liquid, wherein the reaction liquid includes a sample containing nucleic acid and magnetic beads for adsorbing the nucleic acid, and the first carrier component includes at least a lysis and capture zone, wherein the sample container undergoes a lysis and capture link in the lysis and capture zone, during which cells in the sample of the sample container are lysed to release nucleic acids, and the released nucleic acids are captured by the magnetic beads in the sample container; a mixing magnet component, which is configured to generate a magnetic field that at least covers the lysis and capture zone; and a driving device, which is configured to drive the first carrier component and the mixing magnet component to move relative to each other, so that the magnetic beads in the sample container in the lysis and capture zone move, so that the magnetic beads capture the released nucleic acids.
[0020] In the molecular diagnostic analyzer provided in the fourth aspect of the present application, a mixing magnet assembly is provided that at least covers the lysis and capture zone, so that when the sample container is located in the lysis and capture zone to undergo a lysis and capture step, the magnetic beads in the sample container can move under the action of the magnetic field, so that the magnetic beads can move in the reaction liquid, thereby achieving sufficient mixing of the magnetic beads in the lysis and capture step, thereby achieving sufficient nucleic acid capture.
[0021] In a fifth aspect, the present application provides yet another molecular diagnostic analyzer, comprising a nucleic acid extraction module, an amplification module, and a detection module, wherein the nucleic acid extraction module is configured to perform a lysis capture step, a washing step, and an elution step on a sample contained in a sample container to extract nucleic acids from the sample, wherein, in the lysis capture step, cells in the sample in the sample container are lysed to release nucleic acids, and the released nucleic acids are captured by magnetic beads in the sample container; the amplification module is configured to amplify the nucleic acids extracted by the nucleic acid extraction module, and the detection module is configured to detect the amplified nucleic acids. The molecular diagnostic analyzer also includes a rack, on which the nucleic acid extraction module, the amplification module, and the detection module are mounted.
[0022] The nucleic acid extraction module includes a first mixing component and a second mixing component, which are configured to mix the sample container based on different mixing methods to release the nucleic acid in the sample and / or to allow the magnetic beads to capture the released nucleic acid. The first mixing component mixes the sample container based on a magnetic field, and the second mixing component mixes the sample container based on a non-magnetic field.
[0023] The molecular diagnostic analyzer further includes: a mode selection module for selecting the first lysis capture mode or the second lysis capture mode; and a control module configured to:
[0024] When the first lysis capture mode is selected by the mode selection module, in the lysis capture link, only the first mixing component is controlled to perform a mixing operation on the sample container based on the magnetic field, or only the second mixing component is controlled to perform a mixing operation on the sample container, and
[0025] When the second lysis and capture mode is selected by the mode selection module, in the lysis and capture step, the first mixing component and the second mixing component are controlled to perform a mixing operation on the sample container.
[0026] In the molecular diagnostic analyzer provided in the fifth aspect of the present application, by setting two different lysis capture modes, different degrees of magnetic bead mixing can be achieved for different samples or different needs. BRIEF DESCRIPTION OF THE DRAWINGS
[0027] The present application will be more clearly described below with reference to the embodiments and accompanying drawings. The above advantages and other advantages will become clear to those skilled in the art through a detailed description of the embodiments of the present application. The accompanying drawings are only used to illustrate preferred embodiments and should not be considered as limiting the present application. In the accompanying drawings:
[0028] FIG1 is a schematic block diagram of an analytical diagnostic analyzer according to some embodiments of the present application.
[0029] 2 and 3 are schematic block diagrams of analytical diagnostic analyzers according to other embodiments of the present application.
[0030] FIG4 is a schematic three-dimensional diagram of a magnetic bead mixing device according to some embodiments of the present application.
[0031] FIG5 is a perspective schematic diagram and a top view of the mixing magnet assembly in FIG4 .
[0032] FIG6 is a perspective schematic diagram of an extraction member according to some embodiments of the present application.
[0033] FIG. 7 is a cross-sectional view of an extraction member according to some embodiments of the present application.
[0034] FIG8 is a cross-sectional view of an extraction member according to some other embodiments of the present application.
[0035] 9 to 19 are side views and top views showing different magnet arrangement heights according to different embodiments of the present application.
[0036] FIG20 is a schematic diagram of magnets arranged along a circumferential direction according to some embodiments of the present application.
[0037] FIG21 is a schematic diagram of magnets arranged along a straight line according to some embodiments of the present application.
[0038] Figure 22 is a schematic top view of the first supporting assembly according to some embodiments of the present application.
[0039] FIG23 is a schematic diagram of a magnet structure according to some embodiments of the present application.
[0040] FIG24 is a schematic diagram of a magnet structure according to other embodiments of the present application.
[0041] Figure 25 is a schematic top view of the first supporting assembly according to some embodiments of the present application.
[0042] Figure 26 is a three-dimensional schematic diagram of a magnetic bead mixing device and a magnetic bead aggregation device according to other embodiments of the present application.
[0043] Figure 27 is a three-dimensional schematic diagram of a magnetic bead mixing device and a magnetic bead aggregation device according to other embodiments of the present application.
[0044] 28 to 31 are schematic three-dimensional views of a second sample-carrying assembly according to different embodiments of the present application.
[0045] 32 to 34 are schematic three-dimensional views of heating devices according to different embodiments of the present application.
[0046] Figure 35 is a schematic flow chart of the nucleic acid extraction method in some embodiments of the present application.
[0047] Figure 36 is a schematic flow chart of the nucleic acid extraction method in other embodiments of the present application.
[0048] FIG37 is a flow chart of the sample extraction method in an embodiment of the present application.
[0049] FIG38 is a flow chart of a sample extraction method according to another embodiment of the present application. DETAILED DESCRIPTION
[0050] The following will clearly and completely describe the embodiments of the present application in conjunction with the accompanying drawings. Obviously, the embodiments described are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments of the present application, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of this application.
[0051] It should be noted that the terms "first\second\third" involved in the embodiments of the present application are only used to distinguish similar objects and do not represent a specific order for the objects. It can be understood that "first\second\third" can be interchanged with a specific order or sequence when permitted.
[0052] Those skilled in the art will understand that, unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by those skilled in the art to which this application belongs.
[0053] As shown in FIG1 , the first aspect of the present application provides a molecular diagnostic analyzer 1 , comprising a nucleic acid extraction module 100 , an amplification module 200 and a detection module 300 .
[0054] The nucleic acid extraction module 100 is configured to extract nucleic acids from a sample. Here, the nucleic acid extraction module 100 extracts nucleic acids from a biological sample stored in a sample container based on a magnetic bead method, which mainly includes steps such as lysis capture, washing, and elution. In other words, the nucleic acid extraction module 100 is configured to perform a lysis capture step, a washing step, and an elution step on the sample contained in the sample container to extract the nucleic acids from the sample. The sample container contains a reaction solution, which includes a sample containing nucleic acids and magnetic beads for adsorbing (i.e., capturing) nucleic acids.
[0055] In the lysis and capture step, the cells in the sample in the sample container are lysed to release nucleic acids. For example, a lysis solution is used to break the cells and release nucleic acids. The released nucleic acids are adsorbed on the magnetic beads in the sample container or captured by the magnetic beads in the sample container. In the washing step, a washing solution or a cleaning solution is used to remove unnecessary components in the sample, for example, to wash away various impurities such as proteins, lipids, etc. remaining on and between the magnetic beads. In the elution step, the nucleic acids are separated from the magnetic beads by an eluent, so that purified nucleic acids can be obtained. In some detection projects, the washed nucleic acid sample needs to be dried before elution.
[0056] It should be noted that the lysis and capture process includes a lysis phase and a capture phase. The lysis phase involves lysing cells in a sample container to release nucleic acids, for example, by disrupting the cells with a lysis solution. The capture phase involves capturing nucleic acids with magnetic beads in the sample container. It should be understood that for the same sample container, the lysis and capture phases can be completed in the same timeframe or in separate timeframes.
[0057] The amplification module 200 is configured to amplify the nucleic acid extracted by the nucleic acid extraction module 100 so as to significantly increase the amount of nucleic acid in a relatively short period of time. The amplification methods that can be used include polymerase chain reaction (PCR), loop mediated isothermal amplification (LAMP), isothermal chimeric primer initiated amplification (ICAN), nucleic acid sequence-dependent amplification (NASBA), strand displacement amplification (SDA), ligase chain reaction (LCR), and rolling circle amplification (RCA).
[0058] The detection module 300 is configured to detect the amplified nucleic acid. For example, the detection module 300 is configured to perform fluorescence detection on the amplified nucleic acid. During the nucleic acid amplification and real-time fluorescence detection process, the signal of each nucleic acid amplification cycle is read to obtain a fluorescence amplification curve. The detection module 300 obtains a qualitative result (negative or positive) based on the fluorescence amplification curve, or obtains a quantitative analysis result or the concentration of the analyte in the test sample based on a calibration curve.
[0059] In some embodiments, as shown in Figures 2 and 3, the molecular diagnostic analyzer 1 further includes a first consumables supply device 400, a second consumables supply device 500, and a pipetting device not shown. The first consumables supply device 400 is at least used to provide a nucleic acid extraction container for receiving a sample, such as an extraction strip. The second consumables supply device 500 is at least used to provide an amplification reaction container. The pipetting device is used to draw at least a portion of the nucleic acid extract from the nucleic acid extraction container and inject it into the amplification reaction container provided by the second consumables supply device 500. The amplification module 200 is used to amplify the liquid containing at least the nucleic acid extract in the amplification reaction container to obtain a liquid to be tested.
[0060] The nucleic acid extraction container and the amplification reaction container are used as consumables, that is, the nucleic acid extraction container and the amplification reaction container are both disposable containers. A nucleic acid extraction container is discarded and recycled after completing the nucleic acid extraction of a detection project, and an amplification reaction container is discarded and recycled after completing the amplification reaction and detection of a detection project, without the need for cleaning and recycling. This can eliminate the container cleaning step in the detection process, thereby helping to improve detection efficiency and avoid the problem of cross-contamination caused by unclean cleaning affecting the accuracy of sample detection results.
[0061] Furthermore, the molecular diagnostic analyzer 1 also includes a sample storage device 600, which is at least used to store sample tubes loaded with samples. The sample tubes can be manually loaded into the sample storage device by a user, or automatically loaded by an automatic sample loading device.
[0062] As an embodiment, the sample storage device 600 is also used for an operator or an operating robot to place sample tubes for loading the sample tubes, that is, the storage position and loading position of the sample tubes are located at the same location on the molecular diagnostic analyzer 1. Of course, in specific applications, as an alternative embodiment, the storage position and loading position of the sample tubes on the molecular diagnostic analyzer 1 can also be located in two different locations.
[0063] As an embodiment, the molecular diagnostic analyzer 1 further includes a scheduling device, which includes a first consumable material transport assembly 710 and a second consumable material transport assembly 720. The first consumable material transport assembly 710 is at least used to carry the nucleic acid extraction container for linear motion along a first horizontal direction, and the second consumable material transport assembly 720 is at least used to carry the amplification reaction container for linear motion along the first horizontal direction. The first consumable material transport assembly 710 and the second consumable material transport assembly 720 are arranged side by side along a second horizontal direction, and the second horizontal direction is approximately perpendicular to the first horizontal direction. The first consumable material transport assembly 710 and the second consumable material transport assembly 720 are two consumable material transport assemblies that can independently transport consumables from each other, that is, the first consumable material transport assembly 710 and the second consumable material transport assembly 720 can operate in parallel.
[0064] Furthermore, the molecular diagnostic analyzer 1 also includes a reagent storage device 810 and a reagent dispensing device (not shown). The reagent storage device 810 is used to store reagents, and the reagent dispensing device is used to dispense the reagents provided by the reagent storage device 810 into the nucleic acid extraction container and / or the amplification reaction container. In this embodiment, the reagent dispensing device is used to dispense the reagents into the nucleic acid extraction container and / or the amplification reaction container; of course, in specific applications, as an alternative embodiment, the reagents can also be pre-stored in the nucleic acid extraction container and / or the amplification reaction container, and thus the reagent storage device 101 and the reagent dispensing device can be omitted.
[0065] In one embodiment, the reagent storage device 810 includes a first reagent storage assembly 811 and a second reagent storage assembly 812, and the reagent dispensing device includes a first reagent dispensing assembly and a second reagent dispensing assembly. The first reagent storage assembly 811 is used to store a first type of reagent, and the first reagent dispensing assembly is used to draw the first type of reagent from the first reagent storage assembly 811 and dispense it into a nucleic acid extraction container. The second reagent storage assembly 812 is used to store a second type of reagent, and the second reagent dispensing assembly is used to draw the second type of reagent from the second reagent storage assembly 812 and dispense it into an amplification reaction container. The first type of reagent is primarily used for nucleic acid extraction and is also referred to as the extraction reagent. The second type of reagent is primarily used for amplification reactions and is also referred to as the amplification reagent. In this embodiment, the extraction reagent is dispensed into the nucleic acid extraction container by aspiration, and the amplification reagent is dispensed into the amplification reaction container by aspiration. Of course, in specific applications, as an alternative embodiment, either the extraction reagent or the amplification reagent may be pre-stored in a container, for example, the extraction reagent may be pre-stored in the nucleic acid extraction container, or the amplification reagent may be pre-stored in the amplification reaction container.
[0066] As shown in Figures 4 and 5, the nucleic acid extraction module 100 includes a magnetic bead mixing device, which includes a mixing magnet assembly 110 and a first carrier assembly 120 arranged above the mixing magnet assembly 110. The mixing magnet assembly 110 includes at least a first magnet array 111 and a second magnet array 112 extending horizontally. As shown in Figure 5, the first magnet array and the second magnet array extend in a horizontal extension direction R. Each magnet array includes a plurality of magnets installed at intervals on a magnet support 113, that is, there is a distance between two adjacent magnets in each magnet array. The first carrier assembly 120 includes a container receiving portion 121 for placing a sample container 101 containing a reaction liquid. Here, the reaction liquid includes a sample containing nucleic acid and magnetic beads for adsorbing nucleic acid.
[0067] It can be understood here that the extension of the first magnet array and the second magnet array in the horizontal extension direction R means that the individual magnets in the first magnet array and the second magnet array are continuously and spaced apart along the horizontal extension direction R, in particular, the center line of the individual magnets of the first magnet array extends in the horizontal extension direction R and the center line of the individual magnets of the second magnet array extends in the horizontal extension direction R, and the magnets themselves can be arranged tilted relative to the horizontal extension direction R.
[0068] As shown in FIG5 , the first carrier assembly 120 and the mixing magnet assembly 110 are positioned relative to each other such that, when a sample container 101 is received in the container receiving portion 121, at least the bottom of the sample container 101, particularly the portion of the sample container containing the reaction liquid, is positioned between the first magnet array 111 and the second magnet array 112. The first carrier assembly 120 and the mixing magnet assembly 110 are capable of horizontal movement relative to each other, allowing the mixing magnet assembly 110 to mix the magnetic beads in the sample container 101 received in the receiving portion 121.
[0069] According to some embodiments of the present application, the first carrier assembly 120 and the mixing magnet assembly 110 are arranged relative to each other so that when the first carrier assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, at least two magnets in the mixing magnet assembly 110 have different heights relative to the bottom of the sample container received in the receiving portion 121.
[0070] It is understood that the at least two magnets in the mixing magnet assembly 110 are at different heights relative to the bottom of the sample container received in the receiving portion 121, meaning that the centers, top surfaces, or bottom surfaces of the at least two magnets are at different vertical distances from the bottom of the sample container received in the receiving portion 121. For example, the centers, top surfaces, or bottom surfaces of the at least two magnets are at different vertical heights relative to the ground.
[0071] It should be understood that the at least two magnets may have a positive height difference or a negative height difference relative to the bottom of the sample container received in the receiving portion 121. Therefore, when the first magnet of the at least two magnets has a positive height difference relative to the bottom of the sample container received in the receiving portion 121, and the second magnet of the at least two magnets has a negative height difference relative to the bottom of the sample container received in the receiving portion 121, and the positive height difference and the negative height difference have the same absolute value, it can also be said that the first magnet and the second magnet have different heights relative to the bottom of the sample container received in the receiving portion 121.
[0072] As the first carrier assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, the sample container received in the receiving portion 121 moves horizontally between the first magnet array 111 and the second magnet array 112, relative to the first magnet array 111 and the second magnet array 112, thereby generating a relatively horizontally varying magnetic field for the sample container received in the container receiving portion 121. Furthermore, since at least two magnets in the mixing magnet assembly 110 are at different vertical heights from the bottom of the sample container received in the container receiving portion 121 when the first carrier assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, a relatively vertically varying magnetic field is also generated for the sample container received in the container receiving portion 121. By generating a magnetic field that changes relatively in the horizontal and vertical directions, the magnetic beads in the sample container placed in the changing magnetic field are caused to move three-dimensionally in space, especially so that the magnetic beads are spatially distributed as much as possible throughout the reaction liquid or the temporal movement trajectory of the magnetic beads is spread throughout the entire reaction liquid. In particular, the magnetic beads in the sample container placed in the changing magnetic field can circulate, thereby achieving sufficient mixing of the magnetic beads.
[0073] Here, the magnetic bead mixing device of the nucleic acid extraction module 100 according to the above embodiment can be used to move the magnetic beads in the sample container in the reaction solution in at least one of the lysis and capture step, the washing step, and the elution step to achieve magnetic bead mixing. For example, the magnetic bead mixing device of the nucleic acid extraction module 100 according to the above embodiment can be used to move the magnetic beads in the sample container in the reaction solution in the lysis and capture step, or alternatively or additionally used to move the magnetic beads in the sample container in the reaction solution in the washing step and / or the elution step, or only used in the nucleic acid washing or elution step.
[0074] It is preferred that, when the nucleic acid extraction module 100 is in operation, the relative horizontal movement of the first supporting assembly 120 and the mixing magnet assembly 110 is uninterrupted and continuous.
[0075] It should be noted here that when it comes to the description of orientation, the embodiment of the present application is described based on the nucleic acid extraction module being in a normal working state. In this normal working state, the sample container is vertically placed in the receiving part of the first supporting component 120, and the axial direction of the sample container is the vertical direction.
[0076] In the embodiment of the present application, the molecular diagnostic analyzer further includes a rack not shown, wherein the nucleic acid extraction module, the amplification module and the detection module are installed on the rack.
[0077] In a specific example, as shown in Figures 4, 5, and 25, the nucleic acid extraction module 100 includes a magnetic bead mixing device, which includes a mixing magnet assembly 110 and a first carrier assembly 120 arranged above the mixing magnet assembly 110. The mixing magnet assembly 110 includes at least a first magnet array 111 and a second magnet array 112 extending horizontally. Each magnet array includes a plurality of magnets spaced apart and mounted on a magnet support 113. The first carrier assembly 120 includes a container receiving portion 121 for accommodating a sample container 101 containing a reaction solution. Here, the reaction solution includes a sample containing nucleic acid and magnetic beads for adsorbing nucleic acids. The first carrier assembly 120 includes multiple different functional areas, namely, the first carrier assembly 120 includes at least a lysis and capture area 124, a washing area 125, and an elution area 126. In other words, the lysis and capture area 124, the washing area 125, and the elution area 126 are integrated into the first carrier assembly, for example, integrated into the incubation plate shown in Figure 25. The lysis and capture zone 124, the wash zone 125, and the elution zone 126 are each provided with a receiving portion 121 for receiving a sample container 101 containing a sample and a magnetic bead reagent. The mixing magnet assembly 110 is configured to perform at least one, and for example, two or all, of the following functions: mixing the magnetic beads in the sample container in the lysis and capture zone 124 to achieve nucleic acid capture; mixing the magnetic beads in the sample container in the wash zone 125 to clean nucleic acids captured by the beads; and mixing the magnetic beads in the sample container in the elution zone 126 to elute nucleic acids from the beads. By providing the lysis and capture zone 124, the wash zone 125, and the elution zone 126 on the first carrier assembly 120, the lysis and capture, washing, and elution processes can be integrated within the first carrier assembly 120, helping to reduce the size of the sample analyzer. In some cases, the area of the first carrier assembly 120 not covered by the magnetic field also includes a resting area for placing the sample container 101 during the extraction process.
[0078] More embodiments of the functional area arrangement of the first carrying assembly 120 will be described in detail below.
[0079] In some embodiments, the sample container 101 and its associated reagent container are uniformly placed on the extraction member, and the sample container 101 is transferred by being placed on the extraction member. The extraction member can be configured as an elongated strip structure, with the sample container 101 and its associated cavities for reagents and / or pipette tips arranged sequentially along the length of the extraction member, with the sample container 101 typically located at the very front end of the extraction member. Based on this structure, the receiving portion 121 is constructed as a strip-shaped groove on the first supporting component 120, which is adapted to the shape of the extraction member.
[0080] In some embodiments, as shown in Figures 6 and 7 , the extraction unit includes an open sample container 101 and a reagent container 102. Sample container 101 is used to hold the sample and the first reagent, while reagent container 102 is used to hold the second reagent. By providing open sample container 101 and reagent container 102, the first and second reagents can be subsequently injected into sample container 101 and reagent container 102. This eliminates the need to consider membrane puncture, thereby simplifying the molecular diagnostic process.
[0081] In other embodiments, the opening of the sample container 101 and the opening of the reagent container 102 may be sealed by a sealing film, and the first reagent may be pre-placed in the sample container 101, and the second reagent may be pre-placed in the reagent container 102. In these embodiments, a piercer is required to pierce the sealing film on the extraction member in order to access the reagents in the containers.
[0082] In some embodiments, as shown in Figures 6 and 7, the extraction member further includes an open third cavity 103 and a fourth cavity 105. The third cavity 103 is used to accommodate the first pipetting head 21, and the fourth cavity 105 is used to accommodate the second pipetting head 22. The volume of the second pipetting head 22 is greater than that of the first pipetting head 21. For example, the volume of the first pipetting head 21 is 300 μL, and the volume of the second pipetting head 22 is 1000 μL. Of course, the volume of the first pipetting head 21 and the volume of the second pipetting head 22 can also be the same, and the specific volume can be determined according to actual design requirements.
[0083] In some embodiments, the extraction component further includes a sealed or open fifth cavity 104 , and the fifth cavity 104 is used to accommodate a third reagent injected by the molecular diagnostic device.
[0084] In some embodiments, the extraction unit further includes an open sixth cavity 106 for accommodating waste liquid. By integrating the sample container 101 with the sixth cavity 106, all nucleic acid extraction operations can be performed within a single extraction unit, significantly reducing the number of consumables and facilitating production, packaging, and transportation. Furthermore, performing all extraction operations within a single extraction unit simplifies the testing process and improves efficiency.
[0085] As shown in FIG8 , in one embodiment, a first flow-guiding structure 1011 is provided on the sidewall of the sample container 101. The first flow-guiding structure 1011 extends from the opening of the sample container 101 to the bottom of the sample container 101. In this embodiment, by providing the first flow-guiding structure 1011 on the sidewall of the sample container 101 to guide the liquid injected into the sample container 101, the liquid injected into the sample container 101 can be prevented from rolling, thereby preventing the formation of aerosols and reducing the risk of infection for test personnel.
[0086] As shown in FIG8 , in some embodiments, the sample container 101 has a first central axis L, and the first flow guiding structure 1011 includes a first inclined surface 1012 , which extends obliquely from the edge of the opening of the sample container 101 toward the first central axis L.
[0087] It should be noted that the first inclined surface 1012 is not limited to being provided at the opening edge of the sample container 101 , but may also be provided at the middle or bottom of the sample container 101 .
[0088] It should also be noted that the first flow-guiding structure 1011 is not limited to being set as the first inclined surface 1012. For example, in some other embodiments, the first flow-guiding structure 1011 includes a second spiral surface, which spirally extends from the edge of the opening of the sample container 101 around the first central axis L toward the bottom of the sample container 101.
[0089] As shown in FIG8 , in some embodiments, the first inclined surface 1012 has an inclination angle α1 relative to the first central axis L, where α1 = 15°-45°. For example, the inclination angle of the first inclined surface 1012 relative to the first central axis L is 15°, 20°, 25°, 30°, 35°, 40°, 45°, or any value between adjacent ones of 15°, 20°, 25°, 30°, 35°, 40°, and 45°. In this embodiment, the inclination angle of the first inclined surface 1012 relative to the first central axis L is 27.5°.
[0090] As shown in Figure 8, in some embodiments, the wall of the sample container 101 also includes a first wall 1013 and a second wall 1014. The first wall 1013 is connected between the first inclined surface 1012 and the second wall 1014. The second wall 1014 extends from the bottom end of the first wall 1013 to the bottom of the sample container 101. The inclination angle of the first wall 1013 relative to the first central axis L is α2, α2 = 0°~2°, and the inclination angle of the second wall 1014 relative to the first central axis L is β3, β3 = 5°~45°.
