WO2021223184A1 - 体外诊断仪及提取装置 - Google Patents

体外诊断仪及提取装置 Download PDF

Info

Publication number
WO2021223184A1
WO2021223184A1 PCT/CN2020/089053 CN2020089053W WO2021223184A1 WO 2021223184 A1 WO2021223184 A1 WO 2021223184A1 CN 2020089053 W CN2020089053 W CN 2020089053W WO 2021223184 A1 WO2021223184 A1 WO 2021223184A1
Authority
WO
WIPO (PCT)
Prior art keywords
liquid supply
extraction
unit
outlet
inlet
Prior art date
Application number
PCT/CN2020/089053
Other languages
English (en)
French (fr)
Inventor
赵蒙
陶伟
韦嘉
陈娉
徐强
Original Assignee
广州再生医学与健康广东省实验室
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 广州再生医学与健康广东省实验室 filed Critical 广州再生医学与健康广东省实验室
Priority to PCT/CN2020/089053 priority Critical patent/WO2021223184A1/zh
Publication of WO2021223184A1 publication Critical patent/WO2021223184A1/zh

Links

Images

Classifications

    • 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
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/10—Processes for the isolation, preparation or purification of DNA or RNA
    • 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

Definitions

  • the invention relates to the technical field of in vitro diagnostics, in particular to an in vitro diagnostic instrument and an extraction device.
  • the extraction device is easy to operate and can improve the binding rate of biomolecules.
  • the in-vitro diagnostic apparatus adopts the extraction device and can perform preliminary screening detection.
  • an extraction device including:
  • the extraction part is provided with an extraction cavity and an inlet and an outlet communicating with the extraction cavity;
  • Liquid supply unit which is connected with the inlet and outlet ends;
  • the control valve unit is arranged between the liquid supply unit and the inlet and outlet ends, and is used to control the connection and disconnection between the liquid supply unit and the inlet and outlet ends;
  • the adsorption unit which is arranged between the outlet of the control valve unit and the extraction chamber;
  • Power unit the power unit is used to provide negative pressure and positive pressure for the extraction chamber.
  • the sample liquid is stored in the liquid supply unit, and the preset reagent liquid is mixed with the sample liquid to decompose biomolecules.
  • the liquid supply unit and the inlet and outlet ends are in a disconnected state.
  • the control valve unit is used to connect the liquid supply unit with the inlet and outlet ends, and then the power unit provides negative pressure to the extraction chamber, so that the above-mentioned mixed liquid will flow to the extraction chamber. In this process, it will pass through the adsorption unit.
  • the biomolecules will be adsorbed by the adsorption unit.
  • the power unit can provide positive pressure to the extraction chamber so that the mixed liquid is discharged from the extraction chamber.
  • This process will pass through the adsorption unit again and use the adsorption unit to further adsorb Biomolecules, in turn, can increase the binding rate of biomolecules.
  • the above operations can be repeated as needed.
  • the control valve unit is used to control the inlet and outlet ends to be disconnected from the liquid supply unit, and other outlets are opened, so that the mixed liquid is discharged.
  • the extraction device is easy to operate and can improve the binding rate of biomolecules.
  • reagents can be injected into the liquid supply unit to perform the next step processing on the biomolecules in the adsorption unit.
  • control valve unit includes a first one-way valve that can only be opened toward the extraction chamber, and a first on-off valve for controlling the connection and disconnection between the liquid supply unit and the inlet and outlet ends, and the first one-way valve is opposite to
  • the first switch valve is arranged near the inlet and outlet ends, and the adsorption unit is arranged between the outlet of the first one-way valve and the extraction cavity.
  • the liquid supply unit includes a first liquid supply member and a second liquid supply member, the outlet of the first liquid supply member and the outlet of the second liquid supply member are respectively connected to the liquid supply unit, and the first liquid supply unit A first on-off valve is respectively provided between the outlet of the component and the outlet of the second liquid supply component and the liquid supply unit;
  • the liquid supply unit includes a third liquid supply member, the outlet of the third liquid supply member communicates with the inlet and outlet ends, and the first on-off valve is provided between the outlet and the inlet and outlet ends of the third liquid supply member, and the third liquid supply member Pieces are provided with a detachable cover.
  • the first liquid supply member is used to store the lysate
  • the second liquid supply member is used to store the eluent
  • the liquid supply unit further includes a fourth liquid supply member for storing cleaning liquid, the outlet of the fourth liquid supply member is in communication with the inlet and outlet ends, and the outlet of the fourth liquid supply member is provided between the inlet and outlet ends.
  • a first on-off valve There is a first on-off valve.
  • the first liquid supply member is provided with a second one-way valve that can only open toward the inside of the first liquid supply member, or/and the second liquid supply member is provided with a second one-way valve that can only open toward the second liquid supply member The third one-way valve opened inside.
  • the extraction device further includes a cavity, the cavity is in communication with the inlet and outlet ends, and a second on-off valve for on-off control is provided between the cavity and the inlet and outlet ends.
  • the adsorption unit is an adsorption film or magnetic beads.
  • the power unit is a piston pump, and the inlet and outlet of the piston pump are in communication with the extraction chamber; or the power unit and the extractor form a syringe structure, and the power unit is provided with a piston rod that matches the extraction chamber; or the power unit is a drip chamber.
  • the pipe, the inlet and outlet of the dropper are connected with the extraction cavity; or the power unit and the extraction part form a dropper structure, and the power unit is provided with an elastic rubber cap matched with the extraction cavity.
  • the extraction device further includes a self-heating unit, the self-heating unit is used to heat the liquid supply unit, and the self-heating unit is arranged outside the liquid supply unit.
  • the present application also provides an in vitro diagnostic apparatus, including the extraction device in any of the above embodiments.
  • the in-vitro diagnostic apparatus adopts the extraction device, and can use the extraction device to obtain biomolecules for preliminary screening detection.
  • the extraction device is easy to operate and can be used in a variety of occasions (such as family, community), and also makes the use of the in vitro diagnostic apparatus easier to use, without the need for professional induction training to use the in vitro diagnostic apparatus for specificity Initial screening for testing.
  • the in-vitro diagnostic apparatus further includes a test paper, a communication structure is provided between the drop sample area of the test test paper and the extraction chamber, and the communication structure is provided with a third on-off valve for on-off control.
  • Fig. 1 is a schematic diagram of the structure of the extraction device of the first embodiment
  • Fig. 2 is a schematic cross-sectional view of the extraction device of the second embodiment in a non-working state
  • FIG. 3 is a schematic diagram of the first liquid supply member of the extraction device shown in FIG. 2 in an opened state
  • FIG. 4 is a schematic diagram of the first liquid supply member of the extraction device shown in FIG. 2 being sucked;
  • Fig. 5 is a schematic diagram of the second liquid supply member of the extraction device shown in Fig. 2 in an opened state;
  • FIG. 6 is a schematic diagram of the second liquid supply member of the extraction device shown in FIG. 2 being sucked;
  • FIG. 7 is a schematic diagram of the structure of the extraction device of the third embodiment.
  • FIG. 8 is a schematic diagram of the structure of the extraction device of the fourth embodiment.
  • Fig. 9 is a schematic diagram of the structure of the extraction device of the fifth embodiment.
  • an extraction device which includes: an extraction element 100, a liquid supply unit 200, a control valve unit 300, an adsorption unit 400 and a power unit 500.
  • the extraction member 100 is provided with an extraction cavity 110 and an inlet and outlet 120 communicating with the extraction cavity 110.
  • the liquid supply unit 200 communicates with the inlet and outlet 120.
  • the control valve unit 300 is disposed between the liquid supply unit 200 and the inlet and outlet ends 120, and is used to control the communication and disconnection between the liquid supply unit 200 and the inlet and outlet ends 120.
