WO2023040477A1 - 体外诊断分析装置及试剂卡盒 - Google Patents

体外诊断分析装置及试剂卡盒 Download PDF

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Publication number
WO2023040477A1
WO2023040477A1 PCT/CN2022/108238 CN2022108238W WO2023040477A1 WO 2023040477 A1 WO2023040477 A1 WO 2023040477A1 CN 2022108238 W CN2022108238 W CN 2022108238W WO 2023040477 A1 WO2023040477 A1 WO 2023040477A1
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Prior art keywords
chamber
hole
holes
rotary valve
reagent
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PCT/CN2022/108238
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English (en)
French (fr)
Inventor
阎玉川
付满良
吴金龙
舒高烽
张劼
罗七一
常兆华
Original Assignee
上海微创惟微诊断技术有限公司
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Publication of WO2023040477A1 publication Critical patent/WO2023040477A1/zh

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • C12M1/02—Apparatus for enzymology or microbiology with agitation means; with heat exchange means
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • C12M1/34—Measuring or testing with condition measuring or sensing means, e.g. colony counters
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • C12M1/36—Apparatus for enzymology or microbiology including condition or time responsive control, e.g. automatically controlled fermentors
    • C12M1/38—Temperature-responsive control

Definitions

  • the present application relates to the technical field of molecular diagnosis, in particular to an in vitro diagnostic analysis device and a reagent cartridge.
  • Molecular diagnosis refers to the technique of using molecular biological methods to detect changes in the structure or expression level of genetic material in patients to make a diagnosis.
  • Molecular diagnosis is the main method of predictive diagnosis, which can be used for diagnosis of individual genetic diseases and prenatal diagnosis.
  • Molecular diagnosis mainly refers to the detection of genes encoding various structural proteins, enzymes, antigen antibodies, and immune active molecules related to diseases.
  • the main technologies of molecular diagnosis include nucleic acid molecular hybridization, polymerase chain reaction and biochip technology.
  • nucleic acid detection of samples it is generally divided into three steps: nucleic acid extraction, nucleic acid amplification and nucleic acid detection.
  • nucleic acid detection products nucleic acid extraction, nucleic acid amplification and nucleic acid detection are mostly carried out independently. Sequential steps cannot be efficiently integrated with subsequent steps in succession.
  • a reagent cartridge includes: a microfluidic chip, the bottom surface of the microfluidic chip is provided with a first hole, a plurality of second holes, and a third hole; The second hole and the third hole are arranged at intervals around the circumference of the first hole; the microfluidic chip is also provided with a plurality of first microfluidics arranged in one-to-one correspondence with the plurality of second holes.
  • the base is arranged on the bottom surface of the microfluidic chip, and the base includes a rotary valve set by rotation; the rotary A communication groove is provided on the valve, one end of the communication groove corresponds to and communicates with the first hole, and the other end of the communication groove connects with one of all the second holes or the first hole as the rotary valve rotates.
  • the third hole communicates correspondingly; a storage box, the storage box is provided with a first chamber and a plurality of second chambers; the first chamber communicates with the first hole; a plurality of the second chambers One-to-one correspondence and communication with a plurality of the first micro-flow channels; the first chamber can be connected to a power source mechanism for promoting reagent flow, or all of the second chamber and the PCR chamber can be Connect the power source mechanism used to drive the flow of reagents.
  • the base further includes a fixed seat, the rotary valve is rotatably arranged on the bottom surface of the fixed seat, a plurality of communication holes are provided on the bottom surface of the fixed seat, the first hole, All the second holes and the third holes are arranged in a one-to-one correspondence with all the communication holes and communicate with each other.
  • the base further includes a gasket arranged between the fixed seat and the rotary valve; the gasket is provided with a plurality of through holes; the plurality of through holes and the plurality of the The positions of the communicating holes are arranged in one-to-one correspondence and communicated.
  • the fixed seat is provided with a first recess
  • the rotary valve and the sealing gasket are both arranged in the first recess, and the rotary valve rotates relative to the fixed seat, the The top surface of the gasket is in close contact with the bottom wall of the first recess; a barb is provided on the wall of the first recess, and the barb engages and contacts the rotary valve.
  • the sealing gasket is fixedly arranged on the bottom wall of the first recess; the end surface of the rotary valve facing the sealing gasket is provided with a second recess, and the bottom of the sealing gasket is in contact with the sealing gasket.
  • the second recess is compatible.
  • the storage box is provided with a positioning post
  • the microfluidic chip is provided with a first positioning hole corresponding to the position of the positioning post
  • the fixing seat is provided with a positioning hole corresponding to the position of the first positioning post.
  • a positioning hole corresponds to a second positioning hole, and the positioning column is inserted into the first positioning hole and the second positioning hole.
  • the reagent cartridge further includes a freeze-drying chamber for storing frozen reagents, and the second microfluidic channel communicates with the PCR chamber through the freeze-drying chamber.
  • the microfluidic chip is also provided with a main flow channel, at least two branch flow channels and at least two first vent holes; the main flow channel communicates with the freeze-drying chamber , one end of all the branch channels communicates with the main channel, and the other end of the branch channels communicates with the first air hole one by one; each of the branch channels is connected in series with the The PCR chamber described above.
  • the microfluidic chip is further provided with at least two first waterproof and gas-permeable membranes, and the first waterproof and gas-permeable membranes are arranged on the walls of the first ventilation holes in a one-to-one correspondence.
  • the storage box includes a first box body, a first cover plate covered on the first box body, and a blocking cover; the first chamber and the plurality of first The two chambers are all arranged on the first box body; the first cover plate is provided with a first sample injection hole and a plurality of second ventilation holes, and the first sample injection hole is connected to one of the second ventilation holes.
  • the positions of the chambers are set correspondingly and communicated with each other.
  • the blocking cover is detachably covered on the first sample injection hole. connected.
  • the storage box also includes a sealing film and a plurality of second waterproof and gas-permeable films arranged on the top surface of the first cover plate; the sealing film is provided with a second sampling hole and A plurality of third air holes, the second sample injection hole corresponds to and communicates with the first sample injection hole, and the plurality of third air holes are set in one-to-one correspondence with the plurality of second air holes.
  • a plurality of the second waterproof and gas-permeable membranes are arranged on the hole walls of the plurality of third ventilation holes in a one-to-one correspondence.
  • the first cover plate is provided with a first piston hole; the first piston hole is set corresponding to the position of the first chamber and communicated with each other, and the power source mechanism includes a piston head and A piston rod, the piston head is movably arranged in the first chamber, the piston head is connected to the piston rod, and the piston rod protrudes into the first chamber through the first piston hole. external.
  • the in vitro diagnostic analysis device includes the reagent cartridge, the in vitro diagnostic analysis device also includes a heating and cooling mechanism and a fluorescence detection mechanism, and the heating and cooling mechanism is arranged on the microfluidic chip One side of the PCR chamber is used for heating or cooling the PCR chamber, and the fluorescence detection mechanism is arranged on the other side of the microfluidic chip for optical detection of the PCR chamber.
  • reagents such as lysate, sample solution, cleaning solution and eluent are respectively installed in multiple second chambers, and one end of the communication tank is connected to the first chamber by driving the rotary valve to rotate.
  • the communication holes corresponding to the holes are connected, and the other end of the communication groove can move to the position of communicating with the remaining communication holes with the rotation of the rotary valve.
  • the other end of the communication groove communicates with one of the remaining communication holes
  • the first The chamber communicates through the first hole, the communication groove, one of the second holes, the first micro-channel corresponding to the second hole, and the second chamber corresponding to the first micro-channel.
  • the reagent in one of the second chambers can be transferred to the first chamber for processing.
  • the first chamber can also communicate with other second chambers.
  • the reagents in the other second chambers can be transferred to the first chamber and processed accordingly, so that the nucleic acid in the sample liquid can be extracted.
  • the first chamber can pass through the first hole, the communication groove, the third hole, the second microchannel corresponding to the third hole, and the PCR chamber corresponding to the second microchannel.
  • the first chamber can transfer the nucleic acid to the PCR chamber for amplification and detection processing.
  • the above-mentioned in vitro diagnostic analysis device includes the above-mentioned reagent cartridge, the technical effect is brought by the reagent cartridge, and the beneficial effect is the same as that of the reagent cartridge, so it will not be repeated here.
  • FIG. 1 is a schematic structural view of an in vitro diagnostic analysis device according to an embodiment of the present application
  • Fig. 2 is a schematic diagram of the structure after the heating and cooling mechanism and the fluorescence detection mechanism are hidden in Fig. 1;
  • Fig. 3 is a schematic diagram of the exploded structure of Fig. 2;
  • Fig. 4 is a schematic cross-sectional structure diagram of Fig. 2;
  • Fig. 5 is a perspective view of the top view angle of Fig. 2;
  • Fig. 6 is a schematic diagram of an exploded structure of a base according to an embodiment of the present application.
  • Fig. 7 is a bottom view of a fixing seat according to an embodiment of the present application.
  • Fig. 8 is a bottom view of a gasket according to an embodiment of the present application.
  • Fig. 9 is a top view of a rotary valve according to an embodiment of the present application.
  • Fig. 10 is a cross-sectional structure diagram of a base according to an embodiment of the present application.
  • FIG. 11 is a schematic structural diagram of a microfluidic chip according to an embodiment of the present application.
  • Fig. 12 is a schematic bottom view of the microfluidic chip according to an embodiment of the present application.
  • Fig. 13 is a schematic diagram of an exploded structure of a freeze-drying box according to an embodiment of the present application.
  • Fig. 14 is a schematic diagram of an exploded structure of a storage box according to an embodiment of the present application.
  • FIG. 15 is a schematic top view of the first box body according to an embodiment of the present application.
  • Reagent cartridge 11. Base; 111. Fixing seat; 1111. Communication hole; 1112. First recess; 1113. Barb; 1114. Limit port; 1115. Second positioning hole; 112. Rotary valve; 1121 , communication groove; 1122, second recess; 1123, socket; 113, sealing gasket; 1131, through hole; 1132, protrusion; 12, microfluidic chip; 121, first hole; 122, second hole; 123 , the third hole; 124, the first microchannel; 125, the PCR chamber; 126, the second microchannel; 127, the first positioning hole; 1283, the main channel; 1284, the branch channel; 1285, the first Air vent; 1286, first waterproof and breathable membrane; 13, storage box; 131, first chamber; 1311, first via hole; 132, second chamber; 1321, second via hole; 132a, first reagent chamber 132b, the second reagent chamber; 132c, the third reagent chamber; 132d, the fourth reagent chamber; 131
