Colloidal gold detection kit for HPV16 and HPV18 typing

Abstract

The utility model provides a colloidal gold detection kit for HPV16 and HPV18 typing. The colloidal gold detection kit comprises a sampler and a detection card, the sampler comprises a sampling tube 2, a liquid storage component 1 arranged at the top end of the sampling tube 2 and a handheld component 3 arranged at the tail part of the sampling tube 2, and a button 4 is arranged on the handheld component 3; the detection card comprises a card shell and a test strip; the test strip comprises a substrate, and a sample pad, a combination pad, an NC membrane and a water absorption pad which are sequentially arranged on the substrate in a lap joint manner, an HPV16 typing nano antibody colloidal gold marker, an HPV18 typing nano antibody colloidal gold marker and a DNP antibody colloidal gold marker are distributed on the combination pad; the NC membrane contains a detection line T1, a detection line T2 and a quality control line C; anti-HPV16 typing monoclonal antibodies are distributed on the detection line T1, anti-HPV18 typing monoclonal antibodies are distributed on the detection line T2, and DNP proteins are distributed on the quality control line C.

Description

Technical Field

[0001] The utility model belongs to the technical field of in vitro diagnosis, and specifically relates to a colloidal gold detection kit for HPV16 and HPV18 typing. Background Art

[0002] Colloidal gold immunochromatography is a new type of membrane detection technology based on antigen-antibody specific immune reaction. This technology uses a strip of fiber chromatography material fixed with a test line (coated antibody or coated antigen) and a quality control line (anti-antibody) as the stationary phase, the test liquid as the mobile phase, and the colloidal gold labeled antibody or antigen fixed to the connection pad, and the analyte moves on the chromatography strip through capillary action. For macromolecular antigens with multiple antigenic determinants (proteins, viruses, pathogenic bacteria, etc.), a "sandwich" type double antibody sandwich immunochromatography method is usually used, that is, the analyte first binds to the fluorescent labeled antibody under the action of the mobile phase, and then binds to the coated antibody when it reaches the test line to form a double antibody sandwich "sandwich" type.

[0003] Cervical cancer, also known as cervical cancer, refers to a malignant tumor that occurs at the junction of endometrial epithelial cells and squamous cells of the cervical vagina. Cervical cancer is one of the common malignant tumors of the female reproductive system. Studies on the etiology and pathogenesis of cervical cancer show that human papillomavirus-DNA (HPV-DNA) exists in more than 99% of cervical cancers. HPV infection is the primary factor and initiating factor in the occurrence of cervical cancer. HPV has obvious species-specific and host-specific affinity. Humans are its only host, and it mainly infects the skin and mucous membranes of the human body, causing varying degrees of lesions in the human skin, reproductive tract, and respiratory tract. There are four main types of HPV: low-risk skin type, high-risk skin type, low-risk mucosal type, and high-risk mucosal type (16, 18, 30, 31, 33, 35, 39). There are obvious differences in the genotypes of HPV in different regions. Studies have shown that HPV16 and HPV18 are the types with the highest positive rates worldwide; HPV16, HPV18, HPV58, HPV33, HPV52, HPV45 and HPV31 are mainly found in East Asia.

[0004] HPV detection methods include typing detection and non-typing detection. HPV typing detection can identify the specific type of HPV infection, can identify mixed infection of multiple types, and can also determine whether it is a persistent infection or reinfection of the same type of HPV; HPV non-typing detection can identify whether it is a high-risk HPV infection, and has become one of the main methods for cervical cancer screening, and the numerical value can determine the progress. The main methodologies include: second-generation hybrid capture method (HC2), fluorescent PCR method, enzyme switching signal amplification method, mRNA detection method, flow-through hybridization method, flow fluorescence hybridization method and gene sequencing method. PCR technology has higher sensitivity and specificity and can be absolutely quantitative, but it also has certain limitations, such as expensive instruments and reagents, complex operation, and long detection time. Therefore, it is of great significance to use colloidal gold technology to research and develop HPV antigen detection kits suitable for professional and home self-testing to achieve rapid screening of HPV infection and improve the health screening rate of all women. Utility Model Content

[0005] In view of the deficiencies in the prior art, the purpose of the utility model is to provide a colloidal gold detection kit for HPV16 and HPV18 typing.

