High-throughput full-automatic nucleic acid detection instrument and method

Abstract

A high-throughput full-automatic nucleic acid detection instrument and method. The high-throughput full-automatic nucleic acid detection instrument comprises: a base; a transfer module, which is arranged on the base; a pipetting module, which is used for adding detection samples into a plurality of plate holes in a nucleic acid extraction plate on the transfer module; a nucleic acid extraction module, which comprises a plurality of magnetic head assemblies, wherein the magnetic head assembly comprises a driving device, a sleeve, a magnetic rod and magnetic beads, the driving device being used for driving the magnetic rod to be extended into or withdrawn from the sleeve, the magnetic rod being used for attracting or releasing the magnetic beads, when the magnetic rod is extended into the sleeve, the magnetic beads being attracted to an outer wall of the sleeve, and the magnetic beads being transferred between the plate holes along with the sleeve, and when the magnetic rod is withdrawn from the sleeve, the magnetic beads with nucleic acids adsorbed being released in the plate holes, so as to transfer the nucleic acids; and a PCR detection module, which is used for performing PCR detection on a PCR detection plate added with the nucleic acids. Regional division and pressure control are performed on modules on the basis of a nucleic acid detection process, and contamination leakage of a PCR detection region is prevented and controlled by means of a closable chamber door and a negative pressure system.

Description

High-throughput fully automatic nucleic acid detection instrument and method

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to Chinese patent application number 202311535375.3, filed on November 17, 2023, entitled “High-throughput fully automatic nucleic acid detection instrument and method,” the entire text of which is hereby incorporated by reference. Technical Field

[0003] The present application relates to the field of nucleic acid detection technology, and specifically to a high-throughput fully automatic nucleic acid detection instrument and method. Background Art

[0004] With the development of nucleic acid detection technology, nucleic acid detection has been widely used in various fields such as pathogen diagnosis, scientific research, and environmental monitoring. In particular, with the promotion of nucleic acid detection technology in the field of blood safety in recent years, fluorescent PCR technology has been widely used.

[0005] Currently, the most widely used nucleic acid testing instruments include semi-automated instruments, which are divided into nucleic acid extractors and fluorescent PCR instruments. These instruments, when used together, cannot automatically seal, transfer, and analyze PCR reaction tubes, requiring manual operation of multiple devices. A small number of fully automated nucleic acid testing instruments simply combine nucleic acid extraction and PCR amplification testing. However, their detection throughput and speed cannot meet the needs of large sample volumes and rapid testing. Furthermore, the shared set of pipettes for sample addition, nucleic acid extraction, and PCR reaction solution preparation can cause cross-contamination during sample testing.

[0006] The main limiting factors that prevent existing technical solutions from achieving rapid testing of large sample volumes and are prone to cross-contamination are: the nucleic acid extraction process is a critical step, which is time-consuming and prone to cross-contamination. Although existing solutions have achieved automation of nucleic acid extraction, existing implementation methods often use pipetting devices or oscillating devices to simulate manual operations for nucleic acid extraction. There are mainly two methods. Existing method 1: Nucleic acid extraction uses a pipette tip to repeatedly blow and aspirate the sample and nucleic acid extraction reagent to mix them, and a magnetic module is used to separate the magnetic beads outside the container such as the nucleic acid extraction tube or plate, and then the nucleic acid extract is aspirated and discarded with a pipette tip. The disadvantage of this method is that the use of a sample needle and a pipette tip to repeatedly aspirate and discard the waste liquid is prone to aerosol contamination, resulting in false positive test results. At the same time, due to the limited number of pipette needles used for multiple aspiration and discard of waste liquid, the time required is long and the extraction speed is slow. In addition, the residue of the extract on the tube wall affects the purity of the nucleic acid extraction. Existing method 2: Using a temperature-controlled oscillation module to openly oscillate and mix the extraction plate, this method is prone to liquid splashing and aerosol contamination. This method also utilizes a magnetic module outside the nucleic acid extraction tube or plate container to separate the magnetic beads, and then uses a pipette tip to aspirate and discard the nucleic acid extract. However, this method suffers from the risk of aerosol contamination from the repeated use of pipette tips and waste liquid, which can lead to false-positive test results. Furthermore, the repeated use of a limited number of pipette tips for waste liquid aspiration increases the time required and slows the extraction process. Furthermore, residual extractant residues on the tube walls can affect the purity of the nucleic acid extraction.

[0007] Summary of the Invention

[0008] The present application aims to provide a high-throughput fully automatic nucleic acid detection instrument and method, which aims to solve the problems in the prior art of using sample needles and pipette tips to repeatedly blow and aspirate samples to mix and aspirate waste liquid, which easily generate aerosol contamination, and the long time required to aspirate waste liquid, slow extraction speed, and residual extract on the tube wall that affects the purity of nucleic acid extraction.

[0009] On the one hand, the present application provides a high-throughput fully automatic nucleic acid detection instrument, the high-throughput fully automatic nucleic acid detection instrument comprising:

[0010] base;

[0011] A transfer module is disposed on the base and is used to carry a nucleic acid extraction plate, a nucleic acid release plate, and a PCR detection plate, wherein the nucleic acid extraction plate, the nucleic acid release plate, and the PCR detection plate are each provided with a plurality of plate wells, the plate wells of the nucleic acid extraction plate and the nucleic acid release plate being used to accommodate extraction reagents, and the plate wells of the PCR detection plate being used to accommodate PCR reaction solutions;

[0012] A mechanical gripper, which is used to transport the nucleic acid extraction plate, the nucleic acid release plate, and the PCR detection plate;

[0013] a pipetting module, configured to add a test sample to a plurality of plate wells on a nucleic acid extraction plate on the transfer module;

[0014] A nucleic acid extraction module, comprising a plurality of magnetic head assemblies, each of which comprises a drive device, a sleeve, a magnetic rod, and magnetic beads. The drive device is used to drive the magnetic rod to extend into or out of the sleeve, and the magnetic rod is used to adsorb or release the magnetic beads. The magnetic beads are used to adsorb nucleic acids. When the magnetic rod is extended into the sleeve, the magnetic beads are adsorbed to the outer wall of the sleeve and are transferred between the plate holes along with the sleeve. When the magnetic rod is pulled out of the sleeve, the magnetic beads adsorbed with nucleic acids are released into the plate holes, thereby transferring the nucleic acids.

[0015] A PCR detection module is provided on the base, and is used for performing PCR detection on the PCR detection plate to which nucleic acid is added to obtain a detection result.

[0016] Optionally, the number of the mechanical grippers may be one or more. In a preferred embodiment of the present application, the mechanical grippers include a first mechanical gripper and a second mechanical gripper, wherein the first mechanical gripper is used to transport the nucleic acid extraction plate and the nucleic acid release plate, and the second mechanical gripper is used to transport the PCR detection plate.