  • FIG. 1 shows a schematic structural view of an in vitro diagnostic analysis device according to an embodiment of the present application
  • Figure 2 shows a schematic structural view after the heating and cooling mechanism 20 and the fluorescence detection mechanism 30 are hidden in Figure 1
  • FIG. 3 shows a schematic diagram of the exploded structure of FIG. 2
  • An embodiment of the present application provides an in vitro diagnostic analysis device, which includes a reagent cartridge 10 , a heating and cooling mechanism 20 and a fluorescence detection mechanism 30 .
  • the heating and cooling mechanism 20 is arranged on one side of the microfluidic chip 12 for heating or cooling the PCR chamber 125
  • the fluorescence detection mechanism 30 is arranged on the other side of the microfluidic chip 12 for controlling the PCR chamber 125. 125 for optical detection.
  • FIG. 4 shows a schematic cross-sectional structure of FIG. 2
  • FIG. 5 shows a perspective view of a top view of FIG. 2
  • FIG. , Fig. 7 to Fig. 8 respectively show the bottom view of the fixed seat 111 and the gasket 113 of an embodiment of the present application
  • Fig. 9 shows the top view of the rotary valve 112
  • Fig. 10 shows the bottom view of an embodiment of the present application
  • the reagent cartridge 10 includes a base 11 , a microfluidic chip 12 and a storage box 13 .
  • FIG. 11 shows a schematic structural view of a microfluidic chip 12 according to an embodiment of the present application
  • FIG. 12 shows a schematic bottom view of a microfluidic chip 12 according to an embodiment of the present application.
  • the bottom surface of the microfluidic chip 12 is provided with a first hole 121 , a plurality of second holes 122 and a third hole 123 .
  • a plurality of second holes 122 and third holes 123 are arranged at intervals around the first hole 121 .
  • the microfluidic chip 12 is further provided with a plurality of first microfluidic channels 124 corresponding to the plurality of second holes 122 .
  • a PCR chamber 125 is also provided on the microfluidic chip 12 , and the third hole 123 communicates with the PCR chamber 125 through a second microfluidic channel 126 .
  • the base 11 is disposed on the bottom surface of the microfluidic chip 12 .
  • the base 11 specifically includes, for example, a fixed seat 111 and a rotary valve 112 rotatably disposed on the bottom surface of the fixed seat 111 , and a plurality of communication holes 1111 are provided on the bottom surface of the fixed seat 111 .
  • the plurality of communication holes 1111 are arranged in communication with the plurality of connection holes in one-to-one correspondence.
  • the rotary valve 112 is provided with a communication groove 1121, one end of the communication groove 1121 communicates with the communication hole 1111 corresponding to the first hole 121, and the other end of the communication groove 1121 can move to the other communication holes as the rotary valve 112 rotates. 1111 connected location.
  • the fixed seat 111 may not be provided, that is, the rotary valve 112 is, for example, rotatably arranged on the base 11, and is located on the bottom surface of the microfluidic chip 12, and one end of the communication groove 1121 is connected to the bottom surface of the microfluidic chip 12.
  • the first holes 121 correspond to and communicate with each other, and the other end of the communication groove 1121 communicates with one of all the second holes 122 or the third hole 123 as the rotary valve 112 rotates.
  • the storage box 13 is disposed on the top surface of the microfluidic chip 12 , and the storage box 13 is provided with a first chamber 131 and a plurality of second chambers 132 .
  • the bottom wall of the first chamber 131 is provided with a first via hole 1311 , and the first via hole 1311 communicates with the first hole 121 .
  • the plurality of second chambers 132 correspond to and communicate with the plurality of first microchannels 124 .
  • second via holes 1321 are provided on the bottom wall of the second chamber 132 , and the plurality of second via holes 1321 correspond to and communicate with the positions of the plurality of first micro-channels 124 .
  • the first chamber 131 can be connected with a power source mechanism for driving reagent flow; or all the second chamber 132 and the PCR chamber 125 can be connected with a power source mechanism for driving reagent flow.
  • the power source mechanism includes, but is not limited to, a piston driving method, an air pump driving method, etc., as long as the driving force can be provided to make the reagent enter the second chamber 132 and the PCR chamber 125 from the first chamber 131 respectively, And it only needs to enter from the second chamber 132 into the first chamber 131 .
  • both the first hole 121 needs to communicate with the first through hole and the first via hole 1311 , that is, the first hole 121 is a through hole.
  • both the second hole 122 and the third hole 123 may be blind holes or through holes, which are not limited here.
  • both the first via hole 1311 and the second via hole 1321 are through holes, that is, the first chamber 131 communicates with the first hole 121 through the first via hole 1311 , and the second chamber 132 communicates with the first hole 121 through the second via hole 1321 .
  • a micro channel 124 communicates with it.
  • reagents such as lysate, sample solution, cleaning solution and eluent are respectively installed in the interior of a plurality of second chambers 132, and one end of the communication tank 1121 is connected by driving the rotary valve 112 to rotate. It communicates with the communication hole 1111 corresponding to the first hole 121, and the other end of the communication groove 1121 can move to the position of communicating with the rest of the communication holes 1111 with the rotation of the rotary valve 112.
  • the first chamber 131 passes through the first hole 121, the communication hole 1111 corresponding to the first hole 121, the communication groove 1121, the communication hole 1111 corresponding to the other end of the communication groove 1121, the second The hole 122 communicates with the first microchannel 124 corresponding to the second hole 122, and one of the second chambers 132 correspondingly communicates with the first microchannel 124. Under the action of the power source mechanism, one of the first microchannels 132 can be realized.
  • the reagent in the second chamber 132 is transferred to the first chamber 131 for processing, similarly, under the rotating action of the rotary valve 112, the first chamber 131 can also be communicated with other second chambers 132. Under the action of the source mechanism, the reagents in other second chambers 132 can be transferred to and from the first chamber 131 and processed accordingly, so that the nucleic acid in the sample liquid can be extracted.
  • the first chamber 131 can pass through the first hole 121, the communication hole 1111 corresponding to the first hole 121, the communication groove 1121, the communication hole 1111 corresponding to the other end of the communication groove 1121, the second The three holes 123, the second micro-channel 126 corresponding to the third hole 123, and the PCR chamber 125 corresponding to the second micro-channel 126 are in communication, and the first chamber 131 can be realized under the action of the power source mechanism.
  • the nucleic acids are transferred to the PCR chamber 125 for amplification and detection processing.
  • the base 11 further includes a gasket 113 disposed between the fixing seat 111 and the rotary valve 112 .
  • the gasket 113 defines a plurality of through holes 1131 .
  • the positions of the plurality of through holes 1131 and the plurality of communication holes 1111 are arranged in one-to-one correspondence and communicated with each other.
  • the gasket 113 can ensure better sealing performance at the docking position between one end of the communication groove 1121 and the communication hole 1111 corresponding to the first hole 121, And ensure the tightness at the position where the other end of the communication groove 1121 is connected with the rest of the communication holes 1111 .
  • the top surface of the gasket 113 is in close contact with the bottom surface of the fixed seat 111, and the bottom surface of the gasket 113 is in close contact with the top surface of the rotary valve 112, so that the top surface of the gasket 113 can be avoided from contacting the fixed seat.
  • the sealing pad 113 is specifically selected from an elastic pad, such as a silicone pad, a rubber pad, a latex pad, etc. Of course, it can also be an elastic pad of other elastic materials, which is not limited here.
  • a first recess 1112 is provided on the bottom surface of the fixed seat 111, the rotary valve 112 and the gasket 113 are both arranged in the first recess 1112 and the rotary valve 112 rotates relative to the fixed seat 111, specifically In other words, the sidewall of the rotary valve 112 can rotate relative to the sidewall of the first recess 1112 .
  • the top surface of the gasket 113 is in close contact with the bottom wall of the first recess 1112 .
  • a barb 1113 is disposed on the wall of the first concave portion 1112 , and the barb 1113 engages and contacts the rotary valve 112 .
  • the sealing gasket 113 and the rotary valve 112 are installed in the first recess 1112, and the position of the rotary valve 112 is limited by the barb 1113 abutting against the bottom surface of the rotary valve 112, so that the two sides of the sealing gasket 113 are respectively in contact with the bottom surface of the rotary valve 112.
  • the rotary valve 112 is in close contact with the fixed seat 111 ; in addition, the rotary valve 112 operates more stably during rotation.
  • the number of barbs 1113 is not limited to one, for example, it can be two, three or other numbers, that is, more than two barbs 1113 are used to synchronously interfere with the bottom surface of the rotary valve 112 .
  • the barb 1113 is specifically an elastic hook body, such as a metal hook, a silicone hook, a rubber hook, a plastic hook, etc., which can be an integrated structure with the fixing seat 111, or can be a separate structure and assembled with each other. There is no restriction, and it is set according to actual needs.
  • the rotary valve 112 in order to facilitate the free rotation of the rotary valve 112 in the first concave portion 1112 , the rotary valve 112 is in the shape of a cylinder, and the first concave portion 1112 is adapted to the shape of the rotary valve 112 .
  • a draw-in groove can also be provided on the wall of the first recess 1112, and the outer edge of the rotary valve 112 is rotatably arranged in the draw-in groove. 112 is in close contact with the fixed seat 111, and on the other hand, the rotation of the rotary valve 112 can also be realized.
  • the gasket 113 is fixedly disposed on the bottom wall of the first concave portion 1112 .
  • the end surface of the rotary valve 112 facing the sealing gasket 113 is provided with a second concave portion 1122 , the bottom of the sealing gasket 113 is adapted to the second concave portion 1122 , and the bottom surface of the sealing gasket 113 and the bottom wall of the second concave portion 1122 are both circular surfaces.
  • the rotary valve 112 can rotate freely relative to the gasket 113, and the alignment between the rotary valve 112 and the gasket 113 is accurate, so that after the rotary valve 112 rotates a preset angle, the other end of the communication groove 1121 can be accurately moved to A position communicating with one of the plurality of through holes 1131 .
  • the rotary valve 112 is connected with the driving rod 40 , and the rotary valve 112 is driven to rotate through the driving rod 40 .
  • the rotary valve 112 is connected with the driving rod 40 , and the rotary valve 112 is driven to rotate through the driving rod 40 .
  • the insertion hole 1123 is adapted to the shape of the end of the drive rod 40, so that the end of the drive rod 40 The part is inserted into the socket 1123, and the rotation of the driving rod 40 can correspondingly drive the rotation of the rotary valve 112 to adjust the angle.
  • the driving rod 40 can also use other methods to drive the rotary valve 112 to rotate, which is not limited here.
  • the outer edge of the gasket 113 is provided with a protrusion 1132, and the first recess 1112
  • the bottom wall of the bottom wall is provided with a limit opening 1114 adapted to the protrusion 1132, and the protrusion 1132 is set in the limit opening 1114, so that the sealing gasket 113 can be fixedly arranged on the bottom wall of the first recess 1112, that is, in When the rotary valve 112 rotates, the gasket 113 will not rotate together with the rotary valve 112 .
