Molecular diagnostic analyzers and nucleic acid extraction methods

Abstract

This invention discloses a molecular diagnostic analyzer and a nucleic acid extraction method. The analyzer includes: a nucleic acid extraction module for extracting nucleic acids from a sample; an amplification module for amplifying the extracted nucleic acids; a detection module for detecting the amplified nucleic acids; and a rack on which each module is mounted. The nucleic acid extraction module includes a first sample carrying mechanism, a heating device, and a mixing mechanism. The first sample carrying mechanism includes at least an elution zone with a placement position. The placement position of the elution zone is used to place a sample container containing magnetic beads adsorbed with nucleic acids and injected with elution solution. The elution solution is used to elute the nucleic acids from the magnetic beads. The heating device is configured to heat at least the sample container placed at the placement position of the elution zone. The mixing mechanism is configured to: simultaneously heat at least the sample container and mix at least the magnetic beads in the sample container to promote the elution of nucleic acids from the magnetic beads.

Description

[0001] This application is a divisional application of Chinese invention patent application number "202380088993.X". The original application was filed on December 29, 2023, and the invention was entitled "Molecular Diagnostic Analyzer and Nucleic Acid Extraction Method". Technical Field

[0002] This invention relates to the field of medical devices, and in particular to a molecular diagnostic analyzer and a nucleic acid extraction method. Background Technology

[0003] With technological advancements, polymerase chain reaction (PCR)-based sample analyzers are increasingly used in medical testing. The testing process involves extracting nucleic acid samples from biological samples, amplifying the nucleic acid samples, and then testing the amplified samples. The nucleic acid extraction process mainly includes lysis, washing, and elution. Currently, sample analyzers use different modules to perform these steps separately, resulting in a relatively large analyzer size. Furthermore, integrating these different steps typically slows down nucleic acid extraction efficiency. Summary of the Invention

[0004] This invention aims to at least solve one of the technical problems existing in the prior art. To this end, this invention proposes a molecular diagnostic analyzer and a nucleic acid extraction method that can simultaneously heat the sample container in the elution zone and mix the magnetic beads in the sample container, thereby improving the elution efficiency of nucleic acids eluted from the magnetic beads.

[0005] A first aspect of the present invention provides a molecular diagnostic analyzer, comprising: a nucleic acid extraction module configured to extract nucleic acids from a sample; an amplification module configured to amplify the nucleic acids extracted by the nucleic acid extraction module; and a detection module configured to detect the amplified nucleic acids. The molecular diagnostic analyzer further includes a rack on which the nucleic acid extraction module, the amplification module, and the detection module are mounted. The nucleic acid extraction module includes a first sample carrying mechanism, a heating device, and a mixing mechanism. The first sample carrying mechanism includes at least an elution zone with a placement position. The placement position of the elution zone is used to place a sample container containing magnetic beads adsorbed with the nucleic acids and injected with elution solution, the elution solution being used to elute the nucleic acids from the magnetic beads. The heating device is configured to heat at least the sample container placed at the placement position of the elution zone, and the mixing mechanism is configured to: while the heating device heats at least the sample container, simultaneously mix at least the magnetic beads in the sample container to promote the elution of the nucleic acids from the magnetic beads.

[0006] A second aspect of the present invention provides a method for nucleic acid extraction, comprising: Capture step: Place a sample container containing at least a sample containing nucleic acid and magnetic beads for adsorbing the nucleic acid in the placement position of the lysis zone of the first sample carrier mechanism to release the nucleic acid in the sample so that it can be adsorbed onto the magnetic beads; Washing step: Inject washing solution into the sample container after the capture step and transfer the sample container with the washing solution to the placement position of the washing area of ​​the first sample carrying mechanism, so as to wash away impurities on and between the magnetic beads; Elution step: The elution buffer is injected into the sample container after the washing step is completed, and the sample container containing the elution buffer is transferred to the placement position of the elution zone of the first sample carrier. The sample container containing the elution buffer is heated at the placement position of the elution zone by means of a heating device, and at the same time, the magnetic beads in the sample container are mixed by means of a mixing mechanism to promote the elution of the nucleic acid in the sample container from the magnetic beads.

[0007] In the technical solutions provided by various aspects of the present invention, efficient elution can be achieved by heating and mixing the sample container in the elution zone in parallel, thereby improving the detection throughput of the molecular diagnostic analyzer.

[0008] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0009] The present invention will be further described below with reference to the accompanying drawings and embodiments, wherein: Figure 1 This is a three-dimensional schematic diagram of the nucleic acid extraction module in an embodiment of the present invention; Figure 2 This is a three-dimensional schematic diagram of the magnetic bead mixing device in an embodiment of the present invention; Figure 3 for Figure 2 Top view of the first sample-bearing mechanism; Figure 4 for Figure 3 Enlarged view of region A in the middle; Figure 5 for Figure 3 Enlarged view of region B in the middle; Figures 6 to 9 This is a three-dimensional schematic diagram of the second sample carrying mechanism in different embodiments of the present invention; Figure 10 To display Figure 2 A three-dimensional schematic diagram of the assembly relationship between the bearing mechanism and the heating device of the first sample. Figure 11 This is a flowchart illustrating the nucleic acid extraction method in some embodiments of the present invention; Figure 12 This is a flowchart illustrating the nucleic acid extraction method in other embodiments of the present invention. Figure 13 This is a flowchart illustrating the sample extraction method in an embodiment of the present invention; Figure 14 This is a schematic flowchart of a sample extraction method in another embodiment of the present invention. Detailed Implementation

[0010] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0011] In the description of this invention, it should be understood that the orientation descriptions, such as up, down, front, back, left, right, etc., are based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting this invention.

[0012] In the description of this invention, "several" means one or more, "multiple" means two or more, "greater than," "less than," and "exceeding" are understood to exclude the stated number, while "above," "below," and "within" are understood to include the stated number. The use of "first" and "second" in the description is merely for distinguishing technical features and should not be construed as indicating or implying relative importance, or implicitly indicating the number of indicated technical features, or implicitly indicating the order of the indicated technical features.

[0013] In the description of this invention, unless otherwise explicitly defined, terms such as "set up," "install," and "connect" should be interpreted broadly, and those skilled in the art can reasonably determine the specific meaning of the above terms in this invention in conjunction with the specific content of the technical solution.

[0014] In the description of this invention, the terms "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0015] This invention first proposes a molecular diagnostic analyzer, including a nucleic acid extraction module, an amplification module, and a detection module. The extraction module extracts nucleic acids from biological samples stored in a sample container using a magnetic bead method. This extraction mainly includes lysis, washing, and elution steps. In the lysis step, a lysis buffer is used to rupture cells and release nucleic acids, which are then adsorbed onto magnetic beads in the sample container. In the washing step, a washing solution or cleaning solution is used to remove unwanted components from the sample, such as various impurities like proteins and lipids remaining on and between the magnetic beads. In the elution step, an elution solution is used to separate the nucleic acids from the magnetic beads, thus obtaining purified nucleic acids. In some detection tests, the washed nucleic acid samples need to be dried before elution. The nucleic acids extracted by the nucleic acid extraction module are amplified by the amplification module, which can significantly increase the nucleic acid quantity in a short time. The detection module is used to detect the amplified nucleic acids.

[0016] In this embodiment of the invention, the molecular diagnostic analyzer further includes a rack, on which the nucleic acid extraction module, amplification module, and detection module are mounted. It should be noted that all descriptions of orientation in this invention are based on the premise that the extraction module is in normal working condition. In this case, the sample container 500 is placed vertically, and the axial direction of the sample container 500 is the vertical direction.

[0017] like Figure 1 and 2 As shown, the nucleic acid extraction module includes a magnetic bead mixing device 700, a magnetic bead aggregation device 800, and a transfer device 900. The magnetic bead mixing device 700 and the magnetic bead aggregation device 800 are arranged separately, for example, side-by-side. The sample is transferred between the magnetic bead mixing device 700 and the magnetic bead aggregation device 800 via the transfer device 800 to complete nucleic acid extraction.

[0018] The magnetic bead mixing device 700 includes a first sample holding mechanism 100 and a mixing mechanism 200. The first sample holding mechanism 100 is used to hold a sample container 500 containing a sample and magnetic bead reagent, wherein the magnetic beads in the magnetic bead reagent are used to adsorb nucleic acids in the sample. The mixing mechanism 200 is used to mix the magnetic beads in the sample container 500.

[0019] The magnetic bead gathering device 800 includes a second sample carrying mechanism 810 and a gathering magnet 820. The second sample carrying mechanism 810 is used to hold the sample container 500 that has been mixed by the magnetic bead mixing device 700, and the gathering magnet 820 is used to gather the magnetic beads in the sample container.

[0020] The transfer device 900 is configured to transfer the sample container 500 between the first sample carrier 100 and the second sample carrier 810, for example, to transfer the sample container 500, which has been mixed by the magnetic bead mixing device 700, from the first sample carrier 100 to the second sample carrier 810.

[0021] By separating the magnetic bead mixing device 700 and the magnetic bead aggregating device 800, magnetic bead mixing and aggregating operations can be performed on different samples in parallel, thereby improving the sample detection throughput.

[0022] The following describes some embodiments of the magnetic bead mixing device 700, but the invention is not limited thereto.

[0023] It can be understood here that the first sample carrier 100 is used to provide an area for the sample to perform the aforementioned lysis, washing and elution operations, while the mixing mechanism 200 is used to mix the magnetic beads in the sample container 500 located on the first sample carrier 100 in order to achieve sufficient lysis, washing and elution.

[0024] In some embodiments, the mixing mechanism 200 may be configured to mix the magnetic beads by blowing, shaking, or stirring.

[0025] In other embodiments, the mixing mechanism 200 may be configured to generate a magnetic field for mixing the magnetic beads. For example, the mixing mechanism 200 may include a permanent magnet or electromagnet independent of the gathering magnet 820. Compared to mixing methods such as blowing, shaking, and stirring, which cause violent oscillations in the gas-liquid surface of the sample container, the oscillations / fluctuations caused by magnetic field mixing are very small, which can significantly reduce the risk of aerosol contamination.

[0026] It is understandable that waste liquid in the sample container needs to be aspirated before adding the washing or elution solution to the sample container 500. At this time, in order to prevent the magnetic beads with adsorbed nucleic acid from being aspirated, a magnetic bead aggregation device 800 is set up to aggregate the magnetic beads in the sample container, especially to aggregate them on the side wall of the sample container.

[0027] In some embodiments, the focusing magnet 820 may be a permanent magnet. In other embodiments, the focusing magnet 820 may be an electromagnet.

