WO2024037302A1 - 一种便携式核酸检测设备、系统及方法 - Google Patents

一种便携式核酸检测设备、系统及方法 Download PDF

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Publication number
WO2024037302A1
WO2024037302A1 PCT/CN2023/109464 CN2023109464W WO2024037302A1 WO 2024037302 A1 WO2024037302 A1 WO 2024037302A1 CN 2023109464 W CN2023109464 W CN 2023109464W WO 2024037302 A1 WO2024037302 A1 WO 2024037302A1
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WIPO (PCT)
Prior art keywords
module
nucleic acid
light
acid detection
reaction tube
Prior art date
Application number
PCT/CN2023/109464
Other languages
English (en)
French (fr)
Inventor
宋金召
庞飞彪
代丰翼
王开正
倪寅越
焦天骄
张礼懿
Original Assignee
杭州逸检科技有限公司
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
Priority claimed from CN202222162713.0U external-priority patent/CN218860746U/zh
Priority claimed from CN202210983377.8A external-priority patent/CN115404159A/zh
Application filed by 杭州逸检科技有限公司 filed Critical 杭州逸检科技有限公司
Publication of WO2024037302A1 publication Critical patent/WO2024037302A1/zh

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    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • C12M1/02—Apparatus for enzymology or microbiology with agitation means; with heat exchange means
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • C12M1/34—Measuring or testing with condition measuring or sensing means, e.g. colony counters
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M1/00—Apparatus for enzymology or microbiology
    • C12M1/36—Apparatus for enzymology or microbiology including condition or time responsive control, e.g. automatically controlled fermentors
    • C12M1/38—Temperature-responsive control
    • 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

Definitions

  • the present disclosure relates to the field of nucleic acid detection, and in particular, to a portable nucleic acid detection device, system and method.
  • virus detection instruments in the existing technology are often bulky and inconvenient to carry and use.
  • virus testing requires centralized sampling, centralized processing, etc., resulting in a long time interval between sampling and obtaining test results, and testing needs to be performed in a certified laboratory. It also requires corresponding large-scale instruments and well-trained operators, which is cumbersome. Steps greatly increase the risk of cross-contamination.
  • the present disclosure provides a portable nucleic acid detection device, system and method to at least solve the above technical problems existing in the prior art.
  • a portable nucleic acid detection device includes a main body; the main body is provided with an installation cavity for installing a load-bearing module, and the load-bearing module is used to supply a reaction tube container.
  • the reaction tube is used to accommodate the object to be measured;
  • the load-bearing module is connected to a heating module, and the heating module is used to adjust the temperature of the load-bearing module to adjust the temperature of the reaction tube;
  • the main body is connected to a light-emitting module,
  • the light-emitting module is arranged at the bottom of the carrying module, and the carrying module is provided with a light hole toward the light-emitting module, so that the emitted light of the light-emitting module passes through the light hole.
  • an observation window is also provided on the main body, and a first observation hole is provided on the first side of the load-bearing module, and the first observation hole is used to observe the reaction tube; when the When the carrying module is installed in the installation cavity, the observation window is used to observe the reaction tube through the first observation hole.
  • the carrying module is provided with a plurality of grooves, and the grooves are used to accommodate the reaction tubes; the number of the light holes is consistent with the number of the grooves, and the The light hole is provided at the bottom of the groove, and the light-emitting module is fastened to the bottom of the carrying module, so that the emitted light of the light-emitting module shines on the reaction tube through the light hole;
  • the load-bearing module also includes a mounting plate, which is used to cooperate with the main body to fix the load-carrying module in the installation cavity.
  • the heating module is connected to a second side of the carrying module, and the second side is different from the first side;
  • the heating module includes a heating element, a temperature sensor and an overheating protection module,
  • the temperature sensor is arranged between the heating element and the bearing module, the heating module is used to adjust the temperature of the bearing module, and the temperature sensor is used to detect the temperature of the bearing module;
  • the temperature sensor An overheat protection module is connected, and the overheat protection module is connected to the heating element; when the temperature detected by the temperature sensor is higher than a specified temperature, the overheat protection module is used to stop the heating element from heating.
  • the temperature sensor includes at least one or more of a thermistor, a platinum resistor, and a thermocouple
  • the heating element includes at least a ceramic heating plate, an electric heating film, an electric heating wire, a power resistor, a semiconductor One or more types of heating elements.
  • the main body includes a cover and a shell, the cover and the shell are rotationally connected, and the shell is used for the bearing module to abut;
  • the cover includes a pressure plate, and the The pressure plate is elastically connected to the cover through an elastic member. When the cover is closed on the housing, the pressure plate is used to press the reaction tube in the load-bearing module.
  • a magnetic switch is provided on the cover, and the magnetic switch is used to cooperate with the housing to open or close the cover.
  • the portable nucleic acid detection equipment is provided with a control module, and the control module is connected to the heating module for controlling the heating module to adjust the temperature of the carrying module; the control module is also connected to a The light-emitting module is used to control the light-emitting module to emit light to illuminate the reaction tube; the control module is connected to a mobile device and is used to receive control instructions from the mobile device to control all the components through the control instructions.
  • the heating module adjusts the temperature of the carrying module, or controls the light-emitting module to emit light through the control instructions.
  • the portable nucleic acid detection equipment further includes a darkroom housing, which can be installed on a mobile device or a camera; a second observation hole is provided on the darkroom housing, and the second observation hole is provided on the darkroom housing.
  • the observation hole is used to cooperate with the mobile device or the camera to observe the reaction tube.
  • a fixing mechanism is provided on the darkroom housing, and the fixing mechanism is used to fix the mobile device so that the mobile device can observe the reaction tube through the second observation hole.
  • a filter is installed on the observation window.
  • a portable nucleic acid detection system includes: a mobile terminal device and the above-mentioned portable nucleic acid detection device; the mobile terminal device and the portable nucleic acid detection device are communicatively connected, To cooperate with the portable nucleic acid detection equipment to perform detection operations.
  • a nucleic acid detection method includes: placing a reaction tube containing a substance to be tested in a load-bearing module; installing the load-bearing module in an installation cavity; according to the According to the detection instructions from the mobile terminal device, the heating module is controlled to heat the carrier module to a specified temperature so that the reaction tube is at the specified temperature; according to the detection instructions from the mobile terminal device, the light-emitting module is controlled to emit light so that the emission Light shines on the reaction tube through the light hole; the reaction tube is observed through the observation window on the main body and the first observation hole on the load-bearing module. According to the reaction tube emitting light, The fluorescence reaction under irradiation determines the detection result.
  • the present disclosure discloses a portable nucleic acid detection equipment and method.
  • the reaction tube containing the object to be tested is placed in the bearing module; the bearing module is installed in the installation cavity; according to the detection instructions from the mobile terminal device, the heating module is controlled to The load-bearing module is heated to a specified temperature, and the light-emitting module is controlled to emit light so that the emitted light shines on the reaction tube through the light hole; the reaction tube is heated to fully react the substance to be measured in the reaction tube, and the light-emitting module emits light to The emitted light is irradiated on the reaction tube through the light hole, thereby observing the fluorescence reaction of the reaction tube under the irradiation of the emitted light to determine the detection result.
  • This application has simple steps and convenient processes, and can quickly obtain the inspection results of the object to be tested, and
  • the structure of the device is simple and lightweight, making it easy to carry and use at home.
  • Figure 1 shows a schematic structural diagram of a portable nucleic acid detection device according to an embodiment of the present disclosure
  • Figure 2 shows a second structural schematic diagram of a portable nucleic acid detection device according to an embodiment of the present disclosure
  • Figure 3 shows a schematic structural diagram three of a portable nucleic acid detection device according to an embodiment of the present disclosure
  • Figure 4 shows a schematic structural diagram 4 of a portable nucleic acid detection device according to an embodiment of the present disclosure
  • Figure 5 shows a schematic structural diagram 5 of a portable nucleic acid detection device according to an embodiment of the present disclosure
  • Figure 6 shows a schematic structural diagram six of a portable nucleic acid detection device according to an embodiment of the present disclosure
  • Figure 7 shows a schematic structural diagram of a portable nucleic acid detection device according to an embodiment of the present disclosure
  • Figure 8 shows a schematic structural diagram of a portable nucleic acid detection device according to an embodiment of the present disclosure.
