Portable isothermal amplification nucleic acid detection bag based on phase change heat release

Abstract

The utility model discloses a portable isothermal amplification nucleic acid detection bag based on phase change heat release, which relates to the field of isothermal amplification nucleic acid detection, and comprises a phase change material mounting bag 101, and a heat conduction main reaction cabin, an enzyme-free water mounting bag and a flow measurement chromatography test strip mounting cabin which are arranged on the phase change material mounting bag 101, a first weak sealing strip is arranged on the enzyme-free water installation bag, an outlet of the heat conduction main reaction cabin is communicated with an inlet of the infusion apparatus, an outlet of the infusion apparatus is communicated with a liquid inlet of the flow measurement chromatography test strip installation cabin, and a second weak sealing strip is arranged on the infusion apparatus. The problems that a current isothermal amplification nucleic acid detection device is complex in structure and high in cost are solved, and instrument-free reaction and result visualization functions aiming at portable isothermal amplification reaction can be achieved.

Description

Technical Field

[0001] This utility model relates to the field of isothermal amplification nucleic acid detection, specifically to a portable isothermal amplification nucleic acid detection bag based on phase change exothermic reaction. Background Technology

[0002] Nucleic acid detection in molecular biology is an important method in the field of pathogen detection, characterized by its strong detection capability and high detection accuracy.

[0003] Existing nucleic acid amplification assays are mainly divided into two types based on temperature control: temperature-switched nucleic acid amplification assays represented by PCR, and isothermal amplification assays represented by loop-mediated amplification (LAMP) and recombinase polymerase amplification (RPA). PCR-based temperature-switched nucleic acid amplification assays require significant temperature fluctuations exceeding 30°C within a short period, placing high demands on the equipment. LAMP and RPA-based isothermal amplification assays only require maintaining a constant temperature to amplify the target nucleic acid in large quantities, eliminating the need for high-precision equipment and promoting their application in rapid on-site testing. While isothermal amplification nucleic acid assays have lower equipment requirements, they still inevitably require temperature control equipment such as water baths or metal baths, exhibiting a strong dependence on the instruments. Furthermore, the visualization of the final results of isothermal amplification nucleic acid assays often uses flow chromatography test strips. During the visualization process after the reaction, it is necessary to open the lid and pipette the system onto the test strip, a process that poses certain biosafety risks.

[0004] Currently, there are several user-friendly isothermal amplification nucleic acid detection devices suitable for non-professionals, such as the utility model patent with application number 202220250338.2 entitled "A Device for Loop-Mediated Isothermal Amplification Nucleic Acid Detection." This device includes a shell and a heater detachably connected to the shell. The shell has a accommodating cavity and a sample dispensing port connected thereto. A reagent strip is placed in the accommodating cavity, and a reaction capsule for holding reagents is placed in the sample dispensing port. The reaction capsule includes a capsule body with openings at both the top and bottom, and a top cap with an opening at the top that covers the capsule body. Encapsulation layers are provided at the bottom opening of the capsule body and the top opening of the top cap. A sealing film is provided at the top opening of the capsule body. The top cap serves as another reaction capsule, with its top and bottom sealed by encapsulation layers. A buffer solution is encapsulated inside the top cap. A heat-conducting component is provided on the outer surface of the capsule body, and a heating head is provided at the end of the heater. The shell has a corresponding insertion interface, and the heating head contacts the heat-conducting component after being inserted into the insertion interface. However, when using it, the piercing column of the propeller needs to pierce the top cover and the top of the capsule body to allow the reagent inside the capsule to enter the surface of the reagent strip in the containment chamber for chromatography. This additional addition of a heater, heat-conducting components and a propeller makes the device more complex and costly, which is not conducive to its widespread application. Utility Model Content

[0005] To address the shortcomings of existing technologies, this invention provides a portable isothermal amplification nucleic acid detection bag based on phase change exothermic reaction, which solves the problems of complex structure and high cost of current isothermal amplification nucleic acid detection devices, and realizes instrument-free reaction and result visualization functions for portable isothermal amplification reaction.

