An infectious disease detection device, a reaction chip, a sampling test tube and a detection method

Abstract

The application discloses an infectious disease detection device, a reaction chip, a sampling test tube and a detection method. The device comprises a detection box, a heating module is arranged in the detection box, the heating module is connected with a reaction chip, an ultrasonic oscillation module is arranged on one side of the heating module, and an optical detection module is arranged on the side of the ultrasonic oscillation module away from the heating module. A first optical window is formed in the side wall of the detection box, an image acquisition device is arranged outside the first optical window, and the image acquisition device acquires a detection result through the optical window and the optical detection module. A control switch is arranged on the outer side wall of the detection box, a control unit is arranged in the detection box, the control switch is connected with the control unit, and the optical detection module, the heating module and the ultrasonic oscillation module are all connected with the control unit. The device is integrated in function, can realize integrated detection of sample input and result output without the aid of external equipment, is simple to operate and meets the demand of on-site rapid detection.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of infectious disease detection, and relates to an infectious disease detection device, a reaction chip, a sampling test tube and a detection method. BACKGROUND

[0002] Nowadays, the requirement for nucleic acid detection is higher and higher, and detection instruments need to be portable, samples can be collected outdoors and can be detected in time. The traditional nucleic acid detection process is complex, and nucleic acid extraction and amplification often need to be carried out independently, and samples need to be transferred between different devices at each link, which is high in cost and needs professional personnel, and meanwhile, sample pollution is easy to occur in the transfer process, affecting the detection accuracy. These factors limit the realization of on-site instant rapid detection of nucleic acid detection technology. At present, the globally recognized standard method for viral nucleic acid detection is the real-time fluorescent quantitative PCR method, but this method can only be completed in a laboratory, and is long in detection period, complex in equipment and needs professional operation, so it is difficult to use in limited conditions. SUMMARY

[0003] The purpose of the present application is to solve the problems in the prior art that samples need to be transferred between different devices at each link, depend on professional personnel and are easy to cause sample pollution, and the existing instrument is long in detection period and complex in equipment, and cannot meet the demand of on-site rapid detection, and provide an infectious disease detection device, a reaction chip, a sampling test tube and a detection method.

[0004] To achieve the above-mentioned purpose, the following technical solutions are adopted in the present application:

[0005] An infectious disease detection device, comprising a detection box, a heating module is arranged in the detection box, the heating module is connected with a reaction chip, an ultrasonic oscillation module is arranged on one side of the heating module, and an optical detection module is arranged on the side of the ultrasonic oscillation module away from the heating module;

[0006] A first optical window is formed in the side wall of the detection box, the first optical window is located on the side of the optical detection module away from the ultrasonic oscillation module, an image acquisition device is arranged on the outside of the first optical window, and the image acquisition device acquires a detection result through the first optical window and the optical detection module;

[0007] A control switch is arranged on the outer side wall of the detection box, a control unit is arranged in the detection box, the control switch is connected with the control unit, and the optical detection module, the heating module and the ultrasonic oscillation module are all connected with the control unit.

[0008] Further improvement of the present application is as follows:

[0009] An isothermal amplification chamber and a detection chamber are arranged in the detection chip.

[0010] The ultrasonic oscillation module is horizontally arranged corresponding to the isothermal amplification chamber.

[0011] The optical detection module is horizontally arranged corresponding to the detection chamber.

[0012] The heating module comprises a heating mold, the reaction chip is arranged inside the heating mold, and the heating sheet is attached to the outer sidewall of the heating mold.

[0013] The ultrasonic oscillation module comprises a support connected with the inner sidewall of the detection box, and the ultrasonic oscillator is fixed on the support.

[0014] The optical detection module comprises an optical unit, and the lower portion of the optical unit is provided with an LED lamp.

[0015] The optical unit comprises a detection shell, the detection shell is arranged above the LED lamp, the lower end surface of the detection shell is provided with a first filter mounting groove, the first filter mounting groove is provided with a blue light filter, the end surface of the detection shell close to the reaction chip is provided with a second optical window, the end surface of the detection shell close to the first optical window is provided with a second filter mounting groove, and the second filter mounting groove is provided with a green light filter.

[0016] The inner portion of the detection shell is obliquely provided with a dichroic mirror, the oblique angle of the dichroic mirror is °, the light of the LED lamp is transmitted to the reaction chip through the dichroic mirror, and then returned to the dichroic mirror through the reaction chip.

[0017] The inner sidewall of the detection shell is provided with a clamping groove, the oblique angle of the clamping groove is °, and the dichroic mirror is arranged in the clamping groove.

