Portable constant-temperature nucleic acid extraction and amplification detection device suitable for vertical test paper box

Abstract

The portable constant-temperature nucleic acid extraction and amplification detection device comprises a shell, a display screen, a mounting rack, a test paper box lower control assembly, a test paper box upper control assembly, a heating assembly, a test paper image acquisition assembly and a control system, a vertical test paper box positioning bin is arranged on the mounting frame; the test paper box lower control assembly is arranged below the vertical test paper box positioning bin; the test paper box upper control assembly is arranged above the vertical test paper box positioning bin; the heating assembly is arranged on one side of the vertical test paper box positioning bin, a heating cavity is formed in one side wall of the vertical test paper box, and the heating assembly is arranged on the side corresponding to the heating cavity; the test paper image acquisition assembly is arranged on one side of the vertical test paper box positioning bin, and the control system comprises a control circuit board. The nucleic acid extraction and amplification detection of the vertical test paper box is realized, the miniaturized portable full-automatic design of the detection device is realized, the possibility that an operator is in contact with a reagent or a virus is avoided, and the use safety is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of nucleic acid detection equipment, in particular to a portable constant-temperature nucleic acid extraction amplification detection device suitable for a vertical test strip box. BACKGROUND

[0002] Nucleic acid amplification detection technology is a technology that amplifies specific nucleic acid sequences through molecular biology methods to achieve high-sensitivity detection. In the prior art, there are mainly real-time fluorescent quantitative PCR detection method and isothermal amplification detection technology. The real-time fluorescent quantitative PCR detection method amplifies target DNA through "denaturation-annealing-extension" cycles, and the sensitivity can reach the single molecule level. Real-time fluorescent quantitative PCR (RT-PCR) combined with fluorescent probes can simultaneously realize amplification and quantitative analysis. Isothermal amplification detection technology includes RPA (recombinase polymerase amplification) and LAMP (loop-mediated isothermal amplification). RPA is completed at a constant temperature of 37-42℃ without the need for a thermal cycler device, and can detect extremely small amounts of nucleic acid in 10-30 minutes, which is suitable for on-site rapid screening. LAMP targets six gene regions through four primers and amplifies at a constant temperature of 60-65℃. The product can be observed by turbidity to determine the result.

[0003] Isothermal amplification detection technology includes various mainstream types, including but not limited to RPA (recombinase polymerase amplification), LAMP (loop-mediated isothermal amplification), RCA (rolling circle amplification), NASBA (nucleic acid sequence-dependent amplification), SDA (strand displacement amplification technology), and HAD (helicase-dependent amplification technology). RPA (recombinase polymerase amplification) is performed at a constant temperature of 37-42℃ without the need for a thermal cycler device, has fast detection speed, and can detect extremely small amounts of nucleic acid in 10-30 minutes, which is suitable for on-site rapid screening. LAMP (loop-mediated isothermal amplification) targets the target gene through 4-6 pairs of primers and realizes amplification at a constant temperature of 60-65℃. NASBA (nucleic acid sequence-dependent amplification) is mainly for RNA templates, and the reaction temperature is usually around 41℃. This technology can quickly amplify RNA and is suitable for rapid detection of RNA viruses.

[0004] The detection equipment used in the real-time fluorescent quantitative PCR detection method needs to use a temperature control device, a temperature sensor, a fluorescence device, and a sensor for detecting fluorescence. In the PCR detection process, 25-40 cycles are required, and the process of "denaturation-annealing-extension" must be performed in each cycle. Different temperatures are required for denaturation, annealing, and extension stages, so the reaction temperature must be accurately controlled, and the temperature control device is required to be high. According to relevant regulations, the fluorescence device and heating device of the real-time fluorescent quantitative PCR detection equipment need to be sent to a professional detection institution for calibration every year. Therefore, devices using fluorescence detection equipment or temperature detection equipment are usually used in hospitals or specialized detection institutions. At present, there is still a great gap in portable nucleic acid amplification detection equipment suitable for home or personal users. Such equipment needs to meet the core requirements of low cost, simple operation, and easy-to-read results, and does not need to rely on expensive temperature rising and falling components and fluorescence calibration systems.

[0005] The constant temperature detection technology in the prior art has developed rapidly, and nucleic acid amplification detection equipment without fluorescence detection usually uses test paper detection method. For example, the patent with publication number CN105273997A discloses a paper-based nucleic acid extraction, amplification, and detection integrated detection system and detection method. This scheme discloses a horizontal test paper nucleic acid amplification detection system and detection method. When performing nucleic acid amplification detection, 10 μL of the total amount of the sample to be detected is dropped on the FTA card to extract nucleic acid. After 15 minutes, the FTA card is cleaned with 40 μL of FTA purification agent and 80 μL of TE buffer, and the absorption pad is removed. After 5 minutes, the amplification combination pad and the FTA card are combined, 25 μL of amplification reagent and primer are dropped on the amplification combination pad to form an amplification zone, the amplification zone of the test paper is covered with adhesive tape to separate the amplification zone and the detection zone of the test paper, and then the test paper is placed in the heating cavity of the detection box for nucleic acid amplification. After amplification is completed, the adhesive tape is removed, the amplification zone and the detection zone of the test paper are combined through single-sided adhesive, the upper cover of the detection cavity is opened, 50 μL of buffer is added to the detection cavity, the test paper combined with the amplification zone and the detection zone is placed in the detection cavity for nucleic acid detection. After the detection reaction is completed, the detection zone and the control zone are observed. If the detection zone and the control zone develop color at the same time, it indicates positive. If the detection zone does not develop color and the control zone develops color, it indicates negative. If neither the detection zone nor the control zone develops color, the result is unreliable, and the detection needs to be repeated.

[0006] The disadvantages of the above scheme are that firstly, when the nucleic acid detection is performed, the reagent needs to be added to the test paper for multiple times, and the test paper is in an exposed state, which has great safety hazards for the detection of infectious bacteria and viruses; and finally, the detection result needs to be observed manually, and the automatic nucleic acid extraction and amplification detection cannot be realized. Secondly, because the test paper is in an exposed state, the detection result is affected by the atmospheric pressure of the environment during the detection. In a high-pressure area, such as an atmospheric pressure greater than 120 kPa, because the high pressure inhibits the capillary action of the test paper, the sample stays on the membrane for too long, the unbound label is easy to deposit on the T line non-specifically, leading to false positives, and the high pressure squeezes the internal pores of the test paper, so that the sample cannot migrate normally, and invalid results of no color development of both lines may also occur. In a low-pressure area, such as a high-altitude area, the atmospheric pressure is less than 80 KPa, because the pressure difference between the internal and external of the test paper increases under low pressure, the capillary driving force increases, the sample quickly passes through the T line, leading to insufficient antigen / antibody binding, which may result in false negatives; because the low pressure reduces the boiling point of the liquid, the water in the sample or the solvent of the reagent is easy to evaporate, the concentration of the colloidal gold label is abnormal, the color development is affected, the detection sensitivity is reduced, and the liquid absorption capacity of the water-absorbing pad is reduced, the sample is easy to overflow or not to migrate completely.

[0007] In the prior art, the test paper strip is horizontally placed in the device for nucleic acid detection. The test paper is horizontally placed to avoid the influence of gravity on the migration of the reagent and the sample. However, when the test paper is horizontally placed, the length of the test paper is relatively long, and accordingly, the volume of the test paper box for carrying the test paper must also be increased. A large space needs to be reserved in the detection device to place the test paper box. The volume of the detection device is limited by the volume of the test paper strip, and accordingly, the detection device becomes larger, and miniaturization and portability cannot be realized. It is more difficult to realize full automation of the nucleic acid extraction and amplification detection process on the basis of miniaturization and portability. For family users or individual users, it is more required that the nucleic acid extraction and amplification detection device has the advantages of miniaturization, portability, automation, and easy operation. Therefore, the existing nucleic acid amplification and detection device needs to be improved in terms of miniaturization, portability, and full automation. SUMMARY

[0008] The purpose of the present application is to solve the problem that the nucleic acid amplification and detection device cannot realize miniaturization and portability, and it is more difficult to realize full automation of the nucleic acid extraction and amplification detection process on the basis of miniaturization and portability due to the design of the test paper box with horizontal test paper in the prior art. A portable constant-temperature nucleic acid extraction and amplification detection device suitable for a vertical test paper box is provided.

