A portable nucleic acid detection device and method

Abstract

This disclosure provides a portable nucleic acid detection device and method. The device includes a main body; the main body is provided with an installation cavity for mounting a carrier module, the carrier module is used to accommodate a reaction tube, and the reaction tube is used to accommodate a analyte; the carrier module is connected to a heating module, which is used to adjust the temperature of the carrier module to adjust the temperature of the reaction tube; the main body is connected to a light-emitting module, which is located at the bottom of the carrier module, and the carrier module has a light-transmitting hole facing the light-emitting module so that the emitted light from the light-emitting module can irradiate the reaction tube through the light-transmitting hole; the main body is also provided with an observation window, and a first observation hole is provided on the first side of the carrier module for observing the reaction tube; when the carrier module is installed in the installation cavity, the observation window is used to observe the reaction tube through the first observation hole.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to the field of nucleic acid detection, and in particular to a portable nucleic acid detection device and method. BACKGROUND

[0002] How to quickly and efficiently detect viruses, so as to timely discover and prevent virus infection, has important significance for epidemic prevention work. However, the virus detection instruments in the prior art are generally bulky, inconvenient to carry and use, and virus detection needs centralized sampling, centralized processing, etc., resulting in a long time interval from sampling to obtaining a detection result, and the detection needs to be performed in a certified laboratory, and also needs a large instrument and trained operators, so that the cumbersome steps greatly increase the risk of cross infection. SUMMARY

[0003] The present disclosure provides a portable nucleic acid detection device and method to at least solve the above technical problems in the prior art.

[0004] According to a first aspect of the present disclosure, a portable nucleic acid detection device is provided, the device comprising a main body; the main body is provided with a mounting cavity for mounting a carrying module, the carrying module is used for accommodating a reaction tube, and the reaction tube is used for accommodating a to-be-tested substance; the carrying module is connected with a heating module, the heating module is used for adjusting the temperature of the carrying module to adjust the temperature of the reaction tube; the main body is connected with a light-emitting module, the light-emitting module is arranged at the bottom of the carrying module, the carrying module is provided with a light transmission hole towards the light-emitting module, so that the emitted light of the light-emitting module is irradiated on the reaction tube through the light transmission hole; the main body is further provided with an observation window, and a first observation hole is arranged on the first side of the carrying module, the first observation hole is used for observing the reaction tube; when the carrying module is mounted in the mounting cavity, the observation window is used for observing the reaction tube through the first observation hole.

[0005] In an implementable manner, the carrying module is provided with a plurality of recesses formed therein, the recesses are used for embedding the reaction tube; the number of the light transmission holes is consistent with the number of the recesses, the light transmission holes are arranged at the bottom of the recesses, and the light-emitting module is tightly connected at the bottom of the carrying module, so that the emitted light of the light-emitting module is irradiated on the reaction tube through the light transmission hole; the carrying module further comprises a mounting plate, the mounting plate is used for cooperating with the main body to fix the carrying module in the mounting cavity.

[0006] In one embodiment, the heating module is connected to a second side of the support module, which is different from the first side; the heating module includes a heating element, a temperature sensor, and an overheat protection module; the temperature sensor is disposed between the heating element and the support module; the heating module is used to adjust the temperature of the support module; the temperature sensor is used to detect the temperature of the support module; the temperature sensor is connected to the overheat protection module, 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.

[0007] In one embodiment, the temperature sensor includes at least one or more of thermistors, platinum resistance thermometers, and thermocouples, and the heating element includes at least one or more of ceramic heating elements, heating films, heating wires, power resistors, and semiconductor heating elements.

[0008] In one embodiment, the main body includes a cover and a housing, the cover and the housing being rotatably connected, the housing being used for the support module to abut against; the cover includes a pressure plate, the pressure plate being elastically connected to the cover by an elastic element, and when the cover is closed on the housing, the pressure plate is used to press the reaction tube tightly into the support module.

[0009] In one embodiment, a magnetic switch is provided on the cover, which is used to engage with the housing to open or close the cover.

[0010] In one embodiment, the device is provided with a control module, which is connected to the heating module and used to control the heating module to adjust the temperature of the carrier module; the control module is also connected to the light-emitting module and used to control the light-emitting module to emit light to irradiate the reaction tube; the control module is connected to a mobile terminal device and used to receive control commands from the mobile terminal device, so as to control the heating module to adjust the temperature of the carrier module through the control commands, or to control the light-emitting module to emit light through the control commands.