[0091] As shown in FIG8 , in some embodiments, the wall surface of the sample container 101 further includes a first wall surface 1013, and the first flow-guiding structure 1011 further includes a curved surface 1015. The curved surface 1015 is connected between the first inclined surface 1012 and the first wall surface 1013. The first wall surface 1013 extends from the curved surface 1015 toward the bottom of the sample container 101. The curved surface 1015 is used to achieve a smooth transition between the first inclined surface 1012 and the first wall surface 1013. In this embodiment, the liquid injected into the sample container 101 can flow horizontally along the wall surface of the sample container 101, avoiding liquid splashing on the wall surface of the sample container 101 and the formation of aerosols.
[0092] As shown in FIG8 , in some embodiments, the depth of the first inclined surface 1012 is 0.2 to 0.3 of the total depth of the sample container 101. The depth of the first inclined surface 1012 refers to the height of the first inclined surface 1012 along the first central axis L, and the total depth of the sample container 101 refers to the total height of the sample container 101 along the first central axis L.
[0093] In the embodiments of FIG. 6 to FIG. 8 , the sample container 101 has a conical bottom.
[0094] Next, different embodiments of the height change of at least two magnets in the mixing magnet assembly 110 relative to the bottom of the sample container received in the receiving portion 121 are described, but the present application is not limited thereto. As some implementations, in order to achieve that when the first supporting assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, the at least two magnets have different heights relative to the bottom of the sample container received in the receiving portion 121, it can be stipulated herein that when the first supporting assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, the at least two magnets in the mixing magnet assembly 110 can move relative to the first supporting assembly 120 in the vertical direction. However, these implementations require the addition of a mechanism for enabling the first supporting assembly 120 and the mixing magnet assembly 110 to move vertically relative to each other, which increases the complexity and cost of the analyzer.
[0095] As another simpler implementation, at least two magnets in the mixing magnet assembly 110 are at different heights from the first supporting assembly 120, that is, at least two magnets in the mixing magnet assembly 110 have different heights relative to the first supporting assembly 120, so that at least two magnets in the mixing magnet assembly 110 have different heights relative to the bottom of the sample container received in the container receiving portion. Preferably, there is no relative movement between the mixing magnet assembly 110 and the first supporting assembly 120 in the vertical direction, and in particular, no relative movement in the vertical direction. This makes it possible to simply achieve that when the first supporting assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, the at least two magnets M have different heights relative to the bottom of the sample container received in the receiving portion 121.
[0096] In some embodiments, the at least two magnets M in the mixing magnet assembly 110 are mounted at different heights on the magnet support 113, such that the at least two magnets M in the mixing magnet assembly 110 have different heights relative to the first supporting assembly 120. In other words, the at least two magnets in the mixing magnet assembly 110 are fixed to the magnet support 113 at different heights.
[0097] It is understood that the installation height H can be the vertical distance between the bottom surface S1 of the magnet and the bottom surface S2 of the magnet holder when the magnet is installed on the magnet holder 113. Of course, in other embodiments, the installation height H can also be the vertical distance between the top surface of the magnet or the center of the magnet and the bottom surface S2 of the magnet holder when the magnet is installed on the magnet holder 113.
[0098] In some embodiments, as shown in Figure 9, the at least two magnets M in the mixing magnet assembly 110 include at least two magnets M1 in the first magnet array 111, and the at least two magnets M1 in the first magnet array 111 are installed at different heights on the magnet bracket 113, so that the at least two magnets in the mixing magnet assembly 110 have different heights relative to the bottom of the sample container received in the container receiving portion.
[0099] Alternatively or additionally, as shown in Figure 10, the at least two magnets M in the mixing magnet assembly 110 include at least two magnets M2 in the second magnet array 112, and the at least two magnets M2 in the second magnet array 112 are installed at different heights on the magnet holder 113, so that the at least two magnets in the mixing magnet assembly 110 have different heights relative to the bottom of the sample container received in the container receiving portion.
[0100] In other embodiments, the at least two magnets M in the mixing magnet assembly 110 include at least one magnet M1 in the first magnet array 111 and at least one magnet M2 in the second magnet array 112. The at least one magnet M1 and the at least one magnet M2 are mounted at different heights on the magnet holder 113, thereby ensuring that the at least two magnets in the mixing magnet assembly 110 have different heights relative to the bottom of the sample container received in the container receiving portion. In some embodiments, the magnet holder 113 can be an integrally manufactured holder, on which the magnets M1 in the first magnet array 111 and the magnets M2 in the second magnet array 112 are both mounted.
[0101] In other embodiments, the magnet bracket 113 may include a first bracket and a second bracket, the magnets M1 in the first magnet array 111 are mounted on the first bracket, and the magnets M2 in the second magnet array 112 are mounted on the second bracket.
[0102] In some specific examples, as shown in FIG11 , the first magnet array 111 includes at least one first magnet unit 1111 and at least one second magnet unit 1112, each magnet unit including one magnet or a plurality of adjacently distributed magnets. Each magnet M11 (also referred to as a lower magnet) in the first magnet unit 1111 is mounted on the magnet support 113 at a first height H1, and each magnet M12 (also referred to as an upper magnet) in the second magnet unit 1112 is mounted on the magnet support 113 at a second height H2 greater than the first height H1. In other words, the first magnet array 111 includes at least two layers of magnets at different heights.
[0103] In the embodiment shown in Figure 11 , the first magnet array 111 includes two first magnet units 1111 and one second magnet unit 1112 , each of which includes two magnets. However, the present application is not limited thereto.
[0104] Alternatively or additionally, as shown in FIG12 , the second magnet array 112 includes at least one third magnet unit 1121 and at least one fourth magnet unit 1122, each magnet unit including one magnet or a plurality of adjacently distributed magnets. Each magnet M21 (also referred to as a lower magnet) in the third magnet unit 1121 is mounted on the magnet support 113 at a third height H3, and each magnet M22 (also referred to as an upper magnet) in the fourth magnet unit 1122 is mounted on the magnet support 113 at a fourth height H4 greater than the third height H3. In other words, the second magnet array 112 includes at least two layers of magnets at different heights.
[0105] In the embodiment shown in FIG12 , the first magnet array 111 includes two first magnet units 1111 and one second magnet unit 1112, each of which includes two magnets. The second magnet array 112 includes two third magnet units 1121 and one fourth magnet unit 1122, each of which includes two magnets. However, the present application is not limited thereto.
[0106] Here, preferably, the first height H1 is equal to the third height H3. Alternatively or additionally, the second height H2 is equal to the fourth height H4.
[0107] In other embodiments, the first height H1 may not be equal to the third height H3, and the second height H2 may not be equal to the fourth height H4.
[0108] 13 , the first magnet units 1111 and the second magnet units 1112 are alternately arranged, for example, alternately arranged along the extension direction R, and especially alternately arranged in sequence to form a first magnet array 111. That is, the first magnet array 111 includes two layers of magnets at different heights.
[0109] 14 , the third magnet units 1121 and the fourth magnet units 1122 are alternately arranged, for example, alternately arranged along the extension direction R, and especially alternately arranged in sequence to form the second magnet array 112. That is, the second magnet array 112 also includes two layers of magnets at different heights.
[0110] Further, as shown in Figure 15, the first magnet array 111 may also include at least one fifth magnet unit 1113, the fifth magnet unit including one magnet or multiple adjacently distributed magnets. Each magnet M13 in the fifth magnet unit 1113 is mounted on the magnet bracket 113 at a fifth height H5 greater than the second height H2. Optionally, the second magnet array 112 may also include at least one sixth magnet unit 1123, the sixth magnet unit including one magnet or multiple adjacently distributed magnets. Each magnet M23 in the sixth magnet unit 1123 is mounted on the magnet bracket 113 at a sixth height H6 greater than the fourth height H4.
[0111] Preferably, the fifth height H5 is equal to the sixth height H6. In other embodiments, the fifth height H5 may not be equal to the sixth height H6.
[0112] 16 , the first magnet unit 1111, the second magnet unit 1112, and the fifth magnet unit 1113 are alternately arranged, for example, alternately arranged along the extension direction R, and in particular alternately arranged in sequence to form a first magnet array 111. That is, the first magnet array 111 includes three layers of magnets at different heights.
[0113] 16 , the third magnet unit 1121, the fourth magnet unit 1122, and the sixth magnet unit 1123 are alternately arranged, for example, alternately arranged, and in particular alternately arranged in sequence, along the extension direction R to form the second magnet array 112. That is, the second magnet array 112 also includes three layers of magnets at different heights.
[0114] Thus, by alternating the arrangement of magnet units at different heights to form magnet arrays 111 and 112, when the first carrier assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, the mixing magnet assembly can generate a magnetic field that uniformly alternates in the horizontal and vertical directions relative to the sample container received in the container receiving portion, so that the magnetic beads in the sample container placed in the uniformly alternating magnetic field are spatially distributed as uniformly as possible in the entire reaction liquid or the temporal movement trajectory of the magnetic beads is uniformly distributed throughout the entire reaction liquid. In particular, the magnetic beads in the sample container placed in the changing magnetic field can circulate uniformly, thereby achieving uniform and sufficient mixing of the magnetic beads.
[0115] In Figures 11 to 16, each magnet unit is exemplarily shown to include two magnets, but the present application is not limited thereto. For example, each magnet unit may include only one magnet, or may include three, four, or more magnets, which is not specifically limited in the present application.
[0116] In addition, the magnet units at different heights may also have different numbers of magnets, which is not specifically limited in this application.
[0117] It should be understood that in Figures 11 to 16 , the upper portion of the figure shows a side view of the mixing magnet assembly 110, and the lower portion of the figure shows a top view of the mixing magnet assembly 110. It should be noted that Figures 11 to 16 show the side view and top view of the mixing magnet assembly 110 after unfolding in the plane of the figure, and the extension direction R can be either a circumferential direction or a linear direction.
[0118] In some embodiments, as mentioned above, the sample container may include multiple tube sections with different diameters. In this case, to achieve uniform mixing of the magnetic beads in such a sample container, it can be provided that: the first height is equal to the third height, and the second height is equal to the fourth height; the first magnet units 111a and the second magnet units 111b are alternately arranged, for example, along the extension direction R, and in particular, are alternately arranged in sequence to form the first magnet array 111; and the third magnet units 112a and the fourth magnet units 112b are alternately arranged, for example, along the extension direction R, and in particular, are alternately arranged in sequence to form the second magnet array 112. Here, as shown in Figure 17, the magnet M11 (also called the lower layer magnet) at the first height H1 in the first magnet array 111 and the magnet M21 (also called the lower layer magnet) at the third height H3 adjacent to the magnet M11 in the second magnet array have a first vertical distance L1 between their opposite magnet sides (in the direction perpendicular to the extension direction R), and the magnet M12 (also called the upper layer magnet) at the second height H2 in the first magnet array 111 and the magnet M22 (also called the upper layer magnet) at the fourth height H4 adjacent to the magnet M12 in the second magnet array 112 have a second vertical distance L2 between their opposite magnet sides (in the direction perpendicular to the extension direction R), wherein the first vertical distance L1 is different from the second vertical distance L2.
[0119] In particular, the first vertical distance L1 is smaller than the second vertical distance L2, which is advantageous when the sample container has a conical bottom. Therefore, such an arrangement enables the magnetic attraction force exerted by the lower magnet on the magnetic beads to be roughly equal to the magnetic attraction force exerted by the upper magnet on the magnetic beads, so that when each magnet passes through the sample container 101 in turn, the circumferential movement amplitude of the magnetic beads is roughly equal, thereby making the mixing more uniform.
[0120] For example, the sample container 101 has a first tube section and a second tube section, wherein the second tube section is connected below the first tube section and has a diameter smaller than that of the first tube section. For example, the second tube section is conical, and its diameter gradually decreases from top to bottom. When the sample container 101 is placed in the receiving portion 121 of the first supporting assembly 120, the first tube section is at least partially located between the upper magnet M12 of the first magnet array 111 and the upper magnet M22 of the second magnet array 112, and the second tube section is at least partially located between the lower magnet M11 of the first magnet array 111 and the lower magnet M12 of the second magnet array 112. That is, the upper magnet can attract magnetic beads to the first tube section, and the lower magnet can attract magnetic beads to the second tube section.
[0121] To adapt to the shape of the sample container, the first vertical distance L1 is smaller than the second vertical distance L2. This configuration enables the magnetic attraction force exerted by the lower magnet on the magnetic beads to be substantially equal to the magnetic attraction force exerted by the upper magnet on the magnetic beads.
[0122] In other embodiments, the end surfaces of the lower magnets in the first magnet array 111 and the second magnet array 112 facing the sample container 101 may be set as inclined surfaces or curved surfaces that match the diameter change of the second tube segment to further ensure equal magnetic attraction.
[0123] It can be understood here that the distance between a magnet in the first magnet array 111 and an adjacent magnet in the second magnet array refers to the distance between the mutually opposing sides of the two magnets.
[0124] In some embodiments, the first magnet array and the second magnet array respectively include a plurality of magnet units, each magnet unit respectively including one magnet or a plurality of adjacently distributed magnets. The installation heights of the individual magnet units in the first magnet array on the magnet support vary uniformly, for example, as in the embodiments shown in Figures 13 and 14, the first magnet unit and the second magnet unit are alternately arranged in sequence. Alternatively or additionally, the installation heights of the individual magnet units in the second magnet array on the magnet support vary uniformly, for example, as in the embodiment shown in Figure 14, the third magnet unit and the fourth magnet unit are alternately arranged in sequence.
[0125] In other embodiments, the installation height of each magnet unit in the first magnet array 111 on the magnet bracket increases gradually along the magnet arrangement of the first magnet array 111 , for example, along the extension direction R, preferably increases gradually and uniformly.
[0126] For example, as shown in Figure 18 , the first magnet array 111 is composed of 6 magnet units, each magnet unit includes two continuously distributed magnets. As can be seen from Figure 18 , the installation heights of the magnets in the 6 magnet units gradually increase along the extension direction R.
[0127] For another example, as shown in Figure 19 , the first magnet array 111 is composed of 8 magnet units, each magnet unit includes a magnet. As can be seen from Figure 19 , the installation heights of the magnets in the 8 magnet units gradually increase along the extension direction R.
[0128] In some alternative or additional embodiments, the installation height of each magnet unit in the second magnet array on the magnet support increases gradually along the magnet arrangement of the second magnet array, for example, along the extension direction R, preferably increases gradually and uniformly.
[0129] For example, as shown in Figure 18 , the second magnet array 112 is composed of 6 magnet units, each of which includes two continuously distributed magnets. As can be seen from Figure 18 , the installation heights of the magnets in the 6 magnet units gradually increase along the extension direction R.
[0130] For another example, as shown in Figure 19 , the second magnet array 112 is composed of 8 magnet units, each magnet unit includes a magnet. As can be seen from Figure 19 , the installation heights of the magnets in the 8 magnet units gradually increase along the extension direction R.
[0131] The above describes different embodiments of the arrangement heights of the magnets in each magnet array. Next, different embodiments of the arrangement of each magnet array are described. It is understood that the present application is not limited to these embodiments.
[0132] In some embodiments, the number of magnets in the first magnet array 111 and the second magnet array 112 may be equal or different.
[0133] In some embodiments, the magnets in the first magnet array 111 and the second magnet array 112 are magnets of the same specifications. It should be noted that the magnets in the first magnet array 11 and the second magnet array 112 can also be configured as magnets of different specifications according to needs, such as different magnetic field strengths, different quantities, different sizes, etc., so as to adapt to mixing in different scenarios.
[0134] In some embodiments, when viewed in a vertical direction, that is, from a top or bottom perspective, the first magnet array 111 and the second magnet array 112 are respectively arranged on concentric circles, as shown in FIG20 . In other words, the extension direction R is the circumferential direction, and the magnets in the first magnet array 111 and the magnets in the second magnet array 112 are both distributed along the circumferential direction serving as the extension direction R, and the first magnet array 111 and the second magnet array 112 are arranged concentrically.
[0135] It can be understood here that concentric circles refer to circles with the same center but different radii on the same plane.
[0136] In one specific example, the magnet support 113 and the first bearing assembly 120 can be configured as a disk, in which case each magnet array is a circular array. In another example, the magnet support 113 and the first bearing assembly 120 can be configured as a sector disk, in which case each magnet array is an arc array.
[0137] In other embodiments, viewed in the vertical direction, that is, in a top view, the first magnet array 111 and the second magnet array 112 are respectively arranged on straight lines parallel to each other, as shown in FIG21 . In other words, the extension direction R is a straight line direction, and the magnets in the first magnet array 111 and the magnets in the second magnet array 112 are both distributed along the straight line direction serving as the extension direction R.
[0138] In a specific example, the first supporting assembly 120 may be configured as a rectangular disk, and in this case, each magnet array is a linear array.
[0139] In some embodiments, as shown in FIG20 and FIG21 , adjacent magnets MA and MB of the first magnet array 111 and the second magnet array 112 are staggered along the extension direction R. That is, the line connecting the center points of adjacent magnets MA and MB of the first magnet array 111 and the second magnet array 112 is not perpendicular to the extension direction R. For example, the line connecting the center points of adjacent magnets MA and MB of the first magnet array 111 and the second magnet array 112 is not perpendicular to the tangent of the concentric circles (as shown in FIG20 ) or is not perpendicular to the straight line (as shown in FIG21 ).
[0140] By staggering the magnets of the first magnet array 111 and the second magnet array 112 in the extension direction, when the sample container is close to the magnet, the magnetic field strength and gradient generated there reach a maximum, at which time the magnetic beads in the sample container can be quickly pulled to move, causing disturbance to the fluid (reaction liquid) in the sample container and promoting spatial material exchange of the fluid; when the sample container is between adjacent magnets, the magnetic field gradient generated there drops sharply, the magnetic beads in the sample container are subjected to very weak force, and the magnetic beads are affected by the flow field movement and quickly diffused in the spatial flow field, thereby achieving full contact between the magnetic beads and the nucleic acids in the fluid.
[0141] 20 and 21 , the magnets in the first magnet array 111 are spaced apart by the same distance in the extension direction R. That is, adjacent magnets in the first magnet array 111 have the same distance in the extension direction R.
[0142] For example, the magnets in the first magnet array 111 are spaced apart by the same distance on concentric circles as shown in FIG. 20 , or the magnets in the first magnet array 111 are spaced apart by the same distance on a straight line as shown in FIG. 21 .
[0143] Alternatively or additionally, the magnets in the second magnet array 112 are spaced apart by the same distance in the extension direction R. That is, adjacent magnets in the second magnet array 112 have the same distance in the extension direction R.
[0144] For example, the magnets in the second magnet array 112 are spaced apart by the same distance on concentric circles as shown in FIG. 20 , or the magnets in the second magnet array 112 are spaced apart by the same distance on a straight line as shown in FIG. 21 .
[0145] As some implementations, as shown in Figure 20, the magnets in the first magnet array 111 and the magnets in the second magnet array 112 are evenly distributed along the circumferential direction, and the adjacent magnets MA and MB of the first magnet array 111 and the second magnet array 112 are staggered along the extension direction R, that is, the lines connecting the adjacent magnets MA and MB of the first magnet array 111 and the second magnet array 112 to the center of the circle do not overlap, and the center of the circle is the center of the circle formed by the concentric arrangement.
[0146] That is to say, when viewed in the vertical direction, that is, when viewed from above or below, the first magnet array 111 and the second magnet array 112 are respectively arranged on concentric circles, the magnets in the first magnet array 111 are spaced apart by the same distance on the concentric circles, and the magnets in the second magnet array 112 are spaced apart by the same distance on the concentric circles, and the line connecting the center points of adjacent magnets in the first magnet array and the second magnet array is not perpendicular to the tangent of the concentric circles.
[0147] Further preferably, viewed in the vertical direction, ie, viewed from above or below, the angle α1 between adjacent magnets MA and MC in the first magnet array is equal to the angle α1 between adjacent magnets MB and MD in the second magnet array.
[0148] Alternatively or additionally, the angle α2 between adjacent magnets MA and MB in the first magnet array 111 and the second magnet array 112 is half the angle α1 between adjacent magnets MA and MC in the first magnet array or the angle α1 between adjacent magnets MB and MD in the second magnet array, that is, α2 = 1 / 2 * α1. In other words, the first magnet array 111 and the second magnet array 112 have the same number of magnets, and the first magnet array 111 as a whole is staggered by a set angle, α2, relative to the second magnet array 112 in the extension direction. In this way, the angle α2 between adjacent magnets MA and MB in the first magnet array 111 and the second magnet array 112 remains equal, so that the magnetic beads are mixed more evenly.
[0149] As other implementations, as shown in Figure 21, the magnets in the first magnet array 111 and the magnets in the second magnet array 112 are evenly distributed along the straight line direction, and the adjacent magnets MA and MB of the first magnet array 111 and the second magnet array 112 are staggered along the straight line direction, that is, the line connecting the center points of the adjacent magnets MA and MB of the first magnet array 111 and the second magnet array 112 is not perpendicular to the straight line direction.
[0150] That is to say, when viewed in the vertical direction, that is, when viewed from above or below, the first magnet array 111 and the second magnet array 112 are respectively arranged on straight lines parallel to each other, the magnets in the first magnet array 111 are spaced apart by the same distance on the straight line, and the magnets in the second magnet array 112 are spaced apart by the same distance on the straight line, and the line connecting the center points of adjacent magnets in the first magnet array 111 and the second magnet array 112 is not perpendicular to the straight line.
[0151] Further preferably, viewed in the vertical direction, i.e., viewed from above or below, the distance L3 between adjacent magnets MA and MC in the first magnet array in the straight direction is equal to the distance L3 between adjacent magnets MB and MD in the second magnet array in the straight direction.
[0152] Alternatively or additionally, the distance L4 between adjacent magnets MA and MB in the first magnet array 111 and the second magnet array 112 in the linear direction is half the distance L3 between adjacent magnets MA and MC in the first magnet array or the distance between adjacent magnets MB and MD in the second magnet array, i.e., L4 = 1 / 2*L3. In other words, the first magnet array 111 and the second magnet array 112 have the same number of magnets, and the first magnet array 111 as a whole is offset in the linear direction by a set distance, here by a distance L4, relative to the second magnet array 112. In this way, the distance L4 between adjacent magnets MA and MB in the first magnet array 111 and the second magnet array 112 in the linear direction remains equal, so that the magnetic beads are mixed more evenly.
[0153] In some embodiments, the magnets M1 in the first magnet array 111 have first poles facing the first supporting assembly 120 , and the magnets M2 in the second magnet array 112 have second poles facing the first supporting assembly 120 . The first pole and the second pole have opposite polarities.
[0154] In other embodiments, the magnetic poles on the same side of adjacent magnets M1 in the first magnet array 111 have opposite polarities, and / or the magnetic poles on the same side of adjacent magnets M2 in the second magnet array 112 have opposite polarities.
[0155] Next, some embodiments of driving the mixing magnet assembly and the first supporting assembly to move horizontally relative to each other are described.
[0156] In some embodiments, as shown in FIG5 , the nucleic acid extraction module 100 further includes a drive device 130, such as a motor, configured to drive the magnet support 113 to move so as to cause the first supporting assembly 120 and the mixing magnet assembly 110 to move horizontally relative to each other. For example, the drive device 130 is configured to drive the magnet support 113 to move in an extension direction R so as to cause the mixing magnet assembly 110 to move relative to the first supporting assembly 120 in the extension direction R, thereby driving the movement of magnetic beads in the sample container located between the first magnet array and the second magnet array.
[0157] Furthermore, when the driving device 130 drives the magnet holder 113 to move, the first magnet array and the second magnet array installed on the magnet holder 113 generate a changing magnetic field, so that the magnetic beads in the sample container 101 can circulate in the reaction liquid in the sample container 101 under the action of the changing magnetic field.
[0158] It can be understood here that the changing magnetic field generated by the first magnet array and the second magnet array refers to a magnetic field whose magnetic field intensity distribution changes relative to a fixed point in space.
[0159] For example, the driving device 130 is configured to drive the magnet holder 113 to move in the extension direction R so that the sample container placed on the first carrier assembly 120 passes through each magnet of the first magnet array and the second magnet array in the extension direction at least once, preferably multiple times, so that the magnetic beads in the sample container experience a changing, preferably alternating magnetic field.
[0160] For another example, the drive device 130 is configured to drive the magnet holder 113 to move in the extension direction R so that the sample container placed on the first carrier assembly 120 passes back and forth in the extension direction through at least a portion of the magnets of the first magnet array and the second magnet array, so that the magnetic beads in the sample container experience a changing, preferably alternating, magnetic field.
