CN212476702U - Test paper detection box - Google Patents

Abstract

The utility model provides a test paper detection box, including box body, installation department and solution pipe, be equipped with the installation passageway in the installation department, the lower extreme of installation passageway is equipped with piercing mechanism, and solution pipe inserts behind the installation passageway, can be pricked by piercing mechanism for sample solution flows in and holds the intracavity, holds the intracavity and is equipped with liquid storage tank and chromatography test paper, and the upper surface of liquid storage tank is sealed by the sealing layer, and on the chromatography test paper was located the sealing layer, can react with sample solution, and after the reaction was accomplished, the sealing layer can be pricked to the operation installation department. By adopting the technical scheme, after the detection of the chromatographic test paper is finished, the installation part is operated, the end part of the installation part extending into the box body pierces the sealing layer, so that the liquid in the liquid storage tank reacts with the sample solution on the chromatographic test paper and in the solution pipe, the residual nucleic acid in the test paper detection box is completely removed, the solution pipe is prevented from carelessly falling off, or the device is damaged, and the inside is exposed, so that any pollution is caused.

Description

Test paper detection box

Technical Field

The utility model relates to a detection area, concretely relates to test paper detection box.

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 type chromatography strip plastic cartridge, and reference 3(CN205574438U) discloses a sealed 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 test paper detection box, through the device convenient operation to can effectually avoid amplification product to spread to the air in, cause false positive reaction.

In order to solve the problems, the utility model discloses a test paper detection box, which comprises a box body, a mounting part and a solution tube, wherein,

the box body is internally provided with a containing cavity, the box body is provided with a mounting hole, the mounting part is connected with the mounting hole in a sealing way, one end of the mounting part is positioned outside the box body, the other end of the mounting part extends into the box body, the mounting part is internally provided with a mounting channel, the lower end of the mounting channel is provided with a puncturing mechanism, the solution pipe is inserted into the mounting channel and then is connected with the mounting channel in a sealing way and can be punctured by the puncturing mechanism, so that the sample solution flows into the containing cavity from a fluid,

the containing cavity is provided with a liquid storage tank and a chromatography test paper, the upper surface of the liquid storage tank is sealed by a sealing layer, the chromatography test paper is arranged on the sealing layer and can react with the sample solution,

after the reaction is finished, the mounting part is operated, so that the end part of the mounting part extending into the box body punctures the sealing layer.

By adopting the technical scheme, after the detection of the chromatographic test paper is finished, the mounting part is operated, the end part of the mounting part extending into the box body pierces the sealing layer, so that the liquid in the liquid storage tank reacts with the sample solution on the chromatographic test paper and in the solution pipe, and the residual nucleic acid in the test paper detection box is completely removed. Therefore, even if the solution pipe falls off carelessly in the subsequent process or the test paper detection box is damaged, the internal exposure is caused, and no pollution is caused.

According to the utility model discloses a further concrete implementation mode, the installation department passes through threaded connection's mode and links to each other with the mounting hole, through rotatory installation department, can make the installation department stretch into the tip puncture sealing layer in the box body.

According to the utility model discloses a further embodiment, the sealing layer with be equipped with the supporting part between the installation department, before the reaction begins, the supporting part can obstruct the installation department to puncture the sealing layer, after the reaction is accomplished, puts aside the supporting part, and the operation installation department can make the installation department stretch into the tip in the box body and puncture the sealing layer.

According to the utility model discloses a further concrete implementation mode, the supporting part includes operating end and support end, and the operating end is located the outside of box body for the pulling supporting part is putd aside, supports the end and is located the box body, is used for hindering the installation department.

According to the utility model discloses a further embodiment, the lower extreme of installation department is provided with the awl, and the awl is used for puncturing the sealing layer.

According to another embodiment of the present invention, a sealing ring made of an elastomer is disposed in the installation channel, or a sealing ring made of an elastomer is disposed outside the sidewall of the solution pipe.

