A nucleic acid detection device with a separate air duct design and a nucleic acid detection method

Abstract

The application discloses a nucleic acid detection device with a separated air duct design, comprising a bearing table with a reaction consumable bearing part for accommodating nucleic acid amplification reaction consumables, the bearing table further comprises a thermal cycle module for supplying nucleic acid amplification reaction conditions, and further comprises a first air vent on a nucleic acid detection device shell, a driving module for driving the bearing table to move relative to the first air vent, and the driving module drives the bearing table to be connected with the first air vent to form a first air duct during a period of thermal amplification reaction in the reaction consumables, and the bearing table is spaced from the first air vent during at least part of a period of time other than the period of thermal amplification reaction, so that the separated air duct design reduces internal interference and the risk of contamination, and ensures that each module can be maximally prevented from being contaminated during different stage operations.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of in vitro diagnosis (IVD) of medical devices, and particularly relates to a nucleic acid detection device with a separated air duct design. BACKGROUND

[0002] The nucleic acid analysis device analyzes a biological sample by amplifying nucleic acids contained in the biological sample, and can determine whether a human body is infected with a virus by determining whether the nucleic acid of the virus exists in respiratory tract specimens (nasal swabs, throat swabs), blood (whole blood samples), or digestive tract samples (anal swabs, fecal samples), etc. in the field of disease prevention and control and public safety; in the field of food safety, the method of analyzing nucleic acids can determine the safety of agricultural products and food; in criminal investigation and other criminal activities, forensic or detective inspectors usually also verify some evidence or supporting materials for evidence through nucleic acid analysis.

[0003] Generally, in order to achieve the purpose of nucleic acid detection, different companies will develop extraction instruments and PCR amplification instruments, and by dividing different areas in a large laboratory, a similar flow detection can be achieved. However, in some scenarios, a small amount of objects need to be detected quickly for multiple targets, so the development of integrated all-in-one machines has great significance. In the integrated instrument, too much human intervention is not needed, which greatly reduces the operation difficulty and greatly reduces the skill requirement for the operator, and is also conducive to realizing higher repeatability of the results and thus ensuring the reliability of the detection results. Especially in medicine, the diagnosis of a doctor and the treatment of a patient usually depend on the measurement of the concentration of an analyte or other parameters in a patient sample. The measurement is usually performed by an in vitro diagnostic system (more dependent on nucleic acid detection equipment), and since the life and health of a patient can depend on the accuracy and reliability of the results of such measurements, it is very important for the system to operate normally.

[0004] The integrated device adopts a collection design idea to place the sample tube, nucleic acid extraction consumables and PCR amplification reaction consumables in the integrated machine in a collection design, and realizes automatic transfer of the sample liquid in the sample tube to the nucleic acid extraction consumables for nucleic acid extraction operation through the arrangement of the automatic device in the integrated machine and time sequence control, and then transfers the nucleic acid fragments in the sample liquid after extraction to the PCR amplification reaction consumables, and completes the simultaneous detection of multiple diseases through the detection channel formed by cup separation and multiple colors. However, in the detection process of such an integrated machine type, there are two different functions of nucleic acid extraction and PCR amplification, and due to the limitation of space size, the distance between the two different functions cannot be too far apart, which will cause pollution risk in different stages, for example, the same air outlet mode will cause the nucleic acid extraction area located upstream of the PCR amplification area to be polluted by aerosol and air flow, which will pollute the PCR amplification reaction always located downstream, and then may cause inaccurate detection results.

[0005] The invention patent with publication number CN113388507B entitled "Nucleic acid extraction and PCR detection integrated machine" discloses a structure: an air inlet and an air outlet are arranged on the casing, the air inlet is provided with a first filter, the air outlet is provided with a second filter, a wind baffle is arranged on the inner side of the casing close to the air inlet, the wind baffle is arranged between the air inlet and the PCR detection module, and the wind baffle extends from the air inlet to the nucleic acid extraction module; a first air duct is arranged at the bottom of the nucleic acid extraction module, a second air duct is arranged at the bottom of the PCR detection module, the first air duct and the second air duct are communicated; a variable direction air duct and a fan are arranged in sequence on the side of the second air duct away from the first air duct, and the side of the fan away from the variable direction air duct is communicated with the second filter. In this scheme, the air duct between the nucleic acid extraction module and the PCR module is communicated, and a filter is arranged therebetween, the nucleic acid extraction module is in the upper wind direction, and the filter also has the risk of leaking contaminated air. And due to the design of the amplification area and the extraction area, the physical structure door 4 is used to realize the isolation of the two modules, and it is difficult to realize the convenient structure design of integrating the two modules on the same carrying table, and the physical structure door 4 makes the local imbalance of the negative pressure in the instrument more serious.

[0006] Therefore, it is urgent to develop a detection device capable of separating the air duct function, so as to reduce the potential risk of increasing the result error under the condition of space limitation due to the integrated design. SUMMARY

[0007] The purpose of the present application is to provide a nucleic acid detection device with a separate air duct design, which has the advantages of simple structure, reducing pollution caused by space intersection, reducing the risk of external pollution, etc., and solves the problems in the prior art.