[0028] In related technologies, lysis, washing, and elution are performed at different workstations. Therefore, sufficient space needs to be allocated in the molecular diagnostic analyzer to accommodate these workstations and the scheduling devices between them, resulting in a large sample analyzer size. To address this, the lysis, washing, and elution processes can be integrated, thereby helping to reduce the size of the molecular diagnostic analyzer. In some embodiments, refer to... Figure 3The first sample carrier 100 includes multiple different functional areas, namely, it includes at least a lysis zone 110, a washing zone 120, and an elution zone 130. In other words, the lysis zone 110, washing zone 120, and elution zone 130 are integrated into the first sample carrier, for example, integrated into the incubation tray shown in the figure. Each of the lysis zone 110, washing zone 120, and elution zone 130 is provided with a placement position 150 for placing a sample container 500 containing the sample and magnetic bead reagents. Here, the mixing mechanism 200 is also used to: mix the magnetic beads in the sample container located in the lysis zone 110 to achieve magnetic bead capture of nucleic acids; mix the magnetic beads in the sample container located in the washing zone 120 to wash the nucleic acids captured by the magnetic beads; and mix the magnetic beads in the sample container located in the elution zone 130 to elute the nucleic acids from the magnetic beads.

[0029] By setting the lysis zone 110, washing zone 120 and elution zone 130 on the first sample carrier 100, the lysis, washing and elution processes can be integrated on the first sample carrier 100, which helps to reduce the size of the sample analyzer.

[0030] On the other hand, if separate mixing devices are used for the lysis, washing, and elution steps implemented in different locations, the cost and size of the molecular diagnostic analyzer will increase. If a shared mixing device is used for the lysis, washing, and elution steps implemented in different locations, the scheduling time of the sample container 500 between each step and the mixing device will increase, reducing efficiency. In this embodiment, since the lysis zone 110, washing zone 120, and elution zone 130 are integrated into the first sample carrying mechanism 100, the samples in the lysis zone 110, washing zone 120, and elution zone 130 can be mixed simultaneously by a single mixing mechanism 200, thereby improving the shortcomings of related technologies.

[0031] Preferably, the mixing mechanism 200 is configured to generate a magnetic field to mix the magnetic beads in the sample container on the sample carrier device. The mixing mechanism 200 is configured such that the magnetic field it generates can at least cover the lysis zone, the washing zone and the elution zone, so as to simultaneously mix the magnetic beads in the sample container placed on the lysis zone, the washing zone and the elution zone.

[0032] In some embodiments, the washing zone 120 may include a first washing zone and a second washing zone that are different from each other. The mixing mechanism is also used to mix the magnetic beads in the sample container located in the first washing zone in order to wash the nucleic acid captured by the magnetic beads with a first washing solution. The mixing mechanism is also used to mix the magnetic beads in the sample container located in the second washing zone in order to wash the nucleic acid captured by the magnetic beads with a second washing solution.

[0033] Understandably, the number of washing zones can be set according to actual needs, and is not limited to two washing zones, but can also include three or even more washing zones.

[0034] In some tests, samples need to be dried after washing and before elution; therefore, refer to... Figure 2 In some embodiments, the first sample carrier 100 further includes a drying zone 140 for drying the washed magnetic beads in the sample container. The drying zone 140 also has the aforementioned placement position 150.

[0035] This embodiment provides multiple ways to set up the placement position 150. In some embodiments, the sample container 500 and the matching reagent container are placed together on the transport mechanism (e.g., on the extraction strip), and the transfer device 900 directly transfers the entire transport mechanism, thereby transferring the sample container 500. The transport mechanism can be configured as a long strip structure, with the sample container 500 and the matching reagent and / or pipette tip cavities arranged sequentially along the length of the transport mechanism, and the sample container 500 is usually located at the front end of the transport mechanism. Based on this structure, such as... Figures 3 to 4 As shown, both the lysis zone 110 and the washing zone 120 are provided with strip-shaped grooves. These grooves are adapted to the shape of the transport mechanism, and each reagent container and sample container 500 can be inserted into the groove. At this time, the placement position 150 is the foremost part of the groove used to accommodate the sample container 500. For example, refer to... Figure 3 and Figure 5 The elution zone 130 has a strip groove and a corresponding fixing hole. Some reagents can be inserted into the strip groove, and the sample container 500 is inserted into the fixing hole. At this time, the placement position 150 is the fixing hole.

[0036] In some embodiments, such as Figure 3 As shown, the first sample carrier mechanism 100 is constructed as a rotatable disk and can rotate to the transfer position T. The transfer device 900 is configured to transfer the sample container between the transfer position T of the first sample carrier mechanism and the second sample carrier mechanism.

[0037] In one example, the transfer position T is a fixed position of the disk relative to the fixed part of the transfer device. In this fixed position, the movable part of the transfer device 900, such as a three-dimensionally movable robotic arm, can grasp the sample container 500 from the transfer position of the first sample carrier and transfer it to the second sample carrier. The movable part of the transfer device 900 can also grasp the sample container 500 from the second sample carrier and transfer it to the transfer position of the first sample carrier. Here, the first sample carrier 100 rotates to transfer the sample container 500 to the transfer position T, and the transfer device 900 then transfers the sample container 500 located at the transfer position T to the second sample carrier. For example, after completing the pyrolysis operation on the sample container located at placement position A in the pyrolysis zone 110, the first sample carrier 100 rotates so that placement position A reaches the transfer position T, and then the first sample carrier 100 stops rotating so that the transfer device 900 can remove the sample container 500 located at the transfer position T and transfer it to the second sample carrier. For example, after washing the sample container at placement position B in the washing area 120, the first sample carrying mechanism 100 rotates, causing placement position B to reach transfer position T. Then, the first sample carrying mechanism 100 stops rotating, allowing the transfer device 900 to remove the sample container 500 at transfer position T and transfer it to the second sample carrying mechanism. As another example, after drying the sample container at placement position C in the drying area 140, the first sample carrying mechanism 100 rotates, causing placement position C to reach transfer position T. Then, the first sample carrying mechanism 100 stops rotating, allowing the transfer device 900 to remove the sample container 500 at transfer position T and transfer it to the second sample carrying mechanism.

[0038] In other embodiments, the placement positions on the first sample carrier 100 can all be understood as transfer positions T. Here, when a sample container 500 at a certain placement position needs to be transferred, the transfer device 900 can move directly to that placement position to grab the sample container 500 and transfer it to the second sample carrier. The transfer device 900 can also grab the sample container 500 from the second sample carrier and transfer it to an empty placement position of the first sample carrier.

[0039] In some embodiments, refer to Figure 2 The magnetic bead mixing device also includes a drive device 400, such as a drive motor, for driving the first sample carrying mechanism 100 to move, for example, rotate. The movement of the first sample carrying mechanism 100 enables the scheduling of the sample container 500.

[0040] Here, the transfer device 900 is used to transfer the sample container 500. It can coordinate with the movement of the first sample carrying mechanism 100 to schedule the sample container 500 between different placement positions 150. For example, the transfer device includes one or more transfer components arranged adjacent to the first sample carrying mechanism 100. Movement of the first sample carrying mechanism 100 can align a placement position 150 containing the sample container 500 with a transfer component. The transfer component removes the sample container 500 from that placement position 150. Then, movement of the first sample carrying mechanism 100 aligns other placement positions 150 with the transfer component, and the transfer component then places the sample container 500 into a new placement position 150. It is understood that the transfer device can also schedule the sample container 500 between the first sample carrying mechanism 100 and other devices. The transfer component can be a robotic arm capable of moving and / or rotating in a set direction, such as a robotic arm capable of three-dimensional movement.

[0041] As some implementation methods, such Figure 3 As shown, the first sample carrying mechanism 100 is constructed as a circular incubation tray, and the lysis zone 110, washing zone 120, and elution zone 130 are distributed along the circumferential direction. That is, the lysis zone 110, washing zone 120, and elution zone 130 are distributed along the circumferential direction as a whole, and the multiple placement positions 150 in the lysis zone 110, the multiple placement positions 150 in the washing zone 120, and the multiple placement positions 150 in the elution zone 130 are all arranged along the circumferential direction. In this embodiment, one end of the lysis zone 110 is directly connected to one end of the washing zone 120, and the other end of the lysis zone 110 is connected to the other end of the washing zone 120 through the elution zone 130. That is, the elution zone 130 is located between the lysis zone 110 and the washing zone 120, so that the lysis zone 110, washing zone 120, and elution zone 130 are arranged along the circumferential direction as a whole. It should be noted that when the first sample carrying mechanism 100 is also provided with a drying zone 140, the lysis zone 110, washing zone 120, elution zone 130 and drying zone 140 are all distributed along the circumferential direction. In addition, the elution zone 130 and the drying zone 140 can be integrated into a drying / elution zone and set between the lysis zone 110 and the washing zone 120.

[0042] In other implementations not shown, the first sample carrier 100 can be a rectangular incubation tray. The driving device 400 drives the first sample carrier 100 to move along a straight line (e.g., the length direction of the rectangular incubation tray). The lysis zone 110, washing zone 120, and elution zone 130 are arranged along a straight line. That is, the lysis zone 110, washing zone 120, and elution zone 130 are distributed as a whole along a straight line, and the multiple placement positions 150 of the lysis zone 110, the washing zone 120, and the elution zone 130 are all arranged along a straight line. It should be noted that when the first sample carrier 100 is also provided with a drying zone 140, the lysis zone 110, washing zone 120, elution zone 130, and drying zone 140 are all distributed along a straight line.

[0043] As another implementation not shown, the first sample carrier 100 can be a fan-shaped incubation tray, and the driving device 400 drives the first sample carrier 100 to rotate accordingly. The lysis zone 110, washing zone 120 and elution zone 130 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 larger than that of the fan-shaped incubation tray. The circular incubation tray can rotate more than 360°. 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.

[0044] It should be noted that the present invention does not limit the order in which the functional areas such as the pyrolysis zone 110, washing zone 120, elution zone 130, and drying zone 140 are arranged.

[0045] The following describes some embodiments of the magnetic bead gathering device 800, but the invention is not limited thereto.

[0046] In some embodiments, the second sample carrier 810 includes at least one carrier portion for placing a sample container, and an aggregating magnet 820 is correspondingly disposed with the carrier portion for aggregating magnetic beads in the sample container located in the carrier portion. Accordingly, the magnetic bead aggregating device 800 also includes at least one suction / discharge mechanism and at least one liquid injection mechanism. Each suction / discharge mechanism is configured to aspirate waste liquid from the sample container placed in the carrier portion and discharge it; for example, each suction / discharge mechanism may utilize a suction tip housed in a transport mechanism to aspirate waste liquid from the sample container placed in the carrier portion and discharge it. Each liquid injection mechanism is configured to inject liquid into the sample container placed in the carrier portion. Here, the transfer device 900 is used to transfer the sample container between the functional areas of the first sample carrier and the carrier portions of the second sample carrier 810.

[0047] In some embodiments, the sample container 500 is placed on a transport mechanism (e.g., an extraction strip), and the transfer device 900 directly transfers the entire transport mechanism, thereby transferring the sample container 500. The transport mechanism can be configured as an elongated structure, with the sample container 500 and associated cavities for reagents and / or pipette tips arranged sequentially along the length of the transport mechanism, and the sample container 500 typically located at the foremost end of the transport mechanism. Based on this structure, the support portion can be designed as a strip-shaped groove adapted to the shape of the transport mechanism. However, the invention is not limited thereto.

[0048] In some embodiments, each suction and discharge mechanism has a first pipette, a first driving part, and a second driving part. The first driving part drives the first pipette to move into the sample container located in the support part, and the second driving part drives the first pipette to draw waste liquid from the sample container and discharge it. In some embodiments, each liquid injection mechanism has a second pipette, a third driving part, and a fourth driving part. The third driving part drives the second pipette to move into the sample container located in the support part, and the fourth driving part drives the second pipette to inject liquid into the sample container placed in the support part.

