Direct expansion all-in-one machine

The automated design of the direct-amplification integrated machine solves the problem of manual operation required by existing equipment, realizes fully automated sample testing, improves testing efficiency and accuracy, and is suitable for rapid diagnosis in outpatient and emergency departments.

CN223633372UActive Publication Date: 2025-12-05SANSURE BIOTECH INC
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Patent Information

Application Number
CN202423070260.4
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-12-12
Publication Date
2025-12-05
Estimated Expiration
2034-12-12

AI Technical Summary

Technical Problem

In the current technology, most molecular diagnostic equipment is a semi-automatic instrument that requires manual intervention to transfer samples and pipettes, which is difficult to meet the rapid diagnostic needs of outpatient and emergency departments during peak seasons and emergency situations.

Method used

A direct amplification integrated machine is provided, which includes a sample pretreatment module, a nucleic acid direct amplification module, a PCR detection module and a robotic arm module, to realize automated sample pretreatment, nucleic acid amplification and PCR detection, and uses the robotic arm module for sample transport and pipetting operations.

Benefits of technology

It has achieved full automation of the nucleic acid testing process, reduced testing errors and the risk of biological contamination, improved testing efficiency and accuracy, and can quickly produce diagnostic results to meet the rapid diagnostic needs of outpatient and emergency departments.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model belongs to the field of molecular diagnosis, and particularly relates to a direct expansion all-in-one machine which can automatically complete multiple links of pretreatment, nucleic acid amplification and PCR detection of a detection sample through mutual cooperation of a sample pretreatment module, a nucleic acid direct expansion module, a PCR detection module and a mechanical arm module. The pretreated sample is subjected to nucleic acid amplification, so that the detection efficiency and accuracy are improved. The detection efficiency is effectively improved, the detection cost is reduced, the rapid diagnosis requirement of outpatient and emergency treatment in high-incidence seasons and emergency situations can be met, and powerful support is provided for clinical diagnosis and treatment.
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Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of molecular diagnosis, and particularly relates to a direct amplification integrated machine. BACKGROUND

[0002] Molecular diagnosis is a technical means capable of quickly and accurately diagnosing a pathogen, including multiple links such as pathogen sample processing, nucleic acid extraction, PCR amplification, fluorescent labeling and detection, and result analysis. When detecting a pathogen sample, a detection device needs to be used, and a pathogen sample extraction liquid needs to be amplified and detected according to a detection technology to obtain a detection result.

[0003] In the field of respiratory tract and maternal and child health, rapid and accurate molecular diagnosis is crucial for early detection and treatment of diseases. At present, existing molecular diagnosis devices are mostly semi-automatic instruments. When performing molecular diagnosis, manual participation in sample transfer and pipetting operations is required, and therefore, there is certain limitation in detection efficiency, and it is difficult to meet the rapid diagnosis needs of outpatient and emergency departments in high-incidence seasons and emergency situations. CONTENT OF THE INVENTION

[0004] The direct amplification integrated machine provided in the embodiments of the present application aims to shorten detection time, improve detection efficiency, and meet the rapid diagnosis needs of outpatient and emergency departments in high-incidence seasons and emergency situations.

[0005] To achieve the above-mentioned purpose, the direct amplification integrated machine provided in the present application comprises:

[0006] A sample pretreatment module configured to perform information input, cell lysis, and cup separation on a sample;

[0007] A nucleic acid direct amplification module configured to perform nucleic acid amplification on the pretreated sample;

[0008] A PCR detection module configured to detect the amplified sample; and

[0009] A mechanical arm module comprising a transfer mechanism and a pipetting mechanism, wherein the transfer mechanism is configured to transfer the sample between the sample pretreatment module, the nucleic acid direct amplification module, and the PCR detection module; and the pipetting mechanism is configured to perform pipetting inside the sample pretreatment module, inside the nucleic acid direct amplification module, and inside the PCR detection module.

[0010] Optionally, the direct amplification integrated machine further comprises a consumable storage module, wherein the consumable storage module is provided with a partitioned placement seat for storing a storage deep well plate, a PCR plate, a PCR plate sealing cover, and a gun head; and the transfer mechanism is further capable of transferring consumables between the consumable storage module and the sample pretreatment module, between the consumable storage module and the nucleic acid direct amplification module, and between the consumable storage module and the PCR detection module.

