Full-automatic molecular diagnosis all-in-one machine equipment

Abstract

The invention belongs to the field of detection equipment, and discloses full-automatic molecular diagnosis all-in-one machine equipment, the full-automatic molecular diagnosis all-in-one machine equipment comprises a base body frame, a sample cup dividing module, a sample extraction module, a system construction module and a detection module, the base body frame is provided with a sample processing space and a detection space, the sample cup dividing module is located in the sample processing space and is used for carrying out information input and cup dividing on a detection sample, the sample extraction module is located in the sample processing space and is used for extracting a to-be-detected sample after cup dividing, and the system construction module is located in the sample processing space; the system construction module is used for processing the extract and sending out the processed extract, the detection module is located in the detection space and comprises a detection cabin, and the detection cabin is used for receiving the processed extract and carrying out sealing detection. According to the full-automatic molecular diagnosis all-in-one machine equipment, full-automatic detection can be achieved, and the structure is reasonable and reliable.

Description

Technical Field

[0001] The present invention relates to the field of detection equipment, and in particular to a fully automatic molecular diagnosis all-in-one device. Background Art

[0002] Molecular diagnostic technology is a technical means that can quickly and accurately diagnose pathogens, including pathogen sample processing, nucleic acid extraction, PCR amplification, fluorescent labeling and detection, result analysis and other links. When testing pathogen samples, it is necessary to use detection equipment and perform amplification detection on the pathogen sample extract according to the detection technology to obtain the test results. In the prior art, most molecular diagnostic instruments are semi-automatic instruments. When performing molecular diagnosis, manual participation in operations such as sample transfer is required. Manual participation in operations will increase test errors, slow down the detection speed and increase the risk of biological contamination. In addition, the sealing performance of existing amplification devices is weak, which may easily lead to overflow of amplification products, which may not only cause mutual contamination inside the instrument, reduce the accuracy and reliability of detection, but also infect the operator, and the detection safety is poor. In addition, medical diagnosis and patient treatment usually depend on the detection of analyte concentration or other parameters in the sample, and the molecular diagnostic test results mainly rely on the detection equipment. Since the life and health of the patient may depend on the accuracy and reliability of the results of such measurements, the accuracy and reliability of the test are crucial. Summary of the invention

[0003] In view of at least one of the above-mentioned defects or shortcomings of the prior art, the present invention provides a fully automatic molecular diagnosis all-in-one device, which can realize fully automatic detection and has a reasonable and reliable structure.

[0004] To achieve the above object, the present invention provides a fully automatic molecular diagnosis integrated device, the fully automatic molecular diagnosis integrated device comprising:

[0005] A base frame is provided with a sample processing space and a detection space;

[0006] The sample cupping module is located in the sample processing space and is used to input information and cup the test samples;

[0007] A sample extraction module is located in the sample processing space and is used to extract the sample to be tested after being divided into cups;

[0008] A system construction module, located in the sample processing space, and used for processing the extract and sending out the processed extract; and

[0009] The detection module is located in the detection space and includes a detection chamber, and the detection chamber is used to receive the processed extract and perform a sealing detection.

[0010] Optionally, the detection module may be provided with a plurality of detection chambers arranged side by side and capable of independent detection, and each detection chamber is provided with a plurality of detection positions.

[0011] In addition, the sample cupping module may include:

[0012] Sample tube scanner, used to enter information about test samples;

[0013] Clamping units, arranged in pairs and used to clamp sample tubes containing test samples;

[0014] A first motion unit, the motion end of which is provided with a pair of decapping mechanical claws and is used to drive the decapping mechanical claws to transfer the sample tube to the clamping unit for decapping; and

[0015] The second moving unit has a moving end provided with a pair of liquid transfer pump units and is used to drive the liquid transfer pump unit to draw the test sample located in the clamping unit into the sample extraction module.

[0016] In addition, the sample cupping module may include a sample tube loading rack arranged in double rows;

[0017] And / or, the sample cupping module may include a consumable unit for accommodating Tip head consumables and a Tip head waste bin.

[0018] Optionally, the system building blocks may include:

[0019] A detection reagent unit, used for accommodating a detection reagent tube;

[0020] A detection reagent opening unit, used to open the detection reagent tube;

[0021] A reaction tube unit, used to accommodate the reaction tube, and the second motion unit is also used to drive the pipetting pump unit to inject the extract in the detection reagent tube into the reaction tube; and

[0022] The reaction tube moving unit is used to transfer the reaction tube containing the extract to the detection module.

[0023] Furthermore, the fully automatic molecular diagnostic integrated device may also include a closed body shell, in which the base frame is arranged, and the body shell includes a shell sheet metal, an observation window, a touch screen, a sample tube inlet and outlet cabin door, a consumables inlet and outlet cabin door, and a reaction tube inlet and outlet cabin door. The reaction tube inlet and outlet cabin door, the observation window, the sample tube inlet and outlet cabin door, and the consumables inlet and outlet cabin door are all arranged on the front end surface of the shell sheet metal corresponding to the sample processing space, and the touch screen is arranged on the front end surface of the shell sheet metal corresponding to the detection space.

[0024] Furthermore, the fully automatic molecular diagnostic integrated device may also include a sample processing space laminar flow system arranged on the body shell, the sample processing space laminar flow system is used to form a negative pressure inside the body shell to prevent internal contaminated air flow from flowing out without being filtered, the sample processing space laminar flow system includes a sample processing space centrifugal fan and a sample processing space filter, and the sample processing space filter is arranged at the air inlet of the sample processing space centrifugal fan.

[0025] In some embodiments, the base frame may include:

[0026] An upper support portion, located at the upper part of the base frame and having two side portions, the table portion and the bracket portion respectively, the sample cupping module, the sample extraction module and the system construction module are arranged on the table portion, and the detection module is arranged on the bracket portion; and

[0027] The lower supporting part is located at the lower part of the base frame and is used to support the upper supporting part.