[0006] This utility model is achieved through the following technical solution:

[0007] A portable isothermal amplification nucleic acid detection bag based on phase change exothermic reaction includes a phase change material mounting bag and a thermally conductive main reaction chamber, an enzyme-free water mounting bag, and a flow chromatography test strip mounting chamber disposed on the phase change material mounting bag;

[0008] The outlet of the enzyme-free water installation bag is connected to the inlet of the thermally conductive main reaction chamber, and the outlet of the thermally conductive main reaction chamber is connected to the liquid inlet of the flow chromatography test strip installation chamber. The enzyme-free water installation bag is provided with a first weak sealing strip, which temporarily divides the enzyme-free water installation bag into a first enzyme-free water storage chamber and a second enzyme-free water storage chamber.

[0009] The outlet of the thermally conductive main reaction chamber is connected to the inlet of the infusion set, and the outlet of the infusion set is connected to the inlet of the flow chromatography test strip installation chamber. The infusion set is equipped with a second weak sealing strip, which temporarily divides the infusion set into a first infusion set and a second infusion set.

[0010] The further improvement of this utility model is as follows:

[0011] The phase change material mounting bag has a rectangular longitudinal section, the thermally conductive main reaction chamber has a cuboid structure, and the enzyme-free water mounting bag consists of an integral main bag area and a secondary bag area. The longitudinal section of the main bag area is circular, and the longitudinal section of the secondary bag area is rectangular. The width of the longitudinal section of the secondary bag area is smaller than the diameter of the longitudinal section of the main bag area. The outlet of the secondary bag area is connected to the inlet of the thermally conductive main reaction chamber. The enzyme-free water mounting bag and the thermally conductive main reaction chamber are distributed along the length direction parallel to the phase change material mounting bag.

[0012] The longitudinal section of both the infusion set and the flow chromatography test strip mounting compartment is rectangular, and the infusion set and the flow chromatography test strip mounting compartment are distributed along the height direction parallel to the phase change material mounting bag.

[0013] An enzyme-free water installation bag is provided on each side of the thermally conductive main reaction chamber along its length.

[0014] The thermally conductive storage chamber is located at the bottom of one side formed by the length and height of the phase change material mounting bag. The central axis of the secondary bag area is aligned with the center of the main bag area and the center of the thermally conductive main reaction chamber, respectively. The central axis of the infusion set coincides with the central axis of the flow chromatography test strip mounting chamber and the central axis of the thermally conductive main reaction chamber in the height direction, respectively.

[0015] The top of the flow chromatography test strip installation chamber is equipped with a flow chromatography test strip chamber cover. The length of the flow chromatography test strip chamber cover is equal to the length of the flow chromatography test strip installation chamber, the width of the flow chromatography test strip chamber cover is equal to the width of the flow chromatography test strip installation chamber, and the height of the flow chromatography test strip chamber cover is (1 / 7) to (1 / 6) of the height of the flow chromatography test strip installation chamber.

[0016] The enzyme-free water mounting bag, the flow chromatography test strip compartment cover, the flow chromatography test strip mounting compartment, the thermally conductive main reaction compartment, and the infusion set are all fastened and attached to the phase change material mounting bag by heat pressing.

[0017] The outlet of the secondary bag area is hot-pressed and fastened to both sides of the thermally conductive main reaction chamber along its length. The bottom of the infusion set is hot-pressed and fastened to the top of the thermally conductive main reaction chamber. The top of the infusion set is hot-pressed and fastened to the bottom of the flow chromatography test strip mounting chamber. The bottom of the flow chromatography test strip chamber cover is hot-pressed and fastened to the top of the flow chromatography test strip mounting chamber.

[0018] The longitudinal section of the cavity inside the heat-conducting main reaction chamber is an irregular structure, including a main chamber, a horizontal connecting section and a vertical connecting section, all of which are rectangular and integral. The horizontal connecting section coincides with the central axis of the main chamber in the horizontal direction, and the vertical connecting section coincides with the central axis of the main chamber in the vertical direction. The height of the secondary bag area is less than that of the horizontal connecting section.

