CN212476748U - Nucleic acid amplification detection device - Google Patents

Abstract

The utility model provides a nucleic acid amplification detection device, including seal shell and nucleic acid amplification reaction tube, after nucleic acid amplification reaction tube inserted the grafting passageway, can be pricked by piercing mechanism for the reaction liquid flows into the interior intracavity, the intracavity is equipped with reservoir and test paper, the upper surface of reservoir is sealed by the closing film, test paper locates on the closing film, can react with the reaction liquid, the intracavity is equipped with the splenium of pressing that has the press bar, press bar is including pressing end and cone end, the reaction is accomplished the back, press the button of pressing the end, make the pyramis perk of cone end, pierce the closing film. By adopting the technical scheme, after the detection test paper finishes detection, the button is pressed to drive the conical part at the cone end to tilt, the sealing film is punctured, so that the liquid in the liquid storage tank reacts with the reaction liquid on the detection test paper and in the nucleic acid amplification reaction tube, the residual nucleic acid in the nucleic acid amplification detection device is completely removed, and the nucleic acid amplification reaction tube is prevented from falling off carelessly or the device is damaged, so that the inside is exposed and any pollution is caused.

Description

Nucleic acid amplification detection device

Technical Field

The utility model relates to a detection area, concretely relates to nucleic acid amplification detection device.

Background

Nucleic acid diagnostics is one of the most active segments of the future IVD (in vitro diagnostics) industry. The increasing of the prevention and treatment of infectious diseases, the popularization of blood screening nucleic acid detection and the development of individualized medical treatment in China are the main motivations for the development of nucleic acid diagnosis in China. Under the promotion of the factors, the future speed increase of domestic nucleic acid diagnosis is 25-30%, and obviously exceeds the average speed increase of domestic IVD industry. On one hand, the nucleic acid diagnosis benefits large medical centers and realizes early, rapid, specific and high-throughput detection of pathogens, genetic diseases and the like.

POCT (Point-of-care testing), which is a new subdivision industry of In Vitro Diagnosis (IVD), is a new method for analyzing samples immediately on a sampling site, saving complex processing procedures of samples during laboratory testing and quickly obtaining testing results. The main criteria for POCT are that no fixed detection site is required, that the reagents and instruments are portable and that they can be operated in a timely manner. POCT plays the role of a laboratory, does not need traditional hospital laboratory equipment, and can serve patients in all directions within 24 hours without the limitation of time and place.

However, these nucleic acid amplification methods have a problem that the amplification products are easily cross-contaminated, and false positive signals generated by product contamination may cause erroneous interpretation of the detection results. Cross-contamination between samples is often seen during target nucleic acid amplification procedures, and contamination may result from known or unknown positive species introduced during negative sample processing, which causes false positive reactions through air contamination or aerosols.

In the prior art, a series of methods have been developed to prevent cross contamination of amplification products, and for example, reference 1(CN105199940A) discloses a portable anti-contamination gene detection method and apparatus, by which a nucleic acid amplification tube containing an amplification product can be sealed in an apparatus and then the nucleic acid amplification tube is punctured to perform detection. Prevent the pollution of nucleic acid amplification products and avoid false positive. However, in this apparatus, since the nucleic acid amplification tube is sealed after being placed in the apparatus, the puncturing operation is difficult, and the amplification product after the completion of the test remains in the apparatus, and if the nucleic acid amplification tube is broken, the amplification product may also diffuse into the air, causing a false positive reaction.

Further, while reference 2(CN203241416U) discloses a closed test strip plastic cartridge, and reference 3(CN205574438U) discloses a sealed test tube assembly including a tube breaking mechanism, these detection devices are convenient to operate, but the amplification product remains in the device after detection, which may cause contamination.

Therefore, it is an urgent problem in the art to provide a nucleic acid detecting apparatus with less contamination possibility before and after detection.

SUMMERY OF THE UTILITY MODEL

The utility model aims to solve the closed detection device among the prior art and operate inconveniently, and still have the problem of pollution possibility after detecting. In order to solve the problem, the utility model discloses a nucleic acid amplification detection device, through the device convenient operation to can effectually avoid the amplification product to spread to the air in, cause false positive reaction.

