A closed chromatography test paper card box

Abstract

The present invention discloses a closed chromatographic test paper cartridge, comprising: a shell, a detection cavity is formed in the shell; a chromatographic test paper, the chromatographic test paper is arranged in the detection cavity; a liquid addition opening, which is arranged on the upper surface of the shell, communicated with the detection cavity, and is arranged to be inserted by a nucleic acid amplification tube and seal the detection cavity; a spike portion, which is arranged in the liquid addition opening; a cleaning component, which stores a nucleic acid cleaning reagent and can inject the nucleic acid cleaning reagent into the detection cavity. With the above technical solution, during the detection process, the detection cavity remains sealed to prevent the amplification product from leaking out. After recording the test results, the nucleic acid cleaning reagent in the cleaning component can be injected into the detection cavity, and the amplification product can react with the nucleic acid cleaning reagent to completely remove the residual nucleic acid in the chromatographic test paper cartridge. In this way, even if the nucleic acid amplification tube accidentally falls off or the chromatographic test paper cartridge is damaged in the subsequent process, exposing the interior, it will not cause any pollution.

Description

Technical Field

[0001] The invention relates to the field of detection, and in particular to a closed chromatography test paper box. Background Art

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

[0003] POCT (point-of-care testing), which means "immediate testing" in Chinese, is an emerging sub-industry of in vitro diagnostics (IVD). It is a new method that analyzes samples immediately at the sampling site, eliminating the complicated processing procedures of specimens in laboratory tests and quickly obtaining test results. The main standard of POCT is that it does not require a fixed testing site, and the reagents and instruments are portable and can be operated in a timely manner. POCT assumes the functions of a laboratory but does not require traditional hospital laboratory equipment. It can serve patients 24 hours a day without time or location restrictions.

[0004] However, these nucleic acid amplification methods have the problem of cross-contamination of amplified products. False positive signals generated by product contamination can cause misinterpretation of test results. Cross-contamination between samples is often seen during the target nucleic acid amplification operation. 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 aerosols. Therefore, nucleic acid testing needs to be carried out in a special closed laboratory, and it is difficult to conduct real-time testing in some poor or backward areas.

[0005] A series of methods have been developed in the prior art to prevent cross-contamination of amplification products. For example, Reference 1 (CN105199940A) discloses a contamination-proof portable gene detection method and device, through which a nucleic acid amplification tube containing amplification products can be placed in the device and sealed, and then the nucleic acid amplification tube can be punctured to achieve detection. Prevent 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 puncture operation is difficult, and the amplification product after the test is completed still remains in the device. Once damaged, the amplification product may also diffuse into the air, causing a false positive reaction.

[0006] In addition, reference 2 (CN203241416U) also discloses a closed chromatography test paper plastic card box, and reference 3 (CN205574438U) also discloses a sealed test tube assembly containing a tube breaking mechanism. These detection devices are relatively convenient to operate, but the amplification product also remains in the device after detection, which poses 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 the field. Summary of the invention

[0008] The purpose of the present invention is to solve the problem that the closed detection device in the prior art is inconvenient to operate and there is still the possibility of contamination after detection. In order to solve the above problems, the present invention discloses a closed chromatography test paper box with a new structure, which is easy to operate and can effectively prevent the amplification product from diffusing into the air to cause a false positive reaction.

[0009] In order to solve the above problems, the present invention discloses a closed chromatography test paper cartridge, comprising:

[0010] A housing having a detection cavity formed therein;

[0011] Chromatographic test paper, the chromatography test paper is arranged in the detection cavity;

[0012] A liquid adding opening is arranged on the upper surface of the housing, communicated with the detection cavity, and is arranged to be inserted by a nucleic acid amplification tube and seal the detection cavity;

[0013] A spike portion is disposed in the liquid adding opening and is used to pierce the bottom of the inserted nucleic acid amplification tube;

[0014] The cleaning component stores nucleic acid cleaning reagent and can inject the nucleic acid cleaning reagent into the detection cavity.

[0015] By adopting the above technical solution, the detection chamber remains sealed during the detection process, preventing the amplification product from leaking outward. Furthermore, after recording the test results, the nucleic acid cleaning reagent in the cleaning component can be injected into the detection chamber, and the amplification product can react with the nucleic acid cleaning reagent to completely remove the residual nucleic acid in the chromatography test paper cartridge. In this way, even if the nucleic acid amplification tube accidentally falls off or the chromatography test paper cartridge is damaged in the subsequent process, exposing the interior, it will not cause any contamination.

