Reagent preparation device and integrated nucleic acid detection machine equipped with the same

Abstract

To provide a reagent preparation apparatus and a nucleic acid testing integrated machine having the same.SOLUTION: A reagent preparation apparatus includes: a case being provided with an extraction reagent filling position and an amplification reagent filling position; a reagent storage portion, arranged in the case, the reagent storage portion including an extraction reagent storage portion and an amplification reagent storage portion; and a filling portion, movably arranged in the case, the filling portion being able to suck an extraction reagent from the extraction reagent storage portion and move to above the extraction reagent filling position to fill the extraction reagent into a first vessel on the extraction reagent filling position, and the filling portion being able to suck an amplification reagent from the amplification reagent storage portion and move to above the amplification reagent filling position to fill the amplification reagent into a second vessel on the amplification reagent filling position. The technical solution provided by the invention solves the problem that a nucleic acid testing instrument in the related technology cannot meet the requirements for miniaturization.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to the technical field of biological detection, and specifically to a reagent preparation device and a nucleic acid detection integrated machine equipped with the same.

Background Art

[0002] Nucleic acid detection usually requires extracting nucleic acids from a subject's sample, performing an amplification reaction, and detecting the amplification result to further analyze the nucleic acid situation in the subject's body. Such a detection process involves the addition of multiple types of extraction reagents and amplification reagents, as well as the process of loading and using multiple types of container consumables.

[0003] In the prior art, the preparation of extraction reagents and the preparation of amplification reagents are often assigned to multiple device modules, but there is a problem that the nucleic acid detection device becomes too large. However, the space in the hospital laboratory is limited, and the method of adding reagents by installing multiple modules separately is difficult to meet the market needs for miniaturization of nucleic acid detection devices.

Summary of the Invention

Problems to be Solved by the Invention

[0004] In order to solve the problem that nucleic acid detection devices in related technologies cannot meet the needs of miniaturization, a reagent preparation device and a nucleic acid detection integrated machine equipped with the same are provided.

Means for Solving the Problems

[0005] According to one aspect of the present invention, there is provided a reagent preparation device including: a case provided with an extraction reagent injection position and an amplification reagent injection position; a reagent reservoir provided in the case and including an extraction reagent reservoir and an amplification reagent reservoir; and an injection unit movably provided in the case. The injection unit can suck an extraction reagent from the extraction reagent reservoir, move above the extraction reagent injection position, and inject the extraction reagent into a first container at the extraction reagent injection position. The injection unit can suck an amplification reagent from the amplification reagent reservoir, move above the amplification reagent injection position, and inject the amplification reagent into a second container at the amplification reagent injection position.

[0006] Furthermore, the case has a first platform and a second platform located below the first platform, and both the first platform and the second platform are parallel to the horizontal plane. The extraction reagent reservoir, the amplification reagent reservoir, the extraction reagent injection position, and the amplification reagent injection position are all provided on the second platform, and the injection unit is provided on the first platform.

[0007] Furthermore, the reagent preparation device further includes a first container loading mechanism for loading the first container and a gripping member. The first container loading mechanism includes a first container loading bin and a first container transport bin. The case further has a third platform located below the second platform and parallel to the horizontal plane. The first container loading bin is movably provided on the third platform and can move outside the case. The first container transport bin is fixedly provided on the third platform, and a first opening extending above the second platform is provided at the top of the first container transport bin. The gripping member is movably provided on the first platform, and the gripping member can grip the first container through the first opening and move it to the extraction reagent injection position.

[0008] Furthermore, both the first container loading bin and the first container transfer bin extend along the Z-axis direction and are provided at intervals along the X-axis direction. The case has a first side opening, and the first container loading bin can move outside the case through the first side opening.

[0009] Furthermore, the reagent preparation device further includes a second container loading mechanism for loading a second container. The second container loading mechanism includes a second container loading bin that is movably provided within the case and can move outside the case. The second container loading bin is provided with a second opening, and the gripping member can grip the second container through the second opening.

[0010] Furthermore, the second container loading mechanism further includes a second container storage bin that is fixedly provided on the second platform and extends along the Z-axis direction. The second container loading bin is movably provided on the second platform along the X-axis direction and extends along the Z-axis direction. The case further has a second side opening located above the first side opening. The second container loading bin can move outside the case through the second side opening. The top of the second container storage bin is provided with a third opening, and the gripping member can transfer the second container from the second container loading bin to the second container storage bin. The gripping member can grip the second container through the third opening and move it to the amplification reagent injection position.

[0011] Furthermore, the extraction reagent storage part includes a first reagent storage part provided on the second platform and a second reagent storage part provided outside the case. The first reagent storage part and the second container loading bin are provided at intervals along the X-axis direction, and the first reagent storage part can move outside the case along with the second container loading bin.

[0012] Furthermore, the second platform is further provided with a premix position for placing the first container, and the gripping member can grip the first container through the first opening and move it to the premix position.

[0013] Furthermore, the liquid injection part includes a liquid injection assembly including a moving frame and a liquid injection needle, and a reagent arm assembly. The moving frame is provided inside the case so as to be movable along the Y-axis direction, and the liquid injection needle is provided on the moving frame so as to be movable along the Z-axis direction. The liquid injection needle communicates with a second reagent storage part so as to inject a second reagent into a first container. The liquid injection part further includes a reagent arm assembly including a reagent arm and a liquid transfer needle. The reagent arm is provided on a first platform so as to be movable along the X-axis direction and the Y-axis direction, and the liquid transfer needle is provided on the reagent arm so as to be movable along the Z-axis direction. The liquid transfer needle can inject the first reagent into the first container by moving above the first reagent storage part and sucking the first reagent. The liquid transfer needle can inject the amplification reagent into a second container by moving above the amplification reagent storage part, sucking the amplification reagent, and then moving above the amplification reagent injection position.

