WO2023197459A1 - 试剂卡盒、检测装置及检测方法 - Google Patents

试剂卡盒、检测装置及检测方法 Download PDF

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Publication number
WO2023197459A1
WO2023197459A1 PCT/CN2022/102410 CN2022102410W WO2023197459A1 WO 2023197459 A1 WO2023197459 A1 WO 2023197459A1 CN 2022102410 W CN2022102410 W CN 2022102410W WO 2023197459 A1 WO2023197459 A1 WO 2023197459A1
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WO
WIPO (PCT)
Prior art keywords
reagent cartridge
flow channel
fitting
chamber
magnetic rod
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Application number
PCT/CN2022/102410
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English (en)
French (fr)
Inventor
黄超杰
黄宏坤
Original Assignee
广东润鹏生物技术有限公司
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Publication of WO2023197459A1 publication Critical patent/WO2023197459A1/zh

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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6844—Nucleic acid amplification reactions
    • C12Q1/686—Polymerase chain reaction [PCR]
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L9/00—Supporting devices; Holding devices

Definitions

  • the present application relates to the technical field of nucleic acid detection, and in particular to a reagent cartridge, a detection device and a detection method.
  • the traditional molecular detection steps mainly include nucleic acid extraction, reagent packaging, and qPCR instrument installation. testing and result analysis.
  • the purpose of this application is to provide a reagent cartridge, a detection device and a detection method to at least solve the problem of easy contamination in the current nucleic acid detection process.
  • a reagent cartridge provided by some embodiments of the present application may include a box assembly, and the box assembly may be formed with a plurality of accommodation compartments, and the hatch of at least one accommodation compartment in the plurality of accommodation compartments may be provided with a A sealing layer, the plurality of accommodation chambers may include an eluent chamber, and a communication portion may be formed at the bottom of the eluent chamber; a tube member, the tube member may be connected to the box assembly; the first flow Channel, the first flow channel can be conducted from the communication part to the pipe member; a switching component, the switching component can be provided on the first flow channel, when the switching component is in the first position , the first flow channel is turned on, and when the on-off component is in the second position, the first flow channel is closed.
  • the box assembly may include a box body and a connection module, a plurality of the accommodation chambers may be formed on the box body, and the connection module may be close to the eluent chamber of the box body. is connected to one end of , a piston cavity may be formed on the connection module, and one end of the second flow channel away from the pipe member may be connected to the piston cavity, and there may be a device in the piston cavity that can be positioned relative to the piston cavity. Moving moving parts.
  • the diameter of the first flow channel may be 1 mm to 2 mm.
  • the reagent cartridge provided by this application may also include a magnetic rod cover assembly, and the magnetic rod cover assembly may be placed in one of the plurality of holding chambers.
  • the plurality of holding cabins may be a magnetic rod housing cabin, a sample cabin, a magnetic bead storage liquid tank, and a washing liquid tank group.
  • the magnetic rod housing cabin, the sample cabin, the magnetic bead storage liquid tank, and the The washing liquid tank group and the eluent tank may be arranged in sequence from an end of the box body away from the connection module to an end of the box body close to the connection module.
  • the washing liquid tank group may include at least a first washing liquid tank, a second washing liquid tank and a spare tank, and the first washing liquid tank may be located close to the magnetic bead storage tank, and the second washing liquid tank may be disposed close to the magnetic bead storage tank.
  • the washing liquid tank and the backup tank may be arranged sequentially in a direction away from the first washing liquid tank.
  • the box body may be formed with at least two parallel-arranged magnetic rod chambers, at least two parallel-arranged sample chambers, at least two parallel-arranged magnetic bead storage liquid chambers, There are at least two rows of the washing liquid tank groups arranged in parallel and at least two of the eluent tank groups arranged in parallel.
  • At least two first flow channels, at least two piston cavities, and at least two second flow channels may be formed in the connection module, and at least two pipe members are connected to the connection module.
  • the on-off component can be movably connected with the connection module; the on-off component can separate the first flow channel into a first flow section and a second flow section, and the on-off component can be formed with Butt hole; when the on-off component moves relative to the connection module to make the butt hole relative to the port of the first flow section and the port of the second flow section, the first flow section and the second flow section Segment phase conduction.
  • connection module is formed with a positioning part corresponding to the position of the pipe member, and the pipe opening of the pipe member can be sleeved on the positioning part;
  • a first flow guide tube and a second flow guide pipe may be formed on the positioning part, the first flow channel may be formed in the first flow guide pipe, and the second flow channel may be formed in the second guide pipe. inside the flow tube.
  • the reagent cartridge provided by the present application may also include a sliding cover, which may be slidably connected to the box body, and the sliding cover may cover multiple accommodation compartments along the length direction of the box body. hatch.
  • the sliding cover may be formed with an alignment part, a first through hole, and a second through hole, and the alignment part, the first through hole, and the second through hole may be formed along the length direction of the slide cover by One end of the sliding cover is arranged sequentially toward the other end, and the distance from the second through hole to the end of the sliding cover away from the second through hole is not less than the distance from the sample compartment to the box body away from the sample. distance from one end of the cabin.
  • a first fitting part may be formed on the box body, the first fitting part may extend along the length direction of the box body, and a third fitting part may be formed on the sliding cover corresponding to the position of the first fitting part.
  • Two fitting parts, the first fitting part can match with the second fitting part, so that the sliding cover can slide relative to the box body.
  • one end of the box body may be formed with a mating convex part
  • the connection module may be formed with a mating recessed part at a position corresponding to the mating convex part; two sides of the mating convex part that are in contact with the mating recessed part
  • a third fitting part and a fourth fitting part may be respectively formed on the wall, and a fifth fitting part fitting with the third fitting part may be formed at a position of the fitting recess corresponding to the third fitting part, corresponding to the A sixth fitting part that matches the fourth fitting part is formed at the position of the fourth fitting part.
  • the third fitting part and the fourth fitting part may both be fitting buckles, and the fifth fitting part and the sixth fitting part may both be fitting slots.
  • a first sealing gasket may be provided between the mating convex part and the mating recessed part, the eluent chamber may be formed in the mating convex part, and one end of the first flow channel may penetrate the Matching the recess; the first sealing gasket may have a conductive part formed at a position corresponding to the communication part, and one end of the conductive part is connected to the communication part, and the other end is connected to the first flow channel.
  • the magnetic rod cover assembly may include a casing main body, a fixed section, side wings and an anti-lost magnetic coil;
  • the fixed section may be connected to one end of the casing main body, and the fixed section may be formed with a A through hole, the casing main body may be formed with a receiving groove, the through hole may be connected with the receiving groove, and the other end of the casing main body may be formed with a puncture tip;
  • the side wings may be formed along the casing The length direction of the main body extends and is disposed on the outer wall surface of the cannula main body;
  • the anti-lost magnetic coil can be disposed on an end of the cannula main body away from the fixed section, and forms an accommodating position with the puncture tip. concavity.
  • the movable part may include a fixed part, a movable part and a ring part; the fixed part may be rotatably connected with the open end of the piston chamber, and one end of the movable part may be rotatably connected with the fixed part,
  • the ring sleeve part can be sleeved on the other end of the movable part, and the outer wall of the ring sleeve part can be in contact with the inner wall of the piston cavity; when the fixed part rotates relative to the piston cavity, the The movable part can move along the axial direction of the piston cavity to drive the ring sleeve part to move relative to the piston cavity.
  • the reagent cartridge provided by this application has at least the following advantages:
  • the reagent cartridge provided by this application includes a box assembly.
  • the box assembly is formed with multiple accommodation compartments. At least one hatch of the multiple accommodation compartments is provided with a sealing layer.
  • the multiple accommodation compartments include an eluent compartment.
  • a connecting part is formed at the bottom of the deliquidating chamber; a pipe member is connected to the box assembly; a first flow channel is conducted from the connecting part to the pipe member; an on-off component is provided on the first flow channel , when the on-off component is in the first position, the first flow channel is turned on, and when the on-off component is in the second position, the first flow channel is closed.
  • the multiple holding compartments formed on the box body can carry the solvents required for nucleic acid detection such as the sample to be tested, the lysis binding solution, the magnetic bead storage solution, the washing solution, and the eluent.
  • the sealing film covered by the hatch of the holding chamber can seal and protect the various solvents in the holding chamber.
  • the reagent cartridge provided in this application is a disposable product, when the corresponding holding chamber needs to be used, , puncture the sealing film and it can be used.
  • the reagent cartridge also includes an on-off component located between the box component and the tube component, so that the first flow channel can be controlled on and off through the on-off component.
  • the on-off component moves to the first position, thereby allowing the first flow channel to be connected, and the reagents in the eluent compartment to enter the pipe member.
  • the on-off component moves to the second position, thereby disconnecting the first flow channel and blocking the reagent from entering the tube component.
  • the reagent cartridge provided by this application has a simple structure, is easy to operate, and can quickly complete the detection of samples. Correspondingly, it can improve detection efficiency and reduce the manufacturing cost of the overall structure.
  • a detection device which may include a detection module, a pipette, and the reagent cartridge described in the above embodiments; the pipette injects the sample solvent to be tested into the In one of the accommodation compartments of the reagent cartridge, the reagent cartridge is connected to the detection module, and the detection module can detect the solvent of the sample to be tested in the accommodation compartment. Perform testing.
  • the solvent of the sample to be detected is injected into the sample compartment of the reagent cartridge through a pipette, and then the reagent cartridge carrying the solvent of the sample to be detected is installed on the detection module, so that the detection module can Test the sample solvent for testing.
  • the detection module may include a detection module body, a magnetic rod, a moving mechanism, a first pusher, a second pusher, a rotating component and other structures.
  • the detection module body can carry a reagent cartridge, and the magnetic rod can be inserted into the magnetic rod.
  • the moving mechanism can grab and move the magnetic rod set assembly.
  • the first pushing member can push the sliding cover to slide relative to the box body, and the second pushing member can push the sliding cover to slide relative to the box body.
  • the pusher can push the on-off component in the connection module to move relative to the connection module to realize on-off of the first flow channel, so that the sample can be detected quickly and safely through the structure included in the detection module.
  • the detection method may include the following steps: the detection device receives a reagent cartridge, a sample is injected into the sample compartment of the reagent cartridge, and the hatch of the sample compartment is provided with Sealing layer; the detection device takes out the magnetic rod cover assembly from the reagent cartridge, extends the magnetic rod of the detection device into the magnetic rod cover assembly, and then sequentially enters the magnetic bead storage of the reagent cartridge.
  • the detection device pushes the on-off component of the reagent cartridge to conduct the first flow channel, and the first flow channel is connected to the eluent liquid tank and the pipe member; the detection device drives the piston assembly on the reagent cartridge that communicates with the pipe member to form a negative pressure in the pipe member, so that the solvent in the eluent chamber enters through the first flow channel In the tube component, the solvent reconstitutes the freeze-dried amplification reagent in the tube component; the detection device detects and analyzes the reagents in the tube component.
  • the detection method provided by the above embodiments of the present application may also include the detection device controlling the movement of the sliding cover slidingly connected with the reagent cartridge to sequentially close the magnetic rod cover after the magnetic rod cover assembly leaves.
  • the detection device controlling the movement of the sliding cover slidingly connected with the reagent cartridge to sequentially close the magnetic rod cover after the magnetic rod cover assembly leaves.
  • Figure 1 is a schematic diagram of the overall structure of the reagent cartridge provided by the embodiment of the present application.
  • Figure 2 is an exploded schematic diagram of the reagent cartridge provided by the embodiment of the present application.
  • Figure 3 is a cross-sectional view of the reagent cartridge provided by the embodiment of the present application.
  • Figure 4 is a schematic structural diagram of the box body in the reagent cartridge provided by the embodiment of the present application from a first perspective;
  • Figure 5 is a schematic structural diagram of the box body in the reagent cartridge provided by the embodiment of the present application from a second perspective;
  • Figure 6 is a schematic structural diagram of the sliding cover in the reagent cartridge provided by the embodiment of the present application from a first perspective;
  • Figure 7 is a schematic structural diagram of the sliding cover in the reagent cartridge provided by the embodiment of the present application from a third perspective;
  • Figure 8 is a schematic structural diagram of the magnetic rod cover assembly in the reagent cartridge provided by the embodiment of the present application.
  • Figure 9 is a schematic structural diagram of the magnetic rod set assembly in the reagent cartridge provided by the embodiment of the present application from a second perspective;
  • Figure 10 is a schematic structural diagram of the front end of the magnetic rod cover assembly in the reagent cartridge provided by the embodiment of the present application;
  • Figure 11 is a schematic structural diagram of the connection module in the reagent cartridge provided by the embodiment of the present application.
  • Figure 12 is a schematic diagram of the internal structure of the connection module in the reagent cartridge provided by the embodiment of the present application.
  • Figure 13 is a cross-sectional view of the connection module in the reagent cartridge provided by the embodiment of the present application.
  • Figure 14 is a schematic structural diagram of the movable parts in the reagent cartridge provided by the embodiment of the present application.
  • Figure 15 is a cross-sectional view of the movable parts in the reagent cartridge provided by the embodiment of the present application.
  • Figure 16 is a flow chart of the detection method provided by the embodiment of the present application.
  • Figure 17 is an amplification cycle diagram provided by the embodiment of the present application.
  • connection should be understood in a broad sense.
  • connection or integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be an internal connection between two components.
