A kit for detecting novel coronavirus in saliva

Abstract

The present invention discloses a kit for detecting novel coronavirus in saliva, including a kit, wherein the kit includes a sampling plate and a detection plate. One end of the sampling plate is provided with a splicing groove, and one end of the detection plate is provided with an elastic joint. The distance between adjacent elastic joints is the same as the distance between adjacent splicing grooves, and the elastic joint and the splicing groove are buckled with each other. A one-way reverse osmosis head is provided at the sampling port on the top surface of the sampling plate, and an extrusion channel is provided at the bottom surface of the one-way reverse osmosis head. A colloidal gold pad is provided inside the sampling plate, and a detection layer and a water-absorbing filter paper are respectively provided inside the detection plate, and the water-absorbing filter paper is located at the end of the detection layer. An antigen strip and a quality control line are respectively provided on the top surface of the detection layer. It can achieve assembled installation. After the detection is completed, the detection end can be discarded separately, and the sampling end can be retained. After treatment, the sampling end can be reused without affecting the detection result during repeated use, which is convenient for personnel to operate and ensures the success rate of detection.

Description

Technical Field

[0001] The present invention belongs to the field of biological detection technology, and specifically relates to a kit for detecting a novel coronavirus in saliva. Background Art

[0002] According to the kit for detecting NS antigen of saliva novel coronavirus according to Chinese patent number "CN202011285784.9", the test card includes a sample pad, a colloidal carbon binding pad, a nitrocellulose membrane, a water-absorbing filter paper, and a reaction support; the sample pad, the colloidal carbon binding pad, the nitrocellulose membrane and the water-absorbing filter paper are sequentially pasted on the reaction support, one end of the sample pad is pressed on one end of the colloidal carbon binding pad, the other end of the colloidal carbon binding pad is pressed on one end of the nitrocellulose membrane, and the water-absorbing filter paper is pressed on the other end of the nitrocellulose membrane; the colloidal carbon binding pad is a colloidal carbon pad containing colloidal carbon-labeled mAbN1 and mAbS1. The kit provided by the present invention and its application method, with N protein and S protein as the target of novel coronavirus detection, select saliva as the detection sample, can simplify the detection process of novel coronavirus, do not rely on any experimental instrument, environment or operator, simple and convenient operation, short detection cycle, easy to interpret; in addition, no special instruments and equipment are required, no professional training is required, strong adaptability, convenient for monitoring and inspection anytime and anywhere.

[0003] The above patent document introduces a test kit for saliva novel coronavirus. Both the above patent and the existing test kits have the following problems:

[0004] 1. The test kit is disposable. Both the test end and the detection end of the test kit will be discarded after use, and the test end cannot be reused.

[0005] 2. When conducting a saliva test, the saliva cannot smoothly enter the test layer due to various problems, which may easily lead to test failure.

[0006] 3. The existing antigen test on saliva is troublesome to operate, there may be false negatives when testing saliva, and the accuracy of the test is low. Summary of the invention

[0007] In order to overcome the above-mentioned deficiencies in the prior art, one of the purposes of the present invention is to provide a kit for detecting the new coronavirus in saliva, which can be installed in an assembled manner. After the detection is completed, the detection layer, the one-way reverse osmosis head and the extrusion channel can be separately drawn out and discarded, and the sampling plate and the detection plate can be disinfected and then a new detection layer, one-way reverse osmosis head and extrusion channel can be installed. The sampling end can be reused without affecting the detection results during repeated use, which is convenient for personnel operation and ensures the success rate of the detection.

[0008] In order to achieve one of the above purposes, the present invention adopts the following technical solution:

[0009] A kit for detecting the novel coronavirus in saliva, comprising a kit, wherein the kit comprises a sampling plate and a detection plate, one end of the sampling plate is provided with a splicing groove, one end of the detection plate is provided with an elastic joint, and the spacing between adjacent elastic joints is the same as the spacing between adjacent splicing grooves, and the elastic joint and the splicing groove are interlocked, a one-way reverse osmosis head is provided at a sampling port on the top surface of the sampling plate, an extrusion channel is provided on the bottom surface of the one-way reverse osmosis head, a colloidal gold pad entry groove is provided inside the sampling plate, a detection layer and a water-absorbing filter paper are respectively provided inside the detection plate, and the water-absorbing filter paper is located at the end of the detection layer, an antigen strip and a quality control line are respectively provided on the top surface of the detection layer, and the detection layer and the one-way reverse osmosis head are respectively connected with plug-in connectors.

