Totally-closed nucleic acid extraction and detection device

Abstract

The invention discloses a fully-closed nucleic acid extraction and detection device which comprises a purification mechanism, the purification mechanism comprises a fixing part, magnetic beads and a magnetic attraction body, a cracking cavity, at least one washing cavity, an elution cavity and a transfer channel are formed in the fixing part, and the transfer channel is communicated with the cracking cavity, the washing cavity and the elution cavity; the magnetic bead is arranged in the fixing part; the magnetic attraction body is arranged in the fixing part and can magnetically attract the magnetic beads, the magnetic attraction body can drive the magnetic beads to transfer among the transfer channel, the splitting cavity, the washing cavity and the elution cavity, and the size of the magnetic attraction body is larger than that of the magnetic beads. The magnetic attraction body can be matched with an external magnetic field to drive the magnetic beads to move, splitting decomposition, washing and elution are all carried out in the fixed part and are in a totally-closed environment, and external impurities are prevented from interfering with purification of nucleic acid; moreover, during nucleic acid purification, equipment does not need to enter the fixed part, so that the problem of nucleic acid leakage is avoided, nucleic acid leakage during detection is avoided, and the interference of nucleic acid leakage on other nucleic acid detection is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of nucleic acid detection, and in particular to a fully enclosed nucleic acid extraction and detection device. Background Art

[0002] A nucleic acid test kit is a kit used to detect the genetic material (nucleic acid) of microorganisms such as viruses or bacteria, and is usually used to detect viral infectious diseases and genetic testing. It contains a series of reagents and equipment for extracting, amplifying and detecting nucleic acids in samples.

[0003] The working principle of the nucleic acid detection kit is that the nucleic acid detection kit usually adopts the fluorescent quantitative PCR (Polymerase Chain Reaction) method. The detection principle is to use the unique gene sequence of the virus as the detection target, and through PCR amplification, the selected target DNA (Deoxyribo Nucleic Acid) sequence is exponentially increased. Each amplified DNA sequence can be combined with a pre-added fluorescent labeled probe to generate a fluorescent signal. The more target genes are amplified, the stronger the accumulated fluorescent signal. Therefore, nucleic acid testing determines whether there is a specific nucleic acid in the sample by detecting the accumulation of fluorescent signals.

[0004] Publication No. CN112852626A discloses a sample detection device, including a magnetic sleeve and a detection box; the detection box is provided with at least four cavities arranged side by side and not interconnected, and a sealing structure is provided on the top to seal all the cavities, the magnetic sleeve can pierce the sealing structure, and the magnetic sleeve can extend into each cavity; wherein the cavity includes a lysis chamber for lysing samples, a magnetic bead chamber pre-loaded with magnetic beads, a washing chamber for washing, and an elution chamber for elution; a reaction tube is fixed at the bottom of the elution chamber, the top of the reaction tube is sealed, and the reaction tube is pre-loaded with a detection reagent; the other cavities except the magnetic bead chamber are respectively pre-loaded with different reagents for sample extraction. When washing nucleic acid, the magnetic rod of the detection instrument is inserted downward into the magnetic sleeve, and the magnetic sleeve adsorbs the magnetic beads in the lysis chamber; the magnetic sleeve moves into the washing chamber together with the magnetic rod, and the magnetic rod is withdrawn to release the magnetic beads adsorbed on the magnetic sleeve. The magnetic sleeve moves up and down in the washing chamber to mix the reagents and magnetic beads in the chamber; then the magnetic beads are transferred to another washing chamber for secondary washing in the same way.

[0005] In the above-mentioned detection box, when extracting nucleic acid, it is necessary to extend the magnetic sleeve through the sealing structure into the lysis chamber, washing chamber and elution chamber, and then control the movement of the magnetic sleeve of the magnetic rod box through the detection instrument, so that the magnetic beads pass through the lysis chamber, washing chamber and elution chamber in sequence. However, when the magnetic sleeve punctures the sealing mechanism, the sample in the detection box is exposed to the air, and there is a risk of nucleic acid leakage. The leaked nucleic acid may contaminate the laboratory environment or other samples, resulting in false positive test results, thereby affecting the accuracy of the diagnosis. Summary of the invention

[0006] The purpose of the present invention is to overcome the above technical deficiencies and propose a fully enclosed nucleic acid extraction and detection device to solve the technical problem of nucleic acid leakage caused by puncturing the sealing structure when transferring nucleic acid using a magnetic sleeve during nucleic acid extraction from a detection box in the prior art.

[0007] In order to achieve the above technical objectives, the present invention adopts the following technical solutions: The present invention provides a fully enclosed nucleic acid extraction and detection device, including a purification mechanism, wherein the purification mechanism includes: A fixed part, in which a lysis chamber, at least one washing chamber, an elution chamber and a transfer channel are formed, and the transfer channel connects the lysis chamber, the washing chamber and the elution chamber; Magnetic beads, built into the fixing portion; and The magnetic body is built into the fixed part and can magnetically absorb the magnetic beads. The magnetic body can drive the magnetic beads to transfer between the transfer channel, the lysis chamber, the washing chamber, and the elution chamber. The volume of the magnetic body is larger than that of the magnetic beads.

[0008] In one embodiment, the fully enclosed nucleic acid extraction and detection device further includes at least two magnetic suction components, wherein the magnetic suction components are arranged outside the fixing portion and are magnetically connected to the magnetic body.

[0009] In one embodiment, the fixing portion is further formed with a nucleic acid flow channel; The fully enclosed nucleic acid extraction and detection device further comprises a detection reagent mechanism, which is detachably connected to the fixing portion and forms a detection cavity for accommodating the detection reagent, and one end of the detection cavity is open; Wherein, when the detection reagent mechanism is connected to the fixing part, the detection cavity is communicated with the nucleic acid flow channel, and the purification mechanism can block the opening of the detection cavity.

[0010] In one of the embodiments, a plug-in structure is used to achieve a detachable connection between the purification mechanism and the detection reagent mechanism, and the plug-in structure can seal the opening of the detection cavity. When the purification mechanism and the detection reagent mechanism are plugged in, the plug-in structure can at least partially be inserted into the detection cavity and pressurize the detection cavity.

[0011] In one embodiment, the purification mechanism further comprises: A plug-in portion connected to the fixing portion; and A paraffin layer connected to the plug-in portion; When the detection reagent mechanism is connected to the purification mechanism, the plug-in portion and the paraffin layer are inserted into the detection cavity.

