AIDS antibody detection kit

Through the AIDS antibody detection kit combined with a gold standard pad and NC membrane, the problem of low accuracy of AIDS detection in the existing technology is solved, and the rapid and accurate detection results are achieved. It is suitable for a variety of blood samples and meets the clinical testing. need.

CN119246853AInactive Publication Date: 2025-01-03ANHUI DEEP BLUE MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202411447662.3
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-10-16
Publication Date
2025-01-03
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

The low accuracy of existing AIDS testing technologies leads to low diagnostic and screening efficiency, making it difficult to meet the needs of rapid, sensitive and specificity.

Method used

Using an AIDS antibody detection kit with a combination of gold label pad and NC film, the detection line and Control line, combining specific ratios and steps of colloidal gold solution, blocking solution and coating buffer, to form a fast and accurate detection method.

Benefits of technology

The test results are obtained within 15-20 minutes, the reading results are completed within 10 minutes, and the yin-positive compliance rate reaches 100%. It is suitable for whole blood, plasma or serum specimens. The test results are consistent and are suitable for testing under different circumstances. .

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Abstract

The invention discloses an AIDS (Acquired Immune Deficiency Syndrome) antibody detection kit, which belongs to the technical field of medical detection and comprises a gold-labeled pad and an NC (nitrocellulose) membrane, the gold label pad is a glass cellulose membrane soaked with a mixture of an AIDS (Acquired Immune Deficiency Syndrome) 1 + 2 type gold label labeling antigen-colloidal gold compound and a chicken IgY (Immunoglobulin Y) colloidal gold compound; the AIDS (Acquired Immune Deficiency Syndrome) 1 + 2 type gold-labeled labeled antigen-colloidal gold compound is a compound of an AIDS 1 + 2 type gold-labeled labeled antigen and colloidal gold; the AIDS 1 + 2 type gold-labeled labeled antigen is one of HIVIgp41 + 120 and HIVIIgp36, and the AIDS 1 + 2 type gold-labeled labeled antigen is one of HIVIgp41 + 120 and The chicken IgY colloidal gold compound is a compound of a chicken IgY antibody and colloidal gold; a detection line and a control line are arranged on the NC membrane. The AIDS antibody detection kit prepared by the invention has the advantages of rapid result obtaining, high accuracy, comprehensive sample coverage and the like.
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Description

Technical Field

[0001] The invention belongs to the technical field of medical detection, and in particular relates to an AIDS antibody detection kit. Background Art

[0002] AIDS (Acquired Immune Deficiency Syndrome) is a serious infectious disease caused by the human immunodeficiency virus (HIV). The HIV virus attacks the human immune system, causing a gradual loss of immune function, making the patient susceptible to infection with other pathogens and developing serious diseases and tumors. There are two main types of human immunodeficiency virus HIV, HIV-1 and HIV-2, both of which can cause AIDS. HIV-1 is the most common type, and when you hear the word "HIV," you are referring to HIV-1. There are very few people infected with the HIV-2 type, and most of them appear in West Africa. In the United States, HIV-2 accounts for only 0.01% of HIV infections, and the cases are mainly from West Africa. HIV-2 is more difficult to spread between people.

[0003] AIDS prevention and treatment is an important topic of concern to the whole world. my country's AIDS prevention and treatment work is also facing severe challenges. Early detection and early treatment are the basic principles and effective means of AIDS prevention and treatment. At present, there is no effective treatment for AIDS, nor is there an effective vaccine to prevent AIDS. The most important thing is to take preventive measures. With the increasing number of AIDS infections and clinical patients and the changing infected population, the demand for diagnosis, screening and monitoring is increasing, and the workload of testing is increasing. How to make clinical AIDS testing technology easier to operate, the methods more mature, and how to improve the sensitivity and specificity of the test results are of great significance to clinical AIDS testing. Summary of the invention

[0004] The purpose of the present invention is to provide an AIDS antibody detection kit to solve the problem of low accuracy of AIDS detection.

[0005] The purpose of the present invention can be achieved by the following technical solutions:

[0006] An AIDS antibody detection kit, comprising a gold label pad and an NC membrane (nitrocellulose membrane);

[0007] The gold-labeled pad is a glass cellulose membrane soaked in a mixture of AIDS type 1+2 gold-labeled antigen-colloidal gold complex and chicken IgY colloidal gold complex;

[0008] The AIDS type 1+2 gold-labeled antigen-colloidal gold complex is a complex of AIDS type 1+2 gold-labeled antigen and colloidal gold; the AIDS type 1+2 gold-labeled antigen is one of HIVⅠgp41+120 or HIVⅡgp36;

[0009] The chicken IgY colloidal gold complex is a complex of chicken IgY antibody and colloidal gold;

[0010] The NC film is provided with a detection line (T line) and a control line (C line).

