WO2024040739A1 - Dispositif de test - Google Patents

Dispositif de test Download PDF

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Publication number
WO2024040739A1
WO2024040739A1 PCT/CN2022/127640 CN2022127640W WO2024040739A1 WO 2024040739 A1 WO2024040739 A1 WO 2024040739A1 CN 2022127640 W CN2022127640 W CN 2022127640W WO 2024040739 A1 WO2024040739 A1 WO 2024040739A1
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WO
WIPO (PCT)
Prior art keywords
detection device
freeze
heater
excitation light
light diffuser
Prior art date
Application number
PCT/CN2022/127640
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English (en)
Chinese (zh)
Inventor
吴敬梓
张景
Original Assignee
凤凰医学诊断科技有限公司
凤凰桥控股（北京）有限公司
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Publication of WO2024040739A1 publication Critical patent/WO2024040739A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/68—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving nucleic acids
    • C12Q1/6844—Nucleic acid amplification reactions
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
    • C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
    • C12Q1/70—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions involving virus or bacteriophage
    • C12Q1/701—Specific hybridization probes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
    • G01N1/44—Sample treatment involving radiation, e.g. heat
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G01N33/56983—Viruses
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/005—Assays involving biological materials from specific organisms or of a specific nature from viruses
    • G01N2333/08—RNA viruses
    • G01N2333/165—Coronaviridae, e.g. avian infectious bronchitis virus

