A molecular diagnostic device and an operation method thereof

Abstract

The present invention discloses a molecular diagnostic device and an operation method thereof, relating to the field of diagnostic devices related to small amplification devices, especially portable amplification devices. The molecular diagnostic device and the operation method provided by the present invention share a first driving motor between the valve control part and the clamping part, and also share a first driving motor between the hot melt bonding part and the detection and acquisition unit. The gas source driving part and the clamping part cooperate with each other to drive the liquid to flow in each chamber of the integrated detection consumable, with high integration, few driving parts, reliable operation, high detection accuracy, and less pollution.

Description

Technical Field

[0001] The present invention relates to the field of diagnostic devices related to small amplification devices, especially portable amplification devices, and specifically relates to a molecular diagnostic device and an operation method thereof. Background Art

[0002] In vitro diagnostic technology can separate samples such as blood, body fluids, and tissue fluids from organisms and use in vitro detection reagents, test kits, calibrators, quality control materials, etc. to test and verify the samples. The developed sub-application scenarios include biochemical diagnosis, immunoassay, molecular diagnosis, microbial diagnosis, blood and body fluid diagnosis, and POCT, etc. From the perspective of application scenarios, POCT has independently formed a special sub-type device with an increasing proportion from the methodological classification. Molecular POCT takes genetic materials such as DNA or RNA sequence segments of organisms as analysis objects and can achieve timely and accurate detection of low-abundance targets through amplification enrichment technology in the early stage of pathogen (virus, bacteria, microorganism, etc.) invasion. Therefore, this type of device can perform diagnosis in doctor's offices, hospital emergency rooms, workplaces, pharmacies, or even at home, so as to quickly diagnose pathogens. Designing molecular POCT diagnostic devices is the development direction of future precision medicine.

[0003] With the intrusion of various types of diseases, especially the attack of large-scale epidemic diseases, more and more companies are committed to developing miniaturized and highly integrated integrated diagnostic devices. Some well-known companies in the United States have designed IDNOW products based on isothermal amplification technology, and also include isothermal amplification products produced by Cue health. However, from the development in recent years, the primer-probe design of the products corresponding to the isothermal amplification technology is difficult, and the detection sensitivity of the products is insufficient. While GeneXpert and FilmArray based on the thermal cycling amplification technology have seen a faster growth in the number of installed units in the past two years, which to a certain extent illustrates the stability and high sensitivity characteristics of the thermal cycling amplification technology. In terms of design, the volumes of these two products are relatively large, and in actual installation and use, they often present a multi-device combination scheme, which has high limitations for promotion in primary medical treatment. The patent with the publication number CN116328860A and the patent with the publication number US11679387B2 both disclose a scheme of an inherited rotary valve, and it is defined that when the rotary valve is driven to rotate to two different valve positions, different chambers and flow channels can be connected, thereby driving the fluid to flow in different chambers to complete the integration scheme of extraction and detection. This device has high requirements for the processing accuracy of the rotary valve and the matching accuracy with the combination, and the implementation cost is high and the processing technology is difficult; the integrated detection consumables disclosed in the patent with the publication number EP4190890A1 are encapsulated by a sealing film to form a kit containing various processing reagents, and it is defined that the chamber backflow channel is unobstructed after the sealing film is punctured, and the liquid is driven to move to different chambers by a plug rod; in the scheme disclosed in the patent with the publication number EP3741839B1, two groups of gas sources are alternately driven at different positions, so that the solution to be amplified can alternately shuttle between two temperature zones with different target temperatures for amplification, and a fluorescence detection unit is arranged in the flow channel between the two temperature zones to obtain the amplification result. This scheme has very high requirements for the tightness of the consumables and very high requirements for the driving accuracy; in the schemes disclosed in the patents with the publication numbers US11904314B2 and US11904315B2, it is noted that the amplification solution needs to be covered and sealed during the amplification process, and then a wax valve scheme is designed. The wax valves in different chambers are melted by high temperature to connect different chambers, and the melted wax can enter the amplification reaction chamber together with the solution to be amplified to cover the surface of the reaction solution; the patent with the publication number CN117417819A replaces the widely used fluorescence detection with an electrode detection scheme. Although the processing cost may be reduced, it is difficult for the system to achieve multi-target detection. In addition, with the improvement of detection requirements, it is extremely difficult for this scheme to meet the detection needs of obtaining quantitative results. Although various POCT devices have been designed in the prior art, these devices usually have low integration, the system structure is relatively complex, and the processing accuracy and assembly accuracy of the core components are very high. It is very necessary to optimize the integrated detection device specifically.

[0004] How to design a miniaturized diagnostic device with higher integration, fewer driving parts, more reliable operation, higher detection accuracy and less pollution is a technical problem that needs to be solved urgently. Summary of the Invention

[0005] The purpose of the present invention is: to address the above-mentioned problems, the present invention provides a molecular diagnostic device and an operating method thereof, which, when used in conjunction with integrated detection consumables, can realize amplification detection of samples and meet the requirements of high integration, few driving parts, reliable operation, high detection accuracy and low pollution.

[0006] The technical solution adopted in the present invention is as follows:

[0007] A molecular diagnostic device is used for integrated detection consumables, the integrated detection consumables include a buffer chamber for receiving external liquid, a system chamber for distributing liquid, an amplification chamber for testing, and a liquid separation drive unit for controlling the air pressure in the amplification chamber. The buffer chamber and the amplification chamber are both fluidically connected to the system chamber, and the system chamber is connected to the external environment through a return air port. A flow control valve for controlling the on-off relationship is provided between the buffer chamber and the amplification chamber. The liquid separation drive unit can produce elastic deformation under the action of external force and restore the deformation in the absence of external force. The device body is provided with a plurality of integrated detection consumable receiving parts for receiving integrated detection consumables and performing amplification detection on the integrated detection consumables. The integrated The chemical detection consumables receiving part includes a consumables receiving position for carrying integrated detection consumables, a clamping part that can control the on-off relationship between the system cavity and the amplification cavity, a valve control part that can control the on-off relationship of the flow control valve, and an air source driving part that can connect to and control the air pressure in the buffer cavity; the valve control part and the clamping part are movably connected to the device body, the valve control part can move to the position of the flow control valve corresponding to the consumables receiving position and can drive the flow control valve to open, and can move and move away from the consumables receiving position to close the flow control valve, the clamping part can move to the position of the liquid separation driving part corresponding to the consumables receiving position and can press the liquid separation driving part to increase the air pressure in the amplification cavity, and can move and move away from the consumables receiving position to reduce the air pressure in the amplification cavity; the valve control part and the clamping part overlap for at least part of the time when they move.

[0008] Furthermore, the clamping portion includes a pair of clamping units, and the clamping portion can press the liquid separation drive portion under the action of the first drive portion, and the valve control portion is connected to the clamping unit through a transmission block and follows the movement of the clamping unit.

[0009] Further, the clamping part includes a pair of clamping units, which are oppositely arranged on both sides of the consumable receiving position. The pair of clamping units can approach each other under the drive of the first driving part and can press the liquid separation driving part from both sides in the thickness direction of the integrated detection consumable; the first driving part includes a first driving motor and a transmission lead screw. A positive rotation thread section and a reverse rotation thread section are arranged on the transmission lead screw, and the pair of clamping units are respectively in threaded fit with the positive rotation thread section and the reverse rotation thread section of the transmission lead screw.