  • the microfluidic chip 12 is fixed on the top surface of the fixing seat 111 by bonding, welding, or fixedly installed on the top surface of the fixing base 111; the storage box 13 is fixed on the The component is fixedly installed on the top surface of the microfluidic chip 12.
  • a positioning post 133 is provided on the bottom surface of the storage box 13 .
  • the microfluidic chip 12 is provided with a first positioning hole 127 corresponding to the position of the positioning column 133
  • the fixing seat 111 is provided with a second positioning hole 1115 corresponding to the position of the first positioning hole 127
  • the positioning column 133 is inserted into the first positioning hole 1115.
  • the hole 127 and the second positioning hole 1115 are provided.
  • the number of positioning posts 133 may be one, two, three or more
  • the number of first positioning holes 127 and second positioning holes 1115 may be one, two, three or more.
  • the reagent cartridge 10 further includes a freeze-drying chamber 172 for storing frozen reagents.
  • the second microchannel 126 communicates with the PCR chamber 125 through the freeze-drying chamber 172 .
  • the reagent cartridge 10 also includes a freeze-drying box 17 for storing frozen reagents.
  • the freeze-drying box 17 is provided with a freeze-drying chamber 172 .
  • the freeze-drying box 17 is provided with a second docking hole 171 communicating with the second microchannel 126, a freeze-drying chamber 172 communicating with the second docking hole 171, and a freeze-drying chamber 172 communicating with the freeze-drying chamber 172.
  • the third docking hole 173 communicates with the PCR chamber 125 .
  • the freeze-drying reagent can be placed inside the freeze-drying chamber 172, and the nucleic acid is extracted in the first chamber 131, and the rotary valve 112 is turned so that the first chamber 131 passes through the first hole 121, corresponding to the first hole 121
  • the PCR chamber 125 communicates with the first chamber 131 by, for example, pushing the piston, so that the nucleic acid in the first chamber 131 passes through the first via hole 1311, the first hole 121, and the communication hole 1111 corresponding to the first hole 121 , the communication groove 1121, the communication hole 1111 corresponding to the other end of the communication groove 1121, the third hole 123, the second microchannel 126 corresponding to the third hole 123, and the second docking hole
  • the microfluidic chip 12 is further provided with a main channel 1283 , at least two branch channels 1284 and at least two first air holes 1285 .
  • the main channel 1283 communicates with the freeze-drying chamber 172 , one end of all the branch channels 1284 communicates with the main channel 1283 , and the other ends of the branch channels 1284 communicate with the first ventilation holes 1285 one by one.
  • Each branch channel 1284 is provided with a PCR chamber 125 in series.
  • nucleic acid and freeze-dried reagents enter the interior of the PCR chamber 125 in each branch flow channel 1284 through the main flow channel 1283, and the amplification and optical detection are performed synchronously in more than two PCR chambers 125, which can greatly improve the work efficiency. efficiency, and increased reliability of test results.
  • the first air hole 1285 can exhaust air outwards, the air pressure balance can be maintained, so that the nucleic acid and the freeze-dried reagent can enter the interior of the PCR chamber 125 in the branch flow channel 1284 under the push of air pressure.
  • different reaction reagents are packaged in each PCR chamber 125, so as to realize multiple nucleic acid detection.
  • the specific number of PCR chambers 125 is, for example, 2, 3, 4, 8, 16, etc., which are set according to actual needs and are not limited here.
  • At least two first waterproof and gas-permeable membranes 1286 are provided on the microfluidic chip 12, and at least two first waterproof and gas-permeable membranes 1286 are arranged on at least two corresponding one-to-one On the hole wall of the first ventilation hole 1285 .
  • the first waterproof and gas-permeable membrane 1286 can allow the gas to be discharged to the outside, maintain the air pressure balance inside the branch flow channel 1284, but can prevent the liquid from being discharged to the outside, and can prevent the outside liquid from entering, that is, the reagents inside the PCR chamber 125 can be prevented from being affected. pollute.
  • the storage box 13 includes a first box body 134 , a first cover 135 covering the first box body 134 , and a blocking cover 136 .
  • the first chamber 131 and the plurality of second chambers 132 are both disposed on the first box body 134 .
  • the first cover plate 135 is provided with a first piston hole 1351 , a first sample injection hole 1352 and a plurality of second ventilation holes 1353 .
  • the first piston hole 1351 is set corresponding to the position of the first chamber 131 and communicated with it
  • the first sample injection hole 1352 is set corresponding to the position of one of the second chambers 132 and communicated with it
  • the blocking cover 136 is detachably set on the second chamber 132.
  • One sample injection hole 1352 , a plurality of second air holes 1353 are provided in one-to-one correspondence with the rest of the second chambers 132 and communicated with each other.
  • the storage box 13 further includes a sealing film 137 and a plurality of second waterproof and breathable films 138 disposed on the top surface of the first cover 135 .
  • the sealing film 137 is provided with a second piston hole 1371, a second sample injection hole 1372 and a plurality of third vent holes 1373, the second piston hole 1371 corresponds to and communicates with the first piston hole 1351, and the second sample injection hole 1372
  • a plurality of third ventilation holes 1373 are arranged in one-to-one correspondence with a plurality of second ventilation holes 1353 and communicated with each other
  • a plurality of second waterproof gas-permeable membranes 138 are arranged in one-to-one correspondence with each other.
  • FIG. 14 an embodiment of the above-mentioned power source mechanism, which includes a piston head 18 and a piston rod 19 .
  • the piston head 18 is movably disposed in the first chamber 131 , the piston head 18 is connected with the piston rod 19 , and the piston rod 19 protrudes to the outside of the first chamber 131 through the first piston hole 1351 .
  • the piston head 18 is driven by the piston rod 19 to move, and the piston head 18 can provide pushing force or suction during the movement.
  • the reagent in the first chamber 131 can be pushed into one of the second chambers 132, and when the suction force is provided, the reagent in one of the second chambers 132 can be sucked to the interior of the first chamber 131.
  • the piston head 18 and the piston rod 19 are not arranged in the first chamber 131, but instead the piston head 18 and the piston rod 19 are arranged in a plurality of second chambers 132, that is, through the first chamber 131
  • the piston head 18 in the second chamber 132 provides power to realize the transfer between the first chamber 131; similarly, a suction mechanism is set at the end of the branch flow channel 1284, and power is provided according to the actual working state so that The nucleic acid in the first chamber 131 moves into the PCR chamber 125 in the branch flow channel 1284 .
  • the piston head 18 and the piston rod 19 are not provided in the first chamber 131, but the push force and the suction force are provided by connecting the first chamber 131 with a device connecting the air blowing and suction functions .
  • nucleic acid extraction steps are as follows:
  • Step S10 providing the reagent cartridge 10 as shown in Fig. 1 to Fig. 3;
  • the specific number of the second chambers 132 is six, and they are respectively named as the first reagent chamber 132a, the first reagent chamber 132a, and the second chamber respectively from left to right as shown in Fig.
  • Second reagent chamber 132b Third reagent chamber 132c, fourth reagent chamber 132d, fifth reagent chamber 132e and sixth reagent chamber 132f;
  • the reagent chamber 132b is in an empty state, and is used to inject the sample to be tested;
  • the third reagent chamber 132c is used to fill the first cleaning solution, for example, 500ul;
  • the fourth reagent chamber 132d is used to fill the second cleaning solution, for example, 500ul;
  • the fifth reagent chamber 132e is empty;
  • the sixth reagent chamber 132f is used to fill the eluent, for example 80ul.
  • the flow channel 124 communicates with one of the second chambers 132 corresponding to the first micro-channel 124 .
  • the first chamber 131 can be connected to the first reagent chamber 132a, the second reagent chamber 132b, the third reagent chamber 132c, the fourth reagent chamber 132d, the fifth reagent chamber 132e and the sixth reagent chamber respectively.
  • the cavities 132f are in communication.
  • Step S20 open the sealing cap 136, inject, for example, 1000ul of the sample liquid to be tested into the second reagent chamber 132b, and seal the sample port with the sealing cap 136;
  • Step S30 turn the rotary valve 112 to a designated position so that the second reagent chamber 132b communicates with the first chamber 131, pull the piston rod 19, and draw the sample liquid in the second reagent chamber 132b into the first chamber 131; Rotate the rotary valve 112 to the designated position so that the first reagent chamber 132a communicates with the first chamber 131, pull the piston rod 19, and the lysate in the first reagent chamber 132a is also drawn into the first chamber 131; continue to rotate the rotary valve 112 to the designated position so that the fifth reagent chamber 132e communicates with the first chamber 131, pushes the piston rod 19, pushes the mixed liquid of the sample liquid and the lysate into the fifth reagent chamber 132e, repeatedly pushes and pulls the piston rod 19 for example 3 to 4
  • the second time fully mix the sample liquid and the lysate, so that the analyte in the sample liquid is fully lysed, and the nucleic acid is released, and the
  • the nucleic acid cleavage process is completed; the external magnet is removed, and the rotary valve 112 is turned to a designated position so that the first chamber 131 communicates with the third reagent chamber 132c, and the plunger rod 19 is drawn, and the third reagent chamber 132c
  • the first cleaning liquid is pumped into the first chamber 131, continue to turn the rotary valve 112 to the designated position so that the first chamber 131 communicates with the fifth reagent chamber 132e, and push the piston rod 19 to push the first cleaning liquid into the fifth reagent chamber 132e.
  • the magnetic beads adsorbed with nucleic acid remain in the fifth reagent chamber 132e, and the second cleaning solution containing impurities is pushed back into the inside of the fourth reagent chamber 132d.
  • the nucleic acid is eluted from the surface of the magnetic beads with the eluent in the sixth reagent chamber 132f, and mixed with the eluent , the eluent containing nucleic acid is sucked into the first chamber 131, and at the same time, the magnetic beads are adsorbed to the side wall of the fifth reagent chamber 132e.
  • nucleic acid amplification and optical detection steps are as follows:
  • Step S40 turn the rotary valve 112 to a designated position so that the first chamber 131 communicates with the freeze-drying chamber 172, and push the eluent containing nucleic acid into the freeze-drying chamber 172 of the freeze-drying box 17 to dissolve the freeze-drying box 17 the freeze-dried powder in the chamber, and then pump the eluent back into the first chamber 131, and push and pump repeatedly, for example, 3 to 4 times, until the freeze-dried powder is completely reconstituted;
  • Step S50 when the freeze-dried powder is completely redissolved in the eluent containing nucleic acid, push the piston rod 19 to fill the inside of the eight PCR chambers 125 with the eluent, and heat the PCR chambers 125 through the heating and cooling mechanism 20. Thermal cycle processing, and fluorescent detection of samples in the PCR chamber 125 through the optical detection mechanism, thereby completing PCR amplification and detection.
  • first and second are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features.
  • the features defined as “first” and “second” may explicitly or implicitly include at least one of these features.
  • “plurality” means at least two, such as two, three, etc., unless otherwise specifically defined.
  • a first feature being "on” or “under” a second feature may mean that the first and second features are in direct contact, or that the first and second features are indirect through an intermediary. touch.
  • “above”, “above” and “above” the first feature on the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature.
  • “Below”, “beneath” and “beneath” the first feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is less horizontally than the second feature.

