WO2020057193A1 - 核酸提取与扩增荧光检测*** - Google Patents

核酸提取与扩增荧光检测*** Download PDF

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Publication number
WO2020057193A1
WO2020057193A1 PCT/CN2019/091421 CN2019091421W WO2020057193A1 WO 2020057193 A1 WO2020057193 A1 WO 2020057193A1 CN 2019091421 W CN2019091421 W CN 2019091421W WO 2020057193 A1 WO2020057193 A1 WO 2020057193A1
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nucleic acid
sample
acid extraction
amplification
detection system
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PCT/CN2019/091421
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English (en)
French (fr)
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丁永军
张中
孙飞
赵强
刘振宇
许德晨
景宏维
孙家振
张国秀
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基蛋生物科技股份有限公司
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Publication of WO2020057193A1 publication Critical patent/WO2020057193A1/zh

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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6844—Nucleic acid amplification reactions
    • C12Q1/686—Polymerase chain reaction [PCR]
    • 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 present application relates to the field of biological sample analysis and detection, and in particular, to a nucleic acid extraction and amplification fluorescence detection system.
  • Biological sample analysis and testing requires a highly automated, highly integrated, and miniaturized diagnostic system.
  • “Integration” refers to the integration of functions such as sample storage, sample preparation, analytical reaction, signal detection and analysis that need to be automated equipment.
  • Standardization refers to the miniaturization of the automatic molecular diagnostic system to meet the requirements of individualized medical treatment, to be applied to the occasions of various medical institutions, and to timely diagnose.
  • the purpose of this application is to provide a nucleic acid extraction and amplification fluorescence detection system with high degree of automation, high degree of integration, and miniaturization.
  • a nucleic acid extraction and amplification fluorescence detection system includes: a sample injection device, the sample injection device includes a plurality of sample racks for placing sample bottles and a sample transport mechanism; a reagent kit transport device, and the reagent kit transport device includes a plurality of Kit storage assembly and kit transport mechanism; sample pretreatment device, sample pretreatment device is used to mix samples with reagents for heating, stirring and centrifugation; nucleic acid extraction device, nucleic acid extraction device is used to carry out sample extraction using reagents Nucleic acid extraction and magnetic separation; Amplification detection device, which is used to make nucleic acid processed samples into microchips for amplification and fluorescence detection analysis; and Robotic arm system, which is used to sample or reagent Transport to a sample injection device, a kit transport device, a sample pretreatment device, a nucleic acid extraction device, or an amplification detection device.
  • the reagent cartridge storage assembly includes a plurality of receiving chambers for storing the reagent cartridges and a cartridge case; each cartridge contains a cartridge case; a plurality of reagents The boxes are stacked in the magazine housing.
  • the kit transport mechanism includes a gripping component, a moving track, and a driving component; the gripping component is used to remove the reagent cartridge from the cartridge housing; the gripping component is drivingly connected to the driving component, To drive the gripping component to move along the moving track.
  • the sample pretreatment device includes a turntable and a suction component for placing the reagent box; the suction component is connected to the turntable and is located above the turntable, and the suction component can enter the reagent box to suck the test solution or Stir.
  • a heating component is provided at the bottom of the turntable for heating the test solution in the reagent box.
  • the amplification detection device includes a detection device, a microchip, and a chip transfer component; the microchip is used to accommodate a plurality of samples to be detected; the detection device includes a thermal cycle system and a real-time signal detection system The thermal cycling system is used to provide a suitable temperature for nucleic acid amplification of the samples in the microchip; the real-time signal detection system is used to perform fluorescence detection on the sample after the nucleic acid amplification; the chip transport component is used to grab the microchip and Transfer the microchip to the detection area of the detection device.
  • the nucleic acid extraction device includes a magnetic separator, a nucleic acid extraction reagent reservoir, a heater assembly, and a pipetting assembly; a magnetic separator is used to separate a test solution from a magnetic bead; a nucleic acid extraction reagent reservoir is used to Stores one or more reagents for extracting nucleic acid from a sample; a heater assembly is used to provide a suitable temperature for the nucleic acid extraction reaction.
  • the nucleic acid extraction and amplification fluorescence detection system further includes a waste liquid common liquid box; the waste liquid common liquid box is disposed between the nucleic acid extraction device and the sample sampling device.
  • each sample rack is provided with a plurality of receiving chambers for placing sample bottles;
  • the sample transport mechanism includes a driving part and a moving guide; the driving part is drivingly connected to the moving guide; each The sample racks are connected to a moving guide.
  • the robotic arm system includes a suction arm and a gripping arm; the suction arm has used the suction test solution and moved it to the required position; the gripping arm is used to grip the test solution box and move it to the required position position.
  • a nucleic acid extraction and amplification fluorescence detection system includes a sample sampling device, a kit transport device, a sample pretreatment device, a nucleic acid extraction device, an amplification detection device, and a robotic arm system.
  • the sample injection device includes a plurality of sample racks for placing sample bottles and a sample transport mechanism.
  • the kit transporting device includes a plurality of kit storage components and a kit transport mechanism.
  • the sample pretreatment device is used for heating, stirring and centrifuging the sample and reagent after mixing.