[0012] In one embodiment, the purification mechanism further comprises: The sealing layer is arranged in the transfer channel and is detachably connected to the fixing part. When the sealing layer is connected to the fixing part, it blocks the connection between the lysis chamber, the washing chamber and the transfer channel.

[0013] In one embodiment, a mounting cavity communicating with the transfer channel is formed in the fixing portion; The purification mechanism also includes: The winding part is rotatably arranged in the installation cavity and connected to the sealing layer, and is used for winding the sealing layer to release the blockage of the connection between the lysis cavity, the washing cavity and the elution cavity and the transfer channel.

[0014] In one embodiment, a window is opened in the middle of the sealing layer, the dimensions of the two ends of the sealing layer are at least partially smaller than the dimensions of the window, and the two ends of the sealing layer pass through the window and are both connected to the winding portion.

[0015] In one embodiment, the lysis chamber, the washing chamber and the elution chamber are arranged linearly along a first direction, and the side walls of at least part of the lysis chamber, the washing chamber and the elution chamber on both sides along the first direction and the inner walls of the chamber in other directions are smoothly transitioned through arc surfaces.

[0016] In one embodiment, the nucleic acid flow channel has a sealed cavity; The purification mechanism comprises: a sealing part, which is built into the sealing cavity and seals with the inner wall of the sealing cavity to close the nucleic acid flow channel; and An elution plug is slidably disposed in the sealing cavity, and is used to push the sealing part out of the sealing cavity through the fluid in the elution cavity to open the nucleic acid flow channel.

[0017] Compared with the prior art, the fully enclosed nucleic acid extraction and detection device provided by the present invention, when in use, the purification mechanism purifies the nucleic acid in the sample, a lysis solution is provided in the lysis chamber, the sample enters the lysis chamber, the sample is lysed by the lysis solution, the magnetic body is driven to move by an external magnetic field or a special fluid driving mechanism, the magnetic body magnetically absorbs magnetic beads and drives the magnetic beads to move, the magnetic beads are first moved into the lysis chamber, and the lysed nucleic acids are absorbed by the magnetic beads; the magnetic beads are driven to move by the magnetic body and enter the washing chamber through the transfer channel, the washing chamber contains washing solution, the washing solution can wash the nucleic acids absorbed by the magnetic beads, and the washing solution is used to remove impurities that may remain on the magnetic beads, such as proteins, salt ions, etc. If these impurities remain in the subsequent reaction system, they may interfere with subsequent nucleic acid detection or amplification operations. The washed magnetic beads are driven by the magnetic absorber and transferred to the elution chamber through the connecting channel. The elution chamber contains elution liquid, and the nucleic acid adsorbed on the magnetic beads is eluted with the elution liquid. The eluted nucleic acid enters the nucleic acid flow channel, thereby realizing the purification of the nucleic acid in the sample.

[0018] The magnetic body can be driven by the magnetic rod of the existing detection instrument to perform the above movement, or it can be driven by an external magnetic field or a special fluid driving mechanism to ensure that the magnetic beads can move smoothly along the transfer channel.

[0019] The magnetic body can cooperate with the external magnetic field to drive the movement of magnetic beads. During the nucleic acid purification process, lysis, washing and elution are all carried out in the fixed part, which is in a fully closed environment to prevent external impurities from interfering with the purification of nucleic acids. Moreover, when purifying nucleic acids, there is no need for equipment to enter the fixed part, and there will be no problem of nucleic acid leakage, which can avoid nucleic acid leakage during detection and prevent nucleic acid leakage from interfering with other nucleic acid detections. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 is an exploded view of a fully enclosed nucleic acid extraction and detection device provided by an embodiment of the present invention; Figure 2 It is a schematic diagram of the structure of a fully enclosed nucleic acid extraction and detection device provided by one embodiment of the present invention; Figure 3 is a cross-sectional view of a fully enclosed nucleic acid extraction and detection device provided by one embodiment of the present invention; Figure 4 It is a structural schematic diagram of a second shell, a third shell and a detection reagent mechanism in a fully enclosed nucleic acid extraction and detection device provided in one embodiment of the present invention; Figure 5 It is a schematic structural diagram of the second shell in the fully enclosed nucleic acid extraction and detection device provided by one embodiment of the present invention; Figure 6It is a schematic structural diagram of a second shell, a sealing layer and a winding part in a fully enclosed nucleic acid extraction and detection device provided in one embodiment of the present invention; Figure 7 It is a schematic structural diagram of the second shell in the fully enclosed nucleic acid extraction and detection device provided by one embodiment of the present invention; Figure 8 It is a structural schematic diagram of a third housing and a plug-in portion in a fully enclosed nucleic acid extraction and detection device provided in one embodiment of the present invention; Fig. 9 It is a structural schematic diagram of a third housing, a plug-in portion and a detection reagent mechanism in a fully enclosed nucleic acid extraction and detection device provided in one embodiment of the present invention; Fig.10 It is a structural schematic diagram of a plug-in block, a plug-in strip and a paraffin layer in a fully enclosed nucleic acid extraction and detection device provided in one embodiment of the present invention; Fig.11 It is a structural schematic diagram of the first shell in the fully enclosed nucleic acid extraction and detection device provided by one embodiment of the present invention; Fig.12 It is a schematic structural diagram of a magnetic attraction component and a fixing part in a fully enclosed nucleic acid extraction and detection device provided in one embodiment of the present invention.

[0021] Description of reference numerals: Purification mechanism 1; nucleic acid flow channel 1a; sealed cavity 1a1; connecting groove 1a2; connecting hole 1a3; The fixing part 11; the lysis chamber 11a; the washing chamber 11b; the elution chamber 11c; the transfer channel 11d; the communication channel 11e; the installation chamber 11f; the first shell 111; the first through hole 111a; the second through hole 111b; the second shell 112; the first fixing hole 112a; the second fixing hole 112b; the first storage hole 112c; the second storage hole 112d; the liquid inlet channel 112e; the third shell 113; the puncture part 114; Plug-in portion 12; fixing ring 121; plug-in block 122; plug-in strip 123; Paraffin layer 13; sealing layer 14; window 14a; winding portion 15; magnetic body 16; sealing portion 17; elution plug 18; Sampling member 19; sample tube 191; sampling plug 192; closing plug 193; Detection reagent mechanism 2; detection chamber 2a; fourth housing 21; detection shell 22; Magnetic parts 3. DETAILED DESCRIPTION

[0022] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with 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 intended to limit the present invention.