[0011] Optionally, the transferring mechanism comprises a transferring robot arm and a gripper arranged on the transferring robot arm, the gripper being capable of moving in a three-dimensional space under the driving of the transferring robot arm to transfer samples and consumables;

[0012] The pipetting mechanism comprises a pipetting robot arm and a pipetting gun arranged on the pipetting robot arm, the pipetting gun being capable of moving in a three-dimensional space under the driving of the pipetting robot arm to transfer liquid.

[0013] Optionally, the robot arm module comprises a common linear module, a transferring linear module, a transferring lifting module, a rotating module, a pipetting linear module and a pipetting lifting module, the transferring linear module and the transferring lifting module being respectively slidingly arranged on the common linear module, the transferring lifting module being slidingly arranged on the transferring linear module, the gripper being arranged on the transferring lifting module through the rotating module, the common linear module, the transferring linear module, the transferring lifting module and the rotating module jointly constituting the transferring robot arm, the gripper being capable of rotating under the driving of the rotating module, moving up and down under the driving of the transferring lifting module, moving in a first direction under the driving of the transferring linear module and moving in a second direction under the driving of the common linear module, the first direction intersecting the second direction;

[0014] The pipetting lifting module is slidingly arranged on the pipetting linear module, the pipetting gun is arranged on the transferring lifting module, and the common linear module, the pipetting linear module and the pipetting lifting module jointly constitute the pipetting robot arm, the pipetting gun being capable of moving up and down under the driving of the pipetting lifting module, moving in a first direction under the driving of the pipetting linear module and moving in a second direction under the driving of the common linear module.

[0015] Optionally, the sample pretreatment module comprises:

[0016] A sample tube rack for carrying sample tubes;

[0017] A code scanner for information entry of the sample tubes;

[0018] An ultrasonic lysis module for ultrasonic lysis of samples in the sample tubes to release nucleic acids;

[0019] A clamping module for clamping the sample tubes;

[0020] The gripper is capable of moving between the sample tube rack, the ultrasonic lysis module and the clamping module under the driving of the transferring robot arm to transfer samples, and the gripper is also capable of rotating under the driving of the transferring robot arm to open and close the caps of the sample tubes in cooperation with the clamping module;

[0021] The pipette can transfer the sample after ultrasonic lysis to a deep-well plate under the driving of the pipetting robot arm.

[0022] Optionally, the nucleic acid direct amplification module comprises direct amplification reagents and a carrier seat, the transfer mechanism is used to transfer the sample after cupping to the carrier seat, and the pipetting mechanism is used to suck the direct amplification reagents and add them to the sample after cupping to directly amplify the nucleic acid in the sample.

[0023] Optionally, the direct amplification integrated machine further comprises a rack, the rack comprises a rack body and a table surface arranged on the rack body, and the sample pretreatment module and the nucleic acid direct amplification module are arranged on the table surface, and the mechanical arm module is arranged on the rack body above the table surface.

[0024] Optionally, the PCR detection module comprises a liquid preparation carrier and a PCR detector, the liquid preparation carrier is arranged on the table surface to carry a PCR plate, the pipetting mechanism is used to transfer the amplified sample to the PCR plate, the PCR detector is arranged on the rack body below the table surface, the table surface is provided with a avoiding hole for placing the PCR plate into the PCR detector, and the transfer mechanism is used to cover the PCR plate and transfer the covered PCR plate to the PCR detector through the avoiding hole.

[0025] Optionally, a plurality of PCR detectors are arranged, a rack is arranged on the rack body below the table surface, and the plurality of PCR detectors are arranged on the rack from top to bottom in sequence, and the PCR detection module further comprises a lifting mechanism arranged below the table surface and located at one side of the rack, the lifting mechanism is used to insert and lift the PCR detector below the avoiding hole.

[0026] Optionally, the direct amplification integrated machine further comprises a waste collection barrel, the table surface is provided with a discard port, and the waste collection barrel is located below the discard port.

