CN115895855A - Molecular diagnosis system - Google Patents

Abstract

The invention provides a molecular diagnosis system, which comprises a nucleic acid extraction and liquid adding system, a sample introduction system, a nucleic acid amplification system, a hand grip and a detection system, wherein the sample adding system is positioned above the sample introduction system, the hand grip and the detection system are positioned above the nucleic acid amplification system, the nucleic acid extraction and liquid adding system, the sample introduction system, the nucleic acid amplification system and the hand grip and detection system are mutually matched in the mechanical automation of the molecular diagnosis system to realize molecular diagnosis, the sample introduction system comprises a molecular detection card, and the molecular detection card also comprises a card body which cannot be deformed. The full-automatic molecular diagnosis system which has less pollution and simultaneously meets the requirements of multiple projects and multiple amplification types is realized.

Description

Molecular diagnosis system

Technical Field

The invention relates to the field of in-vitro diagnosis molecular detection instruments, in particular to a molecular diagnosis system.

Background

The present in vitro diagnosis molecular detector is mainly used for molecular diagnosis, which is a technology for diagnosing by detecting the structure or expression level change of genetic material in a patient body by applying a molecular biology method, the molecular diagnosis is a main method for predicting diagnosis, and can be used for diagnosing individual genetic diseases and prenatal diagnosis, and the molecular diagnosis mainly refers to the detection of various structural proteins, enzymes, antigen antibodies and immune active molecular genes related to the diseases.

In view of the frequent replacement of the molecular detection plate of the in vitro diagnostic molecular detector, the use frequency is high, and the sealing requirement in the in vitro diagnostic molecular detector is relatively high.

The existing molecular diagnosis system is one single visual test, one is a multi-item visual test, and no system is an instrument and a system which can test a single item and can test a plurality of items (more than 6).

The existing molecular system is either single-step amplification or two-step amplification, and a detection system compatible with the two is not provided.

The existing automatic large-flux analysis instrument can not work in the common laboratory environment because of the pollution control problem, and the pollution problem needs to be solved so as to be used in the common laboratory environment.

Due to the randomness (unplanned) of hospital projects, it is not possible to test one project on the same machine, but it is also possible to test multiple projects.

In order to solve the problem of unplanned precision requirements, the method supports single-step amplification and secondary amplification of some projects with high precision requirements, and supports nested PCR and common PCR.

Therefore, a new molecular diagnostic system is yet to be proposed.

Disclosure of Invention

The invention provides a molecular diagnosis system, which at least solves the technical problems that the molecular diagnosis system in the prior art is polluted and can not meet the full automation of multiple projects and multiple amplification types.

The invention provides a molecular diagnosis system, which comprises a nucleic acid extraction and liquid adding system, a sample feeding system, a nucleic acid amplification system, a hand grip and a detection system, wherein the sample adding system is positioned above the sample feeding system;

the sample introduction system comprises a molecular detection card, the molecular detection card comprises a first liquid suction port, a second liquid suction port, a third liquid suction port and a molecular detection card cavity, the first liquid suction port, the second liquid suction port and the third liquid suction port are respectively connected with the molecular detection card cavity, the molecular detection card further comprises an undeformable card body, and the molecular detection card cavity is arranged in the undeformable card body.

Optionally, the sample introduction system further includes a transport ship, a sample rack, a sample tube, a vacuum cavity, a first heat gun and a second heat gun, the sample tube and the molecular detection card are disposed in the sample rack, the sample rack is disposed in the transport ship, the transport ship transports the sample rack to the vacuum cavity, after a sample to be detected, which needs to be detected by the molecular detection card, is filled in the first liquid suction port and the second liquid suction port, the transport ship transports the sample rack to the vacuum cavity, the vacuum cavity and the transport ship form a vacuum chamber, and the first liquid suction port and the second liquid suction port containing the sample to be detected are evacuated to a negative pressure in the vacuum chamber.