[0017] In some embodiments, the driving device drives the sleeve to rotate and stir the solution in the plate hole, and the outer wall of the sleeve is provided with corrugations.

[0018] In the present application, by providing corrugations on the outer wall of the sleeve, on the one hand, splashing of liquid during stirring can be prevented, and on the other hand, a small volume of solution concentrated at the bottom of the tube can be stirred more evenly.

[0019] In some embodiments, the base includes a nucleic acid extraction area, a PCR detection area and an isolation door, the isolation door is arranged between the nucleic acid extraction area and the PCR detection area, the pipetting module and the nucleic acid extraction module are located in the nucleic acid extraction area, and the PCR detection module is located in the PCR detection area.

[0020] In some embodiments, a sealing module is provided on the base, and the sealing module is arranged in the PCR detection area. The sealing module is used to seal the PCR detection plate added with nucleic acid transported by the mechanical gripper; the PCR detection module is used to detect the PCR detection plate after sealing.

[0021] In some embodiments, a transmission module is provided between the PCR detection module and the nucleic acid extraction module. The transmission module passes through the isolation door. The isolation door cuts off the transmission module when it is closed. When the isolation door is opened, the transmission module moves the PCR detection plate with added nucleic acid from the nucleic acid extraction module to the PCR detection module.

[0022] In some embodiments, a protective rear plate and protective side plates are vertically provided on the edge of the base, and the protective rear plate and the protective side plates surround various devices on the base.

[0023] In some embodiments, the mechanical gripper and the pipetting module are arranged on the protective back plate, and the base is provided with a barcode scanning module, a sample module, a consumables carrying position and a reagent module. The sample module is located below the pipetting module, and the sample module is used to carry the test sample. The barcode scanning module is used to perform barcode scanning on the test samples, reagents and consumables in the sample module, the transfer module, the reagent module and the consumables carrying position.

[0024] In some embodiments, a waste conveying channel is provided on the base, and the waste conveying channel is located between the transfer module and the sample module. A waste collection module is provided at one end of the waste conveying channel, and a spare consumables position is provided on the protective rear plate.

[0025] In some embodiments, an air filter cover is provided on the top of the protective rear plate and the protective side plate, an exhaust fan and an air filter are installed on the air filter cover, and an ultraviolet lamp is provided in the air filter cover, and the ultraviolet lamp is used for disinfection.

[0026] In the present application, the base is set as a layer or includes an upper layer and a lower layer, and a transfer channel is provided between the upper layer and the lower layer, and the transfer channel is used to transfer items; the base shares one mechanical gripper, or corresponding mechanical grippers are provided in different areas of the base.

[0027] In this application, each functional module can be arranged on the upper or lower layer of the base according to actual needs. As an embodiment of this application, the transfer module, pipetting module and nucleic acid extraction module of the high-throughput fully automatic nucleic acid detection instrument of this application are arranged on the upper layer of the base, and the PCR detection module and film sealing module are arranged on the lower layer of the base.

[0028] On the other hand, the present application provides a high-throughput fully-automatic nucleic acid detection method, the high-throughput fully-automatic nucleic acid detection method comprising:

[0029] The pipetting module adds the test sample to the multiple plate wells on the nucleic acid extraction plate on the transfer module;

[0030] The mechanical gripper grabs the nucleic acid extraction plate and places it into the nucleic acid extraction module;

[0031] The multiple sleeves on the nucleic acid extraction module extend into the multiple plate holes on the nucleic acid extraction plate for stirring;

[0032] One or more magnetic rods of the nucleic acid extraction module extend into the sleeve, so that the magnetic beads adsorbed with nucleic acid are adsorbed on the outer wall of the sleeve;

[0033] The plurality of magnetic head assemblies of the nucleic acid extraction module are entirely separated from the nucleic acid extraction plate;

[0034] The multiple magnetic head assemblies of the nucleic acid extraction module are integrally extended into the nucleic acid release plate, and the magnetic rod is pulled out of the sleeve to release the magnetic beads into the multiple plate holes of the nucleic acid release plate;

[0035] The multiple sleeves on the nucleic acid extraction module rotate and stir in the multiple plate holes on the nucleic acid release plate, so that the nucleic acid on the magnetic beads is eluted onto the nucleic acid release plate;

[0036] One or more magnetic rods of the nucleic acid extraction module extend into the casing, so that the magnetic beads are adsorbed on the outer wall of the casing;

[0037] The mechanical gripper moves the nucleic acid release plate carrying the nucleic acid to the transfer module;

[0038] The pipetting module adds the solution in the nucleic acid release plate and the PCR reaction solution to the multiple plate wells on the PCR detection plate on the transfer module to obtain the PCR detection plate with added nucleic acid;

[0039] The mechanical gripper transports the PCR detection plate with added nucleic acid to the PCR detection module for detection to obtain the detection result.

[0040] In the present application, the nucleic acid extraction reagent can be pre-stored in the plate wells, or added to the plate wells through a pipetting module.

[0041] The present application provides a high-throughput, fully automatic nucleic acid detection instrument. The present application realizes the rapid transfer of magnetic beads. The magnetic bead transfer process does not use the method of transferring waste liquid by aspirating with a sample needle. The waste liquid of each step is retained in the plate well, avoiding cross contamination during the transfer process. In this way, the defects of the existing method of using a sample needle and a pipette tip to repeatedly blow and aspirate the sample to mix and aspirate the waste liquid are easily generated, and the defects of aerosol contamination, long time required for aspirating and aspirating the waste liquid, slow extraction speed, and residual extract on the tube wall affecting the purity of nucleic acid extraction are avoided. At the same time, the technical solution of the present application also overcomes the defects of aerosol contamination caused by the open agitation and mixing using an oscillation module in the prior art.

[0042] In addition, the high-throughput fully automatic nucleic acid detection instrument of the present application separates the nucleic acid extraction area and the PCR detection area by setting an isolation door, wherein the PCR detection area is a negative pressure design, and the exhaust speed and direction of the exhaust fan are used to achieve a decreasing pressure gradient, which conforms to the reasonable pressure difference setting of nucleic acid detection, prevents pollution during the detection process, and cooperates with the air filter to further prevent external dust from interfering with the detection. The waste collection module of the high-throughput fully automatic nucleic acid detection instrument in the present application is arranged on the outside of the base and is protected by a metal shell on the outer layer. Used waste consumables are transported through a waste conveying channel, reducing the pollution caused by the exposure of the waste collection module or its proximity to the nucleic acid extraction area and the PCR detection area. The technical solution of the present application significantly improves the accuracy of the test results and reduces the risk of contamination through the cooperation of the above-mentioned structure.