  • the nucleic acid extraction device is used for nucleic acid extraction and magnetic separation using an extraction reagent for a sample.
  • the amplification detection device is used to make a micro-chip after the nucleic acid processed sample is used for amplification and fluorescence detection analysis.
  • the robotic arm system is used to transport a sample or a reagent to a sample sampling device, a kit transport device, a sample pretreatment device, a nucleic acid extraction device, or an amplification detection device.
  • the nucleic acid extraction and amplification fluorescence detection system extracts and processes magnetic bead samples by setting a nucleic acid extraction device, and realizes high-throughput signal detection by setting an amplification detection device, which has a high degree of automation.
  • the nucleic acid extraction and amplification fluorescence detection system integrates various functions of sample injection, kit transportation, sample pretreatment, nucleic acid extraction, amplification detection, and waste liquid treatment into one system, and has a high degree of integration.
  • the functional modules of the nucleic acid extraction and amplification fluorescence detection system have a reasonable layout and compact structure.
  • the entire nucleic acid extraction and amplification fluorescence detection system has the characteristics of miniaturization, can meet the requirements of individualized medical treatment, and is applied to various medical institution occasions Prompt diagnosis, etc.
  • FIG. 1 is a schematic structural diagram of a nucleic acid extraction and amplification fluorescence detection system according to a first embodiment of the present application
  • FIG. 2 is an enlarged view at II in FIG. 1;
  • FIG. 3 is a schematic structural diagram of a first perspective of a kit transport device of a nucleic acid extraction and amplification fluorescence detection system provided by a first embodiment of the present application;
  • FIG. 4 is a schematic structural view of a second perspective of a kit transport device of a nucleic acid extraction and amplification fluorescence detection system provided by the first embodiment of the present application;
  • FIG. 5 is a schematic structural diagram of a cartridge case of a reagent cartridge transporting device of a nucleic acid extraction and amplification fluorescence detection system according to a first embodiment of the present application;
  • FIG. 6 is a schematic structural diagram of a first perspective of a sample pretreatment device of a kit transport device of a nucleic acid extraction and amplification fluorescence detection system provided by a first embodiment of the present application;
  • FIG. 7 is a schematic structural diagram of a second perspective of a sample pretreatment device of a kit transporting device of a nucleic acid extraction and amplification fluorescence detection system according to a first embodiment of the present application;
  • FIG. 8 is a schematic structural diagram of an amplification detection device of a kit transport device of a nucleic acid extraction and amplification fluorescence detection system provided by the first embodiment of the present application;
  • FIG. 9 is an enlarged view of a place in FIG. 1;
  • FIG. 10 is a schematic structural diagram of an amplification detection device of a kit transport device of a nucleic acid extraction and amplification fluorescence detection system provided by the first embodiment of the present application.
  • Icon 10-nucleic acid extraction and amplification fluorescence detection system; 20-substrate; 21-first side; 22-second side; 23-third side; 24-fourth side; 100-sample sampling device; 110- Sample rack; 120-sample transport mechanism; 121-drive unit; 122-mobile guide; 200-reagent box transport device; 210-reagent box storage assembly; 211-receiving cavity; 212-clip case; 213-reagent box 220-kit transport mechanism; 221-clamping component; 222-moving track; 223-drive component; 300-sample pretreatment device; 310-turntable; 320-suction component; 330-heating component; 331-thermal conductive ring; 332-heating belt; 333-insulation layer; 400-amplification detection device; 410-detection device; 411-thermal cycle system; 412-real-time signal detection system; 420-micro chip; 430-chip transfer module; 500- Nucleic acid extraction device; 510-
  • orientations or positional relationships indicated by the terms “up” and “inner” are based on the orientations or positional relationships shown in the accompanying drawings, or the products used in this application are often used.
  • the orientation or position relationship of the placement is only for the convenience of describing the application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, structure and operation in a specific orientation, so it cannot be understood as limit.
  • This embodiment provides a nucleic acid extraction and amplification fluorescence detection system 10, which includes a sample sampling device 100, a reagent cartridge transport device 200, a sample pretreatment device 300, an amplification detection device 400, The nucleic acid extraction device 500, the waste liquid common liquid box 600, and the robot arm system 700.
  • the nucleic acid extraction and amplification fluorescence detection system 10 is provided with a nucleic acid extraction device 500 for extracting and processing magnetic bead samples, and the amplification detection device 400 is provided to realize high-throughput signal detection with a high degree of automation.
  • the nucleic acid extraction and amplification fluorescence detection system 10 integrates various functions of sample injection, kit transportation, sample pretreatment, nucleic acid extraction, amplification detection, and waste liquid processing into one system, and has a high degree of integration.
  • the functional modules of the nucleic acid extraction and amplification fluorescence detection system 10 have a reasonable layout and a compact structure.
  • the entire nucleic acid extraction and amplification fluorescence detection system 10 has the characteristics of miniaturization, can meet the requirements of individualized medicine, and is applied to various medical institutions. Occasions and timely diagnosis.