[0006] In order to achieve the purpose of this utility model, the utility model adopts the following technical solutions:

[0007] In a first aspect, the utility model provides a colloidal gold detection kit for HPV16 and HPV18 typing, the kit comprising a sampler and a detection card;

[0008] The sampler comprises: a sampling tube 2, a liquid storage component 1 arranged at the top of the sampling tube 2, and a handheld component 3 arranged at the tail of the sampling tube 2, wherein a button 4 is arranged on the handheld component 3;

[0009] The test card comprises a card case and a test strip;

[0010] The test strip comprises: a substrate and a sample pad, a binding pad, an NC membrane and a water absorbent pad which are overlapped with each other in sequence on the substrate;

[0011] The conjugate pad is provided with HPV16 typing nano-antibody colloidal gold marker, HPV18 typing nano-antibody colloidal gold marker and DNP antibody colloidal gold marker;

[0012] The NC membrane contains a detection line T1, a detection line T2 and a quality control line C;

[0013] The detection line T1 is distributed with anti-HPV16 typing monoclonal antibodies, the detection line T2 is distributed with anti-HPV18 typing monoclonal antibodies, and the quality control line C is distributed with DNP protein.

[0014] In the utility model, a pair of deoxyribonucleoprotein (DNP protein) and an anti-deoxyribonucleoprotein antibody (anti-deoxyribo-nucleoprotein antibody, DNP antibody) is used as the quality control of the independent quality control C line, and the detection results of clinical samples have a good correlation.

[0015] In the utility model, the sampler can collect liquid samples from the cervix and vagina in a simple and painless manner, and the design of the sampler is to ensure that the top is close to the cervix and inserted into the vagina.

[0016] Preferably, the length of the sampling tube 2 is 11-12 cm, for example, 11 cm, 11.5 cm or 12 cm.

[0017] Preferably, the sampling tube 2 is cylindrical.

[0018] In the utility model, the shape of the sampler is soft and round, and there is no health or safety risk.

[0019] Preferably, the sampling tube 2 is selected from a PVC sampling tube.

[0020] Preferably, the liquid storage component 1 is used to store sterile reagents.

[0021] In the utility model, the liquid storage component 1 contains 1-3 mL of sterile 0.85-0.9% w / w physiological saline.

[0022] Preferably, the liquid storage component 1 is provided with a sealing strip to prevent the diffusion of the sterile reagent.

[0023] Preferably, the handheld component 3 comprises a hollow annular structure, which is convenient for users to hold.

[0024] Preferably, the button 4 is used to control the liquid storage part 1. When the button 4 is pressed, the sterile reagent in the liquid storage part 1 diffuses around the cervix, and the diffused sterile reagent will flow back into the sampler together with the cervical fluid and the vaginal fluid.

[0025] In the utility model, after sampling, the sampler is vertically inserted into the test tube, and the button 4 of the sampler is fully pressed downward, and the sample in the sampler is released into the test tube for subsequent detection.

[0026] In the utility model, the top of the sampler is filled with sterile saline, which is safe for the human body. When the button is pressed, the sterile reagent will diffuse around the cervix. When the button is released, the reagent will flow back into the sampler together with the fluids from the cervix and vagina. After the sampler is removed from the vagina, the sample is transferred to a test tube for testing; the sample can be used for self-testing or sent to a laboratory for testing.

[0027] Preferably, surfactant S9 and Triton 100 are distributed on the sample pad.

[0028] The content of the surfactant S9 on the sample pad is 0.76-1.51 mg / cm, for example, 0.76 mg / cm, 0.8 mg / cm, 0.9 mg / cm, 1.0 mg / cm, 1.1 mg / cm, 1.2 mg / cm, 1.3 mg / cm, 1.4 mg / cm or 1.5 mg / cm.