[0019] The longitudinal sections of the first infusion set and the second infusion set chamber are both elongated strips with the same width and coincident central axes. The central axis of the longitudinal section of the first infusion set chamber coincides with the vertical connecting section of the heat-conducting main reaction chamber. The width of the longitudinal section of the first infusion set chamber is smaller than the width of the vertical connecting section of the heat-conducting main reaction chamber. The central axis of the second infusion set chamber coincides with the central axis of the flow chromatography test strip mounting chamber. The width of the longitudinal section of the second infusion set chamber is smaller than the width of the longitudinal section of the flow chromatography test strip mounting chamber.

[0020] The flow chromatography test strip mounting compartment has an observation window for observing the detection line and the quality control line.

[0021] The heat-conducting main reaction chamber is provided with an installation hole, and the reaction chamber cover is detachably and sealed in the installation hole.

[0022] The first enzyme-free water storage chamber is far from the heat-conducting main reaction chamber, the space of the first enzyme-free water storage chamber is larger than that of the second enzyme-free water storage chamber, and the chamber of the first infusion set is smaller than that of the second infusion set.

[0023] Compared with the prior art, the present invention has the following beneficial technical effects:

[0024] This invention relates to a portable isothermal amplification nucleic acid detection bag based on phase change exothermic reaction. A phase change material is stored in a storage bag, which releases heat upon stimulation. The lyophilized reagent beads used in the reaction process are housed in the thermally conductive main reaction chamber, which also serves as the main reaction chamber for subsequent isothermal amplification of nucleic acid. The reaction is completed after the phase change material releases heat. A first weak sealing strip on the enzyme-free water storage bag allows for the storage of enzyme-free water at room temperature, temporarily isolating and sealing it from the thermally conductive main reaction chamber. With sufficient external force, this weak sealing strip can be opened, connecting the enzyme-free water storage bag to the thermally conductive main reaction chamber. Squeezing the enzyme-free water storage bag allows the enzyme-free water to enter the thermally conductive main reaction chamber, ensuring thorough mixing of the lyophilized reagent beads, the test sample, and the enzyme-free water. The flow chromatography test strip installation compartment is connected to the thermally conductive main reaction chamber via an infusion set. A second weak sealing strip on the infusion set ensures its sealing during the reaction, preventing the reaction system from prematurely entering the flow chromatography test strip installation compartment and contacting the test strip. After the reaction is complete, squeezing the enzyme-free water installation bag opens the second weak sealing strip, allowing the reaction solution to enter the flow chromatography test strip installation compartment and contact the test strip. After a certain time, the result is determined using the flow chromatography test strip. This invention features a simple structure and low cost, enabling isothermal amplification reactions in a fully enclosed state. This effectively reduces the need for instruments in isothermal amplification nucleic acid detection, while the enclosed structure effectively ensures biosafety, ultimately promoting the application of isothermal amplification nucleic acid detection in home rapid testing. Attached Figure Description

[0025] Figure 1 This is a schematic diagram of the isothermal amplification nucleic acid detection bag described in this utility model.

[0026] Figure 2 for Figure 1 A cross-sectional view.

[0027] Figure 3 for Figure 1 A schematic diagram of the separate components.

[0028] Figure 4 for Figure 1 Internal structural cross-sectional view.

[0029] Figure 5 This is a schematic diagram of the isothermal amplification nucleic acid detection bag reagent mixing and isothermal amplification reaction described in this utility model.

[0030] Figure 6 for Figure 5 Internal structural cross-sectional view.

[0031] Figure 7 This is a partial structural diagram of the isothermal amplification nucleic acid detection bag described in this utility model when visualizing the results.

[0032] Figure 8 for Figure 7 Internal structural cross-sectional view.

[0033] In the diagram: 11-Main bag area, 22-Heat-conducting main reaction chamber cavity, 33-Reaction chamber cover, 44-Phase change material installation area, 55-Enzyme-free water installation bag cavity, 66-Infusion set chamber, 101-Phase change material installation bag, 102-Enzyme-free water installation bag, 103-Flow chromatography test strip cover, 104-Flow chromatography test strip installation chamber, 105-Heat-conducting main reaction chamber, 106-Flow chromatography test strip, 107-Lyophilized reagent beads, 108-Infusion set, 1021-First weak sealing strip, 1081-Second weak sealing strip, 1082-First infusion set, 1083-Second infusion set. Detailed Implementation

[0034] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. The description is for explanation and not limitation of the present invention.