In order to solve the above problems, the present invention discloses a nucleic acid amplification detecting device, which comprises a sealed housing and a nucleic acid amplification reaction tube, wherein an inner cavity is arranged in the sealed housing, an insertion part is arranged on the sealed housing, an insertion channel is arranged in the insertion part, a puncture mechanism is arranged at the lower end of the insertion channel, the nucleic acid amplification reaction tube is inserted into the insertion channel and then is hermetically connected with the insertion channel, and can be punctured by the puncture mechanism, so that a reaction liquid flows into the inner cavity from a liquid outlet of the puncture mechanism,

a liquid storage tank and test paper are arranged in the inner cavity, the upper surface of the liquid storage tank is sealed by a sealing film, the test paper is arranged on the sealing film and can react with the reaction liquid,

the pressing part is arranged in the inner cavity and is positioned at one end, close to the insertion part, in the inner cavity, the pressing part comprises a pressing rod, the pressing rod comprises a pressing end and a cone end, the middle part of the pressing rod is in rotary sealing connection with the side wall of the liquid storage tank through a pivot, the pressing end is positioned in the inner cavity, the cone end is positioned in the liquid storage tank, the cone end is provided with a cone part, the cone part can puncture the sealing film, the pressing end is provided with a button,

after the reaction is completed, the button is pressed to tilt the taper part of the taper end and puncture the sealing film.

By adopting the technical scheme, after the detection test paper is detected, the button is pressed to drive the conical part at the cone end to tilt, the sealing membrane is punctured, so that the liquid in the liquid storage tank reacts with the reaction liquid on the detection test paper and in the nucleic acid amplification reaction tube, and the residual nucleic acid in the nucleic acid amplification detection device is completely removed. Thus, even if the nucleic acid amplification reaction tube is inadvertently detached in the subsequent process or the nucleic acid amplification detection device is damaged to expose the inside, no contamination is caused.

According to another embodiment of the present invention, the pressing end is provided with an elastic support member, which is located below the button.

According to the utility model discloses a another embodiment, the one end of sealed housing is equipped with flip, and flip is located the top of button for prevent that the button from being operated by the mistake.

According to the utility model discloses a another embodiment, the lower extreme of grafting portion is provided with elasticity and pushes down the piece, and elasticity pushes down the piece and is used for pushing down sealing membrane and test paper.

According to another embodiment of the present invention, a sealing ring made of an elastomer is disposed in the insertion channel, or a sealing ring made of an elastomer is disposed outside the side wall of the nucleic acid amplification reaction tube.

Drawings

The invention will be described in further detail with reference to the following drawings and detailed description:

FIG. 1 is a schematic perspective view of a nucleic acid amplification detecting apparatus according to the present invention;

FIG. 2 is a sectional view of a nucleic acid amplification detecting apparatus according to the present invention;

FIG. 3 is a cross-sectional view showing a state where a sealing membrane is punctured in the nucleic acid amplification detecting apparatus according to the present invention;

FIG. 4 is a sectional view of a nucleic acid amplification reaction tube according to the present invention;

FIG. 5 is a schematic structural view of a nucleic acid amplification reaction tube according to the present invention.

Detailed Description

The following description is provided for illustrative embodiments of the present invention, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. While the invention will be described in conjunction with the preferred embodiments, it is not intended that features of the invention be limited to only those embodiments. On the contrary, the intention of implementing the novel features described in connection with the embodiments is to cover other alternatives or modifications which may be extended based on the claims of the present invention. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The invention may be practiced without these particulars. Furthermore, some of the specific details are omitted from the description so as not to obscure or obscure the present invention. It should be noted that, in the present invention, the embodiments and features of the embodiments may be combined with each other without conflict.

In the description of the present embodiment, it should be noted that the terms "upper", "lower", "inner", "bottom", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings or orientations or positional relationships that the products of the present invention are usually placed in when used, and are only for convenience of describing the present invention and simplifying the description, but do not indicate or imply that the device or the element to which the present invention is directed must have a specific orientation, be constructed in a specific orientation, and be operated, and thus should not be construed as limiting the present invention.

The terms "first," "second," and the like are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.