  • connection or integral connection
  • connection or integral connection
  • connection can be a mechanical connection or an electrical connection
  • it can be a direct connection or an indirect connection through an intermediate medium
  • it can be an internal connection between two components.
  • specific meanings of the above terms in this application can be understood on a case-by-case basis.
  • this application provides a reagent cartridge, which includes a box assembly and a tube component;
  • the box assembly includes a box body 1 and a connection module 4, and the tube component in this application is an amplification tube 6;
  • the connection module 4 is connected to one end of the box body 1, and the amplification tube 6 is connected to the connection module 4;
  • multiple accommodation cabins are formed on the box body 1, and the hatches of the multiple accommodation cabins are provided with sealing layers, and the sealing layers are made by heat
  • An aluminum sealing film is melted to cover the hatch of the holding chamber.
  • the holding chamber close to the connection module 4 is the eluent chamber 107.
  • a connecting portion 1093 is formed at the bottom of the eluent chamber 107.
  • the connecting module 4 corresponds to the position of the connecting portion 1093.
  • a first flow channel 401 is formed, and one end of the first flow channel 401 is connected to the communication part 1093, and the other end extends into the amplification tube 6; a second flow channel 403 and a piston cavity 404 are formed on the connection module 4.
  • the piston cavity There is a movable component 5 inside 404.
  • One end of the second flow channel 403 is connected to the piston chamber 404, and the other end is connected to the amplification tube 6.
  • the reagent cartridge provided by this application has at least the following advantages:
  • the reagent cartridge provided by this application can, through multiple holding compartments formed on the box body 1, be used to carry out the testing of samples, lysis binding solution, magnetic bead storage solution, washing solution, eluent and other solvents required for nucleic acid detection. carry.
  • the sealing film covered by the hatch of the holding chamber can seal and protect the various solvents in the holding chamber.
  • the reagent cartridge provided in this application is a disposable product, when the corresponding holding chamber needs to be used, , the sealing film can be punctured before use. Therefore, in this embodiment, it can only be ensured that before the sealing film is punctured, the solvent in the holding chamber will not be polluted by the external environment, and aerosol transmission will not occur.
  • the reagent cartridge also includes a connection module 4 connected to the box body 1, and a first flow channel 401 connected to the eluent chamber 107 is formed on the connection module 4, and the other end of the first flow channel 401 extends into the expansion chamber.
  • the connection module 4 is also formed with a second flow channel 403 extending into the amplification tube 6 and a piston cavity 404 connected with the second flow channel 403, so that through the movement of the movable part 5 relative to the piston cavity 404, The gas in the amplification tube 6 can be extracted to generate a negative pressure in the amplification tube 6 , and then the solvent in the eluent chamber 107 can be sucked into the amplification tube 6 through the first flow channel 401 .
  • the sealing film When using the reagent cartridge provided by this application before and during testing, when the sealing film is not punctured, the unused solvents and uncollected samples in the holding chamber will not come into contact with the external environment. Therefore, it can To a certain extent, it can avoid contamination from the external environment and improve detection accuracy.
  • the PCR amplification tube 6 in this application can be a conventional PCR tube or a customized PCR tube.
  • the amplification tube 6 is filled with amplification reagents.
  • the nucleic acid amplification detection reagent includes components such as reverse transcriptase, hot-start Taq enzyme, dNTPs, primers and probes, and is directly formed at the bottom of the PCR amplification tube 6 by freeze-drying.
  • the reagents contained in the accommodation compartment of the box body 1 mainly include cleavage binding solution, first washing solution, second washing solution, magnetic beads, eluent, proteinase K, etc. Therefore, accordingly, in this application, a plurality of reagents are accommodated.
  • the cabins are the magnetic rod cover cabin 101, the sample cabin 102, the magnetic bead storage liquid tank 103, the first washing liquid tank 104, the second washing liquid tank 105 and the spare cabin 106, and the magnetic rod cover cabin 101, the sample cabin 102, the magnetic beads
  • the storage liquid tank 103, the first washing liquid tank 104, the second washing liquid tank 105, the spare tank 106 and the eluent tank 107 are arranged in sequence from one end of the box body 1 away from the connection module 4 to the other end.
  • the magnetic rod cover cabin 101 is used to carry the magnetic rod cover assembly 3, the sample cabin 102 is used to hold the sample solvent, and the magnetic bead preservation liquid compartment 103 is used to hold the magnetic bead preservation liquid, and the magnetic bead preservation liquid contains magnetic beads.
  • a washing liquid tank 104 and a second washing liquid tank 105 are used to accommodate the first washing liquid and the second washing liquid respectively.
  • the spare tank 106 is also used to hold the washing liquid, and the eluent tank 107 is used to hold the eluent.
  • the sample solvent is first injected into the sample cabin 102, and the hatch of the sample cabin 102 is sealed again.
  • the reagent cartridge is then installed in the detection module for detection.
  • the detection module pulls the magnetic rod cover assembly 3 out of the magnetic rod cover assembly 101, and moves the magnetic rod cover assembly 3 above the magnetic bead storage tank 103. After the magnetic rod of the detection module is inserted into the magnetic rod cover assembly 3, The magnetic rod cover assembly 3 penetrates the sealing film of the magnetic bead storage tank 103 and enters the tank to absorb the magnetic beads.
  • the washing liquid tank group includes a first washing liquid tank 104 , a second washing liquid tank 105 and a spare tank 106 . Therefore, after adsorbing the magnetic beads in the magnetic bead storage compartment 103, the magnetic rod set assembly 3 sequentially enters the sample compartment 102, the first washing liquid compartment 104, the second washing liquid compartment 105 and the spare compartment from the magnetic bead storage compartment 103. 106, and finally enters the eluent tank 107.
  • the magnetic rod housing compartment 101, the sample compartment 102, the magnetic bead storage compartment 103, the first washing liquid compartment 104, the second washing liquid compartment 105, the spare compartment 106 and the eluent compartment 107 are separated from the connection module 4 by the box body 1 They are arranged sequentially from one end to the other. Therefore, it is possible to facilitate the detection operation of the detection module to a certain extent, thereby improving the operation efficiency.
  • multiple storage compartments can be arranged sequentially along the length direction of the box 1 to form a box 1 structure with a single row of storage compartments, so that only a single sample can be detected.
  • positive controls and negative controls in the process of testing a single sample, especially negative controls, once aerosol contamination occurs in the testing environment, it is difficult to interpret some weak positive results as false positives caused by contamination due to the lack of negative controls. It is still a true weak positive, which greatly reduces the authority of the diagnostic results.
  • the present application further optimizes the structure of the box 1 and provides a second embodiment.
  • the box body 1 is formed with at least two magnetic rod housing compartments 101, at least two sample compartments 102, at least two magnetic bead storage liquid compartments 103, and at least two first washing solutions.
  • the box body 1 in this application is formed with two parallel magnetic rod housing compartments 101, two parallel arranged sample compartments 102, two parallel arranged magnetic bead storage liquid compartments 103, two rows of parallel arranged
  • the washing liquid tank group has two first washing liquid tanks 104 arranged in parallel, two second washing liquid tanks 105 arranged in parallel, two spare tanks 106 arranged in parallel and two eluent tanks arranged in parallel.
  • 107 that is, the box body 1 provided by this application has double rows of accommodation compartments.
  • the reagents contained in the two rows of accommodation compartments are the same and the operation actions are synchronized.
  • One row is used for sample detection and the other row is used for negative control reagents. This is achieved.
  • Each sample test has a real negative control as a reference to ensure the reliability of the results.
  • At least two first flow channels 401, at least two piston chambers 404, and at least two second flow channels 403 are formed in the connection module 4, and at least two amplification tubes 6 are connected to the connection module 4.
  • One end of the first flow channel 401 is connected to the eluent chamber 107, and the other end is connected to the amplification tube 6.
  • One end of the second flow channel 403 is connected to the piston chamber 404, and the other end is connected to the amplification tube 6.
  • the first flow channel 401, the second flow channel 403 and the piston cavity 404 formed in the connection module 4 in this application all correspond to the row numbers of the above-mentioned accommodation compartments. Therefore, as shown in Figure 11, the first flow channel 401, the second flow channel 403 and the piston cavity 404 formed in the connection module 4 in this application Two first flow channels 401, two second flow channels 403 and two piston chambers 404. Correspondingly, two amplification tubes 6 are connected to the connection module 4, so that synchronous actions of sample detection and negative control can be achieved.
  • the diameter of the first flow channel 401 in this application is 1mm-2mm. Since the diameter of the first flow channel 401 is small, under the action of atmospheric pressure, the eluent chamber 107 can be avoided to a certain extent.
  • the solvent enters the first flow channel 401 in advance during mixing, which affects the mixing effect.
  • a negative pressure can be formed in the amplification tube 6, so that the mixed solvent can flow into the amplification tube 6 through the first flow channel 401.
  • the washing liquid tank group including the first washing liquid tank, the second washing liquid tank and the backup tank is only one of the embodiments required based on the detection of the sample.
  • the washing liquid tank group can also be Only the first washing liquid tank can be set up, the first washing liquid tank and the second washing liquid tank can also be set up, and more washing liquid tanks and spare tanks can also be set up.
  • the specific number of washing liquid tanks and spare tanks is determined by the characteristics of the test sample. .
  • connection module 4 is provided with an on-off component 402, and the on-off component 402 is movably connected to the connection module 4; the on-off component 402 connects the first flow channel 401 is divided into a first flow section 4011 and a second flow section 4012, and a docking hole is formed on the on-off component 402; when the on-off component 402 moves relative to the connection module 4, the docking hole is connected to the port of the first flow section 4011 and the second flow section 4011.
  • the ports of the segments 4012 are in relative positions, the first flow segment 4011 and the second flow segment 4012 are connected.
  • the on-off component 402 in this application extends along the height direction of the connection module 4 and can slide upward relative to the connection module 4 in the connection module 4 along the height direction. Therefore, in the initial position, the butt hole of the on-off component 402 is misaligned with the port of the first flow section 4011 and the port of the second flow section 4012, and is located between the port of the first flow section 4011 and the port of the second flow section 4012. below.
  • the second pusher of the detection module pushes the connection component 402 to move upward, so that the docking hole is connected with the port of the first flow section 4011 and the second flow section 4012.
  • the ports of the two flow sections 4012 are connected to each other, thereby realizing the conduction of the first flow channel 401 so that the solvent in the eluent chamber 107 can flow into the amplification tube 6 .
  • the second pushing member pushes the on-off assembly 402 upward again, so that the docking hole is connected to the port of the first flow section 4011 and the port of the second flow section 4012. Phase dislocation is achieved to block the first flow channel 401.
  • the on-off component 402 can also be in the form of a baffle and a spring, that is, the baffle and the spring are both arranged in the connection module 4, and both the baffle and the spring extend along the height direction of the connection module 4, and there are openings on the baffle.
  • the baffle and the spring are both arranged in the connection module 4, and both the baffle and the spring extend along the height direction of the connection module 4, and there are openings on the baffle.
  • one end of the spring is connected to the baffle, and the other end is in contact with the inner wall of the connection module 4 .
  • the second pushing member pushes the baffle upward so that the docking hole on the baffle can be positioned relative to the port of the first flow section 4011 and the port of the second flow section 4012, thereby achieving
  • the first flow channel 401 is conductive, and the second pushing member is always in contact with the end of the baffle away from the spring, so that the spring is always in a compressed state and the first flow channel 401 is maintained in the conductive state.
  • the second pushing member When it is necessary to block the first flow channel 401, the second pushing member is separated from the baffle, and the baffle returns to the initial state under the action of the spring, thereby enabling the docking hole to connect to the port of the first flow section 4011 and the second flow section.
  • the ports of 4012 are phase-shifted to block the first flow channel 401.
  • the structure of the on-off assembly 402 can be further optimized, that is, the on-off assembly 402 further includes two support plates, the two support plates are respectively arranged on both sides of the baffle, and one of the support plates supports the first For the port of the flow section 4011, another support plate supports the port of the second flow section 4012.
  • the baffle fits the support plate and can move relative to the two support plates to achieve alignment of the docking holes.
  • the ends of the first flow section 4011 and the second flow section 4012 can be supported, making the first flow section 4011 and the second flow section 4012 more stable.
  • the baffle Due to the baffle There is no contact with the port of the first flow section 4011 and the port of the second flow section 4012. Therefore, it can be avoided to a certain extent that the movement of the baffle causes the first flow section 4011 and the second flow section 4012 to deform, causing the docking hole to deform. The problem of not being able to achieve conduction through alignment.
  • the magnetic rod proposal assembly 3 pierces the sealing film of the holding chamber, the residual solvent in the holding chamber is prone to aerosol transmission, thereby contaminating the testing environment in the testing module and affecting the testing results.
  • this application can optionally provide a reagent cartridge as shown in Figure 1 in conjunction with Figures 6 and 7. It also includes a sliding cover 2, which is slidingly connected to the box body 1 and covers the hatches of multiple accommodation compartments along the length direction of the box body 1.
  • the detection module can control the sliding cover 2 to move in the length direction of the box body 1 during detection, so as to cover the hatch of the closed accommodation compartment, thereby avoiding to a certain extent the leakage in the accommodation compartment.
  • the remaining solvent generates aerosol transmission, which affects the detection environment and causes pollution, and improves detection accuracy.
  • an alignment part is formed on the sliding cover 2, and the alignment part in this application is an alignment hole 201.