[0011] In one embodiment, the device further includes a darkroom housing, which can be mounted on a mobile device or a camera; the darkroom housing is provided with a second observation hole, which is used to observe the reaction tube in conjunction with the mobile device or camera.

[0012] In one embodiment, a fixing mechanism is provided on the darkroom housing for fixing a mobile terminal device so that the mobile terminal device can observe the reaction tube through the second observation hole.

[0013] According to a second aspect of this disclosure, a method for nucleic acid detection for non-diagnostic purposes is provided. The method includes: placing a reaction tube containing a analyte in the carrier module; installing the carrier module in the mounting cavity; controlling the heating module to heat the carrier module to a specified temperature according to a detection command from a mobile device, so that the reaction tube is at the specified temperature; controlling the light-emitting module to emit light according to a detection command from the mobile device, so that the emitted light irradiates the reaction tube through a light-transmitting hole; observing the reaction tube through an observation window on the main body and a first observation hole on the carrier module, and determining the detection result based on the fluorescence reaction of the reaction tube under the irradiation of the emitted light.

[0014] This disclosure discloses a portable nucleic acid detection device and method. A reaction tube containing the analyte is placed in a carrier module; the carrier module is installed in an installation cavity; according to a detection command from a mobile device, a heating module is controlled to heat the carrier module to a specified temperature, and a light-emitting module is controlled to emit light so that the emitted light shines onto the reaction tube through a light-transmitting hole; the analyte reacts fully in the reaction tube by heating it, and light is emitted by the light-emitting module so that the emitted light shines onto the reaction tube through the light-transmitting hole, thereby observing the fluorescence reaction of the reaction tube under the illumination of the emitted light to determine the detection result. This application has simple steps and a convenient process, enabling rapid acquisition of the test results for the analyte. Furthermore, the device has a simple and lightweight structure, making it easy to carry and use at home.

[0015] It should be understood that the description in this section is not intended to identify key or essential features of the embodiments of this disclosure, nor is it intended to limit the scope of this disclosure. Other features of this disclosure will become readily apparent from the following description. Attached Figure Description

[0016] The above and other objects, features, and advantages of this disclosure will become readily apparent from the following detailed description of exemplary embodiments, taken in conjunction with the accompanying drawings. Several embodiments of this disclosure are illustrated in the drawings by way of example and not limitation, in which:

[0017] In the accompanying drawings, the same or corresponding reference numerals indicate the same or corresponding parts.

[0018] Figure 1 A schematic diagram of the structure of a portable nucleic acid testing device according to an embodiment of this disclosure is shown. Figure 1 ;

[0019] Figure 2 A schematic diagram of the structure of a portable nucleic acid testing device according to an embodiment of this disclosure is shown. Figure 2 ;

[0020] Figure 3 A schematic diagram of the structure of a portable nucleic acid testing device according to an embodiment of this disclosure is shown.Figure 3 ;

[0021] Figure 4 A schematic diagram of the structure of a portable nucleic acid testing device according to an embodiment of this disclosure is shown. Figure 4 ;

[0022] Figure 5 A schematic diagram of the structure of a portable nucleic acid testing device according to an embodiment of this disclosure is shown. Figure 5 ;

[0023] Figure 6 A schematic diagram of the structure of a portable nucleic acid testing device according to an embodiment of this disclosure is shown. Figure 6 ;

[0024] Figure 7 A schematic diagram of the structure of a portable nucleic acid testing device according to an embodiment of this disclosure is shown. Figure 7 .

[0025] Explanation of the labels in the diagram:

[0026] 1. Main body; 11. Bearing module; 111. Light-transmitting hole; 112. First observation hole; 113. Groove; 114. Mounting plate; 115. Mounting hole; 12. Heating module; 13. Light-emitting module; 14. Observation window; 15. Cover; 151. Pressure plate; 152. Magnetic switch; 153. Cover mounting plate; 154. Elastic element; 155. Pressure plate groove; 16. Housing; 161. Mounting plate mounting post; 162. Button mounting post; 17. Control module; 18. Power module; 2. Reaction tube; 21. Test object; 31. Second observation hole; 32. Fixing mechanism; 321. Camera mounting hole; 322. Slide rail; 323. Fixing stud; 324. Slider; 325. Rubber pad; 4. Base plate. Detailed Implementation

[0027] To make the objectives, features, and advantages of this disclosure more apparent and understandable, the technical solutions in the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this disclosure, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of this disclosure without creative effort are within the scope of protection of this disclosure.