[0011] Furthermore, the AIDS type 1+2 gold-labeled antigen-colloidal gold complex is prepared by the following steps:

[0012] Add 0.1M K2CO3 solution to the colloidal gold solution at a ratio of 30-50 μL / mL, mix well, add AIDS type 1+2 labeled antigen at a ratio of 12-18 μg / mL, react at 18-25°C for 30-60 minutes, add blocking solution with a final concentration of 0.5%-2%, react at 4-25°C for 30-60 minutes, centrifuge at 4-25°C and 10000 rpm for 15-45 minutes, retain the precipitate, add blocking solution to resuspend to obtain AIDS type 1+2 gold labeled antigen-colloidal gold complex.

[0013] Furthermore, the chicken IgY colloidal gold complex is prepared by the following steps:

[0014] Add 0.2M K2CO3 solution to the colloidal gold solution at a ratio of 10-20 μL / mL, mix well, add chicken IgY antibody at a ratio of 5-15 μg / mL, react at 18-25°C for 30-60 minutes, add blocking solution with a final concentration of 0.5%-2%, react at 18-25°C for 30-60 minutes, centrifuge at 4-25°C and 10000 rpm for 15-45 minutes, retain the precipitate, add blocking solution for resuspending, and obtain a chicken IgY colloidal gold complex.

[0015] Furthermore, the colloidal gold solution has a particle size of 530-534 nm and an OD value of 4.0-5.0A;

[0016] The blocking solution is 5% to 15% by mass of BSA (bovine serum albumin) or 5% to 15% by mass of C-Na (Casein-Na, i.e. sodium caseinate).

[0017] Furthermore, the gold label pad is prepared by the following steps:

[0018] Mix the AIDS type 1+2 gold-labeled antigen-colloidal gold complex and the chicken IgY colloidal gold complex evenly, add the glass cellulose membrane to soak, take it out and dry it at 37-45°C for 16-24 hours.

[0019] Furthermore, the mass ratio of the AIDS type 1+2 gold-labeled antigen-colloidal gold complex to the chicken IgY colloidal gold complex is 1:1.

[0020] Furthermore, the coating method of the test line is: diluting the AIDS type 1 and type 2 coating antigens to 0.8 mg / mL to 1.2 mg / mL with coating buffer respectively, and then coating, and drying at 37° C. for 24 to 36 hours.

[0021] Furthermore, the coating method of the control line is: diluting the goat anti-chicken IgY antibody to 0.6 mg / mL to 1.0 mg / mL with a coating buffer, and then coating, and then drying at 45° C. to 55° C. for 24 to 36 hours.

[0022] Furthermore, the AIDS antibody detection kit also includes a sample pad, a water-absorbing pad and a PVC bottom plate; the AIDS antibody detection kit is assembled through the following steps:

[0023] After the humidity of the environment is below 40%, take out the required materials and assemble them as required, tear off the sticker at the absorbent pad, align the absorbent pad with the PVC base plate and attach it, tear off the stickers at the sample pad and gold label pad, align the sample pad and the gold label pad with the PVC base plate in sequence and attach them; first stick the gold label pad so that the upper end covers the nitrocellulose membrane by 1-2mm, then stick the lower end of the sample pad so that it is aligned with the rubber plate and the upper end covers the gold label pad by 1-2mm, and the upper end of the absorbent pad covers the nitrocellulose membrane by 1-2mm.

[0024] Furthermore, the sample pad is prepared by the following steps: pouring the sample pad treatment solution into a container, slowly placing the glass fiber into the solution, and continuously tapping to drive out bubbles, rotating and draining until no obvious water drops, placing it on a drying rack, keeping it flat, and drying it at 37-45°C until dry.

[0025] Beneficial effects of the present invention:

[0026] The AIDS antibody detection kit prepared by the present invention has the following advantages:

[0027] 1. Rapid results: Test results can be obtained in about 15-20 minutes and can be read in 10 minutes, which helps to quickly understand the infection status.

[0028] 2. High accuracy: Clinical trials have shown that the detection method has a 100% positive and negative consistency rate, making it suitable for auxiliary testing in hospitals and physical examination institutions.