[0009] To achieve the above purpose, the present application is implemented by the following technical scheme: A portable constant-temperature nucleic acid extraction amplification detection device suitable for vertical test paper boxes, comprising a shell, a display screen, a mounting rack, a lower test paper box control assembly, an upper test paper box control assembly, a heating assembly, a test paper image acquisition assembly and a control system; The mounting rack, the lower test paper box control assembly, the upper test paper box control assembly, the heating assembly, the test paper image acquisition assembly and the control system are arranged in the shell; A vertical test paper box positioning bin and a sensing device are arranged on the mounting rack; The lower test paper box control assembly is arranged below the vertical test paper box positioning bin, and is used to drive a rotating member on the bottom surface of the vertical test paper box to rotate so as to change the liquid flow channels in the test paper box; The upper test paper box control assembly is arranged above the vertical test paper box positioning bin, and is used to drive a lifting rod to move up and down, and after the lifting rod is inserted into the test paper box and combined with a piston in the test paper box, the lifting up and down of the lifting rod can push the liquid in the test paper box to flow between the liquid flow channels, so as to realize the extraction, amplification and detection of nucleic acid; The heating assembly is arranged on one side of the vertical test paper box positioning bin, a heating cavity is arranged on a side wall of the vertical test paper box, and the heating assembly is arranged on the side corresponding to the heating cavity; The test paper image acquisition assembly is arranged on one side of the vertical test paper box positioning bin, a vertical test paper detection cavity is arranged on a side wall of the vertical test paper box, and the test paper image acquisition assembly is arranged on the side corresponding to the vertical test paper detection cavity; The control system is fixedly arranged in the shell, and comprises a control circuit board; the control system is electrically connected with the display screen, the lower test paper box control assembly, the upper test paper box control assembly, the heating assembly and the test paper image acquisition assembly; The display screen is fixedly arranged on the shell; One side of the shell is provided with a bin door, and the bin door is located corresponding to the vertical test paper box positioning bin.

[0010] In the above scheme, the lower test paper box control assembly comprises a motor, a transmission mechanism and a driving member; the motor drives the driving member to rotate through the transmission mechanism; a control opening is arranged at the bottom of the vertical test paper box positioning bin; the driving member extends into the vertical test paper box positioning bin through the control opening; the shape of the driving member matches the shape of the rotating member at the bottom of the vertical test paper box; when the vertical test paper box is loaded into the vertical test paper box positioning bin, the driving member is engaged with the rotating member at the bottom of the vertical test paper box; and the motor can drive the rotating member to rotate through the transmission mechanism and the driving member. Through this design, the motor can drive the driving member to rotate, and then drive the rotating member at the bottom of the vertical test paper box to rotate, so as to change the liquid flow channels in the test paper box.

[0011] In the above scheme, the lower operating assembly of the test strip box further comprises an ultrasonic assembly, and an ultrasonic head of the ultrasonic assembly abuts against a rotating piece at the bottom of the vertical test strip box through the shaft hole of the driving piece. Through this design, the ultrasonic assembly can vibrate the liquid in the vertical test strip box by ultrasonic waves, and the sample to be measured can be broken and sampled.

[0012] In the above scheme, the vertical test strip box positioning bin is provided with a sliding seat, guide limiting strips are arranged on the upper sides of the two sides of the sliding seat respectively, the guide limiting strips are used for guiding and limiting when the sliding seat slides horizontally, the sliding seat is connected with the vertical test strip box positioning bin in a sliding fit mode, a vertical test strip box positioning groove is arranged on the sliding seat, an opening is arranged in the vertical test strip box positioning groove, and the position of the opening corresponds to the positions of the rotating piece at the bottom of the vertical test strip box and the driving piece of the lower operating assembly of the test strip box. Through this arrangement, when the bin door is opened, the sliding seat can be pulled out, the vertical test strip box can be conveniently loaded in the vertical test strip box positioning groove, the position of the vertical test strip box loaded each time is more accurate, and the operation and processing accuracy in the subsequent operation are guaranteed.

[0013] In the above scheme, the positions close to the outer side ends of the two sides of the sliding seat are provided with connecting plates, the connecting plates are provided with waist-shaped holes, connecting blocks corresponding to the two connecting plates are arranged on the bin door, connecting shafts are arranged on the connecting blocks and arranged in the waist-shaped holes, the connecting shafts can rotate relative to the sliding seat and slide up and down, V-shaped connecting pieces are fixedly connected to the lower parts of the connecting blocks, connecting seats are arranged on the front side parts below the vertical test strip box positioning bin, and the lower end parts of the V-shaped connecting pieces are movably connected with the connecting seats. Through this design, the bin door and the sliding seat can be linked, when the bin door is turned downward and outward relative to the mounting frame to be opened, the bin door and the V-shaped connecting pieces rotate synchronously, the connecting shafts can rotate relative to the sliding seat and slide up and down, the bin door can pull the sliding seat to slide horizontally outward through the connecting shafts, and the sliding seat can be pulled out from the vertical test strip box positioning bin, so that the vertical test strip box can be loaded on the sliding seat or unloaded from the sliding seat after detection.

[0014] In the above scheme, the upper operating assembly of the test strip box comprises a motor, a lifting seat, a lifting transmission mechanism and a lifting rod, the motor drives the lifting seat to lift through the lifting transmission mechanism, the lifting rod is fixedly connected below the lifting seat, the lifting rod extends downward into the vertical test strip box positioning bin, and the position of the lifting rod corresponds to the operating hole at the top of the vertical test strip box. Through this design, the motor can drive the lifting rod to lift up and down through the lifting transmission mechanism, drive the piston in the vertical test strip box to lift, and make various liquids in the vertical test strip box be pumped from the corresponding storage cavities on the vertical test strip box to the mixing cavity below the piston for corresponding operation according to the detection process.

[0015] In the above scheme, the heating assembly comprises a connecting seat, a heating block, a guide connecting rod, a compression spring, the heating block is fixedly connected to the front side of the connecting seat, a through hole is arranged on one side of the connecting seat, the front end of the guide connecting rod passes through the through hole and is fixedly connected to the mounting frame, the position of the heating block corresponds to the position of the heating cavity on the vertical test paper box, a nut is arranged on the rear end of the guide connecting rod, and the compression spring is arranged between the nut and the connecting seat. The connecting seat is pushed forward by the compression spring to move forward, so that the heating block is pushed forward on the outer wall of the heating cavity of the vertical test paper box. Through this arrangement, the compression spring can apply elastic pressure to the connecting seat, and drive the heating block to abut against the outer wall of the heating cavity on the vertical test paper box with a certain pressure. When heating is needed, the heating sheet is powered to generate heat, so that the liquid in the heating cavity of the vertical test paper box can be heated, and the temperature of the liquid in the heating cavity can be quickly raised to a set temperature.

[0016] In the above scheme, the heating assembly comprises a connecting seat and a heating sheet, the position of the heating sheet corresponds to the position of the heating groove, the connecting seat is fixedly connected to the mounting frame, and the heating sheet can heat the two side walls of the heating cavity after being inserted into the heating groove. Through this arrangement, when the vertical test paper box is loaded into the vertical test paper box positioning bin, the heating sheet is inserted into the heating groove on the rear side of the vertical test paper box. When heating is needed, the heating sheet is powered to generate heat, so that the liquid in the heating cavity of the vertical test paper box can be heated, and the temperature of the liquid in the heating cavity can be quickly raised to a set temperature.

[0017] In the above scheme, the vertical test paper box is internally provided with a heating chip, and a contact for power supply is arranged on the side wall of the vertical test paper box. The heating assembly comprises a connecting seat and an electrical connection terminal, the electrical connection terminal is fixedly connected to the front side of the connecting seat, the position of the electrical connection terminal corresponds to the contact, a through hole is arranged on one side of the connecting seat, the front end of the guide connecting rod passes through the through hole and is fixedly connected to the mounting frame, a nut is arranged on the rear end of the guide connecting rod, and the compression spring is arranged between the nut and the connecting seat. The connecting seat is pushed forward by the compression spring to move forward, so that the electrical connection terminal is pushed forward on the contact on the outer wall of the heating cavity of the vertical test paper box. Through this design, the compression spring can apply elastic pressure to the connecting seat, and drive the electrical connection terminal to abut against the contact on the outer wall of the vertical test paper box with a certain pressure. When heating is needed, the electrical connection terminal makes the heating chip powered to generate heat through the contact, so that the liquid in the heating cavity of the vertical test paper box can be heated, and the temperature of the liquid in the heating cavity can be quickly raised to a set temperature, thereby reducing the influence of the environmental temperature on the heating effect of the liquid in the cavity.