  • the nucleic acid extraction and amplification fluorescence detection system 10 includes a substrate 20, the aforementioned sample sampling device 100, kit transport device 200, sample pre-processing device 300, nucleic acid extraction device 500, amplification detection device 400, and waste liquid.
  • the liquid tank 600 and the robot arm system 700 are both disposed on the substrate 20.
  • the shape of the substrate 20 is a square.
  • the substrate 20 has a first side 21 and an opposite second side 22; and a third side 23 and an opposite fourth side 24.
  • the sample pretreatment device 300 and the reagent cartridge transport device 200 are disposed on the first side 21 and the sample pretreatment device 300 is close to the third side 23. Therefore, it is convenient to transport the reagent kit to the sample pretreatment device 300.
  • the sample sampling device 100 is disposed on the third side 23 and is located at an end remote from the sample pre-processing device 300, so that the sample is conveniently transported away from the sample pre-processing device 300.
  • the nucleic acid extraction device 500 is disposed in the middle of the substrate 20, so that the sample injection device 100 can transport samples, the reagent container transport device 200 can transport reagents, and the sample pretreatment device 300 can transport processed samples. Further, the amplification detection device 400 is disposed on the second side 22 so that the sample on the nucleic acid extraction device 500 can be conveniently transferred to the amplification detection device 400.
  • the reagent cartridge transporting apparatus 200 includes a plurality of reagent cartridge storage assemblies 210 and a reagent cartridge transport mechanism 220.
  • the reagent cartridge storage assembly 210 includes a plurality of accommodating chambers 211 for storing reagent cartridges and a magazine holder 212; each of the accommodating chambers 211 houses a magazine holder 212; a plurality of reagent cartridges 213 Stacked inside the magazine housing 212.
  • the reagent cartridge transport mechanism 220 includes a gripping component 221, a moving track 222, and a driving component 223. Further, the gripping component 221 is used to grip the reagent cartridge 213 out of the cartridge housing 212; the gripping component 221 is drivingly connected to the driving component 223 to drive the gripping component 221 to move along the moving track 222.
  • the sample pre-processing device 300 is used for heating, stirring and centrifuging the sample after mixing the sample with the reagent.
  • the sample pretreatment device 300 includes a turntable 310 and a suction component 320 for placing a reagent kit; the suction component 320 is connected to the turntable 310 and is located above the turntable 310, and the suction component 320 can enter the reagent cartridge to suck a test solution or Stir.
  • a heating component 330 is provided at the bottom of the turntable 310 for heating the test solution in the reagent box.
  • the turntable 310 is provided with a plurality of accommodating portions for accommodating a reagent cartridge. During the rotation of the turntable 310, the suction component 320 is used for stirring.
  • the heating assembly 330 includes a thermally conductive ring 331, a heating belt 332, and a heat insulation layer 333.
  • a heat conducting ring 331 is provided at the bottom of each accommodating portion; a heating belt 332 is provided below the heat conducting ring 331.
  • a heat insulation layer 333 is further provided between the heating belt 332 and the bottom wall of the turntable 310. Therefore, the diffusion of heat is avoided, and the structural reliability of the entire sample pre-processing device 300 is further improved.
  • the amplification detection device 400 is configured to perform nucleic acid extraction and magnetic separation on the pretreated sample by using an extraction reagent.
  • the amplification detection device 400 includes a detection device 410, a microchip 420, and a chip transfer component 430.
  • the microchip 420 is used for accommodating a plurality of samples to be detected.
  • the detection device 410 includes a thermal cycling system 411 and a real-time signal detection system 412.
  • the thermal cycling system 411 is used to provide a suitable temperature for nucleic acid amplification of a sample in the microchip 420.
  • the real-time signal detection system 412 is used to perform fluorescence detection on a sample after nucleic acid amplification.
  • the chip transfer component 430 is used for grasping the microchip 420 and transferring the microchip 420 to a detection area of the detection device 410.
  • the nucleic acid extraction device 500 includes a magnetic separator 530, a nucleic acid extraction reagent reservoir, a heater assembly, and a pipetting assembly.
  • the magnetic separator 530 is used to separate the test solution from the magnetic beads;
  • the nucleic acid extraction reagent reservoir is used to store one or more reagents for extracting nucleic acid from the sample;
  • the heater assembly is used to provide a suitable temperature for the nucleic acid extraction reaction.
  • the above-mentioned magnetic separator 530, nucleic acid extraction reagent reservoir, and heater assembly are all disposed on a plurality of brackets 510, each configured to receive a certain number of samples and a corresponding number of holders 520.
  • Each of these holders 520 includes a processing chamber, a waste chamber, one or more pipette tips, and one or more receptacles.
  • One or more of the reservoirs each contain a sufficient amount of one or more reagents for performing nucleic acid extraction from the sample.
  • a magnetic separator 530 configured to move relative to the processing chamber of each holder 520.
  • a heater assembly configured to independently heat each processing chamber.
  • a liquid dispenser or the like configured to perform a fluid transfer operation on two or more holders 520 simultaneously.
  • the waste liquid common liquid cartridge 600 is disposed between the nucleic acid extraction device 500 and the sample sampling device 100.
  • the waste liquid common liquid box 600 includes a first-layer accommodating portion 610, a second-layer accommodating portion 620, and a stirring device 630.