[0161] In some examples, the magnet support 113 may be configured as a rotatable circular disk or a sector disk, and in this case, the driving device 130 is used to drive the magnet support 113 to rotate along the extension direction.
[0162] In other examples, the magnet support 113 may be configured as a rectangular disk that can be translated. In this case, the driving device 130 is used to drive the magnet support 113 to move along the extension direction, especially to move back and forth.
[0163] In other embodiments, the driving device 130 can also be configured to drive the first supporting assembly 120 to move in the extension direction R, so that the mixing magnet assembly 110 moves in the extension direction R relative to the first supporting assembly 120, thereby driving the movement of magnetic beads in the sample container located between the first magnet array and the second magnet array.
[0164] In some embodiments, the drive device 130 is configured to drive the magnet holder 113 to move, for example, in the extension direction R, so that the magnetic beads in the sample container received in the container receiving portion are subjected to the alternating magnetic field generated by the mixing magnet assembly, thereby enabling the magnetic beads in the sample container to move in the reaction solution under the influence of the alternating magnetic field. This movement is, for example, performed cyclically.
[0165] By forming an alternating magnetic field in the area of the sample container loaded with the reaction liquid, the magnetic beads in the sample container are guided to perform periodic reciprocating motion, thereby enhancing the mixed mass transfer of the fluid in the sample container and the collision capture effect of the magnetic beads on the nucleic acid in the fluid.
[0166] In some embodiments, the driving device 130 is configured to drive the magnet holder 113 to move at a varying, especially periodically varying, speed, for example, in the extension direction R, thereby promoting sufficient exchange of fluid substances and enhancing sufficient dispersion of magnetic beads in the flow field.
[0167] In a specific example, as shown in FIG20 , the magnet holder includes a first region Q1 and a second region Q2. The first region Q1 is opposite the magnet side surfaces of the magnets in the mixing magnet assembly, and the second region Q2 is the vacant region between adjacent magnets in the first and second magnet arrays. In this case, the drive device 130 is configured to drive the magnet holder 130 to move at a varying speed, for example, in an extension direction R, such that a sample container received in the container receiving portion passes through the first region Q1 of the magnet holder at a first speed and passes through the second region Q2 of the magnet holder at a second speed that is lower than the first speed.
[0168] That is, the first region Q1 is a region where the magnetic field is relatively strong and the second region Q2 is a region where the magnetic field is relatively weak between adjacent magnets of the first magnet array and the second magnet array.
[0169] As some implementations, the magnets in the first magnet array 111 and the magnets in the second magnet array 112 are distributed along the circumferential direction serving as the extension direction R, and the first magnet array 111 and the second magnet array 112 are concentrically arranged, that is, viewed in the vertical direction, the first magnet array and the second magnet array are respectively arranged on concentric circles. At this time, in some examples, the drive device 130 is configured to drive the magnet bracket 113 to always rotate in the same direction. In other alternative examples, the drive device 130 is configured to first drive the magnet bracket 113 to rotate in a first direction, and then drive the magnet bracket 113 to rotate in a second direction opposite to the first direction.
[0170] Specifically, the driving device 130 is configured to drive the magnet bracket 113 to rotate M times in a first direction and then rotate N times in an opposite second direction, where M and N are both positive integers greater than or equal to 1.
[0171] In some embodiments, M and N can be set equal so that the movement of the magnetic beads 600 on the left and right halves of the sample container 101 is roughly equal, which helps to achieve uniform stirring of the magnetic beads. It is understood that M and N may not be equal.
[0172] In some alternative embodiments, the magnets in the first magnet array and the magnets in the second magnet array are uniformly distributed along a straight line, that is, when viewed in the vertical direction, the first magnet array and the second magnet array are respectively arranged on straight lines parallel to each other. In this case, the driving device 130 is configured to drive the magnet support to reciprocate along the straight line.
[0173] In some embodiments, the first carrying assembly 120 is configured as a rotatable first disk, the magnet holder 113 is configured as a rotatable second disk, and the first disk and the second disk are concentrically arranged.
[0174] Furthermore, the second disk can rotate synchronously with the first disk and independently relative to the first disk. Specifically, the first disk can drive the second disk to rotate together, so that the rotation of the first disk does not affect the relative horizontal movement between the first and second disks caused by the second disk's independent rotation. In other words, the second disk's rotational axis is connected to the first disk's rotational axis, and when the first disk rotates, it can drive the second disk to rotate synchronously, while the second disk can also rotate independently. This ensures that when the position of the sample container changes due to the rotation of the first disk, the relative motion relationship between the sample container and the magnetic field remains essentially unchanged.
[0175] For example, the second disc is rotatably fixedly connected to the first disc, so that the rotation of the first disc synchronously drives the second disc to rotate, and the second disc can rotate independently relative to the first disc.
[0176] In other embodiments, the first disk and the second disk may be independent of each other and have no connection relationship. The control program is set so that the relative movement relationship between the sample container and the magnetic field remains basically unchanged.
[0177] In some embodiments, as shown in Figure 22, the first supporting assembly 120 includes a magnetic field coverage area 122 and a non-magnetic field coverage area 123, and the mixing magnet assembly 110 is also configured so that the magnetic field it generates covers the magnetic field coverage area 122 but does not cover the non-magnetic field coverage area 123.
[0178] Here, both the magnetic field coverage area 122 and the non-magnetic field coverage area 123 are provided with a container receiving portion 121. No magnets are provided below the non-magnetic field coverage area 123 of the first supporting assembly 120, while magnets are provided below the magnetic field coverage area 122 of the first supporting assembly 120. In other words, the first magnet array and the second magnet array extend only below the magnetic field coverage area 122 along the extension direction.
[0179] In some embodiments, the drive device 130 is configured to drive the magnet holder to periodically reciprocate at a preset amplitude, so that the magnetic field generated by the mixing magnet assembly covers the magnetic field coverage area but does not cover the non-magnetic field coverage area. This achieves alternating magnetic field changes in the magnetic field coverage area, thereby driving the magnetic beads to reciprocate in the sample container. For example, it can enhance the mixed mass transfer of the fluid in the sample container and the collision capture effect of the magnetic beads on the nucleic acid in the fluid, while ensuring that the magnetic beads in the non-magnetic field coverage area do not agglomerate due to the influence of the magnetic field.
[0180] For example, adjacent magnets in the first magnet array 111 and the second magnet array 112 are staggered along the extension direction, and adjacent magnet units in the first magnet array 111 are staggered along the vertical direction, and adjacent magnet units in the second magnet array 112 are also staggered along the vertical direction. In this case, the driving device 130 is configured to drive the magnet holder to periodically swing back and forth at a preset amplitude, so that a magnetic field that alternates in the horizontal extension direction and in the vertical direction is generated in the magnetic field coverage area, thereby guiding the magnetic beads in the sample container located in the magnetic field coverage area to reciprocate in the reaction liquid of the sample container, thereby causing the magnetic beads to perform three-dimensional movement in the reaction liquid of the sample container, fully achieving nucleic acid capture, washing and / or elution.
[0181] In some embodiments, the first carrier assembly 120 is configured as a rotatable first disk, the magnet support 113 is configured as a rotatable second disk, and the first disk and the second disk are arranged concentrically. In this case, preferably, the predetermined amplitude is between 20° and 70°, and more preferably, between 30° and 60°.
[0182] In some embodiments, the magnetic field coverage area 122 includes at least a lysis capture zone, which will be described below. The sample container in the lysis capture zone undergoes a lysis and / or capture step. During the lysis and / or capture step, cells in the sample in the sample container are lysed to release nucleic acids and / or the released nucleic acids are captured by magnetic beads in the sample container. Furthermore, the non-magnetic field coverage area 123 is configured as a resting area for placing sample containers to be transferred to the lysis capture zone or for placing sample containers that have undergone at least a lysis step in the lysis capture zone.
[0183] In some embodiments, non-magnetic field coverage area 123 is used to place sample containers that have undergone a first mixing step. This allows the sample container containing the fully mixed reaction solution to rest in non-magnetic field coverage area 123. At this point, the magnetic beads in the reaction solution are fully dispersed, capturing the majority of nucleic acids. After a period of rest, the resting sample container is transferred to magnetic field coverage area 122 for a second mixing step. This allows the magnetic beads to aggregate in a high-density state within the reaction solution under the influence of the changing magnetic field, concentrating on capturing a small amount of remaining, difficult-to-capture nucleic acids. This achieves sufficient capture of nucleic acids.
[0184] For example, another mixing device for performing the first mixing may be provided, which mixes the magnetic beads in the sample container not based on a magnetic field but based on pipetting, shaking, vortexing or ultrasound.
[0185] In some embodiments, a heating mechanism is provided in the static zone for heating the static zone so that the temperature in the static zone is maintained within a preset range.
[0186] In some embodiments, a plurality of magnets that are continuously distributed or sequentially distributed in the first magnet array 111 and the second magnet array 112 constitute a magnet mixing unit 114, and the mixing magnet assembly 110 includes a plurality of magnet mixing units 114 sequentially arranged along a circumferential direction or a linear direction. The magnet mixing unit 114 is defined as follows: when the driving device 130 drives the magnet holder to move so that the sample container 101 passes through a plurality of magnet mixing units 114, the magnetic beads 600 can cyclically undergo multiple groups of mixing actions, wherein each group of mixing actions is the same. Depending on the distribution of the magnets, the magnet mixing unit 114 may include different numbers of magnets, and each group of mixing actions may include one or more mixing actions, which will be described later in conjunction with a specific solution.
[0187] In some embodiments, the driving device 130 can be configured to: drive the magnet holder 113 to move in a first direction, such as rotation or linear movement, so that the sample container 101 passes through M magnet mixing units 114; and then drive the magnet holder 113 to move in a second direction opposite to the first direction, so that the sample container 101 passes through N magnet mixing units 114, where M and N are both positive integers greater than or equal to 1.
[0188] As previously mentioned, when the mixing magnet assembly 110 always moves in one direction, the magnetic beads 600 can only move within a portion of the sample container 101. However, by having the magnet holder 113 drive the individual magnets in the mixing magnet assembly 110 to move alternately in the first and second directions, the movement area of the magnetic beads 600 within the sample container 101 can be expanded, thereby improving the mixing effect.
[0189] Similarly, in this embodiment, M and N can be set equal, so that the movement of the magnetic beads 600 in different areas of the sample container 101 is roughly equal, which helps to achieve uniform stirring of the magnetic beads. It is understandable that M and N can also be unequal.
[0190] In some specific examples, as shown in FIG20 , the driving device 130 is used to drive the magnet support 113 to rotate, and each magnet of the first magnet array 111 and each magnet of the second magnet array 112 are uniformly distributed along the circumferential direction, and the first magnet array 111 and the second magnet array 112 are concentrically arranged, and adjacent magnets of the first magnet array 111 and the second magnet array 112 are staggered along the circumferential direction, and adjacent magnets within the first magnet array 111 are staggered along the vertical direction, and adjacent magnets within the second magnet array 112 are staggered along the vertical direction. Here, a magnet mixing unit 114 includes four magnets distributed continuously in the first magnet array 111 and the second magnet array 112. For example, in FIG18 , magnets MA, MB, MC, and MD together constitute a magnet mixing unit 114. When the driving device 130 drives the magnet support to move so that the sample container 101 passes through each magnet of a magnet mixing unit 114 in sequence, the magnetic beads 600 in the sample container, for example, traverse the reaction liquid in the sample container once.
[0191] In other specific examples, referring to FIG21 , the driving device 130 is used to drive the magnet support 113 to move linearly, and each magnet in the first magnet array 111 and each magnet in the second magnet array 112 are uniformly distributed along the linear direction. Adjacent magnets in the first magnet array 111 and the second magnet array 112 are staggered along the linear direction, adjacent magnets in the first magnet array 111 are staggered along the vertical direction, and adjacent magnets in the second magnet array 112 are staggered along the vertical direction. Here, a magnet mixing unit 114 includes four magnets continuously distributed in the first magnet array 111 and the second magnet array 112. For example, in FIG21 , magnets MA, MB, MC, and MD together constitute a magnet mixing unit 114. Similarly, when the driving device 130 drives the magnet holder to move so that the sample container 101 passes through each magnet of a magnet mixing unit 114 in sequence, the magnetic beads 600 in the sample container, for example, will traverse the reaction liquid in the sample container once.
[0192] In some embodiments, as shown in FIG17 , the first carrier assembly 120 and the mixing magnet assembly 110 are positioned relative to each other such that, when a sample container 101 is received in the container receptacle 121, at least the bottom of the sample container 101, particularly the portion of the sample container containing the reaction liquid, is positioned between the first magnet array 111 and the second magnet array 112. For example, when the sample container 101 is received in the container receptacle 121, a first horizontal distance L5 separates the outer wall of the sample container 101 from the side of the adjacent magnets of the first magnet array 111 facing the sample container, and a second horizontal distance L6 separates the outer wall of the sample container 101 from the side of the adjacent magnets of the second magnet array 112 facing the sample container, with the first horizontal distance L5 being equal to the second horizontal distance L6. This ensures more uniform mixing.
[0193] It is understandable that the first horizontal distance and the second horizontal distance may not be equal.
[0194] It should be noted that the magnet in the present application can be either a permanent magnet or an electromagnet.
[0195] It should be noted that each magnet in the first magnet array 111 and the second magnet array 112 can be an integral magnet as shown in FIG. 23 , or can be a plurality of sub-magnets spaced apart along the axial direction of the sample container 101 as shown in FIG. 24 .
[0196] As mentioned above, the nucleic acid extraction process mainly includes lysis and capture, washing, and elution. In each of these steps, the magnetic beads in the sample container need to be mixed to ensure that the magnetic beads can fully capture the nucleic acids in the lysis and capture step, fully remove impurities adsorbed on the magnetic beads in the washing step, and fully elute the nucleic acids from the magnetic beads in the elution step.
[0197] The mixing magnet assembly 110 provided in the embodiment of the present application can be used for at least one of the lysis and capture steps, the washing step, and the elution step.
[0198] For example, the first carrier component 120 may include at least one of a lysis capture zone, a washing zone, and an elution zone, and the mixing magnet component 110 is configured so that the magnetic field it generates can reach at least the at least one zone of the first carrier component 120, thereby being able to mix the magnetic beads in the sample container placed on the at least one zone.
[0199] In some embodiments, as shown in FIG25 , the first carrier assembly 120 includes a lysis capture zone 124 having a container receiving portion 121. At this time, the mixing magnet assembly 110 is configured such that the magnetic field it generates can at least cover the lysis capture zone 124, thereby enabling the magnetic beads in the sample container placed on the lysis capture zone to move, thereby achieving adsorption of nucleic acids by the magnetic beads or capture of nucleic acids by the magnetic beads.
[0200] For example, the lysis capture zone 124 is disposed in the magnetic field coverage area 122 .
[0201] As some implementations, the first carrier assembly 120 and the mixing magnet assembly 110 are arranged relative to each other: when a sample container is received in the container receiving portion of the lysis capture zone 124, at least the bottom of the sample container is located between the first magnet array and the second magnet array, and when the first carrier assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, at least two magnets in the mixing magnet assembly have different heights relative to the bottom of the sample container located in the lysis capture zone 124, so that the magnetic beads in the sample container can experience a changing, for example, uniformly changing or alternating magnetic field, thereby realizing the movement of the magnetic beads in the reaction liquid in the sample container, and thereby realizing the capture of nucleic acids by the magnetic beads.
[0202] Furthermore, as shown in Figure 25, the first carrier assembly further includes a washing area 125, which has a container receiving portion 121. At this time, the mixing magnet assembly 110 is preferably further configured so that the magnetic field it generates can at least cover the lysis capture area 125 and the washing area 126, thereby enabling the magnetic beads in the sample containers placed on the lysis capture area and the washing area to move, thereby achieving nucleic acid adsorption by the magnetic beads and nucleic acid cleaning.
[0203] For example, the lysis and capture zone 124 and the washing zone 125 are both arranged in the magnetic field coverage area 122 .
[0204] As some implementations, the first carrier assembly 120 and the mixing magnet assembly 110 are arranged relative to each other: when sample containers are received in the container receiving portions of the lysis capture zone 124 and the washing zone 125, at least the bottoms of these sample containers are located between the first magnet array and the second magnet array, and when the first carrier assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, at least two magnets in the mixing magnet assembly have different heights relative to the bottoms of the sample containers located in the lysis capture zone 124 and the washing zone 125, so that the magnetic beads in the sample containers located in the lysis capture zone 124 and the washing zone 125 can simultaneously experience a changing magnetic field, such as a uniform change or an alternating change, to achieve the movement of the magnetic beads in the reaction liquid in the sample container, and thereby simultaneously achieve the capture of nucleic acids by the magnetic beads in the lysis capture zone 124 and the cleaning of nucleic acids in the washing zone 125.
[0205] Furthermore, the lysis capture zone 124 and the washing zone 125 can be arranged successively, especially adjacently, in the first supporting assembly 120 along the extension direction R. For example, when the first supporting assembly is configured as a disk and the first magnet array and the second magnet array are arranged concentrically, the lysis capture zone 124 and the washing zone 125 can be arranged on the same circumference, especially adjacent to each other on the same circumference. As other implementations, the mixing magnet assembly further includes a horizontally extending third magnet array (not shown), the third magnet array including a plurality of magnets installed at intervals on the magnet bracket. The first carrier assembly 120 and the mixing magnet assembly 110 are arranged relative to each other in such a manner that when a sample container is received in the container receiving portion of the lysis capture zone 124, at least the bottom of the sample container is located between the first magnet array and the second magnet array, and when the first carrier assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, at least two magnets in the first magnet array and / or the second magnet array have different heights relative to the bottom of the sample container located in the lysis capture zone 124, so that the magnetic beads in the sample container located in the lysis capture zone 124 can experience a changing, for example, uniformly changing or alternating magnetic field, thereby realizing the movement of the magnetic beads in the reaction liquid in the sample container, and further realizing the capture of nucleic acids by the magnetic beads in the lysis capture zone 124. The first carrier assembly 120 and the mixing magnet assembly 110 are also arranged relative to each other: when a sample container is received in the container receiving portion of the washing area 125, at least the bottom of the sample container is located between the second magnet array and the third magnet array, so that when the first carrier assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, the magnetic beads in the sample container in the washing area 125 can experience a changing, for example, uniformly changing or alternatingly changing magnetic field, thereby realizing the movement of the magnetic beads in the reaction liquid in the sample container, and further realizing the nucleic acid cleaning in the washing area 125.
[0206] For example, the first magnet array, the second magnet array, and the third magnet array can be mounted on the same magnet support. The drive device is configured to drive the magnet support to move so that the first supporting assembly and the mixing magnet assembly move horizontally relative to each other, so that the magnetic beads in the sample containers located in the lysis capture zone 124 and the washing zone 125 can simultaneously experience a changing magnetic field, thereby achieving movement of the magnetic beads in the reaction liquid in the sample container, and further achieving nucleic acid capture by the magnetic beads in the lysis capture zone 124 and nucleic acid cleaning in the washing zone 125.
[0207] In some examples, the first magnet array, the second magnet array, and the third magnet array may be arranged concentrically or on straight lines parallel to each other.
[0208] As yet other implementations, the mixing magnet assembly further includes a third magnet array and a fourth magnet array that are not shown and extend horizontally, and the third magnet array and the fourth magnet array respectively include a plurality of magnets installed at intervals on the magnet bracket. The first supporting assembly 120 and the mixing magnet assembly 110 are arranged relative to each other so that: when a sample container is received in the container receiving portion of the lysis capture zone 124, at least the bottom of the sample container is located between the first magnet array and the second magnet array, and when the first supporting assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, at least two magnets in the first magnet array and / or the second magnet array have different heights relative to the bottom of the sample container located in the lysis capture zone 124, so that the magnetic beads in the sample container located in the lysis capture zone 124 can experience a changing, for example, uniformly changing or alternating magnetic field, thereby realizing the movement of the magnetic beads in the reaction liquid in the sample container, and further realizing the capture of nucleic acids by the magnetic beads in the lysis capture zone 124. The first carrier assembly 120 and the mixing magnet assembly 110 are also arranged relative to each other: when a sample container is received in the container receiving portion of the washing area 125, at least the bottom of the sample container is located between the third magnet array and the fourth magnet array, so that when the first carrier assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, the magnetic beads in the sample container in the washing area 125 can experience a changing, for example, uniformly changing or alternatingly changing magnetic field, thereby realizing the movement of the magnetic beads in the reaction liquid in the sample container, and thereby realizing the nucleic acid cleaning in the washing area 125.
[0209] For example, the first magnet array, the second magnet array, the third magnet array, and the fourth magnet array can be mounted on the same magnet support. The drive device is configured to drive the magnet support to move so that the first supporting assembly and the mixing magnet assembly move horizontally relative to each other, so that the magnetic beads in the sample containers located in the lysis capture zone 124 and the washing zone 125 can simultaneously experience a changing magnetic field, thereby achieving movement of the magnetic beads in the reaction liquid in the sample container, and further achieving nucleic acid capture by the magnetic beads in the lysis capture zone 124 and nucleic acid cleaning in the washing zone 125.
[0210] For another example, the first magnet array and the second magnet array can be mounted on a first magnet support, while the third magnet array and the fourth magnet array can be mounted on a second magnet support. The drive device is configured to drive the first magnet support to move so that the first carrier assembly and the first magnet array and the second magnet array assembly on the first magnet support move horizontally relative to each other, so that the magnetic beads in the sample container located in the lysis capture zone 124 can experience a changing magnetic field, thereby enabling the magnetic beads to move in the reaction liquid in the sample container, thereby enabling the magnetic beads to capture nucleic acids in the lysis capture zone 124. The drive device is also configured to drive the second magnet support to move so that the first carrier assembly and the third magnet array and the fourth magnet array assembly on the second magnet support move horizontally relative to each other, so that the magnetic beads in the sample container located in the washing zone 125 can experience a changing magnetic field, thereby enabling the magnetic beads to move in the reaction liquid in the sample container, thereby enabling nucleic acid cleaning in the washing zone 125.
[0211] In other embodiments, the mixing magnet assembly 110 and the first carrier assembly 120 can also be configured to move horizontally relative to each other so as to successively move the magnetic beads in the sample containers placed on the lysis capture zone and the washing zone. Furthermore, the first carrier assembly 120 also includes an elution zone 126, which has a container receiving portion 121. At this time, the mixing magnet assembly is also configured so that the magnetic field it generates can at least cover the lysis capture zone 124, the washing zone 125 and the elution zone 126, thereby enabling the magnetic beads in the sample containers placed on the lysis capture zone, the washing zone and the elution zone to move, so as to achieve magnetic bead adsorption of nucleic acids, nucleic acid cleaning and nucleic acid elution.
[0212] As some implementations, the first carrier assembly 120 and the mixing magnet assembly 110 are arranged relative to each other: when sample containers are received in the container receiving portions of the lysis capture zone 124, the washing zone 125 and the elution zone 126, at least the bottoms of these sample containers are located between the first magnet array and the second magnet array, and when the first carrier assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, at least two magnets in the mixing magnet assembly have different heights relative to the bottoms of the sample containers located in the lysis capture zone 124, the washing zone 125 and the elution zone 126, so that the magnetic beads in the sample containers located in the lysis capture zone 124, the washing zone 125 and the elution zone 126 can simultaneously experience a changing magnetic field, such as a uniform change or an alternating change, to achieve the movement of the magnetic beads in the reaction liquid in the sample container, and thereby simultaneously achieve the capture of nucleic acids by the magnetic beads in the lysis capture zone 124, the cleaning of nucleic acids in the washing zone 125 and the elution of nucleic acids in the elution zone 126.
[0213] Furthermore, the lysis and capture zone 124, the washing zone 125, and the elution zone 126 can be arranged successively, in particular adjacently, in the first carrier assembly 120 along the extension direction R. For example, when the first carrier assembly is configured as a disk and the first magnet array and the second magnet array are arranged concentrically, the lysis and capture zone 124, the washing zone 125, and the elution zone 126 can be arranged on the same circumference, in particular adjacent to each other on the same circumference.