[0016] According to another specific embodiment of the present invention, the cleaning component is disposed in the housing at one end along a first direction, and the first direction is a direction in which the chromatography test paper extends.

[0017] According to another specific embodiment of the present invention, the cleaning assembly includes a movable plug rod and a cleaning chamber.

[0018] The cleaning chamber stores a nucleic acid cleaning reagent and is connected to the detection chamber through a liquid injection port, and the liquid injection port is sealed by a liquid blocking member;

[0019] The movable plug rod includes a piston portion and a support rod portion. The piston portion is arranged at one end of the cleaning chamber away from the liquid injection port, and the support rod portion is at least partially located outside the shell. By operating the support rod portion, the piston portion can be moved in the cleaning chamber toward the direction of the liquid injection port, compressing the nucleic acid cleaning reagent, breaking through the liquid blocking part, and injecting the nucleic acid cleaning reagent in the cleaning chamber into the detection chamber.

[0020] According to another specific embodiment of the present invention, it also includes a protective shell, which is sleeved outside the support rod portion and is detachably connected to the outer shell.

[0021] According to another specific embodiment of the present invention, the protective shell is snap-connected to the outer shell.

[0022] According to another specific embodiment of the present invention, a flow-conducting hole is provided in the spike portion.

[0023] According to another specific embodiment of the present invention, it also includes a nucleic acid amplification tube, which is inserted into the liquid adding opening to seal the detection cavity.

[0024] According to another specific embodiment of the present invention, the nucleic acid amplification tube and the liquid adding opening are connected by snap-fit ​​connection or threaded connection.

[0025] According to another specific embodiment of the present invention, an annular sealing gasket is further provided in the liquid filling opening. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments:

[0027] Figure 1 It is a structural schematic diagram of a closed chromatography test paper cartridge provided by the present invention;

[0028] Figure 2 It is a cross-sectional schematic diagram of a closed chromatography test paper cartridge provided by the present invention in one state;

[0029] Figure 3 It is a cross-sectional schematic diagram of the closed chromatography test paper cartridge provided by the present invention in another state;

[0030] Figure 4 It is a schematic diagram of the explosion of the closed chromatography test paper cartridge provided by the present invention.

[0031] Reference numerals:

[0032] Nucleic Acid Amplification Tube 100

[0033] Housing 200

[0034] Detection chamber 210

[0035] Clean chamber 221

[0036] Mobile plug rod 222

[0037] Support rod 2221

[0038] Piston 2222

[0039] Liquid injection port 223

[0040] Protective case 230

[0041] Chromatography test paper 240

[0042] Spike 250

[0043] Filling opening 260

[0044] Test result observation area 270 DETAILED DESCRIPTION

[0045] The following specific embodiments illustrate the implementation of the present invention, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. Although the description of the present invention will be introduced in conjunction with the preferred embodiment, this does not mean that the features of this invention are limited to this implementation. On the contrary, the purpose of introducing the invention in conjunction with the implementation is to cover other options or modifications that may extend based on the claims of the present invention. In order to provide a deep understanding of the present invention, the following description will include many specific details. The present invention can also be implemented without using these details. In addition, in order to avoid confusion or blurring the focus of the present invention, some specific details will be omitted in the description. It should be noted that the embodiments of the present invention and the features in the embodiments can be combined with each other without conflict.

[0046] In the description of this embodiment, it should be noted that the terms "upper", "lower", "inner", "bottom", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, or are the orientations or positional relationships in which the inventive product is usually placed when used. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0047] The terms “first”, “second”, etc. are only used for distinguishing descriptions and should not be understood as indicating or implying relative importance.

[0048] In the description of this embodiment, it is also necessary to explain that, unless otherwise clearly specified and limited, the terms "set", "connected", and "connected" 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 a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in this embodiment can be understood according to specific circumstances.