[0028] Figure 1 A schematic diagram of the structure of a portable nucleic acid testing device according to an embodiment of this disclosure is shown. Figure 1 ; Figure 2 A schematic diagram of the structure of a portable nucleic acid testing device according to an embodiment of this disclosure is shown. Figure 2 ; Figure 3 A schematic diagram of the structure of a portable nucleic acid testing device according to an embodiment of this disclosure is shown. Figure 3 ;Figure 4 A schematic diagram of the structure of a portable nucleic acid testing device according to an embodiment of this disclosure is shown. Figure 4 Please refer to Figure 1 , Figure 2 , Figure 3 and Figure 4 ;

[0029] According to a first aspect of this disclosure, a portable nucleic acid testing device is provided, comprising a main body 1; the main body 1 is provided with an installation cavity for mounting a carrier module 11, the carrier module 11 being used to accommodate a reaction tube 2, and the reaction tube 2 being used to accommodate a analyte 21; the carrier module 11 is connected to a heating module 12, the heating module 12 being used to adjust the temperature of the carrier module 11 to adjust the temperature of the reaction tube 2; the main body 1 is connected to a light-emitting module 13, the light-emitting module 13 being disposed at the bottom of the carrier module 11, and the carrier module 11 being provided with a light-transmitting hole 111 facing the light-emitting module 13, so that the emitted light of the light-emitting module 13 shines on the reaction tube 2 through the light-transmitting hole 111; the main body 1 is also provided with an observation window 14, and a first observation hole 112 is provided on a first side of the carrier module 11, the first observation hole 112 being used to observe the reaction tube 2; when the carrier module 11 is mounted in the installation cavity, the observation window 14 is used to observe the reaction tube 2 through the first observation hole 112.

[0030] This disclosure discloses a portable nucleic acid detection device and method. A reaction tube 2 containing a analyte 21 is placed in a support module 11. The support module 11 is installed in an installation cavity. According to a detection command from a mobile device, a heating module 12 is controlled to heat the support module 11 to a specified temperature, and a light-emitting module 13 is controlled to emit light, so that the emitted light shines onto the reaction tube 2 through a light-transmitting hole 111. Heating the reaction tube 2 allows the analyte 21 to react fully within it. The light-emitting module 13 emits light, which shines onto the reaction tube 2 through the light-transmitting hole 111. The fluorescence reaction of the reaction tube 2 under the illumination of the emitted light is then observed to determine the detection result. This application features simple steps and a convenient process, enabling rapid acquisition of the test results for the analyte 21. Furthermore, the device has a simple and lightweight structure, making it easy to carry and use at home.

[0031] Furthermore, the light-emitting module 13 can be omitted, and the reaction tube 2 can be observed directly through the observation window 14. Correspondingly, the reaction tube 2 can contain chemiluminescence, colorimetric reactions, etc. This improves the flexibility of the nucleic acid detection equipment, enabling it to adapt to various detection methods and better meet the needs of home use or portability.

[0032] In this embodiment, the main body 1 refers to the main components of the device. Specifically, the main body 1 includes a housing 16 and a cover 15. The housing 16 is used for mounting the carrier module 11, and the cover 15 is used to cover the housing 16. When the cover 15 is closed on the housing 16, it forms an installation cavity for mounting the carrier module 11. The carrier module 11 has a plurality of grooves 113 formed therein, which are used to accommodate the reaction tube 2. Specifically, the reaction tube 2 is used to accommodate the test object 21. The reaction tube 2 also includes a test reagent for testing the test object 21. The test reagent and the test object 21 are mixed and a detection reaction is carried out in the reaction tube 2 to achieve the detection of the test object 21. During the testing process, the reaction tube 2 needs to be heated. A heating module 12 is connected to the support module 11. The heating module 12 is used to adjust the temperature of the support module 11, thereby adjusting the temperature of the reaction tube 2. The heating module 12 is connected to a second side of the support module 11, which is different from the first side; specifically, the second side is in the opposite direction to the first side. The heating module 12 includes a heating element, a temperature sensor, and an overheat protection module. The temperature sensor is located between the heating element and the support module 11. The heating module 12 is used to adjust the temperature of the support module 11, and the temperature sensor is used to detect the temperature of the support module 11. The temperature sensor is connected to the overheat protection module, which is connected to the heating element. When the temperature detected by the temperature sensor is higher than a specified temperature, the overheat protection module stops the heating element from heating. The specified temperature can be preset by the operator based on the properties of the object to be tested 21. Specifically, mounting holes 115 can be provided on the support module 11 and the heating module 12, located at both ends, to cooperate with fasteners to fix the heating module 12 to the support module 11. The temperature sensor includes at least one or more of thermistors, platinum resistance thermometers, and thermocouples. The heating element includes at least one or more of ceramic heating elements, heating films, heating wires, power resistors, and semiconductor heating elements. The device is equipped with a control module 17, which is connected to a heating module 12 and used to control 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, used to control the light-emitting module 13 to emit light to illuminate the reaction tube 2. Specifically, the control module 17 may include a step-down module for converting 24V to a 5V microcontroller operating voltage; a low-dropout voltage regulator module for converting 5V to 3.3V; a heating drive circuit using PWM control for heating; and a temperature acquisition circuit, a crystal oscillator circuit, and a restart circuit.

