WO2024031805A1 - 一种一体式提取试剂盒 - Google Patents

一种一体式提取试剂盒 Download PDF

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Publication number
WO2024031805A1
WO2024031805A1 PCT/CN2022/122410 CN2022122410W WO2024031805A1 WO 2024031805 A1 WO2024031805 A1 WO 2024031805A1 CN 2022122410 W CN2022122410 W CN 2022122410W WO 2024031805 A1 WO2024031805 A1 WO 2024031805A1
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WO
WIPO (PCT)
Prior art keywords
chamber
groove
communication
movable
kit according
Prior art date
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PCT/CN2022/122410
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English (en)
French (fr)
Inventor
龚培超
Original Assignee
汇鸿健康(苏州)有限公司
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Publication of WO2024031805A1 publication Critical patent/WO2024031805A1/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
    • B01L7/00—Heating or cooling apparatus; Heat insulating devices
    • B01L7/52—Heating or cooling apparatus; Heat insulating devices with provision for submitting samples to a predetermined sequence of different temperatures, e.g. for treating nucleic acid samples
    • 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
    • C12Q1/6806—Preparing nucleic acids for analysis, e.g. for polymerase chain reaction [PCR] assay
    • 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
    • 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
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/10—Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/18—Means for temperature control
    • B01L2300/1805—Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks

Definitions

  • the invention belongs to the field of bioengineering technology, and in particular relates to an integrated extraction kit, which can be used in application scenarios in multiple industries such as human medical in vitro diagnosis (IVD), animal husbandry and pet medical treatment, food safety, environmental protection, criminal investigation and detection, etc.
  • IVD human medical in vitro diagnosis
  • animal husbandry and pet medical treatment food safety, environmental protection, criminal investigation and detection, etc.
  • PCR Polymerase Chain Reaction
  • PCR Polymerase Chain Reaction
  • cell-free molecular cloning and specific DNA sequence in vitro primer-directed enzymatic amplification technology; in During the epidemic prevention and control period, relevant national departments clearly proposed to "promote the production and expansion of nucleic acid rapid testing equipment with short testing time and easy operation, and increase policy, review and approval and other support.”
  • Policies that have been introduced one after another are urging the iterative upgrade of traditional PCR detection technology, and products represented by nucleic acid rapid detection all-in-one machines have gradually become the focus of clinical customers.
  • the design of its kit consumables determines the degree of integration, automation, and miniaturization of the analytical instruments and equipment that are suitable for it.
  • the current mainstream large-scale and small-scale nucleic acid detection and analysis technologies mainly have the following problems:
  • nucleic acid extraction technology cannot be absolutely closed. In order to avoid contaminating the laboratory and instruments, it is artificially divided into extraction instruments and amplification instruments, and must be placed in P2 level extraction laboratories and amplification laboratories respectively. Carrying out nucleic acid testing requires huge investment;
  • nucleic acid detection technology is high-throughput and multi-channel, the machine is bulky and occupies valuable laboratory space. In order to realize detection automation, additional expensive robot arms are required to transfer detection sample materials in the extraction and amplification chamber. Small nucleic acid Although the detection technology is small in size, like large instruments, there are many nucleic acid extraction consumables and amplification consumables, and the integration level is not enough to realize automated detection, and full-time detection personnel are required to operate by hand;
  • the 96-deep well plate extraction kit used in large-scale nucleic acid detection technology cannot be fully enclosed.
  • the full-opening extraction operation of nucleic acids can easily cause aerosol contamination.
  • the consumables of the microplate kit for amplification, although coated with high temperature or Amplification is performed at room temperature, but there is still the possibility of aerosol contamination during the sample addition process.
  • the design of separate kit consumables for small nucleic acid detection technology faces the same problem;
  • Small nucleic acid amplification detection kits on the market are generally designed for single use and cannot perform multi-item detection. They can only rely on more complex multiplex detection technologies. However, some of the more advanced biological detection methodologies such as LAMP and RPA are constant temperature amplification methods. The increased technology does not support multiple detection and has poor compatibility.
  • the present invention provides an integrated extraction kit.
  • an integrated extraction kit which includes a box body and an extraction part and an amplification part arranged on the box body.
  • the extraction part includes a sample chamber, a mixing reaction chamber, There is at least one processing liquid chamber, a waste liquid chamber and a transfer group for transferring liquid.
  • the transfer group includes a first communication groove for communicating with the sample chamber and a second communication channel for communicating with the mixing reaction chamber. tank, a third communication tank used to communicate with the processing liquid chamber, a fourth communication tank used to communicate with the waste liquid chamber, a movable communication group and a power group that provides power to the liquid. By adjusting the movable communication group, the liquid in the sample chamber can pass through the third communication tank.
  • the first communication tank, the movable communication group and the second communication tank enter the mixing reaction chamber; by adjusting the movable communication group, the liquid in the treatment liquid chamber enters the mixing reaction chamber through the third communication tank, the movable communication group and the second communication tank; by adjusting the movable communication group
  • the communication group allows the liquid in the mixed reaction chamber to enter the waste liquid chamber through the second communication groove, the movable communication group and the fourth communication groove; an amplification communication groove is provided on the box body, and the amplification communication groove is connected to the amplification part, by adjusting the movable communication group, the liquid in the mixed reaction chamber enters the amplification part through the second communication groove, the movable communication group and the amplification communication groove.
  • the tops of the sample chamber, mixing reaction chamber, processing liquid chamber, and waste liquid chamber are all openings, and seals are provided at the openings.
  • a positioning cover is provided on the box body, and the positioning cover covers the sealing member.
  • a sampling hole is provided on the positioning cover, and the sampling hole is located above the sample chamber.
  • a plurality of vent holes are provided on the positioning cover, and at least one vent hole is provided above the mixing reaction chamber, the processing liquid chamber, and the waste liquid chamber.
  • an uncut first slit is provided on the seals corresponding to the tops of the sample chamber and the processing liquid chamber; through-holes are provided on the seals corresponding to the tops of the waste liquid chamber and the mixing reaction chamber. hole.
  • a positioning cover is provided on the box body, and the positioning cover covers the sealing member.
  • a sampling hole is provided on the positioning cover, and the sampling hole is located above the sample chamber.
  • a sealing plug is provided on the sampling hole;
  • a fully cut second slit is provided on the corresponding sealing member at the top of the sample chamber and the processing liquid chamber, and the corresponding sealing member on the top of the waste liquid chamber and the mixing reaction chamber Through holes are provided on both sides; thin-wall processing is performed on the positioning covers corresponding to the tops of the mixing reaction chamber and the processing liquid chamber, and the thin walls are pierced through external devices so that the second slit is connected to the outside.
  • a first filter element is provided on the through hole above the waste liquid chamber and the mixing reaction chamber.
  • the thin wall is processed to form an inverted blind hole, and the opening of the blind hole faces the second cutting slit.
  • the movable communication group includes a knob provided on the box and a movable communication groove located on the knob.
  • the rotation of the knob drives the movable communication groove to rotate such that the first communication groove, the third communication groove, and the fourth communication groove are rotated.
  • the communication slot and the amplification communication slot are individually connected to the second communication slot through the movable communication slot.
  • the power group is a power pump or a plunger rod used to generate positive pressure and negative pressure in the mixing reaction chamber.
  • the movable communication group includes a sliding groove provided on the box body, a sliding block provided on the sliding groove, and a transition cylinder provided on the sliding block, and a first movable communication group is provided on the sliding block.
  • the transition cylinder is rotatable, and the rotation of the transition cylinder enables the second movable connection hole to communicate with one of the first movable connection holes.
  • the transition cylinder is provided with a rotation notch for driving the transition cylinder to rotate.
  • the sliding block includes a sliding block body, a first sealing gasket provided at the bottom of the sliding block body, and an accommodating groove provided on the sliding block body.
  • the transition cylinder is disposed in the accommodating groove. Limiting plates extend toward the middle position on both sides of the groove, and the two limiting plates and the receiving groove form an inverted T-shaped groove; the transition cylinder includes a cylinder body, and a radial direction at the bottom of the cylinder body. An outwardly extending positioning plate is inserted into the accommodating groove, and the two limiting plates limit the upward movement of the positioning plate; a second sealing gasket is provided between the bottom of the transition cylinder and the accommodating groove.
  • part of the first sealing gasket protrudes downward to form a first protrusion.
  • the first protrusion contacts the sliding groove and coats lubricating oil at the contact position; in the middle of the second sealing gasket The position protrudes upward to form a second protrusion, and the second protrusion is circular or annular.
  • the opposite sides of the two limiting plates are arc-shaped, and two mutually parallel planes are provided on the transition cylinder as installation openings, and the distance between the two planes is less than two planes.