[0008] The technical scheme adopted by the present application is specifically as follows:

[0009] A nucleic acid detection device with a separate air duct design comprises a bearing table having a reaction consumable bearing part for providing nucleic acid amplification reaction consumables, a thermal cycle module for providing nucleic acid amplification reaction conditions, a first air vent on the nucleic acid detection device shell, a driving module for driving the bearing table to move relative to the first air vent, and the driving module drives the bearing table to be connected to the first air vent to form a first air duct during a period of thermal amplification reaction in the reaction consumables, and the bearing table is spaced apart from the first air vent during at least part of the period other than the period of thermal amplification reaction.

[0010] According to the above structure, the driving module drives the bearing table to directly abut against the first air vent on the detection device shell during the amplification process, thereby forming a relatively sealed first air duct. The waste heat generated during the PCR amplification reaction process will be directly discharged outside the shell through the first air duct, and will not leak into the detection device during the discharge process to cause waste heat accumulation and affect the working environment of the circuit, thereby ensuring the reliability of the entire system.

[0011] Further, the nucleic acid detection device shell further comprises a second air vent, and the second air vent and the first air vent are located on the same side wall of the nucleic acid detection device shell. The second air vent comprises an independent air duct connected thereto, and during at least part of the period when the bearing table is spaced apart from the first air vent, the second air vent and the connected independent air duct are in operation to discharge air from the nucleic acid detection device.

[0012] Preferably, the bearing table further comprises an extraction consumable bearing part for providing nucleic acid extraction reaction consumables, the driving module drives the bearing table to be spaced apart from the first air vent during the period of extraction reaction in the extraction consumables, and the second air vent and the connected independent air duct are in operation.

[0013] Further, the nucleic acid detection device shell further comprises a third air vent, and the third air vent and the first air vent are located on the same side wall of the nucleic acid detection device shell. The nucleic acid detection device shell further comprises a fourth air vent on the bottom or top of the nucleic acid detection device shell, and the third air vent and the fourth air vent form a second air duct with a first air flow direction during at least part of the period. According to the above structure, the second air duct enables the internal air of the system to be replaced in time, and the internal air can be dynamically updated to reduce the risk of aerosol pollution while the waste heat generated by the circuit elements is discharged in time.

[0014] Preferably, the carrying table further comprises an extraction consumable carrying part for accommodating the nucleic acid extraction reaction consumable, and the driving module drives the carrying table to be spaced apart from the first air vent during the time period for performing the extraction reaction in the extraction consumable, and the second air vent and the third air vent form a second air channel with a first air flow direction during the time period. According to the above structure, during the time period for performing the extraction reaction in the extraction consumable, the second air channel is formed, so that the internal air of the system can also be replaced in time, and the waste heat generated by the heating of the circuit element can be discharged in time, and the internal air can also be dynamically updated to reduce the pollution risk of aerosol and the like.

[0015] Further, the second air vent and the third air vent form a third air channel with a second air flow direction during the time period for performing the thermal amplification reaction in the reaction consumable. According to the above structure, at this time, according to the air flow direction in the third air channel, the extraction consumable carrying area is located in the upwind direction of the amplification consumable carrying area, so that even if aerosol and the like exist due to the opening of the cover in the early stage of the amplification process, they can also be quickly discharged from the amplification area, ensuring the reliability of the detection result.

[0016] Further, the third air vent and the first air vent form a fourth air channel with a third air flow direction during the time period for performing the extraction operation in the extraction consumable. According to the above structure, it is ensured that during the nucleic acid extraction time period, since the carrying table is separated from the first air vent, it can serve as an auxiliary air vent to increase the overall air flow, thereby ensuring the effect of faster air update speed in the detection equipment.

[0017] Further, the first air flow direction is the overall flow direction of the air in the nucleic acid detection equipment via the second air vent to the third air vent.

[0018] Further, the first air vent comprises a HEPA air filter unit for filtering the air. According to the above structure, the inflowing or outflowing air is filtered, thereby ensuring the safe and reliable operation of the instrument.

[0019] Further, the second air vent and / or the third air vent further comprises a fan unit for driving the formation of the second air channel with the first air flow direction in the nucleic acid detection equipment during at least part of the time period.

[0020] Preferably, the fan unit can form different rotation directions during at least different time periods, thereby realizing different air flow directions in the nucleic acid detection equipment during different time periods. The wind direction conversion required by each working stage is met.

[0021] A nucleic acid detection method using the above nucleic acid detection equipment with a separated air channel design.

[0022] Further, using the nucleic acid detection device with the separated air duct design described above, at least part of the time in other time periods of the non-thermal amplification reaction time period, the second vent is controlled to be in operation state with the connected independent air duct, and in the thermal amplification reaction time period, the second vent is controlled to be in non-operation state with the connected independent air duct.