[0018] An infectious disease reaction chip comprises a chip shell, a sample channel is formed in the chip shell, a sealing plug is arranged at the port of the sample channel, the inner portion of the sample channel is communicated with an isothermal amplification chamber, a communication groove is formed in the isothermal amplification chamber, and the communication groove is communicated with a detection chamber.

[0019] The communication groove is provided with a sealing film, the inner sidewall of the chip shell is provided with a puncture piece corresponding to the sealing film, and when the puncture piece is pressed into the detection shell, the puncture piece can puncture the sealing film.

[0020] The isothermal amplification chamber and the detection chamber are both placed with freeze-dried reagents required for reaction.

[0021] The further improvement of the reaction chip disclosed in the application is that:

[0022] The communication groove and the detection chamber are sequentially communicated with a first flow channel, a gravity gradient flow channel and a second flow channel.

[0023] An infectious disease detection method, comprising the following steps:

[0024] Collecting a sample with a sampling test tube, transferring the collected sample to a reaction chip, and allowing the collected sample to enter an isothermal amplification cavity;

[0025] Placing the reaction chip in a heating module of a detection device, turning on a switch, heating the reaction chip, starting an ultrasonic oscillation module at the same time, taking out the reaction chip after heating is completed, pressing a piercing piece, and piercing a sealing film to allow the collected sample to enter a detection chamber;

[0026] Placing the reaction chip in the heating module again, and under the action of an optical detection module, an image acquisition device collects an image through a first optical window to obtain a detection result after reaction is completed.

[0027] An infectious disease sampling test tube, comprising a shell, wherein the shell is a soft shell, and a nucleic acid releasing agent is arranged in the shell;

[0028] One end of the shell is connected with a sampling tube, the sampling tube extends into the interior of the shell, a hollow flow channel is arranged in the interior of the sampling tube, one end of the hollow flow channel extending into the interior of the shell is provided with a film, and the other end of the hollow flow channel is connected with a cotton swab.

[0029] Compared with the prior art, the present application has the following beneficial effects:

[0030] The present application discloses an infectious disease detection device, a heating module is arranged in the interior of a detection shell for heating a reaction chip, the temperature required during reaction of the reaction chip is provided, an ultrasonic oscillation module is arranged on one side of the heating module, the ultrasonic oscillation module provides ultrasonic waves, the liquid in the chamber of the reaction chip can be better started and reacted, at the same time, an image acquisition device is arranged on the outside of the detection shell, the image acquisition device can collect an image under the action of an optical detection module, and the detection result can be judged by naked eyes, the device disclosed by the present application integrates functions, the sample-in and result-out integrated detection can be realized without the aid of external equipment, the operation is simple, the dependence on professional personnel is low, and each link during detection does not need to be transferred between different devices, the detection time is saved, the detection demand is accelerated, and the demand for on-site rapid detection is met.

[0031] Further, the detection device disclosed by the present application is arranged horizontally corresponding to the ultrasonic oscillation module and the isothermal amplification chamber, the precise vibration of the ultrasonic oscillation module on the isothermal amplification chamber is improved, at the same time, the detection module and the detection chamber are arranged horizontally corresponding, and the detection result can be more accurately acquired.

[0032] Further, the reaction chip in the detection device is arranged in the interior of the heating mold, which can ensure the uniform heating of the reaction chip and the stability of the reaction chip during ultrasonic oscillation.

[0033] Further, the detection device optimizes the light path during photoelectric detection, and the light path is transmitted through the cooperation of two filter films and a dichroic mirror, so that the image acquisition equipment can acquire the detection result of the detection chamber, and the detection result can be judged through the acquired image, without the need of connecting external equipment, and the acquisition of the detection result is more intuitive and convenient.

[0034] The present application discloses an infectious disease reaction chip, which comprises an isothermal amplification chamber and a detection chamber arranged in the interior of the chip, and the isothermal amplification chamber and the detection chamber are isolated by a sealing film, which can ensure the relative independence of the two chambers in the initial stage, and can realize the rapid transfer of the reaction liquid after the isothermal amplification reaction is completed by piercing the sealing film with a piercing piece, without opening the chip throughout, so that the operation is convenient, the sealing property of the interior after adding the sample is ensured, aerosol pollution is prevented, the accuracy of sample detection is improved, external equipment is not needed, the cost of the chip is low, detection is convenient, the risk of cross contamination is low, the chip can detect different pathogens, only the freeze-dried reagent needs to be replaced, the universality is stronger, and the chip is suitable for various on-site detection requirements.