  • a second filter element is provided in the sample chamber.
  • the mixing reaction chamber is provided with magnetic beads and a filter membrane at the bottom of the chamber to prevent leakage of the magnetic beads.
  • the amplification part includes a PCR reaction chamber and a ventilation groove, the amplification communication groove is connected to the PCR reaction chamber, and the PCR reaction chamber is flat.
  • the PCR reaction chamber includes a reaction tank with openings on both sides and a film sheet attached to the opening.
  • a ventilation chamber is provided in the waste liquid chamber, and the ventilation groove is connected with the ventilation chamber.
  • an ultrasonic welding port is provided on the ventilation groove.
  • nucleic acid testing must rely on P2 laboratories. Under normal laboratory conditions and various portable testing (poct) scenarios, it is possible to carry out nucleic acid testing and analysis;
  • Thin-plate film heating greatly improves amplification efficiency and can save half the time compared to traditional technology
  • Figure 1 is a schematic structural diagram of the integrated extraction kit of the present invention
  • Figure 2 is a schematic cross-sectional structural view of the integrated extraction kit of the present invention.
  • FIG. 3 is an enlarged structural schematic diagram of part A in Figure 2;
  • Figure 4 is a schematic side view of the integrated extraction kit of the present invention.
  • Figure 5 is a schematic cross-sectional structural diagram along the B-B direction in Figure 4.
  • Figure 6 is an enlarged structural schematic diagram of part C in Figure 5;
  • FIGS 7, 8 and 9 are schematic structural diagrams of the box body of the present invention.
  • FIGS 10 and 11 are schematic structural diagrams of active connected groups according to the present invention.
  • Figure 12 is a schematic structural diagram of the sliding block of the present invention.
  • Figures 13 and 14 are schematic structural views of the transition cylinder of the present invention.
  • Figure 15 is a schematic structural diagram of the seal of the present invention.
  • Figure 16 is a schematic cross-sectional structural view of the seal of the present invention.
  • Figure 17 is a schematic structural diagram of the positioning cover of the present invention.
  • Figure 18 is a schematic cross-sectional structural view of the positioning cover of the present invention.
  • 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 the present invention can be understood on a case-by-case basis.
  • technical features involved in different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.
  • an integrated extraction kit includes a box body 1 and an extraction part 2 and an amplification part 3 arranged on the box body 1.
  • the extraction part 2 and amplification part 3 are integrated into It has an integrated structure, and the processed sample of the extraction part 2 is directly sent from the inside to the amplification part 3 in this structure without passing through the external environment, so it will not be interfered by the external environment, making the test results more realistic.
  • the extraction part 2 includes a sample chamber 21, a mixing reaction chamber 22, a processing liquid chamber 23, a waste liquid chamber 24 and a transfer group 4 for transferring liquids.
  • the number of processing liquid chambers 23 is selected according to the type of processing liquid required for sampling samples.
  • the sample chamber 21 is cylindrical and integrally formed with the box body 1.
  • a preservation liquid is stored in the sample chamber 21.
  • the collected samples are placed into the sample chamber 21 and soaked in the preservation solution for storage and transportation.
  • a second filter 211 is provided in the cavity 21.
  • the second filter 211 is used to prevent objects other than samples from entering the mixing reaction chamber 22, such as samples sampled through throat swabs, in which cotton swabs belong to the carrier of the sample.
  • the second filter member 211 can prevent the cotton swab material from entering the mixing reaction chamber 22;
  • the second filter member 211 is cylindrical and has a mesh structure at the bottom.
  • a raising block is provided at the bottom of the mesh structure, and the raising block makes the mesh shape
  • the structure is at a certain distance from the bottom of the sample chamber 21 to prevent the outlet of the sample chamber 21 from being blocked.
  • the mixing reaction chamber 22 is cylindrical and integrally formed with the box body 1. After being placed in the detection equipment, it is used to receive the liquid in the sample chamber 21 and the treatment liquid chamber 23, and perform reaction processing in the mixing reaction chamber 22. The sample collected in the sample chamber 21 is processed by the liquid in the processing liquid chamber 23, and the components required for detection in the sample are retained, waiting for detection and analysis.
  • the processing liquid chamber 23 is cylindrical and integrally formed with the box body 1.
  • the processing liquid chamber 23 is used to store processing liquids, wherein the processing liquids include lysis liquid, cleaning liquid and eluent.
  • Each of the processing liquid chambers 23 is cylindrical.
  • the processing liquid chamber 23 is used to store one kind of processing liquid.
  • Each processing liquid can enter the mixing reaction chamber 22 to react with the sample one after another according to the specific process steps.
  • the waste liquid chamber 24 is designed according to the shape characteristics of the box body 1.
  • the waste liquid chamber 24 is used to store the waste liquid obtained after the reaction of the mixing reaction chamber 22.
  • This waste liquid includes the discarded preservation liquid and treatment liquid of the sample chamber 21.
  • the volume of the waste liquid chamber 24 is larger than the total volume of the storage liquid and the treatment liquid.
  • the form of the transfer group 4 can be in many ways, and its main purpose is to transfer the preservation liquid of the sample stored in the sample chamber 21 and the processing liquid in the processing liquid chamber 23 to the mixing reaction chamber 22 in order to react the sample. Process, and transfer the used preservation liquid and treatment liquid to the waste liquid chamber 24; power is generated in the transfer group 4 to promote the transfer of the preservation liquid and the treatment liquid.
  • the transfer group 4 includes a first communication groove 41 used to communicate with the sample chamber 21 , a second communication groove 42 used to communicate with the mixing reaction chamber 22 , and a third communication groove 42 used to communicate with the processing liquid chamber 23 .
  • a communication groove 41, a movable communication group 46 and a second communication groove 42 enter the mixing reaction chamber 22.
  • the movable communication group 46 only transfers the preservation solution in the sample chamber 21 into the mixing reaction chamber 22; by adjusting the position of the movable communication group 46
  • the processing liquid in the processing liquid chamber 23 enters the mixing reaction chamber 22 through the third communication groove 43, the movable communication group 46 and the second communication groove 42.
  • the movable communication group 46 only transfers the processing liquid in the processing liquid chamber 23 into the mixed reaction. Chamber 22; By adjusting the movable communication group 46, the waste liquid in the mixing reaction chamber 22 enters the waste liquid chamber 24 through the second communication groove 42, the movable communication group 46 and the fourth communication groove 44.
  • the movable communication group 46 only transfers the mixing
  • the waste liquid in the reaction chamber 22 enters the waste liquid chamber 24; at the same time, an amplification communication groove 45 is provided on the box body 1, and the amplification communication groove 45 is connected to the amplification part 3.
  • the movable communication group 46 By adjusting the movable communication group 46 The liquid in the mixing reaction chamber 22 enters the amplification part 3 through the second communication groove 42, the movable communication group 46 and the amplification communication groove 45.
  • the movable communication group 46 only transfers the liquid in the mixing reaction chamber 22 into the amplification part 3 , here the liquid in the mixing reaction chamber 22 is a sample processed by the processing liquid; here, at least one amplification part 3 is provided as needed.
  • the first communication groove 41, the second communication groove 42, the third communication groove 43, the fourth communication groove 44 and the amplification communication groove 45 are all provided on the box body 1 and are connected to the bottom of the corresponding chamber.
  • the first communication groove 41, the second communication groove 42, the third communication groove 43, the fourth communication groove 44 and the expansion communication groove 45 are all grooves formed by processing from outside to inside at the bottom of the box body 1 and are formed on the grooves.
  • a membrane sheet is attached, creating a sealed, liquid-permeable channel.
  • movable connected group 46 There are two main forms of the movable connected group 46, which are rotary motion and linear motion according to their movement modes:
  • the movable communication group 46 includes a knob provided on the box 1 and a movable communication groove located on the knob.
  • the rotation of the knob drives the movable communication groove to rotate so that the first communication groove 41, The third communication groove 43, the fourth communication groove 44 and the expansion communication groove 45 are individually connected to the second communication groove 42 through the movable communication grooves, and then the power generated by the power group causes the liquid to enter the prescribed position; here, the The power group is a device that generates negative pressure or positive pressure on the mixing reaction chamber 22.
  • the power group can be a power pump or a plunger rod; when the power group is a plunger rod, the plunger rod is inserted into the mixing reaction chamber 22. Liquid enters or is discharged from the mixing reaction chamber 22 through the up and down movement of the plunger rod.
  • the movable communication group 46 includes a sliding groove 461 provided on the box body 1, a sliding block 462 provided on the sliding groove 461, and a sliding block 462 provided on the sliding block 462.