  • the sliding cover 2 is in an initial position relative to the box body 1.
  • the sliding cover 2 is formed with a first through hole 202 at a position corresponding to the magnetic rod housing 101 of the box body 1, and a second through hole 203 is formed at a position corresponding to the sample chamber 102.
  • the first pushing member of the detection module can be inserted into the alignment hole 201 of the sliding cover 2 , thereby pushing the sliding cover 2 to move relative to the box body 1 .
  • the first through hole 202 and the second through hole 203 are formed on the sliding cover 2, and when the sliding cover 2 is in the initial position, the first through hole 202 corresponds to the magnetic rod housing 101, and the second through hole 203 corresponds to the sample chamber 102, therefore , in fact, the distance between the first through hole 202 and the second through hole 203 in this application is consistent with the distance between two adjacent accommodation compartments.
  • the second perforation 203 on the sliding cover 2 is far away from the second perforation 203.
  • the distance between one end of the box 1 is not less than the distance between the sample cabin 102 and the end of the box 1 away from the sample cabin 102 .
  • the sliding cover 2 covers the box body 1 , the first through hole 202 corresponds to the magnetic rod housing compartment 101 , and the second through hole 203 corresponds to the sample compartment 102 .
  • the detection module first takes the magnetic rod cover assembly 3 out of the magnetic rod cover chamber 101, and controls the sliding cover 2 to move left until the magnetic bead storage tank 103 is exposed.
  • the detection module controls the magnetic rod cover assembly 3 to enter the magnetic bead storage tank 103 to absorb the magnetic beads.
  • the detection module controls the sliding cover 2 to move left to expose the sample chamber 102, and controls the magnetic rod cover assembly 3 to enter the sample chamber 102 to absorb the sample.
  • the detection module drives the magnetic rod cover assembly 3 to enter the first washing liquid tank 104, the second washing liquid tank 105, the spare tank 106 and the eluent tank 107 in sequence, and finally returns to the magnetic rod cover cabin 101. .
  • the sliding cover 2 moves synchronously, covering the magnetic bead storage tank 103, the first washing liquid tank 104, the second washing liquid tank 105, the spare tank 106 and the eluent tank 107 in sequence.
  • the sliding cover 2 When the sliding cover 2 covers the eluent chamber 107, the sliding cover 2 returns to the initial position, that is, the first through hole 202 is aligned with the magnetic rod housing 101, and the second through hole 203 is aligned with the sample chamber 102, so that the magnetic rod can be
  • the cover assembly 3 enters the magnetic rod cover cabin 101.
  • a first fitting part 108 is formed on the box body 1, and the first fitting part 108 extends along the length direction of the box body 1
  • the sliding cover 2 has a second fitting portion 204 formed at a position corresponding to the first fitting portion 108 .
  • the first fitting portion 108 matches the second fitting portion 204 so that the sliding cover 2 can slide relative to the box body 1 .
  • the first fitting part 108 on the box body 1 is a first convex part
  • the second fitting part 204 formed on the sliding cover 2 is a first groove part.
  • the engagement between the first protrusion and the first groove limits the sliding cover 2 in the width direction and height direction of the box body 1, so that the sliding cover 2 can only move relative to the box body 1 along the length direction of the box body 1.
  • a mating convex portion 109 is formed on one end of the box body 1, and a mating recess 405 is formed in the connection module 4 at a position corresponding to the mating convex portion 109; the mating convex portion A third fitting portion 1091 and a fourth fitting portion 1092 are respectively formed on the two side walls of 109 that are in contact with the fitting recessed portion 405.
  • the fitting recessed portion 405 is formed with a third fitting portion 1091 at a position corresponding to the third fitting portion 1091.
  • the fifth fitting part 4051 has a sixth fitting part 4052 matching with the fourth fitting part 1092 at a position corresponding to the fourth fitting part 1092.
  • the box body 1 and the connection module 4 can be accurately connected through the matching convex portion 109 formed on the box body 1 corresponding to the connecting module 4 and the matching recessed portion 405 formed on the connecting module 4 corresponding to the matching convex portion 109 .
  • a third fitting part 1091 and a fourth fitting part 1092 are formed on the two side walls where the fitting convex part 109 and the fitting recessed part 405 are in contact. As shown in FIG. 4 combined with FIG.
  • the third fitting part 1091 is a second convex part extending along the width direction of the box body 1
  • the fourth fitting part 1092 is extended along the height direction of the box body 1 and has grooves formed on both sides.
  • the boss of the road is a slot that can engage with the second protruding part
  • the sixth fitting part 4052 extends along the height direction of the connection module 4 and has corresponding slots on both sides.
  • a groove with a third convex portion is formed at the track position.
  • connection between the box body 1 and the connection module 4 can be made more stable.
  • a first sealing gasket 7 is provided between the matching convex part 109 and the matching recessed part 405 , and the eluent chamber 107 is formed in the matching convex part 109 , and the first flow channel One end of 401 penetrates the mating recess 405; the first sealing gasket 7 is formed with a conductive portion at a position corresponding to the communication portion 1093, and one end of the conductive portion is connected to the communication portion 1093, and the other end is connected to the first flow channel 401.
  • the first sealing gasket 7 is provided between the first sealing gasket 7 and the corresponding conductive portion is provided on the first sealing gasket 7, which can ensure to a certain extent that the connecting portion 1093 of the eluent chamber 107 is closely connected with one end of the first flow channel 401, thereby enabling the Avoid the problem of leakage to a certain extent.
  • connection module 4 is formed with a positioning portion 406 at a position corresponding to the amplification tube 6 , and the nozzle of the amplification tube 6 is sleeved on the positioning portion 406 ; the positioning portion 406 A first flow guide 4061 and a second flow guide 4062 are formed on the top.
  • the first flow channel 401 is formed in the first flow guide 4061, and the second flow channel 403 is formed in the second flow guide 4062.
  • the nozzle of the amplification tube 6 can be tightly nested on the positioning part 406, thereby improving the efficiency of the amplification tube 6 after being connected to the connection module 4. Air tightness inside the amplification tube 6.
  • a second sealing gasket 8 is also provided between the amplification tube 6 and the connection module 4.
  • the second sealing gasket 8 can further lift the connection module 4 and the amplification tube 6. degree of sealing between them.
  • the first flow channel 4061 and the second flow channel 4062 formed on the positioning part 406 can facilitate the formation of the first flow channel 401 and the second flow channel 403 that are in communication with the amplification tube 6, and due to the formation of the first flow channel 401 and the second flow channel 403.
  • the guide tube 4061 and the second guide tube 4062 therefore can avoid the interference problem between the first flow channel 401 and the second flow channel 403 to a certain extent.
  • the first flow channel 401 and the second flow channel 403 in the connection module 4 are both molded by injection molding.
  • the connecting module 4 also has a molding hole 407 corresponding to the position where the first flow channel 401 and the second flow channel 403 are formed, and the molding hole 407 is filled with a blocking member 4071, so that the molded The flow channel is blocked to avoid leakage.
  • the multiple accommodation compartments formed on the box body 1 mainly have three sections, the first section is a rectangular section, the second section is a cylindrical section, and the third section is a tapered section.
  • the accommodation cabin shown in the figure is only one of the implementations.
  • the depth, shape and size of the accommodation cabin are not specifically limited here and can be changed at will according to needs.
  • the depth of the eluent chamber 107 in this application is smaller than the other six accommodation chambers, and the diameter of the reserved connecting portion 1093 at the bottom of the eluent chamber 107 is 1mm- 1.5mm communication hole.
  • the magnetic rod cover assembly 3 includes a casing body 302, a fixed section 301, a side wing 303 and an anti-lost magnetic coil 305;
  • the fixed section 301 and the casing body 302 are One end is connected, and the fixed section 301 is formed with a through hole, the casing main body 302 is formed with a receiving groove, the through hole is connected with the receiving groove, and the other end of the casing main body 302 is formed with a puncture tip 304;
  • the side wings 303 are formed along the casing main body 302 extends in the length direction and is disposed on the outer wall surface of the cannula body 302;
  • the anti-lost magnetic coil 305 is disposed on an end of the cannula body 302 away from the fixed section 301, and forms a receiving recess 306 with the puncture tip 304.
  • the fixed section 301 is used to facilitate the moving mechanism of the detection module to grasp during detection, and the fixed section 301 is actually a sleeve structure with both ends penetrating, so that it can be connected with the notch of the receiving groove of the casing body 302 , so that the magnetic rod can penetrate deep into the casing body 302.
  • the end of the casing body 302 away from the fixed section 301 is a sealed end, thereby avoiding direct contact between the magnetic rod and the solvent in the holding chamber.
  • a piercing tip 304 is also formed on the sealing end, so that the piercing tip 304 can pierce the sealing film covering the box body 1 .
  • a plurality of side wings 303 are also provided on the outer wall of the casing main body 302, and optionally, as shown in Figure 9, the number of side wings 303 in this application is three, and along the circumference of the casing main body 302 Interval setting.
  • the anti-lost magnetic ring 305 provided at one end of the cannula body 302 away from the fixed section 301 can cooperate with the puncture tip 304 to form a receiving recess 306, so that the captured magnetic beads can be located in the receiving recess 306, and can be To a certain extent, it avoids the problem of magnetic beads being lost due to scratching on the sealing film during the transfer process.
  • the movable part 5 includes a fixed part 501, a movable part 502 and a ring part 503; the fixed part 501 is rotationally connected to the open end of the piston chamber 404, and the movable part One end of 502 is rotatably connected to the fixed part 501, the ring part 503 is sleeved on the other end of the movable part 502, and the outer wall of the ring part 503 is in contact with the inner wall of the piston chamber 404; when the fixed part 501 rotates relative to the piston chamber 404 , the movable part 502 moves along the axial direction of the piston chamber 404 to drive the ring sleeve part 503 to move relative to the piston chamber 404.
  • the fixed part 501 is a threaded sleeve, and the threaded sleeve is rotationally connected to the port of the piston cavity 404, that is, the threaded sleeve can rotate relative to the piston cavity 404.
  • the movable part 502 is a screw rod, and one end of the screw rod is threadedly connected to the threaded sleeve, and the other end A bearing groove 5021 is formed, and the bearing groove 5021 can accommodate the collar portion 503 , and the collar portion 503 can be a rubber ring that can abut against the inner wall of the piston chamber 404 and has a certain elasticity.
  • the rotating component of the detection module can rotate the threaded sleeve. Since the threaded sleeve rotates relative to the piston cavity 404, the screw rod can be reciprocated in the vertical direction, thereby driving the ring sleeve portion 503 to move in the piston cavity 404. Since the collar portion 503 is in contact with the inner wall of the piston chamber 404, when the collar portion 503 moves upward, the gas in the amplification tube 6 can be extracted through the second flow channel 403, forming a negative pressure in the amplification tube 6. pressure, thereby realizing the purpose of the solvent in the eluent chamber 107 automatically entering the amplification tube 6 through the first flow channel 401.
  • the movable part 5 in this application is actually a piston rod that can move relative to the piston chamber 404. Therefore, in addition to the above-mentioned structure of the movable part 5, other piston rod forms can also be used, which will not be described again here. .
  • this application also provides a detection device, including a detection module, a pipette, and the above-mentioned reagent cartridge; the pipette injects the sample solvent to be tested into one of the accommodation compartments of the reagent cartridge, and the reagent cartridge It is connected to the detection module, and the sample solvent to be tested in the holding chamber can be detected through the detection module.
  • the solvent of the sample to be detected is injected into the sample compartment 102 of the reagent cartridge through a pipette, and then the reagent cartridge carrying the solvent of the sample to be detected is installed on the detection module, so that the detection module can Test the solvent of the sample to be tested.
  • the detection module provided by this application includes a detection module main body, a magnetic rod, a moving mechanism, a first pusher, a second pusher, a rotating assembly and other structures.
  • the main body of the detection module can carry the reagent cartridge, and the magnetic rod can be inserted into the magnetic rod sleeve.
  • the magnetic beads carried in one of the accommodation compartments of box 1 are adsorbed.
  • the moving mechanism can grab and move the magnetic rod cover component 3.
  • the first pusher can push the sliding cover 2 to slide relative to the box 1, and the second pusher can The component can push the on-off component 402 in the connection module 4 to move relative to the connection module 4 to realize on-off of the first flow channel 401, so that the sample can be detected quickly and safely through the structure contained in the above-mentioned detection module.
  • the detection device is a microfluidic nucleic acid detection device.
  • the reagents used are nucleic acid detection reagents, including a set of nucleic acid extraction and purification reagents and a set of nucleic acid amplification detection reagents.
  • the nucleic acid extraction and purification reagents include a lysis binding solution, a third First washing liquid, second washing liquid, magnetic beads, eluent, proteinase K, etc.
  • the nucleic acid amplification detection reagent is a freeze-dried reagent containing reverse transcriptase, hot-start Taq enzyme, dNTPs, primers, probes, etc.
  • this application also provides a detection method, which includes the following steps: Step 1. Inject a sample into the sample compartment 102 of the reagent cartridge, and seal the hatch of the sample compartment 102 with a sealing layer.
  • Step 1. Inject a sample into the sample compartment 102 of the reagent cartridge, and seal the hatch of the sample compartment 102 with a sealing layer.
  • the reagent cartridge provided by this application is sealed with a sealing layer on the hatch of the storage compartment during the unused stage.