[0010] Furthermore, the extrusion channel includes a folded section and a fixed section, and the folded section is located between the two fixed sections at the head and tail of the extrusion channel, and the fixed sections at the head and tail ends of the extrusion channel are respectively bonded to the sampling port of the sampling plate and the one-way reverse osmosis head, and the one-way reverse osmosis head is embedded in the sampling port of the sampling plate.

[0011] Furthermore, the first and last ends of the detection layer are respectively attached to the colloidal gold pad entrance slot and one end of the water-absorbing filter paper, and the detection layer is flush with the colloidal gold pad entrance slot and the water-absorbing filter paper.

[0012] Furthermore, the antigen strips are divided into two groups, and the two groups of antigen strips are located on one side of the quality control line.

[0013] Furthermore, an observation port is provided on the top surface of the detection plate, and the antigen strip and the quality control line are both located in the observation port.

[0014] To achieve one of the above purposes, the present invention specifically comprises the following steps:

[0015] The specific application steps of the method for using the kit for detecting the new coronavirus in saliva are as follows:

[0016] S1. Wash your hands and use a saliva collection container to collect the saliva of the test personnel. The saliva collected should be between 5ml and 20ml.

[0017] S2. Immerse the sampling cotton swab in the saliva and rotate it clockwise in an orderly manner in the saliva to quickly take samples;

[0018] S3. After sampling, insert the sampling end into the solvent test tube, seal the solvent test tube, shake the test tube to fully mix the extract and the solvent, and wait for 1-2 minutes;

[0019] S4. Assemble the kit and move it to the detection position. Drop the mixed solvent into the test port of the kit, and the dosage of the dropped mixed solvent is 1 - 3 drops.

[0020] S5. Press down on the one-way reverse osmosis head at the test port, and the solvent attached with saliva thus moves along each attachment on the reaction support in the direction of the absorbent filter paper.

[0021] S6. Wait for 5 - 15 minutes until the solvent moves to the position of the quality control line, and check the information of the antigen strip in the observation port to obtain the detection result of the novel coronavirus N - S antigen in saliva.

[0022] To achieve the second above - mentioned purpose, the present invention adopts the following technical solutions:

[0023] The antigen preparation process for detecting the novel coronavirus N - S antigen in saliva includes a kit, and the specific application process is as follows: The interior of the kit consists of a colloidal gold pad inlet groove, a detection layer, a quality control line, an antigen strip, and an absorbent filter paper. The support layer of the detection layer is made of polyethylene fiber board material, the detection layer is prepared from NC membrane, and the absorbent filter paper is absorbent paper. The antigen strip is divided into an N line and an S line. The N line contains the IgG antibody of the antigen virus S protein, the S line contains the IgM antibody of the antigen virus S protein, the quality control line is the C line, and the C line is the goat anti - rabbit IgG antibody.

[0024] Further, the IgG antibody of the antigen virus S protein is prepared into a 0.4 - 1.5 mg / mL solution with 0.01 mol / L pH7.4 phosphate buffer solution, the IgM antibody of the antigen S protein is prepared into a 0.1 - 1.5 mg / mL solution, the goat anti - rabbit IgG is prepared into a 0.6 - 1.5 mg / mL solution, and a spraying and gold - scribing instrument is used to scribe lines on the upper and lower parts of the NC membrane with parameters of 1.0 - 1.1 μL / cm. After scribing, the NC membrane is placed in a drying room for drying, the temperature is 21 - 25°C, the humidity is less than 30%, and the drying time is 2 - 5 hours.

[0025] The detection principle of the present invention:

[0026] The kit is assembled from a sampling plate and a detection plate. Align the splicing groove of the sampling plate with the elastic joint of the detection plate and insert the two to complete the assembly of the kit. Collect the saliva of the tester, and use a cotton swab to collect the saliva. Place the collected saliva into a solvent and wait for the solvent to fully mix with the extracted saliva. Drop the mixed solvent onto the one-way reverse osmosis head on the test port of the sampling plate. The solvent slowly enters the extrusion channel from the inlet of the one-way reverse osmosis head and flows onto the surface of the test layer until it passes through the part of the quality control line. The quality control line is goat anti-rabbit IgG antibody, and the quality control line changes after the solution passes through. The tester can view the change of the quality control line through the observation port to judge whether the kit is used correctly. After waiting for the specified time, if the antigen strip does not change color when the quality control line shows color, it means that the novel coronavirus S protein antibody is not detected, and the result is judged to be negative. If the quality control line and the antigen strip N or S line show color at the same time, it means that the test result is positive. If the quality control line does not show color, it means that there is an operation error. After dropping the solution, the tester can press down the one-way reverse osmosis head. The one-way reverse osmosis head squeezes the extrusion channel, and the solution can enter from the one-way reverse osmosis head but cannot flow out from here. Therefore, when the one-way reverse osmosis head is pressed down, the solution can be squeezed so that the solution can enter the end of the test layer to ensure that the kit can be operated normally. After testing the outer layer, the tester can take protective measures such as wearing gloves and masks and other tools to pull out the plug-in joint of the test layer outward. Similarly, the one-way reverse osmosis head is the same. When the one-way reverse osmosis head is pulled out upward, it can be pulled out together with the extrusion channel. Discard it and replace it with a new test layer, one-way reverse osmosis head and extrusion channel. After the test is completed, the tester directly manually pulls out the detection plate outward to separate the detection plate from the sampling plate and process the sampling plate. When processing, the tester also needs to wear protective measures and disinfect and sterilize the sampling plate and the detection plate before they can be recycled to avoid the situation of virus infection of personnel.