  • the transition cylinder 463 is provided with a first movable communication hole 464 on the sliding block 462.
  • a transition cavity is formed inside the transition cylinder 463.
  • a second movable communication hole 464 is provided at the bottom of the transition cavity in contact with the sliding block 462.
  • connection hole 465 the first movable connection hole 464 is aligned with the second movable connection hole 465, the power group generates positive pressure and negative pressure on the transition chamber; in this way, by moving the sliding block 462 to the designated position, so that the first movable connection hole 464 is individually connected to the corresponding first communication groove 41, the second communication groove 42, the third communication groove 43, the fourth communication groove 44 and the expansion communication groove 45; here, the power group A negative pressure is generated for the corresponding chamber to extract the liquid in the corresponding chamber into the transition chamber.
  • the sliding block 462 is moved to a designated position and then a positive pressure is applied through the power group to transport the liquid in the transition chamber to the required chamber; where
  • the power group can also be a power pump or a plunger rod.
  • the plunger rod When it is a plunger rod, the plunger rod is inserted into the transition chamber; here, when the transition chamber applies positive pressure to the mixing reaction chamber 22, it is easy to make the mixing reaction
  • the liquid in the chamber 22 is mixed with gas and overflows outward, so a first filter is provided at the opening of the mixing reaction chamber 22 to prevent the aerosol from spreading to the outside of the kit and ensure the safety of the external environment.
  • the sliding block 462 includes a sliding block body 4621, a first sealing gasket 4622 provided at the bottom of the sliding block body 4621, and a receiving groove 4623 provided on the sliding block body 4621.
  • the transition cylinder 463 It is arranged in the accommodation groove 4623, and the limiting plates 4624 extend toward each other at the middle position on both sides of the accommodation groove 4623, and the two limiting plates 4624 and the accommodation groove 4623 form an inverted T-shaped groove; so Part of the first sealing gasket 4622 protrudes downward to form a first protrusion 4625.
  • the first protrusion 4625 contacts the sliding groove 461 and is coated with lubricating oil at the contact position.
  • the first protrusion 4625 is passed through the first protrusion 4625.
  • 4625 makes part of the first sealing gasket 4622 contact the sliding groove 461 and is equipped with lubricating oil to improve the smoothness of its movement;
  • the first protrusion 4625 has a symmetrical structure, such as an H shape;
  • the first sealing gasket 4622 is in contact with the sliding groove 461.
  • the connection of the block body 4621 can be realized through two injection molding processes or through glue dispensing;
  • the first sealing gasket 4622 can be made entirely of silicone, or can be made of PVC material and the first protrusion 4625 Made of silicone material.
  • the transition cylinder 463 includes a cylinder body, a positioning plate 467 extending outward in the radial direction at the bottom of the cylinder body, and an installation opening 468 provided above the positioning plate 467; the positioning plate After 467 is inserted into the receiving groove 4623, the two limiting plates 4624 are located above the positioning plate 467; the opposite sides of the two limiting plates 4624 are arc-shaped, and the installation opening 468 is two mutually parallel planes. , the distance between the two planes here is slightly smaller than the minimum distance between the two limiting plates 4624.
  • the installation port 468 and the limiting plate 4624 are displaced by rotation, which can prevent the transition cylinder 463 Exit from the accommodation groove 4623; a limiting notch 469 is provided on the barrel body, and a limiting block 4626 is provided on the limiting plate 4624.
  • the limiting block 4626 enters the limiting notch 469. This ensures that it is installed in place.
  • a second sealing gasket 4627 is provided at the position where the transition cylinder 463 contacts the accommodation groove 4623.
  • a second protrusion 4628 is formed upwardly in the middle of the second sealing gasket 4627.
  • the second protrusion 4628 is Circular or annular, its main purpose is to reduce contact friction and seal the second movable connection hole 465, and lubricating oil is also provided between the second sealing gasket 4627 and the transition cylinder 463 to reduce friction;
  • the second sealing gasket 4627 can be fixedly connected to the sliding block 462 through two injection molding processes or glue dispensing; the second movable connection hole 465 protrudes outward to form a crater shape; the second sealing gasket 4627 It can be entirely made of silica gel, or it can be made of PVC material and the second protrusion 4628 is made of silica gel material.
  • the plunger rod When the plunger rod is selected, the plunger rod includes a rod body and a piston 4610.
  • the rod body is provided by the testing equipment.
  • the piston 4610 can be directly installed in the transition chamber or the mixing reaction chamber 22, so that when used, One piston 4610 corresponds to one test kit, and cross-contamination will not occur; the piston 4610 includes a piston skeleton and a flexible part set on the piston skeleton, and the surface of the flexible part is wavy; put the test kit into the testing equipment Inside, the rod body is aligned with the piston 4610 and inserted into the piston skeleton, so that the movement of the rod body can promote the movement of the piston 4610; a barbed structure is provided at the connection between the rod body and the piston skeleton to ensure that the two are in contact with each other. Not easy to break away from while working.
  • the first activity corresponds to the arrangement position of the communication holes of the first communication groove 41, the second communication groove 42, the third communication groove 43, the fourth communication groove 44 and the amplification communication groove 45 away from each chamber.
  • the connecting hole 464 and the second movable connecting hole 465 will also be different; when all the connecting holes away from the chamber are in a row, the first movable connecting hole 464 and the second movable connecting hole 465 can be one; When there are more than two rows of communication holes away from the chamber, the number of the corresponding first movable connection holes 464 is consistent with the number of rows.
  • One of the movable connection holes 464 corresponds to one row of communication holes, and the second movable connection holes 464 correspond to one row of communication holes.
  • the number of movable communication holes 465 is at least one, and the transition cylinder 463 is rotatable.
  • the second movable communication hole 465 can be moved by rotation to communicate with one of the first movable communication holes 464 individually, so that Realize liquid transfer.
  • the transition cylinder 463 is provided with a rotation notch 466 for driving the transition cylinder 463 to rotate.
  • the rotation notch 466 is controlled by an external detection device. When the detection equipment is not entered, a rotation notch 466 is provided in the rotation notch 466.
  • the limiting member 7 is used to limit the rotation and forward and backward linear sliding of the transition cylinder 463 during sampling and transportation.
  • the top of the waste liquid chamber 24 is an opening, and a seal 5 is provided at the opening.
  • the seal 5 can be made of silicone material; here, the seal 5 can be directly uncovered and used. .
  • a positioning cover 6 is provided on the box 1.
  • the sampling hole 61 is located above the sample chamber 21.
  • a plurality of ventilation holes 62 are provided on the positioning cover 6.
  • At least one vent 62 is provided above the mixing reaction chamber 22, the treatment liquid chamber 23, and the waste liquid chamber 24. The vent 62 can be used to allow gas to enter each chamber to facilitate the outflow of liquid inside, and can be directly used during use.
  • the seal 5 can also be pierced through an external device; further, in order to facilitate the piercing of the seal 5, an uncut seal 5 is provided on the corresponding seal 5 at the top of the sample chamber 21 and the processing liquid chamber 23.
  • the first cutting slit can be a straight groove, a cross groove or a rice-shaped groove; a through hole 52 is provided on the seal corresponding to the top of the waste liquid chamber 24 and the mixing reaction chamber 22, A first filter element is disposed in the through hole 52 to allow the waste liquid in the waste liquid chamber 24 to float outward from the through hole 52 and the vent hole 62 .
  • a positioning cover 6 is provided on the box body 1, and the positioning cover 6 covers the seal 5.
  • a sampling hole 61 is provided on the positioning cover 6, and the sampling hole 61 is located above the sample chamber 21.
  • a sealing plug 63 is provided on the sampling hole 61; a fully cut second slit 51 is provided on the corresponding sealing member 5 at the top of the sample chamber 21 and the processing liquid chamber 23 (as shown in Figures 17 and 18 shown), a through hole 52 is provided on the seal 5 corresponding to the top of the waste liquid chamber 24 and the mixing reaction chamber 22, and a first filter element is provided in the through hole 52; the second slit 51 It is a straight groove, a cross groove or a rice-shaped groove.
  • Thin-wall processing is performed on the positioning cover 6 corresponding to the top of the mixing reaction chamber 22 and the processing liquid chamber 23.
  • the thin wall can be broken through external devices to make the second cutting slit. 51.
  • the second slit 51 has a certain sealing function, and the blind hole 64 contains a certain amount of gas, during transportation, even if When the box body 1 is turned over, the liquid in each chamber will not flow back into the blind hole 64, thereby ensuring that the blind hole 64 is clean. When using it, you only need to pierce the thin wall of the blind hole 64, and external components will not interact with the liquid. contact, thereby preventing the liquid from being contaminated and ensuring detection accuracy.