Abstract

一种体外诊断分析装置及试剂卡盒(10)。在旋转阀(112)的转动动作下，能实现第一腔室(131)与其中任意一个第二腔室(132)连通，便能实现第二腔室(132)的试剂与第一腔室(131)之间相互转移，并进行相应处理，从而能将样品液中的核酸提取出来。此外，旋转阀(112)转动时还能使得第一腔室(131)与PCR腔室(125)连通，便可以实现第一腔室(131)将核酸转移到PCR腔室(125)中进行扩增与检测处理。

Description

体外诊断分析装置及试剂卡盒
相关申请的交叉引用
本公开要求于2021年9月17日提交中国专利局、申请号为2021110931461、名称为“体外诊断分析装置及试剂卡盒”的中国专利的优先权，所述专利申请的全部内容通过引用结合在本公开中。
技术领域
本申请涉及分子诊断技术领域，特别是涉及一种体外诊断分析装置及试剂卡盒。
背景技术
分子诊断是指应用分子生物学方法检测患者体内遗传物质的结构或表达水平的变化而做出诊断的技术。分子诊断是预测诊断的主要方法，既可以进行个体遗传病的诊断，也可以进行产前诊断。分子诊断主要是指编码与疾病相关的各种结构蛋白、酶、抗原抗体、免疫活性分子基因的检测。分子诊断的主要技术有核酸分子杂交、聚合酶链反应和生物芯片技术等。
然而，对于样品的核酸检测，一般分为核酸提取、核酸扩增和核酸检测三个步骤。目前商品化的核酸检测产品，核酸提取、核酸扩增和核酸检测大多是独立进行的方式，前序步骤完成后再将样品移动到后序的设备中进行后序步骤的完成，相应的，前序步骤不能有效地与后序步骤集成连续进行。
传统的各步骤独立完成的核酸检测试剂产品，每个步骤都需要独立的设备完成，一次核酸检测过程中需要多台设备，设备占用空间大；进一步地，前序步骤完成后需要将试剂样品移动到后序的设备中，操作繁琐，耗时较长，对环境和人员要求较高；同时，非集成的试剂产品，在前序步骤向后序步骤进行切换时，试剂样品在移动过程中也易受到外部环境的污染或污染检测环境。
发明内容
基于此，有必要克服现有技术的缺陷，提供一种体外诊断分析装置及试剂卡盒，它能实现多步骤的生化反应过程，从而减少人工操作能提高操作的一致性，大幅缩短试剂样品的处理时间，能避免交叉污染，并能提高工作效率。
其技术方案如下：一种试剂卡盒，所述试剂卡盒包括：微流控芯片，所述微流控芯片的底面上设有第一孔、多个第二孔、第三孔；多个所述第二孔与所述第三孔绕所述第一孔周向间隔设置；所述微流控芯片上还设有与多个所述第二孔一一对应设置的多个第一微流道、与所述第三孔通过第二微流道连通的PCR腔室；底座，所述底座设于所述微流控芯片的底面， 所述底座包括转动设置的旋转阀；所述旋转阀上设有连通槽，所述连通槽的一端与所述第一孔对应且相连通，所述连通槽的另一端随着所述旋转阀的转动与所有第二孔中的一个或所述第三孔对应相通；存储盒，所述存储盒设有第一腔室与多个第二腔室；所述第一腔室与所述第一孔相连通；多个所述第二腔室与多个所述第一微流道一一对应并连通；所述第一腔室能够连接用于推动试剂流动的动力源机构，或者所有所述第二腔室和所述PCR腔室均能够连接用于推动试剂流动的动力源机构。
在其中一个实施例中，所述底座还包括固定座，所述旋转阀转动地设置于所述固定座的底面，所述固定座的底面上设有多个连通孔，所述第一孔、所有所述第二孔、所述第三孔分别与所有所述连通孔一一对应设置并连通。
在其中一个实施例中，所述底座还包括设置于所述固定座与所述旋转阀之间的密封垫；所述密封垫上设有多个贯穿孔；多个所述贯穿孔与多个所述连通孔位置一一对应设置并连通。
在其中一个实施例中，所述固定座上设置有第一凹部，所述旋转阀与所述密封垫均设置于所述第一凹部内且所述旋转阀相对所述固定座转动，所述密封垫的顶面与所述第一凹部的底壁紧密贴合；所述第一凹部的壁上设有倒钩，所述倒钩卡接抵触于所述旋转阀上。
在其中一个实施例中，所述密封垫固定地设于所述第一凹部的底壁上；所述旋转阀面向所述密封垫的端面上设有第二凹部，所述密封垫的底部与所述第二凹部相适应。
在其中一个实施例中，所述存储盒上设有定位柱，所述微流控芯片上设有与所述定位柱位置相应的第一定位孔，所述固定座上设有与所述第一定位孔位置相应的第二定位孔，所述定位柱插入到所述第一定位孔与所述第二定位孔中。
在其中一个实施例中，所述试剂卡盒还包括用于放置冷冻试剂的冻干腔室，所述第二微流道通过所述冻干腔室与所述PCR腔室相连通。
在其中一个实施例中，所述微流控芯片上还设有主干流道、至少两个分支流道以及至少两个第一通气孔；所述主干流道与所述冻干腔室相连通，所有所述分支流道的一端均与所述主干流道相连通，所述分支流道的另一端与所述第一通气孔一一对应连通；每个所述分支流道上串设有所述PCR腔室。
在其中一个实施例中，所述微流控芯片上还设置有至少两个第一防水透气膜，所述第一防水透气膜一一对应地设置于所述第一通气孔的孔壁上。
在其中一个实施例中，所述存储盒包括第一盒本体、盖设于所述第一盒本体上的第一盖板、以及封堵盖；所述第一腔室与多个所述第二腔室均设置于所述第一盒本体上；所述第一盖板上设有第一加样孔与多个第二通气孔，所述第一加样孔与其中一个所述第二腔室位置对应设置并相连通，所述封堵盖可拆卸地盖设于所述第一加样孔，多个所述第二通气孔与其余所述第二腔室位置一一对应设置并相连通。
在其中一个实施例中，所述存储盒还包括设置于所述第一盖板的顶面上的密封膜与多个 第二防水透气膜；所述密封膜上设有第二加样孔与多个第三通气孔，所述第二加样孔与所述第一加样孔位置相对应并连通，多个所述第三通气孔与多个所述第二通气孔一一对应设置并连通，多个所述第二防水透气膜一一对应地设置于多个所述第三通气孔的孔壁上。
在其中一个实施例中，所述第一盖板上设有第一活塞孔；所述第一活塞孔与所述第一腔室位置对应设置并相连通，所述动力源机构包括活塞头与活塞杆，所述活塞头活动地设置于所述第一腔室内，所述活塞头与所述活塞杆相连，所述活塞杆通过所述第一活塞孔伸出到所述第一腔室的外部。
一种体外诊断分析装置，所述体外诊断分析装置包括所述的试剂卡盒，所述体外诊断分析装置还包括升降温机构与荧光检测机构，所述升降温机构设置于所述微流控芯片的其中一侧面用于对所述PCR腔室进行升温处理或降温处理，所述荧光检测机构设置于所述微流控芯片的另一侧面用于对所述PCR腔室进行光学检测。
上述的试剂卡盒工作时，将试剂例如裂解液、样品液、清洗液以及洗脱液分别装设于多个第二腔室的内部，通过驱动旋转阀转动，连通槽的一端和与第一孔相对应的连通孔相连通，连通槽的另一端随着旋转阀的转动可移动到与其余连通孔相连通的位置，当连通槽另一端与其余连通孔中的其中一个连通时，第一腔室通过第一孔、连通槽、其中一个第二孔、与该第二孔对应连通的第一微流道、与第一微流道对应连通的第二腔室连通，在动力源机构的作用下便可以实现其中一个第二腔室内的试剂转移到第一腔室中进行处理，类似地，在旋转阀的转动动作下，还能实现第一腔室与其它的第二腔室连通，在动力源机构的作用下便能实现其它第二腔室的试剂与第一腔室之间相互转移，并进行相应处理，从而能将样品液中的核酸提取出来。此外，旋转阀转动时还能使得第一腔室通过第一孔、连通槽、第三孔、与第三孔对应连通的第二微流道、与第二微流道对应连通的PCR腔室连通，在动力源机构的作用下便可以实现第一腔室将核酸转移到PCR腔室中进行扩增与检测处理。如此可见，它能利用高度集成的功能单元实现多步骤的生化反应过程，减少人工操作，可以实现样品入-结果出的自动化解决方案，减小反应体系和所需试剂用量，大幅缩短样品处理时间，全封闭的芯片-试剂一体化体系避免交叉污染，自动化控制减少人工操作过程，提高操作的一致性。
上述的体外诊断分析装置，由于包括上述的试剂卡盒，技术效果由试剂卡盒带来，有益效果与试剂卡盒的有益效果相同，在此不再赘述。
附图说明
构成本申请的一部分的附图用来提供对本申请的进一步理解，本申请的示意性实施例及其说明用于解释本申请，并不构成对本申请的不当限定。
为了更清楚地说明本申请实施例中的技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的一些实施例，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为本申请一实施例的体外诊断分析装置的结构示意图；
图2为图1中隐藏掉升降温机构与荧光检测机构后的结构示意图；
图3为图2分解结构示意图；
图4为图2的剖视结构示意图；
图5为图2的俯视视角的透视图；
图6为本申请一实施例的底座的分解结构示意图；
图7为本申请一实施例的固定座的仰视图；
图8为本申请一实施例的密封垫的仰视图；
图9为本申请一实施例的旋转阀的俯视图；
图10为本申请一实施例的底座的剖视结构图；
图11为本申请一实施例的微流控芯片的结构示意图；
图12为本申请一实施例的微流控芯片的仰视结构示意图；
图13为本申请一实施例的冻干盒的分解结构示意图；
图14为本申请一实施例的存储盒的分解结构示意图；
图15为本申请一实施例的第一盒本体的俯视结构示意图。
10、试剂卡盒；11、底座；111、固定座；1111、连通孔；1112、第一凹部；1113、倒钩；1114、限位口；1115、第二定位孔；112、旋转阀；1121、连通槽；1122、第二凹部；1123、插孔；113、密封垫；1131、贯穿孔；1132、凸起；12、微流控芯片；121、第一孔；122、第二孔；123、第三孔；124、第一微流道；125、PCR腔室；126、第二微流道；127、第一定位孔；1283、主干流道；1284、分支流道；1285、第一通气孔；1286、第一防水透气膜；13、存储盒；131、第一腔室；1311、第一过孔；132、第二腔室；1321、第二过孔；132a、第一试剂腔；132b、第二试剂腔；132c、第三试剂腔；132d、第四试剂腔；132e、第五试剂腔；132f、第六试剂腔；133、定位柱；134、第一盒本体；135、第一盖板；1351、第一活塞孔；1352、第一加样孔；1353、第二通气孔；136、封堵盖；137、密封膜；1371、第二活塞孔；1372、第二加样孔；1373、第三通气孔；138、第二防水透气膜；17、冻干盒；171、第二对接孔；172、冻干腔室；173、第三对接孔；174、第二盒本体；175、第二盖板；18、活塞头；19、活塞杆；20、升降温机构；30、荧光检测机构；40、驱动杆。
具体实施方式
为使本申请的上述目的、特征和优点能够更加明显易懂，下面结合附图对本申请的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本申请。但是本申请能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本申请 内涵的情况下做类似改进，因此本申请不受下面公开的具体实施例的限制。
参阅图1至图3，图1示出了本申请一实施例的体外诊断分析装置的结构示意图，图2示出了图1中隐藏掉升降温机构20与荧光检测机构30后的结构示意图，图3示出了图2分解结构示意图。本申请一实施例提供的一种体外诊断分析装置，体外诊断分析装置包括试剂卡盒10、升降温机构20与荧光检测机构30。升降温机构20设置于微流控芯片12的其中一侧面用于对PCR腔室125进行升温处理或降温处理，荧光检测机构30设置于微流控芯片12的另一侧面用于对PCR腔室125进行光学检测。