[0023] In order to solve the technical problem of nucleic acid leakage caused by the existing use of magnetic sleeves to transfer nucleic acids, the present invention provides a fully enclosed nucleic acid extraction and detection device, which can avoid nucleic acid leakage during the transfer of nucleic acids.

[0024] See also Figure 3 , Figure 3 A cross-sectional view of a fully enclosed nucleic acid extraction and detection device provided in an embodiment of the present invention, the fully enclosed nucleic acid extraction and detection device comprises a purification mechanism 1, the purification mechanism 1 comprises a fixed part 11, magnetic beads (not shown in the figure) and a magnetic body 16, a lysis chamber 11a, at least one washing chamber 11b, an elution chamber 11c and a transfer channel 11d are formed in the fixed part 11, and the transfer channel 11d connects the lysis chamber 11a, the washing chamber 11b and the elution chamber 11c; the magnetic beads are built in the fixed part 11; the magnetic body 16 is built in the fixed part 11 and can magnetically absorb the magnetic beads, and the magnetic body 16 can drive the magnetic beads to transfer between the transfer channel 11d, the lysis chamber 11a, the washing chamber 11b and the elution chamber 11c, and the volume of the magnetic body 16 is larger than the magnetic beads. Magnetic beads are superparamagnetic microspheres with specific chemical functional groups modified on the surface, which are used for the extraction and purification of DNA and RNA.

[0025] Specifically, when the fully enclosed nucleic acid extraction and detection device is in use, the purification mechanism 1 purifies the nucleic acid in the sample, a lysis solution is provided in the lysis chamber 11a, the sample enters the lysis chamber 11a, the sample is lysed by the lysis solution, the magnetic body 16 is driven to move by an external magnetic field or a special fluid driving mechanism, the magnetic body 16 magnetically absorbs magnetic beads and drives the magnetic beads to move, the magnetic beads are first moved into the lysis chamber 11a, and the lysed nucleic acids are absorbed by the magnetic beads; the magnetic beads are driven to move by the magnetic body 16 and enter the washing chamber 11b through the transfer channel 11d, the washing chamber 11b contains washing solution, the washing solution can wash the nucleic acids absorbed by the magnetic beads, and the washing solution is used to remove impurities that may remain on the magnetic beads, such as proteins, salt ions, etc. If these impurities remain in the subsequent reaction system, they may interfere with subsequent nucleic acid detection or amplification operations; the washed magnetic beads are driven by the magnetic absorber 16 and transferred to the elution chamber 11c through the connecting channel 11e. The elution chamber 11c contains an eluent, and the eluent is used to elute the nucleic acids adsorbed on the magnetic beads. The eluted nucleic acids enter the nucleic acid flow channel 1a, thereby achieving the purification of the nucleic acids in the sample.

[0026] The material of the magnetic body 16 can be iron, cobalt, nickel, silicon steel, Permalloy, AlNiCo alloy, NdFeB, SmCo, ferrite, Fe-based amorphous alloy, nanocrystalline alloy, etc. The shape of the magnetic body 16 can be spherical, shuttle-shaped, square, etc. The magnetic body 16 can be driven by the magnetic rod of the existing detection instrument to perform the above movement, or it can be driven by an external magnetic field or a special fluid driving mechanism to ensure that the magnetic beads can move smoothly along the transfer channel 11d.

[0027] Through the magnetic body 16, it can cooperate with the external magnetic field to drive the movement of the magnetic beads. During the nucleic acid purification process, lysis, washing and elution are all carried out in the fixed part 11, which is in a fully closed environment to prevent external impurities from interfering with the nucleic acid purification; moreover, when the nucleic acid is purified, there is no need for equipment to enter the fixed part 11, and there will be no problem of nucleic acid leakage, which can prevent nucleic acid leakage during detection and prevent nucleic acid leakage from interfering with other nucleic acid detections; moreover, if the magnetic beads are directly adsorbed and transferred by the external magnetic field, the magnetic beads are not easily completely magnetically adsorbed. When transferred in different cavities, some magnetic beads will remain in the cavity during the transfer process, which prevents excessive loss of magnetic beads and causes a decrease in nucleic acid concentration. In the present invention, by setting the magnetic body 16, the magnetic body 16 has magnetism and directly contacts the magnetic beads, and can directly adsorb the magnetic beads to avoid loss of magnetic beads during the transfer process.

[0028] It should be understood that the washing chamber 11b is used to store washing liquid and waste liquid generated after washing, and the number of washing chambers 11b is one or more; when the number of washing chambers 11b is more than one, the washing liquids in the washing chambers 11b may be the same or different.

[0029] In order to control the movement of the magnetic body 16, for this purpose, Fig.12 As shown, in one of the embodiments, the fully enclosed nucleic acid extraction and detection device further includes at least two magnetic suction components 3, and the magnetic suction components 3 are arranged outside the fixing portion 11 and are magnetically connected to the magnetic body 16.

[0030] The magnetic element 16 can be magnetically attracted by the magnetic element, and then the magnetic element 3 can be moved to drive the magnetic element 16 and the magnetic beads to move in the fixed part 11. It should be understood that the magnetic element 3 can be a permanent magnetic element and an electromagnetic element, and the magnetic element 3 can be moved by manual control or by a three-dimensional moving mechanism and a robotic arm.

[0031] like Figure 3As shown, in one embodiment, the fixed part 11 is also formed with a nucleic acid flow channel 1a; the fully enclosed nucleic acid extraction and detection device also includes a detection reagent mechanism 2, which is detachably connected to the fixed part 11 and is formed with a detection chamber 2a for accommodating the detection reagent, and one end of the detection chamber 2a is open; wherein, when the detection reagent mechanism 2 is connected to the fixed part 11, the detection chamber 2a is connected to the nucleic acid flow channel 1a, and the purification mechanism 1 can block the opening of the detection chamber 2a. The number of the detection chambers 2a can be one, two, or more.

[0032] The purified nucleic acid enters the nucleic acid flow channel 1a. During the purification process, the nucleic acid flow channel 1a is closed. When the purification is completed, the nucleic acid flow channel 1a is opened, and the nucleic acid enters the detection chamber 2a through the nucleic acid flow channel 1a, mixes and dissolves with the detection reagent in the detection chamber 2a, and is amplified. Then, the fluorescence detection equipment is used to detect whether the amplified nucleic acid produces a fluorescent reaction, so as to perform detection.