  • the first-layer accommodating portion 610 includes a plurality of chambers 611 which are not connected to each other. Each chamber 611 has at least one inlet. At least one chamber 611 is a waste liquid collection chamber.
  • the second layer accommodating portion 620 is disposed below the first layer accommodating portion 610.
  • the second layer accommodating portion 620 is configured to contain waste liquid.
  • Each waste liquid collection chamber is connected to the second-layer accommodating portion 620.
  • the stirring device 630 is connected to the waste liquid collection chamber.
  • the space layout of the multiple chambers 611 and the stirring device 630 of the waste liquid common liquid box 600 is compact and reasonable, which is convenient for operators. Providing a common reagent storage section and a waste liquid collection section in one box not only saves space, but also reduces the number of times the user needs to replace consumables, saves time, and improves the efficiency of use.
  • the setting of the stirring device 630 solves the problem of precipitation of magnetic beads, and the use effect is better.
  • the sample injection device 100 includes a plurality of sample racks 110 for placing sample bottles and a sample transport mechanism 120. Further, each sample rack 110 is provided with a plurality of receiving chambers for placing sample bottles; the sample transport mechanism 120 includes a driving part 121 and a moving guide 122; the driving part 121 is drivingly connected to the moving guide 122; each sample The racks 110 are all connected to the moving rail 122. Specifically, in this embodiment, the sample injection device 100 includes 4 rows of sample racks 110 for sampling, and each row of the sample racks 110 can store 12 sample bottles.
  • the robot arm system 700 is configured to transport a sample or a reagent to the sample injection device 100, the reagent cartridge transport device 200, the sample pretreatment device 300, the nucleic acid extraction device 500, or the amplification detection device 400. Further, the robot arm system 700 includes a suction arm 710 and a grasping arm 720. Further, the sucking arm 710 is used to suck the test solution and move to the required position; the gripping arm 720 is used to grab the test solution box and move to the required position.
  • the suction arm 710 includes a first suction arm 711 provided along the extending direction of the first side 21 of the substrate 20, a second suction arm 712 provided along the extending direction of the second side 22 of the substrate 20, and a sliding arrangement
  • the liquid suction needle set 714 is slidably connected to the third suction arm 713, and can move back and forth on the third suction arm 713.
  • the aspiration needle group 714 moves in both X and Y directions.
  • the aspiration needle group 714 includes an aspiration needle body 715 and a mounting plate 716, and the aspiration needle body 715 is slidably connected to the installation plate 716, thereby realizing the movement of the aspiration needle body 715 in the Z-axis direction, thereby making the entire aspiration
  • the arm 710 can move over the entire range of the substrate 20.
  • the gripping arm 720 is disposed inside the suction arm 710 and has a lower height than the gripping arm 720.
  • the grasping arm 720 is mainly used for grasping a reagent cartridge.
  • the grasping arm 720 includes a first grasping arm 721, a second grasping arm (not shown), a third grasping arm 723, and a jaw assembly (not shown).
  • the first grasping arm 721 is connected to the back plate provided on the fourth side 24 of the substrate 20 and is disposed along the extending direction of the fourth side 24; the second grasping arm is disposed along the direction of the first side 21 and is vertically connected to the first
  • a grasping arm 721 is connected to the first grasping arm 721 in a direction perpendicular to the plane of the substrate 20.
  • the gripper assembly is slidably connected to the second grasping arm, so that when the gripper assembly can move in three directions of XYZ, the reagent cartridge is gripped.
  • nucleic acid extraction and amplification fluorescence detection system 10 is further provided with a display system 800 so that detection data can be displayed.