请参阅图4至图10，图4示出了图2的剖视结构示意图，图5示出了图2的俯视视角的透视图，图6为本申请一实施例的底座11的分解结构示意图，图7至图8分别示出了为本申请一实施例的固定座111、密封垫113的仰视图，图9示出了旋转阀112的俯视图，图10示出了本申请一实施例的底座11的剖视结构图。具体而言，试剂卡盒10包括底座11、微流控芯片12以及存储盒13。
此外，请参阅图10至图12，图11示出了本申请一实施例的微流控芯片12的结构示意图，图12示出了本申请一实施例的微流控芯片12的仰视结构示意图。
微流控芯片12的底面上设有第一孔121、多个第二孔122、第三孔123。多个第二孔122与第三孔123绕第一孔121周向间隔设置。微流控芯片12上还设有与多个第二孔122一一对应设置的多个第一微流道124。微流控芯片12上还设有PCR腔室125，第三孔123与PCR腔室125通过第二微流道126相连通。
请参阅图3、图4与图6，底座11设于微流控芯片12的底面。底座11具体例如包括固定座111与转动地设置于固定座111的底面上的旋转阀112，固定座111的底面上设有多个连通孔1111。多个连通孔1111与多个连接孔一一对应连通设置。旋转阀112上设有连通槽1121，连通槽1121的一端和与第一孔121相对应的连通孔1111相连通，连通槽1121的另一端随着旋转阀112的转动可移动到与其余连通孔1111相连通的位置。
可以理解的是，作为一个可选的方案，也可以不进行设置固定座111，即将旋转阀112例如转动地设置于底座11上，并位于微流控芯片12的底面，连通槽1121的一端与第一孔121对应且相连通，连通槽1121的另一端随着旋转阀112的转动与所有第二孔122中的一个或第三孔123对应相通。
请参阅图3、图4与图6，存储盒13设于微流控芯片12的顶面上，存储盒13设有第一腔室131与多个第二腔室132。第一腔室131的底壁上设有第一过孔1311，第一过孔1311与第一孔121相连通。多个第二腔室132与多个第一微流道124一一对应并连通。具体而言，第二腔室132的底壁上设有第二过孔1321，多个第二过孔1321与多个第一微流道124位置一一对应并连通。
此外，第一腔室131能够连接用于推动试剂流动的动力源机构；或者所有第二腔室132 和PCR腔室125均能够连接用于推动试剂流动的动力源机构。本实施例中，动力源机构包括但不限于活塞驱动方式、气泵驱动方式等等，只要能提供推动力来使得试剂从第一腔室131分别进入到第二腔室132、PCR腔室125，以及从第二腔室132进入到第一腔室131中即可。
需要说明的是，第一孔121由于需要连通第一通孔与第一过孔1311，即第一孔121为通孔。此外，第二孔122、第三孔123均可以是盲孔，也可以是通孔，在此不进行限制。另外，第一过孔1311与第二过孔1321均为通孔，即第一腔室131通过第一过孔1311与第一孔121连通，第二腔室132通过第二过孔1321与第一微流道124连通。
上述的试剂卡盒10工作时，将试剂例如裂解液、样品液、清洗液以及洗脱液分别装设于多个第二腔室132的内部，通过驱动旋转阀112转动，连通槽1121的一端和与第一孔121相对应的连通孔1111相连通，连通槽1121的另一端随着旋转阀112的转动可移动到与其余连通孔1111相连通的位置，当连通槽1121另一端与其余连通孔1111中的其中一个连通时，第一腔室131通过第一孔121、与第一孔121相对应的连通孔1111、连通槽1121、连通槽1121另一端对应连通的连通孔1111、第二孔122、与第二孔122对应连通的第一微流道124、与第一微流道124对应连通的其中一个第二腔室132连通，在动力源机构的作用下便可以实现其中一个第二腔室132内的试剂转移到第一腔室131中进行处理，类似地，在旋转阀112的转动动作下，还能实现第一腔室131与其它的第二腔室132连通，在动力源机构的作用下便能实现其它第二腔室132的试剂与第一腔室131之间相互转移，并进行相应处理，从而能将样品液中的核酸提取出来。此外，旋转阀112转动时还能使得第一腔室131通过第一孔121、与第一孔121相对应的连通孔1111、连通槽1121、连通槽1121另一端对应连通的连通孔1111、第三孔123、与第三孔123对应连通的第二微流道126、与第二微流道126对应连通的PCR腔室125连通，在动力源机构的作用下便可以实现第一腔室131将核酸转移到PCR腔室125中进行扩增与检测处理。如此可见，它能利用高度集成的功能单元实现多步骤的生化反应过程，减少人工操作，可以实现样品入-结果出的自动化解决方案，减小反应体系和所需试剂用量，大幅缩短样品处理时间，全封闭的芯片-试剂一体化体系避免交叉污染，自动化控制减少人工操作过程，提高操作的一致性。
请参阅图6至图10，在一个实施例中，底座11还包括设置于固定座111与旋转阀112之间的密封垫113。密封垫113上设有多个贯穿孔1131。多个贯穿孔1131与多个连通孔1111位置一一对应设置并连通。如此，通过在旋转阀112与固定座111之间设置密封垫113，密封垫113能保证连通槽1121的一端和与第一孔121相对应的连通孔1111的对接位置处较好的密封性，以及保证连通槽1121的另一端与其余连通孔1111对接位置处的密封性。此外，为了保证密封性，密封垫113的顶面与固定座111的底面紧密接触，密封垫113的底面与旋转阀112的顶面紧密接触，这样便能避免密封垫113的顶面与固定座111的底面之间存在间隙而导致试剂通过该间隙流动到其它任意一个连通孔1111中。另外，密封垫113具体例如选 用弹性垫，具体例如为硅胶垫、橡胶垫、乳胶垫等等，当然还可以是其它弹性材质的弹性垫，在此不进行限定。
请参阅图10，在一个实施例中，固定座111的底面上设置有第一凹部1112，旋转阀112与密封垫113均设置于第一凹部1112内且旋转阀112相对固定座111转动，具体而言，旋转阀112的侧壁能相对于第一凹部1112的侧壁转动。密封垫113的顶面与第一凹部1112的底壁紧密贴合。第一凹部1112的壁上设有倒钩1113，倒钩1113卡接抵触于旋转阀112上。如此，密封垫113与旋转阀112装设于第一凹部1112内，并通过倒钩1113抵触于旋转阀112的底面来限制旋转阀112的位置，这样能使得密封垫113的两个侧面分别与旋转阀112与固定座111紧密接触配合；此外旋转阀112转动过程中运行较为稳定。具体而言，为了提高稳定性，倒钩1113的数量不限于是一个，例如可以是两个、三个或其它数量，即通过两个以上倒钩1113来同步抵触于旋转阀112的底面。倒钩1113具体例如为弹性钩体，例如选用金属钩、硅胶钩、橡胶钩、塑胶钩等等，可以与固定座111为一体化结构，也可以是分体结构并相互组装在一起，在此不进行限制，根据实际需求进行设置。另外，为了便于旋转阀112在第一凹部1112内自由转动，旋转阀112呈圆柱体状，第一凹部1112与旋转阀112的形状相适应。
作为一个可选的方案，也可以在第一凹部1112的壁上设置卡槽，旋转阀112的外缘转动地设置于卡槽中，一方面能实现密封垫113的两个侧面分别与旋转阀112与固定座111紧密接触配合，另一方面也能实现旋转阀112的转动。
请参阅图10，在一个实施例中，密封垫113固定地设于第一凹部1112的底壁上。旋转阀112面向密封垫113的端面上设有第二凹部1122，密封垫113的底部与第二凹部1122相适应，密封垫113的底面与第二凹部1122的底壁均为圆形面。如此，旋转阀112能相对于密封垫113自由转动，旋转阀112与密封垫113两者对位准确，这样旋转阀112转动预设角度后，便能实现连通槽1121的另一端准确地移动到与多个贯穿孔1131中的其中一个相连通的位置。
请参阅图1与图10，进一步地，为了便于驱动旋转阀112转动，旋转阀112与驱动杆40相连，通过驱动杆40来驱动旋转阀112转动。具体例如，在旋转阀112背离于密封垫113的端面上设有与驱动杆40装配的插孔1123，插孔1123的形状与驱动杆40的端部形状相适应，这样将驱动杆40的端部插入到插孔1123中，转动驱动杆40便能相应带动旋转阀112转动从而调整角度。当然，驱动杆40也可以采用其它的方式来驱动旋转阀112转动，在此不进行限定。
参阅图7与图8，需要说明的是，为了实现密封垫113固定地设于第一凹部1112的底壁上，作为一个示例，密封垫113的外缘设有凸起1132，第一凹部1112的底壁上设有与凸起1132相适应的限位口1114，凸起1132设于限位口1114中，便能实现密封垫113固定地设于 第一凹部1112的底壁上，即在旋转阀112转动时，密封垫113不会跟随旋转阀112一起转动。
在一个实施例中，微流控芯片12粘接固定于、焊接固定于、或通过安装件固定装设于固定座111的顶面；存储盒13粘接固定于、焊接固定于、或通过安装件固定装设于微流控芯片12的顶面上。
在一个实施例中，存储盒13的底面上设有定位柱133。微流控芯片12上设有与定位柱133位置相应的第一定位孔127，固定座111上设有与第一定位孔127位置相应的第二定位孔1115，定位柱133插入到第一定位孔127与第二定位孔1115中。如此，定位柱133插入到第一定位孔127与第二定位孔1115中后，能实现固定座111、微流控芯片12与存储盒13三者准确对位，利于快速组装，组装效率较高。具体而言，定位柱133的数量例如可以是一个、两个、三个或以上，第一定位孔127与第二定位孔1115的数量均例如相应为一个、两个、三个或以上。
参阅图3、图5、图12与图13，在一个实施例中，试剂卡盒10还包括用于放置冷冻试剂的冻干腔室172。第二微流道126通过冻干腔室172与PCR腔室125相连通。具体而言，试剂卡盒10还包括用于放置冷冻试剂的冻干盒17。冻干盒17设有冻干腔室172。此外，具体而言，冻干盒17设有与第二微流道126相连通的第二对接孔171，与第二对接孔171相连通的冻干腔室172，与冻干腔室172连通的第三对接孔173。第三对接孔173与PCR腔室125相连通。如此，可以将冻干试剂设置于冻干腔室172的内部，待核酸提取于第一腔室131，转动旋转阀112使得第一腔室131通过第一孔121、与第一孔121相对应的连通孔1111、连通槽1121、连通槽1121另一端对应连通的连通孔1111、第三孔123、与第三孔123对应连通的第二微流道126、与第二微流道126对应连通的PCR腔室125连通，通过例如活塞推压第一腔室131，使第一腔室131内的核酸通过第一过孔1311、第一孔121、与第一孔121相对应的连通孔1111、连通槽1121、连通槽1121另一端对应连通的连通孔1111、第三孔123、与第三孔123对应连通的第二微流道126、第二对接孔171进入到冻干腔室172中，核酸将冻干腔室172内的冻干试剂溶解后，在受到第一腔室131的推压力作用下继续前行进入到PCT腔室中进行扩增与光学检测。