  • Figure 1 shows a schematic structural diagram 1 of a portable nucleic acid detection device according to an embodiment of the present disclosure
  • Figure 2 shows a schematic structural diagram 2 of a portable nucleic acid detection device according to an embodiment of the present disclosure
  • Figure 3 shows a schematic structural diagram 2 of a portable nucleic acid detection device according to an embodiment of the present disclosure.
  • Structural diagram three shows a structural diagram four of a portable nucleic acid detection device according to an embodiment of the present disclosure
  • Figure 5 shows a structural diagram five of a portable nucleic acid detection equipment according to an embodiment of the present disclosure
  • Figure 8 shows a portable nucleic acid detection equipment according to an embodiment of the present disclosure.
  • a portable nucleic acid detection device includes a main body 1; the main body 1 is provided with an installation cavity for a load-bearing module 11, and the load-bearing module 11 is used to accommodate a reaction tube 2.
  • the reaction tube 2 is used to accommodate the object to be tested 21;
  • the carrying module 11 is connected to a heating module 12, and the heating module 12 is used to adjust the temperature of the carrying module 11 to adjust the temperature of the reaction tube 2;
  • the main body 1 is connected to a light-emitting module 13, and the light-emitting module 13 is arranged at the bottom of the carrying module 11, and the carrying module 11 faces the light emitting module.
  • the main body 1 is also provided with an observation window 14, and a first observation window 14 is provided on the first side of the carrying module 11. Hole 112, the first observation hole 112 is used to observe the reaction tube 2; when the carrying module 11 is installed in the installation cavity, the observation window 14 is used to observe the reaction tube 2 through the first observation hole 112.
  • the present disclosure discloses a portable nucleic acid detection equipment and a corresponding nucleic acid detection method.
  • the reaction tube 2 containing the object to be tested 21 is placed in the load-bearing module 11; the load-bearing module 11 is installed in the installation cavity; according to the movement from According to the detection instructions of the terminal equipment, the heating module 12 is controlled to heat the carrier module 11 to a specified temperature, and the light-emitting module 13 is controlled to emit light, so that the emitted light shines on the reaction tube 2 through the light hole 111; by heating the reaction tube 2, the reaction tube 2 is heated.
  • the test object 21 fully reacts in the reaction tube 2 and emits light through the light-emitting module 13, so that the emitted light is irradiated on the reaction tube 2 through the light hole 111, thereby observing the fluorescence reaction of the reaction tube 2 under the irradiation of the emitted light to determine the detection. result.
  • the application has simple steps and convenient processes, can quickly obtain the inspection results of the object to be tested 21, and the device has a simple and lightweight structure, making it easy to carry and use at home.
  • the light-emitting module 13 may not be used, and the reaction tube 2 may be observed directly through the observation window 14.
  • chemiluminescence, colorimetric reactions, etc. may be performed in the reaction tube 2. This improves the flexible use of portable nucleic acid detection equipment, can be adapted to a variety of detection methods, and is more in line with home or portable needs.
  • nucleic acid detection can also be achieved.
  • the main body 1 refers to the main component of the equipment.
  • the main body 1 includes a housing 16 and a cover 15.
  • the housing 16 is used to install the load-bearing module 11, and the cover 15 is used to cover the device.
  • an installation cavity is formed for the installation of the load-bearing module 11; several/multiple grooves 113 are formed in the load-bearing module 11, and the grooves 113 are used for It is accommodated in the supply reaction tube 2, specifically, the supply reaction tube 2 is inserted therein.
  • the reaction tube 2 is used to accommodate the object to be tested 21.
  • the reaction tube 2 also includes a test agent used for testing the object to be tested 21.
  • the reaction tube 2 needs to be heated during the detection process, and the bearing module 11 is connected to the heating module 12.
  • the heating module 12 is used to adjust the temperature of the bearing module 11 to adjust the temperature of the reaction tube 2; the heating module 12 is connected to the bearing module 11
  • the second side is different from the first side; specifically, the directions of the second side and the first side are opposite.
  • the heating module 12 includes a heating element 121, a temperature sensor 122 and an overheating protection module 123. ;
  • the temperature sensor 122 is arranged between the heating element 121 and the carrying module 11.
  • the heating module 12 is used to adjust the temperature of the carrying module 11, and the temperature sensor 122 is used to detect the temperature of the carrying module 11; the temperature sensor 122 is connected to an overheating protection module 123, The overheat protection module 123 is connected to the heating element 121; when the temperature sensor 122 detects that the obtained temperature is higher than a specified temperature, the overheat protection module 123 is used to stop the heating element 121 from heating. where the specified temperature can be the working
  • the personnel makes presets based on the properties of the object 21 to be tested.
  • the bearing module 11 and the heating module 12 may be provided with mounting holes 115 at both ends to cooperate with fasteners to fix the heating module 12 on the bearing module 11 .
  • the temperature sensor 122 at least includes one or more of a thermistor, a platinum resistor, and a thermocouple, and the heating element 121 at least includes one or more of a ceramic heating piece, an electric heating film, an electric heating wire, a power resistor, and a semiconductor heating piece.
  • the portable nucleic acid detection equipment is provided with a control module 17.
  • the control module 17 is connected to the heating module 12 for controlling the heating module 12 to adjust the temperature of the carrying module 11; the control module 17 is also connected to a light-emitting module 13 for controlling the light-emitting module 13. Light is emitted to illuminate the reaction tube 2.
  • control module 17 may include a step-down module for converting 24V to 5V microcontroller operating voltage; a low-voltage voltage stabilizing module for converting 5V to 3.3V; a heating drive circuit that uses PWM to control heating; and temperature collection. circuit, crystal oscillator circuit, restart circuit.
  • the main body 1 is connected to a light-emitting module 13.
  • the light-emitting module 13 is arranged at the bottom of the carrying module 11.
  • the carrying module 11 is provided with a light hole 111 toward the light-emitting module 13, so that the emitted light of the light-emitting module 13 can be illuminated on the reaction tube through the light hole 111.
  • the number of light holes 111 is consistent with the number of grooves 113, the light holes 111 are arranged at the bottom of the groove 113, and the light-emitting module 13 is fastened to the bottom of the carrying module 11, so that the light-emitting module 13
  • the emitted light is illuminated on the reaction tube 2 through the light hole 111; specifically, the emitted light is perpendicular to the reaction tube 2, and the emitted light is distributed perpendicularly to the first observation hole 112, so that the emitted light will not have a direct impact in the direction of the first observation hole 112. Incidence, so the impact on the observation hole of the emitted light is minimal.
  • the main body 1 is also provided with an observation window 14, and the first side of the carrying module 11 is provided with a first observation hole 112, which is used to observe the reaction tube 2; the first observation hole 112 is a trapezoidal hole, and the first observation hole 112 is a trapezoidal hole.
  • the 112 section is just tangent to the bearing cavity of the tapered reaction tube 2, so that the first observation hole 112 can just observe all the reaction liquid; when the bearing module 11 is installed in the installation cavity, the observation window 14 is used to pass the first observation Hole 112 observes reaction tube 2.
  • a mounting plate 114 is connected above the load-bearing module 11. The mounting plate 114 is used to cooperate with the main body 1 to fix the load-bearing module 11 in the installation cavity.
  • a mounting plate mounting column 161 is formed inside the housing 16.
  • the mounting plate The mounting post 161 is used to cooperate with the mounting plate 114 to fix the load-bearing module 11 so that the first observation hole 112 on the load-bearing module 11 matches the position of the observation window 14 on the housing 16 .
  • a filter can be installed on the observation window 14 .
  • the observation window 14 may include an observation window, a filter and a light baffle.
  • the filter may be an inexpensive orange acrylic plate to reduce the cost of the instrument.
  • the purpose of the filter is to filter out the light in the first observation hole 112
  • the excitation light signal passes through the fluorescence signal
  • the purpose of the light baffle is to prevent light signals from other places except the first observation hole 112 from affecting the observation results.
  • the camera collects and saves images, and then processes the images to obtain detection results.
  • the main body 1 is also provided with a power module 18.
  • the power module 18 Block 18 can be an internal power supply and/or an external power supply.
  • the housing 16 may be provided with a power socket, and further, may be provided with a boat-shaped switch matching the power module 18 to control the power on or off.
  • the housing 16 can also be provided with a button switch that instructs the execution of designated functions.