[0010] Further, the integrated detection consumable receiving part further includes a thermal cycling part for heating the integrated detection consumable additionally and a detection part for detection. The detection and acquisition units of the thermal cycling part and the detection part are respectively arranged on opposite sides of the consumable receiving position.

[0011] Further, the integrated detection consumable receiving part further includes a thermal fusion bonding part for destructively sealing the amplification cavity. An equipment air inlet is arranged at the front end of the equipment body, and an equipment air outlet is arranged at the rear end. The thermal cycling part is arranged on the side close to the equipment air outlet, and the thermal fusion bonding part and the detection and acquisition unit are arranged on the side close to the equipment air inlet.

[0012] Further, the thermal fusion bonding part and the detection and acquisition unit are movably connected to the equipment body through a second driving part; the second driving part includes an alternating transmission mechanism and a second driving motor. The second driving motor can drive the alternating transmission mechanism to drive the thermal fusion bonding part and the detection and acquisition unit away from the consumable receiving position, or drive one of the thermal fusion bonding part and the detection and acquisition unit close to the consumable receiving position and act on the integrated detection consumable in the consumable receiving position.

[0013] Further, the gas source driving part includes a gas source driving member and a gas source connecting pipe. The buffer cavity is communicated with the gas source connecting pipe through an air inlet; a receiving port for receiving the integrated detection consumable is arranged on the integrated detection consumable receiving part. A receivable cover that can be opened and closed is arranged at the receiving port. A gas source interface is arranged on the receiving cover. One side of the gas source interface can be communicated with the gas source connecting pipe, and the other side can be matched with the air inlet of the integrated detection consumable in the consumable receiving position. A rubber pad for sealing and pressing the air inlet is arranged on the side of the gas source interface that is matched with the air inlet.

[0014] An operation method of a molecular diagnosis device, using the above-mentioned molecular diagnosis device, includes the following steps:

[0015] Pre - operation steps: Place the integrated detection consumable in the consumable receiving position of the molecular diagnostic device; Driving preparation steps: Drive the clamping part to move towards the integrated detection consumable until the clamping part presses tightly against the liquid separation driving part, causing elastic deformation of the liquid separation driving part, increasing the air pressure in the amplification cavity, restricting the flow of liquid from the system cavity into the amplification cavity, driving the valve control part to approach and act on the flow control valve to open the flow control valve, connecting the buffer cavity and the system cavity, and at least part of the movement of the valve control part and the clamping part overlaps;

[0016] Gas source driving steps: Start the gas source driving component to change the air pressure in the buffer cavity, enabling the liquid to flow between the buffer cavity and the system cavity. After the liquid is fully mixed, drive the liquid to be stored in the system cavity; Liquid separation driving steps: Drive the clamping part to release from the liquid separation driving part, and the liquid separation driving part gradually deforms and recovers, creating a negative pressure in the amplification cavity. Under the action of the negative pressure, the liquid in the system cavity is driven into the amplification cavity until the amplification cavity is filled.

[0017] Further, it also includes

[0018] Amplification detection steps: Start the thermal cycling part to apply a constant temperature or variable temperature effect to the amplification cavity, causing the liquid in the amplification cavity to undergo an amplification reaction, and drive the detection part to perform fluorescence detection on the amplification system liquid during amplification to obtain the amplification detection result.

[0019] Further, an amplification cavity sealing step is also provided between the liquid separation driving steps and the amplification detection steps: Drive the thermal fusion bonding part to contact the integrated detection consumable, so that the filled amplification cavity is hermetically sealed by thermal fusion;

[0020] The amplification detection steps further include driving the detection acquisition unit of the detection part to move towards the integrated detection consumable until the detection acquisition unit contacts and presses tightly against the amplification cavity, and then performing fluorescence detection on the amplification system liquid during amplification.

[0021] In summary, due to the adoption of the above - mentioned technical solutions, the beneficial effects of the present invention are:

[0022] 1. In the present invention, the valve control part and the clamping part share the first driving motor, and the thermal fusion bonding part and the detection acquisition unit share the first driving motor. The gas source driving part and the clamping part cooperate with each other to drive the liquid to flow in each chamber of the integrated detection consumable, with high integration, few driving components, reliable operation, high detection accuracy, and low pollution.

[0023] 2. When the clamping part of the present invention presses tightly against the liquid separation driving part, the air pressure in the amplification cavity increases, preventing the liquid in the system cavity from entering the amplification cavity. When the clamping part releases the liquid separation driving part, the liquid separation driving unit deforms and recovers, reducing the air pressure in the amplification cavity to form a suction effect, enabling the liquid in the system cavity to be suctioned into the amplification cavity.

[0024] 3. The valve control part of the present invention can follow the clamping part, so that when the buffer cavity is communicated with the system cavity, the amplification cavity is closed to the system cavity; when the buffer cavity is closed to the system cavity, the amplification cavity is communicated with the system cavity.

[0025] 4. The air input into the device body from the air inlet of the device of the present invention can flow through the first driving motor, the second driving motor and the thermal fusion bonding part in time, so that the waste heat in the device body can be effectively taken out of the device body in time by the action of the heat dissipation fan of the heat circulation part.

[0026] 5. The present invention can realize the simultaneous or separate detection of multiple integrated detection consumables.

[0027] 6. The clamping part of the present invention acts on the liquid distribution driving part in a way of pressing from both sides. Compared with the single-side pressing scheme, pressing from both sides makes the film of the liquid distribution driving part require less deformation when being pressed, and the pressure adjustable range is larger.

[0028] 7. The thermal fusion bonding part of the present invention can seal the amplification cavity, reliably ensure the pressure in the amplification cavity, and can form a state of low pressure leakage or even no pressure leakage similar to that of a pressure cooker. In this way, air bubbles can be avoided in the amplification system liquid during high and low temperature cycling amplification, and the destructive sealing operation also makes multiple amplification cavities in an independent closed state, with almost no problems of steam generation and mutual interference.

[0029] 8. The present invention uses a gas source driving part and a clamping part to realize the dual-driving source driving of the integrated detection consumable. The gas source driving part and the clamping part cooperate with each other and serve as the power source for liquid transfer between different chambers at different time periods. Different power sources also meet the different requirements of different driving forces and driving precisions, which can ensure the low-cost and high-efficiency realization of the whole detection method, and the risk of mutual interference is small.

[0030] 9. The detection and acquisition unit and the heat circulation part of the present invention are arranged on opposite sides of the consumable receiving position, so that when the heat circulation part contacts the amplification cavity for heat transfer on one side, the detection and acquisition unit can press the amplification cavity on the other side, so that the central detection hole of the detection and acquisition unit can fit the amplification cavity more closely, reducing adverse effects such as chromatic dispersion.