In the description of the present embodiment, it should be further noted that, unless explicitly stated or limited otherwise, the terms "disposed," "connected," and "connected" are to be interpreted broadly, e.g., as a fixed connection, a detachable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present embodiment can be understood in specific cases by those of ordinary skill in the art.

In order to make the objects, technical solutions and advantages of the present invention clearer, embodiments of the present invention will be described in further detail below with reference to the accompanying drawings.

Referring to fig. 1-5, the present invention discloses a nucleic acid amplification detecting device, which comprises a sealed housing 200 and a nucleic acid amplification reaction tube 100, wherein an inner cavity 210 is disposed in the sealed housing 200, an inserting portion 260 is disposed on the sealed housing 200, an inserting channel 261 is disposed in the inserting portion 260, a piercing mechanism 250 is disposed at a lower end of the inserting channel 261, the nucleic acid amplification reaction tube 100 is inserted into the inserting channel 261, and is hermetically connected to the inserting channel 261 and can be pierced by the piercing mechanism 250, so that a reaction liquid flows into the inner cavity 210 from a liquid outlet 252 of the piercing mechanism 250, a liquid storage tank 220 and a detection test paper 240 are disposed in the inner cavity 210, an upper surface of the liquid storage tank 220 is sealed by a sealing film 221, the detection test paper 240 is disposed on the sealing film 221 and can react with the reaction liquid, a pressing portion 230 is disposed in the inner cavity 210, the pressing portion 230 is located at an end of the pressing portion 210, the pressing rod 231 comprises a pressing end 234 and a cone end 236, the middle part of the pressing rod 231 is connected with the side wall 222 of the liquid storage tank 220 in a rotating and sealing mode through a pivot 232, the pressing end 234 is located in the inner cavity 210, the cone end 236 is located in the liquid storage tank 220, the cone end 236 is provided with a cone portion 237, the cone portion 237 can puncture the sealing membrane 221, the pressing end 234 is provided with a button 235, and after the reaction is completed, the button 235 is pressed to enable the cone portion 237 of the cone end 236 to be tilted, and the sealing membrane 221 is punctured. Meanwhile, the sealed housing 200 is further provided with a detection result observation area 270 for a user to observe the detection result.

That is, the nucleic acid amplification detecting apparatus mainly comprises a sealed housing 200 and a nucleic acid amplification reaction tube 100, wherein an inner cavity 210 is provided in the sealed housing 200, a reservoir 220, a sealing film 221 and a detection test paper 240 are sequentially provided in the inner cavity 210 from bottom to top (as shown in the direction X in fig. 1), and the upper surface of the reservoir 220 is sealed by the sealing film 221. When the detection device is not used, the sealing film 221 can seal the reservoir 220, so as to prevent the liquid in the reservoir 220 from reacting with the reaction solution on the test paper 240 and in the nucleic acid amplification reaction tube 100, thereby ensuring the usability of the detection device, and at this time, the insertion part 260 is located at the first position.

When the test paper 240 completes the test, the button 235 is pressed to rotate the pressing rod 231 around the pivot 232, forming a lever structure, such that the tapered portion 237 of the tapered end 236 is tilted, and the tapered portion 237 pierces the sealing membrane 221. So that the liquid in the reservoir 220 reacts with the reaction solution on the test strip 240 and in the nucleic acid amplification reaction tube 100, thereby completely removing the residual nucleic acid in the nucleic acid amplification detection device. Thus, even if the nucleic acid amplification reaction tube 100 is inadvertently detached or the nucleic acid amplification detecting apparatus is damaged to expose the inside thereof, no contamination is caused.

In this embodiment, the reservoir 220 may contain a nucleic acid-damaging agent, such as a sodium hypochlorite solution or a solution of a commercially available DNA detergent. In other embodiments, other solutions may be stored in the reservoir as long as the solutions can react with the reaction solution to prevent the reaction solution from causing pollution.