[0028] Furthermore, the fully automatic molecular diagnostic integrated device may also include a detection module shell located on the base frame and defining a detection space, the detection module shell is provided with a detection module side opening for receiving a reaction tube containing an extract, and the detection module also includes a third motion unit having a reaction tube clamp at the moving end, and the third motion unit is used to drive the reaction tube clamp to transfer the reaction tube containing the extract to the detection chamber.

[0029] Furthermore, the detection module may also include a detection module door mechanism, which is disposed on the detection module housing and is used to open and close the side opening of the detection module.

[0030] Optionally, the detection chamber may include:

[0031] A cabin body is located at the bottom of the detection space and is provided with a cabin body opening, wherein the cabin body opening is located at the top of the cabin body;

[0032] a detection unit, disposed in the cabin and used to detect the extract in the reaction tube; and

[0033] The hatch cover mechanism is arranged on the cabin body and is used for opening and closing the cabin body opening.

[0034] In addition, the detection module may also include a negative pressure cabin arranged on one side of the cabin and connected to the interior of the cabin, and a detection module centrifugal fan for extracting the internal air of the cabin to the outside is provided in the negative pressure cabin.

[0035] Optionally, the bottom wall of the negative pressure cabin may be provided with a negative pressure cabin air outlet, the bottom wall of the detection module shell may be provided with a first air duct penetration opening, and the top wall of the detection module shell may be provided with a second air duct penetration opening. The detection module also includes an exhaust duct at one end of which is connected to the negative pressure cabin air outlet from the bottom surface of the bottom wall of the negative pressure cabin, and the other end of the exhaust duct is upwardly penetrated into the first air duct penetration opening and the second air duct penetration opening in sequence to exhaust air outside the detection module shell.

[0036] Furthermore, the detection module may also include a reaction tube waste barrel unit located at the front, the reaction tube waste barrel unit includes a waste barrel mounting seat with a barrel cavity disposed therein and a barrel body extendably disposed in the barrel cavity, the front side wall of the detection module shell is provided with a detection module front opening arranged in alignment with the barrel body extending opening of the waste barrel mounting seat, and the barrel body can extend from the detection module front opening or close the detection module front opening.

[0037] Furthermore, the top of the waste barrel mounting seat may be provided with a mounting seat top opening, and the reaction tube waste barrel unit also includes a mounting seat cover mechanism, which is arranged on the waste barrel mounting seat and is used to open and close the mounting seat top opening.

[0038] It can be seen from the above technical scheme that the fully automatic molecular diagnostic integrated device of the present invention includes a base frame and a sample cup module, a sample extraction module, a system construction module and a detection module arranged on the base frame. It can automatically complete multiple links of pathogen sample processing, nucleic acid extraction, PCR amplification, fluorescent labeling and detection without manual intervention, and has low operation difficulty. It can realize the full process of sample input and result output in nucleic acid detection. Automatic diagnosis, which not only greatly reduces the degree of human intervention, reduces test errors and biological contamination risks during the detection process, has high safety and reliability, but also can quickly obtain diagnostic results, effectively improve detection efficiency and reduce detection costs, and effectively overcome the weaknesses of the current detection means with low automation and insufficient systematic diagnosis and treatment capabilities. In addition, since the safety, reliability and accuracy of the molecular diagnosis detection process and test results are crucial to the life and health of patients and medical staff, in order to avoid the potential risk of increasing the error of the test results under space-limited conditions due to the use of an integrated design, the fully automatic molecular diagnosis all-in-one device of the present invention is designed with a double-layer isolation and protection structure. First, the sample processing space and the detection space are independently set on the base frame for the first layer of isolation and protection, and then the detection module in the detection space is set with a detection cabin capable of performing sealed detection of the extract for the second layer of isolation and protection. The double-layer isolation and protection structure is reasonable, has good sealing performance, and high protection performance. It not only solves the technical difficulties of mutual contamination inside the fully automatic molecular diagnostic instrument, but also effectively reduces the risk of infection caused by the overflow of the amplification product during the detection process. The detection accuracy and safety reliability are high, which effectively guarantees the life and health safety of medical staff and patients.

[0039] Other features and advantages of the present invention will be described in detail in the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The accompanying drawings are used to provide a further understanding of the present invention and constitute a part of the specification. Together with the following specific embodiments, they are used to explain the present invention but do not constitute a limitation of the present invention. In the accompanying drawings:

[0041] Figure 1 A schematic diagram of the structure of a fully automatic molecular diagnostic all-in-one device according to a specific embodiment of the present invention is shown;

[0042] Figure 2 Shown Figure 1 A front view of the fully automatic molecular diagnostic all-in-one device;

[0043] Figure 3 Shown Figure 1 A schematic diagram of the structure of the base frame in FIG.

[0044] Figure 4 Shown Figure 1 Schematic diagram of the internal structure of the fully automatic molecular diagnostic all-in-one device;

[0045] Figure 5 and Figure 6 They were shown Figure 4 A magnified schematic diagram of the internal structure;

[0046] Figure 7 Shown Figure 4 A schematic diagram of the structure of the detection module in FIG.

[0047] Figure 8 Shown Figure 4 A schematic diagram of the structure of the detection module from another perspective;

[0048] Fig. 9 Shown Figure 7 Schematic diagram of the internal structure of the detection module;

[0049] Fig.10 Shown Fig. 9 A schematic diagram of the internal structure of the detection module from another perspective;

[0050] Fig.11 Shown Fig. 9 A schematic diagram of a local structure of a detection module housing;

[0051] Fig.12 Shown Fig. 9 A schematic diagram of the structure of the detection cabin in FIG.

[0052] Fig.13 Shown Fig. 9 A schematic diagram of the structure of the reaction tube waste barrel unit; and

[0053] Fig.14 Shown Fig. 9 Schematic diagram of the structure of the third motion unit in .