[0033] The main body 1 is connected to a light-emitting module 13, which is located at the bottom of the support module 11. The support module 11 has a light-transmitting hole 111 facing the light-emitting module 13, so that the emitted light from the light-emitting module 13 can irradiate the reaction tube 2 through the light-transmitting hole 111. Specifically, the number of light-transmitting holes 111 is the same as the number of grooves 113. The light-transmitting holes 111 are located at the bottom of the grooves 113. The light-emitting module 13 is fastened to the bottom of the support module 11, so that the emitted light from the light-emitting module 13 can irradiate the reaction tube 2 through the light-transmitting hole 111. Specifically, the emitted light is perpendicular to the reaction tube 2 and perpendicular to the first observation hole 112. In this way, the emitted light will not have direct incident in the direction of the first observation hole 112, so the impact on the observation of the emitted light is minimized. The main body 1 is also provided with an observation window 14, and the first side of the support 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 cross-section of the first observation hole 112 is exactly tangent to the support cavity of the conical reaction tube 2, so that the first observation hole 112 can observe the entire reaction liquid. When the support module 11 is installed in the mounting cavity, the observation window 14 is used to observe the reaction tube 2 through the first observation hole 112. Specifically, a mounting plate 114 is connected above the support module 11. The mounting plate 114 is used to cooperate with the main body 1 to fix the support module 11 in the mounting cavity. Specifically, a mounting post is formed inside the housing 16. The mounting post is used to cooperate with the mounting plate 114 to fix the support module 11, so that the observation hole on the support module 11 matches the position of the observation window 14 on the housing 16. For convenient observation, a filter can be installed at the opening of the observation window 14. Furthermore, the observation window 14 may include an observation window 14 opening, a filter, and a light-blocking plate. The filter can be an inexpensive orange acrylic plate to reduce instrument costs. The purpose of the filter is to filter out the excitation light signal in the observation hole and allow the fluorescence signal to pass through. The purpose of the light-blocking plate is to prevent light signals from other places besides the observation hole from affecting the observation results. There are two ways to obtain the detection results: one is for the inspector to directly observe whether there is a fluorescence signal in the reaction tube 2 through the observation window 14 opening to obtain the detection results qualitatively; the other is to use software developed on a mobile device to capture and save images using a mobile camera, and then obtain the detection results by processing the images. The main body 1 also includes a power module 18, which can be a built-in power supply and / or an external power supply. When the power module 18 includes an external power supply, a power socket can be provided on the housing 16. Furthermore, a rocker switch that works with the power module 18 can be provided to control the power supply to be turned on or off. In addition, a button switch can be provided on the housing 16 to indicate the specified function. The button switch is connected to the control module 17 to realize the specified function, such as start button, end button, preheat button, heating button, etc., to facilitate user use.

[0034] Specifically, regarding the button switch, a control method for a portable nucleic acid testing device based on the button switch is provided: Upon initial use, the control module 17 stores control instructions corresponding to each control button. Clicking the button switch triggers the control instructions associated with that button. For example, the start button can store first operating parameters, which control the nucleic acid testing device to perform testing on the reaction tube 2 according to these parameters. The first operating parameters are pre-stored by the operator. Further, after the mobile device performs a complete nucleic acid test on the device, the control module 17 stores the test parameters as second operating parameters. Subsequently, when a nucleic acid testing operation is triggered by the button switch, the second operating parameters are read from the memory to instruct the portable nucleic acid testing device to perform the test. Specifically, the first and second operating parameters may include time parameters, temperature parameters, and settling parameters. This allows the device to perform testing in environments with or without mobile networks, adapting to most working conditions and improving portability.

[0035] Figure 5 A schematic diagram of the structure of a portable nucleic acid testing device according to an embodiment of this disclosure is shown. Figure 5 ; Figure 6 A schematic diagram of the structure of a portable nucleic acid testing device according to an embodiment of this disclosure is shown. Figure 6 Please refer to Figure 5 and Figure 6 ;

[0036] In one embodiment, the main body 1 includes a cover 15 and a housing 16, which are rotatably connected. The housing 16 is used for the support module 11 to abut against. The cover 15 includes a pressure plate 151, which is elastically connected to the cover 15 via an elastic member 154. When the cover 15 is closed on the housing 16, the pressure plate 151 is used to press the reaction tube 2 into the support module 11.