Further, the upper surface of the sealing housing 200 is provided with an insertion portion 260 and a detection result observation region 270, an insertion channel 261 of the insertion portion 260 is configured to allow the nucleic acid amplification reaction tube 100 to be inserted, and after the nucleic acid amplification reaction tube 100 is inserted into the insertion channel 261, the inner cavity 210 is sealed, the puncture mechanism 250 punctures the nucleic acid amplification reaction tube 100, and the reaction solution flows into the inner cavity 210 from the liquid outlet hole 252 to react with the detection test paper 240 in the inner cavity 210.

Wherein, realize that inner chamber 210 sealed concrete structure can refer to any mode that has among the prior art, the utility model discloses in no longer giving unnecessary details, for example grafting passageway 261 can be through setting up the shape with nucleic acid amplification reaction pipe 100 phase-match, after nucleic acid amplification reaction pipe 100 inserts grafting passageway 261, the two surface is laminated mutually, realizes inner chamber 210's sealed.

During the detection process, the inner cavity 210 is always sealed, so that the amplification product is prevented from leaking outwards. After the detection result is recorded, the plugging portion 260 may puncture the sealing film 221, and the detection test paper 240 may react with the nucleic acid damaging reagent, thereby completely removing the nucleic acid remaining in the nucleic acid amplification detecting apparatus. Thus, even if the nucleic acid amplification reaction tube 100 is inadvertently detached or the nucleic acid amplification detecting apparatus is damaged to expose the inside thereof, no contamination is caused.

By adopting the technical scheme, after the detection test paper is detected, the button is pressed to drive the conical part at the cone end to tilt, the sealing membrane is punctured, so that the liquid in the liquid storage tank reacts with the reaction liquid on the detection test paper and in the nucleic acid amplification reaction tube, and the residual nucleic acid in the nucleic acid amplification detection device is completely removed. Thus, even if the nucleic acid amplification reaction tube is inadvertently detached in the subsequent process or the nucleic acid amplification detection device is damaged to expose the inside, no contamination is caused.

In accordance with another embodiment of the present invention, as shown in fig. 1-2, the pressing end 234 is provided with an elastic support 233, and the elastic support 233 is located below the button 235. By providing the elastic support member 233, the pressing end 234 can be continuously pushed up, the tilting of the tapered portion 237 of the tapered end 236 under non-manual operation is avoided, and it is ensured that the tilting of the tapered portion 237 of the tapered end 236 can be performed only under manual pressing. In this embodiment, the elastic supporting member 233 is a spring, and in other embodiments, the elastic supporting member may have other structures, such as a spring sheet.

Further, in order to prevent the misoperation, according to another embodiment of the present invention, as shown in fig. 1 to 3, one end of the sealing housing 200 is provided with a flip 201, and the flip 201 is located above the button 235 for preventing the button 235 from being operated by a mistake. In the length direction of the sealed housing 200 (shown in the reverse direction of Y in fig. 1), the flip cover 201 is hinged to the sealed housing 200, and can be flipped up by the user's operation, so that the button 235 is exposed and operated, thereby preventing the button from being pressed during transportation or in an unnecessary situation.

According to another embodiment of the present invention, as shown in fig. 2-3, the lower end of the insertion portion 260 is provided with an elastic pressing member 262, and the elastic pressing member 262 is used for pressing the sealing film 221 and the test paper 240. The resilient hold down member 262 presses at least a portion of the test strip 240 into the reservoir 220. The elastic pressing member 262 is not particularly limited, and may be a spring, a leaf spring, or an elastic protrusion.

Further, realize that the sealed concrete structure of inner chamber 210 can refer to any mode that has in the prior art, the utility model discloses in no longer giving details, for example grafting portion 260 can be through setting up the shape with nucleic acid amplification reaction tube 100 phase-match, after nucleic acid amplification reaction tube 100 inserts grafting portion 260, the laminating of the two surface mutually realizes inner chamber 210's sealing. According to another embodiment of the present invention, referring to FIGS. 1 to 2, a sealing ring 263 made of an elastomer is provided in the insertion channel 261, or a sealing ring 263 made of an elastomer is provided outside the side wall of the nucleic acid amplification reaction tube 100. The sealing ring can effectively prevent the expansion product from leaking into the air.