[0029] The content of Triton 100 on the sample pad is 0.76-1.51 mg / cm, for example, 0.76 mg / cm, 0.8 mg / cm, 0.9 mg / cm, 1.0 mg / cm, 1.1 mg / cm, 1.2 mg / cm, 1.3 mg / cm, 1.4 mg / cm or 1.5 mg / cm.

[0030] In the utility model, the sample pad is obtained by soaking a glass cellulose membrane in a sample pad treatment solution and then drying it. The surfactant S9 and Triton 100 are evenly distributed on the sample pad, and the sample pad treatment solution includes: 50-100mm pH8.0-8.5 Tris-HCL, 0.5-1% S9 and 0.5-1% Triton 100 in terms of concentration.

[0031] Preferably, the content of HPV16 typing nanoantibody colloidal gold marker on the conjugate pad is 0.2-0.8 μg / cm, for example, 0.2 μg / cm, 0.3 μg / cm, 0.4 μg / cm, 0.5 μg / cm, 0.6 μg / cm, 0.7 μg / cm or 0.8 μg / cm.

[0032] Preferably, the content of HPV18 typing nanoantibody colloidal gold marker on the conjugate pad is 0.2-0.8 μg / cm, for example, 0.2 μg / cm, 0.3 μg / cm, 0.4 μg / cm, 0.5 μg / cm, 0.6 μg / cm, 0.7 μg / cm or 0.8 μg / cm.

[0033] Preferably, the content of DNP antibody colloidal gold marker on the conjugate pad is 0.02-0.1 μg / cm, for example, 0.02 μg / cm, 0.04 μg / cm, 0.06 μg / cm, 0.08 μg / cm or 0.1 μg / cm.

[0034] In the utility model, the antibody marker mixture is sprayed on the binding membrane material to form a binding pad, which is dried for standby use. The final concentration of the HPV16 typing nano-antibody colloidal gold marker in the antibody marker mixture is 24-96 μg / mL; the final concentration of the HPV18 typing nano-antibody colloidal gold marker is 24-96 μg / mL; the final concentration of the DNP antibody colloidal gold marker is 2.4-12 μg / mL. The HPV16 typing nano-antibody colloidal gold marker, the HPV18 typing nano-antibody colloidal gold marker and the DNP antibody colloidal gold marker are evenly distributed on the binding membrane material.

[0035] Preferably, the content of anti-HPV16 typing monoclonal antibody on the test line T1 is 1-1.5 mg / mL, for example, it can be 1 mg / mL, 1.1 mg / mL, 1.2 mg / mL, 1.3 mg / mL, 1.4 mg / mL or 1.5 mg / mL.

[0036] Preferably, the content of anti-HPV18 typing monoclonal antibodies on the test line T2 is 1-1.5 mg / mL, for example, it can be 1 mg / mL, 1.1 mg / mL, 1.2 mg / mL, 1.3 mg / mL, 1.4 mg / mL or 1.5 mg / mL.

[0037] Preferably, the content of DNP protein on the quality control line C is 0.5-1 mg / mL, for example, it can be 0.5 mg / mL, 0.6 mg / mL, 0.7 mg / mL, 0.8 mg / mL, 0.9 mg / mL or 1 mg / mL.

[0038] Preferably, the distances between the detection line T1 and the detection line T2, and the distances between the detection line T2 and the quality control line C are the same.

[0039] Preferably, the card shell includes an upper card shell and a lower card shell that are locked to each other, the inner surface of the lower card shell is provided with a card slot for placing the test strip, the upper card shell is provided with a sample addition port corresponding to the sample pad of the test strip, and an observation port is provided corresponding to the NC membrane of the test strip, and the T1 test line, T2 test line and quality control line C on the NC membrane are all exposed at the observation port.