[0023] In summary, due to the adoption of the technical solutions described above, the present application has the following beneficial effects:

[0024] 1. The nucleic acid detection device with the separated air duct design is adopted, the driving module in the nucleic acid detection device drives the carrier table located thereon to be transferred to different positions of the detection device, so that the PCR amplification reaction and the corresponding quantitative detection process are in different environments from the nucleic acid extraction process and even the sample transfer process, which can reduce the pollution caused by space crossing, further, the driving module drives the carrier table to be connected with the first vent to form a first air duct during the thermal amplification reaction time period in the reaction consumables, the first air duct formed by connection can quickly dissipate the heat required to be dissipated by the Peltier heat dissipation element, and the amplification insufficient phenomenon caused by the interference such as the violent disturbance to the internal environment of the nucleic acid detection device due to the non-independent air duct design will not occur.

[0025] 2. In order to ensure that the pollution risk in the detection process is smaller, a second vent is further arranged on the same side wall of the nucleic acid detection device shell, the second vent comprises an independent air duct connected thereto, in at least part of the time period when the carrier table is spaced apart from the first vent, the second vent is in operation state with the connected independent air duct to realize the air exhaust of the nucleic acid detection device, here the independent air duct operation time can be the nucleic acid extraction step in the open state of the extraction consumables, and the air duct does not operate in the amplification step, realizing the non-interference or small interference operation of the exhaust air duct in the amplification and extraction stages, and maximizing the possibility of pollution of the extraction and amplification in the moving open platform.

[0026] 3、To ensure less pollution risk in the detection process, a third vent is also arranged on the same side wall of the nucleic acid detection device shell, and a fourth vent is arranged at the bottom of the nucleic acid detection device shell. During at least part of the time period, the third vent and the fourth vent form a second air duct with a first air flow direction. In this way, the second air duct of the internal air forms a whole directional flow of the internal air, so as to ensure the exchange between the internal air of the nucleic acid detection device and the outside. In this way, the pollution risk caused by the space limitation in the internal can be further reduced. Further, the third air duct formation time period can be the time period during which the nucleic acid extraction is performed in the nucleic acid extraction consumable. Through the whole design, the whole directional flow direction of the air in the third air duct is from the third vent to the fourth vent. In this way, during the time period in which the nucleic acid extraction is performed in the extraction consumable, the extraction consumable can be located in the downwind direction of the PCR amplification consumable. In this way, the problem that the aerosol pollution in the extraction operation process may affect the subsequent PCR amplification and detection, and further affect the detection result can be greatly reduced. Of course, the construction of the above-mentioned third air duct can rely on the fan unit arranged at the third vent and / or the fourth vent (the number of fans is not limited here).

[0027] 4、During the time period in which the thermal amplification reaction is performed in the reaction consumable, the third vent and the fourth vent form a third air duct with a second air flow direction. The second air flow direction can be a whole direction during the time period in which the thermal amplification and / or detection operation is performed in the PCR amplification reaction consumable. In this way, the PCR amplification consumable can be located in the downwind direction of the extraction consumable during the thermal amplification reaction stage. In this way, there is no risk of contaminating the upwind extraction consumable, thereby reducing the cross-contamination risk in the operation space during different time periods. Even if there is an aerosol pollution risk during the amplification stage, it can be quickly wrapped by the second air flow direction, so as to be quickly transferred to the filter assembly of the vent for adsorption and filtration, thereby reducing the risk of external pollution.

[0028] 5、Since the side wall is provided with the first vent, a fourth air duct with a third air flow direction can also be formed between the extraction operation time period and the fourth vent. In this way, the air exchange rate in the nucleic acid detection device can be increased, and the pollution risk can be reduced, so as to achieve the purpose of fully utilizing the same vent during different operation time periods. Of course, during the nucleic acid extraction operation time period, the third air flow direction is a direction in which the internal air flows from the first vent to the fourth vent.

[0029] 6. Finally, by changing the rotation direction of the fan, different airflow directions are created within the nucleic acid testing equipment at different time periods. This eliminates the need for additional sheet metal isolation structures, simplifying the overall design and reducing the risk of surface contamination caused by building more partitions. It also overcomes the problem of weaker sterilization and disinfection effects when combined with ultraviolet light under conditions of too many partitions, which may lead to cross-contamination risks from multiple tests. Attached Figure Description

[0030] Figure 1 This is a schematic diagram of an all-in-one machine system structure provided by the present invention;

[0031] Figure 2 This is a schematic diagram of another all-in-one machine system structure provided by the present invention;

[0032] Figure 3 This is a schematic diagram of a device with a housing and a support platform extending beyond the housing area provided by the present invention;

[0033] Figure 4 This is a schematic diagram of a system scheme provided by the present invention, in which a support platform is driven to a predetermined position to perform nucleic acid extraction;

[0034] Figure 5 This is a schematic diagram of a system scheme for performing PCR amplification by moving a support platform to a predetermined position, as provided by the present invention.