[0043] In addition, the high-throughput fully automatic nucleic acid detection instrument of this application has a large sample throughput, with up to 576 samples loaded at a time, and supports multiple rounds of continuous loading, with a detection throughput of up to 4,608 samples, a huge improvement over the 96 sample positions of similar devices, and a faster detection speed. The high-throughput fully automatic nucleic acid detection instrument of this application also has a higher detection sensitivity, up to 40 IU / mL. For some samples, the detection sensitivity can even be as low as 3 IU / mL, which is much higher than similar instruments already on the market. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present application. For those skilled in the art, other drawings can be obtained based on these drawings without creative work.

[0045] FIG1 is a schematic diagram of the structure of a high-throughput fully automatic nucleic acid detection instrument provided in an embodiment of the present application;

[0046] FIG2 is a schematic diagram of the internal structure of a high-throughput fully automatic nucleic acid detection instrument provided in an embodiment of the present application;

[0047] FIG3 is a schematic diagram of cannula stirring in a high-throughput fully automatic nucleic acid detection instrument provided in an embodiment of the present application;

[0048] FIG4 is a schematic diagram of a high-throughput fully-automatic nucleic acid detection instrument provided in an embodiment of the present application, in which a magnetic rod is inserted into a cannula and magnetic beads are adsorbed and collected below the cannula;

[0049] FIG5 is a schematic diagram of the entire magnetic head assembly being separated from the plate hole in the high-throughput fully-automatic nucleic acid detection instrument provided in an embodiment of the present application;

[0050] FIG6 is a schematic diagram of the release of magnetic beads after the magnetic rod of the magnetic head assembly is separated from the sleeve in the high-throughput fully automatic nucleic acid detection instrument provided in an embodiment of the present application;

[0051] FIG7 is a schematic diagram of a cannula in a high-throughput fully automatic nucleic acid detection instrument provided in an embodiment of the present application;

[0052] FIG8 is a schematic diagram of the structure of a high-throughput fully automatic nucleic acid detection instrument provided in an embodiment of the present application; and

[0053] Figure 9 is a schematic flow chart of an embodiment of a high-throughput fully-automatic nucleic acid detection method provided in an embodiment of the present application.

[0054] In the figure: 1-barcode scanning module; 2-sample module; 3-pipetting module; 4-transfer module; 5-reagent module; 6-consumables holding position; 7-nucleic acid extraction module; 8-transmission module; 9-isolation door; 10-sealing module; 11-PCR detection module; 12-first mechanical gripper; 13-second mechanical gripper; 14-waste conveying channel; 141-waste collection module; 15-spare consumables position; 16-air filter cover; 17-protective side panel; 18-protective rear panel; 19-exhaust fan; 20-base; 30-magnetic head assembly; 31-sleeve; 32-corrugation; 33-magnetic beads; 34-plate hole; 35-magnetic rod; 36-transfer channel. DETAILED DESCRIPTION

[0055] The following will be combined with the drawings in the embodiments of this application to clearly and completely describe the technical solutions in the embodiments of this application. Obviously, the embodiments described are only part of the embodiments of this application, not all of the embodiments. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without making creative efforts are within the scope of protection of this application.

[0056] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more features. In the description of the present application, "multiple" means two or more, unless otherwise clearly and specifically defined.

[0057] In this application, the word "exemplary" is used to mean "serving as an example, illustration, or illustration." Any embodiment described in this application as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments. The following description is given to enable any person skilled in the art to implement and use the present application. In the following description, details are listed for the purpose of explanation. It should be understood that one of ordinary skill in the art can recognize that the present application can be implemented without using these specific details. In other instances, well-known structures and processes are not elaborated in detail to avoid obscuring the description of the present application with unnecessary details. Therefore, the present application is not intended to be limited to the embodiments shown, but is consistent with the widest scope consistent with the principles and features disclosed in this application.

[0058] The embodiments of the present application provide a high-throughput fully automatic nucleic acid detection instrument and method, which are described in detail below.

[0059] First, a high-throughput fully automatic nucleic acid detection instrument is provided in an embodiment of the present application, and the high-throughput fully automatic nucleic acid detection instrument includes: a base; a transfer module, the transfer module is arranged on the base, and the transfer module is used to carry a nucleic acid extraction plate, a nucleic acid release plate and a PCR detection plate, wherein the nucleic acid extraction plate, the nucleic acid release plate and the PCR detection plate are provided with a plurality of plate holes, the plate holes of the nucleic acid release plate are used to accommodate the extracted nucleic acid, and the plate holes of the PCR detection plate are used to accommodate the PCR reaction liquid; a first mechanical gripper, the first mechanical gripper is used to transport the nucleic acid extraction plate; a second mechanical gripper, the second mechanical gripper is used to transport the PCR detection plate; a pipetting module, the pipetting module is used to add the detection sample to the The nucleic acid extraction plate on the transfer module is placed in multiple plate holes; the nucleic acid extraction module includes multiple magnetic head assemblies, which include a driving device, a sleeve, a magnetic rod and magnetic beads. The driving device is used to drive the magnetic rod to extend into or out of the sleeve. The magnetic rod is used to adsorb or release magnetic beads. The magnetic beads are used to adsorb nucleic acids. When the magnetic rod is extended into the sleeve, the magnetic beads are adsorbed on the outer wall of the sleeve, and the magnetic beads follow the sleeve to transfer between the plate holes; when the magnetic rod is pulled out of the sleeve, the magnetic beads adsorbed with nucleic acid are released in the plate holes, thereby transferring the nucleic acid; the PCR detection module is arranged on the base, and the PCR detection module is used to perform PCR detection on the PCR detection plate added with nucleic acid to obtain the detection result.

[0060] Referring to Figures 1-7 , in the embodiments of the present application, a high-throughput, fully-automatic nucleic acid detection instrument comprises: a base 20, a transfer module 4, a first mechanical gripper 12, a second mechanical gripper 13, a pipetting module 3, a nucleic acid extraction module 7, and a PCR detection module 11. In other embodiments, the positions of the various functional modules may be varied based on the specific layout and space requirements, and these simple variations fall within the scope of the present invention.

[0061] The base 20 is a platform.

[0062] In the embodiment of the present application, the transfer module 4 is disposed on the base 20 and is used to carry the nucleic acid extraction plate, the nucleic acid release plate, and the PCR detection plate. The nucleic acid extraction plate, the nucleic acid release plate, and the PCR detection plate are each provided with a plurality of plate wells 34. The plate wells 34 of the nucleic acid release plate are used to accommodate extraction reagents, and the plate wells 34 of the PCR detection plate are used to accommodate PCR reaction solutions.