  • the button switch is connected to the control module 17 to implement designated functions, such as a start button, an end button, a preheating button, a heating button, an excitation light button, etc. , to suit the user's needs.
  • a button switch-based control method for portable nucleic acid detection equipment is provided: in the case of first use, control instructions corresponding to each button switch are stored in the control module 17, and the button switch can be clicked to Trigger control instructions related to the button switch; specifically, for example, the start button can store a first operating parameter, and the first operating parameter can be used to control the portable nucleic acid detection equipment to detect the reaction tube 2 according to the first operating parameter.
  • the first operating parameters are pre-stored by the staff.
  • the control module 17 can store the detection parameters as the second operating parameters.
  • the second operating parameters in the memory are read, and the second operating parameters are used to instruct the portable nucleic acid detection equipment to perform nucleic acid detection.
  • the first operating parameters and the second operating parameters may include: time parameters, temperature parameters, resting parameters, etc.
  • Figure 6 shows a schematic structural diagram 6 of a portable nucleic acid detection device according to an embodiment of the present disclosure; please refer to Figure 6 .
  • the main body 1 includes a cover 15 and a shell 16, which are rotationally connected.
  • the shell 16 is used for the load-carrying module 11 to abut;
  • the cover 15 includes a pressure plate 151, and the pressure plate 151 passes through
  • the elastic member 154 is elastically connected to the cover 15 .
  • the pressure plate 151 is used to press the reaction tube 2 into the load-bearing module 11 .
  • the main body 1 includes a cover 15 and a shell 16.
  • the cover 15 can be connected by a hinge;
  • the cover 15 includes a pressure plate 151, the pressure plate 151 is C-shaped, and the back is in contact with the cover 15, and the C-shaped
  • the two ends are attached to the load-bearing module 11, so that the heat of the heating module 12 is conducted upward through the two ends of the C-shape, thus preventing condensation on the top of the cover 15 during the reaction.
  • the pressure plate 151 is elastically connected to the cover body 15 through an elastic member 154.
  • the elastic member 154 can be a spring and is connected to the cover body 15 through a guide shaft.
  • the cover 15 is provided with a magnetic switch 152, and the magnetic switch 152 is used to cooperate with the housing 16 to open or close the cover 15.
  • the magnetic switch 152 can be two magnetic parts, or it can be realized by one magnetic part and a metal part.
  • the cover 15 may be provided with a cover installation plate 153, and a pressure plate groove 155 for connecting the pressure plate 151 is formed on the cover installation plate 153.
  • the housing 16 may also include a mounting plate mounting column 161 for It cooperates with the mounting plate 114 of the load-bearing module 11 for fixing; it also includes a button mounting post 162 for installing and fixing the button switch.
  • Figure 7 shows a schematic structural diagram of a portable nucleic acid detection device according to an embodiment of the present disclosure; please refer to Figure 7 .
  • the portable nucleic acid detection equipment further includes a darkroom housing 3, which can be installed for mobile devices or cameras; the darkroom housing 3 is provided with a second observation hole 31, and the second observation hole 31 is used for For observing the reaction tube 2 with mobile devices or cameras.
  • the darkroom casing 3 is provided with a fixing mechanism 32 , which is used to fix the mobile device so that the mobile device can observe the reaction tube 2 through the second observation hole 31 .
  • taking pictures requires a relatively dark environment to avoid the reflection of the filter from affecting the taking effect and affecting the detection results.
  • a mobile device or camera is required to take pictures and process them in real time, so the portable
  • the packaging box of the nucleic acid detection equipment is designed to be a structure suitable for use as a mobile device or a camera darkroom.
  • the packaging box can be the darkroom shell 3 in this embodiment, or it can be other products with the same function/function as the darkroom shell 3
  • the shape of the shell is not specifically limited here. Therefore, the darkroom housing 3 forms a darkroom that can be loaded with a camera or a mobile device to take pictures.
  • the darkroom housing 3 is connected to a base plate 4.
  • the base plate 4 is equipped with an installation slot for positioning and installing the portable nucleic acid detection equipment, and is also provided with Installation steps that match the darkroom housing 3; as shown in Figure 7, the portable nucleic acid detection equipment and the darkroom housing 3 are installed on the bottom plate 4 respectively, and the portable nucleic acid detection equipment is located inside the darkroom housing 3.
  • the housing 16 is disposed on the surface of the second observation hole 31. Specifically, the observation window 14 on the housing 16 of the main body 1 matches the position of the second observation hole 31 of the darkroom housing 3, so as to facilitate the camera or mobile device.
  • the reaction tube 2 can be observed through the second observation hole 31 , the observation window 14 and the first observation hole 112 .
  • the darkroom casing 3 may be connected to a fixing mechanism 32 for fixing the mobile device;
  • the fixing mechanism 32 includes a first mechanism for installing a camera.
  • the first mechanism is a camera mounting hole 321.
  • the second mechanism includes a slide rail 322, a fixing stud 323, a slide block 324 and a rubber pad 325.
  • the slide block 324 is arranged inside the slide rail 322 and can slide along the slide rail 322.
  • the rail 322 moves, and one end of the slider 324 is connected to a fixed stud 323.
  • the fixed stud 323 is used to fasten the slider 324 on the slide rail 322, so that the slider 324 tightens the mobile device.
  • a rubber pad 325 is provided on the side of the slider 324 facing the mobile device.
  • the rubber pad 325 is used to prevent the mobile device from being scratched.
  • the mobile terminal device communicates with the portable nucleic acid detection equipment.
  • the control module 17 can be connected to realize the control of the portable nucleic acid detection equipment, which specifically includes: adjustment of heating time, adjustment of heating temperature; and acquisition of real-time temperature information. , reaction time information, and acquisition of test results.
  • the control module 17 is connected to a mobile device and is used to receive control instructions from the mobile device to control the heating module 12 to adjust the temperature of the carrying module 11 through the control instructions, or to control the light-emitting module 13 to emit light through the control instructions.
  • the object to be tested 21 (specifically, the detection sample) and supporting reagents are added into the reaction tube 2.
  • the detection volume can be up to eight channels at a time, and the reaction tube 2 with the sample added is placed into the carrying module 11 , cover the cover 15, one end of the cover 15 and the housing 16 is connected by a hinge, and the other end is opened and closed by a magnetic switch 152; after the cover 15 is covered, the pressure plate 151 in the structure of the cover 15 is pressed by the elastic member 154
  • the compression elastic force is used to compress the reaction tube 2 to avoid leakage caused by the top opening of the reaction tube 2 being forced to open due to the heating and expansion of the gas in the reaction tube 2 during the reaction.
  • the pressure plate 151 is simultaneously connected with the load-bearing module 11
  • the close fit can conduct the heat of the load-bearing module 11 to the pressure plate 151, which can achieve a better temperature control effect;
  • the control module 17 is divided into two parts, one is the heating module 12, and the other is the light-emitting module 13;
  • the heating module 12 is controlled by the heating button switch, and the heating module 12 performs heating according to the temperature and time flow set by the reaction;
  • the light-emitting module 13 is controlled by the excitation light button switch to start and stop, making it convenient to observe the reaction at any time; after the reaction is completed, turn on the light-emitting module 13.
  • the results can be observed with the naked eye, or the mobile device can be used to take pictures to automatically identify the results, or an integrated camera (such as an open mv camera) can be used for result identification; the mobile device and the portable nucleic acid detection equipment are connected wirelessly, and the mobile device can also
  • the heating and excitation light switches can be controlled; and the heating time, heating temperature and other heating parameters of the heating program can be modified to be suitable for isothermal amplification reactions at different temperatures.
  • this disclosure provides the following two specific application scenarios
  • Human body alcohol tolerance is divided into three levels, homozygous wild type - alcohol tolerance, heterozygous mutant type - slightly alcohol tolerance, homozygous mutant type - alcohol intolerance; when testing alcohol tolerance, you need to focus on Prepare two different reaction systems for one sample, and design primers for the wild type and the mutant type respectively. If only the wild type primer reaction system produces amplification, it means that it is the homozygous wild type; if only the mutant primer reaction system produces amplification, It means that it is a homozygous mutant type; if both reaction systems produce amplification, it means that it is a heterozygous mutant type.
  • Alcohol tolerance testing involves the following steps:
  • Sampling use a sampling swab to wipe the oral epithelial cells to complete the sampling.