[0035] This invention relates to a portable isothermal amplification nucleic acid detection bag based on phase change exothermic reaction. It can store relevant reaction reagents at room temperature, achieve isothermal amplification of nucleic acid without other instruments, and visualize the detection results under fully enclosed conditions. Specifically, it mainly includes a phase change material mounting bag 101 and an enzyme-free water mounting bag 102, a flow chromatography test strip mounting chamber 104, and a thermally conductive main reaction chamber 105, all made of heat-resistant plastic. The phase change material mounting bag 101 stores phase change material that, after appropriate stimulation, exothermics and can then perform isothermal amplification of nucleic acid; this is generally a cooled supersaturated sodium acetate solution. The enzyme-free water mounting bag 102 stores the enzyme-free water required for the reaction. The thermally conductive main reaction chamber 105 houses lyophilized reagent microbeads 107 used in the reaction process and also serves as the main reaction chamber for subsequent isothermal amplification reactions.

[0036] The outlet of the enzyme-free water installation bag 102 is connected to the inlet of the thermally conductive main reaction chamber 105. The thermally conductive main reaction chamber 105 contains lyophilized reagent microbeads 107. The outlet of the thermally conductive main reaction chamber 105 is connected to the inlet of the flow chromatography test strip installation chamber 104. The enzyme-free water installation bag 102 is provided with a first weak sealing strip 1021. The hot-press welding process can bond materials by heating and pressurizing. The weak sealing strip refers to the strip-shaped area that can temporarily weld two opposite strip-shaped areas of the installation bag together after the installation bag is hot-press welded. In this way, the first weak sealing strip 1021 can temporarily divide the enzyme-free water installation bag 102 into an independent first enzyme-free water storage chamber and a second enzyme-free water storage chamber, which are temporarily separated from and sealed from the thermally conductive main reaction chamber 105. The first enzyme-free water storage chamber is far away from the thermally conductive main reaction chamber 105. Afterwards, under the application of a sufficiently large external force, the weak sealing strip can be opened, connecting the entire enzyme-free water installation bag 102. The outlet of the thermally conductive main reaction chamber 105 is connected to the inlet of the infusion set 108, and the outlet of the infusion set 108 is connected to the inlet of the flow chromatography test strip mounting chamber 104. The infusion set 108 and the flow chromatography test strip mounting chamber 104 form a detection unit, which, together with the enzyme-free water mounting bag 102 and the thermally conductive main reaction chamber 105, constitutes a complete detection assembly. The phase change material mounting bag 101, the enzyme-free water mounting bag 102, and the infusion set 108 are all made of the same material, which is soft plastic with low hardness, and can be polyvinyl chloride, polypropylene, or polyethylene. The thermally conductive main reaction chamber 105 and the flow chromatography test strip mounting chamber 104 are both made of rigid plastic with high hardness, and can be polyphenylene sulfide or polyphthalamide. The phase change material installation bag 101 contains a supersaturated sodium acetate solution containing a metal sheet, which can be an iron sheet, a copper sheet, or an aluminum sheet. Taking an iron sheet as an example, by simply bending the iron sheet, the small bubbles generated by the momentum during the bending process act as condensation nuclei, thereby providing conditions for the precipitation of crystals in the supersaturated solution. The precipitation process is exothermic.

[0037] Before the reaction begins, pressing the first enzyme-free water storage chamber opens the first weak sealing strip 1021, allowing enzyme-free water to enter the heat-conducting main reaction chamber 105. Squeezing the enzyme-free water installation bag 102 thoroughly mixes the lyophilized reagent beads 107, the test sample, and the enzyme-free water. At this point, breaking the iron sheet causes crystals in the supersaturated solution to precipitate, releasing heat. The heat-conducting main reaction chamber 105 then conducts heat, initiating the reaction. The infusion set 108 is equipped with a second weak sealing strip 1081, which temporarily divides the infusion set 108 into a first infusion set 1082 and a second infusion set 1083. 1081 can ensure the sealing condition of the infusion set 108 during the reaction process, preventing the reaction system from prematurely entering the flow chromatography test strip installation chamber 104 and prematurely contacting the flow chromatography test strip 106. After the reaction is completed, squeezing the enzyme-free water installation bag 102 can open the second weak sealing strip 1081, allowing the reaction solution to enter the flow chromatography test strip installation chamber 104 and contact the flow chromatography test strip 106. After a certain period of time, the result is determined by the flow chromatography test strip 106.

