Disposable nucleic acid detection device
By designing a portable nucleic acid detection device that integrates sample processing, reaction amplification and result interpretation functions, the problem of complex structure, large size and inability to portability in the prior art is solved, and rapid and accurate nucleic acid detection is achieved on-site or in primary medical institutions.
Patent Information
- Application Number
- CN202421146363.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-05-23
- Publication Date
- 2025-03-04
- Estimated Expiration
- 2034-05-23
AI Technical Summary
The existing nucleic acid detection devices have complex structures and large sizes, which are inconvenient for movement and sample pick-up and placement. At the same time, nucleic acid detection experiments require professional personnel to operate, and they cannot be carried out quickly on-site or at primary medical institutions.
A disposable nucleic acid detection device is designed, including a reagent tube and a nucleic acid detection device. The device is assembled from the upper case, the lower case and the back cover plate, integrating sample processing, reaction amplification and result interpretation functions, and automated control is achieved using circuit boards, emission light sources, color sensors and main control chips.
It realizes portable nucleic acid testing, simplifies the operation process, does not require additional equipment, and can conduct rapid testing on site or in primary medical institutions, improving the convenience and accuracy of testing.
Smart Images

Figure CN222556944U_ABST
Abstract
Description
Technical Field
[0001] The utility model belongs to the technical field of biological detection, and specifically relates to a disposable nucleic acid detection device. Background Art
[0002] Nucleic acid testing is a laboratory test method used to diagnose viral infections. Nucleic acid refers to the DNA or RNA of the virus. Nucleic acid testing is to analyze the viral gene sequence after obtaining body fluids or blood through nucleic acid extraction technology, reverse transcription technology, and PCR molecular amplification technology. It is mainly used for the diagnosis of hepatitis B, AIDS, and new coronavirus infections, and has high sensitivity and specificity.
[0003] The substance of nucleic acid testing is the nucleic acid of the virus. Whether the virus is infected is determined by looking for the nucleic acid of the invading virus in respiratory specimens, blood or feces. At present, nucleic acid testing has important applications in disease diagnosis, epidemic prevention and control, health monitoring and virus detection. PCR instruments are expensive, and the fluorescent quantitative PCR method has high requirements for personnel operation and detection instruments, which cannot meet the requirements of grassroots health institutions to quickly test a large number of clinical samples.
[0004] The loop-mediated isothermal amplification (LAMP) technique can overcome these problems well. It only needs to provide a constant temperature to complete the amplification reaction. Currently, metal baths and constant temperature water baths are commonly used as heating instruments for LAMP reactions. At the same time, according to the characteristics of the LAMP reaction, after the reaction, agarose gel electrophoresis, turbidity and other methods can be used to determine whether the sample contains viral nucleic acid. However, both of these result interpretation methods require the use of additional instruments. Agarose gel electrophoresis requires the use of an electrophoresis instrument, and it is easy to produce aerosol pollution, which affects the accuracy of subsequent tests; the turbidity detection method requires the use of a turbidity meter to judge the results. Since LAMP detection requires the use of multiple instruments from sample processing to result interpretation, and the above instruments are large and inconvenient to carry, they cannot be used in scenarios such as on-site testing, primary medical institutions, and bedside testing (POCT).
[0005] If you use test strips, the test may be inaccurate due to improper storage or carrying, as well as operating errors by older people or not being able to see the indicator strip clearly;
[0006] Therefore, there is a need to provide a portable nucleic acid detection device that can integrate sample processing, reaction amplification, and result interpretation without the need for additional equipment and has accurate testing to solve the problems existing in the above-mentioned prior art. Utility Model Content
[0007] In view of this, the present utility model provides a disposable nucleic acid detection device, which is intended to solve the problems of existing nucleic acid detection, nucleic acid amplification and detection devices, which are complex in structure, large in size, inconvenient to move and take and place samples. If test strips are used, inaccurate tests may occur due to improper storage or carrying, as well as operating errors by older people or unclear indication of the indicator strip.