[0029] 3. Comprehensive sample coverage: Applicable to the testing of whole blood, plasma or serum specimens. The samples have good equivalence after clinical verification, and the test results of different blood samples are consistent, which is suitable for testing in different situations. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The present invention will be further described below in conjunction with the accompanying drawings.

[0031] Figure 1 is a result graph corresponding to the whole blood sample to be tested prepared in an embodiment of the present invention;

[0032] Figure 2 is a result graph corresponding to the plasma sample to be tested prepared in an embodiment of the present invention;

[0033] Figure 3 is a result graph corresponding to the test sample serum prepared in an embodiment of the present invention;

[0034] Figure 4 This is a result graph corresponding to the test sample prepared in the embodiment of the present invention after testing for 15 minutes;

[0035] Figure 5 This is the result graph corresponding to the commercially available sample to be tested in Example 1 after 15 minutes of testing;

[0036] Figure 6 This is the result graph corresponding to the commercially available sample to be tested in Comparative Example 1 after 15 minutes of testing. DETAILED DESCRIPTION

[0037] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0038] Example 1

[0039] Preparation of gold label pad:

[0040] Add 0.1M K2CO3 solution to the colloidal gold solution at a ratio of 30μL / mL, mix well, add AIDS type 1+2 labeled antigen at a ratio of 12μg / mL, react for 30 minutes at a temperature range of 18-25°C, add blocking solution with a final concentration of 0.5%, react for 30 minutes at a temperature range of 4-25°C, centrifuge for 15 minutes at a temperature range of 4-25°C and 10000rpm, retain the precipitate, add blocking solution and resuspend to obtain AIDS type 1+2 gold labeled antigen-colloidal gold complex. The particle size of the colloidal gold solution is 530-534nm, and the OD value is 4.0-5.0A; the blocking solution is 15% BSA by mass. The AIDS type 1+2 gold labeled antigen is HIVⅠgp41+120;

[0041] Add 0.2M K2CO3 solution to the colloidal gold solution at a ratio of 10μL / mL, mix well, add chicken IgY antibody at a ratio of 5g / mL, react for 30min at 18℃, add blocking solution with a final concentration of 0.5%, react for 30min at a temperature range of 18-25℃, centrifuge for 15min at a temperature range of 4-25℃ and 10000rpm, retain the precipitate, add blocking solution to resuspend, and obtain chicken IgY colloidal gold complex. The colloidal gold solution has a particle size of 530-534nm and an OD value of 4.0-5.0A; the blocking solution is 15% BSA by mass.

[0042] Mix the AIDS type 1+2 gold-labeled antigen-colloidal gold complex and the chicken IgY colloidal gold complex in a mass ratio of 1:1, add glass fiber KB50 to soak, take out and dry at 37°C for 16 hours.

[0043] Example 2

[0044] Preparation of gold label pad:

[0045] Add 0.1M K2CO3 solution to the colloidal gold solution at a ratio of 40μL / mL, mix well, add AIDS type 1+2 labeled antigen at a ratio of 15μg / mL, react for 50 minutes at a temperature range of 18-25°C, add blocking solution with a final concentration of 1%, react for 40 minutes at 20°C, the temperature range is 4-25°C, 10000rpm, centrifuge for 30 minutes, retain the precipitate, add blocking solution and resuspend to obtain AIDS type 1+2 gold labeled antigen-colloidal gold complex. The particle size of the colloidal gold solution is 530-534nm, and the OD value is 4.0-5.0A; the blocking solution is 15% BSA by mass. The AIDS type 1+2 gold labeled antigen is HIVⅠgp41+120;

[0046] Add 0.2M K2CO3 solution to the colloidal gold solution at a ratio of 15μL / mL, mix well, add chicken IgY antibody at a ratio of 10μg / mL, react for 50min at a temperature range of 18-25℃, add blocking solution with a final concentration of 1%, react for 50min at a temperature range of 18-25℃, centrifuge for 30min at a temperature range of 4-25℃ and 10000rpm, retain the precipitate, add blocking solution to resuspend, and obtain chicken IgY colloidal gold complex. The colloidal gold solution has a particle size of 530-534nm and an OD value of 4.0-5.0A; the blocking solution is 15% BSA by mass.

[0047] Mix the AIDS type 1+2 gold-labeled antigen-colloidal gold complex and the chicken IgY colloidal gold complex in a mass ratio of 1:1, add glass fiber KB50 to soak, take out and dry at 40°C for 20 hours.