[0214] As other implementations, the mixing magnet assembly further includes a horizontally extending third magnet array not shown, the third magnet array including a plurality of magnets spaced apart and mounted on a magnet support. The first carrier assembly 120 and the mixing magnet assembly 110 are arranged relative to each other such that when a sample container is received in the container receiving portion of the lysis capture zone 124, at least the bottom of the sample container is located between the first magnet array and the second magnet array, and when the first carrier assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, at least two magnets in the first magnet array and / or the second magnet array have different heights relative to the bottom of the sample container located in the lysis capture zone 124, so that the magnetic beads in the sample container located in the lysis capture zone 124 can experience a changing, for example, uniformly changing or alternating, magnetic field, thereby enabling the movement of the magnetic beads in the reaction liquid in the sample container, and thereby enabling the magnetic beads in the lysis capture zone 124 to capture nucleic acids. The first carrier assembly 120 and the mixing magnet assembly 110 are also arranged relative to each other: when sample containers are received in the container receiving parts of the washing area 125 and the elution area 126, at least the bottoms of these sample containers are located between the second magnet array and the third magnet array, so that when the first carrier assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, the magnetic beads in the sample containers located in the washing area 125 and the elution area 126 can simultaneously experience a changing magnetic field, such as a uniform change or an alternating change, to achieve the movement of the magnetic beads in the reaction liquid in the sample container, and thereby simultaneously achieve nucleic acid cleaning in the washing area 125 and nucleic acid elution in the elution area 126.
[0215] For example, the first magnet array, the second magnet array, and the third magnet array can be mounted on the same magnet support. The drive device is configured to drive the magnet support to move so that the first supporting assembly and the mixing magnet assembly move horizontally relative to each other, so that the magnetic beads in the sample containers located in the lysis capture zone 124, the washing zone 125, and the elution zone 126 can simultaneously experience a changing magnetic field, thereby achieving movement of the magnetic beads in the reaction liquid in the sample container, and further achieving nucleic acid capture by the magnetic beads in the lysis capture zone 124, nucleic acid cleaning in the washing zone 125, and nucleic acid elution in the elution zone 126.
[0216] In some examples, the first magnet array, the second magnet array, and the third magnet array may be arranged concentrically or on straight lines parallel to each other.
[0217] As yet other implementations, the mixing magnet assembly further includes a third magnet array and a fourth magnet array that are not shown and extend horizontally, and the third magnet array and the fourth magnet array respectively include a plurality of magnets installed at intervals on the magnet bracket. The first supporting assembly 120 and the mixing magnet assembly 110 are arranged relative to each other so that: when a sample container is received in the container receiving portion of the lysis capture zone 124, at least the bottom of the sample container is located between the first magnet array and the second magnet array, and when the first supporting assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, at least two magnets in the first magnet array and / or the second magnet array have different heights relative to the bottom of the sample container located in the lysis capture zone 124, so that the magnetic beads in the sample container located in the lysis capture zone 124 can experience a changing, for example, uniformly changing or alternating magnetic field, thereby realizing the movement of the magnetic beads in the reaction liquid in the sample container, and further realizing the capture of nucleic acids by the magnetic beads in the lysis capture zone 124. The first carrier assembly 120 and the mixing magnet assembly 110 are also arranged relative to each other: when sample containers are received in the container receiving portions of the washing area 125 and the elution area 126, at least the bottoms of these sample containers are located between the third magnet array and the fourth magnet array, so that when the first carrier assembly 120 and the mixing magnet assembly 110 move horizontally relative to each other, the magnetic beads in the sample containers in the washing area 125 and the elution area 126 can simultaneously experience a changing magnetic field, such as a uniform change or an alternating change, to achieve the movement of the magnetic beads in the reaction liquid in the sample container, and thereby simultaneously achieve nucleic acid cleaning in the washing area 125 and nucleic acid elution in the elution area 126.
[0218] For example, the first magnet array, the second magnet array, the third magnet array, and the fourth magnet array can be mounted on the same magnet support. The driving device is configured to drive the magnet support to move so that the first supporting assembly and the mixing magnet assembly move horizontally relative to each other, so that the magnetic beads in the sample containers located in the lysis capture zone 124, the washing zone 125, and the elution zone 126 can simultaneously experience a changing magnetic field, thereby achieving movement of the magnetic beads in the reaction liquid in the sample container, and further achieving nucleic acid capture by the magnetic beads in the lysis capture zone 124, nucleic acid cleaning in the washing zone 125, and nucleic acid elution in the elution zone 126.
[0219] For another example, the first magnet array and the second magnet array can be mounted on a first magnet support, while the third magnet array and the fourth magnet array can be mounted on a second magnet support. The drive device is configured to drive the first magnet support to move so that the first carrier assembly and the first and second magnet array assemblies on the first magnet support move horizontally relative to each other, so that the magnetic beads in the sample container located in the lysis and capture zone 124 can experience a changing magnetic field, thereby enabling the magnetic beads to move in the reaction solution in the sample container, thereby achieving nucleic acid capture by the magnetic beads in the lysis and capture zone 124. The drive device is also configured to drive the second magnet support to move so that the first carrier assembly and the third and fourth magnet array assemblies on the second magnet support move horizontally relative to each other, so that the magnetic beads in the sample containers located in the washing zone 125 and the elution zone 126 can simultaneously experience a changing magnetic field, thereby enabling the magnetic beads to move in the reaction solution in the sample container, thereby simultaneously achieving nucleic acid cleaning in the washing zone 125 and nucleic acid elution in the elution zone 126.
[0220] Because the magnetic field control requirements for nucleic acid capture by magnetic beads may differ from those for nucleic acid cleaning or elution, the addition of a third and fourth magnet array, independent of the first and second magnet arrays, generates magnetic fields that differ from those generated by the first and second magnet arrays. This adapts to the different control requirements for nucleic acid capture and nucleic acid cleaning. Sample containers can be transferred between the two magnetic fields using a transfer component, such as a robotic arm.
[0221] In other embodiments, the mixing magnet assembly 110 and the first carrier assembly 120 can also be configured to move horizontally relative to each other so as to move the magnetic beads in the sample containers placed on the lysis capture zone, the washing zone, and the elution zone in sequence.
[0222] In some embodiments, as shown in FIG4 , at least one container receiving portion 121 has a raised portion 1211 , so that the bottom of a sample container placed in the container receiving portion having the raised portion is higher than the bottom of a sample container placed in the container receiving portion without the raised portion.
[0223] For example, a plurality of container receptacles 121 may have a common raised portion 1211 or may each have its own raised portion.
[0224] Preferably, the container receiving portion of the elution zone 127 has a raised portion. The amount of reaction liquid in the sample container 101 during the lysis, capture, and washing steps is greater than the amount of reaction liquid in the sample container 101 during the elution step. By providing the raised portion on the receiving portion of the elution zone 127, the magnetic beads in the sample container in the elution zone can be concentrated as much as possible at the bottom of the sample container, thereby preventing nucleic acid loss.
[0225] In some embodiments, the first carrier assembly 120 further includes a drying area 127 , which is used to dry the magnetic beads adsorbed with the washed nucleic acids in the sample container 101 .
[0226] As described above, in some embodiments, the first carrier component 120 is used to provide an area for the sample to perform the aforementioned lysis capture, washing and elution operations, and the mixing magnet component 110 is used to move the magnetic beads in the sample container 101 located on the first carrier component 120, thereby achieving magnetic bead mixing, so as to achieve sufficient lysis capture, washing and elution.
[0227] Before adding the cleaning solution or eluent to the sample container 101, the waste liquid in the sample container needs to be aspirated. In this case, to prevent the magnetic beads adsorbed with nucleic acids from being aspirated, the nucleic acid extraction module 100 may further include a magnetic bead aggregation device 140 for aggregating the magnetic beads in the sample container, particularly on the sidewalls of the sample container.
[0228] Therefore, as shown in Figures 26 and 27, the nucleic acid extraction module 100 can also include a magnetic bead aggregation device 140 and a transfer device 150. The magnetic bead aggregation device 140 includes a second carrier assembly 141 and a aggregation magnet assembly 142. The second carrier assembly 141 is used to place the sample container 101 mixed by the magnetic bead mixing device, especially the mixing magnet assembly 110, and the aggregation magnet assembly 142 is used to aggregate the magnetic beads in the sample container. The transfer device 150 is configured to transfer the sample container 101 between the first carrier assembly 120 and the second carrier assembly 141, for example, transferring the sample container 101 mixed by the magnetic bead mixing device from the first carrier assembly 120 to the second carrier assembly 141.
[0229] Here, the magnetic bead mixing device and the magnetic bead aggregation device 140 are separately provided, so that magnetic bead mixing and magnetic bead aggregation operations can be performed on different samples in parallel, thereby improving the sample detection throughput.
[0230] In some embodiments, as shown in FIG26 , the magnetic bead mixing device and the magnetic bead aggregation device 140 are arranged side by side.
[0231] In other embodiments, as shown in FIG. 27 , the magnetic bead aggregation device 140 is arranged above the magnetic bead mixing device, especially above the first supporting component 120 .
[0232] In some embodiments, the focusing magnet assembly 142 may include a permanent magnet. In other embodiments, the focusing magnet assembly 142 may include an electromagnet.
[0233] In related technologies, the lysis capture, wash, and elution steps are performed at separate workstations. Therefore, sufficient space is required in the diagnostic analyzer to accommodate the relevant workstations and the scheduling devices between them, resulting in a larger sample analyzer. To address this issue, the lysis capture, wash, and elution steps can be integrated, thereby helping to reduce the size of the molecular diagnostic analyzer.
[0234] In some embodiments, referring to FIG. 25 , the first carrier assembly 120 includes multiple different functional areas, namely, the first carrier assembly 120 includes at least a lysis and capture area 124, a washing area 125, and an elution area 126. That is, the lysis and capture area 124, the washing area 125, and the elution area 126 are integrated into the first carrier assembly, for example, integrated into the incubation plate shown in the figure. Each of the lysis and capture area 124, the washing area 125, and the elution area 126 is provided with a receiving portion 121 for placing a sample container 101 containing a sample and a magnetic bead reagent. Here, the mixing magnet assembly 110 is further configured to: mix the magnetic beads in the sample container in the lysis and capture area 124 to achieve nucleic acid capture by the magnetic beads; mix the magnetic beads in the sample container in the washing area 125 to wash the nucleic acids captured by the magnetic beads; and mix the magnetic beads in the sample container in the elution area 126 to elute the nucleic acids from the magnetic beads.
[0235] By providing the lysis capture zone 124 , the washing zone 125 and the elution zone 126 on the first carrier component 120 , the lysis capture, washing and elution steps can be integrated on the first carrier component 120 , which helps to reduce the volume of the sample analyzer.
[0236] On the other hand, if separate mixing devices are provided for the lysis capture link, washing link, and elution link implemented at different positions, the cost and volume of the analytical diagnostic analyzer will increase; if a common mixing device is provided for the lysis capture link, washing link, and elution link implemented at different positions, the scheduling time of the sample container 101 between each link and the mixing device will increase, thereby reducing efficiency. In this embodiment, since the lysis capture zone 124, the washing zone 125, and the elution zone 126 are integrated into the first carrier assembly 120, the samples in the lysis capture zone 124, the washing zone 125, and the elution zone 126 can be mixed simultaneously by a mixing magnet assembly 110, thereby improving the shortcomings existing in the relevant technology.
[0237] Preferably, the mixing magnet assembly 110 is configured to generate a magnetic field to move the magnetic beads in the sample container on the sample carrying device, thereby achieving magnetic bead mixing, wherein the mixing magnet assembly 110 is configured so that the magnetic field it generates can at least cover the lysis capture zone, the washing zone and the elution zone, so that, for example, the magnetic beads in the sample container placed on the lysis capture zone, the washing zone and the elution zone can be moved at the same time, thereby achieving magnetic bead mixing.
[0238] In some embodiments, the washing area 125 may include a first washing area and a second washing area that are different from each other. The mixing magnet assembly is also used to mix the magnetic beads in the sample container located in the first washing area so as to wash the nucleic acids captured by the magnetic beads with a first washing liquid. The mixing magnet assembly is also used to mix the magnetic beads in the sample container located in the second washing area so as to wash the nucleic acids captured by the magnetic beads with a second washing liquid.
[0239] It is understandable that the number of washing zones 125 can be set according to actual needs and is not limited to two washing zones, but may also include three or even more washing zones.
[0240] In some tests, samples need to be dried after washing and before elution. Therefore, referring to FIG25 , in some embodiments, the first carrier assembly 120 further includes a drying area 127 for drying the washed magnetic beads in the sample container. The drying area 127 also includes the aforementioned receiving portion 121.
[0241] In some embodiments, as shown in FIG. 25 , the first carrying assembly 120 is configured as a rotatable disc and can rotate to a transfer position T, and the transfer device 150 is configured to transfer sample containers between the transfer position T of the first carrying assembly and the second carrying assembly.
[0242] In one example, the transfer position T is a fixed position of the disc relative to the fixed portion of the transfer device. In this fixed position, the movable portion of the transfer device 150, such as a three-dimensionally movable manipulator, can grab the sample container 101 from the transfer position of the first carrier assembly and transfer it to the second carrier assembly. The movable portion of the transfer device 150 can also grab the sample container 101 from the second carrier assembly and transfer it to the transfer position of the first carrier assembly. Here, the first carrier assembly 120 transfers the sample container 101 on the first carrier assembly to the transfer position T by rotating, and the transfer device 150 transfers the sample container 101 at the transfer position T to the second carrier assembly. For example, after the lysis operation is completed on the sample container in the receiving portion A of the lysis capture zone 124, the first carrier assembly 120 rotates so that the receiving portion A reaches the transfer position T, and then the first carrier assembly 120 stops rotating so that the transfer device 150 can remove the sample container 101 at the transfer position T and transfer it to the second carrier assembly. For another example, after the washing operation is completed for the sample container in the receiving portion B of the washing zone 125, the first carrying assembly 120 rotates so that the receiving portion B reaches the transfer position T, and then the first carrying assembly 120 stops rotating so that the transfer device 150 can remove the sample container 101 at the transfer position T and transfer it to the second carrying assembly. For another example, after the drying operation is completed for the sample container in the receiving portion C of the drying zone 127, the first carrying assembly 120 rotates so that the receiving portion C reaches the transfer position T, and then the first carrying assembly 120 stops rotating so that the transfer device 150 can remove the sample container 101 at the transfer position T and transfer it to the second carrying assembly.
[0243] In other embodiments, each receiving portion on the first carrier assembly 120 can be understood as a transfer location T. Here, when a sample container 101 on a receiving portion needs to be transferred, the transfer device 150 can directly move to the receiving portion, grab the sample container 101, and transfer it to the second carrier assembly. The transfer device 150 can also grab a sample container 101 from the second carrier assembly and transfer it to an empty receiving portion of the first carrier assembly.
[0244] 27 , the nucleic acid extraction module 100 further includes a driving device 170 , such as a driving motor, for driving the first supporting assembly 120 to move, such as rotate. The movement of the first supporting assembly 120 enables the sample container 101 to be deployed.
[0245] Here, the transfer device 150 is used to transfer the sample container 101, which can cooperate with the movement of the first carrying component 120 to realize the scheduling of the sample container 101 between different receiving parts 121. For example, the transfer device includes one or more transfer components arranged adjacent to the first carrying component 120. The movement of the first carrying component 120 can align a certain receiving part 121 storing the sample container 101 with a certain transfer component. The transfer component takes out the sample container 101 from the receiving part 121, and then the first carrying component 120 moves so that other receiving parts 121 are aligned with the transfer component, and the transfer component then places the sample container 101 into the new receiving part 121. It can be understood that the transfer device can also realize the scheduling of the sample container 101 between the first carrying component 120 and other devices. The transfer component can be a manipulator that can move and / or rotate in a set direction, for example, a manipulator that can move in three dimensions.
[0246] As some implementations, as shown in Figure 25, the first supporting assembly 120 is constructed as a circular incubation tray, and the lysis capture zone 124, the washing zone 125, and the elution zone 126 are distributed along the circumferential direction, that is, the lysis capture zone 124, the washing zone 125, and the elution zone 126 are distributed along the circumferential direction as a whole, and the multiple receiving portions 121 of the lysis capture zone 124, the multiple receiving portions 121 of the washing zone 125, and the multiple receiving portions 121 in the elution zone 126 are all arranged along the circumferential direction. In this embodiment, one end of the lysis capture zone 124 is directly connected to one end of the washing zone 125, and the other end of the lysis capture zone 124 is connected to the other end of the washing zone 125 through the elution zone 126, that is, the elution zone 126 is located between the lysis capture zone 124 and the washing zone 125, so that the lysis capture zone 124, the washing zone 125, and the elution zone 126 are arranged along the circumferential direction as a whole. It should be noted that when the first supporting component 120 is also provided with a drying zone 127, the cleavage capture zone 124, the washing zone 125, the elution zone 126 and the drying zone 127 are all distributed in the circumferential direction. In addition, the elution zone 126 and the drying zone 127 can be integrated into a drying / elution zone and arranged between the cleavage capture zone 124 and the washing zone 125.
[0247] As other implementations not shown, the first supporting assembly 120 can be a rectangular incubation tray, and the driving device 170 is used to drive the first supporting assembly 120 to move in a straight line direction (e.g., the length direction of the rectangular incubation tray), and the lysis and capture zone 124, the washing zone 125, and the elution zone 126 are arranged in a straight line direction. That is, the lysis and capture zone 124, the washing zone 125, and the elution zone 126 are distributed in a straight line as a whole, and the multiple receiving portions 121 of the lysis and capture zone 124, the multiple receiving portions 121 of the washing zone 125, and the multiple receiving portions 121 of the elution zone 126 are all arranged in a straight line direction. It should be noted that when the first supporting assembly 120 is also provided with a drying zone 127, the lysis and capture zone 124, the washing zone 125, the elution zone 126, and the drying zone 127 are all distributed in a straight line direction.
[0248] As another implementation method not shown, the first supporting component 120 can be a fan-shaped incubation tray, and the driving device 170 drives the first supporting component 120 to rotate accordingly. The lysis capture area 124, the washing area 125 and the elution area 126 are distributed along the circumferential direction. This embodiment is roughly similar to the circular incubation tray. The main difference between the two is that the rotation angle of the circular incubation tray is greater than that of the fan-shaped incubation tray. The circular incubation tray can rotate at an angle of more than 166°. The circular incubation tray usually rotates back and forth within the range of the fan-shaped angle. The fan-shaped incubation tray is suitable for compact sample analyzers.
[0249] It should be noted that the present application does not limit the arrangement order of functional zones such as the lysis and capture zone 124 , the washing zone 125 , the elution zone 126 , and the drying zone 127 .
[0250] Next, some embodiments of the magnetic bead aggregation device 140 are described, but the present application is not limited thereto.
[0251] In some embodiments, the second carrying assembly 141 includes at least one carrying portion for placing a sample container, and the collecting magnet assembly 142 is arranged corresponding to the carrying portion, and is used to collect magnetic beads in the sample container located in the carrying portion. Correspondingly, the magnetic bead collecting device 140 also includes at least one suction and discharge mechanism and at least one liquid injection mechanism. Each suction and discharge mechanism is configured to suck waste liquid from the sample container placed in the carrying portion and discharge it. For example, each suction and discharge mechanism can use a suction head accommodated in an extraction member to suck waste liquid from the sample container placed in the carrying portion and discharge it. Each liquid injection mechanism is configured to inject liquid into the sample container placed in the carrying portion. Here, the transfer device 150 is used to transfer sample containers between the functional areas of the first carrying assembly and the carrying portions of the second carrying assembly 141.
[0252] In some embodiments, the sample container 101 is placed on the extraction member, and the transfer device 150 directly transfers the entire extraction member, thereby transferring the sample container 101. As described above, the extraction member can be configured as a long strip structure, with the sample container 101 and the corresponding cavities for placing reagents and / or pipette tips placed in sequence along the length of the extraction member, and the sample container 101 is usually located at the front end of the extraction member. Based on this type of structure, the supporting portion can be designed as a strip groove that adapts to the shape of the extraction member. However, the present application is not limited to this.
[0253] In some embodiments, each suction and discharge mechanism comprises a first pipette, a first drive unit, and a second drive unit. The first drive unit is configured to drive the first pipette to move into a sample container located on the carrier, and the second drive unit is configured to drive the first pipette to draw waste liquid from the sample container and discharge it. In some embodiments, each liquid injection mechanism comprises a second pipette, a third drive unit, and a fourth drive unit. The third drive unit is configured to drive the second pipette to move into a sample container located on the carrier, and the fourth drive unit is configured to drive the second pipette to inject liquid into the sample container located on the carrier.
[0254] Preferably, the arrangement of the carrying portion, the focusing magnet, the suction and discharge mechanism, and the liquid injection mechanism matches the arrangement of the functional areas of the first carrying component 120 , so as to improve the overall efficiency of nucleic acid extraction.
[0255] 28 , the second carrier assembly 141 includes a first carrier portion 1411 for placing a sample container, and the focusing magnet assembly 142 includes a first focusing magnet 1421 disposed corresponding to the first carrier portion 1411. The first focusing magnet 1421 is used to focus magnetic beads in the sample container located in the first carrier portion 1411.
[0256] As shown in Figure 28, the magnetic bead collecting device 140 further includes a first suction and discharge mechanism 143 and a first liquid injection mechanism 144. The first suction and discharge mechanism 143 is configured to suck waste liquid from the sample container placed in the first carrying portion 1411 and discharge it, and the first liquid injection mechanism 144 is configured to inject cleaning liquid into the sample container placed in the first carrying portion 1411.
[0257] Preferably, the first collecting magnet 1421 is arranged relative to the first carrying portion 1411 so that when a sample container is carried in the first carrying portion 1411 , the first collecting magnet 1421 causes the magnetic beads in the sample container to collect on the side wall of the sample container.
[0258] In a preferred example, the first focusing magnet 1421 is fixedly disposed relative to the first bearing portion 1411. In another example, the first focusing magnet 1421 is movably disposed relative to the first bearing portion 1411.
[0259] Here, the transfer device 150 is used to transfer the sample container between the lysis capture zone 124 of the first carrier assembly, the first carrier portion 1411 of the second carrier assembly 141 and the washing zone 125 of the first carrier assembly.
[0260] For example, after a sample container located in the lysis and capture zone 124 is lysed, the transfer device 150 removes the sample container 101 from the lysis and capture zone 124 and transfers it to the first carrier 1411, whereupon the first collecting magnet 1421 aggregates the magnetic beads in the sample container. Subsequently, the first suction and discharge mechanism 143 aspirates and discharges waste liquid from the sample container placed in the first carrier 1411, followed by the first injection mechanism 144 injecting a cleaning solution into the sample container placed in the first carrier 1411. Following the injection of the cleaning solution, the transfer device 150 removes the sample container 101 from the first carrier 1411 and transfers it to the washing zone 125 of the first carrier assembly.
[0261] In some embodiments, if the sample needs to be washed multiple times, for example, twice, multiple first carrying parts 1411, multiple first focusing magnets 1421, multiple first suction and discharge mechanisms 143 and multiple first liquid injection mechanisms 144 can be provided to improve the efficiency of nucleic acid extraction.
[0262] Preferably, the number of the first carrying parts 1411 , the number of the first suction and discharge mechanisms 143 , and the number of the first liquid injection mechanisms 144 of the magnetic bead collecting device 140 corresponds to, that is, is equal to, the number of the washing areas 125 of the first carrying assembly 120 .
[0263] In one example, the first sample carrying part 100 includes a first washing area 125 and a second washing area 125, and two first carrying parts 1411, two first collecting magnets 1421, two first suction and discharge mechanisms 143, and two first liquid injection mechanisms 144 are provided. The two-washing process at this time can be: after completing the lysis and capture operation on a sample container located in the lysis and capture area 124, the transfer device 150 removes the sample container 101 from the lysis and capture area 124 and transfers it to one of the first carrying parts 1411, so that the first collecting magnet 1421 corresponding to one of the first carrying parts 1411 causes the magnetic beads in the sample container to gather. Subsequently, the waste liquid is sucked from the sample container by the first suction and discharge mechanism 143 corresponding to one of the first carrying parts 1411 and discharged, and then the first cleaning liquid is injected into the sample container by the first liquid injection mechanism 144 corresponding to one of the first carrying parts 1411. After the first cleaning liquid is injected, the transfer device 150 removes the sample container 101 located on one of the first carrying parts 1411 and transfers it to the first washing area. After the sample container completes the first washing in the first washing area, the transfer device 150 removes the sample container 101 from the first washing area and transfers it to another first carrying part 1411, so that the first collecting magnet 1421 corresponding to the other first carrying part 1411 causes the magnetic beads in the sample container to gather. Subsequently, the first suction and discharge mechanism 143 corresponding to the other first carrying part 1411 sucks the waste liquid from the sample container and discharges it, and then the first injection mechanism 144 corresponding to the other first carrying part 1411 injects the second cleaning liquid into the sample container. After the second cleaning liquid is injected, the transfer device 150 removes the sample container 101 located on the other first carrying part 1411 and transfers it to the second washing area to complete the second washing.