[0063] In the embodiment of the present application, the first mechanical gripper 12 is used to transport the nucleic acid extraction plate and the nucleic acid release plate.

[0064] In the embodiment of the present application, the second mechanical gripper 13 is used to transport the PCR detection plate.

[0065] In the embodiment of the present application, the pipetting module 3 is used to add the test sample to the multiple plate wells 34 on the nucleic acid extraction plate on the transfer module 4. Specifically, the nucleic acid extraction plate, the nucleic acid release plate and the PCR detection plate are each provided with 96 plate wells 34.

[0066] In an embodiment of the present application, the nucleic acid extraction module 7 includes multiple magnetic head assemblies 30, and the magnetic head assembly 30 includes a driving device, a sleeve 31, a magnetic rod 35 and magnetic beads 33. The driving device is used to drive the magnetic rod 35 to extend in and out of the sleeve 31. The magnetic rod 35 is used to adsorb or release the magnetic beads 33. The magnetic beads 33 are used to adsorb nucleic acids. When the magnetic rod 35 is extended into the sleeve 31, the magnetic beads 33 are adsorbed on the outer wall of the sleeve 31, and the magnetic beads 33 follow the sleeve 31 to transfer between the plate holes 34; when the magnetic rod 35 is pulled out of the sleeve 31, the magnetic beads 33 adsorbed with nucleic acid are released in the plate holes 34, thereby transferring the nucleic acid.

[0067] In the embodiment of the present application, the PCR detection module 11 is disposed on the base 20 , and the PCR detection module 11 is used to perform PCR detection on the PCR detection plate to which nucleic acid is added to obtain a detection result.

[0068] The present application uses a magnetic rod 35 to transfer magnetic beads 33 for nucleic acid extraction. The magnetic head assembly 30 with the magnetic rod 35 can move up and down, and the sleeve 31 rotates in the plate hole 34 to mix the sample and the nucleic acid extraction reagents. When the magnetic rod 35 is inserted into the sleeve 31 and extends into the plate hole 34, the magnetic beads 33 are adsorbed and gathered on the sleeve 31 outside the magnetic rod 35 by the magnetic field of the magnetic rod 35 and separated from the extraction solution. After the sleeve 31 adsorbs the magnetic beads 33, the magnetic rod 35 is lifted up from the plate hole 34, and the magnetic beads 33 are released into the next plate hole 34. The magnetic head assembly 30 can transfer the magnetic beads 33 of 96 plate holes 34 at a time, realizing the rapid transfer of the magnetic beads 33. The transfer process of the magnetic beads 33 does not use the method of aspirating waste liquid by using a sample needle. The waste liquid of each step is retained in the plate hole 34 to avoid cross contamination during the transfer process. The present application overcomes the defects of the existing method of using a sample needle and a pipette tip to repeatedly blow and suck the sample to mix and aspirate the waste liquid, which is prone to aerosol contamination, takes a long time to aspirate the waste liquid, has a slow extraction speed, and the extract residue on the tube wall affects the purity of the nucleic acid extraction.

[0069] In an embodiment of the present application, a driving device drives the sleeve 31 to rotate and stir the solution in the plate hole 34, and the outer wall of the sleeve 31 is provided with corrugations 32. In the new plate hole 34, the magnetic rod 35 is pulled upward out of the sleeve 31, and the magnetic rod 35 is separated from the magnetic adsorption of the magnetic beads 33. The sleeve 31 rotates in the extraction reagent to release the magnetic beads 33 in the extraction solution. The sleeve 31 has corrugations 32, which can better stir the sample, magnetic beads 33 and extraction reagent. In this way, the present application overcomes the defects of aerosol contamination caused by repeated blowing and suction mixing with a sample needle and open shaking mixing with an oscillation module in the existing method.

[0070] In an embodiment of the present application, the base 20 includes a nucleic acid extraction area, a PCR detection area and an isolation door 9. The isolation door 9 is arranged between the nucleic acid extraction area and the PCR detection area. The pipetting module 3 and the nucleic acid extraction module 7 are located in the nucleic acid extraction area, and the PCR detection module 11 is located in the PCR detection area.

[0071] In the embodiment of the present application, a sealing module 10 is provided on the base 20, and the sealing module 10 is arranged in the PCR detection area. The sealing module 10 is used to seal the PCR detection plate added with nucleic acid transported by the second mechanical gripper 13; the PCR detection module 11 is used to detect the PCR detection plate after sealing.

[0072] In an embodiment of the present application, a transmission module 8 is provided between the PCR detection module 11 and the nucleic acid extraction module 7. The transmission module 8 passes through the isolation door 9. The isolation door 9 cuts off the transmission module 8 when it is closed. When the isolation door 9 is opened, the transmission module 8 moves the PCR detection plate with added nucleic acid from the nucleic acid extraction module 7 to the sealing module 10 or the PCR detection module 11.

[0073] In the embodiment of the present application, a protective rear plate 18 and a protective side plate 17 are vertically provided on the edge of the base 20 , and the protective rear plate 18 and the protective side plate 17 surround various components on the base 20 .

[0074] In an embodiment of the present application, a first mechanical gripper 12, a second mechanical gripper 13 and a pipetting module 3 are arranged on a protective rear plate 18, and a barcode scanning module 1, a sample module 2, a consumables carrying position 6 and a reagent module 5 are provided on the base 20. The sample module 2 is located below the pipetting module 3. The sample module 2 is used to carry the test sample, and the barcode scanning module 1 is used to perform barcode scanning on the test sample, reagents and consumables in the sample module 2, the transfer module 4, the reagent module 5 and the consumables carrying position 6.

[0075] In the embodiment of the present application, an air filter cover 16 is provided on the top of the protective rear plate 18 and the protective side plate 17. An exhaust fan 19 and an air filter are installed on the air filter cover 16. An ultraviolet lamp is provided in the air filter cover 16 for disinfection.

[0076] The high-throughput fully automatic nucleic acid detection instrument in this application is divided into a nucleic acid extraction area and a PCR detection area. The PCR detection area is separated independently, and the PCR detection area is isolated by an independent chassis. The PCR detection area is under negative pressure, and the PCR detection plate is transmitted through an openable and closable isolation door 9 to prevent leakage of amplification products and pollution in other areas. The air filter cover 16 and the PCR detection area are designed with negative pressure to prevent external dust and the like from interfering with the detection. An exhaust fan 19 and an air filter are provided. The exhaust speed and direction of the fan realize the formation of an air pressure gradient with decreasing air pressure in the nucleic acid extraction area and the PCR detection area, which conforms to the reasonable pressure difference setting of nucleic acid detection and prevents pollution during the detection process. An ultraviolet lamp is installed in the air filter cover 16. After the detection is completed, the ultraviolet lamp irradiates and disinfects each detection area to eliminate nucleic acid contamination during detection. The defect of the prior art that each functional area is not effectively divided, the air flow is not effectively controlled, and cross contamination of detection is easily caused is solved.