[0048] Example 3

[0049] Preparation of gold label pad:

[0050] Add 0.1M K2CO3 solution to the colloidal gold solution at a ratio of 50μL / mL, mix well, add AIDS type 1+2 labeled antigen at a ratio of 18μg / mL, react for 30-60min at a temperature range of 18-25℃, add blocking solution with a final concentration of 2%, react for 60min at a temperature range of 4-25℃, centrifuge for 45min at a temperature range of 4-25℃ and 10000rpm, retain the precipitate, add blocking solution and resuspend to obtain AIDS type 1+2 gold labeled antigen-colloidal gold complex. The particle size of the colloidal gold solution is 530-534nm, and the OD value is 4.0-5.0A; the blocking solution is 15% BSA by mass. The AIDS type 1+2 gold labeled antigen is HIVⅠgp41+120;

[0051] Add 0.2M K2CO3 solution to the colloidal gold solution at a ratio of 20μL / mL, mix well, add chicken IgY antibody at a ratio of 5-15μg / mL, react for 60 minutes at a temperature range of 18-25°C, add a blocking solution with a final concentration of 2%, react for 60 minutes at a temperature range of 18-25°C, centrifuge for 45 minutes at a temperature range of 4-25°C and 10000rpm, retain the precipitate, add the blocking solution and resuspend, and obtain the chicken IgY colloidal gold complex. The colloidal gold solution has a particle size of 530-534nm and an OD value of 4.0-5.0A; the blocking solution is 15% BSA by mass.

[0052] Mix the AIDS type 1+2 gold-labeled antigen-colloidal gold complex and the chicken IgY colloidal gold complex in a mass ratio of 1:1, add glass fiber KB50 to soak, take out and dry at 37°C for 24 hours.

[0053] Example 4

[0054] An AIDS antibody detection kit comprises the gold label pad prepared in Example 1, an NC membrane, a sample pad, a water-absorbing pad and a PVC bottom plate; the NC membrane is provided with a detection line (T line) and a control line (C line):

[0055] The coating method of the test line is as follows: HIV type 1 and type 2 coating antigens are diluted to 0.8 mg / mL with coating buffer, respectively, and then coated and dried at 37°C for 24 hours.

[0056] The coating method of the control line is as follows: dilute the goat anti-chicken IgY antibody to 0.6 mg / mL with coating buffer and then coat it, and then dry it at 45°C to 55°C for 24 hours.

[0057] The sample pad is prepared by the following steps: pour the sample pad treatment solution into a container, slowly put the glass fiber 8965 into the solution, and keep tapping to drive out the bubbles, rotate and drain until there is no obvious water droplet, place it on a drying rack, keep it flat, and dry it at 37°C until it is completely dry.

[0058] Assembly:

[0059] After the humidity of the environment is below 40%, take out the required materials and assemble them as required, tear off the sticker at the absorbent pad, align the absorbent pad with the PVC base plate and attach it, tear off the stickers at the sample pad and gold label pad, align the sample pad and the gold label pad with the PVC base plate in sequence and attach them; first stick the gold label pad so that the upper end covers the nitrocellulose membrane by 1-2mm, then stick the lower end of the sample pad so that it is aligned with the rubber plate and the upper end covers the gold label pad by 1-2mm, and the upper end of the absorbent pad covers the nitrocellulose membrane by 1-2mm.

[0060] Example 5

[0061] An AIDS antibody detection kit comprises the gold label pad prepared in Example 2, an NC membrane, a sample pad, a water-absorbing pad and a PVC bottom plate; the NC membrane is provided with a detection line (T line) and a control line (C line):

[0062] The coating method of the test line is as follows: AIDS type 1 and type 2 coating antigens are diluted to 1 mg / mL with coating buffer, respectively, and then dried at 37°C for 30 hours.

[0063] The coating method of the control line is as follows: dilute the goat anti-chicken IgY antibody to 0.8 mg / mL with coating buffer and then coat it, and then dry it at 45°C to 55°C for 24 to 36 hours.

[0064] The sample pad is prepared by the following steps: pour the sample pad treatment solution into a container, slowly put the glass fiber 8965 into the solution, and keep tapping to drive out the bubbles, rotate and drain until there is no obvious water droplet, place it on a drying rack, keep it flat, and dry it at 40°C until it is completely dry.