[0014] Furthermore, on the first platform, a first guide rail extending along the Y-axis direction and a second guide rail extending along the X-axis direction are provided. The first guide rail is provided below the second guide rail so as to be movable along the extending direction of the second guide rail, and the reagent arm is provided on the first guide rail so as to be movable along the extending direction of the first guide rail.

[0015] Furthermore, on the first platform, a third guide rail extending along the Y-axis direction is provided. The third guide rail is provided below the second guide rail so as to be movable along the extending direction of the second guide rail. The gripping member includes a gripping frame and a gripper. The gripping frame is provided on the third guide rail so as to be movable along the extending direction of the third guide rail, and the gripper is provided on the gripping frame so as to be movable along the Z-axis direction.

[0016] Furthermore, the reagent preparation device is provided on the second platform and further includes a consumable storage bin for placing the magnetic rod cover and the liquid transfer head. The liquid transfer needle can move above the consumable storage bin to load the magnetic rod cover and the liquid transfer head. Both the consumable storage bin and the first reagent storage section extend along the X-axis direction and are provided at intervals along the Y-axis direction.

[0017] Furthermore, the reagent preparation device further includes a first container transfer assembly provided on the second platform. The first container transfer assembly includes a transfer frame, a slide plate, and a slide plate driving member. The extraction reagent injection position is provided on the upper surface of the slide plate. The transfer frame is provided on the second platform and extends along the X-axis. The slide plate driving member is provided on the transfer frame and is drivingly connected to the slide plate so that the slide plate moves along the extension direction of the transfer frame.

[0018] Furthermore, the upper surface of the extraction reagent injection position is lower than the upper surface of the amplification reagent injection position. According to another aspect of the present invention, there is provided a nucleic acid detection integrated machine including a sample extraction device for extracting an analyte from a sample and mixing the analyte with an amplification reagent to form a measurement mixture, an amplification device for performing an analyte detection measurement on the measurement mixture to analyze the sample, and the reagent preparation device provided above.

Advantages of the Invention

[0019] If the technical means of the present invention are applied, the reagent preparation device includes a case, a reagent storage unit, and a liquid injection unit. When preparing the extraction reagent and the amplification reagent, the first container is placed at the extraction reagent injection position, and the second container is placed at the amplification reagent injection position. The liquid injection unit movably provided in the case moves above the extraction reagent storage unit, sucks the extraction reagent, and discharges it into the first container. The liquid injection unit moves above the amplification reagent storage unit, sucks the amplification reagent, and discharges it into the second container. Since the preparation of the amplification reagent and the extraction reagent can be completed only by using the same liquid injection unit provided in the case, the reagent preparation device can be easily miniaturized.

[0020] The drawings constituting a part of this application are for further understanding of the present invention. The exemplary embodiments of the present invention and their descriptions are for interpreting the present invention and do not unduly limit the present invention. In the drawings,

Brief Description of the Drawings

[0021]

Figure 1

Figure 2

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Figure 4

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Figure 10

Mode for Carrying Out the Invention

[0022] Hereinafter, the technical means of the embodiments of the present invention will be clearly and completely described with reference to the drawings in the embodiments of the present invention. It goes without saying that the embodiments described below are only some of the embodiments of the present invention, not all of them. The description of at least one exemplary embodiment below is for illustrative purposes only and does not impose any limitations on the present invention and its application or use. All other embodiments obtained by those skilled in the art without creative labor based on the embodiments of the present invention belong to the protection scope of the present invention.

[0023] As shown in FIGS. 1 to 10, an embodiment of the present invention provides a reagent preparation device including a case 10, a reagent storage unit 20, and a liquid injection unit 30. Inside the case 10, an extraction reagent injection position 11 and an amplification reagent injection position 12 are provided. The reagent storage unit 20 is provided inside the case 10 and includes an extraction reagent storage unit 21 and an amplification reagent storage unit 22. The liquid injection unit 30 is movably provided inside the case 10. The liquid injection unit 30 can suck the extraction reagent from the extraction reagent storage unit 21 and move above the extraction reagent injection position 11, so as to inject the extraction reagent into the first container at the extraction reagent injection position 11. The liquid injection unit 30 can suck the amplification reagent from the amplification reagent storage unit 22 and move above the amplification reagent injection position 12, so as to inject the amplification reagent into the second container at the amplification reagent injection position 12.

[0024] If the technical means of the present invention are applied, the reagent preparation device includes a case 10, a reagent storage unit 20, and a liquid injection unit 30. When preparing the extraction reagent and the amplification reagent, the first container is placed at the extraction reagent injection position 11, and the second container is placed at the amplification reagent injection position 12. The liquid injection unit 30 movably provided in the case 10 moves above the extraction reagent storage unit 21, sucks the extraction reagent, and discharges it into the first container. The liquid injection unit 30 moves above the amplification reagent storage unit 22, sucks the amplification reagent, and discharges it into the second container. Since the preparation of the amplification reagent and the extraction reagent can be completed only by using the same liquid injection unit provided in the case, the reagent preparation device can be easily miniaturized.

[0025] And since the extraction reagent and the amplification reagent are prepared by separate reagent preparation devices, there is no contamination of the extraction reagent and the amplification reagent by the sample, and the detection result becomes more accurate.

[0026] Among them, both the first container and the second container are porous plates. As shown in FIGS. 2 and 3, the case 10 has a first platform 13 and a second platform 14 located below the first platform 13. Both the first platform 13 and the second platform 14 are parallel to the horizontal plane. The extraction reagent storage unit 21, the amplification reagent storage unit 22, the extraction reagent injection position 11, and the amplification reagent injection position 12 are all provided on the second platform 14, and the liquid injection unit 30 is provided on the first platform 13. By adopting the above structure, the first stage 13 and the second stage 14 are installed at intervals along the Z axis, so that the space of the reagent preparation device in the Z-axis direction can be fully utilized, which is more convenient for miniaturizing the device.