[0054] Description of reference numerals:

[0055] 100 Fully automatic molecular diagnostic equipment

[0056] 21 base frame 211 lower support part

[0057] 212 table portion 213 bracket portion

[0058] 22 Sample cup module 222 Sample tube barcode scanner

[0059] 223 Robotic gripper 224 Pipette pump unit

[0060] 225 First motion unit 226 Second motion unit

[0061] 227 Clamping unit 228 Consumable unit

[0062] 229 Tip Head Waste Bin 23 Sample Extraction Module

[0063] 24 System building blocks 241 Detection reagent unit

[0064] 242 Detection reagent opening unit 243 Reaction tube unit

[0065] 244 Reaction tube motion unit 25 Detection module

[0066] 251 Inspection Chamber 2511 Chamber

[0067] 2512 Cabin opening 2513 Hatch cover mechanism

[0068] 2514 Cabin side opening 2531 X-axis motion module

[0069] 2532 Y-axis motion module 2533 Z-axis motion module

[0070] 252 reaction tube clamp 253 third motion unit

[0071] 254 Reaction tube waste barrel unit 2541 Waste barrel mounting seat

[0072] 2542 Barrel 221 Sample tube loading rack

[0073] 2543 Mounting seat cover mechanism 255 Detection module door mechanism

[0074] 256 Detection module housing 2561 Detection module side opening

[0075] 2562 First air duct installation opening 2563 Second air duct installation opening

[0076] 2564 Detection module front opening

[0077] 257 Negative pressure cabin 2571 Negative pressure cabin air outlet

[0078] 3 Body shell 31 Shell sheet metal

[0079] 36 Sample handling space Laminar flow system 35 Observation window

[0080] 37 Touch screen 32 Sample tube in and out door

[0081] 33. Door for consumables to enter and exit the chamber 34. Door for reaction tubes to enter and exit the chamber DETAILED DESCRIPTION

[0082] The specific implementation of the embodiment of the present invention is described in detail below in conjunction with the accompanying drawings. It should be understood that the specific implementation described here is only used to illustrate and explain the embodiment of the present invention, and is not used to limit the embodiment of the present invention.

[0083] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments may be combined with each other.

[0084] In the embodiments of the present invention, unless otherwise specified, directional words such as "up, down, top, bottom" are usually used to describe the relative positional relationship of components with respect to the directions shown in the drawings or in the vertical, perpendicular or gravity directions.

[0085] like Figures 1 to 4As shown, the present invention provides a new type of fully automatic molecular diagnosis integrated machine equipment, which includes a base frame 21, a sample cup module 22, a sample extraction module 23, a system construction module 24 and a detection module 25. The base frame 21 is provided with a sample processing space and a detection space, the sample cup module 22, the sample extraction module 23 and the system construction module 24 are all located in the sample processing space, and the detection module 25 is located in the detection space. Among them, the sample cup module 22 is used to input information and cup the test sample, the sample extraction module 23 is used to extract the sample to be tested after the cup is divided, the system construction module 24 is used to process the extract and send the processed extract out, and the detection module 25 includes a detection cabin 251 for receiving the processed extract and performing a sealed detection. In this way, the present invention can automatically complete multiple links of pathogen sample processing, nucleic acid extraction, PCR amplification, fluorescent labeling and detection, realize sample input and result output in nucleic acid detection, greatly reduce the degree of personnel intervention, reduce the risk of contamination during the detection process, and improve the detection efficiency. In addition, the sample processing space and the detection space are independently arranged on the base frame 21, and the detection module 25 includes a detection chamber 251 for sealing detection of the extract, adopting a double physical isolation method, with a reasonable structure and good sealing performance, avoiding contamination problems caused by overflow of amplification products during the detection process, improving detection accuracy and reliability, and ensuring the life, health and safety of operators.

[0086] The fully automatic molecular diagnosis integrated device can be used for nucleic acid molecule detection or protein molecule detection, but the present invention is not limited thereto. When the fully automatic molecular diagnosis integrated device is used for nucleic acid molecule detection, the detection module can be a PCR amplification detection module.

[0087] Optionally, the detection module 25 may be provided with a plurality of detection chambers 251 arranged side by side and capable of independent detection, and each detection chamber 251 is provided with a plurality of detection positions. Figures 9 to 12As shown, the detection module 25 may be provided with four detection chambers 251 arranged side by side and capable of independent detection, and each detection chamber 251 is provided with 4 detection positions. In this way, 16 samples can be detected simultaneously, and the detection efficiency is high. And each detection chamber 251 is independently sealed and independently detected, avoiding the cross contamination problem caused by the overflow of the amplification product during the detection process, and ensuring the accuracy and reliability of the detection. In addition, during the detection process, when an emergency occurs and a special queue-jumping detection is required for the emergency sample, there is no need to shut down the entire line, and a part of the detection chamber 251 can be used for special detection purposes, while the other part of the detection chamber 251 does not need to be shut down, and the detection process continues, making the detection process more reasonable, and the sample can be injected and tested at any time, with stronger flexibility and higher detection efficiency. Among them, it should be noted that the detection module 25 can be provided with 2, 3, 5, 6 or even more detection chambers 251, etc., and each detection chamber 251 is provided with 2, 3, 5, 6 or even more detection positions, etc., and the present invention is not limited to this.

[0088] Furthermore, the fully automatic molecular diagnosis integrated device also includes a closed housing 3, and the base frame 21 is arranged in the housing 3. The housing 3 is mainly isolated from the outside world to prevent pollutants from spilling out. The housing 3 can be provided with a hatch, an observation window, a touch screen and other external interfaces. Specifically, Figure 2 As shown, the body shell 3 includes a shell sheet metal 31, an observation window 35, a touch screen 37, a sample tube inlet and outlet cabin door 32, a consumables inlet and outlet cabin door 33 and a reaction tube inlet and outlet cabin door 34. The reaction tube inlet and outlet cabin door 34, the observation window 35, the sample tube inlet and outlet cabin door 32 and the consumables inlet and outlet cabin door 33 are all arranged on the front end surface of the shell sheet metal 31 corresponding to the sample processing space, and the touch screen 37 is arranged on the front end surface of the shell sheet metal 31 corresponding to the detection space.