[0065] Assembly:

[0066] After the humidity of the environment is below 40%, take out the required materials and assemble them as required, tear off the sticker at the absorbent pad, align the absorbent pad with the PVC base plate and attach it, tear off the stickers at the sample pad and gold label pad, align the sample pad and the gold label pad with the PVC base plate in sequence and attach them; first stick the gold label pad so that the upper end covers the nitrocellulose membrane by 1-2mm, then stick the lower end of the sample pad so that it is aligned with the rubber plate and the upper end covers the gold label pad by 1-2mm, and the upper end of the absorbent pad covers the nitrocellulose membrane by 1-2mm.

[0067] Example 6

[0068] An AIDS antibody detection kit comprises the gold label pad prepared in Example 3, an NC membrane, a sample pad, a water-absorbing pad and a PVC bottom plate; the NC membrane is provided with a detection line (T line) and a control line (C line):

[0069] The coating method of the test line is as follows: HIV type 1 and type 2 coating antigens are diluted to 1.2 mg / mL with coating buffer, respectively, and then dried at 37°C for 36 hours.

[0070] The coating method of the control line is as follows: dilute the goat anti-chicken IgY antibody to 1.0 mg / mL with coating buffer and then coat it, and then dry it at 45°C to 55°C for 36 hours.

[0071] The sample pad is prepared by the following steps: pour the sample pad treatment solution into a container, slowly put the glass fiber 8965 into the solution, and keep tapping to drive out the bubbles, rotate and drain until there is no obvious water droplet, place it on a drying rack, keep it flat, and dry it at 45°C until it is completely dry.

[0072] Assembly:

[0073] After the humidity of the environment is below 40%, take out the required materials and assemble them as required, tear off the sticker at the absorbent pad, align the absorbent pad with the PVC base plate and attach it, tear off the stickers at the sample pad and gold label pad, align the sample pad and the gold label pad with the PVC base plate in sequence and attach them; first stick the gold label pad so that the upper end covers the nitrocellulose membrane by 1-2mm, then stick the lower end of the sample pad so that it is aligned with the rubber plate and the upper end covers the gold label pad by 1-2mm, and the upper end of the absorbent pad covers the nitrocellulose membrane by 1-2mm.

[0074] Example 7

[0075] Compared with Example 4, the gold label pad in this example is replaced with the gold label pad prepared according to the method in Example 2. The remaining raw materials and preparation process are the same as those in Example 4.

[0076] Example 8

[0077] Compared with Example 4, the gold label pad in this example is replaced with the gold label pad prepared according to the method in Example 3. The remaining raw materials and preparation process are the same as those in Example 4.

[0078] The samples prepared according to the method in the examples were tested:

[0079] Interpretation of results

[0080] Positive: Two colored lines are observed in the display window.

[0081] Negative: The control line (C) appears in the test window, but the test line (T) is not visible.

[0082] Invalid: The control line (C) cannot be displayed. Whether the test line (T) has a red line or not, the test equipment is invalid.

[0083] Quality Control; The red line appearing in the control area (C) is the internal process control. Sufficient sample size was confirmed.

[0084] For the detection of whole blood, plasma or serum samples, clinical trials were completed by clinical trial institutions, and the samples were all from the laboratory department of Zhengzhou Sixth People's Hospital.

[0085] (1) Whole blood samples remaining from routine clinical testing or reserved by the department;

[0086] (2) The population included in the sample should meet one of the following conditions: 1) People suspected of HIV infection, including those with HIV-related symptoms / signs and those with relevant epidemiological history; 2) Related populations that may produce cross-reactions;

[0087] (3) The samples must comply with the collection, processing and storage requirements of the instructions;

[0088] (4) The relevant information of the sample is complete, including sample traceability number, patient traceability number, sample type, age, gender, clinical diagnosis or ward / department, etc.;

[0089] (5) The sample volume is not less than approximately 30 μL;

[0090] The test results of different blood samples in the embodiment are as follows: Figure 1 , Figure 2 , Figure 3 As shown, Figure 1 The results corresponding to the whole blood samples to be tested prepared in the embodiment; Figure 2 The results corresponding to the plasma samples to be tested prepared in the examples; Figure 3 The results corresponding to the serum samples to be tested prepared in the examples;

[0091] The results of the serum test after 15 minutes of sample addition were recorded. The T line of the reagent prepared in the embodiment of the present invention was uniform and full, and the background was clean. Figure 4 shown.

[0092] Comparative Example 1

[0093] Comparison with commercially available HIV test kits. Tested with serum, results are available at Figure 5-Figure 6 As shown:

[0094] There are cases where T-line chromatography is incomplete and has breakpoints.