[0033] Purification mechanism 1 and detection reagent mechanism 2, purification mechanism 1 is formed with a nucleic acid flow channel 1a that can be opened and closed; detection reagent mechanism 2 is detachably connected to purification mechanism 1, and is formed with a detection cavity 2a for accommodating detection reagents, and one end of detection cavity 2a is open; wherein, when detection reagent mechanism 2 is connected to purification mechanism 1, detection cavity 2a is connected with nucleic acid flow channel 1a, and purification mechanism 1 can block the opening of detection cavity 2a. It should be understood that detection reagent mechanism 2 can also be directly fixedly connected to purification mechanism 1 as a whole after pre-embedded reagents, and the fixed connection method can be welding, bonding, etc.

[0034] Since the detection reagent mechanism 2 is detachably connected to the purification mechanism 1, different detection reagents can be filled into the detection cavity 2a for different samples to be tested. The user can select reagents from different suppliers according to different samples to be tested, and connect the detection reagent mechanism 2 with the purification mechanism 1. After the connection, the reagent filled in the detection reagent mechanism 2 can react with the purified nucleic acid, and different nucleic acid targets can be detected according to the different reagents filled.

[0035] After the detection reagent mechanism 2 is connected to the purification mechanism 1, the purification mechanism 1 can seal the opening of the detection chamber 2a to prevent nucleic acid leakage during detection and to prevent nucleic acid leakage from interfering with other nucleic acid detections.

[0036] It should be understood that the purification mechanism 1 and the detection reagent mechanism 2 can be detachably connected by means of screws, bolts, snaps, etc., and the purification mechanism 1 and the detection reagent mechanism 2 can also be detachably connected by tight plug-in.

[0037] In order to realize the detachable connection between the purification mechanism 1 and the detection reagent mechanism 2, for this purpose, as Figure 1As shown, in one of the embodiments, a plug-in structure is used between the purification mechanism 1 and the detection reagent mechanism 2 to achieve a detachable connection, and the plug-in structure can seal the opening of the detection cavity 2a, and can pressurize the detection cavity 2a when the plug-in structure is inserted into the detection cavity 2a.

[0038] In this embodiment, a detachable connection between the purification mechanism 1 and the detection reagent mechanism 2 is achieved by plugging them together, and the sealing of the opening of the detection chamber 2a is achieved by plugging them together. At the same time, when the purification mechanism 1 and the detection reagent mechanism 2 are plugged together, since the nucleic acid flow channel 1a is closed and the plug-in structure is partially inserted into the detection chamber 2a, the space in the detection chamber 2a will be squeezed, and the gas in the detection chamber 2a will be compressed, so that the gas in the detection chamber 2a is pressurized. When the fully enclosed nucleic acid extraction and detection device is applied to a plateau environment, since the gas in the detection chamber 2a is pressurized, the boiling point of the solution in the detection chamber 2a can be increased, thereby avoiding premature boiling of the solution and loss of reagents due to boiling of the solution, and facilitating the heating of the reagents in the detection chamber 2a.

[0039] The sealing of the opening means preventing the reagent from flowing outward from the gap between the purification mechanism 1 and the detection reagent mechanism 2, without restricting the nucleic acid from entering the detection cavity 2a from the nucleic acid flow channel 1a.

[0040] When the nucleic acid in the detection chamber 2a is detected by the detection device, the solution in the detection chamber 2a will be heated. Since the amount of solution in the detection chamber 2a is small, the solution in the detection chamber 2a will evaporate during the heating process, resulting in a decrease in the solution in the detection chamber 2a, which affects the detection of the nucleic acid. For this reason, Fig. 9 and Fig.10 As shown, in one embodiment, the purification mechanism 1 includes a fixing portion 11, a plug-in portion 12, and a paraffin layer 13. The fixing portion 11 forms a nucleic acid flow channel 1a and is detachably connected to the detection reagent mechanism 2; the plug-in portion 12 is arranged relative to the detection cavity 2a and connected to the fixing portion 11; the paraffin layer 13 is connected to the plug-in portion 12; when the detection reagent mechanism 2 is connected to the purification mechanism 1, the plug-in portion 12 and the paraffin layer 13 are inserted into the detection cavity 2a. It should be understood that the paraffin layer 13 can also be other substances that can play a similar role.

[0041] In this embodiment, the fixed portion 11 has a plug-in portion 12 extending into the detection chamber 2a, and a paraffin layer 13 is arranged on the plug-in portion 12. When the nucleic acid is detected, the solution in the detection chamber 2a heats up, causing the paraffin layer 13 to melt. Since the density of paraffin is less than that of water, the melted paraffin layer 13 will float on the top of the detection reagent, blocking the volatilization of moisture and detection reagent in the detection chamber 2a, thereby avoiding the volatilization of moisture and detection reagent and causing a reduction in the detection reagent.

[0042] It should be understood that the elution chamber 11c can be completely enclosed in the fixed part 11, or one side can be open. When the elution chamber 11c can be completely enclosed in the fixed part 11, the transfer channel 11d can be directly connected to the elution chamber 11c. To this end, in one embodiment, one side of the elution chamber 11c is open, and a connecting channel 11e is also formed in the fixed part 11, and the transfer channel 11d is connected to the elution chamber 11c through the connecting channel 11e.

[0043] Since one side of the elution chamber 11c is open, the inner wall of the open side will hinder the movement of the magnetic beads and the magnetic body 16. For this reason, in this embodiment, a connecting channel 11e is provided, and the connecting channel 11e allows the magnetic beads and the magnetic body 16 to enter the elution chamber 11c from the transfer channel 11d.

[0044] In order to prevent the reagents enclosed in the lysis chamber 11a, the washing chamber 11b, and the elution chamber 11c from overflowing, Figure 6 As shown, in one embodiment, the purification mechanism 1 also includes a sealing layer 14, which is arranged in the transfer channel 11d and is detachably connected to the fixed part 11. When the sealing layer 14 is connected to the fixed part 11, it blocks the connection between the cracking chamber 11a, the washing chamber 11b and the transfer channel 11d, and blocks the connection between the connecting channel 11e and the transfer channel 11d.

[0045] In this embodiment, by setting a sealing layer 14, before using the purification mechanism 1, the sealing layer 14 can seal the lysis chamber 11a, the washing chamber 11b, and the elution chamber 11c to prevent the reagents in the lysis chamber 11a, the washing chamber 11b, and the elution chamber 11c from overflowing and mixing with each other. When detection is required, the sealing layer 14 is removed from the fixed part 11 to allow the magnetic beads to enter the lysis chamber 11a, the washing chamber 11b, and the elution chamber 11c.