  • Reaction preparation and loading drop the nucleic acid crude extract into the reaction tube 2 containing the nucleic acid amplification freeze-dried reagents; the freeze-dried reagents include primers, enzymes and other reactants; shake to completely dissolve and mix the freeze-dried reagents. , load the reaction tube 2 loaded with reagents into the carrying module 11.
  • the reaction proceeds.
  • the preset temperature is 63°C and the preset time is 30 minutes. Press the heating button of the portable nucleic acid detection equipment again to complete isothermal nucleic acid amplification according to the preset temperature and preset time.
  • SARS-Cov-2 is an enveloped positive-strand RNA virus, belonging to the genus Betacoronavirus, causing the global pandemic of coronavirus disease 2019 (COVID-19). -19). Its efficient and rapid detection is of great significance for early detection and prevention of virus spread.
  • amplification primers are designed respectively for the conserved sequences of SARS-CoV-2 ORF1ab and N gene for rapid screening of SARS-CoV-2 and its mutant strains.
  • SARS-Cov-2 testing includes the following steps:
  • Sampling use a sampling swab to take a nose/throat swab to complete the sampling.
  • reaction crude extract Dip the collected test sample swab into the nucleic acid release (lysis) reagent and let it sit for 3-5 minutes to obtain a crude nucleic acid extract.
  • Reaction preparation and loading drop the nucleic acid crude extract into the reaction tube 2 containing the nucleic acid amplification freeze-dried reagents; the freeze-dried reagents include primers, enzymes and other reactants; shake to completely dissolve and mix the freeze-dried reagents. , load the reaction tube 2 loaded with reagents into the carrying module 11.
  • the reaction proceeds.
  • the preset temperature is 63°C and the preset time is 30 minutes. Press the heating button of the portable nucleic acid detection equipment again to complete isothermal nucleic acid amplification according to the preset temperature and preset time.
  • a portable nucleic acid detection system includes: a mobile terminal device and a portable nucleic acid detection device according to an embodiment of the present disclosure; the mobile terminal device and the portable nucleic acid detection device are communicatively connected to cooperate with the portable nucleic acid detection device.
  • the equipment performs detection operations.
  • a nucleic acid detection method includes: placing the reaction tube 2 containing the object to be tested 21 in the bearing module 11; installing the bearing module 11 in the installation cavity; according to the The detection command of the mobile terminal device controls the heating module 12 to heat the carrying module 11 to a specified temperature, so that the reaction tube 2 is at the specified temperature; according to the detection instructions from the mobile device, the light-emitting module 13 is controlled to emit light, so that the emitted light shines on the reaction tube 2 through the light hole 111; through the observation window on the main body 1 14 cooperates with the first observation hole 112 on the carrying module 11 to observe the reaction tube 2, and determine the detection result according to the fluorescence reaction of the reaction tube 2 under the irradiation of the emitted light.
  • nucleic acid detection can also be achieved. Therefore, the present disclosure can be applied to a variety of usage situations, greatly improving the detection efficiency. Scope of use of portable nucleic acid testing equipment.
  • the mobile terminal device is communicatively connected to the portable nucleic acid detection device.
  • the control module 17 may be connected.
  • control instructions may include: adjustment of heating time and heating temperature; acquisition of feedback information may include: real-time The temperature information, reaction time information, and test results are provided for users to observe at any time to achieve a contactless detection mode and reduce the risk of infection that may occur during the detection process.
  • the present invention provides a nucleic acid amplification detection and analysis method, which includes the following steps:
  • the information can be entered manually through the mobile device program, or the health code can be scanned by the mobile device program to enter the information of the person to be tested.