[0049] Preferably, the arrangement of the carrier, the gathering magnet, the suction and discharge mechanism, and the liquid injection mechanism matches the functional area arrangement of the first sample carrier 100 in order to improve the overall efficiency of nucleic acid extraction.

[0050] As some implementation methods, such Figure 6 As shown, the second sample carrier mechanism 810 includes a first carrier portion 811 for placing a sample container, and the gathering magnet 820 includes a first gathering magnet 821 disposed corresponding to the first carrier portion 811. The first gathering magnet 821 is used to gather magnetic beads in the sample container located in the first carrier portion 811.

[0051] like Figure 6 As shown, the magnetic bead gathering device 800 also includes a first suction and discharge mechanism 830 and a first liquid injection mechanism 840. The first suction and discharge mechanism 830 is configured to draw waste liquid from the sample container placed in the first support portion 811 and discharge it, and the first liquid injection mechanism 840 is configured to inject cleaning fluid into the sample container placed in the first support portion 811.

[0052] Preferably, the first gathering magnet 821 is configured relative to the first support portion 811 such that when the first support portion 811 carries a sample container, the first gathering magnet 821 causes the magnetic beads in the sample container to gather on the side wall of the sample container.

[0053] In a preferred embodiment, the first focusing magnet 821 is fixedly disposed relative to the first support portion 811. In another embodiment, the first focusing magnet 821 is movably disposed relative to the first support portion 811.

[0054] Here, the transfer device 900 is used to transfer the sample container between the rupture zone 110 of the first sample carrier, the first carrier portion 811 of the second sample carrier 810, and the washing zone 120 of the first sample carrier.

[0055] For example, after the lysis operation is completed on a sample container located in the lysis zone 110, the transfer device 900 removes the sample container 500 from the lysis zone 110 and transfers it to the first support portion 811, whereby the first gathering magnet 821 causes the magnetic beads in the sample container to gather. Subsequently, the first suction and discharge mechanism 830 draws out the waste liquid from the sample container placed in the first support portion 811 and discharges it. Then, the first liquid injection mechanism 840 injects cleaning fluid into the sample container placed in the first support portion 811. After the cleaning fluid is injected, the transfer device 900 removes the sample container 500 located in the first support portion 811 and transfers it to the washing zone 120 of the first sample support mechanism.

[0056] In some embodiments, if multiple cleanings of the sample are required, such as two cleanings, multiple first carriers 811, multiple first gathering magnets 821, multiple first suction and discharge mechanisms 830, and multiple first liquid injection mechanisms 840 can be provided to improve the efficiency of nucleic acid extraction.

[0057] Preferably, the number of first support parts 811, the number of first suction and discharge mechanisms 830, and the number of first liquid injection mechanisms 840 in the magnetic bead gathering device 800 correspond to, or are equal to, the number of washing zones 120 in the magnetic bead mixing device 700.

[0058] In one example, the first sample carrier 100 includes a first washing zone 120 and a second washing zone 120. Two first carriers 811, two first gathering magnets 821, two first suction / discharge mechanisms 830, and two first liquid injection mechanisms 840 are provided. The two cleaning processes can be as follows: After completing the lysis operation on a sample container located in the lysis zone 110, the transfer device 900 removes the sample container 500 from the lysis zone 110 and transfers it to one of the first carriers 811, whereby the first gathering magnets 821 corresponding to that first carrier 811 cause the magnetic beads in the sample container to gather. Subsequently, the first suction / discharge mechanism 830 corresponding to that first carrier 811 sucks up waste liquid from the sample container and discharges it. Then, the first liquid injection mechanism 840 corresponding to that first carrier 811 injects first cleaning fluid into the sample container. After the first cleaning fluid is injected, the transfer device 900 removes the sample container 500 located in that first carrier 811 and transfers it to the first washing zone. After the sample container completes its first cleaning in the first washing zone, the transfer device 900 removes the sample container 500 from the first washing zone and transfers it to another first support portion 811, whereby the first gathering magnet 821 corresponding to the other first support portion 811 causes the magnetic beads in the sample container to gather. Subsequently, the waste liquid is sucked out of the sample container and discharged by the first suction and discharge mechanism 830 corresponding to the other first support portion 811, followed by the injection mechanism 840 corresponding to the other first support portion 811 injecting a second cleaning solution into the sample container. After the second cleaning solution is injected, the transfer device 900 removes the sample container 500 located in the other first support portion 811 and transfers it to the second washing zone to complete the second cleaning.

[0059] Of course, in other embodiments, the waste liquid suction and discharge and the cleaning liquid injection can also be completed in a first support part 811 by a corresponding first gathering magnet 821, a first suction and discharge mechanism 830, and a first liquid injection mechanism 840. For example, only one first support part 811, one first gathering magnet 821, one first suction and discharge mechanism 830, and one first liquid injection mechanism 840 are provided. In this case, the two cleaning processes can be as follows: after the lysis operation of a sample container located in the lysis zone 110 is completed, the transfer device 900 removes the sample container 500 from the lysis zone 110 and transfers it to the first support part 811, so that the first gathering magnet 821 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 830 and discharged, and then the first liquid injection mechanism 840 injects the first cleaning liquid into the sample container. After the first cleaning liquid is injected, the transfer device 900 removes the sample container 500 located in the first support part 811 and transfers it to the washing zone. After the sample container completes its first cleaning in the washing area, the transfer device 900 removes the sample container 500 from the washing area and transfers it to the same first support portion 811, whereby the same first gathering magnet 821 causes the magnetic beads in the sample container to gather. Subsequently, the same first suction and discharge mechanism 830 removes waste liquid from the sample container and discharges it, followed by the same first injection mechanism 840 injecting a second cleaning solution into the sample container. After the second cleaning solution is injected, the transfer device 900 removes the sample container 500 from the same first support portion 811 and transfers it to the washing area to complete the second cleaning.

[0060] As some implementation methods, such Figure 7 As shown, the second sample carrying mechanism 810 may further include a second carrying portion 812 for placing a sample container, and the gathering magnet 820 includes a second gathering magnet 822 corresponding to the second carrying portion 812. The magnetic bead gathering device 800 also includes a second suction and discharge mechanism 850 and a second liquid injection mechanism 860. The second suction and discharge mechanism 850 is configured to draw waste liquid from the sample container placed in the second carrying portion 812 and discharge it, and the second liquid injection mechanism 860 is configured to inject eluent into the sample container placed in the second carrying portion 812.

[0061] Here, the transfer device 900 is used to transfer the sample container between the washing zone 120 of the first sample carrier, the second carrier portion 812 of the second sample carrier 810, and the elution zone 130 of the first sample carrier.

[0062] For example, after cleaning a sample container 500 located in the washing zone 120, the transfer device 900 removes the sample container 500 from the washing zone 120 and transfers it to the second support section 812, whereby the second gathering magnet 822 causes the magnetic beads in the sample container to gather. Subsequently, the waste liquid is drawn from the sample container placed in the second support section 812 and discharged by the second suction and discharge mechanism 850, and then the second liquid injection mechanism 860 injects the cleaning solution into the sample container placed in the second support section 812. After the eluent is injected, the transfer device 900 removes the sample container 500 located in the second support section 812 and transfers it to the elution zone 130 of the first sample support mechanism.

[0063] Alternative locations, as other implementation methods, such as Figure 8 As shown, the second sample carrier 810 may include a second carrier portion 812 for placing a sample container, and the aggregating magnet 820 includes a second aggregating magnet 822 corresponding to the second carrier portion 812. The magnetic bead aggregating device 800 also includes a second suction and discharge mechanism 850, which is configured to aspirate waste liquid from the sample container placed in the second carrier portion 812 and discharge it. Furthermore, the second sample carrier 810 includes a third carrier portion 813 for placing a sample container, and the magnetic bead aggregating device 800 also includes a second liquid injection mechanism 860, which is configured to inject eluent into the sample container placed in the third carrier portion 813.

[0064] Here, the transfer device 900 is used to transfer sample containers between the washing zone 120 of the first sample carrier, the second carrier portion 812 of the second sample carrier 810, the drying zone 140 and the elution zone 130 of the first sample carrier.

[0065] For example, after cleaning a sample container 500 located in the washing zone 120, the transfer device 900 removes the sample container 500 from the washing zone 120 and transfers it to the second support section 812, whereby the second gathering magnet 822 causes the magnetic beads in the sample container to gather. Subsequently, the waste liquid is drawn from the sample container placed in the second support section 812 and discharged by the second suction / discharge mechanism 850. Next, the transfer device 900 removes the sample container 500 located in the second support section 812 and transfers it to the drying zone 140 of the first sample support mechanism. After drying, the transfer device 900 removes the sample container 500 from the drying zone 140 and transfers it to the third support section 813, whereby the second liquid injection mechanism 860 injects cleaning fluid into the sample container placed in the third support section 813. After injecting the eluent, the transfer device 900 removes the sample container 500 located in the third support section 813 and transfers it to the elution zone 130 of the first sample support mechanism.

[0066] Of course, in other embodiments, the second and third support parts and their corresponding second gathering magnets 822, second suction and discharge mechanisms 850 and second liquid injection mechanisms 860 may not be provided. Instead, the waste liquid suction and discharge and liquid injection required for the cleaning and elution operations may be completed in the first support part by the corresponding first gathering magnets 821, first suction and discharge mechanisms 830 and first liquid injection mechanisms 840.

[0067] In some embodiments, the second support portion and the corresponding second gathering magnet can move vertically relative to each other, such that the magnetic beads in the sample container placed in the second support portion can be gathered on the side wall of the sample container, especially from top to bottom.

[0068] Preferably, the second converging magnet is movable, and more preferably, it can move vertically from top to bottom.

[0069] In some embodiments, such as Figure 9 As shown, the first and second support parts are arranged side by side, or the first, second, and third support parts are arranged side by side. Preferably, the first focusing magnet is disposed on one side of the first support part along the side-by-side direction P, or the second focusing magnet is disposed on one side of the second support part along the side-by-side direction P; or the first focusing magnet is disposed on one side of the first support part along the side-by-side direction P and the second focusing magnet is disposed on one side of the second support part along the side-by-side direction P.

[0070] In a specific example, the first gathering magnet is arranged on one side of the first support portion along the parallel direction P, such that when the sample container containing the reaction liquid of the sample and magnetic beads is placed in the first support portion, the first gathering magnet is located near the reaction liquid in the sample container, so as to gather the magnetic beads in the reaction liquid onto the side wall of the sample container.

[0071] In another specific example, the second gathering magnet is arranged on one side of the second support portion along the parallel direction P in a manner that allows it to move vertically, such that when a sample container containing the reaction liquid is placed in the second support portion, the second gathering magnet can move vertically from top to bottom near the reaction liquid in the sample container in order to gather the magnetic beads in the reaction liquid onto the side wall of the lower part of the sample container.

[0072] More preferably, the first converging magnet and the second converging magnet are disposed on the same side of the first support portion and the second support portion along the parallel direction P.