  • the adsorption unit 400 is disposed between the outlet of the control valve unit 300 and the extraction chamber 110.
  • the power unit 500 is used to provide negative pressure and positive pressure to the extraction chamber 110.
  • the sample liquid is stored in the liquid supply unit 200, and the preset reagent liquid and the sample liquid are added to mix and decompose biomolecules.
  • the liquid supply unit 200 It is disconnected from the inlet and outlet 120.
  • the control valve unit 300 is used to make the liquid supply unit 200 communicate with the inlet and outlet ends 120, and then the power unit 500 provides negative pressure to the extraction chamber 110, so that the above-mentioned mixed liquid will flow to the extraction chamber 110.
  • the decomposed biomolecules will be adsorbed by the adsorption unit 400.
  • the power unit 500 can provide positive pressure to the extraction chamber 110 so that the mixed liquid is discharged from the extraction chamber 110.
  • This process will pass through the adsorption unit 400 again.
  • the adsorption unit 400 to further adsorb biomolecules, the binding rate of biomolecules can be improved.
  • the above operations can be repeated as needed.
  • the control valve unit 300 is used to control the inlet and outlet ends 120 to be disconnected from the liquid supply unit 200, and other cavities (as shown in Figure 2 and Figure 9) are opened to make the mixed liquid Is discharged.
  • the extraction device is easy to operate and can improve the binding rate of biomolecules.
  • the sample liquid can be obtained directly or indirectly through nasopharyngeal swabs, sputum, urine, stool, cervical/vaginal swabs, blood, cerebrospinal fluid, skin, wound swabs, etc.
  • liquid supply unit 200 includes, but is not limited to, liquid supply pipes, liquid supply bags, liquid supply boxes, etc. capable of storing or injecting liquid, and the number of liquid supply pipes, liquid supply bags, liquid supply boxes, etc. It can be set according to needs, such as 1, 2, 3, 4, etc. Refer to Figure 1, Figure 2, Figure 7 and Figure 8 for details.
  • control valve unit 300 is one of the existing technologies that can realize liquid on-off control or flow direction control, and can be a single type of on-off valve, or a combination of a one-way valve and on-off valve, etc. As long as the above requirements can be met.
  • adsorption unit 400 can be any existing adsorption function that can achieve adsorption of biomolecules.
  • the adsorption unit 400 is an adsorption film or/and magnetic beads.
  • the "power unit 500" is any type of existing equipment that can provide the extraction chamber 110 with suction gas to form a negative pressure or inject gas to form a positive pressure.
  • the power unit 500 is a piston pump, and the inlet and outlet of the piston pump are in communication with the extraction chamber 110; or the power unit 500 and the extraction member 100 form a syringe structure, and the power unit 500 is provided with the extraction chamber 110.
  • Piston rod 510; or the power unit 500 is a dropper, and the inlet and outlet of the dropper are in communication with the extraction chamber 110; or the power unit 500 and the extractor 100 form a dropper structure, and the power unit 500 is provided with an elastic rubber that matches with the extraction chamber 110 cap.
  • the power unit 500 and the extractor 100 constitute a syringe structure, and the power unit 500 is provided with a piston rod 510 that matches the extraction cavity 110.
  • the liquid supply unit 200 in this embodiment has a liquid supply function.
  • the sample solution is stored in the liquid supply unit 200, and the lysis solution is added and mixed with the sample solution to lyse nucleic acid molecules.
  • the liquid supply unit 200 and the inlet and outlet 120 are in a disconnected state .
  • the control valve unit 300 is used to connect the liquid supply unit 200 with the inlet and outlet ends 120, and then the power unit 500 provides negative pressure to the extraction chamber 110, so that the above-mentioned mixed liquid containing nucleic acid molecules flows to the extraction chamber 110.
  • the medium will pass through the adsorption unit 400, and the nucleic acid molecules will be adsorbed by the adsorption unit 400.
  • the power unit 500 can provide a positive pressure for the extraction chamber 110, so that the mixed liquid can be discharged from the extraction chamber 110 (it can enter the liquid supply unit 200, or you can Into another preset cavity), this process will pass through the adsorption unit 400 again, and the adsorption unit 400 is used to further adsorb the nucleic acid molecules, thereby increasing the binding rate of the nucleic acid molecules.
  • the above operations can be repeated as needed.
  • the control valve unit 300 is used to control the inlet and outlet ends 120 to be disconnected from the liquid supply unit 200, and other outlets are opened, so that the mixed liquid is discharged.
  • eluent can be injected into the liquid supply unit 200 to elute the adsorption unit 400.
  • This process can also be repeated for suction and ejection. So that the nucleic acid molecules adsorbed on the adsorption unit 400 are fully eluted, and the required extraction solution is obtained.
  • the liquid supply unit 200 can pre-store the required extraction reagent solution, and the sample solution can be injected into the lysis solution.
  • the control valve unit 300 includes a first check valve 310 that can only be opened toward the extraction chamber 110, and a control valve for liquid supply.
  • the unit 200 is connected to and disconnected from the first on-off valve 320 of the inlet and outlet 120.
  • the first one-way valve 310 is arranged near the inlet and outlet 120 relative to the first on-off valve 320.
  • the adsorption unit 400 is arranged at the outlet of the first one-way valve 310 and Between the extraction cavity 110. In this way, the use of the first one-way valve 310 allows the liquid to flow only toward the extraction chamber 110, and the liquid pushed out of the extraction chamber 110 will not return to the original liquid supply unit 200.
  • the operation steps can be further optimized to facilitate the operation of ordinary personnel.
  • the first switch valve 320 only needs to be opened or closed, so that the extraction process is easy to understand and control.
  • the liquid supply unit 200 includes a first liquid supply member 210 and a second liquid supply member 220.
  • the outlet of the member 210 and the outlet of the second liquid supply member 220 are respectively communicated with the inlet and outlet ends 120, and a first switch is respectively provided between the outlet of the first liquid supply member 210 and the outlet of the second liquid supply member 220 and the inlet and outlet ends 120.
  • Valve 320 is respectively provided between the outlet of the first liquid supply member 210 and the outlet of the second liquid supply member 220 and the inlet and outlet ends 120.
  • Valve 320 the first liquid supply member 210 and the second liquid supply member 220 can be controlled by the first on-off valve 320, respectively, so that the extraction reagent can be pre-stored in the first liquid supply member 210 and the second liquid supply member 220.
  • the first liquid supply member 210 is used to store the lysate
  • the second liquid supply member 220 is used to store the eluate.
  • nucleic acid extraction operations can be performed.
  • the sample solution can be injected into the first liquid supply member 210.
  • the first on-off valve 320 is opened to inject the mixture into the extraction chamber 110, and the mixture is pushed out of the extraction chamber 110.
  • the first one-way valve 310 the liquid will not return to the first liquid supply member 210, which prevents the liquid from entering the second liquid supply member 220 due to misoperation, and facilitates the sequential setting of operation steps.
  • the liquid supply unit 200 further includes a fourth liquid supply member 240 for storing cleaning liquid, the outlet of the fourth liquid supply member 240 is in communication with the inlet and outlet ends 120, and the fourth liquid supply unit 240 A first switch valve 320 is provided between the outlet of the liquid supply 240 and the liquid supply unit 200.
  • the fourth liquid supply part 320 can be used to inject the cleaning liquid in the fourth liquid supply part to complete the cleaning step before performing the elution, and then perform the elution step. In this way, the extraction accuracy can be further improved.
  • the first liquid supply member 210 is provided with a first liquid supply member 210 that can only be opened toward the inside of the first liquid supply member 210.
  • the second one-way valve 212 or/and the second liquid supply member 220 are provided with a third one-way valve 222 that can only be opened toward the inside of the second liquid supply member 220.
  • the use of the one-way valve makes the inside of the liquid supply part the same as the outside, which facilitates the extraction of the corresponding liquid.
