CN114184787A - Kit for rapidly detecting human immunodeficiency virus and application thereof - Google Patents

Abstract

The invention relates to a kit for rapidly detecting human immunodeficiency virus and application thereof. The invention discloses an antibody of an anti-HIVp 24 antigen, application thereof in preparing a test strip for rapidly detecting HIV virus, and a preparation method of the test strip for rapidly detecting HIV virus. The detection test paper has the characteristics of high fluorescence brightness, high stability and high sensitivity, can further improve the detection accuracy, is beneficial to detection of early HIV infection, prognosis of HIV infection or monitoring of treatment, and is suitable for large-scale popularization and application.

Description

Kit for rapidly detecting human immunodeficiency virus and application thereof

Technical Field

The invention relates to the field of virus diagnosis, and more particularly relates to a kit for rapidly detecting human immunodeficiency virus and application thereof.

Background

Human Acquired Immunodeficiency Syndrome (Acquired Immunodeficiency Syndrome), abbreviated as Acquired Immunodeficiency Syndrome (AIDS), is a serious infectious disease caused by infection with Human Immunodeficiency Virus (HIV). The HIV virus genus is the genus lentivirus of the family Retroviridae, which is classified into type 1, type 2 and type O. HIV belongs to the genus lentivirus of the family Retroviridae and is divided into two subtypes, type 1 and type 2. Among them, HIV-2 is prevalent mainly in Western Europe, North America and the western Africa, and the virus strain is less toxic. HIV-1 is widely existed all over the world, is the main virus strain of AIDS epidemic in the world, has strong toxicity and seriously threatens human health.

The core of HIV contains two RNA strands, the core proteins p24, p17 and enzymes involved in viral replication, the outer side is the outer membrane structure of the virus, into which two proteins gp120 and gp41 are embedded. The P24 protein is an expression product of HIV-1 structural gene gag, the gag gene firstly generates 55kDa gag protein during translation, then is decomposed into three proteins of P17, P24 and P15 under the action of protease, the P17 forms an inner membrane of virus particles, the P24 forms a firm conical outer shell to surround a core of the virus, and the P15 is continuously decomposed into nucleocapsid proteins P9 and P7 which can be combined with RNA. Due to the conservation of the gag gene sequence, the amino acid sequence of p24 protein, one of its products, is also highly conserved among HIV-1 strains.

Because of a window of detection of HIV antibodies (2 months on average), missed detection is often made in early stage infected persons who have not yet developed antibodies. In the early stages of HIV-1 infection, the p24 protein is produced by replication of the virus in humans. By detecting the p24 protein in blood, the aim of early diagnosis can be achieved, so that the transmission of HIV can be more effectively controlled. The detection of the P24 antigen can also be used to monitor disease progression and to evaluate the therapeutic efficacy of antiretroviral drugs. In addition, the infant born by the HIV-1 positive pregnant woman may have positive antibody because IgG antibody in the blood of the Muqing can be transferred into the infant through placenta, which may interfere with the judgment of whether the infant has the virus infection condition.

At present, the main detection methods for detecting HIV include enzyme-linked immunosorbent assay, chemiluminescence assay, immune complex lysis assay and the like. However, the existing detection methods have the problems of poor sensitivity, high false positive or false negative, and the like, thereby affecting the detection rate, being not beneficial to the early diagnosis and treatment of patients, the monitoring of prognosis or treatment of HIV infection, and the transmission and control of AIDS, and therefore, the development of HIV detection kits with better performance is required.

Disclosure of Invention

In order to better avoid the defects and provide an early and accurate detection result for a patient, the quantum dot labeled fluorescence immunochromatographic test strip is provided, is simple to prepare and convenient to use, can quickly and accurately obtain the detection result, and is beneficial to early treatment of HIV patients and control of HIV transmission.

The invention provides the following technical scheme:

in one aspect, the invention provides a monoclonal antibody m3G7 that specifically binds HIV p24 antigen, comprising a heavy chain variable region (V)_H) Said V is_HComprises the following steps: comprises the amino acid sequence SEQ ID NO:1Heavy chain complementarity determining region (HC-CDR)1 of (a), a light chain comprising the amino acid sequence of SEQ ID NO:2 and HC-CDR2 comprising the amino acid sequence SEQ ID NO: HC-CDR3 of 3; and light chain variable region (V)_L) Said V is_LComprises the following steps: comprises the amino acid sequence SEQ ID NO:4, a light chain complementarity determining region (LC-CDR)1 comprising the amino acid sequence of SEQ ID NO:5 and an LC-CDR comprising the amino acid sequence SEQ ID NO: 6.