[0027] As shown in FIGS. 1, 3, and 6, the reagent preparation device further includes a first container loading mechanism 40 for loading a first container and a gripping member 50. The first container loading mechanism 40 includes a first container loading bin 41 and a first container transport bin 42. Inside the case 10, there is further a third platform 18 located below the second platform 14 and parallel to the horizontal plane. The first container loading bin 41 is movably provided on the third platform 18 and can move outside the case 10. The first container transport bin 42 is fixedly provided on the third platform 18. At the top of the first container transport bin 42, a first opening 421 is provided, and the first opening 421 extends above the second platform 14. The gripping member 50 is movably provided on the first platform 13, and the gripping member 50 can grip the first container through the first opening 421 and move to the extraction reagent injection position 11. By using the first container loading mechanism 40, the user can place the first container outside the case and transfer it into the case. By using the gripping member 50, the first container can be transferred from the first container transport bin 42 to the extraction reagent injection position 11, having the advantage of a compact structure. When the gripping member 50 grips the first container in the first container transport bin 42, it does not affect the placement of the first container on the first container loading bin 41 by the user, and realizes continuous loading of the first container.

[0028] Among them, a first tray movable along the Z-axis is provided in the first container loading bin 41, and a second tray movable along the Z-axis is provided in the first container transport bin 42. The first container is placed on the first tray and moves along the Z-axis in the first container loading bin 41 along with the first tray. The first container is placed on the second tray and moves along the Z-axis in the first container transport bin 42 along with the second tray.

[0029] Specifically, a loading opening is provided at the top of the first container loading bin 41, allowing the user to easily place the first container into the first container loading bin 41 through the loading opening.

[0030] In this embodiment, the first container loading mechanism 40 further includes a horizontal conveying assembly including two rotating members and two conveying belts. The two rotating members are respectively provided below the first container loading bin 41 and the first container conveying bin 42, and are both rotatable around their own axes. Each conveying belt is rotatably wound around the two rotating members, with a gap between the two conveying belts. A first retracting opening is opened at the bottom of the first container loading bin 41, and a second retracting opening is opened at the bottom of the first container conveying bin 42. The first tray can pass through the first retracting opening and move downward to the gap to position the first container on the two conveying belts. The second tray can pass through the second retracting opening and move downward to the gap to receive the tray on the two conveying belts. By adopting the above structure, the first container in the first container loading bin 41 is transferred below the first container conveying bin 42 using the horizontal conveying assembly, and the first container is moved from the bottom to the top of the first container conveying bin 42 by the second tray, so that the gripping member 50 can grip the first container.

[0031] In this embodiment, a drawer-type drawer structure is provided at the lower part of the first container loading bin 41 so that it can move from the inside of the case 10 to the outside of the case 10. Among them, the reagent preparation device includes two first container loading bins 41 provided at intervals along the X-axis direction, and both of the two first container loading bins 41 can be pulled out to the outside of the case 10.

[0032] Specifically, the first container loading mechanism 40 further includes an inversion member that is rotatably provided on one side of the first container loading bin 41. The inversion member has a support position for supporting the first container and an avoidance position for avoiding the first container. The first container can be supported using the inversion member. When the first container is transferred to the conveyor belt along with the first tray, the inversion member in the avoidance position is used to avoid the first tray and the first container located on the first tray, and the inversion member in the support position is used to support another first container above one first container on the first tray, so as to separate the extraction plates arranged in a stacked manner.

[0033] In this embodiment, the inversion of the inversion member is realized by driving with a motor. As shown in FIGS. 2 and 3, both the first container loading bin 41 and the first container conveying bin 42 extend along the Z-axis direction and are provided at intervals along the X-axis direction. The case 10 has a first side opening, and the first container loading bin 41 can move outside the case 10 through the first side opening. By adopting the above configuration, the space of the reagent preparation device in the Z-axis direction can be fully utilized, which is convenient for miniaturization of the device.

[0034] As shown in FIGS. 4 and 5, the reagent preparation device further includes a second container loading mechanism 60 for loading a second container. The second container loading mechanism 60 includes a second container loading bin 61 that is movably provided inside the case 10 and can move outside the case 10. The second container loading bin 61 is provided with a second opening 611, and the gripping member 50 can grip the second container through the second opening 611. By using the second container loading mechanism 60, the user can place the second container outside the case and transfer it inside the case 10.

[0035] As shown in FIGS. 4 and 5, the second container loading mechanism 60 is fixedly provided on the second platform 14 and further includes a second container storage bin 62 extending along the Z-axis direction. The second container loading bin 61 is movably provided on the second platform 14 along the X-axis direction and extends along the Z-axis direction. The case 10 further has a second side opening located above the first side opening. The second container loading bin 61 can move outside the case 10 through the second side opening. A third opening 621 is provided at the top of the second container storage bin 62. The gripping member 50 can transfer the second container from the second container loading bin 61 to the second container storage bin 62. The gripping member 50 can grip the second container through the third opening 621 and move it to the amplification reagent injection position 12. The gripping member 50 can be used to sequentially transfer the second containers in the second container loading bin 61 to the second container storage bin 62. When the gripping member 50 grips the second containers in the second container storage bin 62, it does not affect the user's placing of the second containers into the second container loading bin 61, realizing continuous loading of the second containers.