[0027] The beneficial effects of the direct amplification integrated machine provided in this application are as follows: Compared with the prior art, the direct amplification integrated machine of this application can automatically complete multiple steps of sample pretreatment, nucleic acid amplification, and PCR detection through the cooperation of the sample pretreatment module, nucleic acid direct amplification module, PCR detection module, and robotic arm module. The nucleic acid direct amplification module adopts direct amplification technology to amplify nucleic acid in the pretreated sample, improving the efficiency and accuracy of detection. In practical applications, respiratory or maternal and child test samples are placed into the sample pretreatment module of the direct amplification integrated machine. After pretreatment such as information entry, cell lysis, and cupping, they enter the nucleic acid direct amplification module for nucleic acid amplification. The amplified sample is detected by the PCR detection module. Sample transfer and liquid preparation are completed by the robotic arm module, eliminating the need for manual sample transfer and liquid preparation. This enables fully automated diagnosis of the entire process of sample entry and result output in nucleic acid detection, reducing testing errors and the risk of biological contamination during the detection process. It is highly safe and reliable, and can quickly obtain diagnostic results, effectively improving detection efficiency and reducing detection costs. It can meet the rapid diagnostic needs of outpatient and emergency departments during peak seasons and emergency situations, providing strong support for clinical diagnosis and treatment. Attached Figure Description

[0028] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0029] in:

[0030] Figure 1 This is a schematic diagram of the structure of a direct-drive integrated machine according to an embodiment of this application;

[0031] Figure 2 This is a top view of the structure located on the rack platform in a direct expansion integrated machine according to an embodiment of this application;

[0032] Figure 3 This is a partial structural schematic diagram of a direct-expansion integrated machine shown in one embodiment of this application.

[0033] Explanation of key component symbols:

[0034] 100. Sample preprocessing module;

[0035] 110. Sample tube rack; 120. Barcode scanner; 130. Ultrasonic lysis module; 140. Clamping module;

[0036] 200. Nucleic acid direct amplification module;

[0037] 210, direct spread agent; 220, bearing seat;

[0038] 300, PCR detection module;

[0039] 310, bearing frame; 320, PCR detector;

[0040] 400, mechanical arm module; 401, common linear module; 402, transfer linear module; 403, transfer lifting module; 404, rotating module; 405, pipetting linear module; 406, pipetting lifting module;

[0041] 410, transfer mechanism; 411, gripper;

[0042] 420, pipetting mechanism; 421, pipetting gun;

[0043] 500, consumable storage module;

[0044] 600, rack;

[0045] 610, frame body; 620, table top; 621, avoiding hole; 622, discarding port; 630, storage rack;

[0046] 640, lifting mechanism;

[0047] 700, waste collection barrel;

[0048] 800, control system. DETAILED DESCRIPTION

[0049] For the purpose of facilitating the understanding of the present application, the present application will be described in more detail below with reference to the relevant drawings. The preferred embodiments of the present application are shown in the drawings. However, the present application can be implemented in many other different forms, and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to make the understanding of the disclosure of the present application more thorough and comprehensive.

[0050] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or indirectly on the other element. When an element is referred to as being "connected to" another element, it can be directly connected to the other element or indirectly connected to the other element.

[0051] It should be understood that the terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer," etc., indicating orientation or positional relationships, are based on the orientation or positional relationships shown in the accompanying drawings and are used only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on this application. In the description of this application, "a plurality of" means two or more, unless otherwise explicitly specified.

[0052] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0053] It should also be noted that in the embodiments of this application, the same reference numerals are used to represent the same component or part. For the same part in the embodiments of this application, the reference numerals may only be used to mark one part or component as an example. It should be understood that the reference numerals are also applicable to other identical parts or components.

[0054] As described in the background section, most existing molecular diagnostic equipment is semi-automatic. When performing molecular diagnostics, manual intervention is required for operations such as sample transfer and liquid pipetting. Therefore, there are certain limitations in terms of detection efficiency, making it difficult to meet the rapid diagnostic needs of outpatient and emergency departments during peak seasons and emergency situations.