[0031] 10. The detection and acquisition unit and the transceiver detection unit of the present invention are connected by optical fibers to reduce light transmission loss and can also avoid interference risks such as crosstalk. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 It is a schematic diagram of a sample tube that can be used in combination provided by the present invention;

[0033] Figure 2 It is a schematic structural diagram of the integrated detection consumable of the present invention;

[0034] Figure 3 It is a schematic structural diagram of the molecular diagnostic device of the present invention;

[0035] Figure 4 It is a schematic structure for the molecular diagnostic device of the present invention to receive an integrated detection consumable;

[0036] Figure 5 It is a state diagram of the present invention for receiving a single integrated detection consumable;

[0037] Figure 6 It is a state diagram of another perspective of the present invention for receiving a single integrated detection consumable;

[0038] Figure 7 It is a state diagram of the present invention for two consumable receiving positions to receive two integrated detection consumables;

[0039] Figure 8 It is a side sectional view of the integrated detection consumable of the present invention;

[0040] Figure 9 It is a side sectional view of the valve control part and the clamping part of the present invention acting on the integrated detection consumable under synchronous drive;

[0041] Figure 10 It is a schematic structural diagram of the valve control part and the clamping part of the present invention sharing a first driving motor;

[0042] Figure 11 It is a schematic structural diagram of the valve control part and the clamping part of the present invention acting together on the integrated detection consumable;

[0043] Figure 12 It is a schematic structural diagram of the gas source driving part communicating with the buffer chamber in the open state of the flow control valve of the present invention;

[0044] Figure 13 It is a structural diagram of the layout of the gas source driving part and the first driving motor of the present invention;

[0045] Figure 14 It is a state schematic diagram of the gas source driving part driving liquid to flow between the system chamber and the buffer chamber in the open state of the flow control valve of the present invention;

[0046] Figure 15 It is a state diagram of the liquid stored in the system chamber of the present invention;

[0047] Figure 16 It is a state diagram of the liquid in the system chamber of the present invention being negatively pressure-driven by the liquid separation driving part and distributed to the amplification chamber;

[0048] Figure 17 It is a state diagram of the second driving motor of the present invention driving the heat fusion bonding part to seal the amplification chamber;

[0049] Figure 18It is a state diagram of the hot melt bonding part away from the integrated detection consumable after the fusion of the present invention is completed;

[0050] Figure 19 It is a cross-sectional view of the detection part of the present invention pressing the amplification chamber and cooperating with the thermal cycling part to complete the amplification detection;

[0051] Figure 20 It is a schematic structural diagram of the transceiver detection unit of the present invention;

[0052] Figure 21 It is a schematic structural diagram of the moving bracket of the present invention;

[0053] Figure 22 It is a state diagram of the hot melt bonding part driven by the alternating transmission mechanism of the present invention to extend out;

[0054] Figure 23 It is a state diagram of the alternating transmission mechanism of the present invention driving both the hot melt bonding part and the detection and acquisition part to be spaced from the consumable receiving position;

[0055] Figure 24 It is a state diagram of the detection and acquisition part driven by the alternating transmission mechanism of the present invention to extend out.

[0056] Markings in the figure: 2 - equipment body, 10 - integrated detection consumable, 101 - box cover, 111 - air inlet, 112 - air return port, 12 - buffer chamber, 123 - flow control valve, 13 - system chamber, 14 - amplification chamber, 15 - liquid separation driving part, 161 - bonding auxiliary part, 17 - first flow channel, 18 - second flow channel, 30 - receiving cover, 301 - buckle, 31 - gas source interface, 32 - box cover accommodating part, 100 - sample tube, 200 - middle substrate, 2001, 2002 - integrated detection consumable receiving parts, 201 - consumable receiving position, 202 - control part, 203 - equipment air inlet, 21 - valve control part, 211 - magnet, 22 - alternating transmission mechanism, 221 - second driving motor, 222 - moving bracket, 23 - thermal cycling part, 231 - cooling fan, 232 - fin heat dissipation unit, 233 - heating part, 234 - heat pipe heat exchanger, 24 - clamping part, 241 - first driving motor, 242 - transmission lead screw, 243 - transmission guide rail, 25 - gas source driving part, 26 - detection and acquisition unit, 261 - contact part, 2611 - optical fiber, 27 - hot melt bonding part, 28 - multi-channel transceiver, 280 - optical fiber fixing hole, 108 - first rotating rod, 109 - second rotating rod, 110 - first connecting rod, 120 - second connecting rod, 11 - mounting plate, 1071 - pressing part moving hole, 1072 - sealing part moving hole, 1101 - first connecting part, 1102 - second connecting part, 1201 - third connecting part, 1202 - fourth connecting part. Detailed implementation manners

[0057] The present invention will be described in detail below with reference to the accompanying drawings.

[0058] In order to make the objectives, technical solutions and advantages of the present invention more clearly understood, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0059] Embodiment 1

[0060] Refer to Figure 1 which is a schematic diagram of a sample tube 100 that can be used in combination provided by the present invention. Here, the sample tube 100 can contain a sample preservation solution to enable long-term preservation of the collected sample solution. Here, the sample can be various types of swabs such as nasal swabs and throat swabs, and in other cases, it can also be secretions such as saliva or blood, tissue fluid, etc. Of course, the sample tube 100 can also contain a lysis solution. In this way, the sample inside can be fully lysed by manual action, and then can be directly added into the integrated detection consumable 10. Of course, in a special case, the sample tube 100 may not be included and the sample can be directly added into the integrated detection consumable 10.

[0061] The integrated detection consumable 10 provided by the present invention is as Figure 2As shown, the integrated detection consumable 10 can be adapted to molecular diagnostic equipment, which is also called a small molecular diagnostic POCT device. The integrated detection consumable 10 includes different chambers. In actual operation, in order to smoothly drive the liquid to accurately transfer between different chambers without leakage risk, the integrated detection consumable 10 is vertically inserted into the molecular diagnostic equipment, so that different components in the molecular diagnostic equipment can act on the integrated detection consumable 10 to make the liquid flow in different chambers along a preset path. A sample addition port is arranged in the upper region in the vertical direction of the integrated detection consumable 10. Here, in order to ensure the stability of the internal reagent of the integrated detection consumable 10 and the requirements of closed operation, the sample addition port is detachably connected with a box cover 101, and the two can be detachably connected by means such as buckling or threading. In order to meet the requirements of production and processing for convenience, low cost, etc., the integrated detection consumable 10 is provided with a buffer chamber 12 and a system chamber 13, and the two are connected by a transfer flow channel. A flow control valve 123 is arranged at least at one position of the transfer flow channel to achieve the goal of changing the connection relationship between the buffer chamber 12 and the system chamber 13 by changing the opening degree of the flow control valve 123. In order to ensure that the buffer chamber 12 and the system chamber 13 have a large volume and can transfer the liquid therein with basically no residue, the two are formed into basically the same structure, both having a cylindrical accommodating part with an equal cross-section in the upper part and a conical guiding part with a gradually shrinking cross-section from top to bottom at the bottom. One end of the transfer flow channel is connected to the guiding part at the bottom of the buffer chamber 12, and the other end is connected to the guiding part at the bottom of the system chamber 13. A distribution flow channel is also connected to the guiding part at the bottom of the system chamber 13, and the connection port of the distribution flow channel corresponding to the system chamber 13 and the connection port of the transfer flow channel corresponding to the system chamber 13 are arranged at intervals.