  • the sealing layer is first pierced, and then the sample is injected into the sample cabin 102, and then the second perforation 203 on the sliding cover 2 is sealed to achieve sealing of the sample cabin. Then put the reagent cartridge into the detection module; step 2.
  • the detection module takes out the magnetic rod cover assembly 3, extends the magnetic rod of the detection module into the magnetic rod cover assembly 3, and then enters the magnetic rod assembly in sequence.
  • the bead storage tank 103, the sample tank 102, the washing tank group and the eluent tank 107 are moved together by the detection module to control the sliding cover 2; step 3, the detection module pushes the on-off component 402 to connect the first flow channel 401 , and then the detection module drives the movable member 5 to move relative to the piston chamber 404, forming a negative pressure in the amplification tube 6 through the second flow channel 403, so that the solvent in the eluent chamber 107 enters the eluent chamber 107 through the first flow channel 401.
  • the freeze-dried amplification reagent in the amplification tube 6 is reconstituted; in step 4, the detection module detects and analyzes the reagents in the amplification tube 6 .
  • Step 1 includes: 1. Inject the sample to be tested and the negative control sample into the two sample compartments 102 of the box 1 respectively, and seal the second perforation 203 of the sliding cover 2 .
  • a pipette to absorb 300 ⁇ L of the sample to be tested, such as nasopharyngeal swab preservation solution sample or plasma, etc., add the sample solution to be tested to one of the sample compartments 102 of the box 1, and then suck 300 ⁇ L of the negative control sample solution and add it to the box. 1 in another sample compartment 102.
  • the sample compartment 102 contains 500 ⁇ L of lysis binding solution, and the upper layer of the lysis binding solution is covered with 100 ⁇ L of liquid mineral oil component.
  • Step 2 includes: 1.
  • the moving mechanism of the detection module takes out the magnetic rod cover assembly 3 from the magnetic rod cover compartment 101, moves the slide cover 2 to the left to expose the magnetic bead storage tank 103, and the magnetic rod of the detection module enters the magnetic rod cover assembly 3.
  • the moving mechanism moves the magnetic rod cover assembly 3 to the magnetic bead storage tank 103 to absorb the magnetic beads.
  • the moving mechanism of the detection module is inserted into the fixed section 301 of the magnetic rod cover assembly 3, so that the casing body 302 can be moved out of the magnetic rod cover chamber 101 and transferred to the top of the magnetic bead storage liquid chamber 103.
  • the diving magnetic rod enters the casing body 302, then uses the puncture tip 304 to pierce the sealing film, enters the bottom of the magnetic bead storage tank 103, rotates the casing body 302 and absorbs the magnetic beads, and holds the magnetic beads for 1 minute, in which the magnetic bead storage liquid Chamber 103 contains 100 ⁇ L of magnetic bead storage solution.
  • the moving mechanism transfers the magnetic rod cover assembly 3 to the sample cabin 102. Lift the magnetic rod to mix the adsorbed magnetic beads with the solvent in the sample cabin 102, and then insert the magnetic rod into the sample cabin 102. The rod absorbs magnetic beads.
  • the first washing liquid chamber 104 contains 600 ⁇ L of the first washing liquid, and the upper layer of the first washing liquid is covered with 100 ⁇ L of liquid mineral oil component.
  • the sliding cover 2 moves to the right again to cover the first washing liquid tank 104.
  • the moving mechanism transfers the magnetic rod cover assembly 3 from the first washing liquid tank 104 to the second washing liquid tank 105.
  • the magnetic rod is lifted up to release the magnetic beads. Mix it with the solvent in the second washing liquid chamber 105, and then insert the magnetic rod to absorb the magnetic beads.
  • the second washing liquid chamber 105 contains 700 ⁇ L of the second washing liquid, and the upper layer of the second washing liquid is covered with 100 ⁇ L of liquid mineral oil component.
  • the sliding cover 2 moves to the right again to cover the second washing liquid tank 105.
  • the moving mechanism transfers the magnetic rod cover assembly 3 from the second washing liquid tank 105 to the spare compartment 106, so that the end of the magnetic rod cover assembly 3 is in contact with the spare compartment.
  • the solvents within 106 are in contact with each other.
  • the spare compartment 106 contains 300 ⁇ L of the third washing liquid, and the upper layer of the third washing liquid is covered with 100 ⁇ L of the liquid mineral oil component.
  • the sliding cover 2 moves to the right to cover the spare cabin 106.
  • the moving mechanism transfers the magnetic rod cover assembly 3 from the spare cabin 106 to the eluent compartment 107, so that the end of the magnetic rod sleeve assembly 3 is in contact with the eluent compartment 107.
  • the magnetic rod is lifted up to mix the magnetic beads with the solvent in the eluent chamber 107, and then the magnetic rod is inserted to absorb the magnetic beads.
  • Step 3 Move the sliding cover 2 to the right to cover the eluent chamber 107 and reset the sliding cover 2.
  • the moving mechanism transfers the magnetic rod cover assembly 3 to the magnetic rod cover chamber 101.
  • the second pusher of the detection module pushes the on-off assembly 402.
  • the first flow section 4011 and the second flow section 4012 are connected, the movable member 5 moves relative to the piston chamber 404, and a negative pressure is formed in the amplification tube 6 through the second flow channel 403, so that the solvent in the eluent chamber 107 passes through the third flow channel 403.
  • the first channel 401 enters the amplification tube 6 and reconstitutes the freeze-dried amplification reagent in the amplification tube 6 .
  • the first pusher controls the sliding cover 2 to move to the right to cover the eluent chamber 107, so that the first through hole 202 of the sliding cover 2 can slide to the corresponding magnetic rod. position of the casing cabin 101, and retract the magnetic rod casing assembly 3 into the magnetic rod casing cabin 101, and then proceed to step 4.
  • Step 4 The detection module detects and analyzes the reagents in the amplification tube 6 .