[0055] To address the aforementioned issues, embodiments of this application provide a direct-drive integrated machine, such as... Figures 1-3 As shown, the integrated direct amplification system includes a sample pretreatment module 100, a nucleic acid direct amplification module 200, a PCR detection module 300, and a robotic arm module 400. The sample pretreatment module 100 is used for sample information entry, cell lysis, and aliquoting. Cell lysis is used to break down the cell walls in the sample to release nucleic acids; aliquoting is used to aliquot the sample into different sizes as needed. The nucleic acid direct amplification module 200 uses direct amplification technology to directly amplify nucleic acids from the pretreated sample. The PCR detection module 300 is used to detect the amplified sample, and its detection methods include, but are not limited to, fluorescence detection and electrochemical detection. The robotic arm module 400 includes a transfer mechanism 410 and a pipetting mechanism 420. The transfer mechanism 410 is used to transfer samples and consumables between the sample pretreatment module 100, the nucleic acid direct amplification module 200, and the PCR detection module 300; the pipetting mechanism 420 is used to perform pipetting within the sample pretreatment module 100, the nucleic acid direct amplification module 200, and the PCR detection module 300.

[0056] It can be understood that the sample pretreatment module 100 is used for code scanning, cell lysis, cover opening, and sample transfer to a deep well plate before nucleic acid direct amplification. The nucleic acid direct amplification technology can realize direct amplification of nucleic acid in the pretreated sample through a special amplification reaction buffer system, without the traditional complex extraction and purification steps before nucleic acid amplification, so as to greatly simplify the process of nucleic acid detection.

[0057] In the embodiment of the present application, the direct amplification integrated machine can automatically complete the pretreatment, nucleic acid amplification, and PCR detection of the detection sample through the cooperation of the sample pretreatment module 100, the nucleic acid direct amplification module 200, the PCR detection module 300, and the mechanical arm module 400. The nucleic acid direct amplification module 200 uses direct amplification technology to amplify the nucleic acid of the pretreated sample, thereby improving the efficiency and accuracy of detection. In actual application, the respiratory or maternal and child detection sample is placed in the sample pretreatment module 100 of the direct amplification integrated machine, and after pretreatment such as information input, cell lysis, and cup separation, the sample is subjected to nucleic acid amplification in the nucleic acid direct amplification module 200. The amplified sample is detected by the PCR detection module 300, and the sample transfer and pipetting / liquid preparation operations are completed by the mechanical arm module 400, without manual participation in sample transfer and pipetting. The direct amplification integrated machine can realize full-process automatic diagnosis of sample input and result output in nucleic acid detection, reduce test errors and biological pollution risks in the detection process, has high safety and reliability, can quickly obtain a diagnosis result, effectively improves the detection efficiency and reduces the detection cost, and can meet the rapid diagnosis demand of the outpatient department in the high-incidence season and emergency, thereby providing strong support for clinical diagnosis and treatment.

[0058] It should be noted that the direct amplification integrated machine further comprises a control system 800, which automatically controls each module of the direct amplification integrated machine to realize automatic operation of the whole process such as sample loading, detection, and data analysis. In addition, preferably, the direct amplification integrated machine can be configured with an information interface to support two-way LIS system (Laboratory Information System) docking and star chain, so as to realize rapid transmission and sharing of data.

[0059] The direct amplification integrated machine further comprises a consumable storage module 500, which is provided with a partitioned placement seat for storing deep well plates for cup separation, PCR plates and PCR plate sealing covers for PCR detection, and gun heads (also referred to as Tip heads) for pipetting.

[0060] In one embodiment, as shown in FIG. 1, the direct amplification integrated machine comprises a sample pretreatment module 100, a nucleic acid direct amplification module 200, a PCR detection module 300, a mechanical arm module 400, and a control system 800.Figures 1-2 As shown, the transfer mechanism 410 includes a transfer robot arm and a gripper 411 arranged on the transfer robot arm, the gripper 411 being capable of moving in three-dimensional space under the driving of the transfer robot arm to transfer samples and consumables; the pipetting mechanism 420 includes a pipetting robot arm and a pipetting gun 421 arranged on the pipetting robot arm, the pipetting gun 421 being capable of moving in three-dimensional space under the driving of the pipetting robot arm to transfer liquid.