[0035] The present application discloses an infectious disease sampling test tube, which pre-arranges a reaction reagent in the interior of the sampling test tube, generates pressure in the interior by pressing the pressing part after sampling is completed, breaks the film, and makes the reaction liquid transfer to the cotton swab through the hollow flow channel and mix with the collected sample, so that the liquid transfer operation can be performed without a pipette, the sampling time is reduced, the operation is simple, cross contamination in the pipetting process is avoided, and the accuracy of the detection result is improved. BRIEF DESCRIPTION OF DRAWINGS

[0036] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the drawings needed to be used in the embodiments. It should be understood that the following drawings only show some embodiments of the present application, and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can also be obtained without creative labor.

[0037] Figure 1 The structural schematic diagram of the detection device provided by the present application is shown in the figure.

[0038] Figure 2 The internal plan view of the detection device provided by the present application is shown in the figure.

[0039] Figure 3The side view of the detection device provided by the application;

[0040] Figure 4 The schematic diagram of the assembly structure of the detection device provided by the application;

[0041] Figure 5 The schematic diagram of the partial module structure of the detection device provided by the application;

[0042] Figure 6 The sectional view of the detection device provided by the application;

[0043] Figure 7 The perspective view of the optical detection module provided by the application;

[0044] Figure 8 The overall structure diagram of the reaction chip provided by the application;

[0045] Figure 9 The overall perspective view of the reaction chip provided by the application;

[0046] Figure 10 The front view of the middle layer of the reaction chip provided by the application;

[0047] Figure 11 The back view of the middle layer of the reaction chip provided by the application;

[0048] Figure 12 The structure diagram of the upper layer of the reaction chip provided by the application;

[0049] Figure 13 The overall perspective view of the sampling test tube provided by the application;

[0050] Wherein: 1-pressing part; 2-housing; 3-film; 4-sampling tube; 5-hollow flow channel; 6-flow channel outlet; 7-cotton swab;

[0051] 10-sealing plug; 11-chip lower layer; 12-chip middle layer; 13-chip upper layer; 14-; 15-middle layer inlet channel; 16-upper layer inlet channel; 17-sample channel; 18-middle layer isothermal amplification groove; 19-upper layer isothermal amplification groove; 20-middle layer recess; 21-upper layer recess; 22-piercing piece; 23-communication groove; 24-first flow channel; 25-gravity gradient flow channel; 26-second flow channel; 27-middle layer detection groove, 28-upper layer detection groove; 29-isothermal amplification chamber; 30-detection chamber; 31-USB interface; 32-control switch; 33-image acquisition device; 34-connection block; 35-reaction chip; 36-upper cover; 37-lower shell; 38-heating die; 39-heating sheet; 40-ultrasonic oscillator; 41-fastener; 42-support; 43-bolt; 45-optical unit; 46-support block; 47-first optical window; 48-clamping groove; 49-LED lamp; 50camera-; 51-blue light filter; 52-dichroic mirror; 53-second optical window; 54-green light filter; 56-lower shell; 57-upper and lower shells; 58-first connecting screw; 59-second connecting screw. DETAILED DESCRIPTION

[0052] In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only some but not all of the embodiments of the present application. The components of the embodiments of the present application described and shown in the drawings herein can be arranged and designed in various different configurations.

[0053] Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the claimed present application, but only represents selected embodiments of the present application. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present application without creative labor are within the scope of protection of the present application.

[0054] It should be noted that: similar reference numerals and letters represent similar items in the following drawings, therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings.

[0055] In the description of the embodiments of the present application, it should be noted that if the terms "upper", "lower", "horizontal", "inner" and the like indicating the orientation or position relationship are based on the orientation or position relationship shown in the drawings, or the orientation or position relationship of the product of the present application when it is usually placed, and are only for the convenience of describing the present application and simplifying the description, and therefore cannot be understood as indicating or implying that the device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first", "second" and the like are only used to distinguish the description and cannot be understood as indicating or implying relative importance.

[0056] In addition, if the term "horizontal" appears, it does not mean that the component must be absolutely horizontal, but can be slightly inclined. For example, "horizontal" only means that its direction is relatively more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but can be slightly inclined.