[0046] The sealing layer 14 can be a film connected to the fixing part 11 by bonding or the like, or a sealing sheet sealed by a sealing ring and connected to the fixing part 11. The sealing sheet and the fixing part 11 can be detachably connected by snap fasteners or the like.

[0047] In order to release the sealing layer 14 from the blocking position, for this purpose, as Figure 3 , 4As shown in Figure 6, in one embodiment, a mounting cavity 11f connected to the transfer channel 11d is formed in the fixing portion 11; the purification mechanism 1 also includes a winding portion 15, which is rotatably disposed in the mounting cavity 11f and connected to the sealing layer 14. The winding portion 15 is rotatably disposed in the mounting cavity 11f and connected to the sealing layer 14, and is used to wind the sealing layer 14 to release the blockage of the connection between the lysis chamber 11a, the washing chamber 11b and the transfer channel 11d, and to release the blockage of the connection between the connecting channel 11e and the transfer channel 11d.

[0048] In this embodiment, when a fully enclosed nucleic acid extraction and detection device is needed, the winding portion 15 is rotated, and the winding portion 15 rotates and continuously winds the sealing layer 14, so that the sealing layer 14 is detached from the original sealed position to release the blockage of the connection between the lysis chamber 11a, the washing chamber 11b and the transfer channel 11d, and to release the blockage of the connection between the connecting channel 11e and the transfer channel 11d.

[0049] It should be understood that the sealing layer 14 can be sealed by using a sealing plastic film or an aluminum film sealing film through heat sealing or ultrasonic welding.

[0050] It should be understood that the winding portion 15 can be built into the installation cavity 11f, or it can extend out of the installation cavity 11f. When the winding portion 15 is built into the installation cavity 11f, the winding portion 15 can be connected to an external drive motor by means of a magnetic connection, so that the winding portion 15 can be driven to rotate by the external drive motor; when the winding portion 15 extends out of the installation cavity 11f, the winding portion 15 and the fixed portion 11 can be sealed by a sealing ring or a fit, and the winding portion 15 can be rotated by manual drive or by a drive device such as a motor; the winding portion 15 and the sealing layer 14 can be connected by bonding, plugging, and snapping.

[0051] In order to peel off the sealing layer 14 from the blocked position, the sealing layer 14 can be directly pulled. However, directly pulling the end of the sealing film easily causes the sealing layer 14 to break, and it is not possible to ensure that the sealing layer 14 is completely detached. Figure 6 As shown, in one embodiment, a window 14a is opened in the middle of the sealing layer 14 , and the dimensions of both ends of the sealing layer 14 are at least partially smaller than the dimensions of the window 14a , and the two ends of the sealing layer 14 pass through the window 14a and are both connected to the winding portion 15 .

[0052] In this embodiment, the two ends of the sealing layer 14 are not connected to the fixed part 11. The two ends of the sealing layer 14 are wound by the winding part 15, so that the sealing layer 14 can be torn off from the end toward the center, and during the tearing process, the sealing layer 14 is torn in a direction away from the fixed position, which facilitates tearing off the sealing layer 14.

[0053] In order to drive the magnetic beads to transfer between the transfer channel 11d, the lysis chamber 11a, the washing chamber 11b, the connecting channel 11e, and the elution chamber 11c, the magnetic beads can be directly driven to move along the transfer channel 11d by an external magnetic field. However, it is not easy to drive all the magnetic beads to transfer during the transfer process. Secondly, due to the small size of the magnetic beads, it is impossible to determine whether the magnetic beads have been transferred. For this reason, Figure 5 As shown, in one embodiment, the purification mechanism 1 also includes a magnetic body 16, which is built into the fixed part 11. The magnetic body 16 can magnetically absorb magnetic beads and can be transferred between the transfer channel 11d, the lysis chamber 11a, the washing chamber 11b, the connecting channel 11e, and the elution chamber 11c. The volume of the magnetic body 16 is larger than the magnetic beads.

[0054] In this embodiment, by setting up the magnetic body 16, after the magnetic beads adsorb nucleic acids, the magnetic body 16 is driven to move to the adsorbed magnetic beads through an external magnetic field or a special fluid driving mechanism, and then drives the magnetic beads to pass through the lysis chamber 11a, the washing chamber 11b and enter the elution chamber 11c in sequence. The magnetic beads are adsorbed by the magnetic body 16 so as to drive the magnetic beads to transfer between the lysis chamber 11a, the washing chamber 11b and the elution chamber 11c. At the same time, by setting up the magnetic body 16, and because the volume of the magnetic beads is small and the volume of the magnetic body 16 is larger than the magnetic beads, by observing the position of the magnetic body 16, it is convenient to judge whether the magnetic beads have moved to the set location.

[0055] It should be understood that the magnetic body 16 can be various types of permanent magnetic bodies or electromagnetic bodies, such as Figure 5 As shown, in one embodiment, the magnetic body 16 is a spherical permanent magnetic body.

[0056] It should be understood that the lysis chamber 11a, the washing chamber 11b and the elution chamber 11c can be arranged in a matrix or in a linear arrangement. Figure 3 , 4 As shown in Figure 5, in one embodiment, the lysis chamber 11a, the washing chamber 11b and the elution chamber 11c are arranged linearly along the first direction, and the side walls of at least part of the lysis chamber 11a, the washing chamber 11b and the elution chamber 11c on both sides along the first direction and the inner walls of the chamber in other directions are smoothly transitioned through arc surfaces.

[0057] In the present embodiment, the lysis chamber 11a, the washing chamber 11b and the elution chamber 11c are arranged linearly along the first direction, so that the side walls of the lysis chamber 11a, the washing chamber 11b and the elution chamber 11c on both sides along the first direction are close to the outer wall of the fixed part 11, so as to avoid the overlap of the chambers along the perpendicular first direction; in order to stir the liquid in the chamber so that the magnetic beads can fully adsorb the nucleic acid, fully wash the nucleic acid, and fully elute the nucleic acid, for this purpose, in the present embodiment, a first magnetic field is first set outside the fixed part 11 along one side of the first direction. At this time, the first magnetic field is magnetically adsorbed with the magnetic absorber 16 and the magnetic beads, so that the magnetic absorber 16 and the magnetic beads move to abut against the inner wall of one side of the chamber, and then a second magnetic field is set along the other side of the first direction to control the first magnetic field to move along the direction perpendicular to the first direction. Move in the second direction perpendicular to the cavity, the first magnetic field drives the magnetic body 16 and the magnetic beads to move in the first direction until the magnetic body 16 and the magnetic beads move to the edge of the inner wall on one side of the cavity. At this time, restricted by the inner wall of the cavity, the magnetic body 16 and the magnetic beads cannot move in the first direction. When the first magnetic field moves to a sufficiently far distance so that the magnetic force applied to the magnetic body 16 and the magnetic beads by the first magnetic field disappears, the magnetic body 16 and the magnetic beads are adsorbed to the inner wall on the other side of the cavity under the magnetic adsorption of the second magnetic field. In addition, during the movement of the magnetic body 16 and the magnetic beads, the magnetic body 16 drives the magnetic beads to hit the smooth surface of the cavity and slide along the arc surface, so that the magnetic body 16 and the magnetic beads move in an arc shape in the cavity. Repeating the above steps can stir the solution in the cavity.