[0008] To achieve the above-mentioned purpose, the utility model provides the following technical solution: a disposable nucleic acid detection device, comprising a reagent tube and a nucleic acid detection device,
[0009] The housing portion of the nucleic acid detection device is assembled by an upper housing, a lower housing and a rear cover plate which are buckled in sequence;
[0010] A reagent tube placement slot is provided on the top of the upper shell, and the interior of the upper shell is used to place a nucleic acid detection mechanism, and the nucleic acid detection mechanism is located directly below the reagent tube placement slot;
[0011] The lower housing is used to place a circuit board and a power supply device, and the circuit board is electrically connected to the power supply device;
[0012] The nucleic acid detection mechanism comprises a reagent tube positioning rack, a puncture rack and a reaction cup which are assembled in sequence from top to bottom;
[0013] The puncture frame includes eight flow channels, and a water-absorbing sponge is arranged at the outer end of each flow channel, and a metal puncture needle is arranged at the top of the puncture frame;
[0014] The outer wall of the reaction cup is provided with eight optical paths, the inner cavity of the reaction cup is provided with eight reagent inflow grooves, the eight reagent inflow grooves correspond to the positions of the eight flow channels, and the reagent inflow grooves and flow channels at corresponding positions in each group constitute a passage;
[0015] The circuit board is provided with eight emitting light sources, and the eight emitting light sources are respectively placed in eight optical paths. The circuit board is provided with a color sensor, a main control chip and a display light source, and the emitting light source, the color sensor and the display light source are all electrically connected to the main control chip.
[0016] Preferably, a battery box is provided at the bottom of the inner cavity of the lower shell, and the battery box is used to place the power supply device. The battery box is located below the circuit board, and the power supply device is a battery.
[0017] Preferably, a rear cover plate is detachably mounted on the bottom end of the lower shell.
[0018] Preferably, the inner wall of the reagent tube placement groove is provided with internal reinforcing ribs of the upper shell, and the internal reinforcing ribs of the upper shell are X vertically arranged rubber strips, and the X rubber strips are evenly distributed on the inner wall of the reagent tube placement groove.
[0019] Preferably, X is an integer, and 8≤X≤12.
[0020] Preferably, an external circular positioning column is provided on the top of the reagent tube positioning rack.
[0021] Preferably, a ring-shaped heating copper foil is arranged on the top of the circuit board, and the ring-shaped heating copper foil is electrically connected to the main control chip.
[0022] Preferably, the annular heating copper foil is located directly below the reaction cup.
[0023] Preferably, eight mounting pieces are provided at the bottom of the puncture frame, and eight mounting grooves for use with the mounting pieces are provided on the circuit board.
[0024] Compared with the prior art, the beneficial effects of the automatic control circuit protection device provided by the utility model are:
[0025] The existing nucleic acid amplification and detection devices for nucleic acid detection are complex in structure, large in size, and inconvenient to move and take and place samples;
[0026] Nucleic acid testing experiments are usually conducted in hospitals, but the test kits are usually high-throughput, the cost of single-person testing is expensive, and professional personnel are required to operate;
[0027] Problems such as being unable to conduct on-site testing based on local conditions;
[0028] At the same time, it also solves the problem that easy-to-carry test strips may cause inaccurate testing due to improper storage or carrying, as well as operating errors by older people or unclear reading of the indicator strips. BRIEF DESCRIPTION OF THE DRAWINGS
[0029] In order to more clearly illustrate the technical solution of the implementation mode of the utility model, the drawings required for use in the implementation mode will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the utility model and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without paying creative work.