Definitions

  • the present invention relates to the technical field of virus detection, and in particular to a detection device.
  • Disease diagnosis has always been a popular field. From an application perspective, it includes infectious disease detection, early cancer screening and the detection of other genetic diseases. From a principle and method perspective, it includes biochemical detection, antigen detection, antibody detection and nucleic acid detection. The recent COVID-19 pandemic has greatly promoted the development of the testing field and highlighted the need for rapid diagnosis. Although nucleic acid testing can screen out a large number of positive patients in the incubation period, its labor cost is high and it requires professional testing equipment and testing environment.
  • the purpose of the present invention is to provide a detection device to solve the above-mentioned problems existing in the prior art. It is portable and does not require professional instruments, environments and operators, and reduces costs.
  • the present invention provides the following solutions:
  • the invention provides a detection device, which includes a light separator, a light diffuser and a printed circuit board arranged from top to bottom.
  • the light separator is provided with two sample inlets and two observation windows.
  • the sample inlets are Used to receive samples, the observation window is used to observe detection results, the light diffuser is provided with two freeze-drying chambers and two reaction chambers, each of the freeze-drying chambers is connected to one sample entrance and one laboratory respectively.
  • the reaction chambers are connected, one freeze-drying chamber is used to place detection freeze-dried beads, the other freeze-drying chamber is used to place control freeze-dried beads, the printed circuit board is provided with an excitation light source and a heater, so The excitation light source corresponds to the light diffuser, the heater corresponds to the reaction chamber, and the heater is used to heat reactants in the reaction chamber.
  • the light separator is provided with a filter, and the filter corresponds to the two observation windows;
  • the optical separator is provided with two exhaust ports, each of which is connected to one of the reaction chambers;
  • the light diffuser is provided with two waste chambers, and each waste chamber is connected to one of the reaction chambers.
  • the freeze-drying chamber is arranged at an angle, and the end of the freeze-drying chamber connected to the sample inlet is higher than the end of the freeze-drying chamber connected to the reaction chamber.
  • the light diffuser is provided with two semi-cylindrical lenses, each of the semi-cylindrical lenses corresponds to one of the observation windows, the curved surface of the semi-cylindrical lens faces the light splitter, and the semi-cylindrical lens The flat surface opposite the curved surface faces the light diffuser.
  • a film structure is provided between the light diffuser and the heater.
  • the background color of the printed circuit board is black.
  • the printed circuit board is also provided with a positive buckle clip, a negative buckle clip and a resistor.
  • the positive buckle clip and the negative buckle clip are both used to connect to the battery. Electrically connected, the positive buckle clip and the negative buckle clip are electrically connected to the heater through wires, the positive buckle clip and the negative buckle clip are electrically connected to the excitation light source through wires, and the resistor
  • the device is arranged on the wire between the excitation light source and the positive buckle clip or the negative buckle clip.
  • the excitation light source is arranged at one end of the light diffuser.
  • the two excitation light sources are symmetrically arranged on both sides of the light diffuser.
  • the detection device further includes a sliding cover, the sliding cover is slidingly connected to the optical separator, and the sliding cover is used to close the sample inlet and the exhaust port.
  • the detection device further includes a base, the base is provided below the printed circuit board, a heat insulation layer is provided on the base, and the heat insulation layer corresponds to the position of the heater.
  • samples are put into two sample inlets respectively, and the samples enter the freeze-drying chamber through the sample inlet.
  • the samples dissolve the detection freeze-dried beads and the control freeze-dried beads respectively and enter the corresponding reaction chamber.
  • the reaction is carried out under the action of the excitation light source to excite the reactants in the reaction chamber so that the detection results can be observed through the observation window.
  • the invention is powered by batteries, is easy to carry, can perform one detection, requires no special training, no professional equipment, no need for a sterile environment, is easy to transport, is convenient to operate, and saves costs.
  • Figure 1 is a schematic diagram of the detection device of the present invention.
  • Figure 2 is an exploded view of the detection device of the present invention
  • Figure 3 is a schematic diagram of the optical splitter of the present invention.
  • Figure 4 is a schematic diagram of the bottom of the optical separator of the present invention.
  • Figure 5 is a schematic diagram of the light diffuser of the present invention.
  • Figure 6 is a schematic diagram of the bottom of the light diffuser of the present invention.
  • Figure 7 is a schematic diagram of the printed circuit board of the present invention.
  • Figure 8 is a schematic diagram of the base of the present invention.