[0264] Of course, in other embodiments, waste liquid aspiration and drainage, as well as cleaning liquid injection, can be accomplished twice within a single first carrier 1411 using the corresponding first focusing magnet 1421, first suction and discharge mechanism 143, and first liquid injection mechanism 144. For example, only one first carrier 1411, one first focusing magnet 1421, one first suction and discharge mechanism 143, and one first liquid injection mechanism 144 may be provided. In this case, the two-step cleaning process can be as follows: After the lysis operation is completed on a sample container located in the lysis and capture zone 124, the transfer device 150 removes the sample container 101 from the lysis and capture zone 124 and transfers it to the first carrier 1411, where the first focusing magnet 1421 causes the magnetic beads in the sample container to aggregate. Subsequently, the first suction and discharge mechanism 143 aspirates and discharges waste liquid from the sample container, followed by the first liquid injection mechanism 144 injecting the first cleaning liquid into the sample container. After the first cleaning liquid is injected, the transfer device 150 removes the sample container 101 from the first carrier 1411 and transfers it to the washing zone. After the sample container completes its first wash in the washing area, the transfer device 150 removes the sample container 101 from the washing area and transfers it to the same first carrier 1411, where the same first collecting magnet 1421 aggregates the magnetic beads in the sample container. Subsequently, the same first suction and discharge mechanism 143 aspirates and drains the waste liquid from the sample container, and the same first injection mechanism 144 injects a second wash solution into the sample container. Following the injection of the second wash solution, the transfer device 150 removes the sample container 101 from the same first carrier 1411 and transfers it to the washing area to complete the second wash.
[0265] As some implementations, as shown in FIG29 , the second carrying assembly 141 may further include a second carrying portion 1412 for placing a sample container, and the focusing magnet assembly 142 may include a second focusing magnet 1422 disposed corresponding to the second carrying portion 1412. The magnetic bead aggregation device 140 may further include a second suction and discharge mechanism 145 and a second liquid injection mechanism 146. The second suction and discharge mechanism 145 is configured to aspirate and discharge waste liquid from the sample container placed in the second carrying portion 1412, and the second liquid injection mechanism 146 is configured to inject eluent into the sample container placed in the second carrying portion 1412.
[0266] Here, the transfer device 150 is used to transfer the sample containers between the washing area 125 of the first carrier assembly, the second carrier portion 1412 of the second carrier assembly 141 , and the elution area 126 of the first carrier assembly.
[0267] For example, after a sample container in the washing area 125 is cleaned, the transfer device 150 removes the sample container 101 from the washing area 125 and transfers it to the second carrying section 1412, where the second collecting magnet 1422 aggregates the magnetic beads in the sample container. Subsequently, the second suction and discharge mechanism 145 aspirates and discharges waste liquid from the sample container in the second carrying section 1412, and the second injection mechanism 146 injects cleaning liquid into the sample container in the second carrying section 1412. After the elution liquid is injected, the transfer device 150 removes the sample container 101 from the second carrying section 1412 and transfers it to the elution area 126 of the first carrying assembly.
[0268] Alternatively, as other implementations, as shown in FIG30 , the second carrying assembly 141 may include a second carrying portion 1412 for placing a sample container, and the focusing magnet assembly 142 includes a second focusing magnet 1422 arranged corresponding to the second carrying portion 1412. The magnetic bead gathering device 140 also includes a second suction and discharge mechanism 145, which is configured to aspirate waste liquid from the sample container placed in the second carrying portion 1412 and discharge it. Furthermore, the second carrying assembly 141 includes a third carrying portion 1413 for placing a sample container, and the magnetic bead gathering device 140 also includes a second liquid injection mechanism 146, which is configured to inject eluent into the sample container placed in the third carrying portion 1413.
[0269] Here, the transfer device 150 is used to transfer the sample containers between the washing zone 125 of the first carrier assembly, the second carrier portion 1412 of the second carrier assembly 141 , the drying zone 127 and the elution zone 126 of the first carrier assembly.
[0270] For example, after a sample container in the washing area 125 is cleaned, the transfer device 150 removes the sample container 101 from the washing area 125 and transfers it to the second loading section 1412, where the second collecting magnet 1422 aggregates the magnetic beads in the sample container. Subsequently, the second suction and discharge mechanism 145 aspirates and drains waste liquid from the sample container in the second loading section 1412. Next, the transfer device 150 removes the sample container 101 from the second loading section 1412 and transfers it to the drying area 127 of the first loading assembly. After drying, the transfer device 150 removes the sample container 101 from the drying area 127 and transfers it to the third loading section 1413. The second injection mechanism 146 then injects cleaning solution into the sample container in the third loading section 1413. After injecting the eluent, the transfer device 150 removes the sample container 101 from the third loading section 1413 and transfers it to the elution area 126 of the first loading assembly.
[0271] Of course, in other embodiments, the second carrying part, the third carrying part and their corresponding second collecting magnet 1422, the second suction and discharge mechanism 145 and the second liquid injection mechanism 146 may not be provided. Instead, the waste liquid suction and discharge and liquid injection required for the cleaning operation and the elution operation are completed in the first carrying part through the corresponding first collecting magnet 1421, the first suction and discharge mechanism 143 and the first liquid injection mechanism 144.
[0272] In some embodiments, the second supporting portion and the second collecting magnet corresponding thereto can move up and down vertically relative to each other, so that the magnetic beads in the sample container placed in the second supporting portion can be gathered on the side wall of the sample container, especially moving from top to bottom.
[0273] It is preferred that the second focusing magnet is movable, preferably movable from top to bottom in a vertical direction.
[0274] In some embodiments, as shown in FIG31 , the first and second supporting portions are arranged side by side, or the first, second, and third supporting portions are arranged side by side. Preferably, the first focusing magnet is disposed on one side of the first supporting portion along the side-by-side direction P, or the second focusing magnet is disposed on one side of the second supporting portion along the side-by-side direction P; or the first focusing magnet is disposed on one side of the first supporting portion along the side-by-side direction P and the second focusing magnet is disposed on one side of the second supporting portion along the side-by-side direction P.
[0275] In a specific example, the first focusing magnet is arranged on one side of the first carrying portion along the side-by-side direction P, so that: when a sample container containing a reaction liquid containing a sample and magnetic beads is placed on the first carrying portion, the first focusing magnet is located near the reaction liquid in the sample container so as to gather the magnetic beads in the reaction liquid on the side wall of the sample container.
[0276] In another specific example, the second focusing magnet is arranged on one side of the second carrying portion along the side-by-side direction P in a manner that can move in the vertical direction, so that: when a sample container containing a reaction liquid is placed in the second carrying portion, the second focusing magnet can move from top to bottom in the vertical direction near the reaction liquid in the sample container so as to gather the magnetic beads in the reaction liquid on the side wall of the lower part of the sample container.
[0277] Further preferably, the first focusing magnet and the second focusing magnet are arranged on the same side of the first carrying portion and the second carrying portion along the side-by-side direction P.
[0278] In some embodiments, the length extension direction L of the first supporting portion, the second supporting portion, and the third supporting portion is perpendicular to the parallel direction P.
[0279] In other embodiments, the first supporting portion, the second supporting portion, and the third supporting portion may also be arranged at different heights.
[0280] In order to achieve better nucleic acid extraction results, the sample is heated at least during the lysis and elution steps. Therefore, in some embodiments, the nucleic acid extraction module may further include a heating device 160 for heating the sample.
[0281] Referring to Figure 32, the heating device 160 has at least a first heating zone 161 and a second heating zone 162. The first heating zone 161 is set corresponding to the cleavage and capture zone 124, and is used to heat the reaction liquid in the cleavage and capture zone 124. The second heating zone 162 is set corresponding to the elution zone 126, and is used to heat the reaction liquid in the elution zone 126. In some embodiments, the heating temperatures of the first heating zone 161 and the second heating zone 162 can be adjusted independently to adapt to the different temperature requirements of the cleavage link and the elution link.
[0282] In this embodiment, by providing a lysis capture zone 124, a washing zone 125, and an elution zone 126 on the first carrier assembly 120, and by providing a heating device 160 with a first heating zone 161 and a second heating zone 162 for heating the reaction liquid in the lysis capture zone 124 and the elution zone 126, respectively, the lysis, washing, and elution steps can be integrated on the first carrier assembly 120, thereby helping to reduce the size of the sample analyzer. In some embodiments, the heating device 160 is provided with a third heating zone 163 corresponding to the drying zone 127, and the third heating zone 163 is used to heat the reaction liquid in the drying zone 127. By providing the drying zone 127 and the third heating zone 163, the application scenarios of the sample analyzer can be expanded. It should be noted that the first carrier assembly 120 can be pre-divided into zones: a lysis and capture zone 124, a washing zone 125, an elution zone 126, and a drying zone 127. If the sample does not need to be dried, the drying zone 127 and the third heating zone 163 can be disabled. If the sample does need to be dried, the drying zone 127 and the third heating zone 163 can be enabled accordingly. In some embodiments, the heating temperatures of at least two of the first heating zone 161, the second heating zone 162, and the third heating zone 163 can be independently adjusted.
[0283] When the first carrier assembly 120 includes a drying zone 127 and the heating device 160 includes a third heating zone 163, in some embodiments, at least two of the lysis and capture zone 124, the elution zone 126, and the drying zone 127 are integrated into the same region. Correspondingly, at least two of the first heating zone 161, the second heating zone 162, and the third heating zone 163 are integrated into the same region, and the heating temperature range within the same region is the same. Depending on the sample type, the temperature requirements for lysis, drying, and elution vary. If the temperature ranges of at least two steps are roughly the same, the regions with the same temperature range can be integrated into one region. This reduces the number of heating zones in the heating device 160 and simplifies the control of the heating device 160. As shown in Figures 25 and 32, the drying zone 127 and the elution zone 126 are integrated into the same region, which is designated as the drying / elution zone for ease of description. The second heating zone 162 and the third heating zone 163 are integrated into the same region. Samples to be dried or eluted are dispatched to the drying / elution zone for processing.
[0284] It should be noted that the integration referred to in this application as the same area includes both the situation where two or more areas are mixed with each other, as shown in Figure 25, and the situation where two or more areas are arranged adjacent to each other but are heated to the same temperature range through the heating zone. For example, for the former, the sample to be dried or eluted can be placed in any vacant receiving part 121 in the drying / elution zone; for the latter, the sample to be dried is placed in any vacant receiving part 121 in the drying zone 127, and the sample to be eluted is placed in any vacant receiving part 121 in the elution zone 126. The drying zone 127 and the elution zone 126 are heated to the same temperature range through the heating zone.
[0285] That is, the heating device 160 has multiple heating zones, and the multiple heating zones are set corresponding to at least some of the functional zones. That is, in some embodiments, only samples in some functional zones need to be heated, so it is only necessary to set heating zones corresponding to these functional zones. In other embodiments, samples in each functional zone need to be heated, so it is necessary to set heating zones corresponding to all functional zones. In addition, similar to the aforementioned embodiment, at least two functional zones can be integrated, and the corresponding heating zones can also be integrated. Among the multiple heating zones of the heating device 160, the heating temperature of at least two heating zones can be adjusted independently to adapt to the temperature requirements of different links in different incubation processes.
[0286] In some embodiments, the heating device 160 is provided with multiple heating components corresponding to each heating zone, and each heating component is heated separately, thereby facilitating independent temperature adjustment. For example, referring to FIG32 , the heating device 160 includes a first heating component 164 and a second heating component 165 . The first heating component 164 is provided in the first heating zone 161 for heating the reaction solution in the cleavage and capture zone 124 , and the second heating component 165 is provided in the second heating zone 162 for heating the reaction solution in the elution zone 126 .
[0287] When the first carrier assembly 120 has a drying zone 127 and the heating device 160 has a third heating zone 163, in some embodiments, referring to Figure 32, the heating device 160 further has a third heating component 166, and the third heating component 166 is arranged in the third heating zone 163 to heat the reaction liquid in the drying zone 127. At least two of the cleavage capture zone 124, the elution zone 126 and the drying zone 127 are integrated into the same area. Accordingly, at least two of the first heating zone 161, the second heating zone 162 and the third heating zone 163 are integrated into the same area. The heating temperature range in the same area is the same, and at least two of the first heating component 164, the second heating component 165 and the third heating component 166 are integrated into the same component.
[0288] In the illustrated embodiment, the drying zone 127 and the elution zone 126 are integrated into a drying / elution zone, the second heating zone 162 and the third heating zone 163 are integrated into the same area, and the second heating element 165 and the third heating element 166 are integrated into the same component. Samples to be dried or eluted are dispatched to the drying / elution zone for processing. In some embodiments, when the first carrier assembly 120 has the aforementioned non-magnetic field coverage area 123, the heating device 160 has a fourth heating zone (not shown) and a corresponding fourth heating element. The fourth heating element is disposed in the fourth heating zone to heat the reaction solution in the static zone.
[0289] It is understandable that, in other embodiments, the heating device 160 may also be configured as an integral heating device having a plurality of regions capable of adjusting the temperature separately, to serve as the aforementioned heating zones.
[0290] In some embodiments, referring to Figures 33 and 34, the heating device 160 defines a plurality of heating chambers 169 corresponding to at least the respective receiving portions 121 of the lysis capture zone 124 and the elution zone 126. The heating chambers 169 are used to accommodate the sample container 101. Specifically, the heating chambers 169 are used to insert at least a portion of the sample container 101. The shape of the heating chambers 169 corresponds to the outer contour of the inserted portion of the sample container 101. This, on the one hand, increases the contact area to ensure the heating effect, and on the other hand, enables the stable placement of the sample container 101. Specifically, in the illustrated embodiment, the heating chambers 169 are disposed below the receiving portions 121 and have an opening at the top. After the lower end of the sample container 101 passes through the receiving portion 121, it can continue to be inserted into the heating chambers 169.
[0291] 33 and 34 , the heating device 160 includes a heating component 167 and a heat-conducting component 168. The heat-conducting component 168 is made of a material with good thermal conductivity, such as copper, aluminum, a copper alloy, or an aluminum alloy. The heat-conducting component 168 defines the aforementioned heating chamber 169. When the sample container 101 is inserted into the heating chamber 169, the heat-conducting component 168 at least circumferentially surrounds the inserted portion of the sample container 101, thereby providing a large contact area between the heat-conducting component 168 and the sample container 101. This allows the heat generated by the heating component 167 to be evenly transferred to the sample container 101, ensuring heating efficiency and more uniform heating.
[0292] The heating component 167 is thermally connected to the heat conducting component 168. The so-called thermal connection can be that the heating component 167 is directly connected to the heat conducting component 168, or the heating component 167 is indirectly connected to the heat conducting component 168 through other heat conducting components. In the illustrated embodiment, the heating component 167 is in contact with the bottom of the heat conducting component 168.
[0293] It should be noted that, generally, the samples in the washing area 125 do not need to be heated, so there is no need to set up a corresponding heating area. However, a corresponding mounting structure can still be provided to fix the sample container 101 , wherein the mounting structure can be understood with reference to the aforementioned heat conducting component 168 .
[0294] The nucleic acid extraction module in the embodiment of the present application further discloses a plurality of auxiliary stations for assisting in achieving functions such as washing, drying and elution, and these auxiliary stations are arranged in the magnetic bead aggregation device 140 .
[0295] In some embodiments, the molecular diagnostic analyzer further includes a control module (not shown) for controlling the mixing magnet assembly 110 , the magnetic bead aggregation device 140 , and the transfer device 150 .
[0296] In some embodiments, the control module may be hardware, such as a controller or a programmable logic hardware component of a molecular diagnostic analyzer, or software integrated into the controller or programmable logic hardware component of a molecular diagnostic analyzer.
[0297] As some implementations, the control module may be a controller that may include a processor and a computer-readable storage medium having computer-readable instructions stored thereon, which, when executed by the processor, cause the processor to implement some or all of the following steps.
[0298] In some examples, the processor in the embodiments of the present application may include but is not limited to a central processing unit (CPU), a microcontroller unit (MCU), a field-programmable gate array (FPGA), a digital signal processor (DSP), and other devices for interpreting computer instructions and processing data in computer software.
[0299] In some examples, the memory in the embodiments of the present application may be a volatile memory or a non-volatile memory, or may include both volatile and non-volatile memories. Among them, the non-volatile memory may be a read-only memory (ROM), a programmable read-only memory (PROM), an erasable programmable read-only memory (EPROM), an electrically erasable programmable read-only memory (EEPROM), a magnetic random access memory (FRAM), a flash memory, a magnetic surface memory, an optical disc, or a compact disc read-only memory (CD-ROM); the magnetic surface memory may be a magnetic disk memory or a tape memory. The volatile memory may be a random access memory (RAM), which is used as an external cache. By way of example and not limitation, many forms of RAM are available, such as static random access memory (SRAM), synchronous static random access memory (SSRAM), dynamic random access memory (DRAM), synchronous dynamic random access memory (SDRAM), double data rate synchronous dynamic random access memory (DDRSDRAM), enhanced synchronous dynamic random access memory (ESDRAM), synchronous link dynamic random access memory (SLDRAM), and direct rambus random access memory (DRRAM).The memories described in the embodiments of this application are intended to include, but are not limited to, these and any other suitable types of memories.
[0300] Furthermore, the controller may further include a communication interface that communicates with the processor and the computer-readable storage medium via a bus. The communication interface may be an interface using any currently known communication protocol. The communication interface may communicate with the outside world via a network, and the controller may transmit data using a specific communication protocol to any device connected via the communication interface via the communication interface.
[0301] Next, some embodiments of the control module controlling the mixing magnet assembly 110 , the magnetic bead aggregation device 140 , and the transfer device 150 are described.
[0302] In some implementations, the lysed nucleic acid sample can be eluted without drying after washing. In this case, the control module is configured to:
[0303] Controlling the transfer device 150 to transfer the sample container 101 containing the sample and the magnetic bead reagent to the first carrying assembly 120 ;
[0304] Controlling the mixing magnet assembly 110 to mix the magnetic beads in the sample container 101 so that the magnetic beads in the sample container capture nucleic acid;
[0305] Controlling the transfer device 150 to transfer the mixed sample container 101 from the first carrier assembly 120 to the second carrier assembly 141, so that the gathering magnet assembly 142 aggregates the magnetic beads in the mixed sample container, so that after the magnetic beads are aggregated, waste liquid is drawn from the sample container and discharged, and a cleaning solution is injected into the sample container;
[0306] Controlling the transfer device 150 to transfer the sample container 101 injected with the cleaning solution from the second carrying assembly 141 to the first carrying assembly 120 ;
[0307] Controlling the mixing magnet assembly 110 to mix the magnetic beads in the sample container 101 injected with the cleaning solution, so as to clean the nucleic acid captured by the magnetic beads in the sample container;
[0308] Controlling the transfer device 150 to transfer the washed sample container 101 from the first carrier assembly 120 to the second carrier assembly 141, so that the collecting magnet assembly 142 collects the magnetic beads in the washed sample container, so that after the magnetic beads are collected, waste liquid is drawn from the sample container and discharged, and an eluent is injected into the sample container;
[0309] Controlling the transfer device 150 to transfer the sample container 101 injected with the eluent from the second carrying assembly 141 to the first carrying assembly 120;
[0310] The mixing magnet assembly 110 is controlled to mix the magnetic beads in the sample container 101 injected with the eluent, so that the nucleic acid in the sample container is eluted from the magnetic beads.
[0311] In some embodiments, the control module controls the transfer device to transfer the sample container containing the sample and the magnetic bead reagent to the first carrying component, including: the control module controls the transfer device to transfer the sample container containing the sample and the magnetic bead reagent to the lysis capture area.
[0312] In some alternative or additional embodiments, the control module controls the transfer device to transfer the mixed sample container from the first carrying component to the second carrying component, so that the focusing magnet causes the magnetic beads in the mixed sample container to gather, so that after the magnetic beads are gathered, waste liquid is aspirated from the sample container and discharged, and a cleaning liquid is injected into the sample container, including: the control module controls the transfer device to transfer the mixed sample container from the lysis capture area to the first carrying component, so that the focusing magnet causes the magnetic beads in the mixed sample container to gather, and after the magnetic beads are gathered, controls the first suction and discharge mechanism to aspirate waste liquid from the sample container and discharge it, and controls the first injection mechanism to inject a cleaning liquid into the sample container.
[0313] In some alternative or additional embodiments, the control module controls the transfer device to transfer the sample container injected with cleaning liquid from the second carrying component to the first carrying component, including: the control module controls the transfer device to transfer the sample container injected with cleaning liquid from the first carrying part to the washing area.
[0314] In some alternative or additional embodiments, the control module controls the transfer device to transfer the washed sample container from the first carrying component to the second carrying component, so that the focusing magnet causes the magnetic beads in the washed sample container to gather, so that after the magnetic beads are gathered, waste liquid is aspirated from the sample container and discharged, and eluent is injected into the sample container, including: the control module controls the transfer device to transfer the washed sample container from the washing area to the second carrying component, so that the focusing magnet causes the magnetic beads in the washed sample container to gather, and after the magnetic beads are gathered, controls the second suction and discharge mechanism to aspirate waste liquid from the sample container and discharge it, and controls the second injection mechanism to inject eluent into the sample container.
[0315] In some alternative or additional embodiments, the control module controls the transfer device to transfer the sample container injected with eluent from the second carrying component to the first carrying component, including: the control module controls the transfer device to transfer the sample container injected with eluent from the second carrying part to the elution area.
[0316] As another implementation, the lysed nucleic acid sample is washed and dried before being eluted. In this case, the control module is configured as follows:
[0317] Controlling the transfer device 150 to transfer the sample container 101 containing the sample and the magnetic bead reagent to the first carrying assembly 120 ;
[0318] Controlling the mixing magnet assembly 110 to mix the magnetic beads in the sample container 101 so that the magnetic beads in the sample container capture nucleic acid;
[0319] Controlling the transfer device 150 to transfer the mixed sample container 101 from the first carrier assembly 120 to the second carrier assembly 141, so that the gathering magnet assembly 142 aggregates the magnetic beads in the mixed sample container, so that after the magnetic beads are aggregated, waste liquid is drawn from the sample container and discharged, and a cleaning solution is injected into the sample container;
[0320] Controlling the transfer device 150 to transfer the sample container 101 injected with the cleaning solution from the second carrying assembly 141 to the first carrying assembly 120 ;
[0321] Controlling the mixing magnet assembly 110 to mix the magnetic beads in the sample container 101 injected with the cleaning solution, so as to clean the nucleic acid captured by the magnetic beads in the sample container;
[0322] Controlling the transfer device 150 to transfer the cleaned sample container 101 from the first carrier assembly 120 to the second carrier assembly 141, so that the collecting magnet assembly 142 collects the magnetic beads in the cleaned sample container, so that waste liquid is sucked out of the sample container and discharged after the magnetic beads are collected;
[0323] Controlling the transfer device 150 to transfer the sample container 101 from which the waste liquid has been drawn from the second carrying assembly 141 to the first carrying assembly 120 so as to dry the magnetic beads in the sample container;
[0324] Controlling the transfer device 150 to transfer the dried sample container 101 from the first carrying assembly 120 to the second carrying assembly 141 so as to inject the eluent into the sample container;
[0325] Controlling the transfer device 150 to transfer the sample container 101 injected with the eluent from the second carrying assembly 141 to the first carrying assembly 120 ; and
[0326] The mixing magnet assembly 110 is controlled to mix the magnetic beads in the sample container 101 injected with the eluent, so that the nucleic acid in the sample container is eluted from the magnetic beads.
[0327] In some embodiments, the control module controls the transfer device to transfer the sample container containing the sample and the magnetic bead reagent to the first carrying component, including the control module controlling the transfer device to transfer the sample container containing the sample and the magnetic bead reagent to the lysis capture area.
[0328] In some alternative or additional embodiments, the control module controls the transfer device to transfer the mixed sample container from the first carrying component to the second carrying component, so that the focusing magnet causes the magnetic beads in the mixed sample container to gather, so that after the magnetic beads are gathered, waste liquid is aspirated from the sample container and discharged, and a cleaning liquid is injected into the sample container, including: the control module controls the transfer device to transfer the mixed sample container from the lysis capture area to the first carrying component, so that the focusing magnet causes the magnetic beads in the mixed sample container to gather, and after the magnetic beads are gathered, controls the first suction and discharge mechanism to aspirate waste liquid from the sample container and discharge it, and controls the first injection mechanism to inject a cleaning liquid into the sample container.
[0329] In some alternative or additional embodiments, the control module controls the transfer device to transfer the sample container injected with the cleaning liquid from the second carrying assembly to the first carrying assembly, including: the control module controls the transfer device to transfer the sample container injected with the cleaning liquid from the first carrying portion to the washing area; and / or
[0330] In some alternative or additional embodiments, the control module controls the transfer device to transfer the washed sample container from the first carrying component to the second carrying component, so that the focusing magnet causes the magnetic beads in the washed sample container to be gathered, so that waste liquid is sucked from the sample container and discharged after the magnetic beads are gathered, including: the control module controls the transfer device to transfer the washed sample container from the washing area to the second carrying component, so that the focusing magnet causes the magnetic beads in the washed sample container to be gathered, and controls the second suction and discharge mechanism to suck waste liquid from the sample container and discharge it after the magnetic beads are gathered.