[0049] like Figure 1-4 As shown, the present invention discloses a closed chromatography test paper box, comprising:

[0050] A housing 200, wherein a detection cavity 210 is formed in the housing 200;

[0051] A chromatography test paper 240, the chromatography test paper 240 is disposed in the detection chamber 210;

[0052] The liquid adding opening 260 is disposed on the upper surface of the housing 200 and communicates with the detection chamber 210 , and is configured to be inserted by the nucleic acid amplification tube 100 and seal the detection chamber 210 ;

[0053] The spike portion 250 is disposed in the liquid adding opening 260 and is used to pierce the bottom of the inserted nucleic acid amplification tube 100;

[0054] The cleaning component stores nucleic acid cleaning reagent and can inject the nucleic acid cleaning reagent into the detection cavity 210 .

[0055] By adopting the above technical solution, during the detection process, the detection chamber 210 remains sealed to prevent the amplification product from leaking outward. Furthermore, after recording the test results, the nucleic acid cleaning reagent in the cleaning component can be injected into the detection chamber 210, and the amplification product can react with the nucleic acid cleaning reagent to completely remove the nucleic acid remaining in the chromatography test paper 240 cartridge. In this way, even if the nucleic acid amplification tube 100 accidentally falls off or the chromatography test paper 240 cartridge is damaged in the subsequent process, exposing the interior, no contamination will be caused.

[0056] According to another specific embodiment of the present invention, the cleaning component is disposed in the housing 200 at one end along a first direction, wherein the first direction is the direction in which the chromatography test paper 240 extends (i.e. Figure 2 XX direction as shown).

[0057] According to another specific embodiment of the present invention, the cleaning assembly includes a movable plug rod 222 and a cleaning chamber 221.

[0058] The cleaning chamber 221 stores a nucleic acid cleaning reagent and is connected to the detection chamber 210 through a liquid injection port 223, and the liquid injection port 223 is sealed by a liquid blocking member;

[0059] The movable plug rod 222 includes a piston portion 2222 and a support rod portion 2221. The piston portion 2222 is arranged at one end of the cleaning chamber 221 away from the injection port 223, and the support rod portion 2221 is at least partially located outside the housing 200. By operating the support rod portion 2221, the piston portion 2222 can be moved in the cleaning chamber 221 toward the direction of the chromatography test paper 240, compressing the nucleic acid cleaning reagent, breaking through the liquid blocking member, and injecting the nucleic acid cleaning reagent in the cleaning chamber 221 into the detection chamber 210.

[0060] Specifically, when the detection is not completed, the moving plug rod 222 is located at Figure 2 In the first position shown, the liquid blocking member is sealed at the liquid injection port 223. The nucleic acid amplification tube 100 can be inserted into the liquid injection opening 260, the detection chamber 210 is sealed, the spike portion 250 pierces the nucleic acid amplification tube 100, and the nucleic acid solution to be tested drips onto the chromatography test paper 240, and the test result can be observed later.

[0061] After the detection is completed, the plug rod 222 can be conveniently pushed by the support rod portion 2221 located outside the housing 200 to move along the first direction toward the position where the injection port 223 is located. Figure 3 In the position shown, since the nucleic acid cleaning reagent is compressed, it breaks through the liquid blocking member and flows into the detection cavity 210 from the liquid injection port 223, destroying all the nucleic acids in the detection cavity 210, and the operation is convenient and quick.

[0062] Furthermore, the structure of the liquid blocking member is not particularly limited, and may be an elastic rubber plug disposed in the liquid injection port 223 , or a plastic film adhered to the outside of the liquid injection port 223 , a sealing film, or a wax seal, etc.

[0063] According to another specific embodiment of the present invention, in order to avoid accidentally touching the support rod portion 2221 before the test is completed, so that the nucleic acid cleaning reagent does not damage the chromatography test paper 240, the closed chromatography test paper box also includes a protective shell 230, which is sleeved on the outside of the support rod portion 2221 and is detachably connected to the outer shell 200. Preferably, the protective shell 230 is snap-fitted and connected to the outer shell 200.

[0064] According to another specific embodiment of the present invention, a flow-conducting hole is provided in the spike portion 250 , and the spike portion 250 may be a syringe needle, which pierces the bottom of the nucleic acid amplification tube 100 as the nucleic acid amplification tube 100 is inserted, and the nucleic acid liquid to be tested falls along the flow-conducting hole in the spike portion 250 onto the chromatography test paper 240 .