Alternatively, the first heat gun may be moved to the third liquid suction port to heat-seal the third liquid suction port, and the second heat gun may be moved to the first liquid suction port and the second liquid suction port to heat-seal the first liquid suction port and the second liquid suction port.

Optionally, the nucleic acid extraction and liquid feeding system comprises a molecule detection plate, the molecule detection plate is provided with a dovetail groove, the dovetail groove is located at the tail of the molecule detection plate, the molecule detection plate further comprises a cover plate, the cover plate is connected with the dovetail groove in a matched mode in two-gear matched mode, the two-gear matched mode comprises an uncovering connection and a closing connection, the cover plate is changed from the uncovering connection to the closing connection under the action of external force, and the dovetail groove and the molecule detection plate are fixedly connected into an integral structure.

Optionally, the cavity of the molecular detection card includes a liquid storage cavity, a mixing cavity, a first amplification cavity and a second amplification cavity, the first liquid suction port is communicated with the first amplification cavity, the second liquid suction port is communicated with the liquid storage cavity, the liquid storage cavity is connected with the mixing cavity, the mixing cavity is connected with the first amplification cavity, the mixing cavity is connected with the second amplification cavity, and the third liquid suction port is communicated with the second amplification cavity; and/or

In an initial state, the liquid storage chamber is connected but not communicated with the mixing chamber, the mixing chamber is connected but not communicated with the first amplification chamber, and the mixing chamber is connected and communicated with the second amplification chamber; and/or

In the working state, the liquid storage chamber is communicated with the mixing chamber, the mixing chamber is communicated with the first amplification chamber, and the mixing chamber is communicated with the second amplification chamber.

Optionally, the liquid storage chamber and/or the mixing chamber and/or the first amplification chamber are deformable chambers.

Optionally, a pressing shell is disposed on the non-deformable card body, the pressing shell is disposed outside the liquid storage cavity and/or the first amplification cavity, and the pressing shell is stressed to act on the liquid storage cavity and/or the first amplification cavity to deform the liquid storage cavity and/or the first amplification cavity; and/or

The number of the mixing cavities is more than 1, and the mixing cavities with the number more than 1 are sequentially connected in series.

Optionally, the liquid storage chamber, the mixing chamber, the first amplification chamber, and the second amplification chamber are configured such that the frame of the chamber body cannot deform;

the liquid storage cavity is connected with the mixing cavity through a first reaction liquid valve V1, the mixing cavity is connected with the first amplification cavity through a second amplification valve V2, and the mixing cavity is connected with the second amplification cavity through a third valve V3.

Optionally, the nucleic acid amplification system includes a temperature control system and a valve control system, the first amplification is completed in the first amplification chamber, after the first reaction liquid valve V1 and the second amplification valve V2 are opened, the sample to be detected, which is to be detected by the molecular detection card, is mixed in the mixing chamber, and the third valve V3 is opened, so that the mixed sample to be detected enters the second amplification chamber for the second amplification.

Optionally, the molecular diagnostic system is a fully-automatic integrated molecular diagnostic system for vacuumizing the molecular detection card during real-time detection.

The detection potential of the molecular diagnosis system provided by the invention is compatible with a single-item detection tube and a multi-item detection tube, the item detection supports both single-step amplification and two-step amplification, and is compatible with a nested PCR technology and a common PCR technology, and simultaneously, the molecular diagnosis system also has a complete anti-pollution system: nucleic acid extraction and reagents are sucked into the reaction consumable material under negative pressure, the nucleic acid extraction bin and the sample bin are provided with closed covers, the nucleic acid transfer cup is added with a reagent for dissolving nucleic acid, the whole machine is in a negative pressure state and is filtered by a filter membrane, and an ultraviolet sterilization system and a machine can be cascaded in a large scale, so that large-flux and multiple varieties can be detected simultaneously.