[0331] In some alternative or additional embodiments, the control module controls the transfer device to transfer the sample container from which waste liquid has been absorbed from the second carrying component to the first carrying component, including: the control module controls the transfer device to transfer the sample container from which waste liquid has been absorbed from the second carrying component to the drying area, so as to dry the magnetic beads in the sample container.
[0332] In some alternative or additional embodiments, the control module controls the transfer device to transfer the dried sample container from the first carrying component to the second carrying component so as to inject eluent into the sample container, including: the control module controls the transfer device to transfer the dried sample container from the drying area to the third carrying part, and controls the third liquid injection mechanism to inject eluent into the sample container.
[0333] In some alternative or additional embodiments, the control module controls the transfer device to transfer the sample container injected with eluent from the second carrying component to the first carrying component, including: the control module controls the transfer device to transfer the sample container injected with eluent from the third carrying part to the elution area.
[0334] Some different embodiments of the nucleic acid extraction process of the nucleic acid extraction module according to the present application are described below.
[0335] In the first embodiment, the lysed nucleic acid sample can be eluted without drying after being washed once, and the nucleic acid extraction module includes a first auxiliary station and a third auxiliary station.
[0336] Specifically, the first auxiliary station is used to assist in the washing step and includes the first carrier 1411, the first focusing magnet 1421, the first suction and discharge mechanism 143, and the first liquid injection mechanism 144. Driven by the drive device 170, the first carrier assembly 120 can move so that the sample container 101 containing the lysed sample in the lysis capture zone 124 moves to the transfer position T. The transfer device removes the sample container 101 from the first carrier assembly 120 and transfers it to the first auxiliary station. The first focusing magnet 1421 attracts the magnetic beads in the removed sample container 101 at the first auxiliary station, causing the magnetic beads to remain stationary on one side of the sample container 101. After the first focusing magnet 1421 completes magnetic attraction, the first suction and discharge mechanism absorbs the waste liquid in the sample container 101 and discharges it to a designated location. After absorbing the waste liquid, the first liquid injection mechanism injects washing solution into the sample container. After the washing liquid is injected into the sample container, the preliminary preparations for washing have been made. At this time, the first carrying component 120 moves so that an empty receiving portion 121 in the washing area 125 moves to the transfer position T. The transfer device transfers the sample container 101 injected with the washing liquid to the receiving portion 121 for subsequent washing operations.
[0337] The third auxiliary station is used to assist in the elution step and includes the second carrier 1412, the second focusing magnet 1422, the second suction and discharge mechanism 145, and the second liquid injection mechanism 146. Driven by the drive device 170, the first carrier assembly 120 is capable of moving the sample container 101 containing the washed sample in the washing area 125 to the transfer position T. The transfer mechanism then removes the sample container 101 from the first carrier assembly 120 and transfers it to the third auxiliary station. At the third auxiliary station, the second focusing magnet 1422 attracts the magnetic beads from the removed sample container 101, causing the beads to remain stationary on one side of the sample container 101. After the second focusing magnet 1422 completes magnetic attraction, the second suction and discharge mechanism draws waste liquid from the sample container 101 and discharges it to a designated location. The second liquid injection mechanism is used to inject eluent into the sample container after absorbing the waste liquid. After the elution liquid is injected into the sample container, the preliminary preparations for elution have been made. At this time, the first carrying component 120 moves to move an empty receiving part 121 in the elution area 126 to the transfer position T, and the transfer device transfers the sample container 101 injected with the washing liquid to the receiving part 121 for subsequent elution operations.
[0338] In the second embodiment, the lysed nucleic acid sample is washed once and needs to be dried before elution. The nucleic acid extraction module includes a first auxiliary station, a second auxiliary station, and a third auxiliary station.
[0339] Specifically, the first auxiliary station is used to assist in the washing step and includes the first carrier 1411, the first focusing magnet 1421, the first suction and discharge mechanism 143, and the first liquid injection mechanism 144. Driven by the drive device 170, the first carrier assembly 120 can move so that the sample container 101 containing the lysed sample in the lysis capture zone 124 moves to the transfer position T. The transfer device removes the sample container 101 from the first carrier assembly 120 and transfers it to the first auxiliary station. The first focusing magnet 1421 attracts the magnetic beads in the removed sample container 101 at the first auxiliary station, causing the magnetic beads to remain stationary on one side of the sample container 101. After the first focusing magnet 1421 completes magnetic attraction, the first suction and discharge mechanism absorbs the waste liquid in the sample container 101 and discharges it to a designated location. After absorbing the waste liquid, the first liquid injection mechanism injects washing solution into the sample container. After the washing liquid is injected into the sample container, the preliminary preparations for washing have been made. At this time, the first carrying component 120 moves to move an empty receiving portion 121 in the washing area 125 to the transfer position T. The transfer device transfers the sample container 101 injected with the washing liquid to the receiving portion 121 for subsequent washing operations.
[0340] The second auxiliary station, which assists in the drying step, includes the aforementioned second focusing magnet assembly 1421 and the aforementioned second suction and discharge mechanism 145. Driven by the drive device 170, the first carrier assembly 120 moves the sample container 101 containing the washed sample in the washing zone 125 to a transfer position T. The transfer mechanism removes the sample container 101 from the first carrier assembly 120 and transfers it to the second auxiliary station. The second focusing magnet at the second auxiliary station attracts the magnetic beads in the removed sample container 101, causing them to rest on one side of the sample container 101. After the second focusing magnet completes magnetic attraction, the second suction and discharge mechanism draws waste liquid from the sample container 101 and discharges it to a designated location. At this point, the sample container 101 is ready for drying. The first carrier assembly 120 moves an empty receptacle 121 in the drying zone 127 to a loaded transfer position T. The transfer mechanism then transfers the sample container 101, after the waste liquid has been absorbed, to an empty receptacle 121 in the drying zone 127 for subsequent drying operations.
[0341] The third auxiliary station is used to assist in the elution step, and includes the above-mentioned third carrier 1413 and the above-mentioned second liquid injection mechanism 146. Driven by the driving device 170, the first carrier assembly 120 can move so that the sample container 101 containing the dried sample in the drying area 127 moves to the transfer position T. The transfer device moves the sample container 101 out of the first carrier assembly 120 and transfers it to the third auxiliary station. The second liquid injection mechanism injects eluent into the sample container. After the eluent is injected into the sample container, the preliminary preparations for elution have been made. At this time, the first carrier assembly 120 moves so that an empty receiving part 121 in the elution area 126 moves to the transfer position T. The transfer device transfers the sample container 101 injected with the eluent to the receiving part 121 for subsequent elution operations.
[0342] In the third embodiment, the lysed nucleic acid sample can be eluted without drying after secondary washing, and the extraction module includes a first auxiliary station, a third auxiliary station, and a fourth auxiliary station.
[0343] Specifically, the first auxiliary station is used to assist in the first washing step and includes the first carrier 1411, the first focusing magnet 1421, the first suction and discharge mechanism 143, and the first liquid injection mechanism 144. Driven by the drive device 170, the first carrier assembly 120 can move so that the sample container 101 containing the lysed sample in the lysis capture zone 124 moves to the transfer position T. The transfer device removes the sample container 101 from the first carrier assembly 120 and transfers it to the first auxiliary station. The first focusing magnet 1421 at the first auxiliary station attracts the magnetic beads in the removed sample container 101, causing the magnetic beads to remain stationary on one side of the sample container 101. After the first focusing magnet completes magnetic attraction, the first suction and discharge mechanism absorbs the waste liquid in the sample container 101 and discharges it to a designated location. The first liquid injection device is used to inject the first washing solution into the sample container after absorbing the waste liquid. After the first washing liquid is injected into the sample container, preliminary preparations for the first washing have been made. At this time, the first carrying component 120 moves so that an empty receiving portion 121 in the washing area 125 moves to the transfer position T. The transfer device transfers the sample container 101 injected with the first washing liquid to the receiving portion 121 for subsequent washing operations.
[0344] The fourth auxiliary station is used to assist in the second washing step and includes another first carrier 1411, another first focusing magnet 1421, another first suction and discharge mechanism 143, and another first liquid injection mechanism 144. Driven by the drive device 170, the first carrier assembly 120 is capable of moving so that the sample container 101 containing the sample that has completed the first wash in the washing area 125 is moved to the transfer position T. The transfer device removes the sample container 101 from the first carrier assembly 120 and transfers it to the fourth auxiliary station. At the fourth auxiliary station, another first focusing magnet attracts the magnetic beads in the removed sample container 101, causing the magnetic beads to remain stationary on one side of the sample container 101. After the other first focusing magnet completes magnetic attraction, the other first suction and discharge mechanism aspirates the waste liquid in the sample container 101 and discharges it to a designated location. The other first liquid injection device is used to inject the second washing solution into the sample container after aspirating the waste liquid. After the second washing liquid is injected into the sample container, preliminary preparations for the second washing have been made. At this time, the first carrying component 120 moves to move an empty receiving portion 121 in the washing area 125 to the transfer position T. The transfer device transfers the sample container 101 injected with the second washing liquid to the receiving portion 121 for the subsequent second washing operation.
[0345] The third auxiliary station is used to assist in the elution step and includes the second carrier 1412, the second focusing magnet 1422, the second suction and discharge mechanism 145, and the second liquid injection mechanism 146. Driven by the drive device 170, the first carrier assembly 120 is capable of moving the sample container 101 containing the sample that has completed the second wash in the washing area 125 to the transfer position T. The transfer mechanism removes the sample container 101 from the first carrier assembly 120 and transfers it to the third auxiliary station. At the third auxiliary station, the second focusing magnet 1422 attracts the magnetic beads in the removed sample container 101, causing the beads to remain stationary on one side of the sample container 101. After the second focusing magnet 1422 completes magnetic attraction, the second suction and discharge mechanism draws waste liquid from the sample container 101 and discharges it to a designated location. The second liquid injection mechanism is used to inject eluent into the sample container after absorbing the waste liquid. After the elution liquid is injected into the sample container, the preliminary preparations for elution have been made. At this time, the first carrying component 120 moves to move an empty receiving part 121 in the elution area 126 to the transfer position T, and the transfer device transfers the sample container 101 injected with the washing liquid to the receiving part 121 for subsequent elution operations.
[0346] In the fourth embodiment, the lysed nucleic acid sample is washed twice and needs to be dried before elution. The nucleic acid extraction module includes a first auxiliary station, a second auxiliary station, a third auxiliary station and a fourth auxiliary station.
[0347] Specifically, the first auxiliary station is used to assist in the first washing step and includes the first carrier 1411, the first focusing magnet 1421, the first suction and discharge mechanism 143, and the first liquid injection mechanism 144. Driven by the drive device 170, the first carrier assembly 120 can move so that the sample container 101 containing the lysed sample in the lysis capture zone 124 moves to the transfer position. The transfer device removes the sample container 101 from the first carrier assembly 120 and transfers it to the first auxiliary station. The first focusing magnet 1421 absorbs the magnetic beads in the removed sample container 101 at the first auxiliary station, causing the magnetic beads to remain stationary on one side of the sample container 101. After the first focusing magnet completes magnetic attraction, the first suction and discharge mechanism absorbs the waste liquid in the sample container 101 and discharges it to a designated location. The first liquid injection device is used to inject the first washing liquid into the sample container after absorbing the waste liquid. After the first washing liquid is injected into the sample container, preliminary preparations for the first washing have been made. At this time, the first carrying component 120 moves so that an empty receiving portion 121 in the washing area 125 moves to the transfer position, and the transfer device transfers the sample container 101 injected with the first washing liquid to the receiving portion 121 for subsequent washing operations.
[0348] The fourth auxiliary station is used to assist in the second washing step and includes another of the aforementioned first carriers 1411, another of the aforementioned first focusing magnets 1421, another of the aforementioned first suction and discharge mechanisms 143, and another of the aforementioned first liquid injection mechanisms 84. Driven by the drive device 170, the first carrier assembly 120 is capable of movement, causing the sample container 101 containing the sample that has completed the first wash in the washing area 125 to move to a transfer position. The transfer device removes the sample container 101 from the first carrier assembly 120 and transfers it to the fourth auxiliary station. At the fourth auxiliary station, another of the first focusing magnets attracts the magnetic beads from the removed sample container 101, causing the beads to remain stationary on one side of the sample container 101. After the other of the first focusing magnets completes magnetic attraction, the other of the first suction and discharge mechanisms absorbs the waste liquid in the sample container 101 and discharges it to a designated location. The other of the first liquid injection devices is used to inject the second washing solution into the sample container after absorbing the waste liquid. After the second washing liquid is injected into the sample container, preliminary preparations for the second washing have been made. At this time, the first carrying component 120 moves to move an empty receiving portion 121 in the washing area 125 to the transfer position, and the transfer device transfers the sample container 101 injected with the second washing liquid to the receiving portion 121 for the subsequent second washing operation.
[0349] The second auxiliary station, which assists in the drying step, includes the aforementioned second focusing magnet assembly 1421 and the aforementioned second suction and discharge mechanism 145. Driven by the drive device 170, the first carrier assembly 120 moves the sample container 101 containing the sample that has completed the second wash in the washing zone 125 to a transfer position T. The transfer mechanism removes the sample container 101 from the first carrier assembly 120 and transfers it to the second auxiliary station. The second focusing magnet at the second auxiliary station attracts the magnetic beads in the removed sample container 101, causing them to rest on one side of the sample container 101. After the second focusing magnet completes magnetic attraction, the second suction and discharge mechanism draws waste liquid from the sample container 101 and discharges it to a designated location. At this point, the sample container 101 is ready for drying. The first carrier assembly 120 moves an empty receptacle 121 in the drying zone 127 to a loading position T. The transfer mechanism then transfers the sample container 101, after the waste liquid has been absorbed, to an empty receptacle 121 in the drying zone 127 for subsequent drying operations.
[0350] The third auxiliary station is used to assist in the elution step, and includes the above-mentioned third carrier 1413 and the above-mentioned second elution injection mechanism 86. Driven by the driving device 170, the first carrier assembly 120 can move so that the sample container 101 containing the dried sample in the drying area 127 moves to the transfer position T. The transfer device moves the sample container 101 out of the first carrier assembly 120 and transfers it to the third auxiliary station. The second injection mechanism injects eluent into the sample container. After the eluent is injected into the sample container, the preliminary preparations for elution have been made. At this time, the first carrier assembly 120 moves so that an empty receiving part 121 in the elution area 126 moves to the transfer position T. The transfer device transfers the sample container 101 injected with the eluent to the receiving part 121 for subsequent elution operations.
[0351] Accordingly, as shown in FIG35 , the embodiment of the present application further provides a nucleic acid extraction method 1000, comprising:
[0352] Capturing step S1100: transferring a sample container containing a sample containing nucleic acid and magnetic beads for adsorbing nucleic acid to a first carrier assembly of a magnetic bead mixing device, so that a mixing magnet assembly mixes the magnetic beads in the sample container on the first carrier assembly, so that the magnetic beads in the sample container capture nucleic acid;
[0353] First magnetic bead aggregation step S1200: transferring the mixed sample container from the first carrying assembly to a second carrying assembly of a magnetic bead aggregation device provided separately from the magnetic bead mixing device, so that the aggregation magnet of the magnetic bead aggregation device aggregates the magnetic beads in the mixed sample container, so that after the magnetic beads are aggregated, waste liquid is drawn from the sample container and discharged, and a cleaning solution is injected into the sample container;
[0354] Washing step: S1300: The sample container injected with the washing liquid is transferred from the second carrier assembly to the first carrier assembly, so that the mixing magnet assembly mixes the magnetic beads in the sample container injected with the washing liquid to wash the nucleic acid captured by the magnetic beads in the sample container;
[0355] Second magnetic bead aggregation step S1400: transferring the washed sample container from the first carrying assembly to the second carrying assembly, so that the aggregation magnet aggregates the magnetic beads in the washed sample container, so that after the magnetic beads are aggregated, waste liquid is aspirated from the sample container and discharged, and eluent is injected into the sample container;
[0356] Elution step S1101: Transfer the sample container injected with the eluent from the second carrier assembly to the first carrier assembly, so that the mixing magnet assembly mixes the magnetic beads in the sample container injected with the eluent to elute the nucleic acid in the sample container from the magnetic beads.
[0357] As shown in FIG36 , the present application also provides another nucleic acid extraction method 2000 including:
[0358] Capturing step S2100: transferring the sample containing the nucleic acid and the sample container for adsorbing magnetic beads to the first supporting component of the magnetic bead mixing device, so that the mixing magnet assembly mixes the magnetic beads in the sample container on the first supporting component, so that the magnetic beads in the sample container capture the nucleic acid;
[0359] First magnetic bead aggregation step S2200: transferring the mixed sample container from the first carrying assembly to a second carrying assembly of a magnetic bead aggregation device provided separately from the magnetic bead mixing device, so that the aggregation magnet of the magnetic bead aggregation device aggregates the magnetic beads in the mixed sample container, so that after the magnetic beads are aggregated, waste liquid is drawn from the sample container and discharged, and a cleaning solution is injected into the sample container;
[0360] Washing step S2300: transferring the sample container injected with the washing liquid from the second carrying assembly to the first carrying assembly, so that the mixing magnet assembly mixes the magnetic beads in the sample container injected with the washing liquid, thereby washing the nucleic acid captured by the magnetic beads in the sample container;
[0361] Second magnetic bead aggregation step S2400: transferring the washed sample container from the first carrying assembly to the second carrying assembly, so that the aggregation magnet aggregates the magnetic beads in the washed sample container, so that waste liquid can be drawn from the sample container and discharged after the magnetic beads have aggregated;
[0362] Drying step S2101: transferring the sample container from which the waste liquid has been drawn from the second carrying assembly to the first carrying assembly, so as to dry the magnetic beads in the sample container;
[0363] Eluent injection step S2600: transferring the dried sample container from the first carrying assembly to the second carrying assembly so as to inject eluent into the sample container;
[0364] Elution step S2700: Transfer the sample container injected with the eluent from the second carrier assembly to the first carrier assembly, so that the mixing magnet assembly mixes the magnetic beads in the sample container injected with the eluent to elute the nucleic acid in the sample container from the magnetic beads.
[0365] In some embodiments, the first magnetic bead aggregation step S1200 / S2200 and the washing step S1300 / S2300 include:
[0366] A first magnetic bead aggregation sub-step: transferring the mixed sample container from the first carrying assembly to the second carrying assembly, so that the aggregation magnet aggregates the magnetic beads in the mixed sample container, so that after the magnetic beads are aggregated, waste liquid is drawn from the sample container and discharged, and a first washing liquid is injected into the sample container;
[0367] A first washing sub-step: transferring the sample container injected with the first washing liquid from the second carrying assembly to the first carrying assembly, so that the mixing magnet assembly mixes the magnetic beads in the sample container injected with the first washing liquid, thereby washing the nucleic acid captured by the magnetic beads in the sample container;
[0368] A second magnetic bead aggregation sub-step: transferring the sample container that has undergone the first wash from the first carrying component to the second carrying component, so that the aggregation magnet aggregates the magnetic beads in the sample container that has undergone the first wash, so that after the magnetic beads are aggregated, waste liquid is sucked out of the sample container and discharged, and a second washing liquid is injected into the sample container; and
[0369] The second washing sub-step: the sample container injected with the second washing liquid is transferred from the second carrying component to the first carrying component, so that the mixing magnet component mixes the magnetic beads in the sample container injected with the second washing liquid to wash the nucleic acid captured by the magnetic beads in the sample container.
[0370] Specifically, some embodiments of the present application disclose a nucleic acid extraction method, which uses a nucleic acid extraction module, which includes a first carrier component 120 and a heating device 160, wherein the first carrier component 120 is used to provide an operating area for performing the aforementioned lysis, washing and elution steps, and the heating device 160 is used to heat the sample.
[0371] The first carrier assembly 120 comprises at least a lysis and capture zone 124, a wash zone 125, and an elution zone 126. These zones are integrated into a single component, such as the incubation tray shown. Each of the lysis and capture zone 124, the wash zone 125, and the elution zone 126 is provided with a receiving portion 121 for receiving a sample container 101 containing a sample and magnetic beads.
[0372] The heating device 160 is at least used to heat the samples in the lysis capture zone 124 and the elution zone 126. In some embodiments, it has at least a first heating zone 161 and a second heating zone 162. The first heating zone 161 is set corresponding to the lysis capture zone 124 and is used to heat the samples in the lysis capture zone 124. The second heating zone 162 is set corresponding to the elution zone 126 and is used to heat the samples in the elution zone 126.
[0373] It should be noted that the extraction module using the extraction method of this embodiment can be used as a separate extraction device or integrated into the sample analyzers of the aforementioned embodiments. For example, the sample analyzer includes an amplification module and a detection module, and the extraction module also includes a mixing magnet assembly 110, a driving device 170 and a transfer device. The mixing magnet assembly 110 is used to mix the magnetic beads in the sample container, the driving device 170 is used to drive the first carrier assembly 120 to move, and the transfer device is used to transfer the sample container 101.
[0374] The transfer device is used to transfer the sample container 101, which can cooperate with the movement of the first carrying component 120 to realize the scheduling of the sample container 101 between different receiving parts 121. For example, the transfer device includes one or more transfer components arranged adjacent to the first carrying component 120. The first carrying component 120 can align a certain receiving part 121 storing the sample container 101 with a certain transfer component through movement. The transfer component takes out the sample container 101 from the receiving part 121, and then the first carrying component 120 moves so that other receiving parts 121 are aligned with the transfer component, and the transfer component then places the sample container 101 into the new receiving part 121. It can be understood that the transfer device can also realize the scheduling of the sample container 101 between the first carrying component 120 and the device therein. The transfer component can be a manipulator that can move and / or rotate in a set direction. Based on the above structure, referring to Figure 37, the sample extraction method includes the following steps:
[0375] Step S100: Perform a lysis step of the sample to be lysed in the lysis capture zone 124. Specifically, the lysis system construction can be completed at other devices in the previous step, for example, adding lysis solution into the sample container, and transferring the sample container with the lysis solution to the empty receiving part 121 of the lysis capture zone 124, and heating the sample container 101 to be lysed in the lysis capture zone 124 by the heating device 160.
[0376] Step S200: After the lysis step is completed, a first auxiliary step is performed to assist in the subsequent washing process. The first auxiliary step includes magnetically adsorbing the magnetic beads in the sample container 101, sucking the waste liquid in the sample container 101 after the magnetic beads are adsorbed and discharging the waste liquid, and injecting the washing liquid after sucking the waste liquid.
[0377] Step S300 : After the first auxiliary step is completed, a washing step of the sample to be washed is performed in the washing area 125 .
[0378] Step S400: After the washing step is completed, a second auxiliary step is performed, which includes magnetically adsorbing the magnetic beads in the sample container, and sucking and discharging the waste liquid in the sample container after the magnetic beads are adsorbed;
[0379] Step S101: After the second auxiliary step is completed, the third auxiliary step is performed, which includes injecting eluent into the sample container;
[0380] Step 600: After the third auxiliary step is completed, the elution step of the sample to be eluted is performed in the elution zone.
[0381] In this embodiment, a lysis capture zone 124, a washing zone 125 and an elution zone 126 are provided on the first carrier component 120, so that the lysis, washing and elution steps can be integrated on the first carrier component 120, which helps to reduce the volume of the sample analyzer.
[0382] In some embodiments, the time of the cracking step is defined as t1, the time of the washing step is t2, the time of the elution step is t3, and the time of the first auxiliary step, the second auxiliary step and the third auxiliary step is set to be equal, defined as t0, wherein t1, t2, and t3 are all set to integer multiples of t0. That is, this embodiment unifies the time spent on each auxiliary step and uses it as the minimum unit to plan the time consumed by the cracking, washing, drying and other links, thereby facilitating the controller to record the start and end time of each link, simplifying the timing design of the first carrier component 120, and thus reducing the overall control difficulty.
[0383] It should be noted that t1, t2, and t3 may be equal or different.
[0384] It should also be noted that the operations required to be performed in the first auxiliary step, the second auxiliary step and the third auxiliary step are the same. In order to unify the time, the auxiliary step that consumes the longest time can be used as the basic planning t0. After the operations in other auxiliary steps are completed, you can wait for the preset time so that the total time reaches t0.
