A device for detecting respiratory system infection virus-like samples

Abstract

The present application relates to the technical field of pathogen testing, and discloses a respiratory system infection virus sample detection device, which comprises a detection cylinder, a detection card is installed in the detection cylinder, a one-way air inlet blow nozzle is arranged at the port of the detection cylinder, and the blow gas is guided to the air cavity in the detection cylinder; the detection card comprises a gas sampling area, the surface of the gas sampling area is horizontally expanded towards the air outlet end of the blow nozzle, and a gap for contacting the air cavity is reserved in the gas sampling area; a transparent window is arranged outside the detection cylinder, and a display area is arranged in the middle of the detection card. The present application adopts a handheld convenient blow gas detection cylinder, guides the mouth gas containing droplets to be concentrated and blown on the sampling area of the detection card, has a simple structure, efficiently integrates sampling and detection, greatly reduces the infection risk in the use process, does not need medical staff to detect, saves a large amount of manpower and material resources, is especially suitable for rapid screening of a large number of suspected cases and close contacts of confirmed cases, and can effectively relieve the pressure of detection and diagnosis work.

Description

Technical Field

[0001] This invention relates to the field of pathogen testing technology, specifically to a device for detecting respiratory system infection virus samples. Background Technology

[0002] With the increase in population size and density, the risk of large-scale outbreaks of infectious diseases is also increasing. Airborne transmission is the most important route of transmission for infectious respiratory diseases. Timely, rapid, accurate, simple, low-cost, and high-throughput diagnosis of infected individuals is key to controlling disease outbreaks.

[0003] Chinese patent application number 202010377997.8 discloses an integrated device for respiratory virus sample collection and detection. By configuring a detection card on the wearable device and using protective equipment to collect droplets as samples for direct detection, it integrates protection, sample collection, and detection into one unit, enabling automatic detection of viruses in droplet samples without the need for manual throat swab sampling and testing. However, wearing masks has many drawbacks. It requires putting them on, aligning them with the mouth, and loosening them, during which the fabric layer is easily contaminated, and the entire mask is difficult to preserve and process properly. Furthermore, the internal detection structure is complex and unsuitable for large-area, flexible testing applications.

[0004] To address these issues, the authors propose a device for detecting respiratory infection virus samples. Summary of the Invention

[0005] The purpose of this invention is to provide a respiratory infection virus sample detection device, which adopts a handheld, convenient blowing tube for detection. It has a simple structure, efficiently integrates sampling and detection, and greatly reduces the risk of infection during use, thereby solving the problems mentioned in the background art.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a respiratory system infection virus sample detection device, comprising:

[0007] The detection cylinder has a detection card installed inside, and a one-way air inlet nozzle is set at the port of the detection cylinder to guide the blown air into the air chamber inside the detection cylinder;

[0008] The test card includes a gas sampling area, which is horizontally unfolded with its surface facing the gas outlet end of the nozzle, and a gap is left in the gas sampling area to contact the gas chamber.

[0009] A transparent window is located on the outside of the detection cylinder, and the display area is located in the middle of the detection card.

[0010] As an optional embodiment of the respiratory system infection virus sample detection device of the present invention, the detection tube includes a tube base, which is a straight cylindrical structure, and a mouthpiece is connected to one end of the tube base. A tube cover is detachably connected to one end of the tube base where the mouthpiece is located. A protective cover is integrally connected inside the tube cover, which is a ring structure and seals and covers the mouthpiece.

[0011] As an optional embodiment of the respiratory system infection virus sample detection device of the present invention, the mouthpiece is configured as a soft rubber tube, and a latex valve for one-way air intake is fixedly connected inside.

[0012] As an optional embodiment of the respiratory system infection virus sample detection device of the present invention, the detection card includes a PVC backing plate, and the upper surface is sequentially bonded with a sample injection area, a binding area, a display area and a water absorption area. The edge of the PVC backing plate is fixedly connected to the inner wall of the top of the cylinder, and the space below forms an air cavity.

[0013] As an optional embodiment of the respiratory system infection virus sample detection device of the present invention, wherein: one end of the sample injection area is bent downwards and tilted to form a gas collection area to receive droplets exhaled from the oral cavity.

[0014] As an optional embodiment of the respiratory system infection virus sample detection device of the present invention, wherein: a strip-shaped air hole is formed on the air sampling area, the air hole and the mouthpiece are on the same central axis and extend inward to communicate with the air cavity.