Drawings

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

FIG. 1 is a sectional view of the test paper box according to the present invention;

FIG. 2 is a cross-sectional view of the reagent paper cartridge provided by the present invention;

fig. 3 is a cross-sectional view of a solution tube provided by the present invention;

fig. 4 is a schematic structural diagram of a solution tube provided by 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. 1-4, the utility model discloses a test paper detection box, including a box body 200, an installation part 260 and a solution tube 100, wherein, a containing cavity 210 is arranged in the box body 200, an installation hole 201 is arranged on the box body 200, the installation part 260 is connected with the installation hole 201 in a sealing way, one end of the installation part 260 is arranged outside the box body 200, one end extends into the box body 200, an installation channel 261 is arranged in the installation part 260, the lower end of the installation channel 261 is provided with a puncture mechanism 250, after the solution tube 100 is inserted into the installation channel 261, the solution tube is connected with the installation channel 261 in a sealing way and can be punctured by the puncture mechanism 250, so that a sample solution flows into the containing cavity 210 from a fluid channel 252 of the puncture mechanism 250, a liquid storage tank 220 and a chromatography test paper 240 are arranged in the containing cavity 210, the upper surface of the liquid storage tank 220 is sealed by a sealing, after the reaction is completed, the end of the mounting portion 260 protruding into the cartridge 200 is manipulated to pierce the sealant 221. Meanwhile, the box 200 is further provided with a detection result observation area 270 for a user to observe the detection result.

That is, the reagent test cassette is mainly composed of a cassette body 200, a mounting part 260 and a solution tube 100, wherein a containing cavity 210 is provided in the cassette body 200, a liquid storage tank 220, a sealing layer 221 and a chromatography test paper 240 are provided in the containing cavity 210 from bottom to top in sequence, and the upper surface of the liquid storage tank 220 is sealed by the sealing layer 221. When the detection device is not used, the sealing layer 221 can seal the liquid storage tank 220 to prevent the liquid in the liquid storage tank 220 from reacting with the sample solution on the chromatography test paper 240 and in the solution tube 100, so as to ensure the usability of the detection device, and at this time, the mounting portion 260 is located at the first position.

After the detection of the chromatographic test paper 240 is completed, the mounting portion 260 can be moved to the second position to puncture the sealing layer 221, so that the liquid in the liquid storage tank 220 reacts with the sample solution on the chromatographic test paper 240 and in the solution tube 100, and the nucleic acid remaining in the test paper cartridge is completely removed. Therefore, even if the solution tube 100 is accidentally dropped off in the subsequent process or the test paper detection box is damaged, the inner part is exposed, and no pollution is caused.

In this embodiment, the liquid storage tank 220 may store therein a nucleic acid-damaging reagent such as a sodium hypochlorite solution or a solution of a commercial DNA detergent. In other embodiments, other solutions may be stored in the liquid holding tank, as long as the solutions react with the sample solution to prevent contamination of the sample solution.

Further, the cartridge 200 is provided at the upper surface thereof with a mounting portion 260 and a test result observation region 270, a mounting passage 261 of the mounting portion 260 is provided for insertion of the solution tube 100, and after the solution tube 100 is inserted into the mounting passage 261, the receiving chamber 210 is sealed, the puncturing mechanism 250 punctures the solution tube 100, and the sample solution flows from the fluid passage 252 into the receiving chamber 210 to react with the chromatography test paper 240 in the receiving chamber 210.

Wherein, the realization holds the sealed concrete structure of chamber 210 and can refer to the existing any mode in the prior art, the utility model discloses in no longer giving unnecessary details, for example installation passageway 261 can through set up the shape with solution pipe 100 phase-match, after solution pipe 100 inserted installation passageway 261, the two surface was laminated mutually, realizes holding the sealed of chamber 210.

During the detection process, the accommodating cavity 210 is always sealed, so that the amplification product is prevented from leaking outwards. After the test result is recorded, the sealing layer 221 may be punctured by the mounting portion 260, and the chromatographic test paper 240 may react with the nucleic acid-disrupting reagent to completely remove the nucleic acid remaining in the test paper cartridge. Therefore, even if the solution tube 100 is accidentally dropped off in the subsequent process or the test paper detection box is damaged, the inner part is exposed, and no pollution is caused.

By adopting the technical scheme, after the detection of the chromatographic test paper is finished, the mounting part is operated, the end part of the mounting part extending into the box body pierces the sealing layer, so that the liquid in the liquid storage tank reacts with the sample solution on the chromatographic test paper and in the solution pipe, and the residual nucleic acid in the test paper detection box is completely removed. Therefore, even if the solution pipe falls off carelessly in the subsequent process or the test paper detection box is damaged, the internal exposure is caused, and no pollution is caused.

It should be noted that the utility model discloses do not restrict the concrete structure of installation department and the connected mode with the box body, can carry out reasonable setting according to the reality, as long as can make the installation department puncture the sealing layer after chromatography test paper accomplishes the detection can.

According to another embodiment of the present invention, referring to fig. 1-4, the mounting portion 260 is connected to the mounting hole 201 by a screw connection, and the end of the mounting portion 260 extending into the box body 200 can pierce the sealing layer 221 by rotating the mounting portion 260.