[0035] Figure 6 This invention provides that... Figure 1 A schematic diagram showing the air discharge within the system during extraction in the system structure;

[0036] Figure 7 This invention provides that... Figure 1 The system structure was extracted and amplified to obtain schematic diagrams of different air duct operations during the process;

[0037] Figure 8 This is a schematic diagram of another system scheme provided by the present invention, in which the support stage moves to a predetermined position to perform PCR amplification;

[0038] Figure 9 The present invention provides that Figure 2 A schematic diagram of the second air duct in the system structure;

[0039] Figure 10 The present invention provides that Figure 2 A schematic diagram of the second air duct and the auxiliary fourth air duct in the system structure;

[0040] Figure 11 The present invention provides that Figure 2 A schematic diagram of the third air duct in the system structure;

[0041] Figure 12 is a second air duct principle schematic diagram provided by the present application in the system structure of Figure 2

[0042] Figure 13 is a second air duct principle schematic diagram provided by the present application in the system structure of Figure 2

[0043] Figure 14 is a third air duct principle schematic diagram provided by the present application in the system structure of Figure 2 DETAILED DESCRIPTION

[0044] In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some but not all of the embodiments of the present application. The components of the embodiments of the present application described and shown in the drawings herein can be arranged and designed in various different configurations.

[0045] Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the claimed present application, but only represents selected embodiments of the present application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present application without creative labor are within the scope of protection of the present application.

[0046] It should be noted that: similar reference numerals and letters represent similar items in the following drawings, therefore, once an item is defined in one drawing, it does not need to be further defined and explained in the subsequent drawings.

[0047] Embodiment 1:

[0048] Figure 1 ​​​A nucleic acid detection device provided by the embodiment of the present application includes a bearing table 10, which includes a bearing part of a sample tube 101 for placing a sample tube collecting a sample, and the sample tube contains the sample collected by a throat swab, a nose swab, an anus swab or the like, and is stored by using a sample storage solution. Of course, the sample can be blood, saliva, excrement or the like, and of course, the sample tube can be a single collection type sample tube or a mixed collection type sample tube such as 5 mixed 1, 10 mixed 1 and 20 mixed 1. Here, it is not limited. The sample in the sample tube can be detected in vitro. The bearing table 10 further includes a bearing part of an extraction consumable 102. The extraction consumable 102 is an integrated consumable, which includes two Tip head bearing parts, a first Tip head for transferring a sample solution to be extracted from the sample tube to the extraction consumable, and a second Tip head for transferring the extracted nucleic acid sample solution from the final extraction hole of the extraction consumable to a PCR amplification consumable. The second Tip head can also be used to transfer the PCR mixture from the mixed solution bearing hole after the extraction solution is transferred in the PCR amplification consumable. The remaining hole positions further include a magnetic stirring sleeve bearing hole, a lysis hole, a washing hole (which can include two or more washing holes), an elution hole and the like for completing the entire nucleic acid extraction operation. The integrated extraction consumable design of the present application stores the disposable consumables required in the nucleic acid extraction operation and the lysis solution, washing solution and elution solution required in different operation steps in different consumable holes. Further, it can be packaged by plastic sealing and packaging method to construct an integrated consumable which is easy to store and transport. Similarly, the bearing table 10 further includes a bearing part of a PCR amplification consumable 103. The PCR amplification consumable can be provided as a multi-connector type, which includes a PCR premix hole integrated in the multi-connector and a plurality of parallel cup holes to realize multi-target simultaneous detection of the same sample. In order to ensure the detection capacity, the sample tube bearing part can receive a plurality of sample tubes at the same time, and the integrated extraction consumable and the PCR amplification consumable are correspondingly provided as a plurality of consumables. The bearing table includes a driving part such as a motor cooperating with a screw structure, a gear chain cooperating structure and the like. The driving motor can drive the bearing table to move between the warehouse state and the warehouse state, and can control the bearing table to enter the nucleic acid detection device shell at different positions to perform different operations. For example, the magnetic stirring sleeve can be used to realize the nucleic acid extraction operation of different holes in the open nucleic acid extraction consumable at a certain position, and the PCR thermal cycling amplification reaction can be performed at another position. 20 is a sample tube opening cover mechanism. A plurality of meshing opening units driven by a motor can realize the simultaneous opening of a plurality of sample tubes 101 (here, the opening mode can be a rotating opening and closing mode of internal thread cooperation or an external thread cooperation structure of other cooperating clamping structure, and the specific implementation mode is not limited).30 is the switch cover mechanism of the extraction consumables, because the invention adopts the design of integrated extraction consumables, the switch cover mechanism has a long groove-shaped switch cover processing part for clamping the fly edge part of the extraction consumables cover, and then realizes the opening operation of the extraction consumables by driving the switch cover mechanism in the vertical direction. 40 is the identification mechanism, which includes a camera unit for image recognition of the consumable state or identification of the barcode of the consumable, etc. 50 is the pipetting mechanism, which cooperates with two different types of pipetting tips in two different hole positions in the integrated extraction consumables to perform pipetting operation. The pipetting mechanism can be driven by a motor screw mechanism to realize movement consistent with the movement direction of the carrier table. Of course, in order to ensure the accuracy of the pipetting operation position, the driving screw thread can be encrypted, so that the carrier table can basically not move during the entire extraction operation, and the precision of the carrier table movement driving design can be reduced to improve the adjustment speed of the entire nucleic acid detection equipment during detection. 60 is the magnetic stirring mechanism, which is used for mixing and stirring, magnetic attraction and magnetic release between different hole positions, and other operations, so as to complete the required cracking, washing and elution of nucleic acid extraction, etc. In order to cooperate with the higher accuracy of nucleic acid extraction operation between different hole positions, the magnetic stirring mechanism 60 and the pipetting mechanism are located on the same connecting structure and are driven by the same motor screw mechanism. Further, in order to ensure the more accurate control of the extraction and pipetting process, the identification mechanism 40 is also connected with the above two mechanisms, so that the opening of the sample tube, the extraction consumables and the PCR amplification consumables, etc. Whether the tip head magnetic stirring sleeve in the extraction consumables is complete after opening, etc. The common use of different mechanisms for the motor screw drive also ensures the simplicity of the system design. 70 is the PCR amplification consumables switch cover mechanism, which cooperates with the pipetting mechanism to perform the opening operation of the PCR amplification consumables after the extraction mechanism completes the extraction operation. The pipettor transfers part of the cracked solution to the mixing hole of the PCR amplification consumables to mix the sample liquid, and then transfers the solution with different volumes to different holes for PCR amplification. Of course, the amplification consumables switch cover mechanism can integrate the heat cover function, so as to ensure that the top temperature is high under the condition that the top of the consumables is tightly pressed during the amplification process, thereby reducing or even avoiding the condensation problem caused by the cold wall surface during the thermal cycling process.801 is a first vent, the carrier table 10 can be driven to approach or move away from the first vent 801, for example, there is a certain interval between the carrier table 10 and the first vent 801 during the nucleic acid extraction operation, and the carrier table 10 is connected with the first vent 801 to form a first air duct during the PCR amplification stage, so that the waste heat generated by the amplification thermal cycle during the PCR amplification stage will be quickly and little disturbed to the internal nucleic acid detection equipment. The outside of the equipment shell, at the same time, the extraction and amplification can be operated in different positions by the driving of the driving part, thereby maximizing the reliability of the integrated carrier table during the composite function operation, and minimizing or even avoiding the pollution caused by aerosol. On the same side of the nucleic acid detection equipment shell as the first vent 801, a second vent 802 is also provided, which can be directly or indirectly connected with an independent air duct 8021, and more preferably an independent fan assembly 8022 connected with the independent air duct 8021, so that the second vent and the connected independent air duct can be in running state to realize the air exhaust of the nucleic acid detection equipment during the period when the carrier table is spaced from the first vent (for example, the nucleic acid extraction operation period after the nucleic acid extraction consumables are opened), which ensures that even in the open cover state, the extraction operation will not produce serious aerosol pollution. Of course, in this example, the same side as the first vent 801 is also provided with a third vent 803, which can provide heat dissipation, negative pressure and reduce pollution functions in other time periods.

[0049] Embodiment 2:

[0050] Figure 2 Another system layout schematic diagram of the present application, compared with Figure 1 The second vent 802 and the independent air duct 8021 connected therewith are cancelled, and the rest of the structure is similar, and the working principle is also similar. The carrier table with integrated functions is driven to be in different positions to realize extraction and amplification operation, so that the detection system with separated air duct established can also reduce the risk of aerosol pollution generated in the sample tube opening operation by position transfer. Other similar structures and functions are not described here.

[0051] Figure 3 A schematic diagram of a carrier table with a shell driven to expose outside the shell range is provided by the present application. Of course, in the shell, as Figure 1 Or Figure 2Any one system layout to achieve the extraction and amplification integrated operation. The carrying table can realize the push away the open-close door structure on the shell 80 under the drive of the motor, and then the whole carrying table 10 can be exposed outside the nucleic acid detection equipment shell range, at this time the corresponding all sample tubes 101 can be installed on the sample tube receiving part of the carrying table 10, the sample tube receiving part in the figure can receive up to 8 sample tubes 101, in this design the actual number of sample tubes 101 loaded can be corresponding to 8, of course, it can also be less than 8, the carrying table also contains an extraction consumable receiving part, according to the actual number of sample tubes and the corresponding position, set the corresponding integrated extraction consumable 102, while in other parts, it is not necessarily set integrated extraction consumable 102. Similarly, the PCR amplification consumable receiving part of the carrying table also sets the corresponding amplification consumable 103 according to the actual number of sample tubes and the corresponding position, after completing the sample tube and consumable sample installation, the carrying table can be pulled back into the shell 80 of the nucleic acid detection equipment through the button control to complete the detection, and the open-close door structure can be pulled back and buckled with the shell 80 by the pulling force of the spring, etc., forming a relatively closed operation space, so that the pollution risk in the whole detection process is reduced, and the equipment is also configured with a display control module 90 for controlling the whole detection process and displaying the progress result, etc.

