CN218629826U

CN218629826U - Novel coronavirus antigen detection kit

Info

Publication number: CN218629826U
Application number: CN202222037991.3U
Authority: CN
Inventors: 王思宇; 王新宇; 骆辉; 薛凤; 程国进; 常晓刚; 冯杏芬; 许梦灵
Original assignee: Hai Hat Hainan Free Trade Zone Medical Technology Co ltd
Current assignee: Hai Hat Hainan Free Trade Zone Medical Technology Co ltd
Priority date: 2022-08-03
Filing date: 2022-08-03
Publication date: 2023-03-14
Anticipated expiration: 2032-08-03

Abstract

The utility model discloses a novel coronavirus antigen detection kit, which comprises a box body, a sampler and a sampling bottle which are arranged in the box body, and an antigen detection card which is also arranged in the box body, wherein the antigen detection card comprises a shell, a test strip and a sample shell; the test strip is provided with a microsphere marker binding pad, so that a latex microsphere antibody on the microsphere marker binding pad is specifically bound with 2019-nCoV N protein to form a compound, the compound moves forwards along the test strip due to chromatography, and is captured by a rabbit anti-N protein antibody coated on a nitrocellulose membrane detection line (T) to form a sandwich compound for coagulation and color development; when the sample is a negative sample, the compound can not be formed, namely the compound can not be captured by the specific antibody in the detection area (T) without color development, thereby effectively improving the detection efficiency of the patient in the early stage of infection.

Description

Novel coronavirus antigen detection kit

Technical Field

The utility model relates to a virus detection technical field, concretely relates to novel coronavirus antigen detect reagent box.

Background

At present, the gold standard for detecting the neocorolla antigen is nucleic acid detection, but the detection environment needs to be operated by professional personnel in medical institutions, a specific detection instrument is needed, and the risk of inconvenient detection, long time and even secondary infection caused by aggregation exists. There is therefore a need for tools for the initial screening of large populations that require the following features: the detection speed is high, professional equipment and personnel are not needed, and the accuracy is high. Antibodies are one of the rapid detection reagents, but are not suitable for population screening or discovery at the early stage of infection. Since antibodies are produced 8-10 days after infection, many infected individuals are already clearly ill or are already severe, already in the convalescent phase. In addition, igG and IgM are multiple antibodies in human body fluid, and are easily interfered by other substances to cause the increase of false positive rate, and unnecessary isolation and panic occur.

SUMMERY OF THE UTILITY MODEL

The utility model aims at the weak point that exists among the above-mentioned technique, provides a novel coronavirus antigen detect reagent box, aims at solving the above-mentioned problem that exists.

The utility model provides a novel coronavirus antigen detection kit, which comprises a box body, a sampler and a sampling bottle which are arranged in the box body, and an antigen detection card which is also arranged in the box body, wherein the antigen detection card comprises a shell, a test strip and a sample shell, the test strip is arranged in the shell, and the sample shell is in splicing fit with the shell; the shell is provided with a color development frame for checking a color development result of the test strip, the sample shell is provided with a sample adding frame for dropwise adding a sample treatment solution, the test strip comprises a water absorption pad, a nitrocellulose membrane, a sample adding pad, a microsphere marker combination pad and a bottom plate, and the sample adding pad, the microsphere marker combination pad, the nitrocellulose membrane and the water absorption pad are sequentially stuck on the bottom plate from left to right. The microsphere marker combination pad comprises an immune latex microsphere-monoclonal antibody N72 compound and a glass fiber membrane, and the immune latex microsphere-monoclonal antibody N72 compound is coated on the glass fiber membrane by gold spraying. The immune latex microsphere-monoclonal antibody N72 compound is formed by mixing and marking red latex microsphere EDC/NHS activated and monoclonal antibody N72.

Furthermore, the contact ratio of the sample adding pad and the microsphere marker binding pad is 1.5-2.5mm, and the contact ratio of the microsphere marker binding pad and the nitrocellulose membrane is 1.5-2.5mm. The sample adding pad, the microsphere marker combining pad, the nitrocellulose membrane and the water absorption pad are sequentially stuck on the bottom plate from left to right through the self-adhesive.

Furthermore, the sample shell is inserted into one end of the shell, the collection end of the test strip is positioned outside one end of the shell, and the sample shell is inserted into one end of the shell, so that the collection end of the test strip is inserted into the sample adding frame. The sample shell is provided with an insertion slot which is communicated with the sample adding frame, and the sample shell is inserted into the shell to enable the collection end of the test strip to be inserted into the insertion slot. One end protrusion of sample shell is equipped with grafting portion, and the one end of shell is equipped with the socket, and grafting portion is pegged graft with the socket and is cooperated. The sampler is a disposable nasal swab, and the sampling bottle is a disposable virus sampling tube; a double-lug extraction tube and a sample processing liquid tube are also arranged in the box body.