  • step 4 the second pusher pushes the on-off component 402 to connect the first flow channel 401, and the rotating component rotates the threaded sleeve, thereby driving the screw to move upward, forming a negative pressure in the amplification tube 6, and realizing the elution liquid chamber 107. Transfer all the reagents to the amplification tube 6, and reconstitute the freeze-dried amplification reagent in the amplification tube 6.
  • the detection module starts the temperature control module and the optical detection module to control the amplification program of the amplification tube 6.
  • the instrument starts to automatically perform PCR amplification detection, automatically collects the fluorescence signal in each cycle reaction, and optimizes the collected signal.
  • the processing is presented on the software interface in real time, and the fluorescence curve analysis is completed after 30 minutes.
  • the instrument automatically gives the analysis results and prompts the operator to issue a test report.
  • the detection module prompts you to take out the reagent cartridge. After taking it out, put it into a ziplock bag and dispose of it accordingly as medical device waste. The instrument then automatically turns on the UV cleaning mode and automatically turns off the power after 15 minutes or prompts the operator to start the next round of testing.
  • the detection reagent uses an influenza A virus specific detection reagent.
  • the nucleic acid extraction of 300 ⁇ L of pseudovirus simulated sample and the mixing of amplification reagents are manually completed, and then from the mixed Take 50 ⁇ L of the system from the amplification reagent and put it into ABI7500 for fluorescence quantitative PCR amplification.
  • use conventional viral nucleic acid extraction reagents to extract the nucleic acid of 300 ⁇ L of the pseudovirus simulation sample use 50 ⁇ L of eluent for elution, and take 10 ⁇ L of the extracted product as a template.
  • a 50 ⁇ L amplification system was put into ABI7500 for amplification, and the amplification results were used as controls.
  • the amplification results showed that using the reagent cartridge, detection device and detection method provided by this application, detection can be performed 3-4 cycles in advance, as shown in Figure 17
  • a in the figure is the result curve obtained according to the detection method using the reagent cartridge and detection device provided by this application
  • B is the curve obtained by the traditional qPCR method.
  • this application has significant results for low-abundance samples.
  • the detection rate is significantly improved, and the detection sensitivity is much higher than conventional detection methods.
  • the application provides a reagent cartridge, a detection device and a detection method, which relate to the technical field of nucleic acid detection and can simplify the structure of the reagent cartridge and reduce costs to a certain extent.
  • the reagent cartridge provided by this application includes a box assembly.
  • the box assembly is formed with multiple accommodation compartments. At least one hatch of the multiple accommodation compartments is provided with a sealing layer.
  • the multiple accommodation compartments include an eluent compartment.
  • a connecting part is formed at the bottom of the deliquidating chamber; a pipe member is connected to the box assembly; a first flow channel is conducted from the connecting part to the pipe member; an on-off component is provided on the first flow channel , when the on-off component is in the first position, the first flow channel is turned on, and when the on-off component is in the second position, the first flow channel is closed.
  • the reagent cartridge, detection device and detection method of the present application are reproducible and can be used in a variety of industrial applications.
  • the reagent cartridge, detection device and detection method of the present application can be used in the technical field of nucleic acid detection.

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Abstract

一种试剂卡盒、检测装置及检测方法，试剂卡盒包括盒体组件，盒体组件形成有多个容纳舱，多个容纳舱中至少一个的舱口设有密封层，多个容纳舱中包括洗脱液舱，洗脱液舱的底部形成有连通部；管构件，管构件与盒体组件相连接；第一流道，第一流道从连通部导通至管构件；通断组件，通断组件设于第一流道上，当通断组件处于第一位置时，第一流道导通，当通断组件处于第二位置时，第一流道关闭。

Description

试剂卡盒、检测装置及检测方法
相关申请的交叉引用
本申请要求于2022年04月15日提交中国国家知识产权局的申请号为202210399871.X、名称为“试剂卡盒、检测装置及检测方法”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及核酸检测技术领域，尤其是涉及一种试剂卡盒、检测装置及检测方法。
背景技术
新型冠状病毒疫情爆发以来，对于基于荧光定量qPCR(Quantitative Polymerase Chain Reaction)技术为首的分子检测技术的需求呈现井喷式的增长，传统的分子检测步骤主要包括核酸提取、试剂分装、qPCR仪上机测试以及结果分析等步骤。
但是，这些步骤首先需要在专业的物理分区的qPCR分子实验室完成上述检测流程，其次，实验室需配置昂贵的仪器包括核酸提取仪、生物安全柜、荧光定量qPCR仪等，然后还需要依赖于经过专门培训的专业操作人员操作才可以完成检测。
总体来说，传统的分子检测试剂存在着检测平台搭建和运行投入昂贵、设备昂贵、需要专业的操作人员，且人工操作繁琐、检测周期长、易污染、对操作人员安全产生危害风险等问题。这些问题导致只有部分三甲医院或大型医院才有资格、资质和能力去开展相关分子检测项目，很多二甲医院和基层医疗机构无法开展相关检测项目，而新冠疫情爆发后，基层医院检测以及现场检测是阻止传染病疫情扩散蔓延的关键所在。
目前市面上存在多种基于微流控芯片技术开发的分子POCT(Point Of Care Testing)类产品，大都是通过制造负压或者离心等方式实现液体在不同腔室之间的转移，如赛沛公司的GeneXpert产品、梅里埃公司的filmArray等均是通过推拉泵体改变气压的方式驱动液体转移流动，这些经典的微流控设计通过后续试剂优化很好地解决了液体残留对于后续扩增步骤的影响。这些依靠微流控设计驱动液体转移的方式对操控液体的体积做了限制，尤其是对加样体积也有比较大的限制，这样做导致产品的检测灵敏度不高，稳定性也较差，最终产品的应用价值大打折扣。
但由于现阶段POCT卡盒结构复杂，导致成本增加，且检测过程繁琐，造成检测效率降低。
因此，急需提供一种试剂卡盒、检测装置及检测方法，以在一定程度上解决相关技术中存在的问题。
发明内容
本申请的目的在于提供一种试剂卡盒、检测装置及检测方法，以至少解决现阶段核酸检测过程中易产生污染的问题。
本申请一些实施例所提供的一种试剂卡盒可以包括盒体组件，所述盒体组件可以形成有多个容纳舱，多个所述容纳舱中的至少一个容纳舱的舱口可以设有密封层，多个所述容纳舱中可以包括洗脱液舱，所述洗脱液舱的底部可以形成有连通部；管构件，所述管构件可以与所述盒体组件相连接；第一流道，所 述第一流道可以从所述连通部导通至所述管构件；通断组件，所述通断组件可以设于所述第一流道上，当所述通断组件处于第一位置时，所述第一流道导通，当所述通断组件处于第二位置时，所述第一流道关闭。
其中，所述盒体组件可以包括盒体和连接模块，多个所述容纳舱均可以形成于所述盒体上，且所述连接模块可以与所述盒体的接近所述洗脱液舱的一端相连接；所述第一流道可以形成于所述连接模块内，且所述连接模块内还可以形成有第二流道，所述第二流道的一端可以与所述管构件相连通，所述连接模块上可以形成有活塞腔，所述第二流道的远离所述管构件的一端可以与所述活塞腔相连通，所述活塞腔内可以设有能够相对于所述活塞腔运动的活动件。
具体地，所述第一流道的直径可以为1mm至2mm。
可选地，本申请提供的试剂卡盒，还可以包括磁棒套组件，所述磁棒套组件可以置于多个所述容纳舱中的一个内。
其中，多个所述容纳舱可以为磁棒套舱、样本舱、磁珠保存液舱以及洗涤液舱组，所述磁棒套舱、所述样本舱、所述磁珠保存液舱、所述洗涤液舱组以及所述洗脱液舱可以由所述盒体的远离所述连接模块的一端向所述盒体的接近所述连接模块的一端依次设置。
具体地，所述洗涤液舱组至少可以包括第一洗涤液舱、第二洗涤液舱以及备用舱，且所述第一洗涤液舱可以接近所述磁珠保存液舱设置，所述第二洗涤液舱以及所述备用舱可以向远离所述第一洗涤液舱的方向依次设置。
可选地，所述盒体上可以形成有至少两个并列设置的所述磁棒套舱、至少两个并列设置的所述样本舱、至少两个并列设置的所述磁珠保存液舱、至少两排并列设置的所述洗涤液舱组以及至少两个并列设置的所述洗脱液舱。
其中，所述连接模块内可以形成至少两条所述第一流道、至少两个所述活塞腔、至少两条所述第二流道，且所述连接模块上至少连接两个管构件。
具体地，所述通断组件可以与所述连接模块活动连接；所述通断组件可以将所述第一流道分隔成第一流通段和第二流通段，所述通断组件上可以形成有对接孔；当所述通断组件相对所述连接模块运动使所述对接孔与第一流通段的端口和第二流通段的端口相对位时，所述第一流通段与所述第二流通段相导通。
可选地，所述连接模块对应所述管构件的位置形成有定位部，所述管构件的管口可以套设在所述定位部上；
所述定位部上可以形成有第一导流管和第二导流管，所述第一流道可以形成于所述第一导流管内，所述第二流道可以形成于所述第二导流管内。
其中，本申请提供的试剂卡盒，还可以包括滑盖，所述滑盖可以与所述盒体滑动连接，所述滑盖可以沿所述盒体的长度方向覆盖多个所述容纳舱的舱口。具体地，所述滑盖上可以形成有对位部、第一穿 孔和第二穿孔，所述对位部、所述第一穿孔以及所述第二穿孔可以沿所述滑盖的长度方向由所述滑盖的一端向另一端依次设置，且所述第二穿孔到所述滑盖的远离所述第二穿孔的一端的距离不小于所述样本舱到所述盒体的远离所述样本舱的一端的距离。
