A portable test strip detection device

Abstract

The present invention provides a portable test strip detection device, including a main body and a sample tube. A second puncturing mechanism is provided on the wall of the main body. One end of the second puncturing mechanism is arranged inside the main body and the other end is arranged outside the main body. The second puncturing mechanism can move from a first position to a second position. When the detection device is not in use, the second puncturing mechanism is located at the first position. When the second puncturing mechanism is moved to the second position, the second puncturing mechanism punctures the sealing layer. By adopting the above technical solution, after the chromatographic test strip completes the detection, the second puncturing mechanism can move to the second position to puncture the sealing layer, so that the liquid in the liquid storage tank reacts with the sample solution on the chromatographic test strip and in the sample tube, completely removing the residual nucleic acid in the portable test strip detection device. In this way, even if the sample tube accidentally falls off during the subsequent process, or the portable test strip detection device is damaged and the inside is exposed, no contamination will be caused.

Description

Technical Field

[0001] The present invention relates to the field of detection, and particularly to a portable test strip detection device. Background Art

[0002] Nucleic acid diagnosis is one of the most dynamic sub - fields in the future IVD (in vitro diagnosis) industry. The strengthening of infectious disease prevention and control in China, the popularization of nucleic acid testing for blood screening, and the development of personalized medicine are the main driving forces for the development of domestic nucleic acid diagnosis. Driven by these factors, the future growth rate of domestic nucleic acid diagnosis will be between 25% and 30%, significantly exceeding the average growth rate of the domestic IVD industry. On the one hand, nucleic acid diagnosis benefits large medical centers, enabling early, rapid, specific, and high - throughput detection of pathogens, genetic diseases, etc.

[0003] POCT (point - of - care testing), which is translated into Chinese as "instant testing", is an emerging sub - industry of in vitro diagnosis (IVD). It is a new method that analyzes immediately at the sampling site, eliminating the complex processing procedures of specimens in the laboratory and quickly obtaining test results. The main criteria for POCT are that it does not require a fixed testing location, the reagents and instruments are portable, and can be operated in a timely manner. POCT undertakes the functions of a laboratory but does not require traditional hospital laboratory equipment, and can serve patients 24 hours a day without being restricted by time and location.

[0004] However, these nucleic acid amplification methods have the problem of easy cross - contamination of amplification products. False - positive signals caused by product contamination can lead to misinterpretation of test results. During the operation of target nucleic acid amplification, cross - contamination between samples is often visible. The contamination may come from known or unknown positive substances introduced during the processing of negative samples, which cause false - positive reactions through air pollution or aerosol.

[0005] In the prior art, a series of methods have been developed to prevent cross - contamination of amplification products. For example, in Reference 1 (CN105199940A), a pollution - proof portable gene detection method and device are disclosed. Through this device, a nucleic acid amplification tube containing amplification products can be placed into the device for sealing, and then the nucleic acid amplification tube is punctured to achieve detection. It can prevent the contamination of nucleic acid amplification products and avoid false positives. However, in this device, since the nucleic acid amplification tube is placed in the device and sealed, the puncturing operation is relatively difficult, and the amplification products after the test still remain in the device. Once damaged, the amplification products may also spread into the air, causing false - positive reactions.

[0006] In addition, a closed chromatographic test strip plastic cartridge is also disclosed in Reference Document 2 (CN203241416U), and a sealed test tube assembly with a tube-breaking mechanism is also disclosed in Reference Document 3 (CN205574438U). These detection devices are relatively convenient to operate, but the amplified products also remain in the devices after detection, posing a risk of contamination.

[0007] Therefore, providing a nucleic acid detection device with a lower possibility of contamination before and after detection has become an urgent problem to be solved in this field. Summary of the Invention

[0008] The object of the present invention is to solve the problems that the existing closed detection devices are inconvenient to operate and there is still a possibility of contamination after detection. To solve the above problems, the present invention discloses a portable test strip detection device, which is convenient to operate through this device, and can effectively prevent the amplified products from diffusing into the air and causing false positive reactions.

[0009] To solve the above problems, the present invention discloses a portable test strip detection device, including a main body and a sample tube.