  • Nucleic acid sampling that is, using nucleic acid sampling swabs for sampling.
  • reaction crude extract that is, immersing the collected test sample swab into the nucleic acid release (lysis) reagent to obtain a crude nucleic acid extract.
  • reaction preparation and loading specifically, drop the nucleic acid crude extract into the reaction tube 2 containing the nucleic acid amplification freeze-dried reagent, shake to completely dissolve and mix the freeze-dried reagent, and place the loaded reagent into the reaction tube 2 Load bearer module 11.
  • the detection reaction proceeds; specifically, press the heating button of the portable nucleic acid detection equipment to complete rapid isothermal nucleic acid amplification according to the preset temperature and preset time.
  • A The tester directly observes whether there is a fluorescence signal in the reaction tube 2 through the observation window, thereby qualitatively obtaining the test result.
  • the camera of the mobile device is used to collect and save images, and then the detection results are obtained by processing the images; this method can achieve end-point detection, and can also be based on The set program completes real-time sampling at time intervals and draws a real-time amplification curve on the screen of the mobile device to complete real-time detection.
  • C Use integrated cameras to collect and process images, such as open mv cameras. This method can achieve end-point detection, and can also complete real-time sampling at time intervals according to the set program, and then transmit the data to the mobile device through the wireless module for real-time The amplification curve is drawn to complete real-time detection.
  • test results can be filled in manually to correspond to the test participant information one by one; and the test information can be saved.
  • the specific reaction tube 2 can be matched one-to-one with the test participant information, and the test information can be saved.
  • the mobile device software While saving the results, the mobile device software will automatically save the geographical location of the current detection point and associate the detection results with the geographical location on the map. You can view the corresponding detection results by clicking on the corresponding detection point location on the map.
  • first and second are used for descriptive purposes only and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of indicated technical features. Thus, features defined as “first” and “second” may explicitly or implicitly include at least one of these features.
  • “plurality” means two or more than two, unless otherwise expressly and specifically limited.

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Abstract

一种便携式核酸检测设备、系统及方法，设备包括主体（1）；主体（1）上设置有供承载模块（11）安装的安装腔，承载模块（11）用于供反应管（2）容置，反应管（2）用于供待测物（21）容置；承载模块（11）连接有加热模块（12），加热模块（12）用于调节承载模块（11）的温度，以调节反应管（2）的温度；主体（1）连接有发光模块（13），发光模块（13）设置在承载模块（11）的底部，承载模块（11）朝向发光模块（13）设置有通光孔（111），以使发光模块（13）的发射光通过通光孔（111）照射在反应管（2）上；主体（1）上还设置有观测窗（14），承载模块（11）的第一侧设置有第一观测孔（112），第一观测孔（112）用于观测反应管（2）；当承载模块（11）安装在安装腔的情况下，观测窗（14）用于通过第一观测孔（112）观测反应管（2）。

Description

一种便携式核酸检测设备、系统及方法
相关申请的交叉引用
本申请要求中国申请日为2022年8月16日，申请号为202210983377.8，发明名称为“一种便携式核酸检测设备及方法”的专利申请的优先权，以及中国申请日为2022年8月16日，申请号为202222162713.0，发明名称为“一种便携式核酸检测设备及系统”的专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本公开涉及核酸检测领域，尤其涉及一种便携式核酸检测设备、系统及方法。
背景技术
如何快速地、高效地对病毒进行检测，从而及时地发现和预防病毒传染，对防疫工作具有重要意义，而现有技术中的病毒检测仪器往往体积庞大，不便于携带及使用。此外，病毒检测需要集中采样、集中处理等，导致采样到获取检测结果的时间间隔长，且检测需要在获得认证的实验室进行，还需要相应的大型仪器以及训练有素的操作人员，繁琐的步骤大大增加了交叉感染的风险。
发明内容
本公开提供了一种便携式核酸检测设备、系统及方法，以至少解决现有技术中存在的以上技术问题。
根据本公开的第一方面，提供了一种便携式核酸检测设备，所述便携式核酸检测设备包括主体；所述主体上设置有供承载模块安装的安装腔，所述承载模块用于供反应管容置，所述反应管用于供待测物容置；承载模块连接有加热模块，所述加热模块用于调节所述承载模块的温度，以调节反应管的温度；所述主体连接有发光模块，所述发光模块设置在所述承载模块的底部，所述承载模块朝向所述发光模块设置有通光孔，以使发光模块的发射光通过所述通光孔 照射在所述反应管上；所述主体上还设置有观测窗，所述承载模块的第一侧设置有第一观测孔，所述第一观测孔用于观测所述反应管；当所述承载模块安装在所述安装腔的情况下，所述观测窗用于通过第一观测孔观测所述反应管。
在一可实施方式中，所述承载模块上设置有多个凹槽，所述凹槽用于供所述反应管容置；所述通光孔的数量与所述凹槽数量一致，所述通光孔设置在所述凹槽的底部，所述发光模块紧固连接在所述承载模块的底部，以使发光模块的发射光通过所述通光孔照射在所述反应管上；所述承载模块还包括有安装板，所述安装板用于配合所述主体，以将所述承载模块固定在所述安装腔内。
在一可实施方式中，所述加热模块连接在所述承载模块的第二侧，所述第二侧与所述第一侧不同；所述加热模块包括加热元件、温度传感器和过热保护模块，所述温度传感器设置在所述加热元件和所述承载模块之间，所述加热模块用于调节所述承载模块的温度，所述温度传感器用于检测所述承载模块的温度；所述温度传感器连接有过热保护模块，所述过热保护模块和加热元件连接；当所述温度传感器检测获得的温度高于指定温度的情况下，所述过热保护模块用于使加热元件停止加热。