[0015] As an optional embodiment of the respiratory system infection virus sample detection device of the present invention, wherein: the bottom of the gas sampling area is bent inward to form an extension area, and a ventilation gap is left at the bottom of the air chamber inner wall.

[0016] As an optional embodiment of the respiratory system infection virus sample detection device of the present invention, wherein: the surface of the binding region is distributed with a chromogenic antibody for capturing the viral S protein; the display region includes a detection line and a quality control line; the detection line is provided with a detection antibody for the S protein; and the quality control line is provided with a secondary antibody for binding the capture antibody.

[0017] As an optional embodiment of the respiratory system infection virus sample detection device of the present invention, wherein: the bottom of the cylinder is provided with a movable telescopic cover, the edge of the telescopic cover is connected to the bottom of the cylinder via a folded airbag strap, a shaping belt is fixedly connected to the inner wall of the airbag strap, and the outer surface of the shaping belt is coated with anhydrous copper sulfate coating for moisture discoloration detection.

[0018] As an optional embodiment of the respiratory system infection virus sample detection device of the present invention, wherein: the inner wall of the telescopic cover is connected to the bottom wall of the cylinder seat by a limiting band.

[0019] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0020] This respiratory infection virus sample detection device uses a handheld, convenient breath test tube. Air is safely blown through a one-way inlet nozzle, guiding the droplet-containing air to be concentrated in the sample injection area of ​​the test card. Excess air fills the air chamber inside the tube, still contaminating the sample injection area, ensuring that oral samples are collected for effective testing. The volume of air blown is checked by a telescopic cap at the bottom of the tube. This highly efficient device integrates sampling and testing, eliminating the need for medical personnel and saving significant manpower and resources. The main structure consists of a tube, nozzle, and test card, making it simple, efficient, and easy to dispose of, greatly reducing the risk of infection during use. It is particularly suitable for rapid screening of large numbers of suspected cases and close contacts of confirmed cases, effectively alleviating the pressure on testing and diagnosis. Attached Figure Description

[0021] Figure 1 This is a partial cross-sectional structural diagram of the present invention;

[0022] Figure 2 This is a schematic diagram of the unfolded structure of the present invention;

[0023] Figure 3 This is a partial structural diagram of the detection card of the present invention;

[0024] Figure 4 This is a schematic cross-sectional view of the cap structure of the present invention;

[0025] Figure 5 This is a partial structural diagram of the connection relationship at the telescopic cover of the present invention.

[0026] In the diagram: 1. Detection tube; 2. Tube base; 3. Tube cover; 4. Detection card; 5. Transparent window; 6. Nozzle; 7. Latex valve; 8. Air chamber; 9. PVC backing board; 10. Sample injection area; 11. Binding area; 12. Display area; 13. Water absorption area; 14. Gas sampling area; 15. Extension area; 16. Air hole; 17. Protective cover; 18. Telescopic cover; 19. Airbag belt; 20. Shaping belt; 21. Limiting belt. Detailed Implementation

[0027] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0028] Please see Figures 1-5The present invention provides a technical solution: a device for detecting respiratory system infection virus samples, comprising:

[0029] The testing cylinder 1 includes a cylinder base 2, which has a straight cylindrical structure and can be made of transparent plastic material. A mouthpiece 6 is connected to one end of the cylinder base 2. A cylinder cover 3 can be detachably connected to the other end of the cylinder base 2 where the mouthpiece 6 is located. The detachable connection method is threaded connection or sleeve connection, which are both conventional cover sealing methods. The specific structure will not be described in detail.

[0030] A detection card 4 is installed inside the detection cylinder 1. The detection card 4 includes a PVC backing plate 9. The upper surface is sequentially bonded with a sample injection area 10, a bonding area 11, a display area 12, and a water absorption area 13. The edge of the PVC backing plate 9 is fixedly connected to the inner wall of the top of the cylinder base 2. An air cavity 8 is formed in the space below the detection card 4.

[0031] A one-way air inlet nozzle 6 is provided at the port of the detection cylinder 1 to guide the blown air into the air chamber 8 inside the detection cylinder 1.

[0032] To facilitate the guide of oral droplets from the mouthpiece 6 onto the test card 4:

[0033] One end of the sample injection area 10 is bent downwards and tilted to form the gas collection area 14. The surface of the gas collection area 14 is horizontally spread out facing the air outlet end of the mouthpiece 6 to receive droplets exhaled from the mouth.