[0010] A receiving cavity is provided in the main body. A liquid storage tank, a sealing layer, a chromatographic test strip and a first puncturing mechanism are sequentially arranged in the receiving cavity from bottom to top. The upper surface of the liquid storage tank is sealed by the sealing layer. The first puncturing mechanism is fixedly connected in the main body, and a fluid channel is provided on the first puncturing mechanism.

[0011] A second puncturing mechanism is further provided on the wall of the main body. One end of the second puncturing mechanism is arranged inside the main body, and the other end is arranged outside the main body. The second puncturing mechanism can move from a first position to a second position. When the detection device is not in use, the second puncturing mechanism is located at the first position. When the second puncturing mechanism is moved to the second position, the second puncturing mechanism punctures the sealing layer.

[0012] Adopting the above technical solution, when the chromatographic test strip completes the detection, the second puncturing mechanism can move to the second position and puncture the sealing layer, so that the liquid in the liquid storage tank reacts with the sample solution on the chromatographic test strip and in the sample tube, completely removing the residual nucleic acid in the portable test strip detection device. In this way, even if the sample tube accidentally falls off or the portable test strip detection device is damaged and the inside is exposed during the subsequent process, no contamination will be caused.

[0013] According to another specific embodiment of the present invention, the second puncturing mechanism is connected to the main body by a threaded connection. By rotating the second puncturing mechanism, the second puncturing mechanism can be moved from the first position to the second position.

[0014] According to another specific embodiment of the present invention, a baffle is provided between the sealing layer and the second puncturing mechanism. The baffle can move from a third position to a fourth position. When the baffle is in the third position, the baffle hinders the downward movement of the second puncturing mechanism. When the baffle moves to the fourth position, as the second puncturing mechanism is screwed in, the second puncturing mechanism can puncture the sealing layer.

[0015] According to another specific embodiment of the present invention, the sample solution addition area includes a cylindrical first channel. A sealing ring made of an elastic body is provided at the insertion end of the first channel, or a sealing ring made of an elastic body is provided outside the side wall of the sample tube.

[0016] According to another specific embodiment of the present invention, the detection result observation area is made of a transparent material. Description of the Drawings

[0017] The present invention will be further described in detail below in conjunction with the drawings and specific embodiments:

[0018] Figure 1 is a three-dimensional structure diagram of the portable test strip detection device provided by the present invention;

[0019] Figure 2 is a cross-sectional view of the portable test strip detection device provided by the present invention;

[0020] Figure 3 is an exploded schematic view of the portable test strip detection device provided by the present invention;

[0021] Figure 4 is a cross-sectional view of the sample tube provided by the present invention;

[0022] Figure 5 is a structural schematic diagram of the sample tube provided by the present invention. Specific Embodiments

[0023] The following specific embodiments illustrate the implementation manners of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. Although the description of the present invention will be introduced in conjunction with the preferred embodiments, this does not mean that the features of this invention are limited to this implementation manner. On the contrary, the purpose of introducing the invention in conjunction with the implementation manner is to cover other alternatives or modifications that may be extended based on the claims of the present invention. In order to provide a deep understanding of the present invention, many specific details will be included in the following description. The present invention can also be implemented without these details. In addition, in order to avoid confusing or obscuring the key points of the present invention, some specific details will be omitted in the description. It should be noted that, without conflict, the embodiments and features in the embodiments of the present invention can be combined with each other.

[0024] In the description of this embodiment, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner", "bottom", etc. is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the inventive product is customarily placed during use. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the present invention.

[0025] The terms "first", "second", etc. are only used for distinguishing descriptions and cannot be understood as indicating or implying relative importance.

[0026] In the description of this embodiment, it should also be noted that unless otherwise clearly specified and defined, the terms "set", "connected", "connected to" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in this embodiment can be understood according to specific circumstances.

[0027] To make the objectives, technical solutions, and advantages of the present invention clearer, the embodiments of the present invention will be further described in detail below in conjunction with the accompanying drawings.