[0037] In this embodiment, the main body 1 includes a cover 15 and a housing 16, which can be connected by a hinge. The cover 15 includes a pressure plate 151, which is C-shaped. The back of the pressure plate 151 abuts against the cover 15, and the two ends of the C-shape are attached to the support module 11. This allows the heat from the heating module 12 to be conducted upwards through the two ends of the C-shape, thus preventing condensation from forming on the cover during the reaction. The pressure plate 151 is elastically connected to the cover 15 by an elastic element 154, which can be a spring and connected to the cover plate via a guide shaft. When the cover 15 is closed on the housing 16, the two ends of the C-shape of the pressure plate 151 abut against the support module 11 to press the reaction tube 2 tightly. A magnetic switch 152 is provided on the cover 15. 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 elements or one magnetic element combined with a metal element. Specifically, the cover 15 may be provided with a cover mounting plate 153, and the cover mounting plate 153 has a pressure plate groove 155 for connecting the pressure plate 151. Specifically, the housing 16 may also include a mounting plate mounting post 161 for fixing with the mounting plate 114 of the support module 11; and a button mounting post 162 for mounting and fixing the button.

[0038] Figure 7 A schematic diagram of the structure of a portable nucleic acid testing device according to an embodiment of this disclosure is shown. Figure 7 Please refer to Figure 7 ;

[0039] In one embodiment, the device further includes a darkroom housing, which can be used to mount a mobile device or a camera; the darkroom housing is provided with a second observation hole 31, which is used to observe the reaction tube 2 with the mobile device or camera. The darkroom housing 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.

[0040] In this embodiment, a relatively dark environment is required for taking photos to avoid the filter reflecting light and affecting the photo quality, which would affect the detection results. To complete real-time quantitative detection, a mobile device or camera needs to take photos and process them in real time. Therefore, the instrument's packaging box is designed to be a darkroom suitable for taking photos with a mobile device or camera. The darkroom shell has a darkroom that can accommodate a camera or mobile device for taking photos. The darkroom shell is connected to a base plate 4, which has a mounting groove for positioning and installing a portable nucleic acid detection device, and also has mounting steps that cooperate with the darkroom shell. The darkroom shell has a surface containing a second observation hole 31, which can be connected to a fixing mechanism 32 for fixing the mobile device. The fixing mechanism 32 includes a first mechanism for mounting the camera, specifically, a camera mounting hole 321. Alternatively, a second mechanism can be used to mount the mobile terminal device. Specifically, the second mechanism includes a slide rail 322, a fixing stud 323, a slider 324, and a rubber pad 325. The slider is located inside the slide rail and can move along the slide rail. One end of the slider is connected to a fixing stud, which is used to fasten the slider to the slide rail, so that the slider clamps the mobile terminal device. A rubber pad is provided on the side of the slider facing the mobile terminal device to prevent scratches on the mobile terminal device. The mobile terminal device communicates with the nucleic acid detection equipment. Specifically, it can be connected to a control module 17 to control the nucleic acid detection equipment, including: adjusting the heating time and heating temperature; and acquiring real-time temperature information, reaction time information, and detection results. Specifically, the control module is connected to the mobile terminal device to receive control commands from the mobile terminal device, so as to control the heating module to adjust the temperature of the carrier module, or to control the light-emitting module to emit light.

[0041] A specific embodiment is provided: First, the analyte 21 (specifically the test sample) and the matching reagents are added to the test tube. The maximum detection volume is eight channels at a time. The test tube with the sample is placed in the carrier module 11, and the cover 15 is closed. The cover 15 is connected to the shell 16 at one end by a hinge, and the other end is opened and closed by a magnetic switch 152. After the cover 15 is closed, the pressure plate 151 in the structure of the cover 15 receives the compression force of the spring, and uses this force to press the test tube tightly, avoiding leakage caused by the forced opening of the test tube opening due to the heating and expansion of the gas in the test tube during the reaction. The pressure plate 151 is also in close contact with the sample carrier module 11. The combined heat from the sample carrier module 11 can be conducted to the pressure plate 151, resulting in better temperature control. The control module 17 consists of two parts: a heating module 12 and a light-emitting module 13. The heating module 12 is controlled by a heating button switch and executes heating according to the set temperature and time sequence of the reaction. The light-emitting module 13 is controlled by an excitation light button switch, facilitating observation of the reaction at any time. After the reaction is complete, the light-emitting module 13 can be turned on, and the results can be observed with the naked eye, automatically recognized by taking a picture with a mobile device, or identified using an integrated camera (such as an OpenMV camera). The mobile device is wirelessly connected to this device and can also control the heating and excitation light switch. Furthermore, the heating parameters such as heating time and heating temperature can be modified to suit isothermal amplification reactions at different temperatures.