[0058] The first direction may be any direction. In one embodiment, the first direction is the length direction of the fixing portion 11 .

[0059] It should be understood that the first magnetic field and the second magnetic field may be formed by permanent magnets or electromagnetic magnets. In one embodiment, the first magnetic field and the second magnetic field are two magnetic elements 3 disposed on both sides of the first direction of the fixing portion 11 .

[0060] The movement of the first magnetic field and the second magnetic field can be manual movement or the movement of the first magnetic field and the second magnetic field can be controlled by a mobile device; two permanent magnetic bodies can be set on the side walls on both sides of the fixed part 11 along the first direction to control the formation of the magnetic field, and the magnetic field can be moved by controlling the movement of the permanent magnetic bodies.

[0061] It should be understood that the opening and closing of the nucleic acid flow channel 1a can be performed by a valve or by other means, such as Figure 3As shown, in one embodiment, the nucleic acid flow channel 1a has a sealed cavity 1a1, and the purification mechanism 1 includes a sealing portion 17 and an elution plug 18. The sealing portion 17 is built into the sealed cavity 1a1 and seals with the inner wall of the sealed cavity 1a1 to close the nucleic acid flow channel 1a; the elution plug 18 is slidably disposed in the sealed cavity 1a1, and the elution plug 18 is used to push the sealing portion 17 out of the sealed cavity 1a1 through the fluid in the elution cavity 11c to open the nucleic acid flow channel 1a. The sealing portion 17 can be a silica gel ball, a rubber ball, a rubber block, etc.

[0062] In this embodiment, during the purification of nucleic acid, the elution plug 18 does not move. When the magnetic body 16 drives the magnetic beads to move to the elution chamber 11c and elutes, the flow of nucleic acid needs to be opened to allow the eluted nucleic acid in the elution chamber 11c to enter the nucleic acid flow channel 1a and enter the detection chamber 2a through the nucleic acid flow channel 1a. At this time, the elution plug 18 is drawn, and the elution plug 18 gradually closes the connection between the elution chamber 11c and the connecting channel 11e, and continues to slide the elution plug 18. At this time, the elution plug 18 pressurizes the flow in the elution chamber 11c, and the pressurized flow pushes the sealing part 17 in the sealing chamber 1a1 to slide, so that the sealing part 17 is separated from the sealing chamber 1a1. At this time, the nucleic acid flow channel 1a is opened, and the fluid in the elution chamber 11c can flow through the nucleic acid flow channel 1a and enter each detection chamber 2a.

[0063] It should be understood that, in order to seal and open the liquid inlet channel 111e, in one embodiment, the liquid inlet channel 111e also has a sealing cavity 1a1, and a sealing portion 17 that can be engaged and disengaged is also provided in the sealing cavity 1a1.

[0064] It should be understood that in the present application, the purification mechanism 1 and the fixing part 11 can be an integrally formed structure or can be formed by combining and splicing multiple components. During the splicing process, welding, bonding, bolts, screws and snaps can be used.

[0065] Specifically, Figure 3 , 4, 5, in one embodiment, the fixing portion 11 includes a first shell 111, a second shell 112 and a third shell 113 connected in sequence, the first shell 111 is formed with a first through hole 111a, the second shell 112 is provided with a first fixing hole 112a relative to the first through hole 111a, the first fixing hole 112a and the first through hole 111a are combined to form an elution chamber 11c, the second shell 112 is further formed with a lysis chamber 11a, at least one washing chamber 11b, an installation chamber 11f, a connecting channel 11e and a sealing chamber 1a1, a transfer channel 11d is formed between the second shell 112 and the first shell 111, and the lysis chamber 11a, the washing chamber 11b and the connecting channel 11e are connected to each other. b. The installation cavity 11f opens toward one side of the first shell 111 and is connected with the transfer channel 11d through the opening. The sealing cavity 1a1 is connected with the first fixing hole 112a and is arranged on the side of the first fixing hole 112a away from the first shell 111. One end of the connecting channel 11e is connected with the transfer channel 11d, and the other end is connected with the first fixing hole 112a. The third shell 113 and the second shell 112 are combined to form a connecting groove 1a2. The third shell 113 is formed with a connecting hole 1a3 connected with the connecting groove 1a2 and the detection chamber 2a. The sealing cavity 1a1, the connecting groove 1a2 and the connecting hole 1a3 are connected and combined to form the nucleic acid flow channel 1a.

[0066] During operation, the extracted sample is passed into the lysis chamber 11a, the magnetic beads are passed into the lysis chamber 11a, the cleaved nucleic acid is adsorbed by the magnetic beads, and then the magnetic beads are driven by the magnetic absorption body 16 to pass through the lysis chamber 11a, the transfer channel 11d, the washing chamber 11b, the transfer channel 11d, the connecting channel 11e and the elution chamber 11c in sequence, and enter the sealed chamber 1a1 through the elution chamber 11c, and enter the connecting groove 1a2 under the push of the elution plug 18, and enter the connecting hole 1a3 through the connecting groove 1a2, and finally enter the detection chamber 2a.

[0067] like Figure 3 As shown, a relatively large chamber is provided at the connection point between the connecting groove 1a2 and the sealing cavity 1a1, and the chamber accommodates the squeezed sealing portion 17, so that there is a space between the third shell 113 and the second shell 112 to accommodate the sealing portion 17 after the seal is released, and the liquid can flow through the squeezed sealing portion 17.

[0068] Since the first fixing hole 112a and the first through hole 111a are combined to form the elution chamber 11c, the inner wall of the first through hole 111a blocks the transfer channel 11d from being directly connected to the first fixing hole 112a, so that the magnetic body 16 cannot drive the magnetic beads into the first fixing hole 112a. Figure 3 and Figure 5As shown, in one embodiment, the end surface of the top inner wall of the connecting channel 11e is flush with the end surface of the top inner wall of the washing chamber 11b, the connecting channel 11e is arc-shaped, and the connecting point with the first fixing hole 112a is located on the peripheral wall of the first fixing hole 112a.