  • the liquid supply unit 200 includes a third liquid supply member 230, the outlet of the third liquid supply member 230 is in communication with the inlet and outlet ends 120, and the outlet of the third liquid supply member 230 and the inlet and outlet ends 120 are provided between
  • the first on-off valve 320 and the third liquid supply member 230 are provided with a detachable cover 232.
  • the required reagent or sample can be added to the third liquid supply member 230 by opening the cover 232 to perform a corresponding extraction action.
  • the third liquid supply 230 can be used to sequentially add required reagents, and the control valve unit 300 can be used to implement the aforementioned extraction operation.
  • the equivalent liquid supply member in the foregoing embodiment can also be provided with a cover structure to facilitate the addition of liquid.
  • first liquid supply member 210 the second liquid supply member 220, the third liquid supply member 230, and the fourth liquid supply member 240 may be a liquid supply tube, a liquid supply bag, a liquid supply box, etc.
  • a component capable of liquid storage may be a liquid supply tube, a liquid supply bag, a liquid supply box, etc.
  • the extraction device further includes a cavity 600, the cavity 600 is in communication with the inlet and outlet ends 120, and a utility model is provided between the cavity 600 and the inlet and outlet ends 120.
  • the second on-off valve for on-off control.
  • the cavity 600 can be used as a buffer cavity, so that the liquid in the combining process can enter the waste liquid cavity for buffering.
  • the one-way valve 310 when it is necessary to perform the combination step, due to the action of the one-way valve 310, the liquid drawn away will not return to the liquid supply member.
  • the second on-off valve can be opened to make the cavity 600 communicate with the inlet and outlet ends 120, and then The liquid pushed out from the extraction cavity 110 can enter the cavity 600 for buffering, and then be withdrawn to combine. After the combination is completed, the waste liquid is pushed into the cavity 600; then the second on-off valve is closed. When cleaning is required, after the cleaning is completed, the second on-off valve can also be opened, and the used cleaning liquid can be pushed into the cavity 600 for storage.
  • the cavity 600 can be used as a waste liquid cavity and a buffer cavity, which can not only improve the combination efficiency, but also store the waste liquid.
  • cavities 600 there may be multiple cavities 600, that is, the binding step, the cleaning step, and the elution step respectively correspond to one cavity 600, so that the above steps can be repeatedly pumped.
  • the cavity 600 is used for repeated suction in this way to achieve a centrifugal effect.
  • the extraction device further includes a waste liquid cavity 800, and a fourth check valve 810 is provided between the waste liquid cavity 800 and the inlet and outlet ends 120.
  • a waste liquid cavity 800 is required for waste liquid storage, and the operation is simple, which can be adapted to the extraction of molecules with relatively low extraction requirements.
  • the extraction device further includes a self-heating unit (not shown).
  • the self-heating unit is used to heat the liquid supply unit 200, and the self-heating unit is disposed in the liquid supply unit 200. Outside. In this way, the self-heating unit is used to provide heat for the lysis process of the sample solution, increase the lysis speed and the lysis rate, and help improve the extraction efficiency and extraction quality.
  • the self-heating unit can be realized by adopting any self-heating package that meets the requirements in the prior art, and the self-heating package can be sealed and stored in the preset position of the liquid supply unit 200, and the self-heating package can be stimulated by a preset means to react and produce Heat.
  • the extraction device further includes an installation unit 700, and the foregoing structure can be integrated and installed on the installation unit 700 to facilitate modular assembly.
  • the specific structure of the mounting unit 700 can be varied.
  • the installation unit 700 is a closed box. In this way, pollution can be avoided and the authenticity of the detection data can be ensured.
  • an in vitro diagnostic apparatus including the extraction device in any of the above embodiments.
  • the in-vitro diagnostic apparatus adopts the extraction device, and can use the extraction device to obtain biomolecules for preliminary screening detection.
  • the extraction device is easy to operate and can be used in a variety of occasions (such as family, community), and also makes the use of the in vitro diagnostic apparatus easier to use, without the need for professional induction training to use the in vitro diagnostic apparatus for specificity Initial screening for testing.
  • the in-vitro diagnostic apparatus further includes a test paper (not shown), a communication structure is provided between the drop sample area of the test test paper and the extraction chamber 110, and the communication structure is provided for The third on-off valve for on-off control.
  • a test paper not shown
  • a communication structure is provided between the drop sample area of the test test paper and the extraction chamber 110, and the communication structure is provided for The third on-off valve for on-off control.
  • the device of the present invention uses alkaline lysis solution and guanidine salt lysis solution to extract and enrich nucleic acids, specifically as follows:
  • the eluate is sent to the extraction chamber through the power unit 500.
  • the eluate is used to elute the nucleic acid molecules adsorbed by the adsorption unit 400, and the liquid containing the nucleic acid molecules is collected.
  • guanidine salt lysis solution and the device of the present invention Utilize the guanidine salt lysis solution and the device of the present invention to enrich nucleic acid once without eluting; enrich once and elution once; enrich once and elution twice; enrich twice without eluting Elution; enrichment 2 times and elution 1 time; enrichment 2 times and elution 2 times.
  • concentration of the extracted nucleic acid was determined separately.
  • the device of the present invention is easy to operate and improves the binding rate of biomolecules.
  • first”, “second”, “third”, and “fourth” are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of indicated technical features.
  • the features defined with “first”, “second”, “third”, and “fourth” may explicitly or implicitly include at least one of the features.
  • “plurality” means at least two, such as two, three, etc., unless otherwise specifically defined.
  • the terms “installed”, “connected”, “connected”, “fixed” and other terms should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. , Or integrated; it can be mechanically connected or electrically connected; it can be directly connected or indirectly connected through an intermediary, it can be the internal communication of two components or the interaction relationship between two components, unless otherwise specified The limit.
  • installed can be a fixed connection or a detachable connection. , Or integrated; it can be mechanically connected or electrically connected; it can be directly connected or indirectly connected through an intermediary, it can be the internal communication of two components or the interaction relationship between two components, unless otherwise specified The limit.
  • the specific meanings of the above-mentioned terms in the present invention can be understood according to specific situations.
  • the “on” or “under” of the first feature on the second feature may be in direct contact with the first and second features, or the first and second features may be indirectly through an intermediary. touch.
  • the “above”, “above” and “above” of the first feature on the second feature may mean that the first feature is directly above or diagonally above the second feature, or it simply means that the level of the first feature is higher than that of the second feature.
  • the “below”, “below” and “below” of the second feature of the first feature may mean that the first feature is directly below or obliquely below the second feature, or it simply means that the level of the first feature is smaller than the second feature.
  • an element when an element is referred to as being “fixed to”, “installed on”, “fixed on” or “installed on” another element, it can be directly on the other element or there may also be a centered element .
  • an element When an element is considered to be “connected” to another element, it can be directly connected to the other element or an intermediate element may be present at the same time.
  • one element when one element is considered to be a "fixed transmission connection” another element, the two can be fixed by a detachable connection or a non-detachable connection, which can realize power transmission, such as socket connection and snap connection. , One-piece molding, fixing, welding, etc., which can be realized in the prior art, so it will not be redundant here.