[0062] In the middle region of the integrated detection consumable 10, a number of amplification chambers 14 are arranged. The specific number can be set according to requirements. To ensure the balance of flow resistance, the amplification chambers 14 are preferably configured as an even number here. The amplification chambers 14 are preferably configured in a shape with a changing cross-sectional area, including droplet-shaped or droplet-like, egg-shaped, ellipsoidal, cone-like or other rotating bodies. In this way, it can ensure the full development during the liquid filling process, making the turbulence smaller and the probability of generating air gaps smaller. Finally, the filling degree in the amplification chamber 14 is higher, and a filling degree of 95%-100% can be achieved, and subsequent amplification is more reliable and the detection accuracy is also higher. A liquid distribution driving part 15 is arranged at the lower part of the integrated detection consumable 10. Here, to ensure that the liquid distribution driving part 15 can apply a uniform and consistent driving force to the liquid filling in several amplification chambers 14, the liquid distribution driving part 15 can include liquid distribution driving units corresponding to the number of amplification chambers 14. In this embodiment, both the amplification chambers 14 and the liquid distribution driving units in the liquid distribution driving part 15 are configured as hollow through-cavity structures formed on the consumable matrix of the integrated detection consumable 10, and then deformable and recoverable films are attached to both opposite sides in the thickness direction. The deformable and recoverable film here can be made of materials such as propylene, polyethylene, polystyrene, cycloolefin copolymer (COC), polyester film, polyacetate, etc., or even made of leather materials or rubber materials. The deformable and recoverable film can also be a metal film that meets the requirements. Of course, the deformable and recoverable film here can also be a composite film composed of multiple materials; the deformable and recoverable film here preferably has a light transmittance of 80%-95%. To balance the requirements of film strength, light transmittance and heat conduction performance, the film with an optimal thickness is configured to be 0.02 mm - 0.12 mm. In the closed integrated detection consumable 10, heat can be directly transferred through the film at the amplification chamber 14 to contact the thermal cycling part 23. Therefore, configuring the film with the optimal thickness can ensure the highest heat transfer efficiency. The liquid distribution driving cavity and the attached film enclose to form a liquid distribution driving unit, and the clamping part 24 can press at least part of the film corresponding to the liquid distribution driving unit, and the film at the pressing part by the clamping part 24 deforms. After the clamping of the liquid distribution driving unit by the clamping part 24 is released, the deformed film forms a suction effect during the deformation recovery process, so that the liquid to be distributed in the system cavity 13 is filled into the amplification chamber 14. In this way, there is no need to independently configure a deformation recovery part to act as the driving force for the filling of the amplification chamber 14, and the film with a suitable thickness itself has sufficient strength and deformation recovery ability, making the design of the entire integrated detection consumable 10 simpler, and also avoiding the problem that the detection quality is affected due to the too thick film affecting the light transmittance. In this embodiment, a plurality of hollow combination assisting parts 161 are also arranged between the amplification chambers 14 and the liquid distribution driving part 15.

[0063] Figure 3 is a schematic structural diagram of the molecular diagnostic equipment of the present invention, Figure 4It is a schematic diagram of the structure of the molecular diagnostic equipment for receiving the integrated detection consumables 10; the molecular diagnostic equipment includes the equipment body 2, on which there are an integrated detection consumables receiving part 2001 and an integrated detection consumables receiving part 2002. The integrated detection consumables receiving part 2001 and the integrated detection consumables receiving part 2002 have the same structure and can both receive the integrated detection consumables 10. A control part 202 is configured at the front part of the molecular diagnostic equipment. The control part 202 includes an interface that can interact with the user, enabling the molecular diagnostic equipment to be independently operated by the user. Below the control part 202, there is an equipment air inlet 203. In this embodiment, the integrated detection consumables 10 are in a closed state, so the equipment air inlet 203 can provide a flowing heat dissipation air flow source for each module in the molecular diagnostic equipment. Here, both the integrated detection consumables receiving part 2001 and the integrated detection consumables receiving part 2002 include a matching receiving cover 30. The receiving cover 30 can be snap-connected to the equipment body 2, and a box cover accommodating part 32 and an air source interface 31 are also configured on the receiving cover 30. The box cover accommodating part 32 is used to accommodate the box cover 101 on the integrated detection consumables 10 when the receiving cover 30 is snap-connected to the equipment body 2; the air source interface 31 can be fluidly connected to the air source driving part 25. Here, a rubber pad is also provided on one side of the air source interface 31 that matches the integrated detection consumables 10. When the receiving cover 30 is snap-connected to the equipment body 2 through the buckle 301, the air source interface 31 can tightly seal and press the air inlet 111 of the integrated detection consumables 10 through the rubber pad. The air inlet 111 is communicated with the buffer cavity 12, so that the air source driving part 25 can be fluidly connected to the integrated detection consumables 10. The system cavity 13 is communicated with the external environment through the air return port 112. The system cavity 13 can inhale or discharge air through the air return port 112 to maintain the air flow balance in the system cavity 13 when the liquid is transferred in the system cavity 13. In this embodiment, the integrated detection consumables receiving part 2001 and the integrated detection consumables receiving part 2002 can be independently operated, and can receive two integrated detection consumables 10 at the same time to perform efficient simultaneous detection, or can receive two integrated detection consumables 10 separately. While one integrated detection consumables 10 is being detected, another integrated detection consumables 10 can be added to the equipment body 2. For example, when the integrated detection consumables receiving part 2001 is performing a detection operation, the non-operating integrated detection consumables receiving part 2002 can receive the arriving integrated detection consumables 10, thus adapting to the scene requirements of arriving and being detected immediately.