[0040] In the utility model, the card shell not only protects the test strip and prevents it from being damaged and contaminated, but also plays a fixing role, so that the test strip is not easy to slide and affect the measurement. The upper and lower card shells can fix and press the test strip, and the colloidal gold labeled antibody and sample diluent on the binding pad can run synchronously. At the same time, it is easy to operate, and the test can be quickly tested by laying it flat and adding the sample directly, without rigid technical requirements for the operator. In addition, the card shell does not require supporting detection equipment, making the operation easier.

[0041] Preferably, the substrate is selected from PVC substrate.

[0042] Preferably, the sample pad is selected from glass cellulose membrane sample pads.

[0043] Preferably, the bonding pad is selected from glass fiber bonding pads.

[0044] Preferably, the length of the test strip is 7-8 cm, such as 7 cm or 8 cm, and the width of the test strip is 3-5 mm, such as 3 mm, 4 mm or 5 mm.

[0045] The numerical range described in the present invention not only includes the point values ​​listed above, but also includes any point values ​​between the above numerical ranges that are not listed. Due to space limitations and for the sake of simplicity, the present invention no longer exhaustively lists the specific point values ​​included in the range.

[0046] Compared with the prior art, the utility model has the following beneficial effects:

[0047] 1. The kit of the utility model can be used for joint detection, one sample, one sample addition, one test, and the test results of HPV16 and HPV18 can be obtained at the same time, which simplifies the operation steps, saves time and saves costs.

[0048] 2. The kit of the utility model eliminates the influence of the sample on the quality control C line, screens out a suitable C line for independent quality control, and ensures that the sample will not affect the quality control C line.

[0049] 3. After the test kit of the utility model directly samples through the sampler, the sample is collected into a test tube and directly loaded, which reduces the operation steps and the possible pollution generated therein. BRIEF DESCRIPTION OF THE DRAWINGS

[0050] Figure 1 is a schematic diagram of the sampler. DETAILED DESCRIPTION

[0051] The technical solution of the present invention is further described below by specific implementation methods. Those skilled in the art should understand that the embodiments are only to help understand the present invention and should not be regarded as specific limitations of the present invention.

[0052] If no specific techniques or conditions are specified in the examples, the techniques or conditions described in the literature in the field or the product instructions are used. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased through regular channels.

[0053] The sources of materials in the following specific embodiments are as follows:

[0054] HPV16 typing nanoantibody: biosynth, 10-7988;

[0055] HPV18 typing nanoantibody: biosynth, 10-7990;

[0056] DNP antibody: Boyue Biotechnology Co., Ltd.;

[0057] Anti-HPV18 typing monoclonal antibody: biosynth, 10-7989;

[0058] Anti-HPV16 typing monoclonal antibody: biosynth, 10-7991;

[0059] DNP protein: Boyue Biotechnology Co., Ltd.

[0060] Example 1

[0061] This embodiment provides a colloidal gold detection kit for HPV16 and HPV18 typing, the kit comprising a sampler, a detection card, a calibration card and a sample diluent.

[0062] The sampler is Figure 1 As shown, the sampler comprises: a sampling tube 2 and a liquid storage component 1 arranged at the top end of the sampling tube 2, and a handheld component 3 arranged at the tail end of the sampling tube 2, and a button 4 is arranged on the handheld component 3.

[0063] The detection card includes a card shell and a test strip; the test strip includes: a substrate and a sample pad, a binding pad, an NC membrane and a water-absorbing pad which are overlapped with each other in sequence on the substrate, the substrate is a PVC bottom plate, and the material of the sample pad is a glass cellulose membrane; the sample pad contains surfactants S9 and Triton 100; the binding pad contains HPV16 typing nano-antibody colloidal gold markers, HPV18 typing nano-antibody colloidal gold markers and DNP antibody colloidal gold markers; the NC membrane contains a detection line T1 coated with anti-HPV16 typing monoclonal antibodies, a detection line T2 coated with anti-HPV18 typing monoclonal antibodies and a quality control line C coated with DNP protein.