[0034] It should be noted that: the sample injection zone 10 and the absorbent zone 13 are filter paper sheets made of cellulose material, and the absorbent zone 13 is used to absorb excess liquid. The binding zone 11 superimposed at one end of the sample injection zone 10 is a glass fiber filter membrane, which is also a colloidal gold binding pad. The surface is covered with capture antibodies for the viral S protein labeled with colloidal gold particles (red). The display zone 12 superimposed between the binding zone 11 and the absorbent zone 13 is a nitrocellulose membrane, which facilitates the flow of droplet liquid.

[0035] The display area 12 includes a detection line and a quality control line. The detection line is equipped with a detection antibody for the S protein, and the quality control line is equipped with a secondary antibody for binding the capture antibody.

[0036] When using this test line, a positive result is indicated when both the test line and the quality control line are red. If the test line remains red but the quality control line does, the result is negative; if the test line turns red but the quality control line does not, the result is invalid.

[0037] In this embodiment, the viral S protein was selected as the antigen. The S protein sequence was ligated into the PET 28a vector and transformed into E. coli BL21 for expression. After purification, the product protein can be used as an antigen in detection.

[0038] In some embodiments, the device can also be used to detect coronaviruses, such as SARS virus, SARS virus, and MERS virus. In this case, if the viral S protein cannot be obtained directly, a capture antibody against the viral S protein can be prepared using the following method:

[0039] The gene that binds to the viral S protein (or RBD) in the human ACE2 protein was tagged with GST and transformed into E. coli BL21 for expression.

[0040] The process by which coronaviruses invade host cells mainly relies on the spike protein (S protein) on the viral surface, while the receptor for coronaviruses on human cells is angiotensin-converting enzyme II (ACE2). Therefore, for coronaviruses, expressing the portion of the ACE2 protein that binds to the S protein by adding a GST tag can also be used as a detection antibody. For some coronaviruses for which antibodies are not yet available, this method can also be used as an alternative, achieving detection results comparable to directly using antibodies.

[0041] As a further improvement of this embodiment, a transparent window 5 is provided on the outside of the detection cylinder 1, and the display area 12 in the middle of the detection card 4 is provided in the transparent window 5 for external viewing of the detection results.

[0042] To prevent the breath blown into detection tube 1 from escaping:

[0043] In this embodiment, the nozzle 6 is set as a soft rubber tube, and a latex valve 7 for one-way air intake is fixedly connected inside, so that air can only be blown in one direction, preventing the nozzle 6 from leaking gas inside the tube and preventing external pollution.

[0044] To further improve the sealing safety of the nozzle 6, a protective cover 17 is integrated inside the cylinder cover 3, which has a ring-shaped structure to seal and cover the nozzle 6, thereby improving safety.

[0045] To improve the adhesion of droplets to the sample injection area 10 during air blowing:

[0046] In this embodiment, a strip-shaped air hole 16 is formed on the gas collection area 14. The air hole 16 and the nozzle 6 are on the same central axis and extend inward to connect with the air chamber 8. The bottom of the gas collection area 14 is bent inward to form an extension area 15, and a ventilation gap is left at the bottom between the air chamber 8 and the inner wall.

[0047] When in use, air enters through the mouthpiece 6 and first passes through the air hole 16. The annular inner wall of the air hole 16 increases the contact area, allowing the incoming air droplets to be intercepted by the annular inner wall. The air hole 16 does not obstruct the blowing process, allowing the air to enter the air chamber 8 and be held for collection.

[0048] In addition, the bottom of the gas sampling area 14 is bent inward to form an extension area 15. The extension area 15 expands the contact surface to contact the oral air stored in the gas chamber 8, ensuring that the sample injection area collects oral samples for effective testing.

[0049] That is, a handheld, convenient air-blowing test tube is used. Air is safely blown through a one-way air intake nozzle to guide the air containing droplets to be concentrated in the sample injection area 10 of the test card 4. Excess air fills the air chamber 8 inside the tube and can still contaminate the sample injection area 10, ensuring that the oral sample is collected in the sample injection area for effective testing.

[0050] The overall structure efficiently integrates sampling and testing, eliminating the need for medical personnel and saving significant manpower and material resources. The main structure consists of a tube, a mouthpiece, and a test card, making it simple, efficient, and easy to dispose of the tube later. This greatly reduces the risk of infection during use, making it particularly suitable for rapid screening of large numbers of suspected cases and close contacts of confirmed cases, effectively alleviating the pressure on testing and diagnosis work.