在一可实施方式中，所述温度传感器至少包括热敏电阻、铂电阻、热电偶中的一种或多种，所述加热元件至少包括陶瓷加热片、电热膜、电热丝、功率电阻、半导体加热片中的一种或多种。
在一可实施方式中，所述主体包括盖体和壳体，所述盖体和所述壳体转动连接，所述壳体用于供承载模块抵接；所述盖体包括压板，所述压板通过弹性件弹性连接在所述盖体上，当所述盖体盖合在所述壳体上的情况下，所述压板用于将所述反应管压紧在所述承载模块中。
在一可实施方式中，所述盖体上设置有磁吸开关，所述磁吸开关用于配合所述壳体，以使所述盖体打开或闭合。
在一可实施方式中，所述便携式核酸检测设备设置有控制模块，所述控制模块连接有所述加热模块，用于控制所述加热模块，以调节承载模块的温度；控制模块还连接有所述发光模块，用于控制所述发光模块发射光，以照射所述反应管；所述控制模块连接有移动端设备，用于接收来自移动端设备的控制指令，以通过所述控制指令控制所述加热模块调节承载模块的温度，或者，通过所述控制指令控制所述发光模块发射光。
在一可实施方式中，所述便携式核酸检测设备还包括暗室壳体，所述暗室壳体可供移动端设备或摄像头安装；所述暗室壳体上设置有第二观测孔，所述第二观测孔用于配合所述移动端设备或所述摄像头观测所述反应管。
在一可实施方式中，所述暗室壳体上设置有固定机构，所述固定机构用于固定所述移动端设备，以使所述移动端设备通过所述第二观测孔观测所述反应管。
在一可实施方式中，所述观测窗的观测窗口上安装有滤光片。
根据本公开的第二方面，提供了一种便携式核酸检测系统，所述便携式核酸检测系统包括：移动端设备和上述便携式核酸检测设备；所述移动端设备和所述便携式核酸检测设备通信连接，以配合所述便携式核酸检测设备进行检测操作。
根据本公开的第三方面，提供了一种核酸检测方法，所述方法包括：将容置有待测物的反应管放置在承载模块中；将所述承载模块安装在安装腔内；根据来自移动端设备的检测指令，控制加热模块将所述承载模块加热至指定温度，以使所述反应管处于指定温度；根据来自所述移动端设备的检测指令，控制发光模块发射光，以使发射光通过通光孔照射在所述反应管上；通过主体上的观测窗和所述承载模块上的第一观测孔进行配合，对所述反应管进行观测，根据所述反应管在发射光的照射下的荧光反应确定检测结果。
本公开的一种便携式核酸检测设备及方法，将容置有待测物的反应管放置在承载模块中；将承载模块安装在安装腔内；根据来自移动端设备的检测指令，控制加热模块将承载模块加热至指定温度，和控制发光模块发射光，以使发射光通过通光孔照射在反应管上；通过加热反应管使待测物在反应管中充分反应，通过发光模块发射光，以使发射光通过通光孔照射在反应管上，从而观测反应管在发射光的照射下的荧光反应确定检测结果，本申请步骤简单、流程方便，能快速的获得待测物的检查结果，而且设备的结构简单、轻便，可以方便携带和家庭使用。
应当理解，本部分所描述的内容并非旨在标识本公开的实施例的关键或重要特征，也不用于限制本公开的范围。本公开的其它特征将通过以下的说明书而变得容易理解。
附图说明
通过参考附图阅读下文的详细描述，本公开示例性实施方式的上述以及其他目的、特征和优点将变得易于理解。在附图中，以示例性而非限制性的方式示出了本公开的若干实施方式，其中：在附图中，相同或对应的标号表示相同或对应的部分。
图1示出了本公开实施例便携式核酸检测设备的结构示意图一；
图2示出了本公开实施例便携式核酸检测设备的结构示意图二；
图3示出了本公开实施例便携式核酸检测设备的结构示意图三；
图4示出了本公开实施例便携式核酸检测设备的结构示意图四；
图5示出了本公开实施例便携式核酸检测设备的结构示意图五；
图6示出了本公开实施例便携式核酸检测设备的结构示意图六；
图7示出了本公开实施例便携式核酸检测设备的结构示意图七；
图8示出了本公开实施例便携式核酸检测设备的结构示意图八。
图中标号说明：
1、主体；11、承载模块；111、通光孔；112、第一观测孔；113、凹槽；114、
安装板；115、安装孔；12、加热模块；121、加热元件；122、温度传感器；123、过热保护模块；13、发光模块；14、观测窗；15、盖体；151、压板；152、磁吸开关；153、盖体安装板；154、弹性件；155、压板凹槽；16、壳体；161、安装板安装柱；162、按钮安装柱；17、控制模块；18、电源模块；2、反应管；21、待测物；3、暗室壳体；31、第二观测孔；32、固定机构；321、摄像头安装孔；322、滑轨；323、固定螺柱；324、滑块；325、橡胶垫；4、底板。
具体实施方式
为使本公开的目的、特征、优点能够更加的明显和易懂，下面将结合本公开实施例中的附图，对本公开实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本公开一部分实施例，而非全部实施例。基于本公开中的实施例，本领域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，都属于本公开保护的范围。
图1示出了本公开实施例便携式核酸检测设备的结构示意图一；图2示出了本公开实施例便携式核酸检测设备的结构示意图二；图3示出了本公开实施例便携式核酸检测设备的结构示意图三；图4示出了本公开实施例便携式核酸检测设备的结构示意图四；图5示出了本公开实施例便携式核酸检测设备的结构示意图五；图8示出了本公开实施例便携式核酸检测设备的结构示意图八。请参考图1至图5以及图8。
根据本公开的第一方面，提供了一种便携式核酸检测设备，设备包括主体1；主体1上设置有供承载模块11安装的安装腔，承载模块11用于供反应管2容置，反应管2用于供待测物21容置；承载模块11连接有加热模块12，加热模块12用于调节承载模块11的温度，以调节反应管2的温度；主体1连接有发光模块13，发光模块13设置在承载模块11的底部，承载模块11朝向发光模块 13设置有通光孔111，以使发光模块13的发射光通过通光孔111照射在反应管2上；主体1上还设置有观测窗14，承载模块11的第一侧设置有第一观测孔112，第一观测孔112用于观测反应管2；当承载模块11安装在安装腔的情况下，观测窗14用于通过第一观测孔112观测反应管2。
本公开的一种便携式核酸检测设备及相应的一种核酸检测方法，将容置有待测物21的反应管2放置在承载模块11中；将承载模块11安装在安装腔内；根据来自移动端设备的检测指令，控制加热模块12将承载模块11加热至指定温度，和控制发光模块13发射光，以使发射光通过通光孔111照射在反应管2上；通过加热反应管2使待测物21在反应管2中充分反应，通过发光模块13发射光，以使发射光通过通光孔111照射在反应管2上，从而观测反应管2在发射光的照射下的荧光反应确定检测结果。本申请步骤简单、流程方便，能快速地获得待测物21的检查结果，而且设备的结构简单、轻便，可以方便携带和家庭使用。
此外，可以不使用发光模块13，可以直接通过观测窗14对反应管2进行观察，对应的，反应管2中可以为化学发光、比色反应等。从而提高便携式核酸检测设备的柔性运用，能够适应于多种检测方式，更符合家用或可携带的需求。或者，使用发光模块13，反应管2中采用比色反应，同样可以实现核酸检测。
在本公开实施例中，主体1指的是设备的主要构成部分，具体的，主体1包括壳体16和盖体15，壳体16用于供承载模块11进行安装，盖体15用于盖合在壳体16上，盖体15盖合在壳体16的情况下，形成有供承载模块11安装的安装腔；承载模块11中形成有若干个/多个凹槽113，凹槽113用于供反应管2容置，具体的，是供反应管2进行插设。其中，反应管2用于供待测物21容置，具体的，反应管2还包括有对待测物21进行测试所用的测试剂，通过测试剂和待测物21混合，在反应管2中进行检测反应，以实现对待测物21的检测。其中，检测过程中需要对反应管2进行加热，承载模块11连接有加热模块12，加热模块12用于调节承载模块11的温度，以调节反应管2的温度；加热模块12连接在承载模块11的第二侧，第二侧与第一侧不同；具体的，第二侧和第一侧的方向相反，如图8所示，加热模块12包括加热元件121、温度传感器122和过热保护模块123；温度传感器122设置在加热元件121和承载模块11之间，加热模块12用于调节承载模块11的温度，温度传感器122用于检测承载模块11的温度；温度传感器122连接有过热保护模块123，过热保护模块123和加热元件121连接；当温度传感器122检测获得的温度高于指定温度的情况下，过热保护模块123用于使加热元件121停止加热。其中，指定温度可以是工作 人员根据待测物21的性质进行预设。具体的，承载模块11和加热模块12上可以设置有安装孔115，安装孔115位于两端，以配合紧固件实现将加热模块12固定在承载模块11上。温度传感器122至少包括热敏电阻、铂电阻、热电偶中的一种或多种，加热元件121至少包括陶瓷加热片、电热膜、电热丝、功率电阻、半导体加热片中的一种或多种。便携式核酸检测设备设置有控制模块17，控制模块17连接有加热模块12，用于控制加热模块12，以调节承载模块11的温度；控制模块17还连接有发光模块13，用于控制发光模块13发射光，以照射反应管2。具体的，控制模块17可以包括降压模块，用于将24V转为5V单片机工作电压；低压差稳压模块，用于将5V转为3.3V；加热驱动电路，采用PWM控制加热；以及温度采集电路、晶振电路、重启电路。