  • 100-detection device 100-detection device; 1-light separator, 11-sample inlet, 12-observation window, 13-exhaust port, 14-sliding cover, 15-optical filter, 16-opening; 2-light diffuser, 21-lyophilization chamber, 22-reaction chamber, 23-waste chamber, 24-semi-cylindrical lens, 25-lyophilized beads; 3-printed circuit board, 31-excitation light source, 32-heater, 33-positive clip, 34-Negative clip, 35-Resistor, 36-Wire; 4-Membrane structure; 5-Base, 51-Insulation layer.
  • the purpose of the present invention is to provide a detection device to solve the above-mentioned problems existing in the prior art. It is portable and does not require professional instruments, environments and operators, and reduces costs.
  • This embodiment takes the detection of novel coronavirus pneumonia as an example.
  • This embodiment is based on isothermal amplification technology.
  • Isothermal amplification technology does not require temperature changes during the amplification process, but only requires a constant temperature.
  • There are many types of isothermal amplification technologies including loop-mediated isothermal amplification (LAMP), helicase-dependent amplification (HDA), rolling circle amplification (Rolling Circle Replication, RCA), Multiple Displacement Amplification (MDA), Recombinase polymerase amplification (RPA) and Nucleic Acid Sequence-Dependent Amplification (NASBA).
  • LAMP loop-mediated isothermal amplification
  • HDA helicase-dependent amplification
  • MDA Multiple Displacement Amplification
  • RPA Recombinase polymerase amplification
  • NASBA Nucleic Acid Sequence-Dependent Amplification
  • This embodiment is based on the loop-mediated isothermal amplification technology among the isothermal
  • This embodiment provides a detection device 100, which includes a light separator 1, a light diffuser 2 and a printed circuit board 3 arranged from top to bottom.
  • the light separator 1 is non-transparent. Any color, such as white, that is, the light separator 1 is made of a material with weak light penetration, the light diffuser 2 is a transparent structure, the lower surface of the light separator 1 is provided with a groove, and the light diffuser 2 is provided in the groove.
  • the light separator 1 is provided with two sample inlets 11 and two observation windows 12. The sample inlet 11 is used to receive the sample, the observation window 12 is used to observe the detection results, and the light diffuser 2 is provided with two freeze-drying windows.
  • Each freeze-drying chamber 21 is connected with a sample inlet 11 and a reaction chamber 22 respectively.
  • One freeze-drying chamber 21 is used to place detection freeze-dried beads, and the other freeze-drying chamber 21 is used to place controls.
  • Freeze-dried beads, the printed circuit board 3 is provided with an excitation light source 31 and a heater 32.
  • the excitation light source 31 corresponds to the light diffuser 2
  • the heater 32 corresponds to the reaction chamber 22.
  • the heater 32 is used to control the reaction chamber 22.
  • the reactants are heated.
  • the samples dissolve the detection freeze-dried beads and the control freeze-dried beads and enter the corresponding reaction chamber 22.
  • the reaction is performed under the action of the heater 32 , and the excitation light source 31 excites the reactants in the reaction chamber 22 so that the detection results can be observed through the observation window 12 .
  • the freeze-drying chamber 21 is arranged at an angle, preferably at an angle of 121°, and the end of the freeze-drying chamber 21 communicating with the sample inlet 11 is higher than the end connecting the freeze-drying chamber 21 with the reaction chamber 22 .
  • the sample is dropped into the freeze-drying chamber 21 from the sample inlet 11. Since the freeze-drying chamber 21 is tilted, the sample will flow to the end where the freeze-drying chamber 21 communicates with the reaction chamber 22.
  • An outlet is provided at the connection between the freeze-drying chamber 21 and the reaction chamber 22. The size of the outlet gradually decreases from the freeze-drying chamber 21 to the reaction chamber 22, and the sample passes through the outlet and flows into the capsule-shaped reaction chamber 22, which is 2 mm wide and 1 mm high.
  • the optical separator 1 is provided with an optical filter 15.
  • the optical filter 15 corresponds to the two observation windows 12.
  • the two observation windows 12 are arranged on one side of the two sample inlets 11.
  • the optical filter 15 is Amber, the filter 15 is used to remove light in the remaining wavelength bands;
  • the light splitter 1 is also provided with two exhaust ports 13, and the two exhaust ports 13 are provided on the other side of the two sample inlets 11; light diffusion
  • the upper surface of the container 2 is provided with two waste chambers 23. Each waste chamber 23 is connected to a reaction chamber 22 through a flow channel.
  • Each exhaust port 13 is connected to a waste chamber 23.
  • the function of the exhaust port 13 is to ensure that the sample
  • the reaction chamber 22 can be fully filled, and the role of the waste chamber 23 is to avoid leakage from the exhaust port 13 when excess sample is dripped;
  • the light diffuser 2 is also provided with two semi-cylindrical lenses 24, each semi-cylindrical lens 24 is connected to a Corresponding to the observation window 12, the curved surface of the semi-cylindrical lens 24 faces the light separator 1, and the plane opposite the curved surface of the semi-cylindrical lens 24 faces the light diffuser 2 to improve the observation field of view of the reaction results.
  • the detection device 100 also includes a sliding cover 14.
  • the sliding cover 14 is provided with a chute.
  • the optical separator 1 is provided with a guide rail.