[0077] In the embodiment of the present application, a waste conveying channel 14 is provided on the base 20. The waste conveying channel 14 is located between the transfer module 4 and the sample module 2. A waste collection module 141 is provided at one end of the waste conveying channel 14. The waste collection module 141 is located outside the base 20. A spare consumables position 15 is provided on the protective back plate 18. The present application moves waste to the waste collection module 141 through the waste conveying channel 14. The waste collection module 141 is located outside the base 20, outside the nucleic acid extraction area and the PCR detection area. The opening is small and is only used for discarding pipette tips. The inner layer of the waste collection module 141 is a plastic garbage bag, and the outer layer is protected by a metal shell. This solves the problem of the existing technology that the waste bin is open and is adjacent to the liquid preparation area within the detection area, which easily causes waste contamination.

[0078] In this embodiment of the present application, the pipetting module 3 may contain 1 to 96 sample injection channels, which can be used with sample injection needles or pipette tips. The sample module 2 may have 1 to 1000 sample positions. The transfer module 4 and the reagent module 5 may have 1 to 100 positions. The sealing module 10 may use a heat sealing module or an adhesive film sealing module. The transmission module 8 may be placed in the PCR detection area or other areas.

[0079] The PCR detection plate entry and exit port of the PCR detection module 11 in the present application can be opened and closed by a push-pull method or by a flip-up method.

[0080] As shown in Figure 7, the upper portion of the sleeve 31 is provided with a corrugated structure 32 to prevent the liquid from splashing out of the plate hole 34 during stirring. The corrugated structure 32 in the middle and lower portions of the sleeve 31 can make the solution, especially the small volume solution concentrated at the bottom of the tube, more evenly stirred.

[0081] Refer to Figure 9, which is a schematic flow chart of an embodiment of a high-throughput fully-automatic nucleic acid detection method provided in an embodiment of the present application. The high-throughput fully-automatic nucleic acid detection method includes 201-212:

[0082] 201 . The pipetting module 3 adds the test sample into the multiple plate wells 34 on the nucleic acid extraction plate on the transfer module 4 .

[0083] In this embodiment of the present application, before step 201, the barcode scanning module 1 can perform barcode scanning on the test samples, reagents, and consumables in the sample module 2, the consumables holding position 6, and the reagent module 5. The scanned information is recorded in the instrument computer, achieving barcode monitoring of the entire test process.

[0084] In an embodiment of the present application, the pipetting module 3 includes a robotic arm and a sample adding needle or pipette tip, which can insert and remove the pipette tip in the consumable module, and then pipette the sample in the sample module 2 and the nucleic acid reagent in the reagent module 5, and add them to the multiple plate holes 34 in each nucleic acid extraction plate in the transfer module 4.

[0085] 202. Control the first mechanical gripper 12 to grab the nucleic acid extraction plate and place it on the nucleic acid extraction module 7 for nucleic acid extraction.

[0086] In the embodiment of the present application, after the pipetting is completed, the first mechanical gripper 12 is controlled to grab the nucleic acid extraction plate and place it on the nucleic acid extraction module 7 for nucleic acid extraction.

[0087] 203. The multiple sleeves 31 on the nucleic acid extraction module 7 extend into the multiple plate holes 34 on the nucleic acid extraction plate to rotate and stir.

[0088] In this embodiment, the sleeves 31 of the multiple magnetic head assemblies 30 correspond to the plate holes 34 on the multiple nucleic acid extraction plates. As shown in Figure 3, the multiple sleeves 31 on the nucleic acid extraction module 7 extend into the multiple plate holes 34 on the nucleic acid extraction plate to stir the sample. The sleeves 31 can be moved up and down and rotated to stir the sample and the nucleic acid extraction reagents.

[0089] 204 . The multiple magnetic rods 35 of the nucleic acid extraction module 7 extend into the sleeve 31 , so that the magnetic beads 33 adsorbed with nucleic acid are adsorbed on the outer wall of the sleeve 31 .

[0090] As shown in FIG4 , when the magnetic rod 35 is inserted into the sleeve 31 , the magnetic beads 33 are adsorbed on the outer wall of the sleeve 31 , and the magnetic beads 33 are collected by the sleeve 31 . The magnetic beads 33 follow the sleeve 31 and transfer between the plate holes 34 .

[0091] 205. The multiple magnetic head assemblies 30 of the nucleic acid extraction module 7 are completely separated from the nucleic acid extraction plate.

[0092] As shown in FIG5 , the multiple magnetic head assemblies 30 of the nucleic acid extraction module 7 are completely separated from the nucleic acid extraction plate.

[0093] 206. The multiple magnetic head assemblies 30 of the nucleic acid extraction module 7 are integrally extended into the nucleic acid release plate. The magnetic rods 35 are pulled out of the sleeves 31 to release the magnetic beads 33 into the multiple plate holes 34 of the nucleic acid release plate.

[0094] As shown in FIG6 , the multiple magnetic head assemblies 30 of the nucleic acid extraction module 7 are integrally extended into the nucleic acid release plate, and the magnetic rod 35 is pulled out of the sleeve 31 to release the magnetic beads 33 into the multiple plate holes 34 of the nucleic acid release plate, thereby realizing the transfer of the magnetic beads 33 .

[0095] 207. The multiple sleeves 31 on the nucleic acid extraction module 7 rotate and stir in the multiple plate holes 34 on the nucleic acid release plate, so that the nucleic acid on the magnetic beads 33 is eluted onto the nucleic acid release plate.

[0096] Sleeve 31 rotates within the extraction reagent in the nucleic acid release plate, releasing magnetic beads 33 into the extraction solution. Corrugations 32 on sleeve 31 provide enhanced agitation of the sample, magnetic beads 33, and extraction reagent. The extraction reagent extracts nucleic acids, leaving them within the nucleic acid release plate.

[0097] 208 . The multiple magnetic rods 35 of the nucleic acid extraction module 7 extend into the sleeve 31 , so that the magnetic beads 33 are adsorbed on the outer wall of the sleeve 31 .

[0098] In the embodiment of the present application, after the sample is lysed by the nucleic acid extraction reagent, the nucleic acid is adsorbed by the magnetic beads 33, and washed, the magnetic beads 33 adsorbed with nucleic acid are transferred from the nucleic acid extraction module 7 to the nucleic acid release plate filled with elution solution for elution. The magnetic beads 33 are collected and separated by the magnetic rod 35 and the sleeve 31 to complete the extraction of nucleic acid.