[0027] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0028] (1) A kit for detecting novel coronavirus in saliva provided by the present invention uses the kit as an assembled type. After the kit is used, the tester can take protective measures and pull out the one-way reverse osmosis head, extrusion channel and test layer separately and discard them. Then separate the detection plate from the sampling plate. After processing the sampling plate, assemble a new one-way reverse osmosis head, extrusion channel and test layer and continue to use them in a cycle without discarding the entire kit, saving resources.

[0029] (2) A kit for detecting novel coronavirus in saliva provided by the present invention uses the one-way reverse osmosis head to prevent the solvent from flowing out after entering and can squeeze the solvent that has entered, so that the solvent can pass through the antigen strip and quality control line on the test layer, with simple operation and avoiding the situation where the solvent cannot be detected.

[0030] (3) The kit provided by the present invention for detecting novel coronavirus in saliva uses the N-S antigen of the novel coronavirus to detect saliva, improving the detection accuracy and greatly reducing the false negative situation. Description of the Drawings

[0031] In order to more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings required for use in the embodiments or the description of the prior art. Obviously, the following described drawings are only some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0032] Figure 1 It is a three-dimensional structure diagram of the kit provided by the present application;

[0033] Figure 2 It is an exploded view of the kit provided by the present application;

[0034] Figure 3 It is a top view of the kit provided by the present application;

[0035] Figure 4 It is a cross-sectional view of the kit provided by the present application;

[0036] Figure 5 It is a usage method diagram of the kit provided by the present application.

[0037] In the figure: 1. Kit; 101. Sampling plate; 1011. Unidirectional reverse osmosis head; 1012. Colloidal gold pad inlet groove; 1013. Splicing groove; 1014. Extrusion channel; 102. Detection plate; 1021. Detection layer; 1022. Quality control line; 1023. Antigen strip; 1024. Elastic joint; 1025. Observation port; 1026. Absorbent filter paper; 2. Plug-in joint. Detailed Embodiments

[0038] In order to make the technical problems to be solved, technical solutions and beneficial effects of the present application clearer, the following will clearly and completely describe the technical solutions of the present application in combination with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and are not used to limit the present application.

[0039] The reagents or instruments used without indicating the manufacturer can all be conventional products obtained through commercial purchase.

[0040] Example 1

[0041] Reference Figures 1-4, this embodiment provides a kit for detecting novel coronavirus in saliva, including Kit 1, where Kit 1 includes a sampling plate 101 and a detection plate 102. A splicing groove 1013 is provided at one end of the sampling plate 101, and an elastic joint 1024 is provided at one end of the detection plate 102. The distance between adjacent elastic joints 1024 is the same as the distance between adjacent splicing grooves 1013, and the elastic joint 1024 and the splicing groove 1013 are snap-fitted with each other. A one-way reverse osmosis head 1011 is provided at the sampling port on the top surface of the sampling plate 101. An extrusion channel 1014 is provided at the bottom surface of the one-way reverse osmosis head 1011. The extrusion channel 1014 includes a folding section and a fixed section. The folding section is located between the two fixed sections at the head and tail of the extrusion channel 1014. The fixed sections at both ends of the extrusion channel 1014 are respectively adhered to the sampling port of the sampling plate 101 and the one-way reverse osmosis head 1011. The one-way reverse osmosis head 1011 is embedded in the sampling port of the sampling plate 101.