[0061] In an implementation, the gripper 411 includes two driving parts capable of relative opening and closing, a first clamping arm arranged on each of the two driving parts, and a second clamping arm arranged on each of the two driving parts, the two second clamping arms being staggered in the horizontal direction with the two first clamping arms; the spacing between the two first clamping arms is different from the spacing between the two second clamping arms in the opening and closing direction of the two driving parts, for respectively clamping samples and consumables of different width ranges. It can be understood that the two first clamping arms form a first clamping assembly, the two second clamping arms form a second clamping assembly, the two first clamping arms are staggered in the horizontal direction with the two second clamping arms, avoiding that one of the first clamping assembly and the second clamping assembly interferes with the other when clamping materials, and the spacing between the two first clamping arms is different from the spacing between the two second clamping arms in the opening and closing direction of the two driving parts, so that the first clamping assembly and the second clamping assembly can respectively clamp materials of different width ranges, realizing clamping of a wider range of materials and improving the application range of the transfer mechanism 410. Exemplarily, the gripper 411 can realize clamping and transferring of consumables such as sample tubes, deep-well plates, PCR plates, PCR plate sealing covers, multi-tubes, gun heads, etc. under the action of the transfer robot arm. Specifically, the two driving parts capable of relative opening and closing can be realized by two clamping jaws on opening and closing driving members such as pneumatic clamping jaws or electric clamping jaws.

[0062] It can be understood that the transfer robot arm and the pipetting robot arm can respectively adopt two sets of independent three-axis linear modules to respectively realize the movement of the gripper 411 and the pipetting gun 421 in the X-axis, Y-axis and Z-axis. As shown in the following embodiments, two sets of cross-shaped linear modules can be arranged on a Y-axis linear module to realize, so as to simplify the structure and save costs.

[0063] In a specific embodiment, as Figures 1-2As shown, the robotic arm module 400 includes a common linear module 401, a transfer linear module 402, a transfer lifting module 403, a rotary module 404, a pipetting linear module 405, and a pipetting lifting module 406. The linear modules and lifting modules can be synchronous belt type, ball screw type, or linear motor type linear slides, and the rotary module 404 can be a motor or a turntable. The transfer linear module 402 and the transfer lifting module 403 are slidably mounted on the common linear module 401, and the transfer lifting module 403 is slidably mounted on the transfer linear module 402. The gripper 411 is mounted on the transfer lifting module 403 via the rotating module 404. The common linear module 401, the transfer linear module 402, the transfer lifting module 403, and the rotating module 404 together constitute a transfer robotic arm. The gripper 411 can rotate under the drive of the rotating module 404, move up and down under the drive of the transfer lifting module 403, and move along the first direction under the drive of the transfer linear module 402. The pipetting arm has two directions: one direction of movement and the other direction of movement. The first direction intersects with the second direction. The pipetting lifting module 406 is slidably mounted on the pipetting linear module 405, and the pipetting gun 421 is mounted on the transfer lifting module 403. The common linear module 401, the pipetting linear module 405, and the pipetting lifting module 406 together constitute a pipetting robot arm. The pipetting gun 421 can move up and down under the drive of the pipetting lifting module 406, move along the first direction under the drive of the pipetting linear module 405, and move along the second direction under the drive of the common linear module 401.

[0064] For ease of understanding and explanation, a three-axis coordinate system (XYZ) is established in the figure, where the first direction is the direction of the X-axis, the second direction is the direction of the Y-axis, and the vertical direction is the direction of the Z-axis.

[0065] In one embodiment, such as Figures 1-2 As shown, the sample pretreatment module 100 includes a sample tube rack 110, a barcode scanner 120, an ultrasonic lysis module 130, and a clamping module 140, as well as a deep-well plate placement area (not shown). The sample tube rack 110 is used to hold sample tubes, the barcode scanner 120 is used to input information about the sample tubes, the ultrasonic lysis module 130 is used to ultrasonically lyse the samples in the sample tubes to release nucleic acids, and the clamping module 140 is used to clamp the sample tubes. A gripper 411 can move between the sample tube rack 110, the ultrasonic lysis module 130, and the clamping module 140 under the drive of a transfer robotic arm to transfer samples; the gripper 411 can also rotate under the drive of the transfer robotic arm to cooperate with the clamping module 140 to open and close the sample tube caps. A pipette 421 can transfer the ultrasonically lysed samples to a deep-well plate for dispensing under the drive of a pipetting robotic arm.