[0073] In some embodiments, the length extension direction L of the first support portion, the second support portion, and the third support portion is perpendicular to the side-by-side direction P.

[0074] In other embodiments, the first support portion, the second support portion, and the third support portion may also be arranged at different heights.

[0075] To achieve better nucleic acid extraction results, the sample is heated at least during the lysis and elution stages. Therefore, in some embodiments, the nucleic acid extraction module may also include a heating device 300 for heating the sample.

[0076] Reference Figure 10 The heating device 300 has at least a first heating zone 310 and a second heating zone 320. The first heating zone 310 is set to correspond to the lysis zone 110 and is used to heat the sample in the lysis zone 110. The second heating zone 320 is set to correspond to the elution zone 130 and is used to heat the sample in the elution zone 130. In some embodiments, the heating temperatures of the first heating zone 310 and the second heating zone 320 can be adjusted independently to adapt to the different temperature requirements of the lysis and elution stages.

[0077] In this embodiment, by providing a lysis zone 110, a washing zone 120, and an elution zone 130 on the first sample carrier 100, and by having a first heating zone 310 and a second heating zone 320 respectively for heating the samples in the lysis zone 110 and the elution zone 130, the lysis, washing, and elution processes can be integrated into the first sample carrier 100, which helps to reduce the size of the sample analyzer. In some embodiments, the heating device 300 is provided with a third heating zone 330 corresponding to the drying zone 140, which is used to heat the samples in the drying zone 140. By providing the drying zone 140 and the third heating zone 330, the application scenarios of the sample analyzer can be expanded. It should be noted that the first sample carrying mechanism 100 can be pre-divided into a lysis zone 110, a washing zone 120, an elution zone 130, and a drying zone 140. If the sample does not need to be dried, the drying zone 140 and the third heating zone 330 can be deactivated; if the sample needs to be dried, the drying zone 140 and the third heating zone 330 can be activated accordingly. In some embodiments, the heating temperature of at least two of the first heating zone 310, the second heating zone 320, and the third heating zone 330 can be adjusted independently.

[0078] When the first sample carrier 100 has a drying zone 140 and the heating device 300 has a third heating zone 330, in some embodiments, at least two of the pyrolysis zone 110, elution zone 130, and drying zone 140 are integrated into the same region. Correspondingly, at least two of the first heating zone 310, second heating zone 320, and third heating zone 330 are integrated into the same region, with the same heating temperature range within the same region. Depending on the sample type, the temperature requirements for pyrolysis, drying, and elution differ. If the temperature ranges of at least two stages are approximately the same, regions with the same temperature range can be integrated into one region. This reduces the number of heating zones in the heating device 300 and simplifies the control of the heating device 300. Figure 2 , Figure 5 As shown, the drying zone 140 and the elution zone 130 are integrated into the same area, which is named the drying / elution zone for ease of description. The second heating zone 320 and the third heating zone 330 are integrated into the same area. Samples to be dried or eluted will be dispatched to the drying / elution zone for processing.

[0079] It should be noted that the integration referred to in this invention is the same region, which includes, for example... Figure 2 The case shown includes the situation where two or more regions are mixed together, as well as the situation where two or more regions are arranged adjacent to each other but are heated to the same temperature range by the heating zone. For example, in the former case, the sample to be dried or eluted can be placed in any empty placement position 150 in the drying / elution zone. In the latter case, the sample to be dried is placed in any empty placement position 150 in the drying zone 140, and the sample to be eluted is placed in any empty placement position 150 in the elution zone 130. The drying zone 140 and the elution zone 130 are heated to the same temperature range by the heating zone.

[0080] In other words, the heating device 300 has multiple heating zones, each corresponding to at least some functional areas. Specifically, in some embodiments, only samples in certain functional areas need heating, so only heating zones need to be set for those functional areas. In other embodiments, samples in every functional area need heating, so heating zones need to be set for all functional areas. Furthermore, similar to the aforementioned embodiments, at least two functional areas can be integrated, and the corresponding heating zones can also be integrated. Among the multiple heating zones of the heating device 300, the heating temperature of at least two heating zones can be independently adjusted to adapt to the temperature requirements of different stages in different incubation processes.

[0081] In some embodiments, the heating device 300 is provided with multiple heating elements corresponding to each heating zone, and each heating element heats the zone independently, thereby facilitating independent temperature adjustment. For example, refer to... Figure 5The heating device 300 includes a first heating element 340 and a second heating element 350. The first heating element 340 is disposed in the first heating zone 310 for heating the sample in the lysis zone 110, and the second heating element 350 is disposed in the second heating zone 320 for heating the sample in the elution zone 130.

[0082] When the first sample carrier 100 has a drying zone 140 and the heating device 300 has a third heating zone 330, in some embodiments, referring to Figure 5 The heating device 300 also has a third heating element 360, which is disposed in the third heating zone 330 for heating the sample in the drying zone 140. At least two of the lysis zone 110, elution zone 130 and drying zone 140 are integrated into the same region. Correspondingly, at least two of the first heating zone 310, second heating zone 320 and third heating zone 330 are integrated into the same region. The heating temperature range within the same region is the same. At least two of the first heating element 340, second heating element 350 and third heating element 360 are integrated into the same element.

[0083] In the illustrated embodiment, the drying zone 140 and the elution zone 130 are integrated into a drying / elution zone, the second heating zone 320 and the third heating zone 330 are integrated into the same area, and the second heating component 350 and the third heating component 360 are integrated into the same component. Samples to be dried or eluted will be dispatched to the drying / elution zone for processing.

[0084] It is understood that in other embodiments, the heating device 300 may also be configured as an integral heating device having multiple areas on which the temperature can be adjusted separately, serving as the aforementioned heating zones.

[0085] In some embodiments, refer to Figure 4 , Figure 5 The heating device 300 defines a plurality of heating chambers 390 corresponding to each placement position 150 of the lysis zone 110 and the elution zone 130. The heating chambers 390 are used to accommodate sample containers 500. Specifically, the heating chambers 390 are used to insert at least a portion of the sample containers 500. The shape of the heating chambers 390 corresponds to the outer contour of the inserted portion of the sample containers 500. This increases the contact area and ensures the heating effect, while also ensuring stable placement of the sample containers 500. In the illustrated embodiment, the heating chambers 390 are located below the placement positions 150, and have an opening at the top. The lower end of the sample container 500 can pass through the placement position 150 and continue to be inserted into the heating chambers 390.

[0086] In some embodiments, continue to refer to Figure 4 , Figure 5The heating device 300 includes a heating element 370 and a heat-conducting element 380. The heat-conducting element 380 is made of a material with good thermal conductivity, such as copper, aluminum, copper alloy, or aluminum alloy. The heat-conducting element 380 defines the aforementioned heating cavity 390. When the sample container 500 is inserted into the heating cavity 390, the heat-conducting element 380 at least circumferentially surrounds the inserted portion of the sample container 500, so that there is a large contact area between the heat-conducting element 380 and the sample container 500. This allows the heat generated by the heating element 370 to be evenly transferred to the sample container 500, ensuring heating efficiency and making the heating more uniform.

[0087] The heating element 370 is thermally connected to the heat-conducting element 380. This thermal connection can be either a direct connection between the heating element 370 and the heat-conducting element 380, or an indirect connection between the heating element 370 and the heat-conducting element 380 via other heat-conducting components. In the illustrated embodiment, the bottoms of the heating element 370 and the heat-conducting element 380 are attached to each other.

[0088] It should be noted that the samples in the washing area 120 usually do not need to be heated, so there is no need to set up a corresponding heating area. However, it is still possible to set up a corresponding mounting structure to fix the sample container 500. The mounting structure can be understood with reference to the aforementioned heat-conducting component 380.

[0089] The nucleic acid extraction module in this embodiment of the invention also discloses multiple auxiliary stations that assist in achieving functions such as washing, drying and elution. These auxiliary stations are set in the magnetic bead gathering device 800.

[0090] In some embodiments, the molecular diagnostic analyzer further includes a control module (not shown) for controlling the magnetic bead mixing device 700, the magnetic bead aggregation device 800, and the transfer device 900.

[0091] In some implementations, the lysed nucleic acid samples can be eluted without drying after washing. In this case, the control module is configured as follows: The control transfer device 900 transfers the sample container 500 containing the sample and magnetic bead reagent to the first sample carrying mechanism 100; The mixing mechanism 200 mixes the magnetic beads in the sample container 500 so that the magnetic beads in the sample container can capture nucleic acids; The control transfer device 900 transfers the mixed sample container 500 from the first sample carrier 100 to the second sample carrier 810, thereby the gathering magnet 820 gathers the magnetic beads in the mixed sample container so that after the magnetic beads gather, waste liquid can be drawn out from the sample container and discharged, and cleaning liquid can be injected into the sample container. The control transfer device 900 transfers the sample container 500, which has been injected with cleaning fluid, from the second sample carrying mechanism 810 to the first sample carrying mechanism 100; The mixing mechanism 200 mixes the magnetic beads in the sample container 500, which has been injected with cleaning solution, in order to clean the nucleic acids captured by the magnetic beads in the sample container; The control transfer device 900 transfers the cleaned sample container 500 from the first sample carrier 100 to the second sample carrier 810, thereby the gathering magnet 820 gathers the magnetic beads in the cleaned sample container so that after the magnetic beads gather, waste liquid can be drawn from the sample container and discharged, and eluent can be injected into the sample container. The control transfer device 900 transfers the sample container 500 containing the eluent from the second sample carrier 810 to the first sample carrier 100; The mixing mechanism 200 mixes the magnetic beads in the sample container 500 containing the elution buffer so that the nucleic acid in the sample container is eluted from the magnetic beads.

[0092] In some embodiments, the control module controls the transfer device to transfer a sample container containing a sample and magnetic bead reagent to the first sample carrying mechanism, including: the control module controls the transfer device to transfer the sample container containing a sample and magnetic bead reagent to the lysis zone.

[0093] In some alternative or additional embodiments, the control module controls the transfer device to transfer the homogenized sample container from the first sample support mechanism to the second sample support mechanism, thereby causing the aggregating magnet to aggregate the magnetic beads in the homogenized sample container so that, after the magnetic beads aggregate, waste liquid is drawn from the sample container and discharged, and cleaning fluid is injected into the sample container. This includes: the control module controlling the transfer device to transfer the homogenized sample container from the lysis zone to the first support part, thereby causing the aggregating magnet to aggregate the magnetic beads in the homogenized sample container, and after the magnetic beads aggregate, controlling the first suction and discharge mechanism to draw waste liquid from the sample container and discharge it, and controlling the first injection mechanism to inject cleaning fluid into the sample container.

[0094] In some alternative or additional embodiments, the control module controls the transfer device to transfer the sample container filled with cleaning fluid from the second sample carrier to the first sample carrier, including: the control module controls the transfer device to transfer the sample container filled with cleaning fluid from the first carrier to the washing area.