[0099] 209 . The first mechanical gripper 12 moves the nucleic acid release plate with nucleic acid to the transfer module 4 .

[0100] The first mechanical gripper 12 transfers the nucleic acid release plate from which nucleic acid extraction has been completed to the transfer module 4 .

[0101] 210. The pipetting module 3 adds the solution in the nucleic acid release plate and the PCR reaction solution to the multiple plate wells 34 on the PCR detection plate on the transfer module 4 to obtain a PCR detection plate with added nucleic acid.

[0102] In the embodiment of the present application, the pipetting needle of the pipetting module 3 uses the pipette tip in the consumables module to aspirate the PCR reaction reagents in the reagent module 5 to prepare a PCR reaction solution, and then aspirates and dispenses the PCR reaction solution into the wells 34 of the PCR detection plate of the transfer module 4. The solution in the nucleic acid release plate is then transferred to the wells 34 of the PCR detection plate of the transfer module 4, thereby completing the preparation of the PCR reaction solution.

[0103] 211. The second mechanical gripper 12 transfers the PCR test plate with added nucleic acid to the transmission module 8 for sealing, thereby obtaining the sealed PCR test plate.

[0104] In this embodiment of the present application, the first robotic gripper 12 moves the PCR test plate containing the added nucleic acid from the transfer module 4 to the transport module 8. The isolation door 9 opens, and the transport module 8 transports the PCR test plate containing the added nucleic acid to the PCR testing area via the transport track. The isolation door 9 then closes. The second robotic gripper 13 transfers the PCR test plate to the sealing module 10, where the PCR test plate is sealed.

[0105] 212. The second mechanical gripper 13 transfers the sealed PCR test plate to the PCR test module 11 for testing to obtain the test results.

[0106] The second mechanical gripper 13 transfers the sealed PCR detection plate to the PCR detection module 11 for fluorescence PCR amplification detection. After the detection is completed, the software automatically analyzes the detection data and generates a detection result.

[0107] Discarded pipette tips during the detection process are stored in the waste collection module 141, and various extraction waste liquids during the extraction process are left in the corresponding extraction plates, eliminating the need to collect waste liquids separately, making waste disposal convenient. The protective rear plate 18 and protective side plates 17 are in a closed state and locked during the detection process, ensuring the airtightness of the detection process and personnel safety. The air filter cover 16 serves to prevent interference from external dust and the like on the detection. The air filter cover 16 is equipped with an exhaust fan 19 and an air filter. The exhaust speed and direction of the exhaust fan 19 are used to form a pressure gradient with decreasing air pressure in the sample area, nucleic acid extraction area and PCR detection area, which conforms to the reasonable pressure difference setting for nucleic acid detection and prevents contamination during the detection process. At the same time, the PCR detection area is isolated by an independent chassis with negative pressure inside the chassis. The PCR detection plate is transmitted through an openable and closable isolation door 9 to prevent leakage of amplification products and contamination of other areas. An ultraviolet lamp is installed in the air filter cover 16. After the detection is completed, the ultraviolet lamp irradiates each detection area to eliminate nucleic acid contamination during the detection.

[0108] The high-throughput fully automatic nucleic acid detection instrument of the present application has a large sample throughput. The sample module 2 can hold 1 to multiple columns of samples, with up to 576 samples loaded at a time. It also supports multiple rounds of continuous loading, and can take 1, 6, 8, 24, or 48 samples mixed into 1 well for combined detection. The detection throughput of each experiment is as high as 4608 samples, which is a huge improvement over the 96 sample positions of similar devices currently available. The nucleic acid extraction module 7 of the high-throughput fully automatic nucleic acid detection instrument of the present application contains 48 / 96 magnetic head assemblies 30, which can extract 96 well samples at a time. Compared with the 1 to 8 needle pipetting device used in existing devices to extract 1-8 well samples at a time, the extraction speed is increased by 12 times. The extraction and transfer of magnetic beads 33 does not use the method of aspirating waste liquid by a needle, which also saves extraction time. The total detection time for the 558 plasma samples and 3 quality control products of blood donors using the instrument of the present application in combination with the hepatitis B virus / hepatitis C virus / human immunodeficiency virus (1+2) type nucleic acid detection reagent is 4 hours. This test was 2.5 hours faster than the 6.5 hours required by the conventional Roche cobas AmpliPrep / cobas TaqMan assay system for similar samples. The entire test time for 4,464 plasma samples from blood donors and three quality control samples was 8.25 hours. This was verified by the following example:

[0109] (1) Example of mixed testing of 6 samples

[0110] 558 plasma samples and 3 quality control samples from blood donors were tested using the instrument described in this application in conjunction with the Hepatitis B Virus / Hepatitis C Virus / Human Immunodeficiency Virus (1+2) nucleic acid detection reagent (purchased from Beijing Wantai Biopharmaceutical Co., Ltd.). The testing time was calculated.

[0111] Step 1: Scan the barcodes of 3 quality control samples and 558 samples, and pool 6 plasma samples into 1 sample. The sample loading time is 45 minutes.

[0112] Step 2: Reagent addition and nucleic acid extraction time is 96 minutes;

[0113] Step 3: PCR reagent preparation time is 6 minutes;

[0114] Step 4: The PCR reaction system was set up in 13 minutes.

[0115] Step 5: PCR sealing and PCR detection time is 80 minutes.

[0116] The total detection time is 240 minutes, or 4 hours, which is 2.5 hours faster than the 6.5 hours required by the conventional Roche cobas AmpliPrep / cobas TaqMan detection system to detect similar samples.

[0117] (2) Example of mixed testing of 48 samples

[0118] 4,464 plasma samples and 3 quality control samples from blood donors were tested using the instrument in this application in combination with the Hepatitis B Virus / Hepatitis C Virus / Human Immunodeficiency Virus (1+2) nucleic acid detection reagent. The testing time was calculated.

[0119] Step 1: Scan the barcodes of 3 quality control samples and 4464 samples, and pool 48 plasma samples into 1 sample. The sample loading time is 300 minutes.

[0120] Step 2: Reagent addition and nucleic acid extraction time is 96 minutes;

[0121] Step 3: PCR reagent preparation time is 6 minutes;

[0122] Step 4: The PCR reaction system was set up in 13 minutes.

[0123] Step 5: PCR sealing and PCR detection time is 80 minutes.

[0124] The total testing time for the above process is 495 minutes, or 8.25 hours.