Landscapes

  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Wood Science & Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Biotechnology (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Microbiology (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Chemistry (AREA)
  • Sustainable Development (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Plant Pathology (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)

Abstract

一种体外诊断仪及提取装置，提取装置包括：提取件（100）、供液单元（200）、控制阀单元（300）、吸附单元（400）及动力单元（500），提取件（100）设有提取腔（110）、以及与提取腔（110）相通的进出端（120），供液单元（200）与进出端（120）连通，控制阀单元（300）设置于供液单元（200）与进出端（120）之间，并用于控制供液单元（200）与进出端（120）连通及断开，吸附单元（400）设置于控制阀单元（300）的出口与提取腔（110）之间，动力单元（500）用于为提取腔（110）提供负压及正压。提取装置操作简便，能提高生物分子的结合率。采用了该提取装置的体外诊断仪，能够进行初筛检测。

Description

体外诊断仪及提取装置 技术领域
本发明涉及体外诊断技术领域，特别是涉及一种体外诊断仪及提取装置。
背景技术
目前进行生物样品中提取生物分子进行特异性检测，需要在实验室依赖复杂的分析仪器，并由专业人士经过多次操作步骤才能够完成，这导致这个检测结果的分析耗时较长。如核酸提取,一般需要进行裂解、结合、清洗、洗脱等四个步骤是特异性核酸检测，加上后续的核酸分子杂交、聚合酶链反应(PCR)和生物芯片等检测步骤，使得整个检测过程耗时漫长。
当特异性检测需求短时间内大规模爆发时，如何简化操作步骤，快速获得能够进行初筛的提取物具有重要意义。而目前针对这一块的提取装置虽然能够简化了操作步骤，但生物分子的结合率偏低。
发明内容
基于此，有必要提供一种体外诊断仪及提取装置。该提取装置操作简便，能提高生物分子的结合率。该体外诊断仪采用了该提取装置，能够进行初筛检测。
其技术方案如下：
一方面，本申请提供一种提取装置，包括：
提取件，提取件设有提取腔、以及与提取腔相通的进出端；
供液单元，供液单元与进出端连通；
控制阀单元，控制阀单元设置于供液单元与进出端之间，并用于控制供液单元与进出端连通及断开；
吸附单元，吸附单元设置于控制阀单元的出口与提取腔之间；及
动力单元，动力单元用于为提取腔提供负压及正压。
上述提取装置使用时，将样品液存入供液单元中，并加入预设试剂液与样品液进行混合分解出生物分子，此过程中，供液单元与进出端处于断开状态。完成生物分子的分解后，利用控制阀单元使得供液单元与进出端连通，然后动力单元为提取腔提供负压，使得上述混合液会往流向提取腔，此过程中会经过吸附单元，分解后的生物分子会被吸附单元吸附。上述混合液全部经过或大部分经过吸附单元进入提取腔后，可以让动力单元为提取腔提供正压，使得混合液从提取腔中排出，此过程又会再次经过吸附单元，利用吸附单元进一步吸附生物分子，进而可以提高生物分子的结合率。当然了，可以根据需要再次循环上述操作。最后一次从提取腔将混合液推出的过程中，利用控制阀单元控制进出端与供液单元断开，打开其他出口，使得该混合液被排出。该提取装置操作简便，能提高生物分子的结合率。
进一步地，结合下一步提取需要，可以往供液单元注入其他试剂，对吸附单元的生物分子进行下一步处理。
下面进一步对技术方案进行说明：
在其中一个实施例中，控制阀单元包括只可朝提取腔打开的第一单向阀、以及用于控制供液单元与进出端连通及断开的第一开关阀，第一单向阀相对于第一开关阀靠近进出端设置，吸附单元设置于第一单向阀的出口与提取腔之间。
在其中一个实施例中，供液单元包括第一供液件及第二供液件，第一供液件的出口及第二供液件的出口分别与供液单元连通，且第一供液件的出口及第二供液件的出口与供液单元之间分别设有第一开关阀；
或供液单元包括一个第三供液件，第三供液件的出口与进出端连通，且第三供液件的出口与进出端之间设有所述第一开关阀，第三供液件设有可拆卸的盖体。
在其中一个实施例中，第一供液件用于存储裂解液，第二供液件用于存储洗脱液。
在其中一个实施例中，供液单元还包括用于存储清洗液的第四供液件，第四供液件的出口与进出端连通，且第四供液件的出口与进出端之间设有第一开关阀。
在其中一个实施例中，第一供液件设有只可朝第一供液件的内部打开的第二单向阀，或/和第二供液件设有只可朝第二供液件的内部打开的第三单向阀。
在其中一个实施例中，提取装置还包括腔体，腔体与进出端连通，且腔体与进出端之间设有用于通断控制的第二开关阀。
在其中一个实施例中，吸附单元为吸附膜或磁珠。
在其中一个实施例中，动力单元为活塞泵，活塞泵的进出口与提取腔连通；或动力单元与提取件构成注射器结构，动力单元设有与提取腔相配合活塞杆；或动力单元为滴管，滴管的进出口与提取腔连通；或动力单元与提取件构成滴管结构，动力单元设有与提取腔相配合的弹性胶帽。
在其中一个实施例中，提取装置还包括自热单元，自热单元用于对供液单元进行加热，自热单元设置于供液单元的外侧。
另一方面，本申请还提供了一种体外诊断仪，包括上述任一实施例中的提取装置。
该体外诊断仪采用了该提取装置，能够利用提取装置获得生物分子进行初筛检测。此外，该提取装置操作简便，可以在多种场合下进行使用(如家庭、社区)，也使得该体外诊断仪的使用更加简便，无需进行专业的上岗培训即可利用该体外诊断仪进行特异性检测的初筛。
下面进一步对技术方案进行说明：
在其中一个实施例中，体外诊断仪还包括检测试纸，检测试纸的滴样区与提取腔之间设有连通结构，连通结构设有用于通断控制的第三开关阀。
附图说明
为了更好地描述和说明这里公开的那些发明的实施例和/或示例，可以参考一幅或多幅附 图。用于描述附图的附加细节或示例不应当被认为是对所公开的发明、目前描述的实施例和/或示例以及目前理解的这些发明的最佳模式中的任何一者的范围的限制。
图1为实施例一的提取装置的结构示意图；
图2为实施例二的提取装置的未工作状态的剖视示意图；
图3为图2所示的提取装置的第一供液件打开状态的示意图；
图4为图2所示的提取装置的第一供液件被抽吸的示意图；
图5为图2所示的提取装置的第二供液件打开状态的示意图；
图6为图2所示的提取装置的第二供液件被抽吸的示意图；
图7为实施例三的提取装置的结构示意图；
图8为实施例四的提取装置的结构示意图；
图9为实施例五的提取装置的结构示意图。
附图标记说明：