[0028] See Figures 1-5 As shown, the present invention discloses a portable test strip detection device, which includes a main body 200 and a sample tube 100. A notch is provided on the bottom wall 120 of the sample tube 100. An accommodation cavity 210 is provided inside the main body 200. A liquid storage tank 220, a sealing layer 221, a chromatographic test strip 240, and a first puncturing mechanism 250 are sequentially arranged in the accommodation cavity 210 from bottom to top. The upper surface of the liquid storage tank 220 is sealed by the sealing layer 221. The first puncturing mechanism 250 is fixedly connected inside the main body 200, and a fluid channel 251 is provided on the first puncturing mechanism 250.

[0029] A second puncturing mechanism 29 is also provided on the wall of the main body 200. One end of the second puncturing mechanism 29 is arranged inside the main body 200, and the other end is arranged outside the main body 200. The second puncturing mechanism 29 can move from a first position to a second position. When the detection device is not in use, the second puncturing mechanism 29 is located at the first position. When the second puncturing mechanism 29 is moved to the second position, the second puncturing mechanism 29 punctures the sealing layer 221.

[0030] The upper surface of the main body 200 is provided with a sample solution adding area 260 and a test result observation area 270. The sample solution adding area 260 is configured for the sample tube 100 to be inserted. After the sample tube 100 is inserted into the sample solution adding area 260, the accommodation cavity 210 is sealed, and the first puncturing mechanism 250 punctures the bottom wall 120 of the sample tube 100, and the sample solution flows into the accommodation cavity 210 through the fluid channel 251.

[0031] That is to say, the portable test strip detection device mainly consists of the main body 200 and the sample tube 100. Among them, an accommodation cavity 210 is provided in the main body 200. Inside the accommodation cavity 210, a liquid storage tank 220, a sealing layer 221, a chromatography test strip 240, and a first puncturing mechanism 250 are arranged in sequence from bottom to top. The upper surface of the liquid storage tank 220 is sealed by the sealing layer 221. When the detection device is not in use, the sealing layer 221 can seal the liquid storage tank 220, preventing the liquid in the liquid storage tank 220 from reacting with the sample solution on the chromatography test strip 240 and in the sample tube 100, and ensuring the performance of the detection device. At this time, the second puncturing mechanism 29 is in the first position. After the chromatography test strip 240 completes the detection, the second puncturing mechanism 29 can move to the second position to puncture the sealing layer 221, enabling the liquid in the liquid storage tank 220 to react with the sample solution on the chromatography test strip 240 and in the sample tube 100, and completely removing the residual nucleic acid in the portable test strip detection device. In this way, even if the sample tube 100 accidentally falls off or the portable test strip detection device is damaged and the inside is exposed during the subsequent process, no pollution will be caused.

[0032] In this embodiment, the liquid stored in the liquid storage tank 220 can be a nucleic acid destruction reagent, such as sodium hypochlorite solution or a commercial DNA decontamination agent solution. In other embodiments, other solutions can also be stored in the liquid storage tank, as long as they can react with the sample solution to avoid sample solution contamination.

[0033] Furthermore, the upper surface of the main body 200 is provided with a sample solution adding area 260 and a test result observation area 270. The sample solution adding area 260 is configured for the sample tube 100 to be inserted. After the sample tube 100 is inserted into the sample solution adding area, the accommodation cavity 210 is sealed, and the first puncturing mechanism 250 punctures the sample tube 100, and the sample solution flows into the accommodation cavity 210 through the fluid channel 251 and reacts with the chromatography test strip 240 in the accommodation cavity 210.

[0034] Among them, the specific structure for realizing the sealing of the accommodation cavity 210 can refer to any existing method in the prior art, which will not be elaborated in the present invention. For example, the sample solution adding area 260 can be set to match the shape of the sample tube 100. After the sample tube 100 is inserted into the sample solution adding area 260, the surfaces of the two fit together to realize the sealing of the accommodation cavity 210.