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Abstract

本申请提供一种核酸提取与扩增荧光检测***，其属于生物样本分析检测领域。该核酸提取与扩增荧光检测***包括：样本进样装置、试剂盒运送装置、样本预处理装置、核酸提取装置、扩增检测装置以及机械臂***。通过设置核酸提取装置对磁珠样本进行提取与处理，通过设置扩增检测装置实现了高通量信号检测，具有较高的自动化程度。通过将样本进样、试剂盒运送、样本预处理、核酸提取、扩增检测、废液处理各个功能集成到一个***，一体化程度高。该核酸提取与扩增荧光检测***的各个功能模块布局合理，结构紧凑，整个核酸提取与扩增荧光检测***具有小型化的特点，能够适应个体化医疗的要求，应用于各种医疗机构场合以及及时诊断等。

Description

核酸提取与扩增荧光检测*** 技术领域
本申请涉及生物样本分析检测领域，具体而言，涉及一种核酸提取与扩增荧光检测***。
背景技术
生物样本分析检测需要自动化程度高、一体化程度高且小型化的诊断***的需求迫切。
“自动化”是指全自动分子诊断***能够完成“样本制备-靶分子富集或扩增-信号检测-数据分析”的生物分子检测分析的全过程自动化。
“一体化”是指将自动化设备需要能够将样本存储，样本制备，分析反应，信号检测和分析等功能集成。
“小型化”是指全自动分子诊断***小型化以适应个体化医疗的要求，以应用于各个医疗机构场合以及及时诊断等。
发明内容
本申请的目的在于提供一种核酸提取与扩增荧光检测***，自动化程度高、一体化程度高且小型化。
为了实现上述目的，本申请实施例采用的技术方案如下：
一种核酸提取与扩增荧光检测***，包括：样本进样装置，样本进样装置包括多个用于放置样本瓶的样本架以及样本输送机构；试剂盒运送装置，试剂盒运送装置包括多个试剂盒存储组件以及试剂盒输送机构；样本预处理装置，样本预处理装置用于将样本与试剂混合后进行加热、搅拌及离心处理；核酸提取装置，核酸提取装置用于对样本采用提取试剂进行核酸提取以及磁性分离；扩增检测装置，扩增检测装置用于将经过核酸处理的样本制成微观芯片后进行扩增及荧光检测分析；以及机械臂***，机械臂***用于将样本或者试剂运输至样本进样装置、试剂盒运送装置、样本预处理装置、核酸提取装置或者扩增检测装置。
在本申请较佳的实施例中，试剂盒存储组件包括多个用于存放试剂盒的容置腔以及***壳体；每一个容置腔内均放置有一个***壳体；多个试剂盒叠放在***壳体内。
在本申请较佳的实施例中，试剂盒输送机构包括夹取组件、移动轨道以及驱动组件；夹取组件用于将试剂盒从***壳体内夹取出；夹取组件传动连接于驱动组件，以带动夹取组件沿移动轨道移动。
在本申请较佳的实施例中，样本预处理装置包括用于放置试剂盒的转盘和吸取组件；吸取组件连接于转盘，且位于转盘的上方，吸取组件能够进入到试剂盒内吸取试液或者搅拌。
在本申请较佳的实施例中，转盘的底部设置有加热组件，用于对试剂盒内的试液加热。
在本申请较佳的实施例中，扩增检测装置包括检测装置、微观芯片以及芯片移运组件；微观芯片用于容置多个待检测的样本；检测装置包括热循环***和实时信号检测***，热循环***用于为微观芯片中的样本进行核酸扩增提供合适的温度；实时信号检测***用于对发生核酸扩增后的样本进行荧光检测；芯片移运组件用于抓取微观芯片并将微观芯片转移至检测装置的检测区。
在本申请较佳的实施例中，核酸提取装置包括磁性分离器、核酸提取试剂贮器、加热器组件以及移液组件；磁性分离器用于将试液与磁珠分离；核酸提取试剂贮器用于存储从样品提取核酸的一种或多种试剂；加热器组件用于对核酸提取反应提供适合温度。
在本申请较佳的实施例中，核酸提取与扩增荧光检测***还包括废液公共液盒子；废液公共液盒子设置在核酸提取装置和样本进样装置之间。
在本申请较佳的实施例中，每一个样本架上均设置有多个用于放置样本瓶的容置腔；样本输送机构包括驱动部和移动导轨；驱动部传动连接于移动导轨；每一个样本架均连接于移动导轨。
在本申请较佳的实施例中，机械臂***包括吸取臂和抓取臂；吸取臂用过吸取试液并移动至需要的位置；抓取臂用于抓取试液盒并移动至需要的位置。
本申请的有益效果是：
本申请提供的一种核酸提取与扩增荧光检测***，包括：样本进样装置、试剂盒运送装置、样本预处理装置、核酸提取装置、扩增检测装置以及机械臂***。其中， 样本进样装置包括多个用于放置样本瓶的样本架以及样本输送机构。试剂盒运送装置包括多个试剂盒存储组件以及试剂盒输送机构。样本预处理装置用于将样本与试剂混合后进行加热、搅拌及离心处理。核酸提取装置用于对样本采用提取试剂进行核酸提取以及磁性分离。扩增检测装置用于将经过核酸处理的样本制成微观芯片后进行扩增及荧光检测分析。机械臂***用于将样本或者试剂运输至样本进样装置、试剂盒运送装置、样本预处理装置、核酸提取装置或者扩增检测装置。该核酸提取与扩增荧光检测***通过设置核酸提取装置对磁珠样本进行提取与处理，通过设置扩增检测装置实现了高通量信号检测，具有较高的自动化程度。该核酸提取与扩增荧光检测***将样本进样、试剂盒运送、样本预处理、核酸提取、扩增检测、废液处理各个功能集成到一个***，一体化程度高。该核酸提取与扩增荧光检测***的各个功能模块布局合理，结构紧凑，整个核酸提取与扩增荧光检测***具有小型化的特点，能够适应个体化医疗的要求，应用于各种医疗机构场合以及及时诊断等。
附图说明