The nested PCR technology can eliminate the interference of other nonspecific pathogenic bacteria nucleic acid substances to the maximum extent, and meanwhile, the two-step PCR amplification can also ensure that the pathogenic bacteria can be quickly detected under the condition of extremely low content of the pathogenic bacteria, so that the detection sensitivity is improved.

For some samples with high abundance, the cost can be solved by adopting common PCR, the detection time is saved, the molecular diagnosis system provided by the invention can be used for common PCR and nested PCR, different requirements are met in the same system, the pollution problem is also solved, and the automatic molecular diagnosis instrument can be used in the common laboratory environment. Consumable and sample can automatic introduction and withdraw a kind, and the machine can cascade on a large scale, realizes that big flux many varieties detect simultaneously.

Drawings

The above and other objects, features and advantages of exemplary embodiments of the present invention will become readily apparent from the following detailed description read in conjunction with the accompanying drawings. Several embodiments of the invention are illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings and in which:

FIG. 1 is a schematic diagram of an alternative molecular diagnostic system in accordance with embodiments of the present invention;

FIG. 2 is a schematic diagram of one representation of an alternative molecular test card in accordance with embodiments of the present invention;

FIG. 3 is a schematic structural diagram of an alternative sample injection system according to an embodiment of the present invention;

FIG. 4 is a schematic view of an alternative transportation process of a sample injection system according to an embodiment of the present invention;

FIG. 5 is a schematic diagram illustrating an alternative sample injection system evacuation provided by an embodiment of the present invention;

FIG. 6 is a schematic diagram of an alternative heat-sealing process for a sample injection system according to an embodiment of the present invention;

FIG. 7 is a schematic structural diagram of a sample tube of an alternative sample injection system according to an embodiment of the present invention;

FIG. 8 is an enlarged schematic view of the molecular detection plate 11;

FIG. 9 is an enlarged schematic view of another structure of a nested PCR detection card included in the molecular detection card;

FIG. 10 is a perspective view of FIG. 9;

FIG. 10-1 is a schematic view of the partially exploded structure of FIG. 9;

FIG. 11 is a schematic diagram of an alternative nucleic acid extraction and priming system according to an embodiment of the present invention.

The following detailed description is intended to further illustrate but not limit the invention, the following example being only one preferred embodiment of the invention.

Detailed Description

The principles and spirit of the present invention will be described with reference to several exemplary embodiments. It is understood that these embodiments are given solely for the purpose of enabling those skilled in the art to better understand and to practice the invention, and are not intended to limit the scope of the invention in any way. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

As shown in fig. 1, fig. 1 is a schematic view of a molecular diagnostic system provided by an embodiment of the present invention, the molecular diagnostic system includes a nucleic acid extracting and liquid adding system 1, a sample adding system 2, a sample injection system 3, a nucleic acid amplification system 4, and a gripper and detection system 5, the sample adding system 2 is located above the sample injection system 3, the gripper and detection system 5 is located above the nucleic acid amplification system 4, and the nucleic acid extracting and liquid adding system 1, the sample injection system 2, the sample injection system 3, the nucleic acid amplification system 4, and the gripper and detection system 5 are mutually matched in mechanical automation of the molecular diagnostic system to implement molecular diagnosis;

the sample injection system 3 includes a molecular detection card 34, as shown in fig. 2, fig. 2 is a schematic structural diagram of an expression form of the molecular detection card according to an embodiment of the present invention, the molecular detection card 34 includes a first liquid suction port 341, a second liquid suction port 342, a third liquid suction port 347, and a molecular detection card cavity, the first liquid suction port 341, the second liquid suction port 342, and the third liquid suction port 347 are respectively connected to the molecular detection card cavity, the molecular detection card 34 further includes a non-deformable card body 348, the molecular detection card cavity is disposed in the non-deformable card body 348, in an embodiment of the present invention, the molecular detection card having the non-deformable card body is adopted, such that automatic transportation, packaging, and detection of the molecular detection card in the molecular diagnosis system are possible, and the unique structure of the molecular detection card enables real-time detection of vacuum negative pressure in the molecular diagnosis system, and all mechanical detection in the molecular diagnosis system is completed in real time, and the sample injection system is low in cost and full automation is possible.