[0038] like Figure 1 and Figure 3 As shown, the phase change material storage bag 101 of this invention is designed with a rectangular longitudinal section, and the storage location of the phase change material can be from... Figure 2 As can be seen from the phase change material installation area 44, the heat-conducting main reaction chamber 105 has a cuboid structure. The enzyme-free water installation bag 102 is specifically a main bag area 11 and a secondary bag area with an integrated structure. The longitudinal section of the main bag area 11, which is far away from the heat-conducting main reaction chamber 105, is circular, while the longitudinal section of the secondary bag area is rectangular. The width of the rectangle is smaller than the diameter of the longitudinal section of the main bag area. The outlet of the secondary bag area is connected to the inlet of the heat-conducting main reaction chamber 105. The space of the first enzyme-free water storage chamber is larger than that of the second enzyme-free water storage chamber. The chamber of the first infusion set 1082 is smaller than that of the second infusion set 1083. In this way, the pressing force of the enzyme-free water installation bag 102 is easily concentrated and the pressing force is increased, and the force transmission path is reduced, which is more conducive to opening the first weak sealing strip 1021 and the second weak sealing strip 1081. The enzyme-free water installation bag 102 and the heat-conducting main reaction chamber 105 are distributed along the length direction parallel to the phase change material installation bag 101. On the other hand, both the infusion set 108 and the flow chromatography test strip mounting chamber 104 have rectangular longitudinal sections. The infusion set 108 and the flow chromatography test strip mounting chamber 104 are distributed along the height direction parallel to the phase change material mounting bag 101. This layout facilitates liquid flow and provides a certain degree of neatness to the overall structure. Furthermore, an enzyme-free water mounting bag 102 is provided on each side of the thermally conductive main reaction chamber 105 along its length.

[0039] Specifically, this invention arranges the heat-conducting storage chamber 105 at the bottom of one side of the phase change material mounting bag 101, which is composed of its length and height. Further, the central axis of the secondary bag area is flush with the center of the main bag area and the center of the heat-conducting main reaction chamber 105, respectively. The central axis of the infusion set 108 coincides with the central axis of the flow chromatography test strip mounting chamber 104 and the central axis of the heat-conducting main reaction chamber 105 in the height direction. A flow chromatography test strip cover 103 is also installed on the top of the flow chromatography test strip mounting chamber 104, with its length and width equal to those of the flow chromatography test strip mounting chamber 104. Generally, the height of the flow chromatography test strip cover 103 is (1 / 7) to (1 / 6) of the height of the flow chromatography test strip mounting chamber 104. An observation window for observing the detection line and control line is further provided on the flow chromatography test strip mounting chamber 104, allowing visualization of the results without removing the flow chromatography test strip 106.

[0040] In this invention, the enzyme-free water mounting bag 102, the flow chromatography test strip compartment cover 103, the flow chromatography test strip mounting compartment 104, the thermally conductive main reaction compartment 105, and the infusion set 108 are all hot-pressed onto the phase change material mounting bag 101. During assembly, the top of the infusion set 108 is first hot-pressed onto the bottom of the flow chromatography test strip mounting compartment 104, then the bottom of the infusion set 108 is hot-pressed onto the top of the thermally conductive main reaction compartment 105, and finally the entire assembly is hot-pressed onto the phase change material mounting bag 101. Next, the outlet of the enzyme-free water installation bag 102 is hot-pressed and fastened to both sides of the thermally conductive main reaction chamber 105 along its length. Finally, the flow chromatography test strip 106 is inserted into the flow chromatography test strip installation chamber 104, and the bottom of the flow chromatography test strip chamber cover 103 is hot-pressed and fastened to the top of the flow chromatography test strip installation chamber 104.