为了更清楚地说明本申请实施例的技术方案，下面将对实施例中所需要使用的附图作简单地介绍，应当理解，以下附图仅示出了本申请的某些实施例，因此不应被看作是对范围的限定，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他相关的附图。
图1为本申请第一实施例提供的核酸提取与扩增荧光检测***的结构示意图；
图2为图1中Ⅱ处的放大图；
图3为本申请第一实施例提供的核酸提取与扩增荧光检测***的试剂盒运送装置的第一视角的结构示意图；
图4为本申请第一实施例提供的核酸提取与扩增荧光检测***的试剂盒运送装置的第二视角的结构示意图；
图5为本申请第一实施例提供的核酸提取与扩增荧光检测***的试剂盒运送装置的***壳体的结构示意图；
图6为本申请第一实施例提供的核酸提取与扩增荧光检测***的试剂盒运送装置的样本预处理装置的第一视角的结构示意图；
图7为本申请第一实施例提供的核酸提取与扩增荧光检测***的试剂盒运送装 置的样本预处理装置的第二视角的结构示意图；
图8为本申请第一实施例提供的核酸提取与扩增荧光检测***的试剂盒运送装置的扩增检测装置的结构示意图；
图9为图1中Ⅸ处的放大图；
图10为本申请第一实施例提供的核酸提取与扩增荧光检测***的试剂盒运送装置的扩增检测装置的结构示意图。
图标：10-核酸提取与扩增荧光检测***；20-基板；21-第一侧；22-第二侧；23-第三侧；24-第四侧；100-样本进样装置；110-样本架；120-样本输送机构；121-驱动部；122-移动导轨；200-试剂盒运送装置；210-试剂盒存储组件；211-容置腔；212-***壳体；213-试剂盒；220-试剂盒输送机构；221-夹取组件；222-移动轨道；223-驱动组件；300-样本预处理装置；310-转盘；320-吸取组件；330-加热组件；331-导热环；332-加热带；333-隔热层；400-扩增检测装置；410-检测装置；411-热循环***；412-实时信号检测***；420-微观芯片；430-芯片移运组件；500-核酸提取装置；510-支架；520-固定器；530-磁性分离器；600-废液公共液盒子；610-第一层容置部；620-第二层容置部；630-搅拌装置；611-腔室；700-机械臂***；710-吸取臂；711-第一吸取臂；712-第二吸取臂；713-第三吸取臂；714-吸液针组；715-液针本体；716-安装板；720-抓取臂；721-第一抓取臂；723-第三抓取臂；800-显示***。
具体实施方式
为使本申请实施例的目的、技术方案和优点更加清楚，下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本申请一部分实施例，而不是全部的实施例。通常在此处附图中描述和示出的本申请实施例的组件可以以各种不同的配置来布置和设计。
因此，以下对在附图中提供的本申请的实施例的详细描述并非旨在限制要求保护的本申请的范围，而是仅仅表示本申请的选定实施例。基于本申请中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
应注意到：相似的标号和字母在下面的附图中表示类似项，因此，一旦某一项在一个附图中被定义，则在随后的附图中不需要对其进行进一步定义和解释。
在本申请实施例的描述中，需要说明的是，术语“上”、“内”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，或者是该申请产品使用时惯常摆放的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。
在本申请的描述中，还需要说明的是，除非另有明确的规定和限定，术语“设置”、“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；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本申请中的具体含义。
请参照图1-图10，本实施例提供一种核酸提取与扩增荧光检测***10，其包括样本进样装置100、试剂盒运送装置200、样本预处理装置300、扩增检测装置400、核酸提取装置500、废液公共液盒子600以及机械臂***700。该核酸提取与扩增荧光检测***10通过设置核酸提取装置500对磁珠样本进行提取与处理，通过设置扩增检测装置400实现了高通量信号检测，具有较高的自动化程度。该核酸提取与扩增荧光检测***10将样本进样、试剂盒运送、样本预处理、核酸提取、扩增检测、废液处理各个功能集成到一个***，一体化程度高。该核酸提取与扩增荧光检测***10的各个功能模块布局合理，结构紧凑，整个核酸提取与扩增荧光检测***10具有小型化的特点，能够适应个体化医疗的要求，应用于各种医疗机构场合以及及时诊断等。
进一步地，核酸提取与扩增荧光检测***10具有基板20，前述的样本进样装置100、试剂盒运送装置200、样本预处理装置300、核酸提取装置500、扩增检测装置400、废液公共液盒子600以及机械臂***700均设置在该基板20上。