[0052] Embodiment 3:

[0053] Based on embodiment 1, Figure 4 The schematic diagram for driving module driving the carrying table 10 to move to the nucleic acid extraction position to complete the extraction operation of the extraction consumable 102 opening cover state, at this position, the pipette 50 and the magnetic stirring mechanism 60 can complete the whole extraction operation, first, after the sample tube opening cover module opens the sample tube, the extraction consumable 102 also performs the opening cover operation at the extraction consumable opening cover structure 40, the pipette 50 can transfer an appropriate amount of sample liquid to the integrated extraction consumable, and the transfer by the magnetic stirring mechanism 60 realizes the steps of lysis, washing and elution, etc., finally completes the acquisition from sample liquid to nucleic acid fragments, and during the whole extraction operation time period, the independent fan assembly 8022 is in running state, so that the second ventilation opening 802 and the connected independent air duct 8021 are also in running state, so that even in the opening cover state during the extraction operation, the aerosol pollution that may be generated can be quickly eliminated, of course, the second ventilation opening 802 can be equipped with a specific level filter according to the need, for example, G4 or higher level, which is not limited here.

[0054] Figure 5The schematic diagram of driving the module to drive the bearing table 10 to move to the PCR amplification module for amplification, the solution containing nucleic acid fragments transferred to the amplification module is divided into multiple parts after the premixing cup to form multiple parts that can perform amplification reaction, wherein the switch cover mechanism is 70, and of course the thermal cover function module can be integrated on the switch cover mechanism 70. During the PCR amplification reaction process, the mechanism presses and heats the top cover of the PCR consumables to achieve the effect of preventing evaporation condensation. During the amplification process, the driving module drives the bearing table 10 to be directly connected to the first ventilation port 801 on the detection equipment shell, thereby forming a relatively sealed first air duct. At this time, the waste heat generated during the PCR amplification reaction process will be directly discharged outside the shell through the first air duct, without leaking into the detection equipment during the discharge process to cause waste heat accumulation and affect the working environment of the circuit, thereby ensuring the reliability of the entire system. In addition, the motor of the second ventilation port can be driven to rotate during the PCR amplification process to form a separate second air duct, thereby ensuring that the internal air of the system can also be replaced in time. In addition to discharging the waste heat generated by the circuit components, the internal air can also be dynamically updated to reduce the risk of aerosol pollution. In fact, during the PCR amplification cycle process, the two air ducts can maximize the risk of mixed cross-contamination. During at least part of the time period in the non-thermal amplification reaction time period, the bearing table is spaced apart from the first ventilation port 801. Thus, the environment in which the PCR stage is located can be quickly changed, which is different from the extraction stage position shown in the previous Figure 4 Thus, the reaction environment can be quickly changed to reduce the risk of pollution. At the same time, the first ventilation port 801 can serve as an auxiliary air exchange port during the spaced-apart time period, thereby enabling the internal air of the detection equipment to be replaced more quickly.

[0055] Figure 6 The schematic diagram of air flow in the detection equipment in the independent fan assembly operating state. During the extraction process, the independent fan assembly 8022 can be controlled to operate, thereby enabling the second ventilation port 802 and the connected independent air duct 8021 to also be in an operating state. At this time, the air in the detection equipment can be quickly updated through the independent air duct 8021 to reduce the possibility of aerosol pollution, Figure 7 The entire flowchart of nucleic acid extraction is shown in the schematic diagram of driving the bearing table to move by cooperating with the driving mechanism. When the sample tube and the extraction integrated consumables are correctly executed to open the cover, the driving module drives the bearing table to move to a predetermined position such as Figure 7(a) as shown, at this time the independent fan assembly 8022 can be controlled to be in a running state, so the entire extraction operation step can be in a constant negative pressure state, and the air in the detection device can be discharged through the independent air duct 8021 and the second vent, thereby minimizing the risk of aerosol pollution, and after the extraction is completed, the nucleic acid fragments are divided into the corresponding PCR amplification consumables, at this time the driving part can drive the carrier table to move to the position connected with the first vent 801, as shown in Figure 7 (b) as shown, in this way, the effect of rapid switching in the reaction environment can be achieved, and during the amplification reaction process, the fan located at the third vent 803 can be controlled to be in a running state, and the independent fan assembly 8022 is controlled to be in a non-running state, thereby realizing the design of the separate air duct in the non-physical layer, and minimizing the pollution risk in the amplification and extraction operation states. Of course, the running time period of the separate air duct is not limited to the above description, for example, the fan of the third vent 803 can be operated in other time periods other than the extraction step to ensure that the device is in a negative pressure state.