Compared with the prior art, the method has the following beneficial effects:

the utility model provides a novel coronavirus antigen detection kit, through set up the microsphere marker conjugate pad on the test paper strip, make the latex microsphere antibody specificity on the microsphere marker conjugate pad combine 2019-nCoV N albumen to form the complex, this complex because the chromatography moves forward along the test strip, is caught by the rabbit anti-N albumen antibody of peridium on the nitrocellulose membrane detection line (T), forms sandwich complex and gathers the color development; when the specimen is a negative sample, a complex cannot be formed, that is, the complex cannot be captured by the specific antibody in the detection region (T) without developing color; by adopting the technical scheme, the early-stage infection detection of the patient can be realized, the method is suitable for screening of new-canopy outbreak cities, general investigation of border customs and the like, personnel blockage is avoided, and the false positive problem caused by interference of other substances is effectively reduced.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly introduced below, and it is obvious that the drawings in the description below are only preferred embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to these drawings without inventive labor.

FIG. 1 is a schematic view of the test strip of the present invention;

FIG. 2 is a schematic view of the antigen detection card of the present invention;

FIG. 3 is an internal schematic view of the antigen detection card of the present invention.

In the figure, 1-housing; 2-test paper strip; 3-sample shell; 4-a color development frame; 5-a sample adding frame; 6-slot; 7-a plug-in part; 8-socket; 21-a sample addition pad; 22-microsphere label conjugate pad; 23-nitrocellulose membrane; 24-absorbent pads; 25-a base plate; 221-immune latex microsphere-monoclonal antibody N72 compound; 222-fiberglass membrane.

Detailed Description

In order to make the structure and features and advantages of the present invention easier to understand, preferred embodiments of the present invention will be described in detail below with reference to the accompanying drawings:

example 1:

as shown in fig. 1, the utility model provides a novel coronavirus antigen detection kit, which comprises a box body, a sampler and a sampling bottle which are arranged in the box body, and an antigen detection card which is also arranged in the box body, wherein the antigen detection card comprises a shell 1, a test strip 2 and a sample shell 3, the test strip 2 is arranged in the shell 1, and the sample shell 3 is connected with one end of the shell 1; the shell 1 is provided with a color development frame 4 for checking the color development result of the test strip 2 so as to display the detection result of the novel coronavirus antigen. The sample shell 3 is provided with a sample adding frame 5 for dripping sample processing liquid, and the sample adding frame 5 is of an oval structure. The test strip 2 comprises a water absorption pad 24, a nitrocellulose membrane 23, a sample addition pad 21, a microsphere marker binding pad 22 and a bottom plate 25. Further, the absorbent pad 24 is absorbent paper; the sample adding pad 21, the microsphere marker binding pad 22, the nitrocellulose membrane 23 and the absorbent pad 24 are sequentially adhered to the bottom plate 25 from left to right through the self-adhesive. The contact ratio of the sample addition pad 21 and the microsphere marker binding pad 22 is 1.8mm or 2mm, and the contact ratio of the microsphere marker binding pad 22 and the nitrocellulose membrane 23 is 1.8mm or 2mm. The microsphere marker combination pad 22 comprises an immune latex microsphere-monoclonal antibody N72 composite 221 and a glass fiber membrane 222, and the immune latex microsphere-monoclonal antibody N72 composite 221 is coated on the glass fiber membrane 222 by gold spraying. Further, the immunolatex microsphere-monoclonal antibody N72 complex 221 was sprayed on the glass fiber membrane 222 using a film-drawing gold spraying machine, and then dried to form the microsphere label conjugate pad 22. The immune latex microsphere-monoclonal antibody N72 compound 221 is prepared by mixing and labeling red latex microsphere EDC/NHS after being activated and monoclonal antibody N72 according to a certain proportion. Wherein EDC is 1- (3-dimethylaminopropyl) -3-ethylcarbodiimide, and NHS is N-hydroxysuccinimide.

The working principle is as follows: when the kit adopts a microsphere immunochromatography technology, if 2019-nCoV exists in a sample during detection, after the sample is treated, a latex microsphere antibody on a marker pad (namely a microsphere marker binding pad 22) is specifically bound with 2019-nCoV N protein to form a complex, and the complex moves forwards along a test strip due to the chromatography action and is captured by a rabbit anti-N protein antibody coated on a nitrocellulose membrane 23 detection line (T) to form a sandwich complex for coagulation and color development. If the sample is a negative sample, the complex cannot be formed, and the specific antibody cannot be captured in the detection region, so that no color develops. No matter whether 2019-nCoV exists in the sample or not, a colored strip appears at the position of the quality control line (C) and is used as an internal control standard for judging whether the chromatography process is normal or not and whether the reagent is invalid or not.