  • the sliding cover 14 and the optical separator 1 are slidingly connected through the chute and the guide rail.
  • the sliding cover 14 is provided with a slide groove. 14 is used to close the sample inlet 11 and the exhaust port 13 to ensure that the sample is located in the reaction chamber 22.
  • the detection device 100 of this embodiment is a self-testing POCT (point-of-care testing) device that uses LAMP (loop-mediated isothermal amplification reaction) to detect viral nucleic acids in patient samples.
  • the detection lyophilized beads include all the biological or chemical components required for the LAMP reaction, including DNA polymerase, reverse transcriptase, dNTPs, magnesium ions (MgSO 4 ), and a set of SARS-CoV-2N genes.
  • control freeze-dried beads include DNA polymerase, reverse transcriptase, dNTPs, magnesium ions (MgSO 4 ), human genome-specific primers (6 primers, including F3_H, B3_H, FIP_H, BIP_H, LB_H and LF_H), Other necessary buffers as well as the fluorescent dye SYTO 9.
  • DNA polymerase reverse transcriptase
  • dNTPs reverse transcriptase
  • MgSO 4 magnesium ions
  • human genome-specific primers 6 primers, including F3_H, B3_H, FIP_H, BIP_H, LB_H and LF_H
  • Other necessary buffers as well as the fluorescent dye SYTO 9.
  • composition list of freeze-dried beads (a total of 25 ⁇ L after the sample dissolves the freeze-dried beads)
  • Control freeze-dried beads ingredient list (a total of 25 ⁇ L after the sample dissolves the freeze-dried beads)
  • the freeze-drying chamber 21 equipped with control freeze-dried beads is the control group
  • the freeze-drying chamber 21 equipped with test freeze-dried beads is the test group.
  • the test results are divided into the following situations: Positive result: the test group has green fluorescence, the control group The group also has green fluorescence; negative result: the test group has no fluorescence, and the control group has green fluorescence; invalid result: regardless of whether the test group has fluorescence, the control group has no fluorescence.
  • a film structure 4 is provided between the light diffuser 2 and the heater 32.
  • the thickness of the film structure 4 ranges from 10 to 800 ⁇ m.
  • the film structure 4 is in contact with the light diffuser 2 and the heater 32 respectively.
  • the film structure 4 Being a thin film, the membrane structure 4 mainly has two functions: first, it acts as a barrier to ensure the interaction between the reactants in the reaction chamber 22 and the heater 32, and protects the printed circuit board 3 and the heater 32; Keep the final temperature constant.
  • the heater 32 is preferably a PTC heater, which does not require additional sensors, fuses or controls, thereby reducing possible failures and structural complexity.
  • the starting temperature before or room temperature depending on where the user uses the device, the starting temperature can be 20-30°C, or 30-40°C in tropical countries) consumes almost all the power for warming up, and can reach the threshold temperature very quickly.
  • the PTC heater is made of PTC ink. Since the working temperature of PTC ink has selection restrictions, including about 40°C, about 55°C, about 60°C, about 90°C and about 120°C. Among the above temperatures, there is no 60-65°C that we need suitable for LAMP reaction.
  • the heat loss is proportional to the thickness of the membrane structure 4. As the thickness of the membrane structure 4 increases, the heat loss also increases. For example, if a 100 ⁇ m membrane structure 4 is sandwiched in a PTC at about 60°C between the heater and the reaction chamber 22, the final temperature in the reaction chamber 22 is approximately 50°C. Membrane structure 4 starts from 100 ⁇ m, and every 10 ⁇ m increase in thickness will result in a heat loss of 10°C. Therefore, the thermal conductivity of the membrane structure 4 (in the range of 0.167-0.3 W/(m ⁇ K)) and the operating temperature of the PTC heater are crucial to determine the final temperature in the reaction chamber 22.
  • the background color of the printed circuit board 3 is black.
  • the printed circuit board 3 is also provided with a positive clip 33, a negative clip 34 and a resistor 35.
  • the positive clip 33 and the negative clip 34 are riveted to the printed circuit.
  • the positive buckle clip 33 and the negative buckle clip 34 are both used for electrical connection with the battery.
  • the positive buckle clip 33 and the negative buckle clip 34 are respectively electrically connected to the heater 32 through the wire 36.
  • the positive buckle clip 33 and the negative buckle clip 34 They are electrically connected to the excitation light source 31 through wires 36 respectively, and the resistor 35 is provided on the wire 36 between the excitation light source 31 and the positive clip 33 or the negative clip 34 .
  • screen printing is used to print conductive silver ink (conductor 36), PTC ink (PTC heater), and carbon resistance ink (resistor 35) on PET (polyethylene terephthalate) film.
  • conductive silver ink conductor 36
  • PTC ink PTC heater
  • carbon resistance ink resistor 35
  • PET polyethylene terephthalate
  • PTC ink or carbon resistor Inks can also be replaced by flexographic and gravure printing or spray, dipping and brushing techniques.
  • the optical separator 1 is provided with an opening 16. Both the positive buckle clip 33 and the negative buckle clip 34 correspond to the opening 16.
  • the opening 16 is used to install the battery.
  • the battery is electrically connected to the positive buckle clip 33 and the negative buckle clip 34. Connection, the battery is used to power the heater 32 and the excitation power supply.
  • a 9VDC battery can be selected.
  • the power capacity selection of the battery depends on the standard of the heater 32, including the power of the heater 32 and the heating duration.