[0095] In some alternative or additional embodiments, the control module controls the transfer device to transfer the cleaned sample container from the first sample carrier to the second sample carrier, thereby causing the aggregating magnet to aggregate the magnetic beads in the cleaned sample container so that waste liquid can be drawn from the sample container and discharged after the magnetic beads have aggregated, and eluent can be injected into the sample container. This includes: the control module controlling the transfer device to transfer the cleaned sample container from the washing zone to the second carrier, thereby causing the aggregating magnet to aggregate the magnetic beads in the cleaned sample container, and after the magnetic beads have aggregated, controlling the second suction and discharge mechanism to draw waste liquid from the sample container and discharge it, and controlling the second injection mechanism to inject eluent into the sample container.

[0096] In some alternative or additional embodiments, the control module controls the transfer device to transfer the sample container injected with eluent from the second sample carrier to the first sample carrier, including: the control module controls the transfer device to transfer the sample container injected with eluent from the second carrier to the elution zone.

[0097] In some other implementations, the lysed nucleic acid samples are washed and dried before elution. In this case, the control module is configured as follows: The control transfer device 900 transfers the sample container 500 containing the sample and magnetic bead reagent to the first sample carrying mechanism 100; The mixing mechanism 200 mixes the magnetic beads in the sample container 500 so that the magnetic beads in the sample container can capture nucleic acids; The control transfer device 900 transfers the mixed sample container 500 from the first sample carrier 100 to the second sample carrier 810, thereby the gathering magnet 820 gathers the magnetic beads in the mixed sample container so that after the magnetic beads gather, waste liquid can be drawn out from the sample container and discharged, and cleaning liquid can be injected into the sample container. The control transfer device 900 transfers the sample container 500, which has been injected with cleaning fluid, from the second sample carrying mechanism 810 to the first sample carrying mechanism 100; The mixing mechanism 200 mixes the magnetic beads in the sample container 500, which has been injected with cleaning solution, in order to clean the nucleic acids captured by the magnetic beads in the sample container; The control transfer device 900 transfers the cleaned sample container 500 from the first sample carrier 100 to the second sample carrier 810, thereby the gathering magnet 820 gathers the magnetic beads in the cleaned sample container so that waste liquid can be drawn out of the sample container and discharged after the magnetic beads gather. The control transfer device 900 transfers the sample container 500 containing the waste liquid to the first sample carrier 100 from the second sample carrier 810 in order to dry the magnetic beads in the sample container. The control transfer device 900 transfers the dried sample container 500 from the first sample carrier 100 to the second sample carrier 810 so as to inject the eluent into the sample container. The control transfer device 900 transfers the sample container 500, which has been injected with eluent, from the second sample carrier 810 to the first sample carrier 100; and The mixing mechanism 200 mixes the magnetic beads in the sample container 500 containing the elution buffer so that the nucleic acid in the sample container is eluted from the magnetic beads.

[0098] In some embodiments, the control module controls the transfer device to transfer a sample container containing the sample and magnetic bead reagent to the first sample carrying mechanism, including the control module controlling the transfer device to transfer the sample container containing the sample and magnetic bead reagent to the lysis zone.

[0099] In some alternative or additional embodiments, the control module controls the transfer device to transfer the homogenized sample container from the first sample support mechanism to the second sample support mechanism, thereby causing the aggregating magnet to aggregate the magnetic beads in the homogenized sample container so that, after the magnetic beads aggregate, waste liquid is drawn from the sample container and discharged, and cleaning fluid is injected into the sample container. This includes: the control module controlling the transfer device to transfer the homogenized sample container from the lysis zone to the first support part, thereby causing the aggregating magnet to aggregate the magnetic beads in the homogenized sample container, and after the magnetic beads aggregate, controlling the first suction and discharge mechanism to draw waste liquid from the sample container and discharge it, and controlling the first injection mechanism to inject cleaning fluid into the sample container.

[0100] In some alternative or additional embodiments, the control module controls the transfer device to transfer the sample container filled with cleaning fluid from the second sample carrier to the first sample carrier, including: the control module controlling the transfer device to transfer the sample container filled with cleaning fluid from the first carrier to the washing area; and / or

[0101] In some alternative or additional embodiments, the control module controls the transfer device to transfer the cleaned sample container from the first sample carrier to the second sample carrier, thereby causing the gathering magnet to gather magnetic beads in the cleaned sample container so that waste liquid can be drawn from the sample container and discharged after the magnetic beads have gathered. This includes: the control module controlling the transfer device to transfer the cleaned sample container from the washing area to the second carrier, thereby causing the gathering magnet to gather magnetic beads in the cleaned sample container, and controlling the second suction and discharge mechanism to draw waste liquid from the sample container and discharge it after the magnetic beads have gathered.

[0102] In some alternative or additional embodiments, the control module controls the transfer device to transfer the sample container with the absorbed waste liquid from the second sample support mechanism to the first sample support mechanism, including: the control module controls the transfer device to transfer the sample container with the absorbed waste liquid from the second support part to the drying zone, so as to dry the magnetic beads in the sample container.

[0103] In some alternative or additional embodiments, the control module controls the transfer device to transfer the dried sample container from the first sample carrier to the second sample carrier 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 zone to the third carrier, and controls the third injection mechanism to inject eluent into the sample container.

[0104] In some alternative or additional embodiments, the control module controls the transfer device to transfer the sample container injected with eluent from the second sample carrier to the first sample carrier, including: the control module controls the transfer device to transfer the sample container injected with eluent from the third carrier to the elution zone.

[0105] The following describes some different embodiments of the nucleic acid extraction process of the nucleic acid extraction module according to the present invention.

[0106] In the first embodiment, the lysed nucleic acid sample can be eluted after one washing without drying, and the nucleic acid extraction module includes a first auxiliary station and a third auxiliary station.

[0107] Specifically, the first auxiliary station assists in the washing process and includes the first support unit 811, the first gathering magnet 821, the first suction and discharge mechanism 830, and the first liquid injection mechanism 840. Driven by the driving device 400, the first sample support mechanism 100 moves to move the sample container 500 containing the lysed sample in the lysis zone 110 to the transfer position T. The transfer device removes the sample container 500 from the first sample support mechanism 100 and transfers it to the first auxiliary station. The first gathering magnet 821 adsorbs the magnetic beads from the removed sample container 500 at the first auxiliary station, causing the magnetic beads to remain stationary on one side of the sample container 500. After the first gathering magnet 821 completes its magnetic attraction, the first suction and discharge mechanism sucks up the waste liquid from the sample container 500 and discharges it to a designated location. The first liquid injection mechanism injects washing liquid into the sample container after sucking up the waste liquid. Once the washing solution is injected into the sample container, the initial preparation for washing is complete. At this time, the movement of the first sample carrying mechanism 100 causes an empty placement position 150 in the washing area 120 to move to the transfer position T. The transfer device then transfers the sample container 500 containing the washing solution to the placement position 150 for subsequent washing operations.

[0108] The third auxiliary station assists in the elution step and includes the second carrier 812, the second gathering magnet 822, the second suction and discharge mechanism 850, and the second liquid injection mechanism 860. Driven by the drive device 400, the first sample carrier 100 moves to move the sample container 500 containing the washed sample in the washing area 120 to the transfer position T. The transfer device removes the sample container 500 from the first sample carrier 100 and transfers it to the third auxiliary station. The second gathering magnet 822 adsorbs the magnetic beads from the removed sample container 500 at the third auxiliary station, causing the magnetic beads to remain stationary on one side of the sample container 500. After the second gathering magnet 822 completes its magnetic attraction, the second suction and discharge mechanism sucks up the waste liquid in the sample container 500 and discharges it to a designated location. The second liquid injection mechanism injects elution solution into the sample container after the waste liquid is sucked up. Once the elution buffer is injected into the sample container, the preparation for elution is complete. At this time, the first sample carrying mechanism 100 moves, causing an empty placement position 150 in the elution zone 130 to move to the transfer position T. The transfer device then transfers the sample container 500 containing the washing buffer to the placement position 150 for subsequent elution operations.

[0109] In the second embodiment, the lysed nucleic acid sample is washed once and dried before elution. The nucleic acid extraction module includes a first auxiliary station, a second auxiliary station and a third auxiliary station.

[0110] Specifically, the first auxiliary station assists in the washing process and includes the first support unit 811, the first gathering magnet 821, the first suction and discharge mechanism 830, and the first liquid injection mechanism 840. Driven by the driving device 400, the first sample support mechanism 100 moves to move the sample container 500 containing the lysed sample in the lysis zone 110 to the transfer position T. The transfer device removes the sample container 500 from the first sample support mechanism 100 and transfers it to the first auxiliary station. The first gathering magnet 821 adsorbs the magnetic beads from the removed sample container 500 at the first auxiliary station, causing the magnetic beads to remain stationary on one side of the sample container 500. After the first gathering magnet 821 completes its magnetic attraction, the first suction and discharge mechanism sucks up the waste liquid from the sample container 500 and discharges it to a designated location. The first liquid injection mechanism injects washing liquid into the sample container after sucking up the waste liquid. Once the washing solution is injected into the sample container, the initial preparation for washing is complete. At this time, the first sample carrying mechanism 100 moves, causing an empty placement position 150 in the washing area 120 to move to the transfer position T. The transfer device then transfers the sample container 500 containing the washing solution to the placement position 150 for subsequent washing operations.

[0111] The second auxiliary station assists in the drying process and includes the second gathering magnet 821 and the second suction and discharge mechanism 850. Driven by the driving device 400, the first sample carrying mechanism 100 moves, causing the sample container 500 containing the washed sample in the washing area 120 to move to the transfer position T. The transfer device removes the sample container 500 from the first sample carrying mechanism 100 and transfers it to the second auxiliary station. The second gathering magnet at the second auxiliary station attracts the magnetic beads from the removed sample container 500, causing the magnetic beads to remain stationary on one side of the sample container 500. After the second gathering magnet completes its magnetic attraction, the second suction and discharge mechanism sucks up the waste liquid in the sample container 500 and discharges it to a designated location. At this point, the sample container 500 is ready for drying. The first sample carrying mechanism 100 moves, causing an empty placement position 150 in the drying area 140 to move to the transfer position T. The transfer device then transfers the sample container 500, after sucking up the waste liquid, to the empty placement position 150 in the drying area 140 for subsequent drying operations.

[0112] The third auxiliary station assists in the elution step and includes the third carrier 813 and the second injection mechanism 860. Driven by the drive device 400, the first sample carrier 100 moves to move the sample container 500 containing the dried sample in the drying zone 140 to the transfer position T. The transfer device moves the sample container 500 out of the first sample carrier 100 and to the third auxiliary station, where the second injection mechanism injects elution solution into the sample container. Once the elution solution is injected into the sample container, the preparatory work for elution is complete. At this point, the first sample carrier 100 moves to move an empty placement position 150 in the elution zone 130 to the transfer position T. The transfer device then transfers the sample container 500 containing the elution solution to this placement position 150 for subsequent elution operations.

[0113] In the third embodiment, the lysed nucleic acid sample can be eluted without drying after a second washing. The extraction module includes a first auxiliary station, a third auxiliary station, and a fourth auxiliary station.