100、提取件；110、提取腔；120、进出端；200、供液单元；210、第一供液件；212、第二单向阀；220、第二供液件；222、第三单向阀；230、第三供液件；232、盖体；240、第四供液件；300、控制阀单元；310、第一单向阀；320、第一开关阀；400、吸附单元；500、动力单元；510、活塞杆；600、腔体；610、第二开关阀；700、安装单元；800、废液腔体；810、第四单向阀。
具体实施方式
为使本发明的目的、技术方案及优点更加清楚明白，以下结合附图及具体实施方式，对本发明进行进一步的详细说明。应当理解的是，此处所描述的具体实施方式仅用以解释本发明，并不限定本发明的保护范围。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
如图1及图2所示，一实施例中，提供一种提取装置，包括：提取件100、供液单元200、控制阀单元300、吸附单元400及动力单元500。提取件100设有提取腔110、以及与提取腔110相通的进出端120。供液单元200与进出端120连通。控制阀单元300设置于供液单元200与进出端120之间，并用于控制供液单元200与进出端120连通及断开。吸附单元400设置于控制阀单元300的出口与提取腔110之间。动力单元500用于为提取腔110提供负压及正压。
如图2至图6所示，上述提取装置使用时，将样品液存入供液单元200中，并加入预设试剂液与样品液进行混合分解出生物分子，此过程中，供液单元200与进出端120处于断开状态。完成生物分子的分解后，利用控制阀单元300使得供液单元200与进出端120连通，然后动力单元500为提取腔110提供负压，使得上述混合液会往流向提取腔110，此过程中会经过吸附单元400，分解后的生物分子会被吸附单元400吸附。上述混合液全部经过或大部分经过吸附单元400进入提取腔110后，可以让动力单元500为提取腔110提供正压，使得混合液从提取腔110中排出，此过程又会再次经过吸附单元400，利用吸附单元400进一步吸附生物分子，进而可以提高生物分子的结合率。当然了，可以根据需要再次循环上述操 作。最后一次从提取腔110将混合液推出的过程中，利用控制阀单元300控制进出端120与供液单元200断开，打开其他腔体(如图2、图9所示)，使得该混合液被排出。该提取装置操作简便，能提高生物分子的结合率。
进一步地，结合下一步提取需要，可以往供液单元200注入其他试剂，对吸附单元400的生物分子进行下一步处理，具体可参考图1、图2、图7、图8及图9所示的等相同或等同的实施例。
样品液可以通过鼻咽拭子、痰液、尿液、粪便、宫颈/阴道拭子、血液、脑脊液、皮肤、伤口拭子等方式直接或间接获得。
需要说明的是，“供液单元200”包括但不限于能够存储或注入液体的供液管、供液袋、供液盒等等，而供液管、供液袋、供液盒等的数量可以根据需要进行设置，如1个、2个、3个、4个等。具体可参考图1、图2、图7及图8所示。
需要说明的是，“控制阀单元300”为能够实现液体通断控制或流向控制的现有技术中的一种，可以为单一的一类开关阀，或单向阀与开关阀等的组合，只要能够实现上述要求即可。
需要说明的是，“吸附单元400”可以任意一种能够实现生物分子吸附的现有吸附功能件。
具体到本实施例中，该吸附单元400为吸附膜或/和磁珠。
需要说明的是，“动力单元500”为任意一种能够为提取腔110提供吸走气体形成负压或注入气体形成正压的现有设备。
可选地，一实施例中，动力单元500为活塞泵，活塞泵的进出口与提取腔110连通；或动力单元500与提取件100构成注射器结构，动力单元500设有与提取腔110相配合活塞杆510；或动力单元500为滴管，滴管的进出口与提取腔110连通；或动力单元500与提取件100构成滴管结构，动力单元500设有与提取腔110相配合的弹性胶帽。
具体到本实施例中，动力单元500与提取件100构成注射器结构，动力单元500设有与提取腔110相配合活塞杆510。
为了更好地说明本申请的提取装置，下面结合核酸提取进行阐述。
如图2至图4所示，结合前述说明，本实施例中供液单元200具有供液功能。利用提取装置进行核酸提取时，将样品液存入供液单元200中，并加入裂解液与样品液进行混合，裂解出核酸分子，此过程中，供液单元200与进出端120处于断开状态。完成核酸分子的裂解后，利用控制阀单元300使得供液单元200与进出端120连通，然后动力单元500为提取腔110提供负压，使得上述含有核酸分子的混合液流向提取腔110，此过程中会经过吸附单元400，核酸分子会被吸附单元400吸附。上述混合液全部经过或大部分经过吸附单元400进入提取腔110后，可以让动力单元500为提取腔110提供正压，使得混合液从提取腔110中排出(可以进入供液单元200，也可以进入其他预设腔体中)，此过程又会再次经过吸附单元400，利用吸附单元400进一步吸附核酸分子，进而可以提高核酸分子的结合率。当然了，可以根据需要再次循环上述操作。最后一次从提取腔110将混合液推出的过程中，利用控制阀单元300控制进出端120与供液单元200断开，打开其他出口，使得该混合液被排出。
如图5及图6所示，进一步地，结合下一步提取需要，可以往供液单元200注入洗脱液，对吸附单元400的进行洗脱，此过程也可以重复进行抽吸及推出操作，使得吸附单元400上吸附的核酸分子被充分洗脱，获得所需的提取液。
当然了，也可以先注入清洗液，完成清洗后，再注入洗脱液，获得提取液。
当然了，在其他实施例中，该供液单元200可以预存所需的提取试剂液，将样品液注入裂解液中即可进行。
在上述任一实施例的基础上，如图1及图2所示，一实施例中，控制阀单元300包括只可朝提取腔110打开的第一单向阀310、以及用于控制供液单元200与进出端120连通及断开的第一开关阀320，第一单向阀310相对于第一开关阀320靠近进出端120设置，吸附单元400设置于第一单向阀310的出口与提取腔110之间。如此，利用第一单向阀310，使得 液体只可朝提取腔110流动，提取腔110推出的液体不会再回到原供液单元200中，可以进一步优化操作步骤，便于普通人员进行操作。而利用第一开关阀320只需进行开或关的操作，使得提取流程易于理解及控制。
在上述控制阀单元300的实施例的基础上，如图1及图2所示，一实施例中，供液单元200包括第一供液件210及第二供液件220，第一供液件210的出口及第二供液件220的出口分别与进出端120连通，且第一供液件210的出口及第二供液件220的出口与进出端120之间分别设有第一开关阀320。进而第一供液件210及第二供液件220可以分别利用第一开关阀320进行控制，便于在第一供液件210及第二供液件220中预存提取试剂。
如图2至图6所示，可选地，一实施例中，第一供液件210用于存储裂解液，第二供液件220用于存储洗脱液。进而可以进行核酸提取操作，可以将样品液注入第一供液件210，完成裂解后，打开第一开关阀320，将混合液注入提取腔110中，而混合液被推出提取腔110的过程中，利用第一单向阀310，该液体不会再回到第一供液件210，避免误操作导致该液体进入第二供液件220中，便于按顺序设置操作步骤。完成结合步骤后，只需打开第二供液件220对应的第一开关阀320，即可将洗脱液注入提取腔110中，此过程完成对吸附单元400上核酸分子的洗脱提取。