  • the detection device 100 further includes a base 5 , which is disposed below the printed circuit board 3 .
  • the base 5 is provided with a heat insulation layer 51 , and the heat insulation layer 51 is positioned correspondingly to the heater 32 .
  • the base 5 is also provided with a first protruding part and a second protruding part. The number of the first protruding part and the second protruding part is set as needed.
  • the first protruding part is connected with the first protruding part on the optical splitter 1.
  • the groove corresponds to the second protruding portion corresponding to the second groove on the light diffuser 2 .
  • the excitation light source 31 is a 465nm LED light source, and there is one excitation light source 31.
  • the excitation light source 31 is arranged at one end of the light diffuser 2, and the light-emitting part of the excitation light source 31 is aligned with the ends of the two reaction chambers 22.
  • the excitation light of 31 is diffused through the transparent light diffuser 2.
  • the DNA is amplified, and the SYTO9 dye will be embedded in the DNA and generate green fluorescence through excitation by the excitation light source 31.
  • the luminous angle and luminous intensity of the excitation light source 31 depend on the distance between the two reaction chambers 22.
  • this embodiment sets two semi-cylindrical lenses 24 respectively located in the two reaction chambers 22 directly above to improve the observation field of reaction results.
  • the light splitter 1 can block all the 465nm wavelength light around the reaction chamber 22, and the amber filter 15 further attenuates the 465nm wavelength light in the reaction chamber 22, so after passing through the filter 15, only the light from SYTO 9 is left emit fluorescence.
  • the background color of the printed circuit board 3 is black, which enhances the contrast of the fluorescent emission and makes it visible to the naked eye.
  • the detection device 100 needs to be sealed and packaged in a drying chamber to prevent the impact of humidity on the freeze-dried beads 25 and enzyme activity.
  • a drying chamber to prevent the impact of humidity on the freeze-dried beads 25 and enzyme activity.
  • users conduct testing they should check the shelf life on the package and whether it is damaged. Only a completely sealed package can ensure that the product inside can be used normally.
  • the use process of the detection device 100 in this embodiment specifically includes:
  • Step 1 Open the package and take out the detection device 100;
  • Step 2 Collect nasal swab samples
  • Step 3 Elute the sample into the extraction buffer.
  • the buffer will help stabilize the viral nucleic acid and improve the test sensitivity of LAMP;
  • Step 4 Remove the aluminum foil seal on the detection device 100;
  • the aluminum foil seal helps prevent the lyophilized beads 25 (test lyophilized beads and control lyophilized beads) from absorbing moisture in the environment, thereby preventing enzymatic degradation.
  • the detection device 100 should be used within 1 hour. If it exceeds 1 hour, then the freeze-dried beads 25 in the detection device 100 will absorb water and become ineffective, and the detection device 100 should be discarded;
  • Step 5 Drop the extraction buffer containing the sample into the sample inlet 11, close the sliding cover 14, and ensure that the sliding cover 14 is tightly sealed;
  • the extraction buffer will slowly flow from the sample inlet 11 to the location of the freeze-dried beads 25 due to capillary action. This process will have strict liquid volume control. 25 ⁇ L of liquid will dissolve the freeze-dried beads 25 and then enter the final reaction chamber 22.
  • the 25 ⁇ L reagent contains DNA polymerase, reverse transcriptase, dNTPs, primers that specifically bind to COVID-19 RNA (6 primers, including F3, B3, FIP, BIP, LB, and LF), magnesium ions necessary for enzyme activation (MgSO 4 ), dNTPs as DNA building blocks, and other basic buffers that help maintain a stable environment for the LAMP reaction, and the fluorescent dye SYTO 9;
  • Step 6 Insert the 9VDC battery to start the detection device 100 to react
  • This step will start the heater 32 and heat the temperature of the reaction chamber 22 to 60°C, and activate the LAMP reaction;
  • Step 7 Set the timer for 30 minutes
  • This step is the reaction step of LAMP.
  • LAMP amplification requires a stable temperature of 60°C to allow Bst DNA polymerase and reverse transcriptase to work and start the amplification reaction.
  • the reverse transcriptase will bind to the target RNA and will It is reverse transcribed into cDNA, and then Bst DNA polymerase will use the cDNA as a template to synthesize a DNA strand complementary to the cDNA, followed by a series of DNA synthesis;
  • Step 8 Read the results
  • the detection device 100 When the viral load in the sample is relatively high (1000copies/ ⁇ L), the detection device 100 will give results within an average of 12 minutes; when the viral load in the sample is relatively low (4-1000copies/ ⁇ L), the detection device 100 will give results within 12 minutes. Results are delivered in an average of 17 minutes to 30 minutes.
  • the detection device 100 of this embodiment is powered by a battery, is easy to carry, and can perform one detection. No special training, professional equipment, or sterile environment is required during detection. It is easy to operate and saves costs.
  • Embodiment 1 The difference between this embodiment and Embodiment 1 is that in this embodiment, there are two excitation light sources 31 , the two excitation light sources 31 are symmetrically arranged on both sides of the light diffuser 2 , and the two excitation light sources 31 are connected to a reaction chamber 22 respectively. correspond.