[0057] In the description of the embodiments of the present application, it should be noted that unless otherwise explicitly specified and limited, if the terms "arrangement", "installation", "connection", "connection" appear, they should be understood in a broad sense, for example, they can be fixedly connected, or can be detachably connected, or integrally connected, can be mechanically connected, or can be electrically connected, can be directly connected, or indirectly connected through an intermediate medium, or can be connected inside two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0058] The present application will be described in further detail below in conjunction with the accompanying drawings:

[0059] Referring to Figures 1 to 13 The embodiments of the present application disclose an infectious disease detection device, a reaction chip, a sampling test tube and a detection method. The device disclosed by the embodiments of the present application can be applied in the field of nucleic acid detection. The series of devices disclosed by the present application can realize sample collection, rapid nucleic acid extraction, amplification, mobile phone detection and multi-function, can complete sample input-result output within 25 minutes, simplify the traditional nucleic acid detection process, and develop a series of devices integrating biological principles, which have low requirements for operating personnel, accurate results and are convenient and reliable.

[0060] The embodiments of the present application disclose an infectious disease detection device, referring to Figures 1 to 7, including a detection box, a heating module is arranged in the detection box, the heating module is connected with a reaction chip 35, one side of the heating module is provided with an ultrasonic oscillation module, and one side of the ultrasonic oscillation module away from the heating module is provided with an optical detection module; a first optical window 47 is formed in the side wall of the detection box, the first optical window 47 is located on the side of the optical detection module away from the ultrasonic oscillation module, and an image acquisition device is arranged outside the first optical window 47; the image acquisition device obtains a detection result through the first optical window 47 and the optical detection module. A control switch 32 is arranged on the outer side wall of the detection box, a control unit is arranged in the detection box, the control switch 32 is connected with the control unit, and the optical detection module, the heating module and the ultrasonic oscillation module are all connected with the control unit.

[0061] Further, in the embodiment of the present application, a chip hole is formed in the end face of the upper cover 36, the chip hole corresponds to the internal heating module, the reaction chip 35 is inserted into the inside of the heating module through the chip hole, and temperature control is provided through the detection device to ensure that biological reactions in the reaction chip 35 occur smoothly.

[0062] Further, in the embodiment of the present application, the detection box comprises an upper cover 36 and a lower shell 37, the materials of the upper cover 36 and the lower shell 37 are both opaque plastics, a USB interface 31 is arranged on the lower shell 37, the control unit of the present application is a control panel, the control panel is placed at any position in the inside of the lower shell 37, the control panel is connected with the USB interface 31 and the control switch 32, power supply is provided through the USB interface 31, and after power supply, the operation of the device is controlled through the control switch 32; when the control switch 32 is turned on, the heating module can be heated to a specified temperature in a short time and kept, the mobile phone is placed in the specified position of the detection device through the connecting block 34, and the optical channel has been arranged; the mobile phone is in place and can be subjected to fluorescence detection.

[0063] Further, in the embodiment of the present application, the heating module comprises a heating mold 38 and a heating sheet 39, the structure of the heating mold corresponds to the structure of the reaction chip 35, the reaction chip 35 can be clamped in the inside of the heating mold 38, the material of the heating mold 38 is aluminum, and the chip 35 is in good contact with the heating mold 38, so that the isothermal amplification cavity 29 and the CRISPR detection cavity 30 of the chip 35 can be heated well; the heating sheet 39 and the heating mold 38 are glued together, so that the temperature of the heating sheet 39 is consistent with the temperature of the heating mold 38; the heating sheet 39 is electrically connected with the control panel, and the heating mold 38 is vertically corresponding to the chip hole.

[0064] Further, the thin film heating sheet 39 is a resistance heating sheet, and resistance heat is generated through power supply.

[0065] Further, the temperature provided by the temperature module in the detection device is 39 degrees Celsius.

[0066] Further, in the embodiment of the present application, the oscillation module comprises an ultrasonic oscillator 40 and a support, the support is connected with the inner side wall of the detection box, the ultrasonic oscillator 40 is fixed on the support, the support comprises a fastener 41 and a support 42, the support 42 and the fastener 41 are fixed at intervals, both ends of the support 42 and both ends of the fastener 41 are connected with the inner side wall of the lower shell 37, the fastener 41 is symmetrically arranged on the outer side of the ultrasonic oscillator 40, and the ultrasonic oscillator 40 is fixed by two bolts 43.

[0067] The ultrasonic oscillator 40 is electrically connected with the control panel, the ultrasonic oscillator 40 is aligned with the chip isothermal amplification chamber 29, when the reaction chip 35 is injected with a sample, the sample is put into the detection device, the control switch 32 is turned on, the ultrasonic oscillator 40 starts to work, and the liquid and solid samples in the isothermal amplification chamber 29 in the reaction chip 35 are mixed, so that the reaction is efficiently started.