  • the blind hole 64 can also be set as a through hole, and a layer of film is attached to the outside of the hole to achieve the effect of a blind hole.
  • magnetic beads, magnets, and a filter membrane at the bottom of the chamber to prevent the leakage of magnetic beads need to be installed in the mixing reaction chamber 22.
  • the magnetic beads are used to adsorb samples.
  • the amplification section 3 includes a PCR reaction chamber 31 and a ventilation groove 32.
  • the amplification communication groove 45 and the PCR reaction chamber 31 Connected, the PCR reaction chamber 31 is flat, so that the surface area of the liquid to be detected is increased, and the required temperature can be quickly reached when the liquid to be detected is heated, and the detection time is reduced; in order to further improve the heat conduction of the liquid to be detected , the PCR reaction chamber 31 includes a reaction tank with openings on both sides and a film sheet 34 attached to the opening. By heating the film sheet 34, the heat can be quickly transferred to the liquid to be detected, achieving Quickly heats up and reduces detection time.
  • a ventilation chamber 35 is provided in the waste liquid chamber 24.
  • the height of the ventilation chamber 35 needs to be greater than the height of the liquid level filled with waste liquid in the waste liquid chamber 24.
  • the ventilation groove 32 is connected with the ventilation chamber 35 and is detected.
  • the liquid enters the PCR reaction chamber 31 from the amplification connecting groove 45 and drives the gas in the PCR reaction chamber 31 out of the ventilation groove 32 into the ventilation chamber 35 until the PCR reaction chamber 31 is full; at the same time, a ventilation groove 32 is provided with After the gas is completely discharged, the ultrasonic welding port 33 is welded and sealed through the ultrasonic welding process to ensure that the waste liquid in the waste liquid chamber 24 will not affect the PCR reaction chamber 31.
  • the operation process of the present invention is described for nucleic acid detection.
  • there are 6 processing liquid chambers namely the first processing liquid chamber 231, the second processing liquid chamber 232, the third processing liquid chamber 233, the fourth The processing liquid chamber 234, the fifth processing liquid chamber 235 and the sixth processing liquid chamber 236 respectively store the lysis liquid in the first processing liquid chamber 231, the first cleaning liquid in the second processing liquid chamber 232, and the first cleaning liquid in the third processing liquid chamber 232.
  • the second cleaning liquid is stored in the processing liquid chamber 233
  • the third cleaning liquid is stored in the fourth processing liquid chamber 234, and the eluent is stored in the fifth processing liquid chamber 235.
  • the sixth processing liquid chamber 236 is reserved for backup.
  • the sixth processing liquid chamber 236 can be used to store other liquids or to balance the internal air pressure.
  • samples are collected through throat swabs, the sealing plug 63 of the sampling hole 61 is opened and the sample is placed in the preservation solution in the sample chamber 21, and then the sealing plug 63 is tightly plugged, and the kit is put into the detection device.
  • the detection equipment starts to work automatically; first, the preservation solution and sample in the sample chamber 21 are transferred to the mixing reaction chamber 22 through the movable connecting group 46, and then, the lysate in the first processing liquid chamber 231 is transferred through the movable connecting group 46. Transfer the preservation solution to the mixing reaction chamber 22 to react with the sample to obtain a nucleic acid sample.
  • the nucleic acid sample is captured by the magnetic beads in the mixing reaction chamber 22.
  • the magnetic beads are then adsorbed by the electromagnetic mechanism in the detection device and connected to the power group through the movable connection group 46.
  • the reacted waste liquid is discharged into the waste liquid chamber 24 for storage.
  • the movable communication group 46 transfers the first cleaning liquid in the second processing chamber 232 to the mixing reaction chamber 22.