参阅图3、图5、图12与图13，在一个实施例中，微流控芯片12上还设有主干流道1283、至少两个分支流道1284以及至少两个第一通气孔1285。主干流道1283与冻干腔室172相连通，所有分支流道1284的一端均与主干流道1283相连通，分支流道1284的另一端与第一通气孔1285一一对应连通。每个分支流道1284上串设有PCR腔室125。如此，核酸与冻干试剂通过主干流道1283分别进入到各个分支流道1284中的PCR腔室125的内部，通过两个以上PCR腔室125内同步进行扩增与光学检测，能大大提高工作效率，以及提高试验结果的可靠性。此外，由于第一通气孔1285可以向外排气，能维持气压平衡，使得核酸与冻干试剂在气压推动下便能进入到分支流道1284中的PCR腔室125的内部。另外，各个PCR腔室125内 具体例如封装不同的反应试剂，以实现核酸多重检测。需要说明的是，PCR腔室125的具体数量例如为2个、3个、4个、8个、16个等等，根据实际需求进行设置，在此不进行限定。
参阅图5与图11，在一个实施例中，微流控芯片12上还设置有至少两个第一防水透气膜1286，至少两个第一防水透气膜1286一一对应地设置于至少两个第一通气孔1285的孔壁上。如此，第一防水透气膜1286能允许气体向外排出，维持分支流道1284内部气压平衡，但能避免液体向外排出，以及能避免外界液体进入，即能避免PCR腔室125内部的试剂受到污染。
请参阅图14，在一个实施例中，存储盒13包括第一盒本体134、盖设于第一盒本体134上的第一盖板135、以及封堵盖136。第一腔室131与多个第二腔室132均设置于第一盒本体134上。第一盖板135上设有第一活塞孔1351、第一加样孔1352与多个第二通气孔1353。第一活塞孔1351与第一腔室131位置对应设置并相连通，第一加样孔1352与其中一个第二腔室132位置对应设置并相连通，封堵盖136可拆卸地盖设于第一加样孔1352，多个第二通气孔1353与其余第二腔室132位置一一对应设置并相连通。
请参阅图14，进一步地，存储盒13还包括设置于第一盖板135的顶面上的密封膜137与多个第二防水透气膜138。密封膜137上设有第二活塞孔1371、第二加样孔1372与多个第三通气孔1373，第二活塞孔1371与第一活塞孔1351位置相对应并连通，第二加样孔1372与第一加样孔1352位置相对应并连通，多个第三通气孔1373与多个第二通气孔1353一一对应设置并连通，多个第二防水透气膜138一一对应地设置于多个第三通气孔1373的孔壁上。
请参阅图14，上述动力源机构的一实施例，其包括活塞头18与活塞杆19。活塞头18活动地设置于第一腔室131内，活塞头18与活塞杆19相连，活塞杆19通过第一活塞孔1351伸出到第一腔室131的外部。如此，当通过转动旋到指定位置来使得第一腔室131与其中一个第二腔室132连通后，通过活塞杆19带动活塞头18移动，活塞头18移动过程中能提供推压力或抽吸力，提供推压力时便能实现将第一腔室131内的试剂推到其中一个第二腔室132中，提供抽吸力时便能实现将其中一个第二腔室132中的试剂抽吸到第一腔室131的内部。
需要说明的是，多个第二腔室132的具体数量与具体体积尺寸根据实际情况进行设置，在此不进行限定。
作为一个可选的方案，并不在第一腔室131中设置活塞头18与活塞杆19，而是反过来在多个第二腔室132中均设置活塞头18与活塞杆19，即通过第二腔室132中的活塞头18来提供动力实现与第一腔室131之间的转移；同样地，以及在分支流道1284的端部设置抽吸机构，并根据实际工作状态时提供动力使得第一腔室131中的核酸移动到分支流道1284中的PCR腔室125中。
作为一个可选的方案，并不在第一腔室131中设置活塞头18与活塞杆19，而是通过将第一腔室131连通鼓气与抽吸功能的装置来提供推压力与抽吸力。
为了使得本实施例更加清楚，下面对核酸的提取、扩增与光学检测的具体方法进行详细说明。其中，核酸提取步骤如下：
步骤S10、提供如图1至图3所示的试剂卡盒10；
具体而言，请参阅图4、图14与图15，以第二腔室132的具体数量为6个，并按照从如图4所示的左到右依次分别命名为第一试剂腔132a、第二试剂腔132b、第三试剂腔132c、第四试剂腔132d、第五试剂腔132e与第六试剂腔132f；第一试剂腔132a用于装设磁珠裂解液，例如为1000ul；第二试剂腔132b为空置状态，用于注入待检测样本；第三试剂腔132c用于装入第一清洗液，例如为500ul；第四试剂腔132d用于装入第二清洗液，例如为500ul；第五试剂腔132e为空置状态；第六试剂腔132f用于装入洗脱液，例如为80ul。当第二腔室132为6个时，相应地，第二过孔1321、第一微流道124、第二孔122均相应为6个，当旋转阀112转动时能使得第一腔室131通过第一孔121、与第一孔121相对应的连通孔1111、连通槽1121、连通槽1121另一端对应连通的连通孔1111、第二孔122、与第二孔122对应连通的第一微流道124、与第一微流道124对应连通的其中一个第二腔室132连通。换言之，通过转动旋转阀112，能实现第一腔室131分别与第一试剂腔132a、第二试剂腔132b、第三试剂腔132c、第四试剂腔132d、第五试剂腔132e与第六试剂腔132f相连通。此外，PCR腔室125具体例如为8个，且8个PCR腔室125内具体例如封装不同的反应试剂，以实现核酸多重检测。
步骤S20、打开封堵盖136，向第二试剂腔132b中注入例如1000ul待检测的样本液体后，用封堵盖136密封加样口；
步骤S30、转动旋转阀112到指定位置使得第二试剂腔132b与第一腔室131相连通，抽动活塞杆19，将第二试剂腔132b内的样本液体抽入到第一腔室131；再转动旋转阀112到指定位置使得第一试剂腔132a与第一腔室131相连通，抽动活塞杆19，将第一试剂腔132a内的裂解液也抽入第一腔室131；继续转动旋转阀112到指定位置使得第五试剂腔132e与第一腔室131相连通，推动活塞杆19，将样本液体和裂解液的混合液体推入第五试剂腔132e，反复推拉活塞杆19例如3～4次，充分混合样本液体和裂解液，使样本液体中的待测物充分裂解，释放出核酸，并由裂解液中的磁珠通过化学键结合的方式将核酸吸附到磁珠表面。此时移动外部磁铁到第五试剂腔132e的侧壁，将磁珠吸附到第五试剂腔132e的侧壁；抽动活塞杆19将第五试剂腔132e内不含磁珠的废液抽入到第一腔室131，再转动旋转阀112使得第二腔室132与第五试剂腔132e相连通，推动活塞杆19将废液推入第二试剂腔132b。此时完成了核酸的裂解过程；将外部磁铁移开，并转动旋转阀112到指定位置使得第一腔室131与第三试剂腔132c相连通，抽动活塞杆19，将第三试剂腔132c内的第一清洗液抽入第一腔室131，继续转动旋转阀112到指定位置使得第一腔室131与第五试剂腔132e相连通，并推动活塞杆19将第一清洗液推入第五试剂腔132e，反复推抽活塞杆19例如为3～4次，将第一清洗液与 第五试剂腔132e内的磁珠充分混合，并请将残留在磁珠表面的细胞壁、蛋白等杂质洗掉。重复排除样本裂解液混合液体的步骤，将含有杂质的第一清洗液推回到第三试剂腔132c内，完成核酸的第一次清洗；类似于核酸的第一次清洗步骤，通过转动旋转阀112位置的不同，借助第四试剂腔132d室内的第二清洗液能完成核酸的第二次清洗，此时吸附有核酸的磁珠保留在第五试剂腔132e内部，含有杂质的第二清洗液被推回带第四试剂腔132d的内部。类似于上述对核酸的第一次清洗步骤，通过转动旋转阀112位置的不同，用第六试剂腔132f内的洗脱液，将核酸从磁珠表面洗脱下来，并与洗脱液混匀，将含有核酸的洗脱液抽吸到第一腔室131，同时磁珠吸附到第五试剂腔132e的侧壁上。
此外，核酸的扩增与光学检测步骤如下：
步骤S40、转动旋转阀112到指定位置使得使得第一腔室131与冻干腔室172连通，将含有核酸的洗脱液推入到冻干盒17的冻干腔室172溶解冻干盒17内的冻干粉，再将洗脱液抽回到第一腔室131内，反复推抽例如3～4次，至冻干粉完全复溶；
步骤S50、当冻干粉完全复溶于带有核酸的洗脱液中后，推动活塞杆19使洗脱液充满8个PCR腔室125的内部，通过升降温机构20对PCR腔室125进行热循环处理，以及通过光学检测机构对PCR腔室125内的样品进行荧光检测，从而完成PCR扩增和检测。
以上实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对申请专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请专利的保护范围应以所附权利要求为准。
在本申请的描述中，需要理解的是，术语“中心”、“纵向”、“横向”、“长度”、“宽度”、“厚度”、“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”、“顺时针”、“逆时针”、“轴向”、“径向”、“周向”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装置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”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括至少一个该特征。在本申请的描述中，“多个”的含义是至少两个，例如两个，三个等，除非另有明确具体的限定。
在本申请中，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”、“固 定”等术语应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接；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或两个元件的相互作用关系，除非另有明确的限定。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本申请中的具体含义。
在本申请中，除非另有明确的规定和限定，第一特征在第二特征“上”或“下”可以是第一和第二特征直接接触，或第一和第二特征通过中间媒介间接接触。而且，第一特征在第二特征“之上”、“上方”和“上面”可是第一特征在第二特征正上方或斜上方，或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”可以是第一特征在第二特征正下方或斜下方，或仅仅表示第一特征水平高度小于第二特征。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所使用的术语“垂直的”、“水平的”、“上”、“下”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。