[0068] The fastening module 41 and the support mechanism 42 are used to fix the position of the ultrasonic oscillator 40 during work.

[0069] Further, in the embodiment of the present application, the specific structure of the optical detection module is:

[0070] Four support blocks 46 are arranged at intervals on the bottom end face of the lower shell 37, LED lamps 49 are arranged between the four support blocks 46, the LED lamps 49 are fixed by two screws, light is collected to the CRISPR detection chamber 30 of the chip 35 through the reflection of the photoelectric unit, the fluorescence signal in the detection chamber 30 is excited, the upper ends of the four support blocks 46 are provided with a detection shell, a first filter mounting groove is formed in the lower end face of the detection shell, a blue light filter 51 is arranged in the first filter mounting groove, a second optical window 53 is arranged on the end face of the detection shell close to the reaction chip 35, a second filter mounting groove is formed in the end face of the detection shell close to the first optical window 47, a green light filter 54 is arranged in the second filter mounting groove, a clamping groove is formed in the inner side wall of the detection shell, the inclination angle of the clamping groove is 45°, and a dichroic mirror 52 is arranged in the clamping groove.

[0071] The excitation light path is that the light source LED lamp 49 emits light, the light is filtered through the blue light filter 51, the blue light of a specific wavelength is reflected through the dichroic mirror 52, passes through the second optical window 53, and irradiates on the detection chamber 30 of the reaction chip 35,

[0072] Further, the working principle of the dichroic mirror is that low-wavelength light is reflected and high-wavelength light is transmitted.

[0073] Further, the reflection angle of the dichroic mirror 52 is 45°.

[0074] Further, the dichroic mirror 52 is in the shape of a cuboid.

[0075] Further, the LED lamp 49 is a white light lamp, the LED lamp 49 is electrically connected with the control panel, the LED lamp 49 keeps working when the control switch 32 is turned on, and the lower end of the detection shell is kept at a certain distance from the LED lamp 49.

[0076] Further, the detection shell comprises an upper shell 56 and a lower shell 57, the lower shell 56 and the upper shell 57 are connected through a first connecting screw 58 and a second connecting screw 59, the second optical window 53 is arranged on the side wall of the upper shell 57, the green light filter 54 is arranged on the side wall of the lower shell 56, and the blue light filter 51 is arranged on the bottom end face of the lower shell 56.

[0077] Further, the optical unit disclosed in the embodiment of the application is constructed in the form of an ink cartridge, can be placed by transfer, can be used in different detection environments and devices, and has high universality.

[0078] Further, the outer side of the first optical window 47 is provided with a connecting block 34, the outer side wall of the lower shell 37 is provided with a clamping groove 48 corresponding to the connecting block 34, the connecting block 34 is arranged in the clamping groove 48, and the image acquisition device 33 is arranged in the connecting block 34; the image acquisition device 33 in the embodiment of the application is a mobile phone, the mobile phone is inverted in the connecting block 34, the camera 50 of the mobile phone corresponds to the first optical window 47, and the camera 50 shoots the fluorescent image of the detection chamber 30 of the chip 35 through the first optical window 47, the green light filter 54, the dichroic mirror 52 and the second optical window 53.

[0079] The camera 50, the dichroic mirror 52 and the detection chamber 30 are on a straight line in the horizontal direction.

[0080] When there is a detection requirement, the mobile phone 33 can be placed at a specified position to take a photo for identification, if there is a fluorescent bright spot in the photo, it means that the measured sample is positive, otherwise it is negative.

[0081] The first optical window 47 and the green light filter 54 are on a straight line.

[0082] The detection device can be machined by 3D printing or machining.

[0083] The embodiment of the application discloses an infectious disease reaction chip, as shown in Figures 8 to 12, including a chip shell, a sample channel 17 is formed on the chip shell, a port of the sample channel 17 is provided with a sealing plug 10, the sample channel 17 is internally communicated with an isothermal amplification chamber 29, a communicating groove 23 is formed in the isothermal amplification chamber 29, and the communicating groove 23 is communicated with a detection chamber 30; a sealing film is arranged on the communicating groove 23, a puncture piece 22 corresponding to the sealing film is arranged on the inner side wall of the chip shell, and when the puncture piece 22 is pressed into the detection shell, the puncture piece 22 can puncture the sealing film; the isothermal amplification chamber 29 and the detection chamber 30 are both placed with freeze-dried reagents required for reaction.

[0084] Further, the shell of the reaction chip disclosed in the embodiment of the present application comprises a lower chip layer 11, a middle chip layer 12 and an upper chip layer 13, the three layers of the chip are sealed by using glue, the chip is made of transparent material, and the upper chip layer 13 is made of soft material.