[0066] Specifically, the sample tube rack 110 can adopt a pull-up sampling mode, and the code scanner 120 is placed on the left side of the sample tube rack 110. During the pushing-in process of the sample tube rack 110, the code scanner 120 captures the sample tube information and completes the code scanning function.

[0067] The clamping module 140 can adopt a clamping mechanism capable of being opened and closed, including but not limited to an electric clamping jaw and a pneumatic clamping jaw, as long as it can clamp and fix the tube body of the sample tube.

[0068] The code scanner 120 and the clamping module 140 are located on one side of the sample tube rack 110, and the ultrasonic lysis module 130 is located on the other side of the sample tube rack 110. In this way, the structure of the sample pretreatment module 100 can be more compact, and the detection efficiency is higher.

[0069] During the working process, after the sample tube rack 110 moves to the specified position, the clamping jaw moves to the specified position of the sample tube through the transfer mechanical arm, the clamping jaw is opened, the sample tube is clamped and transferred to the ultrasonic lysis module 130 for ultrasonic lysis. In this process, the clamping jaw clamps the deep-well plate used for cupping at the consumable storage module 500 under the drive of the transfer mechanical arm and transfers it to the deep-well plate placement position. After the ultrasonic lysis is completed, the clamping jaw clamps the sample tube through the transfer mechanical arm and transfers it to the clamping module 140 position, the clamping module 140 acts to clamp the sample tube, the clamping jaw rotates to open the sample tube cap, at the same time, the pipette 421 moves to the consumable storage module 500 under the drive of the pipetting mechanical arm to press the pipette tip, then moves to the clamping module 140 to suck the sample liquid, and then moves to the deep-well plate to cup. After cupping is completed, the pipette 421 moves to the discard port 622 to push away the used pipette tip, and the discarded pipette tip falls into the waste collection barrel 700 below, and thus the sample pretreatment is completed.

[0070] In an embodiment, as shown in FIG. 2, the nucleic acid direct amplification module 200 includes a direct amplification reagent 210 and a carrier seat 220. The transfer mechanism 410 is used to transfer the cupped sample to the carrier seat 220, and the pipetting mechanism 420 is used to suck the direct amplification reagent 210 and add it to the cupped sample to directly amplify the nucleic acid in the sample. Figures 1-2 In an embodiment, as shown in FIG. 2, the nucleic acid direct amplification module 200 includes a direct amplification reagent 210 and a carrier seat 220. The transfer mechanism 410 is used to transfer the cupped sample to the carrier seat 220, and the pipetting mechanism 420 is used to suck the direct amplification reagent 210 and add it to the cupped sample to directly amplify the nucleic acid in the sample.

[0071] Figures 1-3 In an embodiment, as shown in FIG. 2, the nucleic acid direct amplification module 200 includes a direct amplification reagent 210 and a carrier seat 220. The transfer mechanism 410 is used to transfer the cupped sample to the carrier seat 220, and the pipetting mechanism 420 is used to suck the direct amplification reagent 210 and add it to the cupped sample to directly amplify the nucleic acid in the sample.

[0072] ​The PCR detection module 300 comprises a liquid preparation carrier 310 and a PCR detector 320. The liquid preparation carrier 310 is arranged on the table top 620 to carry a PCR plate. The PCR plate is transferred from the consumable storage module 500 to the liquid preparation carrier 310 by the transfer mechanical arm through the clamping jaw. The liquid transfer mechanism 420 is used to transfer the amplified sample from the nucleic acid direct amplification module 200 to the PCR plate. The PCR detector 320 is arranged on the rack 610 below the table top 620. The table top 620 is provided with a avoiding hole 621 for placing the PCR plate into the PCR detector 320. The transfer mechanism 410 is also used to clamp the PCR plate cover of the PCR plate in the consumable storage module 500 to seal the PCR plate and transfer the sealed PCR plate to the PCR detector 320 through the avoiding hole 621. After the detection is completed, the transfer mechanism 410 discards the PCR plate into the waste collection barrel 700.