Further, as shown in fig. 3, fig. 3 is a schematic structural diagram of a sample injection system according to an embodiment of the present invention, the sample injection system 3 further includes a transport ship 31, a sample rack 32, a sample tube 33, a vacuum chamber 35, and a first heat gun 36 and a second heat gun 37 as shown in fig. 6, the sample tube 33 and the molecular detection card 34 are disposed in the sample rack 32, the sample rack 32 is disposed in the transport ship 31, the transport ship 31 transports the sample rack 32 to the vacuum chamber 35 as shown in fig. 4, fig. 4 is a schematic transport process diagram of the sample injection system according to the embodiment of the present invention as shown in fig. 5, fig. 5 is a schematic evacuation schematic diagram of the sample injection system according to the embodiment of the present invention, after a sample to be detected by the molecular detection card 34 is loaded in the first suction port 341 and the second suction port 342, the transport ship 31 transports the sample rack 32 to the vacuum chamber 35, the vacuum chamber 35 and the transport ship 31 form a vacuum chamber, the first suction port 341 and the second suction port 342 are included in the vacuum chamber, so that the vacuum system can further reduce the cost of the contamination of the vacuum system, and the contamination of the sample to be detected automatically detected.

Further, as shown in fig. 6, fig. 6 is a schematic diagram of a heat sealing process of a sample injection system according to an embodiment of the present invention, in which the first heat gun 36 is movable to the third liquid absorption port 347 to heat seal the third liquid absorption port 347, and the second heat gun 37 is movable to the first liquid absorption port 341 and the second liquid absorption port 342 to heat seal the first liquid absorption port 341 and the second liquid absorption port 342.

Further, as shown in fig. 7, fig. 7 is a schematic structural diagram of a sample tube of a sample injection system according to an embodiment of the present invention, a pot mouth-shaped avoiding structure 331 is disposed on the sample tube 33, the pot mouth-shaped avoiding structure 331 can effectively avoid collision with a sample suction tube of a consumable molecular detection card during sample injection, and each of the liquid suction ports is a liquid suction port of the sample suction tube of the molecular detection card.

Further, the nucleic acid extracting and feeding system 1 includes a molecule detecting plate 11, as shown in fig. 8, fig. 8 is an enlarged schematic view of the molecule detecting plate 11, a dovetail groove 112 is provided on the molecule detecting plate 11, the dovetail groove 112 is located at the tail of the molecule detecting plate 11, the molecule detecting plate 11 further includes a cover plate 111, the cover plate 111 is cooperatively connected with the dovetail groove 112 in two stages, the two stages include an open cover connection and a close cover connection, the cover plate 111 is changed from the open cover connection to the close cover connection under an external force, the dovetail groove 112 is fixedly connected with the molecule detecting plate 11 into an integrated structure, the integrated structure provides a possibility of full-automatic integration, because the operations of opening and closing the cover do not need to be performed manually, for a disposable molecule detecting plate, the initial state can be an open cover state, and after sample feeding, a motion such as a mechanical baffle plate applies an external force to the cover plate 111 and changes the connection from the connection into the close cover connection, which can replace manual operation of opening and closing the cover.

Further, as shown in FIG. 9, FIG. 9 is an enlarged schematic view of another structure of the nested PCR detection card included in the molecular detection card, wherein the molecular detection card cavity includes a liquid storage cavity 343, a mixing cavity 344, a first amplification cavity 345 and a second amplification cavity 346, the first pipette port 341 communicates with the first amplification cavity 345, the second pipette port 342 communicates with the liquid storage cavity 343, the liquid storage cavity 343 communicates with the mixing cavity 344, the mixing cavity 344 communicates with the first amplification cavity 345, the mixing cavity 344 communicates with the second amplification cavity 346, and the third pipette port 347 communicates with the second amplification cavity 346;

in the initial state, the liquid storage chamber 343 is connected to but not in communication with the mixing chamber 344, the mixing chamber 344 is connected to but not in communication with the first amplification chamber 345, and the mixing chamber 344 is connected to and in communication with the second amplification chamber 346;

in the operating state, the liquid storage chamber 343 communicates with the mixing chamber 344, the mixing chamber 344 communicates with the first amplification chamber 345, and the mixing chamber 344 communicates with the second amplification chamber 346.