[0064] The preparation method of the test card is as follows:

[0065] 1. Preparation of NC membrane

[0066] From the sample pad to the absorbent pad, the NC membrane (nitrocellulose membrane) is provided with test line T1, test line T2 and quality control line C at equal intervals. Test line T1 is coated with anti-HPV16 typing monoclonal antibody (purchased from biosynth, 10-7989, with a coating concentration of 1 mg / mL); test line T2 is coated with HPV18 typing monoclonal antibody (purchased from biosynth, 10-7991, with a coating concentration of 1 mg / mL; quality control line C is coated with DNP protein (purchased from Boyue Biology), with a coating concentration of 1 mg / mL. Spray on the analytical membrane material with a spray volume of 0.25-4.0 μL / cm on the film dot meter. The distances between test line T1 and test line T2, and between test line T2 and quality control line C are the same, which is convenient for marking and has a good detection effect.

[0067] 2. Preparation of conjugate pad

[0068] The conjugate pad is coated with HPV16 typing nano antibody colloidal gold marker and HPV18 typing nano antibody colloidal gold marker. The preparation method of the reagent strip conjugate pad comprises the following steps:

[0069] 2.1 The specific preparation steps of HPV16 typing nanoantibody colloidal gold labeling include:

[0070] Antibody labeling: Colloidal gold labeled antibody: Take 0.4mL of 40nm colloidal gold (100OD), add 0.6mL of 0.01M borate buffer (pH8.5), and mix. Dilute the HPV16 typing nanoantibody to 1mg / mL with 0.01M borate buffer (pH8.5), take 0.1mg of the diluted HPV16 typing nanoantibody and add it to the colloidal gold solution, react on a roller mixer at room temperature (25℃) for 1h. Add 0.1mL of 10% BSA solution to block for 1h. Centrifuge at 4℃, 13000rpm for 10min. Remove the supernatant and add 0.1mL of resuspension solution to resuspend.

[0071] 2.2 The specific preparation steps of HPV18 typing nanoantibody colloidal gold labeling include:

[0072] Antibody labeling: Colloidal gold labeled antibody: Take 0.4mL of 40nm colloidal gold (100OD), add 0.6mL of 0.01M borate buffer (pH8.5), and mix well. Dilute the HPV18 typing nanoantibody to 1mg / mL with 0.01M borate buffer (pH8.5), take 0.1mg of the diluted HPV18 typing nanoantibody and add it to the colloidal gold solution, react on a roller mixer at room temperature (25℃) for 1h. Add 0.1mL of 10% BSA solution to block for 1h. Centrifuge at 4℃, 13000rpm for 10min. Remove the supernatant and add 0.1mL of resuspension solution to resuspend.

[0073] 2.3DNP antibody colloidal gold labeling specific preparation steps include:

[0074] Antibody labeling: Colloidal gold labeled antibody: Take 0.1 mL of 40 nm colloidal gold (100 OD), add 0.15 mL of 0.01 M borate buffer (pH 8.5), and mix. Dilute DNP antibody to 1 mg / mL with 0.01 M borate buffer (pH 8.5), take 0.25 mg of the diluted DNP antibody and add it to the colloidal gold solution. React on a roller mixer at room temperature (25°C) for 1 hour. Add 0.1 mL of 10% BSA solution to block for 1 hour. Centrifuge at 4°C, 13,000 rpm for 10 minutes. Remove the supernatant and add 0.1 mL of resuspension solution to resuspend.