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  1. 一种试剂卡盒，所述试剂卡盒包括：
    微流控芯片，所述微流控芯片的底面上设有第一孔、多个第二孔、第三孔；多个所述第二孔与所述第三孔绕所述第一孔周向间隔设置；所述微流控芯片上还设有与多个所述第二孔一一对应设置的多个第一微流道、与所述第三孔通过第二微流道连通的PCR腔室；
    底座，所述底座设于所述微流控芯片的底面，所述底座包括转动设置的旋转阀；所述旋转阀上设有连通槽，所述连通槽的一端与所述第一孔对应且相连通，所述连通槽的另一端随着所述旋转阀的转动与所有第二孔中的一个或所述第三孔对应相通；
    存储盒，所述存储盒设有第一腔室与多个第二腔室；所述第一腔室与所述第一孔相连通；多个所述第二腔室与多个所述第一微流道一一对应并连通；所述第一腔室能够连接用于推动试剂流动的动力源机构，或者所有所述第二腔室和所述PCR腔室均能够连接用于推动试剂流动的动力源机构。
  2. 根据权利要求1所述的试剂卡盒，其中，所述底座还包括固定座，所述旋转阀转动地设置于所述固定座的底面，所述固定座的底面上设有多个连通孔，所述第一孔、所有所述第二孔、所述第三孔分别与所有所述连通孔一一对应设置并连通。
  3. 根据权利要求2所述的试剂卡盒，其中，所述底座还包括设置于所述固定座与所述旋转阀之间的密封垫；所述密封垫上设有多个贯穿孔；多个所述贯穿孔与多个所述连通孔位置一一对应设置并连通。
  4. 根据权利要求3所述的试剂卡盒，其中，所述固定座上设置有第一凹部，所述旋转阀与所述密封垫均设置于所述第一凹部内且所述旋转阀相对所述固定座转动，所述密封垫的顶面与所述第一凹部的底壁紧密贴合；所述第一凹部的壁上设有倒钩，所述倒钩卡接抵触于所述旋转阀上。
  5. 根据权利要求4所述的试剂卡盒，其中，所述密封垫固定地设于所述第一凹部的底壁上；所述旋转阀面向所述密封垫的端面上设有第二凹部，所述密封垫的底部与所述第二凹部相适应。
  6. 根据权利要求2所述的试剂卡盒，其中，所述存储盒上设有定位柱，所述微流控芯片上设有与所述定位柱位置相应的第一定位孔，所述固定座上设有与所述第一定位孔位置相应的第二定位孔，所述定位柱插入到所述第一定位孔与所述第二定位孔中。
  7. 根据权利要求1所述的试剂卡盒，其中，所述试剂卡盒还包括用于放置冷冻试剂的冻干腔室，所述第二微流道通过所述冻干腔室与所述PCR腔室相连通。
  8. 根据权利要求7所述的试剂卡盒，其中，所述微流控芯片上还设有主干流道、至少两 个分支流道以及至少两个第一通气孔；所述主干流道与所述冻干腔室相连通，所有所述分支流道的一端均与所述主干流道相连通，所述分支流道的另一端与所述第一通气孔一一对应连通；每个所述分支流道上串设有所述PCR腔室。
  9. 根据权利要求8所述的试剂卡盒，其中，所述微流控芯片上还设置有至少两个第一防水透气膜，所述第一防水透气膜一一对应地设置于所述第一通气孔的孔壁上。
  10. 根据权利要求1所述的试剂卡盒，其中，所述存储盒包括第一盒本体、盖设于所述第一盒本体上的第一盖板、以及封堵盖；所述第一腔室与多个所述第二腔室均设置于所述第一盒本体上；所述第一盖板上设有第一加样孔与多个第二通气孔，所述第一加样孔与其中一个所述第二腔室位置对应设置并相连通，所述封堵盖可拆卸地盖设于所述第一加样孔，多个所述第二通气孔与其余所述第二腔室位置一一对应设置并相连通。
  11. 根据权利要求10所述的试剂卡盒，其中，所述存储盒还包括设置于所述第一盖板的顶面上的密封膜与多个第二防水透气膜；所述密封膜上设有第二加样孔与多个第三通气孔，所述第二加样孔与所述第一加样孔位置相对应并连通，多个所述第三通气孔与多个所述第二通气孔一一对应设置并连通，多个所述第二防水透气膜一一对应地设置于多个所述第三通气孔的孔壁上。
  12. 根据权利要求10所述的试剂卡盒，其中，所述第一盖板上设有第一活塞孔；所述第一活塞孔与所述第一腔室位置对应设置并相连通，所述动力源机构包括活塞头与活塞杆，所述活塞头活动地设置于所述第一腔室内，所述活塞头与所述活塞杆相连，所述活塞杆通过所述第一活塞孔伸出到所述第一腔室的外部。
  13. 一种体外诊断分析装置，其中，所述体外诊断分析装置包括如权利要求1至12任意一项所述的试剂卡盒，所述体外诊断分析装置还包括升降温机构与荧光检测机构，所述升降温机构设置于所述微流控芯片的其中一侧面用于对所述PCR腔室进行升温处理或降温处理，所述荧光检测机构设置于所述微流控芯片的另一侧面用于对所述PCR腔室进行光学检测。
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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115382586A (zh) * 2021-05-24 2022-11-25 广州万孚生物技术股份有限公司 驱动装置与医疗检测系统