Example 2:

as shown in fig. 2 and 3, in combination with the technical solution of embodiment 1, in this embodiment, a sample case 3 is inserted into one end of a housing 1; the collection end of the test strip 2 is located outside one end of the shell 1, namely, one end of the test strip 2 protrudes out of one end of the shell 1, and the sample shell 3 is inserted into one end of the shell 1, so that the collection end of the test strip 2 is inserted into the sample adding frame 5. The sample shell 3 is provided with a slot 6, the slot 6 is communicated with the sample adding frame 5, the sample shell 3 is inserted into the slot 6 through being inserted into the shell 1, so that the collection end of the test strip 2 is inserted into the slot 6, and the test solution is dripped into the collection end through the sample adding frame 5 to be detected. One end of the sample shell 3 is provided with a plug-in part 7 in a protruding mode, one end of the shell 1 is provided with a socket 8, and the plug-in part 7 is matched with the socket 8 in a plug-in mode so that the sample shell 3 can be fixedly connected to the end portion of the shell 1 in a plug-in mode. The collection end of the test strip 2 is the sample addition pad 21. By adopting the technical scheme, the detection efficiency of the novel coronavirus antigen is effectively improved, and the method is suitable for rapid detection of large-batch sampling bottles. The sampler is a disposable nasal swab, and the sampling bottle is a disposable virus sampling tube; a double-ear extraction tube and a sample processing liquid tube are also arranged in the box body, and a disposable sealing bag is covered outside the antigen detection card, the sampler and the sampling bottle.

The working principle is as follows: the sample shell 3 capable of testing the sample at one end of the shell 1 is arranged, so that the acquisition end of the test strip 2 in the shell 1 can be exposed in a sample mode, and the acquisition end of the test strip 2 is conveniently inserted into a sampling bottle to quickly acquire a detection result; through setting up application of sample frame 5 and slot 6 on sample shell 3, when sample shell 3 was in the grafting state with shell 1, the collection end of test paper strip 2 was located the slot 6 of application of sample frame 5 below to realize novel coronavirus antigen detection through the mode of dropwise add test solution.

The above description is only for the preferred embodiment of the present invention, and is not intended to limit the present invention in any way. The technical solution of the present invention can be used by anyone skilled in the art to make many possible variations and modifications to the technical solution of the present invention without departing from the scope of the technical solution of the present invention, or to modify equivalent embodiments with equivalent variations. Therefore, any modification, equivalent change and modification of the above embodiments according to the present invention are all within the protection scope of the present invention.

Claims

1. The novel coronavirus antigen detection kit comprises a kit body, a sampler and a sampling bottle, and is characterized by also comprising an antigen detection card, wherein the sampler and the sampling bottle are placed in the kit body, the antigen detection card is also placed in the kit body, the antigen detection card comprises a shell (1), a test strip (2) and a sample shell (3), the test strip (2) is arranged in the shell (1), and the sample shell (3) is arranged at one end of the shell (1); the shell (1) is provided with a color development frame (4) for checking the color development result of the test strip (2), and the sample shell (3) is provided with a sample adding frame (5) for dropwise adding a sample treatment solution; the test strip (2) comprises a sample adding pad (21), a microsphere marker combining pad (22), a nitrocellulose membrane (23), a water absorbing pad (24) and a bottom plate (25), wherein the sample adding pad (21), the microsphere marker combining pad (22), the nitrocellulose membrane (23) and the water absorbing pad (24) are sequentially adhered to the bottom plate (25) from left to right.

2. The novel coronavirus antigen detection kit according to claim 1, wherein the microsphere label binding pad (22) comprises an immunolatex microsphere-monoclonal antibody N72 complex (221) and a glass fiber membrane (222), and the immunolatex microsphere-monoclonal antibody N72 complex (221) is gold-sprayed on the glass fiber membrane (222).

3. The novel coronavirus antigen detection kit according to claim 2, wherein the immunolatex microsphere-monoclonal antibody N72 complex (221) is formed by mixing and labeling red latex microspheres EDC/NHS activated and monoclonal antibody N72.

4. The novel coronavirus antigen detection kit according to claim 1, wherein the sample shell (3) is inserted into one end of the housing (1), the collection end of the test strip (2) is located outside one end of the housing (1), and the sample shell (3) is inserted into one end of the housing (1) so that the collection end of the test strip (2) is inserted into the sample addition frame (5).

5. The novel coronavirus antigen detection kit according to claim 4, wherein the sample shell (3) is provided with a slot (6), the slot (6) is communicated with the sample adding frame (5), and the sample shell (3) is inserted into the shell (1) to enable the collection end of the test strip (2) to be inserted into the slot (6).

6. The novel coronavirus antigen detection kit according to claim 5, wherein an insertion part (7) is protruded from one end of the sample shell (3), a socket (8) is arranged at one end of the outer shell (1), and the insertion part (7) is in insertion fit with the socket (8).

7. The novel coronavirus antigen detection kit of claim 1, wherein the sampler is a disposable nasal swab, and the sampling bottle is a disposable virus sampling tube; a double-lug extraction tube and a sample processing liquid tube are further arranged in the box body.

8. The novel coronavirus antigen detection kit according to claim 1, wherein the contact ratio of the sample addition pad (21) and the microsphere label binding pad (22) is 1.5-2.5mm, and the contact ratio of the microsphere label binding pad (22) and the nitrocellulose membrane (23) is 1.5-2.5mm.

9. The novel coronavirus antigen detection kit according to claim 1, wherein the sample application pad (21), the microsphere marker binding pad (22), the nitrocellulose membrane (23) and the water absorption pad (24) are sequentially adhered to the bottom plate (25) from left to right through the self-adhesive sticker.