进一步地，在本实施例中，基板20的形状为方形。基板20具有第一侧21和相对的第二侧22；以及第三侧23和相对的第四侧24。样本预处理装置300和试剂盒运送装置200设置在第一侧21且样本预处理装置300靠近第三侧23。从而方便将试剂盒运送至样本预处理装置300处。进一步地，样本进样装置100设置在第三侧23，且位于远离样本预处理装置300的一端，从而方便将样本运输至远离样本预处理装置300处。进一步地，核酸提取装置500设置在基板20中间，从而方便样本进样装置100运送样本、试剂盒运送装置200运送试剂以及样本预处理装置300运送经过处理 的样本。进一步地，扩增检测装置400设置在第二侧22，方便核酸提取装置500上的样本运送至扩增检测装置400上。
进一步地，试剂盒运送装置200包括多个试剂盒存储组件210以及试剂盒输送机构220。
进一步地，试剂盒存储组件210包括多个用于存放试剂盒的容置腔211以及***壳体212；每一个容置腔211内均放置有一个***壳体212；多个试剂盒213叠放在***壳体212内。进一步地，试剂盒输送机构220包括夹取组件221、移动轨道222以及驱动组件223。进一步地，夹取组件221用于将试剂盒213从***壳体212内夹取出；夹取组件221传动连接于驱动组件223，以带动夹取组件221沿移动轨道222移动。
进一步地，样本预处理装置300用于将样本与试剂混合后进行加热、搅拌及离心处理。具体地，样本预处理装置300包括用于放置试剂盒的转盘310和吸取组件320；吸取组件320连接于转盘310，且位于转盘310的上方，吸取组件320能够进入到试剂盒内吸取试液或者搅拌。进一步地，转盘310的底部设置有加热组件330，用于对试剂盒内的试液加热。转盘310上设置有多个容置试剂盒的容置部。在转盘310转动的过程中与吸取组件320配合进行搅拌。
进一步地，加热组件330包括导热环331、加热带332和隔热层333。每一个容置部的底部均设置有导热环331；加热带332设置在导热环331之下。加热带332与转盘310的底壁之间还设置有隔热层333。从而避免了热量的扩散，进一步提高整个样本预处理装置300结构可靠性。
进一步地，扩增检测装置400用于对经过预处理的样本采用提取试剂进行核酸提取以及磁性分离。具体地，扩增检测装400包括检测装置410、微观芯片420以及芯片移运组件430。微观芯片420用于容置多个待检测的样本。检测装置410包括热循环***411和实时信号检测***412，热循环***411用于为微观芯片420中的样本进行核酸扩增提供合适的温度。实时信号检测***412用于对发生核酸扩增后的样本进行荧光检测。芯片移运组件430用于抓取微观芯片420并将微观芯片420转移至检测装置410的检测区。
进一步地，核酸提取装置500包括磁性分离器530、核酸提取试剂贮器、加热器组件以及移液组件。磁性分离器530用于将试液与磁珠分离；核酸提取试剂贮器用于存储从样品提取核酸的一种或多种试剂；加热器组件用于对核酸提取反应提供适合温 度。具体地，上述的磁性分离器530、核酸提取试剂贮器、加热器组件均设置在多个支架510上，各自配置成接受一定数目的样品和相应数目的固定器520。其中每个固定器520包括处理室，废料室，一个或多个移液管吸头，和一个或多个贮器。其中一个或多个贮器分别含有足够量的用于进行从样品提取核酸的一种或多种试剂。配置成相对于每个固定器520的处理室移动的磁性分离器530。配置成独立加热每一个处理室的加热器组件。和配置成在两个或多个固定器520上同时进行流体传递操作的液体分配器等。
进一步地，废液公共液盒子600设置在所述核酸提取装置500和样本进样装置100之间。具体地，废液公共液盒子600包括第一层容置部610、第二层容置部620以及搅拌装置630。其中，第一层容置部610包括多个相互不连通的腔室611。每一个腔室611均具有至少一个入口。至少一个腔室611为废液收集腔。第二层容置部620设置在第一层容置部610之下。第二层容置部620被配置为用于盛放废液。每一个废液收集腔均连通于第二层容置部620。搅拌装置630连接于废液收集腔。该废液公共液盒子600的多个腔室611以及搅拌装置630的空间布局紧凑合理，方便了操作者的使用。在一个盒子中同时设置公共试剂容置部和废液收集部，不仅节省空间，而且减少了使用者更换耗材的次数，节约了时间，提高了使用效率。搅拌装置630的设置，解决了磁珠沉淀的问题，使用效果更好。
进一步地，样本进样装置100包括多个用于放置样本瓶的样本架110以及样本输送机构120。进一步地，每一个样本架110上均设置有多个用于放置样本瓶的容置腔；样本输送机构120包括驱动部121和移动导轨122；驱动部121传动连接于移动导轨122；每一个样本架110均连接于移动导轨122。具体地，在本实施例中，样本进样装置100包括4排样本架110进样，每排样本架110可存放12个样本瓶。
进一步地，机械臂***700用于将样本或者试剂运输至样本进样装置100、试剂盒运送装置200、样本预处理装置300、核酸提取装置500或者扩增检测装置400处。进一步地，机械臂***700包括吸取臂710和抓取臂720。进一步地，吸取臂710用过吸取试液并移动至需要的位置；抓取臂720用于抓取试液盒并移动至需要的位置。具体地，在本实施例中，吸取臂710包括沿基板20第一侧21延伸方向设置的第一吸取臂711、沿基板20第二侧22延伸方向设置的第二吸取臂712、滑动设置在第一吸取臂711和第二吸取臂712之间的第三吸取臂713以及吸液针组714。吸液针组714滑动连接于第三吸取臂713，能够在第三吸取臂713上来回移动，同时当第三吸取臂713在第二吸取臂712和第一吸取臂711上滑动时，能够实现吸液针组714在X和Y 两个方向的移动。进一步地，吸液针组714包括吸液针本体715和安装板716，吸液针本体715滑动连接于安装板716，从而实现了吸液针本体715在Z轴方向的运动，进而使得整个吸取臂710能够在整个基板20的范围内运动。