[0042] Specifically, two application scenarios are provided;

[0043] Application Scenario 1: Alcohol Tolerance Testing

[0044] Human alcohol tolerance is classified into three levels: homozygous wild-type - alcohol-tolerant, heterozygous mutant - slightly alcohol-tolerant, and homozygous mutant - alcohol-intolerant. When testing alcohol tolerance, two different reaction systems need to be prepared for a single sample, with primers designed separately for wild-type and mutant types. If only the wild-type primer reaction system produces amplification, it indicates a homozygous wild-type; if only the mutant primer reaction system produces amplification, it indicates a homozygous mutant; and if both reaction systems produce amplification, it indicates a heterozygous mutant.

[0045] The alcohol tolerance test includes the following steps: 1. Enter the information of the person to be tested. 2. Sampling: Use a sampling swab to wipe the oral epithelial cells to complete the sampling. 3. Preparation and preheating of the crude nucleic acid extract: Immerse the collected test sample swab in the nucleic acid release (lysis) reagent and let it stand for 3-5 minutes to obtain the crude nucleic acid extract. 4. Simultaneously plug in the detector power supply and turn on the power switch to preheat the instrument. 5. Reaction preparation and loading: Drop the crude nucleic acid extract into reaction tube 2 containing the lyophilized nucleic acid amplification reagent, which includes primers, enzymes, and other reactants. Shake to completely dissolve and mix the lyophilized reagent. Load the reagent-loaded reaction tube 2 into the sample carrying module 11. 6. Reaction proceeds: The preset temperature is 63℃ and the preset time is 30 minutes; press the detector heating button again to complete the isothermal nucleic acid amplification according to the preset temperature and preset time. 7. Result detection: Turn on the excitation light switch and observe the results directly. If only the wild-type primer reaction system produces a fluorescence signal, it indicates that it is a homozygous wild-type; if only the mutant primer reaction system produces a fluorescence signal, it indicates that it is a homozygous mutant; if both reaction systems produce fluorescence signals, it indicates that it is a heterozygous mutant. The results can also be acquired and processed using a mobile camera or an integrated camera; real-time quantitative amplification detection can also be achieved.

[0046] Application Scenario 2: SARS-CoV-2 Detection: SARS-CoV-2 is an enveloped positive-sense RNA virus belonging to the genus β-coronavirus. Its efficient and rapid detection is crucial for early detection and prevention of virus transmission. This example designs amplification primers targeting the conserved sequences of SARS-CoV-2 ORF1ab and N gene for rapid screening of SARS-CoV-2 and its mutant strains.

[0047] SARS-CoV-2 testing includes the following steps: 1. Entering the information of the person to be tested. 2. Sampling: Using a sampling swab, a nasal / pharyngeal swab is collected to complete the sampling. 3. Preparation of crude extract for reaction. Immerse the collected test sample swabs in nucleic acid release (lysis) reagent and let stand for 3-5 minutes to obtain crude nucleic acid extract. 4. Preheat: While preparing the crude extract, insert the detector power supply and turn on the power switch to preheat the instrument. 5. Reaction preparation and loading: Drop the crude nucleic acid extract into reaction tube 2 containing lyophilized nucleic acid amplification reagents (including primers, enzymes, and other reactants). Shake to completely dissolve and mix the lyophilized reagents. Load reaction tube 2 with the reagents into sample carrier module 11. 6. Reaction proceeds: The preset temperature is 63℃ and the preset time is 30 minutes. Press the detector heating button again to complete isothermal nucleic acid amplification according to the preset temperature and time. 7. Result detection: Turn on the excitation light switch and directly observe the result. If the reaction system produces a fluorescent signal, it is SARS-CoV-2 positive; otherwise, it is negative. Result acquisition can also be achieved using a mobile camera or integrated camera; real-time quantitative amplification detection can also be realized.