[0064] Figure 5 It is a state diagram of the present invention for receiving a single integrated detection consumables 10. Figure 6This is a state diagram of another perspective of the single integrated detection consumable 10 of the present invention; a consumable receiving position 201 capable of independently receiving the integrated detection consumable 10 is configured in both the integrated detection consumable receiving part 2001 and the integrated detection consumable receiving part 2002. After the integrated detection consumable 10 is correctly configured in one of the integrated detection consumable receiving part 2001 and the integrated detection consumable receiving part 2002, the integrated detection consumable 10 can be clamped in the consumable receiving position 201. Here, in order to ensure that the integrated detection consumable 10 can be reliably clamped, the consumable receiving position 201 includes two opposed vertical card slots. In this embodiment, a thermal cycling part 23 is arranged on one side of the consumable receiving position 201 in the thickness direction of the integrated detection consumable 10, and a detection and acquisition unit 26 and a thermal fusion bonding part 27 are arranged on the other side; the thermal cycling part 23 includes a cooling fan 231, a fin heat dissipation unit 232, a heating part 233 and a heat pipe heat exchanger 234; the cooling fan 231 is matched with the fin heat dissipation unit 232; the heating part 233 is matched with the consumable receiving position 201. When the integrated detection consumable 10 is received in the consumable receiving position 201, the heating surface of the heating part 233 can contact the amplification cavity 14 of the integrated detection consumable 10 to achieve efficient heat transfer heating of the liquid to be amplified in the amplification cavity 14. More specifically, the heating surface of the heating part 233 can directly contact and act on the corresponding film covering of the amplification cavity 14; the heat pipe heat exchanger 234 is arranged between the fin heat dissipation unit 232 and the heating part 233. The cold end of the heat pipe heat exchanger 234 penetrates through and is arranged in the fin heat dissipation unit 232, and the hot end is fitted and connected in the heating part 233. A detection and acquisition unit 26 and a thermal fusion bonding part 27 are arranged on the other side of the integrated detection consumable 10 in the thickness direction. The thermal fusion bonding part 27 and the detection and acquisition unit 26 are movably connected to the device body 2 through a second driving part. The second driving motor 221 can drive the alternating transmission mechanism 22 to drive the thermal fusion bonding part 27 and the detection and acquisition unit 26 away from the integrated detection consumable 10, or drive one of the thermal fusion bonding part 27 and the detection and acquisition unit 26 to approach and act on the integrated detection consumable 10, such as Figure 21As shown, the alternating drive mechanism 22 includes a first rotating rod 108, a second rotating rod 109, a first connecting rod 110, a second connecting rod 120, a moving bracket 222, a column 1011, a mounting plate 11, a first connecting portion 1101, a second connecting portion 1102, a third connecting portion 1201, and a fourth connecting portion 1202. The mounting plate 11 is fixed to the middle substrate 200. A column 1011 is provided on the mounting plate 11. The columns 1011 are distributed on both sides of the moving bracket 222. The first connecting rod 110 passes through the moving bracket 222 and is connected to the first connecting holes on the columns 1011 on both sides. The second connecting rod 120 passes through the moving bracket 222 and is connected to the second connecting holes on the columns 1011 on both sides. The moving bracket 222 is provided with a pressing portion moving hole 1071 and a sealing portion moving hole 1072. The second rotating rod 109 passes through the pressing portion moving hole 1071, and the first rotating rod 108 passes through the sealing portion moving hole 1072. The structures on both sides of the moving bracket 222 are symmetrical. On the first side of the moving bracket 222, the first connecting rod 110 is connected to the first rotating rod 108 through the first connecting portion 1101. One side of the first connecting portion 1101 is hinged to the first connecting rod 110, and the other side is hinged to the first rotating rod 108. The first rotating rod 108 is connected to the hot melt bonding portion 27 through the second connecting portion 1102. One side of the second connecting portion 1102 is hinged to the first rotating rod 108, and the other side is hinged to the hot melt bonding portion 27. The second connecting rod 120 is connected to the second rotating rod 109 through the third connecting portion 1201. One side of the third connecting portion 1201 is hinged to the second connecting rod 120, and the other side is hinged to the second rotating rod 109. The second rotating rod 109 is connected to the detection and acquisition unit 26 through the fourth connecting portion 1202. One side of the fourth connecting portion 1202 is hinged to the second rotating rod 109, and the other side is hinged to the detection and acquisition unit 26. When the second driving motor 221 drives the moving bracket 222 to move upward in the vertical direction, as Figure 22 shown, the first rotating rod 108 and the second rotating rod 109 follow the upward movement of the moving bracket 222. The first rotating rod 108 moves horizontally along the pressing portion moving hole 1071, so that the third connecting portion 1201 and the fourth connecting portion 1202 form an upward-bending angle, thereby driving the detection and acquisition unit 26 to retract horizontally away from the consumable receiving position 201. At the same time, the second rotating rod 109 moves horizontally along the sealing portion moving hole 1072, so that the first connecting portion 1101 and the second connecting portion 1102 form a horizontal linear structure, thereby driving the hot melt bonding portion 27 to extend horizontally toward the consumable receiving position 201. When the second driving motor 221 drives the moving bracket 222 to move downward in the vertical direction, as Figure 23As shown, the first rotating rod 108 and the second rotating rod 109 follow the downward movement of the moving bracket 222. The first rotating rod 108 moves horizontally along the pressing part moving hole 1071, so that the angle of the folding angle formed by the third connecting part 1201 and the fourth connecting part 1202 that bends upward gradually increases, and then drives the detection and acquisition unit 26 to extend horizontally towards the consumable receiving position 201. At the same time, the second rotating rod 109 moves horizontally along the sealing part moving hole 1072, so that the folding angle formed by the first connecting part 1101 and the second connecting part 1102 bends downward, and then drives the hot melting and bonding part 27 to retract horizontally away from the consumable receiving position 201. At this time, both the detection and acquisition unit 26 and the hot melting and bonding part 27 are spaced from the consumable receiving position 201. As the second driving motor 221 drives the moving bracket 222 to continue moving downward in the vertical direction, as Figure 24 shown, a horizontal linear structure is formed between the third connecting part 1201 and the fourth connecting part 1202, and then drives the detection and acquisition unit 26 to be able to press on the integrated detection consumable 10 in the consumable receiving position 201. At the same time, the second rotating rod 109 moves horizontally along the sealing part moving hole 1072, so that the folding angle formed by the first connecting part 1101 and the second connecting part 1102 that bends downward decreases, and then drives the hot melting and bonding part 27 to retract horizontally away from the consumable receiving position 201.

[0065] In the actual configuration, the detection and acquisition unit 26 and the hot melting and bonding part 27 are arranged at the equipment air inlet 203 closer to the front end of the molecular diagnostic equipment, while the thermal cycling part 23 is arranged near the equipment air outlet at the rear end of the molecular diagnostic equipment. In this way, the air input into the molecular diagnostic equipment through the equipment air inlet 203 can flow through the second driving motor 221 and the hot melting and bonding part 27 in time, so that the waste heat in the molecular diagnostic equipment can be effectively taken out of the molecular diagnostic equipment in time under the action of the cooling fan 231.

[0066] Figure 7 is a state diagram of the two consumable receiving positions 201 of the present invention receiving two integrated detection consumables 10; in this configuration, integrated detection consumables 10 are arranged in both the two integrated detection consumable receiving parts 2001 and the integrated detection consumable receiving part 2002. In this embodiment, the two integrated detection consumables 10 can be clamped in the corresponding consumable receiving positions 201, and independent thermal cycling parts 23, detection and acquisition units 26, and hot melting and bonding parts 27 are arranged in both the integrated detection consumable receiving part 2001 and the integrated detection consumable receiving part 2002. In this way, the integrated detection consumables 10 in the two consumable receiving positions 201 can be detected simultaneously or separately.

[0067] Figure 8 is a side sectional view of the integrated detection consumable 10 of the present invention, Figure 9It is a side sectional view in which the valve control part 21 and the clamping part 24 are synchronously driven to act on the integrated detection consumable 10; in this embodiment, a transfer flow channel capable of communicating the buffer cavity 12 and the system cavity 13 is arranged near the top of the integrated detection consumable 10, and a flow control valve 123 capable of opening or closing the transfer flow channel is arranged at the transfer flow channel, and a liquid separation driving part 15 is arranged at the bottom of the integrated detection consumable 10. The flow control valve 123 is a magnetically controlled valve. When the valve control part 21 is not close to the flow control valve 123, the flow control valve 123 is in a normally closed state, closing the transfer flow channel between the buffer cavity 12 and the system cavity 13; when the magnet 211 on the valve control part 21 approaches the flow control valve 123, the flow control valve 123 can release the seal of the transfer flow channel between the buffer cavity 12 and the system cavity 13 under the magnetic attraction of the magnet 211, so that the transfer flow channel is opened. In this way, the gas source driving part 25 can be communicated with the buffer cavity 12 and change the air pressure in the buffer cavity 12. When the air pressure in the buffer cavity 12 increases, the liquid can flow from the buffer cavity 12 into the system cavity 13 through the opened transfer flow channel. When the air pressure in the buffer cavity 12 decreases, the liquid can flow from the system cavity 13 into the buffer cavity 12 through the opened transfer flow channel. The clamping part 24 can apply a clamping force to the liquid separation driving part 15, so that the pressure in the amplification cavity 14 which is fluidly connected to the liquid separation driving part 15 increases, which can limit the liquid from flowing from the system cavity 13 into the amplification cavity 14, and also ensures the reliability in the process of the gas source driving part 25 driving the liquid to flow, effectively reducing the pollution risk.