[0018] In the above scheme, the test paper image acquisition assembly comprises a camera and a light source, the lens of the camera is arranged towards the vertical test paper detection cavity, and the light source is arranged beside the camera and is arranged towards the vertical test paper detection cavity at an angle alpha. The test paper on the vertical test paper box is irradiated by the light source, and the image information on the test paper is acquired by the camera. The image data is transmitted to the control system, and the image can be analyzed by the processor of the control system to determine the nucleic acid detection result, and the nucleic acid detection result is displayed on the display screen.

[0019] In the above scheme, the mounting frame comprises a lower mounting frame and an upper mounting frame, the upper mounting frame is fixedly connected above the lower mounting frame, a lower assembly chamber for assembling the lower control assembly of the test paper box is arranged on the lower mounting frame, a vertical test paper box positioning bin for loading the vertical test paper box is arranged at the lower part of the upper mounting frame, an upper assembly chamber for assembling the upper control assembly of the test paper box is arranged above the vertical test paper box positioning bin, a through hole for the lifting rod of the upper control assembly of the test paper box to enter is arranged at the top of the vertical test paper box positioning bin, a vertical test paper box inlet corresponding to the bin door is arranged at the front side of the vertical test paper box positioning bin, and a rear detection port is arranged at the rear side of the vertical test paper box positioning bin. The heating assembly and the test paper image acquisition assembly are arranged at the rear detection port, and the control system is fixedly connected at the rear side of the lower mounting frame and the upper mounting frame. Through this design, the layout of each component in the shell can be optimized, each component is distributed around the vertical test paper box positioning bin, the space utilization rate of the shell is improved, and the operation of each component is not interfered with each other, the stability of the equipment operation is improved, and the assembly and maintenance of each component are more convenient.

[0020] In the above scheme, the two side walls of the upper mounting frame are provided with loudspeakers. By setting the loudspeakers, the user can be prompted to operate the equipment according to the voice prompt, and the detection result can be broadcasted by voice.

[0021] In the above scheme, the top of the upper mounting frame is provided with a cooling fan, and the upper part of the shell is provided with a cooling hole. By setting the cooling fan, the components in the shell can be ventilated and cooled.

[0022] In the above scheme, an electromagnet for locking the door is arranged above the vertical test paper box inlet on the front side of the upper mounting frame, a clamping block is arranged at the movable end of the electromagnet, and a locking hole corresponding to the clamping block is arranged at the top of the door. Through this design, the opening of the door can be intelligently controlled. For example, after the detection of the sample to be detected in the vertical test paper box is completed, the processor of the control system sends a signal to the electromagnet, so that the clamping block of the electromagnet is away from the locking hole, and the door can be opened. Before starting the detection, the sample information is recorded into the control system by scanning the code, and the processor of the control system sends a signal to the electromagnet, so that the clamping block of the electromagnet is away from the locking hole, and the door can be opened. Alternatively, during the detection process, if it is found that the vertical reagent box is incorrect and needs to be replaced, the pause button on the touch screen can be clicked, or the pause button on the device can be clicked. After the control system receives the signal, the processor of the control system sends a signal to the electromagnet, so that the clamping block of the electromagnet is away from the locking hole, and the door can be opened.

[0023] In the above scheme, a code scanning machine is arranged on the side wall of the upper mounting frame, the code scanning machine is electrically connected with the electromagnet, and the code scanning machine is used for scanning the bar code or two-dimensional code arranged on the sample container and the vertical test paper box. After the code scanning machine scans the bar code or two-dimensional code on the vertical test paper box, the control system controls the electromagnet to drive the clamping block to be away from the locking hole, so that the door is unlocked. Through this design, before the vertical test paper box is loaded, the bar code or two-dimensional code on the sample container and the vertical test paper box can be scanned by the code scanning machine, the information of the vertical test paper box and the related information in the vertical test paper box can be read, the information can be stored in the control system, and the information can be displayed on the display screen, so as to associate and store the detection result with the information.

[0024] The application has the following positive effects: 1) The portable constant-temperature nucleic acid extraction and amplification detection device suitable for the vertical test paper box realizes the nucleic acid extraction and amplification detection of the vertical test paper box. The vertical test paper strip arranged in the vertical test paper box is greatly shortened in length compared with the horizontal test paper strip, so that the height of the test paper box is reduced, and the portable design of the vertical test paper box can be realized, and the full automation of the nucleic acid extraction and amplification detection process can be realized.

[0025] 2) The portable constant-temperature nucleic acid extraction amplification detection device suitable for the vertical test paper box of the application is positioned at the center of the vertical test paper box positioning bin, a test paper box lower operation assembly is arranged below the vertical test paper box positioning bin, a test paper box upper operation assembly is arranged above the vertical test paper box positioning bin, a heating assembly and a test paper image acquisition assembly are arranged at the rear side of the vertical test paper box positioning bin, the space in the shell is more compact, each assembly is modularized, the assembly is convenient for assembly and maintenance, meanwhile, mutual interference of each assembly during operation can be avoided, and each assembly is more stable and reliable. Through the combination of the assemblies, the nucleic acid extraction, amplification and detection process of the sample in the vertical test paper box are fully automated, and the detection process and the detection result can be displayed on the display screen, so that the device is intelligent, and the user is more convenient for operation and use. Through the optimization design of the application, the volume of the nucleic acid amplification detection device is greatly reduced, the length, width and height are 103 mm, 129 mm and 280 mm respectively, and the weight is less than 2 kg. Through the miniaturization, full automation and intelligent design of the application, the constant-temperature nucleic acid amplification detection device is designed as a portable device, constant-temperature amplification is adopted, and test paper detection is adopted, so that the device can be used by large detection institutions, individual users, family users or small community hospitals. BRIEF DESCRIPTION OF DRAWINGS

[0026] Figure 1 It is a structure schematic view of the portable constant-temperature nucleic acid extraction amplification detection device suitable for the vertical test paper box of the application.

[0027] Figure 2 It is a structure schematic view of the portable constant-temperature nucleic acid extraction amplification detection device suitable for the vertical test paper box of the application.

[0028] Figure 3 It is a structure schematic view of the portable constant-temperature nucleic acid extraction amplification detection device suitable for the vertical test paper box of the application.

[0029] Figure 4 It is a structure schematic view of the portable constant-temperature nucleic acid extraction amplification detection device suitable for the vertical test paper box of the application.

[0030] Figure 5 It is a structure schematic view of the portable constant-temperature nucleic acid extraction amplification detection device suitable for the vertical test paper box of the application.

[0031] Figure 6 It is a structure schematic view of the portable constant-temperature nucleic acid extraction amplification detection device suitable for the vertical test paper box of the application.

[0032] Figure 7 It is a structure schematic view of the portable constant-temperature nucleic acid extraction amplification detection device suitable for the vertical test paper box of the application.

[0033] Figure 8 It is a structure schematic view of the portable constant-temperature nucleic acid extraction amplification detection device suitable for the vertical test paper box of the application.

[0034] Figure 9 This is a schematic diagram of the control components under the test strip box.

[0035] Figure 10 This is a schematic diagram of the control components on the test strip box.

[0036] Figure 11a This is a schematic diagram of the heating assembly in the first heating embodiment.

[0037] Figure 11b A schematic diagram of the structure of the vertical test paper box in the first heating embodiment.

[0038] Figure 11c This diagram illustrates the relationship between the heating component and the vertical test paper box in the first heating embodiment.

[0039] Figure 12a This is a schematic diagram of the heating assembly in the second heating embodiment.

[0040] Figure 12b A schematic diagram of the structure of the vertical test paper box in the second heating embodiment.

[0041] Figure 12c This diagram illustrates the relationship between the heating component and the vertical test paper box in the second heating embodiment.

[0042] Figure 13a This is a schematic diagram of the heating assembly in the third heating embodiment.

[0043] Figure 13b A schematic diagram of the structure of the vertical test paper box in the third heating embodiment.

[0044] Figure 13c This diagram illustrates the relationship between the heating component and the vertical test paper box in the third heating embodiment.

[0045] Figure 14 This is a schematic diagram showing the interaction between the test strip image acquisition component and the vertical test strip box.

[0046] Figure 15 This is a schematic diagram of the structure of a vertical test paper box (with the lid open).

[0047] Figure 16 This is a schematic diagram of the internal cavity structure of a vertical test paper box.