[0073] Specifically, the top of the PCR detector 320 is provided with a detection cabin. Each detection cabin is provided with a plurality of detection sites.

[0074] Further, the PCR detector 320 is provided with a plurality of racks 630 arranged below the table top 620. The plurality of PCR detectors 320 are arranged on the racks 630 from top to bottom. The PCR detection module 300 further comprises a lifting mechanism 640 arranged below the table top 620 and located on one side of the racks 630. The lifting mechanism 640 is used to insert and lift the PCR detector 320 below the avoiding hole 621. In this way, the amount of detection samples is increased to adapt to the detection of a large number of samples.

[0075] Specifically, the lifting mechanism 640 is located below the avoiding hole 621 and comprises a lifting mechanism capable of lifting up and down, a telescopic mechanism arranged on the lifting mechanism and capable of telescoping horizontally, and a supporting plate arranged on the telescopic mechanism. The supporting plate can be horizontally extended and retracted under the drive of the telescopic mechanism and can move up and down under the drive of the lifting mechanism, so as to selectively insert and lift one PCR detector 320 below the avoiding hole 621 during the detection process.

[0076] In addition, the direct amplification integrated machine further comprises a shell (not shown in the figure). The shell is arranged on the rack 600. The sample pretreatment module 100, the nucleic acid direct amplification module 200, the PCR detection module 300, the mechanical arm module 400 and the consumable storage module 500 are all covered in the shell. The shell protects the devices covered therein, reduces the interference of the external environment on the test process during the detection process, and improves the accuracy of the detection. In addition, the shell can be provided with an observation window, a man-machine operation interface, a filtering module, a warning light and other supporting equipment to improve the convenience of use.

[0077] Any technical features in the above embodiments can be combined, and for the sake of brevity, not all possible combinations are described above, however, any combination of these technical features is considered to be within the scope of the present disclosure.

[0078] The above embodiments only express several implementation manners of the present application, and the description is relatively specific and detailed, but it should not be understood as a limitation on the scope of the application. It should be pointed out that for ordinary skilled persons in the art, several modifications and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the appended claims.

Claims

1. A direct spread one-pack machine characterized by comprising: The application relates to a nucleic acid direct amplification integrated machine. The nucleic acid direct amplification integrated machine comprises a sample pretreatment module (100) for information input, cell lysis and cup separation of a sample; a nucleic acid direct amplification module (200) for nucleic acid amplification of the pretreated sample; a PCR detection module (300) for detection of the amplified sample; and a mechanical arm module (400) comprising a transfer mechanism (410) and a pipetting mechanism (420), wherein the transfer mechanism (410) is used for transferring the sample between the sample pretreatment module (100), the nucleic acid direct amplification module (200) and the PCR detection module (300); and the pipetting mechanism (420) is used for pipetting inside the sample pretreatment module (100), inside the nucleic acid direct amplification module (200) and inside the PCR detection module (300). The nucleic acid direct amplification integrated machine further comprises a consumable storage module (500) provided with partitioned placing seats for storing deep well plates, PCR plates, PCR plate sealing covers and gun heads; and the transfer mechanism (410) can also transfer consumables between the consumable storage module (500) and the sample pretreatment module (100), between the consumable storage module (500) and the nucleic acid direct amplification module (200) and between the consumable storage module (500) and the PCR detection module (300). The transfer mechanism (410) comprises a transfer mechanical arm and a gripper (411) arranged on the transfer mechanical arm, and the gripper (411) can move in a three-dimensional space under the driving of the transfer mechanical arm to transfer the sample and the consumables. The pipetting mechanism (420) comprises a pipetting mechanical arm and a pipetting gun (421) arranged on the pipetting mechanical arm, and the pipetting gun (421) can move in a three-dimensional space under the driving of the pipetting mechanical arm to transfer liquid. The mechanical arm module (400) comprises a common linear module (401), a transfer linear module (402), a transfer lifting module (403), a rotating module (404), a pipetting linear module (405) and a pipetting lifting module (406), the transfer linear module (402) and the transfer lifting module (403) are respectively slidably arranged on the common linear module (401), the transfer lifting module (403) is slidably arranged on the transfer linear module (402), the gripper (411) is arranged on the transfer lifting module (403) through the rotating module (404), the common linear module (401), the transfer linear module (402), the transfer lifting module (403) and the rotating module (404) jointly constitute the transfer mechanical arm, the gripper (411) can rotate under the driving of the rotating module (404), move up and down under the driving of the transfer lifting module (403), move in a first direction under the driving of the transfer linear module (402) and move in a second direction under the driving of the common linear module (401), and the first direction intersects the second direction.