[0036] Among them, a third tray movable along the Z-axis direction is provided in the second container loading bin 61, and a fourth tray movable along the Z-axis direction is provided in the second container storage bin 62. The second containers are placed on the third tray and move along the Z-axis direction in the second container loading bin 61 along with the third tray. The second containers are placed on the fourth tray and move along the Z-axis direction in the second container storage bin 62 along with the fourth tray.

[0037] Specifically, the gripping member 50 is used to grip the second container in the second container loading bin 61 and move it above the second container storage bin 62. Then, the fourth tray is moved along the extending direction of the second container storage bin 62 to the third opening 621 at the top of the second container storage bin 62, and the second container is released from the gripping member 50 onto the fourth tray. After the transfer of the first second container is completed, the gripping member 50 is used to grip the second second container located below the first second container from the second container loading bin 61, and the fourth tray is moved downward along the extending direction of the second container storage chamber 62 by a certain distance, and the second second container is placed on the first second container. Similarly, all the second containers in the second container loading bin 61 are transferred to the second container storage bin 62. That is, by transferring the second container at the lower part of the second container loading bin 61 to the upper part of the second container storage bin 62 and transferring the second container at the upper part of the second container loading bin 61 to the lower part of the second container storage bin 62, the second container previously placed in the second container loading bin 61 can be transferred to the second container storage bin 62 and preferentially used.

[0038] Of course, the gripping member 50 can also be used to grip the second container through the second opening 611 and directly transfer the second container to the amplification reagent injection position 12 to prepare the amplification reagent.

[0039] As shown in FIG. 4, the extraction reagent storage unit 21 includes a first reagent storage unit 211 provided on the second platform 14 and a second reagent storage unit provided outside the case 10. The first reagent storage unit 211 and the second container loading bin 61 are provided at intervals along the X-axis direction, and the first reagent storage unit 211 can move outside the case 10 along with the second container loading bin 61. By adopting the above structure, the first reagent storage unit 211 and the second reagent storage unit can be arranged by making full use of the X-axis direction of the device, and the first reagent storage unit 211 and the second container loading bin 61 can be installed on the same pedestal that can move in the X-axis direction and moved outside the case 10 together, which is convenient for miniaturizing the device.

[0040] Specifically, the first reagent storage unit 211 includes a magnetic bead bottle body, an eluate bottle body, a rotary table, and a bottle body drive member. The magnetic bead bottle body and the eluate bottle body are both provided inside the case 10. The rotary table is rotatably provided inside the magnetic bead bottle body, and the bottle body drive member is drivingly connected to the rotary table so that the rotary table rotates around its axis. By rotating the rotary table using the bottle body drive member, the magnetic beads in the magnetic bead bottle body can always be in a uniformly mixed state.

[0041] Since magnetic beads tend to precipitate, a rotatable magnetic bead bottle body is installed to keep the magnetic beads in a uniformly mixed state. And in order to prevent the magnetic beads from precipitating during the transfer, only the so-called "one suction and one discharge" liquid injection mode, in which the magnetic bead liquid is suctioned once from the magnetic bead bottle body and then immediately discharged into one reagent tank, can be adopted, and the "one suction and multiple discharges" liquid injection mode cannot be adopted. However, in the process of sucking and injecting the eluate, after the reagent is suctioned once from the eluate bottle body, it can be injected into the first container multiple times.

[0042] As shown in FIG. 1, the second platform 14 is further provided with a premix position 141 for placing the first container. The grasping member 50 can grasp the first container through the first opening 421 and move it to the premix position 141. By using the premix position 141, the amplification reagent can be extracted into the first container and premixed, and the mixing of the amplification reagent can be made more uniform.

[0043] The amplification reagent includes two types. In the amplification reagent storage unit, two types of amplification reagents respectively stored in the first amplification reagent bottle and the second amplification reagent bottle are stored. The first amplification reagent is stored in the first amplification reagent bottle, the second amplification reagent is stored in the second amplification reagent bottle, and a mixed solution of the first amplification reagent and the second amplification reagent is used for amplifying the sample.

[0044] In this embodiment, the first container can not only realize the preparation of the extraction reagent, but also use the first container as a premix plate to realize the uniform mixing of the first amplification reagent and the second amplification reagent.

[0045] Specifically, when preparing the amplification reagent, the liquid transfer needle 34 is moved above the amplification reagent storage part 22 to aspirate the first amplification reagent in the first amplification reagent bottle and the second amplification reagent in the second amplification reagent bottle respectively. Then, the liquid transfer needle 34 is moved above the first container, and the first amplification reagent and the second amplification reagent are both injected into the first container and mixed into a mixed solution. Further, the mixed solution after mixing is aspirated using the liquid transfer needle 34 and moved to the injection position, and the mixed solution is injected into the second container, thereby completing the preparation of the amplification reagent. Compared with the method of manually preparing the amplification reagent, it has the advantage of high efficiency.

[0046] Among them, the amplification reagent storage part 22 includes an amplification reagent bottle, a chassis frame and a chassis. The chassis frame is provided on the second platform 14, the amplification reagent bottle is provided on the chassis frame, and the chassis is rotatably provided around its axis in the amplification reagent bottle and has a plurality of first placement positions for placing the first amplification reagent bottle and a plurality of second placement positions for placing the second amplification reagent bottle. By adopting the amplification reagent storage part 22 configured as above, the liquid transfer head can be made to correspond to the first amplification reagent bottle and the second amplification reagent bottle by rotating the chassis to aspirate the first amplification reagent and the second amplification reagent, which has the advantage of being easy to operate.

[0047] Among them, the second platform 14 is further provided with a lid buffer position. The second container includes a porous plate and a lid covering the upper surface of the porous plate. The gripping member 50 can grip the lid and move it to the lid buffer position. By placing the lid using the lid buffer position, the injection of the amplification reagent can be facilitated.