[0048] The reference numerals in the figure are as follows: housing 1, display screen 11, compartment door 12, sliding seat 121, guide limit strip 122, vertical test paper box positioning groove 123, connecting plate 124, oblong hole 1241, connecting block 125, connecting shaft 126, connecting seat 127, V-shaped connecting piece 128, locking port 129, compartment door sensor 120, electromagnet 13, snap-fit ​​block 131, barcode scanner 14; Mounting frame 2, lower mounting frame 21, lower assembly chamber 211, upper mounting frame 22, vertical test paper box positioning chamber 221, upper assembly chamber 222, vertical test paper box inlet 223, rear detection port 224, control port 225. The test strip box includes a control component 3, a motor 31, a transmission mechanism 32, a drive component 33, a protrusion 331, an ultrasonic component 34, an ultrasonic transducer 341, an ultrasonic head 342, and a compression spring 343. The test strip box includes control components 4, motor 41, lifting base 42, lifting transmission mechanism 43, and lifting rod 44. Heating component 5, connecting base 51, heating block 52, compression spring 53, guide rod 54, heating element 55, power terminal 56; Test strip image acquisition component 6, camera 61, light source 62; Control system 7; Vertical test strip box 8, box body 81, through hole 811, heating tank 812, contact 813, detection plate 82, vertical test strip detection chamber 821, test strip 822, heating chamber 823, rotating part 83, groove 831, internal cavity 84, mixing chamber 841, sample chamber 842, waste liquid chamber 843, washing liquid chamber 844, elution liquid chamber 845, amplification reagent chamber 846, dilution liquid chamber 847, internal standard chamber 848, nucleic acid elution chamber 849, liquid flow channel 85, speaker 9, cooling fan 10. Detailed Implementation

[0049] The technical solution of the present invention will be clearly and completely described below through embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0050] like Figures 1-6 As shown, the portable isothermal nucleic acid extraction and amplification detection device for vertical test kits of the present invention includes a housing 1, a display screen 11, a mounting frame 2, a lower control component 3 for the test kit, an upper control component 4 for the test kit, a heating component 5, a test strip image acquisition component 6, and a control system 7.

[0051] The housing 1 can be made of injection molding or other materials. A door 12 is provided on the front side of the housing 1, and a display screen 11 is provided above the door. The display screen 11 can preferably be a touch screen.

[0052] Heat dissipation holes also need to be designed on housing 1 as needed to allow external cool air to enter housing 1 and dissipate heat from the internal components. Speaker holes also need to be designed on the upper left and right sides of housing 1 to allow the sound from the speakers to travel outside the housing.

[0053] The mounting rack 2 is fixedly arranged in the shell 1, and the structure of the mounting rack 2 can be designed according to the layout mode of the internal components. The mounting rack 2 needs to have a mounting rack with a required strength.

[0054] Preferably, as shown in Figures 4-7 The mounting rack 2 includes a lower mounting rack 21 and an upper mounting rack 22. The upper mounting rack 22 is fixedly connected above the lower mounting rack 21. A lower assembly chamber 211 for assembling the lower operation assembly 3 of the test paper box is arranged on the lower mounting rack 21. A vertical test paper box positioning bin 221 for loading the vertical test paper box 8 is arranged at the lower part of the upper mounting rack 22. An upper assembly chamber 222 for assembling the upper operation assembly 4 of the test paper box is arranged above the vertical test paper box positioning bin 221. A through hole for the lifting rod 44 of the upper operation assembly 4 of the test paper box to enter is arranged at the top of the vertical test paper box positioning bin 221. A vertical test paper box entrance 223 corresponding to the bin door 12 is arranged at the front side of the vertical test paper box positioning bin 221. A rear detection opening 224 is arranged at the rear side of the vertical test paper box positioning bin 221. The heating assembly 5 and the test paper image acquisition assembly 6 are arranged at the rear detection opening 224. The control system 7 is fixedly connected at the rear side of the lower mounting rack 21 and the upper mounting rack 22. Through this design, the layout of each component in the shell 1 can be more optimized. Each component is distributed around the vertical test paper box positioning bin 221, which improves the space utilization rate of the shell 1 and ensures that each component does not interfere with each other during operation, thereby improving the stability of the equipment operation and making the assembly and maintenance of each component more convenient.

[0055] The bin door 12 can be designed as needed, for example, the bin door can be designed as a hinged bin door, which is opened horizontally.

[0056] As shown in Figure 5 and 8 Preferably, the bin door 12 is designed as a bin door that flips from top to bottom. When the bin door 12 is opened, the sliding seat 121 is linked with the bin door 12 and slides horizontally out of the shell 1, which facilitates loading the vertical test paper box 8 onto the sliding seat 121. When the bin door 12 is flipped upward and closed, the sliding seat 121 can be linked and horizontally slides into the shell 1 and moves to the position set in the vertical test paper box positioning bin 221. Through this design, the loading of the vertical test paper box is convenient, and the position accuracy of the vertical test paper box 8 loaded into the shell 1 is higher, which improves the reliability of subsequent operations.

[0057] The specific structure of the aforementioned bin door 12 can be designed according to the above-mentioned action mode, for example, the vertical test paper box positioning bin 221 is provided with a sliding seat 121, guide limiting strips 122 are respectively arranged on the upper sides of the two sides of the sliding seat 121, the guide limiting strips 122 are used for guiding and limiting when the sliding seat 121 horizontally slides, the sliding seat 121 is in sliding fit connection with the vertical test paper box positioning bin 221, a vertical test paper box positioning groove 123 is arranged on the sliding seat 121, and an opening is arranged in the vertical test paper box positioning groove 123. The position of the opening corresponds to the positions of the rotating piece 83 at the bottom of the vertical test paper box 8 and the driving piece 33 of the test paper box lower control assembly 3.

[0058] The positions close to the outer side ends of the two sides of the sliding seat 121 are provided with connecting plates 124, the connecting plates 124 are provided with waist-shaped holes 1241, connecting blocks 125 corresponding to the two connecting plates 124 are arranged on the bin door 12, connecting shafts 126 are arranged on the connecting blocks 125 and arranged in the waist-shaped holes 1241, the connecting shafts 126 can rotate relative to the sliding seat 121 and slide up and down, V-shaped connecting pieces 128 are fixedly connected to the lower parts of the connecting blocks 125, connecting seats 127 are arranged on the mounting frame 2 at the lower front sides of the vertical test paper box positioning bins 221, and the lower ends of the V-shaped connecting pieces 128 are hinged to the connecting seats 127. Through the design, the bin door 12 and the sliding seat 121 can be linked, when the bin door 12 is turned downward and outward relative to the mounting frame 2 to be opened, the bin door 12 is synchronously rotated with the V-shaped connecting pieces 128, the connecting shafts 126 can rotate relative to the sliding seat 121 and slide up and down, the bin door 12 can pull the sliding seat 121 to slide horizontally outward through the connecting shafts 126, so that the sliding seat 121 is stretched out of the vertical test paper box positioning bin 221, so as to facilitate loading the vertical test paper box 8 on the sliding seat 121 or taking the vertical test paper box 8 after detection from the sliding seat 121. Through the design of the vertical test paper box positioning groove 123 on the sliding seat 121, the position of the vertical test paper box 8 loaded each time is more accurate, and the subsequent operation and processing accuracy are guaranteed. In order to guarantee that the bin door 12 is closed in place, a bin door sensor 120 is arranged on the mounting frame 2, the bin door sensor 120 can be arranged opposite to the connecting blocks 125 connected to the bin door 12, when the bin door is closed in place, the connecting blocks 125 press on the sensing head of the bin door sensor 120, the bin door sensor 120 triggers a signal to send to the control system, and the bin door 12 is confirmed to be closed. In order to reduce the resistance when the bin door 12 is closed, a torsional spring is arranged on the hinge shaft of the hinge between the V-shaped connecting piece 128 and the connecting seat 127, and the torsional force provided by the torsional spring can be used to assist the bin door to be closed.

[0059] In order to facilitate prompting the user to operate the equipment according to the voice prompt and broadcasting the detection result through the voice, a loudspeaker 9 can be arranged on the two side walls of the upper mounting frame 2.

[0060] In order to facilitate heat dissipation of the components inside the shell 1, a heat dissipation fan 10 can be provided on the top of the upper mounting frame 2, and a heat dissipation hole is provided on the upper part of the shell 1.