[0114] Specifically, the first auxiliary station is used to assist in the first washing step, and includes a first support part 811, a first gathering magnet 821, a first suction and discharge mechanism 830, and a first liquid injection mechanism 840. Driven by the driving device 400, the first sample support mechanism 100 can move to move the sample container 500 containing the lysed sample in the lysis zone 110 to the transfer position T. The transfer device removes the sample container 500 from the first sample support mechanism 100 and transfers it to the first auxiliary station. The first gathering magnet 821 adsorbs the magnetic beads from the removed sample container 500 at the first auxiliary station, causing the magnetic beads to remain stationary on one side of the sample container 500. After the first gathering magnet completes its magnetic attraction, the first suction and discharge mechanism sucks up the waste liquid in the sample container 500 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 sucking up the waste liquid. After the first washing solution is injected into the sample container, the preparation for the first washing is completed. At this time, the first sample carrying mechanism 100 moves, causing an empty placement position 150 in the washing area 120 to move to the transfer position T. The transfer device transfers the sample container 500 containing the first washing solution to the placement position 150 for subsequent washing operations.

[0115] The fourth auxiliary station assists in the second washing step and includes another first carrier 811, another first gathering magnet 821, another first suction and discharge mechanism 830, and another first liquid injection mechanism 840. Driven by the drive device 400, the first sample carrier 100 moves to move the sample container 500 containing the sample that has completed the first washing in the washing area 120 to the transfer position T. The transfer device moves the sample container 500 out of the first sample carrier 100 and to the fourth auxiliary station. The other first gathering magnet at the fourth auxiliary station attracts the magnetic beads from the sample container 500 after it has been moved out, causing the magnetic beads to remain stationary on one side of the sample container 500. After the other first gathering magnet completes its magnetic attraction, the other first suction and discharge mechanism sucks up the waste liquid in the sample container 500 and discharges it to a designated location. The other first liquid injection device injects the second washing liquid into the sample container after the waste liquid is sucked up. After the second washing solution is injected into the sample container, the preparation for the second washing is completed. At this time, the first sample carrying mechanism 100 moves, causing an empty placement position 150 in the washing area 120 to move to the transfer position T. The transfer device transfers the sample container 500 containing the second washing solution to the placement position 150 for the subsequent second washing operation.

[0116] The third auxiliary station assists in the elution step and includes the second carrier 812, the second gathering magnet 822, the second suction and discharge mechanism 850, and the second liquid injection mechanism 860. Driven by the drive device 400, the first sample carrier 100 moves to move the sample container 500 containing the sample that has undergone secondary washing in the washing area 120 to the transfer position T. The transfer device removes the sample container 500 from the first sample carrier 100 and transfers it to the third auxiliary station. The second gathering magnet 822 adsorbs the magnetic beads from the removed sample container 500 at the third auxiliary station, causing the magnetic beads to remain stationary on one side of the sample container 500. After the second gathering magnet 822 completes its magnetic attraction, the second suction and discharge mechanism sucks up the waste liquid in the sample container 500 and discharges it to a designated location. The second liquid injection mechanism injects elution solution into the sample container after the waste liquid is sucked up. Once the elution buffer is injected into the sample container, the preparation for elution is complete. At this time, the first sample carrying mechanism 100 moves, causing an empty placement position 150 in the elution zone 130 to move to the transfer position T. The transfer device then transfers the sample container 500 containing the washing buffer to the placement position 150 for subsequent elution operations.

[0117] In the fourth embodiment, the lysed nucleic acid sample is washed twice and 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.

[0118] Specifically, the first auxiliary station is used to assist in the first washing step, and includes a first carrier 811, a first gathering magnet 821, a first suction and discharge mechanism 830, and a first liquid injection mechanism 840. Driven by the driving device 400, the first sample carrier 100 can move to move the sample container 500 containing the lysed sample in the lysis zone 110 to the transfer position. The transfer device moves the sample container 500 out of the first sample carrier 100 and to the first auxiliary station. The first gathering magnet 821 adsorbs the magnetic beads from the sample container 500 after it has been removed, causing the magnetic beads to remain stationary on one side of the sample container 500. After the first gathering magnet completes its magnetic attraction, the first suction and discharge mechanism sucks up the waste liquid in the sample container 500 and discharges it to a designated location. The first liquid injection device injects the first washing liquid into the sample container after the waste liquid is sucked up. After the first washing solution is injected into the sample container, the preparation for the first washing is completed. At this time, the first sample carrying mechanism 100 moves, causing an empty placement position 150 in the washing area 120 to move to the transfer position. The transfer device transfers the sample container 500 containing the first washing solution to the placement position 150 for subsequent washing operations.

[0119] The fourth auxiliary station assists in the second washing step and includes another first carrier 811, another first gathering magnet 821, another first suction and discharge mechanism 830, and another first liquid injection mechanism 84. Driven by the drive device 400, the first sample carrier 100 moves to move the sample container 500 containing the sample that has completed the first washing in the washing area 120 to the transfer position. The transfer device moves the sample container 500 out of the first sample carrier 100 and to the fourth auxiliary station. The other first gathering magnet at the fourth auxiliary station attracts the magnetic beads from the sample container 500 after it has been moved out, causing the magnetic beads to remain stationary on one side of the sample container 500. After the other first gathering magnet completes its magnetic attraction, the other first suction and discharge mechanism sucks up the waste liquid in the sample container 500 and discharges it to a designated location. The other first liquid injection device injects the second washing liquid into the sample container after the waste liquid is sucked up. After the second washing solution is injected into the sample container, the preparation for the second washing is completed. At this time, the first sample carrying mechanism 100 moves, causing an empty placement position 150 in the washing area 120 to move to the transfer position. The transfer device transfers the sample container 500 containing the second washing solution to the placement position 150 for the subsequent second washing operation.

[0120] The second auxiliary station assists in the drying process and includes the second gathering magnet 821 and the second suction and discharge mechanism 850. Driven by the driving device 400, the first sample carrying mechanism 100 moves, causing the sample container 500 containing the sample that has undergone secondary washing in the washing area 120 to move to the transfer position T. The transfer device moves the sample container 500 out of the first sample carrying mechanism 100 and to the second auxiliary station. The second gathering magnet at the second auxiliary station attracts the magnetic beads from the sample container 500 after it has been removed, causing the magnetic beads to remain stationary on one side of the sample container 500. After the second gathering magnet completes its magnetic attraction, the second suction and discharge mechanism sucks up the waste liquid in the sample container 500 and discharges it to a designated location. At this point, the sample container 500 is ready for drying. The first sample carrying mechanism 100 moves, causing an empty placement position 150 in the drying area 140 to move to the transfer position T. The transfer device then transfers the sample container 500, after sucking up the waste liquid, to the empty placement position 150 in the drying area 140 for subsequent drying operations.

[0121] The third auxiliary station assists in the elution step and includes the third carrier 813 and the second eluent injection mechanism 86. Driven by the drive device 400, the first sample carrier 100 moves to move the sample container 500 containing the dried sample in the drying zone 140 to the transfer position T. The transfer device moves the sample container 500 out of the first sample carrier 100 and to the third auxiliary station, where the second eluent injection mechanism injects eluent into the sample container. Once the eluent is injected into the sample container, the preparatory work for elution is complete. At this point, the first sample carrier 100 moves to move an empty placement position 150 in the elution zone 130 to the transfer position T. The transfer device then transfers the sample container 500 containing the eluent to this placement position 150 for subsequent elution operations.

[0122] Accordingly, such as Figure 11 As shown, this embodiment of the invention also provides a nucleic acid extraction method 1000, comprising: Capture step S1100: The sample container containing a sample containing nucleic acid and magnetic beads for adsorbing nucleic acid are transferred to the first sample carrying mechanism of the magnetic bead mixing device, so that the mixing mechanism of the magnetic bead mixing device mixes the magnetic beads in the sample container on the first sample carrying mechanism so that the magnetic beads in the sample container capture nucleic acid. First magnetic bead aggregation step S1200: The mixed sample container is transferred from the first sample carrying mechanism to the second sample carrying mechanism of the magnetic bead aggregation device, which is set separately from the magnetic bead mixing device. The aggregation magnet of the magnetic bead aggregation device aggregates the magnetic beads in the mixed sample container so that waste liquid can be drawn out from the sample container after the magnetic beads are aggregated and discharged, and cleaning liquid can be injected into the sample container. Cleaning step: S1300 The sample container injected with cleaning solution is transferred from the second sample carrier to the first sample carrier, so that the mixing mechanism mixes the magnetic beads in the sample container injected with cleaning solution in order to clean the nucleic acids captured by the magnetic beads in the sample container; Second magnetic bead aggregation step S1400: The cleaned sample container is transferred from the first sample carrying mechanism to the second sample carrying mechanism, so that the aggregation magnet aggregates the magnetic beads in the cleaned sample container, so that after the magnetic beads are aggregated, waste liquid is drawn from the sample container and discharged, and elution liquid is injected into the sample container. Elution step S1500: The sample container injected with elution solution is transferred from the second sample carrier to the first sample carrier, so that the mixing mechanism mixes the magnetic beads in the sample container injected with elution solution so that the nucleic acid in the sample container is eluted from the magnetic beads.

[0123] like Figure 12 As shown, this invention also provides another nucleic acid extraction method 2000, comprising: Capture step S2100: The sample containing nucleic acid and the sample container for adsorbing magnetic beads are transferred to the first sample carrying mechanism of the magnetic bead mixing device, so that the mixing mechanism of the magnetic bead mixing device mixes the magnetic beads in the sample container on the first sample carrying mechanism so that the magnetic beads in the sample container capture nucleic acid. First magnetic bead aggregation step S2200: The mixed sample container is transferred from the first sample carrying mechanism to the second sample carrying mechanism of the magnetic bead aggregation device, which is set separately from the magnetic bead mixing device. The aggregation magnet of the magnetic bead aggregation device aggregates the magnetic beads in the mixed sample container so that waste liquid can be drawn out from the sample container after the magnetic beads are aggregated and discharged, and cleaning liquid can be injected into the sample container. Cleaning step S2300: The sample container injected with cleaning solution is transferred from the second sample carrier to the first sample carrier, so that the mixing mechanism mixes the magnetic beads in the sample container injected with cleaning solution in order to clean the nucleic acids captured by the magnetic beads in the sample container; Second magnetic bead aggregation step S2400: The cleaned sample container is transferred from the first sample carrying mechanism to the second sample carrying mechanism, so that the aggregation magnet aggregates the magnetic beads in the cleaned sample container, so that waste liquid can be drawn out from the sample container and discharged after the magnetic beads are aggregated. Drying step S2500: The sample container with the waste liquid to be absorbed is transferred from the second sample carrier to the first sample carrier so as to dry the magnetic beads in the sample container; Eluent injection step S2600: The dried sample container is transferred from the first sample carrier to the second sample carrier so as to inject eluent into the sample container; Elution step S2700: The sample container injected with elution solution is transferred from the second sample carrier to the first sample carrier, so that the mixing mechanism mixes the magnetic beads in the sample container injected with elution solution so that the nucleic acid in the sample container is eluted from the magnetic beads.