  • the electromagnetic mechanism releases the magnetic beads.
  • the first cleaning liquid cleans the magnetic beads and retains the nucleic acid sample, and detaches substances that affect the nucleic acid sample from the magnetic beads.
  • the electromagnetic mechanism adsorbs the magnetic beads and discharges the reacted waste liquid through the movable connection group 46 and the power group. into the waste liquid chamber 24 for storage.
  • the movable communication group 46 sequentially sends the second cleaning liquid in the third processing chamber 233 and the third cleaning liquid in the fourth processing chamber 234 to the mixing reaction chamber 22 for magnetization.
  • the beads are cleaned, and the waste liquid is discharged into the waste liquid chamber 24 in sequence.
  • the movable communication group 46 sends the eluate in the fifth processing chamber 235 to the mixing reaction chamber 22 to react with the magnetic beads.
  • the nucleic acid sample on the magnetic beads is separated from the magnetic beads and stored in the eluate.
  • the movable connection group 46 transfers the eluate containing the nucleic acid sample to the PCR reaction chamber 31 and fills the PCR reaction chamber 31 , and then uses ultrasonic waves to The ventilation slot 32 is blocked by welding, and finally the detection equipment detects the nucleic acid sample in the amplification section 3 .
  • automated extraction, purification, and amplification can be achieved without complex sample preprocessing and other equipment, which can reduce detection costs and detection time.
  • the overall detection is in a sealed environment, which can avoid too many personnel. Participation reduces the risk of infection during the testing process, and novices can complete the testing process without the need for professionals to handle it; the closure of the entire process can reduce the risk of false positives and improve the accuracy of testing.

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Abstract

本发明提供一种一体式提取试剂盒，属于生物工程领域，该一体式提取试剂盒包括盒体以及提取部与扩增部，提取部包括样本腔、混合反应腔、处理液腔、废液腔以及转移组，转移组包括第一连通槽、第二连通槽、第三连通槽、第四连通槽、活动连通组以及动力组，通过调整活动连通组使得样本腔内液体进入混合反应腔；通过调整活动连通组使得处理液腔内液体进入混合反应腔；通过调整活动连通组使得混合反应腔内液体进入废液腔；在所述盒体上设置有扩增连通槽，所述扩增连通槽连通至扩增部，通过调整活动连通组使得混合反应腔内液体进入扩增部。在常规实验室条件和各种便携检测场景，可开展核酸检测分析；全自动全过程无人工干预；全过程全封闭，零气溶胶污染，假阴性和假阳性结果几率大大降低。

Description

一种一体式提取试剂盒 技术领域
本发明属于生物工程技术领域，尤其是涉及一种一体式提取试剂盒，可应用于人类医学体外诊断(IVD)、畜牧及宠物医疗、食品安全、环保及刑侦检测等多行业的应用场景。
背景技术
PCR(Polymerase Chain Reaction)，即聚合酶链式反应，属于核酸变温扩增检测技术的一种，在一些情况下又称无细胞分子克隆、特异性DNA序列体外引物定向酶促扩增技术；在疫情防控期间，国家有关部门明确提出要“推进检测时间短、且操作便捷的核酸快速检测设备生产扩能，加大政策、审评审批等支持”。陆续出台的政策都在催促着传统PCR检测技术进行迭代升级，以核酸快速检测一体机为代表的产品逐渐成为临床客户的关注点。
PCR检测的很多过程和步骤都会影响检测结果，不同的操作人员之间的差异有时也较为明显，减少人员干扰、环境干扰最好的措施就是做成全自动核酸快速检测一体机，即样本直接上机，由机器全自动完成整个检测过程。简单来说就是要能做到核酸提取、扩增一体化、小型化、甚至是便携化，全程“样本进、结果出”，“随到随检”，一体机特别适合后疫情时代常规零星检测场景和没有P2实验室条件的数量庞大的中小医院、社区诊所使用。
对于核酸检测技术，其试剂盒耗材设计决定了与之相适配的分析仪器设备的集成度、自动化、小型化程度。当前主流大型、小型核酸检测分析技术，主要存在以下几个方面问题：
1.核酸提取技术做不到绝对封闭性，为了避免污染实验室和仪器，被人为地分割为提取仪器和扩增仪器，并同时要被分别放置在P2级别提取实验室和扩增实验室里进行核酸检测，投资巨大；
2.大型核酸检测技术虽然高通量多通道但是机器体积庞大，占据宝贵的实验室空间，为了实现检测自动化，需要额外配备昂贵的机器人手臂在提取和扩增室进行检测样本物料传输，小型核酸检测技术虽然尺寸不大，但是和大型仪器一样，核酸提取耗材和扩增耗材众多，集成度不够，无法实现自动化检测，需要配备专职检测人员徒手操作；
3.大型核酸检测技术所用的96深孔板提取试剂盒无法做到全封闭，全开口提取操作核酸容易造成气溶胶污染，而扩增用的微孔板试剂盒耗材，虽然是覆膜高温或者常温扩增，但是加样过程中仍然有气溶胶污染的可能，小型核酸检测技术分离式的试剂盒耗材设计，面临同样的问题；
4.传统试剂盒耗材设计一般为圆锥体造型，因为模塑工艺原因，管壁0.35-0.5mm厚，由于塑料本身导系数非常之低，加之扩增试剂体积较厚，导热困难，这是传统核酸扩增检测时间较长的最主要的原因；
5.市面上小型核酸扩增检测试剂盒一般为单人份设计，无法做到多项目检测，只能借助更复杂的多重检测技术，但是部分更先进生物检测方法学如LAMP、RPA等恒温扩增技术并不支持多重检测，兼容性差。
发明内容
为解决上述技术问题，本发明提供一种一体式提取试剂盒。
本发明解决其技术问题所采取的技术方案是：一种一体式提取试剂盒，包括盒体以及设置于盒体上的提取部与扩增部，所述提取部包括样本腔、混合反应腔、处理液腔、废液腔以及用于转移液体的转移组，所述处理液腔至少一个，所述转移组包括用于连通样本腔的第一连通槽、用于连通混合反应腔的第二连通槽、用于连通处理液腔的第三连通槽、 用于连通废液腔的第四连通槽、活动连通组以及对液体提供动力的动力组，通过调整活动连通组使得样本腔内液体通过第一连通槽、活动连通组以及第二连通槽进入混合反应腔；通过调整活动连通组使得处理液腔内液体通过第三连通槽、活动连通组以及第二连通槽进入混合反应腔；通过调整活动连通组使得混合反应腔内液体通过第二连通槽、活动连通组以及第四连通槽进入废液腔；在所述盒体上设置有扩增连通槽，所述扩增连通槽连通至扩增部，通过调整活动连通组使得混合反应腔内液体通过第二连通槽、活动连通组以及扩增连通槽进入扩增部。
进一步具体的，所述样本腔、混合反应腔、处理液腔、废液腔的顶部均为开口，在所述开口处设置密封件。
进一步具体的，在所述盒体上设置有定位盖，所述定位盖覆盖在所述密封件上，在所述定位盖上设置有采样孔，所述采样孔位于样本腔上方，在所述定位盖上设置有多个通气孔，在所述混合反应腔、处理液腔、废液腔上方均设置至少一个所述通气孔。
进一步具体的，在所述样本腔、处理液腔顶部对应的密封件上设置有未切透的第一切开缝；在所述废液腔以及混合反应腔顶部对应的密封件上均设置通孔。