[0048] In this embodiment, the amplification reagent is injected into the reagent tank, and the prepared amplification reagent can be heat-pressed and sealed with a lid. Before preparing the extraction reagent, it is necessary to move the lid to the lid buffer position using the gripping member 50 in the second container.

[0049] As shown in FIG. 6, the injection unit 30 includes an injection assembly including a moving frame 31 and an injection needle 32. The moving frame 31 is provided in the case 10 so as to be movable along the Y-axis direction, and the injection needle 32 is provided on the moving frame 31 so as to be movable along the Z-axis direction. The injection needle 32 communicates with the second reagent reservoir so as to inject the second reagent into the first container. By adopting the above structure, the biaxial movement of the injection needle 32 within the vertical plane can be realized using the moving frame 31, and further, the second reagent can be injected into the first container.

[0050] In this embodiment, the second reagent includes a lysate, a first washing solution, a second washing solution, and a third washing solution, and is used to remove impurities such as cell components other than the analyte in the sample. Four injection needles 32 capable of injecting the lysate, the first washing solution, the second washing solution, and the third washing solution into the corresponding reagent tanks in the first container are provided on the moving frame 31.

[0051] Among them, the injection unit 30 further includes a reagent arm assembly including a reagent arm 33 and a liquid transfer needle 34. The reagent arm 33 is provided on the first platform 13 so as to be movable along the X-axis direction and the Y-axis direction, and the liquid transfer needle 34 is provided on the reagent arm 33 so as to be movable along the Z-axis direction. The liquid transfer needle 34 can move above the first reagent reservoir 211 to suck the first reagent and inject the first reagent into the first container. The liquid transfer needle 34 can move above the amplification reagent reservoir 22 to suck the amplification reagent and move above the amplification reagent injection position 12 to inject the amplification reagent into the second container. The three-axis movement of the liquid transfer needle 34 can be realized using the reagent arm 33, and the liquid transfer needle 34 can inject the first reagent and the amplification reagent respectively.

[0052] In this embodiment, the first reagent contains an eluent and magnetic beads. When extracting the same type of nucleic acid, the required amounts of the lysate, the first washing solution, the second washing solution, and the third washing solution in different reagent tanks are about 500 μL to 600 μL, the required amount of magnetic beads is about 80 μL, and the required amount of the eluent is about 150 μL. For the second reagent with a large required amount, the liquid injection needle 32 can be directly used for liquid injection. For the first reagent with a small required amount, a control member can be provided on the reagent arm 33 to accurately control the suction amount of the reagent. By adopting the method of extracting according to each type as described above, the liquid injection efficiency of the extraction reagent can be greatly improved.

[0053] In some other embodiments, the liquid injection unit 30 may only include the reagent arm 33 and the liquid transfer needle 34. The reagent arm 33 is provided in the case 10 so as to be movable along the X-axis direction and the Y-axis direction. The liquid transfer needle 34 is provided on the reagent arm 33 so as to be movable along the Z-axis direction. The liquid transfer needle 34 can move above the extraction reagent storage unit 21 to suck the extraction reagent, and can move above the extraction reagent injection position 11 to inject the extraction reagent into the extraction plate. The liquid transfer needle 34 can move above the amplification reagent storage unit 22 to suck the amplification reagent, and can move above the amplification reagent injection position 12 to inject the amplification reagent into the amplification plate. It is possible to realize the three-axis movement of the liquid transfer needle 34 by using the reagent arm 33, and the liquid transfer needle 34 can inject the extraction reagent and the amplification reagent respectively.

[0054] As shown in FIG. 6, in the case 10, a first guide rail 15 extending in the Y-axis direction and a second guide rail 16 extending in the X-axis direction are provided. The first guide rail 15 is provided below the second guide rail 16 so as to be movable along the extending direction of the second guide rail 16. The reagent arm 33 is provided on the first guide rail 15 so as to be movable along the extending direction of the first guide rail 15. By adopting the first guide rail 15 and the second guide rail 16, the movement of the reagent arm 33 in a plane parallel to the horizontal plane can be realized, the three-axis movement of the liquid transfer needle 34 can be realized, and there is an advantage that the structure is simple.

[0055] As shown in Fig. 6, inside the case 10, a third guide rail 17 extending along the Y-axis direction is further provided. The third guide rail 17 is movably provided below the second guide rail 16 along the extending direction of the second guide rail 16. The gripping member 50 includes a gripping frame 51 and a gripper 52. The gripping frame 51 is movably provided on the third guide rail 17 along the extending direction of the third guide rail 17, and the gripper 52 is movably provided on the gripping frame 51 along the Z-axis direction. The three-axis movement of the gripper 52 can be realized by using the third guide rail 17, which has the advantage of simple structure. And since the first guide rail 15 and the third guide rail 17 are provided on the same second guide rail 16, the structure can be made more compact.

[0056] As shown in Fig. 1, the reagent preparation device is provided on the second platform 14 and further includes a consumable storage bin 70 for placing the magnetic rod cover and the liquid transfer head. The liquid transfer needle 34 can move above the consumable storage bin 70 to load the magnetic rod cover and the liquid transfer head. Both the consumable storage bin 70 and the first reagent storage part 211 extend along the X-axis direction and are provided at intervals along the Y-axis direction. Installed as described above, the space of the second platform 14 in the X-axis direction and the Y-axis direction can be fully utilized, which is convenient for miniaturizing the device.

[0057] Specifically, it is necessary to load the liquid transfer head before the liquid transfer needle 34 transfers the first reagent and the amplification reagent so as to prevent contamination between different reagents.