主体1连接有发光模块13，发光模块13设置在承载模块11的底部，承载模块11朝向发光模块13设置有通光孔111，以使发光模块13的发射光通过通光孔111照射在反应管2上；具体的，通光孔111的数量与凹槽113数量一致，通光孔111设置在凹槽113的底部，发光模块13紧固连接在承载模块11的底部，以使发光模块13的发射光通过通光孔111照射在反应管2上；具体的，发射光与反应管2垂直，发射光与第一观测孔112垂直分布，这样发射光不会在第一观测孔112方向有直接入射，所以对观测孔观测发射光的影响最小。主体1上还设置有观测窗14，承载模块11的第一侧设置有第一观测孔112，第一观测孔112用于观测反应管2；第一观测孔112为梯形孔，第一观测孔112切面刚好与锥形反应管2承载腔相切，使得第一观测孔112刚好可以观测到全部的反应液；当承载模块11安装在安装腔的情况下，观测窗14用于通过第一观测孔112观测反应管2。具体的，承载模块11上方连接有安装板114，安装板114用于配合主体1，以将承载模块11固定在安装腔内，具体的，壳体16内部形成有安装板安装柱161，安装板安装柱161用于配合安装板114实现承载模块11的固定，以使承载模块11上的第一观测孔112与壳体16上的观测窗14位置匹配。为了观测方便，可以在观测窗14的观测窗口上安装滤光片。进一步的，观测窗14可以包括观测窗口、滤光片和挡光板，滤光片可以选择为价格低廉的橙色亚克力板，以降低仪器成本，滤光片的目的是过滤掉第一观测孔112中的激发光信号并通过荧光信号，挡光板的目的是为了防止除第一观测孔112外其他地方的光信号对观测结果造成影响。检测结果获取的方式分为两种，一种是检测人员通过观测窗口直接观测反应管2是否存在荧光信号，以此定性地获取检测结果；另一种是通过移动端开发的软件，利用移动端摄像头进行图像采集并保存，然后通过处理图像获得检测结果。其中，主体1中还设置有电源模块18，电源模 块18可以为内置电源和/或外置电源。当电源模块18包括外置电源的情况下，壳体16上可以设置有电源插口，进一步，可以设置有配合电源模块18的船型开关，以控制电源打开或关闭。此外，在壳体16上还可以设置有指示进行指定功能的按钮开关，按钮开关与控制模块17连接，以实现指定功能，例如开始按钮、结束按钮、预热按钮、加热按钮、激发光按钮等，以配合使用者使用。
具体的，针对按钮开关，提供一种基于按钮开关对便携式核酸检测设备的控制方法：在首次使用的情况下，在控制模块17中存储有与各个按钮开关对应的控制指令，通过点击按钮开关可以触发与按钮开关相关的控制指令；具体的，例如，开始按钮对应可以存储有第一运行参数，通过第一运行参数可以控制便携式核酸检测设备按第一运行参数对反应管2进行检测。第一运行参数由工作人员进行预存。进一步，在移动端设备对便携式核酸检测设备进行了一次完整的核酸检测后，控制模块17可以对本次的检测参数进行存储，存储为第二运行参数，在此之后，若通过按钮开关触发的核酸检测操作时，读取存储器中的第二运行参数，以第二运行参数指示便携式核酸检测设备进行核酸检测。具体的，第一运行参数和第二运行参数可以包括：时间参数、温度参数、静置参数等。从而使便携式核酸检测设备在有移动网络或无移动网络的工作环境下，都能够进行检测工作，以适应大多数的工作环境，从而提高便携性。
图6示出了本公开实施例便携式核酸检测设备的结构示意图六；请参考图6。
在一可实施方式中，主体1包括盖体15和壳体16，盖体15和壳体16转动连接，壳体16用于供承载模块11抵接；盖体15包括压板151，压板151通过弹性件154弹性连接在盖体15上，当盖体15盖合在壳体16上的情况下，压板151用于将反应管2压紧在承载模块11中。
在本公开实施例中，主体1包括盖体15和壳体16，具体的，可以采用铰链连接；盖体15包括压板151，压板151呈C字形，背部与盖体15抵接，C字型两端与承载模块11贴合，这样通过C字两端将加热模块12的热量传导上去，这样可以防止反应过程中，盖体15的上方产生冷凝。压板151通过弹性件154弹性连接在盖体15上，具体的，弹性件154可以为弹簧，通过导向轴连接在盖体15上。当盖体15盖合在壳体16上的情况下，压板151的C字两端抵接在承载模块11上，以将反应管2压紧。盖体15上设置有磁吸开关152，磁吸开关152用于配合壳体16，以使盖体15打开或闭合。其中，磁吸开关152，可以为两个磁吸件，也可以是，一个磁吸件配合金属件实现。具体的，盖体15上可以设置有盖体安装板153，盖体安装板153上形成有供压板151连接的压板凹槽155。具体的，如图3所示，壳体16上还可以包括有，安装板安装柱161，用于 配合承载模块11的安装板114进行固定；还包括有，按钮安装柱162，用于配合按钮开关的安装与固定。
图7示出了本公开实施例便携式核酸检测设备的结构示意图七；请参考图7。
在一可实施方式中，便携式核酸检测设备还包括暗室壳体3，暗室壳体3可供移动端设备或摄像头安装；暗室壳体3上设置有第二观测孔31，第二观测孔31用于配合移动端设备或摄像头观测反应管2。暗室壳体3上设置有固定机构32，固定机构32用于固定移动端设备，以使移动端设备通过第二观测孔31观测反应管2。
在本公开实施例中，拍照需要有相对暗环境，避免滤光片反光影响到拍照效果，导致影响检测结果，如果要完成实时定量检测，需要移动端设备或者摄像头实时拍照并处理，所以将便携式核酸检测设备的包装盒设计为适合作为移动端设备或者摄像头拍照暗室的结构，该包装盒可以为本实施例中的暗室壳体3，也可以是与暗室壳体3具有相同功能/作用的其他形状的外壳，在此不作具体限定。所以暗室壳体3形成有可以供装载摄像头或移动端设备拍照的暗室，暗室壳体3连接有底板4，底板4上有安装有可供便携式核酸检测设备定位和安装的安装槽，也设置有与暗室壳体3配合的安装台阶；如图7所示，便携式核酸检测设备和暗室壳体3分别安装在底板4上，并且便携式核酸检测设备位于暗室壳体3的内部。其中壳体16设置在第二观测孔31的表面，具体地，主体1的壳体16上的观测窗14与暗室壳体3的第二观测孔31的位置匹配，以便于摄像头或移动端设备可以通过第二观测孔31、观测窗14以及第一观测孔112观测到反应管2。暗室壳体3上可以连接有用于固定移动端设备的固定机构32；固定机构32包括用于安装摄像头的第一机构，具体的，第一机构为摄像头安装孔321。或者用于安装移动端设备的第二机构，具体的，第二机构包括，滑轨322、固定螺柱323、滑块324和橡胶垫325，滑块324设置在滑轨322内部，可以沿滑轨322运动，滑块324的一端连接有固定螺柱323，固定螺柱323用于将滑块324紧固在滑轨322上，以使滑块324将移动端设备加紧。滑块324朝向移动端设备的一侧设置有橡胶垫325，橡胶垫325用于防止移动端设备划伤。移动端设备与便携式核酸检测设备通信连接，具体的，可以是连接有控制模块17，从而实现对便携式核酸检测设备的控制，具体包括：加热时间的调节、加热温度的调节；以及获取实时温度信息、反应时间信息、以及检测结果的获取。具体的，控制模块17连接有移动端设备，用于接收来自移动端设备的控制指令，以通过控制指令控制加热模块12调节承载模块11的温度，或者，通过控制指令控制发光模块13发射光。
提供一个具体实施例：首先将待测物21(具体为检测样本)以及配套的试剂加入反应管2中，一次检测量最多可以为八通道，将加好样品的反应管2放入承载模块11，盖上盖体15，盖体15与壳体16一端通过铰链链接，另一端通过磁吸开关152进行开合；盖上盖体15后，盖体15结构中的压板151受到弹性件154的压缩弹力，利用该力对反应管2进行压紧，避免在反应中由于反应管2内的气体加热膨胀导致的反应管2顶部开口被迫打开而造成的泄漏，该压板151同时与承载模块11紧密贴合，可以将承载模块11的热量传导至压板151，可以起到更好的温控效果；控制模块17分为两个部分，一是加热模块12，另外一个是发光模块13；加热模块12通过加热按钮开关控制，加热模块12按照反应设定的温度以及时间流程执行加热；发光模块13由激发光按钮开关控制启停，方便在任何时间观测反应情况；待反应结束后，打开发光模块13，可以采用裸眼观测结果，也可以采用移动端设备拍照自动识别结果，还可以采用集成摄像头(例如open mv摄像头)进行结果识别；移动端设备与便携式核酸检测设备通过无线连接，移动端设备也可以控制加热以及激发光开关；且能够对加热程序的加热时间、加热温度等加热参数进行修改，以适用于不同温度的等温扩增反应。
具体的，本公开提供以下两个具体应用场景；
应用场景1，酒精耐受度检测：
人体酒精耐受度分为三个档次，纯合野生型-酒精耐受、杂合突变型-酒精略微耐受、纯合突变型-酒精不耐受；在检测酒精耐受度时，需要针对一个样本配制两种不同的反应体系，针对野生型和突变型分别设计引物，若只有野生型引物反应体系产生扩增，则说明是纯合野生型；若只有突变型引物反应体系产生扩增，则说明是纯合突变型；若两种反应体系均产生扩增，则说明是杂合突变型。
酒精耐受度检测包括以下步骤：
1、录入待检测人信息。
2、采样，利用采样拭子擦拭口腔上皮细胞，完成采样。
3、反应粗提液配制、预热，将采取的检测样本拭子浸入核酸释放(裂解)试剂中，静置3-5分钟，得到核酸粗提液。
4、同时插入便携式核酸检测设备电源并打开电源开关，进行设备预热。
5、反应配制与加载，将核酸粗提液滴入盛放有核酸扩增冻干试剂的反应管2中；冻干试剂包括引物、酶和其他反应物；摇晃使得冻干试剂完全溶解并混合，将加载好试剂的反应管2载入承载模块11。
6、反应进行，预设温度为63℃，预设时间为30分钟；再次按下便携式核酸检测设备的加热按钮，按照预设温度和预设时间完成等温核酸扩增。
7、结果检测，打开激发光按钮，直接观测结果。若只有野生型引物反应体系产生荧光信号，则说明是纯合野生型；若只有突变型引物反应体系产生荧光信号，则说明是纯合突变型；若两种反应体系均产生荧光信号，则说明是杂合突变型。结果的获取还可以采用移动端摄像头或者集成摄像头进行采集处理；当然也可以实现实时定量扩增检测。
应用场景2，新型冠状病毒(SARS-Cov-2)检测：SARS-CoV-2是一种有包膜的正链RNA病毒，属β冠状病毒属，引起2019年冠状病毒病全球大流行(COVID-19)。其高效、快速检测对于及早发现和预防病毒传播具有重要意义。本实例针对SARS-CoV-2 ORF1ab和N gene保守序列分别设计扩增引物，用于SARS-CoV-2及其突变株的快速筛查。
SARS-Cov-2检测包括以下步骤：
1、录入待检测人信息。
2、采样，利用采样拭子采取鼻/咽拭子，完成采样。
3、反应粗提液配制。将采取的检测样本拭子浸入核酸释放(裂解)试剂中，静置3-5分钟，得到核酸粗提液。
4、预热，配制反应粗提液的同时插入便携式核酸检测设备电源并打开电源开关，进行设备预热。
5、反应配制与加载，将核酸粗提液滴入盛放有核酸扩增冻干试剂的反应管2中；冻干试剂包括引物、酶和其他反应物；摇晃使得冻干试剂完全溶解并混合，将加载好试剂的反应管2载入承载模块11。
6、反应进行，预设温度为63℃，预设时间为30分钟；再次按下便携式核酸检测设备的加热按钮，按照预设温度和预设时间完成等温核酸扩增。
7、结果检测，打开激发光按钮，直接观测结果。若反应体系产生荧光信号，则为SARS-Cov-2阳性；反之，阴性。结果的获取还可以采用移动端摄像头或者集成摄像头进行采集处理；当然也可以实现实时定量扩增检测。
根据本公开的第二方面，提供了一种便携式核酸检测系统，系统包括：移动端设备和本公开实施例的便携式核酸检测设备；移动端设备和便携式核酸检测设备通信连接，以配合便携式核酸检测设备进行检测操作。