Further, as shown in fig. 9 and 10-1, the liquid storage chamber 343, the mixing chamber 344, and the first amplification chamber 345 are deformable chambers, that is, the liquid storage chamber 343, the mixing chamber 344, and the first amplification chamber 345 may deform to squeeze out the liquid in the chambers when receiving an external force, so that the liquid flows into the next chamber, and the external force may be generated by a hard object such as a robot arm or a baffle of the system.

Further, as shown in fig. 9, 10 and 10-1, fig. 10 is a schematic perspective view of fig. 9, fig. 10-1 is a schematic partial explosion structure of fig. 9, the non-deformable card body is provided with a first pressing shell 3431 and a second pressing shell 3451, the first pressing shell 3431 and the second pressing shell 3451 are disposed outside the liquid storage chamber 343 and the first amplification chamber 345 shown in fig. 9, the first pressing shell 3431 and the second pressing shell 3451 are stressed and act on the liquid storage chamber 343 and the first amplification chamber 345 shown in fig. 9, so that the liquid storage chamber 343 and the first amplification chamber 345 are deformed, and thus the fluid in the chambers flows to generate an impulsive force to break the state that the two films are adhered to each other to block the two chambers from communicating, the number of the mixing chambers 344 is greater than 1, for example, may be 8 or more, the mixing chambers 344 are sequentially connected in series, which may function as a fully mixing, a second time of nested PCR is prepared, and the origin of adhesion is shown in fig. 349.

Further, the frames of the liquid storage chamber 343, the mixing chamber 344, the first amplification chamber 345 and the second amplification chamber 346 shown in fig. 2 cannot be deformed, so that full-automatic mechanization is realized; as shown in fig. 2, the liquid storage chamber 343 is connected to the mixing chamber 344 through a first reaction liquid valve V1, the mixing chamber 344 is connected to the first amplification chamber 345 through a second amplification valve V2, and the mixing chamber 344 is connected to the second amplification chamber 346 through a third valve V3, and the direction of the liquid in the chambers is controlled by the valves.

Further, the nucleic acid amplification system 4 includes a temperature control system and a valve control system, and after the first amplification is completed in the first amplification chamber 345 and the first reaction solution valve V1 and the second amplification valve V2 are opened, the sample to be detected by the molecular detection card 34 is mixed in the mixing chamber 344, and the third valve V3 is opened to allow the mixed sample to enter the second amplification chamber 346 for the second amplification.

Further, the liquid storage chamber 343 and/or the mixing chamber 344 and/or the first amplification chamber 345 are soft balloon chambers, and the molecular detection card is a molecular detection card for detecting multiple items of nested PCR.

Furthermore, the molecular diagnosis system is a fully-automatic integrated molecular diagnosis system which vacuumizes the molecular detection card during real-time detection.

The working principle of the whole machine is as follows:

as shown in fig. 1 to 11, fig. 11 is an enlarged schematic view of the nucleic acid extracting and feeding system 1, a reagent-integrated consumable, such as the molecular detection plate 11, is added into the nucleic acid extracting and feeding system 1, the molecular detection card, such as the nested PCR detection card 34, is placed into the sample rack of the sample injection system 3, the machine is started to inject the sample into the nucleic acid extraction hole for nucleic acid extraction, after the extraction is completed, the multi-head feeding system injects the system liquid into the cuvette, the sample injection system 2 injects the nucleic acid extract and the system liquid mixture into the sample tube 33, the other sample tube injects the PCR-II reaction liquid, the transport boat 31 of the sample injection system 3 transports the sample rack 32 to the vacuum cavity 35, the vacuum cavity 35 descends to the sealing ring of the transport boat 31 to form a sealed cavity, the vacuum system pumps the negative pressure, the first heat gun 36 descends to the third liquid suction port 347, the vacuum cavity 35, the transport boat 31 is communicated with the atmosphere, the liquid in the sample tube 33 descends to the first liquid suction port 341 and the second heat sealing port 342 along the first liquid suction port of the second liquid suction gun to heat sealing port 342. The transport ship 31 transports the sample rack 32 to the amplification site, the gripper of the gripper and detection system 5 places the molecular detection card 34 to the nucleic acid amplification site of the nucleic acid amplification system 4, the nucleic acid amplification supports two-step amplification, adapting to nested PCR, and the gripper is provided with a detection system for detecting fluorescent signals on each consumable.

In the above-mentioned nucleic acid extraction and liquid feeding system 1, the improvement point of the core lies in having adopted the above-mentioned molecular detection board 11 of reagent integration consumptive material, above-mentioned molecular detection board 11 is by the reaction cup, the reaction storehouse, the magnetic bead position, the reagent position, the magnetic sleeve, the sample tube position, the tip head position and the apron is constituteed, wherein the biggest improvement point just as above, has adopted dovetail and apron complex structure, for disposable molecular detection board, initial condition can be the state of uncapping, add the back by the system, for example the motion of mechanical baffle etc. exert the exogenic action for above-mentioned apron 111 and become above-mentioned lid connection by above-mentioned uncapping, can replace artifical application of sample and lid operation, thereby bring the detection of single-tube reagent card into entire system and realized full automatization's possibility.

Inserting a reagent integrated consumable, placing a sample tube into a sample position of the consumable, starting detection, extracting nucleic acid by using the instrument according to a nucleic acid extraction flow, and adding a reagent system into a reaction tube by using the multi-head liquid adding system.

The sample introduction system 3 comprises a sample rack, a sample tube, a molecule detection consumable, a transportation system, a heat gun, a vacuum cavity and a vacuum pumping system, wherein a spout-shaped avoiding structure is arranged on the sample tube, collision with a sample suction tube of the consumable is avoided during sample addition, a pipette on the molecule detection consumable is inserted into the sample tube, liquid is always higher than a pipette port, the transportation ship transports the sample rack, the sample tube and the molecule detection consumable on the sample rack and the sample tube and the molecule detection consumable on the sample rack to a vacuum pumping vacancy, the vacuum cavity is tightly pressed by a sealing ring with the transportation ship under the action of a movement mechanism, the vacuum system vacuumizes the cavity, after all cavities in the molecule consumable are vacuumized, the third pipette port 347 of a PCR-II reaction cavity (the second amplification cavity 346) is thermally sealed by the first heat gun 36, the vacuum cavity is opened, the sample and the PCR-II reaction liquid are sucked into the corresponding cavities, the transportation system transports the sample rack to a thermal sealing position, and the second heat gun 37 transports the first pipette port 341 and the second pipette port 342 to be thermally sealed, so that the transportation ship 31 continuously moves to the PCR amplification position.

The sampling tube is inserted into the sample tube 33, the consumable and the sample tube are transported to the vacuum chamber for vacuum pumping, the third liquid suction port 347 is heat sealed by the first heat gun 36, then the vacuum chamber is opened to be communicated with the atmosphere, the sample flows into each PCR-I reaction chamber (the first amplification chamber 345) from the first liquid suction port 341, and the PCR-II reaction solution flows into the PCR-II liquid storage chamber (the liquid storage chamber 343) from the second liquid suction port 342. The second heat gun 37 heat-seals the first liquid suction port 341 and the second liquid suction port 342. The PCR-I reaction cavity is provided with a freeze-dried probe, a primer, taq polymerase and 4 DNTPs. PCF amplification is then performed. After the first-step amplification is completed, a PCR-II reaction liquid valve V1 (a first reaction liquid valve V1) and a valve V2 (a second amplification valve V2) for the first PCR-I amplification in the consumable are opened, the two liquids are uniformly mixed in the uniformly mixing cavity, the two valves are closed, a third valve V3 (a third valve V3) is opened, the mixed liquid flows into a PCR-II reaction chamber (a second amplification cavity 346), a freeze-dried probe, a nested primer, taq polymerase and 4 DNTPs are arranged in the reaction cavity, and after the third valve V3 is closed, PCR amplification and fluorescence detection are performed.