进一步地，如图8所示，一实施例中，供液单元200还包括用于存储清洗液的第四供液件240，第四供液件240的出口与进出端120连通，且第四供液件240的出口与供液单元200之间设有第一开关阀320。如此，具体地结合实施例二的相关操作步骤，利用第四供液件320可以在进行洗脱之前，可以将第四供液件内的清洗液注入完成清洗步骤，然后再进行洗脱步骤，如此可以进一步提高提取精度。
在上述任一供液单元200实施例的基础上，如图1及图2所示，一实施例中，第一供液件210设有只可朝第一供液件210的内部打开的第二单向阀212，或/和第二供液件220设有只可朝第二供液件220的内部打开的第三单向阀222。如此，利用单向阀使得供液件内部能够与外界相同，便于将相应的液体抽离。
另一实施例中，供液单元200包括一个第三供液件230，第三供液件230的出口与进出端120连通，且第三供液件230的出口与进出端120之间设有第一开关阀320，第三供液件230设有可拆卸的盖体232。如此，可以通过打开盖体232往第三供液件230中添加所需的试剂或样品进行相应的提取动作。具体到核酸提取中，可以利用该第三供液件230来依次添加所需的试剂，并利用控制阀单元300来实现前述的提取操作。
等同的前述实施例中的供液件亦可设置盖体结构，便于添加液体。
需要说明的的是，第一供液件210、第二供液件220、第三供液件230及第四供液件240的具体结构可以为供液管、供液袋、供液盒等能够进行液体存储的构件。
在上述任一实施例的基础上，如图9所示，一实施例中，提取装置还包括腔体600，腔体600与进出端120连通，且腔体600与进出端120之间设有用于通断控制的第二开关阀。如此，利用腔体600可以缓冲腔使用，使得结合过程中的液体可以进入废液腔进行缓存。具体地，当需要进行结合步骤时，因单向阀310的作用，被抽离的液体不会返回供液件，此时可以打开第二开关阀，使得腔体600与进出端120连通，进而从提取腔110推出的液体可以进入腔体600中进行缓存，然后又抽离进行结合。完成结合后，将废液推入腔体600；然后关闭第二开关阀。如需进行清洗时，清洗完成后，也可以打开第二开关阀，将使用后的清洗液推入腔体600中进行存储。
此时，该腔体600可以作为废液腔及缓冲腔来使用，既能够提高结合效率，又能够存储废液。
进一步地，该腔体600可以有多个，即结合步骤、清洗步骤、洗脱步骤分别对应一个腔体600，使得上述步骤可以进行反复抽吸。特别地，在进行洗脱时，如此利用腔体600进行反复抽吸，能达到离心效果。
如图2至图6所示，实施例二中，提取装置还包括废液腔体800，废液腔体800与进出 端120之间设有第四单向阀810。如此，可以只需外一个废液腔体800进行废液存储，且操作简单，能适应对提取要求相对较低的分子提取。
在上述任一实施例的基础上，一实施例中，提取装置还包括自热单元(未示出)，自热单元用于对供液单元200进行加热，自热单元设置于供液单元200的外侧。如此，利用自热单元为样品液裂解过程提供热量，提高裂解速度及裂解率，有利于提高提取效率及提取质量。
该自热单元可以采用现有技术中任一一种满足要求的自热包实现，即可将自热包封存于供液单元200的预设位置，通过预设手段激发自热包进行反应产生热量。
在上述任一实施例的基础上，如图1及图2所示，一实施例中，提取装置还包括安装单元700，进而上述结构可以集成安装于安装单元700上，便于模块化组装。该安装单元700具体结构可以由多种。
具体到本实施例中，该安装单元700为封闭式的盒体。如此可以避免污染，有利于保证检测数据的真实性。
一实施例中，还提供了一种体外诊断仪，包括上述任一实施例中的提取装置。
该体外诊断仪采用了该提取装置，能够利用提取装置获得生物分子进行初筛检测。此外，该提取装置操作简便，可以在多种场合下进行使用(如家庭、社区)，也使得该体外诊断仪的使用更加简便，无需进行专业的上岗培训即可利用该体外诊断仪进行特异性检测的初筛。
在上述任一实施例的基础上，一实施例中，体外诊断仪还包括检测试纸(未示出)，检测试纸的滴样区与提取腔110之间设有连通结构，连通结构设有用于通断控制的第三开关阀。如此，利用连接结构可以将提取腔110内获得的提取液直接输入检测试纸中进行检测，能够快速获得初筛结果。
需要说明的是，本申请的“单元”为一种具有特定功能的组合体的简称。
实施例1加裂解液提取
利用本发明装置分别使用碱裂解液和胍盐裂解液提取富集核酸，具体如下：
(1)取2ul质粒加入1ml裂解液中；
(2)将上述含有质粒的裂解液加入本发明的第一供液件210中；
(3)打开第一开关使得第一供液件210与进出端连通，通过动力单元500将第一供液件210中的液体吸入至提取腔110中，此过程中，液体会经过吸附单元400，核酸分子会被吸附单元400吸附；然后再将液体推出，此过程，再次利用吸附单元400进行核酸分子的吸附；
(4)完成吸附后，向第二供液件210中加100ul洗脱液；
(5)通过动力单元500将洗脱液送入提取腔，此过程中，利用洗脱液洗脱吸附单元400吸附的核酸分子，并将含有核酸分子的液体进行收集。
结果显示，在碱裂解液条件下，富集后的浓度很低，碱性条件下核酸与硅膜的结合效率很低。在胍盐裂解液条件下，核酸与硅膜具有较高的结合效率。
利用胍盐裂解液，利用本发明的装置，分别对核酸进行富集1次，不洗脱；富集1次，洗脱一次；富集1次，洗脱2次；富集2次，不洗脱；富集2次、洗脱1次；富集2次，洗脱2次。分别对提取的核酸进行浓度测定。
结果显示，与富集一次相比，富集两次的核酸浓度有明显的提高。因此，本发明的装置操作简便，提高了生物分子的结合率。
在本发明的描述中，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”、“第四”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”、“第三”、“第四”的特征可以明示或者隐含地包括至少一个该特征。在本发明的描述中，“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。
在本发明中，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发明中的具体含义。
在本发明中，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”、“设置于”、“固设于”或“安设于”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。进一步地，当一个元件被认为是“固定传动连接”另一个元件，二者可以是可拆卸连接方式的固定，也可以不可拆卸连接的固定，能够实现动力传递即可，如套接、卡接、一体成型固定、焊接等，在现有技术中可以实现，在此不再累赘。当元件与另一个元件相互垂直或近似垂直是指二者的理想状态是垂直，但是因制造及装配的影响，可以存在一定的垂直误差。本文所使用的术语“垂直的”、“水平的”、“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。
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发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (10)