That is, the upper wall of the cartridge 200 is provided with a mounting hole 201 for mounting the mounting portion 260, an internal thread (not shown) is provided in the mounting hole 201, the mounting hole 201 is provided along a direction perpendicular to the upper surface of the cartridge 200 (as shown by X in fig. 1), the mounting portion 260 is provided with an external thread, and by rotating the mounting portion 260, the lower end of the mounting portion 260 can be extended into the cartridge 200. When the detecting unit is not in use, the mounting portion 260 is located at a first position where the mounting portion 260 can contact the chromatographic test paper 240 without piercing the sealing layer 221 below the chromatographic test paper 240, and the liquid in the liquid storage tank 220 does not react with the sample solution on the chromatographic test paper 240 and in the solution tube 100, thereby ensuring smooth use of the chromatographic test paper 240. When the mounting portion 260 is moved to the second position, i.e., the mounting portion 260 is rotated continuously, the lower end of the mounting portion 260 approaches the sealing layer 221, and the sealing layer 221 can be punctured, so that the liquid in the liquid storage tank 220 reacts with the sample solution on the chromatography test paper 240 and in the solution tube 100, and the nucleic acid remaining in the detection device is prevented from being contaminated when exposed inside.

In order to ensure that the mounting portion 260 does not pierce the sealing layer 221 when the detection device is not in use, and to ensure the usability of the detection device, according to another embodiment of the present invention, as shown in fig. 1-3, a supporting portion 230 is disposed between the sealing layer 221 and the mounting portion 260, the supporting portion 230 can prevent the mounting portion 260 from piercing the sealing layer 221 before the reaction starts, and after the reaction is completed, the supporting portion 230 is removed, and the mounting portion 260 is operated, so that the mounting portion 260 can pierce the sealing layer 221 at the end portion inside the box body 200. By providing the support part 230, the operator is further prevented from operating erroneously, and the nucleic acid-disrupting reagent comes into contact with the chromatographic test paper 240 when the detection has not been completed.

It should be noted that the utility model discloses do not restrict the concrete structure of supporting part and the connected mode with the box body, can carry out reasonable setting according to the reality, as long as can make the supporting part hinder the installation department and puncture the sealing layer before the reaction begins can.

According to another embodiment of the present invention, referring to fig. 1-4, the supporting portion 230 includes an operation end 231 and a supporting end 232, preferably, in the length direction of the cartridge (as shown by Y in fig. 1), the supporting portion 230 is disposed at one end of the cartridge 200 close to the solution tube 100, the operation end 231 is located outside the cartridge 200 for pulling the supporting portion 230 to move away, and the supporting end 232 is located inside the cartridge 200 for obstructing the installation portion 260. The operation end 231 protrudes outside the cartridge body 200 to facilitate manual operation, and the supporting part 230 is hermetically coupled to the cartridge body 200 in order to prevent leakage of the liquid stored in the liquid storage tank 220, and the supporting part 230 is removed by operating the operation end 231, and the mounting part 260 is operated such that the end of the mounting part 260 protruding into the cartridge body 200 pierces the sealing layer 221.

In accordance with another embodiment of the present invention, as shown in fig. 1-2, the lower end of the mounting portion 260 is provided with a prick 262, and the prick 262 is used to pierce the sealing layer 221. The prick 262 may be an elastic prick structure, and when the supporting portion 230 is opened, the mounting portion 260 moves downward, and the prick 262 presses at least a portion of the chromatography test paper 240 into the liquid storage tank 220. The awl 262 is not limited in particular, and may be a spring, a leaf spring, or a protrusion.

Further, the realization holds the sealed concrete structure of chamber 210 and can refer to the existing any mode in the prior art, the utility model discloses in no longer giving details, sample solution adds regional 260 can through setting up the shape with solution pipe 100 phase-match, and after solution pipe 100 inserted sample solution and adds regional 260, the laminating of the two surface mutually realizes holding chamber 210's sealed. According to another embodiment of the present invention, as shown in fig. 1-2, a sealing ring 263 made of an elastomer is provided in the installation channel 261, or a sealing ring 263 made of an elastomer is provided outside the sidewall of the solution pipe 100. The sealing ring can effectively prevent the expansion product from leaking into the air.

It should be noted that the utility model discloses do not restrict the concrete structure and the preparation material of solution pipe, can carry out reasonable selection according to actual need, as long as ensure that the storage sample solution that the solution pipe can be stable, can be punctured by puncturing the mechanism can.