[0089] Furthermore, the fully automatic molecular diagnosis integrated device may also include a sample processing space laminar flow system 32 disposed on the top plate of the body shell 3 aligned with the sample processing space, and the sample processing space laminar flow system 32 is used to form a negative pressure in the sample processing space inside the body shell 3 to prevent the internal contaminated airflow from flowing out without being filtered. The sample processing space laminar flow system includes a high-power sample processing space centrifugal fan and a sample processing space filter (not shown in the figure), etc. The sample processing space filter is disposed at the air inlet of the sample processing space centrifugal fan, so that a negative pressure can be formed in the sample processing space inside the body shell 3, ensuring that the airflow enters the sample processing space inside the body shell 3 from the outside, and flows out only through the sample processing space filter, preventing the contaminated airflow in the sample processing space from flowing out of the device without being filtered at other gap positions.

[0090] In addition, the fully automatic molecular diagnostic integrated device may also include a detection space laminar flow system arranged on the top plate of the body shell 3 that is aligned with the detection space, and the detection space laminar flow system and the sample processing space laminar flow system 32 are independently arranged. The detection space laminar flow system is used to form a negative pressure in the detection space inside the body shell 3 to prevent the internal contaminated airflow from flowing out without filtering. The detection space laminar flow system includes a high-power detection space centrifugal fan and a detection space filter (not shown in the figure), etc. The detection space filter is arranged at the air inlet of the detection space centrifugal fan, so that a negative pressure can be formed in the detection space inside the body shell 3, ensuring that the airflow enters the detection space inside the body shell 3 from the outside, and only flows out through the detection space filter, preventing the contaminated airflow in the detection space from flowing out of the device without filtering at other gap positions.

[0091] In addition, the fully automatic molecular diagnostic integrated device may also include a first sensor, a second sensor and a controller, wherein the first sensor is used to detect the air pressure in the sample processing space, and the second sensor is used to detect the air pressure in the detection space. The controller is respectively connected to the first sensor, the second sensor, the centrifugal fan in the sample processing space, and the centrifugal fan in the detection space. When the air pressure detected by the second sensor is greater than the air pressure detected by the first sensor, the controller can control the centrifugal fan in the detection space to increase the speed to reduce the air pressure in the detection space, thereby preventing the gas in the detection space from flowing into the sample processing space, thereby further improving the protection performance of the equipment.

[0092] Alternatively, if Figure 3 As shown, the base frame 21 includes an upper support portion and a lower support portion 211, the upper support portion is located at the upper part of the base frame 21, and the lower support portion 211 is located at the lower part of the base frame 21 and is used to support the upper support portion. The left and right sides of the upper support portion are the table portion 212 and the bracket portion 213, respectively. The upper part of the table portion 212 defines the sample processing space, and the upper part of the bracket portion 213 defines the detection space. The sample cupping module 22, the sample extraction module 23 and the system construction module 24 are arranged in the sample processing space on the table portion 212, and the detection module 25 is arranged in the detection space on the bracket portion 213. In this way, the structure of the fully automatic molecular diagnostic integrated device can be made more reasonable and compact. Among them, the base frame 21 is composed of aluminum profiles, table aluminum fine plates, pillars, etc., which mainly play the role of supporting and fixing other functional modules.

[0093] In addition, the sample cupping module 22 may include a sample tube loading carrier 221, a sample tube barcode scanner 222, a clamping unit 227, a first motion unit 225, a second motion unit 226, a consumables unit 228, and a Tip head waste bin 229. The sample tube barcode scanner 222 is used to input information about the test sample, the clamping unit 227 is arranged in pairs and is used to clamp the sample tube containing the test sample, the moving end of the first motion unit 225 is provided with a lid opening mechanical gripper 223 in pairs and is used to drive the lid opening mechanical gripper 223 to transfer the sample tube to the clamping unit 227 for lid opening, the moving end of the second motion unit 226 is provided with a liquid transfer pump unit 224 in pairs and is used to drive the liquid transfer pump unit 224 to suck the test sample located in the clamping unit 227 into the sample extraction module 23, the consumables unit 228 is used to accommodate Tip head consumables, and the Tip head waste bin 229 is used to accommodate discarded Tip heads.

[0094] Specifically, Figure 5 As shown, the first motion unit 225 and the second motion unit 226 are three-axis motion modules, which are arranged at the upper part of the sample processing space and are respectively located on both sides of the sample processing space. The sample tube barcode scanner 222, the sample tube barcode scanner 222 and the clamping unit 227 are arranged on the table portion 212, located at the lower part of the sample processing space and below the first motion unit 225. The consumable unit 228 is arranged on the table portion 212, located at the lower part of the sample processing space and below the second motion unit 226, and the Tip head waste trash can 229 is arranged under the table portion 212. The sample tube injection carrier 221 is located between the sample tube barcode scanner 222 and the clamping unit 227. In this way, the structure of the sample cup module 22 can be made more reasonable and compact, and the detection efficiency is higher. The sample tube injection carrier 221 is arranged in double rows, the clamping units 227 are arranged in pairs, the cover opening robot claws 223 are arranged in pairs on the moving end of the first moving unit 225, and the pipetting pump units 224 are arranged in pairs on the moving end of the second moving unit 226. In this way, two-by-two coordinated detections can be carried out simultaneously, which can further improve the detection efficiency.