可选地，所述盒体上可以形成有第一配合部，所述第一配合部可以沿所述盒体的长度方向延伸，所述滑盖对应所述第一配合部的位置形成有第二配合部，所述第一配合部可以与所述第二配合部相配合，以使所述滑盖能够相对所述盒体滑动。
其中，所述盒体的一端可以形成有配合凸部，所述连接模块对应所述配合凸部的位置可以形成有配合凹部；所述配合凸部的与所述配合凹部相接触的两个侧壁上可以分别形成有第三配合部和第四配合部，所述配合凹部对应所述第三配合部的位置可以形成有与所述第三配合部相配合的第五配合部，对应所述第四配合部的位置形成有与所述第四配合部相配合的第六配合部。
具体地，所述第三配合部和所述第四配合部可以均为配合卡扣，所述第五配合部和所述第六配合部可以均为配合卡槽。
可选地，所述配合凸部与所述配合凹部之间可以设有第一密封垫，所述洗脱液舱可以形成于所述配合凸部内，所述第一流道的一端可以贯通所述配合凹部；所述第一密封垫对应所述连通部的位置可以形成有导通部，且所述导通部的一端与所述连通部相连通，另一端与所述第一流道相连通。
更可选地，所述磁棒套组件可以包括套管主体、固定段、侧翼以及防丢磁圈；所述固定段可以与所述套管主体的一端相连接，所述固定段可以形成有通孔，所述套管主体可以形成有容纳槽，所述通孔可以与所述容纳槽相连通，所述套管主体的另一端可以形成有穿刺尖端；所述侧翼可以沿所述套管主体的长度方向延伸，且设置于所述套管主体的外壁面上；所述防丢磁圈可以设置于所述套管主体的远离所述固定段的一端，且与所述穿刺尖端形成容纳凹部。
其中，所述活动件可以包括固定部、活动部以及环套部；所述固定部可以与所述活塞腔的敞口端转动连接，所述活动部的一端可以与所述固定部转动连接，所述环套部可以套设于所述活动部的另一端，所述环套部的外壁可以与所述活塞腔的内壁相抵接；当所述固定部相对于所述活塞腔转动时，所述活动部可以沿所述活塞腔的轴向运动，以带动所述环套部相对所述活塞腔运动。
相对于相关技术，本申请提供的试剂卡盒至少具有以下优势：
本申请提供的试剂卡盒，包括盒体组件，盒体组件形成有多个容纳舱，多个容纳舱中至少一个的舱口设有密封层，多个容纳舱中包括洗脱液舱，洗脱液舱的底部形成有连通部；管构件，管构件与盒体组件相连接；第一流道，第一流道从连通部导通至管构件；通断组件，通断组件设于第一流道上，当通断组件处于第一位置时，第一流道导通，当通断组件处于第二位置时，第一流道关闭。
由此分析可知，通过盒体上形成的多个容纳舱，能够对待检测样本、裂解结合液、磁珠保存液、洗涤液以及洗脱液等核酸检测中所需应用的溶剂进行承载。而通过容纳舱的舱口覆盖的封膜，能够对容纳舱内的多种溶剂进行密封保护，并且，由于本申请提供的试剂卡盒为一次性使用产品，因此，当需要使 用对应容纳舱时，将封膜刺破即可进行使用。
而本申请中试剂卡盒还包括位于盒体组件和管构件之间的通断组件，从而通过通断组件能够对第一流道进行通断控制。当需要使洗脱液舱内的试剂进入管构件中时，通断组件移动至第一位置，从而使第一流道导通，洗脱液舱内的试剂进入管构件中。当需要阻隔洗脱液舱内的试剂进入管构件中时，通断组件移动至第二位置，从而使第一流道断开，阻断试剂进入管构件中。
本申请提供的试剂卡盒结构简单，操作方便，能够快速地完成对样本的检测，相应地，能够提高检测效率，降低整体结构的制造成本。
此外，本申请另一些实施例还提供了一种检测装置，该检测装置可以包括检测模块、移液器以及上述实施例所述的试剂卡盒；所述移液器将待测样本溶剂注入所述试剂卡盒的所述容纳舱中的一个所述容纳舱内，所述试剂卡盒与所述检测模块相连接，通过所述检测模块能够对所述容纳舱内的所述待测样本溶剂进行检测。
本申请提供的检测装置使用时，通过移液器将待检测样本溶剂注入试剂卡盒的样本舱中，再将携带待检测样本溶剂的试剂卡盒安装在检测模块上，从而通过检测模块能够对待检测样本溶剂进行检测。
本申请所提供的检测模块可以包括检测模块主体、磁棒、移动机构、第一推动件、第二推动件以及转动组件等结构，通过检测模块主体能够承载试剂卡盒，磁棒能够插入磁棒套组件中对盒体的容纳舱中的一个容纳舱中所承载的磁珠进行吸附，移动机构能够抓取并移动磁棒套组件，第一推动件能够推动滑盖相对盒体滑动，第二推动件能够推动连接模块内的通断组件相对连接模块运动，以实现第一流道的通断，从而通过上述检测模块包含的结构，能够快速且安全地对样本进行检测。
本申请再一些实施例还提供了一种检测方法，检测方法可以包括如下步骤：检测装置接收试剂卡盒，所述试剂卡盒的样本舱内注入有样本，所述样本舱的舱口设有密封层；所述检测装置从所述试剂卡盒上取出磁棒套组件，并将所述检测装置的磁棒伸入所述磁棒套组件中后依次进入所述试剂卡盒的磁珠保存液舱、所述样本舱、洗涤液舱组以及洗脱液舱；所述检测装置推动所述试剂卡盒的通断组件导通第一流道，所述第一流道连通所述洗脱液舱与管构件；所述检测装置驱动所述试剂卡盒上连通所述管构件的活塞组件，以使管构件内形成负压，从而使所述洗脱液舱内溶剂经过所述第一流道进入所述管构件内，所属溶剂使得所述管构件内的冻干扩增试剂复溶；检测装置对管构件内试剂进行检测分析。
可选地，本申请上述实施例所提供的检测方法还可以包括所述检测装置控制与所述试剂卡盒滑动连接的滑盖移动，以依次封闭所述磁棒套组件离开后的所述磁珠保存液舱、所述样本舱、所述洗涤液舱组以及所述洗脱液舱。
通过上述方法，能够实现样本的快速检测，并且由于在检测前和检测过程中通过封膜以及滑盖的移动，能够使样本以及各个容纳舱内的溶剂均处于密封状态，因此，能够避免封膜被破坏后的容纳舱内的溶剂产生气溶胶传播，影响检测环境的问题，提高检测准确度。
附图说明
为了更清楚地说明本申请具体实施方式或相关技术中的技术方案，下面将对具体实施方式或相关技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本申请的一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本申请实施例提供的试剂卡盒的整体结构示意图；
图2为本申请实施例提供的试剂卡盒的分解示意图；
图3为本申请实施例提供的试剂卡盒的剖视图；
图4为本申请实施例提供的试剂卡盒中盒体第一视角的结构示意图；
图5为本申请实施例提供的试剂卡盒中盒体第二视角的结构示意图；
图6为本申请实施例提供的试剂卡盒中滑盖第一视角的结构示意图；
图7为本申请实施例提供的试剂卡盒中滑盖第三视角的结构示意图；
图8为本申请实施例提供的试剂卡盒中磁棒套组件的结构示意图；
图9为本申请实施例提供的试剂卡盒中磁棒套组件第二视角的结构示意图；
图10为本申请实施例提供的试剂卡盒中磁棒套组件前端的结构示意图；
图11为本申请实施例提供的试剂卡盒中连接模块的结构示意图；
图12为本申请实施例提供的试剂卡盒中连接模块内部结构示意图；
图13为本申请实施例提供的试剂卡盒中连接模块的剖视图；
图14为本申请实施例提供的试剂卡盒中活动件的结构示意图；
图15为本申请实施例提供的试剂卡盒中活动件的剖视图；
图16为本申请实施例提供的检测方法的流程图；
图17为本申请实施例提供的扩增循环图。
图中：1-盒体；101-磁棒套舱；102-样本舱；103-磁珠保存液舱；104-第一洗涤液舱；105-第二洗涤液舱；106-备用舱；107-洗脱液舱；108-第一配合部；109-配合凸部；1091-第三配合部；1092-第四配合部；1093-连通部；2-滑盖；201-对位孔；202-第一穿孔；203-第二穿孔；204-第二配合部；3-磁棒套组件；301-固定段；302-套管主体；303-侧翼；304-穿刺尖端；305-防丢磁圈；306-容纳凹部；4-连接模块；401-第一流道；4011-第一流通段；4012-第二流通段；402-通断组件；403-第二流道；404-活塞腔；405-配合凹部；4051-第五配合部；4052-第六配合部；406-定位部；4061-第一导流管；4062-第二导流管；407-成型孔；4071-封堵件；5-活动件；501-固定部；502-活动部；5021-承载槽；503-环套部；6-扩增管；7-第一密封垫；8-第二密封垫。
具体实施方式
下面将结合附图对本申请的技术方案进行清楚、完整地描述，显然，所描述的实施例是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
在本申请的描述中，需要说明的是，术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的系统或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本申请的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电气连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本申请中的具体含义。
实施例1
如图1所示，本申请提供一种试剂卡盒，包括盒体组件和管构件；盒体组件包括盒体1和连接模块4，且本申请中的管构件为扩增管6；连接模块4与盒体1的一端相连接，扩增管6与连接模块4相连接；盒体1上形成有多个容纳舱，多个容纳舱的舱口设有密封层，且密封层为通过热熔方式覆盖于容纳舱的舱口的铝封膜，接近连接模块4的容纳舱为洗脱液舱107，洗脱液舱107的底部形成有连通部1093，连接模块4对应连通部1093的位置形成有第一流道401，且第一流道401的一端与连通部1093相导通，另一端伸入扩增管6内；连接模块4上形成有第二流道403和活塞腔404，活塞腔404内设有活动件5，第二流道403的一端与活塞腔404相连通，另一端与扩增管6相连通。
相对于相关技术，本申请提供的试剂卡盒至少具有以下优势：
本申请提供的试剂卡盒，通过盒体1上形成的多个容纳舱，能够对待检测样本、裂解结合液、磁珠保存液、洗涤液以及洗脱液等核酸检测中所需应用的溶剂进行承载。而通过容纳舱的舱口覆盖的封膜，能够对容纳舱内的多种溶剂进行密封保护，并且，由于本申请提供的试剂卡盒为一次性使用产品，因此，当需要使用对应容纳舱时，将封膜刺破即可进行使用，从而在此实施方式中，仅能够保证封膜刺破前，容纳舱内的溶剂不受外部环境污染，且也不会出现气溶胶传播。
而本申请中试剂卡盒还包括与盒体1连接的连接模块4，且连接模块4上形成有与洗脱液舱107相连通的第一流道401，第一流道401的另一端延伸进入扩增管6内，连接模块4上还形成有伸入扩增管6内的第二流道403以及与第二流道403连通的活塞腔404，从而通过活动件5相对活塞腔404的运动，能够抽取扩增管6内的气体，使扩增管6内产生负压，进而使洗脱液舱107内的溶剂经由第一流道401被吸入扩增管6内。
而采用本申请提供的试剂卡盒在检测前和检测时，当封膜未刺破时，容纳舱内的未使用的溶剂以及未采集的样本等均不会与外界环境接触，因此，能够在一定程度上避免受到外界环境的污染，提高检测准确度。
此处需要补充说明的是，本申请中PCR扩增管6可以采用常规的PCR管，也可以采用定制化的PCR 管。扩增管6内装填有扩增试剂，核酸扩增检测试剂包含有逆转录酶、热启动Taq酶、dNTPs、引物和探针等成分，通过冻干直接形成在PCR扩增管6的管底。而盒体1的容纳舱内承装的试剂主要包括裂解结合液、第一洗涤液、第二洗涤液、磁珠、洗脱液以及蛋白酶K等，因此，相应地，本申请中多个容纳舱为磁棒套舱101、样本舱102、磁珠保存液舱103、第一洗涤液舱104、第二洗涤液舱105以及备用舱106，且磁棒套舱101、样本舱102、磁珠保存液舱103、第一洗涤液舱104、第二洗涤液舱105、备用舱106以及洗脱液舱107由盒体1远离连接模块4的一端向另一端依次设置。
磁棒套舱101用于承载磁棒套组件3，样本舱102用于承装样本溶剂，磁珠保存液舱103用于承装磁珠保存液，且磁珠保存液内含有磁珠，第一洗涤液舱104和第二洗涤液舱105分别用于容纳第一洗涤液和第二洗涤液，备用舱106同样用于承装洗涤液，洗脱液舱107用于承装洗脱液。
检测前，先将样本溶剂注入样本舱102内，并再次将样本舱102的舱口进行封膜。之后将试剂卡盒安装在检测模块中进行检测。
检测时，检测模块将磁棒套组件3抽离磁棒套舱101，并将磁棒套组件3移动至磁珠保存液舱103上方，检测模块的磁棒插入磁棒套组件3内后，磁棒套组件3穿透磁珠保存液舱103的封膜进入舱内吸附磁珠。
在本实施方式中，洗涤液舱组包括第一洗涤液舱104、第二洗涤液舱105以及备用舱106。因此，在吸附磁珠保存液舱103内的磁珠后，磁棒套组件3由磁珠保存液舱103依次进入样本舱102、第一洗涤液舱104、第二洗涤液舱105以及备用舱106，并最终进入洗脱液舱107。
由于磁棒套舱101、样本舱102、磁珠保存液舱103、第一洗涤液舱104、第二洗涤液舱105、备用舱106以及洗脱液舱107由盒体1远离连接模块4的一端向另一端依次设置，因此，能够在一定程度上便于检测模块进行检测作业，从而提高作业效率。
实施例2
在上述实施方式中，多个容纳舱可以沿盒体1的长度方向依次排列，形成具有单排容纳舱的盒体1结构，从而仅能够对单个样本进行检测。但由于对单个样本进行检测的过程缺乏阳性对照和阴性对照，尤其是阴性对照，一旦检测环境出现气溶胶污染，一些弱阳性结果因为缺乏阴性对照导致在判读上很难界定是污染导致的假阳性还是真实的弱阳性，从而使诊断结果的权威性大打折扣。
因此，基于上述实施方式，本申请进一步地优化了盒体1结构，提供了第二种实施方式。
其中，如图1-图5所示，盒体1上形成有至少两个磁棒套舱101、至少两个样本舱102、至少两个磁珠保存液舱103、至少两个第一洗涤液舱104、至少两个第二洗涤液舱105、至少两个备用舱106以及至少两个洗脱液舱107。
可选地，本申请中的盒体1上形成有两个并列设置的磁棒套舱101、两个并列设置的样本舱102、两个并列设置的磁珠保存液舱103、两排并列设置的洗涤液舱组，从而具有两个并列设置的第一洗涤液舱104、两个并列设置的第二洗涤液舱105、两个并列设置的备用舱106以及两个并列设置的洗脱液舱 107，即本申请提供的盒体1具有双排容纳舱，两排容纳舱内承装的试剂相同，操作动作同步，其中一排作为样本检测用，另一排作为阴性对照试剂用，实现了每一个样本检测均有真实的阴性对照做参考，保障了结果的可靠性。
可选地，本申请中连接模块4内形成有至少两个第一流道401、至少两个活塞腔404以及至少两个第二流道403，且连接模块4上至少连接两个扩增管6；第一流道401的一端与洗脱液舱107对应导通，另一端与扩增管6对应导通，第二流道403的一端与活塞腔404对应导通，另一端与扩增管6对应导通。
本申请中连接模块4内形成的第一流道401、第二流道403以及活塞腔404均与上述的容纳舱的排数对应，因此，如图11所示，本申请中连接模块4内形成两个第一流道401、两个第二流道403以及两个活塞腔404。相应地，连接模块4上对应连接有两个扩增管6，因此，能够实现样本检测和阴性对照的同步动作。
可选地，本申请中的第一流道401的直径为1mm-2mm，由于第一流道401的直径较小，因此，在大气压力的作用下，能够在一定程度上避免洗脱液舱107内的溶剂在混匀时提前进入第一流道401内，影响混匀效果。当活动件5在活塞腔404内移动时，能够使扩增管6内形成负压，从而能够使混匀后的溶剂通过第一流道401流入扩增管6中。
此处需要补充说明的是，本申请中洗涤液舱组包括第一洗涤液舱、第二洗涤液舱以及备用舱仅为基于检测样本所需的其中一种实施方式，洗涤液舱组也可仅设置第一洗涤液舱，也可设置第一洗涤液舱和第二洗涤液舱，还可设置更多的洗涤液舱和备用舱，具体洗涤液舱和备用舱的数量由检测样本特性决定。