[0068] Figure 10 It is a schematic structural diagram of the valve control part 21 and the clamping part 24 of the present invention sharing the first driving motor 241. Figure 11It is a schematic structural diagram of the valve control part 21 and the clamping part 24 of the present invention acting on the integrated detection consumable 10 together; during the process of the gas source driving part 25 driving the liquid to transfer between the buffer cavity 12 and the system cavity 13, it is necessary to restrict the liquid from flowing from the system cavity 13 into the amplification cavity 14. Since the amplification cavity 14 is fluidly connected to the liquid distribution driving part 15, the liquid distribution driving part 15 can be used to make the amplification cavity 14 in a positive pressure state, and then a resistance to restrict the liquid flow is formed between the amplification cavity 14 and the system cavity 13. To achieve the reliability of the system operation, in this embodiment, the valve control part 21 and the clamping part 24 share the first driving motor 241, the integration degree of the whole system is higher, the control difficulty is low, and it can ensure that the connection relationships between the buffer cavity 12 and the system cavity 13, and between the amplification cavity 14 and the system cavity 13 can be synchronously regulated. To ensure that the clamping part 24 can be driven with high precision, the output of the first driving motor 241 is connected to the transmission lead screw 242 through a coupling. Here, the transmission lead screw 242 is a double-thread transmission lead screw including a positive thread section and a reverse thread section. Here, to ensure that the clamping part 24 can apply a pressing force to the liquid distribution driving part 15 more reliably, the clamping part 24 includes a pair of clamping units. The pair of clamping units are opposed and are respectively threadedly fitted to different thread sections of the transmission lead screw 242. When the first driving motor 241 rotates, the pair of clamping units can approach each other relatively, and then press the liquid distribution driving part 15 from both sides in the thickness direction of the integrated detection consumable 10. Compared with the single-side pressing scheme, pressing from both sides makes the film covering of the liquid distribution driving part 15 require a smaller deformation amount when being pressed, and the pressure-adjustable range is larger. To ensure that each amplification cavity 14 has basically the same driving pressure, the liquid distribution driving part 15 includes a plurality of liquid distribution driving units. Correspondingly, the clamping unit includes a connecting part and clamping elements corresponding to the liquid distribution driving units one by one. One end of the connecting part is threadedly connected to the transmission lead screw 242, and the other end is connected to the clamping element. The clamping element protrudes from the connecting part. The valve control part 21 is connected and follows the corresponding side clamping unit through a transmission block. When the first driving motor 241 drives the clamping part 24 to clamp the liquid distribution driving part 15, the valve control part 21 synchronously approaches the fluid control valve 123, so that the fluid control valve 123 is opened, and the two actions of connecting the buffer cavity 12 and the system cavity 13 and closing between the amplification cavity 14 and the system cavity 13 are carried out synchronously; when the first driving motor 241 drives the clamping part 24 to release the liquid distribution driving part 15, the valve control part 21 synchronously moves away from the fluid control valve 123, so that the fluid control valve 123 is closed, and the two actions of closing between the buffer cavity 12 and the system cavity 13 and connecting between the amplification cavity 14 and the system cavity 13 are carried out synchronously. To ensure the stable and reliable characteristics of the transmission operation, a transmission guide rail 243 parallel to the length direction of the transmission lead screw 242 is also provided. The connecting part is movably connected to the transmission guide rail 243, and the transmission guide rail 243 provides a supporting force for the connecting part.

[0069] Figure 12It is a schematic structural diagram of the gas source driving member 25 communicating with the buffer chamber 12 in the open state of the flow control valve 123; under the drive of the common first drive motor 241, the flow control valve 123 is in the open state, and the gas source driving member 25 can be connected to the buffer chamber 12 of the integrated detection consumable 10 through the gas source interface 31 on the buckled receiving cover 30. Here, the gas source driving member 25 can be a driving member of the plunger pump type, and the air pressure state in the buffer chamber 12 is changed through the suction action of the plunger, so that the liquid is transferred between the buffer chamber 12 and the system chamber 13. At the same time, since the clamping portion 24 presses the liquid distribution driving portion 15, the liquid in the system chamber 13 can be restricted from entering the amplification chamber 14. Of course, the gas source driving member 25 can output a drive to make the liquid flow between the buffer chamber 12 and the system chamber 13 several times to fully mix various reagents and samples.

[0070] Figure 13 It is a layout structure diagram of the gas source driving member 25 and the first drive motor 241; to ensure the rationality of the system configuration, a middle substrate 200 is configured in the molecular diagnosis equipment. A consumable receiving position 201, a thermal cycling unit 23, a detection and acquisition unit 26, and a thermal fusion bonding unit 27 are arranged on the upper part of the middle substrate 200 and distributed on both sides of it. Two gas source driving members 25, two first drive motors 241, and two second drive motors 221 are arranged on the lower part of the middle substrate 200. Such a centralized arrangement of the motion driving unit can minimize the noise during operation and make the maintenance of the molecular diagnosis equipment simpler. In one case, the two gas source driving members 25 are arranged in the middle, and the two first drive motors 241 are arranged on both sides of the two gas source driving members 25, making the resonance risk smaller during the operation of the whole machine.

[0071] Figure 14 It is a schematic diagram of the state where the gas source driving member 25 drives the liquid to flow between the system chamber 13 and the buffer chamber 12 in the open state of the flow control valve; in this embodiment, the reagent in the system chamber 13 is configured in a freeze-dried state. Therefore, driving the liquid to flow between the buffer chamber 12 and the system chamber 13 several times can fully dissolve the freeze-dried reagent to form a system liquid with higher sensitivity.

[0072] Figure 15 It is a state diagram of the liquid stored in the system chamber 13. Figure 16It is a state diagram in which the liquid in the system cavity 13 is driven by the liquid separation drive part 15 to be distributed to the amplification cavity 14 under the negative pressure; the mixed liquid, i.e., the system liquid, can be driven by the gas source drive part 25 to be stored in the system cavity 13. At this time, the first drive motor 241 can output a rotational drive to move the two opposing clamping units of the clamping part 24 away from each other, and the valve control part 21 can gradually move away from the integrated detection consumables 10. The film of the liquid separation drive part 15 can gradually deform and recover to generate negative pressure in the amplification cavity 14. The system liquid in the system cavity 13 can be driven to flow into the amplification cavity 14 and mix the reagents in the amplification cavity 14 to form an amplification liquid. In this step, the valve control part 21 in the away state can release the magnetic attraction of the flow control valve 123 to seal the transfer flow channel between the buffer cavity 12 and the system cavity 13. In this way, the integrated detection consumables 10 can achieve timely valve sealing and minimize the risk of contamination.