The detection position can be compatible with a single-item detection tube and a multi-item detection tube, the item detection supports single-step amplification and two-step amplification, the nested PCR technology and the common PCR technology are compatible, a complete anti-pollution system is embodied in that nucleic acid extraction and reagents are sucked into a reaction consumable material under negative pressure, a nucleic acid extraction bin and a sample bin are provided with closed covers, a nucleic acid transfer cup is added with a reagent for dissolving nucleic acid, the whole machine is in a negative pressure state, a filter membrane is used for filtering, and an ultraviolet sterilization system is used.

An anti-pollution system: the integrated reagent strip is provided with a mechanism for sealing a sample and a nucleic acid extraction cavity, a sample tube can be timely thrown into the solid-liquid garbage can, PCR amplification consumables adopt heat sealing and negative pressure sample introduction, the top of the whole machine is provided with a negative pressure system and a filter membrane, and the top of the whole machine is also provided with an ultraviolet sterilization system.

The core improvement of the technical scheme of the embodiment of the invention is that negative pressure sample suction in sample adding is realized, the consumable part is less, the pollution is reduced, the automation and less pollution can be better realized by the molecular detection plate with the dovetail groove cover structure, the vacuum-pumping sample adding detection can be fully automatically realized when molecular diagnosis is needed, and the full-automatic partial sharing function of micro-fluidic technology and nucleic acid extraction is realized through multiple projects, so that the full automation of nested PCR is realized for the first time.

Claims (10)

1. A molecular diagnosis system is characterized by comprising a nucleic acid extraction and liquid adding system (1), a sample adding system (2), a sample feeding system (3), a nucleic acid amplification system (4) and a gripper and detection system (5), wherein the sample adding system (2) is positioned above the sample feeding system (3), the gripper and detection system (5) is positioned above the nucleic acid amplification system (4), and the nucleic acid extraction and liquid adding system (1), the sample adding system (2), the sample feeding system (3), the nucleic acid amplification system (4) and the gripper and detection system (5) are matched with each other in the mechanical automation of the molecular diagnosis system to realize molecular diagnosis;

sample feeding system (3) are including molecule detection card (34), molecule detection card (34) are including first imbibition mouth (341), second imbibition mouth (342), third imbibition mouth (347) and molecule detection card cavity, first imbibition mouth (341), second imbibition mouth (342) and third imbibition mouth (347) respectively with molecule detection card cavity links to each other, molecule detection card (34) still include the card body that can not take place deformation, molecule detection card cavity is arranged in the card body that can not take place deformation.

2. The molecular diagnostic system according to claim 1, wherein the sample introduction system (3) further comprises a transport ship (31), a sample rack (32), a sample tube (33), a vacuum chamber (35), a first heat gun (36) and a second heat gun (37), the sample tube (33) and the molecular detection card (34) are disposed in the sample rack (32), the sample rack (32) is disposed in the transport ship (31), the transport ship (31) transports the sample rack (32) to the vacuum chamber (35), when the first fluid suction port (341) and the second fluid suction port (342) are filled with a sample to be detected by the molecular detection card (34), the transport ship (31) transports the sample rack (32) to the vacuum chamber (35), the vacuum chamber (35) is formed with the transport ship (31), and the first fluid suction port (341) and the second fluid suction port (342) containing the sample to be detected are evacuated to a vacuum chamber (342).