可选地，如图3结合图12和图13所示，本申请中连接模块4内设有通断组件402，且通断组件402与连接模块4活动连接；通断组件402将第一流道401分隔成第一流通段4011和第二流通段4012，通断组件402上形成有对接孔；当通断组件402相对连接模块4运动使对接孔与第一流通段4011的端口和第二流通段4012的端口相对位时，第一流通段4011与第二流通段4012相导通。
以图3中视出的连接模块4的放置方向为基准，本申请中的通断组件402沿连接模块4的高度方向延伸，且能够在连接模块4内相对连接模块4沿高度方向向上滑动。因此，在初始位置时，通断组件402的对接孔与第一流通段4011的端口和第二流通段4012的端口相错位，且位于第一流通段4011的端口和第二流通段4012的端口的下方。
当需要导通第一流通段4011的端口和第二流通段4012的端口时，检测模块的第二推动件推动通断组件402上移，从而使对接孔与第一流通段4011的端口和第二流通段4012的端口相对接，进而实现第一流道401的导通，使洗脱液舱107内的溶剂能够流入扩增管6中。
而当洗脱液舱107内的溶剂全部流入扩增管6后，第二推动件再次推动通断组件402上移，使对接孔与第一流通段4011的端口和第二流通段4012的端口相错位，实现第一流道401的阻断。
本申请中通断组件402还可以采用挡板和弹簧的形式，即挡板和弹簧均设置在连接模块4内，且挡板和弹簧均沿连接模块4的高度方向延伸，挡板上开设有对接孔，弹簧的一端与挡板相连接，另一端抵 接于连接模块4的内壁上。
当需要使第一流道401导通时，第二推动件推动挡板上移，使挡板上的对接孔能够与第一流通段4011的端口和第二流通段4012的端口相对位，从而实现第一流道401的导通，并且，第二推动件始终与挡板远离弹簧的一端相抵接，从而能够使弹簧始终处于压缩状态，第一流道401保持在导通状态。
而当需要阻断第一流道401时，第二推动件与挡板分离，挡板在弹簧的作用下回复至初始状态，从而能够使对接孔与第一流通段4011的端口和第二流通段4012的端口相错位，实现第一流道401的阻断。
而在此种方式中，可进一步地优化通断组件402结构，即通断组件402还包括两个支板，两个支板分别设置在挡板的两侧，且其中一个支板支撑第一流通段4011的端口，另一个支板支撑第二流通段4012的端口，挡板与支板相贴合，且能够相对两个支板上移，以实现对接孔的对位。
通过设置两个支板，一方面能够对第一流通段4011和第二流通段4012的端部进行支撑，使第一流通段4011和第二流通段4012更加稳定，另一方面，由于挡板不与第一流通段4011的端口和第二流通段4012的端口产生接触，因此，能够在一定程度上避免挡板的运动造成第一流通段4011和第二流通段4012产生变形，使对接孔无法对位实现导通的问题。
在进行检测过程中，当磁棒提案组件3刺破容纳舱的封膜后，容纳舱内的残留溶剂容易产生气溶胶传播，从而污染检测模块内的检测环境，对检测结果产生影响。
因此，本申请为进一步地避免检测过程中的容纳舱内的溶剂扩散对检测环境产生影响及污染，可选地，如图1结合图6和图7所示，本申请提供的试剂卡盒，还包括滑盖2，滑盖2与盒体1滑动连接，且沿盒体1的长度方向覆盖多个容纳舱的舱口。
通过设置的滑盖2能够在进行检测时，通过检测模块控制滑盖2在盒体1的长度方向上运动，从而能够覆盖封闭容纳舱的舱口，进而能够在一定程度上避免容纳舱内的剩余溶剂产生气溶胶传播，对检测环境产生影响和污染的问题，提高检测准确度。
可选地，本申请中滑盖2上形成有对位部，且本申请中的对位部为对位孔201，试剂卡盒在未使用状态下，滑盖2相对盒体1处于初始位置，且滑盖2对应盒体1的磁棒套舱101的位置形成有第一穿孔202，对应样本舱102的位置形成有第二穿孔203。
使用时，检测模块的第一推动件能够插入滑盖2的对位孔201中，从而能够推动滑盖2相对盒体1的运动。由于本申请中滑盖2上形成有第一穿孔202和第二穿孔203，且滑盖2在初始位置时，第一穿孔202对应磁棒套舱101，第二穿孔203对应样本舱102，因此，实际上本申请中的第一穿孔202和第二穿孔203之间的距离与相邻两个容纳舱的距离一致。而当样本注入样本舱102后，由于样本舱102上覆盖的封膜已被刺破，因此，为避免试剂卡盒安装入检测模块的过程以及磁棒套组件3插入磁棒并进入磁珠保存液舱103内吸附磁珠的过程中样本舱102内的样本被污染或产生气溶胶传播，在实际作业时，注入样本后，再次通过封膜对第二穿孔203进行封堵，从而能够在一定程度上避免样本的污染。
为保证滑盖2能够在配合磁棒套组件3移动的过程中始终覆盖并封闭已刺破封膜的容纳舱，本申请 中滑盖2上第二穿孔203距离滑盖2远离第二穿孔203的一端之间的距离不小于样本舱102与盒体1远离样本舱102的一端之间的距离。
在检测前，滑盖2对应覆盖在盒体1上，且第一穿孔202对应磁棒套舱101，第二穿孔203对应样本舱102。当开始检测时，以图1中视角方向为例，检测模块先将磁棒套组件3取出磁棒套舱101中，并控制滑盖2左移，直至露出磁珠保存液舱103。检测模块控制磁棒套组件3进入磁珠保存液舱103内吸取磁珠。待吸取完成后，检测模块控制滑盖2左移露出样本舱102，并控制磁棒套组件3进入样本舱102内吸取样本。
当吸取完成后，检测模块带动磁棒套组件3依次进入第一洗涤液舱104、第二洗涤液舱105、备用舱106以及洗脱液舱107，并最终回位至磁棒套舱101内。滑盖2同步移动，依次覆盖磁珠保存液舱103、第一洗涤液舱104、第二洗涤液舱105、备用舱106以及洗脱液舱107。当滑盖2覆盖洗脱液舱107时，滑盖2回复到初始位置，即第一穿孔202与磁棒套舱101对位，第二穿孔203与样本舱102对位，从而能够使磁棒套组件3进入磁棒套舱101内。
为保证滑盖2和盒体1仅能够沿盒体1的长度方向往复运动，本申请中盒体1上形成有第一配合部108，且第一配合部108沿盒体1的长度方向延伸，滑盖2对应第一配合部108的位置形成有第二配合部204，第一配合部108与第二配合部204相配合，以使滑盖2能够相对盒体1滑动。
可选地，如图4-图7所示，本申请中盒体1上的第一配合部108为第一凸部，滑盖2上形成的第二配合部204为第一槽部，通过第一凸部和第一槽部的卡接，对滑盖2在盒体1宽度方向和高度方向上进行限位，使滑盖2仅能够相对盒体1沿盒体1的长度方向运动，提高整体装置的稳定性。
如图1-图5结合图11所示，可选地，本申请中盒体1的一端形成有配合凸部109，连接模块4对应配合凸部109的位置形成有配合凹部405；配合凸部109与配合凹部405相接触的两个侧壁上分别形成有第三配合部1091和第四配合部1092，配合凹部405对应第三配合部1091的位置形成有与第三配合部1091相配合的第五配合部4051，对应第四配合部1092的位置形成有与第四配合部1092相配合的第六配合部4052。
通过本申请中盒体1对应连接模块4处形成的配合凸部109以及连接模块4对应配合凸部109形成的配合凹部405，便能够实现盒体1与连接模块4的精准对接。而为了进一步地提高盒体1与连接模块4连接的稳定性，本申请中配合凸部109与配合凹部405相接触的两个侧壁上形成有第三配合部1091和第四配合部1092，且如图4结合图5所示，第三配合部1091为沿盒体1宽度方向延伸的第二凸部，第四配合部1092为沿盒体1的高度方向延伸的且两侧形成有槽道的凸台。相应地，如图11结合图13所示，第五配合部4051为能够与第二凸部相卡接的卡槽，第六配合部4052为沿连接模块4的高度方向延伸且两侧对应槽道位置形成有第三凸部的凹槽。
通过第二凸部与卡槽的卡接以及凸台与凹槽的卡接，能够使盒体1和连接模块4的连接更加稳定。
此处需要补充说明的是，上述提供的结构形式仅为其中一种实现盒体1和连接模块4稳定连接的实 施方式，也可采用其他形态的卡接结构或插接结构以实现盒体1和连接模块4之间的稳定连接，而上述方式均在本申请构思范围内，在此不再赘述。
可选地，如图2结合图3所示，本申请中配合凸部109与配合凹部405之间设有第一密封垫7，洗脱液舱107形成于配合凸部109内，第一流道401的一端贯通配合凹部405；第一密封垫7对应连通部1093的位置形成有导通部，且导通部的一端与连通部1093相连通，另一端与第一流道401相连通。
由于盒体1与连接模块4为分体式结构，且盒体1的洗脱液舱107需要与连接模块4的第一流道401相导通，因此，通过在配合凸部109与配合凹部405之间设置第一密封垫7，且在第一密封垫7上对应开设导通部，能够在一定程度上保证洗脱液舱107的连通部1093与第一流道401的一端紧密连通，从而能够在一定程度上避免渗液的问题。
可选地，如图11结合图12所示，本申请中连接模块4对应扩增管6的位置形成有定位部406，扩增管6的管口套设在定位部406上；定位部406上形成有第一导流管4061和第二导流管4062，第一流道401形成于第一导流管4061内，第二流道403形成于第二导流管4062内。
通过连接模块4上对应扩增管6的位置形成的定位部406，能够使扩增管6的管口紧密套设在定位部406上，从而提高扩增管6与连接模块4相连接后，扩增管6内的气密性。
可选地，如图2所示，本申请中扩增管6和连接模块4之间还设有第二密封垫8，通过第二密封垫8能够进一步地提升连接模块4与扩增管6之间的密封程度。
而通过定位部406上形成的第一导流管4061和第二导流管4062能够便于形成与扩增管6相导通的第一流道401和第二流道403，且由于形成有第一导流管4061和第二导流管4062，因此，能够在一定程度上避免第一流道401和第二流道403之间产生干扰的问题。
此处需要补充说明的是，如图2结合图11所示，本申请中连接模块4内的第一流道401和第二流道403均通过注塑方式成型，而为了便于第一流道401和第二流道403的注塑成型，连接模块4上对应形成第一流道401和第二流道403的位置还开设有成型孔407，且成型孔407内填充有封堵件4071，从而能够对成型后的流道进行封堵，避免漏液。
此处需要补充说明的是，在上述实施方式中，盒体1上形成的多个容纳舱主要具有三段，第一段为矩形段，第二段为圆柱段，第三段为锥形段，但图中视出的容纳舱仅为其中一种实施方式，对于容纳舱的深度、形状以及大小在此不做具体限定，可根据需求随意变化。而容纳舱内对应存储的试剂在注入相应的容纳舱后，统一进行铝膜热封，从而能够在一定程度上避免在检测前各试剂受到污染的问题。
此处需要进一步补充说明的是，如图3所示，本申请中的洗脱液舱107的深度小于其他6个容纳舱，洗脱液舱107底部预留的连通部1093的直径为1mm-1.5mm的连通孔。
可选地，如图8-图10所示，本申请提供的磁棒套组件3包括套管主体302、固定段301、侧翼303以及防丢磁圈305；固定段301与套管主体302的一端相连接，且固定段301形成有通孔，套管主体302形成有容纳槽，通孔与容纳槽相连通，套管主体302的另一端形成有穿刺尖端304；侧翼303沿套管主 体302的长度方向延伸，且设置于套管主体302的外壁面上；防丢磁圈305设置于套管主体302远离固定段301的一端，且与穿刺尖端304形成容纳凹部306。
固定段301用于在检测时，便于检测模块的移动机构进行抓取，而固定段301实际上为两端均贯通的套筒结构，从而能够与套管主体302的容纳槽的槽口相连通，使磁棒能够深入套管主体302内。
而本申请中套管主体302远离固定段301的一端为封口端，从而能够避免磁棒与容纳舱内的溶剂的直接接触。并且，在封口端还形成有穿刺尖端304，从而通过穿刺尖端304能够刺破盒体1上覆盖的封膜。
本申请中套管主体302的外壁面上还设有多个侧翼303，且可选地，如图9所示，本申请中的侧翼303的数量为三个，且沿套管主体302的周向间隔设置。通过侧翼303能够在套管主体302插入容纳舱后对容纳舱内的试剂进行搅动，提升混合速度，加大搅拌力度，使混合更加均匀。
而本申请中在套管主体302远离固定段301的一端设置的防丢磁圈305，能够与穿刺尖端304配合形成容纳凹部306，从而能够使捕获的磁珠位于容纳凹部306内，进而能够在一定程度上避免磁珠在转移过程中剐蹭封膜而出现丢失的问题。
可选地，如图14结合图15所示，本申请提供的活动件5包括固定部501、活动部502以及环套部503；固定部501与活塞腔404的敞口端转动连接，活动部502的一端与固定部501转动连接，环套部503套设于活动部502的另一端，且环套部503的外壁与活塞腔404的内壁相抵接；当固定部501相对活塞腔404转动时，活动部502沿活塞腔404的轴向运动，以带动环套部503相对活塞腔404运动。
本申请中固定部501为螺纹套，且螺纹套与活塞腔404的端口转动连接，即螺纹套能够相对活塞腔404转动，活动部502为螺杆，且螺杆的一端与螺纹套螺纹连接，另一端形成有承载槽5021，承载槽5021能够容纳环套部503，且环套部503可以为能够与活塞腔404内壁相抵接，且具有一定弹性的橡胶圈。
使用时，检测模块的转动组件能够转动螺纹套，由于螺纹套相对活塞腔404转动，因此，能够使螺杆沿竖直方向往复运动，从而能够带动环套部503在活塞腔404内运动。由于环套部503与活塞腔404的内壁相抵接，因此，当环套部503上移时，能够通过第二流道403将扩增管6内的气体抽出，使扩增管6内形成负压，从而实现洗脱液舱107内的溶剂经由第一流道401自动进入扩增管6内的目的。
此处需要补充说明的是，本申请中活动件5实际为能够相对活塞腔404运动的活塞杆，因此，除上述活动件5的结构外，也可采用其他活塞杆形式，在此不再赘述。
此外，本申请还提供一种检测装置，包括检测模块、移液器以及上述的试剂卡盒；移液器将待测样本溶剂注入试剂卡盒的容纳舱中的一个容纳舱内，试剂卡盒与检测模块相连接，通过检测模块能够对容纳舱内的待测样本溶剂进行检测。
本申请提供的检测装置使用时，通过移液器将待检测样本溶剂注入试剂卡盒的样本舱102中，再将携带待检测样本溶剂的试剂卡盒安装在检测模块上，从而通过检测模块能够对待检测样本溶剂进行检测。
而本申请提供的检测模块包括检测模块主体、磁棒、移动机构、第一推动件、第二推动件以及转动 组件等结构，通过检测模块主体能够承载试剂卡盒，磁棒能够插入磁棒套组件3中对盒体1其中一个容纳舱中承载的磁珠进行吸附，移动机构能够抓取并移动磁棒套组件3，第一推动件能够推动滑盖2相对盒体1滑动，第二推动件能够推动连接模块4内的通断组件402相对连接模块4运动，以实现第一流道401的通断，从而通过上述检测模块包含的结构，能够快速且安全地对样本进行检测。
本申请提供的检测装置为微流控核酸检测装置，所使用的试剂为核酸检测试剂，包括一套核酸提取纯化试剂和一套核酸扩增检测试剂，其中核酸提取纯化试剂包括裂解结合液、第一洗涤液、第二洗涤液、磁珠、洗脱液，蛋白酶K等，核酸扩增检测试剂为包含有逆转录酶、热启动Taq酶、dNTPs、引物和探针等的冻干试剂。
如图16所示，本申请还提供一种检测方法，包括如下步骤：步骤1、向试剂卡盒的样本舱102内注入样本，并将所述样本舱102的舱口封上密封层，实际上，当试剂卡盒上设有滑盖2时，本申请提供的试剂卡盒在未使用阶段容纳舱的舱口上均封有密封层。当需要向样本舱102内注入样本时，先刺破密封层，之后将样本注入样本舱102内，再对滑盖2上的第二穿孔203进行封膜，实现样本舱的密封。之后将所述试剂卡盒放入检测模块；步骤2、所述检测模块将磁棒套组件3取出，并将所述检测模块的磁棒伸入所述磁棒套组件3中后依次进入磁珠保存液舱103、所述样本舱102、洗涤液舱组以及洗脱液舱107，检测模块控制滑盖2配合移动；步骤3、所述检测模块推动通断组件402导通第一流道401，之后检测模块再驱动活动件5相对活塞腔404移动，通过第二流道403使扩增管6内形成负压，从而使所述洗脱液舱107内溶剂经过第一流道401进入所述扩增管6内，复溶扩增管6内的冻干扩增试剂；步骤4、检测模块对扩增管6内试剂进行检测分析。