根据本公开的第三方面，提供了一种核酸检测方法，方法包括：将容置有待测物21的反应管2放置在承载模块11中；将承载模块11安装在安装腔内；根据来自移动端设备的检测指令，控制加热模块12将承载模块11加热至指定 温度，以使反应管2处于指定温度；根据来自移动端设备的检测指令，控制发光模块13发射光，以使发射光通过通光孔111照射在反应管2上；通过主体1上的观测窗14和承载模块11上的第一观测孔112进行配合，对反应管2进行观测，根据反应管2在发射光的照射下的荧光反应确定检测结果。此外，也可以不使用发光模块而采用化学发光、比色反应等，或者使用白光发光模块采用比色反应，同样可以实现核酸检测，所以本公开能够适用于多种的使用情况，大大的提高了便携式核酸检测设备的使用范围。
移动端设备与便携式核酸检测设备通信连接，具体的，可以是连接有控制模块17。
通过移动端设备向便携式核酸检测设备发送控制指令，或者接收来自便携式核酸检测设备的反馈信息，具体的，控制指令可以包括：加热时间的调节、加热温度的调节；反馈信息的获取可以包括：实时的温度信息、反应时间信息、以及检测结果，以供使用者随时观察，以实现无接触的检测模式，降低检测过程中可能会发生的感染的风险。
本公开提供一种具体实施例：本发明提供一种核酸扩增检测分析方法，包括以下步骤：
S1、录入待检测人信息，具体的，录入信息的方式可以为移动端设备程序手动录入，也可以为移动端设备程序扫描健康码进行待检测人信息录入。
S2、核酸采样，即采用核酸采样拭子进行采样。
S3、反应粗提液配制，即将采取的检测样本拭子浸入核酸释放(裂解)试剂中，得到核酸粗提液。
S4、同时插入便携式核酸检测设备电源并打开电源开关，进行设备预热。
S5、反应配制与加载；具体的，将核酸粗提液滴入盛放有核酸扩增冻干试剂的反应管2中，摇晃使得冻干试剂完全溶解并混合，将加载好试剂的反应管2载入承载模块11。
S6、检测反应进行；具体的，按下便携式核酸检测设备的加热按钮，完成按照预设温度和预设时间完成快速等温核酸扩增。
S7、获取结果检测，具体的，该便携式核酸检测设备的结果检测可选择三种结果检测方法，即下述A、B或C中任一项。
A：检测人员通过观测窗口直接观测反应管2是否存在荧光信号，以此定性的获取检测结果。
B：通过移动端设备开发的软件，利用移动端设备摄像头进行图像采集并保存，然后通过处理图像获得检测结果；该方法可以实现终点检测，也可以根据 设定的程序按照时间间隔完成实时采样后在移动端设备屏幕上绘制出实时扩增曲线，完成实时检测。
C：利用集成摄像头进行图像采集并处理，例如open mv摄像头，该方法可以实现终点检测，也可以根据设定的程序按照时间间隔完成实时采样后，将数据通过无线模块传输给移动端设备进行实时扩增曲线的绘制，完成实时检测。
S8、结果保存与分享，针对两种检测方法分别由两种对应的结果录入方式，即下述D或E中任一项；
D：针对检测人员通过观测窗口直接观测反应管2定性获取检测结果的方式，可以通过手动填写的方式将检测结果一一对应于参检人信息；并保存检测信息。
E：通过图像处理获得检测结果的方式，可以将特定反应管2与参检人信息一一对应，并保存检测信息。
保存结果的同时移动端设备软件会自动保存当前检测点的地理位置，并且将检测结果与地图中的地理位置关联，点击地图上对应的检测点位置就可以查看对应的检测结果。
应该理解，可以使用上面所示的各种形式的流程，重新排序、增加或删除步骤。例如，本发公开中记载的各步骤可以并行地执行也可以顺序地执行也可以不同的次序执行，只要能够实现本公开公开的技术方案所期望的结果，本文在此不进行限制。
此外，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或隐含地包括至少一个该特征。在本公开的描述中，“多个”的含义是两个或两个以上，除非另有明确具体的限定。
以上，仅为本公开的具体实施方式，但本公开的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本公开揭露的技术范围内，可轻易想到变化或替换，都应涵盖在本公开的保护范围之内。因此，本公开的保护范围应以权利要求的保护范围为准。

Claims (12)

  1. 一种便携式核酸检测设备，其中，所述便携式核酸检测设备包括主体(1)；
    所述主体(1)上设置有供承载模块(11)安装的安装腔，所述承载模块(11)用于供反应管(2)容置，所述反应管(2)用于供待测物(21)容置；
    承载模块(11)连接有加热模块(12)，所述加热模块(12)用于调节所述承载模块(11)的温度，以调节反应管(2)的温度；
    所述主体(1)连接有发光模块(13)，所述发光模块(13)设置在所述承载模块(11)的底部，所述承载模块(11)朝向所述发光模块(13)设置有通光孔(111)，以使发光模块(13)的发射光通过所述通光孔(111)照射在所述反应管(2)上；
    所述主体(1)上还设置有观测窗(14)，所述承载模块(11)的第一侧设置有第一观测孔(112)，所述第一观测孔(112)用于观测所述反应管(2)；当所述承载模块(11)安装在所述安装腔的情况下，所述观测窗(14)用于通过第一观测孔(112)观测所述反应管(2)。
  2. 根据权利要求1所述的便携式核酸检测设备，其中，所述承载模块(11)上设置有多个凹槽(113)，所述凹槽(113)用于供所述反应管(2)容置；
    所述通光孔(111)的数量与所述凹槽(113)数量一致，所述通光孔(111)设置在所述凹槽(113)的底部，所述发光模块(13)紧固连接在所述承载模块(11)的底部，以使发光模块(13)的发射光通过所述通光孔(111)照射在所述反应管(2)上；
    所述承载模块(11)还包括有安装板(114)，所述安装板(114)用于配合所述主体(1)，以将所述承载模块(11)固定在所述安装腔内。
  3. 根据权利要求1所述的便携式核酸检测设备，其中，
    所述加热模块(12)连接在所述承载模块(11)的第二侧，所述第二侧与所述第一侧不同；
    所述加热模块(12)包括加热元件(121)、温度传感器(122)和过热保护模块(123)，所述温度传感器(122)设置在所述加热元件(121)和所述承载模块(11)之间，所述加热模块(12)用于调节所述承载模块(11)的温度，所述温度传感器(122)用于检测所述承载模块(11)的温度；
    所述温度传感器(122)连接有过热保护模块(123)，所述过热保护模块(123)和加热元件(121)连接；当所述温度传感器(122)检测获得的温度高于指定 温度的情况下，所述过热保护模块(123)用于使加热元件(121)停止加热。
  4. 根据权利要求3所述的便携式核酸检测设备，其中，
    所述温度传感器(122)至少包括热敏电阻、铂电阻、热电偶中的一种或多种，所述加热元件(121)至少包括陶瓷加热片、电热膜、电热丝、功率电阻、半导体加热片中的一种或多种。
  5. 根据权利要求1所述的便携式核酸检测设备，其中，
    所述主体(1)包括盖体(15)和壳体(16)，所述盖体(15)和所述壳体(16)转动连接，所述壳体(16)用于供承载模块(11)抵接；所述盖体(15)包括压板(151)，所述压板(151)通过弹性件(154)弹性连接在所述盖体(15)上，当所述盖体(15)盖合在所述壳体(16)上的情况下，所述压板(151)用于将所述反应管(2)压紧在所述承载模块(11)中。
  6. 根据权利要求5所述的便携式核酸检测设备，其中，所述盖体(15)上设置有磁吸开关(152)，所述磁吸开关(152)用于配合所述壳体(16)，以使所述盖体(15)打开或闭合。
  7. 根据权利要求1所述的便携式核酸检测设备，其中，所述便携式核酸检测设备设置有控制模块(17)，所述控制模块(17)连接有所述加热模块(12)，用于控制所述加热模块(12)，以调节承载模块(11)的温度；
    控制模块(17)还连接有所述发光模块(13)，用于控制所述发光模块(13)发射光，以照射所述反应管(2)；
    所述控制模块(17)连接有移动端设备，用于接收来自所述移动端设备的控制指令，以通过所述控制指令控制所述加热模块(12)调节承载模块(11)的温度；或者，通过所述控制指令控制所述发光模块(13)发射光。
  8. 根据权利要求1所述的便携式核酸检测设备，其中，所述便携式核酸检测设备还包括暗室壳体(3)，所述暗室壳体(3)可供移动端设备或摄像头安装；
    所述暗室壳体(3)上设置有第二观测孔(31)，所述第二观测孔(31)用于配合所述移动端设备或所述摄像头观测所述反应管(2)。
  9. 根据权利要求8所述的便携式核酸检测设备，其中，所述暗室壳体(3)上设置有固定机构(32)，所述固定机构(32)用于固定所述移动端设备，以使所述移动端设备通过所述第二观测孔(31)观测所述反应管(2)。
  10. 根据权利要求1所述的便携式核酸检测设备，其中，所述观测窗(14)的观测窗口上安装有滤光片。
  11. 一种便携式核酸检测系统，其中，所述便携式核酸检测系统包括：移动端设备和权利要求1-10任一项所述的便携式核酸检测设备；所述移动端设备 和所述便携式核酸检测设备通信连接，以配合所述便携式核酸检测设备进行检测操作。
  12. 一种核酸检测方法，其中，所述核酸检测方法包括：
    将容置有待测物(21)的反应管(2)放置在承载模块(11)中；
    将所述承载模块(11)安装在安装腔内；
    根据来自移动端设备的检测指令，控制加热模块(12)将所述承载模块(11)加热至指定温度，以使所述反应管(2)处于指定温度；
    根据来自所述移动端设备的检测指令，控制发光模块(13)发射光，以使发射光通过通光孔(111)照射在所述反应管(2)上；
    通过主体(1)上的观测窗(14)和所述承载模块(11)上的第一观测孔(112)进行配合，对所述反应管(2)进行观测，根据所述反应管(2)在发射光的照射下的荧光反应确定检测结果。
PCT/CN2023/109464 2022-08-16 2023-07-27 一种便携式核酸检测设备、系统及方法 WO2024037302A1 (zh)

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