In another aspect, the present invention provides a monoclonal antibody m3G7 that specifically binds to HIV p24 antigen, comprising a heavy chain variable region (V)_H) Said V is_HComprises the amino acid sequence shown as SEQ ID NO: 7, and a light chain variable region (V)_L) Said V is_LComprises the amino acid sequence shown as SEQ ID NO: 8.

In some embodiments, the anti-HIV p24 antibodies of the invention comprise or consist of two heavy chains and two light chains, wherein each heavy chain comprises a heavy chain constant region sequence, a heavy chain variable region sequence, or a CDR sequence as described above, and each light chain comprises a light chain constant region sequence, a light chain variable region sequence, or a CDR sequence as described above. The antibody of the invention may be a full length antibody comprising a constant region, the full length antibody light chain constant region further comprising murine kappa, lambda chain sequences. The full-length antibody heavy chain constant region further comprises murine IgG1, IgG2a, IgG2b, IgG3, IgA or IgM sequences.

In some embodiments, the anti-HIV p24 antibody of the invention is a Fab fragment, Fab 'fragment, F (ab')2 fragment, Fv fragment, diabody, linear antibody, single chain antibody molecule, or multispecific antibody formed from the anti-HIV p24 antibody or antibody fragment described above.

In some embodiments, the present invention provides an isolated nucleic acid molecule encoding an anti-HIV p24 antibody as described above. In some embodiments, a vector is contemplated, the vector comprising a nucleic acid molecule as described above. In some embodiments, a host cell comprising an anti-HIV p24 antibody as described above, a nucleic acid molecule as described above, or a vector as described above is contemplated.

In some implementationsIn a mode, the invention provides a human immunodeficiency virus quantum dot fluorescence immunochromatographic test strip which is composed of a sample pad, a glass fiber membrane, an NC membrane and water absorption paper. In some embodiments, the anti-HIV p24 monoclonal antibody labeled with quantum dots is immobilized in the upper test strip. In some embodiments, the test quantum dot labeled anti-HIV p24 monoclonal antibody comprises a heavy chain variable region (V)_H) Said V is_HComprises the following steps: comprises the amino acid sequence SEQ ID NO:1, a heavy chain complementarity determining region (HC-CDR)1 comprising the amino acid sequence SEQ ID NO:2 and HC-CDR2 comprising the amino acid sequence SEQ ID NO: HC-CDR3 of 3; and light chain variable region (V)_L) Said V is_LComprises the following steps: comprises the amino acid sequence SEQ ID NO:4, a light chain complementarity determining region (LC-CDR)1 comprising the amino acid sequence of SEQ ID NO:5 and an LC-CDR comprising the amino acid sequence SEQ ID NO: 6. In some embodiments, the test quantum dot labeled anti-HIV p24 monoclonal antibody comprises a heavy chain variable region (V)_H) Said V is_HComprises the amino acid sequence shown as SEQ ID NO: 7, and a light chain variable region (V)_L) Said V is_LComprises the amino acid sequence shown as SEQ ID NO: 8. In some embodiments, the kits described above are used for detection of early infection by HIV, prognosis of HIV infection, or monitoring of treatment. In some embodiments, the anti-HIV p24 antibody labeled with a quantum dot in the test strip described above specifically binds to p24 protein in a biological sample from a patient. In some embodiments, the biological sample of the invention is blood, serum, saliva, urine, sputum, a cell swab sample, or a tissue biopsy.

Advantageous effects

The invention screens HIV p24 antigen and obtains monoclonal antibody with better effect, and fixes quantum dot marked anti-HIV p24 monoclonal antibody and capture antibody on glass fiber film and nitrocellulose film, respectively, to prepare and obtain the human immunodeficiency virus quantum dot fluorescence immunochromatography test paper, which has the characteristics of high fluorescence brightness, high stability and high sensitivity, can further improve the accuracy of detection, is beneficial to the detection of HIV early infection, the prognosis of HIV infection or the monitoring of treatment, and is suitable for large-scale popularization and use.

Drawings

The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention and not to limit the invention.

FIG. 1 binding curves of anti-HIV p24 antibody m3G7 and p24 protein

Detailed Description

The preferred embodiments of the present invention will be described in conjunction with the accompanying drawings, and it will be understood that they are described herein for the purpose of illustration and explanation and not limitation.