[0061] In order to facilitate the locking and unlocking of the door 12, an electromagnet 13 for locking the door 12 is provided on the front side of the upper mounting frame 22 above the vertical test paper box inlet 223, a clamping block 131 is provided on the movable end of the electromagnet 13, and a corresponding locking hole 129 is provided on the top of the door 12. Through this design, the opening of the door 12 can be intelligently controlled. For example, after the detection of the sample in the vertical test paper box is completed, the processor of the control system 7 sends a signal to the electromagnet 13, so that the clamping block 131 of the electromagnet 13 is away from the locking hole, and the door 12 can be opened. Before starting the detection, the sample information is recorded into the control system 7 by scanning the code, and the processor of the control system 7 sends a signal to the electromagnet 13, so that the clamping block 131 of the electromagnet 13 is away from the locking hole, and the door 12 can be opened. Alternatively, during the detection process, if it is found that the vertical reagent box 8 is incorrect and needs to be replaced, the pause button on the touch screen can be clicked, and after the control system 7 receives the signal, the processor sends a signal to the electromagnet 13, so that the clamping block 131 of the electromagnet 13 is away from the locking hole, and the door 12 can be opened.

[0062] In order to facilitate reading the bar code or two-dimensional code on the vertical test paper box 8, a code scanner 14 can be provided above the front wall of the upper mounting frame 22, the code scanner 14 is electrically connected with the electromagnet 13, the code scanner 14 is used for scanning the bar code or two-dimensional code provided on the sample container and the vertical test paper box 8, and the electromagnet 13 is driven to drive the clamping block 131 to be away from the locking hole after the code scanner 14 scans the two-dimensional code provided on the vertical test paper box 8, so that the door 12 is unlocked. Through this design, before the vertical test paper box 8 is loaded, the bar code or two-dimensional code on the vertical test paper box 8 can be scanned by the code scanner 14, the information of the vertical test paper box 8 and the related information in it can be read, and the information can be stored in the control system 7 and displayed on the display screen 11, so as to associate and store the detection results with the information.

[0063] As Figure 9As shown, the lower test cartridge operating assembly 3 comprises a motor 31, a transmission mechanism 32 and a driving member 33. The motor 31 drives the driving member 33 to rotate through the transmission mechanism 32. A control opening 225 is arranged at the bottom of the vertical test cartridge positioning bin 221. The driving member 33 extends into the vertical test cartridge positioning bin 221 through the control opening 225. The shape of the driving member 33 matches that of the rotating member 83 at the bottom of the vertical test cartridge 8. When the vertical test cartridge 8 is loaded into the vertical test cartridge positioning bin 221, the driving member 33 is engaged with the rotating member 83 at the bottom of the vertical test cartridge 8. The motor 31 drives the rotating member 83 to rotate through the transmission mechanism 32 and the driving member 33. Through this design, the motor 31 drives the driving member 33 to rotate through the transmission mechanism 32, and then drives the rotating member 83 at the bottom of the vertical test cartridge 8 to rotate, so as to change the liquid flow path in the test cartridge.

[0064] The engagement structure of the driving member 33 and the rotating member 83 at the bottom of the vertical test cartridge 8 can be designed as required. For example, a protrusion 331 is arranged on the driving member 33, and a groove 831 matching the protrusion 331 is arranged on the rotating member 83. When the vertical test cartridge 8 is loaded into the vertical test cartridge positioning bin 221, the protrusion 331 is inserted into the groove 831, and the engagement of the two is achieved, so that the driving member 33 can drive the rotating member 83 to rotate. The groove 831 is preferably designed as a trapezoidal groove, and the protrusion 331 can be correspondingly designed as a trapezoidal block. When the equipment is stopped, the driving member 33 drives the rotating member 83 to rotate to a zero position. The narrow side of the protrusion 331 faces the direction of the equipment bin door 12, and the wide side of the groove 831 on the rotating member 83 faces the direction of the rear side of the vertical test cartridge positioning bin. Through this design, the engagement of the rotating member 83 and the driving member 33 is more convenient. Similarly, a groove can be arranged on the driving member 33, and a protrusion can be arranged on the rotating member 83 of the vertical test cartridge to achieve the engagement of the driving member 33 and the rotating member 83.

[0065] In specific applications, the motor 31 is preferably a stepping motor, and a position sensor can be designed to detect the rotation angle of the driving member 33, so as to accurately control the conduction or closure of each liquid flow path. The transmission mechanism 32 can be selected as required, for example, a gear transmission mechanism or a synchronous belt wheel transmission mechanism can be selected.

[0066] Preferably, the lower test cartridge operating assembly 3 further comprises an ultrasonic assembly 34, which comprises an ultrasonic transducer 341 and an ultrasonic head 342. The ultrasonic head 342 is connected with the ultrasonic transducer 341, and extends through the shaft hole of the driving member 33 to abut against the rotating member 83 at the bottom of the vertical test cartridge 8. Through this design, the ultrasonic assembly can vibrate the liquid in the vertical test cartridge by ultrasonic waves, and break the sample to be measured, so as to facilitate the extraction of nucleic acid. In order to control the pressure of the ultrasonic head 342 abutting against the rotating member 83 at the bottom of the vertical test cartridge 8, a compression spring 343 can be arranged at the bottom of the ultrasonic transducer 341.

[0067] As shown in Figure 10 , the upper test strip box operating assembly 4 includes a motor 41, a lifting seat 42, a lifting transmission mechanism 43 and a lifting rod 44. The motor 41 drives the lifting seat 42 to move up and down through the lifting transmission mechanism 43. The lifting rod 44 is fixedly connected below the lifting seat 42 and extends downward into the vertical test strip box positioning bin 221. The position of the lifting rod 44 corresponds to the operating hole at the top of the vertical test strip box 8. Through this design, the motor 41 can drive the lifting rod 44 to move up and down through the lifting transmission mechanism 43, drive the piston in the vertical test strip box 8 to move up and down, and make various liquids in the vertical test strip box 8 be sucked from the corresponding storage cavity on the vertical test strip box 8 to the mixing cavity 841 below the piston for corresponding operation according to the detection process.

[0068] In specific applications, the motor 41 can be a servo motor or a stepper motor. The lifting transmission mechanism 43 can be a gear and rack mechanism, a screw mechanism or other mechanisms. A position sensor can be arranged on the lifting seat 42 to detect the lifting height of the lifting rod 44. The lifting rod 44 is fixedly connected to the lifting seat 42. The lower end of the lifting rod 44 is provided with a piston connecting head matched with the piston in the mixing cavity 841 of the vertical test strip box 8.

[0069] The control system 7 is fixedly arranged in the shell 1. The control system 7 includes a control circuit board and is electrically connected with the display screen 11, the lower test strip box operating assembly 3, the upper test strip box operating assembly 4, the heating assembly 5, the test strip image acquisition assembly 6, the code scanner 14, the electromagnet 13 and the loudspeaker 9.

[0070] The structure of the heating assembly 5 can be designed according to needs. For example, the following three implementation manners can be adopted.

[0071] As a first embodiment, as shown in Figure 11a , Figure 11b and Figure 11cAs shown in the drawings, the heating assembly 5 comprises a connecting seat 51, a heating block 52, a guide connecting rod 54, and a compression spring 53. The heating block 52 is fixedly connected to the front side of the connecting seat 51. A through hole is arranged on one side of the connecting seat 51. The front end of the guide connecting rod 54 penetrates through the through hole and is fixedly connected to the mounting frame 2. The position of the heating block 5 corresponds to the position of the heating cavity 823 on the vertical test paper box 8. The rear end of the guide connecting rod 54 is provided with a nut. The compression spring 53 is arranged between the nut and the connecting seat 51. The connecting seat 51 is pushed forward by the compression spring 53, so that the heating block 52 is pushed forward against the outer wall of the heating cavity 823 of the vertical test paper box 8. Through this arrangement, the compression spring 53 can apply elastic pressure to the connecting seat 51, so that the heating block 52 is pressed against the outer wall of the heating cavity 823 on the vertical test paper box 8 with a certain pressure. When heating is needed, the heating block 52 is powered to generate heat, so that the liquid in the heating cavity 823 of the vertical test paper box 8 can be heated, and the temperature of the liquid in the heating cavity 823 can be quickly raised to a set temperature.