[0030] Figure 1 This is a schematic diagram of the overall appearance of the utility model;
[0031] Figure 2 This is the overall exploded view of the utility model;
[0032] Figure 3 This is a schematic diagram for explaining the positioning of the reagent tube in the utility model;
[0033] Figure 4 It is a structural schematic diagram of the puncture frame in the utility model;
[0034] Figure 5 This is a schematic diagram of the structure of the reaction cup in the utility model;
[0035] Figure 6 It is a structural schematic diagram of the circuit board in the utility model;
[0036] Figure 7 It is a structural schematic diagram of the indicator light in the utility model;
[0037] Figure 8 This is a structural block diagram of the main control chip in the circuit board of the utility model;
[0038] Fig. 9 It is a schematic diagram of the workflow of the utility model.
[0039] In the accompanying drawings, the components represented by the reference numerals are listed as follows:
[0040] 1-reagent tube; 2-nucleic acid detection device; 21-upper shell; 211-inner reinforcement ribs of the upper shell; 22-lower shell; 23-back cover; 3-reagent tube positioning frame; 31-external circular positioning column; 4-puncture frame; 41-metal puncture needle; 42-absorbent sponge; 43-flow channel; 44-mounting piece; 5-reaction cup; 51-reagent inflow slot; 52-optical path; 6-circuit board; 61-emitting light source; 62-ring heating copper foil; 63-color sensor; 64-main control chip; 65-display light source; 66-mounting slot; 7-battery; DETAILED DESCRIPTION
[0041] In order to make the purpose, technical solution and advantages of the implementation of the utility model clearer, the technical solution in the implementation of the utility model will be clearly and completely described below in conjunction with the drawings in the implementation of the utility model. Obviously, the described implementation is a part of the implementation of the utility model, not all of the implementations. Based on the implementation of the utility model, all other implementations obtained by ordinary technicians in this field without creative work are within the scope of protection of the utility model.
[0042] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in the field without creative work are within the scope of protection of the present invention.
[0043] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.
[0044] In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.
[0045] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of the present utility model, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.
[0046] like Figure 1-3 As shown, the utility model provides a disposable nucleic acid detection device, including a reagent tube 1 and a nucleic acid detection device 2.
[0047] The housing portion of the nucleic acid detection device 2 is assembled by an upper housing 21, a lower housing 22 and a rear cover plate 23 which are buckled in sequence;
[0048] A reagent tube placement slot is provided on the top of the upper shell 21, and a nucleic acid detection mechanism is placed inside the upper shell 21, and the nucleic acid detection mechanism is located directly below the reagent tube placement slot;
[0049] The lower housing 22 is used to place the circuit board 6 and the power supply device, and the circuit board 6 is electrically connected to the power supply device;
[0050] The nucleic acid detection mechanism comprises a reagent tube positioning frame 3, a puncture frame 4 and a reaction cup 5 which are assembled in sequence from top to bottom;
[0051] The puncture frame 4 includes eight flow channels 43, and a water-absorbing sponge 42 is provided at the outer end of each flow channel 43, and a metal puncture needle 41 is provided at the top of the puncture frame;
[0052] The outer wall of the reaction cup 5 is provided with eight optical paths 52, and the inner cavity of the reaction cup 5 is provided with eight reagent inflow grooves 51, the eight reagent inflow grooves 51 correspond to the positions of the eight flow channels 43, and the reagent inflow grooves 51 and the flow channels 43 at the corresponding positions in each group constitute a passage;
[0053] The circuit board 6 is provided with eight emitting light sources 61, and the eight emitting light sources 61 are respectively placed in eight optical paths 52. The circuit board is provided with a color sensor 63, a main control chip 64 and a display light source 65, and the emitting light source 61, the color sensor 63 and the display light source 65 are all electrically connected to the main control chip 64.
[0054] The main control chip 64 adopts a microcontroller (model Stm32f103c8t6).
[0055] The reagent tube is loaded into a disposable portable nucleic acid detection device, and with a little force, the metal puncture needle pierces the coated tape. Under the action of the absorbent sponge, the reagent flows along the flow channel into the designated position of the reaction cup, and then the annular heating copper foil on the circuit board is heated to keep the reagent at a constant temperature of 37℃±0.1℃ for a period of time; there is an emitting light source (of a certain wavelength) on the circuit board, which is recognized by the color sensor on the circuit board after passing through the reaction tank, and the main control chip judges and gives a judgment result.