[0095] In addition, the sample tube loading carrier 221 can adopt a pull-out type loading, and the sample tube barcode scanner 222 is placed on the left side of the sample tube loading carrier 221. During the pushing process of the sample tube loading carrier 221, the sample tube barcode scanner 222 captures the sample tube information and completes the barcode scanning function. Driven by the first motion unit 225, the opening cover mechanical claw 223 realizes the X-axis, Y-axis, and Z-axis movement of the opening cover mechanical claw 223, moves to the position of the specified sample tube, and clamps the sample tube. The clamping unit 227 mainly realizes the clamping of the sample tube during the opening and closing of the cover, and adopts flexible fingers to realize the clamping of different sample tubes. The liquid transfer pump unit 224 adopts a high-precision liquid transfer pump, and under the drive of the second motion unit 226, realizes the movement of the X-axis, Y-axis, and Z-axis, moves to the specified position, presses the Tip head at the position of the consumable unit 228, realizes the absorption and discharge of the sample liquid, and withdraws the discarded Tip head at the position of the Tip head discard trash can 229. During the working process, after the sample tube injection carrier 221 moves to the specified position, the lid opening robot claw 223 moves to the specified position of the sample tube through the XYZ three-axis, the robot claw opens, clamps the sample tube, lifts it and moves to the position of the clamping unit 227, the clamping module acts to clamp the sample tube, the lid opening robot claw 223 rotates, and opens the sample tube cover. At the same time, the pipette pump, driven by the second motion unit 226, moves to the position of the consumable unit 228 to press the Tip head, then moves to the clamping unit 227, absorbs the sample liquid, and then moves to the sample extraction module 23 to complete the injection. After the injection is completed, the pipette pump moves to the Tip waste bin 229 to complete the drop of the Tip head into the trash can, and the sample cupping function is completed.

[0096] Among them, the sample extraction module 23 uses the upper adsorption magnetic bead method and the magnetic rod movement method to realize nucleic acid extraction, which has the advantages of fast speed and simple structure. The distance between the magnetic rods can be reasonably designed to prevent contamination during the extraction process. The pre-packaged 96-well deep-well plate is encapsulated with lysate, washing solution and other extraction reagents. The sample solution completed in the cup is injected into the sample hole of the deep-well plate, and the deep-well plate is pushed into the module. The motor drives the magnetic rod / magnetic rod sleeve to move up and down and left and right. The cleavage and purification of nucleic acids are realized through repeated combination and separation of the magnetic rod and nucleic acid.

[0097] Optionally, the system construction module 24 may include a detection reagent unit 241, a detection reagent cover opening unit 242, a reaction tube unit 243, and a reaction tube motion unit 244. The detection reagent unit 241 is used to accommodate the detection reagent tube, the detection reagent cover opening unit 242 is used to open the detection reagent tube, the reaction tube unit 243 is used to accommodate the reaction tube, the second motion unit 226 is also used to drive the pipetting pump unit 224 to inject the extract in the detection reagent tube into the reaction tube, and the reaction tube motion unit 244 is used to transfer the reaction tube containing the extract to the detection module 25.

[0098] Specifically, Figure 6 As shown, the detection reagent unit 241, the detection reagent cover opening unit 242, the reaction tube unit 243 and the reaction tube moving unit 244 are arranged at the lower part of the sample processing space, the detection reagent unit 241 is located below the detection reagent cover opening unit 242, the reaction tube unit 243 and the reaction tube moving unit 244 are located on the side of the sample processing space close to the detection module 25, and the reaction tube unit 243 is arranged on the reaction tube moving unit 244. The main function of the system construction module 24 is to inject the purified nucleic acid sample into the PCR reaction tube through the pipetting pump unit 224, the detection reagent cover opening unit 242 presses and lifts the amplification reagent tube cover, and discards it to the Tip head discard trash can 229 to complete the amplification reagent tube cover opening, and at the same time, the pipetting pump unit 224 moves to the position of the consumable unit 228 to press the Tip head, and then moves to the detection reagent unit 241 to absorb the amplification reagent, and injects the amplification reagent into the PCR reaction tube unit 243 to blow and mix, and moves to the Tip head discard trash can 229 to discard the discarded Tip head.

[0099] Furthermore, the fully automatic molecular diagnostic integrated device also includes a detection module shell 256 located on the base frame 21 and defining a detection space. The detection module shell 256 is provided with a detection module side opening 2561 for receiving a reaction tube containing an extract. The detection module also includes a reaction tube waste barrel unit 254 and a third motion unit 253 with a reaction tube clamp 252 at the moving end. The third motion unit 253 is used to drive the reaction tube clamp 252 to transfer the reaction tube containing the extract to the detection chamber 251.

[0100] Furthermore, the detection module may further include a detection module door mechanism 255 , which is disposed on the detection module housing 256 and is used to open and close the detection module side opening 2561 .

[0101] Specifically, Figures 7 to 12 , Fig.14As shown, the third motion unit 253 is arranged at the upper part of the detection module housing 256, the detection chamber 251 is located at the lower part of the detection module housing 256, the reaction tube motion unit 244 extends from the detection module side opening 2561 to the detection module 25, and the reaction tube discard barrel unit 254 is located at the front of the detection module 25. The detection module 25 mainly realizes the clamping and moving of the amplification reaction tube, the amplification of the sample nucleic acid, the data analysis, and the discarding of the amplification reaction tube. The detection module 25 adopts an independent sealed space design to maximize the guarantee that the amplification product remains in the design space and will not cause pollution to other positions of the instrument. During the working process, the detection module door mechanism 255 is opened, the reaction tube motion unit 244 moves the PCR amplification tube to the specified position of the detection module 25, and the reaction tube gripper 252 is driven by the third motion unit 253 to move to the specified position, clamp the PCR reaction tube, and move it to the detection chamber 251. After completion, the PCR amplification module door is closed. PCR performs an amplification reaction. After completion, the PCR reaction tube is discarded into the reaction tube discard barrel unit 254, and the amplification reaction is completed.

[0102] Optionally, the detection module door mechanism 255 includes a cover plate, a drive motor, a pivot shaft and a threaded block, the drive motor is arranged on a mounting plate formed with a detection module side opening 2561, the pivot shaft is drivingly connected to the drive motor, the threaded block is penetrated on the pivot shaft and threadedly connected to the pivot shaft, the cover plate and the threaded block are fixed, and under the driving action of the drive motor, the threaded block moves along the axial direction of the pivot shaft with the cover plate to open or close the detection module side opening 2561. Further, the detection module side opening 2561 is opened only when the detection flat tube enters the interior of the detection module 25, and is closed at other times, which reduces the time for the air inside the detection module housing 256 and the air outside the detection module housing 256 to exchange, further enhances the sealing of the interior of the detection module housing 256 and the interior of the detection cabin 251, and is conducive to further reducing the possibility of contamination.