Example 1 anti-HIV p24 antibody preparation

Preparation of P24 antigen

The full-length p24 gene (synthesized by Nanjing Kingsrei Biotechnology Co., Ltd.) was amplified by PCR, and the target gene and pUC57 vector were double digested and ligated, and then transferred into E.coli DH 5. alpha. to obtain the correct recombinant plasmid pUC57-p 24. pUC57-p24 and pET28a vector were digested and ligated with Nde I and Xho I, and then transferred to E.coli DH 5. alpha. positive bacteria were selected and sequenced correctly, and after amplification, a plasmid was extracted and named pET28a-p 24.

pET28a-p24 was transformed into the expression host E.coli BL21(DE3) and inoculated into LB medium for scale-up culture. IPTG (final concentration: 1mM) was added to the culture solution, and the mixture was cultured overnight at 18 ℃ and 225rpm, to induce the expression of the target protein. And (3) centrifuging 5000g to collect the thallus, washing, adding Lysis Buffer to resuspend the thallus, and crushing the thallus by ultrasonic waves under the ice bath condition. After centrifugation at 12000rpm for 30min, the supernatant was collected and filtered through a 0.22. mu.M low protein binding filter. Performing affinity chromatography by using a nickel (Ni) column, and collecting eluent after a sample passes through the column and is eluted. Adding the eluent containing the target protein into the treated dialysis bag, putting into a beaker containing the dialysate, stirring at low speed at 4 ℃ for dialysis for 12h, changing the liquid, continuing dialysis for 12h, and collecting the dialyzed protein liquid. The concentration of p24 protein was measured using a microspectrophotometer at a concentration of 850. mu.g/mL.

After mixing and emulsifying purified p24 protein (100 mu g/mouse) and Freund's complete adjuvant with the same volume for the first immunization, 0.5 mL/mouse is immunized on the back and in a plurality of ditches for subcutaneous immunization of 6-8 weeks old BALB/c mice. After 1 month, the same dose of p24 protein was mixed with Freund's incomplete adjuvant and then immunized subcutaneously at multiple points on the back, 0.5 mL/mouse. Booster immunizations were performed with the same dose of p24 protein i.p. every 3 weeks later. The spleen was harvested on the fourth day after the last immunization and cell fusion was performed. Taking immunized Balb/c mouse spleen cells, fusing the immunized Balb/c mouse spleen cells with a myeloma Sp2/0 cell line by using a PEG method, re-suspending the fused cells by using a 20% FBS-HAT-DMEM culture medium, then uniformly paving the cells in a 96-well plate at 37 ℃ and 5% CO₂And (5) culturing. And (3) after the fused cells are cultured for about one week, carrying out half-amount liquid change by using a 10% FBS-HT-DMEM culture medium, when the area of the cell colony covering the bottom of the hole reaches 1/3-1/2, taking culture supernatant, and carrying out detection on positive clones by using an indirect ELISA method. Wells with higher OD450nm values and fewer colonies were selected and cloned by limiting dilution. Screening by ELISA method, finally obtaining positive hybridoma cell strain and naming it as m3G 7. After expansion culture, the hybridoma cells were cryopreserved.

EXAMPLE 2 purification of monoclonal antibodies

BALB/c mice were injected intraperitoneally with 0.5 mL/mouse, 1 week before hybridoma inoculation. After 1 week, each mouse was inoculated intraperitoneally at about 1X10⁶(ii) individual hybridoma cells; after 7-10 days, ascites is collected. Centrifuging ascites at 10000 Xg for 30min, removing precipitate, salting out with 50% ammonium sulfate, coarse extracting, dissolving with PBS, and dialyzing with flowing water for 5 hr; dialyzing and equilibrating with 0.1mol/L phosphate buffer (pH8.0) overnight; and (3) loading, eluting the hybrid protein by using 0.1mol/L phosphate buffer solution (pH8.0), eluting by using citrate eluents with different pH values, collecting elution peaks in a segmented mode, and concentrating to obtain the purified anti-HIV p24 antibody m3G 7.