[0124] In some embodiments, the first magnetic bead aggregation step S1200 / S2200 and the cleaning step S1300 / S2300 include: First magnetic bead aggregation sub-step: The mixed sample container is transferred from the first sample carrying mechanism to the second sample carrying mechanism, whereby 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 cleaning solution is injected into the sample container. First washing sub-step: The sample container injected with the first washing solution is transferred from the second sample carrier to the first sample carrier, so that the mixing mechanism mixes the magnetic beads in the sample container injected with the first washing solution in order to wash the nucleic acids captured by the magnetic beads in the sample container; The second magnetic bead aggregation sub-step involves transferring the sample container, after first cleaning, from the first sample carrier to the second sample carrier, whereby the aggregation magnet aggregates the magnetic beads in the first-cleaned sample container. This allows for the extraction and discharge of waste liquid from the sample container after aggregation, followed by the injection of a second cleaning solution into the sample container. The second washing sub-step involves transferring the sample container injected with the second washing solution from the second sample carrier to the first sample carrier, whereby the mixing mechanism mixes the magnetic beads in the sample container injected with the second washing solution to clean the nucleic acids captured by the magnetic beads in the sample container.

[0125] Specifically, some embodiments of the present invention disclose a nucleic acid extraction method, which uses a nucleic acid extraction module. The nucleic acid extraction module includes a first sample carrying mechanism 100 and a heating device 300. The first sample carrying mechanism 100 is used to provide an operating area for the aforementioned lysis, washing and elution steps, and the heating device 300 is used to heat the sample.

[0126] The first sample carrier 100 has at least a lysis zone 110, a washing zone 120, and an elution zone 130, which are integrated into the same component, such as the incubation tray shown in the figure. Each of the lysis zone 110, washing zone 120, and elution zone 130 is provided with a placement position 150 for placing a sample container 500 containing the sample and magnetic beads.

[0127] The heating device 300 is used to heat the samples in the lysis zone 110 and the elution zone 130 at least. In some embodiments, it has at least a first heating zone 310 and a second heating zone 320. The first heating zone 310 is provided corresponding to the lysis zone 110 and is used to heat the samples in the lysis zone 110. The second heating zone 320 is provided corresponding to the elution zone 130 and is used to heat the samples in the elution zone 130.

[0128] It should be noted that the extraction module using the extraction method of this embodiment can be used as a standalone extraction device or integrated into the sample analyzer 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 device 200, a driving device 400, and a transfer device. The mixing device 200 is used to mix the magnetic beads in the sample container, the driving device 400 is used to drive the first sample carrying mechanism 100 to move, and the transfer device is used to transfer the sample container 500.

[0129] The transfer device is used to transfer the sample container 500. It can coordinate with the movement of the first sample carrying mechanism 100 to schedule the sample container 500 between different placement positions 150. For example, the transfer device includes one or more transfer components arranged adjacent to the first sample carrying mechanism 100. The first sample carrying mechanism 100 can align a placement position 150 containing the sample container 500 with a transfer component through movement. The transfer component removes the sample container 500 from that placement position 150. Then, the first sample carrying mechanism 100 moves to align other placement positions 150 with the transfer component, and the transfer component then places the sample container 500 into the new placement position 150. It is understood that the transfer device can also schedule the sample container 500 between the first sample carrying mechanism 100 and the devices therein. The transfer component can be a robotic arm capable of moving and / or rotating in a set direction. Based on the aforementioned structure, refer to... Figure 13 The sample extraction method includes the following steps: Step S100: The lysis step of the sample to be lysed is carried out in the lysis zone 110. Specifically, the lysis system can be constructed in other devices in the previous step, such as adding lysis solution to the sample container and transferring the sample container with added lysis solution to the empty placement position 150 of the lysis zone 110. The heating device 300 heats the sample container 500 to be lysed in the lysis zone 110.

[0130] Step S200: After the lysis step is completed, a first auxiliary step is performed to assist the subsequent washing process. The first auxiliary step includes magnetic adsorption of magnetic beads in the sample container 500. After the magnetic beads are adsorbed, the waste liquid in the sample container 500 is absorbed and discharged. After the waste liquid is absorbed, washing liquid is injected.

[0131] Step S300: After the first auxiliary step is completed, the sample to be washed is washed in the washing area 120.

[0132] Step S400: After the washing step is completed, a second auxiliary step is performed, which includes magnetic adsorption of magnetic beads in the sample container, and after the magnetic beads are adsorbed, the waste liquid in the sample container is absorbed and discharged. Step S500: After the second auxiliary step is completed, the third auxiliary step is performed, which includes injecting elution buffer into the sample container; Step 600: After the third auxiliary step is completed, the elution step of the sample to be eluted is carried out in the elution zone.

[0133] The first sample carrier 100 of this embodiment is provided with a lysis zone 110, a washing zone 120 and an elution zone 130, so that the lysis, washing and elution processes can be integrated into the first sample carrier 100, which helps to reduce the size of the sample analyzer.

[0134] In some embodiments, the time for the pyrolysis step is defined as t1, the time for the washing step is defined as t2, the time for the elution step is defined as t3, and the times for the first auxiliary step, the second auxiliary step, and the third auxiliary step are set to be equal and defined as t0. Here, t1, t2, and t3 are all set to integer multiples of t0. That is, in this embodiment, the time spent by each auxiliary step is unified and used as the smallest unit to plan the time consumed by the pyrolysis, washing, drying and other links, so as to facilitate the controller to record the start and end time of each link, simplify the timing design of the first sample carrying mechanism 100, and thus reduce the overall control difficulty.

[0135] It should be noted that t1, t2, and t3 can be equal or unequal.

[0136] It should also be noted that the operations to be performed in the first, second and third auxiliary steps are not the same. In order to facilitate the unification of time, the auxiliary step with the longest time consumption can be used as the basic time plan t0. After the operations in other auxiliary steps are completed, a preset time can be waited for the total time to reach t0.

[0137] In some embodiments, the lysed sample needs to be washed twice. Therefore, for ease of description, the washing solution injected in the first auxiliary step is referred to as the first washing solution. Figure 14The washing step S300 includes: S310: After the first auxiliary step is completed, the first washing sub-step of the sample to be washed is carried out in the washing area 120 with the first washing solution.

[0138] S320: After the first washing sub-step is completed, a fourth auxiliary step is performed. The fourth auxiliary step includes magnetic adsorption of magnetic beads in the sample container 500. After the magnetic beads are adsorbed, the waste liquid in the sample container 500 is aspirated and discharged. After the waste liquid is aspirated and discharged, the second washing liquid is injected.

[0139] S330: After the fourth auxiliary step is completed, the second washing sub-step of the sample to be washed is carried out in the washing zone 120 with the second washing solution.

[0140] When the sample requires two washing cycles, in some embodiments, the time for the first washing sub-step is defined as t21, the time for the second washing sub-step as t22, and the time for the fourth auxiliary step as t0, where t21 and t22 are both set as integer multiples of t0. Similarly, this embodiment unifies the time spent on each auxiliary step and uses it as the smallest unit to plan the time consumed by the pyrolysis, washing, and drying processes, thereby facilitating the controller to record the start and end times of each process, simplifying the timing design of the first sample carrying mechanism 100, and thus reducing the overall control difficulty.

[0141] In some embodiments, each auxiliary step further includes the step of transferring the sample container 500. Specifically, the first auxiliary step further includes: transferring the sample container 500 out of the first sample carrying mechanism 100 and transferring it to the first operating position through a transfer device, and performing operations such as magnetic suction, suction and discharge of waste liquid and injection of washing liquid at the first operating position. The sample container 500 injected with washing liquid is then transferred into the washing area 120 of the first sample carrying mechanism 100 through the transfer device.

[0142] The second auxiliary step also includes: moving the sample container 500 out of the first sample carrying mechanism 100 and transferring it to the second operating position using a transfer device, and performing operations such as magnetic suction and waste liquid suction and discharge at the second operating position. After suctioning and discharging the waste liquid, the sample container 500 is moved into an empty placement position 150 of the first sample carrying mechanism 100. In some embodiments, the sample container 500 is preferentially moved into the empty placement position 150 closest to the second operating position. In other embodiments, the sample container is preferentially moved into an empty placement position 150 within the drying area 140.

[0143] The third auxiliary step also includes: moving the sample container 500 out of the first sample carrier 100 and transferring it to the third operating position using a transfer device, injecting elution solution at the third operating position, and then moving the sample container 500 back into the elution zone 130 of the first sample carrier 100 using the transfer device after injecting the elution solution.

[0144] In this embodiment, since a transfer device is provided to move the sample container 500 that needs to perform auxiliary steps out of the first sample carrying mechanism 100, the first sample carrying mechanism 100 can perform other scheduling while the sample container 500 is performing auxiliary steps, thereby enabling the scheduling of different sample containers 500. Furthermore, since the first sample carrying mechanism 100 can transport the sample container 500 to different locations, the transfer device can be relatively fixed, requiring only to perform fixed actions, thus simplifying the control of the transfer device.

[0145] It should be noted that, as mentioned above, in some embodiments, each auxiliary station is provided with a separate transfer component, while in other embodiments, at least two auxiliary stations share a single transfer component to reduce costs.

[0146] It should also be noted that if the sample does not need to be dried, the second and third operating positions can be the same operating position. That is, after completing the second auxiliary step, the third auxiliary step can be performed directly in the same operating position, thereby eliminating the step of transferring the first sample carrier 100 in and out between the second and third auxiliary steps, which can improve efficiency.

[0147] In some embodiments, the sample needs to be dried after washing before elution. The first sample carrier 100 of the corresponding sample analyzer also has a drying zone 140 with a placement position 150. The heating device 300 also has a third heating zone 330 for heating the sample in the drying zone 140. Both the drying zone 140 and the third heating zone 330 can be understood with reference to the foregoing embodiments and will not be described in detail here. The sample extraction method also includes a drying step, as described above. Figure 10 and Figure 11 After the second auxiliary step is completed, the sample to be washed is dried in the drying zone 140. After the drying step is completed, the third auxiliary step is performed. For example, after the sample washing is completed and the waste liquid in the sample container 500 is aspirated and drained, the sample container is moved into the empty placement position 150 of the drying zone 140 by a transfer device. After drying is completed, the sample container 500 is moved into the third operation position by a transfer device.

[0148] It should be noted that the sample container 500 in this embodiment is not limited to the extraction tube of the aforementioned embodiment. It can be selected as other sample containers depending on the sample to be incubated, and correspondingly, the definition of the placement position 150 is also adjusted according to the different sample containers. Similarly, the function and number of functional areas can also be adjusted according to the incubation requirements of different samples.

[0149] Furthermore, embodiments of the present invention also provide a molecular diagnostic analyzer, comprising: a nucleic acid extraction module configured to extract nucleic acids from a sample; an amplification module configured to amplify the nucleic acids extracted by the extraction module; a detection module configured to detect the amplified nucleic acids; and a rack on which the nucleic acid extraction module, the amplification module, and the detection module are mounted.

[0150] Here, the nucleic acid extraction module includes a sample carrier and an adsorption magnet. The sample carrier includes a lysis zone, a washing zone, and an elution zone. Each of the lysis zone, washing zone, and elution zone has a placement position for holding a sample container containing the sample and magnetic bead reagent. The magnetic beads in the magnetic bead reagent are used to adsorb nucleic acids from the sample. The adsorption magnet is used to adsorb the magnetic beads in the sample container.