[0073] Figure 17 14. The state diagram of the second driving motor 221 driving the hot melt bonding part 27 to close the amplification chamber 14; the amplification chamber 14 can be fluidically connected to the corresponding liquid separation driving unit through the first flow channel 17 corresponding to the amplification chamber 14, and is fluidically connected to the distribution flow channel through the second flow channel 18 corresponding to the amplification chamber 14. Here, the second driving motor 221 can drive the movable bracket 222 to move upward, and then drive the hot melt bonding part 27 to approach and contact the integrated detection consumables 10 through the alternating transmission mechanism 22. Here, the hot melt bonding part 27 can output a contact temperature of 180°C-240°C, so that the coating is thermally fused to the consumables substrate, thereby destructively sealing the first flow channel 17 and The second flow channel 18 keeps the amplification chamber 14 in a sealed state. If the temperature here is too low, it will cause a loose seal, which will lead to the risk of leakage, while if the temperature is too high, it may cause excessive thermal shrinkage of the coating or even partial carbonization of the coating, which will lead to the problem of thermal fusion failure. In order to improve the fusion reliability and success rate, the consumable base is also provided with a combining auxiliary part 161. The first flow channel 17 or the second flow channel 18 is arranged between the two combining auxiliary parts 161, so that the first flow channel 17 and the second flow channel 18 corresponding to each amplification chamber 14 can be separated. The combining auxiliary part 161 can bear the thermal fusion deformation, so that the stress and strain in the fusion process are released in time, thereby ensuring the reliability of the fusion bond. Figure 18 In order to complete the state diagram of the hot melt bond 27 being away from the integrated detection consumable 10 after fusion, the second drive motor 221 can drive the movable bracket 222 to move downward, driving the detection acquisition unit 26 to approach and contact the integrated detection consumable 10, and the distant hot melt bond 27 does not affect the closed integrated detection consumable 10, and can quickly discharge the waste heat of the hot melt bond 27. In order to ensure the reliability of the closure, the hot melt bond 27 includes triangular, conical and other configurations with gradually shrinking cross-sections close to the side of the integrated detection consumable 10, so that the hot melt bond 27 can quickly and reliably close the amplification cavity 14 in a smaller operating area. Figure 19It is a cross-sectional view showing that the detection and collection unit 26 presses against the amplification chamber 14 and cooperates with the thermal cycling unit 23 to complete amplification detection; the second driving motor 221 can drive the detection and collection unit 26 to contact the integrated detection consumable 10. The thermal cycling unit 23 and the detection and collection unit 26 are respectively arranged on both sides of the integrated detection consumable 10 in the thickness direction. The detection and collection unit 26 includes a protruding contact portion 261, and the contact portion 261 is configured as a spherical or quasi-spherical contact head, which can contact and press the amplification chamber 14 of the integrated detection consumable 10 from one side in the thickness direction. The thermal cycling unit 23 on the other side can more closely contact the coating film of the amplification chamber 14, improving the heat transfer condition, and also making the central detection hole located at the center of the contact portion 261 fit more closely to the amplification chamber 14, reducing adverse effects such as chromatic dispersion. The detection and collection unit 26 and the transceiver detection unit are connected by an optical fiber 2611 to reduce light transmission loss and can also avoid interference risks such as crosstalk. Combined with Figure 20 The transceiver detection unit includes a plurality of transmitting units formed by optical fibers 2611, a plurality of receiving units formed by optical fibers 2611, and a multi-channel transceiver 28. One end of the transmitting unit and the receiving unit is connected to the detection and collection unit 26, and the other end is connected to the corresponding optical fiber fixing holes 280 on the transceiver connection plate. The plurality of optical fiber fixing holes 280 are arranged at intervals in a straight line along the length direction of the transceiver connection plate. The multi-channel transceiver 28 can reciprocate along the length direction of the transceiver connection plate driven by the transceiver driving motor. Furthermore, the multi-channel transceiver 28 can move through and scan the plurality of through optical fiber fixing holes 280 arranged in a straight line to complete the operations of transmitting light waves and receiving light waves to obtain the amplification result in the amplification chamber 14. The transceiver driving motor can drive the multi-channel transceiver 28 to move through belt drive, chain drive and other methods. Figure 20 As shown in

[0074] Embodiment 2

[0075] An operation method of a molecular diagnostic device, as Figures 1 - 24 shown, using the molecular diagnostic device in Embodiment 1, includes the following steps:

[0076] Run the pre-step: Open the lid 101 of the integrated detection consumable 10, transfer the liquid including the sample liquid or the sample processing liquid to the buffer chamber 12 and close the lid 101; Open the receiving lid 30 of the molecular diagnostic device, place the integrated detection consumable 10 in the consumable receiving position 201, and close the receiving lid 30 of the molecular diagnostic device so that the air source interface 31 on the receiving lid 30 tightly presses the air inlet 111 of the integrated detection consumable 10 through the gasket.

[0077] Drive preparation step: The first drive motor 241 is started, driving the transmission lead screw 242 to rotate forward, and the two clamping units matching the positive-thread section and the reverse-thread section of the transmission lead screw 242 move relatively closer until the liquid separation drive part 15 is pressed from both sides in the thickness direction of the integrated detection consumable 10. The liquid separation drive part 15 undergoes elastic deformation, increasing the air pressure in the amplification chamber 14 and restricting the liquid from flowing from the system chamber 13 into the amplification chamber 14. At the same time, the valve control part 21 follows the clamping unit, approaches and acts on the flow control valve 123, opening the flow control valve 123 and connecting the buffer chamber 12 and the system chamber 13; Gas source drive step: The gas source drive member 25 is started. By injecting gas into the buffer chamber 12 to increase the air pressure in the buffer chamber 12 and extracting gas from the buffer chamber 12 to reduce the air pressure in the buffer chamber 12, the liquid flows from the buffer chamber 12 into the system chamber 13 when the air pressure in the buffer chamber 12 increases and flows from the system chamber 13 into the buffer chamber 12 when the air pressure in the buffer chamber 12 decreases, changing the air pressure in the buffer chamber 12 and causing the liquid to flow between the buffer chamber 12 and the system chamber 13. After the liquid is fully mixed with the reagent sealed in the system chamber 13, the liquid is driven to be stored in the system chamber 13;

[0078] Liquid separation drive step: The first drive motor 241 is started, driving the transmission lead screw 242 to rotate in the reverse direction, and the two clamping units matching the positive-thread section and the reverse-thread section of the transmission lead screw 242 move relatively away from each other. The clamping part 24 gradually releases the clamping force on the liquid separation drive part 15 until the clamping part 24 disengages from the liquid separation drive part 15. The liquid separation drive part 15 gradually recovers its deformation, generating a negative pressure in the amplification chamber 14. The liquid in the system chamber 13 is driven to flow into the amplification chamber 14 under the action of the negative pressure; Amplification chamber 14 closing step: The second drive motor 221 is started. The second drive motor 221 drives the moving bracket 222 to move upward in the vertical direction. The first rotating rod 108 and the second rotating rod 109 follow the moving bracket 222 and move upward. The first rotating rod 108 moves horizontally along the pressing part moving hole 1071, causing the third connecting part 1201 and the fourth connecting part 1202 to form an upward-bending angle, thereby driving the detection and collection unit 26 to retract horizontally away from the consumable receiving position 201. At the same time, the second rotating rod 109 moves horizontally along the sealing part moving hole 1072, causing the first connecting part 1101 and the second connecting part 1102 to form a horizontal linear structure, thereby driving the hot melt bonding part 27 to extend horizontally toward the consumable receiving position 201, driving the hot melt bonding part 27 to contact the first flow channel 17 and the second flow channel 18 in the integrated detection consumable 10, and hermetically sealing the already filled amplification chamber 14 by hot melting;

[0079] Amplification detection step: The second driving motor 221 is started, and the second driving motor 221 drives the moving bracket 222 to move downward in the vertical direction. The first rotating rod 108 and the second rotating rod 109 move downward following the moving bracket 222. The first rotating rod 108 moves horizontally along the pressing part moving hole 1071, so that the angle of the folding angle formed by the third connecting part 1201 and the fourth connecting part 1202 that bends upward gradually increases, and then drives the detection and collection unit 26 to extend horizontally toward the consumable receiving position 201. At the same time, the second rotating rod 109 moves horizontally along the sealing part moving hole 1072, so that the folding angle formed by the first connecting part 1101 and the second connecting part 1102 bends downward, and then drives the hot melting and bonding part 27 to retract horizontally away from the consumable receiving position 201 until a horizontal linear structure is formed between the third connecting part 1201 and the fourth connecting part 1202, so that the detection and collection unit 26 contacts and presses the amplification chamber 14. The thermal cycling part 23 is started to apply a constant temperature or variable temperature effect to the amplification chamber 14, so that the liquid in the amplification chamber 14 generates an amplification reaction. The transceiver driving motor is started to drive the multi-channel transceiver 28 to reciprocate along the length direction of the transceiver connecting plate. The multi-channel transceiver 28 moves to traverse and scan a plurality of through optical fiber fixing holes 280 arranged in a line on the transceiver connecting plate, and completes the operations of transmitting light waves and receiving light waves to obtain the amplification result in the amplification chamber 14.