[0103] Optionally, the detection chamber 251 may include a chamber body 2511, a detection unit, and a chamber cover mechanism 2513. The chamber body 2511 is provided with a chamber body opening 2512, the detection unit is disposed in the chamber body 2511 and is used to detect the extract in the reaction tube, and the chamber cover mechanism 2513 is disposed on the chamber body 2511 and is used to open and close the chamber body opening 2512. Fig.10 and Fig.12 As shown, the cabin 2511 is located at the bottom of the detection space, and the cabin opening 2512 is located at the top of the cabin 2511.

[0104] In addition, the detection module 25 may also include a negative pressure cabin 257 disposed on one side of the cabin 2511 and connected to the interior of the cabin 2511. The negative pressure cabin 257 is provided with a detection module centrifugal fan (not shown in the figure) for extracting the internal air of the cabin 2511 to the outside. Fig.10 As shown, the negative pressure chamber 257 is located at the lower part of the detection module housing 256.

[0105] Specifically, a plurality of air inlets are provided on the side wall of the detection chamber 251 away from the negative pressure chamber 257. When the centrifugal fan rotates, the air inside the detection chamber 251 can be drawn into the negative pressure chamber 257 and then discharged from the negative pressure chamber 257, so that a negative pressure detection environment is formed in the detection chamber 251, which can further prevent the detection liquid or pollutants in the detection chamber 251 from overflowing to the outside of the detection chamber 251 and causing pollution to the outside of the detection chamber 251. Furthermore, the number of negative pressure chambers 257 is consistent with the number of detection chambers 251. If there are multiple detection chambers 251, the number of negative pressure chambers 257 will increase accordingly.

[0106] In addition, if Figure 7 and Fig.11 As shown, the bottom wall of the negative pressure cabin 257 may be provided with a negative pressure cabin air outlet 2571, the bottom wall of the detection module shell 256 is provided with a first air duct penetration opening 2562, and the top wall of the detection module shell 256 is provided with a second air duct penetration opening 2563. The detection module 25 also includes an exhaust duct (not shown in the figure) with one end connected to the negative pressure cabin air outlet 2571 from the bottom surface of the bottom wall of the negative pressure cabin 257, and the other end of the exhaust duct is upwardly penetrated into the first air duct penetration opening 2562 and the second air duct penetration opening 2563 in sequence to exhaust air outside the detection module shell 256.

[0107] Specifically, a filter (not shown in the figure) is provided at the second air duct penetration opening 2563, and the side of the negative pressure cabin 257 is connected to the cabin side opening 2514 on the detection cabin 251, that is, the air in the detection cabin 251 enters the negative pressure cabin 257 from the side of the negative pressure cabin 257, and flows out of the negative pressure cabin 257 from the bottom of the negative pressure cabin 257, and the air flowing out of the negative pressure cabin 257 passes through the exhaust pipe, and flows out of the detection module 25 after being filtered, so as to avoid the air flowing out of the detection cabin 251 carrying pollutants and polluting the air outside the amplification device. Further, the exhaust pipe is arranged in the detection module housing to realize the reasonable layout of the exhaust pipe direction; when the number of detection cabins 251 and negative pressure cabins 257 increases, the number of the first air duct penetration opening 2562, the second air duct penetration opening 2563 and the exhaust pipe increases accordingly, so as to avoid cross contamination of the air flowing out of different detection cabins 251.

[0108] Furthermore, if Figure 8 and Fig.13As shown, the reaction tube waste barrel unit 254 may include a waste barrel mounting seat 2541 with a barrel cavity therein and a barrel body 2542 which can be extended in the barrel cavity. The front side wall of the detection module shell 256 is provided with a detection module front opening 2564 which is arranged to be aligned with the barrel body extending opening of the waste barrel mounting seat 2541. The barrel body 2542 can extend from the detection module front opening 2564 or close the detection module front opening 2564.

[0109] Furthermore, if Fig.13 As shown, the top of the waste barrel mounting seat 2541 may be provided with a mounting seat top opening, and the reaction tube waste barrel unit 254 also includes a mounting seat cover mechanism 2543, which is arranged on the waste barrel mounting seat 2541 and is used to open and close the mounting seat top opening.

[0110] Specifically, the reaction tube waste barrel unit 254 is arranged at a position close to the mounting plate formed with the front opening 2564 of the detection module, and the barrel body 2542 can be inserted into the barrel cavity laterally through the front opening 2564 of the detection module, so as to put in the empty barrel body 2542 or take out the fully loaded barrel body 2542; the mounting seat cover body mechanism 2543 includes a cover plate, a driving motor, a pivot shaft and a threaded block, the driving motor is arranged at the top of the waste barrel mounting seat 2541, the pivot shaft is connected to the driving motor, the threaded block is penetrated on the pivot shaft and is threadedly connected to the pivot shaft, the cover plate and the threaded block are fixed, and under the driving action of the driving motor, the threaded block moves along the axial direction of the pivot shaft with the cover plate to open or close the top opening of the mounting seat. Further, the top opening of the mounting seat is opened only when the detected flat tube is placed in the barrel body 2542, and is closed at other times to prevent the overflow of the detection liquid from contaminating the inside of the detection module 25.

[0111] In one embodiment of the present invention, the detection chamber 251 also includes a disinfection lamp arranged in the detection module housing 256. The disinfection lamp can be optionally an ultraviolet lamp, which can be turned on after the detection of the detection liquid is completed to irradiate and disinfect the inside of the detection module housing 256, thereby avoiding residual contaminants from the previous detection and contamination of the detection liquid in subsequent detection operations, reducing the occurrence of contamination, and helping to further improve the accuracy of the detection results.