[0065] According to another specific embodiment of the present invention, a nucleic acid amplification tube 100 is further included, and the nucleic acid amplification tube 100 is inserted into the liquid adding opening 260 to seal the detection chamber 210. The specific structure for sealing the detection chamber 210 can refer to any existing method in the prior art, and will not be repeated in the present invention. For example, the liquid adding opening 260 can be shaped to match the nucleic acid amplification tube 100. After the nucleic acid amplification tube 100 is inserted into the liquid adding opening 260, the surfaces of the two are in contact with each other, thereby sealing the detection chamber 210.

[0066] Furthermore, in order to ensure a stable connection between the nucleic acid amplification tube 100 and the liquid adding opening 260 , it is preferred that the nucleic acid amplification tube 100 and the liquid adding opening 260 are connected by snap-fitting or threading.

[0067] In order to further ensure the sealed connection between the nucleic acid amplification tube 100 and the liquid adding opening 260 , an annular sealing gasket (not shown) is further provided in the liquid adding opening 260 .

[0068] According to another specific embodiment of the present invention, a detection result observation area 270 made of a transparent material is further provided on the housing 200 .

[0069] According to another specific embodiment of the present invention, the nucleic acid cleaning reagent can be a sodium hypochlorite solution or a commercial DNA detergent.

[0070] In summary, by adopting the technical solution of the present application, during the detection process, the detection chamber 210 remains sealed to prevent the amplification product from leaking outward. Furthermore, after recording the test results, the nucleic acid cleaning reagent in the cleaning component can be injected into the detection chamber 210, and the amplification product can react with the nucleic acid cleaning reagent to completely remove the nucleic acid remaining in the chromatography test paper 240 cartridge, and the operation is convenient and quick. In this way, even if the nucleic acid amplification tube 100 accidentally falls off or the chromatography test paper 240 cartridge is damaged in the subsequent process, exposing the interior, it will not cause any contamination.

[0071] Although the present invention has been illustrated and described with reference to certain preferred embodiments of the present invention, it should be understood by those skilled in the art that the above is a further detailed description of the present invention in conjunction with specific embodiments, and it cannot be determined that the specific implementation of the present invention is limited to these descriptions. Those skilled in the art may make various changes in form and details, including making several simple deductions or substitutions, without departing from the spirit and scope of the present invention.

Claims

1. A closed chromatography test paper cartridge, characterized in that: include: A housing having a detection cavity formed therein; Chromatographic test paper, the chromatography test paper is arranged in the detection cavity; A liquid adding opening, arranged on the upper surface of the housing, communicated with the detection cavity, and configured to be inserted by a nucleic acid amplification tube and seal the detection cavity; A spike portion is arranged in the liquid adding opening and is used to pierce the bottom of the inserted nucleic acid amplification tube, and a guide hole is arranged in the spike portion; A cleaning component stores a nucleic acid cleaning reagent and can inject the nucleic acid cleaning reagent into the detection cavity. The cleaning component includes a movable stopper rod and a cleaning cavity. The cleaning chamber stores the nucleic acid cleaning reagent and is connected to the detection chamber through a liquid injection port, and the liquid injection port is sealed by a liquid blocking member; The movable plug rod includes a piston portion and a support rod portion, wherein the piston portion is arranged at one end of the cleaning chamber away from the liquid injection port, and the support rod portion is at least partially located outside the outer shell. By operating the support rod portion, the piston portion can be moved in the cleaning chamber toward the direction of the liquid injection port, compressing the nucleic acid cleaning reagent, breaking through the liquid blocking member, and injecting the nucleic acid cleaning reagent in the cleaning chamber into the detection chamber.

2. The closed chromatography test paper cartridge according to claim 1, characterized in that: The cleaning component is arranged in the housing at one end along a first direction, and the first direction is the direction in which the chromatography test paper extends.

3. The closed chromatography test paper cartridge according to claim 1, characterized in that: It also includes a protective shell, which is sleeved outside the support rod part and is detachably connected to the outer shell.

4. The closed chromatography test paper cartridge according to claim 3, characterized in that: The protective shell is snap-connected with the outer shell.

5. The closed chromatography test paper cartridge according to claim 1, characterized in that: It also includes a nucleic acid amplification tube, which is inserted into the liquid adding opening to seal the detection cavity.

6. The closed chromatography test paper cartridge according to claim 1, characterized in that: The nucleic acid amplification tube and the liquid adding opening are connected by snap-fitting or threading.

7. The closed chromatography test paper cartridge according to claim 1, characterized in that: An annular sealing gasket is also arranged in the liquid adding opening.

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