进一步具体的，在所述盒体上设置有定位盖，所述定位盖覆盖在所述密封件上，在所述定位盖上设置有采样孔，所述采样孔位于样本腔上方，在所述采样孔上设置有密封塞；在所述样本腔、处理液腔顶部对应的密封件上设置有完全切开的第二切开缝，在所述废液腔以及混合反应腔顶部对应的密封件上均设置有通孔；在所述混合反应腔、处理液腔顶 部对应的定位盖上进行薄壁处理，通过外部器件捅破薄壁使得第二切开缝连通外部。
进一步具体的，在所述废液腔以及混合反应腔上方的通孔上均设置有第一过滤件。
进一步具体的，所述薄壁处理为形成一倒置的盲孔，所述盲孔开口处朝向第二切开缝。
进一步具体的，所述活动连通组包括设置于盒体上的旋钮以及位于旋钮上的活动连通槽，所述旋钮转动带动所述活动连通槽转动使得第一连通槽、第三连通槽、第四连通槽以及扩增连通槽通过活动连通槽分别单独与第二连通槽连通。
进一步具体的，所述动力组为用于对混合反应腔产生正压与负压的动力泵或者柱塞杆。
进一步具体的，所述活动连通组包括设置于盒体上的滑动槽、设置于滑动槽上的滑动块、设置于滑动块上的过渡筒体，在所述滑动块上设置有第一活动连通孔，所述过渡筒体内部形成过渡腔，在所述过渡腔底部与滑动块接触位置设置有第二活动连接孔，所述第一活动连接孔与第二活动连接孔对齐，所述动力组对过渡腔产生正压与负压。
进一步具体的，所述第一活动连通孔至少两个，所述过渡筒体可旋转，所述过渡筒体旋转使得所述第二活动连接孔与所述第一活动连接孔中的一个连通。
进一步具体的，在所述过渡筒体上设置有用于驱动所述过渡筒体转动的转动缺口。
进一步具体的，所述滑动块包括滑块本体、设置于滑块本体底部的第一密封垫、设置于滑块本体上的容纳槽，所述过渡筒体设置于容纳槽内，在所述容纳槽上方两侧向中间位置相向伸出限位板，两个所述限位板与所述容纳槽形成倒置的T型槽；所述过渡筒体包括筒本体、在筒本体底部沿径向方向向外伸出的定位板，所述定位板插入容纳槽内，两个所述限位板限制所述定位板向上移动；在所述过渡筒体底部与容纳槽之间设置第二密封垫。
进一步具体的，所述第一密封垫中部分部位向下凸出形成第一凸起，所述第一凸起与滑动槽接触并在接触位置涂附润滑油；在所述第二密封垫中间位置向上凸出形成第二凸起，所述第二凸起为圆形或者环形。
进一步具体的，两个所述限位板相对的一侧均呈弧形，在所述过渡筒体上设置有两个相互平行的平面作为安装口，两个所述平面之间的距离小于两个所述限位板之间的最短距离；所述过渡筒体插入所述容纳槽后旋转使得安装口移位并与限位板错开；在所述筒本体上设置有限位缺口，在所述限位板上设置有限位块，当所述筒本体转动后所述限位块进入限位缺口。
进一步具体的，在所述样本腔内设置有第二过滤件。
进一步具体的，在所述混合反应腔内设置有磁珠以及防止磁珠泄露的腔底滤膜。
进一步具体的，所述扩增部包括PCR反应腔以及通气槽，所述扩增连通槽与PCR反应腔连通，所述PCR反应腔呈扁平状。
进一步具体的，所述PCR反应腔包括两侧为开口的反应槽以及贴附 于所述开口上的薄膜片。
进一步具体的，在所述废液腔内设置有通气腔，所述通气槽与通气腔连通。
进一步具体的，在所述通气槽上设置有超声波焊接口。
本发明的有益效果是：
a.解决了核酸检测必须依赖P2实验室的问题，常规实验室条件和各种便携检测(poct)场景，开展核酸检测分析成为可能；
b.全自动全过程无人工干预，节省宝贵检测人力资源，特别是疫情期间；
c.全过程全封闭，零气溶胶污染，假阴性假阳性结果几率大大降低；
d.薄板式薄膜加热，扩增效率大大提升，可比传统技术节省一半时间；
e.支持传统变温和新兴的恒温扩增技术，兼容性、检测灵活性强。
附图说明
图1是本发明一体式提取试剂盒的结构示意图；
图2是本发明一体式提取试剂盒的剖视结构示意图；
图3是图2中A部位的放大结构示意图；
图4是本发明一体式提取试剂盒的侧视结构示意图；
图5是图4中B-B方向的剖视结构示意图；
图6是图5中C部位的放大结构示意图；
图7、图8与图9是本发明盒体的结构示意图；
图10与图11是本发明活动连通组的结构示意图；
图12是本发明滑动块的结构示意图；
图13与图14是本发明过渡筒体的结构示意图；
图15是本发明密封件的结构示意图；
图16是本发明密封件的剖视结构示意图；
图17是本发明定位盖的结构示意图；
图18是本发明定位盖的剖视结构示意图。
图中：1、盒体；2、提取部；3、扩增部；4、转移组；5、密封件；6、定位盖；7、限位件；21、样本腔；22、混合反应腔；23、处理液腔；24、废液腔；211、第二过滤件；231、第一处理液腔；232、第二处理液腔；233、第三处理液腔；234、第四处理液腔；235、第五处理液腔；236、第六处理液腔；31、PCR反应腔；32、通气槽；33、超声波焊接口；34、薄膜片；35、通气腔；41、第一连通槽；42、第二连通槽；43、第三连通槽；44、第四连通槽；45、扩增连通槽；46、活动连通组；461、滑动槽；462、滑动块；4621、滑块本体；4622、第一密封垫；4623、容纳槽；4624、限位板；4625、第一凸起；4626、限位块；4627、第二密封垫；4628、第二凸起；463、过渡筒体；464、第一活动连通孔；465、第二活动连通孔；466、转动缺口；467、定位板；468、安装口；469、限位缺口；4610、活塞；51、第二切开缝；52、通孔；61、采样孔；62、通气孔；63、密封塞；64、盲孔。
具体实施方式
下面将结合附图对本发明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发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，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，都属于本发明保护的范围。
在本发明的描述中，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发明和简化描述，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发明的限制。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。
在本发明的描述中，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发明中的具体含义。此外，下面所描述的本发明不同实施方式中所涉及的技术特征只要彼此之间未构成冲突就可以相互结合。
如图1与图2所示一种一体式提取试剂盒，包括盒体1以及设置于盒体1上的提取部2与扩增部3，将所述提取部2与扩增部3整合为一体式结构，并直接在该结构中将提取部2的处理样本从内部送至扩增部3，不经过外部环境，则不会受到外部环境的干扰，使得测试结果更趋于真实状况。
其中，所述提取部2包括样本腔21、混合反应腔22、处理液腔23、废液腔24以及用于转移液体的转移组4，所述处理液腔23至少一个，此处可以根据针对不同采样样本所需要的处理液种类来选择处理液腔23的个数。
所述样本腔21呈筒状且与盒体1一体成型，在所述样本腔21内存储保存液，采集到的样本放入样本腔21内通过浸泡在保存液内进行存储 以及运输，在样本腔21内设置第二过滤件211，所述第二过滤件211用于防止除样本外的其它物体进入混合反应腔22，例如通过咽拭子采样的样本，其中棉签属于样本的承载物，过滤件211可防止棉签物质进入混合反应腔22；所述第二过滤件211呈筒状且其底部呈网状结构，同时在网状结构底部设置有垫高块，所述垫高块使得网状结构距离样本腔21底部有一定距离，以防止堵住样本腔21的出口。
所述混合反应腔22呈筒状且与盒体1一体成型，放入检测设备后，用于接收样本腔21、处理液腔23内的液体，并在混合反应腔22内进行反应处理，将样本腔21内采集到的样本通过处理液腔23内的液体进行处理，保留样本中检测所需的成分，等待进行检测与分析。
所述处理液腔23呈筒状且与盒体1一体成型，所述处理液腔23内用于存储处理液，其中所述处理液包括裂解液、清洗液以及洗脱液，每个所述处理液腔23用于存储一种处理液，每种处理液可根据具体工艺步骤，先后进入混合反应腔22与样本进行反应。
所述废液腔24依据盒体1形状特征进行设计，所述废液腔24用于存储经过混合反应腔22反应后得到的废液，这种废液包括样本腔21废弃的保存液、处理液腔23废弃的处理液，所述废液腔24的容积要大于保存液以及处理液的总体积。
所述转移组4的形式可以有多种方式，其主要目的是将样本腔21内存储样本的保存液、处理液腔23内的处理液按照顺序依次转移至混合反应腔22内对样本进行反应处理，并将使用过的保存液以及处理液转移至废液腔24；所述转移组4内产生动力来促使保存液与处理液的转移。
如图7-图9所示所述转移组4包括用于连通样本腔21的第一连通槽41、用于连通混合反应腔22的第二连通槽42、用于连通处理液腔23的第三连通槽43、用于连通废液腔24的第四连通槽44、活动连通组46以及对液体提供动力的动力组；通过调整活动连通组46的位置可使得样本腔21内保存液通过第一连通槽41、活动连通组46以及第二连通槽42进入混合反应腔22，此时活动连通组46仅转移样本腔21内的保存液进入混合反应腔22；通过调整活动连通组46的位置使得处理液腔23内处理液通过第三连通槽43、活动连通组46以及第二连通槽42进入混合反应腔22，此时活动连通组46仅转移处理液腔23内的处理液进入混合反应腔22；通过调整活动连通组46使得混合反应腔22内的废液通过第二连通槽42、活动连通组46以及第四连通槽44进入废液腔24，此时活动连通组46仅转移混合反应腔22内的废液进入废液腔24；同时，在所述盒体1上设置有扩增连通槽45，所述扩增连通槽45连通至扩增部3，通过调整活动连通组46使得混合反应腔22内的液体通过第二连通槽42、活动连通组46以及扩增连通槽45进入扩增部3，此时活动连通组46仅转移混合反应腔22内液体进入扩增部3，此处混合反应腔22内的液体为经过处理液进行处理后的样本；在此处，所述扩增部3根据需要设置至少一个。