[0056] Embodiment 4:

[0057] Figure 8 On the basis of embodiment 2, the driving module drives the carrier table 10 to move to the PCR amplification module for amplification, and Figure 5 The difference is that the design cancels the independent air duct 8021 and the second vent connected thereto, and the third vent 803 is arranged on the same side wall as the first vent 801. The fourth vent 804 is arranged at the bottom of the shell. The other processes are similar to embodiment 3, which will not be described here. Figure 9 The third vent 803 arranged on the shell and the fourth vent 804 at the bottom have a second air duct, as shown in the figure. The third vent 803 and the fourth vent 804 at the bottom have a second air duct in a time period, and the air as a whole flows from the third vent 803 to the fourth vent 804. Further, the time period is the nucleic acid extraction operation time period, and the entire operation is carried out in the integrated consumable open cover state, so the pollution risk is also relatively large. At this time, by separating the second air duct from the PCR amplification stage, the cross-contamination risk caused by the approximate air flow direction in most regions of the air duct can be minimized.

[0058] In combination with Figure 10 During this time period, the first vent 801 is spaced apart from the carrier table 10, so the first vent 801 can also serve as an auxiliary vent. A small amount of air enters the detection device shell from the first vent 801 under the negative pressure effect of the internal flow, thereby increasing the air renewal speed in the device shell as a whole, Figure 10The middle A area can be a nucleic acid extraction consumable carrying area on the carrying table 10, and the B area can be a PCR amplification consumable carrying area. Under the air duct and air flow conditions, the nucleic acid extraction consumable carrying area is located in the downwind direction of the PCR amplification consumable carrying area. Thus, although the consumable needs to be operated in an open cover state during the extraction period, the module is in a downwind position, so even if there is a risk of contamination, it will not affect the detection results of the PCR detection module in the upwind direction. Therefore, the final results obtained in the entire detection equipment are more accurate and reliable. Under the action of negative pressure, a fourth air duct can be formed between the first air vent 801 and the fourth air vent 804 in the period, and the overall air flow direction in the fourth air duct is from the first air vent 801 to the fourth air vent 804. Of course, in order to achieve the above effect, the fan can also be arranged on the fourth air vent 804 located at the bottom of the shell. Here, it is not limited.

[0059] On the basis of the above scheme, Figure 11 A schematic diagram of a third air duct formed between the third air vent 803 and the fourth air vent 804 in another time period range, for example, in the PCR amplification time period range, the air flow direction in the third air duct is from the fourth air vent 804 to the third air vent 803 by controlling the rotation direction of the fan. In comparison Figure 10 According to the air flow direction in the third air duct, the extraction consumable carrying area is located in the upwind direction of the amplification consumable carrying area at this time. Thus, even if there is aerosol pollution during the amplification process due to the open cover in the early stage, it can be quickly discharged from the amplification area, ensuring the reliability of the detection results.

[0060] On the basis of the above embodiment, Figure 12 And Figure 13 A different air duct schematic diagram corresponding to Figure 9 And Figure 10 The carrying table is not connected between the first air vent 801 during the nucleic acid extraction period. At this time, in order to reduce the pollution that may be caused by the extraction open cover operation, the overall direction of air flow in the device of the present application includes from the third air vent 803 to the fourth air vent 804. Thus, it is ensured that the extraction module is in the downwind direction during the extraction operation, so as not to affect other modules in the upwind direction. In Figure 13In the extraction process, the rectified airflow direction is the second air duct, labeled T01, which points from the third vent 803 to the fourth vent 804. This process may also include a fourth air duct, labeled T02, which points from the first vent 801 to the fourth vent 804. The airflow that the second air duct can exchange with the outside is A01, and the airflow that the fourth air duct can exchange with the outside is A02. This design ensures that during the nucleic acid extraction period, since the support platform is separated from the first vent 801, it can act as an auxiliary vent, increasing the overall airflow and thus ensuring a faster air renewal speed inside the detection equipment.

[0061] Based on the above embodiments, Figure 14 This illustrates a kind of Figure 8 The diagram shows the internal airflow path of the equipment during the corresponding PCR amplification period. During the PCR amplification period, the drive module drives the support platform 10 to connect with the first vent 801. At this time, the waste heat generated during the thermal circulation process under the action of the fan can be quickly discharged outside the shell through the relatively closed first vent formed by the contact. The air carrying waste heat in this vent can minimize the impact on the internal environment of the detection equipment, which is of great significance for the reliable operation of the circuit control devices. At the same time, by establishing a third vent with the airflow direction from the fourth vent 804 to the third vent 803, the waste heat generated by circuit components can be quickly discharged, and the risk of internal contamination can be reduced. In addition, the first vent and the third vent have basically the same outflow direction, which can reduce the risk of cross-contamination caused by turbulence due to large differences in flow direction. Of course, the fourth vent 804 can also be located at the top of the shell, and the effect is similar to that at the bottom, which will not be repeated here. Of course, HEPA filters or other filter components can be installed in all or some of the above-mentioned vents to filter the incoming or outgoing air, thereby ensuring the safe and reliable operation of the instrument. The fans in different vents can be designed according to parameters such as flow rate, and the specific number is not limited.