其中，步骤1包括：一、吸取待检测样本及阴性对照样本分别注入盒体1的两个样本舱102内，并对滑盖2的第二穿孔203进行封膜。
采用移液器吸取300μL待检测样本，如鼻咽拭子保存液样本或血浆等，待检测样本溶液加入到盒体1的其中一个样本舱102，然后再吸取300μL阴性对照样本溶液加入到盒体1的另一个样本舱102中。其中样本舱102含有500μL裂解结合液，裂解结合液上层覆盖100μL液体矿物油组分。
二、将带有待检测样本和阴性对照样本的盒体组件与检测模块的检测模块主体相连接。待盒体1安装入检测模块主体的对应位置后，样本舱102底部加热模块温度启动加热，温度为65℃，同时检测模块启动进行步骤2。
步骤2包括：一、检测模块的移动机构将磁棒套组件3由磁棒套舱101取出，滑盖2左移露出磁珠保存液舱103，检测模块的磁棒进入磁棒套组件3，移动机构将磁棒套组件3移动至磁珠保存液舱103内吸附磁珠。
检测模块的移动机构插入磁棒套组件3的固定段301，从而能够将套管主体302移出磁棒套舱101并转移至磁珠保存液舱103的上方。下潜磁棒进入套管主体302，然后利用穿刺尖端304刺破封膜，进入磁珠保存液舱103的底部，旋转套管主体302并吸附磁珠，吸附1分钟，其中，磁珠保存液舱103含 有100μL磁珠保存液。
二、滑盖2左移露出样本舱102，移动机构将磁棒套组件3转移至样本舱102内，抬起磁棒，使吸附的磁珠与样本舱102内的溶剂混合，再伸入磁棒吸附磁珠。
移动磁棒套组件3带着磁珠转移至样本舱102中，抬起磁棒，利用套管主体302旋转混匀样本、裂解结合液和磁珠，转速中速，孵育6分钟，然后下潜磁棒进入套管主体302，选择循环吸磁模式吸附90秒，之后进行步骤5。
三、滑盖2右移覆盖磁珠保存液舱103，移动机构将磁棒套组件3由样本舱102转移至第一洗涤液舱104内，抬起磁棒，使磁珠与第一洗涤液舱104内的溶剂混合，再伸入磁棒吸附磁珠。
将磁棒套组件3转移至第一洗涤液舱104的上方，利用穿刺尖端304刺破封膜，进入第一洗涤液舱104的底部，抬起磁棒，旋转磁棒套组件3快速混匀30秒，下潜磁棒进入磁棒套组件3，吸附磁珠30秒，其中第一洗涤液舱104含有600μL第一洗涤液，第一洗涤液上层覆盖100μL液体矿物油组分。
四、滑盖2再次右移，覆盖第一洗涤液舱104，移动机构将磁棒套组件3由第一洗涤液舱104转移至第二洗涤液舱105内，抬起磁棒，使磁珠与第二洗涤液舱105内的溶剂混合，再伸入磁棒吸附磁珠。
将磁棒套组件3转移至第二洗涤液舱105的上方，利用穿刺尖端304刺破封膜，进入第二洗涤液舱105的底部，抬起磁棒，旋转磁棒套组件3快速混匀30秒，下潜磁棒进入磁棒套组件3，循环模式吸附磁珠1分钟，其中第二洗涤液舱105含有700μL第二洗涤液，第二洗涤液上层覆盖100μL液体矿物油组分。
五、滑盖2再次右移覆盖第二洗涤液舱105，移动机构将磁棒套组件3由第二洗涤液舱105转移至备用舱106内，使磁棒套组件3的端部与备用舱106内的溶剂相接触。
将磁棒套组件3转移至备用舱106的上方，利用穿刺尖端304刺破封膜，进入备用舱106的底部，旋转磁棒套组件3快速混匀5秒钟，迅速抬起磁棒套组件3，其中备用舱106含有300μL第三洗涤液，第三洗涤液的上层覆盖100μL液体矿物油组分。
六、滑盖2右移覆盖备用舱106，移动机构将磁棒套组件3由备用舱106转移至洗脱液舱107内，使磁棒套组件3的端部与洗脱液舱107内的溶剂相接触，抬起磁棒，使磁珠与洗脱液舱107内的溶剂混合，再伸入磁棒吸附磁珠。
将磁棒套组件3转移至洗脱液舱107的上方，通过穿刺尖端304刺破封膜，进入洗脱液舱107的底部，抬起磁棒，旋转磁棒套组件3慢速混匀3分钟，下潜磁棒进入套管主体302，吸附磁珠1分钟，其中洗脱液舱107含有50μL洗脱液，洗脱液上层覆盖10μL液体矿物油组分。
步骤3、滑盖2右移覆盖洗脱液舱107，使滑盖2复位，移动机构将磁棒套组件3转移至磁棒套舱101内，检测模块的第二推动件推动通断组件402导通第一流通段4011和第二流通段4012，活动件5相对活塞腔404移动，通过第二流道403使扩增管6内形成负压，从而使洗脱液舱107内溶剂经过第一流道401进入扩增管6内，复溶扩增管6内的冻干扩增试剂。
将磁棒套组件3转移至磁棒套舱101的上方，同时第一推动件控制滑盖2右移覆盖洗脱液舱107，从而使滑盖2的第一穿孔202能够滑动到对应磁棒套舱101的位置，并将磁棒套组件3退入磁棒套舱101中，之后进行步骤4。
步骤4、检测模块对扩增管6内试剂进行检测分析。
在步骤4中，第二推动件推动通断组件402导通第一流道401，转动组件旋转螺纹套，从而带动螺杆上移，使扩增管6内形成负压，实现洗脱液舱107内的试剂全部转移至扩增管6中，复溶扩增管6中的冻干扩增试剂。
之后，检测模块启动温控模块和光学检测模块对扩增管6进行扩增程序控制，仪器开始自动进行PCR扩增检测，自动采集每个循环反应中的荧光信号，并将采集的信号经过优化处理实时呈现在软件界面上，30min后完成荧光曲线分析，仪器自动给出分析结果，并提示操作人员出具检测报告。
完成检测后，检测模块提示取出试剂卡盒，取出后放入自封袋中按照医疗器械垃圾进行相应处理。然后仪器自动开启紫外清理模式，15分钟后自动关闭电源或者提示操作者开启下一轮检测。
此处需要补充说明的是，检测试剂采用甲型流感病毒特异性检测试剂，按照上述操作步骤手工完成300μL假病毒模拟样本的核酸提取以及扩增试剂的混匀等动作，然后从混匀后的扩增试剂中吸取50μL体系放入ABI7500进行荧光定量PCR扩增，同时采用常规病毒核酸提取试剂提取300μL假病毒模拟样本的核酸，采用50μL洗脱液进行洗脱，吸取其中10μL提取产物作为模板采用50μL扩增体系放入ABI7500进行扩增，扩增结果作为对照，扩增结果显示采用本申请提供的试剂卡盒、检测装置及检测方法，可以提前3-4个循环检出，如图17所示，图中A采用本申请提供的试剂卡盒以及检测装置依照检测方法获得的结果曲线，B为传统qPCR法进行检测获得的接过去曲线，由图17可知，本申请对于低丰度样本显著性的提高了检出率，检测灵敏度远远高于常规检测方法。
以上所述仅为本申请的较佳实施例而已，并不用以限制本申请，凡在本申请的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本申请的保护范围之内。
工业实用性
本申请提供的一种试剂卡盒、检测装置及检测方法，涉及核酸检测技术领域，以在一定程度上简化试剂卡盒结构，降低成本。本申请提供的试剂卡盒，包括盒体组件，盒体组件形成有多个容纳舱，多个容纳舱中至少一个的舱口设有密封层，多个容纳舱中包括洗脱液舱，洗脱液舱的底部形成有连通部；管构件，管构件与盒体组件相连接；第一流道，第一流道从连通部导通至管构件；通断组件，通断组件设于第一流道上，当通断组件处于第一位置时，第一流道导通，当通断组件处于第二位置时，第一流道关闭。
此外，可以理解的是，本申请的试剂卡盒、检测装置及检测方法是可以重现的，并且可以用在多种工业应用中。例如，本申请的试剂卡盒、检测装置及检测方法可以用于核酸检测的技术领域。

Claims (22)

  1. 一种试剂卡盒，其特征在于，包括盒体组件，所述盒体组件形成有多个容纳舱，多个所述容纳舱中的至少一个容纳舱的舱口设有密封层，多个所述容纳舱中包括洗脱液舱，所述洗脱液舱的底部形成有连通部；
    管构件，所述管构件与所述盒体组件相连接；
    第一流道，所述第一流道从所述连通部导通至所述管构件；
    通断组件，所述通断组件设于所述第一流道上，当所述通断组件处于第一位置时，所述第一流道导通，当所述通断组件处于第二位置时，所述第一流道关闭。
  2. 根据权利要求1所述的试剂卡盒，其特征在于，所述盒体组件包括盒体和连接模块，多个所述容纳舱均形成于所述盒体上，且所述连接模块与所述盒体的接近所述洗脱液舱的一端相连接；
    所述第一流道形成于所述连接模块内，且所述连接模块内还形成有第二流道，所述第二流道的一端与所述管构件相连通，所述连接模块上形成有活塞腔，所述第二流道的远离所述管构件的一端与所述活塞腔相连通，所述活塞腔内设有能够相对于所述活塞腔运动的活动件。
  3. 根据权利要求1或2所述的试剂卡盒，其特征在于，所述第一流道的直径为1mm至2mm。
  4. 根据权利要求1至3中的任一项所述的试剂卡盒，其特征在于，还包括磁棒套组件，所述磁棒套组件置于多个所述容纳舱中的一个容纳舱内。
  5. 根据权利要求2至4中的任一项所述的试剂卡盒，其特征在于，多个所述容纳舱为磁棒套舱、样本舱、磁珠保存液舱以及洗涤液舱组，所述磁棒套舱、所述样本舱、所述磁珠保存液舱、所述洗涤液舱组以及所述洗脱液舱由所述盒体的远离所述连接模块的一端向所述盒体的接近所述连接模块的一端依次设置。
  6. 根据权利要求5所述的试剂卡盒，其特征在于，所述洗涤液舱组至少包括第一洗涤液舱、第二洗涤液舱以及备用舱，且所述第一洗涤液舱接近所述磁珠保存液舱设置，所述第二洗涤液舱以及所述备用舱向远离所述第一洗涤液舱的方向依次设置。
  7. 根据权利要求6所述的试剂卡盒，其特征在于，所述盒体上形成有至少两个并列设置的所述磁棒套舱、至少两个并列设置的所述样本舱、至少两个并列设置的所述磁珠保存液舱、至少两排并列设置的所述洗涤液舱组以及至少两个并列设置的所述洗脱液舱。
  8. 根据权利要求2至7中的任一项所述的试剂卡盒，其特征在于，所述连接模块内形成至少两条所述第一流道、至少两个所述活塞腔、至少两条所述第二流道，且所述连接模块上至少连接两个管构件。
  9. 根据权利要求2至8中的任一项所述的试剂卡盒，其特征在于，所述通断组件与所述连接模块活动连接；
    所述通断组件将所述第一流道分隔成第一流通段和第二流通段，所述通断组件上形成有对接孔；
    当所述通断组件相对所述连接模块运动而使所述对接孔与第一流通段的端口和第二流通段的端口相对位时，所述第一流通段与所述第二流通段相导通。
  10. 根据权利要求2至9中的任一项所述的试剂卡盒，其特征在于，所述连接模块对应所述管构件的位置形成有定位部，所述管构件的管口套设在所述定位部上；
    所述定位部上形成有第一导流管和第二导流管，所述第一流道形成于所述第一导流管内，所述第二流道形成于所述第二导流管内。
  11. 根据权利要求5至10中的任一项所述的试剂卡盒，其特征在于，还包括滑盖，所述滑盖与所述盒体滑动连接，所述滑盖沿所述盒体的长度方向覆盖多个所述容纳舱的舱口。
  12. 根据权利要求11所述的试剂卡盒，其特征在于，所述滑盖上形成有对位部、第一穿孔和第二穿孔，所述对位部、所述第一穿孔以及所述第二穿孔沿所述滑盖的长度方向由所述滑盖的一端向另一端依次设置，且所述第二穿孔到所述滑盖的远离所述第二穿孔的一端的距离不小于所述样本舱到所述盒体的远离所述样本舱的一端的距离。
  13. 根据权利要求11或12所述的试剂卡盒，其特征在于，所述盒体上形成有第一配合部，所述第一配合部沿所述盒体的长度方向延伸，所述滑盖对应所述第一配合部的位置形成有第二配合部，所述第一配合部与所述第二配合部相配合，以使所述滑盖能够相对所述盒体滑动。
  14. 根据权利要求2至13中的任一项所述的试剂卡盒，其特征在于，所述盒体的一端形成有配合凸部，所述连接模块对应所述配合凸部的位置形成有配合凹部；
    所述配合凸部的与所述配合凹部相接触的两个侧壁上分别形成有第三配合部和第四配合部，所述配合凹部对应所述第三配合部的位置形成有与所述第三配合部相配合的第五配合部，对应所述第四配合部的位置形成有与所述第四配合部相配合的第六配合部。
  15. 根据权利要求14所述的试剂卡盒，其特征在于，所述第三配合部和所述第四配合部均为配合卡扣，所述第五配合部和所述第六配合部均为配合卡槽。
  16. 根据权利要求14或15所述的试剂卡盒，其特征在于，所述配合凸部与所述配合凹部之间设有第一密封垫，所述洗脱液舱形成于所述配合凸部内，所述第一流道的一端贯通所述配合凹部；
    所述第一密封垫对应所述连通部的位置形成有导通部，且所述导通部的一端与所述连通部相连通，另一端与所述第一流道相连通。
  17. 根据权利要求4至16中的任一项所述的试剂卡盒，其特征在于，所述磁棒套组件包括套管主体、固定段、侧翼以及防丢磁圈；
    所述固定段与所述套管主体的一端相连接，所述固定段形成有通孔，所述套管主体形成有容纳槽，所述通孔与所述容纳槽相连通，所述套管主体的另一端形成有穿刺尖端；
    所述侧翼沿所述套管主体的长度方向延伸，且设置于所述套管主体的外壁面上；
    所述防丢磁圈设置于所述套管主体的远离所述固定段的一端，且与所述穿刺尖端形成容纳凹部。
  18. 根据权利要求2至17中的任一项所述的试剂卡盒，其特征在于，所述活动件包括固定部、活动部以及环套部；
    所述固定部与所述活塞腔的敞口端转动连接，所述活动部的一端与所述固定部转动连接，所述环套部套设于所述活动部的另一端，所述环套部的外壁与所述活塞腔的内壁相抵接；
    当所述固定部相对所述活塞腔转动时，所述活动部沿所述活塞腔的轴向运动，以带动所述环套部相对所述活塞腔运动。
  19. 一种检测装置，其特征在于，包括检测模块、移液器以及上述权利要求1至18中的任一项所述的试剂卡盒；
    所述移液器将待测样本溶剂注入所述试剂卡盒的所述容纳舱中的一个所述容纳舱内，所述试剂卡盒与所述检测模块相连接，通过所述检测模块能够对所述容纳舱内的所述待测样本溶剂进行检测。
  20. 根据权利要求19所述的检测装置，其特征在于，所述检测模块包括检测模块主体、磁棒、移动机构、第一推动件、第二推动件以及转动组件，通过所述检测模块主体承载所述试剂卡盒，所述磁棒插入所述磁棒套组件中对所述盒体的所述容纳舱中的一个容纳舱中所承载的磁珠进行吸附，所述移动机构抓取并移动所述磁棒套组件，所述第一推动件推动所述滑盖相对所述盒体滑动，所述第二推动件推动所述连接模块内的所述通断组件相对所述连接模块运动，以实现所述第一流道的通断。
  21. 一种检测方法，其特征在于，包括如下步骤：
    检测装置接收试剂卡盒，所述试剂卡盒的样本舱内注入有样本，所述样本舱的舱口设有密封层；
    所述检测装置从所述试剂卡盒上取出磁棒套组件，并将所述检测装置的磁棒伸入所述磁棒套组件中后依次进入所述试剂卡盒的磁珠保存液舱、所述样本舱、洗涤液舱组以及洗脱液舱；
    所述检测装置推动所述试剂卡盒的通断组件导通第一流道，所述第一流道连通所述洗脱液舱与管构件；
    所述检测装置驱动所述试剂卡盒上连通所述管构件的活塞组件，以使管构件内形成负压，从而使所述洗脱液舱内溶剂经过所述第一流道进入所述管构件内，所述溶剂使得所述管构件内的冻干扩增试剂复溶；
    检测装置对管构件内试剂进行检测分析。
  22. 根据权利要求21所述的检测方法，其特征在于，还包括所述检测装置控制与所述试剂卡盒滑动连接的滑盖移动，以依次封闭所述磁棒套组件离开后的所述磁珠保存液舱、所述样本舱、所述洗涤液舱组以及所述洗脱液舱。
PCT/CN2022/102410 2022-04-15 2022-06-29 试剂卡盒、检测装置及检测方法 WO2023197459A1 (zh)

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