[0035] During the detection process, the accommodating cavity 210 remains sealed all the time, preventing the amplification products from leaking outwards. After recording the detection results, the second puncturing mechanism 29 can puncture the sealing layer 221, and the chromatographic test strip 240 can react with the nucleic acid-destroying reagent to completely remove the residual nucleic acid in the portable test strip detection device. In this way, even if the sample tube 100 accidentally falls off during subsequent processes, or the portable test strip detection device is damaged, resulting in internal exposure, no contamination will be caused.

[0036] With the above technical solution, when the chromatographic test strip finishes the detection, the second puncturing mechanism can move to the second position to puncture the sealing layer, enabling the liquid in the liquid storage tank to react with the sample solution on the chromatographic test strip and in the sample tube, and completely removing the residual nucleic acid in the portable test strip detection device. In this way, even if the sample tube accidentally falls off during subsequent processes, or the portable test strip detection device is damaged, resulting in internal exposure, no contamination will be caused.

[0037] It should be noted that the present invention does not limit the specific structure of the second puncturing mechanism and its connection manner with the main body, and can be reasonably set according to the actual situation, as long as the second puncturing mechanism can puncture the sealing layer after the chromatographic test strip finishes the detection.

[0038] According to another specific embodiment of the present invention, refer to Figures 1-5 As shown, the second puncturing mechanism 29 is arranged on the upper wall of the main body 200, with one end extending into the main body 200 and the other end extending outside the main body 200, and is connected to the main body 200 in a threaded connection manner. By rotating the second puncturing mechanism 29, the second puncturing mechanism 29 can be moved from the first position to the second position. A threaded channel (not marked in the figure) for installing the second puncturing mechanism 29 is provided on the upper wall of the main body 200, and the threaded channel is along the vertical (such as Figure 2It is arranged in the direction of the upper surface of the main body 200 as shown by X. The threaded channel is provided with internal threads, and the second puncturing mechanism 29 is provided with external threads. By rotating the second puncturing mechanism 29, the second puncturing mechanism 29 can pass through the threaded channel and extend into the main body 200. When the detection device is not in use, the second puncturing mechanism 29 is located at the first position. At this position, the second puncturing mechanism 29 can contact the chromatographic test strip 240, but does not puncture the sealing layer 221 below the chromatographic test strip 240, and the liquid in the liquid storage tank 220 will not react with the sample solution on the chromatographic test strip 240 and in the sample tube 100, ensuring that the chromatographic test strip 240 can be used smoothly. When the second puncturing mechanism 29 is moved to the second position, that is, when the second puncturing mechanism 29 is continuously rotated, the second puncturing mechanism 29 approaches the sealing layer 221 and can puncture the sealing layer 221, enabling the liquid in the liquid storage tank 220 to react with the sample solution on the chromatographic test strip 240 and in the sample tube 100, avoiding contamination caused by the residual nucleic acid in the detection device when it is internally exposed.

[0039] To ensure that the second puncturing mechanism 29 does not puncture the sealing layer 221 when the detection device is not in use and to ensure the performance of the detection device, according to another specific embodiment of the present invention, refer to Figures 1-3 As shown, a baffle 230 is provided between the sealing layer 221 and the second puncturing mechanism 29. The baffle 230 can move from the third position to the fourth position. When the baffle 230 is in the third position, the baffle 230 hinders the downward movement of the second puncturing mechanism. When the baffle 230 moves to the fourth position, as the second puncturing mechanism 29 is screwed in, the second puncturing mechanism 29 can puncture the sealing layer 221. By providing the baffle 230, it further prevents the operator from misoperating and the nucleic acid destruction reagent from contacting the chromatographic test strip 240 before the detection is completed.

[0040] According to another specific embodiment of the present invention, an elastic pressing structure 280 is provided above the chromatographic test strip 240. When the baffle 230 is opened, the elastic pressing structure 280 presses at least part of the chromatographic test strip 240 into the liquid storage tank 220. The elastic pressing structure 280 is not particularly limited and can be a spring or an elastic sheet.