[0112] In one embodiment of the present invention, Fig.14As shown, the third motion unit 253 includes an X-axis motion module 2531, a Y-axis motion module 2532, a Z-axis motion module 2533 and a reaction tube clamp 252 for clamping the detection flat tube. The Y-axis motion module 2532 can be laterally movably arranged on the X-axis motion module 2531, the Z-axis motion module 2533 can be longitudinally movably arranged on the Y-axis motion module 2532, and the reaction tube clamp 252 can be vertically movably arranged on the Z-axis motion module 2533. Specifically, the X-axis motion module 2531 includes a first guide rail, a first slider, a synchronous belt assembly, a ball screw assembly and a drive motor. The first guide rail is arranged in the horizontal direction, and the first slider is movably arranged on the first guide rail. The drive motor is connected to the first slider through the ball screw assembly. Due to the long lateral travel, the above arrangement can effectively improve the accuracy of lateral movement. Among them, a synchronous belt assembly is used for transmission between the drive motor and the ball screw assembly; the Y-axis motion module 2532 includes a second guide rail, a second slider and a drive motor. The second guide rail is arranged in the longitudinal direction and fixed to the first slider, so that the X-axis motion module 2531 moves laterally with the Y-axis motion module 2532, the Z-axis motion module 2533 and the reaction tube clamp 252. The slider is movably arranged on the second guide rail, and the drive motor is connected to the second slider through the conveyor belt assembly. The above arrangement is conducive to reducing the production cost; the Z-axis motion module 2533 includes a third guide rail, a third slider and a drive motor. The third guide rail is arranged vertically and fixed to the second slider, so that the Y-axis motion module 2532 moves the Z-axis motion module 2533 and the reaction tube clamp 252 horizontally, the third slider is movably arranged on the third guide rail, the drive motor is connected to the third slider, and the reaction tube clamp 252 is fixed to the third slider, so that the Z-axis motion module 2533 moves vertically with the reaction tube clamp 252, wherein, since the vertical movement is a constant load, the drive motor can be selected as a linear screw motor. The above-mentioned various components cooperate with each other to realize 5-degree-of-freedom movement, so that the reaction tube clamp 252 transfers the clamped detection flat tube to various positions in the detection module 25 (such as the detection cabin 251, the reaction tube waste barrel unit 254, etc.).

[0113] Furthermore, the reaction tube clamp 252 in this embodiment includes a first clamp and a second clamp that can be opened and closed, and a flexible clamping layer made of flexible material is provided on the clamping surface of the first clamp and the second clamp, so that the first clamp and the second clamp have a certain elasticity and can clamp targets of different sizes, which can further expand the application range of the amplification device.

[0114] During the working process, the automatic molecular diagnosis integrated device is powered on, and the power button is pressed, and the device starts working. Open the consumables in and out cabin door 36, pull out the consumables drawer, put the extraction deep well plate, Tip head consumables, and amplification reagents into the designated position, and close the consumables in and out cabin door 36. Open the sample tube in and out cabin door 35, pull out the sample tube carrier, insert the sample tube into the sample tube carrier, push the sample tube carrier to the designated position, close the sample tube in and out cabin door 35, click the start button, and the device starts working. After the work is completed, the sample tube is pulled out for sample retention or discarded, and the discarded deep well plate, Tip head consumables rack, and amplification reagent tube are discarded into the medical waste bag. At the same time, the discarded Tip head garbage bag and PCR reaction tube garbage bag are sealed and discarded to the designated location for medical waste, the table is disinfected, and the ultraviolet light is turned on for disinfection. At this point, a single test is completed.

[0115] In summary, the fully automatic molecular diagnosis integrated machine of the present invention realizes the functions of original tube sampling of sample tubes, automatic cupping of sample liquid, nucleic acid extraction by adsorption magnetic beads, reaction system construction, PCR nucleic acid amplification, background data analysis, result uploading and review, etc., realizes the full automation of nucleic acid detection process, samples can be tested as soon as they arrive, and the waiting time for sample detection is reduced, providing a strong guarantee for molecular diagnosis.

[0116] The optional implementation modes of the embodiments of the present invention are described in detail above in conjunction with the accompanying drawings. However, the embodiments of the present invention are not limited to the specific details in the above implementation modes. Within the technical concept of the embodiments of the present invention, various simple modifications can be made to the technical scheme of the embodiments of the present invention, and these simple modifications all belong to the protection scope of the embodiments of the present invention.

[0117] It should also be noted that the various specific technical features described in the above specific implementation methods can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the embodiments of the present invention will no longer separately describe various possible combinations.

[0118] In addition, various implementation modes of the embodiments of the present invention may be arbitrarily combined, and as long as they do not violate the concept of the embodiments of the present invention, they should also be regarded as the contents disclosed by the embodiments of the present invention.

Claims

1. A fully automatic molecular diagnostic all-in-one device, characterized in that: The fully automatic molecular diagnostic all-in-one device comprises: A base frame (21) is provided with a sample processing space and a detection space; A sample cupping module (22), located in the sample processing space and used for inputting information and cupping the test sample; A sample extraction module (23), located in the sample processing space and used to extract the sample to be tested after being divided into cups; A system construction module (24), located in the sample processing space, the system construction module (24) is used to process the extract and send out the processed extract; and The detection module (25) is located in the detection space and comprises a detection chamber (251), wherein the detection chamber (251) is used to receive the processed extract and perform a sealing test.

2. The fully automatic molecular diagnostic all-in-one device according to claim 1, characterized in that: The detection module (25) is provided with a plurality of detection chambers (251) arranged side by side and capable of independent detection, and each detection chamber (251) is provided with a plurality of detection positions.

3. The fully automatic molecular diagnostic all-in-one device according to claim 1, characterized in that: The sample cupping module (22) comprises: A sample tube scanner (222) for entering information about the test sample; Clamping units (227), arranged in pairs and used to clamp a sample tube containing a test sample; A first moving unit (225), the moving end of which is provided with a pair of cover-opening mechanical claws (223) and is used to drive the cover-opening mechanical claws (223) to transfer the sample tube to the clamping unit (227) for cover-opening; and The second moving unit (226) has a moving end provided with a liquid transfer pump unit (224) in pair and is used to drive the liquid transfer pump unit (224) to draw the test sample located in the clamping unit (227) into the sample extraction module (23).