3. The molecular diagnostic system according to claim 2, wherein the first heat gun (36) is movable to the third liquid suction port (347) to heat-seal the third liquid suction port (347), and the second heat gun (37) is movable to the first liquid suction port (341) and the second liquid suction port (342) to heat-seal the first liquid suction port (341) and the second liquid suction port (342).

4. The molecular diagnostic system of claim 1, wherein the nucleic acid extraction and liquid feeding system (1) comprises a molecular detection plate (11), a dovetail groove (112) is formed in the molecular detection plate (11), the dovetail groove (112) is located at the tail of the molecular detection plate (11), the molecular detection plate (11) further comprises a cover plate (111), the cover plate (111) is connected with the dovetail groove (112) in a matched manner in two stages, the two stages of the matched connection comprise an uncovering connection and a covering connection, the cover plate (111) is changed from the uncovering connection to the covering connection under the action of external force, and the dovetail groove (112) and the molecular detection plate (11) are fixedly connected into an integral structure.

5. The molecular diagnostic system of claim 1, wherein the molecular assay card chamber comprises a liquid storage chamber (343), a mixing chamber (344), a first amplification chamber (345), and a second amplification chamber (346), the first pipette port (341) is in communication with the first amplification chamber (345), the second pipette port (342) is in communication with the liquid storage chamber (343), the liquid storage chamber (343) is connected to the mixing chamber (344), the mixing chamber (344) is connected to the first amplification chamber (345), the mixing chamber (344) is connected to the second amplification chamber (346), and the third pipette port (347) is in communication with the second amplification chamber (346); and/or

In an initial state, the liquid storage chamber (343) is connected to but not in communication with the mixing chamber (344), the mixing chamber (344) is connected to but not in communication with the first amplification chamber (345), and the mixing chamber (344) is connected to and in communication with the second amplification chamber (346); and/or

In the working state, the liquid storage chamber (343) is communicated with the mixing chamber (344), the mixing chamber (344) is communicated with the first amplification chamber (345), and the mixing chamber (344) is communicated with the second amplification chamber (346).

6. The molecular diagnostic system according to claim 5, characterized in that the liquid storage chamber (343) and/or the mixing chamber (344) and/or the first amplification chamber (345) is a deformable chamber.

7. The molecular diagnostic system according to claim 5, wherein the non-deformable card body is provided with a pressing shell, the pressing shell is arranged outside the liquid storage cavity (343) and/or the first amplification cavity (345), and the pressing shell acts on the liquid storage cavity (343) and/or the first amplification cavity (345) after being stressed to deform the liquid storage cavity (343) and/or the first amplification cavity (345); and/or

The number of the mixing cavities (344) is more than 1, and the mixing cavities (344) with the number more than 1 are sequentially connected in series.

8. The molecular diagnostic system of claim 5, wherein the rims of the liquid storage chamber (343), the mixing chamber (344), the first amplification chamber (345) and the second amplification chamber (346) are not deformable;

the liquid storage chamber (343) is connected to the mixing chamber (344) through a first reaction liquid valve (V1), the mixing chamber (344) is connected to the first amplification chamber (345) through a second amplification valve (V2), and the mixing chamber (344) is connected to the second amplification chamber (346) through a third valve (V3).

9. The molecular diagnostic system according to claim 8, wherein the nucleic acid amplification system (4) comprises a temperature control system and a valve control system, the first amplification is performed in the first amplification chamber (345), after the first reaction solution valve (V1) and the second amplification valve (V2) are opened, the sample to be detected by the molecular detection card (34) is mixed in the mixing chamber (344), and the third valve (V3) is opened, so that the mixed sample to be detected enters the second amplification chamber (346) for the second amplification.

10. The molecular diagnostic system according to any one of claims 1 to 9, wherein the molecular diagnostic system is a fully automated integrated molecular diagnostic system that evacuates the molecular test card during real-time testing.

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