[0048] According to a second aspect of this disclosure, a non-diagnostic nucleic acid detection method is provided. The method includes: placing a reaction tube 2 containing a analyte 21 in a carrier module 11; installing the carrier module 11 in an installation cavity; controlling a heating module 12 to heat the carrier module 11 to a specified temperature according to a detection command from a mobile device, so that the reaction tube 2 is at the specified temperature; controlling a light-emitting module 13 to emit light according to a detection command from the mobile device, so that the emitted light irradiates the reaction tube 2 through a light-transmitting hole 111; observing the reaction tube 2 through an observation window 14 on the main body 1 and a first observation hole 112 on the carrier module 11, and determining the detection result based on the fluorescence reaction of the reaction tube 2 under the irradiation of the emitted light. Alternatively, a light-emitting module can be omitted, and chemiluminescence, colorimetric reactions, etc., can also be used to achieve nucleic acid detection. Therefore, this disclosure is applicable to a variety of situations, greatly improving the scope of application of nucleic acid detection equipment.

[0049] The mobile device communicates with the nucleic acid testing equipment; specifically, it may be connected to a control module 17.

[0050] Users can send control commands to the nucleic acid testing equipment via mobile devices or receive feedback information from the equipment. Specifically, control commands may include adjusting the heating time and heating temperature. Feedback information may include real-time temperature information, reaction time information, and test results, which users can observe at any time to achieve a contactless testing mode and reduce the risk of infection that may occur during the testing process.

[0051] A specific embodiment is provided: This invention provides a nucleic acid amplification detection and analysis method, including the following steps:

[0052] S1. Enter the information of the person to be tested. Specifically, the information can be entered manually through the mobile device app, or by scanning the health code through the mobile device app.

[0053] S2. Nucleic acid sampling, which involves using nucleic acid sampling swabs for sampling.

[0054] S3. Preparation of crude extract: The swab sample to be tested is immersed in nucleic acid release (lysis) reagent to obtain crude nucleic acid extract.

[0055] S4. Simultaneously plug in the detector power supply and turn on the power switch to preheat the instrument.

[0056] S5. Reaction configuration and loading; Specifically, drop the crude nucleic acid extract into the reaction tube 2 containing the lyophilized nucleic acid amplification reagent, shake to completely dissolve and mix the lyophilized reagent, and load the reaction tube 2 with the reagent into the sample carrying module 11.

[0057] S6. The detection reaction proceeds; specifically, press the heating function button on the detector to complete rapid isothermal nucleic acid amplification at the preset temperature and time.

[0058] S7. Obtaining Result Detection: Specifically, the portable nucleic acid testing device can select three result detection methods, namely any one of A, B or C below.

[0059] A: The testing personnel directly observe whether there is a fluorescent signal in reaction tube 2 through the observation window, thereby obtaining the test results qualitatively.

[0060] B: Software developed for mobile devices uses the device's camera to capture and save images, and then processes the images to obtain detection results. This method can achieve endpoint detection, or it can complete real-time sampling at time intervals according to a set program and then draw a real-time amplification curve on the mobile device screen to complete real-time detection.

[0061] C: Using an integrated camera for image acquisition and processing, such as an OpenMV camera, this method can achieve endpoint detection. Alternatively, it can perform real-time sampling at set time intervals according to a pre-defined program, and then transmit the data to a mobile device via a wireless module to plot real-time amplification curves, thus completing real-time detection.

[0062] S8. Result saving and sharing: For the two detection methods, there are two corresponding result entry methods, namely either D or E below.

[0063] D: For the method of obtaining qualitative test results by directly observing reaction tube 2 through the observation window, the test results can be manually filled in to correspond one by one with the information of the test participants; and the test information can be saved.

[0064] E: By obtaining the detection results through image processing, a specific reaction tube 2 can be matched one-to-one with the information of the examinee, and the detection information can be saved.

[0065] 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 on the map.

[0066] It should be understood that the various forms of processes shown above can be used to rearrange, add, or delete steps. For example, the steps described in this disclosure can be executed in parallel, sequentially, or in different orders, as long as the desired result of the technical solution disclosed in this disclosure can be achieved, and this is not limited herein.

[0067] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this disclosure, "a plurality of" means two or more, unless otherwise explicitly specified.

[0068] The above are merely specific embodiments of this disclosure, but the scope of protection of this disclosure is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this disclosure should be included within the scope of protection of this disclosure. Therefore, the scope of protection of this disclosure should be determined by the scope of the claims.