[0042] A colloidal gold pad entry groove 1012 is provided inside the sampling plate 101. A detection layer 1021 and a water-absorbing filter paper 1026 are respectively provided inside the detection plate 102. The water-absorbing filter paper 1026 is located at the end of the detection layer 1021. The two ends of the detection layer 1021 are respectively attached to the colloidal gold pad entry groove 1012 and one end of the water-absorbing filter paper 1026. The detection layer 1021 is flush with the colloidal gold pad entry groove 1012 and the water-absorbing filter paper 1026. An antigen strip 1023 and a quality control line 1022 are respectively provided on the top surface of the detection layer 1021. There are two groups of antigen strips 1023, and both groups of antigen strips 1023 are located on the side of the quality control line 1022. An observation port 1025 is provided on the top surface of the detection plate 102. The antigen strip 1023 and the quality control line 1022 are both located inside the observation port 1025.

[0043] After the solution is dropped, the operator can press down the one-way reverse osmosis head 1011. The one-way reverse osmosis head 1011 squeezes the extrusion channel 1014. The solution can enter from the one-way reverse osmosis head 1011 but cannot flow out from here. Therefore, when the one-way reverse osmosis head 1011 is pressed down, the solution can be squeezed so that the solution can enter the end of the detection layer 1021, ensuring that the kit 1 can be operated normally. After detecting the outer layer, the operator can take protective measures such as wearing gloves and masks and other tools to pull out the plug-in joint 2 of the detection layer 1021 outward. Since one end of the detection layer 1021 is a water-absorbing filter paper 1026, the detected liquid can be absorbed to prevent the detected liquid from overflowing. Similarly, the one-way reverse osmosis head 1011 is the same. Since the plug-in joint 2 of the one-way reverse osmosis head 1011 is L-shaped, after the operator wears protective equipment, when the one-way reverse osmosis head 1011 is pulled out upward, it can be pulled out together with the extrusion channel 1014, and then discarded and replaced with a new detection layer 1021, one-way reverse osmosis head 1011 and extrusion channel 1014. When replacing, only need to align one end of the new detection layer 1021 with the groove of the detection plate 102 and push the detection layer 1021 inward until the plug-in joint 2 fits with one end of the detection plate 102. Since the extrusion channel 1014 is connected to the one-way reverse osmosis head 1011, the operator only needs to insert the extrusion channel 1014 into the sampling hole of the sampling plate 101. After the test is completed, the operator directly manually pulls out the detection plate 102 outward to separate the detection plate 102 from the sampling plate 101, and processes the sampling plate 101. When processing, the operator also needs to wear protective measures and disinfect and sterilize the sampling plate 101 and the detection plate 102 before they can be reused to avoid the situation of the operator being infected by the virus.

[0044] Example 2

[0045] Reference Figure 5 As shown in the figure, a method for using a kit for detecting novel coronavirus in saliva includes a kit 1, and the specific application steps are as follows:

[0046] S1. Wash hands and collect the saliva of the required tested person using a saliva collection container. The collection of saliva is between 5 ml and 20 ml;

[0047] S2. Immerse the sampling cotton swab in the saliva and rotate it clockwise in the saliva in an orderly manner to quickly sample;

[0048] S3. After sampling, insert the sampling end into the solvent test tube, seal the solvent test tube and shake the test tube to fully mix the extract and the solvent, and wait for 1-2 minutes;

[0049] S4. Assemble the kit 1 and move it to the detection position, drop the mixed solvent into the test port of the kit 1, and the dosage of the dropped mixed solvent is 1-3 drops;

[0050] S5. Press down the one-way reverse osmosis head 1011 at the test port, and thus the solvent attached with saliva moves along each attachment on the reaction support in the direction of the water-absorbing filter paper 1026;

[0051] S6. Wait for 5 - 15 min until the solvent moves to the position of the quality control line 1022, check the information of the antigen strip 1023 in the observation port 1025, and obtain the detection result of the novel coronavirus N-S antigen in saliva.

[0052] Example 3

[0053] A preparation process of a kit for detecting novel coronavirus in saliva, including Kit 1, and the specific application process is as follows: The inside of Kit 1 is composed of a colloidal gold pad 1012, a detection layer 1021, a quality control line 1022, an antigen strip 1023, and a water-absorbing filter paper 1026. The support layer of the colloidal gold pad 1012 is made of polyethylene fiber board material, the detection layer 1021 is prepared from an NC membrane, the water-absorbing filter paper 1026 is absorbent paper, the antigen strip 1023 is divided into an N line and an S line. The N line contains the antigen virus S protein IgG antibody, the S line contains the antigen virus S protein IgM antibody, the quality control line 1022 is the C line, and the C line is the goat anti-rabbit IgG antibody. Prepare the antigen virus S protein IgG antibody into a 0.4 - 1.5 mg / mL solution with 0.01 mol / L pH 7.4 phosphate buffer, prepare the antigen S protein IgM antibody into a 0.1 - 1.5 mg / mL solution, and prepare the goat anti-rabbit IgG into a 0.6 - 1.5 mg / mL solution. Use a gold-spraying and membrane-drawing instrument to draw lines on the upper and lower parts of the NC membrane with a parameter of 1.0 - 1.1 μL / cm. After drawing the lines, place the NC membrane in a drying room for drying, with the temperature at 21 - 25 °C, the humidity less than 30%, and the drying time being 2 - 5 h.