Example 3 detection of monoclonal antibodies by ELISA method

The purified p24 protein was diluted with coating solution and 2. mu. g p24 protein was added per well overnight at 4 ℃. mu.L of blocking solution was added to each well and blocked at 37 ℃ for 1 hour. After washing 3 times with PBST solution, addThe anti-HIV p24 antibody m3G7 was added in a gradient dilution, 50. mu.L/well and incubated for 1h at 37 ℃. After washing the PBST solution 6 times, goat anti-mouse IgG-HRP antibody (Abcam, ab6808) was added at 50. mu.L/well and incubated at 37 ℃ for 1 h. After washing 6 times with PBST solution, 50. mu.L of TMB was added to each well and incubated at 37 ℃ for 5-10 min. 2M H was added₂SO₄The reaction was terminated. The absorbance values at 450nm were read using a microplate reader and binding curves were generated by GraphPad PRISM (FIG. 1).

Example 4 monoclonal antibody sequencing

Taking out the m3G7 hybridoma cell freezing tube from liquid nitrogen, quickly melting at 37 ℃, centrifuging at 1000rpm for 5min to remove freezing solution, placing in a 100mm pore plate, culturing until the culture plate occupies about 80%, adding 1ml Trizol reagent (Thermo company), and extracting hybridoma cell total RNA according to the instruction. Mu.g of the above total RNA was taken, DECP water was added thereto to make the volume 11. mu.l, 1.0. mu.l of oligo (dT) (10. mu.M) was added thereto, 1. mu.l of dNTPs (10mM) was added thereto, the mixture was mixed well, incubated at 65 ℃ for 5 minutes and then placed on ice for 1 minute, followed by addition of 4. mu.l of RT buffer (5X), 1.0. mu.l of DTT (100mM), 1. mu.l of Ribonucleae Inhibitor and 1. mu.l of reverse transcriptase (takara Co., Ltd.), and reacted at 50 ℃ for 10 minutes. The reaction was terminated by incubation at 80 ℃ for 10 minutes, and the obtained cDNA was stored at-20 ℃. Designing specific nested PCR primer, the primer sequence used in the amplification reaction is complementary with the first frame region and the constant region of the antibody variable region, and amplifying the target gene by adopting a conventional PCR method. The primer sequences were designed according to the literature (Bodo Brocks. Specifes-Cross active scFv Against the turbine Stroma Marker "fibrous Activation Protein" Selected by phase Display From an amplified FAP)^-/-Knock-Out Mouse).

Sequencing results show that the amino acid sequences of the heavy chain and light chain variable regions of the anti-HIV p24 antibody m3G7 are respectively shown as SEQ ID NO: 7 and SEQ ID NO: 8 is shown in the specification; the amino acid sequences of 3 CDRs in the heavy chain variable region of the antibody are respectively shown as SEQ ID NO 1, SEQ ID NO 2 and SEQ ID NO 3; the amino acid sequences of 3 CDRs in the light chain variable region are shown in SEQ ID NO. 4, SEQ ID NO. 5 and SEQ ID NO. 6, respectively.

Example 5 preparation of polyclonal anti-HIV p24 antibody

After mixing and emulsifying the HIV p24 antigen solution and an equal volume of Freund's complete adjuvant according to the dose of 0.5mg/kg, New Zealand white rabbits are immunized subcutaneously on both soles. After 2 weeks of separation, New Zealand white rabbits were immunized in the lymph nodes of the flank pits with the same dose of p24 protein mixed with Freund's incomplete adjuvant. Two weeks later, the same dose of p2 protein was mixed with Freund's incomplete adjuvant, and then the New Zealand white rabbits were immunized subcutaneously on the back. The ear margin venous blood was collected for the detection of antiserum titer. After the titer reaches the standard, collecting the blood of the rabbit by adopting a carotid bleeding mode. Standing rabbit blood at 4 deg.C for 2h, demixing the blood, centrifuging at 2500rpm for 20min, collecting rabbit serum, and purifying polyclonal antibody by n-octanoic acid-saturated sulfuric acid precipitation method. 10mL of serum was placed in a beaker, 20mL of 0.06mol/L sodium acetate buffer (pH4.0) was added, HCl was added to adjust the pH to 4.8, and octanoic acid was added dropwise while stirring at room temperature for 30 min. After centrifugation at 5000g for 30min, the supernatant was removed. After adjusting the pH to 5.7 by adding NaOH, IgG, i.e., an anti-HIV p24 polyclonal antibody, was obtained after dialysis with PBS.