It should be noted that the present invention does not limit the specific structure and the manufacturing material of the nucleic acid amplification reaction tube, and can reasonably select the nucleic acid amplification reaction tube according to actual needs, as long as the nucleic acid amplification reaction tube can stably store the reaction solution and can be punctured by the puncturing mechanism.

Specifically, referring to FIGS. 4 to 5 in combination with FIGS. 1 to 3, in the present embodiment, the nucleic acid amplification reaction tube 100 includes a side wall 110, a bottom wall 120, and an upper wall 130, and a sealed reaction solution storage chamber 140 defined by the side wall 110, the bottom wall 120, and the upper wall 130, wherein the side wall 110 is a cylindrical side wall, and the outer surface of the side wall 110 is provided with external threads 150 for matching with the internal threads of the insertion channel 261 to seal the side wall 110 of the nucleic acid amplification reaction tube 100 and the insertion channel 261.

According to another embodiment of the present invention, in order to facilitate the nucleic acid amplification reaction tube 100 to be punctured by the puncturing mechanism 250 after the nucleic acid amplification reaction tube 100 is inserted into the nucleic acid amplification detecting apparatus, the bottom wall 120 of the nucleic acid amplification reaction tube 100 may be provided with a cut mark to facilitate the puncturing part 251 of the puncturing mechanism 250 to puncture the nucleic acid amplification reaction tube 100.

Further, since the bottom wall 120 of the nucleic acid amplification reaction tube 100 is provided with a cut, the nucleic acid amplification reaction tube 100 may be damaged at the cut position during the process of being taken and placed before the nucleic acid amplification detecting apparatus is inserted. Therefore, according to another embodiment of the present invention, the bottom wall 120 of the nucleic acid amplification reaction tube 100 is recessed into the reaction solution storage cavity 140 to form the recessed portion 121, and only the recessed portion 121 is provided with a cutting trace, so that the damage of the nucleic acid amplification reaction tube 100 during the taking and placing process can be effectively avoided.

According to another embodiment of the present invention, the general nucleic acid amplification reaction tube 100 is an open-lid structure, i.e., the upper wall 130 is an openable lid, and the sample to be amplified and the reagents related to the amplification reaction system are placed in the nucleic acid amplification reaction tube 100, and then the lid is closed, thereby achieving the sealing. In addition, the upper portion of the nucleic acid amplification reaction tube 100 may also be directly a closed structure, i.e., the upper wall 130 and the side wall 110 are fixedly connected, or even directly integrally formed, and cannot be opened. When in use, the syringe with the fine needle pierces the upper wall 130 of the nucleic acid amplification reaction tube 100, injects the reaction system, and then seals the breach with a sealing film or a wax droplet having a higher melting point, thereby achieving better sealing of the nucleic acid amplification reaction tube 100.

Further, some poor or laggard areas have been heavily stricken by infectious diseases due to poor quality, poor hygiene, low hygiene awareness, malnutrition, etc. The infectious diseases have high incidence and death rate, and the high treatment cost is difficult to be borne by the ordinary families. However, in these areas, advanced infectious disease detection methods are not widespread, mainly because of the difficulty in supplying power in most areas and the inability to operate large instruments; the cost of large-scale medical equipment and the corresponding cost of maintenance equipment cannot be borne; site restriction; the patient cannot afford the high examination cost, etc. However, the amplification reaction in the nucleic acid amplification reaction tube 100 needs to be performed in a specific temperature range, and it may be difficult for the detection personnel to obtain a temperature constant device in the above-mentioned region, and the detection cannot be performed on the spot, which limits the immediacy of the nucleic acid detection.

According to another embodiment of the present invention, the surface of the nucleic acid amplification reaction tube 100 is coated with at least two reversible temperature-sensitive color-changing materials. The color-changing temperature of the temperature-sensitive color-changing material can be set according to the actual situation, and the specific reversible temperature-sensitive color-changing material can be a commercially available product. For a certain amplification reaction, if the reaction temperature is required to be between a first temperature T1 and a second temperature T2, two temperature-sensitive color-changing materials can be selectively coated on the surface of the nucleic acid amplification reaction tube 100, wherein the color-changing temperature of the first temperature-sensitive color-changing material is the first temperature T1, and the color-changing temperature of the second temperature-sensitive color-changing material is the second temperature T2. Thus, when the first temperature sensitive material is discolored and the second temperature sensitive material is not discolored during the amplification reaction, it is indicated that the temperature is suitable for the amplification reaction in the nucleic acid amplification reaction tube 100. In this way, the nucleic acid amplification reaction tube 100 can be directly placed in a thermos flask, and the temperature of water in the thermos flask can be controlled by adjusting the amount of cold and hot water, so that the amplification reaction can be maintained, and the sample can be detected at any time and any place without using a thermostat.