[0095] According to the test results, the AIDS antibody detection kit prepared by the present invention has the following advantages:

[0096] 1. Rapid results: Test results can be obtained in about 15-20 minutes and can be read in 10 minutes, which helps to quickly understand the infection status.

[0097] 2. High accuracy: Clinical trials have shown that the detection method has a 100% positive and negative consistency rate, making it suitable for auxiliary testing in hospitals and physical examination institutions.

[0098] 3. Comprehensive sample coverage: Applicable to the testing of whole blood, plasma or serum specimens. The samples have good equivalence after clinical verification, and the test results of different blood samples are consistent, which is suitable for testing in different situations.

[0099] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device.

[0100] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. An AIDS antibody detection kit, characterized in that: Includes gold label pad and NC film; The gold-labeled pad is a glass cellulose membrane soaked in a mixture of AIDS type 1+2 gold-labeled antigen-colloidal gold complex and chicken IgY colloidal gold complex; The AIDS type 1+2 gold-labeled antigen-colloidal gold complex is a complex of AIDS type 1+2 gold-labeled antigen and colloidal gold; the AIDS type 1+2 gold-labeled antigen is one of HIVⅠgp41+120 or HIVⅡgp36; The chicken IgY colloidal gold complex is a complex of chicken IgY antibody and colloidal gold; The NC film is provided with a detection line and a control line.

2. An AIDS antibody detection kit according to claim 1, characterized in that: The AIDS type 1+2 gold-labeled antigen-colloidal gold complex is prepared by the following steps: Add 0.1M K2CO3 solution to the colloidal gold solution at a ratio of 30-50 μL / mL, mix well, add AIDS type 1+2 labeled antigen at a ratio of 12-18 μg / mL, react at 18-25°C for 30-60 minutes, add blocking solution with a final concentration of 0.5%-2%, react at 4-25°C for 30-60 minutes, centrifuge at 4-25°C and 10000 rpm for 15-45 minutes, retain the precipitate, add blocking solution to resuspend to obtain AIDS type 1+2 gold labeled antigen-colloidal gold complex.

3. An AIDS antibody detection kit according to claim 1, characterized in that: The chicken IgY colloidal gold complex is prepared by the following steps: Add 0.2M K2CO3 solution to the colloidal gold solution at a ratio of 10-20 μL / mL, mix well, add chicken IgY antibody at a ratio of 5-15 μg / mL, react at 18-25°C for 30-60 minutes, add blocking solution with a final concentration of 0.5%-2%, react at 18-25°C for 30-60 minutes, centrifuge at 4-25°C and 10000 rpm for 15-45 minutes, retain the precipitate, add blocking solution for resuspending, and obtain a chicken IgY colloidal gold complex.

4. An AIDS antibody detection kit according to claim 2 or 3, characterized in that: The colloidal gold solution has a particle size of 530-534 nm and an OD value of 4.0-5.0A; The blocking solution is 5% to 15% BSA or 5% to 15% C-Na.

5. The AIDS antibody detection kit according to claim 1, characterized in that: The gold label pad is prepared by the following steps: Mix the AIDS type 1+2 gold-labeled antigen-colloidal gold complex and the chicken IgY colloidal gold complex evenly, add the glass cellulose membrane to soak, take it out and dry it at 37-45°C for 16-24 hours.

6. An AIDS antibody detection kit according to claim 5, characterized in that: The mass ratio of the AIDS type 1+2 gold-labeled antigen-colloidal gold complex to the chicken IgY colloidal gold complex is 1:

1.

7. The AIDS antibody detection kit according to claim 1, characterized in that: The coating method of the test line is: dilute the AIDS type 1 and type 2 coating antigens to 0.8 mg / mL to 1.2 mg / mL with coating buffer respectively, and then coat them and dry them at 37° C. for 24 to 36 hours.

8. The AIDS antibody detection kit according to claim 1, characterized in that: The coating method of the control line is: diluting the goat anti-chicken IgY antibody to 0.6 mg / mL-1.0 mg / mL with a coating buffer, then coating, and then drying at 45° C.-55° C. for 24-36 hours.

9. The AIDS antibody detection kit according to claim 1, characterized in that: The AIDS antibody detection kit also includes a sample pad, a water-absorbing pad and a PVC bottom plate.

10. An AIDS antibody detection kit according to claim 9, characterized in that: The sample pad is prepared by the following steps: pouring the sample pad treatment solution into a container, slowly placing the glass fiber into the solution, and continuously tapping to drive out bubbles, rotating and draining until no water drops, placing it on a drying rack, keeping it flat, and drying it at 37-45°C until it is dry.

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