[0056] Specifically, a battery box is provided at the bottom of the inner cavity of the lower shell 22 . The battery box is used to place a power supply device. The battery box is located below the circuit board 6 . The power supply device is a battery 7 .
[0057] Specifically, a rear cover plate 23 is detachably mounted on the bottom end of the lower housing 22 .
[0058] Specifically, the inner wall of the reagent tube placement groove is provided with an upper shell internal reinforcing rib 211, and the upper shell internal reinforcing rib 211 is X vertically arranged rubber strips, and the X rubber strips are evenly distributed on the inner wall of the reagent tube placement groove.
[0059] The reagent tube is limited by the internal reinforcing ribs of the upper shell, and the reagent tube can be reliably positioned and limited by the upper shell and the reagent tube positioning frame.
[0060] Specifically, X is an integer, and 8≤X≤12.
[0061] Specifically, an external circular positioning column 31 is provided on the top of the reagent tube positioning rack 3 .
[0062] Specifically, a ring-shaped heating copper foil 62 is disposed on the top of the circuit board 6 , and the ring-shaped heating copper foil 62 is electrically connected to the main control chip 64 .
[0063] Specifically, the annular heating copper foil 62 is located directly below the reaction cup 5 .
[0064] Specifically, eight mounting members 44 are disposed at the bottom of the puncture frame 4, and eight mounting grooves 66 for use with the mounting members are disposed on the circuit board 6.
[0065] Working principle: Install the battery into the disposable portable nucleic acid detection device, buckle the back cover into the disposable portable nucleic acid detection device, and the Ready light will be on; collect the specimen using the throat swab specimen collection method, and place the specimen into the reagent tube; install the reagent tube into the disposable portable nucleic acid detection device, and use a little force, the metal puncture needle will pierce the coated tape, and the reagent will flow into the designated position of the reaction cup along the flow channel under the action of the absorbent sponge, and then the annular heating copper foil on the circuit board will heat the reagent to keep the constant temperature at 37℃±0.1℃ for a period of time.
[0066] DNA denaturation refers to the breaking of hydrogen bonds between double helices, the unwinding of double helices, and the formation of single-stranded irregular coils, which results in changes in properties (such as decreased viscosity, increased sedimentation velocity, increased buoyancy, increased ultraviolet absorption, etc.). Heating, changing the pH of the DNA solution, or being affected by physical and chemical factors such as organic solvents (such as ethanol, urea, formamide, and propionamide, etc.) can all cause DNA to denature.
[0067] Usually, the change of ultraviolet absorption at 260nm wavelength after DNA denaturation can be used to track the denaturation process. Because DNA has the maximum absorption value at 260nm, this characteristic is due to the base composition. In the DNA double helix structure model, the base is hidden inside. When denaturing, the double helix is unwound, so the base is exposed, and the ultraviolet absorption value at 260nm increases. This phenomenon is called the hyperchromic effect.
[0068] The bases that make up the nucleic acid molecules have certain ultraviolet absorption characteristics, and the maximum absorption wavelength is 260nm. If there is viral nucleic acid in the sample, the bases are amplified into virus-specific DNA under the action of virus-specific primers and amplification enzymes, resulting in a decrease in the absorbance of the sample at 260nm, which is called the "DNA subtractive reaction". If there is no viral nucleic acid in the sample, the absorbance of the sample remains unchanged. The optical sensor can determine the degree of change in ultraviolet light, thereby determining whether there is viral nucleic acid in the sample, and thus determining the positive and negative nature of the sample. There is an LED emitting light source on the circuit board. After the emitting light source passes through the reaction cup, the change in ultraviolet light is recognized by the optical sensor on the circuit board, and the optical sensor outputs an analog signal. The analog signal is read and processed by the microcontroller and converted into a digital signal, and the judgment result is output at the same time. The judgment result is displayed by the LED; after the test is completed, the display light Done is on, and when the display light Positive is on, the result is negative, not infected; when the Negative light is on, the result is positive, infected.