[0072] As a second embodiment, as shown in Figure 12a 、 Figure 12b and Figure 12c , heating grooves 812 are arranged on both sides of the heating cavity 823 of the vertical test paper box 8. The heating assembly 5 comprises a connecting seat 51 and a heating sheet 55. The position of the heating sheet 55 corresponds to the position of the heating groove 812. The connecting seat 51 is fixedly connected to the mounting frame 2. After the heating sheet 55 is inserted into the heating groove 812 at the rear side of the vertical test paper box 8, the heating sheet 55 can heat the two side walls of the heating cavity 823. Through this arrangement, when the vertical test paper box 8 is loaded into the vertical test paper box positioning bin 221, the heating sheet 55 is inserted into the heating groove 812 at the rear side of the vertical test paper box 8. When heating is needed, the heating sheet 55 is powered to generate heat, so that the liquid in the heating cavity 823 of the vertical test paper box 8 can be heated, and the temperature of the liquid in the heating cavity 823 can be quickly raised to a set temperature. Similarly, the heating sheet 55 can also be designed as a U-shaped piece. The two side walls are inserted into the grooves, and the middle part is pressed against the outer wall of the heating cavity 823. The heating cavity 823 is heated through three surface contacts, so that the temperature of the heating cavity 823 can be more quickly raised to a set temperature.

[0073] As a third embodiment, as shown in Figure 13a 、 Figure 13b and Figure 13cAs shown, the heating chip is arranged inside the vertical test paper box 8, and the contact 813 for power supply is arranged on the side wall of the vertical test paper box 8. The heating assembly 5 comprises a connecting seat 51 and an electrical terminal 56, the electrical terminal 56 is fixedly connected to the front side of the connecting seat 51, the position of the electrical terminal 56 corresponds to the position of the contact 813, a through hole is arranged on one side of the connecting seat 51, the front end of the guide connecting rod 54 passes through the through hole and is fixedly connected to the mounting frame 2, and the rear end of the guide connecting rod 54 is provided with a nut. The compression spring 53 is arranged between the nut and the connecting seat 51, the connecting seat 51 is pushed forward by the compression spring, and the electrical terminal 56 is pushed forward on the contact 813 on the outer wall of the heating cavity 823 of the vertical test paper box 8. Through this design, the compression spring 53 can apply elastic pressure to the connecting seat 51, and drive the electrical terminal 56 to abut against the contact 813 on the outer wall of the vertical test paper box 8 with a certain pressure. When heating is needed, the electrical terminal 56 makes the heating chip power on and heat through the contact 813, so as to heat the liquid in the heating cavity 823 of the vertical test paper box 8, and make the temperature of the liquid in the heating cavity quickly rise to a set temperature, thereby reducing the influence of the ambient temperature on the heating effect of the liquid in the cavity.

[0074] As shown in Figure 14 The test paper image acquisition assembly 6 comprises a camera 61 and a light source 62, the lens of the camera 61 is arranged towards the vertical test paper detection cavity 821, and the light source 62 is arranged beside the camera 61. The light source 62 can be an LED light bar or an LED light plate or other light sources. The light source 62 is arranged towards the vertical test paper detection cavity at an angle a, and the angle a can be 15°-75°. The angle can be adjusted to an optimal angle according to the needs of image acquisition of the camera 61, so that the image obtained by the camera 61 is clearer. The test paper on the vertical test paper box is irradiated by the light source 62, and the image information on the test paper is obtained by the camera 61. The image data is transmitted to the control system 7, and the processor of the control system 7 can analyze the image, determine the nucleic acid detection result, and display the nucleic acid detection result on the display screen 11.

[0075] As shown in Figures 15-16As shown, the structure of the vertical test paper box 8 includes a box body 81 and a test paper strip 822. An internal cavity 84 is arranged inside the box body 81, a mixing cavity 841 for liquid mixing is arranged at the middle position of the internal cavity 84, sample cavities 842, waste liquid cavities 843, cleaning liquid cavities 844, elution liquid cavities 845, amplification reagent cavities 846, dilution liquid cavities 847, waste liquid cavities 843 and nucleic acid elution cavities 849 are distributed around the mixing cavity 841, the sample cavities 842, the waste liquid cavities 843, the cleaning liquid cavities 844, the elution liquid cavities 845, the amplification reagent cavities 846, the dilution liquid cavities 847, the waste liquid cavities 843 and the nucleic acid elution cavities 849 are respectively communicated with the mixing cavity 841 through liquid flow channels, the rotating member 83 is arranged at the bottom of the mixing cavity 841, a through hole is arranged on the rotating member 83, when the through hole on the rotating member 83 is rotated to a position opposite to the liquid flow channel of the sample cavity 842, the waste liquid cavity 843, the cleaning liquid cavity 844, the elution liquid cavity 845, the amplification reagent cavity 846, the dilution liquid cavity 847, the internal standard cavity 848 or the nucleic acid elution cavity 849, the mixing cavity 841 is communicated with the corresponding cavity. A detection plate 82 is arranged on one side of the box body 81, the detection plate 82 is an integral transparent material piece or a back plate with a transparent outer side surface, so that the camera 61 can take pictures to obtain images of test paper detection. A vertical test paper detection cavity 821 is arranged on one side of the detection plate 82, the test paper strip 822 is arranged in the vertical test paper detection cavity 821, a flow guide part is arranged at the lower part thereof, a flow guide film is arranged in the flow guide part, an amplification product sampling inlet is arranged above the flow guide film, and the inlet of the amplification product sampling flow channel is located at the bottom of the mixing cavity. When the amplification is completed, the through hole on the rotating member 83 is rotated to a position opposite to the amplification product sampling flow channel, the lifting rod 44 is lowered by the control assembly 4 on the test paper box, the piston in the mixing cavity 841 is pushed down, the amplification product is pushed into the vertical test paper detection cavity 821 through the amplification product flow channel, the amplification product can reach the bottom of the test paper strip 822 at a set speed under the action of the flow guide film, the amplification product rises along the test paper strip 822 under the capillary action of the water absorption pad on the test paper strip, the latex microsphere-antibody complex on the combination pad is dissolved in the amplification product, continues to rise to the color developing part on the upper part of the test paper strip 822, and several lines are displayed according to the positive or negative of the sample to be detected, for example, if it is negative, one red line is displayed, and if it is positive, two red lines are displayed.

[0076] The other side of the detection plate 82 is also provided with a heating cavity 823, which is connected with the mixing cavity 841 through a heating cavity liquid channel. When the sample to be detected is mixed with the amplification reagent and needs to be heated for amplification, the through hole on the rotating part 83 at the bottom of the mixing cavity 841 is rotated to a position opposite to the heating cavity liquid channel, the lifting rod 44 on the control assembly 4 of the test strip box is lowered to push the piston in the mixing cavity 841 to descend, and the amplification liquid is sent into the heating cavity 823. The heating assembly 5 heats the liquid in the heating cavity 823, so that the temperature of the amplification liquid rapidly rises to a set temperature, and the amplification is completed within a set time. After the amplification is completed, the lifting rod 44 on the control assembly 4 of the test strip box is raised to suck the amplification product into the mixing cavity 841, and then the amplification product is sent into the vertical test paper detection cavity 821 for detection according to the foregoing method.

[0077] When the vertical test strip box 8 is loaded into the vertical test strip box positioning bin 221, the heating cavity 823 is arranged towards the heating block 52 of the heating assembly 5, the heating block 52 abuts against the outer wall of the heating cavity 823, and when heating, the heat of the heating block 52 is conducted to the amplification liquid in the heating cavity 823 through the outer wall of the heating cavity 823, so that the temperature of the amplification liquid rises to a set temperature and the amplification is completed within a set time.

[0078] The vertical test strip box of the second structure is provided with the heating cavity 823 on the detection plate 82, and heating grooves 812 are arranged on both sides of the heating cavity 823. When the vertical test strip box 8 is loaded into the vertical test strip box positioning bin 221, the heating sheet on the heating assembly 5 is inserted into the heating groove 812 to heat the amplification liquid in the heating cavity 823. Or the two arms of the U-shaped heating sheet are inserted into the heating groove 812, and the middle part of the heating sheet abuts against the outer wall of the heating cavity 823, so that the amplification liquid in the heating cavity 823 is heated by the two arms and the middle part at the same time.

[0079] The vertical test strip box of the third structure is provided with the heating cavity 823 on one side of the detection plate, and a heating chip is arranged in the heating cavity 823. A contact 813 for power supply is arranged beside the heating cavity. When the vertical test strip box 8 is loaded into the vertical test strip box positioning bin 221, the power terminal 56 of the heating assembly 5 is connected with the contact 813. When heating is needed, the heating assembly 5 is powered on to heat the heating chip in the heating cavity 5, so that the amplification liquid is heated to an amplification temperature and the amplification is completed within a set time.