[0058] Specifically, the reagent arm 33 moves along the first guide rail 15 and the second guide rail 16, and further moves above the consumable storage bin 70, so as to position the liquid transfer needle 34 at the loading position above the consumable storage bin 70. The liquid transfer needle 34 moves along the Z-axis direction so that the liquid transfer head in the consumable storage bin 70 can be loaded. Further, as the reagent arm 33 moves along the first guide rail 15 and the second guide rail 16, the liquid transfer needle is moved above the first reagent storage section 211, and the liquid transfer needle 34 moves in the Z-axis direction so that the liquid transfer head can suck the eluate. Further, as the reagent arm 33 moves along the first guide rail 15 and the second guide rail 16, the liquid transfer needle 34 moves above the extraction reagent injection position 11 along the Z-axis direction, and the eluate in the liquid transfer head is discharged into the reagent tank of the corresponding first container. The loading process of the magnetic beads and the amplification reagent is similar to the above process, so the description is omitted here.

[0059] As shown in FIG. 10, the reagent preparation device further includes a first container transfer assembly 80 provided on the second platform 14. The first container transfer assembly 80 includes a transfer frame 81, a slide plate 82, and a slide plate driving member. The extraction reagent injection position 11 is provided on the upper surface of the slide plate 82. The transfer frame 81 is provided on the second platform 14 and extends along the X-axis. The slide plate driving member is provided on the transfer frame 81, and the slide plate driving member is drivingly connected to the slide plate 82 so that the slide plate 82 moves along the extending direction of the transfer frame 81. By using the first container transfer assembly 80, the first container can be easily moved along the X-axis in accordance with the liquid injection by the liquid injection needle 32.

[0060] In this embodiment, since the liquid injection needle 32 can only achieve a two-axis movement in the vertical plane, in order to move the liquid injection needle 32 above the first container of the slide plate 82, it is necessary to move the first container along the X-axis by the slide plate 82.

[0061] In this embodiment, for example, members that can be horizontally moved outside the case along the X-axis on the second platform 14, including the extraction reagent storage unit 21, the second container loading bin 61, the consumable storage bin 70, etc., are all horizontally removed from the same side of the device. The amplification reagent storage unit 22 may be partially protruded outside the case 10, which contributes to the user loading reagents, containers, and consumables on the same side of the device. Other mechanisms are provided on the side away from the above-mentioned removable mechanism in the device. At the same time, a container delivery mechanism is provided on the side away from the above-mentioned removable mechanism in the device. After the liquid injection is completed, the first container and the second container are delivered from the reagent preparation device by the container delivery mechanism to perform the next operation.

[0062] Specifically, the upper surface of the extraction reagent injection position 11 is lower than the upper surface of the amplification reagent injection position 12. By adopting the above structure, the structural layout can be made more compact.

[0063] In this embodiment, since the height of the first container is higher than the height of the second container, by adopting the above installation, the upper surfaces of the first container and the second container can have the same height, which is more convenient for gripping by the gripper 52.

[0064] The usage process of the reagent preparation device will be described below. The user moves the first container loading bin 41 along the X-axis direction outside the case 10, places the first container in the first container loading bin 41, transports the first container from the first container loading bin 41 to the first container transport bin 42 using the horizontal transport assembly, and moves the first container from the first container transport bin 42 to the slide plate 82 of the first container transfer assembly 80 using the gripper 52, thereby realizing placing the first container at the extraction reagent injection position 11. By moving the injection needle 32 above the first container at the extraction reagent injection position 11, the second reagent is injected into the first container. By sliding the slide plate 82 into the transfer frame 81, the liquid transfer head is loaded using the liquid transfer needle 34 and moved to the first reagent storage section 211 to aspirate the first reagent, and then the liquid transfer needle 34 is moved above the first container at the extraction reagent injection position 11 to inject the first reagent into the first container. Thereby, the preparation of the extraction reagent is realized. The user moves the second container loading bin 61 along the X-axis direction outside the case 10 so as to place the second container in the second container loading bin 61. The second container is transferred from the second container loading bin 61 to the second container storage bin 62 using the gripper 52, and further, the second container in the second container storage bin 62 is moved to the amplification reagent injection position 12 using the gripper 52, the first container is moved from the first container transport bin 42 to the premix position 141 using the gripper 52, the liquid transfer head is loaded using the liquid transfer needle 34 and moved to the amplification reagent storage section 22 to aspirate the amplification reagent, and then the liquid transfer needle 34 is moved to the first container at the premix position 141 to inject the amplification reagent into the first container, and the amplification reagent is uniformly mixed using the liquid transfer needle 34. Further, the uniformly mixed amplification reagent is aspirated using the liquid transfer needle 34 and transferred to the second container at the amplification reagent injection position 12, thereby realizing the preparation of the amplification reagent.

[0065] Another embodiment of the present invention provides a nucleic acid detection integrated machine including a specimen extraction device for extracting an analyte from a sample and mixing the analyte with an amplification reagent to form a measurement mixture, an amplification device for performing an analyte detection measurement on the measurement mixture to analyze the sample, and a reagent preparation device provided as above. When applying the nucleic acid detection integrated machine, when preparing the extraction reagent and the amplification reagent, place the first container at the extraction reagent injection position 11, place the second container at the amplification reagent injection position 12, move the injection part 30 movably provided in the case 10 above the extraction reagent storage part 21 to suck the extraction reagent and discharge the extraction reagent into the first container, move the injection part 30 above the amplification reagent storage part 22 to suck the amplification reagent and discharge the amplification reagent into the second container. Since the preparation of the amplification reagent and the extraction reagent can be completed only by using the same injection part provided in the case, it is convenient for miniaturization of the reagent preparation device.