[0125] The nucleic acid extraction module of this application uses a magnetic rod and cannula to adsorb, separate and transfer magnetic beads, avoiding cross contamination caused by repeated pipetting and mixing with a sample needle or open-mouthed mixing with a shaking module. Examples are as follows:

[0126] Anti-cross contamination performance verification:

[0127] The serum plate (purchased from Beijing Kangshitan Biotechnology Co., Ltd.) was used for verification, which contained 24 mixed HBV and HCV positive samples (PC): HBV concentration was 6.6×10 4 IU / mL, HCV concentration was 3.3×10 4 IU / mL, Specifications: 2mL / vial. 72 negative samples (NC): negative human plasma. The instrument performed cross-dosing, with each positive sample surrounded by negative samples. The sample extraction and amplification plate layout is shown in Table 1 below.

[0128] Table 1

[0129] The positive and negative coincidence rates of the test results were statistically analyzed to verify the anti-cross-contamination performance of this application in detecting strongly positive DNA and RNA samples.

[0130] The statistical distribution of the test results is shown in Table 2 below.

[0131] Table 2 Note: - represents a negative result, + represents a positive result.

[0132] All positive wells tested were positive, with a compliance rate of 24 / 24; all negative wells tested were negative, with a compliance rate of 72 / 72. There was no detection contamination in the negative samples, indicating that the present application has excellent anti-cross-contamination performance for the detection of strong positive samples of DNA and RNA.

[0133] (2) Example of functional modules arranged in two layers

[0134] In the embodiment shown in Figure 8, the base 20 is configured with an upper layer and a lower layer, with the functional modules arranged in layers above and below. In this embodiment, the sealing module 10 and PCR detection module 11 are placed in the lower layer of the base. This utilizes the space below the tabletop, reducing the instrument's left-right length by 30-90 cm and minimizing floor space.

[0135] The mechanical gripper can transfer the experimental items through the transfer channel 36 in the table. A single mechanical gripper can be shared, or corresponding mechanical grippers can be set up on the upper and lower levels to transfer the experimental items.

[0136] The nucleic acid extraction module of the present application uses a magnetic rod sleeve to mix and transfer magnetic beads to extract nucleic acids. The waste liquid is retained in the plate wells. Compared with relying on a pipette to transfer the extracted waste liquid, the influence of residual waste liquid on the purity of nucleic acid extraction is avoided. The instrument of the present application is used in combination with the hepatitis B virus / hepatitis C virus / human immunodeficiency virus (1+2) type nucleic acid detection reagent (purchased from Beijing Wantai Bio-Pharmaceutical Co., Ltd.) to detect the national reference materials of the China Food and Drug Inspection Institute. The HBV DNA detection sensitivity reaches 3IU / mL, the HCV RNA detection sensitivity reaches 10IU / mL, the HIV-1RNA detection sensitivity reaches 40IU / mL, and the HIV-2RNA detection sensitivity reaches 10IU / mL. They are all higher than similar detection systems currently on the market. The examples are verified as follows:

[0137] Detection sensitivity performance verification:

[0138] The national reference material of the China Food and Drug Inspection Institute was diluted with plasma samples to the following concentrations: HBV DNA 3 IU / mL, HCV RNA 10 IU / mL, HIV-1 RNA 40 IU / mL, HIV-2 RNA 10 IU / mL, and the packaging specification was 2 mL / vial. The specific background of the samples is shown in Table 3 below.

[0139] Table 3

[0140] Testing was performed using the instrument described in this application in conjunction with the Hepatitis B Virus / Hepatitis C Virus / Human Immunodeficiency Virus (1+2) nucleic acid detection reagent. Twenty samples were tested for each concentration. The detection rate for each test and concentration was calculated, and the repeat detection rate for all four tests was 100%. The results are shown in Table 4 below.

[0141] Table 4

[0142] The high-throughput fully automatic nucleic acid detection instrument in this application is divided into a nucleic acid extraction area and a PCR detection area. The PCR detection area is separated independently, and the PCR detection area is isolated by an independent chassis. The PCR detection area is under negative pressure, and the PCR detection plate is transmitted through an openable and closable isolation door 9 to prevent leakage of amplification products and pollution in other areas. The air filter cover 16 and the PCR detection area are designed with negative pressure to prevent external dust and the like from interfering with the detection. An exhaust fan 19 and an air filter are provided. The exhaust speed and direction of the fan realize the formation of an air pressure gradient with decreasing air pressure in the nucleic acid extraction area and the PCR detection area, which conforms to the reasonable pressure difference setting of nucleic acid detection and prevents pollution during the detection process. An ultraviolet lamp is installed in the air filter cover 16. After the detection is completed, the ultraviolet lamp irradiates each detection area to eliminate nucleic acid contamination during detection. The defect of the prior art that each functional area is not effectively divided, the air flow is not effectively controlled, and cross contamination of detection is easily caused is solved.

[0143] The waste collection module 141 of the present application is set outside the detection area and is only used for discarding pipette tips. The inner layer is a plastic garbage bag and the outer layer is protected by a metal shell to prevent waste from polluting other areas.

[0144] In the above embodiments, the description of each embodiment has its own focus. For parts that are not described in detail in a certain embodiment, please refer to the detailed description of other embodiments above and will not be repeated here.

[0145] In specific implementation, the above units or structures can be implemented as independent entities, or can be arbitrarily combined to implement as the same or several entities. The specific implementation of the above units or structures can refer to the previous method embodiments and will not be repeated here.

[0146] The specific implementation of the above operations can be found in the previous embodiments and will not be repeated here.

[0147] The above is a detailed introduction to a high-throughput fully automatic nucleic acid detection instrument and method provided in the embodiments of the present application. Specific examples are used herein to illustrate the principles and implementation methods of the present application. The description of the above embodiments is only used to help understand the method of the present application and its core idea; at the same time, for technical personnel in this field, based on the ideas of the present application, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as a limitation on the present application.