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Abstract

L'invention concerne un dispositif de test (100) comprenant un séparateur de lumière (1), un diffuseur de lumière (2) et une carte de circuit imprimé (3), qui sont agencés de haut en bas. Le séparateur de lumière (1) est pourvu de deux entrées d'échantillon (11) et de deux fenêtres d'observation (12), les entrées d'échantillon (11) servent à recevoir les échantillons et les fenêtres d'observation (12) servent à observer les résultats des tests ; le diffuseur de lumière (2) est pourvu de deux chambres de lyophilisation (21) et de deux chambres de réaction (22), chaque chambre de lyophilisation (21) est en communication avec une entrée d'échantillon (11) et une chambre de réaction (22), une chambre de lyophilisation (21) sert à placer une bille lyophilisée de test (25), et l'autre chambre de lyophilisation (21) sert à placer une bille lyophilisée de contrôle (25) ; la carte de circuit imprimé (3) est pourvue d'une source de lumière d'excitation (31) et d'éléments chauffants (32), les éléments chauffants (32) correspondent aux chambres de réaction (22), et les éléments chauffants (32) servent à chauffer les réactifs dans les chambres de réaction (22). Le dispositif de test (100) est portable, et n'a pas besoin d'instruments, d'environnements et d'opérateurs spécialisés, ce qui permet de réduire les coûts.
PCT/CN2022/127640 2022-08-22 2022-10-26 Dispositif de test WO2024040739A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202211006990.0A CN115290606A (zh) 2022-08-22 2022-08-22 一种检测装置
CN202211006990.0 2022-08-22