  1. 一种提取装置，其特征在于，包括：
    提取件，所述提取件设有提取腔、以及与所述提取腔相通的进出端；
    供液单元，所述供液单元与所述进出端连通；
    控制阀单元，所述控制阀单元设置于所述供液单元与所述进出端之间，并用于控制所述供液单元与所述进出端连通及断开；
    吸附单元，所述吸附单元设置于所述控制阀单元的出口与所述提取腔之间；及
    动力单元，所述动力单元用于为提取腔提供负压及正压。
  2. 根据权利要求1所述的提取装置，其特征在于，所述控制阀单元包括只可朝所述提取腔打开的第一单向阀、以及用于控制所述供液单元与所述进出端连通及断开的第一开关阀，所述第一单向阀相对于所述第一开关阀靠近所述进出端设置，所述吸附单元设置于所述第一单向阀的出口与所述提取腔之间。
  3. 根据权利要求2所述的提取装置，其特征在于，所述供液单元包括第一供液件及第二供液件，所述第一供液件的出口及所述第二供液件的出口分别与所述进出端连通，且所述第一供液件的出口及所述第二供液件的出口与所述进出端之间分别设有所述第一开关阀；
    或所述供液单元包括一个第三供液件，所述第三供液件的出口与所述进出端连通，且所述第三供液件的出口与所述进出端之间设有所述第一开关阀，所述第三供液件设有可拆卸的盖体。
  4. 根据权利要求3所述的提取装置，其特征在于，所述第一供液件用于存储裂解液，所述第二供液件用于存储洗脱液。
  5. 根据权利要求4所述的提取装置，其特征在于，所述供液单元还包括用于存储清洗液的第四供液件，所述第四供液件的出口与所述进出端连通，且所述第四供液件的出口与所述进出端之间设有所述第一开关阀。
  6. 根据权利要求3所述的提取装置，其特征在于，所述第一供液件设有只可朝所述第一供液件的内部打开的第二单向阀，或/和所述第二供液件设有只可朝所述第二供液件的内部打开的第三单向阀。
  7. 根据权利要求1所述的提取装置，其特征在于，所述提取装置还包括腔体，所述腔体与所述进出端连通，且所述腔体与所述进出端之间设有用于通断控制的第二开关阀。
  8. 根据权利要求1所述的提取装置，其特征在于，所述动力单元为活塞泵，所述活塞泵的进出口与所述提取腔连通；或所述动力单元与提取件构成注射器结构，所述动力单元设有与所述提取腔相配合活塞杆；或所述动力单元为滴管，所述滴管的进出口与所述提取腔连通；或所述动力单元与所述提取件构成滴管结构，所述动力单元设有与所述提取腔相配合的弹性胶帽；或/和所述提取装置还包括自热单元，所述自热单元用于对供液单元进行加热，所述自热单元设置于所述供液单元的外侧。
  9. 一种体外诊断仪，其特征在于，包括如权利要求1至8任一项所述的提取装置。
  10. 根据权利要求9所述的体外诊断仪，其特征在于，所述体外诊断仪还包括检测试纸，所述检测试纸的滴样区与所述提取腔之间设有连通结构，所述连通结构设有用于通断控制的第三开关阀。
PCT/CN2020/089053 2020-05-07 2020-05-07 体外诊断仪及提取装置 WO2021223184A1 (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/CN2020/089053 WO2021223184A1 (zh) 2020-05-07 2020-05-07 体外诊断仪及提取装置