Specifically, referring to fig. 3-4 in combination with fig. 1-2, in the present embodiment, the solution pipe 100 includes a side wall 110, a bottom wall 120 and an upper wall 130, and a sealed sample 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 installation channel 261 to achieve the sealing of the side wall 110 of the solution pipe 100 and the installation channel 261.

According to another embodiment of the present invention, in order to facilitate the solution pipe 100 to be punctured by the puncturing mechanism 250 after being inserted into the test paper detection box, the bottom wall 120 of the solution pipe 100 may be provided with a cut mark, which facilitates the puncturing mechanism 250 to puncture the solution pipe 100.

Further, since the bottom wall 120 of the solution tube 100 is provided with a cut, the solution tube 100 may be damaged at the cut before the strip cartridge is inserted. Therefore, according to another embodiment of the present invention, the bottom wall 120 of the solution tube 100 is recessed into the sample solution storage cavity 140 to form the concave portion 121, and only the concave portion 121 is provided with a cut trace, so that the damage of the solution tube 100 during the taking and placing process can be effectively avoided.

According to another embodiment of the present invention, the general solution tube 100 is an open-lid structure, that is, the upper wall 130 is an openable lid, and the sample to be amplified and the reagents related to the amplification reaction system are put into the solution tube 100, and then the lid is closed to achieve sealing. In addition, the upper portion of the solution pipe 100 may also be directly of a closed structure, i.e., the upper wall 130 and the side wall 110 are fixedly connected, even directly and integrally formed, and cannot be opened. When in use, the injector with a thin needle penetrates through the upper wall 130 of the solution tube 100, the reaction system is injected, and then the opening is sealed by a sealing film or a wax drop with a higher melting point, so that the solution tube 100 can be better sealed.

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 solution tube 100 needs to be performed in a specific temperature range, and it may be difficult for a human detector 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 nucleic acid detection.

According to another embodiment of the present invention, the surface of the solution pipe 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. Aiming at 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 solution 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 changes color and the second temperature sensitive material does not change color during the amplification reaction, it indicates that the temperature is suitable for the amplification reaction in the solution tube 100. In this way, the solution tube 100 can be directly placed in a thermos bottle, and the temperature of water in the thermos bottle 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 thermostatic device.

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 allows a more direct reaction of the temperature of solution tube 100.

Further, if the solution tube 100 is used in amplification reaction systems with different temperatures, a plurality of temperature-sensitive color-changing materials can be arranged.

According to another embodiment of the present invention, the solution tube 100 of the present invention is a special nucleic acid amplification tube, and the sidewall 110 of the solution tube 100 can be made of a series of materials, preferably materials 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 (6)

1. A test paper detection box is characterized by comprising a box body, a mounting part and a solution tube, wherein,

the box body is internally provided with an accommodating cavity, the box body is provided with a mounting hole, the mounting part is hermetically connected with the mounting hole, one end of the mounting part is positioned outside the box body, and the other end of the mounting part extends into the box body, the mounting part is internally provided with a mounting channel, the lower end of the mounting channel is provided with a puncture mechanism, the solution pipe is inserted into the mounting channel, is hermetically connected with the mounting channel and can be punctured by the puncture mechanism, so that the sample solution flows into the accommodating cavity from the fluid channel of the puncture mechanism,

the containing cavity is internally provided with a liquid storage groove and a chromatography test paper, the upper surface of the liquid storage groove is sealed by a sealing layer, the chromatography test paper is arranged on the sealing layer and can react with the sample solution,

after the reaction is finished, the installation part is operated, so that the installation part extends into the end part in the box body to puncture the sealing layer.

2. A test strip testing cassette according to claim 1, wherein said mounting portion is threadably engaged with said mounting hole, and wherein rotation of said mounting portion causes an end of said mounting portion extending into said cassette body to pierce said sealing layer.

3. A test strip testing cassette according to claim 1, wherein a support portion is provided between said sealing layer and said mounting portion, said support portion being adapted to prevent said mounting portion from piercing said sealing layer before the reaction is initiated, and said support portion being adapted to be removed after the reaction is completed to operate said mounting portion such that the end of said mounting portion extending into said cassette body pierces said sealing layer.

4. A strip cassette according to claim 3, wherein the support portion includes an operating end located outside the cassette body for pulling the support portion apart, and a support end located inside the cassette body for obstructing the mounting portion.

5. A test strip cartridge according to claim 1, wherein a lower end of the mounting portion is provided with a prick for piercing the sealing layer.

6. A test strip cartridge according to claim 1, wherein a sealing ring made of an elastomer is provided in the mounting passage, or a sealing ring made of an elastomer is provided outside a side wall of the solution tube.

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