[0069] In this embodiment, by setting the connecting channel 11e in an arc shape and setting it on the surrounding wall of the first fixed hole 112a at the connecting point between the connecting channel 11e and the first fixed hole 112a, when the magnetic absorption body 16 drives the magnetic beads to move in the transfer channel 11d, it can enter the connecting channel 11e from the transfer channel 11d, slide in an arc shape in the connecting channel 11e, and slide into the second fixed hole 112b, thereby realizing the transfer of nucleic acid to the elution chamber 11c.

[0070] In order to achieve the sample into the lysis chamber 11a, for this purpose, as Figure 3 , 4 , 11 In one embodiment, the first shell 111 is provided with a second through hole 111b, and the second shell 112 is provided with a second fixing hole 112b opposite to the second through hole 111b. A puncture portion 114 is formed in the second fixing hole 112b, and is combined with the second through hole 111b to form a sampling cavity. The second shell 112 is also provided with a liquid inlet channel 111e connected to the lysis chamber 11a on the side away from the first shell 111, and the connection point between the liquid inlet channel 111e and the lysis chamber 11a is higher than the bottom inner wall of the lysis chamber 11a. The purification mechanism 1 also includes a sampling part 19, and the sampling part 19 includes a sample tube 191, a sampling plug 192 and a closing plug 193. The sample tube 191 is slidably inserted in the sampling cavity, the sampling plug 192 cooperates and is slidably inserted in the sample tube 191, and the closing plug 193 cooperates and is inserted in the second through hole 111b, and is used to close the open end of the sampling cavity.

[0071] The sampled sample is stored in the sample tube 191, and a preservation solution is set in the sample tube 191. The preservation solution can play a preservative role to prevent tissue samples, blood, saliva, etc. from deteriorating. When the sample in the sample tube 191 needs to be sent to the lysis chamber 11a, the closing plug 193 is opened, the sample tube 191 is inserted into the sampling chamber, and the bottom of the sample tube 191 is made to abut the puncture part 114. The bottom of the sample tube 191 is opened under the puncture of the puncture part 114, and then the sampling plug 192 is slid. The sampling plug 192 presses the sample in the sample tube 191 into the sampling chamber, and the sample enters the lysis chamber 11a through the liquid inlet channel 111e at the bottom of the sampling chamber, and then the opening of the sampling chamber is closed by the closing plug 193; since the connection between the liquid inlet channel 111e and the lysis chamber 11a is higher than the bottom inner wall of the lysis chamber 11a, the magnetic beads can be prevented from entering the liquid inlet channel 111e. The sampling plug 192 can slide manually or relative to the sample tube 191 driven by a motor rod. The liquid in the sample tube 191 breaks open the elastic sealing portion 17 at the bottom and enters the lysis chamber 11a through the flow channel at the bottom.

[0072] In order to store magnetic beads and magnetic body 16, in one embodiment, the second shell 112 is further provided with a first storage hole 112c and a second storage hole 112d, the first storage hole 112c and the second storage hole 112d are open to one side of the first shell 111, and the opening is connected with the transfer channel 11d, the top end surfaces of the first storage hole 112c, the second storage hole 112d, the lysis chamber 11a, the washing chamber 11b and the connecting channel 11e are flush, the sealing layer 14 is arranged at the top of the first storage hole 112c, the second storage hole 112d, the lysis chamber 11a, the washing chamber 11b, the connecting channel 11e and the sealing chamber 1a1, the connecting channel 11e, the magnetic beads are arranged in the first storage hole 112c, and the magnetic body 16 is arranged in the second storage hole 112d.

[0073] In this embodiment, by setting the first storage hole 112c and the second storage hole 112d, the first storage hole 112c and the second storage hole 112d can store the magnetic beads and the magnetic body 16 respectively, so that the product can be fixed to the first storage hole 112c and the second storage hole 112d respectively before use, so as to avoid the magnetic beads and the magnetic body 16 being scattered between the first shell 111 and the second shell 112; by making the top end surfaces of the first storage hole 112c, the second storage hole 112d, the lysis chamber 11a, the washing chamber 11b and the connecting channel 11e flush, so that the sealing layer 14 adheres to the top end surfaces of the first storage hole 112c, the second storage hole 112d, the lysis chamber 11a, the washing chamber 11b and the connecting channel 11e, the top end surfaces of the first storage hole 112c, the second storage hole 112d, the lysis chamber 11a, the washing chamber 11b and the connecting channel 11e can be sealed.

[0074] In order to achieve the sealing between the purification mechanism 1 and the detection reagent mechanism 2, for this purpose, as Figure 8 and Fig.10 As shown, in one embodiment, the plug-in portion 12 includes a fixing ring 121, a plug-in block 122 and a plug-in strip 123, the fixing ring 121 is connected to the side of the third shell 113 facing away from the second shell 112, one end of the plug-in block 122 is connected to the third shell 113 and passes through the fixing ring 121, the connecting hole 1a3 passes through the plug-in block 122, the plug-in strip 123 is connected to the plug-in block 122 and is arranged on the side of the plug-in block 122 facing away from the third shell 113; the detection reagent mechanism 2 includes a fourth shell 21 and a detection shell 22 connected to the fourth shell 21, the detection shell 22 is connected to the fourth shell 21, the outer diameter of the detection shell 22 is matched with the inner diameter of the fixing ring 121, the detection shell 22 is formed with a detection cavity 2a, the top of the detection cavity 2a is open, the detection cavity 2a can be inserted with the plug-in block 122 and the plug-in strip 123, and the plug-in strip 123 is provided with a paraffin layer 13.

[0075] In this embodiment, in order to achieve the seal between the detection reagent mechanism 2 and the purification mechanism 1, the detection shell 22 is matched with the fixing ring 121, and the sealed connection between the two is achieved through the sealing cooperation between the detection shell 22 and the fixing ring 121. The detection cavity 2a is used to store reagents, and at the same time, it can be inserted from the plug-in block 122 and the plug-in strip 123.

[0076] It should be understood that the detection shell 22 and the plug-in part 12 can be one, two or more, etc. Specifically, the detection shell 22 and the plug-in part 12 are both multiple, and the multiple detection shells 22 are spaced apart along the length direction of the fourth shell 21. The plug-in part 12 and the detection shell 22 are arranged in a one-to-one correspondence, and the connecting holes 1a3 in the plug-in blocks 122 in the multiple plug-in parts 12 are all connected to the connecting grooves 1a2.