[0385] In some embodiments, the lysed sample needs to be washed twice. Based on this, for ease of description, the washing solution injected in the first auxiliary step is named the first washing solution. Referring to FIG. 38 , the washing step S300 includes:
[0386] S161 : After the first auxiliary step is completed, a first washing sub-step of washing the sample to be washed is performed in the washing area 125 using a first washing solution.
[0387] S162: After the first washing sub-step is completed, the fourth auxiliary step is performed. The fourth auxiliary step includes magnetically adsorbing the magnetic beads in the sample container 101, sucking and discharging the waste liquid in the sample container 101 after the magnetic beads are adsorbed, and injecting the second washing liquid after the waste liquid is sucked and discharged.
[0388] S163: After the fourth auxiliary step is completed, a second washing sub-step of washing the sample to be washed is performed in the washing area 125 using a second washing solution.
[0389] When a sample requires two washes, in some embodiments, the time for the first wash sub-step is defined as t21, the time for the second wash sub-step is defined as t22, and the time for the fourth auxiliary step is defined as t0, where t21 and t22 are both set to integer multiples of t0. Similarly, this embodiment unifies the time spent on each auxiliary step and uses it as the minimum unit to plan the time consumed by the lysis, washing, drying and other steps. This facilitates the controller to record the start and end time of each step, simplifies the timing design of the first carrier assembly 120, and thus reduces the overall control difficulty.
[0390] In some embodiments, each auxiliary step also includes the step of transferring the sample container 101. Specifically, the first auxiliary step also includes: moving the sample container 101 out of the first carrier component 120 and transferring it to the first operating position through a transfer device, and performing magnetic suction, waste liquid suction and discharge, and washing liquid injection operations at the first operating position. The sample container 101 injected with the washing liquid is then moved into the washing area 125 of the first carrier component 120 through the transfer device.
[0391] The second auxiliary step also includes: moving the sample container 101 out of the first carrying component 120 and transferring it to the second operating position through the transfer device, and performing magnetic suction and waste liquid suction and discharge operations at the second operating position. After suction and discharge of the waste liquid, the sample container 101 is moved into the empty receiving part 121 of the first carrying component 120. In some embodiments, the sample container 101 is preferentially moved into the empty receiving part 121 closest to the second operating position. In other embodiments, the sample container is preferentially moved into the empty receiving part 121 in the drying area 127.
[0392] The third auxiliary step also includes: moving the sample container 101 out of the first carrier component 120 and transferring it to the third operating position through the transfer device, and injecting eluent at the third operating position. After the eluent is injected, the sample container 101 is moved into the elution area 126 of the first carrier component 120 through the transfer device.
[0393] In this embodiment, a transfer device is provided to move the sample container 101 that needs to undergo an auxiliary step out of the first carrier assembly 120. Therefore, the first carrier assembly 120 can perform other operations while the sample container 101 undergoes an auxiliary step, thereby enabling the dispatch of different sample containers 101. In addition, because the first carrier assembly 120 can transport the sample container 101 to different locations, the transfer device can be relatively fixed and only needs to perform fixed actions, which can simplify the control of the transfer device.
[0394] It should be noted that, as mentioned above, in some embodiments, each auxiliary station is provided with a corresponding independent transfer component, and in other embodiments, at least two auxiliary stations share one transfer component to reduce costs.
[0395] It should also be noted that if the sample does not need to be dried, the second operating position and the third operating position can be the same operating position, that is, after completing the second auxiliary step, the third auxiliary step is performed directly at the same operating position, thereby eliminating the step of transferring the first carrier component 120 in and out between the second auxiliary step and the third auxiliary step, which can improve efficiency.
[0396] In some embodiments, the sample needs to be dried after washing before elution. The first carrier component 120 of the corresponding sample analyzer also has a drying area 127, and the drying area 127 has a receiving portion 121. The heating device 160 also has a third heating area 163. The third heating area 163 is used to heat the sample in the drying area 127. The drying area 127 and the third heating area 163 can be understood with reference to the aforementioned embodiments and will not be described in detail here. The sample extraction method also includes a drying step. Referring to Figures 10 and 11, after the second auxiliary step is completed, the drying step of the sample to be washed is performed in the drying area 127. After the drying step is completed, the third auxiliary step is performed. For example, when the sample is washed and the waste liquid in the sample container 101 is sucked and discharged, the sample container is moved into the vacant receiving portion 121 of the drying area 127 by a transfer device. After the drying is completed, the sample container 101 is moved into the third operating position by a transfer device.
[0397] It should be noted that the sample container 101 in this embodiment is not limited to the extraction tube of the aforementioned embodiment. It can be selected as another sample container depending on the incubation sample. Accordingly, the definition of the receiving portion 121 is also adjusted accordingly. Similarly, the function and number of functional areas can also be adjusted according to the incubation requirements of different samples.
[0398] In a second aspect, the present application provides another molecular diagnostic analyzer, comprising a nucleic acid extraction module 100, an amplification module 200, and a detection module 300. The nucleic acid extraction module 100 is configured to extract nucleic acid from a sample, the amplification module 200 is configured to amplify the nucleic acid extracted by the extraction module, and the detection module 300 is configured to detect the amplified nucleic acid.
[0399] The nucleic acid extraction module 100 includes a magnetic bead mixing device and a driving device. The magnetic bead mixing device includes a first carrying component 110 and a mixing magnet component 120. The first carrying component is configured to place a sample container containing a reaction liquid. The reaction liquid includes a sample containing nucleic acid and magnetic beads for adsorbing nucleic acid. The mixing magnet component 110 includes a movable magnet bracket 113 and a plurality of magnets fixed on the magnet bracket. The driving device 130 is configured to drive the magnet bracket 113 to move, so as to drive the plurality of magnets fixed on the magnet bracket 113 to move relative to the sample container on the first carrying component 120, so that the magnetic beads in the sample container placed on the first carrying component 110 perform three-dimensional movement in the reaction liquid under the action of the moving magnet, especially so that the magnetic beads in the sample container traverse the entire reaction liquid under the action of the moving magnet and perform a circulating motion in the reaction liquid.
[0400] Here, the magnetic bead mixing device of the nucleic acid extraction module 100 according to the above embodiment can be used to move the magnetic beads in the sample container in the reaction solution in at least one of the lysis and capture step, the washing step, and the elution step to achieve magnetic bead mixing. For example, the magnetic bead mixing device of the nucleic acid extraction module 100 according to the above embodiment can be used to move the magnetic beads in the sample container in the reaction solution in the lysis and capture step, or alternatively or additionally used to move the magnetic beads in the sample container in the reaction solution in the washing step and / or the elution step, or only used in the nucleic acid washing or elution step.
[0401] In some embodiments, the driving device 130 is configured to drive the magnet holder 113 to move, so that the magnetic beads in the sample container placed on the first carrier assembly 110 experience the alternating magnetic field generated by the multiple magnets.
[0402] Furthermore, at least two magnets among the plurality of magnets are fixed on the magnet bracket at different heights.
[0403] In some embodiments, the first carrier assembly 120 is configured as a rotatable first disk, and the magnet holder 113 is configured as a rotatable second disk, with the first disk and the second disk being concentrically disposed. Preferably, the second disk is configured to rotate synchronously with the first disk and independently of the first disk. For example, the second disk is rotatably fixedly connected to the first disk, such that rotation of the first disk synchronously drives rotation of the second disk, and the second disk can rotate independently of the first disk.
[0404] In some embodiments, the first carrier assembly 120 includes a lysis capture zone, a wash zone, and an elution zone. In this case, the mixing magnet assembly 110 is further configured to: move the magnetic beads in the sample container in the lysis capture zone to achieve nucleic acid adsorption by the magnetic beads, move the magnetic beads in the sample container in the wash zone to wash the nucleic acid adsorbed by the magnetic beads, and move the magnetic beads in the sample container in the elution zone to elute the nucleic acid from the magnetic beads.
[0405] It is preferred here that the mixing magnet assembly 110 is also configured so that the magnetic field it generates can at least cover the lysis capture zone, the washing zone and the elution zone, so that the magnetic beads in the sample containers placed on the lysis capture zone, the washing zone and the elution zone can be moved at the same time.
[0406] In some embodiments, the nucleic acid extraction module 100 further includes a transfer device 150 and a magnetic bead aggregation device 140. The magnetic bead aggregation device 140 includes a second carrier assembly 141 and a focusing magnet assembly 142. The second carrier assembly 141 is used to place a sample container containing a sample liquid, and the focusing magnet assembly 142 is used to aggregate the magnetic beads in the sample container.
[0407] The transfer device 150 is configured to transfer sample containers between the first carrier assembly and the second carrier assembly.
[0408] Preferably, the magnetic bead collecting device 140 is arranged above the first supporting component 120 .
[0409] In other embodiments, the molecular diagnostic analyzer further comprises a frame, and the nucleic acid extraction module, the amplification module, and the detection module are mounted on the frame.
[0410] For more embodiments and advantages of the molecular diagnostic analyzer of the second aspect of the present application, reference can be made to the above description of the molecular diagnostic analyzer of the first aspect of the present application, which will not be repeated here.
[0411] In a third aspect, the present application provides another molecular diagnostic analyzer, comprising a nucleic acid extraction module 100, an amplification module 200, and a detection module 300. The nucleic acid extraction module 100 is configured to extract nucleic acid from a sample, the amplification module 200 is configured to amplify the nucleic acid extracted by the extraction module, and the detection module 300 is configured to detect the amplified nucleic acid.
[0412] The nucleic acid extraction module 100 includes a magnetic bead mixing device and a driving device 130. The magnetic bead mixing device includes a first carrying component 110 and a mixing magnet component 120. The first carrying component 120 is configured to place a sample container containing a reaction liquid. The reaction liquid includes a sample containing nucleic acid and magnetic beads for adsorbing nucleic acid. The mixing magnet component 110 is configured to generate a magnetic field. The driving device 130 is configured to drive the first carrying component and the mixing magnet component to move relative to each other, so that the mixing magnet component generates an alternating magnetic field relative to the sample container on the first carrying component, so that the magnetic beads in the sample container can perform three-dimensional movement in the reaction liquid under the action of the alternating magnetic field.
[0413] Here, the magnetic bead mixing device of the nucleic acid extraction module 100 according to the above embodiment can be used to move the magnetic beads in the sample container in the reaction solution in at least one of the lysis and capture step, the washing step, and the elution step to achieve magnetic bead mixing. For example, the magnetic bead mixing device of the nucleic acid extraction module 100 according to the above embodiment can be used to move the magnetic beads in the sample container in the reaction solution in the lysis and capture step, or alternatively or additionally used to move the magnetic beads in the sample container in the reaction solution in the washing step and / or the elution step, or only used in the nucleic acid washing or elution step.
[0414] In some embodiments, the mixing magnet assembly 110 includes a movable magnet holder 113 and a plurality of magnets fixed to the magnet holder. A drive device 130 is configured to drive the magnet holder to achieve relative movement between the first carrier assembly and the mixing magnet assembly. Preferably, the magnetic beads in the sample container circulate in the reaction solution under the action of the alternating magnetic field.
[0415] Furthermore, at least two magnets among the plurality of magnets are fixed on the magnet bracket at different heights.
[0416] In some embodiments, the first carrier assembly 120 is configured as a rotatable first disk, and the magnet holder 113 is configured as a rotatable second disk, with the first disk and the second disk being concentrically disposed. Preferably, the second disk is configured to rotate synchronously with the first disk and independently of the first disk. For example, the second disk is rotatably fixedly connected to the first disk, such that rotation of the first disk synchronously drives rotation of the second disk, and the second disk can rotate independently of the first disk.
[0417] In some embodiments, the first carrier assembly 120 includes a lysis capture zone, a wash zone, and an elution zone. In this case, the mixing magnet assembly 110 is further configured to: move the magnetic beads in the sample container in the lysis capture zone to achieve nucleic acid adsorption by the magnetic beads, move the magnetic beads in the sample container in the wash zone to wash the nucleic acid adsorbed by the magnetic beads, and move the magnetic beads in the sample container in the elution zone to elute the nucleic acid from the magnetic beads.
[0418] It is preferred here that the mixing magnet assembly 110 is also configured so that the magnetic field it generates can at least cover the lysis capture zone, the washing zone and the elution zone, so that the magnetic beads in the sample containers placed on the lysis capture zone, the washing zone and the elution zone can be moved at the same time.
[0419] In some embodiments, the nucleic acid extraction module 100 further includes a transfer device 150 and a magnetic bead aggregation device 140. The magnetic bead aggregation device 140 includes a second carrier assembly 141 and a focusing magnet assembly 142. The second carrier assembly 141 is used to place a sample container containing a sample liquid, and the focusing magnet assembly 142 is used to aggregate the magnetic beads in the sample container.
[0420] The transfer device 150 is configured to transfer sample containers between the first carrier assembly and the second carrier assembly.
[0421] Preferably, the magnetic bead collecting device 140 is arranged above the first supporting component 120 .
[0422] In other embodiments, the molecular diagnostic analyzer further comprises a frame, and the nucleic acid extraction module, the amplification module, and the detection module are mounted on the frame.
[0423] For more embodiments and advantages of the molecular diagnostic analyzer of the third aspect of the present application, reference can be made to the above description of the molecular diagnostic analyzers of the first and second aspects of the present application, which will not be repeated here.
[0424] In a fourth aspect, the present application provides another molecular diagnostic analyzer, comprising a nucleic acid extraction module 100, an amplification module 200, and a detection module 300. The nucleic acid extraction module 100 is configured to extract nucleic acid from a sample, the amplification module 200 is configured to amplify the nucleic acid extracted by the extraction module, and the detection module 300 is configured to detect the amplified nucleic acid.
[0425] Here, the nucleic acid extraction module 100 includes: a first carrier component 120, the first carrier component is configured to place a sample container containing a reaction liquid, the reaction liquid includes a sample containing nucleic acid and magnetic beads for adsorbing nucleic acid, and the first carrier component includes at least a lysis capture zone 124, the sample container undergoes a lysis capture link in the lysis capture zone, in which the cells in the sample of the sample container are lysed to release nucleic acid, and the released nucleic acid is captured by the magnetic beads in the sample container; a mixing magnet assembly 110, the mixing magnet assembly is configured to generate a magnetic field that at least covers the lysis capture zone; and a driving device 130, the driving device is configured to drive the first carrier component and the mixing magnet assembly to move relative to each other, so that the magnetic beads in the sample container in the lysis capture zone move, so that the magnetic beads capture the released nucleic acid.
[0426] For more embodiments and advantages of the molecular diagnostic analyzer of the fourth aspect of the present application, reference can be made to the above descriptions of the molecular diagnostic analyzers of the first to third aspects of the present application, which will not be repeated here.
[0427] In a fifth aspect, the present application provides another molecular diagnostic analyzer, comprising a nucleic acid extraction module 100, an amplification module 200, and a detection module 300. The nucleic acid extraction module 100 is configured to perform a lysis capture step, a washing step, and an elution step on a sample contained in a sample container to extract nucleic acids from the sample, wherein, in the lysis capture step, cells in the sample in the sample container are lysed to release nucleic acids, and the released nucleic acids are captured by magnetic beads in the sample container. The amplification module 200 is configured to amplify the nucleic acids extracted by the extraction module, and the detection module 300 is configured to detect the amplified nucleic acids.
[0428] The molecular diagnostic analyzer also includes a frame, on which the nucleic acid extraction module, the amplification module and the detection module are installed.
[0429] The nucleic acid extraction module includes a first mixing component and a second mixing component. The first mixing component and the second mixing component are configured to mix the sample container based on different mixing methods to release the nucleic acid in the sample and / or to allow the magnetic beads to capture the released nucleic acid. The first mixing component mixes the sample container based on a magnetic field, and the second mixing component mixes the sample container based on a non-magnetic field.
[0430] The molecular diagnostic analyzer further includes: a mode selection module for selecting the first lysis capture mode or the second lysis capture mode; and a control module configured to:
[0431] When the first lysis capture mode is selected by the mode selection module, in the lysis capture link, only the first mixing component is controlled to perform a mixing operation on the sample container based on the magnetic field, or only the second mixing component is controlled to perform a mixing operation on the sample container, and
[0432] When the second lysis and capture mode is selected by the mode selection module, in the lysis and capture link, the first mixing component and the second mixing component are controlled to perform a mixing operation on the sample container. For example, the second mixing component is first controlled to perform a first mixing operation on the sample container, and after the first mixing operation, the sample container is allowed to stand for a period of time, and then the first mixing component is controlled to perform a second mixing operation based on a magnetic field on the sample container.
[0433] By setting different lysis capture modes, it is possible to match the different lysis requirements of different samples.
[0434] For example, when the sample requires strong lysis, the magnetic beads in the container need to be mixed more vigorously, and the second lysis capture mode can be selected. When the sample requires less lysis, the first lysis capture mode can be selected.
[0435] In some embodiments, the first mixing assembly is configured according to one of the embodiments of the mixing magnet assembly 110 described above.
[0436] In some embodiments, the second mixing component mixes the magnetic beads in the sample container by pipetting, shaking, vortexing or ultrasound.
[0437] In some embodiments, the mode selection module may be a user interaction interface.
[0438] It should be noted that the lysis and capture process includes a lysis phase and a capture phase. The lysis phase involves lysing cells in a sample container to release nucleic acids, for example, by disrupting the cells with a lysis solution. The capture phase involves capturing nucleic acids with magnetic beads in the sample container. It should be understood that for the same sample container, the lysis and capture phases can be completed in the same timeframe or in separate timeframes.
[0439] For example, for the same sample container, a lysis solution is added to the sample container and then a magnetic field-based mixing operation is performed on the sample container after the lysis solution is added, so as to simultaneously perform cell lysis and nucleic acid capture in the sample container.
[0440] For another example, for the same sample container, a lysis solution is first added to the sample container and, optionally, after the lysis solution is added, the sample container is mixed using a mixing method different from a magnetic field to perform cell lysis; after the cell lysis is completed, the sample container is mixed using a magnetic field or is allowed to stand for a period of time to perform nucleic acid capture.
[0441] In some embodiments, the control module is further configured to, when the first lysis and capture mode is selected by the mode selection module, only control the first mixing component to perform mixing operations on the sample container based on the magnetic field in the lysis and capture link, so as to release the nucleic acid in the sample and allow the magnetic beads to capture the released nucleic acid.
[0442] In other embodiments, the nucleic acid extraction module further includes a transfer device for transferring sample containers. In this case, the control module is further configured to, when the first lysis and capture mode is selected by the mode selection module, control only the first mixing component or only the second mixing component to perform a mixing operation on the sample container during the lysis and capture phase to release nucleic acids from the sample; and control the transfer device to transfer the mixed sample container to a resting area for resting, so that the released nucleic acids can be captured by the magnetic beads during the resting period.
[0443] In some embodiments, the control module is further configured to, when the second lysis and capture mode is selected by the mode selection module, in the lysis and capture link: first control the second mixing component to mix the sample container to release the nucleic acid in the sample; and then control the first mixing component to mix the sample container that has been mixed by the second mixing component so that the magnetic beads capture the released nucleic acid.
[0444] In other embodiments, the control module is further configured to, when the second lysis and capture mode is selected by the mode selection module, in the lysis and capture link: first control the first mixing component to mix the sample container so as to release the nucleic acid in the sample; and then control the second mixing component to mix the sample container that has been mixed by the first mixing component so that the magnetic beads capture the released nucleic acid.
[0445] In a specific example, the control module is further configured to:
[0446] When the first lysis and capture mode is selected by the mode selection module, in the lysis and capture phase, only the second mixing component is controlled to perform a mixing operation on the sample container, and in the washing phase and the elution phase, the first mixing component is controlled to perform a mixing operation on the sample container based on the magnetic field; and
[0447] When the second lysis and capture mode is selected by the mode selection module, in the lysis and capture phase, the first mixing component and the second mixing component are controlled to perform mixing operations on the sample container, and in the washing phase and the elution phase, the first mixing component is controlled to perform mixing operations on the sample container based on the magnetic field.
[0448] In some embodiments, as described for the molecular diagnostic analyzer according to the first aspect of the present application, the nucleic acid extraction module includes a first mixing component configured as a mixing magnet component 110 and a first carrying component 120 arranged above the mixing magnet component. A first lysis / capture station, a second lysis / capture station, and a third lysis / capture station are provided on the first carrying component 120, and a container receiving portion is provided in each lysis / capture station. The first lysis / capture station is used to place a sample container to be lysed and / or captured based on a magnetic field (i.e., using the first mixing component), the second lysis / capture station is used to place a sample container to be lysed and / or captured using the second mixing component, and the third lysis / capture station is used to place a sample container that needs to be left to stand for capture.
[0449] For more embodiments and advantages of the molecular diagnostic analyzer of the fifth aspect of the present application, reference can be made to the above descriptions of the molecular diagnostic analyzers of the first to fourth aspects of the present application, which will not be repeated here.
[0450] So far, the various embodiments of the present application have been described in detail. To avoid obscuring the concept of the present application, some details well known in the art have not been described. Based on the above description, those skilled in the art can fully understand how to implement the technical solutions disclosed herein.
[0451] Those skilled in the art will appreciate that the embodiments of the present application can be provided as methods, systems, or computer program products. Therefore, the present application can adopt the form of a complete hardware embodiment, a complete software embodiment, or an embodiment in combination with software and hardware. Moreover, the present application can adopt the form of a computer program product implemented on one or more computer-usable non-transient storage media (including but not limited to magnetic disk storage, CD-ROM, optical storage, etc.) that contain computer-usable program code.
[0452] The present application is described with reference to the flowcharts and / or block diagrams of the methods, devices (systems), and computer program products according to the embodiments of the present application. It should be understood that the functions specified in one or more processes in the flowchart and / or one or more boxes in the block diagram can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer, an embedded processor, or other programmable data processing device to produce a machine, so that the instructions executed by the processor of the computer or other programmable data processing device produce a device for implementing the functions specified in one or more processes in the flowchart and / or one or more boxes in the block diagram.
[0453] These computer program instructions may also be stored in a computer-readable memory that can direct a computer or other programmable data processing device to operate in a specific manner, so that the instructions stored in the computer-readable memory produce a product including an instruction device that implements the functions specified in one or more processes in the flowchart and / or one or more boxes in the block diagram.
[0454] These computer program instructions can also be loaded onto a computer or other programmable data processing device so that a series of operating steps are executed on the computer or other programmable device to produce a computer-implemented process, so that the instructions executed on the computer or other programmable device provide steps for implementing the functions specified in one or more processes in the flowchart and / or one or more boxes in the block diagram.
[0455] The features or feature combinations mentioned above in the description, drawings and claims may be used in any combination or alone as long as they are meaningful within the scope of the present application and do not contradict each other.
[0456] The above description is only a preferred embodiment of the present application and does not limit the patent scope of the present application. All equivalent transformations made using the contents of the present application specification and drawings under the inventive concept of the present application, or direct / indirect application in other related technical fields are included in the patent protection scope of the present application.
Claims
1. A molecular diagnostic analyzer comprising a nucleic acid extraction module, an amplification module, and a detection module, wherein the nucleic acid extraction module is configured to extract nucleic acid from a sample, the amplification module is configured to amplify the nucleic acid extracted by the nucleic acid extraction module, and the detection module is configured to detect the amplified nucleic acid; It is characterized by: The nucleic acid extraction module includes a mixing magnet assembly and a first carrying assembly arranged above the mixing magnet assembly, wherein: The mixing magnet assembly comprises at least a first magnet array and a second magnet array extending horizontally, and each of the magnet arrays comprises a plurality of magnets installed at intervals on a magnet bracket; The first carrying assembly includes a container receiving portion for placing a sample container containing a reaction solution, wherein the reaction solution includes a sample containing nucleic acid and magnetic beads for adsorbing the nucleic acid; The first carrying assembly and the mixing magnet assembly are arranged relative to each other so that when a sample container is received in the container receiving portion, at least the bottom of the sample container is located between the first magnet array and the second magnet array; The first carrying assembly and the mixing magnet assembly are capable of horizontally moving relative to each other, so that the mixing magnet assembly can mix the magnetic beads in the sample container received in the container receiving portion; and The first carrying assembly and the mixing magnet assembly are arranged relative to each other so that when the first carrying assembly and the mixing magnet assembly move horizontally relative to each other, at least two magnets in the mixing magnet assembly have different heights relative to the bottom of the sample container received in the container receiving portion.
2. The molecular diagnostic analyzer according to claim 1, characterized in that The at least two magnets in the mixing magnet assembly have different heights relative to the first carrying assembly, so that the at least two magnets in the mixing magnet assembly have different heights relative to the bottom of the sample container received in the container receiving portion; or The at least two magnets in the mixing magnet assembly are installed at different heights on the magnet bracket, so that the at least two magnets in the mixing magnet assembly have different heights relative to the first bearing assembly.