所述第一连通槽41、第二连通槽42、第三连通槽43、第四连通槽44以及扩增连通槽45均设置于盒体1上且均连接至对应腔室的底部，所述第一连通槽41、第二连通槽42、第三连通槽43、第四连通槽44以及扩增连通槽45均为在盒体1底部由外向内加工形成的凹槽并在该凹槽 上附上一层薄膜片，从而形成了密封且可供液体通行的通道。
所述活动连通组46主要形式为两种，根据其运动方式分别为旋转运动形式和直线运动形式：
在所述旋转运动形式中，所述活动连通组46包括设置于盒体1上的旋钮以及位于旋钮上的活动连通槽，所述旋钮转动带动所述活动连通槽转动使得第一连通槽41、第三连通槽43、第四连通槽44以及扩增连通槽45通过活动连通槽分别单独与第二连通槽42连通，再通过动力组产生的动力使得液体进入规定位置；在此处，所述动力组是对混合反应腔22产生负压或者正压的器件，例如动力组可以是动力泵或者柱塞杆；当动力组为柱塞杆时，所述柱塞杆插入混合反应腔22内，通过所述柱塞杆的上下移动使得液体进入或者排出混合反应腔22内。
如图7-12所示在所述直线运动形式中，所述活动连通组46包括设置于盒体1上的滑动槽461、设置于滑动槽461上的滑动块462、设置于滑动块462上的过渡筒体463，在所述滑动块462上设置有第一活动连通孔464，所述过渡筒体463内部形成过渡腔，在所述过渡腔底部与滑动块462接触位置设置有第二活动连接孔465，所述第一活动连接孔464与第二活动连接孔465对齐，所述动力组对过渡腔产生正压与负压；在此种方式中，通过以移动滑动块462运动到指定位置，使得第一活动连接孔464与对应的第一连通槽41、第二连通槽42、第三连通槽43、第四连通槽44以及扩增连通槽45单独连通；在此处，动力组针对对应腔室产生负压将对应腔室内的液体抽取至过渡腔内，通过滑动块462移动至指定位置再通过动力组施加正压将过渡腔内的液体输送至所需腔室内； 此处的动力组也可为动力泵或者柱塞杆，当为柱塞杆时，所述柱塞杆插入过渡腔内；在此处，过渡腔向混合反应腔22施加正向压力时，容易使得混合反应腔22内的液体混杂着气体向外溢出，故在混合反应腔22的开口处设置第一过滤件，以防止气溶胶扩散至试剂盒外部，保证外部环境的安全。
如图10-12所示所述滑动块462包括滑块本体4621、设置于滑块本体4621底部的第一密封垫4622、设置于滑块本体4621上的容纳槽4623，所述过渡筒体463设置于容纳槽4623内，在所述容纳槽上4623方两侧向中间位置相向伸出限位板4624，两个所述限位板4624与所述容纳槽4623形成倒置的T型槽；所述第一密封垫4622中部分部位向下凸出形成第一凸起4625，所述第一凸起4625与滑动槽461接触并在接触位置涂附润滑油，此处通过所述第一凸起4625使得第一密封垫4622部分部位与滑动槽461接触并配有润滑油提高其运动的顺畅性；所述第一凸起4625呈对称结构，例如H型；所述第一密封垫4622与滑块本体4621的连接可通过两次注塑工艺实现或者通过点胶粘贴的方式实现；所述第一密封垫4622可全部采用硅胶制作而成，也可以采用PVC材料制作且所述第一凸起4625采用硅胶材料制作。
如图14-图15所示所述过渡筒体463包括筒本体、在筒本体底部沿径向方向向外伸出的定位板467以及设置于定位板467上方的安装口468；所述定位板467插入容纳槽4623后，两个所述限位板4624位于定位板467上方；两个所述限位板4624相对的一侧均呈弧形，所述安装口468为两个相互平行的平面，此处两个平面之间的距离略小于两个所述限位 板4624之间的最小距离，在插入后通过旋转使得安装口468与限位板4624移位错开，能够防止过渡筒体463从容纳槽4623退出；在所述筒本体上设置有限位缺口469，在所述限位板4624上设置有限位块4626，当所述筒本体转动后所述限位块4626进入限位缺口469从而保证其安装到位。
在所述过渡筒体463与容纳槽4623接触的位置设有第二密封垫4627，在所述第二密封垫4627中间位置向上凸出形成第二凸起4628，所述第二凸起4628为圆形或者环形，其主要目的可减少接触摩擦的同时可对第二活动连接孔465进行密封，在所述第二密封垫4627与过渡筒体463之间也设置润滑油降低摩擦力；所述第二密封垫4627可通过两次注塑工艺或者点胶粘贴的方式与所述滑动块462固定连接；所述第二活动连接孔465向外凸出形成火山口状；所述第二密封垫4627可全部采用硅胶制作而成，也可以采用PVC材料制作且第二凸起4628采用硅胶材料制作。
当选用柱塞杆的方式时，柱塞杆包括杆本体以及活塞4610，所述杆本体由测试设备提供，所述活塞4610可直接设置于过渡腔或者混合反应腔22内，这样在使用时，一个活塞4610对应一个试剂盒，不会出现交叉污染；所述活塞4610包括活塞骨架以及套设于活塞骨架上的柔性件，所述柔性件表面呈波浪形；将所述试剂盒放入测试设备内，所述杆本体对准活塞4610并插入活塞骨架内，可实现通过杆本体的运动推动活塞4610运动；在所述杆本体与活塞骨架的连接处设置为倒刺型结构，保证两者在工作时不容易脱离。
其中，根据所述第一连通槽41、第二连通槽42、第三连通槽43、 第四连通槽44以及扩增连通槽45的远离各个腔室的连通孔的排列位置对应的第一活动连接孔464与第二活动连接孔465也会不同；当所有远离腔室的所述连通孔为一排时，第一活动连接孔464与第二活动连接孔465均为一个即可；而当所所有远离腔室的连通孔两排以上时，对应的所述第一活动连接孔464的数量与排数一致，一个所述活动连接孔464对应一排的所述连通孔，所述第二活动连通孔465的数量至少一个，所述过渡筒体463为可旋转的，通过旋转可使得第二活动连通孔465移动，用于单独与其中一个所述第一活动连接孔464进行连通，从而实现液体的转移。在所述过渡筒体463上设置有用于驱动所述过渡筒体463转动的转动缺口466，该转动缺口466由外部检测设备进行控制，而在未进入检测设备时，该转动缺口466内设置一限位件7，用于在采样与运输过程中限制所述过渡筒体463的转动与前后线性滑动。
进一步在使用过程中，为了保证所述样本腔21、混合反应腔22、处理液腔23、废液腔24内的液体方便进出，在所述样本腔21、混合反应腔22、处理液腔23、废液腔24的顶部均为开口，并在所述开口处设置密封件5，所述密封件5可采用硅胶材料制作而成；在此处，可将密封件5直接揭开即可使用。
如图1、图2、图15以及图16所示基于密封件5的结构，为了保证在使用过程中不会受到污染，在所述盒体1上设置有定位盖6，所述定位盖6覆盖在所述密封件5上，在所述定位盖6上设置有采样孔61，在所述采样孔61位于样本腔21上方，在所述定位盖6上设置有多个通气孔62，在所述混合反应腔22、处理液腔23、废液腔24上方均设置至少 一个所述通气孔62，使用通气孔62可使各个腔室内进入气体，方便其内液体流出，在使用时可直接撕掉密封件5，也可通过外部器件将密封件5捅破；进一步为了方便捅破密封件5，在所述样本腔21、处理液腔23顶部对应的密封件5上设置有未切透的第一切开缝，所述第一切开缝可以是一字槽、十字槽或者米字槽；在所述废液腔24与混合反应腔22顶部对应的密封件上设置通孔52，在所述通孔52内设置第一过滤件，用于放置废液腔24内的废液从通孔52、通气孔62向外部飘散。
上述通过外部器件捅破密封件5的结构在使用中，外部器件在捅破密封件5时，可能会与腔室内的液体接触，从而对液体造成污染导致检测结果出现偏差，故设计以下结构来解决上述问题。
在所述盒体1上设置有定位盖6，所述定位盖6覆盖在所述密封件5上，在所述定位盖6上设置采样孔61，所述采样孔61位于样本腔21上方，在所述采样孔61上设置有密封塞63；在所述样本腔21、处理液腔23顶部对应的密封件5上设置有完全切开的第二切开缝51(如图17与图18所示)，在所述废液腔24与混合反应腔22顶部对应的密封件5上设置有通孔52，在所述通孔52内设置第一过滤件；所述第二切开缝51为一字槽、十字槽或者米字槽，在所述混合反应腔22、处理液腔23顶部对应的定位盖6上进行薄壁处理，可通过外部器件捅破薄壁使得第二切开缝51将处理液腔23与外部连通，使得混合反应腔22通过第一过滤件与外部连通；在进行薄壁处理时，可将薄壁处设置一倒置的盲孔64(如图3与图18所示)，所述盲孔64的开口处朝向第二切开缝51，由于第二切开缝51具有一定的密封功能，而盲孔64内容纳一定量的气体，在 运输过程中，即使盒体1翻转，各个腔室内的液体也不会倒流至盲孔64内，从而保证盲孔64内清洁，在使用时，只需捅破盲孔64的薄壁处，外部器件不会与液体接触，从而能够防止液体受到污染，保证检测的准确性。
基于上述盲孔64的设置，也可以将所述盲孔64设置为贯通的孔，并在该孔外贴附一层膜，使其能够实现盲孔的效果。
进一步，当该结构进行核酸检测时，需在所述混合反应腔22内设置磁珠，磁以及防止磁珠泄露的腔底滤膜，所述磁珠用于吸附样本。
如图4-图7所示所述扩增部3根据实际需求可以设置多个，所述扩增部3包括PCR反应腔31以及通气槽32，所述扩增连通槽45与PCR反应腔31连通，所述PCR反应腔31呈扁平状，使得被检测液的表面积增大，在对被检测液进行加热时能够快速达到所需温度，降低检测时间；为了进一步提高对被检测液的热量传导，所述PCR反应腔31包括两侧为开口的反应槽以及贴附于所述开口上的薄膜片34，通过对所述薄膜片34进行加热能够很快将热量传递至被检测液内，实现快速升温，降低检测时间。
在所述废液腔24内设置有通气腔35，所述通气腔35的高度需要大于废液腔24内装满废液的液面高度，所述通气槽32与通气腔35连通，被检测液从扩增连通槽45进入PCR反应腔31内并将PCR反应腔31内的气体从通气槽32赶出至通气腔35内，直至PCR反应腔31充满；同时，在通气槽32上设置有超声波焊接口33，在气体完全排出后，通过超声波焊接工艺对超声波焊接口33进行焊接、密封，保证废液腔24内的废 液不会对PCR反应腔31造成影响。
针对核酸检测对本发明的操作过程进行描述，在本发明的方案中，处理液腔有6个，分别为第一处理液腔231、第二处理液腔232、第三处理液腔233、第四处理液腔234、第五处理液腔235以及第六处理液腔236，对应的在第一处理液腔231内存储裂解液，在第二处理液腔232内存储第一清洗液，在第三处理液腔233内存储第二清洗液，在第四处理液腔234内存储第三清洗液，在第五处理液腔235内存储洗脱液，所述第六处理液腔236为备份预留腔，所述第六处理液腔236可用于存放其他液体或者用于平衡内部的气压。