[0069] The existing nucleic acid amplification and detection devices for nucleic acid detection are complex in structure, large in size, and inconvenient to move and take and place samples;
[0070] Nucleic acid testing experiments are usually conducted in hospitals, but the test kits are usually high-throughput, the cost of single-person testing is expensive, and professional personnel are required to operate;
[0071] Problems such as being unable to conduct on-site testing based on local conditions;
[0072] At the same time, it also solves the problem that easy-to-carry test strips may cause inaccurate testing due to improper storage or carrying, as well as operating errors by older people or unclear reading of the indicator strips.
[0073] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.
Claims
1. A disposable nucleic acid detection device, comprising a reagent tube (1) and a nucleic acid detection device (2), characterized in that: The housing portion of the nucleic acid detection device (2) is assembled from an upper housing (21), a lower housing (22) and a rear cover plate (23) which are buckled in sequence; A reagent tube placement slot is provided on the top of the upper shell (21), and a nucleic acid detection mechanism is placed inside the upper shell (21), and the nucleic acid detection mechanism is located directly below the reagent tube placement slot; The lower housing (22) is used to place a circuit board (6) and a power supply device, and the circuit board (6) is electrically connected to the power supply device; The nucleic acid detection mechanism comprises a reagent tube positioning frame (3), a puncture frame (4) and a reaction cup (5) which are assembled in sequence from top to bottom; The puncture frame (4) comprises eight flow channels (43), and a water-absorbing sponge (42) is arranged at the outer end of each flow channel (43), and a metal puncture needle (41) is arranged at the top of the puncture frame; The outer wall of the reaction cup (5) is provided with eight optical paths (52), and the inner cavity of the reaction cup (5) is provided with eight reagent inflow grooves (51), the eight reagent inflow grooves (51) correspond to the positions of the eight flow channels (43), and the reagent inflow grooves (51) and the flow channels (43) at corresponding positions in each group constitute a passage; The circuit board (6) is provided with eight emitting light sources (61), and the eight emitting light sources (61) are respectively placed in eight light paths (52); the circuit board is provided with a color sensor (63), a main control chip (64) and a display light source (65), and the emitting light source (61), the color sensor (63) and the display light source (65) are all electrically connected to the main control chip (64).
2. The disposable nucleic acid detection device according to claim 1, characterized in that: A battery box is provided at the bottom of the inner cavity of the lower housing (22), and the battery box is used to accommodate a power supply device. The battery box is located below the circuit board (6), and the power supply device is a battery (7).
3. The disposable nucleic acid detection device according to claim 2, characterized in that: A rear cover plate (23) is detachably mounted on the bottom end of the lower housing (22).
4. The disposable nucleic acid detection device according to claim 1, characterized in that: The inner wall of the reagent tube placement groove is provided with an upper shell internal reinforcing rib (211), and the upper shell internal reinforcing rib (211) is X vertically arranged rubber strips, and the X rubber strips are evenly distributed on the inner wall of the reagent tube placement groove.
5. The disposable nucleic acid detection device according to claim 4, characterized in that: The X is an integer, and 8≤X≤12.
6. The disposable nucleic acid detection device according to claim 1, characterized in that: An external circular positioning column (31) is arranged on the top of the reagent tube positioning frame (3).
7. The disposable nucleic acid detection device according to claim 1, characterized in that: An annular heating copper foil (62) is provided on the top of the circuit board (6), and the annular heating copper foil (62) is electrically connected to a main control chip (64).
8. The disposable nucleic acid detection device according to claim 7, characterized in that: The annular heating copper foil (62) is located directly below the reaction cup (5).
9. The disposable nucleic acid detection device according to claim 1, characterized in that: The bottom of the puncture frame (4) is provided with eight mounting pieces (44), and the circuit board (6) is provided with eight mounting grooves (66) used in conjunction with the mounting pieces.