Example 6 preparation of quantum dot for human immunodeficiency virus Quantum dot fluorescence immunochromatography test strip

Adding 0.267g of cadmium acetate, 1mL of oleic acid and 4mL of diphenyl ether into a 150mL three-neck flask, heating to 170 ℃, stirring for dissolving, keeping at 170 ℃ for 30min, and cooling to room temperature to obtain a precursor A. 0.158g of metallic selenium powder was dissolved in 2mL of trioctylphosphine under ultrasonic conditions to give a precursor B. And mixing the precursor A and the precursor B to obtain a reaction stock solution C. Adding 10mL of diphenyl ether into a three-neck flask, heating to 140 ℃ under the protection of nitrogen, quickly dropwise adding the reaction stock solution C under the condition of vigorous stirring, and reacting for 5-60 min according to the particle size of the required particles. Under the condition of magnetic stirring, the temperature is rapidly reduced to terminate the reaction. Adding double anhydrous methanol into the obtained reaction liquid for precipitation, and centrifuging to obtain a solid product. Adding the CdSe quantum dots dispersed in the organic solvent into the aqueous solution of thioglycollic acid, and stirring at room temperature for 8 hours to ensure that the quantum dots are fully phase-inverted into the aqueous solution.

Preparation and detection method of quantum dot labeled anti-HIV p24 monoclonal antibody

mu.L of the prepared quantum dots were diluted with 490. mu.L of boric acid buffer (pH5.0) and the pH was adjusted to 5.5 with buffer and a trace of HCl. Adding p-ethyl-N, N-dimethylpropylcarbodiimide (EDC, available from Beijing Solebao technologies, Ltd.) and N-hydroxysuccinimide (NHS, available from Beijing Solebao technologies, Ltd.), rapidly shaking for 15min, adding 150. mu.L of sodium borate buffer (25mmol/L, pH8.6), adjusting the pH to hi 8.5-9.0, adding anti-HIV p24 monoclonal antibody m3G7, shaking at 37 ℃ and 180rpm for 3h, and adding BSA with the final concentration of 1%. Shaking by hand at room temperature for 30min, centrifuging at 20000rpm for 30min, and collecting precipitate. The supernatant was centrifuged at 20000rpm for 30min to obtain a precipitate.

Preparation of immunochromatography test strip

The anti-HIV p24 polyclonal antibody (2.5mg/mL) and the goat anti-mouse IgG antibody (Abcam, ab6808) prepared in example 5 were applied as coating antibodies to nitrocellulose membranes (NC membranes, available from Shanghai Jiening Biotech., Ltd.) at a distance of 6mm, respectively, as a detection line (T line) and a quality control line (C line) for detecting HIV p24 antigen; the quantum dot-labeled anti-HIV p24 monoclonal antibody (40. mu.g/mL) prepared above was uniformly sprayed on a glass fiber membrane (purchased from Millipore), and then the NC membrane and the glass fiber membrane were placed in an electrothermal constant temperature forced air drying oven and dried at 37 ℃ for 12 hours; and finally, sequentially adhering the sample pad, the prepared glass fiber membrane, the prepared NC membrane and the absorbent paper (purchased from Shanghai Jiening biotechnology limited) to a PVC bottom plate (purchased from Shanghai Jiening biotechnology limited), cutting the sample pad, the prepared NC membrane and the absorbent paper into strip-shaped test strips with the thickness of 4mm after assembly, and sealing, drying and storing the test strips at room temperature for later use.

Application method of immunochromatographic test strip

The test strip is laid flat, a sample is added on the sample pad of the test strip, and the result is observed after 10min under a blue light lamp. When the sample contains HIV p24 antigen, the p24 antigen is immediately combined with scalar quantum dot labeled anti-HIV p24 monoclonal antibody, moves to a detection line through chromatography, and is combined with anti-HIV p24 polyclonal antibody coated on the detection line (T line) to form a double-antibody sandwich immune complex, so that the T line area shows fluorescence; when the sample does not contain HIV p24 antigen, the quantum dot marked anti-HIV p24 monoclonal antibody cannot be captured by the antibody on the T line, a sandwich immune complex cannot be formed, and the T line region does not have fluorescence; no matter whether the sample solution contains HIV p24 antigen or not, the anti-HIV p24 monoclonal antibody marked by quantum dots which are not captured by the T line continuously migrates to the C line area and is captured by goat anti-mouse IgG antibody on the C line to generate fluorescence, and if no fluorescence band is generated on the C line, the detection result is invalid. Example 7 evaluation sensitivity of HIV Quantum dot fluorescence immunochromatography test strip

The HIV-1 p24 antigen national reference (purchased from China pharmaceutical and biological products institute) is diluted to 20U/mL by defibrinated plasma (purchased from Wanfu biotechnology, Guangzhou Co., Ltd.), and is diluted 2 times by taking the national reference as an initial concentration, so that the final concentration of the standard is 20, 10, 5, 2.5, 1.25, 0.625, 0.3125 and 0.15625U/mL, the detection is carried out by a standard method of test strip detection, each concentration is repeated for 3 times, and the detection sensitivity of the test strip is judged according to the experimental result.