在使用中，通过咽拭子采集到样本，打开采样孔61的密封塞63并将样本置于样本腔21内的保存液中，然后塞紧密封塞63，将该试剂盒放入检测设备中，检测设备开始自动工作；首先，通过活动连通组46将样本腔21内的保存液与样本转移至混合反应腔22内，之后，通过活动连通组46将第一处理液腔231内的裂解液转移到混合反应腔22内保存液与样本进行反应得到核酸样品，核酸样品被混合反应腔22内的磁珠捕获，之后通过检测设备中的电磁机构吸附磁珠并通过活动连通组46与动力组将反应后的废液排入至废液腔24内进行保存，之后，活动连通组46将第二处理腔232内的第一清洗液转移至混合反应腔22内，此时电磁机构释放磁珠，所述第一清洗液对磁珠进行清洗保留核酸样本，将影响核酸样本的物质从磁珠上脱离，之后电磁机构吸附磁珠并通过活动连通组46与动力组将反应后的废液排入至废液腔24内进行保存，之后，活动连通组46依次将第三处理腔233内的第二清洗液、第四处理腔234 内的第三清洗液送至混合反应腔22内对磁珠进行清洗，并依次将废液排至废液腔24内，之后，活动连通组46将第五处理腔235内的洗脱液送至混合反应腔22内与磁珠进行反应，洗脱液将磁珠上的核酸样本与磁珠脱离并保存在洗脱液内，之后，活动连通组46将含有核酸样本的洗脱液转移至PCR反应腔31内并充满PCR反应腔31，之后通过超声波焊接的方式堵住通气槽32，最后检测设备对扩增部3的核酸样本进行检测。
综上，通过上述结构的使用，可实现自动化提取、纯化、扩增，无需复杂的样本前处理和其他设备，能够降低检测成本以及检测时间，同时整体检测处于密封环境中，能够避免人员过多的参与，降低在检测过程中感染的风险，无需专业人士进行处理，新手也可完成检测过程；全过程封闭能够降低假阳性的风险，提高检测的准确性。
需要强调的是：以上仅是本发明的较佳实施例而已，并非对本发明作任何形式上的限制，凡是依据本发明的技术实质对以上实施例所作的任何简单修改、等同变化与修饰，均仍属于本发明技术方案的范围内。

Claims (21)

  1. 一种一体式提取试剂盒，包括盒体(1)以及设置于盒体(1)上的提取部(2)与扩增部(3)，其特征在于，所述提取部(2)包括样本腔(21)、混合反应腔(22)、处理液腔(23)、废液腔(24)以及用于转移液体的转移组(4)，所述处理液腔(23)至少一个，所述转移组(4)包括用于连通样本腔(21)的第一连通槽(41)、用于连通混合反应腔(22)的第二连通槽(42)、用于连通处理液腔(23)的第三连通槽(43)、用于连通废液腔(24)的第四连通槽(44)、活动连通组(46)以及对液体提供动力的动力组，通过调整活动连通组(46)使得样本腔(21)内液体通过第一连通槽(41)、活动连通组(46)以及第二连通槽(42)进入混合反应腔(22)；通过调整活动连通组(46)使得处理液腔(23)内液体通过第三连通槽(43)、活动连通组(46)以及第二连通槽(42)进入混合反应腔(22)；通过调整活动连通组(46)使得混合反应腔(22)内液体通过第二连通槽(42)、活动连通组(46)以及第四连通槽(44)进入废液腔(24)；在所述盒体(1)上设置有扩增连通槽(45)，所述扩增连通槽(45)连通至扩增部(3)，通过调整活动连通组(46)使得混合反应腔(22)内液体通过第二连通槽(42)、活动连通组(46)以及扩增连通槽(45)进入扩增部(3)。
  2. 根据权利要求1所述一体式提取试剂盒，其特征在于，所述样本腔(21)、混合反应腔(22)、处理液腔(23)、废液腔(24)的顶部均为开口，在所述开口处设置密封件(5)。
  3. 根据权利要求2所述一体式提取试剂盒，其特征在于，在所述盒体(1)上设置有定位盖(6)，所述定位盖(6)覆盖在所述密封件(5)上，在所述定位盖(6)上设置有采样孔(61)，所述采样孔(61)位于样本腔(21)上方，在所述定位盖(6)上设置有多个通气孔(62)，在所述混合反应腔(22)、处理液腔(23)、废液腔(24)上方均设置至少一个所述通气孔(62)。
  4. 根据权利要求3所述一体式提取试剂盒，其特征在于，在所述样本腔(21)、处理液腔(23)顶部对应的密封件(5)上设置有未切透的第一切开缝；在所述废液腔(24)以及混合反应腔(22)顶部对应的密封件(5)上均设置通孔(52)。
  5. 根据权利要求2所述一体式提取试剂盒，其特征在于，在所述盒体(1)上设置有定位盖(6)，所述定位盖(6)覆盖在所述密封件(5)上，在所述定位盖(6)上设置有采样孔(61)，所述采样孔(61)位于样本腔(21)上方，在所述采样孔(61)上设置有密封塞(63)；在所述样本腔(21)、处理液腔(23)顶部对应的密封件(5)上设置有完全切开的第二切开缝(51)，在所述废液腔(24)以及混合反应腔(22)顶部对应的密封件(5)上均设置有通孔(52)；在所述混合反应腔(22)、处理液腔(23)顶部对应的定位盖(6)上进行薄壁处理，通过外部器件捅破薄壁使得第二切开缝(51)连通外部。
  6. 根据权利要求4或5所述一体式提取试剂盒，其特征在于，在所述废液腔(24)以及混合反应腔(22)上方的通孔(52)上均设置有第一过滤件。
  7. 根据权利要求5所述一体式提取试剂盒，其特征在于，所述薄壁处理为形成一倒置的盲孔(64)，所述盲孔(64)开口处朝向第二切开缝(51)。
  8. 根据权利要求1所述一体式提取试剂盒，其特征在于，所述活动连通组(46)包括设置于盒体(1)上的旋钮以及位于旋钮上的活动连通槽，所述旋钮转动带动所述活动连通槽转动使得第一连通槽(41)、第三连通槽(43)、第四连通槽(44)以及扩增连通槽(45)通过活动连通槽分别单独与第二连通槽(42)连通。
  9. 根据权利要求8所述一体式提取试剂盒，其特征在于，所述动力组为用于对混合反应腔(22)产生正压与负压的动力泵或者柱塞杆。
  10. 根据权利要求1所述一体式提取试剂盒，其特征在于，所述活 动连通组(46)包括设置于盒体(1)上的滑动槽(461)、设置于滑动槽(461)上的滑动块(462)、设置于滑动块(462)上的过渡筒体(463)，在所述滑动块(462)上设置有第一活动连通孔(464)，所述过渡筒体(463)内部形成过渡腔，在所述过渡腔底部与滑动块(462)接触位置设置有第二活动连接孔(465)，所述第一活动连接孔(464)与第二活动连接孔(465)对齐，所述动力组对过渡腔产生正压与负压。
  11. 根据权利要求10所述一体式提取试剂盒，其特征在于，所述第一活动连通孔(464)至少两个，所述过渡筒体(463)可旋转，所述过渡筒体(463)旋转使得所述第二活动连接孔(465)与所述第一活动连接孔(464)中的一个连通。
  12. 根据权利要求11所述一体式提取试剂盒，其特征在于，在所述过渡筒体(463)上设置有用于驱动所述过渡筒体(463)转动的转动缺口(466)。
  13. 根据权利要求11所述一体式提取试剂盒，其特征在于，所述滑动块(462)包括滑块本体(4621)、设置于滑块本体(4621)底部的第一密封垫(4622)、设置于滑块本体(4621)上的容纳槽(4623)，所述过渡筒体(463)设置于容纳槽(4623)内，在所述容纳槽(4623)上方两侧向中间位置相向伸出限位板(4624)，两个所述限位板(4624)与所述容纳槽(4623)形成倒置的T型槽；所述过渡筒体(463)包括筒本体、在筒本体底部沿径向方向向外伸出的定位板(467)，所述定位板(467)插入容纳槽(4623)内，两个所述限位板(4624)限制所述定位板(467)向上移动；在所述过渡筒体(463)底部与容纳槽(4623)之间设置第二密封垫(4627)。
  14. 根据权利要求13所述一体式提取试剂盒，其特征在于，所述第一密封垫(4622)中部分部位向下凸出形成第一凸起(4625)，所述第一凸起(4625)与滑动槽(461)接触并在接触位置涂附润滑油；在所述第二密封垫(4627)中间位置向上凸出形成第二凸起(4628)，所述第二凸 起(4628)为圆形或者环形。
  15. 根据权利要求13所述一体式提取试剂盒，其特征在于，两个所述限位板(4624)相对的一侧均呈弧形，在所述过渡筒体(463)上设置有两个相互平行的平面作为安装口(468)，两个所述平面之间的距离小于两个所述限位板(4624)之间的最短距离；所述过渡筒体(463)插入所述容纳槽(4623)后旋转使得安装口(468)移位并与限位板(4624)错开；在所述筒本体上设置有限位缺口(469)，在所述限位板(4624)上设置有限位块(4626)，当所述筒本体转动后所述限位块(4626)进入限位缺口(469)。
  16. 根据权利要求1所述一体式提取试剂盒，其特征在于，在所述样本腔(21)内设置有第二过滤件。
  17. 根据权利要求1所述一体式提取试剂盒，其特征在于，在所述混合反应腔(22)内设置有磁珠以及防止磁珠泄露的腔底滤膜。
  18. 根据权利要求1所述一体式提取试剂盒，其特征在于，所述扩增部(3)包括PCR反应腔(31)以及通气槽(32)，所述扩增连通槽(45)与PCR反应腔(31)连通，所述PCR反应腔(31)呈扁平状。
  19. 根据权利要求18所述一体式提取试剂盒，其特征在于，所述PCR反应腔(31)包括两侧为开口的反应槽以及贴附于所述开口上的薄膜片(34)。
  20. 根据权利要求18所述一体式提取试剂盒，其特征在于，在所述废液腔(24)内设置有通气腔(35)，所述通气槽(32)与通气腔(35)连通。
  21. 根据权利要求18所述一体式提取试剂盒，其特征在于，在所述通气槽(32)上设置有超声波焊接口(33)或者在所述通气槽(32)内设置有石蜡。
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