[0151] In some embodiments, the adsorption magnet may include a mixing magnet for adsorbing magnetic beads in the sample container to mix the beads. Accordingly, the sample carrying device includes the first sample carrying mechanism 100 described above, and further embodiments and advantages thereof can be found in the above description, and will not be repeated here.

[0152] Preferably, the mixing magnet can be configured such that the magnetic field it generates can at least cover the lysis zone, the washing zone and the elution zone, thereby enabling simultaneous mixing of magnetic beads in sample containers placed in the lysis zone, the washing zone and the elution zone.

[0153] In some embodiments, the adsorption magnet may include an aggregation magnet 820 for adsorbing magnetic beads in the sample container to aggregate the beads. Further embodiments and advantages thereof can be found in the above description and will not be repeated here. Correspondingly, the sample carrying device includes the second sample carrying mechanism 810 described above. Further embodiments and advantages thereof can be found in the above description and will not be repeated here.

[0154] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings. However, the present invention is not limited to the above embodiments, and various changes can be made within the scope of knowledge possessed by those skilled in the art without departing from the spirit of the present invention. Furthermore, the embodiments of the present invention and the features thereof can be combined with each other unless otherwise specified.

Claims

1. A molecular diagnostic analyzer, comprising: The nucleic acid extraction module is configured to extract nucleic acids from samples. An amplification module is configured to amplify the nucleic acid extracted by the nucleic acid extraction module; The detection module is designed to detect amplified nucleic acids. The molecular diagnostic analyzer is characterized in that it further includes a rack, on which the nucleic acid extraction module, the amplification module, and the detection module are mounted; The nucleic acid extraction module includes a first sample carrying mechanism, a heating device, and a mixing mechanism. The first sample carrying mechanism includes at least an elution zone with a placement position. The placement position of the elution zone is used to place a sample container containing magnetic beads adsorbed with the nucleic acid and injected with elution solution. The elution solution is used to elute the nucleic acid from the magnetic beads. The heating device is configured to heat at least the sample container placed at the placement position in the elution zone, and the mixing mechanism is configured to: while the heating device heats at least the sample container, mix at least the magnetic beads in the sample container to promote the elution of the nucleic acid in the sample container from the magnetic beads.

2. The molecular diagnostic analyzer according to claim 1, characterized in that, The first sample carrying mechanism further includes a lysis zone, the lysis zone having a placement position, the placement position of the lysis zone being used to place the sample container containing the sample and magnetic bead reagent and injected with lysis buffer, the magnetic bead reagent including the magnetic beads, the lysis buffer being used to release the nucleic acid in the sample so that it adsorbs onto the magnetic beads; The heating device is also configured to heat at least the sample container placed at the placement position in the lysis zone; The heating device has at least a first heating zone and a second heating zone. The first heating zone is provided corresponding to the lysis zone and is used to heat the sample container placed at the placement position in the lysis zone. The second heating zone is provided corresponding to the elution zone and is used to heat the sample container placed at the placement position in the elution zone.

3. The molecular diagnostic analyzer according to claim 2, characterized in that, The heating temperatures of the first heating zone and the second heating zone are independently adjustable. The heating device has at least a first heating component and a second heating component. The first heating component is disposed in the first heating zone to heat the sample container placed at the placement position in the lysis zone. The second heating component is disposed in the second heating zone to heat the sample container placed at the placement position in the elution zone. The heating temperatures of the first heating component and the second heating component are independently adjustable.

4. The molecular diagnostic analyzer according to claim 2 or 3, characterized in that, The first sample carrying mechanism further includes a washing area, which has a placement position for placing the sample container containing the magnetic beads adsorbed with the nucleic acid and injected with washing solution. The washing solution is used to wash impurities on and between the magnetic beads.

5. The molecular diagnostic analyzer according to claim 4, characterized in that, The first sample carrying mechanism further includes a drying zone with a placement position. The placement position of the drying zone is used to place the sample container containing the magnetic beads that have been washed with the washing solution and adsorbed with the nucleic acid. The heating device is also configured to heat the sample container placed in the placement position of the drying zone to dry the magnetic beads in the sample container that have been washed with the washing solution. The drying zone and the elution zone are integrated into the same area of ​​the first sample carrying mechanism.

6. The molecular diagnostic analyzer according to any one of claims 2 to 5, characterized in that, The heating device includes a heating component and a heat-conducting component. The heating component and the heat-conducting component are thermally connected. The heat-conducting component defines a plurality of heating cavities for placing the sample container at least corresponding to each placement position of the lysis zone and the elution zone. The shape of the heating cavity corresponds to the outer contour of the insertion portion of the sample container, and the heat-conducting component is arranged to surround the insertion portion of the sample container at least circumferentially.

7. The molecular diagnostic analyzer according to any one of claims 2 to 6, characterized in that, The mixing mechanism is further configured to mix the magnetic beads in the sample container placed at the location in the lysis zone to achieve capture of the nucleic acid by the magnetic beads, and / or, The mixing mechanism is further configured to mix the magnetic beads in the sample container placed in the placement position of the washing area to wash away impurities on and between the magnetic beads.

8. The molecular diagnostic analyzer according to any one of claims 1 to 7, characterized in that, The mixing mechanism is further configured to generate a magnetic field to mix the magnetic beads in the sample container placed at the placement position in the elution zone.

9. The molecular diagnostic analyzer according to claim 8, characterized in that, The mixing mechanism is further configured to ensure that the magnetic field it generates can at least cover the lysis zone, the washing zone, and the elution zone, thereby enabling simultaneous mixing of the magnetic beads in the sample containers placed at each location in the lysis zone, the washing zone, and the elution zone.

10. The molecular diagnostic analyzer according to any one of claims 1 to 9, characterized in that, The nucleic acid extraction module further includes a magnetic bead aggregation device and a transfer device. The magnetic bead aggregation device includes a second sample carrying mechanism and an aggregation magnet. The second sample carrying mechanism is used to carry the sample container, which contains the magnetic beads that have adsorbed the nucleic acid and have been mixed by the mixing mechanism. The aggregation magnet is used to aggregate the magnetic beads in the sample container. The mixing mechanism and the magnetic bead gathering device are arranged separately, and the transfer device is configured to transfer the sample container between the first sample carrying mechanism and the second sample carrying mechanism.

11. The molecular diagnostic analyzer according to any one of claims 4 to 10, characterized in that, The first sample carrying mechanism is constructed as a rotatable disk. The pyrolysis zone, the washing zone, and the elution zone are distributed on the disk along the circumference of the disk. One end of the pyrolysis zone is connected to one end of the washing zone, and the other end of the pyrolysis zone is connected to one end of the elution zone. The other end of the washing zone is connected to the other end of the elution zone.

12. A method for nucleic acid extraction, characterized in that, The nucleic acid extraction method includes: Capture step: Place a sample container containing at least a sample containing nucleic acid and magnetic beads for adsorbing the nucleic acid in the placement position of the lysis zone of the first sample carrier mechanism to release the nucleic acid in the sample so that it can be adsorbed onto the magnetic beads; Washing step: Inject washing solution into the sample container after the capture step and transfer the sample container with the washing solution to the placement position of the washing area of ​​the first sample carrying mechanism, so as to wash away impurities on and between the magnetic beads; Elution step: The elution buffer is injected into the sample container after the washing step is completed, and the sample container containing the elution buffer is transferred to the placement position of the elution zone of the first sample carrier. The sample container containing the elution buffer is heated at the placement position of the elution zone by means of a heating device, and at the same time, the magnetic beads in the sample container are mixed by means of a mixing mechanism to promote the elution of the nucleic acid in the sample container from the magnetic beads.

13. The nucleic acid extraction method according to claim 12, characterized in that, In the capture step, the sample container located at the placement position in the lysis zone is heated by the heating device, and simultaneously the magnetic beads in the sample container located at the placement position in the lysis zone are mixed by the mixing mechanism to release the nucleic acid in the sample so that it adsorbs onto the magnetic beads; and / or In the washing step, the magnetic beads in the sample container, which has been injected with the washing liquid and is located in the washing area, are mixed by the mixing mechanism in order to wash away impurities on and between the magnetic beads.

14. The nucleic acid extraction method according to claim 12 or 13, characterized in that, The mixing mechanism uses the magnetic field it generates to mix the magnetic beads in the sample container located at the placement position in the lysis zone.

15. The nucleic acid extraction method according to claim 14, characterized in that, The magnetic field generated by the mixing mechanism can cover at least the lysis zone, the washing zone, and the elution zone, thereby enabling simultaneous mixing of the magnetic beads in the sample containers placed at each location in the lysis zone, the washing zone, and the elution zone.

16. The nucleic acid extraction method according to any one of claims 12 to 15, characterized in that, The step of injecting washing liquid into the sample container after the capture step and transferring the sample container with the washing liquid to the placement position of the washing area of ​​the first sample carrying mechanism, so as to wash away impurities on and between the magnetic beads, is achieved through the following actions: The sample container that has completed the capture step is transferred from the placement position of the lysis zone of the first sample carrying mechanism to the first auxiliary station of the second sample carrying mechanism by means of a transfer device. The magnetic beads in the sample container located at the first auxiliary station are gathered by means of a gathering magnet. After the magnetic beads are gathered, the waste liquid is drawn from the sample container and discharged, and the washing liquid is injected into the sample container. The sample container filled with the washing solution is transferred from the first auxiliary station to the placement position of the washing area of ​​the first sample carrying mechanism. The magnetic beads in the sample container are mixed by the mixing mechanism to wash away impurities on and between the magnetic beads.

17. The nucleic acid extraction method according to any one of claims 12 to 16, characterized in that, The process involves injecting elution buffer into the sample container after the washing step and transferring the sample container with the elution buffer into the placement position of the elution zone of the first sample carrier. The sample container, located in the placement position of the elution zone and containing the elution buffer, is heated using a heating device, while simultaneously mixing the magnetic beads in the sample container using a mixing mechanism. This promotes the elution of the nucleic acid from the magnetic beads, achieved through the following actions: The sample container, having completed the washing step, is transferred from the placement position in the washing area of ​​the first sample carrier to the second auxiliary station of the second sample carrier using a transfer device. Magnetic beads in the sample container located at the third auxiliary station are gathered using a gathering magnet. After the magnetic beads are gathered, waste liquid is drawn from the sample container and discharged. The sample container is then transferred to the third auxiliary station of the second sample carrier using the transfer device, and the eluent is injected into the sample container. The sample container, which has been injected with the elution solution, is transferred from the third auxiliary station to the placement position of the elution zone of the first sample carrier. The sample container, which has been injected with the elution solution, is heated at the placement position of the elution zone by the heating device, and at the same time, the magnetic beads in the sample container are mixed by the mixing mechanism to promote the elution of the nucleic acid in the sample container from the magnetic beads.

18. The nucleic acid extraction method according to claim 17, characterized in that, Before transferring the sample container to the third auxiliary station of the second sample carrying mechanism using a transfer device and injecting the elution buffer into the sample container, the nucleic acid extraction method further includes: The sample container, after the waste liquid has been absorbed, is transferred from the second auxiliary station to the drying area of ​​the first sample carrier using a transfer mechanism, and the magnetic beads in the sample container are dried using the heating device.

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