[0080] In addition to the above-mentioned three heating methods, other structures of heating methods can be designed according to needs.

[0081] Preferably, the vertical test paper box 8 can be designed as a sealed vertical test paper box, so that the air pressure in the vertical test paper detection cavity inside it is a set standard air pressure. When nucleic acid detection is performed, the amplification product can enter the vertical test paper detection cavity under the set standard air pressure. Through this setting, whether the nucleic acid detection is performed in a high atmospheric pressure area or a low atmospheric pressure area, the air pressure in the vertical test paper detection cavity is unchanged, which can ensure that the climbing speed and climbing height of the amplification product on the vertical test paper strip are basically consistent, improve the accuracy of the nucleic acid detection result, and avoid the problems of false positive or false negative caused by excessively high or low external atmospheric pressure. When the vertical test paper box with this structure is loaded into the detection device of the application for detection, the influence of external pressure on detection can be considered, and consistent and accurate detection results can be obtained in high atmospheric pressure areas or low atmospheric pressure areas.

[0082] The current nucleic acid detection method based on test paper cards generally faces the dual limitations of operation complexity and sample capacity: one type needs to rely on a complex nucleic acid extraction process, such as the scheme disclosed in the patent with publication number CN105273997A, which has complicated operation steps; another type omits the extraction step and uses direct lysis amplification detection, but is limited by the technical principle, and the sample volume that can be added at a time can only be controlled at about 10 microliters, which seriously restricts the detection performance. The vertical test paper box of the application realizes a key breakthrough in view of the above problems: on the one hand, by designing a vertical test paper box, the sample capacity can be greatly increased to the milliliter level, and by increasing the sample input, the capture efficiency of the target nucleic acid can be significantly improved, thereby fundamentally enhancing the detection sensitivity and effectively solving the problem of low-concentration sample missed detection; on the other hand, the integrated nucleic acid purification function can efficiently remove interfering impurities in different samples, not only suitable for blood, urine, feces, secretions and other biological samples, but also further widening the application range in clinical diagnosis, on-site rapid detection and other scenes. When the vertical test paper box with this structure is loaded into the detection device of the application for detection, the detection sensitivity can be fundamentally enhanced, the problem of low-concentration sample missed detection can be effectively solved, and blood, urine, feces, secretions and other biological samples can be adapted, thereby widening the application range in clinical diagnosis, on-site rapid detection and other scenes.

[0083] The portable constant-temperature nucleic acid extraction amplification detection device suitable for the vertical test paper box of the application can preinstall all reagents required in the detection process in the vertical reagent box, and when used, the user only needs to load the collected sample into the sample tube, load the sample tube into the sample tube sample inlet bin in the vertical reagent box, and then load the vertical reagent box into the detection device, so that the circulation of liquid in each chamber in the vertical test paper box can be completed according to the detection process through the upper control assembly and the lower control assembly of the test paper box of the detection device, and the whole process of nucleic acid extraction, amplification and detection is automatically completed. In this process, no manual addition of any reagent is required, the possibility of contact between the operator and the reagent or virus is avoided, the pollution of the reagent or virus to the environment is avoided, and the safety of use is improved.

[0084] The working principle of the nucleic acid extraction and detection integrated machine provided by the application is as follows: in the initial state, the door is in the closed state, the operator selects the vertical test paper box to be detected, the vertical test paper box is provided with a detection liquid, the operator aligns the vertical test paper box with the code scanning machine, the code scanning machine identifies the type of the vertical test paper box by identifying the two-dimensional code or the bar code on the vertical test paper box, so that the control system calls the corresponding program of the type of the vertical test paper box, and the control system controls the electromagnet to drive the clamping block to move away from the locking port, so that the door is unlocked and opened, the user opens the door, and the vertical test paper box is driven to slide to the outside of the shell, the operator places the vertical test paper box in the vertical test paper box positioning groove on the sliding seat, the shape of the vertical test paper box positioning groove is matched with the shape of the bottom of the vertical test paper box, so that the direction of the vertical test paper box is correct, then the door is closed, at the same time, the sliding seat drives the vertical test paper box into the vertical test paper box positioning chamber, when the door is closed, the vertical test paper box is just located at the detection position of the vertical test paper box, at this time, the rotating part at the bottom of the vertical test paper box is just located in the operation port and is engaged with the driving part of the lower test paper box control assembly, when the motor of the lower test paper box control assembly rotates, the driving part is driven to rotate, so that the rotating part at the bottom of the vertical test paper box rotates. The lifting rod of the upper test paper box control assembly is just opposite to the mixing cavity of the vertical test paper box, the lifting rod is lowered into the mixing cavity, and when the lifting rod is lowered to the position, the lifting rod is combined with the piston in the mixing cavity, and the lifting rod is driven to ascend and descend, so that the liquid in each cavity enters the mixing cavity through the through hole on the bottom rotating part or leaves the mixing cavity and enters the corresponding cavity through the liquid flow channel. When the door is closed, the clamping block on the electromagnet is inserted into the locking port on the door, so that the door is locked; the control system starts to detect the sample in the vertical test paper box according to the operation of the operator. In the operation process, the nucleic acid extraction is performed first, then the nucleic acid amplification is performed, and then the nucleic acid detection is performed, in the nucleic acid extraction process, the through hole on the rotating part at the bottom of the vertical test paper box is opposite to the flow channel port of the sample cavity by rotating the rotating part, the mixing cavity is communicated with the sample cavity, the piston is driven to ascend by the lifting rod, a negative pressure is formed in the mixing cavity, the sample to be detected is sucked into the mixing cavity, then the rotating part is driven to rotate, so that the mixing cavity is opposite to the liquid flow channel port of the storage cavity of the extraction liquid, the piston is driven to ascend by the lifting rod, the extraction liquid is sucked into the mixing cavity, then the rotating part is rotated, the mixing cavity is closed, the liquid in the mixing cavity is vibrated by the ultrasonic head of the lower test paper box control assembly, in order to enhance the vibration effect, the silica microspheres can be preloaded in the test paper box bottom crushing chamber, so that the sample to be detected is crushed, and the nucleic acid extraction efficiency is improved.After the nucleic acid extraction is completed, the piston is lifted by the lifting rod to mix the extraction solution with the reagent, and then the mixed solution is sent into the heating cavity for heating and amplification by the heating assembly. After the amplification is completed, the amplification product is sent into the vertical test paper detection cavity. Under the action of the flow guide film, the amplification product reaches the lower end of the vertical test paper at a set speed. Under the action of the water absorption pad of the vertical test paper, the amplification product climbs along the vertical test paper. When passing through the colloidal gold-antibody complex, the amplification product is combined with the latex microsphere-antibody complex and reacts. At the same time, as the vertical test paper strip continues to climb, it climbs to the color development zone within a set time. According to the positive or negative of the sample to be tested, several bars are displayed in the color development zone. After the color development is completed, the vertical test paper strip is photographed by the camera, the color development image on the test paper strip is obtained, and the image is transmitted to the control system. The control system determines whether the sample to be tested is negative or positive through image recognition, and displays the detection result on the display screen. During the photographing process, the light source is irradiated on the vertical test paper strip at a set angle, which can make the photographed picture clearer and the result of image recognition more reliable. The loudspeaker arranged in the shell can play operation prompts and detection results, so that the operator can operate according to the prompts. The cooling fan arranged in the shell can be used for cooling the components in the shell, so as to ensure that the components operate at a reasonable temperature. After the nucleic acid detection is completed, the control system can control the electromagnet to release the locking of the door, and the operator can take out the vertical test paper box through the loudspeaker prompt. The door can be opened and closed according to the foregoing manner for the next nucleic acid detection.

[0085] Although embodiments of the present application have been shown and described, it is to be understood that various modifications, substitutions, replacements and changes can be made to these embodiments without departing from the principles and spirit of the present application, and the scope of the present application is defined by the appended claims and their equivalents.