3. The molecular diagnostic analyzer according to claim 1 or 2, characterized in that The at least two magnets in the mixing magnet assembly include at least two magnets in the first magnet array, and the at least two magnets in the first magnet array are installed at different heights on the magnet holder, so that the at least two magnets in the mixing magnet assembly have different heights relative to the bottom of the sample container received in the container receiving portion; And / or, the at least two magnets in the mixing magnet assembly include at least two magnets in the second magnet array, and the at least two magnets in the second magnet array are installed at different heights on the magnet bracket, so that the at least two magnets in the mixing magnet assembly have different heights relative to the bottom of the sample container received in the container receiving portion.
4. The molecular diagnostic analyzer according to any one of claims 1 to 3, characterized in that The first magnet array includes at least one first magnet unit and at least one second magnet unit, each of the magnet units includes one magnet or a plurality of adjacently distributed magnets, wherein each magnet in the first magnet unit is mounted on the magnet bracket at a first height, and each magnet in the second magnet unit is mounted on the magnet bracket at a second height greater than the first height; And / or, the second magnet array includes at least one third magnet unit and at least one fourth magnet unit, each of the magnet units includes one magnet or multiple adjacently distributed magnets, wherein each magnet in the third magnet unit is mounted on the magnet bracket at a third height, and each magnet in the fourth magnet unit is mounted on the magnet bracket at a fourth height greater than the third height.
5. The molecular diagnostic analyzer according to claim 4, characterized in that The first height is equal to the third height, and / or the second height is equal to the fourth height.
6. The molecular diagnostic analyzer according to claim 4 or 5, characterized in that The first magnet array further includes at least one fifth magnet unit, the fifth magnet unit including one magnet or a plurality of adjacently distributed magnets, and each magnet in the fifth magnet unit is mounted on the magnet support at a fifth height greater than the second height; And / or, the second magnet array further includes at least one sixth magnet unit, the sixth magnet unit includes one magnet or a plurality of adjacently distributed magnets, and each magnet in the sixth magnet unit is mounted on the magnet support at a sixth height greater than the fourth height; Preferably, the fifth height is equal to the sixth height.
7. The molecular diagnostic analyzer according to any one of claims 4 to 6, characterized in that The first magnet units and the second magnet units are alternately arranged to form the first magnet array, and / or the third magnet units and the fourth magnet units are alternately arranged to form the second magnet array; or The first magnet unit, the second magnet unit, and the fifth magnet unit are alternately arranged to form the first magnet array, and / or the third magnet unit, the fourth magnet unit, and the sixth magnet unit are alternately arranged to form the second magnet array.
8. The molecular diagnostic analyzer according to any one of claims 4 to 7, characterized in that: The first height is equal to the third height, and the second height is equal to the fourth height; The first magnet units and the second magnet units are alternately arranged to form the first magnet array, and the third magnet units and the fourth magnet units are alternately arranged to form the second magnet array; The magnet at the first height in the first magnet array and the magnet at the third height adjacent to the magnet in the second magnet array have a first vertical distance between their opposite magnet sides, and the magnet at the second height in the first magnet array and the magnet at the fourth height adjacent to the magnet in the second magnet array have a second vertical distance between their opposite magnet sides, wherein the first vertical distance is different from the second vertical distance, and preferably the first vertical distance is smaller than the second vertical distance.
9. The molecular diagnostic analyzer according to any one of claims 1 to 3, characterized in that The first magnet array and the second magnet array respectively include a plurality of magnet units, and each magnet unit respectively includes one magnet or a plurality of adjacently distributed magnets; The installation height of each magnet unit in the first magnet array on the magnet bracket changes uniformly, and / or the installation height of each magnet unit in the second magnet array on the magnet bracket changes uniformly; or the installation height of each magnet unit in the first magnet array on the magnet bracket increases gradually along the magnet arrangement of the first magnet array, and / or the installation height of each magnet unit in the second magnet array on the magnet bracket increases gradually along the magnet arrangement of the second magnet array.
10. The molecular diagnostic analyzer according to any one of claims 1 to 9, characterized in that Viewed in the vertical direction, the first magnet array and the second magnet array are respectively arranged on concentric circles or respectively arranged on straight lines parallel to each other.
11. The molecular diagnostic analyzer according to claim 10, characterized in that A line connecting center points of adjacent magnets of the first magnet array and the second magnet array is not perpendicular to a tangent line of the concentric circles or is not perpendicular to the straight line.
12. The molecular diagnostic analyzer according to claim 10 or 11, characterized in that: The magnets in the first magnet array are spaced apart by the same distance on the concentric circles, and / or the magnets in the second magnet array are spaced apart by the same distance on the concentric circles; Alternatively, the magnets of the first magnet array are spaced apart by the same distance on the straight line, and / or the magnets of the second magnet array are spaced apart by the same distance on the straight line.
13. The molecular diagnostic analyzer according to claim 10, characterized in that Viewed in the vertical direction, the first magnet array and the second magnet array are respectively arranged on concentric circles, the magnets in the first magnet array are spaced apart by the same distance on the concentric circles, and the magnets in the second magnet array are spaced apart by the same distance on the concentric circles, and a line connecting center points of adjacent magnets in the first magnet array and the second magnet array is not perpendicular to a tangent line of the concentric circles; Preferably, viewed in the vertical direction, the angle between adjacent magnets in the first magnet array is equal to the angle between adjacent magnets in the second magnet array, and / or the angle between adjacent magnets in the first magnet array and the second magnet array is half the angle between adjacent magnets in the first magnet array or the second magnet array.
14. The molecular diagnostic analyzer according to claim 10, characterized in that Viewed in the vertical direction, the first magnet array and the second magnet array are respectively arranged on straight lines parallel to each other, the magnets in the first magnet array are spaced apart by the same distance on the straight line, and the magnets in the second magnet array are spaced apart by the same distance on the straight line, and a line connecting center points of adjacent magnets in the first magnet array and the second magnet array is not perpendicular to the straight line; Preferably, viewed in the vertical direction, the distance between adjacent magnets in the first magnet array in the straight-line direction is equal to the distance between adjacent magnets in the second magnet array in the straight-line direction, and / or the distance between adjacent magnets in the first magnet array and the second magnet array in the straight-line direction is half of the distance between adjacent magnets in the first magnet array or the second magnet array in the straight-line direction.
15. The molecular diagnostic analyzer according to any one of claims 1 to 14, characterized in that Each magnet in the first magnet array has a first magnetic pole facing the first supporting component, and each magnet in the second magnet array has a second magnetic pole facing the first supporting component. The first magnetic pole and the second magnetic pole have opposite polarities.
16. The molecular diagnostic analyzer according to any one of claims 1 to 15, characterized in that The nucleic acid extraction module further includes a driving device configured to drive the magnet support to move so that the first carrying assembly and the mixing magnet assembly move horizontally relative to each other.
17. The molecular diagnostic analyzer according to claim 16, characterized in that The driving device is configured to drive the magnet holder to move so that the magnetic beads in the sample container received in the container receiving portion experience the alternating magnetic field generated by the mixing magnet assembly, so that the magnetic beads in the sample container can move in the reaction liquid under the action of the alternating magnetic field; preferably, the movement is performed in a cycle.
18. The molecular diagnostic analyzer according to claim 16 or 17, characterized in that The drive device is configured to drive the magnet holder at a varying, in particular periodically varying, speed.
19. The molecular diagnostic analyzer according to claim 18, characterized in that The magnet support includes a first area and a second area, the first area is opposite to the magnet side of the magnet in the mixing magnet assembly, and the second area is an empty area between adjacent magnets in the first magnet array and the second magnet array; The driving device is configured to drive the magnet holder to move at a varying speed so that the sample container received in the container receiving portion passes through the first area of the magnet holder at a first speed and passes through the second area of the magnet holder at a second speed lower than the first speed.
20. The molecular diagnostic analyzer according to any one of claims 16 to 19, characterized in that Viewed in the vertical direction, the first magnet array and the second magnet array are respectively arranged on concentric circles; and The driving device is configured to first drive the magnet bracket to rotate along a first direction, and then drive the magnet bracket to rotate along a second direction opposite to the first direction.
21. The molecular diagnostic analyzer according to any one of claims 16 to 19, characterized in that Viewed in the vertical direction, the first magnet array and the second magnet array are respectively arranged on straight lines parallel to each other; and The driving device is configured to drive the magnet support to reciprocate along the straight line.
22. The molecular diagnostic analyzer according to any one of claims 1 to 21, characterized in that The first bearing assembly is configured as a rotatable first disc, the magnet support is configured as a rotatable second disc, and the first disc and the second disc are concentrically arranged; Preferably, the second disc can rotate synchronously with the first disc and can rotate independently relative to the first disc; More preferably, the second disc is rotatably fixedly connected to the first disc, so that the rotation of the first disc synchronously drives the second disc to rotate, and the second disc can rotate independently relative to the first disc.
23. The molecular diagnostic analyzer according to any one of claims 1 to 22, characterized in that The first carrier assembly includes a lysis capture zone, which has the container receiving portion. The mixing magnet assembly is configured so that the magnetic field it generates can at least cover the lysis capture zone, thereby enabling the magnetic beads in the sample container placed on the lysis capture zone to move, thereby achieving the adsorption of nucleic acids by the magnetic beads.
24. The molecular diagnostic analyzer according to claim 23, characterized in that The first carrier assembly also includes a washing area, which has the container receiving portion. The mixing magnet assembly is also configured so that the magnetic field it generates can at least cover the lysis capture area and the washing area, thereby enabling the magnetic beads in the sample container placed on the lysis capture area and the washing area to move, thereby achieving magnetic bead adsorption of nucleic acids and nucleic acid cleaning.
25. The molecular diagnostic analyzer according to claim 24, characterized in that The first carrier assembly also includes an elution zone, which has the container receiving portion. The mixing magnet assembly is also configured so that the magnetic field it generates can at least cover the lysis capture zone, the washing zone and the elution zone, thereby enabling the magnetic beads in the sample container placed on the lysis capture zone, the washing zone and the elution zone to move, thereby achieving magnetic bead adsorption of nucleic acids, nucleic acid cleaning and nucleic acid elution.
26. The molecular diagnostic analyzer according to any one of claims 1 to 25, characterized in that At least one of the container receiving portions has a raised portion, so that a bottom portion of a sample container placed in the container receiving portion having the raised portion is higher than a bottom portion of a sample container placed in a container receiving portion without the raised portion; Preferably, the container receiving portion of the elution zone has a raised portion.
27. The molecular diagnostic analyzer according to any one of claims 23 to 26, characterized in that The first carrying component further includes a drying area, which is used to dry the magnetic beads adsorbed with the washed nucleic acid in the sample container.
28. The molecular diagnostic analyzer according to any one of claims 1 to 27, characterized in that The first bearing assembly includes a magnetic field coverage area and a non-magnetic field coverage area, and the hybrid magnet assembly is further configured so that the magnetic field generated by it covers the magnetic field coverage area but does not cover the non-magnetic field coverage area; Optionally, the magnetic field coverage area includes at least a lysis and capture area, in which the sample container undergoes a lysis and / or capture step, in which the cells in the sample in the sample container are lysed to release nucleic acids and / or the released nucleic acids are captured by the magnetic beads in the sample container; and the non-magnetic field coverage area is set as a static area, which is used to place sample containers to be transferred to the lysis and capture area or for placing sample containers that have undergone at least a lysis step in the lysis and capture area.
29. The molecular diagnostic analyzer according to claim 28, characterized in that The nucleic acid extraction module further includes a driving device configured to drive the magnet support to periodically reciprocate at a preset amplitude, so that the magnetic field generated by the mixing magnet assembly covers the magnetic field coverage area but does not cover the non-magnetic field coverage area; Preferably, the first bearing assembly is configured as a rotatable first disc, the magnet support is configured as a rotatable second disc, and the first disc and the second disc are concentrically arranged; More preferably, the preset amplitude is between 30° and 60°.
30. The molecular diagnostic analyzer according to any one of claims 1 to 30, characterized in that The nucleic acid extraction module also includes a transfer device and a magnetic bead aggregation device; The magnetic bead aggregation device includes a second carrying component and a gathering magnet component, wherein the second carrying component is used to place the sample container mixed by the mixing magnet component, and the gathering magnet component is used to aggregate the magnetic beads in the sample container; The transfer device is configured to transfer the sample container between the first carrying assembly and the second carrying assembly; Preferably, the magnetic bead gathering device is arranged above the first supporting component.
31. The molecular diagnostic analyzer according to claim 30, characterized in that The second carrying assembly includes a first carrying portion for placing a sample container, and the focusing magnet assembly includes a first focusing magnet corresponding to, and preferably fixed to, the first carrying portion; and The magnetic bead aggregation device further includes a first suction and discharge mechanism and a first liquid injection mechanism, wherein the first suction and discharge mechanism is configured to suck waste liquid from the sample container placed in the first carrying portion and discharge it, and the first liquid injection mechanism is configured to inject cleaning liquid into the sample container placed in the first carrying portion; Preferably, the number of the first carrying parts, the number of the first suction and discharge mechanisms, and the number of the first liquid injection mechanisms of the magnetic bead aggregation device correspond to the number of the washing areas of the first carrying assembly.
32. The molecular diagnostic analyzer according to claim 30 or 31, characterized in that The second carrying assembly includes a second carrying portion for placing the sample container, and the focusing magnet assembly includes a second focusing magnet arranged corresponding to the second carrying portion; and The magnetic bead aggregation device also includes a second suction and discharge mechanism and a second liquid injection mechanism. The second suction and discharge mechanism is configured to suck waste liquid from the sample container placed in the second carrying part and discharge it. The second liquid injection mechanism is configured to inject eluent into the sample container placed in the second carrying part.
33. The molecular diagnostic analyzer according to claim 30 or 31, characterized in that The second carrying assembly includes a second carrying portion for placing a sample container, the collecting magnet assembly includes a second collecting magnet arranged corresponding to the second carrying portion, and the magnetic bead collecting device further includes a second suction and discharge mechanism, the second suction and discharge mechanism being configured to suck waste liquid from the sample container placed in the second carrying portion and discharge the waste liquid; as well as The second carrying assembly includes a third carrying portion for placing a sample container, and the magnetic bead aggregation device also includes a second liquid injection mechanism, which is configured to inject eluent into the sample container placed in the third carrying portion.
34. The molecular diagnostic analyzer according to claim 32 or 33, characterized in that The second carrying part and the second collecting magnet corresponding to it can move up and down relative to each other in the vertical direction, so that the magnetic beads in the sample container placed in the second carrying part can be collected on the side wall of the sample container; preferably, the second collecting magnet moves from top to bottom in the vertical direction.
35. The molecular diagnostic analyzer according to any one of claims 32 to 34, characterized in that The first bearing part and the second bearing part are arranged side by side with each other; preferably, the first focusing magnet is arranged on one side of the first bearing part along the side by side direction; and / or the second focusing magnet is arranged on one side of the second bearing part along the side by side direction; preferably, the first focusing magnet and the second focusing magnet are arranged on the same side of the first bearing part and the second bearing part along the side by side direction.
36. The molecular diagnostic analyzer according to claim 33, characterized in that The first bearing portion, the second bearing portion and the third bearing portion are arranged side by side.
37. The molecular diagnostic analyzer according to any one of claims 23 to 36, characterized in that The nucleic acid extraction module further includes a heating device, which comprises at least a first heating component and a second heating component, wherein the first heating component is used to heat the reaction liquid in the lysis and capture zone, and the second heating component is used to heat the reaction liquid in the elution zone. Preferably, the heating temperatures of the first heating component and the second heating component are independently adjustable; Optionally, the heating device further comprises a third heating component, and the third heating component is used to heat the reaction liquid in the drying zone.
38. A molecular diagnostic analyzer comprising a nucleic acid extraction module, an amplification module, and a detection module, wherein the nucleic acid extraction module is configured to extract nucleic acid from a sample, the amplification module is configured to amplify the nucleic acid extracted by the nucleic acid extraction module, and the detection module is configured to detect the amplified nucleic acid; It is characterized by: The nucleic acid extraction module includes a first carrying component, a mixing magnet component and a driving device, wherein the first carrying component is configured to place a sample container containing a reaction liquid, wherein the reaction liquid includes a sample containing nucleic acid and magnetic beads for adsorbing the nucleic acid, and the mixing magnet component includes a movable magnet bracket and a plurality of magnets fixed on the magnet bracket, wherein the driving device is configured to drive the magnet bracket to move, so as to drive the plurality of magnets fixed on the magnet bracket to move relative to the sample container on the first carrying component, so that the magnetic beads in the sample container placed on the first carrying component perform three-dimensional movement in the reaction liquid under the action of the moving magnets.
39. The molecular diagnostic analyzer according to claim 38, characterized in that The driving device is configured to drive the magnet support to move, so that the magnetic beads in the sample container placed on the first carrying assembly experience the alternating magnetic field generated by the multiple magnets.
40. The molecular diagnostic analyzer according to claim 38 or 39, characterized in that At least two magnets among the plurality of magnets are fixed on the magnet holder at different heights.
41. The molecular diagnostic analyzer according to any one of claims 38 to 40, characterized in that The first bearing assembly is configured as a rotatable first disc, the magnet support is configured as a rotatable second disc, and the first disc and the second disc are concentrically arranged; Preferably, the second disc is configured to rotate synchronously with the first disc and independently of the first disc; More preferably, the second disc is rotatably fixedly connected to the first disc, so that the rotation of the first disc synchronously drives the second disc to rotate, and the second disc can rotate independently relative to the first disc.
42. The molecular diagnostic analyzer according to any one of claims 38 to 41, characterized in that The first supporting component includes a lysis capture zone, a washing zone and an elution zone; The mixing magnet assembly is further configured to: move the magnetic beads in the sample container located in the lysis and capture zone to achieve adsorption of nucleic acids by the magnetic beads, move the magnetic beads in the sample container located in the washing zone to wash the nucleic acids adsorbed by the magnetic beads, and move the magnetic beads in the sample container located in the elution zone to elute the nucleic acids from the magnetic beads; The mixing magnet assembly is also configured so that the magnetic field it generates can at least cover the lysis capture zone, the washing zone and the elution zone, thereby simultaneously moving the magnetic beads in the sample containers placed on the lysis capture zone, the washing zone and the elution zone.
43. The molecular diagnostic analyzer according to any one of claims 38 to 42, characterized in that The nucleic acid extraction module also includes a transfer device and a magnetic bead aggregation device; The magnetic bead aggregation device includes a second carrying component and a gathering magnet component, wherein the second carrying component is used to place a sample container containing a sample liquid, and the gathering magnet component is used to aggregate the magnetic beads in the sample container; The transfer device is configured to transfer the sample container between the first carrying assembly and the second carrying assembly; Preferably, the magnetic bead gathering device is arranged above the first supporting component.
44. A molecular diagnostic analyzer comprising a nucleic acid extraction module, an amplification module, and a detection module, wherein the nucleic acid extraction module is configured to extract nucleic acid from a sample, the amplification module is configured to amplify the nucleic acid extracted by the nucleic acid extraction module, and the detection module is configured to detect the amplified nucleic acid; It is characterized by: The nucleic acid extraction module includes a first carrying component, a mixing magnet component and a driving device. The first carrying component is configured to place a sample container containing a reaction liquid. The reaction liquid includes a sample containing nucleic acid and magnetic beads for adsorbing the nucleic acid. The mixing magnet component is configured to generate a magnetic field. The driving device is configured to drive the first carrying component and the mixing magnet component to move relative to each other, so that the mixing magnet component generates an alternating magnetic field relative to the sample container on the first carrying component, so that the magnetic beads in the sample container can perform three-dimensional movement in the reaction liquid under the action of the alternating magnetic field.
45. The molecular diagnostic analyzer according to claim 44, characterized in that The mixing magnet assembly includes a movable magnet bracket and a plurality of magnets fixed on the magnet bracket, wherein the driving device is configured to drive the magnet bracket to move so as to achieve relative movement between the first carrying assembly and the mixing magnet assembly; preferably, the magnetic beads in the sample container circulate in the reaction liquid under the action of the alternating magnetic field.
46. The molecular diagnostic analyzer according to claim 45, characterized in that At least two magnets among the plurality of magnets are fixed on the magnet holder at different heights.
47. The molecular diagnostic analyzer according to any one of claims 44 to 46, characterized in that The first bearing assembly is configured as a rotatable first disc, the magnet support is configured as a rotatable second disc, and the first disc and the second disc are concentrically arranged; Preferably, the second disc is configured to rotate synchronously with the first disc and independently of the first disc; More preferably, the second disc is rotatably fixedly connected to the first disc, so that the rotation of the first disc synchronously drives the second disc to rotate, and the second disc can rotate independently relative to the first disc.
48. The molecular diagnostic analyzer according to any one of claims 44 to 47, characterized in that The first supporting assembly includes a lysis and capture zone, a washing zone and an elution zone, wherein the lysis and capture zone; The mixing magnet assembly is further configured to: move the magnetic beads in the sample container located in the lysis and capture zone to achieve adsorption of nucleic acids by the magnetic beads, move the magnetic beads in the sample container located in the washing zone to wash the nucleic acids adsorbed by the magnetic beads, and move the magnetic beads in the sample container located in the elution zone to elute the nucleic acids from the magnetic beads; The mixing magnet assembly is also configured so that the magnetic field it generates can at least cover the lysis capture zone, the washing zone and the elution zone, thereby simultaneously moving the magnetic beads in the sample containers placed on the lysis capture zone, the washing zone and the elution zone.
49. The molecular diagnostic analyzer according to any one of claims 44 to 48, characterized in that The nucleic acid extraction module also includes a transfer device and a magnetic bead aggregation device; The magnetic bead aggregation device includes a second carrying component and a gathering magnet component, wherein the second carrying component is used to place a sample container containing a sample liquid, and the gathering magnet component is used to aggregate the magnetic beads in the sample container; The transfer device is configured to transfer the sample container between the first carrying assembly and the second carrying assembly; Preferably, the magnetic bead gathering device is arranged above the first supporting component.
50. A molecular diagnostic analyzer comprising a nucleic acid extraction module, an amplification module, and a detection module, wherein the nucleic acid extraction module is configured to extract nucleic acid from a sample, the amplification module is configured to amplify the nucleic acid extracted by the nucleic acid extraction module, and the detection module is configured to detect the amplified nucleic acid; The nucleic acid extraction module comprises: a first carrying assembly configured to accommodate a sample container containing a reaction solution, wherein the reaction solution includes a sample containing nucleic acid and magnetic beads for adsorbing the nucleic acid, and the first carrying assembly at least includes a lysis and capture zone, wherein the sample container undergoes a lysis and capture step in the lysis and capture zone, during which cells in the sample in the sample container are lysed to release nucleic acid, and the released nucleic acid is captured by the magnetic beads in the sample container; a mixing magnet assembly configured to generate a magnetic field covering at least the lysis capture zone; and A driving device is configured to drive the first supporting assembly and the mixing magnet assembly to move relative to each other, so that the magnetic beads in the sample container in the lysis capture zone move, so that the magnetic beads capture the released nucleic acids.
51. A molecular diagnostic analyzer comprising: a nucleic acid extraction module configured to perform a lysis and capture step, a washing step, and an elution step on a sample contained in a sample container to extract nucleic acids from the sample, wherein in the lysis and capture step, cells in the sample in the sample container are lysed to release nucleic acids, and the released nucleic acids are captured by magnetic beads in the sample container; an amplification module, configured to amplify the nucleic acid extracted by the nucleic acid extraction module; and A detection module, configured to detect the amplified nucleic acid; It is characterized by: The molecular diagnostic analyzer further comprises a frame, on which the nucleic acid extraction module, the amplification module and the detection module are mounted; The nucleic acid extraction module includes a first mixing component and a second mixing component, wherein the first mixing component and the second mixing component are configured to perform mixing operations on the sample container based on different mixing methods to release the nucleic acid in the sample and / or to allow the magnetic beads to capture the released nucleic acid, the first mixing component performing the mixing operation on the sample container based on a magnetic field, and the second mixing component performing the mixing operation on the sample container based on a non-magnetic field; and The molecular diagnostic analyzer further comprises: a mode selection module, configured to select a first lysis capture mode or a second lysis capture mode; and Control module, configured as: When the first lysis capture mode is selected by the mode selection module, in the lysis capture link, only the first mixing component is controlled to perform a mixing operation on the sample container based on the magnetic field, or only the second mixing component is controlled to perform a mixing operation on the sample container, and When the second lysis and capture mode is selected by the mode selection module, in the lysis and capture step, the first mixing component and the second mixing component are controlled to perform a mixing operation on the sample container.
Citation Information
Patent Citations
System and method for automatically separating biological analyte by using gas-liquid interface
CN114381368A