Claims

1. A portable nucleic acid testing device, characterized in that, The device includes a main body (1); The main body (1) is provided with an installation cavity for mounting the carrier module (11), the carrier module (11) is used to accommodate the reaction tube (2), and the reaction tube (2) is used to accommodate the analyte (21); The support module (11) is connected to a heating module (12), which is used to adjust the temperature of the support module (11) in order to adjust the temperature of the reaction tube (2); The main body (1) is connected to a light-emitting module (13), the light-emitting module (13) is disposed at the bottom of the support module (11), and the support module (11) is provided with a light-transmitting hole (111) facing the light-emitting module (13) so that the emitted light of the light-emitting module (13) can irradiate the reaction tube (2) through the light-transmitting hole (111); The main body (1) is also provided with an observation window (14), and the first side of the support module (11) is provided with a first observation hole (112), which is used to observe the reaction tube (2); when the support module (11) is installed in the mounting cavity, the observation window (14) is used to observe the reaction tube (2) through the first observation hole (112). The heating module (12) is connected to the second side of the support module (11), and the second side is in the opposite direction to the first side.

2. The portable nucleic acid testing device according to claim 1, characterized in that, The carrier module (11) is provided with a plurality of grooves (113), which are used for embedding the reaction tube (2); The number of light-transmitting holes (111) is the same as the number of grooves (113). The light-transmitting holes (111) are located at the bottom of the grooves (113). The light-emitting module (13) is fastened to the bottom of the support module (11) so that the light emitted by the light-emitting module (13) shines on the reaction tube (2) through the light-transmitting holes (111). The carrier module (11) also includes a mounting plate (114), which is used to cooperate with the main body (1) to fix the carrier module (11) in the mounting cavity.

3. The portable nucleic acid testing device according to claim 1, characterized in that, The heating module (12) includes a heating element, a temperature sensor and an overheat protection module. The temperature sensor is disposed between the heating element and the support module (11). The heating module (12) is used to adjust the temperature of the support module (11). The temperature sensor is used to detect the temperature of the support module (11). The temperature sensor is connected to an overheat protection module, which 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.

4. The portable nucleic acid testing device according to claim 3, characterized in that, The temperature sensor includes at least one or more of thermistors, platinum resistance thermometers, and thermocouples, and the heating element includes at least one or more of ceramic heating elements, heating films, heating wires, power resistors, and semiconductor heating elements.

5. The portable nucleic acid testing device according to claim 1, characterized in that, The main body (1) includes a cover (15) and a shell (16), the cover (15) and the shell (16) are rotatably connected, and the shell (16) is used for the support module (11) to abut against; the cover (15) includes a pressure plate (151), the pressure plate (151) is elastically connected to the cover (15) by an elastic element (154), when the cover (15) is closed on the shell (16), the pressure plate (151) is used to press the reaction tube (2) into the support module (11).

6. The portable nucleic acid testing device according to claim 5, characterized in that, A magnetic switch (152) is provided on the cover (15), which is used to cooperate with the housing (16) to open or close the cover (15).

7. The portable nucleic acid testing device according to claim 1, characterized in that, The device is equipped with a control module (17), which is connected to the heating module (12) and is used to control the heating module (12) to adjust the temperature of the bearing module (11); The control module (17) is also connected to the light-emitting module (13) for controlling the light-emitting module (13) to emit light to illuminate the reaction tube (2). The control module (17) is connected to a mobile terminal device and is used to receive control commands from the mobile terminal device to control the heating module (12) to adjust the temperature of the carrier module (11) through the control commands; or, to control the light-emitting module (13) to emit light through the control commands.

8. The portable nucleic acid testing device according to claim 1, characterized in that, The device also includes a darkroom housing, which can be installed on a mobile device or a camera. The darkroom housing is provided with a second observation hole (31), which is used to observe the reaction tube (2) in conjunction with the mobile terminal device or camera.

9. The portable nucleic acid testing device according to claim 8, characterized in that, The darkroom housing is provided with a fixing mechanism (32), which is used to fix the mobile terminal device so that the mobile terminal device can observe the reaction tube (2) through the second observation hole (31).

10. A nucleic acid detection method for non-diagnostic purposes, characterized in that, The method is applied to the portable nucleic acid detection device as described in any one of claims 1 to 9, comprising: The reaction tube (2) containing the analyte (21) is placed in the carrier module (11); The carrier module (11) is installed in the mounting cavity; According to the detection command from the mobile terminal device, the heating module (12) is controlled to heat the carrier module (11) to a specified temperature so that the reaction tube (2) is at the specified temperature; According to the detection command from the mobile terminal 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-transmitting hole (111); The reaction tube (2) is observed by means of the observation window (14) on the main body (1) and the first observation hole (112) on the carrier module (11), and the detection result is determined by the fluorescence reaction of the reaction tube (2) under the illumination of the emitted light.

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