Claims

1. A portable isothermal nucleic acid extraction, amplification, and detection device suitable for vertical test kits, characterized in that, It includes a housing, a display screen, a mounting bracket, a lower control component for the test strip box, an upper control component for the test strip box, a heating component, a test strip image acquisition component, and a control system; The mounting bracket, the lower control component of the test strip box, the upper control component of the test strip box, the heating component, the test strip image acquisition component, and the control system are all housed within the casing. The mounting frame is equipped with a vertical test paper box positioning compartment and a sensing device; The control component under the test strip box is located below the positioning compartment of the vertical test strip box. The control component under the test strip box is used to drive the rotating part on the bottom surface of the vertical test strip box to rotate, so as to change the liquid flow channel inside the test strip box. The control component on the test strip box is located above the positioning chamber of the vertical test strip box. The control component on the test strip box is used to drive the lifting rod to move up and down. After the lifting rod is inserted into the test strip box and combined with the piston inside the test strip box, the lifting rod can push the liquid inside the test strip box to flow between the liquid channels to realize the nucleic acid extraction, amplification and detection process. The heating component is located on one side of the positioning compartment of the vertical test strip box. A heating cavity is provided on one side wall of the vertical test strip box, and the heating component is located on the side corresponding to the heating cavity. The test strip image acquisition component is located on one side of the positioning compartment of the vertical test strip box. A vertical test strip detection cavity is provided on one side wall of the vertical test strip box, and the test strip image acquisition component is located on the side corresponding to the vertical test strip detection cavity. The control system is fixedly installed inside the housing. The control system includes a control circuit board and is electrically connected to the display screen, the lower control component of the test strip box, the upper control component of the test strip box, the heating component, and the test strip image acquisition component. The display screen is fixedly mounted on the housing; The housing has a door on one side, and the position of the door corresponds to the positioning compartment of the vertical test paper box.

2. The portable isothermal nucleic acid extraction, amplification, and detection device suitable for vertical test kits according to claim 1, characterized in that: The control component under the test strip box includes a motor, a transmission mechanism, and a drive component. The motor drives the drive component to rotate through the transmission mechanism. A control port is provided at the bottom of the vertical test strip box positioning compartment. The drive component extends through the control port into the vertical test strip box positioning compartment. The shape of the drive component matches the shape of the rotating component at the bottom of the vertical test strip box. When the vertical test strip box is inserted into the vertical test strip box positioning compartment, the drive component engages with the rotating component at the bottom of the vertical test strip box. The motor can drive the rotating component to rotate through the transmission mechanism and the drive component.

3. The portable isothermal nucleic acid extraction, amplification, and detection device suitable for vertical test kits according to claim 1, characterized in that: The control assembly below the test strip box also includes an ultrasonic component, the ultrasonic head of which passes through the shaft hole of the drive component and abuts against the rotating component at the bottom of the vertical test strip box.

4. The portable isothermal nucleic acid extraction, amplification, and detection device suitable for vertical test kits according to claim 1, characterized in that: The vertical test strip box positioning compartment is equipped with a sliding seat. Guide limiting strips are provided on the upper sides of the sliding seat. The guide limiting strips are used to guide and limit the horizontal sliding of the sliding seat. The sliding seat is slidably connected to the vertical test strip box positioning compartment. The sliding seat is equipped with a vertical test strip box positioning groove. An opening is provided in the vertical test strip box positioning groove. The position of the opening corresponds to the position of the rotating part at the bottom of the vertical test strip box and the driving part of the control component under the test strip box.

5. The portable isothermal nucleic acid extraction, amplification, and detection device suitable for vertical test kits according to claim 3, characterized in that: Connecting plates are provided on both sides of the sliding seat near the outer ends. The connecting plates have waist-shaped holes. Connecting blocks corresponding to the two connecting plates are provided on the door. Connecting shafts are provided on the connecting blocks and are set in the waist-shaped holes. The connecting shafts can rotate and slide up and down relative to the sliding seat. A V-shaped connecting piece is fixedly connected to the lower part of the connecting block. A connecting seat is provided on the mounting frame on the lower front part of the vertical test paper box positioning compartment. The lower end of the V-shaped connecting piece is movably connected to the connecting seat.

6. The portable isothermal nucleic acid extraction, amplification, and detection device suitable for vertical test kits according to claim 1, characterized in that: The control components on the test strip box include a motor, a lifting base, a lifting transmission mechanism, and a lifting rod. The motor drives the lifting base to move up and down through the lifting transmission mechanism. The lifting rod is fixedly connected to the bottom of the lifting base and extends downward into the positioning compartment of the vertical test strip box. The position of the lifting rod corresponds to the operation hole on the top of the vertical test strip box.

7. The portable isothermal nucleic acid extraction, amplification, and detection device suitable for vertical test kits according to claim 1, characterized in that: The heating assembly includes a connecting seat, a heating block, a guide rod, and a compression spring. The heating block is fixedly connected to the front side of the connecting seat. A through hole is provided on one side of the connecting seat. The front end of the guide rod passes through the through hole and is fixedly connected to the mounting bracket. The position of the heating block corresponds to the position of the heating cavity on the vertical test paper box. A nut is provided at the rear end of the guide rod. The compression spring is located between the nut and the connecting seat. The compression spring pushes the connecting seat forward, causing the heating block to press against the outer wall of the heating cavity of the vertical test paper box.

8. The portable isothermal nucleic acid extraction, amplification, and detection device suitable for vertical test kits according to claim 1, characterized in that: The vertical test paper box has heating grooves on both sides of the heating chamber. The heating component includes a connecting seat and a heating plate. The position of the heating plate corresponds to the position of the heating groove. The connecting seat is fixedly connected to the mounting bracket. After the heating plate is inserted into the heating groove, it can heat the two side walls of the heating chamber.

9. The portable isothermal nucleic acid extraction, amplification, and detection device suitable for vertical test kits according to claim 1, characterized in that: The vertical test strip box contains a heating chip and has contacts for energizing on its side wall. The heating assembly includes a connecting base and an electrical terminal. The electrical terminal is fixedly connected to the front side of the connecting base, and its position corresponds to the contact. A through hole is provided on one side of the connecting base. The front end of the guide rod passes through the through hole and is fixedly connected to the mounting bracket. A nut is provided at the rear end of the guide rod. A compression spring is provided between the nut and the connecting base. The compression spring pushes the connecting base forward, causing the electrical terminal to press against the contact on the outer wall of the heating chamber of the vertical test strip box.

10. The portable isothermal nucleic acid extraction, amplification, and detection device suitable for vertical test kits according to claim 1, characterized in that: The test strip image acquisition component includes a camera and a light source. The camera lens is positioned towards the vertical test strip detection cavity, and the light source is positioned next to the camera, with the light source positioned towards the vertical test strip detection cavity at an angle α.

11. The portable isothermal nucleic acid extraction, amplification, and detection device suitable for vertical test kits according to claim 1, characterized in that: The mounting frame includes a lower mounting frame and an upper mounting frame. The upper mounting frame is fixedly connected above the lower mounting frame. The lower mounting frame has a lower assembly chamber for assembling the lower control component of the test strip box. The lower part of the upper mounting frame has a vertical test strip box positioning compartment for loading the vertical test strip box. Above the vertical test strip box positioning compartment is an upper assembly chamber for assembling the upper control component of the test strip box. The top of the vertical test strip box positioning compartment has a through hole for the lifting rod of the upper control component of the test strip box to enter. The front side of the vertical test strip box positioning compartment has a vertical test strip box inlet corresponding to the compartment door. The rear side of the vertical test strip box positioning compartment has a heating component and a rear detection port. The test strip image acquisition component is located at the rear detection port. The control system is fixedly connected to the rear side of the lower mounting frame and the upper mounting frame.

12. The portable isothermal nucleic acid extraction, amplification, and detection device suitable for vertical test kits according to claim 1, characterized in that: The upper mounting bracket has speakers installed on both sides of its side walls.

13. The portable isothermal nucleic acid extraction, amplification, and detection device suitable for vertical test kits according to claim 1, characterized in that: The top of the upper mounting bracket is equipped with a cooling fan, and the upper part of the housing is equipped with heat dissipation holes.

14. The portable isothermal nucleic acid extraction, amplification, and detection device suitable for vertical test kits according to claim 1, characterized in that: On the front side of the upper mounting frame, above the entrance of the vertical test paper box, there is an electromagnet for locking the compartment door. A locking block is provided at the movable end of the electromagnet, and a corresponding locking slot is provided at the top of the compartment door.

15. The portable isothermal nucleic acid extraction, amplification, and detection device suitable for vertical test kits according to claim 14, characterized in that: A barcode scanner is installed on the upper front wall of the upper mounting frame. The barcode scanner is electrically connected to the electromagnet. The barcode scanner is used to scan the barcodes or QR codes set on the sample container and the vertical test strip box. When the barcode scanner scans the barcode or QR code set on the vertical test strip box, the control system controls the electromagnet to drive the locking block away from the locking port, so that the compartment door is unlocked.

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