[0041] Further, the specific structure for sealing the accommodation cavity 210 can refer to any existing method in the prior art, which will not be elaborated in the present invention. For example, the sample solution addition area 260 can be set to match the shape of the sample tube 100. After the sample tube 100 is inserted into the sample solution addition area 260, the surfaces of the two fit together to achieve the sealing of the accommodation cavity 210. According to another specific embodiment of the present invention, the sample solution addition area 260 includes a cylindrical first channel (not labeled in the figure). In order to more effectively prevent the amplified product from leaking into the air, a sealing ring made of an elastic body can also be provided at the insertion end of the first channel, or a sealing ring made of an elastic body can be provided outside the side wall 110 of the sample tube 100.

[0042] According to another specific embodiment of the present invention, the detection result observation area 270 is made of a transparent material for easy observation.

[0043] It should be noted that the present invention does not limit the specific structure and manufacturing material of the sample tube, and reasonable selection can be made according to actual needs, as long as it is ensured that the sample tube can stably store the sample solution and can be punctured by the first puncturing mechanism.

[0044] Specifically, referring to Figures 1-2 As shown, in this embodiment, the sample tube 100 includes a side wall 110, a bottom wall 120, and an upper wall 130, and a sealed sample solution storage cavity 140 jointly formed by the side wall 110, the bottom wall 120, and the upper wall 130. The side wall 110 is a cylindrical side wall, and an external thread 150 is provided on its outer surface for mating with the internal thread of the first channel to achieve the sealing between the side wall 110 of the sample tube 100 and the first channel.

[0045] According to another specific embodiment of the present invention, in order to facilitate the sample tube 100 to be punctured by the puncturing mechanism 250 after being inserted into the portable test strip detection device, a notch can be provided on the bottom wall 120 of the sample tube 100 to facilitate the first puncturing mechanism 250 to puncture the sample tube 100.

[0046] Further, since a notch is provided on the bottom wall 120 of the sample tube 100, the sample tube 100 may be damaged at the position of the notch during the process of taking and placing before being inserted into the portable test strip detection device. Therefore, according to another specific embodiment of the present invention, the bottom wall 120 of the sample tube 100 is recessed into the sample solution storage cavity 140 to form a recess 121, and the notch is only provided in the recess 121, which can effectively avoid the damage of the sample tube 100 during the process of taking and placing.

[0047] According to another specific embodiment of the present invention, a general sample tube 100 has an open-top structure, that is, the upper wall 130 is an openable and closable lid. After putting the sample to be amplified and the reagents related to the amplification reaction system into the sample tube 100, the lid is then covered to achieve sealing. In addition, the upper part of the sample tube 100 can also be directly a closed structure, that is, the upper wall 130 and the side wall 110 are fixedly connected, or even directly integrally formed and cannot be opened. When in use, a syringe with a fine needle pierces through the upper wall 130 of the sample tube 100 to inject the reaction system, and then the break is sealed with a sealing film or a wax drop with a relatively high melting point, so as to better achieve the sealing of the sample tube 100.

[0048] Furthermore, in some poverty-stricken or backward regions, due to poverty, poor sanitation conditions, low health awareness, malnutrition, etc., these regions have always been the hardest-hit areas for the rampant spread of infectious diseases. The incidence and fatality rate of infectious diseases are high, and the high treatment costs are generally unaffordable for ordinary families. However, in these regions, advanced infectious disease detection methods cannot be popularized. The main reasons are that there are difficulties in power supply in most regions, making it impossible to operate large-scale instruments; unable to afford the costs of large-scale medical equipment and the corresponding maintenance equipment; site restrictions; and patients are also unable to bear the high inspection costs, etc. And the amplification reaction in the sample tube 100 needs to be carried out within a specific temperature range. In the above-mentioned regions, it may be very difficult for the detection personnel to obtain a temperature constant device and cannot conduct on-site detection, which limits the immediacy of nucleic acid detection.