[0062] This document uses specific embodiments to illustrate the principles and implementation methods of the present invention. The descriptions of the embodiments above are merely for the purpose of helping to understand the present method and its core ideas. It should be noted that those skilled in the art can make various improvements and modifications to the present invention without departing from its principles, and these improvements and modifications also fall within the protection scope of the claims of the present invention.

[0063] It should be noted that the terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but can also include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by "comprises... a" does not, without more constraints, exclude the presence of additional identical elements in the process, method, article, or apparatus that comprises the element.

[0064] In the description of the present application, it is also necessary to explain that, unless explicitly specified and limited, the terms "setting", "mounting", "connecting", "connection" should be understood in a broad sense, for example, it can be fixed connection, or detachable connection, or integral connection; it can be mechanical connection, or electrical connection; it can be direct connection, or indirect connection through intermediate medium, or internal communication of two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

Claims

1. A nucleic acid detection device having a separate air duct design, characterized by, The nucleic acid detection device comprises a carrying platform, which has a reaction consumable carrying part for providing nucleic acid amplification reaction consumables, and a thermal cycle module for providing nucleic acid amplification reaction conditions. The nucleic acid detection device further comprises a first air vent on the nucleic acid detection device shell, and a driving module for driving the carrying platform to move relative to the first air vent. The driving module drives the carrying platform to be connected with the first air vent to form a first air duct during a period of time for thermal amplification reaction in the reaction consumable carrying part, and the carrying platform is spaced apart from the first air vent during at least part of the period of time for non-thermal amplification reaction. The nucleic acid detection device shell further comprises a third air vent and a fourth air vent on the bottom or top of the nucleic acid detection device shell. The third air vent is located on the same side wall of the nucleic acid detection device shell as the first air vent. The third air vent and the fourth air vent form a second air duct with a first air flow direction during at least part of the period of time. The carrying platform further comprises an extraction consumable carrying part for providing nucleic acid extraction reaction consumables. The driving module drives the carrying platform to be spaced apart from the first air vent during a period of time for extraction reaction in the extraction consumable carrying part, and the third air vent and the fourth air vent form a second air duct with a first air flow direction during the period of time. The first air flow direction is the overall flow direction of the air in the nucleic acid detection device from the third air vent to the fourth air vent. The extraction consumable carrying part is located in the downwind direction of the reaction consumable carrying part during the period of time for nucleic acid extraction operation in the extraction consumable carrying part. The third air vent and the fourth air vent form a third air duct with a second air flow direction during the period of time for thermal amplification reaction in the reaction consumable carrying part. The second air flow direction causes the reaction consumable carrying part to be located in the downwind direction of the extraction consumable carrying part during the period of time for thermal amplification and / or detection operation in the reaction consumable carrying part. The second air flow direction is the overall flow direction of the air in the nucleic acid detection device from the fourth air vent to the third air vent.

2. The nucleic acid testing apparatus having a separate air duct design according to claim 1, wherein, The nucleic acid detection device shell further comprises a second air vent, which is located on the same side wall of the nucleic acid detection device shell as the first air vent. The second air vent comprises an independent air duct connected thereto. The second air vent and the connected independent air duct are in an operating state to discharge air in the nucleic acid detection device during at least part of the period of time when the carrying platform is spaced apart from the first air vent.

3. The nucleic acid testing apparatus having a separate air duct design according to claim 2, wherein, The driving module drives the carrying platform to be spaced apart from the first air vent during the period of time for extraction reaction in the extraction consumable carrying part, and the second air vent and the connected independent air duct are in an operating state.

4. The nucleic acid testing apparatus having a separate air duct design according to claim 1, wherein, The first air vent comprises a HEPA air filter unit for filtering the air.

5. The nucleic acid testing apparatus having a separate air duct design according to claim 1, wherein, The third air vent and / or the fourth air vent further comprise a fan unit for driving the formation of a second air duct with the first air flow direction in the nucleic acid detection device during at least part of the period of time.

6. The nucleic acid testing apparatus having a separate air duct design according to claim 5, wherein, The fan unit is capable of forming different rotation directions in at least different time periods, so as to realize different air flow directions in different time periods in the nucleic acid detection device.

7. A method of detecting a nucleic acid, characterized by: Use of a nucleic acid detection device with a separate air duct design as claimed in any one of claims 1 to 6.

8. A method of detecting a nucleic acid, characterized by: Use of a nucleic acid detection device with a separate air duct design as claimed in claim 2, wherein the second vent is controlled to be in an operating state with the connected separate air duct in at least part of the time periods other than the time period of the non-thermal amplification reaction, and in a non-operating state with the connected separate air duct in the time period of the thermal amplification reaction.

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