4. The fully automatic molecular diagnostic integrated device according to claim 1, characterized in that: The sample cupping module (22) comprises a double-row sample tube loading rack (221); And / or, the sample cupping module (22) includes a consumables unit (228) for accommodating Tip head consumables and a Tip head waste bin (229).

5. The fully automatic molecular diagnostic integrated device according to claim 3, characterized in that: The system building module (24) comprises: A detection reagent unit (241), used for accommodating a detection reagent tube; A detection reagent opening unit (242), used for opening the detection reagent tube; A reaction tube unit (243) is used to accommodate a reaction tube, and the second motion unit (226) is also used to drive the liquid transfer pump unit (224) to inject the extract in the detection reagent tube into the reaction tube; and The reaction tube moving unit (244) is used to transfer the reaction tube containing the extract to the detection module (25).

6. The fully automatic molecular diagnostic all-in-one device according to claim 1, characterized in that: The fully automatic molecular diagnosis integrated device further comprises a closed body shell (3), the base frame (21) being arranged in the body shell (3), the body shell (3) comprising a shell sheet metal (31), an observation window (35), a touch screen (37), a sample tube inlet and outlet cabin door (32), a consumables inlet and outlet cabin door (33) and a reaction tube inlet and outlet cabin door (34), the observation window (35), the reaction tube inlet and outlet cabin door (34), the sample tube inlet and outlet cabin door (32) and the consumables inlet and outlet cabin door (33) are all arranged on the front end surface of the shell sheet metal (31) aligned with the sample processing space, and the touch screen (37) is arranged on the front end surface of the shell sheet metal (31) aligned with the detection space.

7. The fully automatic molecular diagnostic all-in-one device according to claim 6, characterized in that: The fully automatic molecular diagnostic integrated device further comprises a sample processing space laminar flow system (36) arranged on the body shell (3), wherein the sample processing space laminar flow system (36) is used to form a negative pressure inside the body shell (3) to prevent the internal polluted airflow from flowing out without being filtered, and the sample processing space laminar flow system (36) comprises a sample processing space centrifugal fan and a sample processing space filter, wherein the sample processing space filter is arranged at the air inlet of the sample processing space centrifugal fan.

8. The fully automatic molecular diagnostic all-in-one device according to claim 1, characterized in that: The base frame (21) comprises: an upper support portion, located at the upper portion of the base frame (21) and having two left and right side portions, respectively, a table portion (212) and a bracket portion (213), wherein the table portion (212) defines the sample processing space, and the bracket portion (213) defines the detection space; and The lower support portion (211) is located at the lower part of the base frame (21) and is used to support the upper support portion.

9. The fully automatic molecular diagnostic integrated device according to any one of claims 1 to 8, characterized in that: The fully automatic molecular diagnostic integrated device also includes a detection module housing (256) located on the base frame (21) and defining the detection space, the detection module housing (256) is provided with a detection module side opening (2561) for receiving a reaction tube containing an extract, and the detection module also includes a third motion unit (253) having a reaction tube clamp (252) at a motion end, and the third motion unit (253) is used to drive the reaction tube clamp (252) to transfer the reaction tube containing the extract to the detection chamber (251).

10. The fully automatic molecular diagnostic all-in-one device according to claim 9, characterized in that: The detection module further comprises a detection module door mechanism (255), wherein the detection module door mechanism (255) is arranged on the detection module housing (256) and is used to open and close the detection module side opening (2561).

11. The fully automatic molecular diagnostic all-in-one device according to claim 9, characterized in that: The detection chamber (251) comprises: A cabin (2511) is located at the bottom of the detection space and is provided with a cabin opening (2512), wherein the cabin opening (2512) is located at the top of the cabin (2511); a detection unit, disposed in the cabin (2511) and used to detect the extract in the reaction tube; and A hatch cover mechanism (2513) is arranged on the cabin body (2511) and is used to open and close the cabin body opening (2512).

12. The fully automatic molecular diagnostic all-in-one device according to claim 11, characterized in that: The detection module (25) further comprises a negative pressure chamber (257) arranged on one side of the chamber (2511) and connected to the interior of the chamber (2511), wherein a detection module centrifugal fan for extracting the internal air of the chamber (2511) is provided in the negative pressure chamber (257).

13. The fully automatic molecular diagnostic integrated device according to claim 12, characterized in that: The bottom wall of the negative pressure cabin (257) is provided with a negative pressure cabin air outlet (2571), the bottom wall of the detection module shell (256) is provided with a first air duct penetration opening (2562), and the top wall of the detection module shell (256) is provided with a second air duct penetration opening (2563). The detection module (25) also includes an exhaust duct having one end connected to the negative pressure cabin air outlet (2571) from the bottom surface of the bottom wall of the negative pressure cabin (257), and the other end of the exhaust duct is upwardly penetrated through the first air duct penetration opening (2562) and the second air duct penetration opening (2563) in sequence to exhaust air outside the detection module shell (256).

14. The fully automatic molecular diagnostic integrated device according to claim 9, characterized in that: The detection module (25) also includes a reaction tube waste barrel unit (254) located at the front, and the reaction tube waste barrel unit (254) includes a waste barrel mounting seat (2541) with a barrel cavity therein and a barrel body (2542) that can be extended in the barrel cavity. The front side wall of the detection module shell (256) is provided with a detection module front opening (2564) that is arranged in alignment with the barrel body extension opening of the waste barrel mounting seat (2541), and the barrel body (2542) can extend from the detection module front opening (2564) or close the detection module front opening (2564).

15. The fully automatic molecular diagnostic integrated device according to claim 14, characterized in that: The top of the waste barrel mounting seat (2541) is provided with a mounting seat top opening, and the reaction tube waste barrel unit (254) also includes a mounting seat cover mechanism (2543), and the mounting seat cover mechanism (2543) is arranged on the waste barrel mounting seat (2541) and is used to open and close the mounting seat top opening.

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