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WO2024040739A1 true WO2024040739A1 (fr) 2024-02-29

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PCT/CN2022/127640 WO2024040739A1 (fr) 2022-08-22 2022-10-26 Dispositif de test

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CN (1) CN115290606A (fr)
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN118179626A (zh) * 2024-05-17 2024-06-14 厦门宝太生物科技股份有限公司 一种多联检测的光激化学发光微流控芯片及其使用方法

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040053268A1 (en) * 2000-09-15 2004-03-18 Frank Karlsen Microfabricated reaction chamber system
US20150298129A1 (en) * 2014-04-21 2015-10-22 Lawrence DUGAN Multi-chamber nucleic acid amplification and detection device
CN110088266A (zh) * 2016-12-21 2019-08-02 吉诺慕特克有限公司 检测生物样品中的遗传物质的方法及其实施设备
CN210945601U (zh) * 2019-09-20 2020-07-07 西人马（厦门）科技有限公司 一种用于lamp扩增以检测基因分型的微流控芯片
CN111808744A (zh) * 2020-08-03 2020-10-23 齐鲁工业大学 一种便携式全自动核酸恒温扩增检测仪
CN113881555A (zh) * 2021-11-05 2022-01-04 北京宏微特斯生物科技有限公司 次抛型核酸等温扩增检测装置
CN114164088A (zh) * 2021-12-10 2022-03-11 西安交通大学 一种居家核酸检测的芯片结构、卡盒及方法
CN114375322A (zh) * 2019-07-26 2022-04-19 莱克斯诊断有限公司 用于核酸扩增测试的系统和模块
CN216550432U (zh) * 2021-11-05 2022-05-17 北京宏微特斯生物科技有限公司 次抛型核酸等温扩增检测装置
CN114836317A (zh) * 2022-05-23 2022-08-02 国力天（深圳）科技有限公司 一种便携式实时荧光定量核酸诊断仪及其检测方法
CN218524590U (zh) * 2022-08-22 2023-02-24 凤凰医学诊断科技有限公司 一种检测装置

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040053268A1 (en) * 2000-09-15 2004-03-18 Frank Karlsen Microfabricated reaction chamber system
US20150298129A1 (en) * 2014-04-21 2015-10-22 Lawrence DUGAN Multi-chamber nucleic acid amplification and detection device
CN110088266A (zh) * 2016-12-21 2019-08-02 吉诺慕特克有限公司 检测生物样品中的遗传物质的方法及其实施设备
CN114375322A (zh) * 2019-07-26 2022-04-19 莱克斯诊断有限公司 用于核酸扩增测试的系统和模块
CN210945601U (zh) * 2019-09-20 2020-07-07 西人马（厦门）科技有限公司 一种用于lamp扩增以检测基因分型的微流控芯片
CN111808744A (zh) * 2020-08-03 2020-10-23 齐鲁工业大学 一种便携式全自动核酸恒温扩增检测仪
CN113881555A (zh) * 2021-11-05 2022-01-04 北京宏微特斯生物科技有限公司 次抛型核酸等温扩增检测装置
CN216550432U (zh) * 2021-11-05 2022-05-17 北京宏微特斯生物科技有限公司 次抛型核酸等温扩增检测装置
CN114164088A (zh) * 2021-12-10 2022-03-11 西安交通大学 一种居家核酸检测的芯片结构、卡盒及方法
CN114836317A (zh) * 2022-05-23 2022-08-02 国力天（深圳）科技有限公司 一种便携式实时荧光定量核酸诊断仪及其检测方法
CN218524590U (zh) * 2022-08-22 2023-02-24 凤凰医学诊断科技有限公司 一种检测装置

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN118179626A (zh) * 2024-05-17 2024-06-14 厦门宝太生物科技股份有限公司 一种多联检测的光激化学发光微流控芯片及其使用方法

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