2. The direct spread integrator of claim 1, wherein ​ 3. The direct spread integrator of claim 1, wherein ​ ​ 4. The direct spread integrator of claim 3, wherein ​ The pipetting lifting module (406) is slidingly arranged on the pipetting linear module (405), the pipetting gun (421) is arranged on the transfer lifting module (403), and the common linear module (401), the pipetting linear module (405) and the pipetting lifting module (406) jointly constitute the pipetting mechanical arm, and the pipetting gun (421) can move up and down under the drive of the pipetting lifting module (406), move in the first direction under the drive of the pipetting linear module (405), and move in the second direction under the drive of the common linear module (401).

5. The direct spread integrator of claim 3, wherein the direct spread integrator is a single chip. The sample pretreatment module (100) comprises: a sample tube rack (110) for carrying sample tubes; a code scanner (120) for information input of the sample tubes; an ultrasonic lysis module (130) for ultrasonic lysis of samples in the sample tubes to release nucleic acids; a clamping module (140) for clamping the sample tubes; The gripper (411) can move between the sample tube rack (110), the ultrasonic lysis module (130) and the clamping module (140) under the drive of the transfer mechanical arm to transport samples; the gripper (411) can also rotate under the drive of the transfer mechanical arm to cooperate with the clamping module (140) to open and close the sample tube cap; The pipetting gun (421) can transfer the ultrasonic lysis sample to a deep well plate under the drive of the pipetting mechanical arm.

6. The direct spread integrator of claim 1, wherein, The nucleic acid direct amplification module (200) comprises a direct amplification reagent (210) and a carrying seat (220), the transfer mechanism (410) is used for transferring the cupped sample to the carrying seat (220), and the pipetting mechanism (420) is used for sucking the direct amplification reagent (210) and adding it into the cupped sample to directly amplify the nucleic acid in the sample.

7. The direct spread integrator of any of claims 1-6, wherein the direct spread integrator is implemented as a single integrated circuit. The direct amplification integrated machine further comprises a rack (600), the rack (600) comprises a rack body (610) and a table top (620) arranged on the rack body (610), the sample pretreatment module (100) and the nucleic acid direct amplification module (200) are arranged on the table top (620), and the mechanical arm module (400) is arranged on the rack body (610) above the table top (620). ​ 8. The direct spread integrator of claim 7, wherein the direct spread integrator is a single chip. The PCR detection module (300) comprises a liquid preparation carrying rack (310) and a PCR detector (320), the liquid preparation carrying rack (310) is arranged on the table top (620) to carry a PCR plate, the pipetting mechanism (420) is used for transferring the amplified sample to the PCR plate, the PCR detector (320) is located on the rack body (610) below the table top (620), the table top (620) is provided with a relief hole (621) for placing the PCR plate into the PCR detector (320), and the transfer mechanism (410) is used for capping the PCR plate and transferring the capped PCR plate into the PCR detector (320) through the relief hole (621).

9. The direct spread integrator of claim 8, wherein, The PCR detector (320) is provided with multiple, the rack (610) below the table top (620) is provided with a rack (630), multiple PCR detectors (320) are placed on the rack (630) in turn from top to bottom, the PCR detection module (300) further includes a lifting mechanism (640) arranged below the table top (620) and located on one side of the rack (630), the lifting mechanism (640) is used to insert and extract the PCR detector (320) and lift it below the avoiding hole (621).

10. The direct spread integrator of claim 8, wherein the direct spread integrator is a single chip. The direct spread integrated machine further includes a waste collection barrel (700), the table top (620) is provided with a discard port (622), and the waste collection barrel (700) is located below the discard port (622).