[0066] Among them, the reagent preparation device and the amplification device are respectively located on both sides of the specimen extraction device. The reagent preparation device, the specimen extraction device and the amplification device are isolated from each other. A first transfer passage is provided between the reagent preparation device and the specimen extraction device, and a second transfer passage is provided between the specimen extraction device and the amplification device. Both the first transfer passage and the first transfer passage have a conducting state and a cutoff state. The nucleic acid detection integrated machine further includes a transfer member provided between the reagent preparation device and the specimen extraction device. The transfer member can transfer the second container and the first container to the specimen extraction device through the first transfer passage. By adopting the above structure, when the reagent preparation device or the specimen extraction device operates, isolation between the two can be achieved by using the first transfer passage. When the specimen extraction device or the amplification device operates, isolation between the two is achieved by using the second transfer passage. Contamination between them can be avoided and the detection accuracy can be improved.

[0067] Note that the terms used herein are merely for explaining specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless otherwise expressly stated in this specification, the singular forms also include the plural forms. Also, when the terms "include" and / or "comprise" are used in this specification, it should be understood that the presence of features, steps, operations, devices, components, and / or combinations thereof is thereby expressly indicated.

[0068] Unless otherwise specified, the relative arrangements, mathematical formulas, and numerical values of the members and steps described in these examples do not limit the scope of the present invention. For the sake of convenience of explanation, it goes without saying that the dimensions of each part shown in the drawings are not drawn according to the actual proportional relationship. Technologies, methods, and devices known to those skilled in the art may not be discussed in detail, but when appropriate, the above-mentioned technologies, methods, and devices should be regarded as part of the specification. In all the examples illustrated and discussed here, any specific value should be construed as merely illustrative and not restrictive. Therefore, in examples other than the exemplary embodiments, different values may be used. Note that similar reference signs and alphabets indicate similar ones in the following drawings. Once any one of them is defined in a drawing, no further consideration is required in the subsequent drawings.

[0069] In the description of the present invention, for example, the orientation or positional relationship indicated by orientation terms such as "front, rear, top, bottom, left, right", "lateral direction, longitudinal direction, vertical, horizontal", and "top, bottom" is usually based on the orientation or positional relationship shown in the drawings, and is merely for the convenience of explanation and simplification of the description of the present invention. In the absence of a contrary description, these orientation terms do not indicate or imply that the indicated device or element must have a specific orientation or be configured and operated in a specific orientation. Therefore, it should not be understood as limiting the protection scope of the present invention. The orientation term "inside, outside" means inside and outside with respect to the contour of each member itself.

[0070] For the sake of convenience in description, relative spatial terms such as, for example, "above...", "above...", "on the upper surface of...", "above...", etc. can be used to describe the spatial positional relationship between one device or feature shown in the figure and other devices or features. The relative spatial terms are intended to encompass uses or different orientations during operation other than the illustrated orientation of the device. For example, if the device is inverted in the figure, a device described as "above another device or structure" or "on another device or structure" will then be positioned as "below another device or structure" or "under another device or structure". Therefore, the exemplary term "above..." includes two orientations, namely "above..." and "below...". The device may be positioned in other different ways (rotated by 90 degrees or in other orientations), and the description of the space used here should be interpreted correspondingly.

[0071] Note that the use of terms such as "first", "second", etc. to limit components is only for the purpose of facilitating the distinction of the corresponding components. Unless otherwise stated, the above terms have no special meaning and should not be understood as limiting the protection scope of the present invention.

[0072] The above are only preferred embodiments of the present invention and do not limit the present invention. Those skilled in the art can make various changes and modifications to the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention should all be included within the protection scope of the present invention.

Description of Reference Numerals

[0073] 10: Case, 11: Extraction reagent injection position, 12: Amplification reagent injection position, 13: First platform, 14: Second platform, 141: Premix position, 15: First guide rail, 16: Second guide rail, 17: Third guide rail, 18: Third platform 20: Reagent storage section, 21: Extracted reagent storage section, 211: First reagent storage section, 22: Amplification reagent storage section, 30: Liquid injection section, 31: Moving frame, 32: Liquid injection needle, 33: Reagent arm, 34: Liquid transfer needle, 40: First container loading mechanism, 41: First container loading bin, 42: First container transport bin, 421: First opening, 50: Gripping member, 51: Gripping frame, 52: Gripper, 60: Second container loading mechanism, 61: Second container loading bin, 611: Second opening, 62: Second container storage bin, 621: Third opening, 70: Consumable storage bin, 80: First container transfer assembly, 81: Transfer frame, 82: Slide plate.

Claims

1. A case (10) provided with an extraction reagent injection position (11) and an amplification reagent injection position (12); A reagent storage unit (20) provided in the case (10) and including an extraction reagent storage unit (21) and an amplification reagent storage unit (22); An injection unit (30) movably provided in the case (10), and including: The injection unit (30) can suck the extraction reagent from the extraction reagent storage unit (21) and move above the extraction reagent injection position (11), so as to inject the extraction reagent into the first container at the extraction reagent injection position (11); The injection unit (30) can suck the amplification reagent from the amplification reagent storage unit (22) and move above the amplification reagent injection position (12), so as to inject the amplification reagent into the second container at the amplification reagent injection position (12); Inside the case (10), there are a first platform (13) and a second platform (14) located below the first platform (13); Further including a gripping member (50); The case (10) has a first side opening; Further including a second container loading mechanism (60) for loading the second container; The second container loading mechanism (60) includes a second container loading bin (61); The second container loading mechanism (60) further includes a second container storage bin (62) fixedly provided on the second platform (14) and extending along the Z-axis direction; The second container loading bin (61) is movably provided on the second platform (14) along the X-axis direction and extends along the Z-axis direction; The case (10) further has a second side opening located above the first side opening; The second container loading bin (61) can move outside the case (10) through the second side opening; A third opening (621) is provided at the top of the second container storage bin (62); The gripping member (50) can transfer the second container from the second container loading bin (61) to the second container storage bin (62); The gripping member (50) can grip the second container through the third opening (621) and move it to the amplification reagent injection position (12). A reagent preparation device characterized by the above.