[0077] Among them, multiple plug-in parts 12 and detection shells 22 only need the central axes to be parallel to each other. The rotation angle of the plug-in parts 12 and the detection shell 22 along the central axis can be set as needed, which can be 90°, 180°, etc. It should be understood that the outer contour of the detection shell 22 can be a flat tube, or it can be flat, conical, cylindrical or other polygonal shapes.

[0078] In the fully enclosed nucleic acid extraction and detection device described in the present invention, the nucleic acid is sealed in the device during the detection process, which can prevent the nucleic acid from leaking outward and causing nucleic acid contamination of other samples and interference with other detections. Nucleic acid detection does not need to be performed in a standard molecular diagnostic laboratory, and can be fully enclosed and integrated. The nucleic acid extraction and amplification process can be shortened, the impact of human factors can be reduced, and the safety and effectiveness of nucleic acid sample preparation can be enhanced.

[0079] In the description of the present invention, it should be understood that the terms "center", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship are based on the orientation or position relationship shown in the drawings, and are 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 on the present invention.

[0080] The terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0081] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" 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 direct connection, or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific conditions.

[0082] In the description of this specification, specific features, structures, materials or characteristics may be combined in an appropriate manner in any one or more embodiments or examples.

[0083] The specific implementation of the present invention described above does not constitute a limitation on the protection scope of the present invention. Any other corresponding changes and modifications made based on the technical concept of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. A fully enclosed nucleic acid extraction and detection device, characterized in that: The invention comprises a purification mechanism (1), wherein the purification mechanism (1) comprises: A fixed portion (11) having a lysis chamber (11a), at least one washing chamber (11b), an elution chamber (11c) and a transfer channel (11d) formed therein, wherein the transfer channel (11d) is connected to the lysis chamber (11a), the washing chamber (11b) and the elution chamber (11c); Magnetic beads, built into the fixing portion (11); and A magnetic body (16) is built into the fixed portion (11) and is capable of magnetically adsorbing the magnetic beads; the magnetic body (16) is capable of driving the magnetic beads to transfer between the transfer channel (11d), the lysis chamber (11a), the washing chamber (11b), and the elution chamber (11c); and the volume of the magnetic body (16) is larger than that of the magnetic beads.

2. The fully enclosed nucleic acid extraction and detection device according to claim 1, characterized in that: It also comprises at least two magnetic attracting members (3), wherein the magnetic attracting members (3) are arranged outside the fixing portion (11) and are magnetically connected to the magnetic attracting body (16).

3. The fully enclosed nucleic acid extraction and detection device according to claim 1, characterized in that: The fixing portion (11) is also formed with a nucleic acid flow channel (1a); The fully enclosed nucleic acid extraction and detection device further comprises a detection reagent mechanism (2), wherein the detection reagent mechanism (2) is detachably connected to the fixing portion (11) and forms a detection cavity (2a) for accommodating the detection reagent, and one end of the detection cavity (2a) is open; When the detection reagent mechanism (2) is connected to the fixing portion (11), the detection chamber (2a) is connected to the nucleic acid flow channel (1a), and the purification mechanism (1) is capable of blocking the opening of the detection chamber (2a).

4. The fully enclosed nucleic acid extraction and detection device according to claim 3, characterized in that: The purification mechanism (1) and the detection reagent mechanism (2) are detachably connected by a plug-in structure, and the plug-in structure is capable of sealing the opening of the detection chamber (2a); when the purification mechanism (1) and the detection reagent mechanism (2) are plugged in, the plug-in structure is at least partially inserted into the detection chamber (2a) and pressurizes the detection chamber (2a).

5. The fully enclosed nucleic acid extraction and detection device according to claim 3, characterized in that: The purification mechanism (1) further comprises: A plug-in portion (12) connected to the fixing portion (11); and A paraffin layer (13) connected to the plug-in portion (12); When the detection reagent mechanism (2) is connected to the purification mechanism (1), the plug-in portion (12) and the paraffin layer (13) are inserted into the detection cavity (2a).

6. The fully enclosed nucleic acid extraction and detection device according to claim 1, characterized in that: The purification mechanism (1) further comprises: A sealing layer (14) is arranged in the transfer channel (11d) and is detachably connected to the fixing portion (11); when the sealing layer (14) is connected to the fixing portion (11), it blocks the connection between the lysis chamber (11a), the washing chamber (11b) and the transfer channel (11d).

7. The fully enclosed nucleic acid extraction and detection device according to claim 6, characterized in that: The fixing portion (11) is formed with a mounting cavity (11f) which is in communication with the transfer channel (11d); The purification mechanism (1) further comprises: A winding portion (15) is rotatably disposed in the installation cavity (11f) and connected to the sealing layer (14), and is used to wind the sealing layer (14) to release the blockage of the connection between the lysis cavity (11a), the washing cavity (11b) and the elution cavity (11c) and the transfer channel (11d).

8. The fully enclosed nucleic acid extraction and detection device according to claim 7, characterized in that: A window (14a) is provided in the middle of the sealing layer (14); the dimensions of the two ends of the sealing layer (14) are at least partially smaller than the dimensions of the window (14a); and the two ends of the sealing layer (14) pass through the window (14a) and are both connected to the winding portion (15).

9. The fully enclosed nucleic acid extraction and detection device according to claim 1, characterized in that: The lysis chamber (11a), the washing chamber (11b) and the elution chamber (11c) are arranged linearly along a first direction, and the side walls of at least part of the chambers in the lysis chamber (11a), the washing chamber (11b) and the elution chamber (11c) on both sides along the first direction and the inner walls of the chambers in other directions are smoothly transitioned through arc surfaces.

10. The fully enclosed nucleic acid extraction and detection device according to claim 3, characterized in that: The nucleic acid flow channel (1a) has a sealed cavity (1a1) therein; The purification mechanism (1) comprises: A sealing portion (17), the sealing portion (17) being built into the sealing cavity (1a1) and sealingly cooperating with the inner wall of the sealing cavity (1a1) to close the nucleic acid flow channel (1a); and An elution plug (18), the elution plug (18) being slidably disposed in the sealing cavity (1a1), the elution plug (18) being used to push the sealing portion (17) out of the sealing cavity (1a1) via the fluid in the elution cavity (11c) to open the nucleic acid flow channel (1a).

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