[0085] Further, the upper chip layer 13 is formed with an upper isothermal amplification groove 19, an upper inlet channel 16 and an upper detection groove 28, the middle chip layer 12 is formed with a middle isothermal amplification groove 18, a middle inlet channel 15 and a middle detection groove 27 corresponding to the upper chip layer 13; wherein the upper isothermal amplification groove 19 and the middle isothermal amplification groove 18 constitute the isothermal amplification chamber 29, the upper inlet channel 16 and the middle inlet channel 15 constitute a sample inlet channel of the reaction chip 35, can be used for liquid sample loading, the formed cylindrical channel is sealed by interference fit with the soft plug 10, can ensure that there is no aerosol pollution, once the chip 35 is completed, the sealing is not opened again, the upper detection groove 28 and the middle detection groove 27 constitute the detection chamber 30, which is the CRISPR detection chamber mentioned in the embodiment of the present application, the communicating groove 23 is formed in the middle isothermal amplification groove 18, the sealing film is arranged on the communicating groove 23, the puncture piece 22 corresponding to the communicating groove 23 is arranged in the upper isothermal amplification groove 19, the function of the sealing film is to meet the nucleic acid liquid extracted in the isothermal amplification chamber 29 for a period of nucleic acid amplification reaction, after the amplification is completed, the puncture device 22 is pressed manually to puncture the film 23, and then the liquid can be transferred to the CRISPR detection chamber, since the upper chip layer 13 is made of soft material, the upper chip layer 13 is deformed, and the puncture device 22 is displaced and deformed, and the sealing film is punctured.

[0086] The first flow channel 24, the gravity gradient flow channel 25 and the second flow channel 26 are sequentially formed between the communicating groove 23 and the detection chamber 30, for communicating the communicating groove 23 and the detection chamber 30.

[0087] The side surface of the middle chip layer 12 is provided with a middle recess 20, and the side surface of the upper chip layer 13 is provided with an upper recess 21, and the middle recess 20 and the upper recess 21 constitute a structure held by hands of the reaction chip 35.

[0088] The chip lower layer 11 is attached to the end face of the chip middle layer 12 away from the chip upper layer 13, and plays a sealing role on the chip middle layer 12, and the detection chamber 30 and the isothermal amplification chamber in the device disclosed in the embodiment of the application are two chambers relatively independent in time phase, and the reaction effect is better, and one sealing film is used to control the two chambers.

[0089] The isothermal amplification chamber 29 stores the freeze-dried reagent for isothermal amplification, and the nucleic acid liquid from the inlet hydrates the freeze-dried reagent, and the freeze-dried reagent contains the components such as primers, dNTPs and enzymes required for nucleic acid isothermal amplification, and can complete specific detection of the detection fragment, and the nucleic acid liquid is combined with the freeze-dried reagent, and starts to react under the temperature support provided by the temperature control device 38, and the isothermal amplification reaction is RPA amplification, and the RPA amplification can well compatible with the CRISPR molecular diagnostic reaction, and the two reactions are independent, and the effect is good.

[0090] The specific operation process is that after the sample injection of the reaction chip 35 is completed, the reaction chip 35 is sealed and placed in the heating module of the detection device, the temperature is kept for ten minutes, the reaction chip 35 is taken out, the position of the piece 22 of the chip upper layer 13 is manually pressed to break the sealing film, the reaction chip 35 is held by hand and shaken several times to transfer the liquid to the detection chamber 30 to perform the CRISPR detection reaction, the CRISPR freeze-dried reagent is pre-embedded in the detection chamber 30, the CRISPR freeze-dried reagent contains various components required for CRISPR detection, is activated by an aqueous solution, and starts to react under the temperature support provided by the temperature control device 38.

[0091] The embodiment of the application discloses an infectious disease sampling test tube, which is used for sampling and releasing nucleic acid. Figure 13 The shell 2 is a soft shell, and the shell 2 is internally provided with a nucleic acid releasing agent; one end of the shell 2 is connected with a sampling tube 4, the sampling tube 4 extends into the inside of the shell 2, a hollow flow channel 5 is formed in the inside of the sampling tube, one end of the hollow flow channel 5 extending into the inside of the shell 2 is provided with a film 3, and the other end is connected with a cotton swab 7; the hollow flow channel 5 is provided with symmetrical flow channel outlets 6 near the cotton swab 7, and the hollow flow channel 5 and the flow channel outlets 6 can form a liquid transfer flow channel, and the sampling and nucleic acid releasing functions are integrated, and the portable sampling device can be used to realize the functions, and the operation process is simplified.