Claims

1. A high-throughput fully automatic nucleic acid detection instrument, the high-throughput fully automatic nucleic acid detection instrument comprising: Base (20); A transfer module (4), the transfer module (4) being arranged on the base (20), the transfer module (4) being used to carry a nucleic acid extraction plate, a nucleic acid release plate and a PCR detection plate, wherein the nucleic acid extraction plate, the nucleic acid release plate and the PCR detection plate are all provided with a plurality of plate holes (34), the plate holes (34) of the nucleic acid extraction plate and the nucleic acid release plate being used to receive extraction reagents, and the plate holes (34) of the PCR detection plate being used to receive PCR reaction liquid; A mechanical gripper, wherein the mechanical gripper is used to transport the nucleic acid extraction plate, the nucleic acid release plate and the PCR detection plate; A pipetting module (3), the pipetting module (3) being used to add the test sample into a plurality of plate wells (34) of the nucleic acid extraction plate on the transfer module (4); A nucleic acid extraction module (7), the nucleic acid extraction module (7) comprising a plurality of magnetic head assemblies (30), the magnetic head assemblies (30) comprising a driving device, a sleeve (31), a magnetic rod (35) and magnetic beads (33), the driving device being used to drive the magnetic rod (35) to extend into or out of the sleeve (31), the magnetic rod (35) being used to adsorb or release the magnetic beads (33), the magnetic beads (33) being used to adsorb nucleic acids, when the magnetic rod (35) is extended into the sleeve (31), the magnetic beads (33) are adsorbed onto the outer wall of the sleeve (31), and the magnetic beads (33) follow the sleeve (31) to transfer between plate holes (34); when the magnetic rod (35) is pulled out of the sleeve (31), the magnetic beads (33) adsorbed with nucleic acids are released into the plate holes (34), thereby transferring the nucleic acids; A PCR detection module (11), wherein the PCR detection module (11) is arranged on the base (20), and the PCR detection module (11) is used to perform PCR detection on a PCR detection plate added with nucleic acid to obtain a detection result.

2. A high-throughput fully automatic nucleic acid detection instrument according to claim 1, wherein the driving device drives the sleeve (31) to rotate and the solution in the stirring plate hole (34), and the outer wall of the sleeve (31) is provided with corrugations (32).

3. A high-throughput fully automatic nucleic acid detection instrument according to claim 1 or 2, wherein the base (20) includes a nucleic acid extraction area, a PCR detection area and an isolation door (9), the isolation door (9) is arranged between the nucleic acid extraction area and the PCR detection area, the pipetting module (3) and the nucleic acid extraction module (7) are located in the nucleic acid extraction area, and the PCR detection module (11) is located in the PCR detection area.

4. A high-throughput fully automatic nucleic acid detection instrument according to claim 3, wherein a sealing module (10) is provided on the base (20), and the sealing module (10) is arranged in the PCR detection area, and the sealing module (10) is used to seal the PCR detection plate added with nucleic acid transported by the mechanical gripper; the PCR detection module (11) is used to detect the PCR detection plate after sealing.

5. A high-throughput fully automatic nucleic acid detection instrument according to claim 3, wherein a transmission module (8) is provided between the PCR detection module (11) and the nucleic acid extraction module (7), and the transmission module (8) passes through the isolation door (9), and the isolation door (9) cuts off the transmission module (8) when it is closed, and when the isolation door (9) is opened, the transmission module (8) moves the PCR detection plate added with nucleic acid from the nucleic acid extraction module (7) to the PCR detection module (11).

6. A high-throughput fully automatic nucleic acid detection instrument according to any one of claims 1-5, wherein a protective rear plate (18) and a protective side plate (17) are vertically arranged on the edge of the base (20), and the protective rear plate (18) and the protective side plate (17) surround the various devices on the base (20).

7. A high-throughput fully automatic nucleic acid detection instrument according to claim 6, wherein the mechanical gripper and the pipetting module (3) are arranged on the protective rear plate (18), and the base (20) is provided with a barcode scanning module (1), a sample module (2), a consumables carrying position (6) and a reagent module (5), the sample module (2) is located below the pipetting module (3), the sample module (2) is used to carry the test sample, and the barcode scanning module (1) is used to perform barcode scanning on the test sample, reagents and consumables in the sample module (2), the transfer module (4), the reagent module (5) and the consumables carrying position (6).

8. A high-throughput fully automatic nucleic acid detection instrument according to claim 7, wherein a waste conveying channel (14) is provided on the base (20), and the waste conveying channel (14) is located between the transfer module (4) and the sample module (2), and one end of the waste conveying channel (14) extends out of the base (20), and a waste collection module (141) is provided at one end of the waste conveying channel (14), and the waste collection module (141) is located outside the base (20), and a spare consumables position (15) is provided on the protective rear plate (18).

9. A high-throughput fully automatic nucleic acid detection instrument according to claim 6 or 7, wherein an air filter cover (16) is provided on the top of the protective rear plate (18) and the protective side plate (17), and an exhaust fan (19) and an air filter are installed on the air filter cover (16), and an ultraviolet lamp is provided in the air filter cover (16), and the ultraviolet lamp is used for disinfection.

10. The high-throughput fully automatic nucleic acid detection instrument according to claim 1, wherein the base (20) is configured as a layer or includes an upper layer and a lower layer, and a transfer channel (36) is provided between the upper layer and the lower layer, and the transfer channel (36) is used to transfer items; The base (20) shares one mechanical gripper, or corresponding mechanical grippers are respectively provided in different areas of the base (20).

11. A high-throughput fully automatic nucleic acid detection method, characterized in that: The high-throughput fully-automatic nucleic acid detection instrument according to any one of claims 1 to 10, wherein the high-throughput fully-automatic nucleic acid detection method comprises: The pipetting module (3) adds the test sample to the multiple plates on the nucleic acid extraction plate on the transfer module (4). Inside the hole (34); The mechanical gripper grabs the nucleic acid extraction plate and places it into the nucleic acid extraction module (7); The plurality of sleeves (31) on the nucleic acid extraction module (7) extend into the plurality of plate holes (34) on the nucleic acid extraction plate for stirring; One or more magnetic rods (35) of the nucleic acid extraction module (7) extend into the sleeve (31), so that the magnetic beads (33) adsorbed with nucleic acid are adsorbed on the outer wall of the sleeve (31); The plurality of magnetic head assemblies (30) of the nucleic acid extraction module (7) are completely separated from the nucleic acid extraction plate; The plurality of magnetic head assemblies (30) of the nucleic acid extraction module (7) are integrally extended into the nucleic acid release plate, and the magnetic rod (35) is pulled out of the sleeve (31) to release the magnetic beads (33) to enter the plurality of plate holes (34) of the nucleic acid release plate; The plurality of sleeves (31) on the nucleic acid extraction module (7) are rotated and stirred in the plurality of plate holes (34) on the nucleic acid release plate, so that the nucleic acid on the magnetic beads (33) is eluted onto the nucleic acid release plate; One or more magnetic rods (35) of the nucleic acid extraction module (7) extend into the sleeve (31), so that the magnetic beads (33) are adsorbed on the outer wall of the sleeve (31); The mechanical gripper moves the nucleic acid release plate carrying the nucleic acid to the transfer module (4); The pipetting module (3) adds the solution in the nucleic acid release plate and the PCR reaction solution to a plurality of plate wells (34) on the PCR detection plate on the transfer module (4) to obtain the PCR detection plate to which nucleic acid is added; The mechanical gripper transports the PCR detection plate with added nucleic acid to the PCR detection module (11) for detection to obtain the detection result.

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