[0041] like Figure 4As shown, the cavity within the heat-conducting main reaction chamber 105, i.e., the longitudinal section of the heat-conducting main reaction chamber cavity 22, is an irregular structure, specifically including an integral main chamber, a horizontal connecting section, and a vertical connecting section, all three of which are rectangular. The horizontal connecting section coincides with the central axis of the main chamber in the horizontal direction, and the vertical connecting section coincides with the central axis of the main chamber in the vertical direction. Furthermore, the height of the secondary bag area is less than that of the horizontal connecting section. The longitudinal sections of the first infusion set 1082 chamber and the second infusion set 1083 chamber are both elongated strips with the same width and coincident central axes. The longitudinal section of the first infusion set 1082 chamber... The central axis of the first infusion set 1082 coincides with the vertical connecting section of the heat-conducting main reaction chamber 105. The longitudinal cross-sectional width of the chamber of the first infusion set 1082 is smaller than the width of the vertical connecting section of the heat-conducting main reaction chamber 105. The central axis of the chamber of the second infusion set 1083 coincides with the central axis of the chamber of the flow chromatography test strip mounting chamber 104. The longitudinal cross-sectional width of the chamber of the second infusion set 1083 is smaller than the longitudinal cross-sectional width of the chamber of the flow chromatography test strip mounting chamber 104. The chamber of the flow chromatography test strip mounting chamber 104 is designed according to the size of the flow chromatography test strip 106 so that the flow chromatography test strip 106 can fit against the inner wall of the chamber.

[0042] As a preferred embodiment, this invention features an installation hole on the thermally conductive main reaction chamber 105, through which a reaction chamber cover 33 is detachably and sealed. This facilitates the placement of enzyme-free water, lyophilized reagent microbeads 107, and test samples into the enzyme-free water installation bag cavity 55 of the enzyme-free water installation bag 102. The specific process is as follows:

[0043] Remove the reaction chamber cover 33, fill the heat-conducting main reaction chamber cavity 22 with enzyme-free water, then heat-press the first weak sealing strip 1021 onto the enzyme-free water installation bag 102 by hot-press welding, pour out the excess enzyme-free water, place the lyophilized reagent microbeads 107 in the heat-conducting main reaction chamber cavity 22, and finally put the reaction chamber cover 33 back on.

[0044] Before the reaction begins, the required test sample is added into the cavity 22 of the thermally conductive main reaction chamber through the reaction chamber cover 33. The first weak sealing strip 1021 is opened by pressing the enzyme-free water installation bags 102 on both sides of the thermally conductive main reaction chamber 105. Figure 5 and Figure 6 As shown, alternately squeeze the left and right enzyme-free water mounting bags 102 to thoroughly mix the lyophilized reagent beads 107, the test sample, and the enzyme-free water. After the reaction is complete, simultaneously squeeze the enzyme-free water mounting bags 102 to open the upper second weak sealing strip 1081, as shown. Figure 7 As shown and Figure 8 As shown, after the reaction is completed, the reaction solution comes into contact with the flow chromatography test strip 106 above, and after waiting for a certain period of time, the result is determined by the flow chromatography test strip 106.

[0045] It should be noted that, in order to demonstrate that the first weak sealing strip 1021 and the second weak sealing strip 1081 will have some marks on their upper and lower parts after being opened, this utility model includes a section showing these marks. Figure 6 and Figure 8 There is a certain protrusion in the middle. Furthermore, the number of thermally conductive main reaction chambers 105, or the number of detection units relative to the thermally conductive main reaction chambers 105, in this portable isothermal amplification nucleic acid detection bag can be adjusted according to actual production and usage needs. Previously, it was explained with one thermally conductive main reaction chamber 105 and one detection unit. Of course, one thermally conductive main reaction chamber 105 can be symmetrically arranged with another detection unit in its vertical direction, that is, opposite to the direction of the infusion set 108 and the flow chromatography test strip mounting chamber 104. Furthermore, the size of the phase change material mounting bag 101 can be adjusted, with multiple relatively separate detection components arranged on one side formed by its length and height, and detection components arranged as needed on the other side formed by its length and height. The following explanation uses one detection component per side.