[0054] The above embodiments are only the preferred embodiments of the present invention and cannot be used to limit the scope of protection of the present invention. Any non-substantial changes and substitutions made by those skilled in the art based on the present invention belong to the scope of protection required by the present invention.

Claims

1. A kit for detecting a novel coronavirus in saliva, comprising a kit (1), wherein the kit (1) comprises a sampling plate (101) and a detection plate (102), one end of the sampling plate (101) is provided with a splicing groove (1013), one end of the detection plate (102) is provided with an elastic joint (1024), and the spacing between adjacent elastic joints (1024) is the same as the spacing between adjacent splicing grooves (1013), and the elastic joint (1024) and the splicing groove (1013) are mutually buckled, and a one-way reverse osmosis is provided at the sampling port on the top surface of the sampling plate (101). The one-way reverse osmosis head (1011) is provided with an extrusion channel (1014) on the bottom surface, a colloidal gold pad entry slot (1012) is provided inside the sampling plate (101), a detection layer (1021) and a water-absorbing filter paper (1026) are provided inside the detection plate (102), and the water-absorbing filter paper (1026) is located at the end of the detection layer (1021), an antigen strip (1023) and a quality control line (1022) are provided on the top surface of the detection layer (1021), and the detection layer (1021) and the one-way reverse osmosis head (1011) are respectively connected with a plug-in connector (2).

2. The kit for detecting novel coronavirus in saliva according to claim 1, wherein, The extrusion channel (1014) comprises a folding section and a fixed section, and the folding section is located between the two fixed sections at the head and tail of the extrusion channel (1014), and the fixed sections at the head and tail ends of the extrusion channel (1014) are respectively bonded to the sampling port of the sampling plate (101) and the one-way reverse osmosis head (1011), and the one-way reverse osmosis head (1011) is embedded in the sampling port of the sampling plate (101).

3. A kit for detecting novel coronavirus in saliva according to claim 1, characterized in that, The head and tail ends of the detection layer (1021) are respectively attached to the colloidal gold pad (1012) and one end of the absorbent filter paper (1026), and the detection layer (1021) is flush with the colloidal gold pad (1012) and the absorbent filter paper (1026).

4. A kit antigen kit (1) for detecting novel coronavirus in saliva according to claim 1, characterized in that, The antigen strips (1023) are in two groups, and both groups of antigen strips (1023) are located on the side of the quality control line (1022).

5. A kit for detecting novel coronavirus in saliva according to claim 1, characterized in that, An observation port (1025) is provided on the top surface of the detection plate (102), and the antigen strip (1023) and the quality control line (1022) are both located in the observation port (1025).

6. A preparation process of a kit for detecting the novel coronavirus in saliva according to claims 1-5, comprising a kit (1), and a specific application process is as follows: the interior of the kit (1) is composed of a colloidal gold pad inlet slot (1012), a detection layer (1021), a quality control line (1022), an antigen strip (1023) and a water-absorbing filter paper (1026), the support layer of the detection layer (1021) is made of polyethylene fiberboard, the detection layer (1021) is prepared by NC membrane, and the water-absorbing filter paper (1026) is absorbent paper, the antigen strip (1023) is divided into an N line and an S line, and the N line contains an IgG antibody to the antigen virus S protein, and the S line contains an IgM antibody to the antigen virus S protein, the quality control line (1022) is a C line, and the C line is a sheep anti-rabbit IgG antibody.

7. The preparation process of a kit for detecting novel coronavirus in saliva according to claim 6, characterized in that: Prepare the antigen virus S protein IgG antibody into a 0.4 - 1.5 mg / mL solution with 0.01 mol / L pH 7.4 phosphate buffer, prepare the antigen S protein IgM antibody into a 0.1 - 1.5 mg / mL solution, and prepare the goat anti-rabbit IgG into a 0.6 - 1.5 mg / mL solution. Use a gold-spraying and membrane-stripping instrument to draw lines on the upper and lower parts of the NC membrane with parameters of 1.0 - 1.1 μL / cm. After drawing the lines, place the NC membrane in a drying room for drying, with the temperature at 21 - 25 °C, the humidity less than 30%, and the drying time being 2 - 5 h.

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