[0049] According to another specific embodiment of the present invention, at least two reversible thermochromic materials are coated on the surface of the sample tube 100. The color-changing temperature of the thermochromic material can be set according to actual needs, and specific reversible thermochromic materials can be commercially available products. For a certain amplification reaction, if the reaction temperature is required to be between the first temperature T1 and the second temperature T2, two thermochromic materials can be selected to be coated on the surface of the sample tube 100. The color-changing temperature of the first thermochromic material is the first temperature T1, and the color-changing temperature of the second thermochromic material is the second temperature T2. In this way, when conducting this kind of amplification reaction, when the first thermosensitive material changes color while the second thermosensitive material does not change color, it indicates that the temperature is just suitable for the amplification reaction in the sample tube 100. In this case, the sample tube 100 can be directly placed in a thermos flask, and the amount of cold and hot water can be adjusted to control the temperature of the water in the thermos flask, so as to maintain the progress of the amplification reaction. There is no need for a temperature constant device, and the sample can be detected anytime and anywhere.

[0050] For example, if the optimal reaction temperature is around 38 degrees, two temperatures can be selected for the temperature-sensitive coating, one greater than 38 and the other less than 38, preferably 37 and 39 degrees. If the optimal reaction temperature is 63 degrees, then the temperature-sensitive coating can be selected as 62 and 64. The shape of the temperature-sensitive coating can be arbitrary, but preferably the Arabic numerals corresponding to the temperature. For example, the temperature-sensitive material that changes color at 38 degrees is displayed as "38". This can more directly reflect the temperature of the sample tube 100.

[0051] Furthermore, when the sample tube 100 is used in amplification reaction systems with multiple different temperatures, multiple temperature-sensitive color-changing materials can be set.

[0052] According to another specific embodiment of the present invention, the sample tube 100 in the present invention is a special nucleic acid amplification tube. The side wall 110 of the sample tube 100 can be composed of a series of materials, which are preferably made of materials with good thermal conductivity, high strength, and good fluidity, such as metals, alloys, thermally conductive plastics, and organic composite materials. The height is 1-3 cm, preferably 2 cm. The general shape can be similar to that of an ordinary nucleic acid amplification tube, but there are differences.

[0053] Although the present invention has been illustrated and described by referring to some preferred embodiments of the present invention, those of ordinary skill in the art should understand that the above content is a further detailed description of the present invention in combination with specific embodiments, and it cannot be determined that the specific implementation of the present invention is only limited to these descriptions. Those skilled in the art can make various changes in form and detail, including making several simple deductions or substitutions, without departing from the spirit and scope of the present invention.

Claims

1. A portable test strip detection device, characterized in that, it includes a main body and a sample tube, a receiving cavity is provided in the main body, a liquid storage tank, a sealing layer, a chromatographic test strip and a first puncturing mechanism are sequentially arranged in the receiving cavity from bottom to top, the upper surface of the liquid storage tank is sealed by the sealing layer, the first puncturing mechanism is fixedly connected in the main body, and a fluid channel is provided on the first puncturing mechanism, a second puncturing mechanism is further provided on the wall of the main body, a baffle is provided between the sealing layer and the second puncturing mechanism, one end of the second puncturing mechanism is arranged in the main body and the other end is arranged outside the main body, the second puncturing mechanism can move from a first position to a second position, when the detection device is not in use, the second puncturing mechanism is located at the first position, when the second puncturing mechanism is moved to the second position, the second puncturing mechanism punctures the sealing layer, the second puncturing mechanism is connected to the main body by a threaded connection, and by rotating the second puncturing mechanism, the second puncturing mechanism can be moved from the first position to the second position.

2. The portable test strip detection device according to claim 1, characterized in that, a baffle is provided between the sealing layer and the second puncturing mechanism, the baffle can move from a third position to a fourth position, when the baffle is located at the third position, the baffle hinders the downward movement of the second puncturing mechanism, when the baffle is moved to the fourth position, as the second puncturing mechanism is screwed in, the second puncturing mechanism can puncture the sealing layer.

3. The portable test strip detection device according to claim 2, characterized in that, a sample solution adding area is provided on the upper surface of the main body, the sample solution adding area includes a cylindrical first channel, a sealing ring made of an elastic body is provided at the insertion end of the first channel, or a sealing ring made of an elastic body is provided outside the side wall of the sample tube.

4. The portable test strip detection device according to claim 1, characterized in that, a detection result observation area is provided on the upper surface of the main body, and the detection result observation area is made of a transparent material.

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