[0075] 2.4 The steps for making the bonding pad include:

[0076] The HPV16 typing nano-antibody colloidal gold markers, HPV18 typing nano-antibody colloidal gold markers, and DNP antibody colloidal gold markers obtained in steps 2.1, 2.2, and 2.3 are mixed according to a volume ratio to form an antibody marker mixture, wherein the volume of the HPV16 antibody marker solution is 5%-20%, the volume of the HPV18 antibody marker solution is 5%-20%, and the volume of the DNP antibody marker solution is 0.5%-2%, wherein the final concentration of the HPV16 antibody marker is 24-96ug / mL, the final concentration of the HPV18 antibody marker is 24-96ug / mL, and the final concentration of the DNP antibody marker is 2.4-12ug / mL; spray on the binding membrane material at 10μL / cm to obtain a binding pad, and dry for later use.

[0077] 3. Preparation of sample pad

[0078] Preparation of sample pad treatment solution: 50-100 mM Tris-HCL (pH 8.0-8.5) was used as a buffer solution, and 0.5-1% S9 and 0.5-1% Triton 100 were added.

[0079] The sample pad is prepared by soaking a glass cellulose membrane in a sample pad treatment solution and then drying the membrane.

[0080] 4. Assembly

[0081] The sample pad, conjugate pad, NC membrane and absorbent pad are sequentially overlapped on the base plate and partially overlapped to obtain a HPV16 and HPV18 combined detection reagent strip; the PVC base plate with the sample pad, conjugate pad, analysis membrane and absorbent pad pasted thereon is cut into paper strips with a length of 7.5 cm and a width of 4 mm, and the strips are loaded into a card shell and packaging to obtain a HPV16 and HPV18 combined detection reagent strip; the reagent strip can be loaded into any form of outer card shell, or can be used directly without an outer card shell.

[0082] The kit in this embodiment is used to test clinical samples and verify the test results of clinical samples. The sample to be tested is treated with a sample test liquid, and the treated liquid is dripped into the sample addition port of the test card.

[0083] The sample detection solution is 0.9% NaCl;

[0084] The sample handling steps include: The sample collected in the sampler is stored. Extend the sampler halfway into the test tube. Keep the test tube and sampler in an upright position. Press the sampler button fully downward. The sample will be released into the test tube.

[0085] The results are shown in Tables 1, 2, 3 and 4. From the results in the tables, it can be seen that using the DNP protein and DNP protein antibody pairing as the quality control of the independent quality control C line has a good correlation with the results of clinical sample detection.

[0086] Table 1

[0087]

[0088]

[0089] Table 2

[0090]

[0091] Table 3

[0092]

[0093] Table 4

[0094]

[0095]

[0096] Comparative Example 1

[0097] This comparative example provides a colloidal gold detection kit for HPV16 and HPV18 typing. The difference between the kit and Example 2 is that donkey anti-chicken IgY is used to replace the DNP protein on the quality control line C in Example 1; and chicken IgY antibody is used to replace the DNP antibody on the binding pad in Example 1.

[0098] Donkey anti-chicken IgY was coated onto the NC membrane as a quality control C line, chicken IgY antibody was coupled to colloidal gold, the binding pad and sample pad were assembled, and clinical samples were measured to verify the test results of clinical samples.

[0099] The test results are shown in Tables 5, 6, 7 and 8. It can be seen from the tables that when chicken IgY is used as the quality control line to test clinical samples, some clinical sample quality control C line signals will have large deviations, resulting in poor consistency between the results and the clinical results.

[0100] Table 5

[0101]

[0102]

[0103] Table 6

[0104]

[0105] Table 7

[0106]

[0107] Table 8

[0108]

[0109]

[0110] Comparative Example 2

[0111] This comparative example provides a colloidal gold detection kit for HPV16 and HPV18 typing. The difference between the kit and Example 2 is that the sample pad is treated with sample pad treatment liquid 2, and the sample pad treatment liquid 2 is 20Mm Tris-HCL (pH8.5), 0.5% surfactant S9 and 0.5% Triton 100.

[0112] The glass cellulose membrane is immersed in the sample pad treatment solution 2 and then dried to prepare a sample pad, which is then assembled and tested.

[0113] The test results are shown in Tables 9, 10, 11 and 12. It can be seen from the results in the tables that reducing the concentration of the buffer solution in the sample pad will cause the sample to affect the test results during the chromatography process, resulting in poor consistency of the test results.