[0092] The sampling tube 4 and the shell 2 are in a plug-in structure and are not easy to fall off, the shell 2 is provided with a pressing portion 1, the film 3 can be broken by air pressure by manually extruding the pressing portion 1, and then the liquid can be transferred.

[0093] The sampling test tube operation process is that the pressing part 1 is held by hand, the cotton swab head is aligned with the sampling part of the sampler for light scraping, after sampling, the sampling test tube is vertically placed with the cotton swab 7 downward, the soft plug 10 is opened, the reaction chip 35 is vertically placed, the cotton swab head 7 is aligned with the entrance of the disposable detection chip, the entrance is a cylindrical channel formed by the entrance channels 15 and 16, the cotton swab head is slightly inserted into the entrance of the disposable detection chip 35, the device 1 is manually squeezed to make the liquid transferred into the chamber of the reaction chip 35 for subsequent reaction.

[0094] The nucleic acid releasing agent in the shell 2 has the function of lysing cells to release nucleic acid, can coordinate the ion balance inside and outside the cell membrane to protect the nucleic acid, and is compatible with the subsequent isothermal amplification system.

[0095] After sampling, the pressing part 1 is held by hand, the pressing force makes the liquid break through the film 3, the nucleic acid releasing agent reaches the flow channel outlet 6 along the hollow channel 5, wets the cotton swab head 7, and then washes away the sample collected by the cotton swab head 7, so that the released nucleic acid is transferred into the isothermal amplification chamber 29 in the reaction chip 35 to start the subsequent isothermal amplification reaction.

[0096] The embodiment of the application discloses an infectious disease detection method, which comprises the following steps:

[0097] Step 1: sample collection is performed by using a sampling test tube, the sealing plug 10 on the reaction chip 35 is opened, the sampling device cotton swab 7 is downward, the pressing part 1 of the sampling test tube is squeezed to deform the container of the sampling test tube, the pressure breaks through the film 3, the nucleic acid releasing agent washes the cotton swab 7 along the hollow channel 5 and the flow channel outlet 6, and then drops into the chamber of the reaction chip 35, the sealing plug 10 is re-plugged, and the sampling device is placed into a waste bag.

[0098] Step 2: the reaction chip 35 is inserted into a detection device, a switch is opened, and the reaction chip 35 is taken out after 10 minutes.

[0099] Step 3: the isothermal amplification chamber 29 of the reaction chip 35 is manually pressed to make the sealing film be pierced, then the two sides of the reaction chip 3 are held by hand, and the chip is shaken several times with force, at this time, the reaction liquid enters the detection chamber 30, and the reaction chip 35 is re-inserted into the detection device and waits for 10 minutes.

[0100] Step 4: the mobile phone is inserted into the outside of the first optical serial port 47 of the detection device, the camera is opened to take a photo, and the result is judged by the human eye, if the photo has bright spots, it represents that the detection is positive, otherwise, it is negative.

[0101] Step 5: the reaction chip 35 is taken out and placed into a waste bag, sealed, and the detection device is turned off.

[0102] The method disclosed by the embodiment of the present application integrates sampling, rapid nucleic acid extraction, amplification and detection functions, provides a detection scheme, has strong universality, can be used for different pathogens, only needs to replace the pre-stored reagent of the chip, is applied to the detection of different infectious diseases, greatly simplifies the operability, and can be completed by ordinary people, has low personnel requirements, the disclosed detection device integrates functions, realizes miniaturization, the mixing scheme solves the problem that the previous integrated detection device cannot solve, the ultrasonic detection effect is good, and the achievement is controlled, in addition, the light path is optimized, the result can be interpreted by using a mobile phone to take a photo, without borrowing external equipment, and the cost is reduced, the reaction chip and the sampling test tube provided by the embodiment of the present application integrate functions, the solid reagent is pre-packaged, the sampling time is reduced, the user only needs to complete the liquid transfer operation by simple pressing and shaking, the operation is simple, the device is easy to write, and the on-site detection demand can be realized, the present application can realize the whole nucleic acid detection process, can be completed by several manual operations, does not need professional training and special laboratory environment, reduces the dependence on the operating personnel and the place, has strong practical value.