[0046] This invention relates to a portable isothermal amplification nucleic acid detection bag based on phase change exothermic reaction. Taking the RPA-LFS detection process of the novel coronavirus as an example, the specific detection process is as follows:

[0047] Step 1: Open the reaction chamber cover 33 of the nucleic acid test bag, add the sample that meets the reaction requirements into the cavity 22 of the thermally conductive main reaction chamber, and reinstall the reaction chamber cover 3 back into the thermally conductive main reaction chamber 105.

[0048] Step 2: Press the left and right enzyme-free water installation bags 102 respectively to open the first weak sealing strip 1021, allowing the enzyme-free water to enter the thermally conductive main reaction chamber cavity 22. Press the left and right enzyme-free water installation bags 102 alternately to ensure that the lyophilized reagent beads 107, the test sample, and the enzyme-free water are thoroughly mixed in the thermally conductive main reaction chamber cavity 22.

[0049] Step 3: Break the iron sheet to stimulate the cooled supersaturated sodium acetate solution to release heat, and start timing for 30 minutes.

[0050] Step 4: After the 30-minute timer expires, simultaneously squeeze the left and right enzyme-free water installation bags 102 to open the second weak sealing strip 1081 and bring it into contact with the flow chromatography test strip 106.

[0051] Step 5: After the system comes into contact with the flow chromatography test strip 106, wait for a certain period of time. The presence and color intensity of the detection line and control line on the flow chromatography test strip 106 can be used to determine whether the sample is infected with the relevant virus.

[0052] Based on 20 simulated clinical samples, the results obtained by this nucleic acid detection kit were consistent with those obtained by the qPCR method, demonstrating that the method has good detection consistency.

Claims

1. A portable isothermal amplification nucleic acid detection bag based on phase transition exothermic reaction, characterized in that, It includes a phase change material mounting bag (101) and a thermally conductive main reaction chamber (105), an enzyme-free water mounting bag (102), and a flow chromatography test strip mounting chamber (104) disposed on the phase change material mounting bag (101). The outlet of the enzyme-free water installation bag (102) is connected to the inlet of the thermally conductive main reaction chamber (105), and the outlet of the thermally conductive main reaction chamber (105) is connected to the liquid inlet of the flow chromatography test strip installation chamber (104). The enzyme-free water installation bag (102) is provided with a first weak sealing strip (1021), which temporarily divides the enzyme-free water installation bag (102) into a first enzyme-free water storage chamber and a second enzyme-free water storage chamber. The outlet of the thermally conductive main reaction chamber (105) is connected to the inlet of the infusion set (108), and the outlet of the infusion set (108) is connected to the inlet of the flow chromatography test strip installation chamber (104). The infusion set (108) is provided with a second weak sealing strip (1081), which temporarily divides the infusion set (108) into a first infusion set (1082) and a second infusion set (1083).

2. The portable isothermal amplification nucleic acid detection bag based on phase change exothermic reaction as described in claim 1, characterized in that, The phase change material mounting bag (101) has a rectangular longitudinal section, the thermally conductive main reaction chamber (105) has a cuboid structure, and the enzyme-free water mounting bag (102) is an integral main bag area and a secondary bag area. The longitudinal section of the main bag area is circular, and the longitudinal section of the secondary bag area is rectangular. The width of the longitudinal section of the secondary bag area is smaller than the diameter of the longitudinal section of the main bag area. The outlet of the secondary bag area is connected to the inlet of the thermally conductive main reaction chamber (105). The enzyme-free water mounting bag (102) and the thermally conductive main reaction chamber (105) are distributed along the length direction parallel to the phase change material mounting bag (101). The longitudinal section of the infusion set (108) and the flow chromatography test strip mounting chamber (104) is rectangular, and the infusion set (108) and the flow chromatography test strip mounting chamber (104) are distributed along the height direction parallel to the phase change material mounting bag (101).

3. The portable isothermal amplification nucleic acid detection bag based on phase transition exothermic reaction according to claim 2, characterized in that, An enzyme-free water installation bag (102) is provided on each side of the thermally conductive main reaction chamber (105) along its length.