The results are shown in Table 1, and the detection line of the human immunodeficiency virus quantum dot fluorescent microsphere immunochromatographic test strip prepared in example 6 is 0.625U/mL

TABLE 1

Note: "+" represents positive, and "-" represents negative

Specificity of

The human immunodeficiency virus quantum dot fluorescence immunochromatography test strip prepared in example 6 was used to perform a cross-reaction test. HIV p24 antigen national reference, HBsAg (Abcam, ab193473), HCV-cAg (Abcam, ab43027), HIV-gp140(Abcam, ab217660), C-reactive protein (Abcam, ab285782) and procalcitonin (ab92843) are dissolved and diluted, and then detected by a standard method of test strip detection, each concentration is repeated for 3 times, and whether cross reaction exists is observed.

The results are shown in table 2, except for HIV p24 antigen, the human immunodeficiency virus quantum dot fluorescence immunochromatography test strip has no cross reaction with the tested sample, and has good specificity.

TABLE 2

Note: "+" represents positive, and "-" represents negative

Example 8 actual sample detection

30 cases of serum are collected from patients with AIDS confirmed by clinical symptoms and experimental examination. The serum of healthy patients (and HIV-negative patients) is taken for 100 cases, the human immunodeficiency virus quantum dot fluorescence immunochromatography test strip prepared in the embodiment 6 is adopted for detection, and the patient samples are provided by the second people hospital in Tianjin. The serum of the patient is taken and respectively detected by using quantum dot labeled anti-HIV p24 antibody immunofluorescence test strips, and the detection results are shown in Table 3. As can be seen from the results in Table 3, the quantum dot fluorescence immunochromatographic test strip for human immunodeficiency virus can well detect HIV virus.

TABLE 3

Sample (I)	Number of samples	+	-
				AIDS patient	30	30	0
Healthy controls	100	0	100

Note: "+" represents positive and "-" represents negative.

Sequence listing

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Claims (9)

1. An antibody that specifically binds to HIV p24 protein, comprising:

heavy chain variable region (V)_H) Said V is_HComprises the following steps: comprises the amino acid sequence SEQ ID NO:1, a heavy chain complementarity determining region (HC-CDR)1 comprising the amino acid sequence SEQ ID NO:2 and HC-CDR2 comprising the amino acid sequence SEQ ID NO: HC-CDR3 of 3; and

light chain variable region (V)_L) Said V is_LComprises the following steps: comprises the amino acid sequence SEQ ID NO:4, a light chain complementarity determining region (LC-CDR)1 comprising the amino acid sequence of SEQ ID NO:5 and an LC-CDR comprising the amino acid sequence SEQ ID NO: 6.

2. An antibody that specifically binds to HIV p24 protein, comprising:

heavy chain variable region (V)_H) Said V is_HComprises the amino acid sequence shown as SEQ ID NO: 7, and

light chain variable region (V)_L) Said V is_LComprises the amino acid sequence shown as SEQ ID NO: 8.

3. The anti-HIV p24 antibody according to claim 1 or 2, wherein the anti-HIV p24 antibody comprises an Fc fragment.

4. A nucleic acid molecule encoding the anti-HIV p24 antibody of any one of claims 1-3.

5. A vector comprising the nucleic acid molecule of claim 4.

6. A test strip for rapidly detecting HIV, wherein a binding pad of the test strip contains the anti-HIV p24 antibody of any one of claims 1-3.

7. The test strip of claim 6, wherein the anti-HIV p24 antibody is labeled with quantum dots.

8. The test strip of claim 6 or 7, further comprising a sample pad, a nitrocellulose membrane, and a bibulous paper.

9. The test strip of claim 8, wherein the nitrocellulose membrane comprises an anti-HIV p24 polyclonal antibody and an anti-goat anti-mouse IgG antibody.

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