[0114] Table 9

[0115]

[0116]

[0117] Table 10

[0118]

[0119] Table 11

[0120]

[0121] Table 12

[0122]

[0123]

[0124] In summary, the kit of the utility model can qualitatively detect HPV16 and HPV18, has low cost, is easy to operate, can be self-tested at home, and has the advantages of sensitivity and specificity close to PCR technology. It can realize rapid screening of HPV infection and improve the health screening rate of women across the country.

[0125] The applicant declares that the above is only a specific implementation method of the present utility model, but the protection scope of the present utility model is not limited thereto. The technicians in the relevant technical field should understand that any changes or substitutions that can be easily thought of by the technicians in the relevant technical field within the technical scope disclosed in the present utility model fall within the protection scope and disclosure scope of the present utility model.

Claims

1. A colloidal gold detection kit for HPV16 and HPV18 typing, characterized in that: The test kit includes a sampler and a test card; The sampler comprises: a sampling tube (2), a liquid storage component (1) arranged at the top end of the sampling tube (2), and a handheld component (3) arranged at the rear end of the sampling tube (2), wherein a button (4) is arranged on the handheld component (3); The test card comprises a card case and a test strip; The test strip comprises: a substrate and a sample pad, a binding pad, an NC membrane and a water absorbent pad which are overlapped with each other in sequence on the substrate; The conjugate pad is provided with HPV16 typing nano-antibody colloidal gold marker, HPV18 typing nano-antibody colloidal gold marker and DNP antibody colloidal gold marker; The NC membrane contains a detection line T1, a detection line T2 and a quality control line C; The detection line T1 is distributed with anti-HPV16 typing monoclonal antibodies, the detection line T2 is distributed with anti-HPV18 typing monoclonal antibodies, and the quality control line C is distributed with DNP protein.

2. The colloidal gold detection kit for HPV16 and HPV18 typing according to claim 1, characterized in that: The length of the sampling tube (2) is 11-12 cm; The sampling tube (2) is cylindrical; The sampling tube (2) is selected from a PVC sampling tube.

3. The colloidal gold detection kit for HPV16 and HPV18 typing according to claim 1, characterized in that: The liquid storage component (1) is used to store sterile reagents; The liquid storage component (1) is provided with a sealing strip, and the sealing strip is used to prevent the sterile reagent from diffusing.

4. The colloidal gold detection kit for HPV16 and HPV18 typing according to claim 1, characterized in that: The handheld component (3) comprises a hollow annular structure, which is convenient for the user to hold; The button (4) is used to control the liquid storage component (1). When the button (4) is pressed, the sterile reagent in the liquid storage component (1) diffuses around the cervix, and the diffused sterile reagent flows back into the sampler together with the cervical fluid and the vaginal fluid.

5. The colloidal gold detection kit for HPV16 and HPV18 typing according to claim 1, characterized in that: Surfactant S9 and Triton 100 are distributed on the sample pad.

6. The colloidal gold detection kit for HPV16 and HPV18 typing according to claim 1, characterized in that: The card shell includes an upper card shell and a lower card shell that are locked to each other. The inner surface of the lower card shell is provided with a card slot for placing the test strip. The upper card shell is provided with a sample addition port corresponding to the sample pad of the test strip, and an observation port is provided corresponding to the NC membrane of the test strip. The T1 detection line, T2 detection line and quality control line C on the NC membrane are all exposed at the observation port.

7. The colloidal gold detection kit for HPV16 and HPV18 typing according to claim 1, characterized in that: The substrate is selected from a PVC substrate; The sample pad is selected from a glass cellulose membrane sample pad; The bonding pad is selected from glass fiber bonding pad.

8. The colloidal gold detection kit for HPV16 and HPV18 typing according to claim 1, characterized in that: The length of the test strip is 7-8 cm, and the width of the test strip is 3-5 mm.

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