4. The portable isothermal amplification nucleic acid detection bag based on phase change exothermic reaction as described in claim 3, characterized in that, The thermally conductive main reaction chamber (105) is located at the bottom of one side formed by the length and height of the phase change material mounting bag (101). The central axis of the secondary bag area is flush with the center of the main bag area and the center of the thermally conductive main reaction chamber (105). The central axis of the infusion set (108) coincides with the central axis of the flow chromatography test strip mounting chamber (104) and the central axis of the thermally conductive main reaction chamber (105) in the height direction.

5. The portable isothermal amplification nucleic acid detection bag based on phase change exothermic reaction according to claim 4, characterized in that, The top of the flow chromatography test strip installation chamber (104) is equipped with a flow chromatography test strip chamber cover (103). The length of the flow chromatography test strip chamber cover (103) is equal to the length of the flow chromatography test strip installation chamber (104), the width of the flow chromatography test strip chamber cover (103) is equal to the width of the flow chromatography test strip installation chamber (104), and the height of the flow chromatography test strip chamber cover (103) is 1 / 7 to 1 / 6 of the height of the flow chromatography test strip installation chamber (104).

6. The portable isothermal amplification nucleic acid detection bag based on phase change exothermic reaction as described in claim 5, characterized in that, The enzyme-free water mounting bag (102), the flow chromatography test strip compartment cover (103), the flow chromatography test strip mounting compartment (104), the thermally conductive main reaction compartment (105), and the infusion set (108) are all fastened to the phase change material mounting bag (101) by heat pressing. The outlet of the secondary bag area is hot-pressed and fastened to both sides of the thermally conductive main reaction chamber (105) along its length. The bottom of the infusion set (108) is hot-pressed and fastened to the top of the thermally conductive main reaction chamber (105). The top of the infusion set (108) is hot-pressed and fastened to the bottom of the flow chromatography test strip installation chamber (104). The bottom of the flow chromatography test strip chamber cover (103) is hot-pressed and fastened to the top of the flow chromatography test strip installation chamber (104).

7. The portable isothermal amplification nucleic acid detection bag based on phase change exothermic reaction as described in claim 6, characterized in that, The longitudinal section of the cavity in the heat-conducting main reaction chamber (105) is an irregular structure, including a main chamber, a horizontal connecting section and a vertical connecting section, all of which are rectangular and integral structures. The horizontal connecting section coincides with the central axis of the main chamber in the horizontal direction, and the vertical connecting section coincides with the central axis of the main chamber in the vertical direction. The height of the secondary bag area is less than that of the horizontal connecting section. The longitudinal sections of the chambers of the first infusion set (1082) and the second infusion set (1083) are both long strips with the same width and coincident central axes. The central axis of the longitudinal section of the chamber of the first infusion set (1082) coincides with the vertical connecting section of the heat-conducting main reaction chamber (105). The width of the longitudinal section of the chamber of the first infusion set (1082) is smaller than the width of the vertical connecting section of the heat-conducting main reaction chamber (105). The central axis of the chamber of the second infusion set (1083) coincides with the central axis of the chamber of the flow chromatography test strip installation chamber (104). The width of the longitudinal section of the chamber of the second infusion set (1083) is smaller than the width of the longitudinal section of the chamber of the flow chromatography test strip installation chamber (104).

8. The portable isothermal amplification nucleic acid detection bag based on phase change exothermic reaction as described in claim 1, characterized in that, The flow chromatography test strip mounting compartment (104) is provided with an observation window for observing the test line and the quality control line.

9. The portable isothermal amplification nucleic acid detection bag based on phase transition exothermic reaction according to claim 1, characterized in that, The heat-conducting main reaction chamber (105) has an installation hole, and the reaction chamber cover (33) is detachably and sealed in the installation hole.

10. The portable isothermal amplification nucleic acid detection bag based on phase transition exothermic reaction according to claim 1, characterized in that, The first enzyme-free water storage chamber is far from the heat-conducting main reaction chamber (105), the space of the first enzyme-free water storage chamber is larger than that of the second enzyme-free water storage chamber, and the chamber of the first infusion set (1082) is smaller than that of the second infusion set (1083).

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