[0103] The above is only the preferred embodiment of the present application, and is not used to limit the present application, for those skilled in the art, the present application can have various changes and variations. Any modification, equivalent replacement, improvement, etc. within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. An infectious disease detection device, characterized by, Including detection box, the detection box is provided with heating module inside, the heating module is connected reaction chip (35), one side of the heating module is provided with ultrasonic oscillation module, one side of the ultrasonic oscillation module away from the heating module is provided with optical detection module; The first optical window (47) is located on the side of the optical detection module away from the ultrasonic oscillation module, and the first optical window (47) is provided with an image acquisition device outside the first optical window (47), and the image acquisition device obtains the detection result through the first optical window (47) and the optical detection module; The control switch (32) is arranged on the outer wall of the detection box, and the control unit is arranged inside the detection box, the control switch (32) is connected with the control unit, and the optical detection module, the heating module and the ultrasonic oscillation module are connected with the control unit; The reaction chip (35) comprises a chip shell, a sample channel (17) is formed in the chip shell, a sealing plug (10) is arranged at the port of the sample channel (17), the sample channel (17) is connected with an isothermal amplification chamber (29) inside, and the isothermal amplification chamber (29) is provided with a communication groove (23); The communication groove (23) is provided with a sealing film, and the inner side wall of the chip shell is provided with a puncture piece (22) corresponding to the sealing film, when the puncture piece (22) is pressed into the detection shell, the puncture piece (22) can pierce the sealing film; The isothermal amplification chamber (29) and the detection chamber (30) are both placed with freeze-dried reagents required for reaction; The communication groove (23) and the detection chamber (30) are provided with a first flow channel (24), a gravity gradient flow channel (25) and a second flow channel (26) connected in sequence therebetween; When sampling, the sample is collected by using a sampling test tube, and the sampling test tube comprises a shell (2), the shell (2) is a soft shell, and a nucleic acid releasing agent is arranged inside the shell (2); One end of the shell (2) is connected with a sampling tube (4), the sampling tube (4) extends into the inside of the shell (2), a hollow flow channel (5) is formed in the inside of the sampling tube (4), one end of the hollow flow channel (5) extending into the inside of the shell (2) is provided with a film (3), and the other end is connected with a cotton swab (7).

2. The infectious disease detection device of claim 1, wherein, The detection chip (35) is provided with an isothermal amplification chamber (29) and a detection chamber (30) inside; The ultrasonic oscillation module is arranged horizontally corresponding to the isothermal amplification chamber (29); The optical detection module is arranged horizontally corresponding to the detection chamber (30).

3. The infectious disease detection device of claim 1, wherein, The heating module comprises a heating mold (38), and the reaction chip (35) is arranged in the inside of the heating mold (38).

4. The infectious disease detection device of claim 1, wherein, The ultrasonic oscillation module comprises a support, the support is connected with the inner side wall of the detection box, and an ultrasonic oscillator (40) is fixed on the support.

5. The infectious disease detection device of claim 1, wherein, The optical detection module comprises an optical unit (45), and an LED lamp (49) is arranged below the optical unit (45). The optical unit (45) comprises a detection housing, the detection housing is arranged above the LED lamp (49), a first filter mounting groove is arranged on the lower end surface of the detection housing, a blue light filter (51) is arranged in the first filter mounting groove, a second optical window (53) is arranged on the end surface of the detection housing close to the reaction chip (35), a second filter mounting groove is arranged on the end surface of the detection housing close to the first optical window (47), and a green light filter (54) is arranged in the second filter mounting groove. The inside of the detection housing is obliquely provided with a dichroic mirror (52), the oblique angle of the dichroic mirror (52) is (45) °, and the light of the LED lamp (49) is transmitted to the reaction chip (35) through the dichroic mirror (52) and then returned to the dichroic mirror (52) through the reaction chip (35).

6. The infectious disease detection device of claim 5, wherein, The inner side wall of the detection housing is provided with a clamping groove, the oblique angle of the clamping groove is (45) °, and the dichroic mirror (52) is arranged in the clamping groove.

7. The method of using an infectious disease detection device of claim 1, wherein, The method comprises the following steps: A sample is collected by a sampling test tube, and the collected sample is transferred to the reaction chip (35), and the collected sample enters the isothermal amplification chamber (29); The reaction chip (35) is placed in the heating module of the detection device, the switch is turned on, the reaction chip (35) is heated, and at the same time, the ultrasonic oscillation module is started, after the heating is completed, the reaction chip (35) is taken out, the puncture piece (22) is pressed to puncture the sealing film, and the collected sample enters the detection chamber (30); The reaction chip (35) is placed in the heating module again, after the reaction is completed, under the action of the optical detection module, the image acquisition equipment collects images through the first optical window (47), and the detection result is obtained.

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