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN117070334B (zh) * 2023-10-13 2024-01-26 鲲鹏基因（北京）科技有限责任公司 一种多指标检测试剂盒及pcr反应装置

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107502544A (zh) * 2017-09-20 2017-12-22 北京丰特云基科技发展有限公司 一种微流控芯片检测控制系统
CN112844505A (zh) * 2021-03-05 2021-05-28 江苏汇先医药技术有限公司 一种用于核酸提取扩增的立式微流控芯片及方法
CN112871230A (zh) * 2021-03-05 2021-06-01 江苏汇先医药技术有限公司 一种核酸扩增用的立式微流控芯片
CN112940922A (zh) * 2021-02-19 2021-06-11 清华大学 一种全集成病原体核酸检测微流控芯片
CN112934285A (zh) * 2021-04-09 2021-06-11 四川微康朴澜医疗科技有限责任公司 一种全自动全封闭式荧光定量pcr微流控诊断芯片
CN112980650A (zh) * 2021-03-05 2021-06-18 江苏汇先医药技术有限公司 一种核酸提取用的立式微流控芯片及方法
CN216149780U (zh) * 2021-09-17 2022-04-01 上海微创惟微诊断技术有限公司 体外诊断分析装置及试剂卡盒

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107502544A (zh) * 2017-09-20 2017-12-22 北京丰特云基科技发展有限公司 一种微流控芯片检测控制系统
CN112940922A (zh) * 2021-02-19 2021-06-11 清华大学 一种全集成病原体核酸检测微流控芯片
CN112844505A (zh) * 2021-03-05 2021-05-28 江苏汇先医药技术有限公司 一种用于核酸提取扩增的立式微流控芯片及方法
CN112871230A (zh) * 2021-03-05 2021-06-01 江苏汇先医药技术有限公司 一种核酸扩增用的立式微流控芯片
CN112980650A (zh) * 2021-03-05 2021-06-18 江苏汇先医药技术有限公司 一种核酸提取用的立式微流控芯片及方法
CN112934285A (zh) * 2021-04-09 2021-06-11 四川微康朴澜医疗科技有限责任公司 一种全自动全封闭式荧光定量pcr微流控诊断芯片
CN216149780U (zh) * 2021-09-17 2022-04-01 上海微创惟微诊断技术有限公司 体外诊断分析装置及试剂卡盒

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN115382586A (zh) * 2021-05-24 2022-11-25 广州万孚生物技术股份有限公司 驱动装置与医疗检测系统

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