[0051] As a further improvement to this embodiment, to avoid some people taking the testing work perfunctorily:

[0052] In this embodiment, a movable telescopic cover 18 is provided at the bottom of the cylinder base 2. The edge of the telescopic cover 18 is connected to the bottom of the cylinder base 2 via a folded airbag strap 19. A shaping strap 20 is fixedly connected to the inner wall of the airbag strap 19. The outer surface of the shaping strap 20 is coated with anhydrous copper sulfate for moisture discoloration detection. During use, the blowing volume needs to reach a certain level, and the folded airbag strap 19 needs to be gradually inflated until it becomes cylindrical. The shaping strap 20 is made of plastic. When the airbag strap 19 inflates, causing the shaping strap 20 to straighten, the shape of the airbag strap 19 is limited and does not bulge outward. At this time, the airbag strap 19 and the cylinder base 2 have the same outer diameter, maintaining a cylindrical structure.

[0053] When the airbag belt 19 inflates, the inner surface of the shaping belt 20 unfolds, and the anhydrous copper sulfate coating on the inner surface comes into contact with the moist air in the air chamber 8. After absorbing water, the anhydrous copper sulfate coating changes from white to blue, and the color development indicates that the air blowing is qualified, avoiding missed screening and improving the accuracy of the testing work.

[0054] Furthermore, the inner wall of the telescopic cover 18 is connected to the bottom wall of the cylinder base 2 by a limiting band 21. The limiting band 21 is made of steel wire to strengthen the structure of the airbag band 19 and the telescopic cover 18, limit and stabilize the position of the telescopic cover 18 and the airbag band 19, prevent the testing personnel from blowing too much air and damaging the testing cylinder 1, and improve the stability of use.

[0055] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A device for detecting respiratory system infection virus samples, characterized in that, include: The detection cylinder (1) has a detection card (4) installed inside. A one-way air inlet nozzle (6) is provided at the port of the detection cylinder (1) to guide the air to be stored in the air chamber (8) inside the detection cylinder (1). The detection card (4) includes a gas sampling area (14), with its surface horizontally unfolded facing the gas outlet end of the nozzle (6), and a gap is left in the gas sampling area (14) to contact the gas cavity (8); A transparent window (5) is set outside the detection cylinder (1), and a display area (12) is set in the middle of the detection card (4); The detection card (4) includes a PVC backing plate (9), and the upper surface is sequentially bonded with a sample injection area (10), a bonding area (11), a display area (12) and a water absorption area (13). The edge of the PVC backing plate (9) is fixedly connected to the inner wall of the top of the cylinder seat (2), and the space below forms an air cavity (8). The bottom of the gas extraction area (14) is bent inward to form an extension area (15), and the inner wall of the bottom spacer gas chamber (8) has a ventilation gap. The detection tube (1) includes a tube base (2), which is a straight cylindrical structure. One end of the tube base (2) is connected to a mouthpiece (6), and the tube base (2) where the mouthpiece (6) is located is detachably connected to a tube cover (3). The tube cover (3) has an integrated protective cover (17) inside, which is a ring structure and seals and covers the mouthpiece (6). The sample injection area (10) is bent downwards at one end to form a gas collection area (14) to receive droplets exhaled from the mouth; The gas extraction area (14) forms strip-shaped air holes (16), which are axially aligned with the nozzle (6) and extend inward to connect with the air chamber (8). The bottom of the cylinder seat (2) is provided with a movable telescopic cover (18). The edge of the telescopic cover (18) is connected to the bottom of the cylinder seat (2) through a folded airbag belt (19). A shaping belt (20) is fixedly connected to the inner wall of the airbag belt (19). The outer surface of the shaping belt (20) is coated with anhydrous copper sulfate coating for moisture discoloration detection.

2. The respiratory system infection virus sample detection device according to claim 1, characterized in that: The mouthpiece (6) is configured as a soft rubber tube, and a latex valve (7) for one-way air intake from the outside is fixedly connected inside.

3. The respiratory system infection virus sample detection device according to claim 1, characterized in that: The surface of the binding region (11) is distributed with capture antibodies of the viral S protein labeled with a chromogenic agent. The display region (12) includes a detection line and a quality control line. The detection line is provided with the detection antibody of the S protein, and the quality control line is provided with a secondary antibody for binding the capture antibody.

4. The respiratory system infection virus sample detection device according to claim 1, characterized in that: The inner wall of the telescopic cover (18) is connected to the bottom wall of the cylinder seat (2) by a limiting band (21).

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