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/CN2020/089053 WO2021223184A1 (zh) 2020-05-07 2020-05-07 体外诊断仪及提取装置

Publications (1)

Publication Number Publication Date
WO2021223184A1 true WO2021223184A1 (zh) 2021-11-11

Family

ID=78467772

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2020/089053 WO2021223184A1 (zh) 2020-05-07 2020-05-07 体外诊断仪及提取装置

Country Status (1)

Country Link
WO (1) WO2021223184A1 (zh)

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150258544A1 (en) * 2014-03-13 2015-09-17 Genapsys, Inc. Microfluidic devices, systems and methods for sample preparation and analysis
WO2015179098A1 (en) * 2014-05-21 2015-11-26 Integenx Inc. Fluidic cartridge with valve mechanism
CN108220125A (zh) * 2018-03-21 2018-06-29 中国检验检疫科学研究院 一种核酸快速提取装置
CN108949507A (zh) * 2018-08-21 2018-12-07 苏州德思普生物科技有限公司 一种提取人类全血中细菌总核酸的微流控芯片
CN109456880A (zh) * 2018-12-20 2019-03-12 中国检验检疫科学研究院 核酸现场快速提取管及其使用方法
CN109797093A (zh) * 2019-03-11 2019-05-24 中国科学院苏州生物医学工程技术研究所 一种用于核酸提取的耗材、装置及核酸提取方法
CN110713917A (zh) * 2018-07-11 2020-01-21 拓原合壹(宁波)生物技术有限公司 一种全自动核酸提取装置
CN110964716A (zh) * 2019-12-05 2020-04-07 广州万孚生物技术股份有限公司 体外诊断分析装置及试剂卡
CN111057638A (zh) * 2018-10-17 2020-04-24 北京致雨生物科技有限公司 样本处理装置及方法，以及包括该处理装置的数字pcr系统
CN111500675A (zh) * 2020-03-30 2020-08-07 珠海黑马生物科技有限公司 一站式全自动封闭式核酸提取与实时荧光pcr测试联合试剂盒

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20150258544A1 (en) * 2014-03-13 2015-09-17 Genapsys, Inc. Microfluidic devices, systems and methods for sample preparation and analysis
WO2015179098A1 (en) * 2014-05-21 2015-11-26 Integenx Inc. Fluidic cartridge with valve mechanism
CN108220125A (zh) * 2018-03-21 2018-06-29 中国检验检疫科学研究院 一种核酸快速提取装置
CN110713917A (zh) * 2018-07-11 2020-01-21 拓原合壹(宁波)生物技术有限公司 一种全自动核酸提取装置
CN108949507A (zh) * 2018-08-21 2018-12-07 苏州德思普生物科技有限公司 一种提取人类全血中细菌总核酸的微流控芯片
CN111057638A (zh) * 2018-10-17 2020-04-24 北京致雨生物科技有限公司 样本处理装置及方法，以及包括该处理装置的数字pcr系统
CN109456880A (zh) * 2018-12-20 2019-03-12 中国检验检疫科学研究院 核酸现场快速提取管及其使用方法
CN109797093A (zh) * 2019-03-11 2019-05-24 中国科学院苏州生物医学工程技术研究所 一种用于核酸提取的耗材、装置及核酸提取方法
CN110964716A (zh) * 2019-12-05 2020-04-07 广州万孚生物技术股份有限公司 体外诊断分析装置及试剂卡
CN111500675A (zh) * 2020-03-30 2020-08-07 珠海黑马生物科技有限公司 一站式全自动封闭式核酸提取与实时荧光pcr测试联合试剂盒

Similar Documents

Publication Publication Date Title
US11273443B2 (en) Devices and methods for molecular diagnostic testing
CN109456880B (zh) 核酸现场快速提取管及其使用方法
CN110964716B (zh) 体外诊断分析装置及试剂卡
CN111607483B (zh) 体外诊断仪及提取装置
WO2018086207A1 (zh) 一种药剂混匀装置及其使用方法
WO2021223184A1 (zh) 体外诊断仪及提取装置
CN212504816U (zh) 体外诊断仪及提取装置
CN110055354B (zh) 核酸组合物、检测单元、微流控芯片及检测装置
CN112574871A (zh) 一种集成试剂切换阀的一体化微流控核酸检测卡盒
CN115400806A (zh) 一体化核酸提取微流控芯片盒和核酸提取及检测方法
CN214599114U (zh) 一种核酸扩增用的立式微流控芯片
CN209193947U (zh) 样本处理耗材、样本处理装置及数字pcr系统
AU2019327425A1 (en) Sample-to-answer microfluidic system and method including vertical microfluidic device and automated actuation mechanisms
CN214612492U (zh) 一种立式微流控芯片及其旋转活塞
Zhou et al. A novel nucleic acid extraction system integrating a switching valve-assisted microfluidic cartridge and a constant pressure pump
CN116832883A (zh) 流-静方式的核酸检测微流控芯片及其使用方法
Ritzi-Lehnert et al. New Lab-on-a-Chip System for Infectious Disease Analysis

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 20934561

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 20934561

Country of ref document: EP

Kind code of ref document: A1

32PN Ep: public notification in the ep bulletin as address of the adressee cannot be established

Free format text: NOTING OF LOSS OF RIGHTS PURSUANT TO RULE 112(1) EPC (EPO FORM 1205A DATED 02/05/2023)

122 Ep: pct application non-entry in european phase

Ref document number: 20934561

Country of ref document: EP

Kind code of ref document: A1