[0080] In this article, specific embodiments are used to elaborate on the principles and implementation manners of the present invention. The description of the above embodiments is only used to help understand the method of the present invention and its core idea. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and modifications can be made to the present invention, and these improvements and modifications also fall within the protection scope of the claims of the present invention.

[0081] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the present invention is usually placed during use. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation to the present invention.

[0082] In the description of the present invention, it should also be noted that, unless otherwise clearly specified and defined, the terms "set", "install", "connect", and "couple" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

Claims

1. A molecular diagnostic device, applied to an integrated detection consumable, characterized in that, The integrated detection consumable includes a buffer chamber for receiving external liquid, a system chamber for dispensing liquid, an amplification chamber for performing detection, and a liquid separation driving part for controlling the air pressure in the amplification chamber. The buffer chamber and the amplification chamber are both fluidly connected to the system chamber. The system chamber is connected to the external environment through a gas return port. A flow control valve for controlling the on-off relationship is provided between the buffer chamber and the amplification chamber. The liquid separation driving part can generate elastic deformation under the action of an external force and recover the deformation without the external force. It includes an equipment body. On the equipment body, there are several integrated detection consumable receiving parts for receiving the integrated detection consumable and performing amplification detection on the integrated detection consumable. The integrated detection consumable receiving part includes a consumable receiving position for carrying the integrated detection consumable, a clamping part for controlling the on-off relationship between the system chamber and the amplification chamber, a valve control part for controlling the on-off relationship of the flow control valve, and a gas source driving part for connecting and controlling the air pressure in the buffer chamber. The valve control part and the clamping part are movably connected to the equipment body. The valve control part can move to the position of the flow control valve corresponding to the consumable receiving position and can drive the flow control valve to open, and can move away from the consumable receiving position to close the flow control valve. The clamping part can move to the position of the liquid separation driving part corresponding to the consumable receiving position and can press the liquid separation driving part to increase the air pressure in the amplification chamber, and can move away from the consumable receiving position to reduce the air pressure in the amplification chamber. At least part of the time periods of the movement of the valve control part and the clamping part overlap. The gas source driving part includes a gas source driving member and a gas source connecting pipe. The buffer chamber is connected to the gas source connecting pipe through an air inlet. The integrated detection consumable receiving part is provided with a receiving port for receiving the integrated detection consumable. A switchable receiving cover is provided at the receiving port. The receiving cover is provided with a gas source interface. One side of the gas source interface can be connected to the gas source connecting pipe, and the other side can be matched with the air inlet of the integrated detection consumable in the consumable receiving position. When the flow control valve releases the seal of the transfer channel between the buffer chamber and the system chamber, the gas source driving member can be connected to the buffer chamber and change the air pressure in the buffer chamber. When the air pressure in the buffer chamber increases, the liquid can flow from the buffer chamber into the system chamber. When the air pressure in the buffer chamber decreases, the liquid can flow from the system chamber into the buffer chamber.

2. The molecular diagnostic device according to claim 1, characterized in that, The clamping part can press the liquid separation driving part under the action of the first driving part. The valve control part is connected and follows the clamping unit through a transmission block.

3. The molecular diagnostic device according to claim 2, wherein The clamping part includes a pair of clamping units. The pair of clamping units are oppositely arranged on both sides of the consumable receiving position. The pair of clamping units can approach each other under the drive of the first driving part and can press the liquid separation driving part from both sides in the thickness direction of the integrated detection consumable. The first driving part includes a first driving motor and a transmission lead screw. A positive rotation thread section and a reverse rotation thread section are provided on the transmission lead screw. The pair of clamping units are respectively in threaded fit with the positive rotation thread section and the reverse rotation thread section of the transmission lead screw.

4. The molecular diagnostic device according to claim 1, characterized in that, The integrated detection consumable receiving part further includes a thermal cycling part for amplifying and heating the integrated detection consumable and a detection part for detection. The thermal cycling part and the detection acquisition unit of the detection part are respectively arranged on opposite sides of the consumable receiving position.

5. The molecular diagnostic device according to claim 4, characterized in that, The integrated test consumable receiving part further includes a thermal fusion bonding part for destructively sealing the amplification cavity. An air inlet of the device body is provided at the front end, and an air outlet of the device is provided at the rear end. The thermal cycling part is arranged on one side close to the air outlet of the device, and the thermal fusion bonding part and the test collection unit are arranged on one side close to the air inlet of the device.

6. The molecular diagnostic device according to claim 5, characterized in that, The thermal fusion bonding part and the test collection unit are movably connected to the device body through a second driving part. The second driving part includes an alternating transmission mechanism and a second driving motor. The second driving motor can drive the alternating transmission mechanism to drive the thermal fusion bonding part and the test collection unit away from the consumable receiving position, or drive one of the thermal fusion bonding part and the test collection unit close to the consumable receiving position and act on the integrated test consumable in the consumable receiving position.

7. The molecular diagnostic device according to claim 1, characterized in that, One side of the gas source interface matching the air inlet is provided with a rubber pad for sealing and pressing the air inlet tightly.

8. A method for operating a molecular diagnostic device, using the molecular diagnostic device according to any one of claims 1-7, characterized in that, It includes the following steps: Pre - operation step: Place the integrated test consumable in the consumable receiving position of the molecular diagnostic device; Driving preparation step: Drive the clamping part to move towards the integrated test consumable until the clamping part presses the liquid separation driving part, and the liquid separation driving part generates elastic deformation, increasing the air pressure in the amplification cavity to limit the liquid from flowing into the amplification cavity from the system cavity. Drive the valve control part to approach and act on the flow control valve to open the flow control valve, and the buffer cavity is communicated with the system cavity. At least part of the time periods of the valve control part and the clamping part overlap when moving. Gas source driving step: Start the gas source driving part to change the air pressure in the buffer cavity, so that the liquid circulates between the buffer cavity and the system cavity. After the liquid is fully mixed, drive the liquid to be stored in the system cavity. Liquid separation driving step: Drive the clamping part to release the liquid separation driving part, and the liquid separation driving part gradually deforms and recovers to generate negative pressure in the amplification cavity. The liquid in the system cavity is driven to flow into the amplification cavity under the action of the negative pressure until the filling of the amplification cavity is completed.

9. The operating method of the molecular diagnostic device according to claim 8, characterized in that, It also includes Amplification detection step: Start the thermal cycling part to apply a constant temperature or variable temperature effect to the amplification cavity, so that the liquid in the amplification cavity undergoes an amplification reaction. Drive the detection part to perform fluorescence detection on the amplification system liquid during amplification to obtain an amplification detection result.

10. The operating method of the molecular diagnostic device according to claim 9, characterized in that, An Amplification cavity sealing step: Drive the thermal fusion bonding part to contact the integrated test consumable to thermally fuse and seal the filled amplification cavity. The amplification detection step further includes driving the test collection unit of the detection part to move towards the integrated test consumable until the test collection unit contacts and presses the amplification cavity, and then performing fluorescence detection on the amplification system liquid during amplification.

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