For example, if the optimal reaction temperature is about 38 ℃, the temperature-sensitive paint can be selected from 2 temperatures, which are respectively greater than 38 and less than 38, preferably 37 and 39 ℃, if the optimal reaction temperature is 63 ℃, the temperature-sensitive paint can be selected from 62 and 64, the shape of the temperature-sensitive paint can be any, but preferably arabic numerals corresponding to the temperature, such as 38-degree discolored temperature-sensitive material, shown as "38". This makes it possible to more directly react the temperature of the nucleic acid amplification reaction tube 100.

Further, when the nucleic acid amplification reaction tube 100 is used in amplification reaction systems of various temperatures, various temperature-sensitive color-changing materials may be provided.

According to another embodiment of the present invention, the nucleic acid amplification reaction tube 100 of the present invention is a specially made nucleic acid amplification tube, and the sidewall 110 of the nucleic acid amplification reaction tube 100 can be made of a series of materials, preferably a material with good thermal conductivity, high strength and good fluidity, such as metal, alloy, thermal conductive plastic and organic composite material, with a height of 1-3cm, preferably 2cm, and the general shape can be similar to that of a common nucleic acid amplification tube, but with some differences.

While the invention has been shown and described with reference to certain preferred embodiments thereof, it will be understood by those skilled in the art that the foregoing is a more detailed description of the invention, and the specific embodiments thereof are not to be considered as limiting. Various changes in form and detail, including simple deductions or substitutions, may be made by those skilled in the art without departing from the spirit and scope of the invention.

Claims (5)

1. A nucleic acid amplification detecting apparatus comprising a sealed casing and a nucleic acid amplification reaction tube, wherein,

an inner cavity is arranged in the sealed shell, an inserting part is arranged on the sealed shell, an inserting channel is arranged in the inserting part, a puncturing mechanism is arranged at the lower end of the inserting channel, the nucleic acid amplification reaction tube is inserted into the inserting channel, then is hermetically connected with the inserting channel and can be punctured by the puncturing mechanism, so that the reaction liquid flows into the inner cavity from a liquid outlet hole of the puncturing mechanism,

a liquid storage tank and detection test paper are arranged in the inner cavity, the upper surface of the liquid storage tank is sealed by a sealing film, the detection test paper is arranged on the sealing film and can react with the reaction liquid,

a pressing part is arranged in the inner cavity and is positioned at one end, close to the insertion part, in the inner cavity, the pressing part comprises a pressing rod, the pressing rod comprises a pressing end and a cone end, the middle part of the pressing rod is connected with the side wall of the liquid storage tank in a rotating and sealing way through a pivot, the pressing end is positioned in the inner cavity, the cone end is positioned in the liquid storage tank and is provided with a cone part, the cone part can pierce the sealing membrane, the pressing end is provided with a button,

and after the reaction is finished, pressing the button to tilt the cone part of the cone body end and puncture the sealing film.

2. The nucleic acid amplification detecting apparatus according to claim 1, wherein the pressing end is provided with an elastic support member, and the elastic support member is located below the button.

3. The nucleic acid amplification detecting apparatus according to claim 1, wherein a flip cover is provided at one end of the sealed housing, and the flip cover is located above the button to prevent the button from being operated by mistake.

4. The nucleic acid amplification detecting apparatus according to claim 1, wherein a lower end of the insertion portion is provided with an elastic pressing member for pressing down the closing film and the detection test paper.

5. The nucleic acid amplification detecting apparatus according to claim 1, wherein a sealing ring made of an elastomer is provided in the insertion channel, or a sealing ring made of an elastomer is provided outside a side wall of the nucleic acid amplification reaction tube.

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