进一步地，抓取臂720设置在吸取臂710的内侧，且高度低于抓取臂720。抓取臂720主要用于抓取试剂盒。抓取臂720包括第一抓取臂721、第二抓取臂(图未示)、第三抓取臂723以及夹爪组件(图未示)。第一抓取臂721连接于基板20第四侧24设置的背板上，且沿第四侧24的延伸方向设置；第二抓取臂沿第一侧21的方向设置，且垂直连接于第一抓取臂721，第三抓取臂723沿垂直基板20平面的方向连接于第一抓取臂721。夹爪组件滑动连接于第二抓取臂，从而当夹爪组件能够沿XYZ三个方向运动，夹取试剂盒。
应理解，上述的夹爪组件的具体结构可以选择本领域常见的能够用于夹取试剂盒的抓手结构。
进一步地，该核酸提取与扩增荧光检测***10还设置有显示***800，从而能够显示检测数据。
以上所述仅为本申请的优选实施例而已，并不用于限制本申请，对于本领域的技术人员来说，本申请可以有各种更改和变化。凡在本申请的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本申请的保护范围之内。应注意到：相似的标号和字母在下面的附图中表示类似项，因此，一旦某一项在一个附图中被定义，则在随后的附图中不需要对其进行进一步定义和解释。

Claims (10)

  1. 一种核酸提取与扩增荧光检测***，其特征在于，包括：
    样本进样装置，所述样本进样装置包括多个用于放置样本瓶的样本架以及样本输送机构；
    试剂盒运送装置，所述试剂盒运送装置包括多个试剂盒存储组件以及试剂盒输送机构；
    样本预处理装置，所述样本预处理装置用于将所述样本与试剂混合后进行加热、搅拌及离心处理；
    核酸提取装置，所述核酸提取装置用于对样本采用提取试剂进行核酸提取以及磁性分离；
    扩增检测装置，所述扩增检测装置用于将经过核酸处理的所述样本制成微观芯片后进行扩增及荧光检测分析；以及
    机械臂***，所述机械臂***用于将所述样本或者试剂运输至所述样本进样装置、所述试剂盒运送装置、所述样本预处理装置、所述核酸提取装置或者所述扩增检测装置。
  2. 如权利要求1所述的核酸提取与扩增荧光检测***，其特征在于，
    所述试剂盒存储组件包括多个用于存放试剂盒的容置腔以及***壳体；每一个所述容置腔内均放置有一个所述***壳体；多个所述试剂盒叠放在所述***壳体内。
  3. 如权利要求2所述的核酸提取与扩增荧光检测***，其特征在于，
    所述试剂盒输送机构包括夹取组件、移动轨道以及驱动组件；
    所述夹取组件用于将所述试剂盒从所述***壳体内夹取出；所述夹取组件传动连接于所述驱动组件，以带动所述夹取组件沿所述移动轨道移动。
  4. 如权利要求1所述的核酸提取与扩增荧光检测***，其特征在于，
    所述样本预处理装置包括用于放置试剂盒的转盘和吸取组件；所述吸取组件连接于所述转盘，且位于所述转盘的上方，所述吸取组件能够进入到所述试剂盒内吸取试液或者搅拌。
  5. 如权利要求4所述的核酸提取与扩增荧光检测***，其特征在于，
    所述转盘的底部设置有加热组件，用于对所述试剂盒内的试液加热。
  6. 如权利要求1所述的核酸提取与扩增荧光检测***，其特征在于，
    所述扩增检测装置包括检测装置、微观芯片以及芯片移运组件；所述微观芯片用于容置多个待检测的样本；所述检测装置包括热循环***和实时信号检测***，所述热循环***用于为所述微观芯片中的所述样本进行核酸扩增提供合适的温度；所述实时信号检测***用于对发生核酸扩增后的所述样本进行荧光检测；所述芯片移运组件用于抓取所述微观芯片并将所述微观芯片转移至所述检测装置的检测区。
  7. 如权利要求1所述的核酸提取与扩增荧光检测***，其特征在于，
    所述核酸提取装置包括磁性分离器、核酸提取试剂贮器、加热器组件以及移液组件；
    所述磁性分离器用于将试液与磁珠分离；所述核酸提取试剂贮器用于存储从样品提取核酸的一种或多种试剂；所述加热器组件用于对核酸提取反应提供适合温度。
  8. 如权利要求1-7任一项所述的核酸提取与扩增荧光检测***，其特征在于，
    所述核酸提取与扩增荧光检测***还包括废液公共液盒子；所述废液公共液盒子设置在所述核酸提取装置和所述样本进样装置之间。
  9. 如权利要求8所述的核酸提取与扩增荧光检测***，其特征在于，
    每一个所述样本架上均设置有多个用于放置样本瓶的容置腔；
    所述样本输送机构包括驱动部和移动导轨；所述驱动部传动连接于所述移动导轨；每一个所述样本架均连接于所述移动导轨。
  10. 如权利要求1所述的核酸提取与扩增荧光检测***，其特征在于，
    所述机械臂***包括吸取臂和抓取臂；
    所述吸取臂用过吸取试液并移动至需要的位置；所述抓取臂用于抓取试液盒并移动至需要的位置。
PCT/CN2019/091421 2018-09-19 2019-06-14 核酸提取与扩增荧光检测*** WO2020057193A1 (zh)

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