2. Both the first platform (13) and the second platform (14) are parallel to the horizontal plane, the extraction reagent storage part (21), the amplification reagent storage part (22), the extraction reagent injection position (11), and the amplification reagent injection position (12) are all provided on the second platform (14), the injection part (30) is provided on the first platform (13), and the reagent preparation device according to claim 1 is characterized in that.

3. It further includes a first container loading mechanism (40) for loading a first container, the first container loading mechanism (40) includes a first container loading bin (41) and a first container transfer bin (42), inside the case (10), there is further a third platform (18) located below the second platform (14) and parallel to the horizontal plane, the first container loading bin (41) is movably provided on the third platform (18) and can move outside the case (10), the first container transfer bin (42) is fixedly provided on the third platform (18), at the top of the first container transfer bin (42), a first opening (421) extending above the second platform (14) is provided, the gripping member (50) is movably provided on the first platform (13), the gripping member (50) can grip the first container through the first opening (421) and move to the extraction reagent injection position (11), and the reagent preparation device according to claim 2 is characterized in that.

4. both the first container loading bin (41) and the first container transfer bin (42) extend along the Z-axis direction and are provided at intervals along the X-axis direction, the first container loading bin (41) can move outside the case (10) through the first side opening, and the reagent preparation device according to claim 3 is characterized in that.

5. The second container loading bin (61) is movably provided inside the case (10) and can move outside the case (10), the second container loading bin (61) is provided with a second opening (611), The reagent preparation device according to claim 4, wherein the gripping member (50) can grip the second container through the second opening (611).

6. The extraction reagent storage unit (21) includes a first reagent storage unit (211) provided on the second platform (14) and a second reagent storage unit provided outside the case (10). The first reagent storage unit (211) and the second container loading bin (61) are provided at intervals along the X-axis direction. The reagent preparation device according to claim 1, wherein the first reagent storage unit (211) can move outside the case (10) along with the second container loading bin (61).

7. The second platform (14) is further provided with a premix position (141) for placing the first container. The reagent preparation device according to claim 3, wherein the gripping member (50) can grip the first container through the first opening (421) and move to the premix position (141).

8. The liquid injection unit (30) includes a liquid injection assembly including a moving frame (31) and a liquid injection needle (32). The moving frame (31) is provided inside the case (10) so as to be movable along the Y-axis direction. The liquid injection needle (32) is provided on the moving frame (31) so as to be movable along the Z-axis direction. The liquid injection needle (32) communicates with the second reagent storage unit so as to inject a second reagent into the first container. The liquid injection unit (30) further includes a reagent arm assembly including a reagent arm (33) and a liquid transfer needle (34). The reagent arm (33) is provided on the first platform (13) so as to be movable along the X-axis direction and the Y-axis direction. The liquid transfer needle (34) is provided on the reagent arm (33) so as to be movable along the Z-axis direction. The liquid transfer needle (34) can move above the first reagent storage unit (211) to suck the first reagent, so as to inject the first reagent into the first container. The reagent preparation device according to claim 6, wherein the liquid transfer needle (34) can move above the amplification reagent storage unit (22) to suck the amplification reagent, and move above the amplification reagent injection position (12) to inject the amplification reagent into the second container.

9. The first platform (13) is provided with a first guide rail (15) extending along the Y-axis direction and a second guide rail (16) extending along the X-axis direction. The first guide rail (15) is provided below the second guide rail (16) so as to be movable along the extending direction of the second guide rail (16). The reagent arm (33) is provided on the first guide rail (15) so as to be movable along the extending direction of the first guide rail (15). The reagent preparation device according to claim 8, characterized in that.

10. The first platform (13) is further provided with a third guide rail (17) extending along the Y-axis direction. The third guide rail (17) is provided below the second guide rail (16) so as to be movable along the extending direction of the second guide rail (16). The gripping member (50) includes a gripping frame (51) and a gripper (52). The gripping frame (51) is provided on the third guide rail (17) so as to be movable along the extending direction of the third guide rail (17). The gripper (52) is provided on the gripping frame (51) so as to be movable along the Z-axis direction. The reagent preparation device according to claim 9, characterized in that.

11. It is provided on the second platform (14) and further includes a consumable storage bin (70) for placing a magnetic rod cover and a liquid transfer head. The liquid transfer needle (34) can move above the consumable storage bin (70) to load the magnetic rod cover and the liquid transfer head. Both the consumable storage bin (70) and the first reagent storage part (211) extend along the X-axis direction and are provided at intervals along the Y-axis direction. The reagent preparation device according to claim 8, characterized in that.

12. It further includes a first container transfer assembly (80) provided on the second platform (14). The first container transfer assembly (80) includes a transfer frame (81), a slide plate (82), and a slide plate driving member. The extraction reagent injection position (11) is provided on the upper surface of the slide plate (82). The transfer frame (81) is provided on the second platform (14) and extends along the X-axis direction. The slide plate driving member is provided on the transfer frame (81), The reagent preparation device according to claim 2, wherein the slide plate driving member is drivingly connected to the slide plate (82) so that the slide plate (82) moves along the extending direction of the transfer frame (81).

13. The reagent preparation device according to claim 1, wherein the upper surface of the extraction reagent injection position (11) is lower than the upper surface of the amplification reagent injection position (12).

14. A specimen extraction device for extracting an analyte from a sample and mixing the analyte with an amplification reagent to form a measurement mixture, An amplification device for performing an analyte detection measurement on the measurement mixture to analyze the sample, A nucleic acid detection integrated machine, comprising the reagent preparation device according to any one of claims 1 to 13.

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